(NaturalNews) The Dietary Supplement Health and Education Act of 1994, or DSHEA, is a decent law. It says supplements are to be treated as food, not drugs, which only makes sense. Supplements are safe and natural food substances. As such, they can't be patented.
This, of course, really irritates the pharmaceutical industry. If they can't get patent protection on a vitamin or mineral, how in the world can they make money off of them? How can they keep smaller supplement manufacturers off their playground?
The answer is simple. Big Pharma already has the US Food and Drug Administration in its pocket. Its money pays many FDA salaries. It helps FDA write opinions on the safety of various drugs (the very drugs that are being assessed by the supposedly independent Agency). All the drug makers need to do now is to chip away at DSHEA, bit by bit.
In January, FDA responded to a Citizen Petition filed by the drug manufacturer Biostratum by banning the sale of pyridoxamine - one of the three natural forms of vitamin B6 found in nature - and declared pyridoxamine a "new drug." Why? Because Biostratum manufactures a drug based on pyridoxamine. By receiving a favorable ruling from FDA, Biostratum now has a solid monopoly on the sale of pyridoxamine.
Up next: a petition filed by another pharmaceutical company, requesting a ban on dietary supplements containing pyridoxal 5'-phosphate (P5P), another natural form of vitamin B6. The petitioner, Medicure Pharma, actually admits that P5P is a naturally occurring molecule and that it qualifies as a dietary supplement. Medicure's point of contention is that P5P in dietary supplements will infringe on their profits from a drug they are currently developing, which includes P5P as an active ingredient!
With surprising candor, Medicure states in their petition, "Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs, because many people may choose to purchase the supplements rather than the drugs" [italics ours]. They might have added that the supplements are much cheaper, too.
Chip, chip, chip. If you can't defeat the DSHEA, then get FDA to say that substances which have been in food, in the body, or in nature since the world began are now "new drugs," and thus patentable. How, you ask, can a natural substance be patented? It's easy. Just add a little of something that is patentable to it and you are all set to create a monopoly on the natural substance. What supplement manufacturer can afford the massively expensive patent protection and FDA approval process? Well, Big Pharma can. They have very, very deep pockets.
They're so deep that they can participate - quite legally - in price-gouging of US citizens. American drug manufacturers sell medicines to foreign countries for much lower prices than they charge Americans, often setting up manufacturing facilities in those countries. Re-importing the same drugs that American manufacturers have produced for other countries is still less expensive than buying them at current US prices.
Sen. Byron Dorgan (D-ND) has just introduced the Pharmaceutical Market Access and Drug Safety Act. It would allow for the re-importation of cheaper prescription drugs from Canada and other countries. And President Obama's healthcare reform team says the administration has a "strong interest in implementing this [re-importation] policy."
Big Pharma's not happy. They, and their deep pockets, will do whatever they can to derail this train.
In general, healthcare is a hot topic in President Obama's Washington. There will be a big bill. How will integrative medicine fit into it?
One of the big problems is that integrative medicine is low on the White House and Congressional radar screen. But that can change. When DSHEA came up, it produced more messages to Congress than any legislation in history. We need to get ready to repeat that. In the meantime, there is news on other Washington fronts.
GAO Report on Dietary Supplements
On March 2, the Government Accountability Office (GAO) released a report on dietary supplements calling for FDA to require "increased adverse event reporting," and to request additional authority to oversee dietary supplements. The GAO report also asks FDA to complete its own long-awaited guidance on new dietary ingredient submissions, and to educate consumers about the safety of supplements. We can imagine what an FDA education about supplements would look like.
The Council for Responsible Nutrition (CRN), a supplement trade group, said, "We disagree with the logic behind the recommendation of submitting all adverse event reports, versus the important need to submit serious adverse event reports. . . . The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working."
Despite the fact that the GAO report never recommended overturning DSHEA, two very powerful members of Congress - House Energy and Commerce Chairman Henry Waxman (D-CA), and Assistant Senate Majority Leader Dick Durbin (D-IL)- were quick to comment that they would "work to strengthen FDA's regulation of supplement products"! In fact, rumors have been circulating for months that Waxman and Durbin are working together on a bill that would over-regulate the dietary supplement industry at best, and would gut DSHEA at worst.
IOM Summit on Integrative Medicine
On a happier note, last month, the government's Institute of Medicine (IOM) held a Summit on Integrative Medicine and the Health of the Public at the National Academy of Sciences to discuss "integrative medicine, its potential to improve the outcomes and efficiency of healthcare for Americans, and the priorities to be addressed to take advantage of that potential." Six hundred key leaders and stakeholders in healthcare - including educators, scientists, community leaders, practitioners, lawmakers, policymakers, and insurance leaders - were in attendance.
In a keynote address, Senator Tom Harkin (D-IA) discussed including coverage of integrative healthcare treatments in Medicare and, citing Dr. Mark Hyman, announced that "we need to rethink not just the way we do medicine, but the medicine that we choose to do."
The Institute of Medicine's stated mission is to serve as advisor to the nation to improve health. The very fact that IOM hosted a Summit on Integrative Health is significant, because it shows a willingness to have controversial conversations about real change, and reminds us that the integrative health movement is picking up momentum.
Senate Hearings on Integrative Healthcare
Also last month, the Senate Health, Education, Labor, and Pensions Committee held a series of hearings on integrative healthcare. They wanted to examine opportunities to include integrative healthcare in President Obama's healthcare reform proposals.
Offering testimony were Dr. Mehmet C. Oz, Dr. Andrew Weil, Dr. Mark Hyman, and others who share a common vision of true prevention - one that addresses the health and lifestyle choices that lead to chronic disease. "Even if we get everything else right," said Dr. Hyman, "it won't matter if we don't address the causes of our current healthcare crisis."
Heading one of the three healthcare reform working groups, Sen. Harkin has promised to step outside the traditional model and to examine additional opportunities to create health and well-being. A hero to the health freedom community, he has promised to stop the discrimination against integrative medicine.
Comparative Effectiveness Research
The Stimulus Bill allotted $1.1 billion for a Comparative Effectiveness Research (CER) program to determine which healthcare treatment options are the most effective - and the most cost-effective. Treatments that don't make the cut would probably not be reimbursed in government health programs. It is also thought likely that private insurers would follow suit.
An IOM committee is being set up to study the needs of various communities and determine how to spend about $400 million of the initial $1.1 billion appropriated.
The $1.1 billion is intended to be used in the short term, over the next eighteen months or so, while lawmakers work to pass a more detailed, comprehensive, and long-term plan. The long-term plan will be introduced as part of the healthcare reform bill President Obama has promised to pass before the end of the year.
Critics of CER within the integrative medicine community fear that it will be a prelude to a completely government controlled medical system which will be dominated and manipulated by the big drug companies with their lobbyists and campaign contributions and their control over the FDA. On the other hand, CER can provide a place for integrative medicine to make its case outside the FDA, to prove its potential for successful treatment and huge cost savings based on the thousands of scientific studies that have been done. It is also an opportunity to educate the general public. For all these reasons, the integrative medicine community has to be sure that it is heard and is part of the process, and Senator Harkin and other friends on the Hill will help to ensure that it is.
We need to explain that while the government and insurance companies pay $10,000 to amputate a diabetic patient's foot, they currently won't pay the small fraction of that amount needed to treat with nutraceuticals or to educate a patient about the benefits of a healthy diet and lifestyle changes that in many cases will prevent or even reverse diabetes.
No matter how uncomfortable we may be at the thought of government controlled medicine, it is a fact that CER has enormous potential to define what medicine is. Integrative medicine needs to speak up now, early in the process, and get a seat at this table. In future articles, we will tell you how you can help.
About the author
Gretchen DuBeau is the Executive Director for the American Association for Health Freedom. An attorney, lifelong environmentalist, and devotee to natural health and healing, Gretchen has found the perfect culmination of her interests in AAHF, a politically active organization that advocates natural and sustainable healthcare using education, legislative efforts, and litigation to protect the practitioner's right to practice and the consumer's right to seek integrative healthcare options. To learn more please visit www.healthfreedom.net or call 800-230-2762.