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More on FDA and Big Pharma

More on FDA and Big Pharma
27/06/2012 Mike

Big pharma has taken a big hit following the extraordinary allegations in recent days of serious shortcomings at the US Food and Drug Administration, including that its relationship with drug companies is far too cosy.

An FDA insider, David Graham, lit the touchpaper by claiming the body failed to act quickly enough on concerns about suicide risk among children taking certain antidepressants. The body was also slow to move on worries about the safety of Merck’s arthritis medication Vioxx, he says, adding that his research led him to estimate that Vioxx hurt 88,000 to 139,000 Americans, with 30-40% of them dying. Vioxx was pulled from the market in September.

Graham went on allege that five other prescribed drugs, including GlaxoSmithKline’s asthma treatment Serevent and AstraZeneca’s cholestrol-lowering drug Crestor also posed serious health risks.

Graham cannot be easily dismissed. He has been at the FDA for 20 years and is an associate director of its Office of Drug Safety. The FDA has sought to distance itself from his comments but that appears only to have riled Graham even more. ‘We have a system that is biased towards approving drugs almost regardless of the safety,’ he said in an ABC ‘Nightline’ interview on Tuesday, adding that ‘any reason will be looked for to approve a drug, unless there is an overwhelming safety reason not to approve a drug’.

Before the FDA and drug industry had the time to reel, never mind recover from Graham’s attack, a series of articles and commentary, also highly critical of the FDA and drug companies, appeared in the influential Journal of the American Medical Association (JAMA). The articles raise a number of concerns about drug approval and monitoring and some of the statistics flung at the two parties look quite damning.

JAMA says for instance that the FDA has decreased drug approval times from 27 months in 1993 to 14 months in 2001. Meanwhile the drug recall rate has leapt from 1.56% for the period 1993 to 1996 to 5.35% for 1997 through to 2001.

Other major concerns highlighted by JAMA include the danger of a conflict of interest from the FDA being responsible for both pre- and post-marketing surveillance systems for prescribed drugs. These, it says, need separating with the creation of an independent unit for post-marketing surveillance.

No drug is completely safe and all have some toxic effect. One cannot therefore overestimate the crucial role the FDA plays, or is supposed to play, as the world’s premier drug assessor and regulator, in balancing risks against benefits of treatments on behalf of the public. That reputation has been dented this week. The accusations flung at the FDA are all the more shocking considering the venerable history of the FDA, which in its modern form will be 100 years old in 2006.

It would be surprising, despite its distancing from Graham’s criticism, if the FDA did not act at all on some of the concerns, especially those relating to conflicts of interest. An intense period in which it will be under heavy scrutiny lies before it.

Big pharma’s woes also look set to continue as the sector looks to reassure an increasingly worried public. That task will not be made any easier by GlaxoSmithKline being currently at the centre of a probe by the UK Medical and Healthcare Products Regulatory Authority (MHRA) for allegedly failing to reveal trial data showing its antidepressant Seroxat did not work in children.

In an echo of the charges levelled at the FDA, the MHRA has been accused of having ignored vital safety data on Seroxat for many years. There are concerns that it also has been too close to the industry, resulting in conflicts of interest. The MHRA report on GSK may be published before the end of the year although a Department of Health spokeswoman said earlier this week that no date has been set yet and the investigation was ‘ongoing’.

With such a saga going on then it is not perhaps surprising Hollywood is looking to muscle in on the act with controversial film-maker Michael Moore, whose documentary work includes Bowling for Columbine and Fahrenheit 9/11, said to be working on a critical film about the health industry, apparently titled ‘Sicko’. Moore, whatever your views about his work, is rather adept at generating publicity and his ‘Sicko’ project promises to further ensure the drug industry’s shortcomings remain high profile. Lets hope the industry and regulators do not provide him with the ammunition to make a sequel.