Merck Falsifies Data (Again).
The Seattle Times and Seattle Post Intelligencer have both reported that Doctor Bruce Psaty and biostatistician Dr. Richard Kronmal, PhD, of the University of Washington have written an article for the Journal of the American Medical Association (JAMA) describing how Merck Pharmaceuticals has misrepresented data regarding its pain relieving drug Vioxx. Vioxx is a COX-2 inhibitor which was supposed to cause less harm to the stomach lining than a more generalized anti-inflammatory COX inhibitor like aspirin or ibuprofen. The study in question showed Vioxx increasing the death rate of Alzheimer’s patients as well as increasing dementia in those patients. Other in-company studies showed an increase in cardiovascular problems in Vioxx users. Merck was aware of this cardiovascular side-effect a full two years before the Food and Drug Administration (FDA) approved the drug.
Merck and Company, the largest pharmaceutical company in the world, spent a huge number of dollars promoting Vioxx. Melody Petersen, in her book Our Daily Meds, describes “The Age of Blockbusters” and “the most expensive and aggressive pharmaceutical marketing battle at the turn of the century.” Advertising for Vioxx was starting to emerge in the late 90s even before Vioxx and Celebrex, a similar drug created by Merck competitors Pfizer and Pharmacia, had gained FDA approval in May of 1999.
Many doctors receive money from Merck and other prescription drug companies for consultations and participation in drug studies. Doctors give these studies credibility even when the data from clinical trials show that a new drug is little better than a placebo. Negative side effects have been understated or ignored. In the case of Vioxx, only patients without heart conditions were allowed in the effectiveness studies after an earlier study showed increased heart problems and even then, four out of one-thousand patients had cardiovascular problems as a result of the drug’s mechanism. That is four times the number as those who were receiving naproxen as part of a control group. That data was disregarded.
Merck has been found guilty of some other unsavory practices. A Friday, February 8, 2008 Washington Post article reports Merck was required to pay a settlement to Medicaid for unfair pricing practices. Merck would give drugs to hospitals and their patients for nothing or next to nothing. Once those patients left the hospital and were dependent on these drugs, Merck would jack up the price and these same drugs would become extremely expensive.
Peterson’s book documents case after case of pharmaceutical companies unduly influencing clinical trials and cherry picking the studies it offers to the FDA. Merck is only the largest of these companies. Recently, the FDA has been remiss in its duty as the agency in charge of regulating the prescription drug industry.
Insurance companies and HMO’s prefer using drugs that regulate symptoms rather than providing therapies that cure a disease. Therapy can be time consuming, difficult, and expensive. Drugs are cheap to make, (only a small percentage of the total retail cost for most drugs), and easy to administer, thus saving doctors time and HMOs money while making drug companies billions. This is also another reason we need to look at removing the profit motive from the health care industry. America needs a single-payer insurance, health care system.
A JAMA editorial by Catherine D. DeAngelis, MD, MPH, and Phil B. Fontanarosa, MD, MBA, about the negative effects of pharmaceutical company influence on the way doctors conduct studies and prescribe drugs offers some suggestions as to how to remove industry influence.
Several ethical doctors are starting to refuse payment from drug companies and they are working pro-bono for their consultations so as to avoid any conflict of interest. This is a start.