COMMENTARY

Don't Turn Your Back on Industry, but Keep It Honest

Jeffrey A. Lieberman, MD

Disclosures

December 19, 2012

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Hello. This is Dr. Jeffrey Lieberman of Columbia University, speaking to you for Medscape. I would like to talk to you today about relationships between the academic medical community and the private sector, pharmaceutical and biotechnology companies.

My comments are prompted by an article[1] that was published on November 24 in the Washington Post, which was highly critical of GlaxoSmithKline and the pharmaceutical industry because of studies that were done with the hyperglycemic agent Avandia (rosiglitazone), which was subsequently recalled.

The last thing I want to be known as is an apologist for the pharmaceutical industry in terms of defending any unscrupulous or mercenary behavior. However, I think we need to be aware of the fact that the pharmaceutical and biotechnology industry is the private sector, which is involved in the drug development enterprise. It is an essential industry in our society and vital to the medical field in terms of being able to further progress in developing treatments for medical illnesses and disease. In other words, we cannot tolerate what would be unprofessional and inappropriate, dishonest, or harmful behavior, but at the same time, we have to resist the temptation to throw the baby out with the bathwater.

The article that was published in the Washington Post was entitled "As Drug Industry's Influence Over Research Grows, So Does the Potential for Bias." The article was referring to a study that was published in the New England Journal of Medicine on December 7, 2006.[2] The lead author was Dr. Kahn for the ADOPT Study Group, and the study was on the glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. This study was a comparison of oral hyperglycemic agents, and it found that rosiglitazone was superior for glycemic control compared with the other agents.

Subsequently, after the drug was released and marketed successfully, concerns about cardiac toxicity emerged. The drug was ultimately recalled, and there have been some medicolegal actions that have occurred in the aftermath.

The Washington Post article reviewed the history of this, calling into question relationships between the investigators from the academic community and the pharmaceutical company, who did not report or failed to detect the signs of safety risks. Therefore, the article pointed the finger at the investigators as having an unhealthy relationship with the pharmaceutical industry.

This is extremely worrisome, but the fact of the matter is that this does not mean that the academic medical community and physician investigators should not or cannot be actively involved collaboratively in the drug discovery and development process. Indeed, this type of interaction and collaboration is not just helpful but is essential if we are going to sustain medical progress in developing treatments for human disease.

We need to understand that although there have been wrongdoings in some instances by both industry and academic physicians collaborating with industry, we should not throw the baby out with the bathwater. The pharmaceutical and biotech industries are not the tobacco industry. If the tobacco industry went away tomorrow, no one in our society would be necessarily the worse off for it. If the pharmaceutical industry disappeared, we would be in big, big trouble.

We have to realize the limitations of the environment in which drug development occurs. Drug development is not for the faint of heart. It is not an easy or inexpensive process. It is very labor intensive, very expensive, and is subject to the regulatory oversight of the US Food and Drug Administration (FDA) legislation and policies and procedures. Everybody wants treatments to be developed faster, less expensively, and be brought to market and made available for clinical use faster. However, given our current FDA development process -- phase 1, phase 2, phase 3 preclinical testing -- we have to realize that by the time a drug has an NDA (new drug application) submitted to the FDA and is approved for marketing and clinical use, only a limited number of people have been exposed to it, from as few as 2000 to as many as 5000 people. The amount of time that they have been taking the drug ranges from a few weeks or days to 1-2 years at the longest.

For toxicities that are rare or infrequent, it may not be statistically possible to detect them at that point. Postmarketing surveillance is essential to bring them to the attention of the medical community and the FDA, and that is what is done. The concern that was pointed out in the article was that, in the rosiglitazone study, there were data indicating concerns about toxicity in the phase 3 testing of the comparative-effectiveness studies that were done, and they should have been reported. Whether that was or was not done is a matter of question. The point is that if we want drugs to be developed as quickly as possible and if we want to try to keep the cost of drug development down, we have to realize that everything and anything about the drug that we would like to know may not be apparent at the time the FDA approves a new drug application. The drug is then used for broader clinical uses and is marketed broadly.

We have to understand this limitation and not expect what is unreasonable unless we want to allow longer periods of time for drug development, more people exposed for longer periods of time, and increased expense. It is a tradeoff.

My admonition is that we have to interpret these instances that raise concerns about potential unhealthy relationships between academic physicians and the pharmaceutical industry and the conduct of the pharmaceutical industry with a broader understanding. Inappropriate actions or transgressions cannot be tolerated, but at the same time, we need to not vilify or demonize but constructively engage industry and the private sector, developing ways to collaborate that are transparent, and reduce or minimize the possibility for unprofessional behavior.

I encourage us to be vigilant and alert, but at the same time, to not turn our backs away from engaging with the pharmaceutical industry and to not vilify them in a way that is going to ultimately be counterproductive to our society.

This is Dr. Jeffrey Lieberman, speaking to you from Columbia University for Medscape. Thank you for your attention.

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