Sam Uretsky

Pharmas Need Regulations

According to the New York Times, representatives of Eli Lilly & Co. are having discussions with federal and state prosecutors about whether the giant pharmaceutical company should pay a penalty of $1 billion for having mispromoted olanzapine, sold under the brand name Zyprexa.

The story isn’t uncommon, at least not lately. Olanzapine is an important drug for treatment of schizophrenia and severe bipolar disorder. It is not, very much not, a drug for casual use, and its package insert has a boxed warning that over 17 studies, the death rate among people using olanzapine was roughly double the rate of death in the placebo group. While the causes of death varied, most appeared to be either from heart attack or infections. This is a drug that should be reserved for people with really serious problems. The company has already accepted a settlement of $1.2 billion to settle 30,000 lawsuits for damages caused by olanzapine.

Under rules dating back to the Reagan administration, physicians are allowed to prescribe FDA-approved drugs pretty much as they see fit. If an MD happened to conclude that olanzapine might be useful in treating age-related dementia, there was nothing to prevent her from prescribing the drug for that purpose. The FDA can limit the way a drug manufacturer promotes a drug for use, but not the way the drug is actually used. If a physician uses a drug in a way that doesn’t conform to its approved indications, the patient’s insurer may refuse to pay; if the patient is harmed, there may be a case for a malpractice attorney — but it’s completely legal. It’s only a violation if the manufacturer has promoted the drug for a use that isn’t specified in the approved labeling.

Apparently Eli Lilly was advising its sales representatives to recommend olanzapine to primary-care physicians for treatment of dementia. A 2006 review of the benefits of olanzapine in dementia concluded that the drug had a modest benefit in controlling the behavioral symptoms, particularly the aggressive behavior, commonly seen in dementia, but only at the risk of death. So, while there might be some justification for using olanzapine in age-related dementia, the drug shouldn’t have been used for treatment of the early or mild dementia that can be treated in a primary-care setting.

Obviously there are many occasions when a drug causes harm but the manufacturer is innocent of any wrongdoing. Drugs are inherently dangerous, and the basis of all drug use is that the risk of harm from the drug is less than the harm from the condition being treated. Sometimes an adverse effect simply doesn’t show up during clinical trials. At other times the drug is properly promoted, but physicians don’t use it properly in spite of responsible efforts by the manufacturer. In rare cases, reports of adverse effects cluster together, giving a false impression about the safety of a drug (this is like flipping a coin ten times and having it land heads each time — the coin may be completely honest, but you conclude that there’s something wrong anyway. It happens.) But, there are also times when a company knows better, but goes after profits instead of following either the laws or ethical standards.

Not that the pharmaceutical companies are as evil as they’re sometimes portrayed. Full-strength evil, the kind that can really only be found in comic books — Dr. Sivana, Baron Zemo, Darkseid — is rare. More often, the companies, or more precisely their representatives, are responding to pressure, nothing terrible, just a need to make sales projections, a small compromise needed to keep a job. There’s no more evil intent than cheating on income tax, or speeding up when the green light turns to yellow. As far as Eli Lilly is concerned For more than 130 years, Eli Lilly and Company (“Lilly”) has sought to earn the public’s trust by upholding the highest standards in the way we make medicines, conduct business and act as a corporate citizen. The small sins grow when there are millions of people affected.

Which, ultimately, is why we need more regulatory protection, and why the Republican pro-business agenda has had such tragic results. A well-run, properly-budgeted FDA is the friend who won’t let a friend drive drunk, just as proper banking regulations would have prevented the mortgage crises, and perhaps more fuel economy regulations might have saved GM and Ford from betting their future on full-size SUVs when gas prices rose and increased he demand for small sedans.

For years now, corporate executives have been claiming that government regulations have been getting in the way of growth, when the regulations, if they had been properly enforced, would have simply prevented the corporations from driving us all off a cliff.

Sam Uretsky is a pharmacist who lives on Long Island, N.Y.,

From The Progressive Populist, March 1, 2008

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