How doctors and patients are kept in the dark about potentially dangerous everyday drugs

Scandal of the poison pen-pushers: How doctors and patients are kept in the dark about potentially dangerous everyday drugs




By
Dr Ben Goldacre
Tamiflu is supposed to be the
miracle flu drug. Patients across the UK rely on it. In medicine
cupboards everywhere patients have eagerly stockpiled it, and in some
winters there has even been talk of rationing.

The
Government itself has spent £500 million on stockpiling the drug to
keep the country from collapse in the wake of a bird-flu epidemic, since
it’s supposed to reduce the risk of pneumonia and death.
And
yet for all we know, Tamiflu might be no better than paracetamol:
because Roche, the company making it, still withholds vital information
on the risks and benefits from researchers, doctors and patients.




Bitter pill: The European Medicines Agency is the subject of a damning report over data on drugs, including Tamiflu

As a result, we doctors are
prescribing the pills in the dark, exposing patients to possible harm
and potentially wasting vast quantities of public money.

But that is just the beginning.
Because, amazingly, there is nothing illegal about what Roche has done,
and there is nothing unusual about it either. Patients throughout the UK
may be suffering – on a scale we are only just beginning to comprehend –
because of a vast, ongoing ethical scandal in medicine.

Under current legislation, drug
companies and researchers are perfectly entitled to withhold
information about whether medicines work or not, even though doctors
desperately need that data to make informed decisions.
But
with Tamiflu, the industry has finally met its match. One group of
researchers has decided that this situation – and its impact on patients
– is unacceptable. At their helm is Dr Tom Jefferson, a tenacious
researcher who was once an Army doctor serving in Bosnia. He is not a
man you can fob off easily.
Dr
Jefferson was leading a review of the evidence on Tamiflu, requested by
the Australian and UK governments. He works for Cochrane, an
international non-profit academic collaboration producing thousands of
gold-standard summaries for doctors and patients on medicine and
treatments.




Flu scare: The Government has spent £500 million on stockpiling Tamiflu in case of a bird-flu epidemic

Cochrane realised that for many
of the clinical trials that had been conducted on Tamiflu, only very
brief summaries of the results were available. This is unacceptable in
medicine, because the devil is often in the detail, and not all trials
are necessarily ‘fair tests’ of a treatment. So Dr Jefferson wrote to
Roche, asking for more: the full Clinical Study Reports, describing the
trials in detail.
This was
the trigger for an extraordinary performance. First, Roche insisted on a
confidentiality agreement, which was unacceptable for Cochrane. Then
they released brief, and in my view, inadequate summaries on the trials.


But the researchers began to spot
discrepancies. Roche seemed unable to answer the simplest questions,
such as how many trials had been conducted.





Possible danger: Roche's brief regarding Tamiflu did not contain all the details
Regulators
and agencies around the world appeared to have different information
on the same drug. One trial was only published ten years after it was
completed. The names of those conducting trials seemed to change
arbitrarily.

There
were also concerns about the design of the trials. Some summaries said
patients received a dummy placebo sugar pill, when in fact those pills
contained an active ingredient.
Other
research was done on ‘ideal patients’ who would be more likely to
recover from flu when given Tamiflu than other patients. Eventually
Cochrane published a review in the British Medical Journal with a huge
warning, and explained that the results should be regarded with caution.

Since then, Roche has
promised to release the full trial reports, but still hasn’t done so,
three years later. Only last month, Roche claimed that the company had
already released 3,200 pages of documents, but even ten million pages
would be useless if they didn’t contain the relevant information.

And
now Roche has announced it will convene a ‘panel’ to discuss how to
analyse the data. But nobody has asked for this: they simply want Roche
to share the information that doctors and patients need to decide if
Tamiflu works.
Thanks to
the doggedness of Cochrane, Roche is now under unique and unprecedented
scrutiny. But this is no isolated case. Overall, about half of all
clinical trials never get published. What’s more, trials with positive
results are twice as likely to be shared as trials with negative ones.
As
a doctor, I am passionate about ‘evidence-based medicine’: GPs and
patients making informed decisions about which treatment works best. But
this is undermined when we can see only the studies that companies and
researchers choose to give us. As a result, the effects of a drug may be
wildly exaggerated, and the relative risks of treatment underplayed.
Pharmaceutical companies insist this
appalling behaviour is all in the past, and claim they are the most
well-regulated industry in the world. They point, for example, at
legislation passed five years ago in the US requiring all drug-trial
results to be published within a year. But in January the British
Medical Journal revealed that only one trial in every five had complied
with this law, and yet no fine had ever been levied.
Even
more astonishingly, despite 25 years of evidence that trial results are
withheld from doctors and patients, the very people we trust the most
have failed to act.




Risky secrets: Manufacturing company Roche has
been keeping information on the risks and benefits of Tamiflu from
researchers, doctors and patients

Not one of the ‘Royal Colleges’
of medicine, psychiatry or general practice has condemned this
activity. The patient groups – many of whom receive huge amounts of
industry funding – have all remained silent, despite potential harm to
their members. And medicine regulators have even conspired with
industry, withholding information from doctors.
But
the worm is slowly turning. Two years ago, the European Ombudsman
unleashed a damning finding of maladministration against the European
Medicines Agency, based in London. The EMA occupies a beautiful building
in London’s Docklands where everyone must speak three European
languages, and many of these 600 bureaucrats are on six-figure salaries.
They approve medicines for use in the UK and are supposed to protect us
from the worst excesses of drug companies.
Yet
they spent nearly four years withholding data on the risks and benefits
of two weight-loss drugs. Worse still, while the regulator insisted the
public had no right to this information, one of the drugs – Acomplia –
had to be taken off the market: its harms outweighed its benefits.
Since
this ruling, the regulators have slowly begun to shift. They are
releasing more documents than before, and are now discussing whether
they can release all clinical trial data, though possibly only for new
trials starting after 2014, which does nothing for any drug currently
on the market.
And a growing
group of senior academics and doctors is calling for more
transparency, including Dr Fiona Godlee, the editor of the British
Medical Journal, and Dr Sarah Wollaston MP, who previously worked as a
GP. But in reality, this problem will be fixed only when patients
themselves demand action. Until then, the industry will claim everything
is fine, while the great and the good of medicine drag their heels. As a
doctor, I am ashamed of my profession’s inaction on the most important
ethical issue facing us today.



Source:-

http://www.dailymail.co.uk/news/article-2241431/Scandal-poison-pen-pushers-How-doctors-patients-kept-dark-potentially-dangerous-everyday-drugs.html