April 27, 2012 at 7:54am
Something that is not discussed very often (or ever) is the fact that clinical trials for pharmaceuticals can be a very profitable business for a university, MS center, clinic and lead investigator. We know that drug companies pay the researchers, and pay for the use of facilities---and this has been a very lucrative business model for many. But something that has been kept quiet is the fact that physicians are paid "finders' fees" for enrolling patients in clinical trials. Because they need your body to test the drugs---signing you up is rewarded.
The published paper that first brought this practice to my attention was written by Maran Wolston, a woman with MS, who found out about her doctor's commercial interests in the drugs and trials he was recommending to her-- I suggest all pwMS and those that love them read her paper-
People are clamoring to be tested and treated for CCSVI. We've seen CCSVI clinical trials fill up within days, patients are turned away. Could the real push back from neurology regarding CCSVI treatment clinical trials be that neurologists do not want to lose potential patients for their own pharmaceutical clinical trials?
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If your doctor suggests you're the perfect candidate for some clinical trial, you might ask how much he's getting paid to recruit you.
Finders fees from $2,000 to $5,000 are common, say University of Toronto researchers Trudo Lemmens and Paul Miller. The fees are being paid to physicians, nurses and other health care professionals.
The tactic is on the rise, the researchers write in the journal PLoS Medicine, because there are more drugs in development and so more trials being conducted, creating greater competition between drug companies to find participants.
The need for speed is a factor, too: Delays in getting a drug to market can mean lost profits.
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The problem is highlighted in Canada--where pharmaceutical companies pay for 80% of clinical trials, and people with MS are needed for phase 2 and 3 trials.
These patients have typically exhausted treatment options, so they're generally motivated to participate in a trial either to gain access to a new medication or, ultimately, to help others who will be afflicted with the disease in the future. They're generally compensated for such expenses as parking, meals or travel.
Phase 2 and 3 trials require more research participants and are highly sought by governments, researchers, doctors and some patient advocacy groups because they typically yield new investments and jobs, as well as access to new medications.
Canadian patients, obviously essential to these trials, are in demand. But there are persistent, major concerns about the interests and safety of Canadian research participants — concerns exacerbated by Canadians' lack of information about numbers, recruitment practices and problems involved in conducting clinical trials. The piecemeal nature of the way research participants are protected is an abiding issue for ethicists, policymakers and legislators.
We see the same problem in the UK-
Randomised clinical trials, often sponsored by pharmaceutical companies with a valid commercial as much as a genuinely scientific interest, are the only reliable way to generate good quality evidence of efficacy.2 Clinicians ideally should be in equipoise about the treatments being tested,3 and patients should give voluntary consent based on full disclosure of relevant information.4 The practice of paying doctors to recruit patients under their care, and not disclosing this pecuniary interest, corrupts both these ideals.
Over the years we have seen the payments on offer soar to thousands of pounds per completed patient. Well organised British general practices can earn an extra £15 000 annually for three hours' work a week.7
As a result, trials designed by non-commercial sponsors aiming to answer clinically important questions but without the funding available to pay recruiters fail to attract doctors.8
http://www.bmj.com//content/325/7354/36.1?variant=full text&ijkey=d85e8046a10cbf5f25b3a4a064d8edbc00a8a47c&keytype2=tf_ipsecsha
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The authors of this paper suggest that patients should be told the following:
1. Who is paying for the study
2. Whether the investigator owns stock in the company
3. Whether the investigator is paid a salary by the sponsoring company
4. Whether the investigator is paid a fee for each patient enrolled
These are the same points Maran brings up in her paper--linked at the beginning of the note.
How does this affect CCSVI trials? I have noticed that the most vocal and negative voices against CCSVI treatment trials tend to be neurologists who run clinical trials for drug companies or are the patent holders for new MS drugs.
The question needs to be asked---how is conflict of interest affecting the research into CCSVI? I'm afraid the answer is more than obvious.
The question needs to be asked---how is conflict of interest affecting the research into CCSVI? I'm afraid the answer is more than obvious.
Joan
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