Kill or cure

Much has been written about the pharmaceutical industry, and new information continues to be uncovered. It is always worth looking deeper into new reports as this industry will do all it can to suppress unwanted coverage.

The industry has become the most fraudulent and its drugs are now more lethal than traffic accidents- Kathryn Borg

During the past 12 months the pharmaceutical industry has become the most fraudulent (outpacing even defence) and its drugs are now more lethal than traffic accidents, killing one person every 14 minutes in the US alone.

Over the past 20 years it has paid out $19.8 billion (€15.7bn) in penalties to US government agencies in penalties, while its drugs have killed 37,485 Americans in a year (1,200 more than were killed in road traffic accidents).

A further 2.3 million patients in the US needed emergency hospital treatment for an adverse reaction during the year, despite following the prescription correctly.

Despite these statistics, the industry has enjoyed extraordinary growth over the past 20 years. Revenues have increased sixfold. This is notwithstanding a period when the introduction of innovative new drugs has almost dried up.

Instead, they benefit from the use of off-label drugs (where medication is prescribed for conditions not specifically linked to the drug, or to treat groups such as the very young for whom safety tests have not been carried out). Off-label drugs generate 40 per cent of revenues and account for one out of every five prescriptions written.

Industry watcher Linda Rosenstock, dean of the University of California at Los Angeles school of public health, reckons that the drugs tsunami started around 10 years ago when deaths from pharmaceuticals were still relatively low, according to America’s Centres for Disease Control and Prevention.

This was around the time that drug companies started to employ a more aggressive ap­proach to sales. Off-label prescribing became more commonplace and adolescents and children were prescribed drugs that were licensed for use in adults only.

Overall, researchers believe that 79 per cent of adolescents have been given at least one off-label prescription – a drug that has never been tested for its safety in that age group.

In the US this is exacerbated by the system of the drug companies running ‘direct to consumer’ advertisements in newspapers and magazines and on television. American consumers are then encouraged to pressure their doctors to write prescriptions for the drug they want.

However, in the US, drug companies are constrained by law to advertise drugs specifically for the condition for which they were originally licensed. It is illegal to advocate off-license use. On occasions, this has happened and on rare occasions, the drug company has ‘had its wrists slapped’.

One company was fined $1.3 billion (€1 billion) for fraud and illegal sales activity, while another paid out $2.3 billion (€1.8 billion) after it was accused of illegally promoting four of its drugs, including painkillers, an antibiotic, an anti-psychotic and an anti-epileptic.

Interestingly, the many cases of illegal promotion, fraud and other misdemeanours did not come to light through the medical profession’s vigilance. They came to light through ‘whistleblowers’ within the industry. Usually the company’s own employees.

Between 2001 and 2010, 67 per cent of the cases against drugs firms were initiated by whistleblowers. The previous decade they were responsible for only nine per cent of all cases. In the US, this reflects a change in the law which allows a reward to be paid to someone who reports fraudulent behaviour to a regulator or state agency.

However, in the UK whistleblowing is done for the sheer glow of doing the right thing. A head of regulatory affairs was frog-marched out of the building after reporting a wrongdoing over the supply of a company’s slimming drug to a clinic.

The company denied this premature departure was anything to do with whistleblowing; however an industrial tribunal disagreed and the employee was awarded £80,000 (€99,000) for wrongful dismissal.

Even researchers, whose studies are ‘sponsored’, can be affected if they speak out. One doctor discovered a diabetes drug that increased the risk of cardiovascular disease.

As a result, executives tried to stop all of the research funding while plans were put in place to sue the doctor who had carried out the research. The plans were leaked and the executives asked to explain themselves to a US Senate committee.

Sidney Wolfe of the Public Citizen’s Health Research Group, a lobby responsible for a report into drug company fines entitled ‘Rapidly increasing criminal and civil monetary penalties against the pharmaceutical industry: 1991 to 2010’ said the escalation of fines mirrors the aggression of the drugs industry in marketing its products and maximising its profit margins.

In the 1990s, commentators came up with the expression ‘pharmageddon’ to describe a time when the risks of drugs finally outweighed their benefits – we seem to be getting close to that scenario.

If so, the fault can be laid at the door of the drugs companies with their aggressive sales policies irrespective of the cost to human health and life. It is a shame they cannot be made to stick to the Hippocratic Oath, as doctors do.

They could work to the strapline ‘First do no harm’; with this industry it appears to be ‘First make a profit’.

In her book The Truth about the Drug Companies (New York, Random House, 2005), Marcia Angell points out that consumer groups in the US are starting to band together to form new collectives, some of whom are filing law suits against more than 20 drug companies.

During the last century, this industry was seen not only as a profit-generating monopoly but also as a benefactor of humanity. In the past 10 years it has become apparent that it will soon have to decide which of the two it really is.

kathryn@maltanet.net