Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short

This morning NIH Director Dr. Francis Collins announced revisions to the existing 1995 regulations on objectivity in research that is funded by the Public Health Service. The focus is on significant financial interests (SFI) and on financial conflicts of interest (FCOI). The regulations illustrate the 3-way dance involving academic institutions (the grantees), NIH (the grantor) and academic scientists (the investigators). Thanks to Senator Grassley (R-Iowa) and his investigator Paul Thacker, headlined revelations in recent years about unacceptable management of FCOI at places like Stanford (Alan Schatzberg), Emory (Charles Nemeroff) and Harvard (Joseph Biederman) forced these revisions of the NIH regulations.

The general initial reaction to the new rules has been critical – here and here, for instance. Many stakeholders had urged the NIH to require that institutions make the disclosed FCOI of their investigators available on a public website. Dr. Collins had intimated that we could expect to see this change, so there is consternation that it somehow became derailed by institutional lobbying in recent months. The stated concern was that institutions would feel burdened by the need to maintain these data bases. Instead, if citizens wish to inquire about FCOI involving PHS-derived research funding, they will need to write to the institution, which is obliged to respond within 5 days. That’s not exactly user friendly. POGO today made the smart suggestion that the data could easily be attached to information about awarded funds on the NIH RePORTER website, that already exists.

A second failing is that the revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident several times on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees.

Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated. Here is the relevant section of today’s announcement (page 89):

We did, however, agree with one respondent that it would be helpful to clarify, in the grants context in particular, that institutional sanctions against an Investigator can travel with the Investigator upon his or her transfer to another Institution. Specifically, we have revised 42 CFR 50.606, paragraph (a), as follows: “If the failure of an Investigator to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. The PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.”

This revision is intended to reference the range of options for the PHS Awarding Component to consider, depending on the specific circumstances at issue. For example, PHS may decide to initiate government-wide suspension or debarment of the Investigator under 2 CFR Part 376; or to use enforcement measures under 45 CFR 74.62, e.g., perhaps to make the approval of a transfer contingent upon the former Institution’s disclosure of the corrective action- including the specific sanctions against the Investigator- to the new Institution; and/or to use special award conditions under 45 CFR 74.14, e.g., perhaps to make the new Institution agree to take the same or similar action against that Investigator or explain to the PHS Awarding Component in writing why such action was not taken and what alternative measures will be used to ensure compliance.

What’s wrong here? Everything is optional; everything is discretionary; everything is contextual – that is a formula for NIH and the academic institutions to just look the other way. And if a Nemeroff decides just to relocate without transferring a grant then he is free to start reapplying again right away. Miami would not be required to continue applying the Emory sanction banning him for 2 years from involvement in federal grants. The PHS Awarding Component (NIMH in this case) may or may not get involved, or it may pass the buck to the new institution. So what has changed? If it is left up to compromised federal bureaucrats like Thomas Insel, and institutional administrators like Pascal Goldschmidt at Miami, then nothing has changed. It's business as usual, folks.

Dr. Collins, you have not done what you set out to do. Too bad.

BUY IT NOW!

Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off

After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs.

Weakening FDA Conflict of Interest Rules

As reported by Reuters,

U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts.

Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.

This was not purely an initiative of legislators, but was egged on by a top FDA administrator

The agency often must delay panel meetings while it searches for experts without conflicts, lawmakers and FDA officials say. Top doctors are usually the ones drugmakers hire as speakers or consultants.

'We have had difficulty in recruiting highly qualified people. And we've had delays in having panels because of this,' Dr. Janet Woodcock, head of the FDA's drugs center, told a House of Representatives hearing earlier this month.

The result is that 23 percent of FDA advisory panels have vacancies, more than double the agency's stated goal, according to the FDA's quarterly report at the end of May.

The rationale was that those paid by drug and device companies are the most expert:

The FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view, partly inspired by the scandal with Merck's pain reliever Vioxx.

Ten of the 32 panelists advising the FDA on the drug consulted for drugmakers. Nine of the 10 recommended putting the drug back on the market after it was pulled in 2004 over concerns about heart risk.

The restrictions go too far, say lawmakers who want the FDA to approve more new medicines, in part because they promote American jobs.

'No longer can we deny experts simply because they have ties to industry,' said Georgia Representative Phil Gingrey during a House of Representative hearing on FDA funding last month. The committee's chairman, Fred Upton from Michigan, called the conflict of interest rules 'rigid and unrealistic.'

Industry executives, who want the FDA to speed drug approvals, also support relaxing the rules. Biogen Idec CEO George Scangos said the guidelines 'exclude a lot of people who would be the best qualified.'

Of course, the drug and device companies have been touting their paid "key opinion leaders" as the best and the brightest for a long time. There is plenty of evidence, however, that they are mainly those whom those companies find the most compliant, and in many cases, those who are willing to be stealth marketers on those companies' payrolls. (See this post about those who recruit KOLs regarding them as salesmen, and more here.)  "Key opinion leaders" supported by commercial grant funding may seem like experts to academic medical institutions' leadership who now value outside funding more than teaching and research excellence (see this post).

Furthermore, as reported by Politco, the Project on Government Oversight, a watchdog group, chastised FDA leadership for exaggerating the difficulty of finding unconflicted experts, concluding in their letter to the FDA Commissioner, "to gain the public trust, we must ensure that the FDA relies on the best available information for its policies, rather than personal opinions and biases."

So far, government officials seem to be more worried about the opinions of corporate leaders than the public trust.

Weakening NIH Conflict of Interest

As discussed in Nature,

Francis Collins hailed it as a 'new era of clarity and transparency in the management of financial conflicts of interest' (S. J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400–2402; 2010). But the director of the US National Institutes of Health (NIH) may have spoken too soon when he described a new rule, proposed last year, that would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers.

Nature has learned that a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped.

In more detail,

The NIH's parent agency, the Department of Health and Human Services (DHHS), proposed the new rule in May 2010, after congressional and media investigations revealed that prominent NIH grant recipients had failed to tell their universities or medical schools about lucrative payments from companies that may have influenced their government-funded research. The DHHS called the proposed websites 'an important and significant new requirement to … underscore our commitment to fostering transparency, accountability, and public trust'. Under the proposal, institutions with NIH-funded researchers would determine, grant by grant, if any financial conflicts existed for senior scientists on the grant. For example, these would include receiving consultancy fees, or holding shares in a company, 'that could directly and significantly affect the design, conduct, or reporting' of the research. The institutions would post the details online, where they would stay for at least five years.

But of course the medical schools decided that it would just be too much trouble to do all this:

'The websites don't appear out of nowhere,' says Heather Pierce, senior director of science policy at the Association of American Medical Colleges (AAMC) in Washington DC. They would 'require employees to not only create the website but to pull the information, review it, and make sure it is up to date and accurate'.

That is not the only objection from the powerful academic lobbies. During the public comment period last summer, the Association of American Universities and the AAMC submitted a joint statement saying: 'There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed.'

Given how academic medical institutions have expanded their administrations and bureaucracy, the enormous amounts they spend on management, and the huge compensation they give their executives, and further given how much of their revenues come from government sources (Medicare, Medicaid money for patient care, Veterans Administration money supporting many faculty members, Medicare money funding graduate medical education, and NIH and other government research grants), the notion that getting a few staffers to process disclosures would be administratively or financially burdensome is just laughable.

At least Iowa's Republican Senator Charles Grassley, seemingly one of the last politicians in Washington who cares about the integrity of government programs and spending, is upset. As reported again by Nature,

The US Senate's leading advocate for government transparency wrote today to the White House's budget office, demanding that it protect a proposed rule that would obligate universities to post their publicly-funded biomedical researchers' financial conflicts on a publicly accessible website.

'The public's business should be public... I urge OMB to follow through and approve a rule that includes a publicly available website,' Senator Charles Grassley, Republican of Iowa ..., wrote in in this letter to Jacob Lew, the director of the White House's Office of Management and Budget (OMB).

Furthermore, he wrote:

I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama's call for more transparency in the government.

We will see if his protest does any good, but again it appears that government officials are more worried about the revenues of big health care organizations than the needs of the public.

Retreating from Threats to Disbar Forest Laboratories CEO

We previously posted about how the US Department of Health and Human Services threatened to disbar the CEO of Forrest Laboratories from dealings with the government after his company pleaded guilty to obstruction of justice and misbranding, and paid a $313 million fine.

Now, per Alicia Mundy writing for the Wall Street Journal, things have changed:

The U.S. government dropped efforts to force the resignation of a prominent pharmaceutical-company chief executive, reversing course after protests from the company and major business groups.

The about-face on Forest Laboratories's longtime leader, Howard Solomon, represents a significant retreat by the Department of Health and Human Services, which has said it wants to step up punishments against drug-company executives when wrongdoing happens on their watch.

Forest agreed last year to plead guilty to misdemeanors involving marketing of its drugs including the antidepressant Celexa, and it paid $313 million to resolve the matter.

Mr. Solomon wasn't personally accused of any wrongdoing. Nonetheless, the government notified him in April that it was considering excluding him from jobs at health-care companies that sell to the U.S. government. It invoked a little-used clause in the Social Security Act that allows such an action against corporate leaders of companies found guilty of criminal misconduct, even if the leaders had no knowledge of the misconduct.

The exclusion move would have effectively forced Forest to remove Mr. Solomon from office, because Forest and other drug companies rely on business from U.S. government agencies such as Medicare and the Veterans Administration.

In a letter to Mr. Solomon on Friday, the office of the inspector general of the Department of Health and Human Services said, 'Based on a review of information in our file, and consideration of the information your attorneys provided to us both in writing and in an in-person meeting, we have decided to close this case.'

We have discussed - some might say endlessly - how despite numerous publicly reported cases of wrongdoing by health care organizations, hardly any individual who authorized, directed or implemented the bad behavior has ever faced any negative consequences. There have been recent fulminations by some government officials that this is going to change. The case of the Forest Laboratories CEO appeared to be an example of such change, but no more.

The Wall Street Journal went on to discuss why the government may have changed course:

The government's retreat came after a barrage of complaints from Forest and business groups including the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, the drug industry's leading trade group.

In July, Forest spent $80,000 to hire former Louisiana Sen. John Breaux to lobby the government regarding exclusion, according to Senate records. Mr. Breaux didn't return a call requesting comment. Forest said earlier that it was just trying to make its case that this was a highly unusual action by the U.S. government.

Of course it was unusual. That is the whole problem.

In any case, it looked like the government was much more concerned about the coddling of corporate CEOs and their lobbyists' and cronies' opinions than about deterring bad behavior by large health care organizations.

Summary

After a bit of blustering by the current US administration about transparency and integrity it appears to be back to business as usual in the US capital. Over the last 20 years, government has increasingly answered to corporate CEOs instead of "we, the people." Protecting patients' and the public's health has given way to protecting the financial health of large health care organizations, and the compensation of rich CEOs. Federalism is giving way to corporatism. As long as this continues, expect our health care system to continue its slow collapse. Eventually, expect the CEOs to get in their private jets and escape while the rest of us picks up the pieces.

Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate CEOs.

See also comments by Alison Bass.

BUY IT NOW!

Former NIH Director Spins Through Revolving Door, Ends Up at Sanofi-Aventis

A bit of news that got little attention this month was a new job for the former head of the US National Institutes of Health (NIH).  Dr Elias Zerhouni had left the NIH in October, 2008.  Here is the Reuters version of the story of his hew career:

French drugmaker Sanofi-Aventis (SASY.PA) replaced its head of research and development with a leading academic and former top U.S. health official on Tuesday to raise its game in medical innovations.

The company said Elias Zerhouni would lead R&D of drugs and bring R&D for vaccines under his control too as Sanofi reshapes its portfolio and looks to vaccines as one area for growth to offset sales losses from mounting generic competition.

The appointment of Zerhouni, a professor of radiology and biomedical engineering, comes as Sanofi battles to buy U.S. rare disease specialist Genzyme.

Chief executive Chris Viehbacher brought in Zerhouni in February 2009 as his scientific adviser, shortly after taking charge of the group which he has been transforming to include the development of drugs based on biotechnology.

Zerhouni's Embrace of Corporate Health Care

Although Zerhouni ostensibly left the NIH to return to academia at Johns Hopkins University, note that by February, 2009, four months after his resignation was announced, Zerhouni was already advising the Sanofi CEO. 

Soon after he joined the corporate health care world in earnest.  In April, 2009, he was proposed for membership on the board of directors of Actelion Ltd, a Swiss biotechnology company.  On December 8, 2009, he was elected to the board of Danaher Corp, a diversified technology corporation which makes medical devices.  At some time he had become President of the Zerhouni Group, which advertised itself as a resource to "pharmaceutical and biotechnology companies, trade organizations, sovereign wealth funds, government agencies, and research entities around the globe."

Zerhouni at the NIH: His Response to the Conflict of Interest Scandal

There is more than a little irony inspired by Zerhouni's quick circuit through the revolving door.

Zerhouni became director of the NIH in 2002, and announced his departure in October, 2008. In December, 2003, David Willman published his landmark article in the Los Angeles Times on severe conflicts of interest affecting NIH scientists and leaders.  It revealed that formerly stringent conflict of interest policies at the Institutes were rescinded by then director Dr Harold Varmus in 1995, during the Clinton administration, and increasingly since 1998, disclosure of NIH personnel's conflicts of interest had been reduced.  Thus, in 2002, Zerhouni had taken charge of an agency already deeply affected by conflicts of interest affecting many of its leaders, even though that was not yet public.  He initially did nothing about the situation. 

Willman published another series of articles revealing even more breathtaking conflicts of interest in December, 2004.  (See our post here.)   By then, a Los Angeles Times editorial said there was the "appearance of corruption" at the NIH, and called for Dr Zerhouni's resignation. 

Only after the second series of articles did Dr Zerhouni swing into action (see post here).  In February, 2005, he announced that he would now hold the NIH to a "higher standard."  Yet new conflict of interest stories kept surfacing and their handling kept provoking concern (e.g., see this post from 2007, and this post from 2008), and concerns about how NIH deals with conflicts of interest affecting the extramural researchers it funds persist to this day (e.g., see this post). 

By the late 1990s, the NIH, like many other government agencies, seemed to have become extremely cozy with the world of big corporations.  Dr Zerhouni did nothing to obvious to reduce the local version of this coziness until it had become a public scandal.  His actions let questions about the relationships of the NIH, once a pristine example of a government run biomedical research agency, with big health care business persist to this day. 

So it should perhaps be no surprise that he so quickly transitioned from the government that is supposed to be"of the people, by the people, for the people" to top leadership positions in corporate health care.

Other US Government Health Care Agency Leaders Transit the Revolving Door

Meanwhile, the previous commissioner of the US Food and Drug Administration, Dr Andrew von Eschenbach, is Senior Director for Strategic Initiatives at the Center for Health Transformation, a group whose membership includes some of the biggest health care organizations, many of which have had their own moments in the sun on Health Care Renewal.  For example, see Charter Members, AstraZeneca, Sutter Health, and Wellpoint; and Platinum Members, GlaxoSmithKline and Merck.  Dr Eschenbach is also on the board of directors of Histosonics Inc. 

Also, the previous director of the Centers for Disease Control, Dr Julie Geberding, became President of Merck Vaccines in late 2009. 

Conclusions

So the revolving door just keeps spinning, its revolutions suggesting how closely tied together big government and big corporations have become in what is now the health care business.  Whatever the motivations of Doctors Zerhouni, von Eschenbach, and Geberding were, the message to every person in a leadership position in health care in the US government has to still be: you too can earn big corporate compensation soon after you leave here.  Who knows how much that siren song will lead current government leaders to avoid antagonizing the leaders of big health care corporations during their government "service."  That is, of course, not what we want them to be thinking about if government agencies ae to serve the people, not the CEOs of big corporations. 

I am sure that the career transitions of Doctors Zerhouni, von Eschenbach, and Geberding were perfectly legal.  If we want government health care agencies to put the peoples' interests ahead of those of the CEOs of big health care corporations, should not, however, the law be changed to at least slow down the revolving door?

BUY IT NOW!

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR

What a difference a month makes. When I went on vacation in June the Director of NIMH, Thomas Insel, was stonewalling about his relationship with Charles Nemeroff. Insel wanted to put distance between himself and the poster boy for conflict of interest in academic medicine. The heat was on Insel because of revelations that he helped Nemeroff get a new position at Miami after his fall from grace at Emory. Insel also gave a green light for Nemeroff to reapply for NIMH grant funding, and he appointed Nemeroff to new research review committees. These actions were widely seen as efforts to help Nemeroff get back into circulation. It didn’t help that people called attention to past favors and lobbying by Nemeroff on behalf of Insel.

Things continued to unravel, and on about June 29 Insel placed a disclaimer on his official blog. Insel here allowed that his earlier official statements “may be viewed as misleading.” This softening of Insel’s position was picked up June 29 by the Chronicle of Higher Education. Not only was Insel’s disclaimer on his official weblog undated, it is mealy mouthed and it was widely criticized – here and here, for instance – as further evidence of Insel’s disingenuousness.

By July 7 we learned of further revisions to Insel’s position. In response to pressure from Senator Charles Grassley (R-Iowa), Insel issued a mea culpa in which he agreed that Nemeroff’s actions constituted “an egregious violation of NIH policy and University rules.” Insel also acknowledged that his willingness to help Nemeroff “may have created the appearance of favoritism. In retrospect, I regret that my actions… appear inappropriate for a Federal research official given my past association with Dr. Nemeroff.” This new statement also was raked over as further evidence of Insel’s dissembling – see here and here and here.

Nowhere in Insel’s new self serving statements is there any apology for his ill advised appointment of Nemeroff to new Federal research review panels. This signals once again that Insel just doesn’t get it when it comes to his crony Nemeroff. It is not in the job description of an NIH Institute Director to taint research review panels with compromised and sanctioned scientists.

Keep in mind that the appearance of malfeasance and impropriety most often occurs in the presence of malfeasance and impropriety. That is a standard Bayesian proposition that Insel seems not to grasp.

In light of these developments, who can take seriously the work Dr. Insel says he has done to develop a new NIH initiative on ethics? The leadership of NIH tacitly acknowledged this problem when they recently extended the period of comment on the new ethics proposals. This was done specifically to mend the regulatory hole that Insel and his crony Nemeroff walked through when Insel assured Pascal Goldschmidt at Miami that Nemeroff could go right ahead to apply for new NIMH funding. Left to his own initiative, Insel kept the hole wide open. His July 7 statement to Senator Grassley that "I do not condone the gap in our policy that allowed (Nemeroff) to avoid the penalty implemented by Emory by moving to another university…” rings hollow: actions speak louder than words, and Insel had many months in which he could have closed the gap before the present scandal surfaced.

How much longer can NIH tolerate an ethical prevaricator as an Institute Director?

Bernard Carroll

BUY IT NOW!

Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D.
Director, National Center for Complementary and Alternative Medicine

Dear Dr. Briggs,

As you know, we've met twice. The first time was at the Yale "Integrative Medicine" Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of having to appear 'open-minded' about nonsense.

More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you'll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group---whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they're "part of your education," as my 91 y.o. mother used to say to me):

Naturopathy: A Critical Appraisal

Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth

The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one.

Thus the second article inevitably became the crash course---call it CAM for Smarties---that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents' inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous 'research' (funded---unwittingly, I'm sure---by the NCCAM), bait-and-switch labeling of rational methods as "CAM," vacuous assertions about 'toxins' and "curing the underlying cause, not just suppressing the symptoms," anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more.

Please excuse me if this sounds preachy; I admit that it does, but understand that I'm writing in good faith. My own views of "CAM" did not dawn on me overnight, but were the result of years of research. My 'internship,' as it were, consisted of sitting on a state commission from the fall of 2000 until the spring of 2002, listening to AANP members (including at least one with whom you will share the podium), reading about 'naturopathic medicine,' and attempting (unsuccessfully) to engage its advocates in rational discussion. I began that task open to forming opinions based on whatever information became available; by its end it had become abundantly clear that the group is best characterized as a pseudoscientific cult, and nothing since has altered that opinion.

Regarding your presence at the convention being tantamount to an endorsement of 'naturopathic medicine,' this is so obviously true that it ought not be necessary to mention it. Previous experience, however, has taught me to expect an air of---please don't take this personally---utter cluelessness whenever I've raised such an issue. If you've read the second naturopathy article linked above, you already know that according to proponents,

The validity of naturopathic medicine is demonstrated by its support in government (including accreditation of its schools and NIH-funded research), on medical school Web sites, and in other parts of the public domain.

An appearance at their annual convention by the most important "CAM" administrator at the NIH surely has the political arm of the AANP licking its chops. NDs, as they call themselves, are currently licensed in 14 or 15 states and a couple of provinces, and aggressively seek licensure throughout the U.S. and Canada. They appear to wield political clout well out of proportion to their numbers, no doubt thanks in part to the legislative language that created the NCCAM's National Advisory Council for Complementary and Alternative Medicine (NACCAM):

Of the 18 appointed members...Nine...shall be practitioners licensed in one or more of the major systems with which the Center is involved. Six of the members shall be appointed by the Secretary from the general public and shall include leaders in the fields of public policy, law, health policy, economics, and management. Three of the six shall represent the interests of individual consumers of complementary and alternative medicine.

Thus there have been 1-3 NDs on the NACCAM since its inception in 1999, although their numbers in general are, by any measure, miniscule: I reckoned there were about 2500 in the U.S. in 2003; the AANP now places that number at 6000. By comparison, there are about 800,000 MDs and 50,000 DOs in the U.S.

NDs claim to be well trained to practice what most people think of as family medicine or primary care medicine, although their version of training is chock full of pseudoscientific nonsense and lacks a true residency program. They began by purporting to use only "natural medicines," but in regions where they've become politically connected they've sought, and been granted, the license to prescribe numerous drugs. Predictably, they've recently begun to bump people off with such exotic choices as intravenous colchicine and disodium ethylenediaminetetraacetic acid (that pesky TACT drug), in addition to more folksy nostrums such as acupuncture, vitamin B12, and an "herbal tincture" for a teenage girl who would shortly die of asthma.

I see that your talk is titled "Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream." I imagine that it will cover some of the material that you covered at the Yale Symposium, where you used the similar phrase, “Quirky Ideas from Outside the Mainstream.” Without reading more into that word substitution than is warranted, let me assure you that there are no promising ideas emanating from naturopathy, even if there are plenty of quirky ones, e.g., inflating balloons in the nasopharynx to effect a “controlled release of the connective tissue tension to unwind the body and return it toward to its original design."

Regarding the implicit requirement of your office that you appear open-minded even to medical absurdities, you made that clear in your own account of our NCCAM meeting and of another that you'd had a few weeks earlier, involving a group of homeopaths and associated crackpots who called themselves "the leading scientists in the field":

Recently, I hosted two meetings with groups that represent disparate views of CAM research. These meetings have given me a renewed appreciation for the value of listening to differing voices and perspectives about the work we do.

My NCCAM colleagues and I know there are differing views of the value of doing CAM research. On one side, we have stakeholders who are staunch CAM advocates, and on the other side, we have CAM skeptics.

Each group has its own beliefs and opinions on the direction, importance, and value of the work that NCCAM funds. The advocates would like to see more research dollars
supporting various CAM approaches while the skeptics see our research investment as giving undue credibility to unfeasible CAM modalities and want less research funding.

As I've stated before, our position is that science must remain neutral, and we should be strictly objective. There are compelling reasons to explore many CAM modalities, and the science should speak for itself. (emphasis yours)

Certainly science must remain neutral in the face of not-yet-seen data from rigorous studies, but that is different from what you, in your dual roles as "CAM" Explicator-in-Chief and Steward of Public Funds, must remain. You typically face questions that are, for all purposes relevant to the NIH, to modern medicine, and to the American citizenry, already settled---whether by basic science, clinical studies, rational thinking, or all three. I've offered several examples in the two naturopathy articles linked above.

Consider homeopathy, a core claim of "naturopathic medicine" and the subject of your meeting with the "staunch CAM advocates." It makes no more sense for you to remain neutral on that topic than it would for the NIMH Director to remain neutral on exorcisms, or for the NCI Director to remain neutral on Krebiozen. Edzard Ernst, a one-time homeopath whose own portfolio of "CAM" investigations dwarfs the entire output of the NCCAM, puts it this way:

Should we keep an open mind about astrology, perpetual motion, alchemy, alien abduction, and sightings of Elvis Presley? No, and we are happy to confess that our minds have closed down on homeopathy in the same way.

Science and skepticism, moreover, are not distinct. Good science involves, first and foremost, skepticism. This is true for the design of any experiment, in which the primary goal is to attempt to falsify the hypothesis, and also for scientific thinking in general. Bruce Alberts, the editor of Science, discussed this in a 2008 editorial titled "Considering Science Education":

...society may less appreciate the advantage of having everyone acquire, as part of their formal education, the ways of thinking and behaving that are central to the practice of successful science: scientific habits of mind. These habits include a skeptical attitude toward dogmatic claims and a strong desire for logic and evidence. As famed astronomer Carl Sagan put it, science is our best "bunk" detector. Individuals and societies clearly need a means to logically test the onslaught of constant clever attempts to manipulate our purchasing and political decisions. (emphasis added)

I believe that you know all this at some level, but that your current job demands that you bend over backward to frame skeptics as extreme---distinguishing them from "neutral" scientists. Thus you, like many reporters, have placed skeptics of homeopathy or naturopathy at one end of a contrived belief spectrum, and "staunch CAM advocates" at the other. Please indulge me while I compare this version of 'neutrality' with others that exist in the popular domain:

• Some people feel strongly that the moon landings were a collective hoax. Others feel just as strongly that they really happened.
• Some people believe that the Holocaust didn't happen. Others believe that it did.
• Some people believe that the variety of species on earth is a product of Intelligent Design (ID). Others believe in the theory of evolution by variation and natural selection.
  

This could go on and on, but you probably get the point. The last bullet is more pertinent to your tacit endorsement of the AANP than you might imagine. What follows is a representative view of herbalism offered by Thomas Kruzel, with whom you will also share the podium at the convention (he will discuss "Emunctorology"; don't ask). Kruzel is Past President of the AANP and the former Vice President of Clinical Affairs and Chief Medical Officer at the Southwest College of Naturopathic Medicine. He was selected Physician of the Year by the AANP in 2000, and Physician of the Year by the Arizona Naturopathic Medical Association in 2003:

Herbal Medicine: Naturopathic physicians have been trained in the art and science of prescribing medications derived from plant sources. The majority of prescription drugs are derived as well from plants but are often altered and used as single constituents. What makes herbal medicine unique is that plants have evolved along with human beings and have been used as non-toxic medications for centuries.

If there is any problem with herbal medicines it is that unless one knows how to prescribe them, they may not be effective. Herbal medications should be prescribed based on the symptoms that the person presents rather than for the name of the disease. Herbal medications are much more effective at relieving the patients symptoms when prescribed in this manner. When prescribed the medicines act with the body’s own innate healing mechanism to restore balance and ultimately allows healing to occur.

What’s nice about plant or herbal medicines is that because they are derived from the whole plant they are considerably less toxic to the body. The plant medicine has evolved to work in harmony with the normal body processes rather than taking over its function as many drug therapies do. Because of this herbal medicines may be taken for longer periods of time without the side effects so often experienced with drugs.

You are particularly impressed, I hope, by the magical, ID-like claim that "plant medicine has evolved to work in harmony with the normal body processes." Other curious assertions include the conflation of herbal medicine with the core claims of either homeopathy or the non-existent 'allopathy' (we can't tell which)---"...should be prescribed based on the symptoms..."---demonstrating that the author doesn't know much about even the fanciful methods for which he claims expertise; and the dangerously false statement that medicines "derived from the whole plant are considerably less toxic" (than are well-researched and precisely dosed "prescription drugs").

Dr. Briggs, please consider the possibility that you no longer must hide your considerable scientific prowess in order to be a good NCCAM Director. Your 'stakeholders' include not only very small numbers of naturopaths, homeopaths, and other fringe practitioners, but also far larger numbers of citizens who wonder about the validity of what those practitioners are peddling. It is to those citizens that you should be directing your efforts, which ought to begin with sober, objective, skeptical, scientific considerations of the various claims, the vast majority of which can, like balloons in the nasopharynx, be deflated in milliseconds by anyone with even a modest understanding of nature. They don't require clinical trials.

Things are changing elsewhere. My colleague Steve Novella has just written about substantial efforts to deny insurance coverage for homeopathy in the land of its birth, Germany. In the UK, homeopathy has been far more popular than it is here, even to the point of its being funded by the National Health Service. One of the "staunch CAM advocates" who reportedly attended your meeting by teleconference was Peter Fisher, Homeopath to the Queen. Yet both the British Medical Association and the House of Commons Science and Technology Committee have seen through the ruse of pseudoscience that is homeopathy, the former declaring it "witchcraft" and latter making this statement:

The Committee concurred with the Government that the evidence base shows that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible.

American citizens want and deserve, for their tax money, exactly that sort of definitive evaluation of such claims. Your first responsibility, Dr. Briggs, is to them---it is not to the AANP, other "CAM stakeholders," Tom Harkin, Orrin Hatch, or Dan Burton, and certainly not to the members of the NACCAM. Yes, we "skeptics see [the NCCAM] research investment as giving undue credibility to unfeasible CAM modalities," because the evidence is overwhelming that this is the case. We also see your appearing at conventions of pseudomedical pseudoprofessional organizations as giving undue credibility to unfeasible and dangerous claims.

Sincerely yours,

Kimball C. Atwood, M.D.
Skeptic

This letter has been cross-posted on Science-Based Medicine.

BUY IT NOW!