Has the regulation of physician-industry relationships gone too far? That very topic is gaining momentum rapidly in the health care debate, and a recent article from Internal Medicine News carefully captures both sides of the argument.
Arguing that regulation is harmful, Dr. Michael Gonzalez-Campoy is an endocrinologist in Eagan, Minnesota, a charter member of the Association of Clinical Researchers and Educators, Former President of the Minnesota Medical Society and a member of the American Association of Clinical Endocrinologists board of directors.
On the other side of the discussion, Dr. Carlat, an associate clinical professor of psychiatry at Tufts University, Boston, and publisher of the Carlat Psychiatry Report.
Dr. Gonzalez-Campoy’s approach at declaring why less regulation of industry relations ties is simple because he starts with three facts:
First, treatments, including medications that are developed through industry-physician relationships help to manage and cure diseases, especially those that are life-threatening.
Second, by working with industry, physicians have developed and made available the vast majority of current treatments through research and development, physician education, and joint monitoring for postmarketing safety.
Finally, participation in research and development, and education of peers on this research, is part of the legal, moral, and ethical work product of physicians because “payment for the work … represents a commonality of interests that is an integral part of the profession of medicine. Moreover such collaboration “improves in patient care, advancement of science, and benefit to medicine from these professional activities.
Letting critics think that physician-industry relations are corrupt will only hurt patients and medicine by “hindering research and development and disrupting the expedient implementation of newer, safer, better treatments.” If such a disruption occurs more disease will spread, and fewer treatments will be available, leading to a higher financial cost to the health care system.”
Dr. Gonzalez-Campoy summed up his recommendations for the future precisely: “Physicians should be proud of the value that comes to science, the profession of medicine, and patient care from the constructive partnership between physicians and industry.”
Although Dr. Carlat believes that regulation of physician industry relationships is necessary, he absolutely agrees on one point: “Interaction between industry and physicians is a good thing … and is crucial for scientific progress because pharmaceutical and device companies depend on doctors for advice on how to design research.”
Physician industry relationships are also important because they help enroll patients in clinical trials to test new treatments, the results of which are used to devise new instruments and procedures.
As Dr. Carlat also correctly notes, physicians depend on industry to develop and market the treatments we and our patients need.
Dr. Carlat himself says that he does not “want to prescribe blindly, and wants to know the right dose, the side effects, how the drug is metabolized, and more.” Like almost every physicians who relies on industry, Dr. Carlat depends “on the manufacturer to tell him these things.”
He also depends on the manufacturer because he “reads their package inserts and ads, and he talks to their reps.” Interactions he calls “completely legitimate,” because like every physician, doctors know going into such interactions ahead of time that they are purely marketing.
Carlat even asserts that “companies make products and have every right to educate us about how to use them.” For once, we could not agree with him more. So then what are the problems that Carlat sees the need for more regulation?
He wants more regulating when it comes to comparing the effectiveness of one drug to another. Dr. Carlat feels that physicians should not go to companies that produce drugs for advice on what drug to choose for a particular treatment because those companies have a “financial interest” in convincing doctors one way or another.
Dr. Carlat also acknowledges that he would not go to a physician for advice about the effectiveness of a drug if a physician was paid to promote it. The problem with this theory is that physicians who are paid to conduct research and clinical studies on drugs are the most knowledgeable and experienced in the field. Their payment is based on their expertise and service. It’s not like physicians are getting paid for every sale of a drug or device they are working on but, they are saving lives and making people healthier.
The only reasoning Dr. Carlat uses to discredit physician interactions with industry is by saying that “if you have a financial incentive to paint the truth a certain way, it is highly likely that you will respond to that incentive.” What Dr. Carlat seems forget about a very obvious factor: physicians who have such interactions are not painting any truth when the drugs they are paid to study are actually effective, or effective enough to recommended as one of many options for treatments.
Dr. Carlat’s solution is to “allow industry- funded research, as long as companies agree to publish all their findings, even when negative.” This is something we both agree on (except the term allow is a naïve term for government control – we allow you to, not it is your right to), the only other caveat is that companies should be required to submit for publication good and bad research post phase II, (prior to that much of the data is proprietary and not always applicable or publishable) companies have no control over publication, therefore should not be penalized for studies not being published.
Dr. Carlat also wants to keep doctors working with industry because it gives such physicians expertise, and “such experts should be free to provide education to their colleagues.” He feels however, that such venues should not involve industry funding. Then who is going to pay for hosting such events? If industry cannot, our doctors will lose out on valuable education from the expertise physicians have gained in working with industry.
There is no question that clinical research and development must be physician led, and therefore those leaders should also take the lead in the development of education, and pass it on to their peers. To exclude such doctors who have the most experience would only harm medicine. Patients must realize a very simple idea about medical education: just because doctors go to a particular source for information that is not a ‘complete medical education.’ There are many sources doctors use to help treat patients, and medical education is only one of many.