Latest Drugwonks' Blog
I am a frequent critic of Jerry Avorn on many issues, but he gets is right -- in my opinion (because I agree with him) in his editorial in Circulation.
He is off-base in his reasoning for opposing the elimination of user fees as a source of funding for FDA activities. See his article in the NEJM. While I tend to agree that user fees are becoming increasing unwieldy -- and should be replaced by public-private partnerships to advance Critical Path -- the implication that companies can't work with FDA to advance science is absurd.
Mark McClellan's editorial in the NEJM saying we have one last chance to get it right on FDA reform is on point. Pair Avorn's Circ article with Mark's NEJM and we have a sensible consensus that is Critical Path focused.
Links to all follow:
http://content.nejm.org/cgi/content/full/NEJMp078041
http://circ.ahajournals.org/cgi/content/full/113/18/2173
http://content.nejm.org/cgi/content/full/NEJMp078057
He is off-base in his reasoning for opposing the elimination of user fees as a source of funding for FDA activities. See his article in the NEJM. While I tend to agree that user fees are becoming increasing unwieldy -- and should be replaced by public-private partnerships to advance Critical Path -- the implication that companies can't work with FDA to advance science is absurd.
Mark McClellan's editorial in the NEJM saying we have one last chance to get it right on FDA reform is on point. Pair Avorn's Circ article with Mark's NEJM and we have a sensible consensus that is Critical Path focused.
Links to all follow:
http://content.nejm.org/cgi/content/full/NEJMp078041
http://circ.ahajournals.org/cgi/content/full/113/18/2173
http://content.nejm.org/cgi/content/full/NEJMp078057
Interesting op-ed in the Washington Post raising concern about a stampede of women who will demand the use of MRIs to scope any cancer in lieu of mammograms and other screening tools in light of studies showing MRIs can catch some cancers in subpopulations and high risk patients that mammo's can't.
Let's look at the presupposition: women are hysterical and too stupid and doctors are unable to explain to women what the risks and benefits and limits of MRIs are. Also, let's look at the facts: the number of women who are seeking out mammo's for screening has declined...in part because irresponsible cults like Breast Cancer (In)action have conducted public campaign to discourage such testing....
So let's get a grip and recognize as does that article that the use of MRI's in select cases can reduce the spread of metastatic cancers and save lives or might do so. And we should research the value of such diagnostics in achieving that goal. No one is suggesting a blank check..except the scaremongers who presuppose that all patients are stupid and all doctors are patsies...
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/06/AR2007040601955_2.html?nav=rss_health
Let's look at the presupposition: women are hysterical and too stupid and doctors are unable to explain to women what the risks and benefits and limits of MRIs are. Also, let's look at the facts: the number of women who are seeking out mammo's for screening has declined...in part because irresponsible cults like Breast Cancer (In)action have conducted public campaign to discourage such testing....
So let's get a grip and recognize as does that article that the use of MRI's in select cases can reduce the spread of metastatic cancers and save lives or might do so. And we should research the value of such diagnostics in achieving that goal. No one is suggesting a blank check..except the scaremongers who presuppose that all patients are stupid and all doctors are patsies...
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/06/AR2007040601955_2.html?nav=rss_health
Interesting article about United Health's PBM cutting copays to insure continued use of asthma inhalers -- as opposed to risking decreased use of Rx and increased use of more expensive services...a proposition FUSA Godfather Ron (I take money from George Soros) Pollack finds ridiculous.
The question is.. why not eliminate the huge co-pays for cancer drugs -- which have jumped many times more than the price of drugs themselves -- to promote compliance in other disease areas? Why not value driven health plans across the board? That is what evidence based medicine should really be about..
UnitedHealth cuts co-pay on asthma inhaler
RSS Feed - Health Business - Briefing
Published: April 13, 2007 at 11:07 AM
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MINNEAPOLIS, April 13, 2007 (UPI) -- U.S. health insurance giant UnitedHealthcare said Friday it has cut the co-payment for certain asthma inhalers due to high cost and short supply.
The insurer said its pharmacy benefit manager UnitedHealth Pharmaceutical Solutions has reclassified its chlorofluorocarbon-free, asthma inhaler Xopenex to its lowest co-pay tier, meaning plan members will pay between $5 and $10 for the prescription treatment.
CFC-free inhalers are gradually replacing CFC-containing albuterol inhalers, due to CFCs' environmental risks, but the CFC-free products cost more, and there are only a handful currently sold, UnitedHealth said.
The supply shortage of both generic and brand-name CFC-free inhalers is expected to increase until the complete phase-out deadline of Dec. 31, 2008, the company said.
"Asthma patients have relied on albuterol inhalers for years because they provide quick and effective relief of asthma symptoms. However, because of the higher cost for the new brand-name CFC-free inhalers, some patients may avoid continued treatment, which would place their health at serious risk," said Tim Heady, CEO of UnitedHealth Pharmaceutical Solutions.
The question is.. why not eliminate the huge co-pays for cancer drugs -- which have jumped many times more than the price of drugs themselves -- to promote compliance in other disease areas? Why not value driven health plans across the board? That is what evidence based medicine should really be about..
UnitedHealth cuts co-pay on asthma inhaler
RSS Feed - Health Business - Briefing
Published: April 13, 2007 at 11:07 AM
E-mail Story | Print Preview | License
MINNEAPOLIS, April 13, 2007 (UPI) -- U.S. health insurance giant UnitedHealthcare said Friday it has cut the co-payment for certain asthma inhalers due to high cost and short supply.
The insurer said its pharmacy benefit manager UnitedHealth Pharmaceutical Solutions has reclassified its chlorofluorocarbon-free, asthma inhaler Xopenex to its lowest co-pay tier, meaning plan members will pay between $5 and $10 for the prescription treatment.
CFC-free inhalers are gradually replacing CFC-containing albuterol inhalers, due to CFCs' environmental risks, but the CFC-free products cost more, and there are only a handful currently sold, UnitedHealth said.
The supply shortage of both generic and brand-name CFC-free inhalers is expected to increase until the complete phase-out deadline of Dec. 31, 2008, the company said.
"Asthma patients have relied on albuterol inhalers for years because they provide quick and effective relief of asthma symptoms. However, because of the higher cost for the new brand-name CFC-free inhalers, some patients may avoid continued treatment, which would place their health at serious risk," said Tim Heady, CEO of UnitedHealth Pharmaceutical Solutions.
Seems that at Consumer Reports, the adage “Ask me no questions, I’ll tell you no lies†has been replaced with “Ask loaded questions and there’s no need to lie.†No matter how you slice it, it equals the same thing – dishonest reporting.
Or as my grandmother used to say, "A half-truth is a whole lie."
Consider some of the findings from CR’s new survey:
* More than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect consumers from harmful prescription drugs.
As opposed to what, “safe" prescription drugs? It doesn’t look like the survey asked respondents if they understood that all drugs have risks.
Similarly:
* 84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited, with 59 percent "strongly agreeing" to such limits.
Again, as opposed to what, drugs that have no safety concerns?
* The survey also found that 84 percent of consumers agree that drug companies have too much influence over the government officials who regulate them. More than two-thirds (67 percent) are concerned that much of the FDA's funding comes from the pharmaceutical industry, with more than half--54 percent--"very concerned" about that situation.
How was this question worded? Did it make clear that PDUFA dollars fund review, not approval? I haven’t seen the survey questions, but I imagine it’s a “safe†bet that point wasn’t introduced into the protocol.
* More than half of consumers say they currently take a prescription drug, which translates to 124 million adults. A significant number -- -40 percent--say they have experienced an adverse reaction to a medication.
And what, precisely, did the survey define as an “adverse reaction?†Did they define it at all?
* Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent "strongly agreeing."
Except that every survey of doctors says otherwise.
Here’s a link to the CR press release:
http://www.consumerreports.org/cro/health-fitness/news/2007/04/consumer-reports-survey-finds-strong-backing-for-drug-reforms-4-07/overview/consumer-reports-survey-finds-strong-backing-for-drug-reforms.htm
The release, BTW, does not say who funded the study or that Consumer Reports receives significant contributions from foundations funded by the generic drug industry. Surprising, considering that another of the “research†results says that Americans are concerned about conflicts of interest. What about CR’s funding conflicts?
Might that explain why CR took a break from testing vacuum cleaners and developed a sudden interest in the public's opinions on drug safety and the FDA? Inquiring minds want to know.
Research, as the saying goes, is like a bikini. What it shows you is interesting but what it conceals is essential.
And what this survey conceals are loaded questions fielded by an organization with an agenda.
Or as my grandmother used to say, "A half-truth is a whole lie."
Consider some of the findings from CR’s new survey:
* More than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect consumers from harmful prescription drugs.
As opposed to what, “safe" prescription drugs? It doesn’t look like the survey asked respondents if they understood that all drugs have risks.
Similarly:
* 84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited, with 59 percent "strongly agreeing" to such limits.
Again, as opposed to what, drugs that have no safety concerns?
* The survey also found that 84 percent of consumers agree that drug companies have too much influence over the government officials who regulate them. More than two-thirds (67 percent) are concerned that much of the FDA's funding comes from the pharmaceutical industry, with more than half--54 percent--"very concerned" about that situation.
How was this question worded? Did it make clear that PDUFA dollars fund review, not approval? I haven’t seen the survey questions, but I imagine it’s a “safe†bet that point wasn’t introduced into the protocol.
* More than half of consumers say they currently take a prescription drug, which translates to 124 million adults. A significant number -- -40 percent--say they have experienced an adverse reaction to a medication.
And what, precisely, did the survey define as an “adverse reaction?†Did they define it at all?
* Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent "strongly agreeing."
Except that every survey of doctors says otherwise.
Here’s a link to the CR press release:
http://www.consumerreports.org/cro/health-fitness/news/2007/04/consumer-reports-survey-finds-strong-backing-for-drug-reforms-4-07/overview/consumer-reports-survey-finds-strong-backing-for-drug-reforms.htm
The release, BTW, does not say who funded the study or that Consumer Reports receives significant contributions from foundations funded by the generic drug industry. Surprising, considering that another of the “research†results says that Americans are concerned about conflicts of interest. What about CR’s funding conflicts?
Might that explain why CR took a break from testing vacuum cleaners and developed a sudden interest in the public's opinions on drug safety and the FDA? Inquiring minds want to know.
Research, as the saying goes, is like a bikini. What it shows you is interesting but what it conceals is essential.
And what this survey conceals are loaded questions fielded by an organization with an agenda.
Isn't everyone getting tired of the "Drug company's overhype products with paid for studies" angle? Or better yet, when are people going to do their own thinking on issues instead of letting journalists with an agenda do it for them?
Carreyrou tries to frame the Merck HPV vaccine mandate issue as whether it is efficacious enough to mandate it's use or more to his point, to justify Merck's effort to support mandatory immunization. He brings in statistician's to question whether it will really be effective in a group not included studied in the clinical trials.
The fact is, no vaccine designed to reduce the spread of a virus is 100 percent effective in preventing disease particularly in those with a pre-existing infection. By Carreyrou's standard then vaccines for HIV, syphillis, TB, denge, herpes should not be mandatory or by other means be part of an aggressive effort to immunize 100 percent of patients.
As my colleague Marc Siegel has pointed out time and again, HPV is a sexually transmitted disease that causes precancerous warts that lead to billions of dollars of screenings, surgeries, etc. For that alone Merck's vaccine makes an important contribution. Whether Merck should have pushed for mandatory immunization (which Peter and I support) is another question. Needless to say, anyone can play the guessing game about real world effectiveness but chances are given the mechanistic understanding of the disease as opposed to fantasy baseball analysis that the epidemiologists often take, I would bet on Merck and not a numbers cruncher John dug up.
In any event, the whole article has the sound and feel of an article from a website called corpwatch.com which lays out the case against Merck in the same way Carreyrou does including an interview with the same Maine legislator who criticizes a woman's legislative groups for taking money from Merck.
You can compare the two articles and decide which is more efficacious:
http://www.corpwatch.org/article.php?id=14401
http://online.wsj.com/article/SB117668541991270825.html?mod=hps_us_pageone
Carreyrou tries to frame the Merck HPV vaccine mandate issue as whether it is efficacious enough to mandate it's use or more to his point, to justify Merck's effort to support mandatory immunization. He brings in statistician's to question whether it will really be effective in a group not included studied in the clinical trials.
The fact is, no vaccine designed to reduce the spread of a virus is 100 percent effective in preventing disease particularly in those with a pre-existing infection. By Carreyrou's standard then vaccines for HIV, syphillis, TB, denge, herpes should not be mandatory or by other means be part of an aggressive effort to immunize 100 percent of patients.
As my colleague Marc Siegel has pointed out time and again, HPV is a sexually transmitted disease that causes precancerous warts that lead to billions of dollars of screenings, surgeries, etc. For that alone Merck's vaccine makes an important contribution. Whether Merck should have pushed for mandatory immunization (which Peter and I support) is another question. Needless to say, anyone can play the guessing game about real world effectiveness but chances are given the mechanistic understanding of the disease as opposed to fantasy baseball analysis that the epidemiologists often take, I would bet on Merck and not a numbers cruncher John dug up.
In any event, the whole article has the sound and feel of an article from a website called corpwatch.com which lays out the case against Merck in the same way Carreyrou does including an interview with the same Maine legislator who criticizes a woman's legislative groups for taking money from Merck.
You can compare the two articles and decide which is more efficacious:
http://www.corpwatch.org/article.php?id=14401
http://online.wsj.com/article/SB117668541991270825.html?mod=hps_us_pageone
Bad Scrabble tiles but good opportunity for a letter to the editor of the Los Angeles Times.
Here's what ran in today's edition:
Price controls on Medicare drugs
Re "Aid for Medicare patients sought," April 11
Although the article states that "Democrats say the government could save money if it used its massive purchasing power to negotiate with pharmaceutical companies," there is little evidence to support their claim.
First, it's not clear that allowing the government to negotiate prices would yield any savings. According to a recent report from the nonpartisan Congressional Budget Office, "Government price negotiation would not yield lower drug prices compared to current law."
Second, Democrats cite the Department of Veterans Affairs' drug benefit as a good model for Medicare Part D. But under the VA model, drug companies must sell their products to the government at a price that is at least 24% less than the non-federal average manufacturer's price. In other words, the VA institutes price controls.
Medicare covers well over 40 million seniors. If price controls are extended to such a large segment of the market, they inevitably would result in reduced consumer choices and stifled drug innovation.
PETER PITTS
Director, Center for Medicine in the Public Interest, New York
Here's what ran in today's edition:
Price controls on Medicare drugs
Re "Aid for Medicare patients sought," April 11
Although the article states that "Democrats say the government could save money if it used its massive purchasing power to negotiate with pharmaceutical companies," there is little evidence to support their claim.
First, it's not clear that allowing the government to negotiate prices would yield any savings. According to a recent report from the nonpartisan Congressional Budget Office, "Government price negotiation would not yield lower drug prices compared to current law."
Second, Democrats cite the Department of Veterans Affairs' drug benefit as a good model for Medicare Part D. But under the VA model, drug companies must sell their products to the government at a price that is at least 24% less than the non-federal average manufacturer's price. In other words, the VA institutes price controls.
Medicare covers well over 40 million seniors. If price controls are extended to such a large segment of the market, they inevitably would result in reduced consumer choices and stifled drug innovation.
PETER PITTS
Director, Center for Medicine in the Public Interest, New York
The following article is NOT a parody. Someone actually wrote this in a serious vein and not as forced confession while being held hostage by Greenpeace...
Clinical trials are saving lives but may be killing the environment
Drug Researcher.com
UK, 4/13/2007 - Clinical trials are saving lives but may be killing the environment due to their 'intensive energy use' and 'substantial contribution to greenhouse gasses.'
Energy use in clinical research premises and trial-related air travel have been identified as the biggest culprits, in an article published in the March 31 issue of the British Medical Journal.
The situation is only set to intensify as the trend towards outsourcing various elements of clinical trials to far flung destinations all over the world continues to gain momentum.
During a one year audit period of a sample clinical trial, the total emission of greenhouse gasses related to the trial was 126 tonnes of carbon dioxide equivalents (CDEs) - an amount that corresponds to that produced by 32 people in one year on the basis of global per capita estimates, said the researchers.
For the entire five-year duration of the sample trial, about 630 tonnes of CDEs were produced - an amount that is equivalent to 525 round trips flights from London to New York for one passenger, the researchers said.
Specifically, the trial coordination centre accounted for the largest proportion of emissions, generating 50 tonnes (39 per cent), with 45 out of the 50 tonnes coming from electricity usage and the remainder from office waste disposal.
The distribution of drugs and documents was the next biggest contributor, with 35 tonnes (28 per cent) and the majority of this stemmed from the airfreight of treatment packs and documents to hospitals.
This was followed closely by trial-related travel, responsible for 29 tonnes (23 per cent) of emissions, with most coming from air travel, as well as hotel stays for site visits, on-site data verification and meetings.
Furthermore, each individual clinical trial employee was found by the researchers to generate 14 tonnes of CDEs each year, compared with the substantially-lower average of 4-6 tonnes for employees in other service industries.
The research was conducted during August 2003 and July 2004 by the Sustainable Trials Study Group, which was convened by the London School of Hygiene and Tropical Medicine to find ways of reducing greenhouse gas emissions from clinical trials.
For the purpose, a 'carbon audit' was conducted on a multicentre international trial being run by the Medical Research Council (MRC), called CRASH.
The CRASH trial involved 10,008 participants at sites in 49 countries over five years and was investigating the effect of corticosteroids on death and disability in adults with head injury.
The trial was coordinated from London; involved a drug made by Pfizer in the US; a placebo made in France; packaging of both study drugs was done in Wales, from where treatment packs were sent to London for distribution to hospitals around the world.
Commenting on the results, the researchers said: "Clinical trials are energy intensive and produce substantial greenhouse gas emissions."
"Our audit provides insights into how to reduce the carbon intensity of clinical trials."
Suggestions given include using renewable energy sources as well as more efficient energy consumption at clinical trial sites, in addition to reducing the number of staff employed, in order to cut emissions.
Other suggestions posed by the researchers were to simplify trial designs to minimise superfluous data collection, coupled with increasing the use of remote electronic data capture; reduce bureaucracy associated with ethics committee- and-regulatory applications; as well as the increased use of teleconferencing and videoconferencing where possible to slash unnecessary travel.
They also made an interesting parting comment: "Trial results should be made publicly available, as the environmental consequences affect us all."
Clinical trials are saving lives but may be killing the environment
Drug Researcher.com
UK, 4/13/2007 - Clinical trials are saving lives but may be killing the environment due to their 'intensive energy use' and 'substantial contribution to greenhouse gasses.'
Energy use in clinical research premises and trial-related air travel have been identified as the biggest culprits, in an article published in the March 31 issue of the British Medical Journal.
The situation is only set to intensify as the trend towards outsourcing various elements of clinical trials to far flung destinations all over the world continues to gain momentum.
During a one year audit period of a sample clinical trial, the total emission of greenhouse gasses related to the trial was 126 tonnes of carbon dioxide equivalents (CDEs) - an amount that corresponds to that produced by 32 people in one year on the basis of global per capita estimates, said the researchers.
For the entire five-year duration of the sample trial, about 630 tonnes of CDEs were produced - an amount that is equivalent to 525 round trips flights from London to New York for one passenger, the researchers said.
Specifically, the trial coordination centre accounted for the largest proportion of emissions, generating 50 tonnes (39 per cent), with 45 out of the 50 tonnes coming from electricity usage and the remainder from office waste disposal.
The distribution of drugs and documents was the next biggest contributor, with 35 tonnes (28 per cent) and the majority of this stemmed from the airfreight of treatment packs and documents to hospitals.
This was followed closely by trial-related travel, responsible for 29 tonnes (23 per cent) of emissions, with most coming from air travel, as well as hotel stays for site visits, on-site data verification and meetings.
Furthermore, each individual clinical trial employee was found by the researchers to generate 14 tonnes of CDEs each year, compared with the substantially-lower average of 4-6 tonnes for employees in other service industries.
The research was conducted during August 2003 and July 2004 by the Sustainable Trials Study Group, which was convened by the London School of Hygiene and Tropical Medicine to find ways of reducing greenhouse gas emissions from clinical trials.
For the purpose, a 'carbon audit' was conducted on a multicentre international trial being run by the Medical Research Council (MRC), called CRASH.
The CRASH trial involved 10,008 participants at sites in 49 countries over five years and was investigating the effect of corticosteroids on death and disability in adults with head injury.
The trial was coordinated from London; involved a drug made by Pfizer in the US; a placebo made in France; packaging of both study drugs was done in Wales, from where treatment packs were sent to London for distribution to hospitals around the world.
Commenting on the results, the researchers said: "Clinical trials are energy intensive and produce substantial greenhouse gas emissions."
"Our audit provides insights into how to reduce the carbon intensity of clinical trials."
Suggestions given include using renewable energy sources as well as more efficient energy consumption at clinical trial sites, in addition to reducing the number of staff employed, in order to cut emissions.
Other suggestions posed by the researchers were to simplify trial designs to minimise superfluous data collection, coupled with increasing the use of remote electronic data capture; reduce bureaucracy associated with ethics committee- and-regulatory applications; as well as the increased use of teleconferencing and videoconferencing where possible to slash unnecessary travel.
They also made an interesting parting comment: "Trial results should be made publicly available, as the environmental consequences affect us all."
Make that a Troy ounce.
According to the Wall Street Journal …
“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.
As Dan Troy has written:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.â€
“FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
Amen.
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.
According to the Wall Street Journal …
“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.
As Dan Troy has written:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.â€
“FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
Amen.
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.
What does the FDA do when a drug is demonstrably safe and efficacious compared to a placebo. It usually approves the drug. In the case of Merck's new COX-2, the AdCom reviewing the drug -- which now includes a lawyer suing Merck -- acknowledged that Arcoxia has the same risk profile as many other painkillers. But the FDA wanted evidence that it met some unmet medical need in a subpopulation.
How about people like me or millions of others who did well on Vioxx or Bextra that have neither?
Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.
According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.
In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.
Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.
How about people like me or millions of others who did well on Vioxx or Bextra that have neither?
Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.
According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.
In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.
Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.
Nevada legislators are once again rolling the dice on patient safety. This time it's not some half-baked and benighted scheme for cheap "Canadian" drugs, but rather an ill-considered plan to build a chinese wall around physician-prescribing data.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
