Merck & Co. was found conducting its own studies of the drug Vioxx, using names of scientific authors and writing academic articles, according to two documents from the Journal of the American Medical Association.
The reports that are based on internal documents of the company stated that Merck didn't disclose its involvement in producing the data and hid risk of death from its product, Vioxx, in patients with Alzheimer's disease.
In 2001 the Food and Drug Administration questioned Merck if the evidence of excess deaths in the first trials were a sign for the company to suspend the second trial to protect patients but Merck said the FDA finding was of small numeric differences and proceeded with the second trial, getting the same results as the first one.
The documents showed there were 21 deaths from heart disease in patients getting Vioxx, compared with 6 of those taking a placebo. In total there were 57 deaths in the group that was administrated with Vioxx and 29 in the placebo group, the documents showed.
The first examination results were shown in 2004 and the second study in 2005.
However, in 2004 Merck retreated Vioxx from the market since the drug was linked to an increase of risk of heart attack and stroke, agreeing to pay $4.85 billion to settle tens of thousands patient claims from its 84 million Vioxx customers.
The files revealed that supposed authors of several Vioxx clinical studies were not noticed or given the documents to be examined, signaling Merck prepared its own studies.
What surged as an issue for many is the fact that several physicians and clinical researches are used by large pharmaceutical groups to pursue ways that would put in danger the health of a patient.
This is just the tip of the iceberg, I've been sitting in this office for eight years, watching physicians and clinical researchers be used by pharmaceutical companies in ways that can end up with patients being hurt said
Catherine DeAngelis, editor of Journal American Medical Association,publisher of the two new studies.
Susan Cruzan, a spokeswoman for the FDA said agency officials declined to comment on the specific reports awaiting for more review.
Merck's research chief said the company provided complete mortality data from the studies to the FDA showing it was dissapointed of JAMA's reports.
Merck shares closed down 18 cents at $41.22 on the New York Stock Exchange on Tuesday.