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Rapid Responses: Rapid Responses published:
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Vioxx was Over Prescibed by Doctors in the UK
- des spence (29 November 2004)
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Re: Vioxx was Over Prescibed by Doctors in the UK
- Brian J. Penney (30 November 2004)
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Over prescribing of Vioxx
- des spence (1 December 2004)
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Vioxx is just one that got caught
- Dr. Herbert H. Nehrlich (2 December 2004)
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A Comment on the Use of FluMist(R) for Children and Adults
- Walter R Schumm (3 December 2004)
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Rofecoxib
- Silvio Garattini (18 February 2005)
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des spence, spokesperson nofreelunch Glasgow G20 9DR
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The regulators have a responsibility for this emerging scandal. We doctors, however, must also shoulder the responsibility for putting so many patients at risk. In General Practice in Glasgow the Cox II derivatives within 4 years became 40% of the NSAID market. This was despite local and national guidelines suggesting limited indications for these medications. Our patients , therefore, were put at unnecessary risk because of the over prescribing of Vioxx. How could this happen? At the time Vioxx was being launched squadrons of representatives across the country descended on doctors promoting Vioxx. The usual seductive cocktail of sponsored education and hospitality were gulped down . This scandal is our fault also. It is time that we recognized the marketing of the industry for what it is. If we had had a public register of contact, hospitality and payments four years ago we could now ask our colleagues their reasons for leaping into prescribing Vioxx. For the sake of our profession and the patients lets have transparency through a register of all contact, hospitality and payments. Des Spence www.Nofreelunch-uk.org Competing interests: nofreelunch-uk.org |
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Brian J. Penney, GP Smiths Falls Ontario Canada K7A 2Y8
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Des Spence conveniently forgets that the most potent event in prescribing a COX 2 NSAID is the experience of having a patient die of GI haemorrhage.It is never, in my experience, a response to any form of marketing. If long term large population studies had shown this drug was safe, it would have been considered medical negligence to have not prescribed it in 2003 in a patient who subsequently died of an NSAID induced GI bleed. I wonder if Des Spence also intends to demean those physicians who do not have the venal self serving interests he describes. It is said that what we most dislike in others are those qualities we dislike in our selves. Competing interests: None declared |
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des spence, spokesperson General Practice Glasgow G20
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I ,in fact, have many more personal failings than you have suggested. I think ,however, that we should consider the facts. In the original VIGOR study Rofecoxib did prevent more GI bleeds as compared to Naproxen as you suggested. The overall mortality ,however, was higher in the Rofecoxib group. Consider, also, that these were high risk RA patients not typical of those we see in General practice. Importantly also, Naproxen has a relatively high GI toxicity compared to other NSAID and is not widely used in the UK. Expert opinion rightly suggested limited indications for Rofecoxib. Research also suggests that 10% of medication have serious side effects unknown at the time of licensing and caution should be exercised when prescribing new medications[2] This new research demonstrates that any potential benefit from Rofecoxib on GI toxicity were certainly out weighed by the increased risk of strokes and heart attacks. Patients have a right to ask why Cox II got such market penetration in such a short time. We did over prescribe vioxx and we are responsible. Painful for all of us to accept(including myself )that prescribed “Vioxx”. [1] VIGOR New England Journal of Medicine 2000;343: 1520-8 [2] Timing of new black box warnings and withdrawals for prescription medications. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. JAMA. 2002 May 1;287(17):2215-20. Competing interests: nofreelunch-uk.org |
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Dr. Herbert H. Nehrlich, Private Practice Bribie Island, Australia 4507
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A clear win for Glasgow over Smiths Falls, Ontario. Dr. Spence (nofreelunch) would be my choice of a doctor even if Dr. Penney did offer a free lunch. The only thing capable of protecting our patients from Vioxx and its many cousins are responsible doctors working with well-informed patients. What do they say in the old country? "A defensive gun is likely to shoot the messenger...." Competing interests: None declared |
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Walter R Schumm, Professor Kansas State University
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A Comment on the Use of FluMist for Children and Adults The shortage of influenza vaccines have reached to the heartland of the United States. Even in my hometown of Manhattan, Kansas, stores are posting signs that their pharmacies do not have any supplies of flu vaccine. The shortages of flu vaccine have increased concerns about the risks of the upcoming flu season in the United States and elsewhere. One solution to the overall shortage of vaccine is the use of FluMist which is administered nasally rather than by injection. The prescribing information for FluMist is available, as a package insert (circular) at http://www.FluMist.com/pdf/prescribinginfo.pdf. The accuracy of pharmaceutical claims has been subject to much recent criticism.1 2 In particular, there have been concerns about an exaggerated role of marketing3 and of attempts to suppress "inconvenient findings."4 Given those concerns and the importance of alternative flu treatments, I reviewed the information in the FluMist circular and found that some information did not seem to be correct. Therefore, I recreated the data and re-ran the same analyses presented in the circular. Some discrepancies were observed. In Table 1 of the circular, the efficacy of the vaccine is cited at 87.4%, with only 3 (1.8%) of 163 FluMist recipients (children 60-71 months old) coming down with culture-confirmed influenza over the flu season compared to 11 (14.7%) of 75 placebo children. The result is cited as significant (p < .05), whereas in fact the significance level by Fisher's Exact Test is much better (p < .001). However, it cannot but be noted that even in the Placebo group, over 85% of the subjects never came down with culture-confirmed influenza despite the relative lack of vaccine protection. Of more concern are the results regarding adverse events observed within ten days of each dose, reported in Table 3 of the circular. A note underneath the table says that "There were no statistically significant differences in any of these events (p-value > .05); Fisher's exact method." However, headache was observed for 6.8% of 161 children who received FluMist compared to 16.0% of placebo subjects, a difference significant by Fisher's exact test (p < .04, two-sided). Runny nose/nasal congestion was observed for 46.0% of the treatment group compared to 32.0% of the placebo groups, again a difference significant by Fisher's exact test (p < .05, two-sided). Combining all events together to create "any event," 66.5% of the treatment group versus 53.3% of the placebo group had at least one adverse event, a difference nearly significant by a two-sided Fisher's exact test (p = .061) and significant by a one-sided test (p < .04). In contrast to the note under Table 3 of the circular, at least some of the statistical tests were significant (p < .05). It is possible that the circular's author(s) used Bonferroni procedures to reduce the alpha level for each test, but if they did so, they did not make that clear. However, if we make the best possible case for FluMist and accept 66.5% adverse events (107 of 161) for the treatment group of children but no flu cases and 68.0% adverse events and/or flu (40 events and 11 flu cases, 51 of 75) for the placebo group, we find no significant differences between the two groups in total health outcomes by Fisher's exact test (p = .882, two-sided). The situation for adults is similar. Table 2 indicates that 8.8% of treatment group adults (18-49 years old) experienced a febrile upper respiratory illness compared to 11.6% of placebo adults (p < .05). However, with respect to "any febrile illness," the differences between treatment group (13.7%) and the placebo group (15.4%) were not significant (p > .05). Table 4 indicates that 71.9% of treatment group adults experienced "any event" within 7 days of each dose compared to 62.6% of placebo group adults (p < .05). Coupled with the flu estimates as was done for the analysis of the children's data, 71.9% of the treatment group had some adverse health outcomes (events) compared to 74.2% (62.6% + 11.6%) of the placebo group. Even bending over backwards to benefit the treatment group outcomes, the net result is barely more than a two percent difference (74.2 – 71.9 = 2.3%) in adverse health outcomes between the treatment and control groups. To me, the results above would indicate that FluMist may be a valuable vaccine for children and adults most at risk of complications, especially severe complications, from an attack of an influenza virus, but the value for healthy children and adults with strong immune systems and with unrestricted access to effective health care systems may be subject to debate. Perhaps of even greater concern is the fact that the statistical information presented to health care professionals in the FluMist circular is either incorrect or incompletely stated. Nor does the information highlight the combined outcomes experienced by subjects, which would be useful for physicians trying to understand the overall advantages and disadvantages of using a particular vaccine. Such issues further complicate discussions concerning the credibility of information provided by drug companies as it may impact adversely the recommendations of medical personnel and the decisions of patients. Walter R. Schumm, Ph.D., Professor School of Family Studies and Human Services, Kansas State University, Justin Hall, 1700 Anderson Avenue, Manhattan, Kansas USA 66506-1403 (Schumm@humec.ksu.edu) 1 Roehr, B. Stronger sanctions needed against companies that suppress data. BMJ 2004; 329: 132. (July 17.) 2 Lenzer, J. FDA's counsel accused of being too close to drug industry. BMJ 2004;329: 189. (July 24.) 3 Kmietowicz, Z. Consumer organizations criticize influence of drug companies. BMJ 2004; 329: 937. (October 23.) 4 Editorial Board. The whole truth: drug companies must tell us all they know about the medicines we take. New Scientist 2004; 182(2445): 3. (May 1.) Competing interests: None declared |
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Silvio Garattini, Director Istituto
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To the Editor: Several months of debate on drug safety have focused on US policy but very little has been said about the European situation (1). Some fundamental questions remain to be answered. For instance, it is very hard to see why the manufacturer, and not the regulatory agencies, withdrew rofecoxib. Both the FDA and EMEA had concluded, before this decision, that this product – and the other drugs belonging to the cyclooxygenase-2 inhibitor class - were essentially safe, and all that was needed was a few changes to the SPC (Summary of the Product Characteristics), a document that is seldom actually read by prescribing physicians. This had happened before for cerivastatin and for other drugs, raising doubts about the regulatory agencies’ efficiency in reaching decisions about benefit-risk ratios. The American government has already decided to create an agency separate from the FDA, the Drug Safety Oversight Board, to monitor the toxicity of drugs after they have entered the market. In Europe there has been practically no reaction from the EU Commission, probably because the EMEA reports to the General Directorate of Enterprises. There are several reasons to support the establishment of national and European agencies not only to keep an eye on spontaneous reports from prescribers but also to take an active part in searching for drug-induced toxicity. At the European level this agency should report to the General Directorate of Health and Consumers (SANCO), and should be independent from EMEA. It is essential to establish a ‘balance of power‘ between approvals and withdrawals of drugs or restrictions of therapeutic indications in order to provide adequate information to physicians and the public, as this would help counteract the pharmaceutical companies’ monopoly of information. Silvio Garattini
1) J. Lenzer, FDA is capable of protecting US “against another Vioxx”, BMJ, 2004, 329:1253 febbraio 2005 Competing interests: None declared |
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