Some Basic Facts about the FDA and How it Fails to Protect Americans from the Dangerous Effects of Drugs and Foods like Genetically Modified Foods, Dangerous Chemical Ingredients and Meat from Factory Farms

So many people ask why the FDA does not protect us more. Others ask us how the FDA works. The FDA is overseen by the Department of Health and Human Services (DHHS), which itself is part of the Executive branch of the United States government. The FDA processes more than $1 trillion worth of products each year and are charged with keeping you safe from these products. We will explore how drugs get approved, the agencies political limitations and ongoing conflicts of interest.

The official website for the FDA offers the following description:

“The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed.”

The over-arching mandate of the FDA is to regulate the multitude of medicinal products in a manner that ensures the safety of the American public and the claims (label) of marketed drugs. The safety of household chemical products, appliances, toys, and other consumer goods is another area of consumer protection pioneered by FDA.

The FDA consists of chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, businessmen and many others. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices.

The FDA was founded with a single chemist in the Department of Agriculture in 1862 and remained under their jurisdiction until June 1940, when the agency was moved to the then new Federal Security Agency.

In April 1953 the agency again was transferred, to the Department of Health, Education, and Welfare (HEW). Fifteen years later FDA became part of the Public Health Service within HEW. In May 1980, the education function was removed from HEW to create the Department of Health and Human Services, FDA's current home.

According to the FDA’s website, it monitors the manufacture, import, transport, storage, and sale of more than $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. But according to a survey by the FDA’s in-house watchdog, less than a quarter of the 51,229 food plants under FDA jurisdiction were inspected annually. And 56% were not inspected at all during a five-year period ending September 2008.

As of the end of 2009, the agency had a staff of 11,000 plus employees. As of 2010, it had a budget of $3.2 billion but only $259.3 million was devoted to food safety.

The FDA’s budget for approving, labeling, and monitoring drugs is in excess of $300 million per year. “Review teams” employ around 1,300 employees to approve new drugs. The “safety team” has 72 employees to determine whether new drugs are hurting people. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a miniscule budget of about $15 million a year.

One of the FDA’s key issues is responsibility for drug safety. Much of the ongoing controversy in the FDA is related to the concept of patents, profits and greed. When a patent is awarded, the drug’s creator is given exclusive manufacturing rights. If the drug is extremely popular, this motivates other companies to invent their own (different) drugs which try to accomplish the same effect. Because a drug is patented, competitors cannot produce the exact same drug without being sued. The legal system is filled with lawsuits between corporate giants fighting over patent and intellectual property rights.

The FDA charges extra fees to pharmaceutical companies that wish to expedite the approval process. Most commentators argue that this is a conflict of interest, as the companies who are supposed to be regulated by the FDA are the ones who are paying the FDA to speed up approvals.

David J. Graham, a scientist with the FDA appearing before a Congressional Investigative Hearing, reasoned that this pay-off to expedite the process sacrifices the quality of studies and increases the likelihood for error and deception.

Dr. Graham once recommended to Congress that a separate independent agency be created which is dedicated to continuously monitoring drug safety. The drug industry opposes any thought of an independent agency free from their political pressure, lobbying, campaign contributions and “legalized” forms of bribery.

The rank and file FDA employees are very dedicated to their work but are burdened with malaise, interference at the highest levels of government and rarely supported by political appointees in altruistic efforts to protect the general public. The department heads and positions subject to presidential appointment are not so altruistic.

The fact that the President has the administrative power to appoint the director of the FDA is sufficient to undermine its objectivity and compromise its actions. Each President has political “due bills” to corporate campaign contributors and it is never more evident than in recent political appointments to such agencies as the FCC, FDA, USDA and the Supreme Court.

In 2000 election, the drug industry contributed $26,686,392 to politicians – 69% to Republicans – an eight fold increase. The amount has increased exponentially since. As a result, industry insiders are appointed to positions intended to protect consumers including Roger Beachy, former director of the Monsanto-funded Danforth Plant Science Center, who is now the director of the USDA National Institute of Food and Agriculture.

Islam Siddiqui, Vice President of the Monsanto and Dupont-funded lobbying group, CropLife created to promote pesticides, was appointed to be the Agriculture Negotiator for the US Trade Representative. His appointment confirms this administration’s commitment to pressuring foreign nations to buy Monsanto’s genetically modified seeds and foods.

Rajiv Shah former agricultural-development director for the pro-biotech Gates Foundation (a frequent Monsanto partner), served as Obama's USDA Under-Secretary for Research Education and Economics and Chief Scientist and is now head of USAID. His mission is to increase grants for biotech research instead of sustainable farming.

On December 22, 2010, the U.S. Senate unanimously confirmed DuPont attorney Ramona Romero, a law school classmate of Michele Obama’s, to serve as General Counsel for the U.S. Department of Agriculture (USDA). This will clearly impact what biotech products the department supports and will have a chilling effect on organic an d sustainable farms.

According to a 2010 survey by the Union of Concerned Scientists, a nonpartisan advocate for unbiased science in government, scientists and inspectors at the FDA and USDA responsible for food safety say they face political and corporate interference with their work. More than 1,700 scientists and inspectors responded to the survey.

Almost half of those surveyed said that in the last year they had experienced "situations where corporate interests have forced the withdrawal or significant modification of [an agency] policy or action designed to protect consumers or public health."

And 45% said they had experienced similar interference from members of Congress. Fifty-four percent said the FDA and USDA gave political interests too much weight in their decision-making.

Francesca Grifo, director of the Scientific Integrity Program at the Union of Concerned Scientists said, "What we found is that action is needed to curtail interference in science, both political and that driven by the private sector. We have two very different agencies giving very identical responses, and this suggests the need for broad reform."

The situation is made worse by the fact that MSG industry representatives and political friends sit on boards of "independent" organizations such as the Scientific Advisory Board of the Center for Science in the Public Interest (CSPI) and the boards of several medical schools including Harvard and the Tufts University School of Nutrition. Well-educated and well-paid foxes in the public henhouse.

Capital investment and profits are the root of the incest between the FDA and drug manufacturers. The drug industry has too large a capital investment in their products to accept either failure or the FDA declining approval of drug after a company spends close to a billion dollars to get the drug to the market’s edge. Since many of these projects are partially or fully funded by government research grants, there is incentive to approve drugs prematurely.

This is made worse by the constant exchange of employees between drug companies and the FDA. Nobel Prize Winner Milton Friedman and other notables have criticized this unholy relationship describing it as “a union of government and big business and a legal form of bribery of government (FDA)”.

The cross pollination between FDA and drug industry employees is more than incestuous, it is an outrageous conflict of interest. In 2005, a major issue was raised regarding real and potential conflicts of interest where researchers were paid as consultants while performing work for the FDA.

This conflict pales in comparison to the drug industry offering employment to FDA commissioners and directors at five times their government salaries. These are rewards or “pay offs” for assisting biotech companies in obtaining approval of their drug applications. Some leave the FDA voluntarily, while others leave under political pressure.

As Daniel C. Dantini, MD points out, 25 years ago, the NIH funded 90% of all research. Now the industry funds 90% of all research. This switch in funding has permitted food and drug companies to test their own products and manipulate the results.

More could be achieved in preventing more deaths from faulty prescription drugs by cleaning up the conflicts of interest and bribery in the drug industry/FDA relationship than any other action taken by Congress or the President.

We believe that there should be a ban of at least one year between an employee of the FDA and drug company changing jobs (especially for higher pay) to the other.

This could be easily accomplished by the FDA requiring contracts for all employees, including department heads and political appointees, containing noncompetition and conflicts of interest clauses. This is the standard in the business community and not to much to ask of someone exercising this level of power to protect the general public.

Our nation should consider placing the position of FDA Commissioner on the ballot to be elected every six years rather than continue the failed policy of a sitting president appointing a person beholden to the food and drug industry as President Bush did by appointing Michael Taylor, a Monsanto lawyer and lobbyist to the post of Deputy Commissioner in 1992 and President Obama appointing the same Michael Taylor to another key post, FDA Deputy Commissioner for Foods, in 2009.

According to Food and Water Watch, Monsanto and the biotech industry have spent "more than half a billion dollars ($547 million) lobbying Congress since 1999". In 2009, the biotech industry spent $71 million lobbying. Monsanto still employs over a dozen lobbying firms, as well as maintaining their own in-house lobbyists to advance their causes on a daily basis. This immense economic power is twisting and corrupting the FDA and has significantly weakened public protection from flawed and dangerous drugs.

Internationally recognized expert in assessing the credibility of medical research, Dr. John Ioannidis discovered that “up to 90% of published medical information directly relied on by doctors to determine treatment is misleading, exaggerated or quite often flat out wrong.” Even more unsettling, the medical community agrees with his assessment. Dr. Ioannidis and his team spent a decade exploring the problem before publishing a landmark paper.

Dr. Ioannidis’ paper showed both theoretically and empirically that 80% of non-randomized studies (the most common type), 25% of the "gold-standard" randomized trials, and nearly 10% of the "platinum-standard" large randomized trials were incorrectly executed.

Economics appear to be an underlying cause of the research inaccuracies. A successful scientific career depends upon research being funded and published. This intellectual conflict of interest motivates scientists to pursue and produce results that will be funded no matter what. This permits companies like Phizer and Merck to control study outcomes.

Scientific journals are naturally biased towards publishing new, exciting research; they rely upon a vetted peer review process that is frequently commandeered by scientists in pursuit of career advancement. Worst of all are drug studies, funded by pharmaceutical companies and commonly corrupted by a much stronger financial conflict of interest.

One way to limit the power politics of the industry would be to create an independent blue-ribbon, watch-dog panel that reports directly to Congress and the public regarding the ethics issues in the FDA. An effective model could be the Internal Affairs Departments employed by most police departments.

If the country does not make a change, there will be more food and drug recalls, more Salmonella recalls, E. coli recalls, more Listeria recalls and recalls because of other food borne illnesses. There will also be increases in the already out of control superbug bacterium and viral illnesses facing Americans. How many deaths will it take for everyone to see that change is needed?