Navigation Links
Physician calls for more rigorous standards for drugs up for FDA approval
Date:3/9/2010

A hospitalist at the University of Rochester Medical Center calls for more stringent Federal guidelines governing the approval of potential new drugs, in a commentary in the March 10 issue of the Journal of the American Medical Association.

Alec B. O'Connor, M.D., M.P.H., associate professor in the Hospital Medicine Division of the Department of Medicine, says that while the U.S. Food and Drug Administration does an "incredible job, considering its long list of responsibilities and budget constraints," the agency should be empowered to demand more detailed data when a new drug is being considered for approval.

O'Connor's main point is that the FDA should require studies comparing the effectiveness and safety of a new drug to an established first-line drug when considering a drug for approval. Currently the agency does not require such studies, known as "active comparator trials," though some large studies of new drugs do include them. In many cases, to gain approval, the main criterion besides safety is that a new drug must be shown to be more effective than placebo.

"When new medications have been compared only to placebo, not to drugs already on the market, it's very difficult to know whether and how we should prescribe them to patients," O'Connor said. "For example, if a new medication to treat depression is approved based only on placebo comparisons, it's very difficult to know how the new drug compares with the dozens of medications already approved for depression. Faced with the extensive and very successful marketing undertaken by the drug manufacturer, oftentimes physicians will assume that the newer drug is more effective or has important advantages over older treatments, even though there may be no evidence showing that to be so."

"The current system makes it very difficult to evaluate a new, more expensive treatment against an established, less expensive option," added O'Connor. "We should consider a differe
'/>"/>

Contact: Tom Rickey
tom_rickey@urmc.rochester.edu
585-275-7954
University of Rochester Medical Center
Source:Eurekalert

Page: 1 2 3

Related medicine news :

1. Increased distance to physician associated with thicker skin cancer at diagnosis
2. Broad-based group of physicians calls for improvement in stroke treatment
3. Latest DES Analysis Stresses Importance of Physicians Well-Trained in Implantation Technique and Patient Follow-Up
4. Psychiatrists are the least religious of all physicians
5. Physician Skin Care Specialist Says Proposed New Rules for Sunscreen Products Will Better Protect the Public
6. One of the Largest Post-WHI Physician Surveys Shows More Education is Needed: Patient Misinformation About Hormone Therapy Remains High
7. Texas Largest Physician Carrier Announces 5th Successive Rate Cut on Anniversary of Lawsuit Reform
8. Maimonides Expands Circulation of Physicians Practice Journal to Staten Island Doctors
9. Scientists, physicians present latest findings in personalized cancer treatment and prevention
10. NNN Healthcare/Office REIT Acquires St. Mary Physicians Center in Long Beach, California
11. Physician Team at Northwestern Memorial Performs Rare Oral Gallbladder Removal
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... Andrie, Inc. V. Dept. of Treasury, Mich. S. Ct., ... made the determination that a purchaser of tangible goods in ... unable to prove during an audit that sales tax ... of Appeals decision on whether a purchaser bears the burden ... from Michigan sellers. The Court states “in order to be ...
(Date:7/31/2014)... Miami, FL (PRWEB) July 31, 2014 ... recently released their innovative compression elbow sleeve , ... other elbow pain, in two new bright colors for ... neon pink and blue. Made of innovative proprietary Zensah® ... moisture wicking and odor-preventing fabric. It features a no-slip ...
(Date:7/31/2014)... Washington, New York (PRWEB) July 31, 2014 ... represents whistleblowers in qui tam cases, comments that whistleblowers ... an end to illegal employer activities that may cause ... recognizes that today is National Whistleblower Appreciation Day. , ... National Whistleblower Center , the Senate declared "National Whistleblower ...
(Date:7/31/2014)... NJ (PRWEB) July 31, 2014 ... leading gastroenterologist, Dr. Masood Rizvi, has joined our ... Dr. Rizvi to the community. Hundreds of highly ... Group, a comprehensive network of top doctors and ... of specialties. This latest acquisition represents CarePoint Health’s ...
(Date:7/31/2014)... (PRWEB) July 31, 2014 You’re having a ... why have you suddenly developed chills and fever, headache, stiff ... you suspect a flu-like illness, it could actually be the ... Your risk of developing Lyme is greater than you might ... new cases occurred in the U.S. annually. But the Centers ...
Breaking Medicine News(10 mins):Health News:Taxpayer Failing To Prove Sales Tax Was Paid At Time Of Purchase Results In Use Tax Due 2Health News:Taxpayer Failing To Prove Sales Tax Was Paid At Time Of Purchase Results In Use Tax Due 3Health News:Compression Elbow Sleeve Provides Relief From Elbow Pain to Golfers and Tennis Players 2Health News:Compression Elbow Sleeve Provides Relief From Elbow Pain to Golfers and Tennis Players 3Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 3Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 4Health News:Dr. Rizvi Joins CarePoint Health Medical Group 2Health News:Feel Like You Have A Summertime 'Flu'? It Could Be Lyme Disease 2Health News:Feel Like You Have A Summertime 'Flu'? It Could Be Lyme Disease 3
... Governors,University (http://www.wgu.edu ) is now offering its ... managers and nurse educators. These,scholarships are designed to ... become educators, managers, and leaders in various healthcare,settings. ... and,M.S. in Nursing-Leadership and Management degree programs., ...
... Oct. 17 Collaborative Drug Discovery,Inc. (CDD, Inc.) ... of,recent publications focused on the fight against Chagas, ... available to researchers free of charge, via,the CDD ... Chemistry, Bioorganic &,Medicinal Chemistry, the Journal of American ...
... Looks to Add Even More Space in the ... W.Va., ReBuilder Medical Technologies,Inc. (Pink Sheets: RBRM), ... device inventor David B. Phillips, Ph.D., today,announced it ... demand,of it cutting edge medical devices and products. ...
... Pacific Design ... WEST HOLLYWOOD, Calif., Oct. 17 Charles S. Cohen,visionary ... to support AIDS Walk Los Angeles and the City of ... Angeles, in addition to,providing Pacific Design Center as the official ...
... consumers manage costs and adopt healthier ... ... in Virginia is now offering new health plan options for employers,and individuals ... healthier lives and gain control over the rising,cost of care. These consumer ...
... the Way Toward Malaria ... Eradication U.S. Presidential Candidates Urged to Sustain and Expand President,s ... Malaria Initiative, SEATTLE, Oct. ... - to reach a,day when no human being has malaria, and no mosquito on earth ...
Cached Medicine News:Health News:Nursing Scholarships Offered by Western Governors University for Master's Degree Programs 2Health News:Free Access to Literature Data on Chagas' Disease Offered Online: Collaborative Drug Discovery, Inc. provides Neglected Disease researchers with 'archive mine and collaborate' access to small molecule bioactivity SAR data on parasitic disease 2Health News:ReBuilder Medical Technologies, Inc. Increases Manufacturing Space to Meet Demand 2Health News:ReBuilder Medical Technologies, Inc. Increases Manufacturing Space to Meet Demand 3Health News:Charles S. Cohen, Pacific Design Center Augment Their Support for AIDS Walk Los Angeles 2Health News:Charles S. Cohen, Pacific Design Center Augment Their Support for AIDS Walk Los Angeles 3Health News:Anthem Blue Cross and Blue Shield in Virginia Introduces New Generation of Consumer Driven Health Products 2Health News:Anthem Blue Cross and Blue Shield in Virginia Introduces New Generation of Consumer Driven Health Products 3Health News:Anthem Blue Cross and Blue Shield in Virginia Introduces New Generation of Consumer Driven Health Products 4Health News:Bill and Melinda Gates Call for New Global Commitment to Chart a Course for Malaria Eradication 2Health News:Bill and Melinda Gates Call for New Global Commitment to Chart a Course for Malaria Eradication 3
(Date:7/31/2014)... MOUNTAIN VIEW, Calif. , July 31, 2014 ... ) today provided an update on its pipeline ... of 2014, Alexza expects to initiate a Phase ... which is being developed for the management of ... identified two new Staccato -based product candidates ...
(Date:7/31/2014)... SARASOTA, Fla. , July 31, 2014 ... announced today that it has initiated the development of ... ; and that it has selected Quotient Clinical, ... United Kingdom (UK) to run its early ... a Clinical Trial Application (CTA) by the end of ...
(Date:7/31/2014)... , July 31, 2014  A substantial share ... decisions about which therapies are included in formularies—say ... according to a new Manhattan Research study, ... The study finds that P&T committee members in ... managers (PBMs) have set a high bar for ...
Breaking Medicine Technology:Alexza Provides Pipeline Update 2Alexza Provides Pipeline Update 3Alexza Provides Pipeline Update 4Alexza Provides Pipeline Update 5Alexza Provides Pipeline Update 6Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs 2Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs 3Rock Creek Pharmaceuticals Provides Update of its European Drug Development Regulatory Strategy and selects Quotient Clinical for its early development programs 4Formulary Decision Makers Say Pharma-Provided Patient Support Solutions Influence Formulary Placement 2Formulary Decision Makers Say Pharma-Provided Patient Support Solutions Influence Formulary Placement 3
... 2011 The MED Group, a Managed Health Care ... www.medicaresuppliersnetwork.com .  The website was created to help answer ... physician offices, about competitive bidding and how patients can ... The Centers for Medicare and Medicaid Services (CMS) ...
... 3, 2011 The MED Group, a Managed Health ... www.medicaresuppliersnetwork.com .  The website was created to help ... as physician offices, about competitive bidding and how patients ... The Centers for Medicare and Medicaid Services ...
Cached Medicine Technology:New Program for Medicare Beneficiaries Will Mean Major Changes Effective January 1, 2011 - Ohio 2New Program for Medicare Beneficiaries Will Mean Major Changes Effective January 1, 2011 - Ohio 3New Program for Medicare Beneficiaries Will Mean Major Changes Effective January 1, 2011 - California 2New Program for Medicare Beneficiaries Will Mean Major Changes Effective January 1, 2011 - California 3
... AEM Laparoscopic Instruments incorporate a layered design ... shielded and monitored to prevent stray electrosurgical ... caused by insulation failure or capacitive coupling; ... shield built into all AEM Instruments provides ...
S-VHS Hi-Fi Video Cassette Recorder...
DP 2020 Series 3-chip cameras offer the user unparalleled clarity and definition. Chroma dynamic range is extended and red colour reproduction is superb....
... protection in three formats, ... with lightweight comfort and ... Lenses provide .75 mm ... anti-reflection coated and tempered ...
Medicine Products: