he problem of undue influence from industry on the “House of Medicine”: Much has been written about the uncomfortable marriage between the businesses that identify, develop and sell their wares to physicians and the physicians who are entrusted with making unbiased recommendations regarding the medical care of their patients. In her recent book “The Truth About Drug Companies: How They Deceive Us and What to Do About It,” Marcia Angell, former editor of the New England Journal of Medicine and a vocal critic of the undue influence of large pharmaceutical companies on the House of Medicine, reminds us that Americans spent more than $200 billion a year on prescription drugs in 2004, and the figure continues to grow at more than 10 percent per year.¹ She tells us “… the magic words, repeated over and over like an incantation, are research, innovation and American. Research. Innovation. American. It makes a great story.” Dr. Angell goes on to point out that the budgets of the big drug companies for research and development (R&D) are dwarfed by their vast expenditures on marketing. Despite the repetitious cries from industry about the expenses of R&D, the pharmaceutical industry has been far and away the most profitable industry in the United States for more than 20 years.

Here is the downside of close relationships between individual physicians and representatives from the pharmaceutical industry. The truth is that massive expenditures on marketing do work.² Pharmaceutical companies spend more than $15 billion each year promoting prescription drugs in the United States. One-third of that amount is spent on “detailing,” an industry term for drug company representatives’ one-on-one promotion to doctors.³ The practice of hiring attractive, young college graduates to roam from physician office to physician office under the guise of bringing them the most up-to-date medical information, along with a luncheon for all of the office staff, is effective: It results in more drug sales.

Even more concerning is the concept of identifying “key opinion leaders” and paying them to blanket the country with lectures in which they present convincing arguments supporting the use of a specific product. Often these arrangements have gone too far, arrangements where physicians who were high-volume users of a specific product were paid “consulting fees” for doing little more than using the products.⁴ On September 27, 2007, the U.S. Department of Justice reported that five companies agreed to pay $310 million in addition to compliance and monitoring in order to settle concerns over kickbacks to surgeons performing hip and knee replacement surgery.⁵ Also, earlier this year, the U.S. Senate Finance Committee called for increased oversight by the Food and Drug Administration (FDA) and additional measures to ensure resolution of speaker conflicts of interest from the Accreditation Council for Continuing Medical Education (ACCME) to quell the pharmaceutical industry’s ongoing use of continuing medical education (CME) venues to unduly influence physicians prescribing practices.⁶

As physicians, we are here to serve our patients. Is there any value to patients when physicians collaborate with industry?

The benefits to medicine of collaboration with industry: There are many benefits to close collaboration — mutual benefits to physicians and our patients and to those in the drug and medical device development world. It is estimated that identifying a new chemical entity and bringing it to safe and effective use in actual patients will cost $802 million⁷ and can take 10 or more years. Our colleagues in industry have the expertise and ability to obtain and secure financial backing, ensure that a comprehensive development plan is assembled with benchmarks for performance and an actual timeline, and they also can absorb the costs of failure. An individual investigator in the laboratory has little chance of bringing a new drug through the development pipeline and should be left to discovery, free from the burdens of development. However, few companies have the needed expertise within their own ranks to understand the real value of a new concept to patients or to formulate the best approach to development. Experts who spend the bulk of their time caring for patients are valuable consultants in all phases of development. It is the practicing clinician who often points out a make-or-break flaw in a new product early in development that avoids a costly program that was ill-conceived from the start. Likewise, assembling clinical trial protocols in ways that will prove most meaningful to the largest group of patients (rather than just the most profitable) requires clinical expertise, not business acumen. I have served as a consultant to drug and device developers, and I have always found this to be a rewarding way of applying my clinical expertise in a meaningful way. Indeed, I have watched the ups and downs of numerous drugs and devices in development, and I have found that most development teams are eager to understand the real value of their ideas in actual patient treatment. Industry is in need of our expertise as practicing physicians, and we have valuable input to give that will benefit our patients in the long run.

Now back to those individuals working at the bedside or in the laboratory who are creating new knowledge and finding innovative approaches to improving the health of and well-being of humanity. Well, they need protected time, and time away from clinical duties is the currency of academic medicine. Our industry sponsors have been generous in providing unrestricted grants, and our own Foundation for Anesthesia Education and Research (FAER) — largely supported through direct funds from ASA — has been the benefactor of this generosity from time to time. FAER, in turn, funds a highly competitive grant process that provides grants to young researchers who go on to be clinician-scientists and leaders in our discipline — the very individuals who are responsible for some of the leading discoveries in our field. Indeed, more than a handful of the well-known leaders in academic anesthesiology began with FAER funding and went on to develop long-term and successful National Institutes of Health-funded research programs. We owe this, in part, to support from our colleagues in industry, and we will look to them in the future to continue this support and ensure the livelihood of research in our field.

Finally, education is expensive, and industry has been very supportive of CME by providing educational grants for CME programs. Yes, the U.S. Senate Finance Committee has taken aim at CME programs where little of value gets across.⁶ In a detailed report issued by the committee in April 2007, the committee called for more oversight from the FDA on CME programs where off-label use of drugs is promoted, and it called for clearer guidance from the ACCME regarding speakers with significant conflicts of interest and resolution of those conflicts before the lecture begins. Why the hubbub? You have been there, to the evening lecture where a highly paid consultant to a given company gets up and espouses the superiority of a specific product, all too often using the slide deck prepared by the company itself. Nonetheless, there are examples of valuable education that would not be available without industry support. One example is that of leading spinal cord stimulation (SCS) device manufacturers: They all fully fund programs that allow pain medicine fellows to attend cadaver-based workshops taught by experts to introduce them to SCS and familiarize them with the currently accepted surgical techniques for implantation. These courses are a valuable start — yes, they are meant to familiarize fellows with a given brand — and they remain applicable to all brands and do provide valuable education.

Even more exciting is the promise of new ways to educate. I have long been a fan of medical simulation, but it was never clear to me that this approach could be adapted well to training in areas such as image-guided intervention or regional anesthesia. I was recently asked to look over a simulation package that was developed in collaboration between Boston Scientific Corporation and Medical Simulation Corporation to help interventional cardiologists learn how to perform cardiac catheterization, angioplasty and coronary stent placement. The simulation began with a patient in the emergency department suffering an acute myocardial infarction and continued through diagnostic work-up and moved on to the cardiac catheter laboratory where actual angioplasty and stent placement were simulated in real time. Not only was the decision-making on the mark, but the look of the cineangiography and the feel of the catheters as they were inserted and advanced was very realistic. Using simulation has proven so valuable in the field of cardiology that generic simulators have been developed and integrated into the education of cardiologists at a national level. Such usage was possible only through Boston Scientific’s investment and promotion of the initial simulators. Simulation continues to evolve, and I am certain that this approach will replace the archaic and limited cadaver-based workshops of today: With direct support from industry, we are likely to perfect these valuable educational tools more quickly.

Striking a balance: For better or for worse, industry and medical practitioners are wed, so we must strike a balance. We all must avoid the undo promotion of specific products that offer no real advantage to our patients. Thought leaders should be certain that they provide a balanced view in each and every lecture and workshop they conduct; those in the audience, the participants, must cry shame when they see such undo promotion in the events they attend. To remain in balance, we must allow industry to call on us for our expertise as it develops new technologies, and we must plead with industry to continue to help us fund the much-needed research and education that will benefit our patients now and into the future.

References:
1. Angell M. The Truth About Drug Companies: How They Deceive Us and What to Do About It. New York: Random House; 2004.
2. Fugh-Berman A. Ahari S. Following the script: How drug reps make friends and influence doctors. PLoS Medicine/Public Library of Science. 2007; 4:e150.
3. Adams M. Drug reps use psychological tactics to successfully influence doctors’ prescribing habits. July 30, 2007. Available at www.NewsTarget.com/021956.html. Accessed on October 31, 2007.
4. Gold J. Medical Implant Makers Pay $310M For Kickbacks. September 28, 2007. Available at www.manufacturing.net/
Medical-Implant-Makers-Pay-Over-Kickbacks.aspx.
5. Christie CJ. United States Department of Justice. Five companies in hip and knee replacement industry avoid prosecution by agreeing to compliance rules and monitoring. September 27, 2007. Available at newark.fbi.gov/dojpressrel/2007/nk092707
.htm. Accessed on October 31, 2007.
6. Baucus M, Grassley CE. Committee staff report to the chairman and ranking member, use of educational grants by pharmaceutical manufacturers. April 2007. Available at www.acme-assn.org/home/prb042507a.pdf. Accessed on October 31, 2007.
7. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003; 22:151-185.

James P. Rathmell, M.D., is Director, Massachusetts General Hospital (MGH) Pain Center, Department of Anesthesia and Critical Care (MGH), and Associate Professor of Anaesthesia, Harvard Medical School, Boston, Massachusetts.