Polarized debate about drugs harms patients
John L. LaMattina Ph.D.
What effects do polarized debates around drug companies have on patients? John L. LaMattina discusses.
The ongoing debate between critics of the pharmaceutical industry and the industry itself is starting to mimic the current, party-based, rancorous discussions in this country on the financial budget. Just as these discussions repeatedly edge the country closer to a fiscal cliff, the pharma debate has the potential to harm the very patients that both sides care passionately about. On one side you have the “Anti-Pharma” contingent represented by Drs. Marcia Angell and Ben Goldacre. Angell, the former editor of the New England Journal of Medicine, has a variety of issues with the pharmaceutical industry but her main themes are that the industry produces little innovation and that its primary mission is to exploit the consumer. As she said in a recent interview:
“The drug companies do almost no innovation nowadays….All they have to do is late development. And that’s the clinical trials.”
Goldacre, a UK based physician, has concerns that are also broadly based, but clinical trial design data transparency is a major one. He has notably published his perspective in the following way:
“Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresented patients, and analyzed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments.”
“Despite these claims, it needs to be acknowledged that there has been a renaissance of new drug approvals with the FDA having approved over 70 new products in 2011 – 2012.”
Despite these claims, it needs to be acknowledged that there has been a renaissance of new drug approvals with the FDA having approved over 70 new products in 2011 – 2012. Pharmaceutical company innovation has been responsible for many of these new drugs which treat a wide-variety of diseases including cancer, heart disease, viral diseases and inflammatory diseases. Not to acknowledge these contributions strains the credibility of the speaker. Similarly, saying that clinical trials are run in “weird, unrepresented patients” ignores the impact of both the FDA, who must approve these studies, and the physicians who carry these out in academic centers. The FDA would not approve drugs tested in such a manner.
For those who devote their life’s work to discovering and developing drugs, these unfounded criticisms are insulting. Worse, they cause people in the pharmaceutical industry to dismiss anything else the speakers have to say, ignoring points that might have some validity.
The “Pro-Pharma” contingent is represented by the Pharmaceutical Research &, Manufacturing Association (PhRMA) and PhRMA is not exactly a white knight in this debate. When confronting the charge of hiding clinical trial data, among its arguments PhRMA states that “[Demands]to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials.” Unfortunately, the validity of this claim must be questioned as one of the world’s largest pharmaceutical companies, GlaxoSmithKline (GSK), has already agreed to make these data available. Surely GSK must believe that they can successfully operate in such a transparent environment.
PhRMA also has trouble getting its members to follow its own principles. PhRMA has established guiding principles for Direct-To-Consumer (DTC) advertising, ads that are a particular lightning rod for industry critics. The problem is that a recent study has shown that the industry ads consistently violate principles set out by PhRMA in these same guidelines. “Anti-Pharma” proponents can easily point to such transgressions as examples where PhRMA cannot self-police itself despite claims that it is fixing its issues.
“For those who devote their life’s work to discovering and developing drugs, these unfounded criticisms are insulting.”
However, while both sides continue to point fingers at each other, it is the patients who are bewildered. Are medicines safe? Do medicines actually provide the benefits claimed? Such doubts will cause people to stop taking drugs that would truly benefit them. As the Department of Health and Human Services showed last year, when adults with chronic diseases do not take their prescribed medications, health care costs go up. Unfortunately, patients hearing these conflicting views are likely to avoid medicines that they may truly need, causing harm to the patients and driving up the costs of healthcare at a time when these costs must be reduced.
Just as the political parties in the U.S. need to tone down the polarized rhetoric and begin to address their mutual concerns more rationally, so too do the “Anti-Pharma” and “Pro-Pharma” factions. All aspects of healthcare need improvement if we are to improve the overall health of people and do so in a financially responsible way. Millions will benefit.
About the author:
Dr. LaMattina is the former president of Pfizer Global R&,D and the author of “Devalued &, Distrusted – Can the pharmaceutical industry restore its broken image?”
How can polarized debates in pharma be reduced?