Goldman Disclosure: Physicians and Pharma
In past blog entries, I have discussed the fact that beginning in January 2009, U.S. drug maker Eli Lilly has said it will report payments made to doctors for consulting and for speaking on its behalf. The announcement is in advance of US legislation that will make the practice mandatory. Merck and Co. in the U.S. has also committed itself to voluntarily listing the fees it pays doctors there to speak.
So far, Canadian pharmaceutical companies have not followed suit, although Eli LIlly Canada has said it will investigate doing so here. Other companies in Canada have said they will study the issue but are concerned that logistical issues will prevent them from making full public disclosure.
In this space, I have committed myself to disclosing such information voluntarily:
On Thursday, November 27, 2008, I'm hosting and speaking at a satellite symposium to be held in conjunction with Family Medicine Forum 2008 at the College of Family Physicians of Canada in Toronto. The title is "Introduction to Chronic Pain Management and the Power of Storytelling". The program has been accredited by the College of Family Physicians of Canada. In addition to hosting the program, I am speaking on how to take a history of a patient with chronic pain. My fee of $2000 is being paid through an unrestricted grant from Purdue Pharma, a pharmceutical company. Unrestricted means the company had no input whatsoever into the development of the content of my presentation.
I have made this declaration knowing full well that doing so invites criticism and approbation from some of you. However, I wanted to make a point about that. It seems to me that relations between physicians and the pharmaceutical industry have been defined in the public domain solely by critics. It reminds me of the way in which politicians are sometimes defined by their critics before they get a chance to define themselves.
At the present time, to some of us, the mere involvement of physicians with pharmaceutical companies is tantamount to a serious lapse in moral judgement. But does that mean there is nothing good to say about it? In a Commentary published in 2004 in the Canadian Medical Association Journal, Dr. David Davis, former Associate Dean of Continuing Medical Education at the University of Toronto wrote the following:
"Big pharma" involvement in CME is a mixed picture. On the one hand, the pharmaceutical industry has its own interests — it's a business, after all — and there are lots of examples of so-called educational events whose real objective is to change prescribing behaviour. On the other hand, a code of marketing practices does exist, many pharmaceutical companies are scrupulous about distinguishing between CME and promotion, and — at the end of the day — many discoveries that extend lives and reduce suffering are made in the research departments of pharmaceutical companies.
One could add to that the fact that many busy physicians -- especially those who practice in remote areas -- derive much of their continuing education from industry sponsored talks. The simplistic solution -- ban all such meetings -- would need to be replaced. In his Commentary, Dr. Davis didn't call for an end to the involvement of pharmaceutical companies. Instead, he proposed the following four suggestions to firm up the boundaries between pharma and physicians:
1. Increase the decision-making capacity of physicians. We need to assure ourselves that physicians have adequate undergraduate, postgraduate and continuing training in critical appraisal and ethical decision-making. This assurance implies both teaching and testing. Let's do both. Let's do them better.
2. Broaden the definition of "full disclosure." It may not be enough to ask the physician-speaker to "disclose" industry connections at the beginning of a talk. All CME providers, medical school and industry included, might consider indicating the full amount that industry (and other sources) have contributed to programming, so that physician-learners can discern the degree of pharmaceutical or other support. This is not a new concept.
3. Level the playing field. Some have called for greater government and professional support for continuing professional development, to balance the influence of industry. Although support from these quarters also has the potential to introduce bias, the diversification of funding sources has in fact begun: the support of the Ontario Ministry of Health and Long-Term Care and of the Ontario Medical Association for the Guidelines Advisory Committee is an example, as is the federal government's Primary Health Care Transition Fund initiative with the Association of Canadian Medical Colleges. This could be just the beginning.
4. Organize dialogue, develop guidelines, give the process legs and teeth. Who will continue the dialogue, and how? Who will develop Canada-wide guidelines and see to their application? Although guidelines do exist at the local level (the University of Toronto's are arguably the most stringent in the country and overall accreditation guidelines are in place, there is wide variability in their application. Clearly, we need a national body to take on the challenge of containing, examining and regulating the issues for all Canadian health care such as the Committee on Accreditation for Continuing Medical Education (a collaborative accreditation process of the Canadian Medical Association), the Association of Canadian Medical Colleges, the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada, among other groups.
For the record, here is Dr. Davis' article -- and his competing interest disclosure: Dr. Davis has provided advice to and has spoken at events sponsored by pharmaceutical companies. He has adjudicated in one case involving a possible abuse of CME guidelines, and he is the chair of the Ontario Guidelines Advisory Committee. He uses honoraria generated from industry activities to support the Academic Development Fund in Continuing Education at the University of Toronto.
What do you think?
Categories: Past Episodes
Previous Comments (4)
Dr. Goldman’s openness about his relationship with Purdue Pharma is welcome and such openness should be encouraged. However, disclosing relationships does not make them go away and does not mean that they do not introduce biases. In fact there is some evidence that by disclosing relationships the audience may be less critical of what speakers have to say. Furthermore, without being an expert in the field people in the audience still have no way of knowing whether or not the speaker is biased. Some older research analyzed the content of two continuing medical education courses in relation to their source of funding. Both were given at a university whose policy guidelines stipulated that all course content be controlled by the institution. Nevertheless, both courses favored the drug produced by the sponsoring company relative to other, equally effective, drugs produced by other companies.
Not only might there be subtle biases but many doctors are naïve about whether or not they will be influenced by interactions with the pharmaceutical industry. A survey of Scottish hospital doctors and general practitioners revealed that 40% felt that industry sponsorship created a conflict of interest, but only 14% thought that attending such events would bias the way they prescribed. Only 1% of medical house staff felt that they personally would be heavily influenced by interactions with the pharmaceutical industry versus 38% who said they would be influenced a little, and 61% who denied they could be influenced at all. Interestingly, however, the same physicians were not so sure of their colleagues: 33% thought their colleagues could be influenced a lot, 51% a little, and only 16% believed other physicians would not be affected at all.
What about the industry guidelines that Dr. Goldman speaks of? The pharmaceutical industry makes no attempt to proactively monitor compliance with its code but relies on complaints. Complaints are adjudicated by a committee dominated by industry representatives and the only substantial penalty for violating the code is a fine which starts at $10,000 (rising to $50,000 for 3 violations in a year). $10,000 for a drug company is “lunch money”, the price of doing business.
Let’s remember that the pharmaceutical industry is not subsidizing continuing medical out of the goodness of its heart. It’s doing so because in the long run it thinks that it will contribute to the bottom line. There’s nothing wrong with the bottom line for business but that bottom line may not be in the best interests of doctors and their patients.Joel Lexchin, November 28, 2008 10:43 AM
Joel Lexchin provides us with all the reasons why disclosure is not a sufficient remedy. It is not a sufficient remedy for physicians and medical researchers in general, and it is even less sufficient for a physician who has an important role as public educator.
The question Dr. Goldman has to ask is: could my professional obligations as a physician with an important public voice be affected or seem to be affected by my acceptance of money from a pharmaceutical company?
Conflict of interest rules are as much about safeguarding public trust in professionals as it is about avoiding that people act unprofessionally as a result of their other interests.
Everyone knows, and evidence confirms this, that gifts and financial payments create relationships and obligations. Dr. Goldman may rightly think that his obligations end with his presentation, but people generally do treat those who gave them something differently, whether consciously or unconsciously. You don’t spit on the hand that feeds you. $ 2,000 may be seen as not a huge amount, but it is clearly more than a token. And where do we draw the line? If one $2,000 presentations is fine, what about three of them?
Accepting an honorarium appears to put Dr. Goldman in a more difficult position when good judgment requires him to be critical, e.g. when judgment about a company’s product, policies or behaviour is appropriate.
Any physician has to use such judgment on a daily basis when prescribing medication. For a public commentator, another conflict is added. Over-consumption of pharmaceuticals, appropriate researching and reporting of side-effects, and disease mongering are among the major challenges of our health care system. It is not unlikely—in fact it would be very appropriate—that Dr. Goldman touches on this in his program. Receiving payment from a pharmaceutical company leads in that context to an undeniable conflict of interest.
The scenario outlined above is precisely the reason why many news agencies (e.g. Bloomberg) have very strict conflict of interest rules: their journalists are not allowed to have any financial interest in or receive any payment from an industry which can be affected by their work. If this is the rule for journalists, it certainly should be the rule for public scientists, who are often even more blindly trusted. I therefore recommend that Dr. Goldman sends his money to Doctors Without Borders, and commits to never receiving an honorarium from industry again.Trudo Lemmens, December 3, 2008 11:03 AM
It is interesting that the first commentary on Dr Goldman's article is by a noted critic of the industry. Does one need to declare their bias when they only consider one side of an issue?Steve Willson, December 8, 2008 6:37 PM
Dr. Goldman; thanks a 10^6. I have learned so very much about the seemingly 90% of medicine that is not the "why am I ill and how can I be well" but, appear to manifest from a secret society whose protocols and mechanisms are obfuscatory, self serving and bureacratic and seemingly serve only to maintain distance from patient and doctor and the mystique of the shaman.
I now know a litle more about why I sit in discomfort for up to 12 hrs counting nurses while the lone doctor attends to the out-patients.
I am also a little more sympathetic when i see what could pass for an all knowing sillence when it fact the human on the other side of my questions ponders medical answers but strives to balance the shaman effect with the business aspects and legal aspects and...maybe even just wants to end this 300th attention to someone else and tennd to his own life?
So, now to my insider 'secrets';
research is most often backwardly directed ie, these are thes results we desire and what experiments can we design that will insure publication AND the results we desire? These results and those methodologies are the content of research group meetings every week in most medical research facilities. I have 9 publications to that end and 6 that were supressed because the results were 'counter-marketable' or exposed difficulties in the long and winding road to drug certification.
Despite your warnings that this 'may' manifest I am sorry to report that it IS the way research is administered.
I could go on.........