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Alert Number 190

News Report: Drug companies "manipulating trials"

Date: August 30, 2006

If the title of this Alert comes as a surprise to you, I suggest you might want to quit reading. This may upset you.

But if, like me, you are inclined to “trust but verify”, the report below from the mainstream media is pretty much par for the course: no surprises here. Over the past few years, we have taken CLL researchers to task if we thought they were guilty of delayed publications, biased reporting, “cherry picking” of clinical trial participants or “spin” in how they report results. It is bad enough when our elected officials indulge in less than candid behavior — I draw the line when physicians do it!

I have had the pleasure of meeting and getting to know many excellent and caring physicians and researchers in the past few years. Many of them have been generous with their time, taking pity on my early floundering efforts and teaching this unofficial and pro-bono “grad student” some of the basics of hematology and immunology. But in my darker moments I have wondered if it is getting harder for the good guys to keep their integrity and compassion going full steam, whether the system is so rigged that only the “rock star researchers” with major hospitals and drug corporations backing them are going to be heard over the noise. If that happens, the ones with the most to lose are the patients. Our lives ride on the honesty of the system.

The report below is not sensational. I wish it were - then we could ignore it as so much media hype. The points made by Prof. Clarke are all too real, all too commonplace. We live in an integrated world of multinational organizations — I would not for a moment assume this stuff happens only in Australia and we in other countries can breathe easy. Well, read it for yourself, make up your own mind.

The little bit of money we bring to the table, the few small clinical trials we can afford to sponsor and fund, our small efforts to speak the truth as best as we know it on our website, these seem all the more precious and poignant in the light of the block-buster business interests out there.

Be well,


News Report:

Drug companies 'manipulating trials'

The Age, Australia - Aug 6, 2006

Melissa Fyfe

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.

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