Latest Drugwonks' Blog
Markup tomorrow for the Food and Drug Administration Revitalization Act. No importation codicil – but, unfortunately, it may yet appear as a floor amendment.
Some topline highlights:
Title I -- Prescription Drug User Fees
Title I establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs.
Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.
Title II -- Drug Safety
Subtitle A -- Risk Evaluation and Mitigation Strategies (REMS)
This subtitle establishes a system of routine active surveillance for post-market drug safety through a public-private partnership. The partnership will aggregate data from Federal and private health databases containing information for at least 100,000,000 covered lives and support the analysis of utilization and safety data from these databases. The establishment of this system will be supported with up to $30 million in appropriations.
Given the ability of this active surveillance system to identify and assess drug risks, most drugs and biologics will not need anything further than this system and the drug label to appropriately manage risk. However, some drugs and biologics will need additional tools to manage serious risks, and these products will be approved with risk evaluation and mitigation strategies (REMS). Sponsors would propose a REMS and FDA would approve it after structured negotiations, if necessary. The REMS will be reviewed at 18 months and three years, as well as in labeling supplements and when FDA requests a review.
Additional Elements —When more is needed, a REMS may include tools to assess, communicate about, or manage risks. The bill contains clear standards detailing the appropriate application of each tool. These standards ensure that new FDA authorities are applied narrowly, and only as necessary.
A REMS would be assessed in response to new information about a serious risk, and could be modified, including by reducing the stringency of elements, in response to new information.
Resources -- Increased drug user fees would be used to review REMS and for FDA’s general drug safety surveillance. This subtitle increases user fee revenue by $50 million over the agreement between industry and the FDA to fund drug safety activities.
Subtitle B -- Reagan-Udall Foundation for the Food and Drug Administration
Subtitle B establishes a foundation to lead collaborations amongst the FDA, academic research institutions, and industry directed to supporting the FDA’s mission. Collaborative research projects will be selected that are designed to bolster R & D productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make regulated product development and safety more predictable and manageable. The Foundation will be financially supported by industry and philanthropic donated funds.
Subtitle C -- Clinical Trials
To enhance patient enrollment and provide a mechanism to track subsequent progress of trials, the data bank at www.clinicaltrials.gov will be expanded to include all phase II and later trials, and to include devices. Currently, only clinical trials of drugs for serious and life threatening conditions are required to register in the data bank.
In addition, to ensure that results of trials are made public, and that patients and providers have the most up-to-date information, results information would be added to this database. Information would be added only after the product in question has been approved or cleared for marketing. Results information would first come from existing FDA and NIH documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured under those conditions.
Subtitle D -- Conflicts of Interest
Subtitle D requires disclosure of conflicts of interest of advisory committee members prior to an advisory committee meeting, and greater efforts by FDA to identify and recruit members of advisory committees.
Title III -- Medical Device User Fees
Title III is reflective of the agreement between FDA and industry regarding the total list of issues within their agreement from the time of the publication of the Federal Register notice. Given that some of the submitted language does not track the intent of the agreement, we expect to provide further improvements to the language at a later date. Those improvements will be agreed to by both FDA and industry.
Per the agreement between FDA and industry, it establishes an overall amount of $287 M of user fees over five years, with $48 M in 2008. This is coupled with a fixed 8.5% annual increase (with no other adjustors) and a further reduction of fees for small business.
Title III also includes the FDA-industry proposal on third party inspection improvements to ensure that the program works more efficiently and clarifying that entities can register and list electronically.
Title IV -- Pediatric Medical Products
Subtitle A -- Best Pharmaceuticals for Children
Subtitle A would reauthorize the Best Pharmaceuticals for Children Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations. BPCA generally provides six months of additional exclusivity to drug manufactures to encourage the determination of safety and efficacy of drugs in pediatric populations. The bill contains an incentive of three months of additional exclusivity if US sales of the active moiety by the innovator and its affiliates exceed $1 billion annually at the time written request for study is issued. The bill is a five-year authorization and will expire in 2012. No PDUFA funds can be used for BPCA studies. The Secretary may send declined requests for study to the NIH Foundation if funds are available.
Subtitle B -- Pediatric Research Improvement
Subtitle B would reauthorize the Pediatric Research Equity Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations.
In order to improve coordination with the pediatric exclusivity provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA would consolidate an internal FDA committee to review all issues of pediatric-related labeling and assessments. Doing so ensures that a drug that falls under PRIA or BPCA is reviewed not only by experts for that particular drug, but experts with pediatric expertise. PRIA will sunset in tandem with BPCA in 2012. If a company chooses not to pursue pediatric exclusivity for an already marketed drug under the Best Pharmaceuticals for Children Act, and no study is performed through NIH, then the Secretary has the authority to require the submission of pediatric data for such drug. PRIA streamlines this process and helps get essential pediatric data for important drugs, while preserving the ability of companies to meet and discuss testing with the agency.
The bill would require two reports – one from the Institute of Medicine and one from the GAO – that would allow us to have better data on the number and ways in which the pediatric rule is used, and evaluate its contributions to ensuring overall pediatric drug safety.
Subtitle C -- Pediatric Medical Devices
Subtitle C modifies the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need. Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. No profit will be allowed for a device used in more than 4,000 individuals. The HDE exemption expansion sunsets in 2013 and a GAO report assessing the HDE exemption expansion and its impact on patients and manufacturers is required.
The FDA’s Office of Pediatric Therapeutics will acquire enhanced authority to collaborate with NIH, AHRQ, and subject matter experts in order to assess pediatric device R&D needs.
Demonstration grants, with tracked results, will be established for non-profit consortia to promote pediatric device development, manufacture and distribution. The bill grants explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety. This approach incorporates several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.
Still plowing through the details – more to follow.
FDA package posted here:
http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf
Have a look and let the debate begin!
Some topline highlights:
Title I -- Prescription Drug User Fees
Title I establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs.
Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.
Title II -- Drug Safety
Subtitle A -- Risk Evaluation and Mitigation Strategies (REMS)
This subtitle establishes a system of routine active surveillance for post-market drug safety through a public-private partnership. The partnership will aggregate data from Federal and private health databases containing information for at least 100,000,000 covered lives and support the analysis of utilization and safety data from these databases. The establishment of this system will be supported with up to $30 million in appropriations.
Given the ability of this active surveillance system to identify and assess drug risks, most drugs and biologics will not need anything further than this system and the drug label to appropriately manage risk. However, some drugs and biologics will need additional tools to manage serious risks, and these products will be approved with risk evaluation and mitigation strategies (REMS). Sponsors would propose a REMS and FDA would approve it after structured negotiations, if necessary. The REMS will be reviewed at 18 months and three years, as well as in labeling supplements and when FDA requests a review.
Additional Elements —When more is needed, a REMS may include tools to assess, communicate about, or manage risks. The bill contains clear standards detailing the appropriate application of each tool. These standards ensure that new FDA authorities are applied narrowly, and only as necessary.
A REMS would be assessed in response to new information about a serious risk, and could be modified, including by reducing the stringency of elements, in response to new information.
Resources -- Increased drug user fees would be used to review REMS and for FDA’s general drug safety surveillance. This subtitle increases user fee revenue by $50 million over the agreement between industry and the FDA to fund drug safety activities.
Subtitle B -- Reagan-Udall Foundation for the Food and Drug Administration
Subtitle B establishes a foundation to lead collaborations amongst the FDA, academic research institutions, and industry directed to supporting the FDA’s mission. Collaborative research projects will be selected that are designed to bolster R & D productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make regulated product development and safety more predictable and manageable. The Foundation will be financially supported by industry and philanthropic donated funds.
Subtitle C -- Clinical Trials
To enhance patient enrollment and provide a mechanism to track subsequent progress of trials, the data bank at www.clinicaltrials.gov will be expanded to include all phase II and later trials, and to include devices. Currently, only clinical trials of drugs for serious and life threatening conditions are required to register in the data bank.
In addition, to ensure that results of trials are made public, and that patients and providers have the most up-to-date information, results information would be added to this database. Information would be added only after the product in question has been approved or cleared for marketing. Results information would first come from existing FDA and NIH documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured under those conditions.
Subtitle D -- Conflicts of Interest
Subtitle D requires disclosure of conflicts of interest of advisory committee members prior to an advisory committee meeting, and greater efforts by FDA to identify and recruit members of advisory committees.
Title III -- Medical Device User Fees
Title III is reflective of the agreement between FDA and industry regarding the total list of issues within their agreement from the time of the publication of the Federal Register notice. Given that some of the submitted language does not track the intent of the agreement, we expect to provide further improvements to the language at a later date. Those improvements will be agreed to by both FDA and industry.
Per the agreement between FDA and industry, it establishes an overall amount of $287 M of user fees over five years, with $48 M in 2008. This is coupled with a fixed 8.5% annual increase (with no other adjustors) and a further reduction of fees for small business.
Title III also includes the FDA-industry proposal on third party inspection improvements to ensure that the program works more efficiently and clarifying that entities can register and list electronically.
Title IV -- Pediatric Medical Products
Subtitle A -- Best Pharmaceuticals for Children
Subtitle A would reauthorize the Best Pharmaceuticals for Children Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations. BPCA generally provides six months of additional exclusivity to drug manufactures to encourage the determination of safety and efficacy of drugs in pediatric populations. The bill contains an incentive of three months of additional exclusivity if US sales of the active moiety by the innovator and its affiliates exceed $1 billion annually at the time written request for study is issued. The bill is a five-year authorization and will expire in 2012. No PDUFA funds can be used for BPCA studies. The Secretary may send declined requests for study to the NIH Foundation if funds are available.
Subtitle B -- Pediatric Research Improvement
Subtitle B would reauthorize the Pediatric Research Equity Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations.
In order to improve coordination with the pediatric exclusivity provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA would consolidate an internal FDA committee to review all issues of pediatric-related labeling and assessments. Doing so ensures that a drug that falls under PRIA or BPCA is reviewed not only by experts for that particular drug, but experts with pediatric expertise. PRIA will sunset in tandem with BPCA in 2012. If a company chooses not to pursue pediatric exclusivity for an already marketed drug under the Best Pharmaceuticals for Children Act, and no study is performed through NIH, then the Secretary has the authority to require the submission of pediatric data for such drug. PRIA streamlines this process and helps get essential pediatric data for important drugs, while preserving the ability of companies to meet and discuss testing with the agency.
The bill would require two reports – one from the Institute of Medicine and one from the GAO – that would allow us to have better data on the number and ways in which the pediatric rule is used, and evaluate its contributions to ensuring overall pediatric drug safety.
Subtitle C -- Pediatric Medical Devices
Subtitle C modifies the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need. Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. No profit will be allowed for a device used in more than 4,000 individuals. The HDE exemption expansion sunsets in 2013 and a GAO report assessing the HDE exemption expansion and its impact on patients and manufacturers is required.
The FDA’s Office of Pediatric Therapeutics will acquire enhanced authority to collaborate with NIH, AHRQ, and subject matter experts in order to assess pediatric device R&D needs.
Demonstration grants, with tracked results, will be established for non-profit consortia to promote pediatric device development, manufacture and distribution. The bill grants explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety. This approach incorporates several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.
Still plowing through the details – more to follow.
FDA package posted here:
http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf
Have a look and let the debate begin!
In an effort to entice me to join, AARP has sent me two emails a day offering me a free pedometer if I become a member. That is one email more a day than I get from the site offering me soft-tab Cialis. AARP has also sent me emails urging me to join in a national call in to support Medicare price controls but there was no toll free number. What if I was on a fixed income and had to choose between food and a phone call?
"AARP Says It Will Become Major Medicare Insurer While Remaining a Consumer Lobby"
That's the headline in today's New York Times story by Robert Pear. The pull quote is more interesting: "Potential for conflicts is seen as a lobbyist plans to expand its insurance role."
Conflicts? Non-issue says AARP. According to the Times story, "AARP officials insisted that its financial interests do not affect the positions it takes on Medicare, Medicaid, Social Security and dozens of other issues on which it lobbies and litigates."
Try this exercise -- take the above paragraph and replace "AARP" with "the insurance industry" and read it out loud.
So, let's pick two items: non-interference and drug importation. AARP supports the revokation of the non-interference clause and supports drug importation. Hmm. Major insurance provider supports price controls both legislated and imported. Conflict?
You be the judge.
On the up side, "the new plans will coordinate care for people with chronic conditions and will develop special programs to treat people with depression."
Big Pharma could learn a lot about spin control from spinmeitster/AARP CEO Bill Novelli.
That's the headline in today's New York Times story by Robert Pear. The pull quote is more interesting: "Potential for conflicts is seen as a lobbyist plans to expand its insurance role."
Conflicts? Non-issue says AARP. According to the Times story, "AARP officials insisted that its financial interests do not affect the positions it takes on Medicare, Medicaid, Social Security and dozens of other issues on which it lobbies and litigates."
Try this exercise -- take the above paragraph and replace "AARP" with "the insurance industry" and read it out loud.
So, let's pick two items: non-interference and drug importation. AARP supports the revokation of the non-interference clause and supports drug importation. Hmm. Major insurance provider supports price controls both legislated and imported. Conflict?
You be the judge.
On the up side, "the new plans will coordinate care for people with chronic conditions and will develop special programs to treat people with depression."
Big Pharma could learn a lot about spin control from spinmeitster/AARP CEO Bill Novelli.
The horrors of medical experimentations in the concentration camps triggered international rules designed to protect the dignity and lives of patients in scientific experiments.
The gruesome nature of the atrocities do not bear repeating. Let us honor the courage of those who survived. Let the memory who died in the Shoa be for a blessing and let us conduct our science and our lives to affirm the principle that each individual's existence has absolute value.
http://www.ushmm.org/research/doctors/twoa.htm
http://www.ushmm.org/research/doctors/Nuremberg_Code.htm
The gruesome nature of the atrocities do not bear repeating. Let us honor the courage of those who survived. Let the memory who died in the Shoa be for a blessing and let us conduct our science and our lives to affirm the principle that each individual's existence has absolute value.
http://www.ushmm.org/research/doctors/twoa.htm
http://www.ushmm.org/research/doctors/Nuremberg_Code.htm
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
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.
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
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.
