“We made a practical and open work environment for engineers and shop workers, forcing the guys behind the drawing boards onto the shop floor to see how their ideas were being translated into actual parts and to make any necessary changes on the spot.”
-from Skunk Works: A Personal Memoir of My Years of Lockheed by Ben Rich and Leo Janos
No, this piece isn’t about fighter jets, but I often think of the remarkable story behind the team that led to one success after another in aerospace design during the heated debates over doctor-industry relations. Interactions between doctor and the pharmaceutical industry have been widely debated and continue to be a source of controversy, though primarily in the realm of clinical trial results and post-approval marketing. A recent Cochrane review suggests more favourable results arising from industry sponsorship of research, while the influence of pharmaceutical industry on marketing of medications after regulatory approval lead to lively discussion on a recent Healthy Debate blog.
What hasn’t gotten enough attention, though, is doctor-industry relations further “upstream” in the product pipeline – before pharma reps, the FDA or even clinical trials – back to the phase of idea incubation where the need of an innovative product and its desired characteristics are identified. Despite the complicated relationships between academia, doctors and industry, opportunities for collaboration ought to be expanded at this stage to catalyze breakthrough drug discovery that could improve the quality of life for patients.
In recent years, we have seen a decline in true innovation of therapeutics in Canada: of the 192 new active substances approved by the Patented Medicine Prices Review Board between 2001 and 2009, only 19 agents were classified as category 3, a product that “provides a breakthrough or substantial improvement.” It is a reality that most drugs that enter the pharmaceutical market today offer little to no improvement over existing agents. Meanwhile, effective treatment continues to elude us for over 3,500 diseases, many of which are considered “neglected” ailments that disproportionately affect socially, politically and financially vulnerable individuals.
Physicians play an important role in medical innovation as front-line healthcare providers, medication prescribers and researchers. Their extensive patient contact each day provides them with an unparalleled view of the challenges patients face in managing their medical conditions, as well as gaps in care that create important opportunities for innovations in pharmaceuticals and medical devices.
Advocates for obstacle-free dissemination of knowledge (also known as “open-access”) argue that transmission of information without barriers is the fertilizer of greater innovation. Meanwhile, quality improvement leaders continue to call for the need to break down silos and integrate care delivery. In a similar vein, concerns about conflict of interest in pharmaceutical development may hinder collaboration between industry and the medical profession at early stages of product development. The results can be disappointing as in the case for Exubera, an inhalable insulin delivery system that promised to revolutionize the landscape of diabetes care. After 11 years of development and less than 1 year on the market, however, its manufacturer withdrew the product due to poor sales. While there are many theories about why it performed so poorly, its bulky design was at least partly to blame.
Would additional input from MDs about Exubera’s design have prevented its failure? Maybe; maybe not. But it does seem clear that failure to align the product with patient needs resulted in lost research resources that could have been better used in other therapeutic areas, an outcome that we ought to avoid. This position is well-reflected by a Working Party paper from the U.K. Royal College of Physicians, which recommends professional organizations “support research collaborations between industry and the [National Health Service] that promote higher quality of care, innovation and continuous learning.”
We want healthcare to be more innovative, cost-effective and timely, the same goals that inspired the Skunk Team. So is it truly in our best interest to lower an iron curtain between the drawing board and the front-line where new ideas are created and new products are tested?
Among the necessary ingredients for effective physician-industry relationship to take place, one is especially important: transparency. As evidenced by court documents unearthed by litigations involving the pharmaceutical industry, lack of oversight promotes a culture of placing profits before people. The Sunshine Act in the United States is a step in the right direction, and we must not forget the need to embrace public accountability while incentivizing partnerships between physicians and the pharmaceutical industry. The need to ensure ethical physician-industry relations, however, should not be used as an argument that such interactions should not occur at all.
Beset by negative business practices, it is clear that the reputation of biomedical industry has reached a historic low. However, what is also clear is the indispensable role that commercialization play in driving innovation in health care, and the potential for novel therapies to improve our health. Without front-line clinicians, basic researchers, patients and industry on board, our dream of providing effective, safe and affordable drugs for all will not take flight. We ought to recognize that regulated collaboration between physicians and industry will continue to provide the fuel for creating the next medical innovation that will further improve our health.
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Of course we should be encouraging new and innovative research into treatments, especially where current therapies are inadequate or non-existent. But a close analysis of the history of the therapeutic innovation shows that there wasn’t any past golden age that has been closed down by the increasing scrutiny over conflict of interest. In a letter to the BMJ (BMJ 2012;345:e5880) Steve Morgan from the University of British Columbia shows that since the 1950s the number of first-of-kind new molecular entities introduced annually has been remarkably stable. What has declined most dramatically is the number of late follow-ons, i.e., new additions to an already established class. While occasionally these products offer some new benefits primarily they don’t have any additional therapeutic advantages. We also need to recognize the current realities of R&D in the pharmaceutical industry that include an obsession with patent protection. Patent protection can ultimately result in both a restriction on new innovations because scientific data is not being shared and the high prices that often accompany patent protected new drugs. These consequences of patents do harm to patients. If researchers do engage with industry in early stage product development they should ensure that any of the results of that research will be accessible to everyone who needs them.
Hi Dr. Lexchin,
Thank you very much for your comment. I agree with you that the number of ‘first-of-class’ compounds has been relatively stable; however, perhaps it is time for us to reject the status quo for speed of novel drug development, especially when effective treatment still eludes us for so many neglected diseases.
Behind the development of many remarkable drugs that have expanded the clinical armamentarium for therapeutic options are stories of MD-pharma interactions. Interview given by Dr. Brian Druker (who is credited with discovery of Gleevec) with the New York Times (http://www.nytimes.com/2009/11/03/science/03conv.html?pagewanted=all&_r=0) shows that symbiotic, collaborative relationship between physicians and pharmaceutical companies is not only possible, but vital. Gleevec has transformed Chronic Myeloid Leukemia from a death sentence to a manageable chronic condition.
The story behind Herceptin and Dr. Dennis Slamon of UCLA is similar.
I agree that a clear delineation of rules, transparency and patent regulations that enable global access. However, the current climate of conflict of interest discourse that views physicians with any pharmaceutical interactions as seemingly lacking in moral compass, I fear that we may be throwing baby out with the bathwater.
I agree with much of where you are going with this argument for more collaborative ‘brainstorming’, with fewer needs for considering conflict of interest and market power vs. actual improvement of health. This brings me to the question. Why does this sort of discussion about openness, collaboration and ‘pillar dismantling’ begin only include ‘physician- ..industry(most often drug or device tech)/government ‘openness’? Why does it not also include the well trained and observant clinical researchers who are not doctors or medical doctors, highly trained care providers who by they way not only use the current constellation of good and bad ‘medical’ interventions in context with patients and families and know much more of that grass roots ‘health stuff’ than physicians, etc. The “shop floor’ and genuine translatability often offers more functional insight in the industrialized countries and the emerging countries.
Open source was the norm at the beginning of the industrial age….Open source is still alive and well in many emerging countries because it actually builds a dynamic, cohesive, creative, functional innovative community. If it is money and its current clout that is sought we should continue along the same pseudo collaborative path and make new “drugs” using the conventional models. Scientific methodology is terrific. Its interpretation into “technology” and the political/corporate power struggles that ensue reduce the ability for ALL committed, passionate investigators to do what is right for the common good and common health of humanity.
Does this discussion echo the late 1800’s when nursing and medicine gradually integrated science and population statistics into their professional practices and challenged many of the dominant notions of ‘health care’ at that time and contributed to a century of huge breakthroughs and discoveries?