Former insider hits out at FDAs links with pharmaceutical industry

A former senior consultant with the Food and Drug Administration (FDA) has criticised the American regulator's close relationship with the pharmaceutical industry. Interviewed in this week's BMJ, he attacks the FDA's decision to allow the re-marketing of a controversial drug.

Dr Paul Stolley joined the FDA in July 2000 to look into the post-marketing safety of alosteron (Lotronex), a treatment for irritable bowel syndrome manufactured by GlaxoSmithKline. Within months he was writing to his superiors about a rising toll of adverse incidents, including ischaemic colitis, hospitalisation, surgery, and deaths.

Glaxo Wellcome (as the company was then) voluntarily withdrew alosteron in November 2000, but almost immediately patient groups were pushing for its return. Stolley claims that his superior, Dr Janet Woodcock, accused him of "brow-beating" colleagues about the drug's risks. He also says other colleagues concerned about the drug's safety were pressurised to "help get this drug back on the market". Woodcock, however, says that alosetron is an example of how difficult it is to provide access to a risky drug for those in greatest need. On Stolley himself she says: "It's our responsibility to be dispassionate and not develop emotionally based positions".

In April a special advisory committee recommended that alosetron be remarketed on the condition that it was prescribed only by specially certified doctors. Six weeks later, however, the FDA formally re-approved marketing based only on "physician self attestation of qualifications".

A number of the committee members are now publicly warning of a risk of more deaths and another withdrawal if the drug returns to the market later this year. What happens in America is likely to determine whether the company pursues approval for the drug elsewhere in the world.

Over the last ten years eight drugs have been approved by the FDA and subsequently withdrawn for safety reasons, pro

Contact: Steve Harman
BMJ-British Medical Journal

Page: 1 2

Related medicine news :

1. Former President George Bush joins leaders from cancer community to announce historic collaboration
2. Former NHLBI director Lenfant receives Lifetime Achievement Award
3. How links with tobacco industry may have influenced the publication of research on second-hand smoke
4. Study links racial and ethnic gap in youth violence to social factors
5. Study links sexual behavior, genetic factors to increased risk of kidney infection in women under 50
6. New UCLA study develops links between socioeconomic status and poor health
7. New study links lead exposure with increased risk of cataract
8. Leading tobacco manufacturer conceals links to tobacco research facility
9. New analysis links breastfeeding to reduced risk of childhood leukemia
10. Study links warm offices to fewer typing errors and higher productivity
11. UMHS study links gonorrhea, prostate cancer in men

Post Your Comments:

(Date:2/13/2019)... ... February 13, 2019 , ... American Vision ... in the nation, announced a new addition to their growing list of ophthalmology ... created within a multi-specialty ophthalmology practice. , Dr. Zachary Berbos, MD, ...
(Date:2/13/2019)... ... February 13, 2019 , ... Surgery that moves both jaws ... treatment for obstructive sleep apnea (OSA), resulting in benefits that include improved breathing, daytime ... a new study. , MMA should be regarded as the preferred treatment for patients ...
(Date:2/13/2019)... MONICA, Calif. (PRWEB) , ... February 13, 2019 ... ... of Southern California has joined the esteemed Haute Beauty network. , The ... privileged to present Dr. Christie as a leading Aesthetic surgeon and our newest ...
(Date:2/12/2019)... ... ... Attorney Harry Nelson , a leading expert on America’s healthcare future, a ... to donate $1-million from the online sales of his soon-to-be-released new book, The United ... America in 2019, according to Nelson. , Proceeds will be initially donated to ...
(Date:2/11/2019)... ... 11, 2019 , ... Z-Medica, LLC, a Linden Capital Partners ... appointment of nationally recognized cardiothoracic surgeon and researcher, Vinod Thourani, M.D., to the ... University School of Medicine and the Chairman of Cardiac Surgery for MedStar Heart ...
Breaking Medicine News(10 mins):
(Date:2/13/2019)... (PRWEB) , ... February 13, 2019 , ... Wound Care ... Wound Care EHR software as an app inside their hospital’s EHR, substantially ... Wound Care EHR (electronic health record) pioneer, will soon launch its award-winning software ...
(Date:2/13/2019)... , ... February 13, 2019 , ... ... part of the Public Private Partnership (PPP) between the Department of Health-Abu Dhabi ... the region’s first Health Information Exchange system (HIE), a centralized platform to streamline ...
(Date:2/13/2019)... (PRWEB) , ... February 13, 2019 , ... The Medicus ... of Staff Physician Recruiters (ASPR). “The Medicus Firm has been a vocal and ... Industry stewardship and support of educational programs are part of our DNA and ...
Breaking Medicine Technology:
Cached News: