Author Archive
Sharing medical research data: Financial conflicts should be included in online abstracts
20/05/2009 by Merav.
There should be not only data transparency but also financial transparency.1 Most major medical journals have made financial disclosure mandatory. Yet, now that the internet allows free access to any biomedical abstract, readers of abstracts may be blinded to papers’ relevant financial disclosure unless they have a paid subscription to the journal.
I reviewed the ICMJE uniform requirements, the author instructions for 20 journals, including the BMJ, JAMA, the nine current Archives journals, New England Journal of Medicine, and the Lancet journals. None of them required, recommended, or even mentioned financial disclosure for structured or unstructured abstracts. Thus, readers might think that there was no potential financial conflict of interest when one exists. This is particularly important when the reader is a layperson attempting self education on the internet.
Of course, a reader could access a paper by paying a fee. One time access to the New England Journal of Medicine costs $10, to JAMA $15, and to Plastic and Reconstructive Surgery $30. Thus, many peer reviewed journals may have a potential financial conflict by not providing free access to the financial disclosure portion of the paper.
The BMJ should lead the way by mandating that abstracts have financial disclosure. Requiring a yes/no financial conflict statement in the structured abstract and allowing a free view of the financial disclosure part of the paper online will give readers valid information to make more reasoned decisions about the validity of abstracts’ conclusions.
BMJ 2009;338:b1934
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Merck defends Vioxx in court, as publisher apologises for fake journal
19/05/2009 by Merav.
Merck has begun the defence of its anti-arthritis drug rofecoxib (Vioxx) in the Federal Court of Australia, amid revelations that it lobbied to quash similar legal action in Britain, and as a publisher apologised for a journal sponsored by the company.
The United States based company is fighting a class action from more than 1000 Australians, led by Graeme Peterson, who had a heart attack in 2003 after taking rofecoxib for several years.
Over the past month Mr Peterson’s lawyers have released many internal company documents showing, they claim, how Merck’s marketing tried to minimise safety concerns about the drug and to “neutralise” and “discredit” potential critics. They also say that the company created an entire medical journal that appeared to be a legitimate peer reviewed journal but that in reality was simply a “marketing publication” (BMJ 2009;338:b1714, 28 Apr, doi:10.1136/bmj.b1714).
Opening the defence case last week, Merck’s legal representative Peter Garling said that the marketing was “consistent with the scientific data” from careful studies involving large numbers of patients. He said that the company would present evidence showing that Mr Peterson’s heart attack “was the result of pre-existing risk factors and not the medicine,” adding that “each person’s medical history and other surrounding facts and circumstances are different.”
Merck has previously settled class actions in the United States, paying out close to $5bn (£3.3bn; 
3.7bn) but without admitting fault or causation.
On the eve of the company launching its defence in the Australian class action, in the United Kingdom the Guardian reported that Merck had run a campaign to “head off government support” for similar legal action there (www.guardian.co.uk/business/2009/may/04/merck-vioxx-campaign-parliament). It said that documents released under freedom of information legislation show that government ministers retreated from supporting people affected by rofecoxib, after a Merck campaign that involved a lobbying firm.
Asked about the alleged lobbying, Merck told the BMJ that the company had simply responded “properly” to comments made by a member of parliament.
Meanwhile one of the world’s leading publishers of medical journals, Elsevier, released a statement last week from a senior executive apologising for the “improper” publication of Merck sponsored marketing material “that was made to look like journals,” published between 2000 and 2005. “This was an unacceptable practice, and we regret that it took place.”
Elsevier had published the Australasian Journal of Bone and Joint Medicine, the Merck sponsored journal that was described in the Australian federal court last month as a “marketing publication” by George Jelinek, a journal editor called by lawyers for the plaintiffs. Merck has not denied the claims but told the BMJ that “according to published reports, Elsevier published a series of similar journals.”
Dr Jelinek also testified that the role of the lead author of an influential 2001 study on rofecoxib published in Circulation involved little more than minor editing of a paper originally written in house by Merck scientists (http://circ.ahajournals.org/cgi/content/full/104/19/2280). The author in question, Marvin Konstam, has been reported as saying he acted properly and took responsibility for everything he published (www.theheart.org/article/965721.do), and Merck maintains that he was “very much involved with the design and authorship of the study.”
The federal court also heard that an internal email exchange discussing the Konstam paper before its publication showed concerns within Merck about the way the data on cardiovascular events associated with rofecoxib were being presented in the paper (http://dida.library.ucsf.edu/pdf/oxx03v10).
The paper’s discussion section stated that there was “no evidence that rofecoxib was associated with excess CV [cardiovascular] events compared with either placebo or non-naproxen NSAIDs [non-steroidal anti-inflammatory drugs].” However, a senior Merck employee, Briggs Morrison, described the claim in an email as “wishful thinking, not a critical interpretation of the data,” and wrote that “the data appears to have been interpreted to support a preconceived hypothesis.”
Despite these concerns a Merck employee signed off the manuscript, and exactly the same wording remained in the published version of the Circulation paper. In response to questions from BMJ, Merck said that the emails reflected the company’s process of “careful scientific review.”
After assessing many internal Merck documents, including these emails, Dr Jelinek testified to the federal court that in his view there was a “systematic attempt to flood the medical literature” with publications “with a well thought out set of objectives and key messages.”
The trial before Justice Jessup continues.
BMJ 2009;338:b1914
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Canadian media company demands right to publish direct to consumer drug advertising
19/05/2009 by Merav.
A long legal battle over advertising drugs directly to consumers is drawing to a close in Canada’s Superior Court.
The Canadian media giant Canwest is suing the federal government, claiming that the prohibition on advertising prescription drugs directly to the public is a contravention of the constitutional charter guaranteeing free speech.
In a document tendered to the court Canwest’s legal team has described the prohibitions as “paternalistic and anachronistic.” It argues that “truthful, balanced and fair statements containing information that is useful to patients cannot be curtailed” under the Canadian Charter of Rights and Freedoms.
The summary of the media company’s position, given in a 67 page “factum” provided to the court, is that the Canadian government already allows its citizens to be “bombarded” with direct to consumer advertisements in United States television, magazines, and the internet, “all of which the government permits to be distributed in Canada without restriction.”
It is estimated that drug companies collectively spend more than US$4bn (£2.7bn; 3bn) a year on such advertising in the United States. Although the industry is currently allowed to freely advertise prescription drugs directly to consumers only in the United States and New Zealand, it is pushing strongly for liberalisation of the ban in Europe, framing the aim as providing “information,” not advertising.
Arguing against any lifting of the prohibition in Canada, the federal government has told the Superior Court that the current restrictions do not impinge on the freedom of speech of media companies and that such restrictions are in place to protect the public’s health. The factum from Canada’s attorney general says that the benefits of such advertising are theoretical but unproved and that “the evidence of harm is much stronger and the known and potential harms outweigh any possible benefits.”
Responding to Canwest’s argument that advertisements will educate and inform consumers, the attorney general’s statement says that the purpose of the advertisements “is not to provide information, but is to convey a message intended to persuade, and which is likely to mislead and/or confuse the listener.”
Unusually the court has given leave to an ad hoc coalition of interest groups, including unions and healthcare groups, to intervene in the case. In its own factum this group argues that advertisements subject patients to “biased, misleading or deceptive” claims, exposes them to greater risk of side effects, damages the doctor-patient relationship, unnecessarily increases the overall costs of drugs, and neglects non-drug solutions to health problems.
The lawyer representing the coalition, Steven Shrybman, says that it has put evidence before the court that direct to consumer advertising disproportionately targets conditions affecting women. “Much of what is conveyed to women about drugs is ill founded,” he said.
Speaking from a personal perspective, the legal counsel for Canwest, Martin Teplitsky, told the BMJ that he disagreed with the “proselytising” of those who believe that society is overmedicated and said that he saw advertisements as educating and informing. “When we talk openly about things like erectile dysfunction, sexually transmitted diseases, and depression, that’s a good thing. It’s good for society, not bad.”
The case is scheduled to have final hearings in the Superior Court in June.
BMJ 2009;338:b1912
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22 member states of the EU are not in favour of the “information to patients”
16/05/2009 by Merav.
22 member states of the EU are not in favour of the “information to
patients” strand of the European Commission’s proposed package of new
pharma legislation, and it is likely that it will not go ahead,
industry officials revealed at the annual meeting of the European
pharmaceutical industry association, …
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Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences
12/05/2009 by Merav.
New research on promotional items : http://archinte.ama-assn.org/cgi/content/abstract/169/9/887
Archives of internal medicine
Also have a read of the accompanying editorial: http://archinte.ama-assn.org/cgi/content/full/169/9/829
Posted in EBM updates | Print | No Comments »
The trouble with tamiflu
07/05/2009 by Merav.
Have a read of this interesting guardian article about the benefits of tamiflu and relenza…
http://www.guardian.co.uk/world/2009/may/07/tamiflu-swine-flu-drugs
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May’s DTB
06/05/2009 by Merav.
The May 2009 issue of Drug and Therapeutics Bulletin (DTB) contains an editorial and four articles. The editorial discusses the large number of epilepsy medications available, questions the rationale of developing more and asks whose responsibility it is for undertaking trials that inform clinical decisions. The issue also includes an update on treatments for head lice, a review of the role of ▼colesevelam in cardiovascular prevention, an explanatory article about summary of product characteristics (SPCs), and the third in a series of Understanding Statistical Terms articles, covering topics relating to study design. A podcast outlining what is in the May issue is also available via our website www.dtb.bmj.com.
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April’s DTB
16/04/2009 by Merav.
The April 2009 issue of Drug and Therapeutics Bulletin (DTB) contains an editorial and three articles. The editorial discusses drugs being prescribed by different people looking after the same patient (their GP and a specialist, for example) and the issues in terms of making sure this information is communicated so that unwanted drug interactions and unwanted effects are recognised. An associated podcast can be found on our website www.dtb.bmj.com. The issue also includes a review preventing recurrent venous thromboembolism, a review of drospirenone in HRT, and an explanatory articles about medical licensing, and a short correction for an article that appeared in DTB’s February 2009 issue: Oral or intramuscular B12?
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cardiologists curtail pharma advertising
03/04/2009 by Merav.
At a giant meeting of more than 20,000 cardiologists, nurses and industry types, something’s missing: the ads.
It used to be that you could identify convention-goers by the drug advertisements that were plastered on their bags full of scientific abstracts, on the badges they wore around their necks and on the lanyards from which the badges hung.
Doctors looked “kind of like a Nascar driver,” says Jack Lewin, the chief executive of the American College of Cardiology (ACC), which runs the meeting. “Things have changed,” he says.
The ACC says it sacrificed nearly half a million dollars by getting rid of these ads. Last year, Pfizer paid $175,000 to get its cholesterol-lowering drug Lipitor on the convention bags and another $70,000 to plaster Lipitor on the lanyards. Merck and Schering-Plough paid $50,000 to get their rival cholesterol drug, Vytorin, on the data cards that were affixed to every convention-goers badge.
Also missing is a CD that contained digital versions of all the scientific abstracts presented at the meeting; that was also paid for by sponsors in the past. The ACC says that has generated lots of complaints from doctors.
“None of us are invulnerable to advertising-related biases,” says Lewin. “I don’t think we should be walking around with advertisements on our backs.”
Forbes.com 31/3/9
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Vioxx maker Merck and Co drew up doctor hit list
01/04/2009 by Merav.
AN international drug company made a hit list of doctors who had to be “neutralised” or discredited because they criticised the anti-arthritis drug the pharmaceutical giant produced.
Staff at US company Merck &Co emailed each other about the list of doctors - mainly researchers and academics - who had been negative about the drug Vioxx or Merck and a recommended course of action.
The email, which came out in the Federal Court in Melbourne yesterday as part of a class action against the drug company, included the words “neutralise”, “neutralised” or “discredit” against some of the doctors’ names.
It is also alleged the company used intimidation tactics against critical researchers, including dropping hints it would stop funding to institutions and claims it interfered with academic appointments.
“We may need to seek them out and destroy them where they live,” a Merck employee wrote, according to an email excerpt read to the court by Julian Burnside QC, acting for the plaintiff.
Merck & Co and its Australian subsidiary, Merck, Sharpe and Dohme, are being sued for compensation by more than 1000 Australians, who claim they suffered heart attacks or strokes as a result of Vioxx.
The Australian, 1/4/9
http://www.theaustralian.news.com.au/story/0,25197,25272600-2702,00.html
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