Danes je izšla nova knjiga Bad Pharma avtorja Bena Goldacre-a, britanskega poljudnoznanstvenega pisca, zdravnika in psihiatra. Goldacre je do leta 2011 pisal redno tedensko kolumno v Guardianu z naslovom Bad Science, kjer je obravnaval slabo poročanje o znanstvenih izsledkih, predvsem medicinskih. Pred nekaj dnevi je v Guardianu tudi objavil izsek iz svoje nove knjige pod naslovom
The drugs don’t work: a modern medical scandal. V njem Goldacre plastično ponazori razloge za to, da bi morali biti vsi rezultati medicinskih raziskav javni. Argumenti so bralcem njegove kolumne verjetno že znani, a kljub temu je esej vreden branja v celoti.
…Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.
…In 2010, researchers from Harvard and Toronto found all the trials
looking at five major classes of drug – antidepressants, ulcer drugs and
so on – then measured two key features: 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. These
cholesterol-lowering drugs reduce your risk of having a heart attack and
are prescribed in very large quantities. 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.
….Because researchers are free to bury any result they please, patients
are exposed to harm on a staggering scale throughout the whole of
medicine. Doctors can have no idea about the true effects of the
treatments they give. Does this drug really work best, or have I simply
been deprived of half the data? No one can tell. Is this expensive drug
worth the money, or has the data simply been massaged? No one can tell.
Will this drug kill patients? Is there any evidence that it’s dangerous?
No one can tell. This is a bizarre situation to arise in medicine, a
discipline in which everything is supposed to be based on evidence.
….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. To cut a long story short, after wading through
documents for several months, in 2007 the US Senate committee on
finance released a report describing the treatment of Buse as
But we are more concerned with the safety and efficacy data. 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.
….Nissen used the rosiglitazone data, when it became available, and
found worrying signs of harm, which they then published to doctors –
something the regulators had never done, despite having the information
years earlier. If this information had all been freely available from
the start, regulators might have felt a little more anxious about their
decisions but, crucially, doctors and patients could have disagreed with
them and made informed choices. This is why we need wider access to all
trial reports, for all medicines.
Missing data poisons the well
for everybody. If proper trials are never done, if trials with negative
results are withheld, then we simply cannot know the true effects of the
treatments we use. Evidence in medicine is not an abstract academic
preoccupation. When we are fed bad data, we make the wrong decisions,
inflicting unnecessary pain and suffering, and death, on people just