Friday, August 12, 2005

 

Merck’s Clinical Research VP Says Studies Showed No CV Risk

Angleton, TX—Merck called its vice president of clinical research, Alise Reicin, to testify on Wednesday and Thursday about her work with Vioxx.

Dr. Reicin received her B.S. in biochemistry from Barnard College, attended Harvard medical school, and is board certified in internal medicine. Before joining Merck, she served as an assistant professor at Columbia University. She has published several peer-reviewed articles about Cox-2 inhibitors including Vioxx and has worked extensively on the development and postmarketing studies of Vioxx for Merck.

Although she did not work at Merck when it performed much of the premarketing Vioxx studies, Dr. Reicin reviewed the results of those studies with the jury. Merck performed 41 pre-clinical and 58 clinical trials on close to 10,000 patients before submitting its Vioxx New Drug Application or NDA to the FDA for review. Its clinical studies included 34 phase 1 studies, 11 phase 2 studies and 13 phase 3 studies. On cross-examination, Dr. Reicin conceded that clinical trials do not provide all relevant safety information for appropriate uses of drugs like Vioxx.

Dr. Reicin also reviewed several postmarketing studies, including VIGOR, which plaintiffs contend showed an increased cardiovascular risk in patients taking Vioxx. Dr. Reicin testified that none of these studies signaled an increased cardiovascular risk. Specifically with regard to VIGOR, in which people taking Vioxx experienced more cardiovascular events than patients taking naproxen, she parroted other Merck witnesses’ responses—naproxen was assumed to protect the heart. Since Naproxen protected the heart or is cardioprotective, patients taking Vioxx experienced more cardiovascular events than patients taking Vioxx. On cross-examination, Dr. Reicin confirmed that the authors of an article on which Merck relies to support its cardioprotective theory have received compensation from Merck for consulting. The plaintiffs contend that the difference in cardiovascular risks is explained by the increased cardiovascular risk in patients taking Vioxx.

Contrary to testimony by plaintiffs’ witnesses that Merck hid the VIGOR results, Dr. Reicin testified that Merck distributed the results promptly. Merck received the preliminary VIGOR results on March 9, 2000, which were faxed to the FDA on March 23, 2000. Merck issued a press release about the results on March 27, 2000. The results were also distributed in a letter to its clinical investigators, discussed in the lay press, and presented at Digestive Disease Week between March and May 2000. The New England Journal of Medicine published the VIGOR results in November 2000. But in response to Dr. Reisin’s testimony that Merck trumpeted the VIGOR results, Lanier showed the jury a video press release about VIGOR, which mentioned nothing about cardiovascular risks.

In October 2001, the FDA proposed adding a warning about Vioxx’s risk of heart attacks into the warnings section of the Vioxx label. Lanier showed the jury proposed edits to the FDA’s proposed label in which Merck argued to move any warning about heart attacks to the less conspicuous precautions section, which in the scheme of labeling carries less weight than placing it in the warnings section. Ultimately, Merck delayed adding any warning whatsoever until April 2002.

On cross-examination, Lanier showed Dr. Reicin several documents evidencing that 2001 was an important year for Vioxx. That was also the year that Bob Ernst died while taking Vioxx. Merck’s 2001 Vioxx Profit Plan reads, “The future growth of Vioxx requires that more patients are brought into the prescription market.” Other documents, most of them marketing documents with which Dr. Reicin was not familiar, confirmed that Merck went to great lengths to increase its profits in 2001 by increasing the number of patients taking Vioxx.

By almost all accounts, Dr. Reicin held her own against the skilled cross-examination of the Great Lan-tini. She provided explanatory context to the plaintiffs’ views of documents and statements that otherwise show a company hiding cardiovascular risks. The lingering question is whether the jury was listening. Much of Dr. Reicin’s testimony reached a jury bored and likely tired of revisiting issues and facts. But in the end, without the unintended repetition, the quagmire of studies and results would otherwise make little if any sense to the untrained ears of this Brazoria County jury. If the evidence ultimately proves that one of the world’s largest drug companies hid life-threatening dangers of its drug, or exonerates that company from reckless accusations, the repetition and boredom will have served its purpose.

Continue to log onto www.firstvioxxtrial.blogspot.com for daily updates about the nation’s first Vioxx trial.

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