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Congress will soon lose its foremost supporter of quackery, but will it matter?

I don’t much like Senator Tom Harkin (D-IA), and, I daresay, neither do any of my fellow bloggers here.

The reason should be painfully obvious. Arguably, no single elected official currently serving today (or ever) has done more over a longer period of time to promote quackery in the United States. I make this harsh assessment because Senator Harkin was the legislator who created the National Center for Complementary and Alternative Medicine (NCCAM) and has been its most powerful patron, promoter, and protector. It’s a center in the National Institutes of Health (NIH) of which we at this blog have regularly been quite critical, right from the very beginning, when I pointed out how our taxpayer dollars were being wasted on pseudoscience and quackery, while Wally Sampson provided some perspective on how this situation came to be and I gave a bit of history of NCCAM. Since then, we’ve been hammering away at NCCAM as a blight on the the science of the NIH, whether intramural or extramural.

Three years ago, we even managed to attract the notice of Josephine Briggs, the current director of NCCAM, who invited us to Bethesda for a meeting. It was a very cordial meeting, as described by Steve Novella and myself. Unfortunately, in the name of “balance,” Dr. Briggs turned right around and met with a bunch of homeopaths and then drew a false equivalency between us “skeptics” and proponents of quackery as represented by the homeopaths. Clearly, she didn’t get it, or, if she did get it, her position was such that she couldn’t bite the hand that feeds NCCAM. A year after that, NCCAM published a five year strategic plan, which I characterized as “let’s do some rigorous science for a change,” given that that’s about all it said. It’s a nice sentiment. We’ll see if it actually happens, although I doubt that it will. Although studying herbs is nothing but a form of pharmacognosy (natural products pharmacology) and studying lifestyle interventions is science-based medicine, neither of them are actually “CAM” per se, because there is nothing “alternative” about them other than their having been co-opted as a “foot in the door” grafted onto the more serious woo. Like a stray limb grafted onto Frankenstein’s monster, they don’t belong and don’t fit.

But I digress. NCCAM has that effect on me.

A Congressional champion of quackery decides to quack no more (after 2014, anyway)

It turns out that over the weekend, Senator Harkin announced that he will not seek a sixth term as a Senator:

U.S. Sen. Tom Harkin said Saturday he will not seek a sixth term in 2014, a decision that eases some of the burden the national Republican Party faces in retaking the Senate.

Harkin, chairman of an influential Senate committee, announced his decision during an interview with The Associated Press, saying the move could surprise some.

The 73-year-old cited his age — he would be 81 at the end of a sixth term — as a factor in the decision, saying it was time to pass the torch he has held for nearly 30 years, freeing a new generation of Iowa Democrats to seek higher office.

“I just think it’s time for me to step aside,” Harkin told the AP.

Harkin, first elected in 1984, ranks seventh in seniority and fourth among majority Democrats. He is chairman of the Health, Education, Labor and Pensions Committee, and chairman of the largest appropriations subcommittee.

So, after his 30 years in the Senate promoting quackery, after January 3, 2015 we at SBM won’t have Tom Harkin to kick around anymore. This comes hot on the heels of the retirement of the other biggest promoter of quackery in Congress, Representative Dan Burton (R-IN), who declined to run for re-election last year and went off into the sunset a few weeks ago when the new Congress was sworn in. He’s been a fairly frequent target of criticism, albeit less so than Tom Harkin, on this blog as well, in particular for his promotion of his antivaccine views, his defense of the supplement industry against the FDA, his key role in the the Dietary Supplement Caucus, and his role in instigating one of the most unethical, wasteful clinical trials of all time, the randomized trial of the Gonzalez therapy for pancreatic cancer, a trial that was not just negative but showed that patients undergoing the Gonzalez therapy actually did considerably worse than patients undergoing standard treatment.

The ironic thing about Tom Harkin is that, if you ask researchers and officials at the NIH, they’ll tell you that Harkin is a major supporter of the biomedical research in general and the NIH in particular. In addition, organizations like The Foundation for the National Institutes of Health, Research!America, and the Albert and Mary Lasker Foundation, and others from declaring Harkin a “champion of research.” For instance, the National Alliance on Mental Illness declared him a “champion of neuroscience research,” and an organization to which I belong, the American Association for Cancer Research, recently awarded him an AACR Award for Distinguished Service and Global Impact in Cancer and Biomedical Research. These are just the most recent awards and recognitions of many over the years. While it’s true that Harkin seems a strong supporter of the NIH on the surface, at the same time he is a corrosive influence, inserting his belief in CAM (or, as it’s increasingly being called, “integrative medicine”) into the NIH and pushing to promote it. Losing him is not going to be an unalloyed good in that the NIH and biomedical research will lose a champion just as much as the quacks will.

Harkin and Herbalife: Two great woos that woo great together

The question, of course, is: Why now? Why is Harkin retiring now? Sure, it might have something to do with his stated reasons. He might be tired. He’d be 81 at the end of another term, and maybe he wants to relax. On the other hand, the history of the Senate is replete with octogenarians and nonagenarians like Strom Thurmond and Frank Lautenberg serving until they’re carried out feet first. Compared to them, Harkin is a mere pup. He could potentially serve another two terms at least, given the propensity of senators to keep legislating until they drop.

Maybe this story, published around the same time as Harkin’s announcement, might at least partially explain his puzzling decision. Basically, it’s the story of how Senator Harkin has been the biggest patron of Herbalife, so much so that the title of the story refers to Harkin as “(D-Herbalife):

Harkin has served as Herbalife’s chief patron in the federal government for decades. Harkin attended the company’s “New Orleans Extravaganza” in June 2002 to speak to Herbalife officials and distributors about “the status of preventative healthcare in the U.S.” Harkin also spoke at the company’s 25th Anniversary “Atlanta Extravaganza” in April 2005. “Il Senatore Tom Arkins” addressed a confab of some 35,000 Herbalife consultants about a bill he sponsored to make “good nutrition available to everyone,” according to an English translation of a report from Leonardo di Paola, an Italian Herbalife distributor.

An interview of Harkin in Herbalife’s internal newsletter illustrates the symbiotic relationship.

Indeed it does. In the interview, Harkin expresses pride for having been one of the chief architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994. This law, which is about as bad a law as you can imagine, basically gives supplement manufacturers a nearly free pass in marketing and selling their supplements. As long as they don’t make specific health claims for their supplements, they can sell practically anything, or, as Peter Lipson put it, “sell whatever you want, just don’t let us catch you.”

As for Harkin’s relationship with Herbalife, let’s just say that it’s been longstanding and mutually profitable. Harkin gets campaign cash (Herbalife has been Harkin’s top donor for many years now) and now gets cash for his new policy institute, while Herbalife gets legislation favorable to its interests (such as the DSHEA) and a champion in Congress in the form of a very senior senator who has a history of fighting tooth and nail against any attempt to pass laws imposing meaningful science-based regulations on the supplement industry while trying his best to insert coverage for CAM therapies in the 2009 Patient Protection and Affordable Care Act (PPACA). It also gets quality face time with the Senator, as described in the story in The Iowa Republican:

In the summer of 2011, when most Hawkeye State politicians spent sweaty sessions with constituents in Iowa’s communities, Sen. Tom Harkin (D-Iowa) sat down to a steak dinner with a team of corporate lobbyists and executives in Beverly Hills, Calif.

Harkin, along with Jeremy Gold, the finance director for his 2014 Senate campaign, met Herbalife International executives at the Four Seasons Hotel at 8 p.m. on Aug. 16. Before Harkin’s rendezvous with Herbalife’s high command, he took a meeting with Hollywood mogul and Democratic donor Steve Bing, according to Harkin’s official schedule, which was provided to TheIowaRepublican.com by a source in Harkin’s Washington, D.C. office.

After Harkin’s meeting with Bing, whose company donated $250,000 to Majority PAC, Senate Democrats’ so-called super PAC, he met with Herbalife executives—CEO Michael Johnson, chief legal officer Brett Chapman and chief lobbyist John Venardos. The fivesome dined at CUT Restaurant, the “classic steakhouse” designed by chef Wolfgang Puck, where a steak can set you back $160. The “chic spot in the heart of Beverly Hills… has become the place to see and be seen,” according to CUT’s website.

Harkin and Herbalife officials chatted about America’s obesity epidemic, which Herbalife aims to combat with its line of weight-loss products, and Federal Drug Administration regulations, Venardos said. The 32-year-old company sells its products through independent distributors in more than 80 countries.

In Oct. 2011, two months after the swank supper, Venardos pledged $100,000 on behalf of Herbalife to the Harkin Institute of Public Policy at Iowa State University in Ames. He is the company’s senior vice president of worldwide regulatory, government and industry affairs, but he is not registered as a federal lobbyist (he terminated his registration in 2007).

The wag in me can’t help but note that this meeting among “natural health” advocates didn’t take place in a vegan—or even vegetarian—restaurant, but in a steakhouse, and a very expensive and swanky one at that. I suppose that those Herbalife products must protect very well against the health consequences of eating all that fatty red meat. In any case, given Harkin’s advocacy of positions beneficial to Herbalife, it’s not surprising that the company would see value in not just donating to his campaign but in donating to his policy institute as well.

It’s been noted that this arrangement is not illegal. It does, however, understandably raise ethical issues, as it’s obviously a method by which a donor can further ingratiate himself with a legislator. As a representative for the Center for Responsive Politics put it, an institute named after a politician “helps to cement the lawmaker’s image as a substantial person,” and donations to the institute help bolster the institute’s strength and visibility.

Also more than a bit fishy is the way this institute came into being. It turns out that Harkin’s wife sits on the Iowa Board of Regents, which created and oversees the Harkin Institute of Public Policy, which will be housed at Iowa State University in Ames. It further turns out that Harkin’s wife appears to have used her influence to bypass opposition:

The Harkin Institute has been dogged by controversy since its inception.

Mrs. Harkin rushed the institute’s approval through the Iowa Board of Regents in April 2011 before two of the senator’s allies on the board rotated off. She excluded two “conservative Republicans” from internal board discussions about the institute, according to current board president Craig Lang, because they might not have supported the institute.

And:

The Iowa Board of Regents voted to prohibit future institutes from being named after an active politician after it approved the Harkin Institute.

Which strikes me as a good idea. Otherwise, powerful politicians with connections on the Board of Regents might use that influence to create such policy institutes. Oh, wait. That’s what the Harkins did. Too bad such a policy wasn’t in place two years ago.

Whither NCCAM (and Senator Harkin)?

The shenanigans that produced the Harkin Institute and the further shenanigans that led Herbalife to donate to it aside, I must admit that I was pleasantly surprised by a detailed description of how Harkin drove the creation of NCCAM:

In 1992, Harkin appropriated $2 million to establish the Office of Unconventional Medicine, which was later renamed the Office of Alternative Medicine. At a congressional hearing, Harkin claimed that bee pollen cured his allergies, according to a report by Stanford University emeritus professor of medicine Wallace Sampson. Harkin appropriated $200,000 to Royden Brown, who sold Harkin the bee pollen, to study the remedy, according to “Natural Causes: death, lies and politics in America’s vitamin and herbal supplement industry,” a book by journalist Dan Hurley. Roydon was later fined the same amount ($200,000) by the Federal Trade Commission for making false claims. Harkin then blasted OAM for its science-based research guidelines, which he described as “the unbendable rules of randomized clinical trials.” Harkin packed OAM’s council with his cronies, such as a travel agent from the Bahamas, where Harkin owns a vacation home.

When then-NIH director Harold Varmus tried to place stricter scientific research standards on the agency, Harkin changed the agency’s status so it would no longer have to answer to NIH and increased its appropriations to $104 million per year by 2002, an increase of 5,130 percent in ten years. In fiscal year 2012, it’s budget was $128 million, a 22 percent increase from 2002.

And so it continues. NCCAM is basically untouchable, thanks to its powerful patron. Any move by an NCCAM director to try to increase the scientific rigor of the center is virtually guaranteed to provoke a rebuke from Senator Harkin, with the implicit threat being that Harkin can easily seek (and get) the removal of an NCCAM director who pursues research or policy changes he doesn’t like. After all, when Harold Varmus ran the NIH and tried to rein in NCCAM, holding it to tighter scientific standards, Harkin’s showed him.

Another important thing to remember is that NCCAM was not created in response to a perceived scientific need or public demand. It was not, as I have said before, the result of a groundswell of support among physicians and scientists who saw all this quackery out there and said, “Hey, we really ought to study homeopathy (or reiki, or therapeutic touch [or: INSERT FAVORITE QUACKERY HERE]) to see if there’s anything to it.” Instead, NCCAM was created primarily through the effort of a single person, Senator Tom Harkin, a woo-friendly legislator who believed that bee pollen had somehow cured his allergies. It’s worth fleshing out yet again the historical background of NCCAM in the above article documenting Harkin’s Herbalife connections.

NCCAM, as befits the subject matter to which it is dedicated, is a bizarre beast. Ostensibly charged with the rigorous investigation of modalities considered “alternative,” NCCAM all too often applies state of the art science to what is at its heart, prescientific mysticism, such as various “energy healing” techniques, acupuncture, and even homeopathy, a practice that Harriet Hall once aptly dubbed “Tooth Fairy science.” As was pointed out above, it was Harkin who first assigned $2 million of his discretionary funds to establish the Office of Unconventional Medicine in 1992. The OUM was soon renamed the Office of Alternative Medicine (OAM). Then, as detailed in Wally Sampson’s classic article Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded, the first director of OAM resigned under Senator Harkin’s pressure because he quite properly objected to nominees to the OAM Council who had been involved in Laetrile and Mexican cancer clinic scams. In 1998, then NIH Director Harold Varmus tried to bring the OAM under tighter NIH scientific control to make its studies more rigorous and was stymied when Harkin introduced legislation to elevate OAM to an independent Center.

Although it’s been discussed on multiple occasions on this blog, it’s worth repeating any time the topic of NCCAM comes up, NCCAM is constituted so that even its director is hamstrung in what she can do. The reason is that charter of the National Advisory Council for Complementary and Alternative Medicine (NACCAM), the committee that oversees NCCAM’s activities, requires that council members be chosen from practitioners and “leaders” in the CAM field, for instance a former president of the American Association of Naturopathic Physicians. In other words, true believers control the agenda, and it is difficult for even scientifically inclined NCCAM directors like Dr. Briggs and her predecessor Dr. Stephen Strauss to keep NCCAM from wasting precious grant money investigating the more ludicrous and implausible CAM “therapies” out there–like reiki or homeopathy. The bottom line is that by design there just isn’t that much an NCCAM director can do to change the way NCCAM operates, at least in terms of how it awards its grants and how it disburses its training grant money. Caught between the Scylla of scientists and physicians practicing science-based medicine and the Charybdis of her alt-med constituency, led by her center’s powerful Congressional patron, Dr. Briggs (or any NCCAM director who wants to support decent science) really is in a virtually no-win situation. All of this is due largely to Senator Harkin.

NCCAM history makes the allegations about the relationship between Senator Harkin and Herbalife all the more interesting, because if there’s one constant about NCCAM it’s that, in addition to the research it funds, NCCAM also funds “educational” programs that promote unscientific practices and, in particular, supplements. There’s a reason why the supplement industry in general (and Herbalife in particular) love Tom Harkin, and it’s not because they think he’s such a nice guy. It’s because Harkin fights for causes they believe in, namely laws like the DSHEA that hamstring the FDA, preventing it from interfering too much with the business of selling supplements with a “wink, wink, nudge, nudge” about the many health claims that are made to sell them, all with the not-so-plausible deniability of the Quack Miranda Warning that’s so ubiquitous on the websites and in the literature used by supplement manufacturers to sell their wares. It’s because Harkin is a true believer. Indeed, my favorite quote of all time from him about NCCAM demonstrates this quite nicely:

One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.

Clearly, Harkin doesn’t understand the nature of science, which involves trying to falsify hypotheses. To him, NCCAM was (and is) clearly intended as a vehicle to produce studies that support the unscientific treatments he believes in. I suppose I should take comfort in Senator Harkin’s bitter disappointment that NCCAM hasn’t validated any of the quackery it studies, even after a couple of billion dollars and 20 years. It’s not for lack of trying, though.

In any case, given the integral nature of the relationship between Harkin and NCCAM, the natural question in wake of Harkin’s announcement is: Whither NCCAM? What will happen in a little less than two years, when NCCAM’s most powerful champion retires, riding off into the sunset to his policy institute and, very likely, a position on the Herbalife board of directors? One also has to wonder whether Harkin will try to do some mischief before he leaves, much as Representative Dan Burton did with his one last antivaccine hurrah in November.

The question as I see it is whether there will be a window beginning in 2015 when there is a possibility that NCCAM might actually be dismantled. After all, two of the most powerful supporters of NCCAM (Representative Dan Burton and Senator Tom Harkin) will be gone from Congress. That just leaves Senator Orrin Hatch (R-UT), who, as I’ve documented before, is a huge champion of the supplement industry. There’s also Representative Jason Chaffetz (R-UT), who is, not surprisingly, also from Utah, which is the capital of the supplement industry in the U.S. He’s a former supplement company executive turned U.S. Representative and co-chair of the Dietary Supplement Caucus. Then there’s Darrell Issa (R-CA), who is known for attacking the NIH for funding studies he doesn’t like. Would it be possible to dismantle NCCAM in the wake of Harkin’s departure?

Alas, I have to conclude: Probably not. While the retirement of Senator Harkin will leave a huge hole in Congressional support for NCCAM, given that he has defended and nurtured it for 20 years and neither Orrin Hatch, Darrell Issa, Jason Chaffetz, nor any other members of the supplement caucus seems particularly interested in NCCAM, except as a political tool, the other side of the equation is lacking. There appears to be no one in Congress with the “fire in the belly” for science-based medicine willing to do what it would take to dismantle NCCAM and distribute its component parts back to the appropriate institutes and centers of the NIH that could do the job better. On the other hand, perhaps in these days of budgetary concerns and deficit reduction, maybe the case could be made that wasting $125 million or so a year to study fairy dust is not an expenditure that the government should be making when that money would do so much more good funding the rest of the NIH.

A guy can hope, can’t he?

Posted in: Politics and Regulation

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