Sunday, December 02, 2012

Big Pharma- a sick industry

Earlier this year, the medical establishment was rocked when pharmaceuticals giant GlaxoSmithKline reached a record-breaking $3bn settlement with US authorities for illegally promoting drugs to treat conditions they weren't designed to fix. So it didn't look good when, just a few months later, a GlaxoSmithKline sales representative was found guilty of doing the same thing, with a different drug. This time, the rep was pushing doctors to prescribe a blood disorder drug to treat a bone marrow condition.

Unfortunately, these were not isolated events. While some new reforms are being forced on big pharma, shockingly poor regulation – especially in the US – means that questionable and unethical practices still pervade an industry that is meant to keep us healthy. Here are just a few of the dangerous trends at play in the pharmaceutical drug business.

Lots of marketing, less research

Big pharma justifies the exorbitant prices it charges for medicine with the argument that the prices sustain expensive and innovative research and development operations – even as the rate of R&D breakthroughs has plummeted and companies have slashed their R&D workforces.

But in the US the industry is thought to spend almost twice as much on marketing as it does on R&D. Academics estimated that the industry spent $57.5 billion promoting their drugs in 2004, mainly by pushing them to doctors, or about $61,000 per physician. That's a full 24.4% of US sales revenue, as opposed to just 13.4% spent on R&D.

Pharmaceutical companies often lavish doctors with free conferences, meals and drug samples – all of which are designed to make a doctor more likely to prescribe their product. And studies show this money works. On top of that, companies actually buy prescription records from pharmacies so they can individually track doctor's prescription records – and use this to tailor their marketing and promotion to the doctor.

As cynical as these profit-driven moves are, there is some hope. Beginning next year pharmaceutical companies will be required to disclose all payments above $10 to physicians – part of the reforms included in President Barack Obama's signature Affordable Care Act. Although there's a world of difference between requiring these payments to be disclosed and outlawing them, it's an important first step.

Bury the data

To get their drugs approved by regulators, and to persuade doctors to prescribe them, big pharmaceutical companies rely heavily on clinical trials. This creates serious problems for consumers.

To begin with, published trials funded by pharmaceutical companies are more likely to be favourable to the sponsor than other studies. This usually isn't because they are rigging the results – it's because they only publish the trials that suit them.

Dr Ben Goldacre describes how it works with a personal recollection in his recent book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients:

Seven trials had been conducted comparing reboxetine against a placebo. Only one ... had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published ...

With between two-thirds and three-quarters of trials published in major medical journals funded by the industry, this is a major problem.

And it gets worse. Many drug companies conduct their testing in developing countries where regulations are poor – and sometimes the people they experiment on die in the process. A BBC investigation revealed last month that drug companies have tested experimental drugs on thousands of poor Indians without their knowledge or consent. Over the last four years, over 2,000 people have died in the process – generally without any compensation for their families.

Activists and lawyers in India are investigating the abuses, buoyed by the press attention. Hopefully that will help fuel the push for more transparent clinical trials. GlaxoSmithKline, fingered in the BBC report, has said it will open up much of its clinical trial data to other researchers. It's too early to tell whether they'll live up to the commitment, but as this is the first major pharmaceutical company to move this move it's an encouraging sign.

Finding new users

Learning new ways to market old drugs is one of the industry's favourite tricks. Take the case of powerful antipsychotic drugs designed to treat schizophrenia and bipolar disorder that are now routinely prescribed to treat mild mood disorders, insomnia and emotional discomfort. Two antipsychotic drugs are now the fifth and sixth best-selling prescription drugs in the US: 3.1 million Americans regularly use an antipsychotic medication.

A UK government review found that 1,800 people died needlessly in nursing homes due to the overuse of antipsychotics on dementia patients. As usual, this over-prescription didn't just happen. In the US, Johnson & Johnson reportedly reached a $2.2bn settlement with the government after it was caught paying tens of millions in kickbacks to medical professionals to increase sales of its drugs in nursing homes, including over $100m in antipsychotic drugs.

Quick growth in the use of drugs to treat new conditions generally involves "off-label" use – using a drug to treat a condition federal regulators have not approved it for. Companies are not allowed to market their drugs for these purposes – but they don't always follow the rules. Earlier this year, in the largest settlement ever for the industry, GlaxoSmithKline agreed to pay a $3bn fine for marketing its antidepressants for use as a weight loss aid and to treat sexual dysfunction. But the company cashed in tens of billions selling these drugs – making the fine little more than an additional business cost.

Towards a healthy industry

There are countless aspects of the drug development and marketing business that need to be investigated and reformed. For a start, we urgently need more unbiased clinical trials, stronger consumer protections, more costly punishment for malfeasance, and greater access to affordable medicines in developing countries – still a long way off.

All too often, the industry remains one of the key blockers of reform, and it's not hard to understand why. For them, the current system works very well: in 2011, the 10 largest US drug companies took more than $43bn in profits.

In the face of these giant challenges, there are small but real signs of hope. The Affordable Care Act fought for and passed in the US, and the decision by GlaxoSmithKline – under pressure – to publish more of their trial data demonstrate that things can change. But much more is needed. The industry built to keep us healthy is still sick – but at least we know what ails it.

Learn more: The Washington Post uncovers the frightening extent to which big drug companies can influence seemingly respectable drug trials.

Sources: New York Times, Guardian, Nature, PLOS Medicine, Journal of Continuing Education in the Health Professions, Journal of General Internal Medicine, Health Affairs, British Medical Journal, EATG, Prevent Disease, Biomet, BBC, Bad Science, Guardian, Boston Herald, World Health Organization, CNN, Washington Post

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