fraudulently promoted drugs
A very informative website to search for fraudulently promoted drugs
22/09/2009
14/09/2009
Physicians, the industry and population health
This week, two healthy skepticism members have written an interesting editorial in the Journal of Epidemiology and Community health on the impact of pharmaceutical advertising on doctor’s prescribing. Have a read at http://jech.bmj.com/cgi/content/short/63/10/773?q=w_jech_current_tab 13/9/9.
11/09/2009
Ghostwriting Is Called Rife in Medical Journals
Six of the top medical journals published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies, according to a study released Thursday by editors of The Journal of the American Medical Association.
Among authors of 630 articles who responded anonymously to an online questionnaire created for the study, 7.8 percent acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed.
Read the full article at http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=2&ref=health
10/9/9, New York Times
04/09/2009
In clear sight
This interesting review looks at the ethics of th SCOT trial (Standard Care versus Celecoxib Outcome trial), both through sign up of GP practices and research design.
BMJ 2009;339:b3443
03/09/2009
September DTB
The September 2009 issue of Drug and Therapeutics Bulletin (DTB) contains an editorial and two articles. The editorial discusses the recent policy and possible consequences of widespread access to Tamiflu in the current flu pandemic. An associated podcast discussing the wider issues associated with this topic is available via our website www.dtb.bmj.com. The issue also includes a review of the management of self-monitoring INR in patients on warfarin, and an article on the non-drug management of chronic low back pain. A podcast outlining what is in the September issue is also available via our website.
01/09/2009
New methods to deal with publication bias
Have a look at this BMJ editorial on new methods to publication bias. (http://www.bmj.com/cgi/content/extract/339/aug26_1/b3272). It is based on a research article later in the edition.
BMJ 29/8/9 volume 339 p468
Exorcising authors
The Financial Times describe the concerns regarding ghostwriting at http://www.ft.com/cms/s/0/f7434ad6-9588-11de-90e0-00144feabdc0.html?nclick_check=1 published on 30/8/9.
27/08/2009
NICE reject renal cancer drugs
The National Institute for Health and Clinical Excellence’s decision to reject an appeal to make Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel available on the National Health Service for renal cancer patients has unsurprisingly led to protests from the drugmakers and patient groups.
NICE has this morning issued guidance saying that Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) are not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma. In addition, the agency has turned down the use of Nexavar andPfizer’s Sutent (sunitinib) as secondary treatment options for people with either form of the disease, adding that those patients who are currently receiving these treatments should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.
A year ago, NICE turned down all four drugs for first-line use but then changed its guidance to recommend Sutent at the beginning of 2009. However an appeal against that Final Appraisal Determination brought by Roche, Wyeth the James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support, have not been upheld.
Peter Littlejohns, NICE’s clinical and public health director, noted that “we are very aware that renal cancer is a devastating disease for the individual and their family” and following the about-turn over Sutent in March, “one of these new treatments is now available”. However, he added that the evidence to support the use of the other first and second line treatments “isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas”.
Prof Littlejohns concluded that “our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost”.
Roche has responded to the guidance by saying that it is “fundamentally flawed” and serves only to reduce treatment access and options “for those UK patients who are sadly dying from this disease whilst being available to other patients in comparable countries”. The company adds that the appraisal committee accepted Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already-approved Sutent “but turned it down simply because it has a licence in other indications - despite the fact that these indications are not currently routinely reimbursed on the NHS”.
The implication of this guidance, Roche claims, is that patients who are unsuitable for sunitinib “may be condemned to faster disease progression of their terminal cancer”. John Melville, general manager of Roche UK, said the decision is “entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda”.
He added that Avastin “demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end-of-life criteria which were devised for this very setting”. The company stated that it is “considering all options”.
Stella Pendleton, executive director of the Rarer Cancers Forum, said “this is a deeply disappointing decision and a bitter blow. It is “harrowing” for patients “to know that effective treatments are available but they can’t get them on the NHS”, she added.
Ms Pendleton went on to note that the guidance will be considered for review by June 2011 and that review and “reversal of this decision cannot come fast enough”.
By Kevin Grogan
20/08/2009
European and US agencies will ensure ethical conduct of trials
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have will work together to ensure that clinical trials related to drug marketing applications in the USA and Europe are conducted “uniformly, appropriately, and ethically.”
The “good clinical practices initiative” is expected to strengthen safeguards for participants in clinical studies. In a joint statement the EMEA and the FDA said that in most cases the same clinical trials are used to support applications to both agencies for approvals of new drugs. Many of the people participating in these clinical trials are recruited in
06/07/2009
July DTB
The July 2009 issue of Drug and Therapeutics Bulletin (DTB) contains an editorial and three articles. The editorial discusses that in the UK, only England will have charges for prescriptions from April 2011. The issue also includes a review of the first licensed ▼Melatonin product, a review of theapproaches for first trimester miscarriage, and an explanatory article on Excipients, and what they are doing in medicinal products. A podcast outlining what is in the July issue is also available via our website www.dtb.bmj.com.