MERCK THE FDA AND THE VIOXX RECALL CASE STUDY QUESTIONS

The study of over patients was initiated without a standard operating procedure for collecting information on cardiovascular events and without a cardiologist on the data safety monitoring board. AHP has research interests in the history of public health and law, including pharmaceutical research and marketing. A memo from Merck statistician Deborah Shapiro to Merck scientist Alise Reicin both are listed as authors of the NEJM paper refers to heart attacks 18, 19 and 20 suffered by patients taking Vioxx during the study. The increased cardiovascular risk compared with placebo was reported in a analysis of the adenomatous polyp prevention on Vioxx APPROVe study, w13 which led to the drug’s withdrawal. The paper had no editorial commentary or critique, w25 even though the study was coordinated internally at Merck, the results highly favoured the safety of rofecoxib, and five of the seven authors were Merck employees the two academic authors acknowledged being paid consultants to Merck.

This study had been designed to determine if VIOXX reduced the risk of recurrent colon polyps a precursor to colon cancer ; Merck hoped it would lead to FDA approval of the drug for this condition. HMK’s research is focused on determining optimal clinical strategies and identifying opportunities for improvement in the prevention, treatment, and outcome of cardiovascular disease with emphasis on older populations. COX-2, on the other hand, contributed to pain and inflammation. Privately, however, the company seemed worried. We might consider adopting some new approaches. The minutes of the panel’s November meeting note that “while the trends are disconcerting, the numbers of events are small. He found that patients on high doses of Vioxx had 3 times the rate of heart attacks as patients on Celebrex, a competing COX-2 inhibitor made by Pfizer.

On Friday, I looked at the data with my team. Letter to Ken Lasseter; manuscript draft for protocol Determing the specific contribution of Vioxx to a particular cardiovascular event would be very difficult. The drug companies defended DTC ads, saying ad informed consumers of newly available therapies and encouraged people to seek medical treatment.

Short and long term use For several years, Merck continued to investigate other indications for rofecoxib and conducted additional trials. US House of Representatives, Nearly million prescriptions for rofecoxib were dispensed in the US between and September21 when the drug was withdrawn from the market, and none of the people picking up those prescriptions had the opportunity to consider the true balance of its risks and benefits.

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Merck discounted this finding, saying that studies of patient records were less reliable than double-blind clinical studies. Associated Data Supplementary Materials [extra: H M Krumholz ude. Later, when defending its decision to continue the study, the safety panel said it recal, tell if Vioxx was causing the heart problems or if naproxen, acting like low-dose aspirin, protected people from them, making Vioxx just look risky by comparison.

Once the FDA had approved a drug, physicians could prescribe it for any purpose, but the manufacturer could market it only for uses for which it had been approved. Gregory Curfman is deposed in connection with the Vioxx product-liability cases.

Timeline: The Rise and Fall of Vioxx

Rofecoxib Vioxx was introduced by Merck in as an effective, safer alternative to non-steroidal anti-inflammatory drugs for the treatment of pain associated with osteoarthritis. Metck B, Saul S.

Inthe FDA for the first time allowed drug companies to advertise directly to consumers. Events reported later won’t be included in the initial analysis.

When journals discover that information has been withheld or that results are incorrect, they need to rapidly disseminate that information and ensure that any web search that identifies the errant manuscript also identifies the correction.

This study had been designed to determine if VIOXX reduced the risk of recurrent colon polyps a precursor to colon cancer ; Merck hoped it would lead to FDA approval of the drug for this condition. Such a drug would offer distinctive benefits to some patients, such as arthritis sufferers who were at risk from ulcers bleeding sores in the intestinal tract.

Early suspicion of cardiovascular risk Since the early development of rofecoxib, some scientists at Merck were concerned that the drug might adversely affect the cardiovascular system by altering the ratio of prostacyclin to thromboxane, which act in opposition, balancing blood flow and clotting.

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merck the fda and the vioxx recall case study questions

He found that patients on high doses of Vioxx had 3 times fva rate of heart attacks as patients on Celebrex, a competing COX-2 inhibitor made by Pfizer. Merck strongly promoted the VIGOR study, purchasing nearly 1 million reprints to circulate to doctors and other health professionals. January to August The report contained data from an interim analysis that had different termination dates for cardiovascular and gastrointestinal wnd gastrointestinal events were counted for one month longer than the cardiovascular events.

He participated in the concept and design of this article and revised it for critical content.

What have we learnt from Vioxx?

November 10, 2: In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. Industry should not be allowed to select who serves on these boards or allowed to compensate members after their ad. Their analysis is significant because they take all the VIGOR data from the FDA Web viosx, recrunch them, and cast serious doubt on the hypothesis that naproxen protects the heart.

Promoting constructive collaboration The rofecoxib case is bad news for industry, academics, journals, and the public.

Case Study; MERCK, the FDA, and the VIOXX RECALL | PerfectCustomPapers

Merck had long enjoyed a reputation as one of the most ethical and socially responsible of the major drug companies. The published results also leave out data on many other kinds of cardiovascular adverse events. Dangerous data—retracing a medical trail.

merck the fda and the vioxx recall case study questions

The drug was later approved for rheumatoid arthritis. In considering articles for publications, journals should understand that studies with immense financial implications require a higher level of scrutiny than others, especially when the study is aand by the company with the financial stake.