Re: FDA Sleeps While Common Medications Poison The Elderly
- From: Citizen Jimserac <Jimserac@xxxxxxxxx>
- Date: Sat, 15 Dec 2007 12:17:30 -0800 (PST)
On Dec 15, 1:47 am, "Jan Drew" <jdrew1...@xxxxxxxxxxxxx> wrote:
"Mark Probert" <markprob...@xxxxxxxxxxxxxxxx> wrote in message
news:vcF8j.254$1X.133@xxxxxxxxxxx
Kevysmom wrote:
NewsTarget) On November 29, 2007 the FDA made a rather surprising,
almost honest announcement. It said that it could not protect
Americans from the dangers of drugs. A 56-page report by its
Subcommittee on Science and Technology stated the FDA "suffers from
serious scientific deficiencies and is not positioned to meet current
or emerging regulatory responsibilities." This blistering report on
the life-threatening shortcomings of the FDA was released with the
stamp of approval of the head of the FDA, Commissioner Andrew von
Eschenbach.
The flagrant disregard for human health by the FDA is not news to
people who follow the subject closely. The FDA has been mostly dormant
while 100,000 Americans die needlessly from drugs every year and
another 3 million are injured so seriously they require
hospitalization (half of those were already in the hospital!). The FDA
management's neglect of duty and follow-up on drugs already on the
market is unconscionable and has been for a long time.
What bullshit. The FDA haters have emasculated their ability to do just
about anything. They are grossly underfunded and their hands are tied. The
best and brightest left before the conflict of interest rules were
tightened.
The Bush-appointed chief counsel for the FDA, Daniel E. Troy, ......
One-third to one-half of this $296.3 million was donated to the Bush
campaign
http://www.mcsweeneys.net/links/bush/
Drug makers lobby US to hike FDA funds
Firms say taxpayers should pay bigger part of bill for safety tests
The industry just doesn't want all of the money coming out of its pocket .
But persuading Congress to its point of view could be a hard sell, and as
more and more new drugs come into the testing pipeline, debate is
intensifying over who will foot the bill.
In fiscal 2004, drug companies paid $232 million in fees to the FDA,
accounting for 53 percent of the agency's $436 million budget for new-drug
review . The 2007 budget includes $320.6 million in fees to be paid by drug
makers .
http://www.boston.com/business/globe/articles/2006/07/13/drug_makers_...
Web Results 1 - 10 of about 175,000 for Conflicts of interest FDA. (0.12
seconds)
USA Today Exposes Conflicts of Interest in FDA Drug Approvals
USA TODAY analyzed financial conflicts of interest on the 18 expert advisory
committees established by the Food and Drug Administration's Center for Drug
Evaluation and Research. These committees vote on whether new drugs should
be approved and what regulations should govern the drug approval process.
The newspaper created a database of financial conflicts disclosed at all 159
advisory committee meetings from Jan. 1, 1998, through June 30, 2000. About
250 members appeared 1,620 times during those meetings.
As required by law, FDA advisory committees disclose when members have a
financial interest in the subject of the meeting. Financial interest is
defined in FDA regulations "as the potential for gain or loss as a result of
government action on a particular matter."
FDA Advisers Tied to Industry
By Dennis Cauchon, USA TODAY
More than half of the experts hired to advise the government on the safety
and effectiveness of medicine have financial relationships with the
pharmaceutical companies that will be helped or hurt by their decisions, a
USA TODAY study found.
These experts are hired to advise the Food and Drug Administration on which
medicines should be approved for sale, what the warning labels should say
and how studies of drugs should be designed.
The experts are supposed to be independent, but USA TODAY found that 54% of
the time, they have a direct financial interest in the drug or topic they
are asked to evaluate. These conflicts include helping a pharmaceutical
company develop a medicine, then serving on an FDA advisory committee that
judges the drug.
The conflicts typically include stock ownership, consulting fees or research
grants.
Federal law generally prohibits the FDA from using experts with financial
conflicts of interest, but the FDA has waived the restriction more than 800
times since 1998.
These pharmaceutical experts, about 300 on 18 advisory committees, make
decisions that affect the health of millions of Americans and billions of
dollars in drugs sales. With few exceptions, the FDA follows the committees'
advice.
The FDA reveals when financial conflicts exist, but it has kept details
secret since 1992, so it is not possible to determine the amount of money or
the drug company involved.
A USA TODAY analysis of financial conflicts at 159 FDA advisory committee
meetings from Jan. 1, 1998, through last June 30 found:
At 92% of the meetings, at least one member had a financial conflict of
interest.
At 55% of meetings, half or more of the FDA advisers had conflicts of
interest.
Conflicts were most frequent at the 57 meetings when broader issues were
discussed: 92% of members had conflicts.
At the 102 meetings dealing with the fate of a specific drug, 33% of the
experts had a financial conflict.
"The best experts for the FDA are often the best experts to consult with
industry," says FDA senior associate commissioner Linda Suydam, who is in
charge of waiving conflict-of-interest restrictions.
But Larry Sasich of Public Citizen , an advocacy group, says, "The industry
has more influence on the process than people realize."
Number of drug experts available is limited
By Dennis Cauchon, USA TODAY
In October, pharmaceutical giant Johnson & Johnson sent a team of executives
to a Holiday Inn ballroom in Silver Spring, Md.
Their job: persuade the Food and Drug Administration's panel of independent
experts that an expensive antibiotic, Levaquin, should be the first drug
approved to treat penicillin-resistant pneumonia.
For Johnson & Johnson executives, the FDA's Anti-Infective Drug Advisory
Committee included some familiar faces. At least two of the experts were
paid consultants to the drug company and had worked on the very same
medicine that they were being asked to evaluate for approval in an important
new market.
The expert panel's "consumer representative," whose assignment is to defend
consumers' interests, had the most extensive financial relationship with
Johnson & Johnson. Keith Rodvold, a pharmacy professor at the University of
Illinois-Chicago, serves on a company anti-infective drug advisory board,
according to Johnson & Johnson spokesman Marc Monseau. Rodvold advised the
company on how to design and analyze the clinical trials that got the drug
approved. In 1999, he designed a study to measure how Levaquin is absorbed
in the lungs. The company also uses him regularly as an consultant on a
variety of issues, Monseau says.
Rodvold declined to discuss his relationship with Johnson & Johnson and his
work on Levaquin. The company declined to say how much Rodvold had been paid
during the five years he has consulted for it.
The case of Levaquin reveals how deeply pharmaceutical industry money and
influence penetrates the drug approval process. FDA advisory committees
consist almost entirely of pharmaceutical industry consultants and
researchers. Even consumers' and patients' representatives on the committees
often receive drug company money.
At least one committee member had a financial stake in the topic under
review at 146 of 159 FDA advisory committee meetings, according to a USA
TODAY study of advisory committee meetings held from Jan. 1, 1998, through
June 30, 2000. At 88 of those meetings, at least half the advisory committee
members had financial interests in the topic being evaluated.
Powerful panels
Eighteen FDA advisory committees play a crucial role in nearly every major
decision on drug regulation. They help decide what drugs should be approved
and how the pharmaceutical industry should be regulated. In recent years,
the FDA has followed every advisory committee recommendation to approve or
reject a medicine - except once, FDA spokeswoman Susan Cruzan says. (The FDA
approved the flu drug Relenza in July 1999 despite an advisory committee
voting 13-4 against approval.)
Investors follow advisory committees closely. A committee vote can add or
subtract hundreds of millions of dollars from a drug company's stock market
value.
The FDA is required by law to screen all committee members for financial
conflicts. The law says members have conflicts when committee action could
have the "direct and predictable effect" of causing the member a financial
gain or loss. The federal agency is forbidden from using experts with
financial conflicts unless a waiver is granted, usually on the grounds that
the experts' value outweighs the seriousness of the conflict. The FDA grants
these waivers routinely.
In the period analyzed by USA TODAY, the FDA granted 803
conflict-of-interest waivers. Seventy-one other times, members had financial
conflicts that were voluntarily disclosed but did not require a waiver. In
the 746 other member appearances on the committees, there was no conflict of
interest.
The FDA says granting waivers lets it tap the nation's leading researchers,
most of whom do work for the pharmaceutical industry.
"The system is designed to bring together the best scientific experts we can
find," says FDA associate commissioner Linda Suydam, who approves waivers.
She says conflict-of-interest waivers go through as many as eight levels of
review before they are granted. But Larry Sasich, a pharmacist who works for
the Ralph Nader-founded Public Citizen's Health Research Group, says, "It is
outrageous that the pharmaceutical industry's influence is so great that
even some consumer representatives are on drug companies' payrolls."
Sasich says it might sometimes make sense to let experts with ...
read more >>
And THIS is the system that 'approves' the standard
"medicines" that are used today.
IS IT ANY WONDER that the rabid and hysterical
shouts of the anti-Homeopathists, serve not only
to impair and indict valid research in this potentially
revolutionary field of medicine, but also serve
to act as a smokestcreen diverting attention
from this FDA-standard pharmaceutical oh so friendly mess of
interlocking relationships and conflicts of interest.
Citizen Jimserac
.
- References:
- FDA Sleeps While Common Medications Poison The Elderly
- From: Kevysmom
- Re: FDA Sleeps While Common Medications Poison The Elderly
- From: Mark Probert
- FDA Sleeps While Common Medications Poison The Elderly
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