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FurrowedBrow
Free yourself from yourself



Registered: 10/26/06
Posts: 2,439
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F.D.A. Seeks to Broaden Range of Use for Drugs
#8029096 - 02/15/08 08:29 PM (15 years, 11 months ago) |
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WASHINGTON — When federal drug regulators approve a medicine for sale, they limit how drug makers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer even if some studies suggest that the medicine may save lung patients.
But the Food and Drug Administration proposed guidelines Friday that would change this, and advocates on both sides of the issue say that lives are at stake.
The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have promise to adequately test the unapproved use discussed in the article.
Advocates of the new rule say that the F.D.A. is so slow in assessing drug and device benefits that companies need to be able to hand out medical journal articles so that doctors can be informed immediately about life-saving uses.
“The consequence of rapid disclosure of these benefits could be measured in lives,” said Dr. Scott Gottlieb, a former F.D.A. deputy commissioner.
Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said that “journal articles can offer physicians valuable insight that helps them make informed decisions regarding appropriate medical treatments for their patients.”
But critics of the proposal say that drug and device companies have a long history of promoting unapproved drug and device uses that later proved dangerous, and that allowing companies to talk about such unapproved uses removes incentives for companies to research adequately whether the new use is actually beneficial.
“People will die if they are getting drugs that don’t have clear evidence that the benefits outweigh the risks,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group.
Representative Henry Waxman, Democrat of California, said the proposed rule “caters to the industry’s desire to market their products without adequate testing or review.”
The reason for this debate is that doctors are not overseen by the F.D.A. Medicine is regulated by state medical boards, which generally allow doctors to prescribe drugs and devices however they see fit regardless of F.D.A. judgments.
In some cases, this is beneficial. Pediatricians for years had very few drugs approved for their use because drug makers often failed to test new medicines in children. So they prescribed drugs for children anyway, and, sometimes, saved lives.
A 2006 study estimated that more than 20 percent of all prescriptions written by doctors were for unapproved uses.
But drug makers have in the past abused doctors’ discretion by telling them that some medicines were appropriate for patients in whom the drugs may have caused more harm than good. In 2004, Pfizer paid a $430 million fine to resolve criminal and civil charges that it marketed its epilepsy drug Neurontin for conditions in which the company’s own studies suggested that the drug was ineffective.
The F.D.A. has for years struggled to find the appropriate balance between the need to inform doctors of experimental but hopeful drug and device uses and the need to guard against hucksters promoting dangerous products as cure-alls.
To complicate the issue, the drug agency’s power to prevent companies from providing truthful, albeit uncertain, information to doctors has been questioned by federal courts as a possible infringement of commercial free-speech rights.
Congress stepped in to resolve the issue in 1997 when it passed a law that allowed drug makers to hand out studies published in medical journals as long as the company provided the reprints to the F.D.A. beforehand and promised to seek approval from the agency of the use discussed.
But that law lapsed in 2006 and “questions have been raised since then about what our policy is,” said Rita Chappelle, an F.D.A. spokeswoman.
In the proposal announced Friday, the agency would allow drug and device companies to pass out articles to doctors if the article was peer-reviewed and published in a journal with an expert editorial board. Companies must accompany the article with a prominent warning that the use described is not approved or cleared by the F.D.A.
The agency abandoned the requirement that drug and device makers must provide the studies to the F.D.A. beforehand or promise to seek approval of the discussed use. An F.D.A. official said the agency did not really enforce those requirements anyway.
Diane Edquist Dorman, vice president of the National Organization for Rare Disorders, said she supported the F.D.A. position because patients with rare diseases are generally treated with unapproved drug uses about which doctors must be informed.
“And these companies are just never going to do the confirmatory trials when only a couple of hundred people have the disease,” she said.
Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said the rule would stop companies from underwriting expensive trials to confirm new drug uses. “Companies could openly promote products for unapproved indications without testing these drugs,” he said. “I’m astonished that this rule would even be considered.”
http://www.nytimes.com/2008/02/16/business/16drug.html?ex=1360818000&en=08c60edd167eb629&ei=5088&partner=rssnyt&emc=rss
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Konryou
Stranger


Registered: 02/10/08
Posts: 25
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Re: F.D.A. Seeks to Broaden Range of Use for Drugs [Re: FurrowedBrow]
#8032341 - 02/16/08 07:21 PM (15 years, 11 months ago) |
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A step in the right direction, but any restriction lifted always leaves room for some jackass to take advantage of it and make everything worse than before.
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Visionary Tools



Registered: 06/23/07
Posts: 7,953
Last seen: 1 year, 7 months
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Re: F.D.A. Seeks to Broaden Range of Use for Drugs [Re: Konryou]
#8032406 - 02/16/08 07:39 PM (15 years, 11 months ago) |
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Pfft, this means SSRI's are going to be prescribed for everything. Headache? You have bullshit pain syndrome, here, have some SSRIS.
The SSRI's making you upset? Here, you have "SSRI suicidcal syndrome" Take some more SSRI's.
SSRI's are making you flip out and kill people/shave all of your hair? You have "Oh fuck, SSRI's have turned me into a psycho" syndrome. Here, take more SSRI's.
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sherm
sherman


Registered: 10/02/03
Posts: 20,498
Loc: Euthanasia
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Re: F.D.A. Seeks to Broaden Range of Use for Drugs [Re: Visionary Tools]
#8032745 - 02/16/08 09:16 PM (15 years, 11 months ago) |
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haha
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HighHat
Repeat Gold Medal eBay -TiVoist



Registered: 01/24/08
Posts: 303
Loc: Delocated
Last seen: 13 years, 11 months
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Re: F.D.A. Seeks to Broaden Range of Use for Drugs [Re: sherm]
#8034296 - 02/17/08 11:16 AM (15 years, 11 months ago) |
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Quote:
“The consequence of rapid disclosure of these benefits could be measured in lives,”
Sounds like Bush when someone asks him about "interrogation techniques."
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