There has been quite a bit of discussion lately about how industry funding influences continuing medical education. One of our industrious scouts pointed out one of the most current entries in this discussion, an article on this subject by the Editor-in-Chief of the Journal of the American College of Cardiology, Dr Anthony N DeMaria [DeMaria AN. Continuing education, industry, and doctors. J Am Coll Cardiol 2008; 52: 1035-1036. Link here.]

Dr DeMaria confessed to “very blended feelings” about the move to end commercial support of CME. He felt that such commercial support did some good.

This support has been estimated to amount to nearly $1 billion per year and has enabled us to have the breadth and depth of learning opportunities we currently enjoy.

Even though he acknowledged that commercial support “sometimes appeared to primarily serve the interests of the supporters,” he felt that full disclosure would allow doctors to be properly skeptical of that support.

I’ve a further, even more basic, reservation about the proposal to end commercial support for CME. Inherent in such an action is the idea that physicians are like sheep: easily led and without the ability to recognize biased or slanted information. I find this demeaning to the profession. In my experience, doctors are more skeptical than naïve; by nature they are not anxious to accept, but rather are waiting to be convinced. Given the competitive demands entailed in becoming a doctor, we are likely intelligent enough to recognize bias when it is present.

Thus, he also felt that terminating commercial support would be bad.

I worry that termination of all commercial support is a major overreaction.

I view the proposal to eliminate all industrial support of medical education as throwing the baby out with the bath water. I agree that certified CME should be objective and free of all bias, and I’m not naïve enough to think that this has been fully achieved. However, I think there are other ways to accomplish this goal, and that we’ve the structure in place to be successful in the ACCME, medical societies, and academic institutions. Tightening existing guidelines and greater diligence to adherence should be adequate. Equally important, I think doctors are intelligent, savvy, and independent enough to know bias when they see it, and to resist suggestions that are not based on firm data. Doctors may not be perfect, but in pursuing continuing education, we have set an example for other professions to follow. Industrial support has helped to make this possible; let’s think long and hard before we upset the cart.

First, note that this is yet another argument that physicians ought to be offended by the notion that they can be influenced by commercial relationships. I concur that maybe few physicians consciously modify their decisions and judgments according to their financial relationships with companies that have vested interests in selling health care products or services. But, common sense and experimental psychology suggests that such relationships can influence judgments and decisions even without conscious awareness of their effects.

Second, note that Dr DeMaria makes yet another argument that full disclosure can resolve conflicts of interest. However, there is also evidence from experimental psychology that disclosing conflicts may give people a license to further exaggerate their communication and actions in favor of their personal financial interests, and that recipients of disclosure may not know how to adjust for it adequately (see post here.)

I disagree with Dr DeMaria. I do not think the current approach, based on full disclosure as an sufficient way to manage the conflicts caused by industry funded CME, and to manage conflicts of individual continuing medical educators, is adequate.

Finally, it appears that Dr DeMaria did not disclose his own financial relationships with commercial suppliers of health care goods and services. A bit of searching revealed that he serves or has served on medical advisory boards for CardioNet, Cardiodynamics International, and ResMed, on the scientific advisory board of BSP, and on the board of directors of Biosite. A disclosure for the American College of Cardiology ACCEL program also said he has gotten modest (2006 CME program included “Stock Options: Resmed, Biosite, Targe GW. Consulting Fees: Resmed, Targe GW, Vasomedical. Research Grants: Resmed, Acoufiant. Speaker: Acoufiant. Employment: Resmed. Ownership/Partnership: Resmed. Officer/Trustee: Resmed, Biosite. Receipt of Royalties: Resmed.”

Although Dr DeMaria asserted that physicians are smart enough to recognize bias when they see it, it isn’t clear they could recognize the effect of financial relationships which are not disclosed to them at all. Dr DeMaria didn’t give his doctor readers an opportunity to judge whether his defense of commercially sponsored CME might have been influenced by his own relationships with industry, nor did he give his readers an opportunity to judge whether his actions and writing as the editor in chief of a major medical journal were otherwise influenced by these relationships.

In my humble view, as I have said before, those who recommend particular health policy positions have the same obligation to disclose relevant conflicts of interest as do those who recommend particular approaches to clinical problems. Policy positions ought to be skeptically evaluated taking into account whether those expressing them stand to gain personally from what they advocate. Failure to adequately disclose conflicts of interest ought to inspire even more skepticism.

I fear much that this day much of the health policy debate amounts to stealth health policy advocacy.

Furthermore, in my humble thought, those who exercise editorial control over health care and medical journals have the same obligation to disclose relevant conflicts of interest as do authors of clinical research articles.

Finally, based on the experimental psychology study to which I alluded above, I doubt that even full disclosure of all conflicts in detail will allow adequate management of the conflicts of interest that now pervade medicine and health care.

[Source : Health Care Renewal]

The role of key thought leaders (KOLs) in marketing drugs and devices has been frequently discussed on this blog (see posts by Dr Bernard Carroll here and here), and on other blogs, such as the Carlat Psychiatry Blog and the Clinical Psychology and Psychiatry Blog.

The British Medical Journal just published an article providing further documentation about how such KOLs function. [Moynihan R. Key thought leaders: independent experts or drug representatives in disguise? Brit Med J 2008; 336: 1402-3. Link here.] The article was based on a discussions with a long-term pharmaceutical representative who was several times “a top national salesperson,” and articles in several business publications. Some key points were:

• Key opinion leaders are salespeople: “Kimberly Elliott, who was a drug company sales representative for almost two decades in the United Says, puts it directly. ‘Key thought leaders were salespeople for us….’ Also, “Ms Elliott states drug companies desperately need key thought leaders. ‘There are a lot of physicians who don’t believe what we as drug representatives state. If we’ve a KOL [key thought leader] stand in front of them and state the same thing, they believe it.’”
• Key opinion leaders are expected to increase drug or device sales: Kimberly Elliott stated “we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations,” she said. “If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.” Also, “the industry’s Richard Tiner, accepts that drug companies often recruit senior specialists and evaluate the return on investment they may bring. They become an integral part of the company’s marketing, education, and research strategies. ‘When these people are receiving a fee, they’re in one sense in the employment of the company,’ he says….”
• Key thought leaders are meant to parrot their corporate patron’s marketing message: “These people are paid a lot of money to say what they state. I’m not saying the key view leaders are bad, but they are salespeople just like the sales representatives are.” Also, an industry publication stated, “drug companies are then encouraged to evaluate the performance of their key opinion leaders continuously to avoid ‘wasting money on the wrong people.’” Lectures were “largely based on slides supplied by the company.”
• Key opinion leaders are well-paid: “Ms Elliott states she would pay these respected physicians $2500 (£1280; 1610) for a single lecture….” Also, “A publicly available summary of one report shows that some physicians can earn more than $25 000 a year in advisory fees. A press release promoting the other report recommends that the average fee paid to a physician for a “scientific speech” is more than $3000.”
• Doctors who show favor to particular products are groomed to be opinion leaders: “Importantly, marketing staff should find doctors who will endorse their products, ‘who may be further down the influence ladder,” and then help “raise their profile, and so develop them into thought leaders.’”

Although pharmaceutical, biotechnology, and device company spokespeople, and some of the industries’ cheer-leaders continue to insist that key view leaders are educators, this article underscores that they are merely costly marketers. What’s most insidious about the use of KOLs, however, is that many of them don’t acknowledge that they are even influenced by the money they are paid.

In my humble view, any physician or other health care professional paid as a key view leader should acknowledge that pay, its amount, its source, and its purpose in detail any time they express an view relevant to their corporate sponsor’s products or services. If disclosing “I was paid $2,000 by company x to give this speak, using slides the company provided. Company x makes drug y. The purpose of this talk is to market drug y” might make some KOLs uncomfortable, then maybe they should reconsider the compromises they’ve made by accepting this role.

Any physician or health care professional, however, who does not make disclosures at least this detailed when talking or writing on a topic relevant to the marketing of his or her corporate sponsor’s products or services is being deceptive and dishonest.

[Source : Health Care Renewal]

On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed the Doctor Payment Sunshine Act. This proposed legislation would mandate disclosure by drug companies of all payments over $500 made to doctors for speaking, consulting, travel, etc. Dr Carlat, however, noted an important loophole. The legislation would not cover payments made to medical education and communication companies (MECCs) to put on continuing medical education (CME) activities. Pharmaceutical, biotechnology and device companies often sponsor CME produced by MECCs. Such CME, although it might be accredited, may be done more for marketing than educational purposes. But payments to physicians by MECCs made with money supplied by industry wouldn’t need to be disclosed according to the present form of the bill. Dr Carlat fears that the legislation, in its present form, might have the unintended consequence of promoting even more industry-sponsored (and industry-friendly) by MECC provided CME.

[Source : Health Care Renewal]

On the Bioethics Forum, see these comments by Karama Neal. Google Health has been getting a lot of buzz for making some sort of personal electronic health record available to the masses. Too bad that, as Neal noted, “it makes sales pitches from pharmaceutical companies part and parcel of medical decision-making.” Apparently the software was designed to provide advertising pitching products relevant to a particular patient’s condition to a physician looking at that patient’s Google Health record. So in signing up for Google Health, patients are also signing up to help drug, biotechnology and device companies hawk their wares to doctors.

[Source : Health Care Renewal]

We often post about conflicts of interest affecting doctors, other health care professionals, and generally those who make decisions about health care. A rather bizarre kerfuffle has developed in Massachusetts over a proposed legislative ban of gifts by pharmaceutical and biotechnology firms to physicians.

As first reported in the Boston Herald (but full article no longer available on the web):

Taking aim at Senate President Therese Murray’s proposed ban on drug firms’ gifts to physicians, the head of GlaxoSmithKline’s U.S. operations is accusing Massachusetts of a ’strong anti-biopharmaceutical streak’ and bemoaning attempts to ‘attack and demonize’ the industry.

Christopher A. Viehbacher, president of U.S. pharmaceuticals for the British-based Glaxo, sent harshly worded letters earlier this week to Murray, Gov. Deval Patrick and House Speaker Sal DiMasi, suggesting his firm might not invest as much in Massachusetts if ‘political developments’ work to ‘devalue’ its assets here.

Viehbacher said the gift-ban provision would make Massachusetts ‘the most hostile state in the nation when it comes to biopharmaceutical sales.’

Similarly, an AP article (available via Forbes) noted:

To hear the industry tell it, the Free World would lose access to the Band-Aid if that were to happen.

‘Strictly interpreted, the `anything-of-value’ ban could bring clinical trials to a stop in Massachusetts, severely cut into necessary and mandated continuing educational studies undertaken by physicians and mean that fewer new medicines are readily available to patients in the state that’s the global hub of medical innovation,’ the Massachusetts Biotechnology Council wrote in a May 1 letter to state legislators.

BIO, the Biotechnology Industry Organization, wrote DiMasi on April 30 that ‘the gift-ban provision threatens research and treatment for patients in the commonwealth.’

However,

Sen. Mark Montigny, who authored the gift-ban provision, stated the legislation would not harm medical research, and the Life Sciences Initiative itself is proof the say isn’t opposed to the biopharmaceutical industry. The bill also expressly grants for physicians to continue receiving free drug samples from the manufacturers.

It’s clear that some people in pharma and biotechnology are greatly opposed to any interference with their capability to give doctors pens, coffee mugs, free meals, etc. They failed to explain how in the world such gifts promote clinical trials, or are necessary for continuing medical education. That at least one company executive would stoop to threatening to take the company’s business elsewhere recommends how important some leaders in pharma and biotech believe these gifts are. In the absence of any good argument that the gifts promote patient care, education or research, presumably what some company leaders really value is the gifts’ marketing effects. However, that is all the more reason for physicians to rethink why they’ve been accepting such gifts.

[Source : Health Care Renewal]