The horrific attack on the World Trade Center witnessed on television by millions of Americans September 11th brought home as nothing else could the reality of the threat to our freedom posed by international terrorism. What those millions of viewers did not realize, however, was that the terrible events of September 11th temporarily derailed a different but equally dangerous threat to one of our most important freedoms here at home...

On September 10th, the Senate Select Committee on Aging held a hearing titled "Swindlers, Hucksters and Snake Oil Salesmen: The Hope and Hype of Anti-Aging Medicine." The title, though, was merely a smokescreen to hide its real purpose. Chaired by Senator John Breaux of Louisiana, the proceeding had little to do with protecting senior citizens. Rather, it was in reality nothing less than a thinly veiled rabid attack on the Dietary Supplement Health and Education Act (DSHEA) and on the very notion of dietary supplements and alternative medicine.

Senator Breaux did not even attempt to give the appearance of balance. Instead, he used the Committee to provide a platform for a rag-tag parade of self-anointed experts, power hungry government bureaucrats and officials with private political agendas to mount a full-fledged media circus. The clear bias of the hearing was underscored by the fact that the only witnesses called to give testimony in favor of DSHEA were Glen Braswell, convicted of mail fraud and pardoned by President Clinton and an associate. Both, understandably, took the Fifth!

In a performance worthy of the legendary Stalinist "show trials," witness after witness recited laundry lists of criticisms of DSHEA and of alternative medicine. In the course of this mindless assault, truth became the victim of ideological self-interest. Indeed, the hostility expressed towards supplements and the use of alternative medicine was palpable.

So what did the other witnesses want?

Although there were a variety of complaints, all agreed on one essential point: more regulation was needed. This, it should be noted was in direct contradiction to the testimony of FDA Commissioner Jane Henney two years earlier who said the FDA had all the authority it needed!

Specifically, what they all wanted was to have dietary supplements subjected to the same sorts of rules that apply to prescription drugs.

How supplement manufacturers were expected to find the money to pay the estimated $600 million price tag that could accompany the testing of each of their products was not addressed.

With C-SPAN cameras rolling, and Committee members posturing, it was clear that Breaux and his colleagues thought that this was going to be the start of something big – and then the terrible events of September 11th knocked them out of the headlines, but not out of the picture.

The sad truth is that the Breaux hearing was only the latest in an ongoing assault on DSHEA and on alternative medicine that has been going on for several years. What is of concern, however, is that over the past year the assault has intensified dramatically and garnered considerable media attention. Although it was temporarily overshadowed by the events of September 11th, as news related to the terrorist threat becomes less prominent in the headlines, the attack on dietary supplements and alternative medicine has been renewed.

Indeed, on January 25th of this year, ABC’s "Prime Time Live" newsmagazine ran an extensive "expose" on Mexican cancer clinics. In an interview posted on ABC’s website, Dr. Stephen Barrett, of "Quackbusters" makes clear his attitude towards alternative and complementary medicine:

"Alternative" is a slogan, not a definable group of therapies. If something works, it would not be proper to refer to it as alternative. The vast majority of cancer treatments referred to as alternative obviously don't work. It's unlikely that any others work."

The following exchange with Barrett is particularly revealing:

MODERATOR

What's the most common health-related scam?

DR. STEPHEN BARRETT

It's the promotion of unnecessary vitamins - the claim that it is difficult or impossible for people to get the nutrients they need from ordinary food.

It is important to understand why DSHEA and supplements such as vitamins have become the focus of so much attention by the defenders of medical orthodoxy. Most forms of alternative and complementary medicine employ some form of supplement as an integral element of their therapy. Whether its vitamins, minerals, herbs or some other form of supplement, without the ability to use them, most of these therapies cannot be employed. It would be like prohibiting a conventional physician from using prescription drugs or a stethoscope.

But what are the concerns being raised about DSHEA, and is there any substance to them? A simple review of the facts makes clear just how specious the claims are.

To begin with, it is important to recognize that DSHEA was not enacted in a vacuum. Congress knew exactly what it was doing. Indeed, the law was enacted in response to a move by the FDA to assume power through regulation it had been denied by legislation.

In the 1970s, the FDA had attempted to classify vitamins and minerals as drugs if, in the Agency’s view, they were at levels of potency that its bureaucrats believed were excessive. There was an immediate public outcry. Alerted to the problem, Congress enacted the "Proxmire Amendment" stopping the proposed action. But the FDA was undeterred in its lust for power. Some years later, it again proposed regulations that would give it authority to regulate vitamins, minerals and other supplements like drugs. This time, over 170,000 citizens filed comments with the Agency opposing the move. As it had in the 1970s, Congress again acted to curb the FDA power grab - this time by enacting the Dietary Supplement Health and Education Act. Representative Dan Burton described what Congress intended in a statement submitted to the Breaux hearing.

"In 1994, Congress passed DSHEA by unanimous consent and with significant grass roots support. With the passage of the DSHEA Congress recognized the important role that vitamins, minerals, botanicals, and other dietary/nutritional substances can play in improving and maintaining health. Congress found that:

• the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
• there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;
• consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
• national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;
• although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers; and
• dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare."

In short, the DSHEA statute, AS A MATTER OF LAW, recognizes the safety and efficacy of dietary supplements. Moreover, Congress found that this fact was well supported by scientific evidence! So there is no doubt of congressional intent.

So how do the DSHEA opponents feel about the congressional findings?

The attitude of witness Dr. Robert Baratz, a professional defender of the status quo was typical of the panel members:

"To get to the National Institutes of Health in Bethesda from DuPont Circle I can take a cab or the Metro, I can walk or even ride a bicycle. These are true "alternative" methods. However, no matter how hard I wish, or whatever I may choose to believe, I can’t ride a magic carpet or self-levitate and fly to Bethesda. The "alternative" to scientific, evidence-based medical practices is non-evidence based non-scientific nonsense. It is grossly wrong and frankly ridiculous to place this collection of anecdotes, pseudo-science and conjecture called "alternative medicine" on the same stage with the real thing."

This emphasis on science sounds reasonable at first glance. In fact it is a mantra repeated time and time again by the self-anointed "quackbusters." But when you examine the content of Baratz’ organization’s (the National Council on Health Fraud) website a different picture emerges. Even a cursory review makes clear that Dr. Baratz and his colleagues never met an alternative therapy or supplement they didn’t hate. Moreover, when the scientific evidence doesn’t confirm their prejudices, they simply dismiss it.

For example, when a consensus conference involving a number of health agencies sponsored by the National Institutes of Health found that:

"There is sufficient evidence . . . of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value."

Despite this, and other strong support from within the SCIENTIFIC medical community, Baratz’s organization insists:

"Acupuncture is an unproven modality of treatment."

Or take the widely used supplement Glucosamine. Baratz’ organization refers visitors wanting to know more about the supplement to a paper by its Vice President Stephen Barrett which quotes the "Medical Letter," a publication it deems the medical professions "most respected drug advisory," as saying:

"Glucosamine with or without chondroitin may have some beneficial effect on osteoarthritis, and studies up to 3 years in duration have found no more adverse effects than with placebo, but most Medical Letter consultants are skeptical. Whether Glucosamine offers any advantages over better-established drugs such as acetaminophen, traditional NSAIDS or selective Cox-2 inhibitors remains to be determined. As with other dietary supplements, the quality and purity of the ingredients may vary [4]."

Barrett’s paper concludes:

"Decisions to use Glucosamine or Chondroitin must be based on information that is far less complete than is desirable. In addition, product quality control is a significant problem."

This highly skeptical attitude concerning Glucosamine and Chondroitin is expressed despite numerous clinical trials, including trials sponsored by the National Institutes of Health that demonstrate the efficacy and safety of these supplements for the treatment of osteorarthritis.

More important, Barrett’s paper implies that patients suffering from osteoarthritis should rely on so-called "Cox-2 inhibitors" such as Celebrex and Vioxx instead of Glucosamine and Chondroitin. His advocacy of these drugs ignores the fact that they have been found to carry the risk of life-threatening adverse effects including sudden, uncontrolled bleeding, liver damage and increased risk of heart attack and blood clots. Further, Barrett makes no mention in his paper of the numerous medical journal articles documenting these risks.

In short, it doesn’t matter what Congress has determined, it doesn’t matter what scientific evidence exists, if it’s outside orthodox medicine, it simply cannot work as far as Baratz, Barrett and their colleagues are concerned!

One other point should be made about the self-anointed "quackbusters."

During the hearing, Dr. Timothy Gorski, a board member of the National Council on Health Fraud mounted a vicious attack on the National Institutes of Health’s National Center for Complementary and Alternative Medicine Policy (NCCAM) and on the White House Commission on Complementary and Alternative Medicine (WHCCAMP), claiming that NCCAM:

"...continues to be staffed and controlled by ideological advocates..."

Yet in his prepared statement, Gorski quotes from a 1998 JAMA article that he says:

"...spoke for us all..."

And just what was the position Gorski says speaks for his group?

"There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine for which scientific medicine is lacking."

Yet, Gorski doesn’t consider the notion that alternative medicine doesn’t exist ideological! What makes Gorski’s assault on alternative and complementary medicine all the more disturbing is that he may have misrepresented himself to the committee.

On his written statement he lists his credentials as including the position of "Assistant Professor, University of North Texas Health Science Center," an impressive credential. However, when officials of the House of Representatives Government Reform Committee checked, they discovered that his claim of being on that prestigious faculty was untrue.

According to the Committee:

" ...we have learned that Dr. Timothy N. Gorski is not currently affiliated with the University of North Texas Health Science Center (UNTHSC). Dr. Gorski lists on the first page of his testimony that he is an Assistant Clinical Professor at UNTHSC. In his testimony he makes strong attacks regarding alternative medicine, including attacks on the credibility of research published after peer-review in the prestigious New England Journal of Medicine. Coming from someone with an academic appointment from UNTSC, these attacks carry significantly more merit than someone who has made a career of attacking CAM practices. Calls from my staff on September 21 to the University of North Texas Health Sciences Center, including to the University President, uncovered that Dr. Gorski is not an employee or on faculty of that center. He is not now, nor has he been on faculty at least as far back as 1998. His intentional misuse of an academic affiliation should completely discount his testimony. A follow up investigation by UNTHSC uncovered that in 1991 Dr. Gorski had been granted a clinical appointment because he was on staff at a community hospital where UNTHSC sent several residents. In 1995 UNTHSC conducted an audit of these clinical appointments, sending letters requesting verification of credentials and licensing was sent to all community physicians. Dr. Gorski never responded and was dropped from the clinical appointment."

The question is why did Dr. Gorski apparently inflate his resume? One reason may be that all of his other credentials derive from his association with the anti-alternative medicine group on whose board he serves. Without the added credential, he would appear "ideological," exactly the charge he levels at the far more qualified officials of the NCCAM.

But what of the claim that more regulatory authority is needed? Here again, the facts do not fit the claims. Indeed, the FDA has broad powers to act if it finds that a dietary supplement poses a threat to the public safety.

Specifically the FDA can:

• Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary [Section 402(a)]
• Obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims [Section 403(a),(r6)]
• Seize dietary supplements that pose an" unreasonable or significant risk of illness or injury" [Section 402(f)]
• Sue any company making a claim that a product cures or treats a disease [Section 201(g)]
• Stop a new dietary ingredient from being marketed if FDA does not receive enough safety data in advance [Section 413]
• Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard [Section 402(f)]
• Require dietary supplements to meet strict manufacturing requirements (Good Manufacturing Practices), including potency, cleanliness and stability [Section 402(g)]

Moreover, the FDA has not been at all shy about using these powers. It has conducted frequent raids on supplement manufacturers and distributors, often with little or no justification. Unlike pharmaceutical manufacturers who often repeatedly commit the same offense without any action being taken, any supplement manufacturer that fails to dot their I’s and cross their T’s perfectly can expect an FDA SWAT team to break down their door.

A few examples:

When the manufacturer of "Stevia" a natural sweetener offered cookbooks to his customers to help them understand the appropriate amounts to use in various foods, the FDA raided his office demanding that he burn the offending volumes. They claimed that making the books available "adulterated" his product. It was only after he began to videotape the agents that they backed down. Later, in the face of a court challenge under the First Amendment, the Agency reversed its position.

Compounding pharmacist Gary Osborne’s office was raided by flak-vested FDA enforcers who herded his staff into a small coffee room and then demanded all of his records. When Osborne read the warrant and discovered it only covered one product that he no longer carried, he offered to simply have his secretary provide the requested information. The FDA enforcers would have none of it. They told Dr. Osborne:

"We decide what to take!"

It was later discovered that Dr. Osborne wasn’t even the target of an investigation, but rather one of sixteen compounding pharmacists raided that day in an effort to obtain information about a physician living abroad!

Perhaps the most extreme example was the raid on Dr. Jonathan Wright’s Seattle clinic. Breaking down the door just as the clinic was about to open, the SWAT team accompanying the FDA held an automatic rifle on Dr. Wright’s middle-aged secretary. Local police enlisted to participate in the raid were outraged when they found that the warrant was for vitamins! Dr. Wright sued the Agency and eventually won a cash settlement.

But it’s not just the federal government that is actively attempting to suppress alternative medicine. The testimony of Dr. Tammy Guerkink Born before a congressional committee exposed what is really going on. I should note that Dr. Born is Vice Chairman of the Michigan Osteopathic Board of Licensing and Regulation and a voting delegate to the Federation of State Medical Boards, and therefore is highly credible. What she told the committee about a presentation at a meeting of the National Association of State Medical Boards conference in Chicago is a warning to us all:

"The focus of the very first presentation was how to stop the practice of alternative and complementary medicine. As one Assistant Attorney General of California said at that meeting: 'It is difficult for us to get patients to complain about these doctors, so we will have to find ways to get them ourselves."

She continued:

"He [The California official] asked for a show of hands for how many states had prosecuted alternative medicine doctors, and many of the state representatives raised their hands. Then he asked for a special conference to compare how other states had been successful in prosecuting alternative physicians simply because they were alternative not because they practiced bad medicine."

Clearly, the deck is being stacked! Even more disturbing, however, is that at the state level, there are various non-judicial forums available to the government that allow state and local officials to make a mockery of the Constitution and deny alternative practitioners and supplement manufacturers the rights of due process under the law. It is one of the most ominous trends in the assault on alternative medicine and one with which I am personally familiar.

The way that states are circumventing the Constitution is to use so-called administrative bodies to harass and persecute anyone who strays from the path of medical orthodoxy. For physicians, dentists and other practitioners, these take the form of state licensing boards. In virtually every state, board members are drawn from the profession that they regulate. The selection of board members, however, who are political appointees, is normally done in consultation with that state’s professional societies. Medical board’s members are selected from prominent members of that state’s medical association, dentists from prominent members of the state dental association and so forth.

Since the most prominent members are inevitably orthodox practitioners, they are hardly likely to be sympathetic to alternative and complementary therapies. Moreover, most will have associations with large medical institutions or even pharmaceutical companies, making them even less likely to view unorthodox therapies with favor. What is particularly important about this characteristic is that they also set the "standard of care" rules for their state. Any medical practitioner who fails to comply with this standard is liable to have his or her license to practice revoked.

On a practical level, this means that doctors must practice conventional medicine – or else! For the patient it often means being subjected to questionable and expensive treatments by doctors afraid to challenge the status quo.

In a his submission to the Breaux hearing, Representative Dan Burton (R-IN) provided an example of what can result:

"At a meeting of the American Society of Clinical Oncologists in the spring of this year, Dr. Ezekiel Emmanuel presented a study showing that doctors are prescribing chemotherapy to patients for cancers known not be unresponsive. Using billing records of nearly 8,000 patients in the state of Massachusetts they found that 41 % of patients received chemotherapy in the final year of life, 33 % in the final six months, and 25% in the final three months. The researchers found that at six months, three months, and one month before death that chemotherapy was given with the same amount of frequency between the two groups. The research showed that for patients with cancers generally recognized as being unresponsive to chemotherapy (gallbladder, kidney, liver, pancreatic, and melanoma) in the last year of life, doctors prescribe treatments that cost $38,000 when they know it is not going to help. Prescribing expensive drugs with serious side effects when there are lower cost, less dangerous options available and prescribing chemotherapy, which has significant risks associated with it and can cause terrible loss of quality of life, when there is no evidence that it will benefit are serious scams within the medical community that need to be addressed."

If only 10% of all cancer patients (and the number is likely to be much, much higher) are administered these useless drugs each year, and they are only administered for 3 months, the cost to the U.S. economy of such unnecessary treatment would be $5.7 billion annually! Even worse, though is the fact that the patients may be denied other alternative or complementary therapies that might have saved their lives!

The use of extra-judicial means to suppress alternative and complementary medicine is not limited to medical practitioners. Manufacturers and distributors of dietary supplements too, can have their rights to due process trampled upon. In their case, however, the tool used against them is what is called an "administrative review board."

While the name given to administrative review boards can vary from state to state, they all have one thing in common: administrative law judges do not have to abide by the rules of evidence and procedure that apply in a court of law. As a result, they have wide discretion in admitting evidence, approving expert witnesses and determining the relevance of testimony. They are essentially a Kangaroo Court with the deck stacked against the defendant from the outset.

Maryland Attorney General J. Joseph Curran testified about one such proceeding at the hearing, engaging in the same sort of obfuscation and dissembling as the witnesses who proceeded him. While trumpeting his victory over "consumer fraud" what Curran failed to note was that no fraud charges were ever brought. Indeed, the specific action he discussed was one in which no consumer complaints had been registered in his state!

More important, the defendants were denied any semblance of due process. Many their expert witnesses were not allowed to testify. Over eighty defense witnesses were barred from testifying, with the administrative law judge saying she would accept their affidavits instead, but then she changed her mind and did not allow them to be considered! At the same time, the State was allowed to present so-called "expert" witnesses who admitted on the stand that they had no knowledge of the products being considered. Amazingly, the administrative law judge allowed their testimony to be considered despite their self-proclaimed ignorance! When the administrative law judge found for the defendants on one count, the Attorney General simply went over her head and had her supervisor reverse her decision!

As unbelievable as this sounds, it is not only true, it is commonplace. All over the United States, dietary supplement manufacturers and distributors are being subjected to the same sort of high-handed, possibly unconstitutional proceeding. If average Americans do not rise up and object, the situation will only get worse.

Each of us who want to have the ability to make choices about our medical care must speak out. We must write our elected officials. We must contact the media. If we do not, we will lose our most precious right – the right to determine what sort of health care we are able to use.