NEW CHOLESTEROL DRUGS ON THE WAY?

The world’s top-selling drug.  The best-selling drug of all time.  With laurels like these being attached to a cholesterol-lowering drug that has now gone off-patent, it is no surprise that pharmaceutical companies are now in a race to introduce a new cholesterol-lowering drug to the world, and reap its benefits.

Lipitor was pharmaceutical company Pfizer’s biggest drug for over 15 years.  In total, it brought in $100 billion dollars in revenue.  When Lipitor went off patent in 2011, Pfizer set into motion every strategy it could think of to hold on to its blockbuster drug.  This led to unprecedented actions in which Pfizer attempted to shut out the generics as completely as possible.  The pharmaceutical giant struck a deal in which health insurance plans would cover Lipitor, but not its generic equivalents.

Geoffrey Joyce, a professor of pharmaceutical economics and policy at the University of Southern California, said, “I knew that Pfizer would be looking at ways to discourage consumers from using the generic.  But blocking it completely seems like collusion between the manufacturer and large PBMs to prohibit a lower-cost drug.”

Pfizer used other strategies to attempt to keep a hold on the market as well, but eventually the company knew that it would have to find a new therapy for high cholesterol, and now several drugs are in the race to close in on a new product.

Enter a new class of drugs called PCSK9 inhibitors, a treatment that drug companies hope will supplement statins to achieve greater cholesterol reduction.  PCSK9 is a protein that interferes with the body’s ability to clear LDL, the bad cholesterol, out of the system.

The drugs are in early and middle-stage trials at this time, with certain pharmaceutical companies beginning to recruit patients for stage III trials at this time.  Therefore even if everything goes as drug companies hope, the drugs wouldn’t enter the market for several years.

But there are several things about these new drugs that might keep them from gaining the same blockbuster status.

First, so far, the studies have been small.  Though the results look promising, a 3 month study on less than 200 people is not enough to assess either the drug’s real promise or its pitfalls.  It is these pitfalls that have in the past been ignored and covered up at the risk of the public’s health that we should be most concerned about.

Second, though the drugs have shown that they can lower cholesterol in these small studies, they have not actually gone a step further and shown any reduction in heart attacks, strokes, or other cardiovascular problems.  This was a problem with traditional statin therapy too.  When long-term studies were consolidated and the effects of the drugs were actually revealed, it was found that statin therapy was in fact much less effective in reducing actual cardiac events than the drug companies were leading doctors and patients to think.  The true benefits of the drugs were only being seen in very narrow populations.  It would be no surprise if these drugs showed the same results.

Sidney Smith, a cardiologist at the University of North Carolina, says that these trials must show that the drug can go further than only lowering LDL to actually showing a reduction in actual cardiovascular events.  The lowering of  a marker for cardiovascular events is not sufficient.

And third, the drugs will not be in pill form, but rather will have to be injected every two to four weeks.  Lipitor would never have become the world’s top-selling medicine had it not been a pill people could pop so easily.  Therefore which pharmaceutical company succeeds in developing and marketing this class of drug will depend greatly on who can develop it into a form that it is easy to administer.

No matter what new drug therapy pharmaceutical companies introduce to control cholesterol levels, none of them will even come close to the standard lifestyle changes to diet and exercise.  They are not glamorous, and making real changes is not as easy as popping a pill or suffering through some injections.  It takes time for the benefits to make themselves known, but for the vast majority of patients suffering from high cholesterol, it is the only real and effective way to cut down on the risk of cardiovascular events.

Sources and Further Reading:

http://www.nytimes.com/2012/11/06/business/new-drugs-for-lipids-set-off-race.html?ref=health&_r=0

http://www.aarp.org/health/drugs-supplements/info-11-2011/lipitor-goes-off-patent.html

http://www.nytimes.com/2011/11/30/health/generic-lipitor-sets-off-an-aggressive-push-by-pfizer.html?pagewanted=all

http://online.wsj.com/article/SB10001424052970203347104578101082109438820.html?mod=googlenews_wsj#

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