Can i buy kamagra over the counter

After a can i buy kamagra over the counter period of falling erectile dysfunction treatment illness rates, the recent spread of the delta variant of erectile dysfunction was a major disappointment and necessitated a reexamination of some previous assumptions. This reconsideration may, at least in part, be a correction to overly optimistic views can i buy kamagra over the counter of what highly effective erectile dysfunction treatments could accomplish. Some observers had hoped the treatments could eliminate transmission of the kamagra, the ultimate goal of reaching herd immunity.1 A more likely picture of our future with this kamagra comes into focus if we examine the well-known patterns of can i buy kamagra over the counter another respiratory kamagra, influenza, both in and outside kamagras. That experience can help us reset expectations and modify goals for dealing with erectile dysfunction as it further adapts in global spread.Early results from the clinical trials and observational studies of mRNA treatments against erectile dysfunction indicated that not only were they highly effective at preventing symptomatic , but they were also effective in preventing asymptomatic and therefore transmission.2 The basic criterion used for emergency use authorization by the Food and Drug Administration was a can i buy kamagra over the counter standard one. Prevention of laboratory-confirmed clinical meeting a can i buy kamagra over the counter case definition.

The effect on asymptomatic s was a welcome surprise, because it has been thought that most treatments can i buy kamagra over the counter for respiratory illnesses, including influenza, are “leaky” — that is, they allow some degree of asymptomatic and are better at preventing symptomatic .The initial data on inapparent erectile dysfunction strengthened the hope that, at a certain level of vaccination, transmission would cease completely. To many of us, this hope appeared overly optimistic, and it seems even can i buy kamagra over the counter more so now. The highly transmissible delta variant causes asymptomatic s and sometimes illnesses (albeit usually mild) in vaccinated people, probably because of increased growth potential, as well as because can i buy kamagra over the counter of waning immunity, which also involves decreasing IgA antibody levels. Elimination of an illness by means of herd immunity works best when the agent has low transmissibility, and it requires the absence of pockets of susceptible can i buy kamagra over the counter people. Eliminating erectile dysfunction treatment seemed theoretically possible, because can i buy kamagra over the counter the original 2002 SARS kamagra ultimately disappeared.

That kamagra, however, did not can i buy kamagra over the counter transmit as well as even the initial strain of erectile dysfunction. It occurred in can i buy kamagra over the counter limited regions and was characterized by focal spread, including superspreading events. Such a pattern, which was also seen in the early days of erectile dysfunction, is called “overdispersion” — 10% of cases, for example, may be responsible for 80% of transmission.3 These dynamics explain why there were great differences in antibody prevalence within a given city and spotty global spread early in can i buy kamagra over the counter the kamagra. Overdispersion was thought to be an unstable trait that would disappear, with can i buy kamagra over the counter transmission becoming more uniform and higher overall. That transition appears to have occurred as newer variants take over.Given the parade of variants, their varying transmissibility, and continuing concern about antigenic changes affecting treatment protection, I believe it should now be clear that it is not possible to eliminate this kamagra from can i buy kamagra over the counter the population and that we should develop long-term plans for dealing with it after the unsupportable surges are fully controlled.

kamagra and seasonal influenza provide the most appropriate models to aid in developing strategies going forward.As with can i buy kamagra over the counter erectile dysfunction, when a novel kamagra influenza strain appears, its spread can overwhelm the health care system. Waves of go through a city in weeks and a can i buy kamagra over the counter country in months, but there is scant evidence that superspreading events occur. Thereafter, the kamagra kamagra persists as a new seasonal strain, and antigenic changes occur can i buy kamagra over the counter — albeit probably not as quickly as we are seeing with erectile dysfunction. The new strain joins the other seasonal influenza types and subtypes that can i buy kamagra over the counter reappear each year. The goal of vaccination becomes managing the inevitable outbreaks and reducing can i buy kamagra over the counter the rates of moderate-to-severe illness and death.

Preventing mild disease, though important, is less critical.Summary of World Health Organization (WHO) Process of kamagra Selection for Annual can i buy kamagra over the counter Influenza treatments. Readministration of influenza treatment has become an annual event for much of the population, in response to both waning immunity and the appearance of variants, termed can i buy kamagra over the counter antigenic drift, necessitating updated treatments. Even when can i buy kamagra over the counter there is no substantial drift, revaccination is recommended because of waning immunity. But antigenic drift is a constant issue and is monitored globally, with treatment composition can i buy kamagra over the counter updated globally twice a year on the basis of recommendations from a World Health Organization consultation.4 As outlined in the table, various criteria are considered in decisions about which strains to include in treatments. treatment effectiveness against laboratory-confirmed symptomatic is never higher can i buy kamagra over the counter than 50 to 60%, and in some years it is much lower.

Thus, the value of influenza treatments, now given to as many as 70% of people in some age can i buy kamagra over the counter groups, lies not in eliminating outbreaks but in reducing them and preventing severe complications.Though there may be similarities between erectile dysfunction and influenza, there are also meaningful differences. The most obvious difference is the efficacy of erectile dysfunction can i buy kamagra over the counter treatments, which is currently much higher than we can achieve with influenza treatments. Whether that degree of efficacy will continue is one of the many open questions that can only be answered over time can i buy kamagra over the counter. It is clear, however, that revaccination will be necessary, for the same reasons can i buy kamagra over the counter that influenza revaccination is necessary. Antigenic variation can i buy kamagra over the counter and waning immunity.

Data on the frequency of re with seasonal erectile dysfunctiones may not be relevant, but they suggest that protection is relatively short term even after natural .5 Revaccination frequency and consequences will need to be determined.Let us hope that certain problems with the influenza treatment — such as the failure of vaccination, in some years, to produce the desired increase in protection in previously vaccinated people — do not occur with can i buy kamagra over the counter the erectile dysfunction treatments. Other issues, such as the variant to be targeted by treatments, will can i buy kamagra over the counter need to be addressed. The successful public–private collaboration in selecting influenza can i buy kamagra over the counter strains offers a model for dealing with such issues. erectile dysfunction treatments will be used globally, and the strain or strains contained in future treatments can i buy kamagra over the counter will need to be chosen globally, in consultation with the manufacturers.Most predictions about the shape of the post–erectile dysfunction treatment world have been inaccurate — a reflection of rapid changes in knowledge. But we can now can i buy kamagra over the counter see a picture emerging in which use of effective treatments will continue to be critical over the long term.

Increases in asymptomatic s and mild can i buy kamagra over the counter illnesses in vaccinated people will nonetheless continue to be possible, as variants continue to emerge. Counts of hospitalizations and deaths may be more important in monitoring the overall impact than numbers of cases, can i buy kamagra over the counter as long as the treatments continue to be largely effective at preventing severe illness. The possibility of severe illnesses can i buy kamagra over the counter in a small proportion of vaccinated people does emphasize one of the greatest unmet needs we currently face. Continued emphasis on better therapeutics can i buy kamagra over the counter and antiviral agents, which will not be affected by molecular changes in the kamagra as much as treatments are.The future timing and composition of booster treatment doses will need to be determined on the basis of observational studies. We currently have few data on non-mRNA treatments, particularly protein-based treatments, which may have characteristics different from those of mRNA treatments, especially in terms of duration of immunity.Overall, the situation will be fluid, but we will require can i buy kamagra over the counter the continuing use of treatments to avert severe consequences, even if milder illnesses still occur at a low frequency.

We need to learn to live with these illnesses, just as we have learned to live with influenza.Participants Phase 1 can i buy kamagra over the counter Figure 1. Figure 1 can i buy kamagra over the counter. Screening, Randomization, and treatment and Placebo Administration among 5-to-11-Year-Old Children in the Phase 1 can i buy kamagra over the counter Study and the Phase 2–3 Trial. Participants who discontinued the vaccination regimen could can i buy kamagra over the counter remain in the study. In the phase 2–3 trial, reasons for not receiving the first dose included withdrawal can i buy kamagra over the counter (14 children), no longer meeting eligibility criteria (2 children), and protocol deviation (1 child).

Discontinuations or withdrawals after the first dose were due to a decision by the parent or guardian or by the participant, except one, for which the reason was classified as “other.” In the phase 2–3 trial, one participant who was randomly assigned to receive placebo was administered BNT162b2 can i buy kamagra over the counter in error for both doses. Therefore, 1518 participants received dose 1 of BNT162b2 and 750 participants received dose 1 of placebo.From March 24 through April 14, 2021, a total of 50 children 5 to 11 years can i buy kamagra over the counter of age were screened for inclusion at four U.S. Sites, and can i buy kamagra over the counter 48 received escalating doses of the BNT162b2 treatment (Figure 1). Half the children were male, 79% can i buy kamagra over the counter were White, 6% were Black, 10% were Asian, and 8% were Hispanic or Latinx. The mean age can i buy kamagra over the counter was 7.9 years (Table S2).

Phase 2–3 Table can i buy kamagra over the counter 1. Table 1 can i buy kamagra over the counter. Demographic and Clinical can i buy kamagra over the counter Characteristics of Children in the Phase 2–3 Trial. From June 7 through June 19, 2021, a total of 2316 children 5 to 11 can i buy kamagra over the counter years of age were screened for inclusion and 2285 underwent randomization across 81 sites in the United States, Spain, Finland, and Poland. 2268 participants received injections, with 1517 randomly assigned to receive BNT162b2 and 751 assigned to receive can i buy kamagra over the counter placebo (Figure 1).

One participant who was randomly assigned to receive can i buy kamagra over the counter placebo was administered BNT162b2 in error for both doses. Therefore, 1518 participants received dose 1 of BNT162b2 and 750 participants received dose can i buy kamagra over the counter 1 of placebo. More than 99% of participants can i buy kamagra over the counter received a second dose. At the data cutoff date, the median follow-up time was 2.3 months (range, 0 to 2.5) can i buy kamagra over the counter. 95% of participants had at least can i buy kamagra over the counter 2 months of available follow-up safety data after the second dose.

Overall, 52% can i buy kamagra over the counter were male, 79% were White, 6% were Black, 6% were Asian, and 21% were Hispanic or Latinx (Table 1). The mean can i buy kamagra over the counter age was 8.2 years. 20% of children had coexisting conditions (including 12% with can i buy kamagra over the counter obesity and approximately 8% with asthma), and 9% were erectile dysfunction–positive at baseline. Apart from younger age and a lower percentage of Black and Hispanic or Latinx 5-to-11-year-olds (6% and 18%, respectively) than 16-to-25-year-olds (12% and 36%, respectively), demographic characteristics were similar among can i buy kamagra over the counter the 5-to-11-year-old and 16-to-25-year-old BNT162b2 recipients who were included in the immunobridging subset (Table S3). Phase 1 Safety and Immunogenicity Most local reactions can i buy kamagra over the counter were mild to moderate, and all were transient (Fig.

S1A and can i buy kamagra over the counter Table S4). Fever was more common in the 30-μg dose-level group than in the 10-μg and 20-μg can i buy kamagra over the counter dose-level groups after the first and second doses (Fig. S1B). All four sentinel participants in the 30-μg dose-level group who received the second 30-μg dose had mild-to-moderate fever within 7 days. The remaining 12 participants in the 30-μg dose-level group received a 10-μg second dose approximately 1 month after the first dose, as recommended by the internal review committee after selection of the phase 2–3 dose.

Adverse events from the first dose through 1 month after the second dose were reported by 43.8% of participants who received two 10-μg doses of BNT162b2, 31.3% of those who received two 20-μg doses, and 50.0% of those who received two 30-μg doses (Table S6). One severe adverse event (grade 3 pyrexia) in a 10-year-old participant began the day of the second 20-μg dose of BNT162b2, with temperature reaching 39.7°C (103.5°F) the day after vaccination and resolving the following day. Antipyretic medications were used, and the investigator considered the event to be related to receipt of the BNT162b2 treatment. Serum neutralizing GMTs 7 days after the second dose were 4163 with the 10-μg dose of BNT162b2 and 4583 with the 20-μg dose (Fig. S2).

On the basis of these safety and immunogenicity findings, the 10-μg dose level was selected for further assessment in 5-to-11-year-olds in phase 2–3. Phase 2–3 Safety Figure 2. Figure 2. Local Reactions and Systemic Events Reported in the Phase 2–3 Trial within 7 Days after Injection of BNT162b2 or Placebo. Panel A shows local reactions and Panel B shows systemic events after the first and second doses in recipients of the BNT162b2 treatment (dose 1, 1511 children.

Dose 2, 1501 children) and placebo (dose 1, 748 or 749 children. Dose 2, 740 or 741 children). The numbers refer to the numbers of children reporting at least one “yes” or “no” response for the specified event after each dose. Responses may not have been reported for every type of event. Severity scales are summarized in Table S5.

Fever categories are designated in the key. The numbers above the bars are the percentage of participants in each group with the specified local reaction or systemic event. Н™¸ bars represent 95% confidence intervals. One participant in the BNT162b2 group had a fever of 40.0°C after the second dose.BNT162b2 recipients reported more local reactions and systemic events than placebo recipients (Figure 2). The reactions and events reported were generally mild to moderate, lasting 1 to 2 days (Table S4).

Injection-site pain was the most common local reaction, occurring in 71 to 74% of BNT162b2 recipients. Severe injection-site pain after the first or second dose was reported in 0.6% of BNT162b2 recipients and in no placebo recipients. Fatigue and headache were the most frequently reported systemic events. Severe fatigue (0.9%), headache (0.3%), chills (0.1%), and muscle pain (0.1%) were also reported after the first or second dose of BNT162b2. Frequencies of fatigue, headache, and chills were similar among BNT162b2 and placebo recipients after the first dose and were more frequent among BNT162b2 recipients than among placebo recipients after the second dose.

In general, systemic events were reported more often after the second dose of BNT162b2 than after the first dose. Fever occurred in 8.3% of BNT162b2 recipients after the first or second dose. Use of an antipyretic among BNT162b2 recipients was more frequent after the second dose than after the first dose. One BNT162b2 recipient had a temperature of 40.0°C (104°F) 2 days after the second dose. Antipyretics were used, and the fever resolved the next day.

From the first dose through 1 month after the second dose, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients (Table S7). Slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were considered by the investigators to be related to the treatment or placebo. Severe adverse events were reported in 0.1% of BNT162b2 recipients and 0.1% of placebo recipients. Three serious adverse events in two participants were reported by the cutoff date. All three (postinjury abdominal pain and pancreatitis in a placebo recipient and arm fracture in a BNT162b2 recipient) were considered to be unrelated to the treatment or placebo.

No deaths or adverse events leading to withdrawal were reported. Lymphadenopathy was reported in 10 BNT162b2 recipients (0.9%) and 1 placebo recipient (0.1%). No myocarditis, pericarditis, hypersensitivity, or anaphylaxis in BNT162b2 recipients was reported. Four rashes in BNT162b2 recipients (observed on the arm, torso, face, or body, with no consistent pattern) were considered to be related to vaccination. The rashes were mild and self-limiting, and onset was typically 7 days or more after vaccination.

No safety differences were apparent when the data were analyzed according to baseline erectile dysfunction status. Phase 2–3 Immunogenicity Table 2. Table 2. Results of Serum erectile dysfunction Neutralization Assay 1 Month after the Second Dose of BNT162b2 among Participants 5 to 11 and 16 to 25 Yr of Age. The geometric mean ratio of neutralizing GMTs for 10 μg of BNT162b2 in 5-to-11-year-olds to that for 30 μg of BNT162b2 in 16-to-25-year-olds 1 month after the second dose was 1.04 (95% confidence interval [CI], 0.93 to 1.18) (Table 2), a ratio meeting the immunobridging criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67, the predefined point estimate of a geometric mean ratio of 0.8 or greater, and the FDA-requested point estimate criterion of a geometric mean ratio of 1.0 or greater.

In both age groups, 99.2% of participants achieved seroresponse 1 month after the second dose. The difference between the percentage of 5-to-11-year-olds who achieved seroresponse and the percentage in 16-to-25-year-olds was 0.0 percentage points (95% CI, –2.0 to 2.2), which also met an immunobridging criterion. Serum-neutralizing GMTs 1 month after the second dose of BNT162b2 were 1198 in 5-to-11-year-olds and 1147 in 16-to-25-year-olds (Fig. S3). Corresponding GMTs among placebo recipients were 11 and 10.

Geometric mean fold rises from baseline to 1 month after the second dose were 118.2 in 5-to-11-year-olds and 111.4 in 16-to-25-year-olds. Corresponding geometric mean fold rises among placebo recipients were 1.1 and 1.0. Of note, the neutralizing GMTs reported in phase 1 are from serum samples obtained 7 days after the second dose (during immune response expansion) and the GMTs in phase 2–3 are from serum samples obtained 1 month after the second dose. Phase 2–3 Efficacy Figure 3. Figure 3.

treatment Efficacy in Children 5 to 11 Years of Age. The graph represents the cumulative incidence of the first occurrence of erectile dysfunction treatment after the first dose of treatment or placebo. Each symbol represents cases of erectile dysfunction treatment starting on a given day. Results shown in the graph are all available data for the efficacy population, and results shown in the table are those for the efficacy population that could be evaluated (defined in Table S1). Participants without evidence of previous were those who had no medical history of erectile dysfunction treatment and no serologic or virologic evidence of past erectile dysfunction before 7 days after the second dose (i.e., N-binding serum antibody was negative at the first vaccination visit, erectile dysfunction was not detected in nasal swabs by nucleic acid amplification test at the vaccination visits, and nucleic acid amplification tests were negative at any unscheduled visit before 7 days after the second dose).

The cutoff date for the efficacy evaluation was October 8, 2021. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual was from 7 days after the second dose to the end of the surveillance period. The 95% confidence intervals for treatment efficacy were derived by the Clopper–Pearson method, adjusted for surveillance time.Among participants without evidence of previous erectile dysfunction , there were three cases of erectile dysfunction treatment (with onset 7 days or more after the second dose) among BNT162b2 recipients and 16 among placebo recipients. The observed treatment efficacy was 90.7% (95% CI, 67.7 to 98.3).

Among all participants with data that could be evaluated, regardless of evidence of previous erectile dysfunction , no additional cases were reported. The observed treatment efficacy was 90.7% (95% CI, 67.4 to 98.3) (Figure 3). No cases of severe erectile dysfunction treatment or MIS-C were reported.The authors’ full names and academic degrees are as follows. Damian Smedley, Ph.D., Katherine R. Smith, Ph.D., Antonio Martin, M.Sc., Ellen A.

Thomas, M.D., Ellen M. McDonagh, Ph.D., Valentina Cipriani, Ph.D., Jamie M. Ellingford, Ph.D., Gavin Arno, Ph.D., Arianna Tucci, M.D., Jana Vandrovcova, Ph.D., Georgia Chan, Ph.D., Hywel J. Williams, Ph.D., Thiloka Ratnaike, M.B., B.S., Ph.D., Wei Wei, Ph.D., Kathleen Stirrups, Ph.D., Kristina Ibanez, Ph.D., Loukas Moutsianas, Ph.D., Matthias Wielscher, Ph.D., Anna Need, Ph.D., Michael R. Barnes, Ph.D., Letizia Vestito, M.Sc., James Buchanan, D.Phil., Sarah Wordsworth, Ph.D., Sofie Ashford, B.Sc., Karola Rehmström, Ph.D., Emily Li, Ph.D., Gavin Fuller, M.Med.Sci., Philip Twiss, M.Sc., Olivera Spasic-Boskovic, M.Sc., Sally Halsall, Ph.D., R.

Andres Floto, M.D., Ph.D., Kenneth Poole, M.D., Ph.D., Annette Wagner, M.D., Ph.D., Sarju G. Mehta, M.D., Mark Gurnell, M.D., Ph.D., Nigel Burrows, M.D., Roger James, Ph.D., Christopher Penkett, D.Phil., Eleanor Dewhurst, B.A., Stefan Gräf, Ph.D., Rutendo Mapeta, B.Sc., Mary Kasanicki, Ph.D., Andrea Haworth, M.Sc., F.R.C.Path., Helen Savage, M.Sc., Dip.R.C.Path., Melanie Babcock, Ph.D., Martin G. Reese, Ph.D., Mark Bale, Ph.D., Emma Baple, M.B., B.S., Ph.D., Christopher Boustred, Ph.D., Helen Brittain, M.D., Anna de Burca, M.B., B.S., Ph.D., Marta Bleda, Ph.D., Andrew Devereau, B.Sc., Dina Halai, M.Sc., Eik Haraldsdottir, M.Sc., Zerin Hyder, M.D., Dalia Kasperaviciute, Ph.D., Christine Patch, Ph.D., Dimitris Polychronopoulos, Ph.D., Angela Matchan, M.Sc., Razvan Sultana, Ph.D., Mina Ryten, M.D., Ph.D., Ana L.T. Tavares, M.B., B.S., Carolyn Tregidgo, Ph.D., Clare Turnbull, M.D., Ph.D., Matthew Welland, M.Sc., Suzanne Wood, M.Sc., Catherine Snow, Ph.D., Eleanor Williams, Ph.D., Sarah Leigh, Ph.D., Rebecca E. Foulger, Ph.D., Louise C.

Daugherty, M.Sc., Olivia Niblock, M.Sc., Ivone U.S. Leong, Ph.D., Caroline F. Wright, Ph.D., Jim Davies, D.Phil., Charles Crichton, B.A., James Welch, B.A., Kerrie Woods, B.A., Lara Abulhoul, M.D., Paul Aurora, M.R.C.P., Ph.D., Detlef Bockenhauer, M.D., Alexander Broomfield, M.D., Maureen A. Cleary, M.D., Tanya Lam, M.B., B.S., M.P.H., Mehul Dattani, F.R.C.P., Emma Footitt, Ph.D., Vijeya Ganesan, M.D., Stephanie Grunewald, M.D., Ph.D., Sandrine Compeyrot-Lacassagne, M.D., Francesco Muntoni, M.D., Clarissa Pilkington, M.B., B.S., Rosaline Quinlivan, M.D., Nikhil Thapar, M.D., Ph.D., Colin Wallis, M.D., Lucy R. Wedderburn, F.R.C.P., Ph.D., Austen Worth, M.D., Teofila Bueser, M.Sc., Cecilia Compton, M.Sc., Charu Deshpande, M.R.C.P.C.H., Hiva Fassihi, F.R.C.P., Eshika Haque, M.Sc., Louise Izatt, Ph.D., Dragana Josifova, M.D., Shehla Mohammed, F.R.C.P., Leema Robert, M.R.C.P.C.H., Sarah Rose, M.Sc., Deborah Ruddy, Ph.D., Robert Sarkany, F.R.C.P., Genevieve Say, M.Sc., Adam C.

Shaw, M.D., Agata Wolejko, M.Sc., Bishoy Habib, B.Sc., Gavin Burns, Ph.D., Sarah Hunter, M.Sc., Russell J. Grocock, Ph.D., Sean J. Humphray, B.Sc., Peter N. Robinson, M.D., Melissa Haendel, Ph.D., Michael A. Simpson, Ph.D., Siddharth Banka, M.D., Ph.D., Jill Clayton-Smith, F.R.C.P., Sofia Douzgou, F.R.C.P., Ph.D., Georgina Hall, M.Sc., Huw B.

Thomas, Ph.D., Raymond T. O’Keefe, Ph.D., Michel Michaelides, F.R.C.Ophth., Anthony T. Moore, F.R.C.Ophth., Sam Malka, B.Sc., Nikolas Pontikos, Ph.D., Andrew C. Browning, M.D., Ph.D., Volker Straub, M.D., Ph.D., Gráinne S. Gorman, F.R.C.P., Ph.D., Rita Horvath, M.D., Ph.D., Richard Quinton, M.D., Andrew M.

Schaefer, M.R.C.P., Patrick Yu-Wai-Man, F.R.C.Ophth., Ph.D., Doug M. Turnbull, F.Med.Sci., F.R.S., Robert McFarland, M.R.C.P.C.H., Ph.D., Robert W. Taylor, F.R.C.Path., Ph.D., Emer O’Connor, M.D., Janice Yip, M.Res., Katrina Newland, M.Sc., Huw R. Morris, F.R.C.P., Ph.D., James Polke, F.R.C.Path., Ph.D., Nicholas W. Wood, Ph.D., F.Med.Sci., Carolyn Campbell, F.R.C.Path., Carme Camps, Ph.D., Kate Gibson, B.Sc., Nils Koelling, Ph.D., Tracy Lester, Ph.D., F.R.C.Path., Andrea H.

Németh, F.R.C.P., D.Phil., Claire Palles, Ph.D., Smita Patel, F.R.C.P., F.R.C.Path., Ph.D., Noemi B.A. Roy, F.R.C.Path., D.Phil., Arjune Sen, M.R.C.P., Ph.D., John Taylor, Ph.D., Pilar Cacheiro, Ph.D., Julius O. Jacobsen, Ph.D., Eleanor G. Seaby, M.D., Val Davison, F.R.C.Path., Lyn Chitty, Ph.D., M.R.C.O.G., Angela Douglas, Ph.D., F.R.C.Path., Kikkeri Naresh, F.R.C.Path., Dom McMullan, Ph.D., F.R.C.Path., Sian Ellard, Ph.D., F.R.C.Path., I. Karen Temple, Ph.D., F.R.C.Path., Andrew D.

Mumford, Ph.D., F.R.C.Path., Gill Wilson, F.R.C.P., Phil Beales, F.Med.Sci., Maria Bitner-Glindzicz, M.B., B.S., Ph.D. (deceased), Graeme Black, M.D., D.Phil., John R. Bradley, D.M., Paul Brennan, F.R.C.P., John Burn, M.B., B.S., Ph.D., Patrick F. Chinnery, F.Med.Sci., Perry Elliott, M.D., Frances Flinter, M.D., Henry Houlden, M.D., Melita Irving, M.D., William Newman, M.D., Ph.D., Shamima Rahman, F.R.C.P., F.R.C.P.C.H., Ph.D., John A. Sayer, M.B., Ch.B., Ph.D., Jenny C.

Taylor, Ph.D., Andrew R. Webster, F.R.C.Ophth., Andrew O.M. Wilkie, F.Med.Sci., F.R.S., Willem H. Ouwehand, F.Med.Sci., F. Lucy Raymond, M.D., Ph.D., John Chisholm, F.R.Eng., Sue Hill, Ph.D., David Bentley, D.Phil., Richard H.

Scott, M.D., Ph.D., Tom Fowler, Ph.D., Augusto Rendon, Ph.D., and Mark Caulfield, F.R.C.P., F.Med.Sci. Genomics England (D.S., K.R.S., A.M., E.A.T., E.M.M., A.T., G.C., K.I., L.M., M. Wielscher, A.N., M. Bale, E.B., C.B., H.B., M. Bleda, A.

Devereau, D.H., E. Haraldsdottir, Z.H., D.K., C. Patch, D.P., A.M., R. Sultana, M.R., A.L.T.T., C. Tregidgo, C.

Turnbull, M. Welland, S. Wood, C.S., E.W., S.L., R.E.F., L.C.D., O.N., I.U.S.L., C.F.W., J.C., R.H.S., T.F., A.R., M.C.), the William Harvey Research Institute, Queen Mary University of London (D.S., K.R.S., V.C., A.T., L.M., M.R.B., D.K., S. Wood, P.C., J.O.J., T.F., M.C.), University College London (UCL) Institute of Ophthalmology (V.C., G.A., M.M., A.T.M., S. Malka, N.P., P.Y.-W.-M., A.R.W.), UCL Genetics Institute (V.C., N.W.W.), GOSgene (H.J.W.), Genetics and Genomic Medicine Programme (L.V., M.R., M.D., L.C., P.

Beales, M.B.-G.), National Institute for Health Research (NIHR) Great Ormond Street Hospital Biomedical Research Centre (BRC) (M.R., S. Grunewald, S.C.-L., F.M., C. Pilkington, L.R.W., L.C., P. Beales, M.B.-G.), , Immunity, and Inflammation Research and Teaching Department (P.A., L.R.W.), Stem Cells and Regenerative Medicine (N.T.), and Mitochondrial Research Group (S. Rahman), UCL Great Ormond Street Institute of Child Health, UCL Ear Institute (L.V.), the Department of Renal Medicine (D.

Bockenhauer), and Institute of Cardiovascular Science (P.E.), UCL, Moorfields Eye Hospital National Health Service (NHS) Foundation Trust (V.C., G.A., M.M., A.T.M., S. Malka, N.P., A.R.W.), the National Hospital for Neurology and Neurosurgery (J.V., E.O., J.Y., K. Newland, H.R.M., J.P., N.W.W., H.H.), the Metabolic Unit (L.A., S. Grunewald, S. Rahman), London Centre for Paediatric Endocrinology and Diabetes (M.D.), and the Department of Gastroenterology (N.T.), Great Ormond Street Hospital for Children NHS Foundation Trust (L.V., D.

Bockenhauer, A. Broomfield, M.A.C., T. Lam, E.F., V.G., S.C.-L., F.M., C. Pilkington, R. Quinlivan, C.W., L.R.W., A.

Worth, L.C., P. Beales, M.B.-G., R.H.S.), the Clinical Genetics Department (M.R., T.B., C. Compton, C.D., E. Haque, L.I., D.J., S. Mohammed, L.R., S.

Rose, D.R., G.S., A.C.S., F.F., M.I.) and St. John’s Institute of Dermatology (H.F., R. Sarkany), Guy’s and St. Thomas’ NHS Foundation Trust, the Division of Genetics and Epidemiology, Institute of Cancer Research (C. Turnbull), Florence Nightingale Faculty of Nursing, Midwifery, and Palliative Care (T.B.), Division of Genetics and Molecular Medicine (M.A.S.), and Division of Medical and Molecular Genetics (M.I.), King’s College London, NIHR BRC at Moorfields Eye Hospital (P.Y.-W.-M.), NHS England and NHS Improvement, Skipton House (V.D., A.

Douglas, S. Hill), and Imperial College Healthcare NHS Trust, Hammersmith Hospital (K. Naresh), London, Open Targets and European Molecular Biology Laboratory–European Bioinformatics Institute, Wellcome Genome Campus, Hinxton (E.M.M.), the Division of Evolution and Genomic Sciences, Faculty of Biology, Medicine, and Health, University of Manchester (J.M.E., S.B., J.C.-S., S.D., G.H., H.B.T., R.T.O., G. Black, W.N.), and the Manchester Centre for Genomic Medicine, St. Mary’s Hospital, Manchester University NHS Foundation Trust (J.M.E., Z.H., S.B., J.C.-S., S.D., G.H., G.

Black, W.N.), Manchester, the Department of Genetic and Genomic Medicine, Institute of Medical Genetics, Cardiff University, Cardiff (H.J.W.), the Department of Clinical Neurosciences (T.R., W.W., R.H., P.F.C.), the Medical Research Council (MRC) Mitochondrial Biology Unit (T.R., W.W., P.Y.-W.-M., P.F.C.), the Department of Paediatrics (T.R.), the Department of Haematology (K.S., C. Penkett, S. Gräf, R.M., W.H.O., A.R.), the School of Clinical Medicine (K.R., E.L., R.A.F., K.P., F.L.R.), the Department of Medicine (S. Gräf), and Cambridge Centre for Brain Repair, Department of Clinical Neurosciences (P.Y.-W.-M.), University of Cambridge, NIHR BioResource, Cambridge University Hospitals (K.S., S.A., R.J., C. Penkett, E.D., S.

Gräf, R.M., M.K., J.R.B., P.F.C., W.H.O., F.L.R.), and Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust (G.F., P.T., O.S.-B., S. Halsall, K.P., A. Wagner, S.G.M., N.B., M.K.), Cambridge Biomedical Campus, Wellcome–MRC Institute of Metabolic Science and NIHR Cambridge BRC (M.G.), Congenica (A.H., H.S.), Illumina Cambridge (A. Wolejko, B.H., G. Burns, S.

Hunter, R.J.G., S.J.H., D. Bentley), NHS Blood and Transplant (W.H.O.), and Wellcome Sanger Institute (W.H.O.), Cambridge, the Health Economics Research Centre (J. Buchanan, S. Wordsworth) and the Wellcome Centre for Human Genetics (C. Camps, J.C.T.), University of Oxford, NIHR Oxford BRC (J.

Buchanan, S. Wordsworth, J.D., C. Crichton, J.W., K.W., C. Camps, S.P., N.B.A.R., A.S., J.T., J.C.T.), the Oxford Centre for Genomic Medicine (A. De Burca, A.H.N.), and the Departments of Haematology (N.B.A.R.) and Neurology (A.S.), Oxford University Hospitals NHS Foundation Trust, Oxford Genetics Laboratories, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital (C.

Campbell, K.G., T. Lester, J.T.), the MRC Weatherall Institute of Molecular Medicine (N.K., N.B.A.R., A.O.M.W.) and the Oxford Epilepsy Research Group (A.S.), Nuffield Department of Clinical Neurosciences (A.H.N.), University of Oxford, and the Department of Clinical Immunology (S.P.), John Radcliffe Hospital, Oxford, Peninsula Clinical Genetics Service, Royal Devon and Exeter NHS Foundation Trust (E.B.), and the University of Exeter Medical School (E.B., C.F.W.), Royal Devon and Exeter Hospital (S.E.), Exeter, Newcastle Eye Centre, Royal Victoria Infirmary (A.C.B.), the Institute of Genetic Medicine, Newcastle University, International Centre for Life (V.S., P. Brennan), Wellcome Centre for Mitochondrial Research, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University (G.S.G., R.H., A.M.S., D.M.T., R. Quinton, R.M., R.W.T., J.A.S.), Highly Specialised Mitochondrial Service (G.S.G., A.M.S., D.M.T., R.M., R.W.T.) and Northern Genetics Service (J. Burn), Newcastle upon Tyne Hospitals NHS Foundation Trust (J.A.S.), and NIHR Newcastle BRC (G.S.G., D.M.T., J.A.S.), Newcastle upon Tyne, the Institute of Cancer and Genomic Sciences, Institute of Biomedical Research, University of Birmingham (C.

Palles), and Birmingham Women’s Hospital (D.M.), Birmingham, the Genomic Informatics Group (E.G.S.), University Hospital Southampton (I.K.T.), and the University of Southampton (I.K.T.), Southampton, Liverpool Women’s NHS Foundation Trust, Liverpool (A. Douglas), the School of Cellular and Molecular Medicine, University of Bristol, Bristol (A.D.M.), and Yorkshire and Humber, Sheffield Children’s Hospital, Sheffield (G.W.) — all in the United Kingdom. Fabric Genomics, Oakland (M. Babcock, M.G.R.), and the Ophthalmology Department, University of California, San Francisco School of Medicine, San Francisco (A.T.M.) — both in California. The Jackson Laboratory for Genomic Medicine, Farmington, CT (P.N.R.).

And the Center for Genome Research and Biocomputing, Environmental and Molecular Toxicology, Oregon State University, Corvallis (M.H.).Participants Figure 1. Figure 1. Enrollment and Randomization. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1.

Brazil, 2. South Africa, 4. Germany, 6. And Turkey, 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale.

Mild, does not interfere with activity. Moderate, interferes with activity. Severe, prevents daily activity. And grade 4, emergency department visit or hospitalization. Redness and swelling were measured according to the following scale.

Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 cm in diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B.

Fever categories are designated in the key. Medication use was not graded. Additional scales were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity.

Moderate. Some interference with activity. Or severe. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization.

Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose.

Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment.

Efficacy Table 2. Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population).

Each symbol represents erectile dysfunction treatment cases starting on a given day. Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases.

Placebo, 44 cases). Figure 3 shows cases of erectile dysfunction treatment or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Participants Figure 1. Figure 1. Screening, Randomization, and Follow-up.

The diagram represents all enrolled participants 16 years of age or older through the data cutoff date (March 13, 2021). The diagram includes two deaths that occurred after the second dose in human immunodeficiency kamagra (HIV)–infected participants (one in the BNT162b2 group and one in the placebo group. These deaths were not reported in the Results section of this article because the analysis of HIV-infected participants is being conducted separately). Information on the screening, randomization, and follow-up of the participants 12 to 15 years of age has been reported previously.11Table 1. Table 1.

Demographic Characteristics of the Participants at Baseline. Between July 27, 2020, and October 29, 2020, a total of 45,441 participants 16 years of age or older underwent screening, and 44,165 underwent randomization at 152 sites (130 sites in the United States, 1 site in Argentina, 2 sites in Brazil, 4 sites in South Africa, 6 sites in Germany, and 9 sites in Turkey) in the phase 2–3 portion of the trial. Of these participants, 44,060 received at least one dose of BNT162b2 (22,030 participants) or placebo (22,030), and 98% (21,759 in the BNT162b2 group and 21,650 in the placebo group) received the second dose (Figure 1). During the blinded period of the trial, 51% of the participants in each group had 4 to less than 6 months of follow-up after the second dose. 8% of the participants in the BNT162b2 group and 6% of those in the placebo group had 6 months of follow-up or more after the second dose.

During the combined blinded and open-label periods, 55% of the participants in the BNT162b2 group had 6 months of follow-up or more after the second dose. A total of 49% of the participants were female, 82% were White, 10% were Black, and 26% were Hispanic or Latinx. The median age was 51 years. A total of 34% of the participants had a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30.0 or more, 21% had at least one underlying medical condition, and 3% had baseline evidence of a previous or current erectile dysfunction (Table 1 and Table S2). Between October 15, 2020, and January 12, 2021, a total of 2306 participants 12 to 15 years of age underwent screening, and 2264 underwent randomization at 29 U.S.

Sites. Of these participants, 2260 received at least one dose of BNT162b2 (1131 participants) or placebo (1129), and 99% (1124 in the BNT162b2 group and 1117 in the placebo group) received the second dose.11 Among participants who received at least one dose of BNT162b2 or placebo, 58% had at least 2 months of follow-up after the second dose, 49% were female, 86% were White, 5% were Black, and 12% were Hispanic or Latinx. Full details of the demographic characteristics of the participants have been reported previously.11 Safety Reactogenicity The subgroup that was evaluated for reactogenicity in the current report, in which reactions were reported in an electronic diary, included 9839 participants 16 years of age or older. In this subgroup, 8183 participants had been included in the previous analysis, and 1656 were enrolled after the data cutoff for that analysis.9 The reactogenicity profile of BNT162b2 in this expanded subgroup did not differ substantially from that described previously.9 This subgroup included 364 participants who had evidence of previous erectile dysfunction , 9426 who did not have evidence, and 49 who lacked the data needed to determine previous status. More participants in the BNT162b2 group than in the placebo group reported local reactions, the most common of which was mild-to-moderate pain at the injection site (Fig.

S1A). Local reactions were reported with similar frequency among the participants with or without evidence of previous erectile dysfunction , and the reactions were of similar severity. No local reactions of grade 4 (according to the guidelines of the Center for Biologics Evaluation and Research12) were reported. More participants in the BNT162b2 group than in the placebo group reported systemic events, the most common of which was fatigue (Fig. S1B).

Systemic events were mostly mild to moderate in severity, but there were occasional severe events. Systemic reactogenicity was similar among those with or without evidence of previous erectile dysfunction , although BNT162b2 recipients with evidence of previous reported systemic events more often after receipt of the first dose, and those without evidence reported systemic events more often after receipt of the second dose. For example, 12% of recipients with evidence of previous erectile dysfunction and 3% of those without evidence reported fever after receipt of the first dose. 8% of those with evidence of previous and 15% of those without evidence reported fever after the second dose. The highest temperature reported was a transient fever of higher than 40.0°C on day 2 after the second dose in a BNT162b2 recipient without evidence of previous .

Adverse Events Analyses of adverse events during the blinded period included 43,847 participants 16 years of age or older (Table S3). Reactogenicity events among the participants who were not in the reactogenicity subgroup were reported as adverse events, which resulted in imbalances between the BNT162b2 group and the placebo group with respect to adverse events (30% vs. 14%), related adverse events (24% vs. 6%), and severe adverse events (1.2% vs. 0.7%).

New adverse events attributable to BNT162b2 that were not previously identified in earlier reports included decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis. Few participants had serious adverse events or adverse events that led to trial withdrawal. No new serious adverse events were considered by the investigators to be related to BNT162b2 after the data cutoff date of the previous report.9 During the combined blinded and open-label periods, cumulative safety data during follow-up were available through 6 months after the second dose for 12,006 participants who were originally randomly assigned to the BNT162b2 group. No new safety signals relative to the previous report were observed during the longer follow-up period in the current report, which included open-label observation of the original BNT162b2 recipients and placebo recipients who received BNT162b2 after unblinding.9 During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died. During the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died.

None of these deaths were considered to be related to BNT162b2 by the investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4). Safety monitoring will continue according to the protocol for 2 years after the second dose for participants who originally received BNT162b2 and for 18 months after the second BNT162b2 dose for placebo recipients who received BNT162b2 after unblinding. Efficacy Table 2. Table 2.

treatment Efficacy against erectile dysfunction treatment from 7 Days after Receipt of the Second Dose during the Blinded, Placebo-Controlled Follow-up Period. Among 42,094 participants 12 years of age or older who could be evaluated and had no evidence of previous erectile dysfunction , erectile dysfunction treatment with an onset of 7 days or more after the second dose was observed in 77 treatment recipients and in 850 placebo recipients up to the data cutoff date (March 13, 2021), corresponding to a treatment efficacy of 91.3% (95% confidence interval [CI], 89.0 to 93.2) (Table 2). Among 44,486 participants with or without evidence of previous who could be evaluated, cases of erectile dysfunction treatment were observed in 81 treatment recipients and in 873 placebo recipients, corresponding to a treatment efficacy of 91.1% (95% CI, 88.8 to 93.0). Among the participants with evidence of previous erectile dysfunction based on a positive baseline N-binding antibody test, erectile dysfunction treatment was observed in 2 treatment recipients after the first dose and in 7 placebo recipients. Among the participants with evidence of previous erectile dysfunction based on a positive nucleic acid amplification test at baseline, cases of erectile dysfunction treatment were observed in 10 treatment recipients and in 9 placebo recipients (Table S5).

erectile dysfunction treatment was less common among the placebo recipients with positive N-binding antibodies at trial entry (7 of 542 participants, for an incidence of 1.3%) than among those without evidence of at trial entry (1015 of 21,521, for an incidence of 4.7%). These findings indicate that previous conferred approximately 72.6% protection. Figure 2. Figure 2. Efficacy of BNT162b2 against erectile dysfunction treatment after Receipt of the First Dose (Blinded Follow-up Period).

The top of the figure shows the cumulative incidence curves for the first occurrence of erectile dysfunction disease 2019 (erectile dysfunction treatment) after receipt of the first dose (efficacy analysis population of participants ≥12 years of age who could be evaluated). Each symbol represents erectile dysfunction treatment cases starting on a given day, and filled symbols represent severe erectile dysfunction treatment cases. Because of overlapping dates, some symbols represent more than one case. The inset shows the same data on an enlarged y axis through 21 days. The bottom of the figure shows the time intervals for the first occurrence of erectile dysfunction treatment in the efficacy analysis population, as well as the surveillance time, which is given as the total time (in 1000 person-years) at risk for the given end point across all participants within each group.

The time period for the accrual of erectile dysfunction treatment cases was from after receipt of the first dose to the end of the surveillance period for the overall row and from the start to the end of the range stated for each time interval. treatment efficacy was calculated as 100×(1–IRR), where IRR (incidence rate ratio) is the ratio of the rate (number per 1000 person-years of follow-up) of confirmed cases of erectile dysfunction treatment in the BNT162b2 group to the corresponding rate in the placebo group. The 95% confidence interval for treatment efficacy was derived with the use of the Clopper–Pearson method, with adjustment for surveillance time.Among the participants with or without evidence of previous , cases of erectile dysfunction treatment were observed in 46 treatment recipients and in 110 placebo recipients from receipt of the first dose up to receipt of the second dose, corresponding to a treatment efficacy of 58.4% (95% CI, 40.8 to 71.2) (Figure 2). During the interval from the approximate start of observed protection at 11 days after receipt of the first dose up to receipt of the second dose, treatment efficacy increased to 91.7% (95% CI, 79.6 to 97.4). From its peak after the second dose, observed treatment efficacy declined.

From 7 days to less than 2 months after the second dose, treatment efficacy was 96.2% (95% CI, 93.3 to 98.1). From 2 months to less than 4 months after the second dose, treatment efficacy was 90.1% (95% CI, 86.6 to 92.9). And from 4 months after the second dose to the data cutoff date, treatment efficacy was 83.7% (95% CI, 74.7 to 89.9). Table 3. Table 3.

treatment Efficacy against erectile dysfunction treatment up to 7 Days after Receipt of the Second Dose among Participants without Evidence of . Severe erectile dysfunction treatment, as defined by the Food and Drug Administration,13 with an onset after receipt of the first dose occurred in 31 participants, of whom 30 were placebo recipients. This finding corresponds with a treatment efficacy of 96.7% (95% CI, 80.3 to 99.9) against severe erectile dysfunction treatment (Figure 2 and Table S6). Although the trial was not powered to definitively assess efficacy according to subgroup, supplemental analyses indicated that treatment efficacy after the second dose in subgroups defined according to age, sex, race, ethnic group, presence or absence of coexisting medical conditions, and country was generally consistent with that observed in the overall population (Table 3 and Table S7). Given the concern about the erectile dysfunction B.1.351 (or beta) variant, which appears to be neutralized less efficiently by BNT162b2-immune sera than many other lineages,14 whole-viral-genome sequencing was performed on midturbinate samples from erectile dysfunction treatment cases observed in South Africa, where this lineage was prevalent.

Nine cases of erectile dysfunction treatment were observed in South African participants without evidence of previous erectile dysfunction , all of whom were placebo recipients. This finding corresponds with a treatment efficacy of 100% (95% CI, 53.5 to 100) (Table 3). Midturbinate specimens from 8 of 9 cases contained sufficient viral RNA for whole-genome sequencing. All viral genomes were the beta variant (Global Initiative on Sharing All Influenza Data accession codes are provided in the Supplementary Appendix)..

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David Bailey, L.M.S.W., is the program therapist for Senior Life Solutions..

May is http://franklinvideo.com/can-i-buy-cialis-online/ Mental can i buy kamagra over the counter Health Awareness Month. Many people in modern society seem to have a perception that the world is divided into two categories when it comes to mental health conditions. Those who can i buy kamagra over the counter have them and those who don’t.

This mentality leads to all sorts of problems, including stigma. According to the American Psychiatric Association a stigma is a pervasive negative perception of people with mental health conditions. They identify three can i buy kamagra over the counter types of stigma.

Public stigma – the negative attitudes others have concerning mental health disordersSelf-stigma – the negative attitude one has about their own mental health, which can show up as internalized shameInstitutional stigma – includes government or organizational policies that limit opportunities for those with mental health conditions, either intentionally or unintentionally Humans have a tendency to divide the world into ‘us’ and‘them,’ no matter what the topic is. People will put down ‘them’ in some way,to perceive ‘them’ as not as good as ‘us.’ This is true for mental healthconditions as well as many other can i buy kamagra over the counter characteristics. Mental health issues haveadditional complexities involved with the perception.

Often people are uncomfortable with mental illness becausethey don’t understand it. Mental health conditions can result in behaviors can i buy kamagra over the counter thatlook bizarre or seem strange to some people. This is especially true forpsychotic disorders.

But people are often uncomfortable even with symptoms relatedto depression or anxiety, which are very common disorders. This may can i buy kamagra over the counter be becausewhen people put all mental health conditions into one category and thatcategory is associated with bizarre behavior they are likely to want to avoidit. When people divide the world into two categories and perceive the ‘other,’ those with a mental illness, as somehow strange, they are not only perpetuating stigma and setting themselves up to treat others poorly, but they are also putting themselves at risk to feel shame when they, themselves, may struggle with a mental health condition, which they are likely to experience at some point.

According to the World Health Organization, 46 percent of people can i buy kamagra over the counter will experience a mental health condition at some point in their life. When people feel ashamed of their mental health status or repeatedly hear messages that they should feel shame, it’s less likely they’ll seek the care they need. According to the Centers for Disease Control and Prevention, embarrassment is one of the many barriers that stop people from seeking treatment.

In fact, only about 20 percent of adults with a mental health condition actually can i buy kamagra over the counter seek treatment. There are many things people can do to reduce stigma. It beginswith each person looking at how they think about mental health conditions.Instead of compartmentalizing the world, it is useful to recognize that everyperson is human and all humans have struggles at times.

Sometimes thesestruggles can i buy kamagra over the counter interfere with functioning. When this disruption of functioning isgreat enough it may be diagnosed and may benefit from treatment. People can also talk about it can i buy kamagra over the counter.

Being open and honest about your own mental health can help others feel comfortable opening up about what they might be going through. People need to be careful with words. Using real mental health conditions as negative adjectives sends a message that those diagnoses aren’t taken can i buy kamagra over the counter seriously and aren’t worthy of seeking treatment for.

People should educate themselves. Learning more about mentalhealth conditions and available treatments can help people to be betterprepared to help friends and family by recognizing symptoms of mental healthconditions, and recognizing and accepting in themselves. There is no shame in seeking help for a mental health issue.In fact, seeking treatment is a commitment can i buy kamagra over the counter to yourself and for everyone youlove.

Recognizing that there is no shame in mental health struggles will resultin reduced stigma and increased compassion for yourself and others. All humans can i buy kamagra over the counter have struggles. It’s part of the human condition.Recognizing this can help people to be honest and accept others, andthemselves, without shame.

For those who are struggling, MidMichigan Health provides aPsychiatric Partial Hospitalization Program at MidMichigan Medical Center –Gratiot. Those interested in more information about the PHP can i buy kamagra over the counter program may call(989) 466-3253. Those interested in more information on MidMichigan’scomprehensive behavioral health programs may visitwww.midmichigan.org/mentalhealth.With May being Mental Health Awareness month, I would like to take this opportunity to introduce myself and the services we offer at Senior Life Solutions.

We provide group and individual therapy for an older adult population. We provide these services in person can i buy kamagra over the counter or by using a telehealth platform. Due to erectile dysfunction treatment, mental health challenges have been on the rise in the senior population.

This can be due to many factors, but isolation can i buy kamagra over the counter and loneliness appear to be two of the largest contributing factors. If you know or are an older adult struggling through this kamagra, there is help available. Many people feel ashamed, anxious or embarrassed about entering group therapy.

This is can i buy kamagra over the counter normal. But for most people, even after one session they feel that they have been heard by their peers and understood by people that are going through very similar situations. Things that you might have noticed about yourself or a loved one like changes in appetite, sleep patterns, not enjoying the things in life that you used to enjoy or giving up on hobbies, can all indicate emotional distress.

These are all symptoms of depression that many people mistake can i buy kamagra over the counter for “normal aging.” Grief is another issue that affects seniors. If you have recently lost a spouse, family member or loved one, your life might be feeling out of control, hopeless or meaningless. It may feel like can i buy kamagra over the counter you are going through all of this alone or that no one could possibly understand.

I have had many people say similar statements to me when they first start this program. But the truth is, there are many people who have gone through and are going through what you are experiencing right now. That is can i buy kamagra over the counter where the power of group therapy comes in.

Recognizing your story in another person can give the feeling of hope and that recovery is a possibility. For some people, “the golden years” are not as golden as they should be. With the erectile dysfunction treatment kamagra, it can seem that there is no way to get out to attend a program like can i buy kamagra over the counter this.

This is where telehealth plays a huge role. We are able to offer these services and you are able to attend group can i buy kamagra over the counter from your home. Telehealth has been a real game changer during this kamagra as it has allowed people who otherwise would not be able to attend group and individual sessions get the help that they deserve.

If you or someone you know could be helped by our services, call our office at (989) 246-6339 and we’ll guide you from there. On a personal note, I have been the can i buy kamagra over the counter program therapist since the beginning, and I’ve had the opportunity to work with many people and see the improvements that people make as they progress through the program. I feel blessed that I have the opportunity to play a part in people’s lives changing for the better.

David Bailey, L.M.S.W., is the program therapist for Senior Life Solutions..

What side effects may I notice from Kamagra?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in hearing
• changes in vision, blurred vision, trouble telling blue from green color
• chest pain
• fast, irregular heartbeat
• men: prolonged or painful erection (lasting more than 4 hours)
• seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• flushing
• headache
• indigestion
• stuffy or runny nose

This list may not describe all possible side effects.

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UC Davis Health endowment gifts also increased to a total of $53 million, and donations can i buy kamagra over the counter received on Give Day increased to over $410,000, up 26% over the $325,540 donated in the previous year. €œDespite the challenges of the kamagra, our donors and friends enabled us to achieve a historic year in fundraising,” said David Lubarsky, CEO of UC Davis Health and Vice Chancellor for Human Health Sciences. €œThey gave extraordinarily generous gifts because they know their investments in our people – our students, our faculty, our can i buy kamagra over the counter researchers — are keeping patients healthier, delivering clinical innovations that improve health for everyone and protect our community’s health into the future.” Among the many standout gifts to UC Davis Health was a $4 million commitment from entrepreneur and philanthropist Daryl Geweke.

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From UC Davis, for the can i buy kamagra over the counter World,” last October, UC Davis has raised more than $1.3 billion from 102,156 donors, and is ahead of schedule to reach the $2 billion goal. Together, donors and UC Davis are advancing work to prepare future leaders, sustain healthier communities and bring innovative solutions to today’s most urgent challenges. From student scholarships and philanthropic grants, to can i buy kamagra over the counter naming opportunities for buildings and facilities – there are countless ways to invest in the future of UC Davis.

As part of the Expect Greater campaign, UC Davis Health can i buy kamagra over the counter is researching several Big Ideas that tackle some of the world’s most difficult challenges, including Healthy Aging in a Digital World and the Center for Violence Prevention Research. €œWe are grateful to our donors, whose partnership and generosity support everything from trailblazing research to life-changing educational experiences for our talented students,” said Allison Brashear, dean of the UC Davis School of Medicine. €œThis tremendous can i buy kamagra over the counter support from our donors helps our medical school transform lives through innovative education, research, clinical care and community partnerships.” “The outside investment in our mission is a testament to our interprofessional programs that complement nursing, collaborations with UC Davis and community partners, and the School of Nursing’s commitment to go beyond clinical education.

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That they visit are ‘following the science’ kamagra oral jelly for ladies has become the watchword of many politicians during the present kamagra, especially when imposing or prolonging lockdowns or other liberty-restricting regulations. The scientists who advise politicians however are usually careful to add that the decision what to restrict and when is ultimately a political one. In science, as in medical practice, there is a delicate balance to be maintained between confidence in the best available information, and the necessary caveat kamagra oral jelly for ladies that the assumptions and calculations on which that information is based are subject to further scientific enquiry. For politicians and the public, moreover, as for patients, whether those informing them are judged to be trustworthy is a necessary consideration, a judgement determined by a variety of personal and political contingencies and circumstances. Ethics, by contrast, unable to appeal to scientific consensus (however revisable) or political authority (however reversible), let alone a confidence-inspiring bedside manner, must rest the case for its essentially contestable assumptions and arguments being judged trustworthy, on its willingness to admit all reasoned voices (including occasionally those that question reason itself) to a conversation that is potentially unending, but in the process often highly enlightening.That conversation is contributed kamagra oral jelly for ladies to in this issue of the Journal by several reasoned voices, mostly on ethical aspects of the erectile dysfunction treatment kamagra.

Relevant to issues on which politicians claim to be ‘following the science’, but also raising fundamental ethical questions, is this month’s feature article. In Ethics of Selective Restriction of Liberty in a kamagra,1 Cameron and colleagues consider ‘if and when it may be ethically acceptable to impose selective liberty-restricting measures in order to reduce the negative impacts of a kamagra by preventing particularly vulnerable groups [for example, the elderly in erectile dysfunction treatment] of the community from contracting the disease’ [and kamagra oral jelly for ladies thereby, for example, increasing the disease burden]. €˜Preventing harm to others when this is least restrictive option’, they argue, ‘fails to adequately accommodate the complexity of the issue or the difficult choices that must be made’. Instead, they propose ‘a dualist consequentialist approach, weighing utility at both a population and individual level’, thereby taking account of ‘two relevant values to be promoted or maximised. Well-being and liberty’, as well as the kamagra oral jelly for ladies value of equality, ‘protected through the application of an additional proportionality test’.

The authors then propose an algorithm to take account of the different values and variables which need to be weighed up. They conclude kamagra oral jelly for ladies. €˜Selective restriction of liberty is justified when the problem is grave, the expected utility of the liberty restriction is high and significantly greater than the alternatives and the costs of the liberty restrictions are relatively small both at a population and individual level… Discrimination can be justified under these conditions when it is proportionate and limited to a very specific public health challenge’. The arguments and conclusions of the feature kamagra oral jelly for ladies article are discussed in the two Commentaries2 3.In erectile dysfunction treatment controlled human studies. Worries about local community impact and demands for local engagement,4 Eyal and Lee review recent arguments which express ‘concern about undue usage of local residents’ direly needed scarce resources at a time of great need and even about their unintended ’ – and hence a requirement for ‘either avoiding controlled trials (CHIs) or engaging local communities before conducting CHIs’.

They then examine and compare the evidence of such adverse (and some potentially positive) effects of CHIs with those of conventional field trials and argue that ‘both small and large negative effects on struggling communities are likelier in field trials than in CHIs’. €˜Whether or not kamagra oral jelly for ladies local community engagement is necessary for urgent treatment studies in a kamagra’, they conclude, ‘the case for its engagement is stronger prior to field trials than prior to controlled human studies’.In Payment of erectile dysfunction treatment challenge trials. Underpayment is a bigger worry than overpayment,5 Blumenthal Barby and Ubel consider the impact not on communities but on individuals, and specifically on ‘how much people should be paid for their participation in erectile dysfunction treatment challenge trials’. Noting recent worries about ‘incentivising people with large amounts of money’, they argue that ‘higher payment that accounts for participant time, and kamagra oral jelly for ladies for pains, burdens and willingness to take risks’ constitutes neither ‘undue inducement’ (for which the remedy is strengthening informed consent processes and minimising risks) nor ‘unjust inducement’ of individuals from ‘already disadvantaged groups’. Evidence of recruitment to challenge trials worldwide suggests, on the contrary, that participants ‘come from all walks of life’.

Nor are these authors convinced that ‘offering substantial payment kamagra oral jelly for ladies waters down the auistic motives of those involved’. €˜auism and payment’ they argue, ‘frequently coexist. Teachers, physicians, public defenders – they all dedicate their lives to helping people. But few do without compensation.’In Money kamagra oral jelly for ladies is not everything. Experimental evidence that payments do not increase willingness to be vaccinated against erectile dysfunction treatment6, Sprengholz and colleagues report on an ‘experiment investigating the impact of payments and the communication of individual and prosocial benefits of high vaccination rates on vaccination intentions.’ In November 2020 over 1,000 ‘individuals from a German non-probabilistic sample’ were asked about their intentions.

The ‘results revealed that none of these interventions or their combinations increased willingness to be vaccinated shortly after kamagra oral jelly for ladies a treatment becomes available.’ Given that this experiment was conducted before treatments became available and only in Germany, the authors suggest that these results ‘should be generalised with caution’, but that ‘decision makers’ also ‘should be cautious about introducing monetary incentives and instead focus on interventions that increase confidence in treatment safety first’.In Voluntary erectile dysfunction treatment vaccination of children. A social responsibility,7 Brusa and Barilan observe a kamagra paradox. €˜while we rely on low quality evidence when harming children by school deprivation and social distancing, we insist kamagra oral jelly for ladies on a remarkably high level of safety data to benefit them with vaccination’. The consequent exclusion of children from vaccination, they argue, is unjust and not in ‘the best interest of the child as a holistic value encompassing physical, psychological, social and spiritual well-being’, something which ‘there is no scientific method for evaluating’. Society, rather, ‘has the political responsibility to factor in the overall impact of the kamagra on children’s well-being’ and the ‘ultimate choice is a matter of paediatric informed consent.

Moreover, jurisdictions that permit non-participation in established childhood vaccination programmes should also permit choice of treatments outside of the kamagra oral jelly for ladies approved programmes.’ The authors conclude by outlining ‘a prudent and ethical scheme for gradual incorporation of minors in vaccination programmes that includes a rigorous postvaccination monitoring.’In Challenging misconceptions about clinical ethics support during erectile dysfunction treatment and beyond. A legal update and future considerations,8 Brierley, Archard and Cave note that the ‘erectile dysfunction treatment kamagra has highlighted the lack of formal ethics processes in most UK hospitals… at a time of unprecedented need for such support’. Unlike Research Ethics Committees (RECs), Clinical Ethics Committees (CECs) in the UK have neither any ‘well-funded governing authority,’ nor the decision-making capacity kamagra oral jelly for ladies over clinical questions which RECs have over research. In 2001 the ‘three central functions of CECs’ were described as ‘education, policy development and case review’. But more recently ‘the role of some was expanding’ and in 2020 the UK General Medical Council ‘mentioned for the first time the value in seeking advice kamagra oral jelly for ladies from CECs to resolve disagreements’.

Misunderstanding of CEC’s role however began to arise when some courts appeared to ‘perceive CECs as an alternative dispute resolution mechanism’ rather than as providing ‘ethics support, with treatment decisions remaining with the clinical team and those providing their consent.’ The future role of CECs, as well as the nature of patient involvement in them, the authors conclude, will depend on a choice between the ‘flexibility and diversity of the current ethical support system’ and ‘greater standardisation, governance and funding’.Important ethical issues not directly related to erectile dysfunction treatment are discussed in this issue’s remaining papers. In Institutional conflict of interest. Attempting to crack the deferiprone mystery,9 Schafer identifies, kamagra oral jelly for ladies places in historical context, and analyses ethical issues raised by the ‘ mystery’ of why between 2009 and 2015 ‘a third of patients with thalassaemia in Canada’s largest hospital were switched from first-line licensed drugs to regimens of deferiprone, an unlicensed drug of unproven safety and efficacy’. He then considers ‘institutional conflict of interest’ as ‘a possible explanatory hypothesis’.The perils of a broad approach to public interest in health data research. A response to Ballantyne and Schaefer10 by Grewal and Newson and Ballantyne and Schaefer’s response In defence of a broad approach to public interest in health data research11 debate legal and philosophical aspects of whether ‘public interest’, and how narrowly or broadly this is conceived, is the most appropriate justification of consent waivers for secondary research on health information.In Do we really know how many clinical trials are conducted ethically,12 Yarborough presents evidence in support of the argument that 'research ethics committee kamagra oral jelly for ladies practices need to be strengthed' and then suggests 'initial steps we could take to strengthen them'.Finally, and returning to how ‘science’ is perceived, in Lessons from Frankenstein 200 years on.

Brain organoids, chimaeras and other ‘monsters’13, Koplin and Massie make a crucial observation. In ‘bioethical debates, Frankenstein is usually evoked as a kamagra oral jelly for ladies warning against interfering with the natural order or “playing God”’. But in the novel, Frankenstein’s ‘most serious moral error’ was made ‘not when he decided to pursue his scientific breakthrough (one which might, after all, have helped save lives), but when he failed to consider his moral obligations to the creature he created.’ Today, when, like Frankenstein, ‘modern scientists are creating and manipulating life in unprecedented ways’ such as brain organoids and chimaeras, Koplin and Massie argue, ‘two key insights’ can be drawn from Mary Shelley’s 1818 novel. First, ‘if we have created an entity in order to experiment on it’ we need ‘to extend much consideration to its interests and preferences, not least because ‘scientists cannot always rely on existing regulations to anticipate moral issues associated with the creation of new kinds of organisms’. And second kamagra oral jelly for ladies.

€˜we should be wary of any prejudice we feel towards beings that look and behave differently from us’ and should ‘interrogate any knee-jerk intuitions we have about the moral status of unfamiliar kinds of beings.’Ethics statementsPatient consent for publicationNot required.IntroductionThalassaemia is an inherited anaemia that exerts an enormous disease burden worldwide.1 Along with sickle cell disease, it is one of the two most common single gene disorders. Indeed, ‘the alpha and beta thalassaemias are the most common inherited single-gene disorders in the world…’2A newly published study by Olivieri, Sabouhanian and Gallie3 analyses and kamagra oral jelly for ladies assesses the comparative efficacy and safety profile of two drugs. Deferiprone (Ferriprox. Apotex) and deferasirox kamagra oral jelly for ladies (Exfade. Novartis).

Both of these ‘iron-chelating’ drugs remove (‘chelate’) iron deposited, as a result of transfusions, in the tissues of patients with kamagra oral jelly for ladies thalassaemia.The present-day first-line chelator, deferasirox, was licensed by the US FDA in 2005. The evidence for its safety and effectiveness was judged to be substantial and, accordingly, the FDA licensed it as a first-line agent. The prime advantage of deferasirox, in comparison to deferoxamine, an older drug that was formerly the gold standard of iron-chelating therapy for thalassaemia, is that deferasirox is orally active (that is, taken in pill form), while deferoxamine is more burdensome for patients because it has to be taken parenterally (that is, via injection). Deferiprone, like deferasirox, is taken orally but has not been licensed anywhere as first-line kamagra oral jelly for ladies treatment. The FDA withheld market approval for deferiprone because there were/are no controlled trials demonstrating direct treatment benefit.

Although the FDA did eventually approve kamagra oral jelly for ladies deferiprone, in 2011, it gave approval only as a last-resort treatment for those patients in whom other chelators had been tried unsuccessfully.1The data presented by Olivieri et al in their PLOS ONE paper indicate that the drugs differ significantly with respect to their effectiveness and safety. This commentary explores some of the ethical issues raised by the PLOS data.Historical contextIn order to understand properly the significance of the PLOS ONE Study some historical context will be helpful. What follows is a brief sketch of that context.2In 1993 Dr Nancy Olivieri, a specialist in blood diseases at Toronto’s Hospital for Sick Children (HSC or ‘Sick Kids’) and Professor of Pediatrics and Medicine at the University of Toronto (U of T), signed a contract with Apotex, a generic drug company, to continue studies of deferiprone, the early promise of which she had already reported in the kamagra oral jelly for ladies literature. Olivieri’s thalassaemia research was initially supported by the Medical Research Council of Canada, but now she sought additional funding to extend her clinical trials. Apotex contributed this additional funding, thereby obtaining worldwide patents on the still-experimental drug.Despite early promise, by 1996 Olivieri’s research began to indicate that deferiprone might be inadequately effective in many patients, posing risks of potentially serious harm.

Olivieri communicated to Apotex her intention to inform patients of this unexpected risk and she proposed also to amend the study’s kamagra oral jelly for ladies consent forms. She wished to continue amended studies of the drug, and to publish her findings.Apotex responded to Olivieri that they disagreed with her interpretation of the data and the company’s CEO threatened her with ‘all legal remedies’ should she inform patients or publish her findings. In issuing these threats, Apotex relied on a confidentiality clause in a legal contract Olivieri had signed with Apotex kamagra oral jelly for ladies in 1993. This contract prohibited disclosure ‘to any third party’ without the express permission of Apotex.3Despite the objections raised by Apotex, Olivieri saw it as her professional duty to disclose her findings. The Research Ethics Board (REB) of Sick Kids Hospital kamagra oral jelly for ladies reached the same conclusion.

In compliance with instructions from the Hospital’s REB, Olivieri duly informed both her patients and the regulatory authorities.When Olivieri later identified a second risk—that liver damage progressed during deferiprone exposure—Apotex issued additional legal warnings. Olivieri nevertheless proceeded to inform her patients of this additional risk and published her findings.Since patient safety, research integrity and academic freedom were all at stake in this dispute, Olivieri appealed for assistance, repeatedly, to senior officials at both the U of T and Sick Kids Hospital. Neither the kamagra oral jelly for ladies University nor the Hospital provided the support she requested. In the words of the Report of the Committee of Inquiry on the Case Involving Dr Nancy Olivieri, the HSC, the U of T, and Apotex Inc4:The HSC and the U of T did not provide effective support either for Dr Olivieri and her rights, or for the principles of research and clinical ethics, and of academic freedom, during the first two and a half years of this controversy.Instead, both the University and the Hospital ‘took actions that were harmful to Dr. Olivieri’s interests and professional reputation and disrupted her work’.4 The harmful actions included firing Olivieri from her position as Director of the Hemoglobinopathy Program at Sick Kids Hospital and referring her for discipline to the College of Physicians and Surgeons of Ontario (CPSO).Only later did it emerge that, during this period of conflict, the U of T was negotiating with Apotex kamagra oral jelly for ladies for a major donation towards building the University’s proposed new molecular medicine building.

Some speculated that the University’s failure to support Olivieri may not have been unconnected from its desire to appease a wealthy corporate donor. This speculation was reinforced when it was discovered that the kamagra oral jelly for ladies then President of the University, Robert Prichard, had secretly lobbied the government of Canada for changes in drug patent law, changes that would favour Apotex.4Apotex proceeded to sue Olivieri for defaming both the company and their drug. She sued the company for defaming her.The Canadian Association of University Teachers (CAUT) and the U of T Faculty Association (UTFA), to whom Olivieri appealed for assistance after being rebuffed by the U of T and HSC, viewed the underlying issue as one of academic freedom. Both CAUT and UTFA provided support, including legal advice, to Olivieri.Thus began what is widely acknowledged to be the greatest scandal in Canadian academic history. Commissions of inquiry, books and articles (both scholarly and popular) proliferated, not to kamagra oral jelly for ladies mention newspaper and television stories.

John le Carré’s novel The Constant Gardener and the Hollywood movie based on the book both appeared to draw heavily on the Olivieri-Apotex scandal. An inquiry into the dispute commissioned by Sick Kids Hospital (the Naimark Inquiry)5 absolved Apotex of wrongdoing but suggested that Olivieri was seriously at fault.5 She was charged with research misconduct and failures of patient care and was referred first to the Hospital’s Medical Advisory Council and subsequently kamagra oral jelly for ladies to the disciplinary committee of the CPSO. Unsurprisingly, these widely publicised referrals were prejudicial to Olivieri’s reputation.The CAUT then commissioned an independent inquiry.6 The 540-page CAUT report on the Olivieri/Apotex affair4 gave a markedly different account of the scandal from that offered by the hospital-commissioned Naimark Report. A few excerpts from the CAUT report will convey its central kamagra oral jelly for ladies findings:Apotex issued more legal warnings to deter Dr. Olivieri from communicating this second unexpected risk of L1 (deferiprone) to anyone.

However, she was legally and ethically obligated to communicate the risk to those taking or prescribing the drug as there were potential safety implications for patients, and she fulfilled these obligations despite the legal warnings.Apotex acted against the public interest in issuing legal warnings to Dr. Olivieri to kamagra oral jelly for ladies deter her from communicating about risks of L1.Apotex’s legal warnings violated Dr. Olivieri’s academic freedom.7Shortly after the CAUT report absolved Olivieri of misconduct, the CPSO published the findings of its inquiry. The CPSO report kamagra oral jelly for ladies exonerated Olivieri of all misconduct charges. Indeed, their report concluded that her conduct had been ‘commendable’.6 This favourable verdict did not, however, bring an end to litigation.In 2004, 8 years after the first legal threats had been issued, Apotex signed a mediated settlement with Olivieri.

Nevertheless, litigation kamagra oral jelly for ladies continued for another 10 years. Those unfamiliar with the workings of the law may wonder how it is possible for litigation to continue for such a long period after a mediated settlement. Litigation continued because Apotex alleged that Olivieri had violated their agreement. Olivieri insisted that she kamagra oral jelly for ladies was in compliance with the terms of the settlement. Court decisions were appealed by both parties.

A final settlement was not reached between Olivieri and kamagra oral jelly for ladies Apotex until 2014.8 Shades of Jarndyce v. Jarndyce in Charles Dicken’s novel Bleak House.The HSC settled its dispute with Olivieri in 2006 and, although her research programme at the Hospital continued, she ceased to provide clinical care to HSC patients. From 1997 to 2009, Olivieri kamagra oral jelly for ladies served as Director of the University Health Network (UHN) Hemoglobinopathy Program. She continued, as she had since 1997, to assist in the clinical care of UHN patients with thalassaemia and to enrol them in her research studies. In March 2009, however, Olivieri was dismissed by UHN from her position kamagra oral jelly for ladies as Director.

No reason was given for her dismissal (Personal communication. Olivieri, 2019).The PLOS ONE Study data3 show that, after Olivieri’s dismissal from her position as Director, the UHN thalassaemia Clinic began almost immediately to switch patients to (unlicensed) deferiprone. Olivieri has described how her UHN research work, from this time forward, was marginalised (https://inthepatientsinterest.org/wp-content/uploads/2019/12/2018-12-20-GallieOlivieri-to-SmithHodges.pdf).Meanwhile, Freedom of Information (FOI) requests filed by kamagra oral jelly for ladies Olivieri after her dismissal revealed that Apotex was supplying unrestricted educational grants to UHN’s thalassaemia programme as well as providing research support. The FOI requests filed by Olivieri also revealed that Apotex was strategising with the programme’s new director about how best to obtain licensing for deferiprone from the regulator (Health Canada).9 With this dramatic background as historical context, we commence our discussion of the ethical implications of the PLOS ONE paper.Findings of the PLOS ONE paperIn their 2019 PLOS ONE study Olivieri et al conclude, based on a retrospective review of patient data at Toronto’s UHN, that deferiprone is inadequately effective and associated with serious toxicity. Their review also confirms that, by contrast, deferasirox is effective and associated with relatively few adverse effects.3Olivieri et al report that ‘[b]etween 2009 and 2015, a third of patients transfused and kamagra oral jelly for ladies managed in Canada’s largest transfusion programme were switched from first-line, licensed drugs to regimens of unlicensed deferiprone’.3 This finding raises the ethically troubling question.

How and why were so many locally transfused patients at UHN treated over such a long time period with an unlicensed drug of unproven safety and efficacy?. This kamagra oral jelly for ladies ethical concern is followed immediately by another related concern. Why did the UHN thalassaemia programme continue to treat large numbers of its patients with deferiprone—despite ongoing evidence of inadequate effectiveness and serious (and often irreversible) adverse effects?. 3To recapitulate. The PLOS ONE paper demonstrates that a substantial proportion of UHN patients with thalassaemia was switched, between the years 2009 and 2015, from first-line licensed therapies (deferasirox or deferoxamine) to deferiprone kamagra oral jelly for ladies.

During this entire period, deferiprone was unlicensed in Canada. To this day in every kamagra oral jelly for ladies jurisdiction in which deferiprone has been licensed it has been licensed only as ‘last resort’ therapy. The ethical concern is to explain and to explore possible justifications for how and why so many patients at one particular thalassaemia treatment centre were prescribed a drug whose safety and efficacy were unproven in face of availability of licensed effective drugs. The urgency of the concern derives partly from the paper’s finding that those patients who were switched to deferiprone displayed evidence of increases in kamagra oral jelly for ladies body iron and experienced the harms associated with body iron increase.3 This finding raises a second troubling ethical question. Why were patients not switched back to a first-line licensed therapy after they began to experience serious adverse effects from treatment with unlicensed deferiprone?.

How and why?. In a sustained effort to discover answers to these kamagra oral jelly for ladies questions, Olivieri and Gallie have been in communication since 2015, by email and in personal meetings, with senior officials at UHN. Olivieri and Gallie report, however, that no definitive answers have yet been provided to any of their questions. FOI requests were filed but they, too, failed to produce kamagra oral jelly for ladies definitive answers. (Olivieri and Gallie to Smith &.

Porter, 2019, https://inthepatientsinterest.org/wp-content/uploads/2019/12/2019-04-23-OlivieriGallie-to-SmithPorter.pdf).10 I, too, wrote to the CEO/President of UHN and to the Chief of Medical Staff, in an attempt to discover answers kamagra oral jelly for ladies to a number of the ethical questions posed in this commentary. The hospital, however, has not responded to any of my questions.11Olivieri and Gallie have recently posted documentation of their correspondence with senior UHN administrators (https://inthepatientsinterest.org/). In September 2019 the UHN administration responded to the PLOS ONE paper by revealing that it had conducted a ‘Review of chelation practice in the red blood cell disorders program at UHN’. However, as Olivieri and Gallie document on the web, the hospital’s ‘Review’ does not address any of the safety kamagra oral jelly for ladies concerns flagged in the PLOS ONE paper (https://inthepatientsinterest.org/wp-content/uploads/2019/12/Letter-to-Smith-and-Hodges-2-12-19.pdf). Nor does the ‘Review’ address any of the ethical concerns raised here.Despite UHN’s apparent reluctance to provide the information requested, here’s what we know or can reasonably infer.

Deferiprone was unlicensed in Canada during the relevant period, that is, from 2009 kamagra oral jelly for ladies to 2015. €˜Unlicensed’ is different from ‘off-label’, the latter referring to a drug that has been licensed but is being provided for an indication other than that for which it is approved. Prescription of any unlicensed drug to Canadian patients can be accomplished only in one of two mutually exclusive kamagra oral jelly for ladies ways. Either through Health Canada’s ‘Special Access Program (SAP)’ or via an REB approved clinical trial. It has to be one or the other since, as Health Canada’s Guidance Document7 makes clear, patients cannot be simultaneously treated through SAP and in a research trial.12 Under the SAP, the treating physician must confirm to Health Canada that ‘conventional therapies have failed, or are unsuitable or unavailable’.

Although some of the UHN patients’ records indicate that deferiprone was released under the SAP, Olivieri et al report that they ‘could identify no explanation for a proposed switch to kamagra oral jelly for ladies deferiprone that was supported by evidence of failure of licensed therapy prescribed as recommended’3. Indeed, the authors write that many patients appear to have been switched to deferiprone despite optimal responses, or improvements during treatment with first-line therapies. Here’s the relevant paragraph from their PLOS ONE article:Deferiprone was prescribed to 41 study patients between 2009 kamagra oral jelly for ladies and 2015. We could identify in the electronic medical records no explanation for a proposed switch to deferiprone that was supported by evidence of failure of licensed therapy prescribed as recommended. There was no kamagra oral jelly for ladies indication that any patient switched to deferiprone over these 6 years had ‘failed’ therapy with either deferoxamine or deferasirox.

Many patients were recorded as tolerant of at least one and (in most), both licensed first-line chelating agents. Some had sustained minor adverse events during deferasirox that had resolved by the time deferiprone was prescribed.3In other words, according to the data found in UHN patient records, there is no evidence that the patients with thalassaemia who were switched to deferiprone met Health Canada’s eligibility criteria under SAP. Since deferiprone is licensed only as a ‘last resort’ therapy, its employment to treat patients who can tolerate either of the first-line therapies might improperly expose those patients to risks of serious medical harms, up to and including death.On kamagra oral jelly for ladies the other hand, one should also consider the alternate possibility that, over the 6-year period studied by Olivieri et al, deferiprone was prescribed as part of a clinical trial. In favour of this hypothesis, one notes that the UHN physician primarily responsible for the widespread prescribing of deferiprone during the relevant time period claimed, in 2011, that deferiprone was provided to patients under a study approved by the REB of the UHN.8 UHN physicians also made this identical claim in a publicly available letter to the US FDA.9 Moreover, in response to an FOI application filed by Olivieri, UHN claimed that deferiprone was provided at UHN during a clinical trial (the data of which are protected from scrutiny under FOI laws), and not under SAP (the data of which are not protected from scrutiny under FOI). However, Olivieri et al have been unable to find any record of registration for such kamagra oral jelly for ladies a trial, as required by Canadian Clinical Trial guidelines.13 Requests to the UHN administration for confirmation that a clinical trial existed remain unanswered.14 My own efforts to find some registration record for this putative clinical trial of deferiprone have been equally unsuccessful.15Two core ethical principles.

Harm-minimisation and informed consentIf the deferiprone used to treat UHN patients with thalassaemia was obtained from Apotex as part of a randomised clinical trial, responsibility for approving the trial would fall to the UHN’s REB. In Canada, both researchers and REBs are governed by the Tri-Council Policy Statement (TCPS) ‘Ethical Conduct for Research Involving Humans’.10 The 1998 version of this policy statement (TCPS1) and kamagra oral jelly for ladies the subsequent 2010 version (TCPS2), both applicable to research trials during this period, stipulate that clinical trials must be designed so that harm to research subjects will be minimised.16 For example, TCPS1 specifies, in section 1.5, that ‘Research subjects must not be subjected to unnecessary risks of harm’. TCPS2, under the rubric ‘Core Principles’, requires similarly that clinical trials must ‘ensure that participants are not exposed to unnecessary risks’.Data presented by Olivieri et al in their PLOS ONE Study indicate that UHN patients exposed to unlicensed deferiprone, either as monotherapy or in combination with low dose of a first-line chelator (‘combination therapy’), experienced significant harms as a result of poor iron control, but very few if any compensating benefits.We provide new evidence of inadequate reduction in hepatic iron, a 17% incidence of new diabetes and new liver dysfunction in 65% of patients, many who were challenged and rechallenged with deferiprone despite elevated liver enzymes developed during previous exposure. We identified no evidence of ‘cardio-protective’ effect during deferiprone therapy.3In light of PLOS ONE Study data indicating serious adverse events (SAEs) for patients switched to deferiprone from first-line drugs one is led to question why the kamagra oral jelly for ladies study protocol did not, in anticipation of such a contingency, provide for a resumption of licensed therapy for patients doing poorly on the unlicensed drug. Moreover, the investigators were obliged to report adverse events to the hospital’s REB.

Were the adverse events so reported?. And if they were then why did the UHN REB not seek to protect patient safety kamagra oral jelly for ladies by insisting that licensed therapy be resumed for deferiprone-harmed patients?. In an effort to establish whether the deferiprone ‘clinical trial’ satisfied the TCPS harm-minimisation principle, I made inquiries about how the adverse findings described by the PLOS ONE paper were reported to the hospital’s REB and also how they were reported to the regulatory authorities, that is, Health Canada and the US FDA. But my queries, like those made previously by Olivieri and Gallie, have not succeeded in eliciting this ethically relevant information.17 Neither UHN nor its thalassaemia clinic responded to my letters kamagra oral jelly for ladies of inquiry. It is known, however, from a publicly available 2011 document, that physicians in the UHN thalassaemia clinic strongly supported the market approval of deferiprone by the FDA.18 This support is difficult to reconcile with the toxicities recorded in UHN patient records.

So, a final verdict on the issue of whether the UHN deferiprone ‘clinical trial design’ violated the TCPS harm-minimisation principle cannot be reached until those involved in conducting and monitoring clinical trials at kamagra oral jelly for ladies UHN make available the relevant information. An independent public inquiry may be necessary to achieve the necessary degree of accountability.Reference has been made, above, to the TCPS core ethical requirement of harm-minimisation, applicable in Canada both to researchers and to REBs. It is important to note, however, that TCPS2, like its predecessor, TCPS1 (and, indeed, like virtually every postwar code of research ethics) also stipulates as a second ‘core principle’ that ‘Researchers shall provide to prospective participants, or authorised third parties, full disclosure of all information necessary for making an informed decision’.19 Moreover, as the then-current TCPS guidelines make clear, ‘consent is an ongoing process’. So, assurance should be given to prospective participants that they ‘will be given in a timely manner throughout the course of the research project, information that is relevant to their decision to continue or withdraw from kamagra oral jelly for ladies participation’.20 (My emphasis). Finally, TCPS2 imposes on researchers the additional ethical requirement that they disclose to research subjects ‘information concerning the possibility of commercialisation of research findings, and the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors’.21 There is also an expectation that conflicts of interest will be disclosed to the REB.

Whether there was adequate disclosure of Apotex funding either to research subjects or to the UHN REB is still unknown.Thus, in order to assess the ethical kamagra oral jelly for ladies adequacy of the putative UHN thalassaemia clinical trial one must inquire whether UHN patients/subjects were given adequate risk information when they were first enrolled, subsequently, when they were switched from treatment with deferasirox or deferoxamine to treatment with deferiprone and then, finally, when they experienced SAEs. That is, in order to know whether the putative deferiprone clinical trial conformed to established principles of research ethics, one would need to know whether patients/research subjects understood that they were being switched from licensed first-line drugs of proven efficacy to an unlicensed and unproven third-line drug. One would also need to know whether the deferiprone ‘research subjects’ were informed about conflicts of interest kamagra oral jelly for ladies arising from Apotex donations (A) to the UHN. (B) To the hospital’s thalassaemia programme,22 as well as the hoped-for commercialisation of deferiprone via Health Canada and FDA licensing.If there was a failure to obtain ongoing informed consent and/or a failure to disclose conflicts of interest (to patients and to the REB) then this would constitute a violation of research ethics. Unfortunately, my attempts to elicit the clinical trial’s consent to research information from the UHN and its thalassaemia clinic met with as little success as earlier attempts made by the PLOS ONE authors.23REB review.

Safety monitoringAlthough every clinical trial requires safety monitoring, those trials which involve non-negligible risk of significant harm to patients/subjects kamagra oral jelly for ladies require especially rigorous safety monitoring.24 Because the exposure of deferiprone to UHN patients posed risks of organ dysfunction and death, the need for safety monitoring was exigent. As the TCPS1 and TCPS2 both make clear, those who conduct research have an obligation to monitor and protect the safety of their research subjects.Moreover, it is now widely recognised that individuals closely involved with the design and conduct of a trial may not be able to be fully objective in reviewing interim data for any emerging concerns.25 Hence the importance of REBs, part of whose role is to provide safety monitoring initially and, for ongoing trials, over the entire period of the trial. In order to assess the adequacy of the safety monitoring for the UHN ‘deferiprone trial’ one would need to know whether the hospital’s REB was provided with regular and accurate reports of SAEs and what actions this REB took in response to those reports.It has become common kamagra oral jelly for ladies practice in North America ‘that for any controlled trial of any size that will compare rates of mortality or major morbidity’, a data safety monitoring board (DSMB) will be established.26,11 12 A DSMB is constituted by a panel of independent (and otherwise unbiased) individuals with expertise pertinent to reviewing trial data on a regular ongoing basis. Its role is to advise the sponsors regarding the safety of trial subjects and to recommend early termination where indicated, for example, on grounds of patient safety.27Since there are no specifically Canadian requirements with respect to the establishment of DSMBs, Canadian REBs tend to follow FDA guidelines. Those guidelines recommend that a DSMB should be established when the study end point is such that a highly favourable or unfavourable result at an interim analysis might ethically kamagra oral jelly for ladies require termination of the study.

Advance information suggesting the possibility of serious toxicity with the study treatment is another a priori reason for safety concern that would justify the establishment of a DSMB.12For reasons given above, the UHN deferiprone trial appears to have been a prime candidate for the establishment of a DSMB. But it is not known whether the study’s research protocol, purportedly submitted for approval to the hospital’s REB, included a DSMB. Nor is it known whether a DSMB was established and reported regularly to the trial’s sponsors kamagra oral jelly for ladies. Data on the toxicity of deferiprone, provided by Olivieri et al from their retrospective study of UHN patient records, suggest that had a DSMB existed for this putative clinical trial the trial might, on grounds of patient safety, have been a candidate for premature cancellation. Lacunae in our knowledge of the safety monitoring provisions of the deferiprone ‘clinical trial’ make it difficult to reach any firm conclusion as to whether the ‘trial’ met prevailing safety monitoring requirements.The apparent unwillingness of the UHN to answer questions kamagra oral jelly for ladies relating to safety monitoring might mean that an inquiry is needed to fill in our knowledge gaps and thereby make ethical evaluation possible.

For the findings of such an inquiry to be minimally credible it should be carried out by individuals who possess the requisite scientific/medical expertise and who are independent of the hospital and its thalassaemia clinic and who are demonstrably impartial. An inquiry carried out, for example, by someone whose research has been funded by Apotex and/or by an expert with close professional and personal ties to one or more of the physicians in the UHN thalassaemia clinic would not satisfy the hospital’s duty of accountability for patient safety.Ethical concernsA RecapitulationThe serious complications experienced by deferiprone-exposed UHN patients, as described by kamagra oral jelly for ladies Olivieri et al in their PLOS ONE article, raise a number of ethically important questions. How could an unlicensed drug of unproven efficacy and safety—a drug that has been questioned by regulatory agencies such that it is licensed only as a “last resort” therapy—have been administered to so many patients over a period of so many years when two licensed drugs, both proven adequately safe and effective and licensed as first-line therapies, were available?. How did UHN physicians gain access to deferiprone from Health Canada when there is little evidence in UHN patient records that the deferiprone-exposed patients satisfied Health Canada’s criteria for Special Access?. Why was a putative UHN REB-approved research study involving deferiprone not registered kamagra oral jelly for ladies as a clinical trial?.

Did the trial design include a DSMB, to protect patient safety and, if not, why not?. Were SAEs reported to the UHN REB and kamagra oral jelly for ladies to regulators, as required?. Were deferiprone-treated UHN patients with thalassaemia adequately informed of the unlicensed status, unproven efficacy and reported toxicities of deferiprone?. Were deferiprone-exposed patients informed of harms they themselves had sustained during deferiprone from this exposure? kamagra oral jelly for ladies. 28 Did the evidence of systematic treatment failure, as outlined in the PLOS ONE paper, raise red flags for thalassaemia clinic physicians and for the REB of UHN?.

And if serious problems were flagged what actions were taken to protect patient safety?. Institutional conflict of interestThe literature on biomedical conflicts of interest tends to focus on the ways in which financial support of individual researchers by the pharmaceutical industry can kamagra oral jelly for ladies adversely affect both research integrity and patient safety.13–16 But similar ethical problems arise at the macro level when institutions, such as hospitals and clinics, depend on drug company funding to support patient care and clinical research.13 15 Notable scandals associated with institutional conflicts of interest include the David Healy/Eli Lilly scandal at Toronto’s Centre for Addictions and Mental Health (CAMH),13 the Aubrey Blumsohn/Proctor and Gamble scandal at Sheffield University (UK)17 and the Carl Elliott/Janssen Pharmaceuticals scandal at the University of Minnesota.17 The underlying pattern in each of these scandals involves (A) a biomedical researcher who is concerned about patient safety coming into conflict with (B) a pharmaceutical company which funds both the researcher’s hospital and university and (C) a failure by the institutions involved vigorously to defend patient safety and research integrity when doing so might offend a wealthy sponsor.It should not be assumed that corporate influence on university medical centres is necessarily exerted by means of threats or other direct forms of intervention. The mere presence of corporate funding can be sufficient to produce a corporate-friendly result. This point is illustrated by a recent STAT article, a propos the financial support which Purdue Pharma provided to kamagra oral jelly for ladies Massachusetts General Hospital. The very title of the article encapsulates the ethical problem of institutional conflict of interest.

€˜Purdue Pharma cemented ties with universities and hospitals to expand opioid sales, documents contend’.18 Nor should it be kamagra oral jelly for ladies supposed that the problem of institutional conflict of interest arises exclusively in the context of biomedical research. A recent Guardian article on the Mobil Oil Corporation describes how ‘Oil giant Mobil sought to make tax-exempt donations to leading universities … to promote the company’s interests and undermine environmental regulation, according to internal documents from the early 1990s obtained by the Guardian’.19As mentioned above, deferiprone, whose safety and efficacy are the central concern of Olivieri et al’s PLOS ONE paper, is manufactured by Apotex. When we seek to understand why deferiprone was so frequently prescribed to UHN patients, from 2009 to 2016, despite its being unlicensed and despite evidence of poor patient outcomes,3 it may be relevant to note that kamagra oral jelly for ladies Apotex provided substantial funding to the UHN thalassaemia clinic.29 Moreover, a publicly displayed UHN banner lists ‘Apotex Inc – Barry and Honey Sherman’ as having donated between $1 million and $5 million to the hospital itself.30As every biomedical researcher understands, correlation is not causation. Nevertheless, the correlation between industry funding of hospitals, on the one hand, and industry-friendly decisions made by researchers and administrators at those hospitals, on the other, is worth pondering. Physicians and researchers who speak or write critically of drugs manufactured by wealthy donor companies may find that their careers are jeopardised.

Nancy Olivieri’s dismissal from two Apotex-funded teaching hospitals illustrates this phenomenon as does the termination of psychiatrist David Healy from Toronto’s CAMH.13 Healy’s appointment as Head of the CAMH Mood Disorders Clinic was rescinded almost immediately after he gave a public kamagra oral jelly for ladies lecture at the hospital—a lecture in which he called for further research into the potentially adverse effects of Eli Lilly’s antidepressant drug, Prozac. Healy was particularly concerned about SSRI-induced suicidal ideation. After his lecture the kamagra oral jelly for ladies hospital decided that he was not ‘a good fit’ with their programme and terminated his appointment. Shortly thereafter the hospital opened its Eli Lilly wing.13UHN, like every other research and teaching hospital in Canada, receives most of its funding, directly or indirectly, from governments.20 ,31 Nevertheless, UHN, again like other hospitals, faces ongoing pressure to find additional sources of revenue to support both patient care and clinical research.32 The pharmaceutical industry is a prime source of much-needed ‘top-up’ financial support for Canadian hospital research and clinical care.21 Hospital administrators, researchers and clinicians are thereby placed, willy nilly, in a conflict-of-interest situation. Because of funding exigencies, kamagra oral jelly for ladies hospitals and other healthcare institutions, like individual physicians and researchers, have a strong vested interest in pleasing corporate sponsors and encouraging their ongoing support.

Moreover, institutional administrators, not unlike individual researchers and clinicians, typically experience a need to express their gratitude to donors by returning kindness for kindness and benefit for benefit. Thus, both the need for ongoing corporate sponsorship and the need to reciprocate for past corporate generosity create for hospital administrators (as well as for researchers and clinicians who work within hospitals) a conflict-of-interest situation in which their decision making may be skewed, consciously or unconsciously, in favour of the benefactors’ products.13 15 16 21Here’s an example of the manner in which an institutional conflict-of-interest situation can potentially bias the judgement of hospital administrators. Hospitals are required to exercise their disinterested judgement in the appointment of kamagra oral jelly for ladies medical and scientific staff and in the ethical monitoring of research. This moral obligation follows directly from their fundamental commitment to promote and defend patient safety and research integrity. To illustrate kamagra oral jelly for ladies.

UHN’s website, under the heading Purpose, Values and Principles, declares that ‘[o]ur Primary Value and above all else. The needs of patients come first’.22 It would be difficult to find any hospital whose Mission Statement did not proclaim a similar commitment to kamagra oral jelly for ladies the primacy of patient well-being. In a similar vein, the UHN website, under the heading Information for Patients, subheaded Our Mission, declares. €˜We believe that health equity is achieved when each person is. Enabled to choose the best care and treatment based on the most current knowledge kamagra oral jelly for ladies available’.From this fundamental commitment, it follows that healthcare institutions are obliged rigorously to monitor the quality of care provided to their patients and research subjects.

As an important element of protecting patient safety, hospitals are required to appoint the most qualified and competent candidates to clinical and research positions. But, as noted above, conflicts of interest are a risk factor for bias, conscious or kamagra oral jelly for ladies unconscious, in personnel decisions.22 So, when a research hospital depends on corporate donations there is a risk that physicians and researchers may be appointed to key positions because they are known to be sympathetic to the donors’ product(s) rather than because they are the best qualified and the most competent. Contrariwise, physicians and researchers believed to be unsympathetic to the donors’ products are at risk of losing their jobs or of not being hired in the first place. The cases of Olivieri, Healy and Blumsohn illustrate this point.13 17As explained above, we know from the extensive literature on conflict of interest that kamagra oral jelly for ladies when research and clinical care are funded by industry there is a marked tendency for both to favour the sponsors’/donors’ products.13 15 16 18 Significantly, the UHN itself explicitly recognises the danger to patient safety posed by systemic biases. Its Mission Statement commits the hospital to ensuring that every patient is ‘[m]ade aware of existing systemic biases to support the best possible health decisions’.22 Unfortunately, it is not possible at present to ascertain whether UHN conformed to this ethical commitment in the case of its deferiprone research/treatment clinic.

In order to make such an ethical determination we would need to know the mechanism by which the UHN thalassaemia clinic gained access to deferiprone and whether the clinic provided information about systemic bias to patients with thalassaemia and to the hospital’s REB.ConclusionsHospitals worldwide proclaim that their primary commitment is to meet the needs of their patients. Institutional codes of ethics and mission statements insist kamagra oral jelly for ladies that patient needs come first. Indeed, meeting ‘patient needs’ is agreed to be the fundamental value to which all other hospital goals should be subordinated. Toronto’s UHN declares unequivocally that it kamagra oral jelly for ladies shares this value. €˜[t]he needs of patients come first’.22Although patients have many and various needs, the need for safety must be counted as the sine qua non.

If the need for safety is not met then other needs become irrelevant.The findings of Olivieri et al in their PLOS ONE paper raise many troubling questions about the safety of patients in UHN’s thalassaemia kamagra oral jelly for ladies clinic. One would expect that when top UHN officials became aware of the PLOS ONE data they would immediately have recognised the ethical red flags. Hospitals are ethically obliged both to investigate thoroughly possible safety failures and to rectify any problems identified.Over a period of several years, both before and after the publication of their research findings, Drs Olivieri and Gallie communicated regularly with UHN officials (https://inthepatientsinterest.org/). Multiple safety concerns kamagra oral jelly for ladies were brought to the hospital’s attention. Numerous questions were asked by the PLOS ONE authors and specific concerns were raised.

To date, the hospital has not kamagra oral jelly for ladies definitively addressed these issues. I posed a series of ethically salient questions to these same hospital officials (see online supplementary appendix A). My queries were ignored kamagra oral jelly for ladies. There was no response from UHN.Supplemental materialIf a healthcare institution such as UHN claims that patient safety is its top priority then when safety issues are raised, it necessarily incurs an obligation of accountability. It would, for example, scarcely be adequate for a hospital, such as UHN, unilaterally to investigate alleged failures, declare that there has been no violation of patient care standards, and then to stonewall all further inquiries, whether those inquiries originate from its own medical staff, as was the case with Olivieri and Gallie, or from outside scholars, as was the case with me.When an unlicensed drug is prescribed to hospital patients, over a period of years, as happened in the UHN thalassaemia programme, it is surely the hospital’s obligation to answer questions about how and why this extraordinary practice occurred.

When hospital records reveal that patients kamagra oral jelly for ladies switched from licensed to unlicensed medication, have experienced serious harms, up to and including death, it is surely the hospital’s obligation to answer in a conscientious and complete manner all the ethically troubling questions that have been identified. This obligation of accountability is owed both to patients and to staff. Thus far, UHN has not been willing to accept the implications of its own mission statement (https://www.uhn.ca/corporate/AboutUHN/Quality_Patient_Safety).The PLOS ONE Study by Olivieri Sabouhanian and Gallie spurs us to inquire whether the benefits which accrue to society from corporate sponsorship of healthcare institutions may, on balance, kamagra oral jelly for ladies be outweighed by the associated harms. Admittedly, for governments committed to constraining public expenditures, the transfer of substantial healthcare costs to private corporations represents a benefit for public finances. But, as we have seen, when one considers this financial benefit, one ought also to kamagra oral jelly for ladies take into account the spectrum of negative consequences potentially generated by institutional conflicts of interest.

The price for our continued acceptance of corporate funding of scientific research and clinical care may be the erosion of public trust. Arguably, it would be preferable if our research hospital were to aim instead for the complete elimination of systemic biases.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary informationEthics statementsPatient consent for publicationNot required.AcknowledgmentsThe author thanks the editors of JME and two JME reviewers for their criticisms of and suggestions for change to an earlier version of this paper..

That they are buy kamagra with free samples ‘following the science’ has become the watchword can i buy kamagra over the counter of many politicians during the present kamagra, especially when imposing or prolonging lockdowns or other liberty-restricting regulations. The scientists who advise politicians however are usually careful to add that the decision what to restrict and when is ultimately a political one. In science, as in medical practice, there is a delicate balance to be maintained between confidence in the best available information, and the necessary caveat that the assumptions and can i buy kamagra over the counter calculations on which that information is based are subject to further scientific enquiry.

For politicians and the public, moreover, as for patients, whether those informing them are judged to be trustworthy is a necessary consideration, a judgement determined by a variety of personal and political contingencies and circumstances. Ethics, by contrast, unable to appeal to scientific consensus (however revisable) or political authority (however reversible), let alone a confidence-inspiring bedside manner, must rest the case for its essentially contestable assumptions and arguments being judged trustworthy, on can i buy kamagra over the counter its willingness to admit all reasoned voices (including occasionally those that question reason itself) to a conversation that is potentially unending, but in the process often highly enlightening.That conversation is contributed to in this issue of the Journal by several reasoned voices, mostly on ethical aspects of the erectile dysfunction treatment kamagra. Relevant to issues on which politicians claim to be ‘following the science’, but also raising fundamental ethical questions, is this month’s feature article.

In Ethics of Selective Restriction of Liberty in a can i buy kamagra over the counter kamagra,1 Cameron and colleagues consider ‘if and when it may be ethically acceptable to impose selective liberty-restricting measures in order to reduce the negative impacts of a kamagra by preventing particularly vulnerable groups [for example, the elderly in erectile dysfunction treatment] of the community from contracting the disease’ [and thereby, for example, increasing the disease burden]. €˜Preventing harm to others when this is least restrictive option’, they argue, ‘fails to adequately accommodate the complexity of the issue or the difficult choices that must be made’. Instead, they propose ‘a dualist consequentialist approach, weighing utility at both a population and individual level’, thereby taking account of ‘two relevant values to be promoted or maximised.

Well-being and liberty’, as well can i buy kamagra over the counter as the value of equality, ‘protected through the application of an additional proportionality test’. The authors then propose an algorithm to take account of the different values and variables which need to be weighed up. They conclude can i buy kamagra over the counter.

€˜Selective restriction of liberty is justified when the problem is grave, the expected utility of the liberty restriction is high and significantly greater than the alternatives and the costs of the liberty restrictions are relatively small both at a population and individual level… Discrimination can be justified under these conditions when it is proportionate and limited to a very specific public health challenge’. The arguments and conclusions of the feature article are discussed in the two Commentaries2 3.In erectile dysfunction treatment can i buy kamagra over the counter controlled human studies. Worries about local community impact and demands for local engagement,4 Eyal and Lee review recent arguments which express ‘concern about undue usage of local residents’ direly needed scarce resources at a time of great need and even about their unintended ’ – and hence a requirement for ‘either avoiding controlled trials (CHIs) or engaging local communities before conducting CHIs’.

They then examine and compare the evidence of such adverse (and some potentially positive) effects of CHIs with those of conventional field trials and argue that ‘both small and large negative effects on struggling communities are likelier in field trials than in CHIs’. €˜Whether or not local community engagement is necessary for urgent treatment studies in a kamagra’, they conclude, ‘the can i buy kamagra over the counter case for its engagement is stronger prior to field trials than prior to controlled human studies’.In Payment of erectile dysfunction treatment challenge trials. Underpayment is a bigger worry than overpayment,5 Blumenthal Barby and Ubel consider the impact not on communities but on individuals, and specifically on ‘how much people should be paid for their participation in erectile dysfunction treatment challenge trials’.

Noting recent worries can i buy kamagra over the counter about ‘incentivising people with large amounts of money’, they argue that ‘higher payment that accounts for participant time, and for pains, burdens and willingness to take risks’ constitutes neither ‘undue inducement’ (for which the remedy is strengthening informed consent processes and minimising risks) nor ‘unjust inducement’ of individuals from ‘already disadvantaged groups’. Evidence of recruitment to challenge trials worldwide suggests, on the contrary, that participants ‘come from all walks of life’. Nor are these authors convinced that ‘offering substantial can i buy kamagra over the counter payment waters down the auistic motives of those involved’.

€˜auism and payment’ they argue, ‘frequently coexist. Teachers, physicians, public defenders – they all dedicate their lives to helping people. But few do without compensation.’In Money can i buy kamagra over the counter is not everything.

Experimental evidence that payments do not increase willingness to be vaccinated against erectile dysfunction treatment6, Sprengholz and colleagues report on an ‘experiment investigating the impact of payments and the communication of individual and prosocial benefits of high vaccination rates on vaccination intentions.’ In November 2020 over 1,000 ‘individuals from a German non-probabilistic sample’ were asked about their intentions. The ‘results revealed that none of these interventions or their combinations increased willingness to be vaccinated shortly after a treatment becomes available.’ Given that this experiment was conducted before treatments became available and only can i buy kamagra over the counter in Germany, the authors suggest that these results ‘should be generalised with caution’, but that ‘decision makers’ also ‘should be cautious about introducing monetary incentives and instead focus on interventions that increase confidence in treatment safety first’.In Voluntary erectile dysfunction treatment vaccination of children. A social responsibility,7 Brusa and Barilan observe a kamagra paradox.

€˜while we rely on low quality evidence when harming children by school deprivation and social distancing, we can i buy kamagra over the counter insist on a remarkably high level of safety data to benefit them with vaccination’. The consequent exclusion of children from vaccination, they argue, is unjust and not in ‘the best interest of the child as a holistic value encompassing physical, psychological, social and spiritual well-being’, something which ‘there is no scientific method for evaluating’. Society, rather, ‘has the political responsibility to factor in the overall impact of the kamagra on children’s well-being’ and the ‘ultimate choice is a matter of paediatric informed consent.

Moreover, jurisdictions that permit non-participation in established childhood vaccination programmes should also permit choice of treatments outside of the approved programmes.’ The authors conclude by outlining ‘a prudent and can i buy kamagra over the counter ethical scheme for gradual incorporation of minors in vaccination programmes that includes a rigorous postvaccination monitoring.’In Challenging misconceptions about clinical ethics support during erectile dysfunction treatment and beyond. A legal update and future considerations,8 Brierley, Archard and Cave note that the ‘erectile dysfunction treatment kamagra has highlighted the lack of formal ethics processes in most UK hospitals… at a time of unprecedented need for such support’. Unlike Research Ethics Committees (RECs), Clinical can i buy kamagra over the counter Ethics Committees (CECs) in the UK have neither any ‘well-funded governing authority,’ nor the decision-making capacity over clinical questions which RECs have over research.

In 2001 the ‘three central functions of CECs’ were described as ‘education, policy development and case review’. But more recently ‘the role of some was expanding’ and in 2020 the UK General Medical Council ‘mentioned for the first time the value in seeking advice can i buy kamagra over the counter from CECs to resolve disagreements’. Misunderstanding of CEC’s role however began to arise when some courts appeared to ‘perceive CECs as an alternative dispute resolution mechanism’ rather than as providing ‘ethics support, with treatment decisions remaining with the clinical team and those providing their consent.’ The future role of CECs, as well as the nature of patient involvement in them, the authors conclude, will depend on a choice between the ‘flexibility and diversity of the current ethical support system’ and ‘greater standardisation, governance and funding’.Important ethical issues not directly related to erectile dysfunction treatment are discussed in this issue’s remaining papers.

In Institutional conflict of interest. Attempting to crack the deferiprone mystery,9 Schafer identifies, places in historical context, and analyses ethical issues raised by the ‘ mystery’ of why between 2009 and 2015 ‘a third of patients with thalassaemia in Canada’s largest can i buy kamagra over the counter hospital were switched from first-line licensed drugs to regimens of deferiprone, an unlicensed drug of unproven safety and efficacy’. He then considers ‘institutional conflict of interest’ as ‘a possible explanatory hypothesis’.The perils of a broad approach to public interest in health data research.

A response to Ballantyne and Schaefer10 by Grewal and Newson and Ballantyne and Schaefer’s response In defence of a broad approach to public interest in health data research11 debate legal and philosophical aspects of whether ‘public interest’, and how narrowly or broadly this is conceived, is the most appropriate justification of consent can i buy kamagra over the counter waivers for secondary research on health information.In Do we really know how many clinical trials are conducted ethically,12 Yarborough presents evidence in support of the argument that 'research ethics committee practices need to be strengthed' and then suggests 'initial steps we could take to strengthen them'.Finally, and returning to how ‘science’ is perceived, in Lessons from Frankenstein 200 years on. Brain organoids, chimaeras and other ‘monsters’13, Koplin and Massie make a crucial observation. In ‘bioethical debates, Frankenstein is usually evoked as a warning against interfering can i buy kamagra over the counter with the natural order or “playing God”’.

But in the novel, Frankenstein’s ‘most serious moral error’ was made ‘not when he decided to pursue his scientific breakthrough (one which might, after all, have helped save lives), but when he failed to consider his moral obligations to the creature he created.’ Today, when, like Frankenstein, ‘modern scientists are creating and manipulating life in unprecedented ways’ such as brain organoids and chimaeras, Koplin and Massie argue, ‘two key insights’ can be drawn from Mary Shelley’s 1818 novel. First, ‘if we have created an entity in order to experiment on it’ we need ‘to extend much consideration to its interests and preferences, not least because ‘scientists cannot always rely on existing regulations to anticipate moral issues associated with the creation of new kinds of organisms’. And second can i buy kamagra over the counter.

€˜we should be wary of any prejudice we feel towards beings that look and behave differently from us’ and should ‘interrogate any knee-jerk intuitions we have about the moral status of unfamiliar kinds of beings.’Ethics statementsPatient consent for publicationNot required.IntroductionThalassaemia is an inherited anaemia that exerts an enormous disease burden worldwide.1 Along with sickle cell disease, it is one of the two most common single gene disorders. Indeed, ‘the alpha and beta thalassaemias are the most common inherited single-gene disorders in the world…’2A newly published study by Olivieri, Sabouhanian and Gallie3 can i buy kamagra over the counter analyses and assesses the comparative efficacy and safety profile of two drugs. Deferiprone (Ferriprox.

Apotex) and can i buy kamagra over the counter deferasirox (Exfade. Novartis). Both of these ‘iron-chelating’ drugs remove (‘chelate’) iron deposited, as a result of transfusions, in the tissues can i buy kamagra over the counter of patients with thalassaemia.The present-day first-line chelator, deferasirox, was licensed by the US FDA in 2005.

The evidence for its safety and effectiveness was judged to be substantial and, accordingly, the FDA licensed it as a first-line agent. The prime advantage of deferasirox, in comparison to deferoxamine, an older drug that was formerly the gold standard of iron-chelating therapy for thalassaemia, is that deferasirox is orally active (that is, taken in pill form), while deferoxamine is more burdensome for patients because it has to be taken parenterally (that is, via injection). Deferiprone, like deferasirox, is taken orally but can i buy kamagra over the counter has not been licensed anywhere as first-line treatment.

The FDA withheld market approval for deferiprone because there were/are no controlled trials demonstrating direct treatment benefit. Although the FDA did eventually approve deferiprone, in 2011, it gave approval only as a last-resort treatment for those patients in can i buy kamagra over the counter whom other chelators had been tried unsuccessfully.1The data presented by Olivieri et al in their PLOS ONE paper indicate that the drugs differ significantly with respect to their effectiveness and safety. This commentary explores some of the ethical issues raised by the PLOS data.Historical contextIn order to understand properly the significance of the PLOS ONE Study some historical context will be helpful.

What follows is a brief sketch of that context.2In 1993 Dr Nancy Olivieri, a specialist in blood diseases at Toronto’s Hospital for Sick Children (HSC or ‘Sick Kids’) and Professor of Pediatrics and Medicine at the University of Toronto (U of T), signed a contract with Apotex, a generic drug company, to continue studies of deferiprone, the early promise of which she had already reported in the can i buy kamagra over the counter literature. Olivieri’s thalassaemia research was initially supported by the Medical Research Council of Canada, but now she sought additional funding to extend her clinical trials. Apotex contributed this additional funding, thereby obtaining worldwide patents on the still-experimental drug.Despite early promise, by 1996 Olivieri’s research began to indicate that deferiprone might be inadequately effective in many patients, posing risks of potentially serious harm.

Olivieri communicated to Apotex her intention to inform patients of this unexpected risk and she proposed also to amend the can i buy kamagra over the counter study’s consent forms. She wished to continue amended studies of the drug, and to publish her findings.Apotex responded to Olivieri that they disagreed with her interpretation of the data and the company’s CEO threatened her with ‘all legal remedies’ should she inform patients or publish her findings. In issuing these threats, Apotex relied on a confidentiality clause in a legal contract Olivieri can i buy kamagra over the counter had signed with Apotex in 1993.

This contract prohibited disclosure ‘to any third party’ without the express permission of Apotex.3Despite the objections raised by Apotex, Olivieri saw it as her professional duty to disclose her findings. The Research can i buy kamagra over the counter Ethics Board (REB) of Sick Kids Hospital reached the same conclusion. In compliance with instructions from the Hospital’s REB, Olivieri duly informed both her patients and the regulatory authorities.When Olivieri later identified a second risk—that liver damage progressed during deferiprone exposure—Apotex issued additional legal warnings.

Olivieri nevertheless proceeded to inform her patients of this additional risk and published her findings.Since patient safety, research integrity and academic freedom were all at stake in this dispute, Olivieri appealed for assistance, repeatedly, to senior officials at both the U of T and Sick Kids Hospital. Neither the University nor the Hospital provided the support she can i buy kamagra over the counter requested. In the words of the Report of the Committee of Inquiry on the Case Involving Dr Nancy Olivieri, the HSC, the U of T, and Apotex Inc4:The HSC and the U of T did not provide effective support either for Dr Olivieri and her rights, or for the principles of research and clinical ethics, and of academic freedom, during the first two and a half years of this controversy.Instead, both the University and the Hospital ‘took actions that were harmful to Dr.

Olivieri’s interests and professional reputation and disrupted her work’.4 The harmful can i buy kamagra over the counter actions included firing Olivieri from her position as Director of the Hemoglobinopathy Program at Sick Kids Hospital and referring her for discipline to the College of Physicians and Surgeons of Ontario (CPSO).Only later did it emerge that, during this period of conflict, the U of T was negotiating with Apotex for a major donation towards building the University’s proposed new molecular medicine building. Some speculated that the University’s failure to support Olivieri may not have been unconnected from its desire to appease a wealthy corporate donor. This speculation was reinforced when it can i buy kamagra over the counter was discovered that the then President of the University, Robert Prichard, had secretly lobbied the government of Canada for changes in drug patent law, changes that would favour Apotex.4Apotex proceeded to sue Olivieri for defaming both the company and their drug.

She sued the company for defaming her.The Canadian Association of University Teachers (CAUT) and the U of T Faculty Association (UTFA), to whom Olivieri appealed for assistance after being rebuffed by the U of T and HSC, viewed the underlying issue as one of academic freedom. Both CAUT and UTFA provided support, including legal advice, to Olivieri.Thus began what is widely acknowledged to be the greatest scandal in Canadian academic history. Commissions of inquiry, books and articles (both scholarly and popular) proliferated, not to can i buy kamagra over the counter mention newspaper and television stories.

John le Carré’s novel The Constant Gardener and the Hollywood movie based on the book both appeared to draw heavily on the Olivieri-Apotex scandal. An inquiry into the dispute commissioned by Sick Kids Hospital (the Naimark Inquiry)5 absolved Apotex of wrongdoing but suggested that Olivieri was seriously at fault.5 She was charged with research misconduct and failures of patient care and was referred first can i buy kamagra over the counter to the Hospital’s Medical Advisory Council and subsequently to the disciplinary committee of the CPSO. Unsurprisingly, these widely publicised referrals were prejudicial to Olivieri’s reputation.The CAUT then commissioned an independent inquiry.6 The 540-page CAUT report on the Olivieri/Apotex affair4 gave a markedly different account of the scandal from that offered by the hospital-commissioned Naimark Report.

A few excerpts from the CAUT report will convey its central can i buy kamagra over the counter findings:Apotex issued more legal warnings to deter Dr. Olivieri from communicating this second unexpected risk of L1 (deferiprone) to anyone. However, she was legally and ethically obligated to communicate the risk to those taking or prescribing the drug as there were potential safety implications for patients, and she fulfilled these obligations despite the legal warnings.Apotex acted against the public interest in issuing legal warnings to Dr.

Olivieri to deter her from communicating about risks of L1.Apotex’s legal warnings can i buy kamagra over the counter violated Dr. Olivieri’s academic freedom.7Shortly after the CAUT report absolved Olivieri of misconduct, the CPSO published the findings of its inquiry. The CPSO report exonerated Olivieri of all misconduct can i buy kamagra over the counter charges.

Indeed, their report concluded that her conduct had been ‘commendable’.6 This favourable verdict did not, however, bring an end to litigation.In 2004, 8 years after the first legal threats had been issued, Apotex signed a mediated settlement with Olivieri. Nevertheless, litigation can i buy kamagra over the counter continued for another 10 years. Those unfamiliar with the workings of the law may wonder how it is possible for litigation to continue for such a long period after a mediated settlement.

Litigation continued because Apotex alleged that Olivieri had violated their agreement. Olivieri insisted that she was can i buy kamagra over the counter in compliance with the terms of the settlement. Court decisions were appealed by both parties.

A final settlement was not reached between Olivieri and Apotex until 2014.8 Shades of can i buy kamagra over the counter Jarndyce v. Jarndyce in Charles Dicken’s novel Bleak House.The HSC settled its dispute with Olivieri in 2006 and, although her research programme at the Hospital continued, she ceased to provide clinical care to HSC patients. From 1997 to 2009, Olivieri can i buy kamagra over the counter served as Director of the University Health Network (UHN) Hemoglobinopathy Program.

She continued, as she had since 1997, to assist in the clinical care of UHN patients with thalassaemia and to enrol them in her research studies. In March 2009, however, Olivieri was dismissed by can i buy kamagra over the counter UHN from her position as Director. No reason was given for her dismissal (Personal communication.

Olivieri, 2019).The PLOS ONE Study data3 show that, after Olivieri’s dismissal from her position as Director, the UHN thalassaemia Clinic began almost immediately to switch patients to (unlicensed) deferiprone. Olivieri has described how her UHN research work, from this time forward, was marginalised (https://inthepatientsinterest.org/wp-content/uploads/2019/12/2018-12-20-GallieOlivieri-to-SmithHodges.pdf).Meanwhile, Freedom of Information (FOI) requests filed by Olivieri after her dismissal revealed that Apotex was supplying can i buy kamagra over the counter unrestricted educational grants to UHN’s thalassaemia programme as well as providing research support. The FOI requests filed by Olivieri also revealed that Apotex was strategising with the programme’s new director about how best to obtain licensing for deferiprone from the regulator (Health Canada).9 With this dramatic background as historical context, we commence our discussion of the ethical implications of the PLOS ONE paper.Findings of the PLOS ONE paperIn their 2019 PLOS ONE study Olivieri et al conclude, based on a retrospective review of patient data at Toronto’s UHN, that deferiprone is inadequately effective and associated with serious toxicity.

Their review also confirms that, by contrast, deferasirox is effective and associated with relatively few adverse effects.3Olivieri et al report that ‘[b]etween 2009 and 2015, a third of patients transfused and managed in Canada’s largest transfusion programme were switched from first-line, licensed drugs to regimens of unlicensed deferiprone’.3 This finding raises can i buy kamagra over the counter the ethically troubling question. How and why were so many locally transfused patients at UHN treated over such a long time period with an unlicensed drug of unproven safety and efficacy?. This can i buy kamagra over the counter ethical concern is followed immediately by another related concern.

Why did the UHN thalassaemia programme continue to treat large numbers of its patients with deferiprone—despite ongoing evidence of inadequate effectiveness and serious (and often irreversible) adverse effects?. 3To recapitulate. The PLOS ONE paper demonstrates that a substantial proportion of UHN patients can i buy kamagra over the counter with thalassaemia was switched, between the years 2009 and 2015, from first-line licensed therapies (deferasirox or deferoxamine) to deferiprone.

During this entire period, deferiprone was unlicensed in Canada. To this day in every jurisdiction can i buy kamagra over the counter in which deferiprone has been licensed it has been licensed only as ‘last resort’ therapy. The ethical concern is to explain and to explore possible justifications for how and why so many patients at one particular thalassaemia treatment centre were prescribed a drug whose safety and efficacy were unproven in face of availability of licensed effective drugs.

The urgency of the concern derives partly from the paper’s finding that those patients who were switched to deferiprone displayed evidence of increases in body iron and experienced the harms associated with body iron increase.3 This finding raises a can i buy kamagra over the counter second troubling ethical question. Why were patients not switched back to a first-line licensed therapy after they began to experience serious adverse effects from treatment with unlicensed deferiprone?. How and why?.

In a sustained effort to discover answers to these questions, Olivieri and Gallie have been in communication since 2015, by email and in personal meetings, can i buy kamagra over the counter with senior officials at UHN. Olivieri and Gallie report, however, that no definitive answers have yet been provided to any of their questions. FOI requests were filed but they, too, failed to produce definitive can i buy kamagra over the counter answers.

(Olivieri and Gallie to Smith &. Porter, 2019, https://inthepatientsinterest.org/wp-content/uploads/2019/12/2019-04-23-OlivieriGallie-to-SmithPorter.pdf).10 I, too, wrote to the CEO/President of UHN and to the Chief of Medical Staff, in an attempt to discover answers to a number of the ethical questions can i buy kamagra over the counter posed in this commentary. The hospital, however, has not responded to any of my questions.11Olivieri and Gallie have recently posted documentation of their correspondence with senior UHN administrators (https://inthepatientsinterest.org/).

In September 2019 the UHN administration responded to the PLOS ONE paper by revealing that it had conducted a ‘Review of chelation practice in the red blood cell disorders program at UHN’. However, as Olivieri and Gallie document on the web, the hospital’s ‘Review’ does can i buy kamagra over the counter not address any of the safety concerns flagged in the PLOS ONE paper (https://inthepatientsinterest.org/wp-content/uploads/2019/12/Letter-to-Smith-and-Hodges-2-12-19.pdf). Nor does the ‘Review’ address any of the ethical concerns raised here.Despite UHN’s apparent reluctance to provide the information requested, here’s what we know or can reasonably infer.

Deferiprone was unlicensed in Canada during can i buy kamagra over the counter the relevant period, that is, from 2009 to 2015. €˜Unlicensed’ is different from ‘off-label’, the latter referring to a drug that has been licensed but is being provided for an indication other than that for which it is approved. Prescription of any unlicensed drug to Canadian can i buy kamagra over the counter patients can be accomplished only in one of two mutually exclusive ways.

Either through Health Canada’s ‘Special Access Program (SAP)’ or via an REB approved clinical trial. It has to be one or the other since, as Health Canada’s Guidance Document7 makes clear, patients cannot be simultaneously treated through SAP and in a research trial.12 Under the SAP, the treating physician must confirm to Health Canada that ‘conventional therapies have failed, or are unsuitable or unavailable’. Although some of the UHN patients’ records indicate that deferiprone was released under the SAP, Olivieri et al report that they ‘could identify no explanation for a proposed switch to deferiprone that was supported by evidence of failure of licensed can i buy kamagra over the counter therapy prescribed as recommended’3.

Indeed, the authors write that many patients appear to have been switched to deferiprone despite optimal responses, or improvements during treatment with first-line therapies. Here’s the relevant paragraph from their PLOS ONE article:Deferiprone was prescribed to 41 study can i buy kamagra over the counter patients between 2009 and 2015. We could identify in the electronic medical records no explanation for a proposed switch to deferiprone that was supported by evidence of failure of licensed therapy prescribed as recommended.

There was no indication that any patient can i buy kamagra over the counter switched to deferiprone over these 6 years had ‘failed’ therapy with either deferoxamine or deferasirox. Many patients were recorded as tolerant of at least one and (in most), both licensed first-line chelating agents. Some had sustained minor adverse events during deferasirox that had resolved by the time deferiprone was prescribed.3In other words, according to the data found in UHN patient records, there is no evidence that the patients with thalassaemia who were switched to deferiprone met Health Canada’s eligibility criteria under SAP.

Since deferiprone is licensed only as a ‘last resort’ therapy, its employment to treat patients who can tolerate either of the first-line therapies might improperly expose those patients to risks of serious medical harms, up to and including death.On the other hand, one should also consider the alternate possibility that, over can i buy kamagra over the counter the 6-year period studied by Olivieri et al, deferiprone was prescribed as part of a clinical trial. In favour of this hypothesis, one notes that the UHN physician primarily responsible for the widespread prescribing of deferiprone during the relevant time period claimed, in 2011, that deferiprone was provided to patients under a study approved by the REB of the UHN.8 UHN physicians also made this identical claim in a publicly available letter to the US FDA.9 Moreover, in response to an FOI application filed by Olivieri, UHN claimed that deferiprone was provided at UHN during a clinical trial (the data of which are protected from scrutiny under FOI laws), and not under SAP (the data of which are not protected from scrutiny under FOI). However, Olivieri et al have been unable to find any record of registration for such a trial, as required by Canadian Clinical Trial guidelines.13 Requests to can i buy kamagra over the counter the UHN administration for confirmation that a clinical trial existed remain unanswered.14 My own efforts to find some registration record for this putative clinical trial of deferiprone have been equally unsuccessful.15Two core ethical principles.

Harm-minimisation and informed consentIf the deferiprone used to treat UHN patients with thalassaemia was obtained from Apotex as part of a randomised clinical trial, responsibility for approving the trial would fall to the UHN’s REB. In Canada, both researchers and REBs are governed by the Tri-Council Policy Statement (TCPS) ‘Ethical Conduct for Research Involving Humans’.10 The 1998 version of this policy statement can i buy kamagra over the counter (TCPS1) and the subsequent 2010 version (TCPS2), both applicable to research trials during this period, stipulate that clinical trials must be designed so that harm to research subjects will be minimised.16 For example, TCPS1 specifies, in section 1.5, that ‘Research subjects must not be subjected to unnecessary risks of harm’. TCPS2, under the rubric ‘Core Principles’, requires similarly that clinical trials must ‘ensure that participants are not exposed to unnecessary risks’.Data presented by Olivieri et al in their PLOS ONE Study indicate that UHN patients exposed to unlicensed deferiprone, either as monotherapy or in combination with low dose of a first-line chelator (‘combination therapy’), experienced significant harms as a result of poor iron control, but very few if any compensating benefits.We provide new evidence of inadequate reduction in hepatic iron, a 17% incidence of new diabetes and new liver dysfunction in 65% of patients, many who were challenged and rechallenged with deferiprone despite elevated liver enzymes developed during previous exposure.

We identified no evidence of ‘cardio-protective’ effect during deferiprone therapy.3In light of PLOS ONE Study data indicating serious adverse events (SAEs) for patients switched to deferiprone from first-line drugs one is led to question why the study protocol did can i buy kamagra over the counter not, in anticipation of such a contingency, provide for a resumption of licensed therapy for patients doing poorly on the unlicensed drug. Moreover, the investigators were obliged to report adverse events to the hospital’s REB. Were the adverse events so reported?.

And if they were then why did the UHN REB not seek to protect patient can i buy kamagra over the counter safety by insisting that licensed therapy be resumed for deferiprone-harmed patients?. In an effort to establish whether the deferiprone ‘clinical trial’ satisfied the TCPS harm-minimisation principle, I made inquiries about how the adverse findings described by the PLOS ONE paper were reported to the hospital’s REB and also how they were reported to the regulatory authorities, that is, Health Canada and the US FDA. But my queries, like those made previously by Olivieri and Gallie, have not succeeded in can i buy kamagra over the counter eliciting this ethically relevant information.17 Neither UHN nor its thalassaemia clinic responded to my letters of inquiry.

It is known, however, from a publicly available 2011 document, that physicians in the UHN thalassaemia clinic strongly supported the market approval of deferiprone by the FDA.18 This support is difficult to reconcile with the toxicities recorded in UHN patient records. So, a final verdict on the issue of whether the UHN deferiprone can i buy kamagra over the counter ‘clinical trial design’ violated the TCPS harm-minimisation principle cannot be reached until those involved in conducting and monitoring clinical trials at UHN make available the relevant information. An independent public inquiry may be necessary to achieve the necessary degree of accountability.Reference has been made, above, to the TCPS core ethical requirement of harm-minimisation, applicable in Canada both to researchers and to REBs.

It is important to note, however, that TCPS2, like its predecessor, TCPS1 (and, indeed, like virtually every postwar code of research ethics) also stipulates as a second ‘core principle’ that ‘Researchers shall provide to prospective participants, or authorised third parties, full disclosure of all information necessary for making an informed decision’.19 Moreover, as the then-current TCPS guidelines make clear, ‘consent is an ongoing process’. So, assurance should be given to prospective participants that they ‘will be can i buy kamagra over the counter given in a timely manner throughout the course of the research project, information that is relevant to their decision to continue or withdraw from participation’.20 (My emphasis). Finally, TCPS2 imposes on researchers the additional ethical requirement that they disclose to research subjects ‘information concerning the possibility of commercialisation of research findings, and the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors’.21 There is also an expectation that conflicts of interest will be disclosed to the REB.

Whether there can i buy kamagra over the counter was adequate disclosure of Apotex funding either to research subjects or to the UHN REB is still unknown.Thus, in order to assess the ethical adequacy of the putative UHN thalassaemia clinical trial one must inquire whether UHN patients/subjects were given adequate risk information when they were first enrolled, subsequently, when they were switched from treatment with deferasirox or deferoxamine to treatment with deferiprone and then, finally, when they experienced SAEs. That is, in order to know whether the putative deferiprone clinical trial conformed to established principles of research ethics, one would need to know whether patients/research subjects understood that they were being switched from licensed first-line drugs of proven efficacy to an unlicensed and unproven third-line drug. One would also need can i buy kamagra over the counter to know whether the deferiprone ‘research subjects’ were informed about conflicts of interest arising from Apotex donations (A) to the UHN.

(B) To the hospital’s thalassaemia programme,22 as well as the hoped-for commercialisation of deferiprone via Health Canada and FDA licensing.If there was a failure to obtain ongoing informed consent and/or a failure to disclose conflicts of interest (to patients and to the REB) then this would constitute a violation of research ethics. Unfortunately, my attempts to elicit the clinical trial’s consent to research information from the UHN and its thalassaemia clinic met with as little success as earlier attempts made by the PLOS ONE authors.23REB review. Safety monitoringAlthough every clinical trial can i buy kamagra over the counter requires safety monitoring, those trials which involve non-negligible risk of significant harm to patients/subjects require especially rigorous safety monitoring.24 Because the exposure of deferiprone to UHN patients posed risks of organ dysfunction and death, the need for safety monitoring was exigent.

As the TCPS1 and TCPS2 both make clear, those who conduct research have an obligation to monitor and protect the safety of their research subjects.Moreover, it is now widely recognised that individuals closely involved with the design and conduct of a trial may not be able to be fully objective in reviewing interim data for any emerging concerns.25 Hence the importance of REBs, part of whose role is to provide safety monitoring initially and, for ongoing trials, over the entire period of the trial. In order to assess the adequacy of the safety monitoring for can i buy kamagra over the counter the UHN ‘deferiprone trial’ one would need to know whether the hospital’s REB was provided with regular and accurate reports of SAEs and what actions this REB took in response to those reports.It has become common practice in North America ‘that for any controlled trial of any size that will compare rates of mortality or major morbidity’, a data safety monitoring board (DSMB) will be established.26,11 12 A DSMB is constituted by a panel of independent (and otherwise unbiased) individuals with expertise pertinent to reviewing trial data on a regular ongoing basis. Its role is to advise the sponsors regarding the safety of trial subjects and to recommend early termination where indicated, for example, on grounds of patient safety.27Since there are no specifically Canadian requirements with respect to the establishment of DSMBs, Canadian REBs tend to follow FDA guidelines.

Those guidelines recommend that a DSMB should be established when the study end point is such can i buy kamagra over the counter that a highly favourable or unfavourable result at an interim analysis might ethically require termination of the study. Advance information suggesting the possibility of serious toxicity with the study treatment is another a priori reason for safety concern that would justify the establishment of a DSMB.12For reasons given above, the UHN deferiprone trial appears to have been a prime candidate for the establishment of a DSMB. But it is not known whether the study’s research protocol, purportedly submitted for approval to the hospital’s REB, included a DSMB.

Nor is it known whether a DSMB was established and reported regularly to the trial’s sponsors can i buy kamagra over the counter. Data on the toxicity of deferiprone, provided by Olivieri et al from their retrospective study of UHN patient records, suggest that had a DSMB existed for this putative clinical trial the trial might, on grounds of patient safety, have been a candidate for premature cancellation. Lacunae in our knowledge of the safety monitoring provisions of the deferiprone ‘clinical trial’ make it difficult to reach any firm conclusion as to whether the ‘trial’ can i buy kamagra over the counter met prevailing safety monitoring requirements.The apparent unwillingness of the UHN to answer questions relating to safety monitoring might mean that an inquiry is needed to fill in our knowledge gaps and thereby make ethical evaluation possible.

For the findings of such an inquiry to be minimally credible it should be carried out by individuals who possess the requisite scientific/medical expertise and who are independent of the hospital and its thalassaemia clinic and who are demonstrably impartial. An inquiry carried out, for example, by someone whose research has been funded by Apotex and/or by an expert with close professional and personal ties to one or more of the physicians in the UHN thalassaemia clinic would not satisfy the hospital’s duty of accountability for patient safety.Ethical concernsA RecapitulationThe serious complications experienced by deferiprone-exposed UHN patients, as described by Olivieri et al in their PLOS ONE article, raise a number of ethically important can i buy kamagra over the counter questions. How could an unlicensed drug of unproven efficacy and safety—a drug that has been questioned by regulatory agencies such that it is licensed only as a “last resort” therapy—have been administered to so many patients over a period of so many years when two licensed drugs, both proven adequately safe and effective and licensed as first-line therapies, were available?.

How did UHN physicians gain access to deferiprone from Health Canada when there is little evidence in UHN patient records that the deferiprone-exposed patients satisfied Health Canada’s criteria for Special Access?. Why was a putative UHN REB-approved research study involving deferiprone not can i buy kamagra over the counter registered as a clinical trial?. Did the trial design include a DSMB, to protect patient safety and, if not, why not?.

Were SAEs reported to can i buy kamagra over the counter the UHN REB and to regulators, as required?. Were deferiprone-treated UHN patients with thalassaemia adequately informed of the unlicensed status, unproven efficacy and reported toxicities of deferiprone?. Were deferiprone-exposed can i buy kamagra over the counter patients informed of harms they themselves had sustained during deferiprone from this exposure?.

28 Did the evidence of systematic treatment failure, as outlined in the PLOS ONE paper, raise red flags for thalassaemia clinic physicians and for the REB of UHN?. And if serious problems were flagged what actions were taken to protect patient safety?. Institutional conflict of interestThe literature on biomedical can i buy kamagra over the counter conflicts of interest tends to focus on the ways in which financial support of individual researchers by the pharmaceutical industry can adversely affect both research integrity and patient safety.13–16 But similar ethical problems arise at the macro level when institutions, such as hospitals and clinics, depend on drug company funding to support patient care and clinical research.13 15 Notable scandals associated with institutional conflicts of interest include the David Healy/Eli Lilly scandal at Toronto’s Centre for Addictions and Mental Health (CAMH),13 the Aubrey Blumsohn/Proctor and Gamble scandal at Sheffield University (UK)17 and the Carl Elliott/Janssen Pharmaceuticals scandal at the University of Minnesota.17 The underlying pattern in each of these scandals involves (A) a biomedical researcher who is concerned about patient safety coming into conflict with (B) a pharmaceutical company which funds both the researcher’s hospital and university and (C) a failure by the institutions involved vigorously to defend patient safety and research integrity when doing so might offend a wealthy sponsor.It should not be assumed that corporate influence on university medical centres is necessarily exerted by means of threats or other direct forms of intervention.

The mere presence of corporate funding can be sufficient to produce a corporate-friendly result. This point is illustrated by a recent STAT article, a propos the financial support can i buy kamagra over the counter which Purdue Pharma provided to Massachusetts General Hospital. The very title of the article encapsulates the ethical problem of institutional conflict of interest.

€˜Purdue Pharma can i buy kamagra over the counter cemented ties with universities and hospitals to expand opioid sales, documents contend’.18 Nor should it be supposed that the problem of institutional conflict of interest arises exclusively in the context of biomedical research. A recent Guardian article on the Mobil Oil Corporation describes how ‘Oil giant Mobil sought to make tax-exempt donations to leading universities … to promote the company’s interests and undermine environmental regulation, according to internal documents from the early 1990s obtained by the Guardian’.19As mentioned above, deferiprone, whose safety and efficacy are the central concern of Olivieri et al’s PLOS ONE paper, is manufactured by Apotex. When we seek to understand why deferiprone was so frequently prescribed to UHN patients, from 2009 to 2016, despite its being unlicensed and despite evidence of poor patient outcomes,3 it may be relevant to note that Apotex provided substantial funding to the UHN thalassaemia clinic.29 Moreover, a publicly displayed UHN banner lists ‘Apotex Inc – Barry and Honey Sherman’ as having donated between $1 million and $5 million can i buy kamagra over the counter to the hospital itself.30As every biomedical researcher understands, correlation is not causation.

Nevertheless, the correlation between industry funding of hospitals, on the one hand, and industry-friendly decisions made by researchers and administrators at those hospitals, on the other, is worth pondering. Physicians and researchers who speak or write critically of drugs manufactured by wealthy donor companies may find that their careers are jeopardised. Nancy Olivieri’s dismissal from two Apotex-funded teaching hospitals illustrates this phenomenon as does the termination of psychiatrist David Healy from Toronto’s CAMH.13 Healy’s appointment as Head of the CAMH Mood can i buy kamagra over the counter Disorders Clinic was rescinded almost immediately after he gave a public lecture at the hospital—a lecture in which he called for further research into the potentially adverse effects of Eli Lilly’s antidepressant drug, Prozac.

Healy was particularly concerned about SSRI-induced suicidal ideation. After his lecture the hospital decided that he was not ‘a good fit’ with their programme and terminated his can i buy kamagra over the counter appointment. Shortly thereafter the hospital opened its Eli Lilly wing.13UHN, like every other research and teaching hospital in Canada, receives most of its funding, directly or indirectly, from governments.20 ,31 Nevertheless, UHN, again like other hospitals, faces ongoing pressure to find additional sources of revenue to support both patient care and clinical research.32 The pharmaceutical industry is a prime source of much-needed ‘top-up’ financial support for Canadian hospital research and clinical care.21 Hospital administrators, researchers and clinicians are thereby placed, willy nilly, in a conflict-of-interest situation.

Because of funding exigencies, hospitals and other healthcare institutions, can i buy kamagra over the counter like individual physicians and researchers, have a strong vested interest in pleasing corporate sponsors and encouraging their ongoing support. Moreover, institutional administrators, not unlike individual researchers and clinicians, typically experience a need to express their gratitude to donors by returning kindness for kindness and benefit for benefit. Thus, both the need for ongoing corporate sponsorship and the need to reciprocate for past corporate generosity create for hospital administrators (as well as for researchers and clinicians who work within hospitals) a conflict-of-interest situation in which their decision making may be skewed, consciously or unconsciously, in favour of the benefactors’ products.13 15 16 21Here’s an example of the manner in which an institutional conflict-of-interest situation can potentially bias the judgement of hospital administrators.

Hospitals are required to exercise their disinterested judgement in the appointment of medical and scientific staff and in the can i buy kamagra over the counter ethical monitoring of research. This moral obligation follows directly from their fundamental commitment to promote and defend patient safety and research integrity. To illustrate can i buy kamagra over the counter.

UHN’s website, under the heading Purpose, Values and Principles, declares that ‘[o]ur Primary Value and above all else. The needs of patients come first’.22 It can i buy kamagra over the counter would be difficult to find any hospital whose Mission Statement did not proclaim a similar commitment to the primacy of patient well-being. In a similar vein, the UHN website, under the heading Information for Patients, subheaded Our Mission, declares.

€˜We believe that health equity is achieved when each person is. Enabled to choose the best care and treatment based on the most current knowledge available’.From this fundamental commitment, it follows that can i buy kamagra over the counter healthcare institutions are obliged rigorously to monitor the quality of care provided to their patients and research subjects. As an important element of protecting patient safety, hospitals are required to appoint the most qualified and competent candidates to clinical and research positions.

But, as noted above, conflicts of interest are a risk factor for bias, conscious or unconscious, in personnel decisions.22 So, when a research hospital depends on corporate donations there is a risk that physicians and researchers may be appointed can i buy kamagra over the counter to key positions because they are known to be sympathetic to the donors’ product(s) rather than because they are the best qualified and the most competent. Contrariwise, physicians and researchers believed to be unsympathetic to the donors’ products are at risk of losing their jobs or of not being hired in the first place. The cases of Olivieri, Healy and Blumsohn illustrate this point.13 17As explained above, we know from the extensive literature on conflict of interest that when research and clinical care are funded by industry there is a marked tendency for both to favour the sponsors’/donors’ products.13 15 16 18 Significantly, the UHN itself explicitly recognises the danger to patient safety posed can i buy kamagra over the counter by systemic biases.

Its Mission Statement commits the hospital to ensuring that every patient is ‘[m]ade aware of existing systemic biases to support the best possible health decisions’.22 Unfortunately, it is not possible at present to ascertain whether UHN conformed to this ethical commitment in the case of its deferiprone research/treatment clinic. In order to make such an ethical determination we would need to know the mechanism by which the UHN thalassaemia clinic gained access to deferiprone and whether the clinic provided information about systemic bias to patients with thalassaemia and to the hospital’s REB.ConclusionsHospitals worldwide proclaim that their primary commitment is to meet the needs of their patients. Institutional codes of ethics and mission statements insist that patient needs come first can i buy kamagra over the counter.

Indeed, meeting ‘patient needs’ is agreed to be the fundamental value to which all other hospital goals should be subordinated. Toronto’s UHN declares unequivocally that it shares this value can i buy kamagra over the counter. €˜[t]he needs of patients come first’.22Although patients have many and various needs, the need for safety must be counted as the sine qua non.

If the need for safety is not met then other needs become irrelevant.The findings of Olivieri et al in their PLOS can i buy kamagra over the counter ONE paper raise many troubling questions about the safety of patients in UHN’s thalassaemia clinic. One would expect that when top UHN officials became aware of the PLOS ONE data they would immediately have recognised the ethical red flags. Hospitals are ethically obliged both to investigate thoroughly possible safety failures and to rectify any problems identified.Over a period of several years, both before and after the publication of their research findings, Drs Olivieri and Gallie communicated regularly with UHN officials (https://inthepatientsinterest.org/).

Multiple safety concerns were brought can i buy kamagra over the counter to the hospital’s attention. Numerous questions were asked by the PLOS ONE authors and specific concerns were raised. To date, the hospital can i buy kamagra over the counter has not definitively addressed these issues.

I posed a series of ethically salient questions to these same hospital officials (see online supplementary appendix A). My queries were ignored can i buy kamagra over the counter. There was no response from UHN.Supplemental materialIf a healthcare institution such as UHN claims that patient safety is its top priority then when safety issues are raised, it necessarily incurs an obligation of accountability.

It would, for example, scarcely be adequate for a hospital, such as UHN, unilaterally to investigate alleged failures, declare that there has been no violation of patient care standards, and then to stonewall all further inquiries, whether those inquiries originate from its own medical staff, as was the case with Olivieri and Gallie, or from outside scholars, as was the case with me.When an unlicensed drug is prescribed to hospital patients, over a period of years, as happened in the UHN thalassaemia programme, it is surely the hospital’s obligation to answer questions about how and why this extraordinary practice occurred. When hospital records reveal that patients switched from licensed to unlicensed medication, have experienced serious harms, up to and including death, it is surely the hospital’s obligation to answer in a conscientious and complete manner all the can i buy kamagra over the counter ethically troubling questions that have been identified. This obligation of accountability is owed both to patients and to staff.

Thus far, UHN has not been willing to accept the implications of its own mission statement (https://www.uhn.ca/corporate/AboutUHN/Quality_Patient_Safety).The PLOS ONE Study by Olivieri can i buy kamagra over the counter Sabouhanian and Gallie spurs us to inquire whether the benefits which accrue to society from corporate sponsorship of healthcare institutions may, on balance, be outweighed by the associated harms. Admittedly, for governments committed to constraining public expenditures, the transfer of substantial healthcare costs to private corporations represents a benefit for public finances. But, as can i buy kamagra over the counter we have seen, when one considers this financial benefit, one ought also to take into account the spectrum of negative consequences potentially generated by institutional conflicts of interest.

The price for our continued acceptance of corporate funding of scientific research and clinical care may be the erosion of public trust. Arguably, it would be preferable if our research hospital were to aim instead for the complete elimination of systemic biases.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary informationEthics statementsPatient consent for publicationNot required.AcknowledgmentsThe author thanks the editors of JME and two JME reviewers for their criticisms of and suggestions for change to an earlier version of this paper..

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