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Senator Tom Harkin and Representative Darrell Issa declare war on science-based medicine

In discussions of that bastion of what Harriet Hall likes to call “tooth fairy science,” where sometimes rigorous science, sometimes not, is applied to the study of hypotheses that are utterly implausible and incredible from a basic science standpoint (such as homeopathy or reiki), the National Center of Complementary and Alternative Medicine (NCCAM), I’ve often taken Senator Tom Harkin (D-IA) to task, as have Drs. Novella, Lipson, and Atwood. That’s because Senator Harkin is undeniably the father of that misbegotten beast that has sucked down over $2.5 billion of taxpayer money with nothing to show for it. NCCAM is the brainchild of Senator Harkin, who foisted it upon the National Institutes of Health not because there was a scientific need for it or because scientists and physicians cried out for it but rather because Senator Harkin, who believed that alternative medicine had healed a friend of his, wanted it, and he used his powerful position to make it happen, first as the Office of Unconventional Therapies, then as the Office of Alternative Medicine, and finally as the behemoth of woo that we know today as NCCAM. The result has included a $30 million trial of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of NCCAM, as have I and others. Not surprisingly, alternative medicine practitioners are appalled at this idea.

Most recently, Harkin has been most disturbed by the observation that NCCAM’s trials have all been negative, going so far as to complain that NCCAM hasn’t produced any positive results showing that various alternative therapies actually work. This is, of course, not a surprise, given that vast majority of the grab bag of unrelated (and sometimes theoretically mutually exclusive) therapies are based on pseudoscience. One of the only exceptions is the study of herbal remedies, which is a perfectly respectable branch of pharmacology known as pharmacognosy. Unfortunately, as David Kroll showed, in NCCAM the legitimate science of pharmacognosy has been hijacked for purposes of woo. Meanwhile, earlier this year, Senator Harkin hosted a hearing in which Drs. Dean Ornish, Andrew Weil, Mehment Oz, and Mark Hyman (he of “functional medicine“) were invited to testify in front of the Senate. Add to that other powerful legislators, such as Representative Dan Burton (R-IN), trying to craft legislation in line with his anti-vaccine views and pressure the NIH to study various discredited hypotheses about vaccines and autism. Clearly, when it comes to quackery, there are powerful legislative forces promoting pseudoscience and studies driven by ideology rather than science.

When politicians play politics with peer review

What brought this to mind (and led to my regurgitation of two paragraphs of history about this) are two very disturbing pieces of news that surfaced on Friday. They come from the opposite sides of the political spectrum. One, as you might imagine, involves Senator Harkin. One involves a Republican. What they share in common is that they serve to illustrate how perilous it is when legislators try to insert their ideology into science and medicine funded by the federal government.

Before I go on, I should point out that, in any endeavor funded by the federal government, the insertion of some politics will be inevitable. It can’t be otherwise, and I’m not sure that it should be. Legislators who write the laws funding, for example, the NIH, the National Science Foundation (NSF), Medicare, and other federally-funded research are accountable to their constituents for how taxpayer money is spent. However, poltics and science are all too often a contentious mixture, which is why it is desirable to place as much buffers between direct involvement meddling of legislators in the science as possible. Part of the genius of how the NIH and NSF are set up is that scientists can apply for funding for virtually any project they wish to do, and their proposals will be considered seriously through careful peer review. In other words, it is scientists, not politicians and bureaucrats, who decide what work is and is not funded “in the trenches” on a day-to-day basis. Meanwhile, elected representatives decide the overall broad picture of what is and is not funded through legislation funding various agencies and through Presidential appointment and Congressional confirmation of Directors of various agencies, such as the NIH and NSF, who then hire the leadership of these agencies and decide how they will run and what science they will emphasize. All in all, for a product of the messy democratic process, it works pretty well, and the track record of NIH- and NSF-funded research is the envy of much of the world (well, except for NCCAM, but nobody’s perfect).

Of course, none of that stops legislators from periodically trying to insert themselves into the process by passing laws targeting specific research proposals, and that’s just what happened late last week through the passage of hte so-called Issa Amendment to the FY 2010 Labor, Health and Human Services and Education Appropriations bill. Specifically, Representative Darrell Issa (R-CA) offered an amendment to rescind funding for three currently funded, peer-reviewed NIH grants that that focus on HIV/AIDS prevention, and the the House of Representatives passed the amendment by voice vote, and Issa is crowing about it on his website:

“It is my mission to hold the federal government accountable for its spending and the NIH is no exception, especially during the current economic crisis” Issa said.  “These studies are clearly not high priorities for U.S. citizens, suffering from disease here at home, who could benefit from the $5 million the NIH plans to spend on foreign alcoholics and prostitutes.  We need to get the NIH’s priorities in line with those of the American people.”

Here are the grants that are targeted for de-funding through the Issa Amendment:

  • Substance Abuse Use and HIV Risk Among Thai Women (1R21 DA026324): The proposed collaboration study between Ms. Usaneya Perngparn, Chulalongkorn University, Thailand and Dr. Nemoto, Public Health Institute, California, will investigate the sociocultural contexts of HIV risk behaviors and drug use among Thai female and male-to-female transgender (kathoey) sex workers in Bangkok. Research is currently needed to develop and adapt HIV prevention models that take into account sociocultural factors so that the further transmission of HIV and sexually transmitted infections can be averted. Participation in these types of studies also can provide a way for persons suffering from the health consequences of illicit sexual activity to receive treatment while contributing to our knowledge of prevention and treatment outcomes in these populations.
  • HIV Prevention for Hospitalized Russian Alcoholics (5R01 AA016059): nvestigators are adapting a prevention approach that has been demonstrated to be effective in decreasing high-risk HIV related behaviors in the U.S. for use in Russia, a country with a rapidly expanding incidence of HIV.C2 The approach, called Health Relationships Intervention, involves the development of a plan of action for each client to increase social support and reduce high-risk behaviors. This includes the disclosure of information to family and friends on the client’s health, social needs and condition thereby assisting the client in maintaining low risk behaviors.
  • Venue-based HIV and Alcohol Use Risk Reduction Among Female Sex Workers in China (1R01 AA018090): Research has provided evidence linking alcohol-related, high risk sexual behavior with HIV and other sexually-transmitted infections. Research has also provided rich descriptions of social, cultural, and economic contexts in which people engage in alcohol-related sexual risk behaviors. More specifically, alcohol use characteristics (e.g., binge drinking) have been linked with sexual risk-taking that occurs in a range of high risk environments. The investigators have proposed a 5-year study to develop, implement, and evaluate a theory-guided, multiple components, and venue-based HIV and alcohol use risk reduction intervention among commercial sex workers (FSWs) in China.

As an NIH-funded researcher and a taxpayer (of quite a bit of tax), I’m very, very disturbed by this, and you as taxpayers should be too. Remember, these are grants that were submitted to the NIH for peer-review. Remember that the NIH peer-review process is the gold standard. Thousands of grant applications per year are evaluated by the study sections charged with reviewing them. In the last three or four years, thanks to the flat NIH budget, which, thanks to biomedical inflation (which is higher than the base rate of inflation), has led to an actual decrease in the purchasing power of the NIH budget allocated for research gratns, as few as 10% of these new applications have been funded, depending upon the Institute. This is a drastic decline compared to the five year time period (FY 1998 to 2003) during which the NIH budget doubled. In those halcyon times, up to 25% or even somewhat more of new grant applications were funded. What this means is that the three grants that Issa is trying to de-fund were considered the cream of the crop as far as HIV/AIDS prevention. They likely had to be at least in the top 15% of grant applications reviewed. What this means is that Representative Issa is intefering with science based on ideology, not because the grants above represent bad science.

Unfortunately, studies like this are easy to ridicule if taken out of context of the broader public health effort. As Dr. Andrew Tartarsky points out:

Given that HIV/AIDS is a global epidemic that has already killed more than 25 million men, women, and children and 33 million are currently living with HIV, it is clear that prevention of HIV infection should be a priority area of research funding.

The research is easy to ridicule if it is taken out of its public health context. The fact is, scientists need to explore a range of research avenues in vulnerable populations around the world to learn the best ways to control the transmission of HIV. In response to previous congressional concerns about whether sexual health research should be funded by the agency, NIH reviewed the entire NIH sexuality portfolio in 2004.

That investigation found that all of the NIH grants in areas of sexual health met the rigorous standards of scientific and ethical quality, that they were not funded out of proportion to the public health burden of these diseases, and that the merit review system had been followed.

Efforts by politicians like Rep. Issa to meddle in the peer review process and second guess NIH peer-reviewers represent a threat to science-based medicine every bit as profound as that of Sen. Harkin’s championing of pseudoscience. If Rep. Issa can force his ideology on the NIH (and let’s face it, this is almost certainly about conservative religious views more than anything else), then what’s to stop any other Representative (of which there are 435) or Senator (of which there are 100) from doing the same thing? Nothing. It’s also profoundly demoralizing to scientists, as Drugmonkey points out:

Great isn’t it? There you are, fighting to get your project funded, surmounting the usual procedural hurdles in the grant process. Finally, you get the grant funded and can get down to the business for which you are employed- doing good science in the interests of national, nay worldwide, public health. And some politician wants to prevent further funding of your project in the middle of the award period for naked political posturing purposes. Grand.

Grand indeed. There is a long history of various legislators trying to make political hay out of NIH- and NSF-funded grants that are easy to ridicule if you don’t know the science or the broader context of the research. It frequently involves studies of sexuality, too. For example, back in 2003, then Representative Pat Toomey (R-PA, who was also said to be planning to challenge Arlen Specter for his Pennsylvania Senate seat) tried to shut down NIH grants R01 HD043689 R03 HD039206, R01 DA013896, and R01 MH065871, all of which were focused on sexuality. (Surprise.) Fortunately, his efforts were shot down (narrowly, alas) and resulted in the formation of the Coalition to Protect Research, part of whose mission is to educate legislators on the importance of the peer review process. We can only hope that the horrible Issa Amendment is removed from the final bill passed after a House-Senate Conference Committee. You can help by contacting your Congressional Representatives to urge them to remove the Issa Amendment.

Finally, let’s not forget the late Senator William Proxmire’s (D-WI) Golden Fleece Award. Although the award often served to highlight truly wasteful government spending, all too often as collateral damage it targeted in a breathtakingly ignorant fashion scientific studies funded by various government agencies because they sounded funny to non-scientists. One researcher, after having received such an honor, went through a rather nasty ordeal:

This silliness went on for many years. The news stories began to swirl around like some kind of toxic cosmic dust. Senator Proxmire would return to Madison on a Sunday (to attend a Badgers’ football game); he’d take that opportunity to appear on a local TV show denouncing (sigh!) love research. I would be asked to reply. On Monday, one of Senator Proxmire’s comic writers would issue a devastatingly funny press release (inaccurate but beguiling) about the inanities of our love and sex research. By Tuesday morning, I’d be reeling from its aftershock. On Wednesday, the fallout would be settling in near Tokyo. Stories would appear in the Asahi Shimbun, Mainichi Shimbun, and Yomiuri Shimbun. A few weeks later, The Bangladeshi Standard‘s Geiger counters would be clicking out the news. Each time an editor in Japan, Bangladesh, or Mozambique translated the story, a name would get misspelled here, a word altered there, and the next thing you know, the Wisconsin State Journal would have picked up the challenge or comic riff yet again. The news story would be so altered and so sensationalized—by now, Dr. Hatfield, the mad doctor of love, would be caught slipping women dime bags of marijuana, asking students to confess their darkest secrets while both were doing God-knows-what in their bedrooms— that the Journal would assume that somehow they’d missed a heck of a story. Then once more the dust would start swirling around the earth, entering newer and higher orbits with each new news cycle.

I got to know the postman very well indeed as he dragged in mail by the bagful…Crazy persons’ letters, with blood curdling threats. Spiky letters, painstakingly, tremblingly constructed. Letters written in Day-Glo colors. Words marching in an orderly way across the top of the page, down the sides, and along the bottom, but then they began to sprawl in upon themselves, growing smaller and smaller as they whirled around the page. At the vortex, the microscopic calligraphy ended in a sinister inkblot. Letters filled with pain and suffering. Most people, of course, wanted to know how they could scam some of the US government’s “loot” for themselves. When they discovered they would have to dash off a grant—and actually get that grant reviewed—they were irate.

Imagine if the Internet had been as easily available in the 1970s as it is now.

I well remember in my youth hearing stories from Senator Proxmire of government-funded studies looking at bear sperm or some other equally ridiculous-sounding research (or so it seemed to me at the time). I’d chuckle and wonder just what those scientists were smoking. Now that I am a scientist, I realize just how toxic Senator Proxmire was when he targeted scientific studies. Fortunately, however, as far as I know Senator Proxmire never tried to insert himself directly into the NIH and NSF peer-review process by directly trying to stop one of these studies. These days, legislators are not content with just making political hay by issuing press releases and awards. They want to stop ongoing research projects.

When politicians impose their ideology on science-based policy

Then there’s Senator Harkin.

I’ve already gone on a bit of a rant about how Sen. Harkin wants to hijack President Obama’s health care reform initiative in order to let alternative medicine into the range of “services” funded by any new government health plan by hiding it in the Trojan horse of “prevention” and “healthy living” initiatives. Of course, Harkin and his fellow travelers co-opt diet and exercise, both of which are science-based interventions, as somehow being “alternative” and then use them as the “foot in the door” to introduce all sorts of other “alternative” medical modalities that represent themselves as being “prevention.”

Now, it appears, that Sen. Harkin has made his desire explicit, as described in an article that appeared in the Boston Globe on Friday:

Naturopathic doctors, herbal healers, mind-body specialists, and acupuncturists often have been scorned by the US medical establishment, but growing numbers of Americans are seeking such care, and now an influential group of US senators believes the time has come to embrace an array of alternative therapies.

Senator Tom Harkin, an Iowa Democrat who is a longtime supporter of nontraditional medicine, is at the forefront of the effort to win insurance coverage for such providers as part of national healthcare legislation.
“It’s time to end the discrimination against alternative healthcare practices,’’ Harkin said at a congressional hearing.

Harkin is the cosponsor of an amendment that says healthcare plans will not be allowed to “discriminate’’ against any healthcare provider who has a license issued by a state, an amendment Senate aides said was designed to provide coverage for alternative medicine.

Here’s the language that Sen. Harkin has slipped into the 615 page Senate version of the health care reform bill:

HEALTH PROFESSIONALS.—The term “health professionals” includes—

(A) dentists, dental hygienists, primary 25 care providers, specialty physicians, nurses, nurse practitioners, physician assistants, psychologists and other behavioral and mental health professionals, social workers, physical therapists, public health professionals, clinical pharmacists, allied health professionals, chiropractors, community health workers, school nurses, certified nurse midwives, podiatrists, licensed complementary and alternative medicine providers, and integrative health practitioners;

Such a tiny passage in a huge bill, yet it has potentially enormous consequences. If this part of the bill remains unchanged in whatever legislation makes it through Congress later this year then any “alternative health care provider” licensed by any state in the union will be entitled to compensation for his services from the government and health insurance companies.

What does this mean? Let’s consider some examples. Acupuncturists are licensed in 44 states; so in those states acupuncturists will be able to bill the government and insurance companies for their services. Naturopaths are licensed in 15 states; so in those states naturopaths will be able to bill for their services. Combine this with recent push by naturopaths to be considered “primary care physicians,” and you can see the potential disaster looming. Remember, naturopathy is the cornucopia of woo. Many of them include in their practice supplements, acupuncture, reiki, and even homeopathy, which is considered to be within the normal scope of naturopathic practice. To them it’s all good as long as it’s “alternative.” Now that I mention homeopathy, let’s not forget that some states actually license “homeopathic physicians,” states such as Arizona, Connecticut, and Nevada. If Harkin has his way, these homeopathic physicians will be able to bill the government and insurance plans for treating their patients with water. Of course, if this bill passes with Harkin’s amendment intact, you can then expect agitation by naturopaths and homeopaths in other states in which they are not licensed to set up licensure, so that they can equal their fellow woo practitioners fortunate enough to live in Arizona, Connecticut, or Nevada or the 14 states that license naturopaths. It would only be fair, right?

Politics as a threat to science-based medicine

In an ideal world, scientists and physicians wouldn’t have to worry about the intrusion of non-science-based ideology into the conduct of scientific research or science-based medicine. However, we do not live in an ideal world. Someone has to fund science, and in the U.S. one major funder of biomedical and other basic research is the federal government. Charities and philanthropic organizations also fund research, but their funding is nearly always targeted far more narrowly at the causes that are the raison d’être of individual organizations. Pharmaceutical companies also fund considerable research, but their priorities are profit-driven. In other words, if a given research project doesn’t have the potential to result in a marketable drug or product, pharmaceutical companies are highly unlikely to fund it.

Which brings us back to the federal government, where support for woo is bipartisan:

The two main sponsors of the Senate amendment were Harkin and Senator Barbara Mikulski, a Maryland Democrat. Republicans, including the ranking member on the Senate health committee, Senator Mike Enzi of Wyoming, also backed the amendment. The Senate committee on Health, Education, Labor and Pensions agreed to the measure, but it will be left to the Senate Finance Committee, which is working on companion legislation, to write crucial language regarding potential reimbursement, Senate aides said. The matter will then be debated on the Senate floor, and a similar amendment is expected to be offered in the House.

Moreover, the problem goes far beyond just biomedical science. Any endeavor of the federal government which contains a large component based on science is fair game, be it climate policy, the environment, the space program, or others. Worse, as is the case with these others, the forces arrayed against science-based medicine tend to be well-funded, more savvy politically, and certainly more motivated than scientists are. Sen. Harkin, for example, knows that few other legislators will understand the significance of the few lines he slipped into the healthcare reform bill and few of their constituents will understand or care. The same is true of Rep. Issa regarding his naked attempt to invalidate NIH peer review. Both also know that their fellow legislators are highly unlikely to hold up such huge bills and that the President is highly unlikely to veto them over such tiny amendments. Indeed, Sen. Harkin knows that health care reform is President Obama’s signature issue and that Obama desperately wants to pass a major health care reform bill before the end of the year.

Unfortunately, as distasteful as it is, if we as physicians and scientists, along with citizens who support science-based medicine, want to stop these sorts of attempts to impose ideology-based, rather than science-based, medicine upon health care reform, we’re going to get involved in the political process. We’re going to have to contact our Senators and Representatives and tell them that we don’t want them interfering in peer review of individual competitive scientific grants and that we don’t want our taxpayer dollars going to pay for quackery.

Posted in: Acupuncture, Chiropractic, Homeopathy, Politics and Regulation, Science and Medicine

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