The real statin controversy

Article Highlights

  • Doctors don't want to appear to be in the pocket of the brand-name drug companies.

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  • Gross failings of drug quality are manifest in most emerging markets.

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  • With new guidelines likely to increase the use of statins, the FDA should conduct random sampling of statins.

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Twice as many Americans are likely to be eligible for cholesterol-lowering drugs called statins, if doctors follow new heart guidelines issued by the American College of Cardiology and the American Heart Association. Statins are widely prescribed to reduce the risk of heart attacks, but the new guidelines recommend that they also be considered for people at high risk of stroke.

Mariell Jessup, President of the American Heart Association, acknowledged that the recommendations "may be very controversial-which is fine. Controversy means discussion." And they have indeed caused a stir in the health community, more so because the calculations may be flawed. But whatever the actual recommendations should be, there is a deeper and more pervasive controversy that no one is discussing: the quality of the statins Americans are already ingesting.

It's far from common knowledge, but many cardiologists will tell you in confidence that they routinely switch patients from a generic statin back to the brand original or to another generic because of clinical problems. As one cardiologist put it to me in view of the new guidelines, "the new heart recommendation may put tens of millions of more US patients on statins, and this may be the correct advice, but only if the statins work properly." But doctors are skittish about saying these things on the record for at least three reasons.

First, they don't want to appear to be in the pocket of the brand-name drug companies. Second, they're confused-after all, generics prescribed in the United States all have US Food and Drug Administration (FDA) approval. Third, it can be difficult to spot when many medicines fail, since clinical symptoms may not be noticed for weeks or months.

Dr. Preston Mason of Brigham and Women's Hospital, Harvard Medical School, is bucking the trend. He recently presented a paper on 36 different generic versions of the most widely prescribed statin, atorvastatin. The generics were procured from pharmacies in North America, Europe and Asia to "evaluate the chemical purity of generic atorvastatin." These generics were compared to the original atorvastatin (patented by Pfizer as Lipitor)-and the findings were alarming. The "widely-available" generics were found to contain an impurity that "may compromise global efforts towards the effective management of hypercholesterolemia among patients with cardiovascular risk." In other words, the statins may not work properly.

A lot of these generics are made in India, where quality is an ongoing concern. In May, one of India's largest companies, Ranbaxy - the manufacturer of generic atorvastatin - pleaded guilty to seven felony counts related to lies about drug quality data, and was fined $500 million by the FDA this May. Yet India's drug regulator, the CDSCO, still has not sanctioned Ranbaxy for its malfeasance. Even the Indian Parliament has described the CDSCO as "corrupt" and "colluding" with local companies.

My research team has sampled thousands of medicines from India and other emerging markets and found major errors in formulations in at least ten per cent of the samples. Gross failings of drug quality are manifest in most emerging markets, as estimates from some therapeutic categories show that a third of medicines fail basic quality control. But because of FDA oversight and the threat of litigation against corporate mistakes, most medicines prescribed in US do not have obvious errors.

The discerning eye will note, however, that the scientific literature is being populated with examples of oncology, transplant and other critical medicines with impurity problems like those found by Dr. Mason - some of which make their way to American patients. FDA conducts comprehensive tests on products under review, including checks for most impurities. But once a product is approved and goes on the market, FDA conducts limited quality assessments and no routine test for impurities.

I was recently contacted by a cardiologist whose patient was failing to respond to a generic diuretic and responded when switched to a different generic. I helped him test the medicine in a sophisticated laboratory, but the quality analysis found no problems. We now wonder if it was impurities in the product that caused the poor clinical performance of the medicine.

With new guidelines likely to increase the use of statins, the FDA should conduct random sampling of statins (and probably all medicines) that are actually sold in the US market, and submit these products to myriad tests to find problems with impurities. There is a growing cause for alarm as evidence of corner-cutting mounts-particularly among Indian generics manufacturers-and the products that are actually sold on the market don't maintain the same quality standards as those that received approval. Only time will tell how lethal the consequences of this corner cutting will be.

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