Studying Complementary and Alternative Therapies

By Paul A. Offit, MD
JAMA, May 2, 2012

In 1992, with an initial budget of $2 million, Congress created the Office of Alternative Medicine (OAM). Based on legislation sponsored by Iowa politicians Tom Harkin and Berkeley Bedell, OAM’s mission was “to explore complementary and alternative healing practices in the context of rigorous science.”

In 1999, OAM became the National Center for Complementary and Alternative Medicine (NCCAM), a center within the National Institutes of Health (NIH). Funding has steadily increased; by 2012, NCCAM’s annual budget had reached $130 million. Since their inception, OAM and NCCAM have spent $1.6 billion. US taxpayers have a right to ask whether money appropriated for NCCAM—like money appropriated for all centers within NIH—has been well spent.

In support of NCCAM’s mission, proponents argue that one century’s folk medicine can be the next century’s mainstream medicine… Indeed, most drugs on today’s hospital formularies were originally derived from plants.

However, unlike studies of drugs derived from plants, many studies funded by NCCAM lack a sound biological underpinning, which should be an important requirement for funding. For example, NCCAM officials have spent $374 000 to find that inhaling lemon and lavender scents does not promote wound healing; $750 000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390 000 to find that ancient Indian remedies do not control type 2 diabetes; $700 000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406 000 to find that coffee enemas do not cure pancreatic cancer. Additionally, NCCAM has funded studies of acupuncture and therapeutic touch. Using rigorously controlled studies, none of these therapies have been shown to work better than placebo. Some complementary and alternative practitioners argue reasonably that although their therapies might not work better than placebos, placebos may still work for some conditions.

Although studies funded by NCCAM have failed to prove that complementary or alternative therapies are anything more than placebos, some proponents—pointing to studies of vaccine safety—argue that negative studies of biologically implausible hypotheses are worthwhile.

Does the same value of rigorously conducted negative studies hold for studies of complementary and alternative therapies? Have negative studies changed behavior? The answer is probably best found in NCCAM-funded studies of dietary supplements and megavitamins. Several studies have shown that garlic does not lower low-density lipoprotein cholesterol, St John’s wort does not treat depression, ginkgo does not improve memory, chondroitin sulfate and glucosamine do not treat arthritis, saw palmetto does not treat prostatic hypertrophy, milk thistle does not treat hepatitis, and echinacea and megavitamins do not treat colds.​ Moreover, some studies have found that megavitamins increase the risk of cancer and heart disease. Because the vitamin and supplement industry is not regulated by the US Food and Drug Administration (FDA), negative studies have not precipitated FDA warnings or FDA-mandated changes on labeling; as a consequence, few consumers are aware that many supplements have not delivered on their claims. In 2010, the vitamin and supplement industry grossed $28 billion, up 4.4% from the year before. “The thing to do with [these studies] is just ride them out,” said Joseph Fortunato, chief executive of GNC Corp. “We see no impact on our business.”

Although evaluating the research portfolio of any institute at the NIH is difficult, social and political pressures may influence area-of-interest funding, and decisions should be based on science. For complementary and alternative medicine, it seems that some people believe what they want to believe, arguing that it does not matter what the data show; they know what works for them. Because negative studies do not appear to change behavior and because studies performed without a sound biological basis have little to no chance of success, it would make sense for NCCAM to either refrain from funding studies of therapies that border on mysticism such as distance healing, purgings, and prayer; redefine its mission to include a better understanding of the physiology of the placebo response; or shift its resources to other NIH institutes.

http://jama.ama-assn.org/content/307/17/1803.full

And…

THINGS GET HOTTER FOR HOXSEY

U.S. Food and Drug Administration posts warning against man who makes millions from cancer victims

LIFE, April 16, 1956

Caption of a photograph of Harry Hoxsey:

HARRY HOXSEY holds the book he wrote which touts his cancer treatment. Beside him on a plaque is his motto: “The world is made up of two kinds of people – dem that takes and dem that gets took.”

http://books.google.com/books?id=Pk8EAAAAMBAJ&pg=PA125&dq=Harry+Hoxsey&hl=en#v=onepage&q=Harry%20Hoxsey&f=false

Complementary and alternative medicine (CAM) is a topic frequently brought up in discussions, forums, and in the medical and lay literature. When confronted on this topic, I usually respond by saying that anyone should be able to spend their own funds as they desire, but when the rest of us are paying the bills, whether through premiums for private insurance or through taxpayer-financed public programs such as Medicare, there is a responsibility for the administrator of the funds to prevent wasteful cost overruns by limiting spending to health care that is compliant to well accepted standards of mainstream medicine, which includes promising new diagnostic and therapeutic options that adhere to the rigors of science.

The application of science to medicine is a dynamic. Many older approaches prove to be ineffective or even harmful. As we gain new evidence, those approaches should be denied payment from our collective health funds, whether private or government. Beneficial new approaches should be added. These decisions should continue to be based on science.

What is different about the scientific evaluation of existing and innovative medical interventions and the evaluation of CAM? Why is CAM segregated, as, for example, in the National Center for Complementary and Alternative Medicine (NCCAM)? Quite simply, complementary and alternative therapies do not arise from inductive scientific reasoning. They are based on faith exclusively and have no basis in the scientific disciplines. If new discoveries suggest that there could be a scientific basis warranting further evaluation of a complementary or alternative therapy – an exceedingly rare event – then it is no longer classified as CAM but is moved into the arena of bone fide scientific research.

Should the government have any role in oversight of CAM? Yes, for two reasons. Most important, some CAM therapy is harmful, and the government has an legitimate role in protecting us from harm by removing from the market truly dangerous products with no redeeming value. The other role of government is to ensure that the producers and sellers of these ineffective products are providing honest disclosure to the consumers. Such disclosure is not required today. If the product is crap, the producers should be required to tell us that it is crap.

What the government should not be doing is wasting our tax dollars on this phony research strictly for the purpose of pleasing the eccentrics who have political influence.

My concerns go back to my teenage years when I had several discussions with my father – a physician – over these topics now classified as CAM though more appropriately referred to then as quackery. I remember very clearly reading a LIFE magazine article on the cancer quack Harry Hoxsey. I have repeated to myself over an over again throughout the years Hoxsey’s motto that appeared in the photograph of him in that article (which I was amazed that I could find today with a Google search – link above):

“The world is made up of two kinds of people – dem that takes and dem that gets took.”

Until now, I have been reserved in my comments on CAM, partly because so many sincere, dedicated individuals in our single payer coalitions are supportive of CAM – including some members of PNHP who should know better. But dammit! Quackery is quackery! The smug CAM producers who retreat to their mansions are “dem that takes,” and the uninformed patient/victims lacking an adequate scientific background are “dem that gets took.”

When I was a teenager, I wanted to become a physician like my father and help clean house of these unscrupulous thieves. Alas, they are still with us, and now they have been joined by their brethren in the insurance industry who don’t have a tangible product to sell us but rather simply expropriate our money directly out of our collective health funds in exchange for taking away our choices in health care. That’s worse than quackery!

(This is not a PNHP policy statement, but is a cathartic release of pent up emotions of the author.)