Re: NEWS - FDA committees say it's time to raise the bar on NSAID trials

[Guest guest]

This part REALLY gets my goat:

" Graham pointed out that many trials that should be conducted never are

because of expense. " Companies don't want to do them and there is no

incentive we are not requiring them to do so, " he said. Graham also argued

that too much emphasis has been placed on efficacy and not enough on safety. "

I thought the job of the FDA was to make sure that these drugs were

proven safe for us to take!!

I thought these studies were required by the FDA to prove safety, and

expense wasn't the concern of the FDA.

I hope Dr Graham get his wish and they do the studies he wants done.

a

On Thu, 10 Mar 2005 07:44:52 -0600, <Matsumura_Clan@...> wrote:

> FDA committees say it's time to raise the bar on NSAID trials

>

>

> Rheumawire

> Mar 9, 2005

> Gandey

>

> Gaithersburg, MD - US Food and Drug Administration committees reviewing the

> benefit-to-risk considerations of COX-2 inhibitors and nonsteroidal

> anti-inflammatory drugs (NSAIDs) complain that trials of these drugs have

> been grossly inadequate. " In arthritis, you can't conduct

> placebo-controlled

> trials, " said committee member Dr Nissen (Cleveland Clinic

> Cardiovascular Coordinating Center, OH). " We therefore need more clarity

> and

> consistency in comparators. " The committees opted for naproxen as the new

> comparator of choice and urged the FDA to raise the bar on future NSAID

> studies.

>

> The decision to make NSAID drug approvals tougher does not bode well for

> etoricoxib (Arcoxia, Merck & Co) and lumiracoxib (Prexige, Novartis), which

> have yet to be approved for use in the US. But panelists were concerned

> about a lack of data of older agents as well as newer COX-2-specific drugs.

> Their concerns spanned a wide range of products, including ibuprofen,

> meloxicam (Mobic, Boehringer Ingelheim), and the coxibs.

>

> In a presentation reviewing epidemiologic studies on cardiovascular risk

> with NSAIDs, Dr Graham from the FDA's Center for Drug Evaluation and

> Research agreed that data have been sparse. " I submit to you that you know

> very little about the population benefit of these drugs, " Graham told

> panelists. " You don't have the data you need from an epidemiological

> standpoint. "

>

> Graham's talk had been the topic of much controversy leading up to the

> meeting. Questions about what he would or would not be allowed to say had

> been the subject of many news articles. Meeting chair Dr Alastair Wood

> (Vanderbilt University Medical Center, Nashville, TN) was quick to point

> out

> that Graham was free to speak openly and was encouraged to do so. But

> despite assurances, Graham frequently responded to questions specifying

> that

> he was speaking for himself and not the agency.

>

> Graham pointed out that many trials that should be conducted never are

> because of expense. " Companies don't want to do them and there is no

> incentivewe are not requiring them to do so, " he said. Graham also argued

> that too much emphasis has been placed on efficacy and not enough on

> safety.

>

> Graham showed panelists an overview of recent studies evaluating the risk

> of

> acute MI with naproxen. Among the many studies, he highlighted 4 positive

> naproxen studies: one by Rahme and colleagues that showed a benefit of

> naproxen over other NSAIDs, another by Kimmel and his team that showed a

> reduced cardiovascular risk with naproxen, as well as studies by

> and

> colleagues and and his group. " None provide critical evidence of a

> protective effect of naproxen, " Graham said.

>

> Nissen suggested that one immediate way to create incentive for companies

> would be to offer industry the opportunity to drop the cardiovascular

> warning on products in exchange for adequate trials demonstrating safety.

> " We've learned this the hard waythe very difficult waylast fall, but we've

> learned it and now we have to set the bar accordingly, " he said.

>

> Dr Temple from the FDA's Center for Drug Evaluation and Research

> agreed. " When you have priors, you have to make changes. We know something

> here. "

>

> Nissen noted that he'd like to see a trial of naproxen 500 mg twice daily

> and celecoxib 200 mg. " Do that trial and add a third arma nonnaproxen NSAID

> such as diclofenac, which appears to be in a class similar to celecoxib, "

> he

> said. Nissen added that in absence of a placebo, naproxen should be the new

> comparator against which all new drugs are assessed.

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

>

>

[Guest guest]

This part REALLY gets my goat:

" Graham pointed out that many trials that should be conducted never are

because of expense. " Companies don't want to do them and there is no

incentive we are not requiring them to do so, " he said. Graham also argued

that too much emphasis has been placed on efficacy and not enough on safety. "

I thought the job of the FDA was to make sure that these drugs were

proven safe for us to take!!

I thought these studies were required by the FDA to prove safety, and

expense wasn't the concern of the FDA.

I hope Dr Graham get his wish and they do the studies he wants done.

a

On Thu, 10 Mar 2005 07:44:52 -0600, <Matsumura_Clan@...> wrote:

> FDA committees say it's time to raise the bar on NSAID trials

>

>

> Rheumawire

> Mar 9, 2005

> Gandey

>

> Gaithersburg, MD - US Food and Drug Administration committees reviewing the

> benefit-to-risk considerations of COX-2 inhibitors and nonsteroidal

> anti-inflammatory drugs (NSAIDs) complain that trials of these drugs have

> been grossly inadequate. " In arthritis, you can't conduct

> placebo-controlled

> trials, " said committee member Dr Nissen (Cleveland Clinic

> Cardiovascular Coordinating Center, OH). " We therefore need more clarity

> and

> consistency in comparators. " The committees opted for naproxen as the new

> comparator of choice and urged the FDA to raise the bar on future NSAID

> studies.

>

> The decision to make NSAID drug approvals tougher does not bode well for

> etoricoxib (Arcoxia, Merck & Co) and lumiracoxib (Prexige, Novartis), which

> have yet to be approved for use in the US. But panelists were concerned

> about a lack of data of older agents as well as newer COX-2-specific drugs.

> Their concerns spanned a wide range of products, including ibuprofen,

> meloxicam (Mobic, Boehringer Ingelheim), and the coxibs.

>

> In a presentation reviewing epidemiologic studies on cardiovascular risk

> with NSAIDs, Dr Graham from the FDA's Center for Drug Evaluation and

> Research agreed that data have been sparse. " I submit to you that you know

> very little about the population benefit of these drugs, " Graham told

> panelists. " You don't have the data you need from an epidemiological

> standpoint. "

>

> Graham's talk had been the topic of much controversy leading up to the

> meeting. Questions about what he would or would not be allowed to say had

> been the subject of many news articles. Meeting chair Dr Alastair Wood

> (Vanderbilt University Medical Center, Nashville, TN) was quick to point

> out

> that Graham was free to speak openly and was encouraged to do so. But

> despite assurances, Graham frequently responded to questions specifying

> that

> he was speaking for himself and not the agency.

>

> Graham pointed out that many trials that should be conducted never are

> because of expense. " Companies don't want to do them and there is no

> incentivewe are not requiring them to do so, " he said. Graham also argued

> that too much emphasis has been placed on efficacy and not enough on

> safety.

>

> Graham showed panelists an overview of recent studies evaluating the risk

> of

> acute MI with naproxen. Among the many studies, he highlighted 4 positive

> naproxen studies: one by Rahme and colleagues that showed a benefit of

> naproxen over other NSAIDs, another by Kimmel and his team that showed a

> reduced cardiovascular risk with naproxen, as well as studies by

> and

> colleagues and and his group. " None provide critical evidence of a

> protective effect of naproxen, " Graham said.

>

> Nissen suggested that one immediate way to create incentive for companies

> would be to offer industry the opportunity to drop the cardiovascular

> warning on products in exchange for adequate trials demonstrating safety.

> " We've learned this the hard waythe very difficult waylast fall, but we've

> learned it and now we have to set the bar accordingly, " he said.

>

> Dr Temple from the FDA's Center for Drug Evaluation and Research

> agreed. " When you have priors, you have to make changes. We know something

> here. "

>

> Nissen noted that he'd like to see a trial of naproxen 500 mg twice daily

> and celecoxib 200 mg. " Do that trial and add a third arma nonnaproxen NSAID

> such as diclofenac, which appears to be in a class similar to celecoxib, "

> he

> said. Nissen added that in absence of a placebo, naproxen should be the new

> comparator against which all new drugs are assessed.

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

>

>