El Guapo And The FDA
There is a great scene in the movie, The Three Amigos, in which Chevy Chase talks about the villain, El Guapo. "I suppose you could say that everyone has an El Guapo. For some, shyness may be an El Guapo. For others, lack of education may be an El Guapo. But for us, El Guapo is a large ugly man who wants to kill us!"
Just swap out the name El Guapo for FDA and you have the theme of this week's newsletter. It doesn't matter what country you live in, you have an El Guapo/FDA-type regulatory authority promoting questionable pharmaceutical solutions while at the same time limiting your access to far safer alternatives. Here in the US, our FDA is the actual FDA, a large ugly agency that despite its best efforts sometimes seems to be trying to kill us.
FDA isn't doing its job
A recent article in the Washington Post once again brings home the point that FDA approval (heck, any government approval) does not guarantee safety. It also makes it clear that approved pharmaceuticals, over the counter medication, medical devices, and even food products are not what you think they are!
This article highlights the findings of a 15-month-long reactionary investigation of the FDA following the flu vaccine shortage. In the process of their investigation, however, investigators documented profound and disturbing indications of much more far-reaching and deep-seated problems.
While the motivation for the investigation was undoubtedly political, the results are inarguable. First, consider the trends:
- In the past 5 years the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers, etc. dropped 54 percent to 535 in 2005 from 1,154 in 2000.
- The seizure of mislabeled, defective and dangerous products dipped 44 percent.
- The biggest decline was found at the agency's device center, where enforcement actions decreased 65 percent in the five-year period of the study despite a wave of problems with devices including implantable defibrillators and pacemakers.
The most disturbing indicator in these statistics is that the research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the FDA continued to uncover about the same number of problems at drug and device companies during the study as during comparable time periods before the study. The inquiry found instead that top officials at the FDA increasingly overruled the investigators' enforcement recommendations.
In fact, the only rise in percentages was found in the number of products that had to be recalled from the market after approval by the FDA: up 44 percent.
Some might argue about the ultimate meaning of these statistics; but at the very least, they are the proverbial canary in the coal mine giving warning of severe problems lurking in the background. Before we can understand what those problems are, though, we need to understand how we got ourselves into this predicament.
What is the FDA?
The FDA was designed as an "intelligent, necessary regulatory agency or 'watchdog' for Foods and Drugs." Sounds simple, yet the size and scope of this job is a tangible example of eyes being bigger than the stomach.
To give you an idea of the monumental task the FDA faces, consider that 'Food and Drug' has been broken into 8 categories, each with a number of subcategories:
- Foodborne Illness, Nutrition, Dietary Supplements...
- Prescription, Over-the-Counter, Generic...
- Medical Devices
- Pacemakers, Contact Lenses, Hearing Aids...
- Vaccines, Blood Products...
- Animal Feed and Drugs
- Livestock, Pets...
- Safety, Labeling...
- Radiation-Emitting Products
- Cell Phones, Lasers, Microwaves…
- Combination Products
- Any combination of the above categories...
Considering such a monumental task, the health environment has definitely benefited in some areas. Since the FDA's inception, instances of food poisoning, for example, have decreased dramatically. Understand, not everything the FDA touches is bad; not everyone who works for the FDA is a villain.
To be fair, there are many, many good, conscientious people working for the FDA. I've talked to a number of them. (It's not hard. They're available to you if call up. Most are very nice.) The problem is that the nice people don't really control the agenda. The reality is that in many ways, the FDA follows the same bell curve that I talked about in Why Your Doctors Do You Like They Do, June 21, 2004. Let me illustrate:
- At the bottom of the curve, particularly out in the field, there are a handful of petty bureaucrats -- little people who sit behind very big desks -- people who get off on wielding power and intimidating anyone who crosses their path. (Most of us have met this type of individual at least once in our lives.)
- In the middle, and comprising the biggest part of the curve by far, are the hardworking, conscientious people trying to do the best they can. Some are open minded, and some religiously follow the party line -- but all are trying to do the best they can, and in their way protect consumers.
- At the executive level, there are some very bright people, but unfortunately, too many, as you will see, who are either negotiating their next job in the pharmaceutical industry or who have just arrived from there to work at the FDA. You can't have a relationship between a multi-billion dollar industry and the people entrusted to oversee it, and not expect, given enough time, to see people crossing the line.
That said, let me restate that there is trouble afoot. So let's take a closer look at what is going on (or going wrong) at the FDA.
On July 20th, the Union of Concerned Scientists published the results of a survey of just under 1,000 doctors who work for the FDA. The results were disturbing:
- Almost one in five (18 percent) responded, "I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document."
- More than three in five (61 percent) knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."
- Three in five (60 percent) also knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions."
- Fifty percent also felt that non-governmental interests (such as advocacy groups) had induced or attempted to induce such changes.
- Less than half of them (49 percent) agreed that "FDA leadership is as committed to product safety as it is to bringing products to the market."
And that's just the tip of the iceberg!
Another glaring example of conflict of interest affecting health decisions at the FDA can be found in the history of Aspartame, which was approved for use in foods by Dr. Arthur Hull Hayes, the former Commissioner of the FDA, two months before retiring. Shortly after leaving the FDA, he accepted a position as Senior Medical Advisor to Aspartame's public relations firm at the rate of $1,000 per day.
More Conflicts of Interest
The example of Dr. Hayes above is not isolated. Many FDA managers have conflicts of interest from holding stock in the pharmaceutical industries they are entrusted to regulate to holding jobs at these same pharmaceutical companies either before they work for the FDA or, as with Dr. Hayes, immediately after. Yes, top FDA officials frequently end up with top paying positions at the very same drug companies they were entrusted to regulate. Does this automatically mean that these positions are improper or that "improper" decisions were made as a result? No, of course not. But sometimes the appearance of impropriety is so overwhelming, it's more than enough to convict.
Consider too that the FDA admits this failure.
In a July 25th article, the FDA issued a peremptory mea culpa: FDA Pledges Conflict Reforms: The agency says it will clarify rules on advisory panel members with ties to drug companies. But a quick review of these proposed reforms makes it clear that they are unlikely to stop many doctors and researchers with such conflicts from serving on the panels whose recommendations can determine the fate of drugs that may be worth millions of dollars in corporate profits -- but that may endanger consumers at the same time.
Looking back at the Vioxx fiasco, for example, the Center for Science in the Public Interest evaluated the 32 scientific experts chosen by the FDA to evaluate Vioxx and its brother Cox-2 inhibitor drugs. The CSPI research uncovered affiliations between 10 of the scientists that served on the committee and the three manufacturers of Cox-2 inhibitors (Pfizer, Merck and Novartis -- including G.D. Searle and Pharmacia, which are now part of Pfizer). According to a New York Times analysis of the votes, the advisory committee would have voted against Bextra and Vioxx staying on the market had scientists with conflicts of interest been excluded from the vote.
The FDA has about 50 advisory panels that are supposed to provide impartial technical advice on issues such as over-the-counter allergy medicines, silicone breast implants, and chemotherapy drugs with toxic side effects. A study published this year found that 28% of panel members disclosed financial conflicts, but only 1% recused themselves.
In case you are wondering, here are the FDA's current guidelines for waivers.
Drug companies are doing their own safety testing!
If all we were talking about was conflict of interest, that would be bad enough; but the problem goes much deeper.
While the world is still dealing with the aftermath of the Vioxx scandal, let us keep in mind that this specific (highly publicized) situation is actually representative of a pervasive problem. Drug companies have been given too much of a role in defining their own approval process -- controlling everything from the drug safety information used to evaluate their products to lab safety information used by the FDA.
The drama surfacing at the FDA concerning drug safety issues plays out much like a movie of the week as accusations fly and tempers flare. Trust is given and taken away, and the ultimate victims of this drama are the consumers. A July 19, 2006, article in Newstarget.com highlights that not much has changed since the Vioxx experience as the safety of a new antibiotic approved by the FDA was challenged by Dr. David Graham. As Dr. Graham says, "For F.D.A. to refer to its being reassured by postmarketing data from Latin America and Europe as a basis for declaring 'Ketek is safe' is, in my opinion, a great abuse of such surveillance data."
Vioxx, Keretek, or any of a number of other pharmaceuticals, it doesn't seem to matter. It case after case, FDA executives deem scientific data gathered by their own researchers to be irrelevant and biased data gathered by the pharmaceutical companies themselves all-persuasive. Again, has anything improper occurred? Not necessarily. But then again, sometimes the appearance of impropriety rises so high, it becomes its own proof.
As I mentioned above, the FDA out-sources the inspection of pharmaceutical laboratories -- sometimes to employees of the lab itself. An article in the New York Times describes how even if government inspectors have found widespread problems in a pharmaceutical factory, the Food and Drug Administration sometimes approves new medicines to be made in that factory without inspecting it again, relying on company employees or consultants to verify that the problems have been fixed.
The practice came to light after a trade journal called Dickinson's FDA Webview reported that the F.D.A. had approved Clarinex, the allergy drug made by Schering-Plough, based on factory inspections done by consultants hired by the company rather than by the government. How can you possibly have any confidence in the certification of a lab when that certification was bought and paid for by the company that had a financial interest in seeing that certification go through?
We are taught as consumers to read and to trust the labels on products. We are told to use these labels as guides to improve our health and nutrition and, in some cases, our safety. The very definition of the term 'label' implies an accurate disclosure of ingredients. But if you were to rely exclusively on FDA approved labels you might be dangerously misled. As explained in another New York Times article, Medicine's Data Gap, when it comes to a drug's "government-approved uses," FDA labeling regulations give doctors important data from clinical tests involving those treatments while spelling out the drug's risks and providing directions for administering it to patients. But FDA regulations have allowed labels to remain silent about a test when the FDA turns down a company's application for approval of a new use or a new patient group. In those situations, the company can then promote that drug for its rejected off-label use with no requirement for full disclosure.
And it's no better for food labels. A recent announcement by the FDA stated that it had checked 28,000 food labels in a 14 month period, however, it failed to mention that they had merely checked to see if labels were present -- not if they were accurate.
As CSPI senior staff attorney, Ilene Ringel Heller, said concerning this issue, "The FDA's report obfuscates the Agency's abdication of its responsibility to ensure honest food labeling by touting irrelevant statistics concerning routine Agency inspection activities. The FDA has been less than forthright with Congress."
I could go on for several hundred pages citing case after case, incident after incident, but I still want to cover the second key issue in this newsletter: the FDA's failure when it comes to dealing with alternative health. For now, suffice it to quote from Sen. Barbara Mikulski, D-MD. "This agency has been politicized and degraded. Many FDA employees don't feel the FDA is doing enough to protect the public's health and are afraid to speak candidly about it."
Can the FDA turn itself around and do a reasonable job at regulating pharmaceutical drugs and medical devices? Absolutely, if:
- It had an expanded budget.
- It was more limited in scope.
- It completely separated itself and its personnel from the companies they regulate.
- If pigs could fly.
How this relates to alternative medicine
At the top of this newsletter I said, "It doesn't matter what country you live in, you have an El Guapo/FDA-type regulatory authority promoting questionable pharmaceutical solutions while at the same time limiting your access to far safer alternatives."
In the time we have left, let's deal with the second half of this statement: the part about the FDA limiting your access to alternative health.
I could give you all kinds of obvious bias in this area, but probably no example is more obvious than testing, the great sine qua non of the FDA and the pharmaceutical industry. These tests are important because government regulators such as the FDA make their decisions based on these tests. It's the big knock held against all alternative health treatments. Pharmaceutical drugs are rigorously tested. Alternative health programs are based on anecdotal evidence and when tested, consistently fail those tests. The list is endless.
- Vitamin E failed testing
- Echinacea has failed testing
- Antioxidants have failed testing
- And the list goes on.
But this is a crock. As we've already seen in this newsletter, the tests that pharmaceutical drugs pass are hardly bullet proof, and in fact, as we've seen, are often misleading. On the other hand, the tests that alternative health treatments fail are almost always fatally flawed. Check out the links above on vitamin E and Echinacea.
Why does this happen? Because as has been made abundantly clear in this newsletter, the FDA and the pharmaceutical industry work closely together:
- Sharing personnel.
- Taking each other's word on test results.
- Getting paid by one entity while working for the other.
- Owning stock in one entity while working for the other.
Asking the FDA to be unbiased while monitoring alternative health is like asking the National Football League owners to oversee the future of professional world soccer (that's real football for everyone outside the US). Consider that:
- The NFL owners don't understand soccer.
- They don't like it.
- At best they view it as irrelevant. At worst as an economic rival.
- In the best of all possible worlds, they would much rather that it just go away and that everyone in the world watched the NFL.
And thus we have the position of the FDA and their partners, the pharmaceutical industry, when it comes to alternative health.
- They don't understand it.
- They don't like it.
- At best they view it as irrelevant. At worst as an economic rival.
- In the best of all possible worlds, they would much rather that it just go away, that anyone involved would just go to jail, and that everyone in the world would fall into line and see their doctor and take a drug for every conceivable condition known to man -- plus those conditions soon to be created by the drug companies' marketing arms.
In effect, the unofficial position of the FDA is that "alternative health" is a contradiction in terms.
Conclusion: Take responsibility for own health
Awareness is the key. Most people spend more time taking care of their cars than they do their bodies. You only get one body (this lifetime anyway) and no owner's manual, no warranty and (for the most part) no spare parts. With all the trouble the FDA is having regulating Food, Drugs, Medical Devices, Biologics, Animal Feed and Drugs, Cosmetics, and Radiation Emitting Products, it is imperative that you pay attention to your own body and your own health. In this newsletter I have raised several questions:
- Is the FDA doing its job if drug safety issues are not tightly regulated without bias?
- Is the FDA doing its job if employees profit from the same agencies they are trusted to regulate?
- Is the FDA doing its job if they do not follow up or follow through when problems are found?
- Is the FDA doing its job if the food and drug labels Americans are told to trust are not accurate?
- Is the FDA doing its job if it dismisses alternative health solutions out of hand with support for biased testing and harassment of practitioners?
The answer of course is a resounding NO!
Remember, FDA approval does not guarantee safety. And as I have said in many previous newsletters, while pharmaceuticals have their place in health care, as a general rule, they should always be the choice of last resort.
Finally, and I cannot emphasize this enough, the FDA should not play any role in regulating alternative medicine. A separate regulating agency that at least has a feel for the discipline needs to be in charge. Far better for the FDA to gets its house in order, work with a more limited scope, and start doing a good and honest job regulating the medical industry.
And for those of you outside the US, don't be smug. Remember you have your own El Guapos -- in most cases even worse than the FDA. Just look at the European Health Initiative and Codex or how Canada treats naturally occurring substances such as DMAE as drugs or Australia's brand new rules requiring massive amounts of documentation for the importation of even the most innocuous natural health supplements. Don't think for one moment that what happens in the US with the FDA doesn't matter to you, or that what happens in your country vis a vis alternative health regulation doesn't matter to those of us in the US. It most assuredly does. To paraphrase Ben Franklin: "We must all stand together (regarding our health rights), or assuredly we shall all hang separately."
While writing this newsletter, I was contacted by Hummingbird Pictures about their new documentary, Money Talks: Profits Before Patient Safety. This documentary addresses a number of issues specifically covered in this newsletter. What's even better, Hummingbird has put an extremely informative 8 minute trailer of the film online. Check it out. Note: since it is an 8 minute clip, it does take a couple of minutes to load, even on broadband.