Navigation Links
No Scientific Evidence to Support Drug Safety Recommendations

During the past several years, there has been a perceived drug safety crisis in the United States.//

A recent editorial published in Health Economics finds no scientific evidence to back up the IOM’s recommendations released recently and little evidence of a drug safety crisis.

The current drug controversy is largely due to the withdrawal of Vioxx from the market, but the decrease in drug approval times thanks to the Prescription Drug User Fee Acts (PDUFA), and undue influence from the pharmaceutical industry that these acts may have invited have also played a role. Yet the scientific basis that too many unsafe drugs enter the market is lacking.

The IOM report does not document, for example, whether the reductions in approval times for bringing drugs to the market negatively affects the well-being of consumers.

The editorial points to a study that the social benefit from reducing drug approval times from 1979 to 2002 —a sum estimated at $16 to $32 billion dollars—substantially outweighed any decrease in safety.

Although a lengthier approval process might reduce the number of drug withdrawals, this doesn’t necessarily mean that too many drugs are withdrawn.

Removing a few drugs from the market may be a necessary price to pay for bringing a larger number of medications more quickly to the public.

The report recommends a two-year ban on advertising drugs directly to consumers because it may lead to increased exposure to unsafe drugs, but it would also mean that fewer consumers would benefit from these medications.

Also, it is not clear if restricting this advertising would limit consumption since it represents only a 15% share of total advertising expenditures.

The authors agree with the report’s recommendation that extensive testing should be done after drugs are on the market. “The science of approval is far more elaborate than the science of withdrawal, many times done under gr eat political pressure,” they note.

They point to a strong need for FDA-mandated post-approval studies, since pharmaceutical companies have little incentive to undertake this research on their own, as it could potentially lower their profits.

The FDA has picked up on this point; at the end of January, the agency announced a new policy to comprehensively assess drugs 18 months after they are introduced.

Source-EurekalertPRI
'"/>




Related medicine news :

1. Scientific markers of aging described
2. A Settlement Over Stem Cell Controversy Through Scientific Research
3. A Scientific Explanation For Out Of Body Experience
4. PUFA Good For Heart: Gets The Scientific Seal
5. Forensic Phonetics – Scientific Solution for Legal Problem
6. Old Indian Advice Has A Scientific Backing Now!
7. India To Highlight Its Scientific Achievements
8. Scientific Research in a War Zone
9. Evidence Links Protein Damage to Neurodegenerative diseases like Parkinsons and Alzheimers
10. Evidence supporting H.pylori eradication
11. Evidence against use of Beta blockers as first choice in the treatment of primary hypertension
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... , ... October 13, 2017 , ... Apple Rehab ... services, staged a mock evacuation of the facility as part of a disaster drill ... Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/13/2017)... ... 13, 2017 , ... “America On The Brink”: the Christian history of the ... is the creation of published author, William Nowers. Captain Nowers and his wife, ... he spent thirty years in the Navy. Following his career as a naval ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of ... announced today its plans to open a flagship location in Covington, LA at 401 ... Rooms To Go store next to Office Depot in the Holiday Square shopping center. ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... Israel and NEW YORK , Sept. 27, ... with mobile health and big data solutions, today announced that its MyDario ... Please check your local TV listings for when The Dr. Oz Show ... ... season this month. ...
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
(Date:9/22/2017)... ROCKVILLE, Md. , Sept. 22, 2017  As ... by Republican Senators Bill Cassidy (R-LA) and ... Kalorama Information notes that the medical device industry is ... the medical device tax, the 2.3% excise tax on ... Act.  But they also want covered patients, increased visits ...
Breaking Medicine Technology: