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[e-drug] Therapeutics Initiative in trouble: Assessment program under attack

E-DRUG: Therapeutics Initiative in trouble: Assessment program under attack
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Highly-lauded drug assessment program under attack
 Early release. Published at www.cmaj.ca on May 28, 2008. Print version subject 
to revision.

International experts are condemning a British Columbia report's recommendation 
that an independent prescription drug watchdog based at the University of 
British Columbia be dismantled.

The 14-year-old Therapeutics Initiative "is the only source of critical 
assessment of new treatments in Canada that is not political or partisan," says 
Dr. Andrew Herxheimer, a clinical pharmacologist who helped establish the 
international Cochrane Collaboration and spent 30 years as editor of the Drug 
and Therapeutics Bulletin in the United Kingdom.

Dr. Jerome Kassirer, former editor of the New England Journal of Medicine, says 
there "are enormous advantages to having independent people assess 
therapeutics. I strongly support any [such] organization that has no ties to 
industry." Kassirer recently publicly praised the objectivity and scientific 
validity of the Initiative's analysis of the cholesterol guidelines issued by 
the National Cholesterol Education Program (United States) in 2004.

The Report of the Pharmaceutical Task Force, made public in late May 
(www.health.gov.bc.ca), was written by a 9-member team, appointed by the 
provincial government, which included Russell Williams, the president of Rx&D, 
the trade association for brand name pharmaceuticals in Canada; David Hall, 
vice president of Angiotech Pharmaceuticals Inc.; and Dr. Mark Schonfeld, chief 
executive officer of the province's medical association. 

Minister of Health George Abbott has said he has accepted the recommendations.

The British Columbia watchdog's mandate is to provide unbiased, evidence-based 
information about drugs to physicians and pharmacists. It operates at arm's 
length from the pharmaceutical industry, government and other vested interest 
groups, (CMAJ 2007;176[4]:429-31).

It is one of a limited number of similar bodies; others include la revue 
Prescrire in France, and the National Prescribing Service in Australia, 
Herxheimer says.

 In its report, the task force slammed the Therapeutics Initiative as "narrow, 
insular and resistant to meaningful stakeholder engagement" and argues that the 
watchdog does not meet "current and future public interest needs of the 
province."

However, advice from the Initiative has led to lower rates of prescribing in 
British Columbia of some drugs that have subsequently been shown to have 
significant safety concerns or been withdrawn from the market, says Dr. Ken 
Bassett, professor of medicine and chair of the initiative's drug assessment 
working group. Examples include the osteoporosis drug alendronate sodium 
(Fosamax), the diabetes drugs rosiglitazone maleate (Avandia), donepezil 
(Aricept) and rofecoxib (Vioxx) and valdecoxib (Bextra), he says.

The work of the Initiative has been deemed useful by 2 provincial Auditor 
General reports, has undergone numerous external reviews and is currently being 
reviewed by the University's Faculty of Medicine, said Bassett.

But the report authors state that the Initiative is "widely regarded as being 
in need of either substantial revitalization or replacement. The Task Force 
regards replacement as the better option."

Some of the task force's recommendations are "clearly an effort to increase 
industry influence," says Dr. Sidney Wolfe, director of the Health Research 
Group of the U.S. watchdog Public Citizen.

The report, which urges faster approval of patented drugs, says the conflict of 
interest guidelines, which rule the Therapeutics Initiative are "so 
restrictive" as to exclude the participation of stakeholders and some disease 
specialists. (The Initiative does not work with anyone who works with industry, 
Bassett says). 

For his part, Wolfe supported recommendations that called for more expert 
involvement, but only under strict conflict of interest guidelines.

The Therapeutics Initiative, an advisory body, is funded by a $1-million grant 
from the province. It consists of a drug assessment working group, which 
analyses clinical trial data to assess benefit and harm; a therapeutics letter 
working group, which writes short articles for physicians and pharmacists; an 
education working group which disseminates information puts on a course for 
doctors and pharmacists; and a pharmaco-epidemiology group which assesses drug 
use data and outcomes.

The task force was clearly struck to give a voice to industry's concerns, says 
Steve Morgan, a professor of health economics at the University of British 
Columbia. It represents the advice "of one sector, not of all of British 
Columbia."

The Health Minister, in a press release, said that implementation of the report 
will be guided by 6 principles, which include the best interests of the 
patient, a transparent process and an evidence-based review process. The 
minister could not be reached for further comment.

The task force had a 5-part mandate, one of which concerned the role of the 
Therapeutics Initiative. The other 4 were to make recommendations on how to 
optimize the decision making process around listing of drugs; how to optimise 
procurement and delivery options for drugs and medical devices; how to build 
positive relations between government and industry; and how to improve the 
effectiveness of the Common Drug Review.

- Ann Silversides, CMAJ

DOI:10.1503/cmaj.080845
http://www.cmaj.ca/cgi/rapidpdf/cmaj.080845

the complete report
"Report of the Pharmaceutical Task Force" can be found at 
http://www.health.gov.bc.ca/library/publications/year/2008/PharmaceuticalTaskForceReport.pdf

Martin Canas
GAPURMED
La Plata (Argentina)
macanas@netverk.com.ar

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