An Open Letter To The PhRMA CEO On Pharma's Image
I, like many others, am very concerned about the poor image of the pharmaceutical industry. This open letter to PhRMA CEO, Mr. John Castellani, expresses these concerns and offers suggestions on how to improve things. Here’s what I have to express:
Dear Mr. Castellani:
We have never met, but I am a veteran of big pharma. I spent 30 years at Pfizer PFE +1.54% in the R&D part of the organization. Since leaving Pfizer, I have spent a good deal of time defending the pharmaceutical industry, having written a couple of books and by writing the occasional piece for Forbes.com. Given my background, I am at times dismissed as a big pharma shill by those who have negative views of pharma. But I can deal with that. Not many have had the chance to see the good that this industry does.
The negative public opinion that exists with regard to the pharmaceutical industry is sad and depressing. I personally experienced this negativity when I was on The Dr. Oz Show with industry critic, Dr. John Abramson. The audience clearly took as gospel all that Drs. Oz and Abramson said. I wasn’t shocked by this. However, I was stunned by how little credence the audience gave to my examples of the value that pharma brings. Their view was that, based on my experience, I couldn’t be trusted.
I shouldn’t have been totally surprised by the reception that I’ve gotten. The pharmaceutical industry has fallen pretty far from the public esteem it once enjoyed. I often get a surprised reaction when I talk of how pharma companies were routinely listed among the world’s most admired. I realize that you have been trying to restore pharma to those better days. However, what you’re doing doesn’t appear to be working. For example, you periodically put out press releases about PhRMA member pipelines and the impressive number of compounds in clinical development. The most recent one showed that there are over “400 innovative medicines in development for top chronic diseases affecting older Americans”. Now, you and I appreciate the hard work that has gone into the discovery of these compounds and the hopes that PhRMA companies have that these compounds will become important medicines. The problem is that this press release is meaningless to the general population. First of all, we both know that 80% of these won’t make it to patients due to the well-known pitfalls of drug development. So, while PhRMA can offer hope, it can’t guarantee that patients with these chronic diseases will soon have a treatment that will help them.
But the bigger issue is that, even for those compounds that become drugs, patients still won’t give PhRMA credit for discovering and developing them. Unfortunately, the general public believes that the real science involved in drug R&D is done by the NIH and academic institutions. They think that pharma companies simply manufacture these drugs and then charge exorbitant prices for them. You need to put more of a human face on the R&D process. So, here’s a thought for you. The FDA has approved more than 70 drugs over the last two years. Many of these are important and valued new medicines. Why not put together a group of PhRMA scientists who were key members of the teams that produced these drugs? Then, pair them up with patients who have personally benefited from these breakthroughs and ask that they give talks or meet with the media in cities throughout the U.S. I have found that, while many members of the pharma industry are viewed with skepticism, scientists still have a good deal of credibility. In addition, it is impossible not to be moved by patients whose lives have been changed by a new drug.
My next thought stems from a recent experience I had involving Dr. Ben Goldacre, author of Bad Pharma. I recently heard Goldacre speak at the New York City Skeptics Society. He proved to be quite engaging. The overflow crowd heard him expound on key themes from his book, particularly his strident view that the pharmaceutical industry hides negative clinical data. The audience hung on his every word and, as evidenced by the Q&A session afterwards, people were outraged at our industry as it was portrayed by Goldacre.
Goldacre isn’t the only one hammering pharma on the issue of clinical trial transparency. The British Medical Journal has also been critical and both cite data that the industry has only reported clinical trial study results for 22% of studies within one year of the trial’s completion. This is not a simple issue. It involves not only the release of clinical trial results but also access to patient-level trial data. In confronting this charge, PhRMA stated 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 PhRMA’s own members, GlaxoSmithKline (GSK), has already agreed to make these data available. Surely, GSK must believe that it can successfully operate in such a transparent environment.
Thus, here are two steps that you should take. All PhRMA members need to replicate GSK’s position. In addition, it would be powerful if you could stand up and say that PhRMA commits to 100% reporting of clinical trial results by 2015. This would require extra resources expended by your member companies to meet these goals. However, doing this would eliminate claims that the industry is hiding negative clinical trial data – a major issue that PhRMA faces in the eyes of the public.
Finally, another hot button that exists is around payments to physicians. Now, you and I know the important role that physicians play across the entire spectrum of the pharmaceutical business. Physicians are invaluable in terms of offering advice on clinical trials, leading these trials, publishing and discussing the results, etc. Doctors justifiably expect to be paid for this work. While these payments had long been hidden, the recently enacted “Sunshine Act” will require disclosure of all physician-pharmaceutical industry ties. Such data will be eye-opening to the public. I believe that the vast majority of these payments are justified. But it would behoove PhRMA to look at those costs with the view to how they would be perceived. It’s one thing for a physician to receive a large amount of funding to run a clinical trial. However, an all expenses paid trip for a physician and family to attend a conference in an exotic location for the purpose of hearing about a new drug won’t be well perceived. Medical education is important. But it would be great for PhRMA members to adopt a policy that would minimize the trips and trinkets and focus more on the science and content of such meetings.
I believe that the greatest challenge that the pharmaceutical industry now faces is overcoming its poor image. There are millions of people who believe that real innovation is done outside of pharma labs, that the industry hides any negative clinical trial data, and that the industry pays off doctors to prescribe drugs. You and I know this is all not true. However, unless these beliefs are changed, people will view our products as overpriced drugs with little potential benefit and with hidden safety issues. My suggestions are not a panacea, but they are a step in the right direction.
John L. LaMattina