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Why is the pharmaceutical industry pulling away from the cardiology market?
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At the annual Cardiology Today Editorial Board Meeting, held in November during the American Heart Association’s Scientific Sessions in New Orleans, our panel of cardiovascular experts discussed a variety of current cardiology events and topics. This year, the question of why pharmaceutical companies are shying away from the development of cardiovascular drugs was one of the most important points of discussion.
Based on the thoughts and ideas that came out of that meeting, I spent some time during the remainder of the AHA meeting and at two other subsequent meetings asking pharmaceutical industry professionals from big and smaller companies: Why is the pipeline shrinking? Why is the industry getting out of the CV market?
A common theme
I spoke to many people from the pharmaceutical industry, including six large companies and a comparable number of smaller ones. The common theme among them is that there is increased regulation related to drug development and marketing, but that message is more complicated.
When I inquired what they meant, many said that their point was that new entries in CV medicine address large targets. They explained, for example, that a novel drug designed for an acute coronary syndrome target population would need to shave 15% to 20% off the current event rates. The phase-3 clinical trials required to prove that this compound achieved such a goal would require approximately 10,000 patients and two trials, as well as a prerequisite phase-1 “proof of concept” and dose-ranging phase-2 trials. This investment would require a return in the range of a $1.5 billion/year. This would also require a very large sales force; for example, a minimum of 15,000 people. These marketing prospects are almost too large to be realistic for most companies in the current economic setting.
Then, they told me, when you consider that reimbursement is also being ratcheted down, a $1.5 billion drug – and its 15,000-member sales force – is just not an ideal business proposition right now and in the future it may not even be profitable.
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Clinical trials present a problem as well. To develop the $1.5 billion CVD drug, companies have to develop it in a situation where event rates (ie, for ACS) are continuing to decline. Just about everybody I spoke to said this means that they have to have huge, costly trials to prove that, in fact, there’s a difference, even a small difference in the future. Several company executives also mentioned that the increasing emphasis on gender and minority differences makes future clinical trials even more complex.
Patent life also hurts companies. Use-patents are just about worthless, according to a couple company executives. Manufacturers used to be able to extend their patent or get a use-patent on an established drug for a new indication; however, nowadays that has little use.
Large purchasing agreements by hospitals and businesses that pay for the insurance for large numbers of employees are becoming so complex that it contributes to the marketing nightmare for these areas. Several others mentioned that they‘ve been scared off by what they call “high-profile duds,” blockbuster-promising drugs like torceptrapib (Pfizer), for example. Another group mentioned that in the last five years the bar for efficacy and safety of CV agents has become very high; it just becomes almost impractical.
One executive told me, “It’s a field where you can’t dabble. You can’t just dip your toe in anymore. You’ve got to be a big player or forget it.” Another one said the incremental benefit in CVD is so small that it’s just not worth it compared with other diseases like cancer.
Are they really leaving?
But are they really pulling out all efforts to develop new CV therapies? Some of the company executives I spoke with told me that if you actually look at the percent of people in a company’s work force, it’s not that they moved away from CV drug development. It’s just that they’re developing for different areas and putting those developments under different names.
Pfizer has $100 million invested in the development of regenerative medicine, which is apparently where it has several CV stem cell programs. Novo Nordisk and Novartis are putting huge money into development of cell therapy treatments for diabetes and related insulin resistance disorders which, again, could be under other areas and not CVD, where they express their adverse outcomes.
GlaxoSmithKline and Johnson & Johnson are likewise investing huge amounts of money in antiinflammation areas that could target atherosclerosis but they’re not calling them CV.
I also learned there’s a lot of fear and uncertainty. The pharmaceutical companies don’t want to be viewed as failures. Nobody wants a dud on their resume and they are trying to hedge their bets a little bit. If something falls into the trash can and is a dud in regenerative medicine, everybody says, ‘so what?’ But if it’s a dud in the CV pharmaceutical field where you’re supposed to succeed, it becomes a media-generating, high-profile event.
The generics
A 2006 article in Forbes placed some of the blame on the “unprecedented flood of generics” as the immediate problem. Some household names like Zocor, Pravachol, Zoloft and Norvasc are now generic. The article cited “new drugs to boost good cholesterol in testing at Pfizer and elsewhere.” But we all know where that notion has gone with the torcetrapib bust.
While some executives say that they’re not throwing in the towel just yet, it sure looks like it from this end. But can you blame them?
Carl J. Pepine, MD, is Eminent Scholar, Professor, Division of Cardiovascular Medicine, University of Florida, Gainesville. He is Chief Medical Editor of Cardiology Today.
For more information:
- Forbes. 2006;177(5).