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approval process might reduce the number of drug withdrawals, this doesn’t necessarily mean that too many drugs are withdrawn.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:6/27/2016)... Lafayette, California (PRWEB) , ... ... ... a pioneer in the patient payment industry today announced its strategic partnership ... and health system workflows. , The two companies’ proven, proprietary technology combine ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer ... they remain in the eye of the beholder, according to experts who offered insights ... American Journal of Managed Care. For the full issue, click here . , ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... Any dentist who has made an implant supported ... Many of them do not even offer this as a ... laboratory costs involved. And those who ARE able to offer ... high cost that the majority of today,s patients would not ... Zadeh , founder of Dental Evolutions Inc. and inventor of ...
(Date:6/23/2016)... startling report released today, National Safety Council research shows ... plan to eliminate prescription opioid overdoses. Prescription Nation ... the worst drug crisis in recorded U.S. history, assigned a "Making ... , New Mexico , Tennessee ... states, three – Michigan , Missouri ...
Breaking Medicine Technology: