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FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market
FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market -- Posted by MrPepper11 on 02-18-05 19:21
New York Times
February 18, 2005
F.D.A. Panel Says Pain Relievers Should Remain on Market
By GARDINER HARRIS
WASHINGTON, Feb. 18 - A federal drug advisory panel unanimously agreed
today that the huge-selling painkillers Celebrex, Bextra and Vioxx
cause worrisome heart problems, but its members voted to recommend that
all three nonetheless be available to patients, accompanied by strong
warnings of the risks.
The panel only narrowly supported the continued marketing of Pfizer's
Bextra or the return of Merck's Vioxx, voting 17-13 on Bextra and 17-15
on Vioxx. The panel was much more comfortable supporting the continued
marketing of Celebrex, favoring the Pfizer painkiller 31-1. The Food
and Drug Administration, which has the final word on the regulation of
pharmaceuticals, is not obliged to accept the panel's recommendations.
Shares of Merck, which took Vioxx off the market late last year, closed
up $3.76, or 13 percent, at $32.61, while Pfizer gained $1.74, or 6.9
percent, at $26.80. Before the hearings, traders feared that the panel
might recommend banning all the drugs, which would have been a severe
blow to their makers.
Most panelists said that the F.D.A. should place stern warnings on the
drugs' labels, ban consumer advertising for the drugs unless they were
balanced by ads shaped by the F.D.A. or an independent group, and
require that drug makers provide patients with a letter or medication
guide outlining the drugs' risks.
"We could have direct-to-consumer advertising and have well-known
people including a skater skating about a rink and then dropping dead,"
the panel's chairman, Dr. Alastair Wood, said.
Despite the recommendation to make the drugs available to patients, the
panel's votes were wounding to Pfizer, which had insisted in its
presentation to the committee that there was little evidence that
either Celebrex or Bextra caused heart problems. The committee greeted
many of Pfizer's claims with deep skepticism.
Several panel members said that patients should be urged to first try
taking naproxen, sold as Aleve, before taking Celebrex, Bextra or
Vioxx. Studies have shown that naproxen does not hurt the heart and may
even provide some protection against heart attacks, although naproxen
may cause more ulcers than the other drugs.
In each case, the panel's members considered varying data indicating
the health risks posed by each medication, but in the end agreed by
varying margins that the potential benefits of the pain-killing drugs
outweighed the dangers they posed for cardiovascular problems.
But there was debate over how restricted the drugs' use should be. Some
committee members suggested that all Cox-2 drugs should be "last
resorts," while others disagreed or quibbled over what "last resort"
meant.
The differing margins in support of the three drugs were in part
related to the varying amounts of research available on each. While a
majority of the panel narrowly agreed that Bextra, a newer Pfizer pain
reliever than Celebrex, should remain on the market, members also
acknowledged that less data was available about Bextra's safety.
The panel's recommendations came during the last of three days of
hearings at which panel members said they believed that all the Cox-2
drugs - which include Vioxx as well as Bextra and Celebrex - carried
heart risks.
In December, the F.D.A. said in a statement that data showed higher
cardiovascular risks for patients taking 400 milligrams or 800
milligrams a day of Celebrex, and it advised physicians who continued
to prescribe Celebrex to choose "the lowest effective dose of
Celebrex." The company says that Celebrex is available in 100- and 200-
milligram capsules, as well as 400 milligrams.
The panel's assessment of the Cox-2 drugs today came just a day after a
top research official at Merck, which makes Vioxx, suggested to the
federal drug advisory panel that the company might soon decide to
resume selling its painkiller in the United States.
The Merck official, Dr. Peter Kim, said that if the panel decided that
Celebrex and Bextra, drugs similar to Vioxx, also hurt the heart, "then
that would be important to us to take that into consideration with
regard to Vioxx."
Dr. Alastair Wood, the chairman of the advisory panel reviewing drugs
in a class known as Cox-2, asked Dr. Kim what he meant. "Are you saying
that if we think that the cardiovascular risk is a class effect, then
you would consider putting Vioxx back on the market?" Dr. Wood asked.
Dr. Kim did not answer directly, but said: "The science has progressed.
There are unique benefits to Vioxx."
In a statement before today's voting, Merck said, "If the advisory
committee and the F.D.A. conclude that the benefits of this class
outweigh the risks in some patient populations, then we would have to
consider the implications of these new data given the unique benefits
Vioxx offers."
Dr. Paul Seligman, a top F.D.A. official, said before the panel's
action today that it was too early to determine how the agency would
respond if Merck sought to resume Vioxx sales.
The Merck statement was a remarkable disclosure in an already landmark
hearing. Panel members have been sifting through studies trying to
weigh the risks and benefits of Vioxx, Celebrex and Bextra. None of the
drugs cure pain any better than older medicines. They were developed
with the hope that they would cause fewer ulcers than older medicines,
but Merck withdrew Vioxx in September after a study showed that the
drug doubled the risks of heart attack and stroke.
Since then, more studies have shown similar risks for Celebrex and
Bextra. The agency called the committee together to tell it what to do.
According to much of the testimony, the committee will probably suggest
that the drugs stay on the market, with tough warnings about the risks
of taking them.
"I don't think any one of us is saying that these drugs should be taken
off the market but that they should be used at the lowest safest dose,"
said Dr. Gary Hoffman of the Cleveland Clinic.
Dr. Michael Domanski of the National Institutes of Health agreed,
saying, "It's pretty clear that there is an excess risk confirmed by
some or all of these drugs."
The problem, many committee members said, is that patients who are at
high risk of developing ulcers are often the same ones who are at risk
of heart attacks.
"Finding the sweet spot for these drugs becomes a little bit harder,"
said Dr. Steven Nissen, a panel member from the Cleveland Clinic.
"Older people are at greater risk for gastrointestinal bleeding, and I
can assure you that they are greater risk for coronary disease."
Trying to find the right balance between the risks and benefits is the
committee's task today. Dr. Wood said that had the advisory panel known
about the cardiac risks years ago, it would probably not have voted to
approve the drug. But he said something had to be done.
"The number of events that these drugs are going to cause are going to
be vastly in excess of anything we've seen before," he said, "so we
have to do something."
Several panel members also expressed frustration that the F.D.A. did
not have the legal authority to force drug makers to test approved
medicines when concerns were presented about their safety.
"I would like to see Congress empower F.D.A. to mandate these kind of
trials as these situations occur," said Dr. John Cush, a rheumatologist
from Dallas.
Among the most widely anticipated presentations was that of Dr. David
Graham, a drug-safety officer for the agency who has sometimes feuded
with top agency officials. Dr. Graham suggested that taking high doses
of Cox-2 drugs hurt the heart even more than smoking, diabetes or high
blood pressure.
He said the Cox-2 drugs did not seem to have clear benefits to outweigh
those risks. The drugs are supposed to cause fewer ulcers than older
pain pills, although evidence for that effect has been mixed. Dr.
Graham said that 40 percent of those who suffer heart attacks die,
compared with 5 percent who suffer serious ulcers. But Dr. Graham also
condemned Indocin and Mobic, both popular painkillers.
A study of California Medicaid patients found that Indocin, known
generically as endomethacin, nearly doubled the risks of heart attacks
in patients, Dr. Graham said.
For Mobic, the risks of heart attack and stroke rose 37 percent, Dr.
Graham's study showed. Mobic is manufactured by Boehringer Ingelheim.
In the wake of Vioxx's withdrawal and news that Celebrex and Bextra may
hurt the heart, sales of Mobic have risen sharply. Dr. Graham suggested
that the move toward Mobic was a problem. Several panel members
expressed skepticism because the findings were derived from
observational studies, which are not completely trustworthy.
Dr. Christopher Grubb, a captain in the Army Medical Corps, said
soldiers in the 82nd Airborne were required to carry a Cox-2 drug in
the event of a battlefield injury. Dr . Grubb said the drugs had
allowed many soldiers who otherwise would have been sidelined by pain
to be deployed overseas.
The drugs, he said, "are essential for our global war on terrorism."
The comment prompted loud laughter in the meeting.
----------------------------------------
Re: FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market -- Posted by kron on 02-25-05 16:41
Ten on US drug panel had industry ties, group says
25 Feb 2005
WASHINGTON, Feb 25 (Reuters) - Ten of the 32 U.S. advisers who
supported future sales of pain relievers Celebrex, Bextra and Vioxx
have consulted in recent years for the drug makers, according to a
consumer group analysis of medical journals and other records.
Last week, a Food and Drug Administration (FDA) advisory panel said
Merck & Co Inc.'s withdrawn arthritis drug Vioxx was safe enough to
rejoin Pfizer's Celebrex and Bextra on the U.S. market after
concluding all three medicines posed some heart risk.
Ten panelists were paid consultants for Pfizer or Merck, according to
the consumer group Center for Science in the Public Interest (CSPI).
If those 10 panelists had not voted, the committee would have rejected
future sales of Bextra and Vioxx. The Celebrex vote would not have
changed because all but one member supported keeping that drug on the
market.
"By failing to at least disclose those conflicts before the meeting,
the (FDA) has undermined the credibility of the committee's advice,"
said Merrill Goozner, director of CSPI's integrity in science program.
The FDA screens panelists' consulting arrangements and stock holdings
before deciding if they can participate in a committee meeting.
Panelists who considered the pain drugs were reviewed "according to
the same strict ethics guidelines FDA applies to all its advisory
committees," said Sheila Dearybury Walcoff, FDA associate commissioner
for external relations.
The analysis sparked more congressional concerns over the FDA and its
policing of drug safety.
"Unfortunately, the votes ... are now, justly or unjustly, tainted,"
said Iowa Republican Sen. Charles Grassley, chairman of the Senate
Finance Committee. Massachusetts Democrat Sen. Edward Kennedy called
on the agency to make its panel selection process more open.
The CSPI analysis, first reported by the New York Times, cited
references from financial disclosures in medical journals and in
public databases such as www.guideline.gov.
Celebrex, Bextra and Vioxx, known as COX-2 inhibitors, were designed
to ease pain like older, nonprescription drugs while being easier on
the stomach but studies have recently shown links to cardiovascular
risks.
Each of the 10 advisers with industry ties voted to keep Bextra on the
market. Nine of them voted to let Vioxx be sold again. Merck withdrew
Vioxx last September after a study linked the pain reliever to heart
attacks and strokes.
If those 10 members had not cast their votes, the committee would have
voted 13-7 to recommend that Bextra be withdrawn and 14-8 that Vioxx
should not return to the market.
Re: FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market -- Posted by Steve on 02-25-05 17:06
kron wrote:
>Ten of the 32 U.S. advisers who
>supported future sales of pain relievers Celebrex, Bextra and Vioxx
>have consulted in recent years for the drug makers
This is not unusual. Disclosure is an issue, but it's otherwise
pretty tough to find the expertise, since big pharma funds most of the
drug studies, and many of the best docs have some tie to the industry.
Re: Advertising and prescription practices. Was: Re: FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market -- Posted by Don Miller on 02-28-05 02:36
Isn't the larger question whether the phenomenon of direct-to-consumer
advertising (along with other factors) doesn't lead to the prescription of
high-profit drugs that are in the marketing spotlight, in preference to
other agents that might be better, but make somebody less money? In this
area, the under-use of meloxicam in North America, and the virtual
abandonment of Disalcid (salsalate), which for some patients is a perfect
and ultra-safe choice, are prime examples.
DM
On Fri, 25 Feb 2005, Steve wrote:
> kron wrote:
> >Ten of the 32 U.S. advisers who
> >supported future sales of pain relievers Celebrex, Bextra and Vioxx
> >have consulted in recent years for the drug makers
>
> This is not unusual. Disclosure is an issue, but it's otherwise
> pretty tough to find the expertise, since big pharma funds most of the
> drug studies, and many of the best docs have some tie to the industry.
>
>
Re: FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market -- Posted by nobody special on 02-26-05 13:09
"kron" wrote in message
news:nchv11h8q17imfslncf67v20snio5s9lqv@4ax.com...
> Ten on US drug panel had industry ties, group says
> 25 Feb 2005
It's hard not to find leaders in the field who have not participated in
industry sponsored trials. That's the sort of expertise you want on AC
panels.
Re: FDA Panel: Celebrex, Bextra and Vioxx Should Remain on Market -- Posted by kron on 02-26-05 14:14
On Sat, 26 Feb 2005 16:09:05 -0500, "nobody special"
wrote:
>
>"kron" wrote in message
>news:nchv11h8q17imfslncf67v20snio5s9lqv@4ax.com...
>> Ten on US drug panel had industry ties, group says
>> 25 Feb 2005
>
>It's hard not to find leaders in the field who have not participated in
>industry sponsored trials. That's the sort of expertise you want on AC
>panels.
>
The public trust in the FDA is at an all-time low. The perception that
they're rubber stamps for the drug industry is being strengthened
every day.
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