THE BULLET YOU HEAR ISN’T ALWAYS THE BULLET TO FEAR By Scott C. Tips July 2007
Why is it that people who cannot take advice, keep on giving it?
- James Bond in Casino Royale
It is absolutely amazing the amount of frenetic energy that health-freedom activists can generate in a hurry – oftentimes over nothing and many times against one another. In the last several months we have seen several health-freedom issues arise that have caused other health-freedom organizations to go ballistic, firing off e-mail alerts like bullets and marshalling troops like a Napoleon. Impressive – until you look deeper.
Since the National Health Federation has never been one to jump on any old bandwagon that happens to come careening around the next corner just because everyone else has done so, we have recently taken some flak due to our – I would like to say – more measured and experienced approach.
FDA CAM Guidance
For example, you will recall the recent outcry over the Food and Drug Administration’s issuance of its Guidance on Complementary and Alternative Medicine (“CAM Guidance”). On February 27, 2007, the FDA published its CAM Guidance in which the FDA set forth its thoughts on CAM products used by doctors and other healthcare practitioners. What alarmed many people was its statement that even food products “prescribed by” doctors could be deemed drugs and regulated as such by the FDA.
Adding to the public’s suspicion that they were being railroaded, this Guidance inadvertently gave the public a shortened notice period until the end of April for submitting its comments. (A clerical error had not correctly adjusted out to the end of May the normal 90-day comment period. This oversight was later corrected.)
Well, one organization jumped on this issue like a screaming banshee, issuing press releases and calls to action that got thousands of people stirred up. From reading those releases one would have thought it was the End of the World for alternative medicine and natural healthcare. This, in turn, led to a panicky and self-reinforcing rush by other organizations to jump on the bandwagon. They feared being depicted as ignorant and generally “out of the know.” On the other hand, they could see the great publicity benefits of thumping this issue regardless of whether it was a problem or not. (See Peter Barry Chowka’s superb article on this mad dash at http://docs.google.com/View?docid=dd3z9z8q_63khsd7w.)
The NHF was one of the few organizations to look at the FDA CAM Guidance issue and see that it was truly much ado about nothing. For that, we received brickbats, with some e-mails and calls incredibly suggesting that we must be in the pocket of the pharmaceutical industry or even a “controlled opposition group.” But, we stood our ground, for we felt that with the limited resources in the hands of the health-freedom community why should we throw them away on a non-issue? In fact, we suspected that this was being done deliberately to distract us.
As we said originally, and we still say today, the FDA CAM Guidance is wrong; but it is not – as some have said – law. The FDA CAM Guidance is not new policy at all - it's just the FDA's written expression of what its policy has been for a very long time. So, there's no change and nothing new here, other than actually using the acronym "CAM”; and others’ claims that the FDA is creating “new law” with this document are simply false.
Look at this pertinent quote from 21 CFR §10.115, Administrative Practices and Procedures, which actually defines guidance documents and what they mean in a regulatory sense: “(3) "You" refers to all affected parties outside of FDA. (d) Are you or FDA required to follow a guidance document? (1) No. guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA. (2) You may choose to use an approach other than the one set forth in a guidance document.” So, the Guidance is neither law nor regulation.
Even Philip Chao of the FDA, and a co-author of the FDA CAM Guidance, admitted earlier this year, “Listen, the FDA does not regulate practitioners. We regulate drugs, devices, biological products, foods, cosmetics, devices, dietary supplements. If a product falls within a statutory definition of one of these categories, then the product may be subject to regulations pertaining to that product. We do not regulate how practitioners prescribe products. The practice of medicine is a state matter.”
In short, while we want the FDA to withdraw the document because of the confusion it has created, we recognize that it is nothing more than a written expression of a position that the FDA has held for years. The most the FDA can do with this document is to try to trick naïve doctors into believing that the Guidance document is law - ironically, this is exactly the impression that current doomsayers are creating by exaggerating the importance of this document!
The FDA cannot regulate what a physician, or other medical provider, does, or says, about drugs, supplements, or the combined use of both, in their practices with individual patients. However, if a doctor – like anyone else in the United States – then proceeds to market a product to the public using “disease” claims, he or she could face regulatory action. Again, this is a regulatory threat we detest and oppose; but the NHF has been opposing this long-held FDA position for decades. It is nothing new at all, except to those who suddenly “discovered” this issue a few months ago and have gotten a lot of mileage out of it in the form of publicity and donations. Nice for them, not nice for health freedom.
S.1082 / H.R.1561
U.S. Senate Bill 1082, the so-called Food and Drug Revitalization Act, was passed by the Senate on May 9th, and then moved on to the U.S. House of Representatives for consideration there. This bill, which basically began its life as a reauthorization of the user fees charged to drug companies by the FDA, morphed into a monstrosity with every log-roller in the Senate attempting to use the bill as a vehicle for his or her favorite pet idea. For one, pathetic Senator Dick Durbin – who never misses an opportunity to promote ill health amongst Americans – wanted to tack on his idiotic “Safe Food Act,” which would have treated food supplements as drugs. Thanks in part to the efforts of the NHF lobbyist, however, this attempt was defeated.
Much attention has been focused on S.1082, with articulate health-freedom writer Byron Richards leading the charge. It was Richards who first pointed out the dangers of the Reagan-Udall Foundation buried in an enhanced version of the bill. This Foundation, ostensibly meant to be independent of the FDA, would instead be dominated by it and other interests adverse to health freedom. As a sort of joint venture among pharmaceutical companies, universities, and the FDA, the Foundation would fund and research, among other things, drug, device and food safety.
Interestingly enough, the Foundation will hold valuable patents and licenses relating to the drugs or devices that are developed, which means that it will also be in the drug and device business. Although required to submit annual reports to the FDA and Congress, the Foundation will be a loose cannon, the ill-effects of which can at this stage only be well imagined. Since when has any new Federal bureaucracy resulted in anything good?
The real controversy over the Foundation concerns the extent to which it will investigate food safety and thereby start infringing on dietary-supplement freedoms. Although a minor part of its mission, the risk is there, particularly when coupled with the incessant drive towards harmonization of food-and-drug regulatory agencies. It was because of this threat that some had pushed for an amendment to S.1082 that would have eliminated any reference to “food” or “food safety” in the Foundation’s mission statement. That push was unsuccessful; but the NHF, through its lobbyist, was able to at least propose and then have happen a colloquy (a verbal exchange) among Senators that clarified the Senate’s intent is that the bill not apply to food supplements. In fact Senators Harkins and Hatch’s questions led Senator Ted Kennedy to respond, “Let me make absolutely clear that the Reagan-Udall Foundation will in no way override, overturn, or conflict with the Dietary Supplement Health and Education Act. Nothing in this bill would have that effect.”
Now, with the House of Representatives taking up the issue, and rolling nine separate bills into one large one (as yet unnumbered at the time of this writing), the issue remains – to protect dietary supplements as the House bill is being considered and then voted upon. Some groups pushed an amendment to the developing House bill – similar to the failed amendment proposed in the Senate – that is, to exclude food and food ingredients from its ambit. This was, and still is, a creditable goal.
Unfortunately, in a manner reminiscent of briar rabbit telling briar fox not to throw him in the briar patch, these calls to action may have had the opposite effect. These words, formerly absent from the House bill language, have now been inserted into it by alerted opponents of health freedom. Sometimes it does not help to get ahead of the legislative curve, it is better to wait for the right moment and then act.
Events are still developing, so stay tuned as the House bill evolves and then must blend with the Senate bill. Without tipping our hand here, I will just say that NHF and its lobbyist have strategies and tactics in mind for what we see as an intermediate and long-term threat caused by yet another completely unnecessary Federal structure. We should be dismantling Federal agencies, not adding to them.
The Ephedra Case
Less well-known is the ephedra case. And yet this more-silent bullet has far more import for health freedom than either the CAM Guidance or S. 1082 and its House offspring.
With the latest court decision on this case already discussed by our NHF Lobbyist (see- http://www.thenhf.com/ephedra_issues_011.html ) I will not repeat what has been written there.. But this case is important enough to note that the U.S. Supreme Court’s decision to let stand the lower Circuit Court panel’s decision is a major threat to our right to free access to dietary supplements.
The Circuit Court’s decision upholding the FDA’s ban on ephedra means that the FDA can now impose upon dietary supplements the same drug-like risk-benefit comparison standard that is supposed to be reserved by statute only for pre-market review of drugs. In other words, as the attorney for the plaintiffs, Jonathan Emord, wrote, “[i]t grants FDA authority to declare any dietary ingredient adulterated on FDA’s subjective assessment of the adequacy of the ingredient’s health benefits if FDA finds even so much as an infinitesimal risk of illness or injury from ingestion of the ingredient (a ubiquitous condition because all ingredients pose some risk at some dose).”
Not only does this court decision undercut the protections of the Dietary Supplement Health and Education Act of 1994, but it also entrusts the FDA with arbitrary enforcement powers that the Agency has already shown it will abuse. The Supreme Court’s failure to step in here has guaranteed further litigation and anguish.
The FDA’s CGMPs for Supplement Manufacturing
The FDA has just issued its 854-page drug-like regulations governing the manufacture of dietary supplements. A significant portion of the document is spent legally justifying the issuance of Current Good Manufacturing Practices (CGMPs) regulations and discussing the various comments made to the draft that preceded these regulations. Then, as is typical with government agencies, many of the subsequent pages are unnecessary, covering as they do such non-issues as sanitation requirements (already covered by State and local laws) and mold contamination, the latter of which is not a problem typically found in supplement manufacture.
When you get down to the meat of the CGMPs, you see that they impose enormous costs upon supplement manufacturers. A significant amount of paperwork will have to be completed, with records constantly updated, consultants and attorneys hired, and good-faith attempts to comply that will result in FDA enforcement actions and grief.
Now, of course, the larger companies are only too happy to see these CGMPs –they even lobbied for them! They can see that if you make the regulatory cost of doing business too high, then the medium- and small-sized companies will go out of business, leaving more market share for the big guys. In fact, the FDA itself says in this document that 172 small supplement companies will go out of business because of the regulatory costs imposed by the CGMPs. The increased costs incurred by the survivors will, of course, just be passed on to the consumer – the ultimate loser in this whole sorry scheme.
And for what? Will the consumer actually be safer? No. Already some 90% of the companies were enforcing their own GMPs; and we all know that dietary supplements have the most enviable safety record on the Planet. Yet, these CGMPs, as pointed out by knowledgeable healthwriter and researcher Bill Sardi (see http://www.thenhf.com/articles/articles_521/articles_521.htm ), provide for absolutely no testing of finished goods and permit manufacturers to rely upon certificates of analysis of the ingredients that go into their supplements. These certificates of analysis, furnished by raw-material suppliers, are all-too often inaccurate or deliberately falsified. Many of the worst offenders seem to come from China.
These CGMPs, then, are nothing more than a huge regulatory burden on the supplement industry that will not improve safety enough to justify the cost. They fail to address key safety issues while controlling the manufacturing process from beginning to end with the dead weight of its regulatory hand. Another round chambered in the gun that has been handed to the FDA by our erstwhile allies.
The U.S.-E.U. Agreement
As if that were not enough, on April 30th, President Bush, German Chancellor Angela Merkel (the current president of the European Council), and European Commission President José Manuel Barroso signed the “Transatlantic Economic Integration” between the United States and the European Union. The Agreement establishes a new Transatlantic Economic Council to help implement its plan, among other things, to integrate the regulatory rules and structures of the two regions, with a special focus on integrating the pharmaceutical sectors.
This act is yet another one of the steps predicted by the NHF and others as an “end run” around domestic American legal protections for health freedom. With very little mainstream media coverage for this event, few people have heard of this new threat, which dovetails very neatly with the standards being developed at Codex meetings as well as a web of other interlocking treaties, trade agreements, and regulatory “handshakes.”
Universal “Healthcare”
And while all eyes are directed towards the various political and legal struggles mentioned above, few see the danger to health freedom that lies in the government plans euphemistically labeled as “Universal Healthcare.” In the same way that the Holy Roman Empire was neither “Holy” nor “Roman” nor even an “Empire,” Universal Healthcare will not be either “Universal” or “Healthcare.” Oh, of course, those who support Universal Healthcare will argue that the government’s coercive intervention into the medical economy will provide healthcare for all. But, the insightful thinkers will ask: What kind of healthcare? And the even deeper thinkers will then ask: Will that be the kind of healthcare I will want for my children and me?
If it is one thing that history has shown over millennia, it is that substituting coercive bureaucratic orders, backed by guns and truncheons, in place of free, voluntary exchanges among individuals has never resulted in greater justice, wealth, or efficiency.
So, it is beyond bizarre that many so-called health-freedom activists and organizations – such as NewsTarget – actually support “Universal Healthcare.” Unaware of their internal contradictions, these persons act like health-freedom fighters all while supporting the suppression of health freedom through increased, illegal government intervention into the healthcare economy. (See Peter Chowka’s “Universal Healthcare Marches On” at http://docs.google.com/View?docid=dd3z9z8q_92dfg9bb .)
For all the rhetoric and mystical awe cast around it, medical care is nothing more than a commodity, a service that you buy and sell like, say, bread. In today’s American market, you can go to any number of stores and buy breads of all kinds, from the kind of bread I would not feed to my worst enemy to the kind that is incredibly nourishing, healthy, and tasty. The point is that you have a choice, and to exercise your choice you do not have to wait in long lines, seek government permission, or fill out forms. Imagine now if the government were the only one allowed to sell bread. And then ask yourself – honestly – how many choices would you have then and would these choices even be for bread that you would want to eat?
That’s what we have today in healthcare. After more than 40 years of increasing government control over healthcare, masquerading as “private” healthcare so that government can avoid the blame, we have finally arrived at that terrible moment when we are being forced to take that last step forward into total and complete government control over our healthcare choices. That is the bullet that most people do not hear; and that is the bullet that some, like Peter Chowka, have been warning us to fear.
