Navigation Links
Drug Industry Seeks Tests to Spot Side Effect Risks

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:
(Date:11/27/2015)... ... November 27, 2015 , ... The print component ... Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation of ... distributed nationally, through a vast social media strategy and across a network of ...
(Date:11/27/2015)... ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in the world, revealed ... 1-1 ). More than 3.7 billion people under the age of 50 – or ... to WHO's first global estimates of HSV-1 infection . , "The data shocks us ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... of the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official ... independent group of Microsoft Dynamics SL software users, partners, industry experts and representatives. ...
(Date:11/27/2015)... Minn. (PRWEB) , ... November 27, 2015 , ... ... start failing. Secura Consultants has prided itself for not only fulfilling the needs ... income protection solutions at an affordable price and providing top-tier customer service. However, ...
(Date:11/27/2015)... Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic ... list of CAAHEP accredited colleges, as only one of twelve colleges and universities in ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ( ... "Advanced Wound Care Market by Type (Dressings, Therapy Devices, ... (In-Patient Facility, Out-Patient Facility), and Geography - Global Forecast ... --> --> The purpose ... and forecast of the global advanced wound care market. ...
(Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Italian ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
Breaking Medicine Technology: