Despite the fact that Pfizer’s newest cholesterol drug, torcetrapib, is still nearly two years away from being commercially available, the product is already creating a positive buzz due to its novel approach to reducing the risk of heart disease. The drug is also raising concerns due to Pfizer’s announcement that it only plans to sell torcetrapib in combination with Lipitor, the company’s highly successful cholesterol treatment. Unfortunately, this decision does not reflect good science, sound business practice or the interests of patients and physicians, but rather solely serves to line Pfizer’s already-brimming coffers.

Jess Cox

Torcetrapib aims to reduce the risk of heart disease by increasing levels of high density lipoproteins — so-called good cholesterol — in contrast to most current cholesterol treatment, which uses a class of drug called statins to lower levels of low density lipoproteins, considered bad cholesterol. Statins have proven widely successful in lowering the risk of heart disease, which has helped make Lipitor the best-selling drug in the world. Pfizer’s patent for Lipitor, however, expires in 2010, at which point it would become legal for companies to sell generic versions with the same active ingredient for much lower prices.

Packaging Lipitor with torcetrapib is little more than a shrewd business maneuver, allowing Pfizer to protect sales of Lipitor beyond the expiration of its patent. As a result of the bundling, anyone who wishes to take torcetrapib will be forced to use it in combination with Lipitor, and will not have the option to take the drug independently or in combination with a generic statin.

It would seem that Pfizer’s plan to only offer a combination torcetrapib/Lipitor pill would violate anti-trust regulations that prohibit companies from “tying” commodities together. Surprisingly, though, Pfizer’s plan is perfectly legal because only a combination pill (and not torcetrapib alone) is being tested in Food and Drug Administration studies. By structuring the clinical trials in this manner, Pfizer has put the FDA in a position to only evaluate the effectiveness of a combination pill, and FDA approval would shield Pfizer from anti-trust litigation.

Pfizer has stated that pursuing clinical tests of the combination pill will ensure that any potentially harmful interactions can be identified early. However, this argument does not preclude the inclusion in the trials of a set of patients taking only torcetrapib, which would allow FDA officials to evaluate whether the effects of torcetrapib were similar when used independently versus when used with a statin. If results were similar, Pfizer’s arguments for bundling — as well as its ability to protect Lipitor — would evaporate.

Interestingly, a clinical study sponsored by Pfizer that tested torcetrapib alone versus a combination of torcetrapib found that the effect of torcetrapib on HDL levels was nearly identical in both conditions. This particular study, however, is not a part of the official FDA evaluation of Torcetrapib, which Pfizer has the liberty to structure.

Although torcetrapib is a promising cholesterol treatment that should be made commercially available, FDA approval of a combination pill of torcetrapib and Lipitor would be an unwise reward of Pfizer’s anti-trust evasion and poor science. Not only would a bundled treatment provide undue protection for Pfizer’s billion-dollar baby, Lipitor, but it would also establish a dangerous precedent that other pharmaceutical companies — who are just as eager as Pfizer to protect expiring patents on lucrative drugs — are likely to follow. The result would be a huge boost in wealth for an already booming pharmaceutical industry, while concerns such as optimizing the health of patients, maximizing the affordability of treatment and adhering to long-standing tenets of scientific inquiry are increasingly marginalized.

 

 

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