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Monday, June 14, 2004
 

ANOTHER BOGUS VITAMIN C REPORT --- LIKE THE OTHERS, DISREGARD THE ADVICE

Like other negative scientific reports about supplemental vitamin C in recent years, the study from Duke University Medical Center was released late on Friday when criticism and rebuttal would be minimal. The report, published in the June issue of Arthritis & Rheumatism [June 2004; vol 50: pp 1822-1831], claims that high-dose vitamin C, when given to guinea pigs, worsens the occurrence of bone spurs in the knee joint. The Duke University researchers warned the public away from vitamin C supplements stating: "Our findings suggest that dietary intake should not be supplemented above the currently recommended dietary allowance: 90 milligrams per day for men and 75 milligrams per day for women," according to researcher Virginia B. Kraus, MD, PhD, of Duke University Medical Center, and colleagues.

But there are glaring inconsistencies in the Duke University report.

First, most animals, except for guinea pigs, fruit bats, primates and humans, produce their own vitamin C and do not exhibit any increased risk for arthritis. A 160-pound goat for example may produce up to 13,000 milligrams of vitamin C per day.

Second, why did Duke University researchers warn the public away from supplemental vitamin C based upon a small animal study when a more comprehensive human study published in the same journal in 8 years earlier by researchers at the Arthritis Center, Boston University Medical Center, found that adults who consume high-dose vitamin C experience a 3-fold reduction in the risk for progression of their knee osteoarthritis and that supplemental vitamin C reduces knee pain? [Arthritis Rheumatism 1996 April;39:648-56]

Furthermore, vitamin C was apparently doing its job --- reducing pain and inflammation. But that would make it possible for guinea pigs to be more physically active and thus induce more wear-and-tear in the knee joint. The same problem occurs when non-steroidal anti-inflammatory drugs like ibuprofen are used to treat arthritis pain. Arthritic individuals would be served better by taking supplements that cushion joints, like oral hyaluronic acid, glucosamine or chondroitin, with their vitamin C.

Two years ago another flawed report, published in Science Magazine, suggested high-dose vitamin C might damage DNA and warned the public to avoid high-dose vitamin C supplements. [Science 294(5543):788, October 26, 2001] The test was conducted in a laboratory dish. But five human studies had already been published showing up to 10,000 milligrams of vitamin C taken orally by humans does not damage DNA. [Science. 293(5537):1993-5, Sept. 14, 2001]


7:55:51 PM    comment []

AMA MAINTAINS PUBLIC ENTITLED TO ADVERSE DRUG STUDY RESULTS!

REALLY! ISN'T IT ABOUT TIME?

CHICAGO -- Drug companies' influence on medical research and on doctors themselves will be under the microscope as the nation's largest group of physicians gathers for its annual meeting this week. Proposals facing the American Medical Association include a measure seeking to make all drug study results public, even unpublished research funded by pharmaceutical companies that might reflect poorly on their products. The measure stems partly from concern over unpublished data linking some antidepressants with suicidal behavior in children. Government officials are investigating the potential link.

Another measure would strengthen a policy the AMA adopted last year on "shadowing," the practice of drug company representatives sitting in on patients" visits with their doctors. Critics say the practice is an attempt to influence what medicines are prescribed. Drug companies say the practice is educational, but they sometimes pay hundreds of dollars a day to the doctors for these visiting rights -- money the new measure says doctors should refuse.

The generally cautious AMA frequently avoids taking bold stands on controversial issues, and many proposals at the five-day meeting will be rejected or revised before being sent to the group's delegates, who begin voting Tuesday on policies to adopt.

The AMA had 250,830 members in 2003, down from 260,455 in 2002, representing about a third of the nation's doctors and medical students. Still, any AMA support could lend credence to the meeting's proposals, including the move to make all drug study results public.

As drafted, the measure would ask the U.S. Department of Health and Human Services to consider forming a national registry of all drug studies, possibly available over the Internet. Alan Goldhammer of the industry group Pharmaceutical Research and Manufacturers of America said a public research registry could lead to misinterpretation.

Calls for publicizing all drug studies also have come from the American Psychiatric Association, the American Academy of Child and Adolescent Psychiatry and bioethicists concerned about industry influence on doctors.

"It would be good to see the AMA get on board," said Merrill Goozner of the Center for Science in the Public Interest. "Medical professionals who are after all the prescribers and the primary users of these tools .. should be the guys in the forefront" of the issue, Mr. Goozner said. It is critical for doctors to have all information on tested drugs so they can make informed prescribing decisions, said Dr. David Fassler, a Vermont psychiatrist.

Drug companies aren't required to publish study results, and medical journal editors "are at the mercy of what is sent in the mail," said Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association. Drug company-funded submissions more often than not have positive results, a phenomenon called publication bias.

Dr. DeAngelis voiced support for the push for a national registry, as did Dr. Jeffrey Drazen, editor of the New England Journal of Medicine.


5:36:03 PM    comment []

AND YET ANOTHER DRUG DISASTER....

Breast milk drug can be harmful, FDA warns

WASHINGTON -- The government is warning breast-feeding women not to use a drug called domperidone to increase their milk production, saying it not only is illegal but could harm both mother and child.

The Food and Drug Administration cracked down on the drug Monday, moving to end imports and ordering several companies to quit making or distributing it here.

The concern: reports of serious side effects among adult users, and domperidone is excreted in breast milk.

Domperidone has never been approved for sale in the United States but is used in some countries to treat certain stomach disorders.

A side effect is stimulation of a breast milk-producing hormone -- but no country has approved the drug's use for lactation, and several require explicit warnings against use by breast-feeding mothers.

Women have been able to order it from abroad via the Internet, but the FDA has discovered a few U.S. pharmacies providing "compounded" supplies -- drugs that pharmacists brew up specially for certain customers.


5:28:14 PM    comment []


HERE'S ANOTHER STATIN DRUG WARNING..

FDA reiterates rosuvastatin warnings
Higher rates of muscle toxicities seen with 40-mg doses.

http://www.pharmacist.com/articles/h_ts_0561.cfm


5:26:10 PM    comment []

TAKING THE HIGH-COST DRUG? READ THIS:

Patients taking aspirin for its cardiovascular benefits who are also taking a high-cost COX-2 anti-inflammatory drug could change to a lower-cost anti-inflammatory drug, a new study by Express Scripts Inc. showed.

Other research has shown that using aspirin along with the COX-2 therapies, such as Pfizer Inc.'s Celebrex or Merck & Co.'s Vioxx, can negate the gastrointestinal benefits of using the high-cost COX-2 drugs, which is one of the main reasons for using the COX-2 drugs, the company said. Aspirin has been shown to increase the risk of gastrointestinal bleeding.

http://stlouis.bizjournals.com/stlouis/stories/2004/06/14/daily5.html

 


5:22:09 PM    comment []


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