In a landmark healthcare fraud prosecution in the US last week, Pfizer Inc., world's largest pharmaceutical company, agreed to plead guilty and pay 430 million US dollars in fines and settle charges in a case involving its Warner-Lambert unit flouting the US federal law by promoting non approved uses of one of its drugs. The settlement with Pfizer includes a 24.6 million dollar payment for whistleblower, David Franklin, a scientist who reported the marketing abuses of the company to the US authorities first. The company agreed to plead guilty of violating the Food, Drug and Cosmetics Act and pay 240 million dollars criminal fine, the second largest ever in a healthcare fraud prosecution in the US. Pfizer also will have to pay 152 million US dollars in civil fines to be shared among the state and federal Medicaid agencies. Another 38 million dollars will go to state consumer protection agencies. The case began in 1996 when Franklin filed a lawsuit against Parke-Davis and its parent company, Warner Lambert, alleging that it used an illegal marketing strategy to push up sales of Neurontin in the 1990s. Neurontin was approved only as an epilepsy drug by the US FDA but the company promoted it for relieving pain, headaches, bipolar disorder and psychiatric illnesses. Franklin's lawsuit filed under the US False Claims Act, alleged that the company paid doctors to put their names on ghostwritten articles about Neurontin and induced them heavily to prescribe the drug for various off label uses. The Neurontin's sales, thus, shot up from 97.5 million dollars in 1995 to nearly 2.7 billion dollars in 2003.

What is disturbing from this case is the kind of unethical practices even the most respected pharmaceutical companies indulge in, world over, at the cost of patients. Thanks to US judicial system and the alertness of the citizens there, Pfizer is made to pay a huge fine for the violation despite the company's strong financial muscle and clout in the government. A point in favour of Pfizer, however, is that it pleaded guilty of violation of the rules and the marketing practices followed by Warner-Lambert, the company it acquired some years ago. Such a gesture can never be expected from pharmaceutical companies in India. They either contest all violations of law till the very end of the legal process or ignore the directions of the authorities if the relevant law is weak. That is what happened in the case of Letrozole in India last year. After Pharmabiz reported the off label promotion of Letrozole for female infertility by companies like Sun Pharma, Natco, Dabur Fourrts, DCGI had taken months to bring some control on such practices. And the companies have not been prosecuted for illegal promotion of the drug by any court of law in this country. As off label use of drugs can cause serious physical damage to patients, the rules against such illegal practices need to be tightened. A law like US False Claims Act can probably be introduced in India in this regard considering large number of products and services marketed with false and misleading claims.