Medical Societies Paid To Do Corporate Public Relations

Background

Last year we posted about how two medical societies which received funding from a drug manufacturer tried to persuade the US Food and Drug Administration (FDA) to deny approval of a generic competitor to one of that company's products.  The medical societies were the Society of Hospital Medicine (SHM) and the North American Thrombosis Forum (NATF).  The company was Sanofi-Aventis and the product involved was its anti-coagulant derivative of heparin, Lovenox. 

At the time, we noted that the SHM CEO denied the need to specifically disclose funding from Sanofi-Aventis in the letter to the FDA, since he asserted the letter was about "providing the best, most effective care to the hospitalized patient." If so, I wondered why the SHM had not raised concerns about the case of the deadly contaminated heparin which was sold by another company from which it received support.  I noted that as long as medical societies accepted money from companies that made drugs or devices their members might prescribe or use, there would be "suspicion that such societies may use their considerable influence to serve the corporations', not patients' interests, and so undermine the professional values of the societies' members."

The Senate Report

Now the US Senate Finance Committee has reported on their investigation of this incident, and the concerns it raises go beyond just suspicions.  As reported by Alicia Mundy in the Wall Street Journal,

The Senate report, 'Sanofi's Strategic Use of Third Parties to Influence the FDA,' said the company enlisted medical experts to conduct 'independent interaction' with the FDA to hold on to Lovenox's market.

Between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000 to Dr. Tapson, the report said.

Sen. Max Baucus (D., Mont.), chairman of the Finance Committee, said: 'Pharmaceutical companies simply cannot be allowed to spend millions of dollars to buy medical opinions that claim objectivity but instead favor their products.'

The Society of Hospital Medicine was initially reluctant to write the letter, according to emails released by the committee. The society's director told Sanofi in a June 2008 email that his group 'has no history of making similar comments to the FDA' and might not have 'the expertise or knowledge to say much about' the issue.

However, the email added, 'we want to give any issue that is important to our partner careful consideration.'

Two months later, the society sent its letter to the FDA. A Sanofi public-relations representative later cited the letter in an internal email as a 'key accomplishment.'

The report itself made clear why Sanofi wanted the FDA to delay or deny approval of the generic version of Lovenox:

According to a 2009 Sanofi slide presentation on its 'Lovenox Patient Safety Strategy,' a core issue faced by Sanofi was the 'imminent threat to [Sanofi’s] Lovenox franchise' posed by 'generic alternatives.'

It also made clear how much financial impact Sanofi had on the SHM:

SHM received $2,675,850 from Sanofi from January 2007 through August 11, 2010 for conference exhibits, sponsorship, and grants. Sanofi’s payments to SHM totaled $1,132,500 between July 1, 2007 and June 30, 2009, accounting for 8 percent of SHM’s total revenue during those 2 years.

It made clear that the letter the SHM wrote to the FDA resulted from its interactions with Sanofi:

Internal Sanofi communications indicate that SHM consulted with the American College of Chest Physicians and Dr. Tapson about sending a letter to the FDA after 'a very positive meeting' with Sanofi officials.

Summary

So let us just walk through this again. Sanofi wanted to keep generic Lovenox off the market. Sanofi pushed two medical societies to which it provided considerable funding to try to persuade the FDA not to approve generic Lovenox, without revealing their financial ties to Sanofi or that Sanofi had instigated their protests. At the time, at least one of the societies' leaders denied that its attempt to persuade the FDA had anything to do with its relationship to Sanofi.

Note that Sanofi's use of two medical societies and a "key opinion leader" to try to influence public policy without disclosing the company's causal role was an example of what Wendell Potter called a "third-party" tactic (see this post).  While Mr Potter outlined a series of tactics used by public relations department of health insurance corporations to further their policy objectives, often in such deceptive and systematic ways as to constitute disinformation campaigns, there has not been such a broad description of these these tactics used by other kinds of health care organizations.  Now it looks like drug companies' PR departments are also users of these techniques.  Most likely they have been deployed throughout the health care sphere to promote policies that benefit particular companies, often at the expense of health care professionals, patients, or the public at large.

On a personal note, I am a general internist who spent some time as an academic hospitalist.  The SHM is the main society for hospitalists, and is allied with the Society for General Internal Medicine (e.g., see here), to which I belong, and which I have served in a variety of capacities.  Thus I am very sad about the hole into which the SHM leadership has apparently fallen. 

The SHM and NATF leadership have apparently become stealth health policy advocates, and actively tried to change government policy on behalf of a corporation that had funded them.  Thus, these medical societies acted more like public relations or lobbying firms.  In doing so, they appeared to subverted their own missions, and their members' values.

A short time ago, we noted the cases of two medical societies that got substantial funding from drug and device companies, and thus seemed to function more like marketing firms that professional associations.  Now we have two cases of medical societies that seemed to function more like public relations and lobbying firms than professional associations.

So all the organizations which ought to have upheld health care professionals' values against the onslaught of laissez faire commercialized medicine, now medical societies as well as academic medical centers, medical schools and their parent universities, and medical and health care foundations, seem to have been systematically sold out to big health care corporations' marketers and public relations flacks. 

What Is To Be Done?

If we health care professionals really want to improve patient care and the public health, we could start by exercising extreme skepticism about the funding and leadership intentions of our own professional associations.  If these societies appear as dependent on industry for money as they are dependent on their own members, and/or if they appear to be acting more like marketing, public relations or lobbying firms, why do we continue to enable such behavior?  Why should we pay dues to marketing, public relations or lobbying firms?  We need to have our medical societies uphold their own missions, or we need to get new medical societies. 

Hat tip to the Project on Government Oversight (POGO) blog.

More Medical Societies Supported by Industry

There were several new reports about the extent that medical societies are supported by industry.  Last week we asked whether the extent of the industrial support provided the Heart Rhythm Society made that organization appear to be more of a marketing firm than a professional society. 

Society for Cardiac Angiography and Interventions (SCAI)

ProPublica reported last week:

The Society for Cardiac Angiography and Interventions (SCAI) received 57 percent of its revenues in 2009 from medical device and pharmaceutical makers, according to financial information on the group's website.

Industry contributions to the society's budget covered $4.7 million of the $8.2 million it received that year.

The group's biggest funders are the companies with the biggest share of the stent market: Cordis Corp. (a subsidiary of Johnson & Johnson), Boston Scientific, Abbott Laboratories and Medtronic.

So here is another medical society that gets more money from pharmaceutical, biotechnology and device companies than it does from its members.

The SCAI does not make obvious any relationships among its board members and officers and industry and does make publicly accessible its CEO's compensation or its recent 990 forms (see its web-site here).


National Lipid Association (NLA)

The CardioBrief blog discussed the somewhat more convoluted case of the sources of support of the National Lipid Association.

First blogger Larry Husten examined the role of industry support for the association's "clinical guidance papers" on familial hypercholesterolemia  (FH). These papers recommended extremely aggressive screening for high cholesterol, that is, starting for 9 year old children, and 2 year olds whose families' had histories of elevated cholesterol and coronary disease. The conference that came up with these ideas was supported by drug companies, per the first blog post in a three-part series:

The January 2011 NLA familial hypercholesterolemia recommendations conference was supported by unrestricted grant funding from the following companies: Abbott Laboratories, Aegerion Pharmaceuticals, Daiichi Sankyo, Genzyme, Kaneka Pharma America LLC, and Merck & Co.

Also,

Each of these companies would benefit from increased screening and treatment of FH and some, such as Keneka, Aegerion, and Genzyme have a huge portion of their future invested in FH.

Furthermore,

The executive summary of the papers includes disclosures from all of the authors, and all the authors list industry ties, and all but two of the authors disclose multiple relationships with industry (see below). Nearly all had ties with the companies that sponsored the conference. In an interview, [chair of the expert panel Dr Anne] Goldberg, told me that 'we believe in transparency' but that, unlike organizations like the ACC and the AHA, 'we have not taken people off of committees because of any ties with industry.'

A second blog post noted that a brochure on FH published by the NLA was supported by a drug company (Genzyme) and that:

The NLA offers a multitude of CME programs, nearly all of which are  commercially supported by the pharmaceutical industry. Often the content of the programs are closely tied to the interests of the sponsor. For instance, the program on 'Lipid-Altering Drug Pharmacology and Safety' is supported by Abbott, Merck/Schering-Plough, and Reliant, all of whom manufacture popular lipid drugs.

However, in pursuit of the "transparency" promised above, Mr Husten was not able to get a clear idea of the total amount of industry support supplied to the NLA:

the NLA does not provide a detailed account of its revenue from industry, so it is impossible to say with certainty precisely how reliant it is upon industry support.

Note that the association's 2010 990 form listed revenues totaling $3,657,060, of which $1,106,091 came from meeting registration, and $216,356 from dues.  So this society received about 36% of its revenue from these traditional sources, while it received 37% from contributions and grants ($1,246,242) plus $116,750 in exhibitor fees.  (Other sources of revenue were less easy to classify.)  This suggests that the NLA does receive substantial revenue from industry.

The NLA did not list amongst its disclosures whether its board members and officers had their own financial relationships with industry.

Furthermore, the NLA seems particularly opaque about its hired executives and how much they are paid. Its 2010 990 form did not name its highest-compensated employees, nor list their compensation. Although it noted that its management was "delegated" to Compass Management & Consulting, it did not state the amount paid to Compass,  or the compensation given to any Compass employees who are effectively the NLA's highest-paid employees, nor did it list Compass as one of its most highly-paid independent contractors. Mr Husten discovered an addendum to a 2010 financial report also posted on the web that did state Compass' compensation was $662,640 in "management fees," and $326,378 for "commissions" for "fund-raising, a total of $989,018, equal to 25% of the organization's total expenses of $3,945,688.

Summary

Here are two more examples of medical societies that receive substantial revenues from companies that make products about which the societies' members may decide to prescribe or implant. In both cases, the societies' seemed to receive at least as much revenue from industry as they did  from members for dues, registration fees, and the like. Although both societies claimed to value transparency, neither disclosed the extent that society leaders and paid managers benefited from the societies' or their own relationships with industry.  So there is reason to be concerned about the extent their volunteer leaders and paid executives may benefit from the soceities' and their own personal relationships with industry.

He who pays the piper calls the tune.  So it does not appear unreasonable to ask whether these societies should be regarded as at least as beholden to their industrial funders as to their members and meeting attendees?  So should they be regarded as commercial marketing firms at least as much as professional societies?

As we said before, if medical societies have come to resemble marketing firms, is it any wonder that they have not spoken up against the commercialization of health care, even when the result has not been good for physicians' core values? But in that case, why would physicians who care about their patients and their core values want to belong and pay dues to marketing firms? Inquiring minds want to know....


Maybe physicians should only join medical societies that really act like medical societies.

Has the Heart Rhythm Society Become More Like a Marketing Firm?

ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir.  (The full ProPublica version is here.)  It's worth doing a little reading between the lines to see its further implications.

The Basic Story

The story focused first on the annual meeting of the Heart Rhythm Society (HRS), a sub-specialized medical society for cardiologists who specialize in electrical or rhythm disorders.  The meeting seemingly has become a giant marketing opportunity, supported by $5 million in industry money, in which practically every flat surface became a medium for advertising.  (The ProPublica article included multiple pictures of branded items from carpets in the exhibit halls to the backs of the seats in shuttle buses.) Also,

St. Jude Medical adorns every hotel key card. Medtronic ads are splashed on buses, banners and the stairs underfoot. Logos splay across shuttle bus headrests, carpets and cellphone-charging stations.

At night, a drug firm gets the last word: A promo for the heart drug Multaq stood on each doctor’s nightstand Wednesday.

Then reporters Charles Ornstein and Tracy Weber looked at the HRS as a whole, noting that half the society's total income comes from industry, and "Twelve of 18 directors are paid speakers or consultants for the companies, one holds stock, and the outgoing president disclosed research ties, according to the society’s website, which does not specify how much they receive."  Furthermore, "Two of the society’s biggest funders — Boston Scientific and St. Jude Medical — have paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices. Neither company admitted wrongdoing."

The article raised tantalizing questions and implied others, but despite the reporters' best attempts, leaders of the HRS and their defenders failed to address them.  Their failure to grapple with the real issues is to me the most disturbing part of the story.

Why Take the Money?

ProPublica published a companion piece consisting of questions to and responses from the HRS President, Dr Douglas L Packer, and President-Elect, Dr Bruce L Wilkoff. The first response was the rationale for taking the money:

Advances in electrophysiology depend on a collaborative relationship between physicians and industry....

Later,

It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials.

This response is very common from physicians and other health professionals defending relationships with industry. Note that this response, similar to previous ones, is off the point. The issue is not all relationships with industry. It is about relationships in which industry pays people, or in this case, a group of people for purposes not always clear, but when clear are related to marketing. Payments from industry to physicians and health professionals are not necessary for collaboration. If the goal is innovation and development of therapies, how is that supported by payments to a medical society to provide marketing opportunities?

Why Subject the Meeting Attendees to All That Advertising?

Much of the money received by the society was obviously for marketing purposes. The effect of these payments was the advertising barrage noted above. So the obvious questions are: is it beneficial for the society to expose its members and other meeting attendees to all this marketing?  Should making its members accessible to marketing be a major part of the society's activities?

When questioned by ProPublica, the organization's leadership evaded:

Q. Items at your conference—from key cards to newspaper wraps—are available for sponsorships. What is the purpose of these sponsorships? Does the livelihood of the organization depend on them? Do the ads have an impact on what your members buy and use in their practices?

A. The Heart Rhythm Society offers sponsorship opportunities at the annual scientific sessions to provide advertising opportunities for participating exhibitors. Approximately 50 percent of the revenue for the annual scientific sessions is generated by industry in a combination of exhibit space rental (largest), sponsorship/promotional advertising opportunities, unrestricted educational grants and exhibitor office suites. The society does not collect data or ask attendees if sponsorship or advertising impacts their purchase decisions.

Very few people quoted in the ProPublic series ventured to defend the marketing onslaught. There was only this. In a newer follow up article, Chris Ornstein quoted meeting attendees with similar sentiments:

'I’ve always been rather offended that people who aren’t doctors think I’m susceptible to bribes and corruption,' [Raleigh, NC electophysiologist Dr Mark] Englehardt said. 'A lot of what you learn about products is from people that sell the products. … You have to learn it somewhere.'

Note that the good Dr Englehardt lead off by invoking a straw-man fallacy. Being influenced by advertising is not the same as taking bribes. No one accused those attending the conference of taking bribes. More importantly, his argument in favor of advertising invoked a false dilemma (or false dichotomy). There certainly are sources of information about products, and particularly about electrophysiologic devices, beyond manufacturers' advertising.  The choice is not simply ignorance versus advertising.

Others merely sought to minimize the harms of exposure to so much advertising. For example, one of the HRS' defenders, who not coincidentally runs a much larger medical society, which also has had its issues with its extensive ties to industry, (look here) said:

The 'circus element' of the exhibit booths doesn’t unduly influence attendees, [CEO of the American College of Cardiology Jack] Lewin said. 'I don’t buy a soft drink just because of the advertising… I buy it because I like it.'

Maybe not, but the analogy may not be apt. Furthermore, we have seen a stream of physicians, other health professionals, and academics deny that they are influenced by marketing or monetary incentives. It is hard to believe, however, that industry would spend so much trying to influence opinions without some evidence that the money provides some results. In addition, most people seem to lack insight about what influences their opinions, especially when consciously admitting such influence might threaten their self-image.

On the other hand, the follow-up article also noted:

Some doctors acknowledged that the corporate barrage must have some effect. 'I hope not, but I’m certain that it does,' said Dr. Christopher Conley of Nashville, Tenn. 'I’m sure the companies do their own research. They wouldn’t be here, they wouldn’t be putting all this money out if it didn’t influence people.'

It seems obvious that all the advertising was meant to sell products. It seems unlikely that marketers spend so much money without some reason to believe it would have an effect. Even if it had little effect, was there any benefit to selling all that marketing space that would counter-act one glaringly obvious harm? By raising so much money from such obvious and widespread marketing, the Cardiac Rhythm Society meeting is liable to be viewed more as a marketing event than a serious scientific or professional venue.

Is It a Professional Society, or a Marketing Firm?

As noted above, accepting so much money for such a large marketing presence at its national meeting makes the Heart Rhythm Society appear to resemble a marketing firm.  Other information revealed by ProPublica increases the apparent similarity. 

Societies are groups of people who gather for a common purpose.  Medical societies ought to be groups of doctors who gather for common purposes, usually including promoting their own professional interests and upholding professional values.  They typically used to convene meetings for educational or advocacy purposes, and publish journals or other media.  Thus their typical sources of revenue could be dues, meeting registrations, and subscription and similar fees. 

However, as noted above, half of the Heart Rhythm Society's budget comes from industry, specifically "from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms," according to ProPublica.  The picture was similar in 2009.  I reviewed the organization's most recent (2009) financial disclosure (990 form) filed with the US Internal Revenue Service and made available to the public by Guidestar.  In that year, the organization's total revenues were $14,772,708.  Revenues from "grants and sponsorships" were $4,061,883 and from annual meeting exhibits were $3,065,750, for a total of $7,127,633.  So only about half of the society's revenues came from traditional sources, including meeting registration ($4,749,974) and dues ($1,513,361).  Given that some of the registration fees doubtless came from industry attendees, and some product sales ($212,298) and royalties ($511,760) also came from industry sources, the organization's revenue makes it appear at least at least as much like a marketing firm as a medical society. 

Note that one group of beneficiaries of this industry largess was the organization's paid managers.  The 990 form listed eight executives who made over $150,000 a year in the worst years so far of the Great Recession.  Its CEO received total compensation of $532,691.  His compensation used 3.6% of the organization's total revenue. 

Moreover, the majority of the Heart Rhythm Society's board and officers have major ties to manufacturers of drugs and devices used in the diagnosis and treatment of heart rhythm problems.  As noted above, 12/18 directors were found to have ties to the companies which advertised at the meeting.  Perusal of disclosure forms which the Society, to its credit, does make public here, revealed only three of 20 officers and directors who had nothing to disclose in 2011-12. The current President, Dr Douglas L Packer, had two pages of disclosures, including 10 different device or biotechnology companies from whom he got "significant" (over $10,000) grants or royalty income.  Many other board members and officers had "significant" financial relationships, consulting/ honoraria, speakers' bureau membership, equity interests, with drug, biotechnology, or device companies which make products relevant to cardiac rhythm disorders.
 
The leaders of the society asserted their ability to "manage" industry relationships:

Due to thorough policies and procedures in place for working with industry, the Heart Rhythm Society is comfortable identifying and managing various interactions with industry. Additionally, the society seeks multiple supporters for its educational programs in order to avoid the perception that programs are tied to a specific company. The society has sufficient measures in place to prevent undue influence from industry or introduction of industry bias into HRS-sponsored educational programs, research, scientific documents and policy initiatives.

Later, when directly questioned about the implications of receiving half the organization's funding from industry, they evaded again:

Q. Some researchers on conflicts of interest say that when a medical society receives half of its funding from industry, it is codependent on them and therefore will—consciously or not—avoid criticizing the products they make. How would you respond?

A.  The Heart Rhythm Society’s first and foremost concern is to provide effective and appropriate treatment options to our patients.  It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials. For this reason, we believe that interacting with industry is not inherently wrong with the correct measures in place to mitigate the possibility of conflicts of interest.

Moreover, the Society maintains a neutral position on all products and services offered by industry. The U.S. Food and Drug Administration is our source for information about new products, safety alerts and drug recalls.

Half of the organization's revenues come from industry, and the organization is willing to expose its meeting attendees to a barrage of advertising to obtain most of these revenues. Providing such advertising does not seem to maintaining "a neutral position." Do its leaders really mean that this proportion of support has no influence on them or how the organization is run? Nearly all the organization's officers and directors have their own financial relationships with industry. Do they really think that these relationships have no effect on their thinking? Would the leaders be indifferent to losing half of the organization's financial support and their own personal financial relationships with industry? If they would not be indifferent to this eventuality, can they argue they are uninfluenced?  Would the organization's CEO, whose compensation is over 3% of the organization's total revenue, be indifferent to a decrease of 50% in that revenue?  If not, could he be uninfluenced by the source of this revenue?

Summary: Why Pay Dues to a Marketing Firm?

As health care dysfunction has gotten worse over the years, as costs rise, access falls, and quality stagnate, as physicians are subject perverse incentives and deceptive marketing, as the medical research literature has been suppressed and manipulated, there have been surprisingly few responses from medical societies.  The case study provided by ProPublica of one such society suggests one reason why.  Medical societies seem to behave increasingly like marketing firms.  The majority of their revenue may not come from their members.  They may be willing to subject their members to a flood of marketing to make more money.  Their leaders may have extensive relationships with industry.  Their paid managers may be dependent on industry revenue for out sized compensation.

If medical societies have come to resemble marketing firms, is it any wonder that they have not spoken up against the commercialization of health care, even when the result has not been good for physicians' core values?  But in that case, why would physicians who care about their patients and their core values want to belong and pay dues to marketing firms?  Inquiring minds want to know....

Maybe physicians should only join medical societies that really act like medical societies.

For further discussion in the blogsphere, see this post by Merrill Goozner on the GoozNews blog, this post by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, this post by Daniel Carlat on the Carlat Psychiatry blog, and this post by Paul Thacker on the Project on Government Oversight blog.

Who You Gonna Call? - How Should a Young Academic Respond to a Proffered Conflict of Interest?

To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a conflict of interest:

Consider a health care researcher called by a commercial health care corporation's marketing department. The department representative proposes paying the researcher as a consultant to write a scholarly article on a specific policy topic of interest to the company. The implication is that the article should be favorable to the interests of the corporation in this arena. The corporation would be delighted to give the researcher editorial and staff assistance in writing the article and getting it published.

Who you gonna call?

The researcher is concerned that getting this consultancy might be a conflict of interest. What organization (e.g., appropriate professional society, unit within his or her academic institution, other academic unit, independent not-for-profit organization or NGO, or government agency) should the researcher contact for support and help? Please give at least one specific example, (preferably including a URL), with a brief justification of why that organization might be helpful.

I sent the case to a few hundred people on our combined mailing list, to see how they might answer.  Responses came from medical academics, with a sprinkling of practitioners, a journalist, and a well-informed lay-person.

Sources of Information: Is It a Conflict of Interest?

Nearly everyone thought it would be unethical for a young academic to be paid as a consultant to write a health policy review policy by a company with a vested interest in the subject, and with editorial and staff support coming from the company.

I implied (but did not make clear) that the faculty member felt uncomfortable with the situation, was looking either for advice and information, or actual support not to accept a conflict of interest that he or she might have felt pressured to take on.

People suggested some sources of information. Most appeared to be useful, but most also were specialized (by clinical specialty, directed at journal editors, directed only at conflicts related to pharmaceuticals, etc)  Those particularly worthy of mention include:
- The Prescription Project's site on medical school conflict of interest policies
- The World Association of Medical Editor's (WAME) site on conflict of interest in scholarly publication
- The PharmedOut.org general resource site
My personal preference for a single source of general information on COIs is the 2009 US Institute of Medicine report on same.  (I will add all these links to our side-bar, and note that there are some other relevant links there.)

The IOM definition of conflict of interest is:

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.

Primary interest include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients.

So the offer in the above case clearly seemed to present a conflict. The situation presented in my case seemed to present the potential to violate the report's recommendations 5.1 that bans scientific publications "that are controlled by industry," or that "contain substantial portions written by someone who is not identified as an author...."

Note, however, that even the IOM report seems not to question the idea that "collaborations between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society — most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health."  It has never been clear to me that collaboration requires payment by one party to the other, or that academic medical institutions ought to be developing drugs and devices (as opposed to discovering knowledge that commercial firms might later use to do so.) Furthermore, the IOM report, while it is moderately tough and comprehensive, did not recommend that detailed public disclosure of all relevant conflicts by all parties to them, or an outright ban on all of the sorts of conflicts that many might think are objectionable.

Support to Resist the Proffered Conflict

Suggested sources of help resisting pressure to assume an unwanted conflict of interest included local sources: mentors, grants and contracts offices, local conflict of interest/ ethics committees, compliance departments, and research officers. Some people thought their local versions of the above might be helpful. No person seemed sure that any of these options would clearly lead to support if the academic was being pressured by his or her academic superiors.

However, I have big concerns about the availability of even these sorts of local support.  We know COIs are very prevalent among individual academics.  About 60% of all academics, and of department chairs have important conflicts according to two articles by Campbell et al.(1-2)  So it might be hard for the young academic to find a mentor or university officer who was not already conflicted.

We also know that medical schools and academic medical centers see commercializing their discoveries as taking precedence over their traditional mission of seeking and disseminating knowledge, and providing and improving patient care and public health.  For example, in 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development…."[caps added for emphasis] Furthermore,

Academic medicine… finds itself struggling to create a precarious equipoise between the world and values of commerce and those of traditional public service….

Also

In our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of academic inventors in the commercial venture; put simply, no participation, no money. It is this demand … that has driven the dramatic increase in medical faculty entrepreneurship.

I have seen university conflict of interest policies that include such verbiage in their introductions. The impression is that most academic medical institutions now think that is their mission, maybe their overriding mission, to develop and commercialize drugs and devices.

So it might also be hard for the young academic to find a local academic unit that is not affected by institutional conflicts of interest. Indeed, none of the people on our list was sure that their institutions had local authorities or units that could help the young academic in the case above avoid the proffered conflict of interest.

A few people suggested external sources of support: e.g., a small medical society, an association of journal editors, a bioethics center. But they too were ambivalent about how helpful they might be. The small medical society would only be helpful for its few members, and the person who mentioned it doubted it could provide more help that citing its own COI policy. The journal editors and their organizations might only be helpful about how the proffered conflict might affect the ability of the faculty member to get the resulting study published. The bioethics center appeared to have heavy institutional conflicts of interest of its own. No one could suggest an independent organization likely to provide effective support to resist COIs to a wide spectrum of academics (or other health care professionals, etc)

Summary

So this exercise did reinforce one of the assumptions I made when writing the case. Young academics at most US (at least) institutions may have little local support for resisting the extant pressure to become conflicted. There are NO generally useful and effective external sources of such support.

I would point out that with all its limitations, the IOM report still called on academic institutions to develop clear guidelines for COIs (3.1, 3.2); ban people with COIs from research on humans (that is, from all clinical research) (4.1); develop educational programs on COIs (5.2); participate in developing continuing medical education that is free of industry influence (5.3); set up a committee on COIs at the board of trustees level (8.1). It also called on the US government to promote research about COIs (9.2).

As far as I can tell, that was all pretty much wishful thinking. Despite the prestige of the IOM, almost none of these recommendations have been implemented. (I have heard so far of one university that seems to have implemented watered down versions of some of the IOM recommendations in their own policy. I would love to be told there are more extensive implementations of these recommendations. If there are, please show me the specifics.)

Furthermore, there seems to be no effective support for the reduction of COIs from accrediting organizations, professional societies, or foundations that fund health care initiatives. (Again, I would love to be told I am wrong, but if I am, show me the specifics.)  Of course, it appears that most professional societies get extensive support from commercial sources, particularly drug, device, and biotechnology companies, and their leadership often have their own financial relationships with for-profit health care corporations.  Foundations that support health care and medicine may have leaders with similar relationships, and may have endowments disproportionately invested in health care corporations.   

Given the pervasive nature of personal and institutional COIs throughout health care, which we have documented on Health Care Renewal , I was saddened, but not surprised by the responses to my query. So many people and so many institutions are making so much money from their industry payments. They will nearly all have excuses so that they can keep accepting the money. Young faculty are unlikely to be able to resist the prevailing culture, especially when it affects so many of their colleagues and supervisors.

I know that the people on our email lists are more aware of this than most. But we all should be saddened and ashamed that so little progress is being made.

Will academic medical institutions ever again put seeking and disseminating new knowledge, and providing and improving patient care and for the public health ahead of trying to be ersatz drug and device companies?

Will professional societies ever again put put their members' core values ahead of pleasing their corporate funders?

Will health care foundations ever again put rescuing health care's core values ahead of bland projects meant not to offend health care corporate leaders?

References


1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. (link here)
2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link here)
3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. (link here)

Sanofi-Funded Society of Hospital Medicine Stands Up for Lovenox

Here is another case to raise questions about the true goal of some medical societies.  As reported by Alicia Mundy in the Wall Street Journal in late June,

A medical researcher and two medical groups with financial ties to Sanofi-Aventis SA have asked federal regulators to hold off on approving generic forms of a Sanofi blood-thinner....

Citing potential patient safety issues, the head of the Society of Hospital Medicine and a medical researcher at Duke University last month sent letters to the Food and Drug Administration contending that Lovenox is too complex for any generic maker to copy fully.

Earlier this year, another Sanofi-sponsored medical group, the North American Thrombosis Forum, sent two letters in favor of Sanofi's position opposing generic Lovenox. None of the letters mentions the signer's financial support from Sanofi.

Two small drug companies, Amphastar Pharmaceuticals Inc. and Momenta Pharmaceuticals Inc., filed applications to the FDA in 2003 and 2005 respectively seeking to sell generic Lovenox, called enoxaparin.

Of course, the two medical societies involved denied that there was any relationship between their support from Sanofi-Aventis and their concerns about the safety of biogeneric medications that might compete with a Sanofi-Aventis product (which, as the WSJ article noted, "had global sales of $4.57 billion in 2009").

Laurence Wellikson, chief executive of The Society of Hospital Medicine, which represents doctors who coordinate patient care, said his letter to the agency 'was based entirely on the best evidence-based medicine available and the collective experience of SHM's senior hospitalists.'

Also

Ilene Sussman, executive director of the North American Thrombosis Forum, said the group's doctors are concerned about generic Lovenox, and its letter was independent of Sanofi.

The CEO of the SHM denied even a responsibility to disclose the Society's support from Sanofi-Aventis:

Dr. Wellikson said it wasn't necessary to disclose that the group receives financial support from Sanofi because its letter 'focused on providing the best, most effective care to the hospitalized patient.'

In fact, the SHM web-site includes a "disclosure of organizational support" page which suggests Sanofi-Aventis provided somewhere between $200,000 to $800,000 for three projects of the Society's projects, "pharmacoeconomics," "improving glycemic control," and "preventing VTE." The latter presumably could have something to do with anti-coagulants such as Lovenox. (The numbers are vague because the statement only discloses the amount of support provided in broad ranges.) Thus, support by Sanofi-Aventis could provide as little as 2.7% or as much as 11.1% of the Society's total income, which was noted to be $7,203,596 in its 2009 Form 990 filed with the IRS, and publicly available via Guidestar.

Given the broad mission of the SHM

SHM is dedicated to promoting the highest quality care for all hospitalized patients. SHM is committed to promoting excellence in the practice of hospital medicine through education, advocacy and research.

one wonders why it would want to get officially entangled in the approval process for specific biogeneric drugs.  If the leadership of the Society is so concerned about the safety of anti-coagulants, one wonders why they did not speak up about the case of the lethal contaminated heparin, about which we have blogged extensively, most recently here.  (I can find nothing on the web to suggest the Society, or Dr Wellikson, ever noted any concerns about this issue.)  Of course, that case involved heparin sold by Baxter International, whose production was out-sourced to a questionable supply chain.  SHM also receives support, amounting to something between 0 and $100,000, according to its "disclosure of organizational support" page, from Baxter International. 

Thus it appears that the leadership of SHM was very concerned about the safety of an anti-coagulant manufactured by a competitor of Sanofi-Aventis which could threaten that company's revenues from the drug, while Sanofi-Aventis is one of the Society's major financial supporters.  On the other hand, the leadership seemed unconcerned about the safety of an anti-coagulant sold under the Baxter International label, while Baxter-International is also one of the Society's major financial supporters.  So it is hard to tell whether the leadership is more concerned about the safety of anti-coagulants, or the financial interests of the drug companies that support it. 

The problem with the funding of health care professional societies by health care corporations that sell products or services that doctors can prescribe or order is that it raises the suspicion that such societies may use their considerable influence to serve the corporations', not patients' interests, and so undermine the professional values of the societies' members.  For this reason, Rothman et al suggested that such societies sever most of their financial ties to such corporations.(1)  (See our blog post here.)  As long as the SHM chooses to accept support from drug and device companies, questions will be asked about the effects of such support on how the Society uses its influence.  Furthermore, assertions that such support is so irrelevant that the Society need not even disclose it will only fuel more suspicion.

If ostensibly mission-driven not-for-profit health care organizations, like health care professional societies, but also including medical schools, academic medical centers, and patient advocacy groups, want the public and health care professionals to believe that they really are mission-driven, they need to spurn funding from organizations with vested interests whose service might distort these missions.

Hat tip to Steve Lucas for his comment here.

References

1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link here.)

Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
  

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….

The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:

How to relate to the patient, evaluate, test and diagnose

How to use solutions, mixtures, methods, supplies and equipment

How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI

How to design and organize your office

How to hire and fire staff and to computerize

How to use public relations and marketing

How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies

Manuals included…

Each attendee receives one set of training materials, including:

Protocol Manual

Physicians Manual

Office Procedure Manual

Forms Book

Marketing Manual

Patient Results Manual

Employee Manual

Audio tapes

and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:

Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director
  

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies
  

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”

Oh yeah: what were the other 2 “avenues”? Those would be:

• Become a Media Personality
• Consult for Wall Street