FDA Approval Is Often Based on Drug Company Information

The Food and Drug Administration is the government agency charged with evaluating, approving, and monitoring the safety of food, drugs, cosmetics, medical devices, radiation treatments, and other health-related products that play a large part in our lives. Most of us view the FDA as a watchdog agency that protects our health and safety – our defense against greedy pharmaceutical companies that falsify results or cut corners in their haste to gain approval for lucrative new drugs.

Indeed, the FDA’s own description of its development and approval process boasts:

American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world.

The main consumer watchdog in this system is the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold. The center’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Surely, then, the FDA’s approval process includes rigorous independent testing of new drugs, careful assessment of the results, and expert corroboration of benefits versus risks.

Not exactly.

In fact, hardly ever.

As the FDA’s website breezily explains, “The center (CDER) doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.”

So, who does conduct the research that provides so-called evidence of a drug’s effectiveness?  Who objectively reports benefits and risks discovered through clinical trials?

You guessed it: drug manufacturers that, time after time, have been caught putting their profit before public safety.

In recent years, we have been shocked to learn that the FDA’s allegedly independent, objective research has been conducted, instead, by pharmaceutical industry insiders and academics on the payroll of the drug companies. That’s like letting the fox guard the hen house: Big drug companies get away with shoddy research and inaccurate reporting that can mask potentially lethal products.

What’s more, medical device manufacturers, as well, have been getting a virtual free pass from the FDA. A study by the National Research Center for Women and Families, released in February 2011, indicates that more than 75% of medical devices recalled over the last five years did not undergo FDA pre-market approval based on required clinical testing and inspections. Automated external defibrillators (AEDs), insulin pumps, intravenous infusion devices and glucose meters are just a few of the devices that bypassed the clinical testing requirements and made it to market by an alternative route: manufacturers’ assertions that these products were similar to ones already approved by the FDA. The result of this free pass? In the case of one of these products, AEDs, more than one out of five has been recalled after posing serious risks to heart patients.

But drug companies are not the only ones responsible for FDA approval of dangerous drugs. For years, FDA scientists have been at odds with administrators who ignore scientific evidence and abuse their authority.

After the election of President Barack Obama, a group of FDA physicians and scientists joined public advocacy groups in calling for systemic reform to eliminate the “corruption and wrongdoing that permeates all levels of FDA.” In a letter to the President, the group charged that the FDA Commissioner, attorneys, and others in top positions “violated laws, rules, and regulations” and “suppressed or altered scientific or technological findings and conclusions.”

A 2005 interview with Dr. David Graham, the senior drug safety researcher who blew the whistle on Vioxx, describes “a culture of suppression and denial” within the FDA. He points out a kind of Catch-22 that sets in when evidence mounts that an already approved drug is causing serious harm. Recall begs the question of why the drug was approved in the first place, making the FDA looks bad. That’s why, in so many cases, the FDA drags its feet . . . and thousands of consumers suffer the consequences of the agency’s inaction.

Here’s the process by which new drugs are supposed to make their way to FDA approval for marketing to American consumers. Unfortunately, at each step there is ample opportunity for profit to edge out public safety.

• Before human testing, a drug manufacturer conducts laboratory tests and animal experiments to learn how a promising drug works and the potential for effectiveness with humans.
• If lab and animal tests appear to validate the drug’s promise, the manufacturer submits to the FDA’s Center for Drug Evaluation and Research an Investigational New Drug (IND) application, seeking permission to conduct human testing in a series of clinical trials.
• CDER has 30 days to review the proposed study, and if necessary, can place a “clinical hold” on human research. Otherwise, the drug company may begin clinical trials 30 days after submitting its IND application.
• The FDA provides regulations to guide clinical trials in determining the effectiveness of a drug, identifying any side effects, and protecting the people who participate in the trials.

Based on evidence provided by clinical trials the drug company itself has likely conducted or funded, the company submits a New Drug Application (NDA) to the FDA.

After the pharmaceutical manufacturer has submitted its documentation of the clinical trials and additional toxicological studies, if any, the FDA conducts a Safety Review, with four principal objectives:

• To identify serious adverse clinical trial results that could dictate keeping the drug off the market, limiting its use, or subjecting it to special risk management.
• To identify and estimate frequency of common, less serious problems caused by the drug.
• To evaluate the information, and the methodology, supporting the drug company’s safety analysis.
• To identify safety concerns that require attention either before approval is granted, or that should be monitored after the drug is marketed.

They make a show of objectivity, but pharmaceutical companies fund grants and pay generous honoraria and fees to the individuals and institutions that conduct research on their behalf.     

When a new drug receives powerful endorsement from a well-known medical research scientist or a prestigious university, consumers have reason to be suspicious. Because when a drug company “launders” its research through a university or medical scientist, the company’s role as funder often proves significant to the research results. Inevitably, research funded by drug companies, including clinical trials, has been found to favor the pharmaceutical industry.

Comparisons with research funded by government or independent sources show that studies funded by the pharmaceutical industry are five times more likely to produce the results that the drug companies want.

Does this mean that the institutions and scientists conducting drug research purposely manipulate the data and/or consciously mischaracterize the results? It is difficult to prove cause and effect, except to quantify the correlation and point out that the profit motive is very powerful.

We might ask the same question of the FDA scientists and administrators who review drug applications with full knowledge that research has been funded by the applicants. What is their motive in ignoring evidence of risks that cause death or serious injury? No one really knows, but Dr. Graham has a theory: He contends that the FDA has come to view the pharmaceutical industry, rather than the American public, as its client.