In September of 2006, the Institute of Medicine (IOM) published its long-awaited investigatory report on the FDA, “The Future of Drug Safety:  Promoting and Protecting the Health of the Public.”  The report is significant because it was paid for by the Department of Health and Human Services.  It sought to understand why a drug like Vioxx could get on the market and kill and injure so many people.  The report dropped a bombshell on the FDA, saying the agency has “a dysfunctional organizational culture, problems with credibility and public trust, and the lack of adequate communication about and limited public awareness of drug risks and benefits.”

Based on extensive interviews with FDA employees, the report makes it quite clear that simply because a drug is approved does not mean it is safe.  There is no system to follow up on approved drugs to ensure their safety.  And the administrative leadership within the FDA suppresses its scientists’ safety concerns as a matter of routine.  The bottom line is that the FDA has almost no clue as to what is actually going on with all the drugs it has approved and whether they are safe or not.

The report was limited in its scope of investigation, preventing the IOM from detailing Big Pharma involvement with the FDA, including the widespread abuse of humans that often occurs during clinical trials.  In general, the report paints a scathing picture of the FDA, although it seeks to strike politically-correct conciliatory tones in hopes that the FDA will improve and Congress will act. 

Unfortunately, the report’s mollifying aspects sometimes go too far.  For example, it states:  “FDA’s credibility is intertwined with that of the industry, and a more credible drug safety system is in everyone’s best interest.”  The statement is true for everyone expect Big Pharma.  Big Pharma makes billions of dollars promoting medications for unapproved use and their profits would be severely impacted by an improved drug safety system.

Trasylol – A Case in Point

Trasylol is a Bayer drug used in cardiovascular bypass surgery.  It helps prevent excessive bleeding during surgery.  It is an emerging blockbuster drug with sales in 2005 of $250 million and projected revenues triple that in 2006.  Trasylol has been under scrutiny since the beginning of 2006 based on several reports of serious side effects, one published in the New England Journal of Medicine.  The FDA dragged its feet and eventually in September of 2006 an industry-friendly FDA Advisory Panel found the NEJM data was not adequate and decided that Trasylol was safe and effective if used as directed.  And then Bayer’s nightmares began.

Bayer had been conducting an independent study of Trasylol involving records of 67,000 patients.  37,000 had used older medications that are less expensive and do not have the same apparent risks as Trasylol.  30,000 had used Trasylol.  The study had gone very poorly, from the Bayer point of view.  Bayer scientists testified before the FDA advisory panel as to the safety of Trasylol, while Bayer withheld from the advisory panel that they had commissioned an outside study and were already in possession of its highly negative results.  One of the independent scientists involved with the study called the FDA and blew the whistle on Bayer. 

On Friday, September 29, 2006, the FDA, stung by the blatant deception, announced on its website that Bayer hid safety data during the FDA investigation.  The FDA reported that the new data showed an “increased risk for death, kidney failure, congestive heart failure and stroke,” yet the FDA failed to pull the drug from the market or turn the matter over to the Justice Department for proper investigation of Bayer’s flagrant misdeeds.

As the crisis unfolds, the FDA is doing virtually nothing to protect Americans from the drug (since it is given as an IV before surgery, most don’t even know when they get it).  The FDA strategy is to attempt to protect Bayer as best they can from a flood of lawsuits. 

Andrew von Eschenbach, temporary head of the FDA, is demonstrating a lack of leadership in crisis.  If he pulls the drug off the market, it will imply guilt that will be used in courts across the U.S.  Von Eschenbach is known as a leader who wants even fewer safeguards on drugs.  Moreover, he is reputed to be a man with a long and profitable Big Pharma friendship.   It appears he would rather help Bayer deflect lawsuits than take effective action to protect the safety of Americans.  He is attempting to use the time-honored method called partial admission to escape taking responsibility.  The FDA admits there might be a serious problem, but says the problem could be caused by something else (like the poor health of patients).  The idea is to stall for time, slow down the flood of inevitable lawsuits, and hope the crisis goes away.  Von Eschenbach is up for Senate confirmation.  So far he has had a free ride, as no Senators have asked tough questions on the real issues.

The Trasylol example is one of many that accurately portray the ethics of drug companies when confronted with the decision to disclose information that protects human health or not disclose the information so as to sustain or increase profits.  The current FDA is little help to Americans.

The Call for Reform Broadens

Furberg told Amanda Gardner, a HealthDay reporter, "Congress cannot leave them [the FDA] on their own…. The main problem is the voice of drug safety is not heard….  There's a lot of unhappiness, low morale, people don't communicate….  The leadership does not get the message….  For a decade, they've [the FDA] had problems, and they've done very little. They deny their problems, and they can't fix them. We're saying Congress has to step in to give them authority, give them money, oversee their operations and make sure drug safety is a priority.”

This criticism comes from a collection of experts that the FDA assembled to give them advice on the safety of drugs.  This particular FDA advisory panel is very significant because it is not focused on one topic but on drug safety in general.  These experts felt the FDA was not following their advice regarding needed drug-safety improvements. 

Recent Congressional Attempts to Correct the FDA are Fruitless

In 2006, various bills were introduced that sought to rein in Big Pharma and get the FDA doing its job.  Rep. John F. Tierney (D-MA) introduced H.R.4429.  This bill wanted to create an independent office within the FDA to regulate the safety and effectiveness of drugs already on the market.  It is identical to S.930 introduced by Sen. Charles Grassley (R-IA).   Rep. Maurice D. Hinchey (D-N.Y.) introduced H.R.2090.  This bill also called for a new office within the FDA for post-market drug safety.  Additionally, it would eliminate the huge conflicts of interest regarding “expert” advisory panels full of industry-friendly advisors, the FDA acceptance of Big Pharma money to approve drugs, and negotiations between Big Pharma and the FDA as to how drug companies will be regulated. 

Rep. Henry Waxman (D-CA) introduced H.R. 3196, the Fair Access to Clinical Trials Act, cosponsored by 41 Democrats.  It would require full disclosure of adverse events occurring during clinical trials, information the FDA currently helps Big Pharma hide from the public.  Sen. Christopher Dodd (D-CT) has introduced S.470, a Senate version of the bill.

None of these bills can even get a committee hearing.  True reform at the FDA is tied up by the FDA itself, the lobbies of Big Pharma, their friends in the White House, and legislators who receive considerable Big Pharma money.

Big Pharma Introduces its Own “Safety Legislation”

On August 3, 2006, Senators Michael Enzi (R-WY) and Edward Kennedy (D-MA) introduced S.3807, the Enhancing Drug Safety and Innovation Act of 2006. Never has a name been more misleading. It should be called “Exposure of Americans to Risky Medications and Creation of a New FDA Drug Company Act of 2006.”

Instead of creating an independent office within the FDA to monitor drug safety, this legislation creates a new office within the FDA to act as a drug company. It will be named the Reagan-Udall Institute for Applied Bio-Medical Research and it will be funded by special interests in Big Pharma and the biotech industry. Its job is to sponsor the fast-track approval of risky medications onto the market. This legislation is seeking to turn the FDA’s risky Critical Path initiative into a full-scale government agency.
 

The legislation was crafted after extensive negotiations with Big Pharma and the FDA, meaning it contains everything they want.  It provides lip service to consumer safety, the smokescreen that is being used to promote the legislation to the public.  In reality, it is full of Big Pharma loopholes that will shift any real safety problems into Advisory Panels composed of Big Pharma members and affiliates.

It pretends to set up a database for clinical trial information to improve disclosure of side effects to the public.  Instead, it specifically excludes all of the FDA/drug company experiments, including experiments on humans that will occur prior to a formal intervention trial.  This means the most risky experimental information will forever be hidden from the public. 

Furthermore, the actual intention of this clinical trial database is not to give consumers more information about the side effects of drugs; it is to act as a major marketing tool for Big Pharma to release results of clinical trials to support off label drug use.  Such off-label use could never meet the standards of safety for a full drug approval; thus, misleading clinical trials will create momentum for physicians to use drugs in ways for which they were not approved.

Enzi and Kennedy receive significant campaign funding from the health and pharmaceutical sectors.  Even worse, these two men are in charge of the Senate committee that holds hearings on FDA-related matters and can easily bring this legislation to the floor of the Senate for a vote.  Unlike true FDA reform proposed by other Congressional leaders, this legislation is creating a government agency to further collusion between Big Pharma and the FDA. 

A Year of Opportunity and Challenge

As the dust settles from the midterm elections, a power structure will emerge and all these vital issues will come before faces both new and old.  This year, the Congress must vote on some type of FDA reform.  This is because the law known as the Prescription Drug User Fee Act (PDUFA) is set to expire in October of 2007.  This law forces the FDA to approve drugs within a certain period of time, a frequent issue for safety concerns.  It also has drug companies pay user fees to facilitate drug approvals, totaling $232 million in 2004, or over half the FDA budget for new drug approvals.

On September 1, 2006, the Wall Street Journal reported that negotiations for a new arrangement are intensively under way.  Negotiators for Big Pharma include former FDA employees.  The FDA is seeking to get 66% of their drug-review budget covered by the new agreement.  Top FDA execs freely admit the FDA is overextended, which is one reason the agency does such a shoddy job on drug safety today. 

Of course, Big Pharma pays out to be protected from the FDA’s enforcement actions, like paying the mob for protection.  There is no other similar situation in government where an industry needing to be regulated gets to negotiate how they will be regulated.  According to the Wall Street Journal, Big Pharma balks at their money being spent on review of their drug ads or monitoring their systems for tracking and reporting adverse events.  Truthfulness and safety are very low on the Big Pharma priority list.

It is now widely acknowledged that the FDA is in need of a major overhaul.  Big Pharma feels threatened and has billions of dollars of profits hanging in the balance.  Americans feel threatened and have their health hanging in the balance.  And these two forces are directly opposed to one another’s best interests.  Big Pharma will buy the White House and Capitol Hill, as best it can.  What will Americans do?