: : : 2005-01-22
Why does the FDA apparently prevent good health?? Because its bad for big business !!
Proposed FDA Action May Cause an Exponential Decrease in Health
January 22, 2005 15:58
In a continuation of its policy to support the pharmaceutical industry by limiting freedom of access to health-giving nutritional products, the FDA is set to ban many perfectly safe natural health products. Citizens must take action to protect their right to proper nutrition, which is almost impossible without supplementation.
Concerned citizens should contact their member of Congress (http://www.senate.gov/general/contact_information/senators_cfm.cfm), representative (http://www.house.gov/writerep/) or visit the Health Action Center (http://www.healthactioncenter.com), where they can get more information.
About Natural Health Information Centre :
Natural Health Information Centre is dedicated to the continuing education of the consumer on all health topics, specifically the information required to make proper, informed choices about health problems, their causes and potential treatments.
Drug advertising: FDA warning may return to haunt Pfizer
January 22, 2005 16:03
January 17, 2005 11:08 AM GMT (Datamonitor) - Pfizer has withdrawn advertising of its COX-2 products in view of the FDA's concerns and the wider controversy surrounding the safety of COX-2s. Whether intentional or not, the 'misleading' advertisements will have benefited sales as the general public will mostly be unaware of the violations against the FDA's rulings. The immediate future does not look good for either the COX-2 class or Pfizer.
The US Food and Drug Administration (FDA) has said in a letter that Pfizer [PFE] failed to disclose appropriate information about the risks of its COX-2 products in advertising campaigns and made "unsubstantiated effectiveness claims" in its ads. The agency focused in on five promotional pieces, including two television ads and print ads for Celebrex, as well as a Bextra direct mail brochure. The FDA requested an immediate halt to all Celebrex ads, which Pfizer gave last month in advance of the agency's letter.
Pfizer's blockbuster arthritis and pain drug Celebrex (celecoxib) has recently come under scrutiny for its possible link to an increased risk of heart problems that has been associated with long term use of COX-2 products.
The company's Celebrex TV ad was said to violate FDA rules for making a claim about Celebrex without outlining the potential side effects and risks of using the drug. The FDA letter stated that that in a print ad for the drug the company makes "unsubstantiated superiority claims" over traditional anti-inflammatory drugs ibuprofen or naproxen for an extended period of arthritis treatment.
A brochure for Bextra, meanwhile, was cited as making claims that it protects the stomach more than other arthritis treatments despite that fact that Pfizer provides warnings indicating that Bextra can cause serious gastro-intestinal side effects, including bleeding in the stomach and intestines. Finally, the letter says that a TV infomercial for both Celebrex and Bextra overstates the proven effectiveness of each drug.
The revelations will come as unwelcome news to Pfizer whose reputation is already on the line following its refusal to withdraw its COX-2 products, unlike rival Merck & Co. Needless to say, the accompanying bad press may well adversely affect Pfizer sales, especially with the FDA meeting in February to discuss the future of the entire COX-2 class. The FDA has not ruled out recommending the class's withdrawal. Should such a scenario arise, the issue of misleading advertising could then cast a shadow over the rest of Pfizer's portfolio.
Senator to propose creating drug safety office within FDA
January 22, 2005 18:05
US Senator Christopher Doddwill propose legislation to create an office of patient protection reporting directly to the commissioner of the Food and Drug Administration, a move to bolster the safety of prescription drugs after a torrent of worrisome announcements about painkillers and antidepressants eroded consumer confidence.
Fla. Court Says Nothing Prohibits Promotion of 'Off-Label' Drug Usage
January 22, 2005 20:08
A Florida court ruled that nothing in the Federal Food, Drug, and Cosmetic Act prohibits a pharmaceutical company from promoting off-label uses for its products ...
Calif. Parents Blame Johnson & Johnson's Motrin for Child's Blindness
January 22, 2005 20:09
The parents of 7-year-old Sabrina Johnson filed a lawsuit against Johnson & Johnson and its McNeil-PPC subsidiary on Dec. 28 ...
Texas Man's Metabolife Suit Barred by Statute of Limitations
January 22, 2005 20:13
The 5th Circuit has affirmed dismissal of a Texas resident's untimely lawsuit against Metabolife, finding that the discovery rule did not apply ...
HarrisMartin's Vioxx Litigation Conference - Feb. 10 & 11, Four Seasons Hotel, Philadelphia
January 22, 2005 20:14
To get a handle on the legal and medical ramifications resulting from Merck's decision to pull Vioxx from the market, please join us at the Vioxx Litigation Conference in Philadelphia at the Four Seasons Hotel Feb. 10-11. Conference topics will include the pharmacology of Vioxx, insight from the FDA, liability theories, causation arguments and much more.