dr ben goldacre bad pharma
Bad Pharma, a new book by Ben Goldacre, looks into the research practices of big pharmacy. Apparently any negative information about new drugs is systematically suppressed even in the academic environment:
In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug…: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin….This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.
…In 2003, two [systematic reviews] were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results….
In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures….In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:
“The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”
How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.
Still feeling confident about your industry sponsored cell phone radiation tests?
Here’s what happens if someone speaks up about negative results:
Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents….
In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.
During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.
Still feeling that independent scientists would be able to get the word out over the billions of dollars of industry sponsored research?
When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct…
The investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.
If the Romney presidential campaign were not illustration enough, some people are prepared to say and write anything for money. And that includes the pharmaceutical companies which are supposed to be looking out for our health.
Why is this article focused on cellphone radiation? We can decide to take pills or not, or accept a certain medical treatment. We have little control over cellphone radiation, just as for decades we had little control over second hand smoke.
Goldacre’s book looks fabulous, peeking behind the curtains of pharmaceutical companies practices. Well researched but popular works like Bad Pharma are essential to reforming out of control industries, like tobacco, oil or pharmacy.
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients will be released on January 3, 2013 by Faber and Faber. A pity that it won’t be out in time for Christmas. In the meantime, Goldacre’s Bad Science: Quacks, Hacks, and Big Pharma Flacks starts down this road. In an interview in 2008, Goldacre stated that “one of the central themes of my book [Bad Science] is that there are no real differences between the $600 billion pharmaceutical industry and the $50 billion food supplement pill industry”. Goldacre has been sued several times for exposing medical shams and won damages and/or court costs up to €220,000 from the plaintiffs.
Excerpts above from Bad Pharma are from an extract published in the The Guardian.