Hard to swallow: pharmaceutical fraud

It seems an odd paradox that a sector dedicated to saving lives and improving health seems so habituated to pulling dodgy tricks, but once again the pharmaceutical industry has been caught with its hand deep in the ethical cookie jar.

So serious were the misdemeanours this time that the American drugmaker Pfizer has had to agree to pay $2.3bn (£1.4bn) in the largest healthcare fraud settlement in the history of the US Department of Justice.

The company was found to have illegally promoted four drugs as "off label" therapies for conditions where such treatment had not been approved by the US Food and Drug Administration. A subsidiary of Pfizer pleaded guilty to misbranding drugs "with the intent to defraud or mislead".

On top of the flagrant misrepresentation, Pfizer was accused of another notorious old drug-company trick: bribery. The civil settlement also relates to allegations that its representatives paid cash and offered lavish hospitality to healthcare providers to encourage them to prescribe four of the company's drugs. These were Bextra, an anti-inflammatory drug, Geodon, an anti-psychotic drug, Zyvox, an antibiotic and Lyrica, an epilepsy treatment.



This being a civil case, no one goes to jail. Instead a pile of cash changes hands and shareholders get miffed. But perhaps most disturbing about the case is the company's reaction. Rather than uttering shamefaced mea culpas all round, Pfizer's general counsel said: "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls."

In similar vein, Pfizer's senior vice president, Amy Schulman, breezed: "These agreements bring final closure to significant legal matters and help to enhance our focus on what we do best - discovering, developing and delivering innovative medicines."

This sort of blithe response to being fined is becoming rather fashionable among drug companies. For example, a couple of years ago in America, Jazz Pharmaceuticals was fined $20m by the US Government for over-pushing a drug called Xyrem, understating its overdose potential and denying to doctors that Xyrem is better known as GHB, the date-rape drug. "We are pleased to have resolved this matter," Jazz CEO Samuel Saks declared. "Our strong commitment to compliance was instrumental in the speedy resolution of this matter."

Is there anything positive to be taken from such cases? One hopeful element is that the Pfizer investigation was trigged by allegations made by six whistleblowers, who will be rewarded by receiving $102m of the civil fines paid by Pfizer. How unlike the treatment of medical whistleblowers in Britain.

We might also take heart that a new initiative to beat fraud in medical publication - another massive problem area - seems to be showing promise. The Journal of the American Medical Association (JAMA) has just examined the results of an initiative where researchers are required to deposit early plans for their drug trials in a registry before proceeding. These details can be compared against a trial's published outcome. If there is a significant variance, this may show that someone has been tampering with the trail's data to produce an outcome more favourable to the treatment under test. The JAMA investigation did find some significant discrepancies, showing that the method may prove a handy tool against research fraud - a practice perpetuated by drug companies, as well as by corrupt or cowed academics.

That's handy, not least because we are still learning the full extent of dodgy publication practices. Newly unveiled court documents in America show that ghostwriters paid by a pharmaceutical company, Wyeth, played a major role in producing 26 scientific papers heavily backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is actually even broader than previously suspected.