Patient safety will remain at risk until big pharma's top executives are brought to book for their companies' actions, says Paul Thacker
THERE have been so many stories about pharmaceutical companies promoting the misuse or abuse of their drugs that the names seem to merge - Zyprexa, Seroquel, Paxil and more.
The latest case concerns GlaxoSmithKline's Avandia (rosiglitazone), an anti-diabetes drug linked to heart attacks. Last month, the European Medicines Agency recommended its suspension from the market, while the US Food and Drug Administration made it all but impossible for doctors to write prescriptions for the drug.
With sales worth over $3 billion in 2006, Avandia was the world's best-selling diabetes drug until May 2007, when The New England Journal of Medicine published a study linking it to heart attacks. Reporters circled, and the finance committee of the US Senate investigated, forcing GSK to hand over internal documents.
As the main investigator into Avandia for the Senate committee for the past three years, I looked closely at the documents. I was appalled. From 2000, GSK pulled out all the stops to keep the drug on the market. Not all studies were provided to regulators, and it intimidated a doctor who criticised the drug. Even though GSK is in the middle of multibillion-dollar lawsuits brought by thousands of patients, it still has hundreds of documents hidden from public view under court seal - a feature of the US system that leaves documents provided under discovery accessible only to the parties involved in the litigation.
How can we stop this? One way is to slash what pharma can spend on encouraging doctors to prescribe their drugs. Companies spend billions wining and dining doctors. For instance, Forest Laboratories' 2004 marketing plan for its antidepressant Lexapro notes it planned to spend $34.7 million to pay doctors to give lectures to their peers, and $36 million on lunches for doctors to create "an extended amount of selling time for representatives".
In legal settlements reached with the US government, several companies have been forced to publish databases listing monies they provide to doctors. A provision in the Health Reform Bill passed this year will from 2013 require companies to disclose payments above $10 made to doctors, and explain why. This will be available in a searchable public database.
This will help, and may shame doctors into not taking handouts, but we also need professional societies to tighten ethical requirements to stop doctors accepting pharma gifts.
A second route is to reform the continuing medical education (CME) courses doctors must take every year. Of the $2 billion spent on CME in the US, pharma funds almost half. Companies claim this has no influence on prescribing practices, but internal company documents made public by the Senate finance committee contradict this. For example, Forest Laboratories' marketing material on Lexapro discussed how CME courses could be used to push sales of the drug.
Several universities have revised rules on industry funding. Stanford University in California now requires companies to pool their money and fund a number of activities instead of funding individual courses, as is still allowed in most medical schools. The Memorial Sloan-Kettering Cancer Center in New York has ended all commercial support for CME in 2007, without ill effects.
Third, we need to penalise executives when companies are caught committing illegal acts. Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.
Only pursuing executives through the courts will make CEOs think twice about unethical behaviour. The government has threatened to bring more criminal charges against executives for breaking the law, but most are never punished. Take Tachi Yamada, head of research at GSK when negative studies on Avandia were being downplayed to keep sales high. He left in 2006 to become president of the Global Health Program at the Bill & Melinda Gates Foundation. Using internal GSK documents, the Senate committee assembled a report, released in 2007, that cited Yamada as part of GSK's intimidation of a doctor who spoke up about Avandia's health risks soon after it came on the market. In 2008, Yamada was awarded an honorary doctorate from Warwick Medical School in the UK, a leader in medical education.
Pursuing executives through the courts will make CEOs think twice about unethical behaviourLast, we must reform the legal process itself. Major problems with drugs usually go public only during litigation, when company documents become part of the legal discovery process. That can take years. In February 2009, for example, a case brought by a whistleblower resulted in AstraZeneca being forced to release more than 100 documents on its psychiatric drug Seroquel, out of view for almost four years. They showed that marketing managers discussed cherry-picking favourable data from one trial and burying results of unfavourable trials that linked the drug with obesity and diabetes.
Permanent staff in the Senate want reforms compelling public disclosure of documents that come to light during discovery, where they show evidence of a product's potential to harm public health. All these reforms should be made as soon as possible. While they may not completely prevent industry misbehaviour, they will set us on the right path.
Paul Thacker is an investigator at the Project On Government Oversight, a non-profit organisation exposing waste, fraud and abuse in federal government. He was congressional investigator for the US Senate's finance committee, where he was Senator Chuck Grassley's lead investigator on Avandia
Hear hear!
1 comment:
Throwing them in jail will be the only solution. These executives are simply too corrupt
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