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Sue's Blog

Wednesday, 03/13/13 - About The FDA from The People's Chemist

Drug safety is a simple matter of majority rule, of 51% telling the other 49% that deadly drugs are safe and necessary. And that majority is fueled by profit, not science. I witnessed this close up as a chemist designing tamoxifen derivatives. Promoted as an-anti-cancer drug, it garnered $4 billion a year. As shown in Over-The-Counter Natural Cures, it caused the same illness it was promoted to treat. Still though, it was “FDA approved.”

Here are two reason not to trust FDA approval.

Reason #1 More than Half of the Experts are Financially Motivated

According to USA Today, more than half of the experts hired by the FDA to advise the government on the safety and effectiveness of medicines have direct financial relationships with the pharmaceutical companies who will either be helped or hurt by FDA approval. A USA Today analysis of financial conflicts of interest shows the following, based on 159 FDA advisory committee meetings:

92% of the meetings had at least one member who had a financial conflict of interest.

At 55% of advisory meetings, at least half, sometimes more among the FDA advisers, had conflicts of interest.

At 102 meetings dealing with the fate of a given drug, 33% of the experts in attendance had a financial conflict

Historically the FDA revealed when these financial conflicts were present, but these conflicts have been kept secret since 1992.

Reason #2: Drug Companies Pay the FDA

Pharmaceutical campaigning led to the passing of the 1997 Food and Drug Administration Modernization Act (FDAMA). The FDAMA allows for a new drug’s approval based on only one clinical trial.

In addition to lowering drug approval standards, pharmaceutical companies have ensured that the FDA is well compensated for their “approval” efforts. The Pharmaceutical campaigning led to the Prescription Drug User Fee Act (PDUFA) of 1992 and its reauthorization in 1997. This allows the FDA to collect fees directly from pharmaceutical companies to review new drug applications.

This sets a new precedent in drug approval. Previously, the United States treasury funded the FDA. However, with the PDUFA, they now receive their paychecks directly from the pharmaceutical industry. This ensures that the FDA remains a lap dog to the pharmaceutical industry.

Congressman Dan Burton has recognized this deadly trend among the FDA. In a noble attempt to notify other members of congress he testified as follows:

“How confident can we be in the recommendations of the Food and Drug Administration (FDA) when the chairman [of Vaccines and Related Biological Products Advisory Committee] and other individuals on their advisory committee own stock in major manufacturers of vaccines?”

“How confident can we be in a system when the agency seems to feel that the number of experts is so few that everyone has a conflict and thus waivers must be granted? It almost appears that there is an ‘old boys’ network” of vaccine advisors that rotate between the CDC and FDA ─ at times serving both simultaneously… It is important to determine if the Department of Health and Human Services has become complacent in its implementation of the legal requirements on conflicts of interest and committee management. If the law is too loose, we need to change it. If the agencies aren’t doing their job, they need to be held accountable…”

“What is at issue is not whether researchers can be bought in the sense of a quid pro quo; at issue is that close and remunerative collaboration with a company naturally creates goodwill on the part of researchers and the hope that the largesse will continue…Can the FDA and the CDC really believe that scientists are more immune to self-interest than other people?”

Select Medical Doctors, Scientists and FDA officials Reveal the Truth

“The people in charge [FDA officials] don’t say ‘Should we approve this drug?’ They say ‘Hey, how can we get this drug approved?’”

─ Michael Elashoff, ex-FDA biostatistician

“The agency [the FDA] neglects drug safety in its rush to speed the drug-approval process because current laws and policies let the drug industry influence FDA decisions.”

─ Paul Stolley, MD, MPH, former senior consultant to the FDA

“The people who approve a drug when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur…As currently configured the FDA is not able to adequately protect the American people.”

─ Dr. David Graham, speaking to Crusader Magazine in 2005, FDA insider for over 20 years

The conflict of interest amongst the FDA has become so apparent that it has caught the attention of major university researchers. A team of Harvard University professors has publicly advised physicians NOT to prescribe new drugs to their patients because their safety has not been established, despite FDA approval!

Call it human nature, greed, or just plain old corruption; the protective mechanism that was once the driving force of the FDA is gone. The FDA has a myriad of “skeletons in the closet” and has repeatedly shown blatant disregard for the public’s health while enriching its pharmaceutical partners.

As pharmaceutical business has grown, the FDA has changed from an institution that was trying to protect public health from bad food to a rubber stamp government organization that only takes public health into account when it is forced to by some form of gross public error.

By: Shane Ellison, MS
The People’s Chemist

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