Navigation Links
Drug Industry Seeks Tests to Spot Side Effect Risks
Date:9/27/2007

7 pharmaceutical giants are pooling resources to develop gene-based screens

THURSDAY, Sept. 27 (HealthDay News) -- Seven major pharmaceutical companies are banding together to develop genetic tests that predict which patients will have adverse side effects from drugs.

The group, a nonprofit organization dubbed the International Serious Adverse Events Consortium (SAEC), will conduct two studies, one to look at drug-related liver toxicity and the other aimed at a rare drug-related skin condition called Stevens-Johnson syndrome.

"SAEC's focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event," Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday.

The findings of the consortium could have an impact on improving the ability of patients to safely use existing drugs, Holden added. "We hope it will improve the productivity and effectiveness not only for those who develop drugs but for those who regulate drug development," he said.

"The immediate goal would be to develop a test that could identify who will have a problem with a drug before they get it," said Dr. Paul Watkins, director of the General Clinical Research Center at the University of North Carolina in Chapel Hill. "The ultimate goal is to look at the genes that are causing the susceptibility and work back to figure out how we can design drugs differently so that no one would have that problem," he added.

"The two drug reactions that are being studied, Stevens-Johnson and liver toxicity, are very common reasons for problems with drugs either being restricted, not being developed, not being approved or being pulled off the market," said Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer at the U.S. Food and Drug Administration.

"This effort is part of personalized medicine -- personalized safety -- that will make treatments safer by understanding individual benefits and risks," she added. "This will help in the development of drugs both in avoiding these side effects in the future and maybe developing tests to help identify people at high risk," she said.

Findings from these studies could lead to the FDA requiring genetic tests to determine risk before the drug is prescribed, Woodcock added.

A recent survey found that most Americans are more concerned with drug safety than with speeding more medications to the marketplace.

Members of the consortium include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Roche, Sanofi-Aventis and Wyeth. In addition, the FDA will consult on the design and conduct of SAEC studies.

The actual research will be done at academic centers in Europe and the United States.

The results of the studies will be made public domain, and none of the companies will have early access or be allowed to patent the findings. When the results are made public, any company can develop and sell the genetic tests that predict side effects.

SAEC is one of several consortiums formed by the pharmaceutical industry to conduct basic research. One of the first was started in 1999 and was headed by Holden. That consortium looked for DNA variations among people. Their data were also put into the public domain.

More information

For more on drug safety and side effects, visit the U.S. Food and Drug Administration.



SOURCES: Sept. 27, 2007, teleconference with Janet Woodcock, M.D., deputy commissioner and chief medical officer, U.S. Food and Drug Administration; Arthur Holden, chairman, International Serious Adverse Events Consortium; and Paul Watkins, M.D., Verne S. Caviness Distinguished Professor of Medicine and Professor of Pharmacotherapy, and Director, General Clinical Research Center, University of North Carolina, Chapel Hill; Sept. 27, 2007, International Serious Adverse Events Consortium, press statement


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Healthcare sector is now a multi billion-dollar industry in India
2. Biotechnology industry expected to grow into a three billion dollar industry by 2002
3. Setting up a new pharmaceutical industry in India
4. Drugs control and industry departments to share a common e-platform
5. Indian pharma industry upbeat on WTO drug deal
6. Cancer risk among nuclear industry workers
7. Adding Credit To The Health Care Industry In India
8. Collaborations planned between British Organization and Indian health care industry
9. Jharkhand Gives Health industry status
10. Unregulated Fish Industry Harms Health Of Women
11. Tourism Industry Affected By Bird Flu
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... ... School of Nursing with an in-kind gift of a VeinViewer® Vision vein ... as they learn how to start an IV and draw blood, combining technology ...
(Date:2/13/2016)... Montreal, Canada (PRWEB) , ... February 13, 2016 , ... ... best foot forward. They’ll groom themselves to perfection, go out of their way to ... their date – just take a look at any online dating profile. , ...
(Date:2/12/2016)... ... ... According to an article published February 4th on mySA, robotically ... hernia repairs throughout the United States. Commenting on this article, Beverly Hills hernia repair ... has not only been expected, but it seems to be a natural result of ...
(Date:2/12/2016)... ... ... The law firm of Morrow, Morrow, Ryan & Bassett is offering scholarships to ... to encourage applicants to pursue a degree in their field of study and upon ... “We have available jobs in St. Landry and Evangeline Parishes that can be filled ...
(Date:2/12/2016)... ... 12, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... at its 10th anniversary Fashion Luncheon on Monday, February 8, 2016. The special ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... , Feb. 12, 2016  Eli Lilly and Company ... Court decided the Alimta® (pemetrexed disodium) vitamin regimen patent would ... the UK, France , Italy ... to dilute the product only with dextrose solution.  ... 2015, the UK Court of Appeal held that Lilly,s patent ...
(Date:2/12/2016)... 12 2016  OMS Supply, a large provider of ... announced today the recent launching of their new company ... of features that enhance the user experience and enable ... --> --> Despite ... company that started in early 2016, they have already ...
(Date:2/12/2016)... Feb. 12, 2016  Apellis Pharmaceuticals, Inc., ... $47.1 million Series D preferred stock financing, ... Hillhouse Capital Group and venBio Global Strategic ... AJU IB Investment, and Epidarex Capital. The proceeds ... further advance clinical trials in the Company,s ...
Breaking Medicine Technology: