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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.

When a drug company applies pressure to get its new product to market, the FDA often disregards public safety in its haste to complete “fast track,” “accelerated,” or “priority” approval.

Especially when a drug company seeks approval for a “groundbreaking” drug to treat serious diseases, the FDA can choose to speed up the review process and let drug manufacturers market their product as soon as possible. In fact, half of the FDA’s budget comes from fees paid by manufacturers to facilitate accelerated approval for new drugs and medical devices.

Obviously, an accelerated process is to the drug company’s advantage: time is money, and a new “miracle drug” can make millions of dollars before post-market toxicity or side effects prompt a recall.

In some cases, manufacturers have used political pressure to put a potentially dangerous drug or medical device on the fast track to approval. In September 2009, the FDA revealed that four Members of Congress from New Jersey had applied persistent pressure for approval of a patch for injured knees, manufactured by ReGen Biologics Inc. The FDA’s scientific reviewers had persistently argued against approval of the device, Menaflex, on the grounds that it often failed and subjected patients to additional surgery.

In the case of Menaflex, all four Congressmen had received generous campaign contributions from ReGen. ReGen’s CEO dismissed allegations of conflict of interest, saying, “We did what people do all the time in Washington: we went to our Congressmen, we went to our Senators.”

To make matters worse, an agency investigation concluded that Dr. Andrew von Eschenbach, who was FDA Commissioner at the time, personally interfered in the scientific evaluation of the product and, an agency manager alleged, demanded a favorable outcome for ReGen.

Another example of the FDA’s failure to protect us is the murky chain of events surrounding approval of the diabetes drug Rezulin, which was withdrawn from the market in 2000.

The story of Rezulin, manufactured by Parke-Davis division of pharmaceutical giant Warner-Lambert, is the stuff of best-selling who-done-its. Rezulin (brand name troglitazone) was marketed to treat Type 2 diabetes and touted as a “function sensitizer,” improving action of the liver, muscles, and fat tissues. It got fast track approval from the FDA in January 1997 after only six months of studies – studies in which there were already indications of liver failure caused by the drug. The FDA medical officer who recommended against Rezulin’s approval was summarily dismissed from his responsibilities.

In December 1997, Rezulin was suspended from the market in the United Kingdom, pending a review of safety data, and it was subsequently withdrawn there. But not in the US, where by 1999, evidence against the drug was mounting rapidly. By then, the Los Angeles Times reported 85 cases of liver failure associated with Rezulin, 58 of them resulting in death. The FDA stood firm, even when its own Dr. David Graham called Rezulin one of the most dangerous drugs on the market. Even when FDA medical officer Dr. Robert Misbin wrote Congress that “I have been frustrated in my efforts to convince my superiors that the time has come to remove Rezulin from the market.”

At this point, the FDA did take action: It launched an internal investigation of Misbin.

After dragging its heels, buying time by ordering a series of label changes, in March 2000 the FDA finally prompted voluntary recall of Rezulin. An estimated 63 deaths had been directly attributed to Rezulin, another 391 deaths were suspected, and Warner-Lambert had made $2.1 billion dollars. In an amazing show of hubris, the drug maker’s recall press release brazenly claimed, “. . . the company continues to believe that the benefits of the drug outweigh its associated risks.”

Given its history of ignoring evidence and pandering to the drug companies, how can we trust the FDA to advocate the safety of the American public rather than guaranteeing profits to the pharmaceutical industry?

One thing’s for sure: Consumers can’t make informed decisions unless they know the truth about drug research and the potential for harmful side effects.

One barrier to public access to FDA information is the agency’s collusion with drug companies on the issue of so-called “trade secrecy” – even when this means withholding evidence about drugs that can kill consumers. The pharmaceutical industry has been successful in applying an arsenal of laws, including the Federal Trade Secrets Act, to maintain the confidentiality of clinical trial results.

For example, in 2007, Dr. Steven Nissen, a Cleveland Clinic cardiologist, published a study indicating that Avandia increased by 42 percent the risk of heart attack among patients taking the drug to treat diabetes. The FDA was aware of this data for two years, but had withheld the alarming statistics.

An outspoken critic of the “proprietary information” excuse, Dr. Nissen has campaigned for more transparency by the FDA. Apparently, the Obama Administration agrees with him. In June 2009, under new Commissioner Margaret Hamburg, the FDA set up a task force to facilitate public information about agency decisions on drugs and medical devices. The written report, due in 2010, is expected to reflect the views of both supporters and opponents of so-called trade secret protections.

Attorneys at Searcy Denney know from experience that one way to deter greedy pharmaceutical companies from pulling the wool over consumers’ eyes is to go toe-to-toe with them in the justice system.

If a family member has died or you or a loved one has become ill or injured because of a dangerous drug or medical device, you may want to know more about your rights. We will provide you with a confidential initial consultation, free of charge. Just complete our Contact Form, or call us at 800-780-8607. A member of our staff will call you back to schedule an appointment.

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