Healthy Skepticism Library item: 5803

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Publication type: news

Fyfe M.
Drug companies 'manipulating trials'
The Age (Melbourne) 2006 Aug 7
http://www.theage.com.au/news/national/drug-companies-manipulating-trials/2006/08/06/1154802756201.html?page=fullpage#contentSwap1

Full text:

Drug companies ‘manipulating trials’

http://www.theage.com.au/news/national/drug-companies-manipulating-trials/2006/08/06/1154802756201.html?page=fullpage#contentSwap1

Melissa Fyfe, August 7, 2006

• Conflict of interest problem endemic: specialist *

ONE of Australia’s most senior cancer specialists has accused
pharmaceutical companies of manipulating some clinical trials of
medicines for commercial reasons, including deliberately delaying the
release of negative findings and being reluctant to fund research into
the toxicity of their drugs.

Professor Stephen Clarke, who has conducted clinical trials involving
humans for 15 years, agreed to speak publicly for the first time because
he said it was essential for governments to fund trials of great public
importance rather than leaving critical research solely to drug companies.

A number of researchers who spoke to The Age agreed, saying commercial
decisions meant the public did not always get the full picture about a
drug’s usefulness and safety.

Professor Clarke, who tests the toxicity of cancer drugs at Sydney
University, said he had been involved in several cases where commercial
realities collided with good medical research. They included:

Two drug companies delaying the publication of data that showed their
medicine was not as effective as they had thought, because, Professor
Clarke said, it “would not have been favourable to their business plan”.
It took four years to publish each trial, and the delay meant the
results had to be published in a less well-read medical journal.

Four instances when Professor Clarke wanted to test the toxicity of
drugs – to determine the side-effects for different patients – but the
drug companies refused to fund the research. “These were commercial
decisions; they wanted to maximise the image of their drug.”

Drug companies controlling, censoring and vetting trial information to
present results in the most favourable light for sharemarkets. “There’s
a degree of owning information, or they will control the timing and
reserve the right to vet a presentation or article that might be written.”

Drug companies being reluctant to fund research to work out how many
people would benefit from a drug because such trials could rule out
certain patients and therefore reduce the number of people who would use
the drug. Professor Clarke said this had happened with companies
involved with new treatments for lung cancer.

“If you proved that a group of patients did not respond to that
treatment, then there goes part of their market,” he said.

“If you had done these trials through a co-operative group or government
sponsor, you could spend the time and add the science to work out who is
likely to benefit. If such research was done, it could enable safer and
more effective treatments.”

He said the companies involved were large multinationals but declined to
name them. Drug companies gave patients with life-threatening conditions
access to new treatments, but there was a cost, he said.

“The drug companies want to maintain control. Their main aim is to sell
a drug, they don’t deny that, and our main aim is to help people, and
those two things don’t always go together,” Professor Clarke said.

“It puts us in a situation where it looks like we are colluding with
‘the enemy’, but there is no other choice. If there was … we would jump
at it and we’ve got the expertise to do first-rate clinical trials in
Australia.”

In Australia, clinical trials of new drugs, which follow animal testing,
are almost always funded by pharmaceutical companies. The Federal
Government funds few trials compared with other countries, such as the
US, which has the National Institutes of Health.

In 2002, a US study on lung cancer was run by the Eastern Co-operative
Oncology Group, using government funding. This study compared the
results of four types of chemotherapy and showed none had a significant
advantage over the others.

A study published last year in the Medical Journal of Australia found
that 24 per cent of specialists surveyed reported potentially
undesirable outcomes of their research collaboration with industry,
including editing of trial reports to favour a drug.

Professor Clarke said Australia’s public funding body, the National
Health and Medical Research Council, often gave grants to laboratory
research, rather than patient trials.

The professor’s concerns were backed by other researchers, who welcomed
the recent requirement of medical journals that trials be recorded on
databases to promote greater transparency. “Until recently, some
companies have made commercial decisions that haven’t let us have the
full picture,” said Osteoporosis Australia’s medical director, Professor
Philip Sambrook.

Associate professor Ray Snyder, co-director of cancer services at St
Vincent’s Hospital, said a number of years ago, a negative study he was
involved in was not published. “It made me feel uneasy and I am unlikely
to want to interact with that company again,” he said.

Professor John Zalcberg, who runs trials at the Peter MacCallum Cancer
Centre, said “a bad drug always collapses. If you produce a lemon, it
only goes so far”.

But he too called for more government funding for research that may not
be in the drug companies’ interest. He said that, for example, the
Federal Government was likely to pay more than $100 million a year for
Herceptin for early-stage breast cancer, based on company-funded trials
that suggested patients should take the expensive drug for a year at a
cost of $50,000 per person. But a study funded by the Finnish Government
found the same benefit was achieved in nine weeks, with less heart
toxicity, and at a far cheaper cost.

Professor Zalcberg said it was understandable that the drug’s maker,
Roche, would refuse to fund a similar study in Australia, but there was
little chance a government-funded study would be held here. The
Pharmaceutical Benefits Advisory Committee, which recommended Herceptin
be subsidised, said the Finnish study was too small for it to base its
decision on. “This sort of (government) funding should be done in the
interests of public health,” Professor Zalcberg said.

The president-elect of the Australian Association of Medical Research
Institutes, Garry Jennings, said it was not a good idea to leave “the
big questions in health” just to the pharmaceutical industry. He said
large clinical trials cost between $20 million and $100 million and the
National Health and Medical Research Council could not afford them.

Medicines Australia, the industry body of the pharmaceutical companies,
denied the allegations that they manipulated or controlled clinical trials.

“Anyone who suggests that companies aren’t testing for toxicity, quite
frankly, has never worked inside a pharmaceutical company and does not
understand clinical trials, a spokesman said.