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Compromise in the Pharmaceutical Industry
Publish date: Sep 1, 2011
Summary: Plant medicine safety pale in comparison to the promotional and safety practices of the mainstream drug industry.
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In the year 2005 alone, the pharmaceutical industry spent nearly $30 billion on the promotion and marketing of prescription drugs, of which $7.2 billion was directed toward physicians. This means that the industry spent on average about $8,800 in drug marketing efforts for each of the 817,000 physicians practicing in the US.
Moreover, over 90,000 drug company sales representatives made numerous promotional visits to these doctor’s offices. These marketing visits continue to be one of the most important ways that practicing doctors learn about the drugs that they prescribe to their patients.i
The drug industry’s influence on the medical profession and prescribing is becoming more widely recognized. Prescription drug costs continue to escalate, becoming one of the fastest growing components of health care spending. As new drugs have been introduced and heavily marketed by the industry, serious drug safety issues and controversies have become more common.
For example, it is estimated that in the year before Rofecoxib (Vioxx) was withdrawn, $208 million was spent on physician detailing and $256 million on direct to consumer advertising for this class of drugs, driving utilization far beyond what was necessary based on patient need.
An official from the U.S. Food and Drug Administration (FDA) estimates that Vioxx caused 88,000-139,000 heart attacks, 40 percent of which were fatal.ii However, going back to the year 2001, Merck—the world's largest drug manufacturer—was reporting to the FDA the that there was no increased risk of death from Vioxx, while the company’s own internal analysis showed a death rate that was three times higher for this drug when compared with a placebo.
Claiming that its popular painkiller Vioxx was “well tolerated,” Merck and Co. underreported the risk of death from the drug in clinical trial data that it supplied to the U.S. Food and Drug Administration, according to a new analysis. A separate article finds that Merck frequently paid academic researchers to put their names on published articles about Vioxx that company employees or company-paid medical writers actually prepared. “This is not (just) about Merck,” said lead author Joseph Ross, a physician and instructor at Mount Sinai School of Medicine in New York. “It happens all the time with other companies. We just need it to stop.”iii
According to a policy brief of the Prescription Project this represents only one example of how ghostwritten scientific articles can negatively impact on patient safety. The practice of ghostwriting is an integral part of drug industry efforts to generate positive reports on various drugs such as Neurontin, Zoloft, Paxil, and Fen Phen, all of which were later found to have undisclosed or underreported adverse effects.iv
In 2008, the blood thinner Heparin was linked to 62 deaths and several hundred serious reactions in the US and the UK. The key ingredient in this popularly used drug is derived from pig intestines from numerous slaughterhouses and channeled through diffuse and poorly-regulated supply chains to a Chinese manufacturer Changzhou SPL. This plant has never been checked by drug regulators in China, and has no certification.
Crude Heparin makers say they suspect that to cut costs, some in the industry have used intestines from pigs infected with a virus, commonly known as blue-ear disease, that has been widespread in Chinese swine herds since mid-2006 (such animals are supposed to be destroyed).
Upon investigating the drug the FDA says that it found “significant amounts” of an undisclosed contaminant in the Heparin active ingredients. When FDA officials toured Changzhou SPL, they described flaws in record-keeping and a lack of evidence that appropriate steps were being taken to effectively rid crude Heparin of possible contaminants. Their report also says that “manufacturing instructions” followed at the plant were “incomplete.”v
A total recall of the shipped drug has not been issued by the FDA as it was feared this could provoke a serious national shortage.
In reality, China has become the world’s leading supplier of allopathic pharmaceutical active ingredients, while India remains as the world’s dominant producer of generic drugs. Roughly 80 percent of the chemical ingredients in drugs and 40 percent of pharmaceuticals are actually imported to North America. Where such drug ingredients and drugs are earmarked for export, there is minimal incentive for overseas domestic regulators to inspect production protocols and end-products.vi Moreover, with very rare exception, the major drug companies themselves don't bother to run quality control checks on the drugs that are imported from China and other countries.
It must be asked, is the motive here to trade safety for profits? It is also a concern that the FDA has not inspected 93% of the factories that manufacture pharmaceuticals outside of North America. In light of this information, it appears that nutritional supplement and herbal product companies actually test their ingredients for contaminants with greater frequency than do the drug companies.vii Since Health Canada drug safety policies generally fall into line with FDA standards and provisions, and the public is served by the same multinational drug giants, it appears very likely that the same concerns apply to Canada.
i. The Prescription Project, Academic Detailing: Evidence-Based Prescribing Information; Fact Sheet – October 5, 2007, http://www.prescriptionproject.org/tools/solutions_factsheets/files/0007.pdf
iii. "Analyses Show Merck Underreported Drug Deaths, Used Ghostwriters," The Milwaukee Journal Sentinel (April 17, 2008). See also Joseph S. Ross et. al., "Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation," Journal of the American Medical Association 299: 15 (April 16, 2008): 1800-1812. See also Neil McLaughlin, Vioxx and Ghostwriting Explained: (Recipe for Disaster) (May 16, 2008).
iv. Pharmaceutical Ghostwriting Trend Mars Credibility of Research and Negatively Impacts Patient Safety: New policy brief by the Prescription Project highlights pervasiveness of pharmaceutical ghostwriting and recommends steps to restore credibility to academic writing (Thursday, April 17, 2008), http://www.centredaily.com/business/story/532623.html.
v. Gordon Fairclough, "How Heparin Maker in China Tackles Risks," Wall Street Journal (March 10, 2008): B1. See also "Heparin Probe Reveals Global Drug Market Perils: Contaminated Blood Thinner Raises Fears about Offshore Production," Associated Press (April 13, 2008).
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