PHA-Exchange> Pharmaceutical houses and clinical research

[Schuftan, Aron]

From: WABA <mailto:waba at streamyx.com>  

	To: bala <mailto:bala at haiap.org>  
	----- Original Message ----- 
	From: Patti Rundall <mailto:prundall at babymilkaction.org>  
	To: IBFAN 1 <mailto:prundall at babymilkaction.org>  
	
	http://news.independent.co.uk/uk/health_medical/story.jsp?story=514316
	http://news.independent.co.uk/uk/health_medical/story.jsp?story=514317
	
	
	Pharmaceutical companies accused of manipulating drug trials for profit
	
	By Jeremy Laurance Health Editor
	
	
	
	The multibillion-pound global pharmaceutical industry is accused today of manipulating the results of drug trials for financial gain and withholding information that could expose patients to the risk of harm.
	
	The stranglehold that the industry exerts over research is causing increasing alarm in medical circles as evidence emerges of biased results, under-reporting and selective publication driven by a market worth more than £10bn a year in the UK.
	
	In cancer, heart disease, mental health and related fields the industry has sponsored trials of new drugs which have held out great promise for patients. But when the same drugs have been tested in independent trials paid for by non-profit organisations - governments, medical institutions or charities - they have yielded different results.
	
	Heart drugs prescribed for abnormal heart rhythm introduced in the late Seventies were estimated to kill more Americans each year by 1990 than the Vietnam War. Yet early evidence which suggested the drugs were lethal, and might have saved thousands, went unpublished.
	
	Expensive new cancer drugs introduced in the last decade and claiming to offer major benefits have increasingly been questioned. Evidence published in the Journal of the American Medical Association showed that 38 per cent of independent studies of the drugs reached unfavourable conclusions about them, compared with just 5 per cent of the studies funded by the pharmaceutical industry.
	
	
	The Association of the British Pharmaceutical Industry said it was prevented under Nice's rules from supplying unpublished data for the preparation of clinical guidelines. But, it has set up a register of clinical trials, and regulations to be introduced next month under the European clinical trials directive would make monitoring easier. 
	
	By Jeremy Laurance
	
	23 April 2004
	
	
	CANCER DRUGS: Just 5 per cent of studies funded by the pharmaceutical industry reached unfavourable conclusions about the companies' drugs compared with 38 per cent paid for by non-profit organisations. ( Journal of the American Medical Association , 1999)
	
	CONTRACEPTIVE PILL: Three independent studies of "third generation" contraceptives - the subject of a safety scare in 1995 - found they caused a higher risk of blood clots. Three studies paid for by the drug industry did not. ( British Medical Journal 2000)
	
	SMOKING: 106 reviews of whether passive smoking causes harm found 63 per cent concluded it was harmful and 37 per cent that it was harmless. The only factor that could be correlated with the conclusion was whether or not the author was affiliated to the tobacco industry.
	
	HORMONE REPLACEMENT THERAPY: An early analysis of data from trials of HRT, published in the BMJ in 1997, suggested that HRT might increase the risk of cancer and heart deaths. Insults were heaped on the authors and the BMJ for publishing such "rubbish". In 2002, the Women's Health Initiative study confirmed that HRT doubled the risk of breast cancer and resulted in increased heart problems.
	
	HEART DRUGS: The class of anti-arrhythmic drugs including Lidocaine and Flecainide introduced in the late 1970s that were given to patients with abnormal heart rhythm were estimated to be killing more Americans every year by 1990 than died in the Vietnam War.
	
	Early evidence suggesting the drugs were lethal, which might have averted the catastrophe, was not published.
	
	ARTHRITIS: Drugs are more often tested on a healthy population, in whom they cause fewer side-effects, than on the population that receives them. Only 2 per cent of patients in trials of non-steroidal anti-inflammatory drugs were aged over 65, even though the drugs are more commonly used by, and have a higher incid- ence of side-effects in, the elderly.
	
	DRUG INDUSTRY SPENDING: The American pharmaceutical industry spent $16bn (£9bn) on promotion in 2000 and gave out a total of $7.2bn of free samples. Seventy-five per cent of trials published in four of the five major medical journals ( The Lancet, New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine ) are sponsored by the pharmaceutical industry. In the fifth journal, the BMJ , it is 30 per cent.
	
	CONFLICTS OF INTEREST: An analysis of 789 articles from major journals found that a third of the lead authors had financial interests in their research in the form of patents, shares, or payments from the companies for being on advisory boards or working as a director. 
	         
	

	 

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