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Friday, 3 April, 2009

What's in the news: Apr. 3 -- Gov't role in pharma study questioned

Feds' role in pharma study raises concerns
Some physicians have expressed concerns about the federal government's role in providing funding for a clinical trial in Quebec offering doctors $100 per patient to enlist new patients to take statins.

The money for the study, called OBSTAT, is being provided by Pfizer and AstraZeneca -- which both produce cholesterol-busting statin drugs -- and the Canadian Institutes of Health Research.

Dr Jim Wright, of the UBC-affiliated Therapeutics Initiative, questioned the government's role in paying for the research. "I'm sure it has some value to the company, but I don't see that it has any value to the public," he told the National Post. "It's a real problem, because it's an incentive for doctors to put people on statins where it may be questionable." [National Post]

Montreal cardiologist Colin Rose, who received a letter soliciting his help in recruiting new patients to take statins as part of the study, criticized the trial last month on his blog Panaceia or Hygeia. Dr Rose wrote that the physician in charge of the research project has been paid by both pharma companies in the past, and he questioned the scientific value of OBSTAT:

"With 4500 enrolled 'patients' $450,000 will be spent by drug dealers on direct bribes to doctors. If each statin pill conservatively costs $2 per day, in just one year, they will have sold $3.3 million worth of drugs, an almost 400% yearly return on the investment including payments to the doctors. Over three years of the 'study' the drug dealers will have sold about $10 million worth of drugs to people, the vast majority of whom will never have had a heart attack or stroke and in whom, 'statins have not been shown to provide an overall health benefit.' And the cost of this study will likely be classified as 'research' by the drug dealers, not a marketing expense. All perfectly legal. Isn’t the drug business wonderful?"
On his blog Dr Rose also reproduced the letter and background information he was sent on the trial. [Panaceia or Hygeia]

The National Post's Tom Blackwell, however, reported that Dr Gordon Guyatt, a senior Canadian epidemiologist credited with coining the term "evidence-based medicine," said that the research has merit.* Mr Blackwell also reported the lead investigator's explanation of the study's scientific value.
[University of Montreal professor] Dr. Jacques LeLorier said the research is driven by the fact that many patients — about 50 per cent in Quebec — stop their statin treatment within a year, though the drugs don't take effect until after about 18 months. That can have "disastrous" implications for the patients' health, and also wastes the money spent by government drug plans, a study summary on the CIHR website says.

As for the payments, they started at $50 per patient, but were doubled because of lack of interest from busy physicians, said LeLorier. The fees are covered by the Pfizer and Astra money, as CIHR will not pay for physician compensation, he said.

Manitoba to cover small fees, relieve doctors of billing
Manitoba doctors will no longer need to collect money from patients for "tray fees" for what had been uninsured services such as suturing supplies, local anesthetics, and other common disposable office items. As of Wednesday, doctors in the province are able to bill the government, instead of their patients, for those items.

"In partnership with the province’s physicians, we are eliminating dozens of tray fees that many Manitobans were routinely required to pay following a procedure at a doctor’s office," said Health Minister Theresa Oswald in a release.

The change is expected to cost the government $1.8 million per year. [Government of Manitoba news release]

Loose nukes
24 moderate- or high-risk radioactive medical devices were either stolen or went missing from 2005 through 2008, the Canadian Nuclear Safety Commission said in a report. All but one were covered, but the CNSC believes the one item "no longer poses a health risk to the public or the environment." No very-high-risk devices were lost. [CNSC information update] [CNSC report (PDF)] [Canadian Press]

U of C to look into Nature retraction
Three of the four living South Korean researchers who published an important 2000 research article in Nature -- about using gene therapy to push type 1 diabetes into remission in mice -- issued a retraction this week after failing to replicate their results. One of the researchers refused to sign the retraction and continues to insist that the paper was accurate. [Nature] Two of the scientists, including Ji-Won Yoon, who died in 2006, were working at the University of Calgary when the research for the 2000 paper was conducted. The university is now investigating the situation. [Calgary Herald] [CBC News]

Allergies in the air
A Regina woman suffered an allergic reaction to a dog that was travelling in the passenger cabin of a WestJet plane. She was disappointed by WestJet officials' response: WestJet said it was the woman's responsibility to warn them of her allergy, whereas she wants WestJet to be take responsibility for warning passengers of the presence of the potential allergen before the flight takes off. "They said they would try and accommodate you as best they could and if they can’t, then they would find another flight for you," said her husband. "Well, we’re paying full fare. I don’t know how much the dog got charged." [Regina Leader-Post]

This is not the first time passengers and physicians have complained about Canadian airlines' failure to protect allergic travellers. [Doctor's Review]

Parliament is bad for your health
"Dr. Raj Sherman, voted Alberta's sexiest MLA by Journal readers, is regularly hitting the gym to lose the 15 pounds he has put on since he was elected." [Edmonton Journal]

MD/MP proposes pot decriminalization
Dr Keith Martin, a Liberal MP from British Columbia, introduced a private member's bill in Parliament on Thursday, proposing to decriminalize marijuana.

The bill would keep marijuana illegal but would change the way the drug is classified such that people caught with 30 grams or less of pot or 1 gram or less of hash, but anyone caught with less than those amounts would still be charged under the Contraventions Act and fined $200 for a first offence. [Bill C-359 full text] [CTV News] Victoria city councillor Philippe Lucas, the executive director of the medical marijuana organization the Vancouver Island Compassion Society, said he supports the bill but favours full legalization and regulation. [Victoria Times-Colonist]

Dr Martin, a former Reform Party MP and physician who currently serves as the Liberal Party's opposition critic for Amateur Sport, Health Promotion and the Olympics, suggested that money raised from the fines could go to fund substance abuse programs. "In the medical profession our mantra is 'do no harm'. We are actually doing terrible harm if we continue to address substance abuse uniquely as a criminal issue from the federal level. The blinders have to come off; we have to take a medical perspective if we are going to reduce harm and drug use in Canada." [Keith Martin's Blog]

Image: Shutterstock

Correction: In the original version of this article, we wrote erroneously that Mr Blackwell had reported Dr Joel Lexchin believed the study had merit.

2 comments:

  1. Narrowing and Broadening

    Narrowing your perspective on any of these issues sets you up to only "see" the tree in front of you....... whereas broadening reveals the forest.

    Two examples:

    1.The Statin argument

    What is wrong with private/public sector partnering? ...nothing

    What is wrong with the study guidelines?....... everything

    Will someone do a side study to see how many patients end up taking statin that don't need it at all because of the financial incentive at the frontline?

    What about the muscle weakness(myopathy)warnings (2008) issued about statins ?
    [ The two great financial drains to public health are "stroke" and "falls" .Do we treat the one to cause the other?]

    Who's holding the wheel at CIHR? ( hmmmmmmm Dr. Beaudet knows all about neuron signalling.... is this really about cholesterol lowering or checking out the myopathy warning?)

    2. Decriminalization

    Looking at the high level of influence drugs have on crime-related incidence..... if we decriminalize...we cannot justify asking the police to intervene.

    Therefore, will you broaden the role of the police to include more creative "interventions"?

    OR

    Will you give the paramedics a gun?

    Whoever gets "the call".....should be equipped to answer it safely.

    Which would you pick?

    ReplyDelete
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