“The American public does not have the knowledge to make wise health care decisions.” – Dr. David Kessler, former FDA Commissioner, June 6, 1992
The Food and Drug Administration exemplifies how Washington bureaucrats can corrupt an otherwise reasonable idea in the blind pursuit of power and influence. Established to protect public health, many FDA actions instead threaten it – largely because the agency has entered into an unholy alliance with the pharmaceutical industry it is supposed to regulate. As a result, the FDA has allowed lethal medicines to reach the American public costing thousands of lives. At the same time the Agency has acted to block safer alternatives because they threatened the “Big Phama’s” stranglehold on healthcare.
A May 2002 article in the Journal of the American Medical Association illustrated the problem. It described a study reviewing the history of all drugs approved by the FDA between 1978 and 1999. It found that 10.2% of the total approved subsequently were either found to have lethal side effects or were withdrawn from the market as unsafe. When the researchers restricted their analysis to the most recent drug approvals reviewed in their study, the figure rose to 20%.
This means that there is now a one in five chance that a drug approved by the FDA will be found to be lethal!
An analysis of nine of the drugs withdrawn from the market after FDA approval found them linked to at least 755 deaths and thousands of severe injuries. And, that’s just the tip of the iceberg. In the case of Redux, for example, while 123 deaths have been reported, its manufacturer, American Home Products has set aside $9.5 billion in a contingency fund to pay future claims. Clearly, the company believes that a lot more than 123 people were hurt.
A recent study by the National Institutes of Health tells the tale. It estimated that properly administered prescription drugs cause at least 100,000 fatalities each year. Another 2.2 million patients suffer adverse reactions to these products to require hospitalization.
How can this happen under the FDA’s allegedly strict review process? One answer may be corruption.
For a drug to be approved, it must first pass muster before an FDA advisory committee. These committees are supposed to bring together unbiased experts who review the clinical trial data on a drug’s safety and efficacy. The committee then votes on whether or not to recommend approval. In practical terms, approval by an advisory committee is tantamount to approval by the agency. Therefore, their role as an “honest broker” is essential to maintaining the integrity of the drug approval system. The only trouble is that the integrity of the advisory committee system itself is in question.
A review of the official records of the 159 FDA advisory committee meetings held between January 1, 1998 and June 30, 2000 revealed a startling fact. In 55% of the meetings that took place during this period, at least half of the participants had a financial conflict of interest. An astounding 92% of the meetings had at least one participant with a financial conflict!
How could this occur?
Simple. FDA bureaucrats issued 803 conflict waivers during the period reviewed! When asked by congressional investigators why the agency issued so many waivers the FDA bureaucrats demurred saying it was the nature of medical research that such conflicts would exist. If they wanted the best people, they had to issue them.
There are over 770,000 licensed physicians in the United States. It begs belief that the FDA could not find 20 (roughly the size of an advisory committee) who did not have financial conflicts of interest related to the drug they were supposed to review. It also begs belief that such conflicts would not influence decisions both in terms of unwarranted approvals and denied applications from potential competitors.
It’s small wonder that the system isn’t working.
Conflicts among members of advisory committees, however, are not the only financial conflict of interest plaguing the agency.
In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). At the time there were widespread complaints from the pharmaceutical industry about delays in new drug approvals. The FDA had countered with complaints that it lacked the financial resources to speed up the approval process. The outcome of this debate was a program to charge a fee for new drug applications that would be used to hire additional staff. On the surface, it seemed like a fair compromise: drug approvals would be faster, and the industry would foot the bill. Increasingly, however, the user fee program is becoming the tail that wags the dog.
In its most recent budget request the FDA calls for user fees to increase to $295 million. This equals roughly 17.1% of the agency’s total budget.
The fees would add 500 industry funded positions, bringing the total number of FDA employees funded by the pharmaceutical industry to 1,530 – roughly one in seven. More important, with the new positions, 55% of all drug reviewers would now be paid by the pharmaceutical industry. The fox would essentially be in charge of the chicken coop!
In fact, the FDA has become so addicted to PDUFA money that it now wants to extend the program to encompass regulatory areas beyond prescription drugs.
What may be the most pernicious aspect of the alliance between the FDA and the industry it is intended to regulate is the incentive it creates to stifle the growing competition from alternative and complementary medicine.
Americans are seeking alternatives to traditional medical therapies in record numbers. Polls indicate that anywhere from 50% to 70% of U.S. consumers have used some form of alternative medicine. Of these 40% say they are regular users. Last year Americans spent over $30 billion on alternative medicine, a figure that exceeds the total of co-pays for conventional care. Over half of this amount represents purchases of the dietary supplements – vitamins, minerals and herbs. Despite this clear demonstration of the public will, however, Congress has had to act on two occasions since the mid-1960s to assure that the public would have continued access to these products.
First, in 1966, the FDA attempted to adopt a rule that would classify vitamins and mineral supplements with potencies greater than 150% of the RDA as drugs. A huge legislative battle ensued generating more than a million letters of protest to Congress. After a decade of controversy, Congress finally passed the “Proxmire Amendment” that blocked the FDA action.
But the FDA didn’t give up the fight. Despite the Proxmire Amendment, it periodically attempted to extend its regulatory grip to encompass supplements. In exasperation, Congress enacted the 1994 Dietary Supplement Health and Education Act, or DSHEA. DSHEA specifically permitted supplement manufactures to make health claims about their products as long as there was “significant scientific agreement” to back them up.
It was the specific intent of Congress to keep the FDA from unduly limiting consumer access to vitamins, minerals, herbs and other similar products.
The FDA’s response was to simply ignore congressional intent and try to manipulate DSHEA for its own benefit and the benefit of its pharmaceutical industry allies.
The law instructed the agency to define what “significant scientific agreement” meant. This might seem straightforward enough, but nothing the FDA does is straightforward. It interpreted the phrase to require a product pass the same clinical trial process as prescription drugs at a cost of hundreds of millions of dollars. More important it excluded from consideration studies by other federal agencies such as the CDC or NIH. In other words, it didn’t matter if a product worked, all that mattered was whether or not the FDA said it worked – and the agency refused to admit that any dietary supplement worked.
The FDA pronouncement so outraged two supplement distributors, Dirk Pearson and Sandy Shaw, that they went to court. In a landmark decision, the U.S. Court of Appeals for the District of Columbia instructed the FDA to allow supplement manufacturers to make true statements about their products.
Stop and consider this for a moment. A federal court had to INSTRUCT the FDA to allow people to tell the truth!
But limiting free speech concerning supplements isn’t the only sign of the FDA’s bias against alternatives.
Consider that between 1997 and 2000, the FDA issued 568 “warning letters” to pharmaceutical companies for offenses ranging from false and misleading advertising to substandard manufacturing practices. In virtually every case, no penalty was imposed for the infraction.
In contrast, dietary supplement manufacturers rarely are warned, they are simply shut down – even where there is a question as to whether an offense actually occurred.
A company called Pharmanex developed a dietary supplement, cholestin, that was proven to be more effective and safer than the prescription drug alternatives for lowering cholesterol. When manufacturers of competing and far more costly “statin” drugs complained, the FDA went to court to remove the supplement from the market.
When the distributor of a natural sweetener called “Stevia” attempted to distribute cookbooks telling consumers how to use his product, the FDA promptly ordered him to destroy them, dispatching agents to his warehouse to supervise their burning.
FDA officials solicited the help of King County, Washington police to mount a SWAT Team raid on the offices of Dr. Jonathan Wright. Only later did the police learn that the “dangerous drugs” they sent to confiscate were injectable vitamins.
Mind you, these extreme actions were taken despite the fact that only 2,500 adverse events are linked to dietary supplements each year – a far cry from the 2.2 million linked to prescription drugs!
The simple truth is that the FDA is out of control. It is waging war on generally safe, effective dietary supplements while at the same time allowing lethal prescription drugs to reach the public. It is fraught with conflicts, and has grown too close to the industry it is supposed to regulate. Indeed, instead of protecting the public health, it now endangers it.