Hepatitis disease - After Drug Approval: Patient Beware

Author

After Drug Approval: Patient Beware

Tim Campbell

2005-12-14, 1:05 am

Millions of Americans unknowingly risk rare but serious drug side
effects, Consumer Reports says.
In its January 2006 issue, the independent consumer magazine points to
a dozen common prescription drugs linked to serious risks -- including
death. These risks, the article says, were "undetected or
underestimated when the FDA approved them for use."
The issue isn't these 12 drugs. For people who need them, their
benefits outweigh their risks. What's flawed is the U.S. drug safety
system, says Marvin M. Lipman, MD, chief medical advisor for Consumers
Union and emeritus professor of medicine at New York Medical College,
Valhalla.
"This is a report that criticizes not only the preapproval process, but
also the postapproval surveillance system," Lipman tells WebMD.

System Geared for Approval

Once upon a time, the FDA was very slow to approve new drugs. That
changed in the early '90s, when Congress passed the Prescription Drug
User Fee Act (PDUFA). The law gave the FDA deadlines for making
approval decisions. In return, it charged drug companies fees used to
hire new drug reviewers.
The Consumer Reports article quotes a former FDA reviewer as saying
that the tight deadlines were frustrating. Indeed, a 2003 HHS survey
found that 20% of FDA reviewers said they felt pressured to recommend
approval despite reservations.
"The relationship of the FDA to the pharmaceutical industry has to be
examined very closely," Lipman says. "Under the PDUFA law, a lot of
money is paid by the drug companies to have their drugs reviewed. There
is something inherently bad about that. It doesn't smell right."

Drug Industry Reaction

Jeff Trewhitt, a spokesman for the Pharmaceutical Research and
Manufacturers of America (PhRMA), says PDUFA fees improve drug safety.
"PDUFA has raised hundreds of millions of dollars for FDA in a time
when Congress has approved only stagnant funding, even though
regulators' duties have expanded dramatically," Trewhitt tells WebMD.
"PDUFA money is also being used to increase staffing in the Office of
Drug Safety at FDA. It's recently allowed FDA to double the number of
safety officers from 100 to 206 officers."
And Trewhitt notes that fewer than 3% of drugs are withdrawn from the
market due to safety concerns -- a rate that hasn't changed since PDUFA
took effect.
Laurence B. Gardner, MD, chairman of the department of medicine at the
University of Miami Miller School of Medicine, agrees with most of the
points made by the Consumer Reports article. But he says the FDA's
preapproval process isn't the problem.
"Consumer Reports implies that people at the FDA rush approvals through
and don't look at safety data," Gardner tells WebMD. "But we are still
the safest country in the world when it comes to drug approval. That
being said, there are a lot of issues with our health care system. And
current regulations don't protect the consumer."

After Drug Approval: Patient Beware

When the FDA approves a drug, it sometimes asks the manufacturer to
conduct further safety studies. Consumer Reports notes that in February
2005, companies agreed to 1,191 such studies. Yet as of September 2005,
more than two-thirds of the studies were still "pending."
The most important drug-safety experiment comes in the years following
drug approval. The subjects of this study: consumers who take the drug.

Preapproval studies enroll no more than a few thousand people --
usually healthier people than many of those who will take the drug
after approval. And the studies usually last only a few months. Rare
side effects, problems for people with multiple conditions taking
multiple other drugs, and long-term side effects can only be seen in
the years following approval.
And that, Lipman says, is where the U.S. system breaks down. Doctors
are supposed to report any side effects that happen. But because there
is no reliable system -- and, Gardner says, because these reports
aren't easy to file -- only a small fraction of side effects actually
get reported.
Compounding this problem, Lipman says, is direct-to-consumer
advertising. Ads heavily promote new drugs. Yet there's a drug risk
associated with every drug benefit. And the Consumer Reports article
states the ads stress benefits but don't adequately identify risks.
"It is impossible to monitor all the ads that are out there," Lipman
says. "And more ludicrous, the ad goes into the media, and it takes FDA

three to six months to catch up with the ad. By that time, the damage
is done. You need an approval system before, not after the ads hit the
media. They should submit copy for vetting by the FDA, and the FDA
needs resources for this. They don't have the personnel or the money."
The Consumer Reports article notes that PhRMA in August 2005 announced
guiding principles for direct-to-consumer ads, including a wait before
advertising new drugs. As of November, the article reports, most of
PhRMA's 33 members had signed on.

Independent Drug Safety Board Needed?

Currently, the FDA's drug-safety office is one of 12 subgroups
reporting to the director of the FDA's Center for Drug Evaluation. It's
been lacking a permanent chief for some time.
Lipman says there should be a drug safety office -- with regulatory
teeth -- outside the FDA.
"What is really needed, in our opinion, is an independent office of
drug safety: nonbiased safety experts not part of either the
pharmaceutical industry or the FDA," he says. "The same people can't be
responsible for drug approval and drug safety. It just makes it that
much harder for a drug to be withdrawn by the people who approved it."
Gardner isn't so sure. He thinks that a drug safety office would be no
better than the expert advisory panels that currently advise the FDA.
Instead of a new layer of bureaucracy, he would like to see more power
given to these panels of experts.
PhRMA's Trewhitt doesn't see the need for any of this. "Simply put, the
FDA still has the world's best drug safety record," he says.

Institute of Medicine to the Rescue

Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The
agency already has asked for help. Last year, it turned to the
independent Institute of Medicine (IOM) for advice. An IOM committee
has since been holding hearings. Its recommendations are expected in
July 2006.
"The FDA has asked the IOM to thoroughly investigate the drug safety
system," Trewhitt says. "It would behoove us to wait to see the
results."
Lipman says it's already time for Congress to act.
"We are getting to where this is a problem for our government," he
says. "There have to be some bills written that would address some of
these problems and that would create a better workforce for the FDA,
and that would give them more monetary resources so they don't have to
rely on pharmaceutical company fees to process new drugs. Basically the
buck passes back to our Congress."
Gardner says the problem goes far beyond the FDA. The real issue, he
says, is health care in America.
"Our health care system is in real trouble," Gardner says. "This is an
example of a real problem where we don't have the politics yet to
create a solution."

The Consumer Reports article lists 12 drugs as examples of
safety-system failures.
"These drugs are just examples," Lipman says. "There are bound to be
others. Even a perfect safety system could never detect every problem
of every drug."
The drugs are:

Celebrex
Estrogen, either alone (Premarin and others) or with progestin (Prempro
and others)
Accutane
Ovide
Depo-Provera
Lariam
Crestor
Serevent
Meridia
SSRI antidepressants and other antidepressants
Zelnorm
Topical immunosuppressants such as Elidel and Protopic
Do not stop taking these drugs if you're using them, Consumer Reports
warns. The drugs are helpful for people for whom the benefits outweigh
the risks.
"These are important drugs. They are very useful drugs," Lipman says.
"But in many cases they are not the only drug for the condition. And
the patient should know that by taking one of these drugs there is a
certain inherent risk, and the patient should be aware of this risk."
Lipman advises patients using these drugs to talk with their doctors
about whether there is another drug that can be used with less risk.
And all patients taking any drug should be aware of possible side
effects and should tell their doctors about any ill effects -- even
those not listed on the label.

2infoseek@gmail.com

2005-12-15, 5:59 pm

There is a very long list of human activities that expose us to more
risk than prescription drugs. Our desire for 100% protection does not
seem balanced with reality. There will always be some risk anytime a
chemical is introduced into someone's body. For some it's peanuts for
others it's Celebrex. A more transparent approval process and readily
available information to the end consumer would allow each individual
to make informed decisions regarding their own treatment. Instead we
have a very heavy handed FDA making blanket decisions that effectively
block individuals and their doctors from crafting the *best* treatment
for that patient.

Even something as benign as aspirin, (see:
http://www.legalfusiongroup.com/art...in/aspirin.html ),
can be harmful. In the year 2000 52 people in the U.S. died from taking
aspirin. So to the original subject: be aware, be especially aware of
those seeking to protect you!

Tim Campbell wrote:
> Millions of Americans unknowingly risk rare but serious drug side
> effects, Consumer Reports says.
> In its January 2006 issue, the independent consumer magazine points to
> a dozen common prescription drugs linked to serious risks -- including
> death. These risks, the article says, were "undetected or
> underestimated when the FDA approved them for use."
> The issue isn't these 12 drugs. For people who need them, their
> benefits outweigh their risks. What's flawed is the U.S. drug safety
> system, says Marvin M. Lipman, MD, chief medical advisor for Consumers
> Union and emeritus professor of medicine at New York Medical College,
> Valhalla.
> "This is a report that criticizes not only the preapproval process, but
> also the postapproval surveillance system," Lipman tells WebMD.
>
>
> System Geared for Approval
>
> Once upon a time, the FDA was very slow to approve new drugs. That
> changed in the early '90s, when Congress passed the Prescription Drug
> User Fee Act (PDUFA). The law gave the FDA deadlines for making
> approval decisions. In return, it charged drug companies fees used to
> hire new drug reviewers.
> The Consumer Reports article quotes a former FDA reviewer as saying
> that the tight deadlines were frustrating. Indeed, a 2003 HHS survey
> found that 20% of FDA reviewers said they felt pressured to recommend
> approval despite reservations.
> "The relationship of the FDA to the pharmaceutical industry has to be
> examined very closely," Lipman says. "Under the PDUFA law, a lot of
> money is paid by the drug companies to have their drugs reviewed. There
> is something inherently bad about that. It doesn't smell right."
>
> Drug Industry Reaction
>
> Jeff Trewhitt, a spokesman for the Pharmaceutical Research and
> Manufacturers of America (PhRMA), says PDUFA fees improve drug safety.
> "PDUFA has raised hundreds of millions of dollars for FDA in a time
> when Congress has approved only stagnant funding, even though
> regulators' duties have expanded dramatically," Trewhitt tells WebMD.
> "PDUFA money is also being used to increase staffing in the Office of
> Drug Safety at FDA. It's recently allowed FDA to double the number of
> safety officers from 100 to 206 officers."
> And Trewhitt notes that fewer than 3% of drugs are withdrawn from the
> market due to safety concerns -- a rate that hasn't changed since PDUFA
> took effect.
> Laurence B. Gardner, MD, chairman of the department of medicine at the
> university of Miami Miller School of Medicine, agrees with most of the
> points made by the Consumer Reports article. But he says the FDA's
> preapproval process isn't the problem.
> "Consumer Reports implies that people at the FDA rush approvals through
> and don't look at safety data," Gardner tells WebMD. "But we are still
> the safest country in the world when it comes to drug approval. That
> being said, there are a lot of issues with our health care system. And
> current regulations don't protect the consumer."
>
> After Drug Approval: Patient Beware
>
> When the FDA approves a drug, it sometimes asks the manufacturer to
> conduct further safety studies. Consumer Reports notes that in February
> 2005, companies agreed to 1,191 such studies. Yet as of September 2005,
> more than two-thirds of the studies were still "pending."
> The most important drug-safety experiment comes in the years following
> drug approval. The subjects of this study: consumers who take the drug.
>
> Preapproval studies enroll no more than a few thousand people --
> usually healthier people than many of those who will take the drug
> after approval. And the studies usually last only a few months. Rare
> side effects, problems for people with multiple conditions taking
> multiple other drugs, and long-term side effects can only be seen in
> the years following approval.
> And that, Lipman says, is where the U.S. system breaks down. Doctors
> are supposed to report any side effects that happen. But because there
> is no reliable system -- and, Gardner says, because these reports
> aren't easy to file -- only a small fraction of side effects actually
> get reported.
> Compounding this problem, Lipman says, is direct-to-consumer
> advertising. Ads heavily promote new drugs. Yet there's a drug risk
> associated with every drug benefit. And the Consumer Reports article
> states the ads stress benefits but don't adequately identify risks.
> "It is impossible to monitor all the ads that are out there," Lipman
> says. "And more ludicrous, the ad goes into the media, and it takes FDA
>
> three to six months to catch up with the ad. By that time, the damage
> is done. You need an approval system before, not after the ads hit the
> media. They should submit copy for vetting by the FDA, and the FDA
> needs resources for this. They don't have the personnel or the money."
> The Consumer Reports article notes that PhRMA in August 2005 announced
> guiding principles for direct-to-consumer ads, including a wait before
> advertising new drugs. As of November, the article reports, most of
> PhRMA's 33 members had signed on.
>
> Independent Drug Safety Board Needed?
>
> Currently, the FDA's drug-safety office is one of 12 subgroups
> reporting to the director of the FDA's Center for Drug Evaluation. It's
> been lacking a permanent chief for some time.
> Lipman says there should be a drug safety office -- with regulatory
> teeth -- outside the FDA.
> "What is really needed, in our opinion, is an independent office of
> drug safety: nonbiased safety experts not part of either the
> pharmaceutical industry or the FDA," he says. "The same people can't be
> responsible for drug approval and drug safety. It just makes it that
> much harder for a drug to be withdrawn by the people who approved it."
> Gardner isn't so sure. He thinks that a drug safety office would be no
> better than the expert advisory panels that currently advise the FDA.
> Instead of a new layer of bureaucracy, he would like to see more power
> given to these panels of experts.
> PhRMA's Trewhitt doesn't see the need for any of this. "Simply put, the
> FDA still has the world's best drug safety record," he says.
>
> Institute of Medicine to the Rescue
>
> Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The
> agency already has asked for help. Last year, it turned to the
> independent Institute of Medicine (IOM) for advice. An IOM committee
> has since been holding hearings. Its recommendations are expected in
> July 2006.
> "The FDA has asked the IOM to thoroughly investigate the drug safety
> system," Trewhitt says. "It would behoove us to wait to see the
> results."
> Lipman says it's already time for Congress to act.
> "We are getting to where this is a problem for our government," he
> says. "There have to be some bills written that would address some of
> these problems and that would create a better workforce for the FDA,
> and that would give them more monetary resources so they don't have to
> rely on pharmaceutical company fees to process new drugs. Basically the
> buck passes back to our Congress."
> Gardner says the problem goes far beyond the FDA. The real issue, he
> says, is health care in America.
> "Our health care system is in real trouble," Gardner says. "This is an
> example of a real problem where we don't have the politics yet to
> create a solution."
>
> The Consumer Reports article lists 12 drugs as examples of
> safety-system failures.
> "These drugs are just examples," Lipman says. "There are bound to be
> others. Even a perfect safety system could never detect every problem
> of every drug."
> The drugs are:
>
> Celebrex
> Estrogen, either alone (Premarin and others) or with progestin (Prempro
> and others)
> Accutane
> Ovide
> Depo-Provera
> Lariam
> Crestor
> Serevent
> Meridia
> SSRI antidepressants and other antidepressants
> Zelnorm
> Topical immunosuppressants such as Elidel and Protopic
> Do not stop taking these drugs if you're using them, Consumer Reports
> warns. The drugs are helpful for people for whom the benefits outweigh
> the risks.
> "These are important drugs. They are very useful drugs," Lipman says.
> "But in many cases they are not the only drug for the condition. And
> the patient should know that by taking one of these drugs there is a
> certain inherent risk, and the patient should be aware of this risk."
> Lipman advises patients using these drugs to talk with their doctors
> about whether there is another drug that can be used with less risk.
> And all patients taking any drug should be aware of possible side
> effects and should tell their doctors about any ill effects -- even
> those not listed on the label.