Top 5 reasons why medical associations should maintain ties with industry

In the April 1st issue of JAMA, Rothman, et al. spelled out a proposal for controlling conflicts of interest that calls for professional medical associations (PMAs) to cut all ties with industry. PMA conferences, continuing education and practice guidelines often set the standard for patient care.

The proposal seems reactionary, albeit understandable given how quickly a handful of high-profile cases—particularly those involving failure to disclose—both blackened the eyes of science and eroded public trust.

But should a few bad apples be allowed to spoil the bunch? I say no. And here are the top 5 reasons why I propose just cutting all the bad apples loose and continuing to reap the best possible fruit.

1. Together, PMAs and industry actually do more good than harm. I could go on and on about all the good new drugs and devices have done for patient care, but we don’t have the space. I will say that I once had a 40-plus year old former patient stop me on the street to thank me for helping save his life. In my opinion, the kudos should have gone to the makers of the intra-aortic balloon pump that kept him alive while his heart recouped. Back in the day, he would never have survived that event regardless of how good the care was.

2. Industry doesn’t have as much power as you think. Industry’s power is diluted by nurses, patients and grass-roots patient advocacy groups, who together wield big clubs called prescriptive pressure and noncompliance: if a drug or device doesn’t work, nurses won’t give it, or patients won’t use it. And don’t forget the 800-lb. gorilla in the room—third-party payers—who have more power than drug and device companies over treatment guidelines and who gets what and when.

3. Industry is on the same side of the fiduciary coin as PMAs. Industry wants to save lives, too. They also want safe and ethical care. If you don’t believe that take a look at how pharma manufactures have come together to police themselves. Visit http://www.phrma.org/ and click on their outline for a revised marketing code.

4. Physicians are business people too. Physicians can’t cut ties with industry; they are industry. We like to believe that pure professionalism lies at the heart of medicine, but the drivers of treatment guidelines, namely the individual physicians and their associations, are in business. Profit isn’t a palatable word, so let’s call what they do “earning a living.” Besides, physicians can cross the line without help from the drug and device part of the industry, as evidence by anti-kickback laws that have more to do with unethical patient referrals than branded pens and notepads.

5. Together, PMAs and industry are on the ethically right path. In the Association of American Medical Colleges’ “The scientific basis of influence and reciprocity: A symposium” the authors show how self-interest can unconsciously bias even those of us who have the best of intentions, but they also demonstrate how just being reminded of an honor code stops cheating completely regardless of the amount of reward. Full transparency is a kind of honor-code reminder, and a huge step in the ethically right direction for all parties involved.

Sources:
Rothman DJ, McDonald WJ, Berkowitz CD, et al. Professional Medical Associations and their relationships with industry. JAMA 2009; 301: 1367–72
Korn D, Ehringhaus SH. Association of American Medical Colleges, The scientific basis of influence and reciprocity: A symposium. 2007. Available at: www.aamc.org/publications Association of American Medical Colleges, Industry funding of medical education: report of an AAMC task force. 2008. Available at: www.aamc.org/publications


Written by Terri Metules.

The value of in vitro data in metabolic disease: Editorial Board member Keith Suckling comments on a review by Clapham et al.

It is not unusual to read at the end of a paper presenting new biology that the novel mechanism or process being described may be a target for pharmacological intervention. The data may well have been obtained from studies in cell culture, perhaps of an immortalised human cell line, perhaps from cells genetically manipulated, and the basic picture (given the rigours of the reviewing process) may be very convincing. But there is always a strong doubt in the reader’s mind. This is because the pathway from a novel and potentially relevant piece of biology to a new drug with demonstrated clinical value is long and hazardous. At this early stage, the relevance to human disease may be little more than a hypothesis, and data of all kinds will be required as drug discovery and development takes place to validate the target.

It has been recognised for many years that one of the major problems to address is how to develop sufficient confidence in a target or agent to allow the major financial commitment that is required to be made. We need confidence that the cell culture models are relevant to an intact animal, and that the data we obtain in a pre-clinical species has relevance to the situation in the patient. Such confidence is hard to obtain, particularly for novel biology. In this review [1], Clapham and colleagues lay out the ground for metabolic disease. Apart from offering a very clear analysis of the issues involved, they make a very useful contribution by illustrating the value of data on drug activity obtained from cell culture studies and from parallel studies in laboratory animals, both in relation to the observed effects in patients. This kind of information is not readily available: it is mostly held in the experience of specialised scientists, an asset that is all too easily lost in the major reorganisation of drug companies.

A central point in the problems clearly illustrated by Clapham et al. is the proper understanding of what a cell culture model or an in vivo model can be expected to achieve. The question has been addressed for animal models in the closely related area of dyslipidaemia [1], but, probably because the relevant data are very widely scattered in the literature, the aligning of in vitro, in vivo and human data has not been widely done. The analysis of Clapham and colleagues is a welcome example of what could be done. But we need to go further. As I have noted recently [3,4], I believe we need to be much more critical of what our models can achieve and what their limitations are. Only then, as Clapham et al. clearly illustrate, will we be able to offer a rigorous scientific foundation for the difficult investment decisions that have to be made.


1. Clapham J.C., Hallén S. (2009), Cell based in vitro and ex vivo models in metabolic disease drug discovery: nice to have or critical path?, Expert Opinion on Drug Discovery, 4: 417-428.

2. Suckling K.E. (2006), The ideal model in atherosclerosis and dyslipidaemia - does it exist? Expert Opinion on Drug Discovery 1: 507-511.

3. Suckling KE (2007), Top down meets bottom-up. The critical interface for drug discovery. International Atherosclerosis Society Commentary.

4. Suckling KE (2008) Animal research: too much faith in models clouds judgement. Nature (letter) 2008, 455, 460.

By Keith Suckling, PhD, Editorial Board member of Expert Opinion on Therapeutic Patents