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Press releases Saturday 1 January 2005
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(1) BMJ TURNS MISSING MURDER CASE DOCUMENTS OVER TO FDA
(2) WHAT IS DRIVING THE RISE IN OVER THE COUNTER DRUGS?
(3) RADON IN THE
HOME RESPONSIBLE FOR 9% OF LUNG CANCER DEATHS ACROSS EUROPE
(1) BMJ TURNS MISSING MURDER CASE DOCUMENTS OVER TO FDA
(FDA to review missing documents
on murder case)
http://bmj.com/cgi/content/full/330/7481/7
The BMJ has turned over confidential drug company documents that went missing from a 10 year old murder case to the US Food and Drug Administration (FDA) for review.
The documents, which were sent to the BMJ by an anonymous source, appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence. They also suggest that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimise their likely negative effect on prescribing.
The documents reportedly went missing during the case of Joseph Wesbecker in 1994, who killed eight people at his workplace in 1989, while taking fluoxetine. He then shot and killed himself.
In 1994, some of the relatives of the victims brought a civil suit against Eli Lilly, alleging that the company had known about the side effects of fluoxetine for years (including the fact that it might increase violence). The company won the case, but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid.
One of the documents, dated November 1988, reports that in clinical trials fluoxetine can cause behavioural disturbances. The FDA recently issued a warning that antidepressants can cause stimulatory side effects such as agitation, panic attacks, insomnia, and aggressiveness.
These documents provide "the missing link" between the recent FDA advice and what Lilly scientists knew 16 years ago, says Harvard psychiatrist Dr Joseph Glenmullen.
Dr Richard Kalpit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. "These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it."
Congressman Maurice Hinchey (Democrat, New York), who is currently reviewing the documents to determine whether Lilly withheld data from the public and the FDA, said: "This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks."
Lilly has defended their drug saying, "Prozac has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine, and has been prescribed for more than 50 million people worldwide. The safety and efficiency of Prozac is well studied, well documented, and well established."
Contact:
Jeanne Lenzer, Freelance journalist,
New York, USA
Email: jeanne.lenzer@verizon.net
(2) WHAT IS DRIVING THE RISE IN OVER THE COUNTER DRUGS?
(Switching prescription drugs
to over the counter)
http://bmj.com/cgi/content/full/330/7481/39
Switching of prescription drugs to over the counter availability is increasingly common, but what are the motives behind this trend, ask US researchers in this week's BMJ?
Generally, a prescription drug becomes a candidate for over the counter availability if it is used for a non-chronic condition that is relatively easy to self-diagnose and has low potential for harm from abuse.
Yet recent switches, such as the cholesterol-lowering drug simvastatin in the United Kingdom, do not fit this description.
The authors suggest that switches are motivated mainly by three factors: pharmaceutical firms' desire to expand their market, attempts to reduce drug bills, and the self care movement.
Much has been said about the UK Healthcare Products Regulatory Agency's controversial decision in May 2004 to reclassify simvastatin 10mg as an over the counter medicine, as there have been no clinical trials of over the counter statins for prevention of heart disease.
Concern has been raised that the main motive behind the government's decision to allow simvastatin to be sold directly to the public is to save NHS costs. But this is unlikely because high risk patients will still be eligible for statins on prescription, say the authors. However, cost was the main motive behind the recent high profile switching of two other drugs - omeprazole for stomach ulcers in Sweden and the antihistamine loratadine in the US.
The number of drugs being switched from prescription to over the counter availability is likely to continue to rise, and healthcare funders are likely to support manufacturers' applications to switch some drugs in an effort to curb the growth of prescription drugs, they say.
For patients, the trend towards more switches will take self care to a new level, focused increasingly on chronic prevention of serious illnesses, they conclude.
Contact:
Joshua Cohen, Senior Research Fellow,
Tufts Center for the Study of Drug Development, University School of Medicine,
Boston, USA
E-mail: joshua.cohen@tufts.edu
(3) RADON IN THE HOME RESPONSIBLE FOR 9% OF LUNG CANCER DEATHS ACROSS EUROPE
Online First
(Radon in the home responsible for 9% of lung cancer deaths across
Europe)
http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38308.477650.63
Radon in homes and risk of lung cancer: collaborative analysis of individual data from 13 European case-control studies, BMJ Online First
The effects of natural radon gas escaping the earth's surface into our homes is causing 9% of all deaths from lung cancer across Europe, and smokers are most at risk, according to a paper on BMJ.com today (21 December 2004).
Radon gas emissions contain radioactive particles which disperse naturally outdoors, but can build up in indoor environments. Most of the radon we breathe is exhaled immediately, but some of the particles can attach themselves to the lungs, exposing them to damaging levels of radiation.
Researchers analysed 7,148 cases of lung cancer and 14,208 controls (people who had not developed lung cancer) across Europe. In the largest study of its kind, they examined radon levels in the present and past homes of all the lung cancer sufferers and the controls. They also obtained detailed smoking histories, including the effects of second-hand smoke on lifelong non-smokers.
They found that radon accounted for 20,000 deaths from lung cancer in Europe each year, equating to 9% of lung cancer deaths and 2% of all cancer deaths across Europe. The risk of radon-induced lung cancer increased proportionally to how much radon people were exposed to.
Smokers were at much greater risk of developing lung cancer, as radon exposure multiplied the effects of smoking.
Concentrations of radon in homes vary widely from house to house, and urban areas tend to have lower levels than rural areas. Action can however be taken to reduce radon exposure in the home, say the authors. At moderate cost increasing underfloor ventilation would reduce high radon concentrations in existing homes. As new homes are constructed, a radon proof barrier installed at ground level would be even lower cost, they conclude.
Contact:
Sarah Darby Professor of Medical
Statistics, Clinical Trial Service Unit, Radcliffe Infirmary, Oxford, UK
Email: sarah.darby@ctsu.ox.ac.uk
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