Big Pharma Gets New Federal Testing Guidelines

The Vioxx affair and Merck’s behavior in developing the drug was one of the biggest acts of corporate malfeasance in this decade.

Released in 1999, the drug was purported to be a revolutionary new anti-inflammatory drug that was supposed to greatly relieve the pains of arthritis sufferers. It was also supposed to relieve pain without causing any upset stomachs in its users. Considering that stomach discomfort was one of the more prominent side effects suffered by arthritis patients that took other analgesics, the development of Vioxx was considered a real breakthrough.

But in the five years that the drug was on the market, it became clear that there was something drastically wrong with the product. A percentage of Vioxx users with no real history of heart problems began to have heart attacks, and some began to even have strokes.

As public scrutiny began to build, doctors and former Merck employees began to allege that Merck was manipulating the testing data to appear favorable. They also maintained that they were being pressured to continue to put the best possible face on the drug. There were even some doctors who claim that they were blackballed and that their careers suffered as a result of voicing their concerns.

This is not an inconceivable scenario. Pharmaceutical companies hold real financial influence over the day to day workings of hospitals, HMO’s, and insurance companies. By the time this public scrutiny began to be raised, Vioxx was a blockbuster drug that was bringing in billions of dollars worth of profits for Merck. It is not a stretch to imagine the pharmaceutical giant bringing real pressure to bear in order to protect its earnings.

Merck finally pulled Vioxx off the shelves in 2004, but only after a long and protracted struggle with the FDA. In fact, the FDA actually went against the recommendations of its independent advisory committee, which recommended that the drug remain on the shelves. They did, however, concede that perhaps the warning label on the packaging should be bigger.

Lawsuits were promptly filed against Merck by those Vioxx users who survived heart attacks and strokes, and also by the family members of those Vioxx users who didn’t. Merck guarded its documentation very zealously. And there was also a very influential tort reform movement that was successfully placing caps on collectable damages in tort cases. As a result, quite a few of these lawsuits were not successful.

But a recent report published by the Journal of the American Medical Association has detailed exactly how the clinical trial testing reports submitted by Merck were altered to make the disturbing mortality and heart attack statistics appear insubstantial and irrelevant.

Manipulating the Data

According to the Journal article, Merck knew there was something wrong with Vioxx as early as 1999. The article provides confidential Merck documents that explained exactly how the numbers were cooked in order to mislead the FDA. During the clinical testing that involved Alzheimer’s patients, Merck claimed that their test results included both the data collected from the subjects during the testing period and the data collected after the testing period was completed. The after testing period (which is called the “intention to treat” period) was described by Merck as “well tolerated” and that there were no mortalities or complications. In fact, the after-testing numbers were not included at all in the testing results that were submitted to the FDA.

This was an incredible manipulation, especially considering that the drug was expected to be taken regularly over an extended period. The internal memorandum revealed that in the intention-to-treat analysis (looking for safety after the completion of the trials), Vioxx was found to be “associated with an increased risk of mortality in each of the studies.” And based on the internal memorandum data, the authors conclude that “in a combined analysis, refecoxib [Vioxx] was associated with a 3-fold increase in total mortality.” (Italics own.)

The Vioxx affair will probably go down as one of the most notorious episodes of neglect by a pharmaceutical company for profit.

New FDA Regulations

The FDA has finally lived up to its responsibilities to the public by requiring that all pharmaceutical companies file any and all trial results to a federal registry within one year of the completion of the trials. This registry is accessible to the public, and will also include any documents pertaining to the FDA’s review of the testing information. Those who do not submit all of the necessary documentation within one year will be subject to sanctions and fines from the NIH.

Every step of any development and testing process of any drug will be forced to be documented in a very particular way, and what this means is that the testing process will be completely transparent. Testing will be above board and no longer susceptible to manipulation. And that can’t be anything but good news for the American public.

If you or a loved one has suffered from the effects of a bad drug, contact our offices for a free legal consultation today.

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