Finally! Guidance on Relationships Between Experts and Pharma

Henry R. Black, MD; Michael A. Weber, MD


February 12, 2013

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Henry R. Black, MD: Hi. I am Dr. Henry Black. I am Clinical Professor of Internal Medicine at the New York University School of Medicine and a former President of the American Society of Hypertension. I am here today with my friend and colleague, Dr. Michael Weber, [Professor of Medicine at SUNY Downstate, in Brooklyn]. Michael what is ACRE?

Michael A. Weber, MD: ACRE is an acronym that stands for the Association of Clinical Researchers and Educators, a group of academics and others from all disciplines -- physicians, surgeons, people involved in cancer research and practice, people involved in cardiovascular disease research and practice, [and other medical specialties] across the board, who understand the importance of collaboration between the academic world, the clinical world, and the industries that give us our drugs, our devices, and our diagnostic tests.

Dr. Black: Why do we need such an organization?

Dr. Weber: I think you know quite well, as we all know, that those of us who are in academic medicine and have worked with industry of one sort or another are now coming under a certain measure of criticism. People seem to believe that simply because we are involved in research projects, educational activities, and such with our colleagues in industry, we might be doing something that is not quite [ethical]. Few seem to have an understanding of the win-win concept -- that if industry develops a new device or a better drug and we do research and help to establish how it should be used or where it should be used, or perhaps that it should not ever be used, that this is a vital and critical part of developing new therapies for people who need better treatment.

Dr. Black: What is the "educator" aspect of this?

Dr. Weber: Many of us get involved with continuing medical education that often, although not always, is supported by industry. Some of us are involved with more direct educational activities that might be supported by a pharmaceutical company or a device company through which, under their support, we might go to a hospital or to a group of colleagues and discuss a product or a new idea that we believe is important for progress in medicine but at the same time is using a product that is in the interest of a particular manufacturer.

Dr. Black: But don't we have to disclose our relationships?

Dr. Weber: Absolutely, and it is obvious when we do this that this or that company has sponsored our meeting, that they are the ones who brought us together. That has always been out there and I have never understood why people would have any difficulty with it. The truth is, most people do not have difficulty with it, but we are under pressure, and I think the pressure comes from those who think that as new developments come along -- better treatments for cancer, hypertension, cholesterol problems, or diabetes -- that these will be more expensive. People in the health insurance industry, for example, and people in some of the governmental agencies worry that if too much important new information comes to doctors and then on to their patients, it could have an effect on the cost of medicine. I understand their concern.

Dr. Black: If we are not participating in programs like this because no one is sponsoring them, where is the doctor who is in practice going to get this information?

Dr. Weber: That is a dismal scenario because in all likelihood they would get this information from the people who are paying for the healthcare, and they would be given a very rationed, limited amount of information in the hope that they would not too quickly take up new ideas or new approaches to treating disease.

Dr. Black: Isn't it more important that we improve outcomes than how much the initial cost actually is?

Dr. Weber: Henry, this is all about patients, isn't it? It is all about how we help people live longer and live better. Both of those are the key criteria that drive us as physicians, and anyone who gives us the tools to get that job done is a valued ally, as far as I am concerned.

Dr. Black: Where would we be without new drugs for cardiovascular disease, or in cancer care or diabetes?

Dr. Weber: You and I have been practicing medicine for roughly the same amount of time, which is a fairly long period. Since we started as young doctors, the life expectancy of the average American has increased by about 10 years, and the main part of that increase in life expectancy are the very things we have been working on: better ways of treating high blood pressure, better ways of dealing with coronary disease, better approaches to cancer. Why this should come under criticism is hard to understand, except that it does cost more, and when you keep someone alive 10 years longer that is not a cheap proposition. That is 10 more years of healthcare that Medicare or other insurers have to deal with.

Dr. Black: As far as I know, we are all going to die of something, and if we live 10 years without being sick or have 6 months where we have to deal with something that could have been prevented, that is going to be expensive. How is ACRE addressing this?

Dr. Weber: To put things out on the table, we wrote a set of guidelines,[1] a statement basically looking at all of the things doctors could do when they work with industry, whether it is consulting, doing research, being involved in publications, support of meetings for doctors, and so forth, and we said, "Let's put out a discussion of all of this with recommendations on how people like you and I and all of our academic colleagues should be reacting with industry. What is ethical? What is proper? What is going to get the best results for our patients, and what should we not do that could be misconstrued, misinterpreted, or perhaps not be in everyone's best interest?"

Dr. Black: What are the highlights?

Dr. Weber: We should be transparent about what we do. We should also be very protective of our primacy as physicians, particularly as academics who are running the research, so that when a new discovery is made, people like you and I, who do not have a direct financial interest in a commercial outcome, are the ones who explain the new data to the practicing community, and when we write papers they really should be our papers. When research findings appear in the medical literature and guide practice, the reports should not be written by a commercial entity. When we have our names on that paper, we are responsible. These are the sorts of things we talk about.

Dr. Black: I was always amused by the financial constraints, because to some people $10 is a lot of money, and to others $1 million is not.

Dr. Weber: Some of the rules do say that if you buy someone a sandwich and it costs more than $10, that sandwich may in some way compromise that person's judgment. Then these same doctors go back to the office and make decisions involving tens and hundreds of thousands of dollars and people's lives.

Dr. Black: How can people get these guidelines?

Dr. Weber: They have been published in a journal called Endocrine Practice. It is the official journal of the American Association of Clinical Endocrinologists. We went to this journal because 2 or 3 of the people on our writing committee at ACRE happened to be endocrinologists. The article is already online and will soon be out in its printed version, called the ACRE Guidelines.

Dr. Black: A few weeks ago, the circuit court in New York decided that a representative of industry could say whatever he or she wished, that it was a free-speech issue. I have always thought (and I think you agree) that this will eventually come down to that. What is your opinion?

Dr. Weber: I think it was a good decision and a heartening decision. That said, it does not mean [that you can] say things that are irresponsible, whether you are a representative of a company or even guys like you and me. We can discuss things that are off-label if they are well supported by credible research and if it is a sincere belief of ours. If people make extravagant claims for drugs or devices that are not supported by evidence, they may be misleading people in the community and hurting them. The ultimate obligation to be absolutely honest and rigorous has not changed.

Dr. Black: I wish the same thing applied to new nutriceutical companies and to people who create strange and weird diets. There seems to be no regulation of that, and the public seems to [be enthralled by those kinds of approaches].

Dr. Weber: I think we need to work hard to make sure that people understand where the real treatments and the real value are coming from.