Pfizer Guilty (Again) for False Marketing: Can we Trust FDA Standards?

Most American’s have been conditioned to trust “FDA approval.” Whether it’s an antidepressant, cholesterol-lowering drug or blood pressure med, FDA approval is thought to represent a full endorsement for safety and efficacy. But as a chemist, I’ve watched FDA standards erode to the point that makes “FDA Approval” the first sign of danger.

History of FDA Standards

Before 1906, there were no laws to protect consumers from unsafe or unsanitary food packaging and processing methods. Death and illness from food poisoning was commonplace, mainly from tainted meat products and canned goods. To address and meet these sanitation needs, The Pure Food and Drug Act was passed in 1906.

This new law heralded the birth of a brand new watchdog agency: the Food and Drug Administration (FDA). The FDA standards were, at first, pointed in the right direction, as can be seen in its mission statement:

“The FDA’s mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Our work is a blending of law and science aimed at protecting consumers.”

In its infancy, the FDA could be applauded for introducing foundational science and sanitation issues to the public. For instance, in 1913, the meat-packing industry was described as nauseating.2 To remedy this, FDA standards implemented a meat inspection law and a comprehensive food and drug law. This made it possible for producers to bring safer food items to market. Ultimately, this resulted in better health to the American public and was in line with the mission statement.

FDA Standards Increase Their Reach

To protect consumers from dangerous products in other markets, the FDA expanded its reach. To do this, the Pure Food and Drug Act of 1906 was enhanced with the 1938 Food, Drug, and Cosmetic Act. This act brought cosmetics and medical devices under direct control of the FDA, and also required pharmaceutical drugs to be labeled with adequate directions for safe use. More importantly, it required pre-market approval of new, man-made drugs.

By passing the 1938 Food, Drug, and Cosmetic Act into law, the FDA was given an unprecedented broad jurisdiction over all food, drugs and medical devices. This legislation gave the FDA sole power in deciding which foods, drugs and medical devices make it to the marketplace. The FDA also determines how these products will be labeled, used and marketed. Having a wide range of authority gave birth to the myth that FDA-approved drugs are safe and effective. But the FDA has failed miserably.

FDA Standards Fail To Stop Pfizer

Pfizer’s recent charges of illegally marketing their kidney-transplant drug Rapamune is emblematic of this. Rapamune, which prevents the body’s immune system from rejecting a transplanted organ, was approved by the FDA in 1999 for use in patients receiving a kidney transplant. However, federal officials said they promoted the drug for use in patients receiving other organ transplants, even offering financial incentives to its sales force to do so. The FDA looked away for four years!

For their guilt, Pfizer was forced to pay about $500 million – a paltry 5% of one years profits. Compared to Pfizer annual profits, this would be the equal to someone paying a fine of $1,500, based on their annual income of $50,000. The slap on the wrist is yet further evidence of lax FDA standards. Reuben A. Guttman, a lawyer for two of the whistle-blowers, told The New York Times that, “We used to trust these companies. You can’t trust these companies anymore.”

You can say that again!

In 2004, former head of the FDA – Lester M. Crawford – pleaded guilty to lying and conflict-of-interest charges in connection with stock he and his wife owned in companies he regulated as chief of the FDA!

The scandal has been going on for decades. Back in 1994, a Vermont Congressman asserted that the FDA collaborated with the manufacturer of a genetically engineered dairy hormone in clearing the new drug for approval and sale!

This is business as usual for Big Pharm and the FDA. Yet, the masses keep swallowing the hype! Sadly, the outcome of weak FDA standards has become all too clear.

FDA Standards Killing You

Prescription drugs kill an estimated 105,000 people per year.3 That equates to one individual dying about every five minutes from an “approved” drug ─ almost three hundred deaths every day ─ that is, twice as many fatalities in a single year from “approved drugs” as the total number of U.S. deaths [58,000] from the Vietnam War.4 This does not include the 98,000 killed every year by hospital medical error.

Illicit drugs, directly and indirectly, kill an estimated 19,000 people annually. Paradoxically, the U.S. Government spends nearly $12 billion every year to “fight a war” against illicit drugs in an effort to ameliorate this death toll. Yet America’s FDA approved drug problem continues to be ignored.

If not killed, an estimated two million people are victims of prescription drug-induced illnesses.6 These may include drug-induced obesity, diabetes, cancer, kidney disease, autism, depression, and heart failure. This trend is ignored by lazy-thinking and myopic medical doctors who dismiss the symptoms as “worsening health.” While revealing this truth, I encountered opposition. The most common argument parroted ─ an ill thought-out hypothesis ─ was that “the benefits of FDA-approved drugs justified the risk.” Since when is masking symptoms considered a benefit? Never.

Conflicts of Interest among FDA

Relaxed FDA standards stem from conflicts of interest among the FDA. 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 the decision of FDA approval.

These conflicts include helping a pharmaceutical company invent a medicine, then serving on the FDA advisory committee which then decides whether the drug will be approved for human consumption. Most conflicts are in the form of stock ownership and obtaining consulting fees or research grants from the drug industry.

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

– Financial conflicts of interest were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts

– 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 1992.8

How Drug Companies Took Over FDA Standards

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 efforts.

Pharmaceutical campaigning also led to the Prescription Drug User Fee Act (PDUFA) of 1992 and its reauthorization in 1997. The PDUFA allows the FDA to collect fees 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 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?”9

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!

Get Off FDA Approved Drugs Already!

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.