Fool Poll: Vytorin, Ethics, and the Scientific Process

• Report this Comment On September 03, 2008, at 10:32 PM, blackbeardz wrote:

  -that second last line should read like this:

  "And there is a distinct possibility that Vytorin actually does have a link to cancer deaths."

  -after reading this article http://fdanews.com/newsletter/article?issueId=11923&arti...

  -I am very sceptical about all the studies, that were designed to answer other questions- not cancer, headed by Oxford University’s Sir Richard Peto, who “may have generated a secret scientific report to FDA — a report whose contents may have been misrepresented to our staff.” -Dingell, chairman of the House Energy and Commerce Committee, and Stupak, chairman of the Oversight and Investigations Subcommittee, say in a letter to company executives.

• Report this Comment On September 06, 2008, at 3:42 PM, Vickery04 wrote:

  A recent article from The Medical Letter on Drugs and Therapeutics, a nonprofit organization that has a reputation among physicians to be free of industry bias and financial support, addresses the recent issues surrounding Vytorin. Two studies have generated all this press. The ENHANCE study showed that Vytorin did lower bad cholesterol by 51% while Zocor alone lowered it by 41%. This has gotten less attention compared to another finding of the study which showed that Vytorin did not improve (and made a minuscule increase in) the thickness of carotid (neck) arteries. This was a "surrogate endpoint" where the researchers basically said that if they could not see improvement in carotid artery thickness, then it is unlikely that that there was any improvement in coronary (heart) artery thickness.

  The SEAS study is the one that is not yet finished and released data early. While not the primary goal of the study, it found an increase in various types of cancers in people taking Vytorin. No other studies have shown this to be the case. The caution here is that when a study is designed, the process of randomizing subjects focuses on the main question at hand (or primary endpoint). When data is available to draw conclusions about secondary endpoints, it must be remembered that the study was best designed to scientifically answer questions about the primary endpoint. However, the dilemma is that these findings do exist. Doctors do put weight on secondary endpoints but not as much as conclusions about the primary endpoints.

  Additionally, researchers routinely do interim data analysis during their studies. Once a potential harm or exceptional benefit is evident, the researchers have an ethical duty to inform the public. Whole studies can be stopped early if a drug should be scrapped or fast tracked for approval. Doctors, and shareholders for that matter, should have as much up to date information as possible to make decisions. How accurately they interpret and utilize that information is another question. The Medical Letter authors conclude that while we are awaiting the results of a large scale trial currently underway, for patients who cannot meet their cholesterol goals on a statin (Zocor's drug class) adding a second cholesterol drug (including Zetia) is a reasonable option for doctors.

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