Today, US pharmaceutical companies fund more than two-thirds of the medical research performed at US universities and colleges. More than two decades ago, this was not the case as the US government was the primary provider of medical research funding. Many suggest that because pharmaceutical companies fund the research, the reported findings about the research and drugs are biased. As citizens we need to be concerned especially since we rely primarily on these experts to fully disclose everything they know about a particular drug - both good and bad. Just how much influence do drug companies have and how does this jeopardize our safety?

The Alliance for Human Research Protection reports that as many as 55,000 people have died from heart attacks as a direct result of taking the drug Vioxx. It adds that the FDA took too long to respond to the warning signals as evidenced by these adverse effects. On Aug 19, 2005, a Texas Jury found Merck and Co. liable in the sudden cardiac death of Carol Ernst who was taking the drug Vioxx at the time of his death. In that report, Swiss scientists assert that evidence of increased heart attack risk associated with the drug Vioxx was available as early as 2000 and yet the drug was not withdrawn by the FDA until 2004. Why didn’t the FDA stop the consumer advertising of Vioxx immediately upon learning of this evidence until the issues were sorted out?

Another case of delayed action to address the adverse side effects of anti-depressants is with the drug Zoloft. Zoloft has been the focus of complaints by both patients and physicians who assert that this drug induces suicidal and homicidal behavior. In 1991, when these complaints first surfaced, the FDA could not find any correlation between the drug and any illegal suicidal or homicidal behavior. In October 2004, the FDA finally called for a black box label on all anti-depressant drugs warning about the risk of suicidal tendencies in adolescents and children. Since then research has shown that agitation is in fact one of the neurological adverse side effects of this drug. The following tragedies are difficult to ignore especially since each one of them involved the use of anti-depressant drugs:

1. Matthew Miller, a 13 year old committed suicide less than one week after taking the drug Zoloft.
2. One of the Columbine shooters, Ed Harris, was taking an antidepressant drug called Luvoc, at the time of his crimes.
3. Kip Kinkel, a 15 year old, was on Prozac when he decided to kill his parents and open fired on his classmates killing two and wounding 22 others.
4. Jason Hoffman was also on anti-depressants when he wounded one teacher and three students at Granite Hills High School in El Cajon, California.

Bandolier (an independent journal about evidence-based healthcare written by Oxford scientists) suggests that Adverse Drug Reactions (ADR) is the fourth to sixth leading cause of death in the US and the costs associated with ADR estimates up to $4 billion per year. In 1994, there were an estimated 2.2 million incidents of serious ADRs and 106,000 of these were fatal.

Clearly, there is a need for stricter regulations for public disclosure of industry-sponsored research. More importantly, all adverse research findings must also be disclosed fully to the FDA before these drug companies are given the go ahead to mass produce them for public consumption.

In a study by the Harvard School of Public Health, 122 medical schools could not agree on how much control they should give pharmaceutical companies in drafting research papers and providing the data for these papers. The general public needs complete objectivity to drug development, prescriptions and disclosure of findings (both positive and negative). Without complete objectivity, our decisions to pursue certain drugs could prove harmful and even fatal.

In the August 2000 newsletter of The People's Medical Society, several conflicts of interest between medical professionals and pharmaceutical companies were revealed:

1. Medical research studies are often designed by the pharmaceutical companies themselves and designed in a way that will favor their drugs.
2. Pharmaceutical companies can control the raw research data and are able to withhold data that they believe may give bad publicity to their drugs
3. These companies can often alter the medical research publication and the findings to present it in a more favorable position towards their own drugs.
4. The studies are often not written by the investigators but by professional medical writers employed by the drug companies
5. Medical students, doctors in training and even, full fledged physicians are being influenced and wooed by pharmaceutical companies with meals, patent and royalty arrangements, speaking engagements, and grants in return for sponsoring and endorsing their drugs.

The following findings were reported by the News Target when 846 FDA scientists were surveyed and asked questions about the FDA agency:

1. As many as 66% lacked confidence in the agency's ability to "adequately monitor the safety of prescription drugs once they are on the market” while 48% say the FDA does not do enough to monitor or improve the drug assessment process.
2. Only 13% of respondents believe that the FDA’s final decision adequately reflects the safety of the drugs it allows.
3. One in five of the FDA scientists admit to having been pressured to approve or recommend approval for drugs that they thought have not fully met the safety assessment process.

Let us petition for the following:

Push for the elimination of gag clauses in research contracts so that hospitals and universities are free to provide feedback about the ill side effects of a particular drug or treatment.

The creation of a uniform standard of principles and ethics for researchers, universities and colleges in how to deal with medical research sponsors at arms-length especially in the reporting of research and disclosing of all findings.

Require all sponsors of medical research to register their studies into a government database and give full access for the findings and research to medical experts and the general public. Enforce all medical journal editors to refrain from publishing any study results that have not been registered in this government database.

Facilitate complete transparency forcing physicians to fully disclose (including amounts of) any gifts they receive from pharmaceutical companies and the venues in which they were received.

Push for reform and stricter controls at the FDA level, in terms of monitoring a drug’s effectiveness and safety even after the drug has been launched.

When drug manufacturers use their financial prowess to extend monetary and gift benefits to physicians, medical schools and research companies, citizens need to question the findings of research studies. More importantly, the health and safety of the general public, who rely on this research, are at risk. Pharmaceutical companies, physicians, medical schools and research companies have a fiduciary obligation to those who rely on their expertise and opinions. It is time that the FDA enforces this obligation so that the experts are always mindful that the general public are depending on them for complete and honest disclosure about research findings. People’s lives (both innocent and of those who take these drugs) are at risk!

This petition will be sent to the FDA Commissioner Lester M Crawford and to the US Congress.


Additional Sources and References:

ABC News: Drug Companies Influence Medical Research (http://abcnews.go.com/Health/wireStory?id=791660&page=2)

Adverse Drug Reactions (http://www.jr2.ox.ac.uk/bandolier/band101/b101-4.html)

Bitter Medicine (http://www.motherjones.com/arts/books/2004/09/08_100.html)

Drug Company Influence on Medical Education in the USA (http://www.mercola.com/2000/sep/10/drug_company_influence.htm)

Drug Company Influence Extends to Research (http://www.findarticles.com/p/articles/mi_qa3795/is_200008/ai_n8921790#continue)

Drug Companies (http://www.newstarget.com/001690.html)

Drug Company Influence Extends to Research (http://www.findarticles.com/p/articles/mi_qa3795/is_200008/ai_n8921790#continue)

Drug Companies Influence Medical Research (http://www.newstarget.com/001690.html)

Doctors Fight Over Drug Firm Influence (http://www.boston.com/business/articles/2005/06/16/doctors_fight_over_drug_firm_influence/?page=20

Drug Company Gifts May Affect the Way Doctors Practice Medicine (http://www.mercola.com/2000/jan/23/drug_co_gifts_affect_doctor_practice.htm)

Lessons from the Vioxx Fiasco (http://www.businessweek.com/magazine/content/04_48/b3910055_mz011.htm)

Medical Journals Aim to Curtail Drug Companies’ Influence (http://www.mercola.com/2001/aug/8/drug_company_interference.htm)

Medical Schools and Drug Firm Dollars (http://www.mercola.com/2000/jan/23/drug_co_gifts_affect_doctor_practice.htm)

Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum (http://www.newstarget.com/002157.html)

Survey: Drug companies influence studies (http://washingtontimes.com/upi-breaking/20050525-040940-5529r.htm)

The FDA, Vioxx, and Crimes Against Humanity (http://www.newstarget.com/009693.html)

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