Which of these is a controllable risk factor of cardiovascular disease or heart attacks?

 

Merck Vioxx

Answer the following questions using the sources below:

1. How much fault would you place on the scientists conducting the study vs the company itself and do you think they should bare any of the repercussions?
2. Do you think including a placebo in this study either as a replacement to naproxen or in addition to it would have prevented this from happening?
3. Weinblatt the safety chair, agreed to wait for all results to be compiled before reviewing the cardiovascular study specifically. A few months later filled out a financial disclosure statement stating he and his wife had purchase $72,985 of Merck stock. Do you think this is indicative of anything fishy?

Sources:

Merck Manipulated the Science about the Drug Vioxx. 2017 Oct 12. Union of Concerned Scientists. 

Prakash S, Valentine V. 2007 Nov 10. Timeline: The Rise and Fall of Vioxx. NPRorg. 

National Institute on Aging. 2020. Placebos in Clinical Trials. National Institute on Aging. 

Merck Vioxx

In the late 90’s a leading pharmaceutical manufacturer Merck had been working on a treatment for osteoarthritis, rheumatoid arthritis and other conditions associated with pain (Prakash S, Velentine V. 2007). Merck’s solution to this health issue came in the form of Vioxx, showing promising therapeutic effects with minimal and reduced side effects associated with competitors (Union of Concerned Scientists, 2017). 1998 saw the submission by Merck for approval by the FDA for vioxx after being tested on 5400 subjects in 8 separate studies (Prakash S, Velentine V. 2007). Come 1999 another study was conducted in order to compare the drug to a popular competitor known as naproxen in which, 8000 participants were observed (Prakash S, Velentine V. 2007). Half of the participants took vioxx and the other naproxen (Prakash S, Velentine V. 2007). By the end of the year the results of the study were compiled among the Vioxx Gastrointestinal Outcomes Research study AKA Vigor where vioxx showed far fewer ulcers and intestinal bleeding than those taking naproxen (Prakash S, Velentine V. 2007). A second meeting however was focused on heart problems where 79 patients of the 4000 taking vioxx were found to have a serious event compare too 41 of 4000 taking naproxen (Prakash S, Velentine V. 2007). These figures were deemed as comparatively small and to be re-evaluated in 30 days (Prakash S, Velentine V. 2007). VIGOR re convened and were notified that vioxx patients were twice as likely to have serious heart problems and or death than those of naproxen (Prakash S, Velentine V. 2007). A vote was successfully held to continue the study under the defense of not knowing if vioxx caused the heart problems or if the patients taking naproxen was acting as a low dose aspririn and protecting patients from them (Prakash S, Velentine V. 2007).

Many pharmaceutical studies are conducted using a placebo in their control group whereas here Merck decided to use naproxen. The reason placebos are commonplace is so to have an understanding of what the effects a drug can have on an individual that isn’t taking the drug at all in order to deem its safety and effectiveness (National Institute on Aging. 2020). The comparative nature of the study was seen as a means of skewing data to push the drug through FDA approval (Union of Concerned Scientists, 2017). Scientists were seen as highlighting the benefits of naproxen making it appear as though Vioxx was safer than the results suggested (Union of Concerned Scientists, 2017). Weinblatt, a safety chair as part of the advisory committee had initially pushed for information in 2000 on cardiovascular risks but ultimately succumbed to waiting on the results to be combined with all other studies (Union of Concerned Scientists, 2017). Another form of data manipulations was found when the first draft of 16 out 20 reports listed an employee as the author but upon final draft the author had changed to an external academic drawing questions of a ghost writer (Union of Concerned Scientists, 2017). Furthermore evidence of three heart attacks were removed from records of patients taking vioxx, thousands of deaths and 100,000 heart attacks due to its approval in 1999 to its recall in 2004 (Union of Concerned Scientists, 2017). Patients who have stopped taking vioxx are still facing complications related it its use (Union of Concerned Scientists, 2017)

An estimated 20 million Americans are thought to have taken the drug and the company began facing 13000 lawsuits on behalf of 23,000 plaintiffs (Union of Concerned Scientists, 2017). Trials persisted for years to which Merck defends the study and withholding information on grounds of certain instance reporting falling outside the timeline required by the studies reporting guidelines(Union of Concerned Scientists, 2017). Of the 7 trials held Merck won 3 and came to a settlement in 2007 noted as the largest drug settlement of its time  seeing Merck pay $4.85 Billion into a settlement account and allowing them to avoid personal injury lawsuits of approximately 47,000 plaintiffs and 265 class action lawsuits (Union of Concerned Scientists, 2017).

1. How much fault would you place on the scientists conducting the study vs the company itself and do you think they should bare any of the repercussions?
2. Do you think including a placebo in this study either as a replacement to naproxen or in addition to it would have prevented this from happening?
3. Weinblatt the safety chair, agreed to wait for all results to be compiled before reviewing the cardiovascular study specifically. A few months later filled out a financial disclosure statement stating he and his wife had purchase $72,985 of Merck stock. Do you think this is indicative of anything fishy?

References:

Merck Manipulated the Science about the Drug Vioxx. 2017 Oct 12. Union of Concerned Scientists. 

Prakash S, Valentine V. 2007 Nov 10. Timeline: The Rise and Fall of Vioxx. NPRorg. 

National Institute on Aging. 2020. Placebos in Clinical Trials. National Institute on Aging.