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'Before You Take that Pill' reveals the cozy relationship between Big Pharma and the FDA

Monday, March 14, 2016 by: Julie Wilson staff writer
Tags: Big Pharma, FDA, J.D. Bremner

Big Pharma
(NaturalNews) Before You Take that Pill, written by J. Douglas Bremner, explores the symbiotic relationship between today's pharmaceutical industry and the U.S. Food and Drug Administration (FDA). The following is an excerpt from the book:

The latest drive to get new pills on the shelves and into people's mouths began when government deregulation and an earnest attempt to help HIV-AIDS patients access important life-extending drugs collided.

In the 1980s there was a strong movement to decrease the role of government regulation in all businesses, and budgets of regulatory agencies like the FDA were slashed as part of that effort. The Reagan administration painted the FDA as a bloated bureaucracy that was slowing down the approval of drugs and getting in the way of business.

There was some truth to that claim. At that time it could take up to two years to gain drug approval, two years too long if you were suffering from HIV-AIDS. Throughout the 1980s, AIDS activists and patients echoed the drug companies' sentiments, complaining that it was taking too long to bring disease-fighting drugs to market.

An expedited approval process

The pharmaceutical industry lent a sympathetic ear and a loud voice to calls for speeding up the approval of AIDS drugs such as Agenerase (amprenavir). Since drugs are on patent for a limited number of years, every year spent waiting for approval from the FDA means losing a year of profits.

Couple that with the fact that the FDA could now honestly say that, because of cuts, it was understaffed. The answer was essentially legislation allowing pharmaceutical companies to pay the salaries of the staff at the FDA.

In 1992, the Prescription Drug User Fee Act (PDUFA) stipulated that a fee (now $576,000) be paid to the FDA by the pharmaceutical companies for each new drug application. The number of staff at the Center for Drug Evaluation and Research (CDER) doubled overnight. Today, the FDA receives about $260 million a year from these fees.

Part of the bill stipulated that funding by Congress for new drug evaluations had to increase by 3% per year. Since the overall funding for the FDA did not increase at 3% per year, the FDA had to actually cut funding for surveillance and research of approved drugs.

The change in law had another interesting result: The boundaries among the drug companies, the FDA, and doctors became increasingly blurred. FDA officials sometimes move to jobs in the pharmaceutical industry, which means they may not want to burn their bridges with industry.

The same FDA officials who approve the drugs are responsible for monitoring them after they are on the market, which gives them an obvious disincentive to say that the drugs they earlier certified as safe were now unsafe. Finally, the FDA gets input from outside advisory panels made up of doctors who are experts in their fields.

Doctors or paid consultants?

Most of these doctors receive payments as consultants, research grants, and support for travel to conferences from drug companies. In some cases, the doctors are working as paid consultants to the same companies whose drugs are coming up for approval by their advisory committees.

For instance, as reported by USA Today on October 16, 2004 ("Cholesterol Guidelines Become a Morality Play") eight of the nine doctors who formed a committee in 2001 to advise the government on cholesterol guidelines for the public were making money from the very same companies that made the cholesterol-lowering drugs that the doctors were urging millions of Americans to take.

For example, one of the committee members, Dr. H. Bryan Brewer, chief of the Molecular Disease Branch at the National Institutes of Health, worked as a consultant or speaker for ten different pharmaceutical companies and made more than $100,000 over three years while he was on the committee and at the same time sat on the board of one of these companies. {Los Angeles Times, December 22, 2004, "The National Institutes of Health: Public Servant or Private Marketer?").

Dr. Brewer left the NIH in 2005 in the midst of adverse publicity about potential conflicts of interest. Nassir Ghaemi, M.D., a psychiatrist at Emory University, was quoted in the Emory Academic Exchange (February 2007) as having said, "Critics say we are being influenced and don't realize it—that drug companies are smarter than we are and know a lot more about human psychology than we think, and they're probably right about that to some extent."

The result of this comingling was a boon for drug makers: Approval time of their products decreased from twenty months to six months right after the law changed. However, the number of drugs that had to be later withdrawn also increased from 2% to 5% of drugs.

To continue reading this fascinating book, be sure to pick up a copy today.

Sources:

Bremner, J. Douglas (2008) Before you take that pill: why the drug industry may be bad for your health: Avery
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