Latest Drugwonks' Blog
First, I am glad we finally got the posting problem fixed. I do appreciate the comments and criticisms (most of them.)
Second, with respect to Merrill's comments. CMPI is a separate 501 c 3 and we would be happy to send you our 990.
Third, I appreciate Dr. Posen's comments too. I think we are all on common ground...what comparative effectiveness should look like. I would be more than happy to debate/discuss with Merrill you or anyone and provide a forum to do so. Here's our view of comparative effectiveness:
Comparative effectiveness research as currently constructed consists of centralizing coverage decisions for entire groups of people using population-based studies. It looks a single treatment or device in isolation, rather than an integrated focus on personalized, predictive and prospective medicine. Comparative effectiveness only looks at the bottom line of insurers. Tailored treatments rely on combining information about individual differences in genetic and clinical responses to improve wellbeing and measuring outcomes and the value of care to patients, employers and families.
Further, the introduction of the use of “quality adjusted life year†as a bench mark for comparative effectiveness, coverage and reimbursement flows from a method and model of analysis that is similarly outdated and which fails to take into account the value that personalized and targeted therapies provide individuals and their families. In general, the default value of a QALY appears to be $50000 US dollars though that figure has little empirical evidence and was developed to assess the value of dialysis for end stage renal patients in 1979.
CMPI has set up a Patient Centric Health Leadership Forum.
In contrast to the reliance on meta-analyses and large trials that exclude patient variation, we hope to advance the use of individual patient level information from conventional clinical assessments, genomic and biomarker analyses, and, where appropriate, advanced imaging studies.
Such information will be used to increase the adoption of the use of real time updates and refinement of the risk prediction algorithms and health plan strategies that are supported by data-mining techniques, filtered through expert panels at the patient level.
Third, we want to work with policymakers, insurers and government to ensure that value of personalized evidenced, integrated care and targeted medicine is fully articulated at all policy considerations about comparative effectiveness.
Second, with respect to Merrill's comments. CMPI is a separate 501 c 3 and we would be happy to send you our 990.
Third, I appreciate Dr. Posen's comments too. I think we are all on common ground...what comparative effectiveness should look like. I would be more than happy to debate/discuss with Merrill you or anyone and provide a forum to do so. Here's our view of comparative effectiveness:
Comparative effectiveness research as currently constructed consists of centralizing coverage decisions for entire groups of people using population-based studies. It looks a single treatment or device in isolation, rather than an integrated focus on personalized, predictive and prospective medicine. Comparative effectiveness only looks at the bottom line of insurers. Tailored treatments rely on combining information about individual differences in genetic and clinical responses to improve wellbeing and measuring outcomes and the value of care to patients, employers and families.
Further, the introduction of the use of “quality adjusted life year†as a bench mark for comparative effectiveness, coverage and reimbursement flows from a method and model of analysis that is similarly outdated and which fails to take into account the value that personalized and targeted therapies provide individuals and their families. In general, the default value of a QALY appears to be $50000 US dollars though that figure has little empirical evidence and was developed to assess the value of dialysis for end stage renal patients in 1979.
CMPI has set up a Patient Centric Health Leadership Forum.
In contrast to the reliance on meta-analyses and large trials that exclude patient variation, we hope to advance the use of individual patient level information from conventional clinical assessments, genomic and biomarker analyses, and, where appropriate, advanced imaging studies.
Such information will be used to increase the adoption of the use of real time updates and refinement of the risk prediction algorithms and health plan strategies that are supported by data-mining techniques, filtered through expert panels at the patient level.
Third, we want to work with policymakers, insurers and government to ensure that value of personalized evidenced, integrated care and targeted medicine is fully articulated at all policy considerations about comparative effectiveness.
Let's be clear: Goozner works for Center for Science in the Public Interest. We run Center for Medicine in the Public Interest. Both groups deal with science and medical issues. Both are agenda driven research based organizations. We both get money from different sources that reflect two very different views about the relationship between science, innovation and the private sector.
CSPI gets $16 million a year from a variety of left wing groups and foundations and from a newsletter that over the years has told people that transfats were good (1980s) and that they were bad (2000s) and that wine, soda, popcorn, Chinese food, cookies, and anything other than raw carrots and celery can kill you. It has a vested interest in pumping out bad news and selling it. It has taken money from foundations to promote campaigns against Olestra, antibiotics in agriculture, wine consumption, gelatin, food additives because it causes ADHD, acrylamide (because it "causes" cancer) in bread and social drinking.
We get less then ten percent of that from individuals, foundations, biotech and pharma companies to discuss, promote and develop strategies and approaches to personalize the delivery of medicine. The blog and our oped writing is a small part of who we are and what we do. We blog and write on comparative effectiveness and its limits because no one else is and no one else seems to have the willingness to do so.
In this context simply calling me or Peter a "paid advocate" is tired and intellectually shallow. If we toed the party line and trashed "Big Pharma" no one would care where we got our money from, even if it came from Soros or Chavez or third generation tobacco scions.
This is the last time we will deal this issue because if our critics lack the self awareness and self-honesty to accept that no one group can claim to speak on behalf of the enlightened public interest because of where they get their support. Calling oneself a public interest group is, as Wildavsky noted, not just convenient, it is flattering. " Perhaps getting money from newletters and liberal foundations puts one on a higher moral plane and less conflicted We just think it makes others more...liberal.
CSPI gets $16 million a year from a variety of left wing groups and foundations and from a newsletter that over the years has told people that transfats were good (1980s) and that they were bad (2000s) and that wine, soda, popcorn, Chinese food, cookies, and anything other than raw carrots and celery can kill you. It has a vested interest in pumping out bad news and selling it. It has taken money from foundations to promote campaigns against Olestra, antibiotics in agriculture, wine consumption, gelatin, food additives because it causes ADHD, acrylamide (because it "causes" cancer) in bread and social drinking.
We get less then ten percent of that from individuals, foundations, biotech and pharma companies to discuss, promote and develop strategies and approaches to personalize the delivery of medicine. The blog and our oped writing is a small part of who we are and what we do. We blog and write on comparative effectiveness and its limits because no one else is and no one else seems to have the willingness to do so.
In this context simply calling me or Peter a "paid advocate" is tired and intellectually shallow. If we toed the party line and trashed "Big Pharma" no one would care where we got our money from, even if it came from Soros or Chavez or third generation tobacco scions.
This is the last time we will deal this issue because if our critics lack the self awareness and self-honesty to accept that no one group can claim to speak on behalf of the enlightened public interest because of where they get their support. Calling oneself a public interest group is, as Wildavsky noted, not just convenient, it is flattering. " Perhaps getting money from newletters and liberal foundations puts one on a higher moral plane and less conflicted We just think it makes others more...liberal.
Drugwonks has been attacked over it's views on comparative effectiveness. The attacks break down into two lines of "thinking".
1. We receive funding from drug companies.
2. We receive funding from drug companies.
Apparently if we supported comparative effectiveness as a wonderful tool for achieving optimal prescribing and reimbursement decisions our funding from drug companies would not be an issue. But because we criticize it and offer the collection of patient-centered data to support improved outcomes and productivity, our views are both wrong and tainted. I guess taking money from George Soros, trial attorneys and left wing foundations or just hating drug companies -- which some bloggers do -- in no way biases the views of others. So people who receive pharmaceutical firm support are tainted but everyone else is objective. Yeah, right.
Indeed, the biomarker and patient-centric approach we support is now being attacked as..no surprise... as another venue for industry to enrich itself. See our previous posts regarding the unwarranted attack on the Reagan Udall Institute.
Follow this logic. Big Pharma used the FDA to push through me-too drugs of limited efficacy so it could market blockbuster drugs to an unthinking public. Critics clamored that companies should invest in breakthroughs based on new genetic research that targeted important diseases and developed drugs that really advanced care.
So now companies are doing just that or trying. They are now being criticized for investing in efforts to develop targeted medicines using new science. Instead, critics want "hard" evidence that people are actually cured or better before a drug is approved though the predictive accuracy of genetic markers is precisely what is revolutionizing health care.
When someone keeps changing the standards and the goalposts it tells you that what they dislike is not the goal but the target of their criticism. Comparative effectiveness, as applied in every health system, is used to control costs and limit access to new medicines. Meanwhile studies show new medicines improve productivity and extend life.
Those who support comparative effectiveness have yet to show me one study they support they demonstrates the better value of new medicines. That's because for the most part they are design by government agencies and others with a bias towards cost containment and against medical innovation. That goes for the ALLHAT and CATIE studies.
And as for the ALLHAT study, Health Care Renewal does not want to accept the fact that the ALLHAT design was bizarre and structured to produce excess mortality in blacks. Don't believe me, believe Michael Weber who was one of the investigators....
"The reality of ALLHAT – it was poorly designed, the interpretations were disingenuous, it violated appropriate scientific reporting, and most frightening, it did something that was so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges: They exposed African-American patients for several years to treatments they knew would not be effective in controlling their blood pressure.
And one thing that did show up in favor of diuretics, the fact that they cause fewer strokes than one of the other drug classes, was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. And they used that as their reason to claim superiority of the diuretic."
I want to know if Health Care Renewal would treat his African American patients with high blood pressure and congestive heart failure without using BiDil and according to the ALLHAT guidelines?
http://hcrenewal.blogspot.com/
Some proponents of comparative effectiveness might because they are ideologues. And that's the difference. For a lot of people and policymakers comparative effectiveness analysis -- from the design of studies right down to the reimbursement -- it's political and a way to wound drug companies.
Finally, I apologize to all who have tried to post comments and have not been able to. It was not intentional. We are making a technical fix to clear this problem up.
1. We receive funding from drug companies.
2. We receive funding from drug companies.
Apparently if we supported comparative effectiveness as a wonderful tool for achieving optimal prescribing and reimbursement decisions our funding from drug companies would not be an issue. But because we criticize it and offer the collection of patient-centered data to support improved outcomes and productivity, our views are both wrong and tainted. I guess taking money from George Soros, trial attorneys and left wing foundations or just hating drug companies -- which some bloggers do -- in no way biases the views of others. So people who receive pharmaceutical firm support are tainted but everyone else is objective. Yeah, right.
Indeed, the biomarker and patient-centric approach we support is now being attacked as..no surprise... as another venue for industry to enrich itself. See our previous posts regarding the unwarranted attack on the Reagan Udall Institute.
Follow this logic. Big Pharma used the FDA to push through me-too drugs of limited efficacy so it could market blockbuster drugs to an unthinking public. Critics clamored that companies should invest in breakthroughs based on new genetic research that targeted important diseases and developed drugs that really advanced care.
So now companies are doing just that or trying. They are now being criticized for investing in efforts to develop targeted medicines using new science. Instead, critics want "hard" evidence that people are actually cured or better before a drug is approved though the predictive accuracy of genetic markers is precisely what is revolutionizing health care.
When someone keeps changing the standards and the goalposts it tells you that what they dislike is not the goal but the target of their criticism. Comparative effectiveness, as applied in every health system, is used to control costs and limit access to new medicines. Meanwhile studies show new medicines improve productivity and extend life.
Those who support comparative effectiveness have yet to show me one study they support they demonstrates the better value of new medicines. That's because for the most part they are design by government agencies and others with a bias towards cost containment and against medical innovation. That goes for the ALLHAT and CATIE studies.
And as for the ALLHAT study, Health Care Renewal does not want to accept the fact that the ALLHAT design was bizarre and structured to produce excess mortality in blacks. Don't believe me, believe Michael Weber who was one of the investigators....
"The reality of ALLHAT – it was poorly designed, the interpretations were disingenuous, it violated appropriate scientific reporting, and most frightening, it did something that was so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges: They exposed African-American patients for several years to treatments they knew would not be effective in controlling their blood pressure.
And one thing that did show up in favor of diuretics, the fact that they cause fewer strokes than one of the other drug classes, was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. And they used that as their reason to claim superiority of the diuretic."
I want to know if Health Care Renewal would treat his African American patients with high blood pressure and congestive heart failure without using BiDil and according to the ALLHAT guidelines?
http://hcrenewal.blogspot.com/
Some proponents of comparative effectiveness might because they are ideologues. And that's the difference. For a lot of people and policymakers comparative effectiveness analysis -- from the design of studies right down to the reimbursement -- it's political and a way to wound drug companies.
Finally, I apologize to all who have tried to post comments and have not been able to. It was not intentional. We are making a technical fix to clear this problem up.
Instead of banning medicines, how about banning people from using drugs until they can follow directions. These are actual cases of how people used OTC and Rx drugs from the Oklahoma Poison Control Center.
Dosing cup errors accounted for 3.8% of all therapeutic errors, but was the fifth leading cause for errors in the less than 5 year-old patient group. The most common reasons for therapeutic errors in all age groups involved taking or giving the wrong formulation or concentration, inadvertently taking/giving medication twice and another incorrect dose. Typical examples of some of these errors are as follows.
Incorrect Formulation or Concentration:
1. A mother mistakenly gave 2.5 ml of lindane 1% shampoo to 6 month-old, 20 pound child instead of promethazine DM cough syrup due to similarity in the appearance of the bottle.
2. A mother gave 2 ml of a sibling’s baclofen suspension instead of acetaminophen syrup to her 8-month-old son.
3. A grandparent gave 5 ml of Benadryl ® Maximum Strength Itch Stopping Gel 2% to a 10 year-old child after being instructed by parents to give the girl her dose of “Benadyl ® syrupâ€. Final dose of diphenhydramine equaled 100 mg instead of 12.5 mg.
4. Four capsules of Hartz Mountain ® Dog Wormer containing piperazine adipate were taken by a 42 year-old woman instead of 4 diphenhydramine 25 mg capsules for sleep. She also gave 4 capsules to her 15 year-old son as well.
Other Incorrect dose:
1. Parents misunderstood prescription directions and double dosed 10 year-old daughter’s dextroamphetamine sulfate® 10 mg for two weeks.
2. Parents gave 2 year-old daughter doses of Tylenol® Syrup for Children and Dimetapp® Nighttime Flu for 3 days before checking the labels and finding acetaminophen in both products.
3. Alendronate sulfate 70 mg was taken daily for 3 days instead of once weekly for 3 weeks by 86 year-old cardiac patient.
4. Six tablets of Triphasil® birth control pills were taken at one time because 34 year-old woman has missed 6 of her doses.
Maybe we should cough medicines for children under the age of 34.
Dosing cup errors accounted for 3.8% of all therapeutic errors, but was the fifth leading cause for errors in the less than 5 year-old patient group. The most common reasons for therapeutic errors in all age groups involved taking or giving the wrong formulation or concentration, inadvertently taking/giving medication twice and another incorrect dose. Typical examples of some of these errors are as follows.
Incorrect Formulation or Concentration:
1. A mother mistakenly gave 2.5 ml of lindane 1% shampoo to 6 month-old, 20 pound child instead of promethazine DM cough syrup due to similarity in the appearance of the bottle.
2. A mother gave 2 ml of a sibling’s baclofen suspension instead of acetaminophen syrup to her 8-month-old son.
3. A grandparent gave 5 ml of Benadryl ® Maximum Strength Itch Stopping Gel 2% to a 10 year-old child after being instructed by parents to give the girl her dose of “Benadyl ® syrupâ€. Final dose of diphenhydramine equaled 100 mg instead of 12.5 mg.
4. Four capsules of Hartz Mountain ® Dog Wormer containing piperazine adipate were taken by a 42 year-old woman instead of 4 diphenhydramine 25 mg capsules for sleep. She also gave 4 capsules to her 15 year-old son as well.
Other Incorrect dose:
1. Parents misunderstood prescription directions and double dosed 10 year-old daughter’s dextroamphetamine sulfate® 10 mg for two weeks.
2. Parents gave 2 year-old daughter doses of Tylenol® Syrup for Children and Dimetapp® Nighttime Flu for 3 days before checking the labels and finding acetaminophen in both products.
3. Alendronate sulfate 70 mg was taken daily for 3 days instead of once weekly for 3 weeks by 86 year-old cardiac patient.
4. Six tablets of Triphasil® birth control pills were taken at one time because 34 year-old woman has missed 6 of her doses.
Maybe we should cough medicines for children under the age of 34.
Excellent/frightening article from today's Newark Star-Ledger. (And not frightening because of safety concerns -- frightening because of creeping Precautionary Principle-ism.
Doctors target remedies for kids, Urge wider restrictions for cough and cold drugs
BY ROBERT COHEN
STAR-LEDGER WASHINGTON BUREAU
SILVER SPRING, Md. -- A group of leading pediatricians said yesterday the drug industry's recent decision to stop selling over-the-counter cough and cold remedies to children under 2 is inadequate and should be extended to age 6.
"The Food and Drug Administration did not approve these products on the basis of evidence of safety and effectiveness, but FDA has permitted widespread marketing that is not supported by scientific evidence," Maryland Commissioner of Health Joshua Sharfstein told an FDA advisory panel that is holding two days of hearings on the issue.
Sharfstein, a pediatrician by training, said the drug industry spent more than $51 million advertising pediatric cough and cold medications from July 1, 2006, to June 30, promoting them in a "misleading" way as pediatrician-recommended and safe for young children.
He said the over-the-counter medicines are no more effective than placebos, have resulted in serious side effects, including death, because of misuse and should be barred in the "vulnerable" population of children under 6 -- points strongly disputed by the drug industry.
"When a treatment is ineffective, its risks, if not zero, will always exceed its benefits," added Michael Shannon, a professor of pediatrics at Harvard Medical School.
The comments were made to back up a petition by the pediatricians asking the FDA to restrict use of the medicines for children. They said they chose age 6 because of safety concerns, but do not believe they are effective for older children, either.
The FDA advisory panel will vote on recommendations today that could include restrictions on marketing of cough and cold medicines for children under 12, adding warnings to labels and allowing only single-ingredient products. The FDA usually follows the recommendations of its panels, although it is not required to do so.
The panel is meeting a week after Johnson & Johnson, Wyeth, Novartis and Prestige Brands voluntarily recalled 14 nonprescription "infant" cough and cold medicines targeted for children under 2 years of age.
At yesterday's hearing, industry representatives continued to insist the drugs can be used safely and effectively at recommended doses for children 2 and over.
"Reported serious adverse events are very rare when cough and cold medicines are administered at therapeutic doses," said Edwin Kuffner of McNeil Consumer Healthcare, a unit of Johnson & Johnson.
Kuffner said side effects tend to result from overdose or accidental ingestion and represent a very small percentage of the tens of millions of children who effectively use the medicines every year.
The Centers for Disease Control and Prevention reported earlier this year at least 1,500 children younger than 2 suffered complications from cough and cold remedies in 2004 and 2005.
A recent FDA staff review described dozens of cases of convulsions, heart problems, troubled breathing, neurological complications and other reactions, including at least 54 deaths involving decongestants and 69 deaths involving antihistamines from 1969 to 2006.
FDA officials said they believe adverse events from the medicines are greatly underreported.
Richard Dart of the University of Colorado School of Medicine, speaking for the industry, said while more research is needed, there are "some pediatric studies that have shown effectiveness in children even as young as 6 months old ... and we know from adult studies that their medicines work."
Asked later by FDA advisor Leon Dure of the University of Alabama School of Medicine if there is "objective data about the benefits of these drugs," Phil Walson, an industry expert from the University of Cincinnati, said, "Not that I am aware of."
FDA Medical Officer Lolita Lopez also told the panel "published clinical studies in children did not establish efficacy of cough and cold medicines."
Linda Suydam, president of the Consumer Healthcare Products Association, the industry trade group, said the industry wants to strengthen labels to stress "do not use" for children under 2 and "do not use to sedate children." She also said companies will undertake an education campaign to ensure proper use of the drugs.
George Goldstein, an industry consultant on the advisory panel, asked that if the medicines are not effective or safe, "how is the purchase of millions -- hundreds of millions -- of doses by parents explained?"
Dan Levy, president of the Maryland chapter of the American Academy of Pediatrics, said parents buy the medicines for emotional reasons, such as fear and caring. He said he recommends to parents they would get better results by "throwing it down the toilet rather than administering by mouth."
Doctors target remedies for kids, Urge wider restrictions for cough and cold drugs
BY ROBERT COHEN
STAR-LEDGER WASHINGTON BUREAU
SILVER SPRING, Md. -- A group of leading pediatricians said yesterday the drug industry's recent decision to stop selling over-the-counter cough and cold remedies to children under 2 is inadequate and should be extended to age 6.
"The Food and Drug Administration did not approve these products on the basis of evidence of safety and effectiveness, but FDA has permitted widespread marketing that is not supported by scientific evidence," Maryland Commissioner of Health Joshua Sharfstein told an FDA advisory panel that is holding two days of hearings on the issue.
Sharfstein, a pediatrician by training, said the drug industry spent more than $51 million advertising pediatric cough and cold medications from July 1, 2006, to June 30, promoting them in a "misleading" way as pediatrician-recommended and safe for young children.
He said the over-the-counter medicines are no more effective than placebos, have resulted in serious side effects, including death, because of misuse and should be barred in the "vulnerable" population of children under 6 -- points strongly disputed by the drug industry.
"When a treatment is ineffective, its risks, if not zero, will always exceed its benefits," added Michael Shannon, a professor of pediatrics at Harvard Medical School.
The comments were made to back up a petition by the pediatricians asking the FDA to restrict use of the medicines for children. They said they chose age 6 because of safety concerns, but do not believe they are effective for older children, either.
The FDA advisory panel will vote on recommendations today that could include restrictions on marketing of cough and cold medicines for children under 12, adding warnings to labels and allowing only single-ingredient products. The FDA usually follows the recommendations of its panels, although it is not required to do so.
The panel is meeting a week after Johnson & Johnson, Wyeth, Novartis and Prestige Brands voluntarily recalled 14 nonprescription "infant" cough and cold medicines targeted for children under 2 years of age.
At yesterday's hearing, industry representatives continued to insist the drugs can be used safely and effectively at recommended doses for children 2 and over.
"Reported serious adverse events are very rare when cough and cold medicines are administered at therapeutic doses," said Edwin Kuffner of McNeil Consumer Healthcare, a unit of Johnson & Johnson.
Kuffner said side effects tend to result from overdose or accidental ingestion and represent a very small percentage of the tens of millions of children who effectively use the medicines every year.
The Centers for Disease Control and Prevention reported earlier this year at least 1,500 children younger than 2 suffered complications from cough and cold remedies in 2004 and 2005.
A recent FDA staff review described dozens of cases of convulsions, heart problems, troubled breathing, neurological complications and other reactions, including at least 54 deaths involving decongestants and 69 deaths involving antihistamines from 1969 to 2006.
FDA officials said they believe adverse events from the medicines are greatly underreported.
Richard Dart of the University of Colorado School of Medicine, speaking for the industry, said while more research is needed, there are "some pediatric studies that have shown effectiveness in children even as young as 6 months old ... and we know from adult studies that their medicines work."
Asked later by FDA advisor Leon Dure of the University of Alabama School of Medicine if there is "objective data about the benefits of these drugs," Phil Walson, an industry expert from the University of Cincinnati, said, "Not that I am aware of."
FDA Medical Officer Lolita Lopez also told the panel "published clinical studies in children did not establish efficacy of cough and cold medicines."
Linda Suydam, president of the Consumer Healthcare Products Association, the industry trade group, said the industry wants to strengthen labels to stress "do not use" for children under 2 and "do not use to sedate children." She also said companies will undertake an education campaign to ensure proper use of the drugs.
George Goldstein, an industry consultant on the advisory panel, asked that if the medicines are not effective or safe, "how is the purchase of millions -- hundreds of millions -- of doses by parents explained?"
Dan Levy, president of the Maryland chapter of the American Academy of Pediatrics, said parents buy the medicines for emotional reasons, such as fear and caring. He said he recommends to parents they would get better results by "throwing it down the toilet rather than administering by mouth."
The VA yanks Avandia from the formulary...which means more people will just tough it out on one less diabetes drug.
If this is evidence-based medicine give me science fiction. Where's Dr. McCoy when you need him?
Here's a question from Stephanie Saul's piece on the VA's Avandia hook...
Dr. Jon LeCroy, a senior pharmaceuticals analyst for the investment and research firm Natixis Bleichroeder, said that before Dr. Nissen’s article last May, about one million prescriptions were being written each month for Avandia.
As of September, Avandia prescriptions had declined about 60 percent, to 426,000 a month, according to Dr. LeCroy.
But he said there had not been a corresponding increase in the use of other drugs for diabetes, indicating that some patients who had stopped taking Avandia had not replaced it in their drug regimens. Diabetes patients often take more than one medication at a time for their conditions.
Actos, a drug similar to Avandia that some studies indicate does not carry the same heart risk, has picked up 100,000 prescriptions a month, but that does not account for the drop of almost 600,000 in Avandia prescriptions.
Ms. Rhyne, of Glaxo, said a survey had shown that 50 percent of patients who discontinued Avandia did not begin another therapy as a substitute. She questioned whether those patients were placing themselves at risk for uncontrolled diabetes.
Here's Nissen's number at the Cleveland Clinic. (216) 445-6852. Someone should call and ask him. He's giddy over his "success."
http://www.nytimes.com/2007/10/18/business/18drug.html?_r=2&ref=health&oref=slogin&oref=login
If this is evidence-based medicine give me science fiction. Where's Dr. McCoy when you need him?
Here's a question from Stephanie Saul's piece on the VA's Avandia hook...
Dr. Jon LeCroy, a senior pharmaceuticals analyst for the investment and research firm Natixis Bleichroeder, said that before Dr. Nissen’s article last May, about one million prescriptions were being written each month for Avandia.
As of September, Avandia prescriptions had declined about 60 percent, to 426,000 a month, according to Dr. LeCroy.
But he said there had not been a corresponding increase in the use of other drugs for diabetes, indicating that some patients who had stopped taking Avandia had not replaced it in their drug regimens. Diabetes patients often take more than one medication at a time for their conditions.
Actos, a drug similar to Avandia that some studies indicate does not carry the same heart risk, has picked up 100,000 prescriptions a month, but that does not account for the drop of almost 600,000 in Avandia prescriptions.
Ms. Rhyne, of Glaxo, said a survey had shown that 50 percent of patients who discontinued Avandia did not begin another therapy as a substitute. She questioned whether those patients were placing themselves at risk for uncontrolled diabetes.
Here's Nissen's number at the Cleveland Clinic. (216) 445-6852. Someone should call and ask him. He's giddy over his "success."
http://www.nytimes.com/2007/10/18/business/18drug.html?_r=2&ref=health&oref=slogin&oref=login
According to an article in today’s edition of the New York Times …
“The F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agency’s stringent approval process, many of them made by small companies … and those companies are crying foul." According to one such manufacturer, “It has no regard for the cost or damage they do to small businesses. There are estimates that only a few of us will make it.â€
The FDA’s response? “This is a public health initiative,†said Deborah A. Autor, director of the Office of Compliance at the F.D.A.’s Center of Drug Evaluation and Research. “Some of these drugs may not be safe. In all likelihood, these companies knew from Day 1 that they were producing illegal drugs.â€
A trade group representing about 50 small to medium-size companies has submitted a bill to Congress that would create a cheaper and simpler process for gaining F.D.A. approval. Mr. Blansett claimed the cost could run up to $5 million for a new drug application.
Here’s a link to the complete article:
http://www.nytimes.com/2007/10/18/business/18hunt.html
My contribution to this reportage, two quotes:
“Many of these drugs were grandfathered in when the current approval process was instituted,†he said. “However, that doesn’t give these companies carte blanche — they still have to play by the rules.â€
And
“The earlier you can get all parties to the table, including manufacturers, the better.â€
Important issue.
“The F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agency’s stringent approval process, many of them made by small companies … and those companies are crying foul." According to one such manufacturer, “It has no regard for the cost or damage they do to small businesses. There are estimates that only a few of us will make it.â€
The FDA’s response? “This is a public health initiative,†said Deborah A. Autor, director of the Office of Compliance at the F.D.A.’s Center of Drug Evaluation and Research. “Some of these drugs may not be safe. In all likelihood, these companies knew from Day 1 that they were producing illegal drugs.â€
A trade group representing about 50 small to medium-size companies has submitted a bill to Congress that would create a cheaper and simpler process for gaining F.D.A. approval. Mr. Blansett claimed the cost could run up to $5 million for a new drug application.
Here’s a link to the complete article:
http://www.nytimes.com/2007/10/18/business/18hunt.html
My contribution to this reportage, two quotes:
“Many of these drugs were grandfathered in when the current approval process was instituted,†he said. “However, that doesn’t give these companies carte blanche — they still have to play by the rules.â€
And
“The earlier you can get all parties to the table, including manufacturers, the better.â€
Important issue.
From today's edition of the New York Times ...
A Test of Bad Health
By PETER PITTS
IF Congress overrides President Bush’s veto of the State Children’s Health Insurance Program, a little-known provision of the original House bill could be revived.
As written, the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.
This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.
Why? Drugs must be tested on large, representative populations that must be monitored for years. Because conducting these studies is so tricky, their findings are regularly overturned or modified by further research. In fact, some are so off the mark that doctors ignore them.
But if Medicare starts using flawed studies like these to determine its list of covered drugs, doctors will have to give them respect they probably don’t deserve. There’s also an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as “wasteful,†the more money it saves.
Look what happened in Britain. In 2001, contrary to expert findings by licensing authorities around the world, the British comparative-effectiveness agency cited “insufficient evidence†for recommending the use of Gleevec in both early- and late-phase chronic leukemia patients.
In 2002, the United States approved Gleevec for another purpose: to treat a rare stomach cancer. It wasn’t until 21 months later that Britain approved the use of Gleevec for victims of the disease.
What aside from cost concerns could explain such restrictions? And what could stop something like this from happening here? The center’s supporters say it will be financed through an independent “trust fund.†But this won’t solve the problem. The center would still be part of the government — and still get in the way of medical innovation.
A Test of Bad Health
By PETER PITTS
IF Congress overrides President Bush’s veto of the State Children’s Health Insurance Program, a little-known provision of the original House bill could be revived.
As written, the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.
This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.
Why? Drugs must be tested on large, representative populations that must be monitored for years. Because conducting these studies is so tricky, their findings are regularly overturned or modified by further research. In fact, some are so off the mark that doctors ignore them.
But if Medicare starts using flawed studies like these to determine its list of covered drugs, doctors will have to give them respect they probably don’t deserve. There’s also an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as “wasteful,†the more money it saves.
Look what happened in Britain. In 2001, contrary to expert findings by licensing authorities around the world, the British comparative-effectiveness agency cited “insufficient evidence†for recommending the use of Gleevec in both early- and late-phase chronic leukemia patients.
In 2002, the United States approved Gleevec for another purpose: to treat a rare stomach cancer. It wasn’t until 21 months later that Britain approved the use of Gleevec for victims of the disease.
What aside from cost concerns could explain such restrictions? And what could stop something like this from happening here? The center’s supporters say it will be financed through an independent “trust fund.†But this won’t solve the problem. The center would still be part of the government — and still get in the way of medical innovation.
Merrill Goozner is a nice guy. We rarely agree -- but he's a nice guy.
Now he shows his colours as a NICE guy with a statement like, ""Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
At least he's honest about where his path leads -- not to "universal" health care but rather to "government" care.
Bad idea.
Now he shows his colours as a NICE guy with a statement like, ""Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
At least he's honest about where his path leads -- not to "universal" health care but rather to "government" care.
Bad idea.
Here's Merrill Goozner of the Center for Science in The Tort Lawyer's Interest giving full voice to a totalitarian view of regulation:
"Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
Regular doctors -- those who are not scientists at our nation's health agencies are, by definition, too stupid, corrupt, tainted by Big Pharma to be trusted and consumers, well, why have consumer groups if you could trusts you and me to act on our own behalf. Thank goodness we have people like Merrill Goozner to lead the way.
Mind you,these are the same consumer groups that were screeching during the run up to PDUFA renewal that the FDA is a tool of Big Pharma and can't be trusted to protect the public.
I guess if you say you are a consumer group you can be as hypocritical all you want.
Here's the the post:
Dr. Congress Makes a House Call
GoozNews: October 17, 2007
As I mentioned yesterday, the Food and Drug Administration wrote a strong letter to Capitol Hill last week backing the Center for Medicare and Medicaid Services' restrictions on the use of erythropoietin-stimulating drugs like Aranesp and Procrit during cancer chemotherapy. The FDA black box warning, the letter pointed out, called on oncologists to use the lowest possible dose for avoiding blood transfusions since higher doses of the drugs to boost energy -- which, of course, results in higher sales for their makers, Amgen and J&J -- leads to more deaths and faster tumor growth in cancer patients.
Despite this evidence, Congress is considering a resolution to overturn the CMS payment decision, which went into effect late last month. It has at least 26 co-sponsors already and the drug companies' lobbyists are out in force trying to get it passed. So is the American Society of Clinical Oncologists, whose members profit from greater sales of the drugs.
Yesterday, a coalition of consumer groups including the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union,
National Research Center for Women & Families, National Women’s Health Network, the TMJ Association and U.S. PIRG wrote every member of Congress asking them to vote no on H.J. Res. 54, which would overturn the CMS decision. I thought it worth reprinting here because of the principles at stake, which are outlined in the letter:
October 16, 2007
Dear Member:
We urge Congress not to interfere in the efforts of the Centers for Medicare & Medicaid Services and the Food and Drug Administration to use the best available science to determine the proper dosing of erythropoietin stimulating agents (ESAs). The safe and proper dosage of this drug in very vulnerable cancer patients is an extremely technical issue. Congress should leave these life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies.
H.J. Res. 54 or similar proposals in the Senate are a direct violation of this principle. The FDA has issued a “black box†label warning against excessive use of ESAs. There is significant evidence that the overuse of ESAs can actually speed tumor growth and early death in cancer patients. After more than a year of study, CMS issued a national coverage decision (NCD) in July that took this latest evidence into account. Congress should not substitute its own judgment for that of CMS and the FDA on these issues.
While it is true that the American Society of Clinical Oncologists, which represents the nation’s cancer physicians, protested the CMS decision, we cannot help but note that companies and physicians make enormous windfall profits from the sale and use of ESAs. Now they are trying to convince Congress that Medicare is denying a needed medical service.
This is not the proper venue for their objections. In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention.
We also must note that some provider groups opposed previous reductions in the windfall profits that came from the reimbursement system of various cancer drugs. They said it would radically reduce treatment options and hurt patients. Those statements have been proven untrue. Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.
Congress should set broad policy objectives and standards for Medicare, but Congressional interference regarding coverage policies for specific medical products would set a terrible precedent. It would encourage companies making medical products as well as medical specialty organizations to constantly ask Members of Congress to override scientific evidence and spend taxpayer dollars needlessly on products whose sale would benefit those companies or specialties more than they benefit patients. In some cases, such overrides could promote the use of medical products in ways that are potentially dangerous to patients because they are unsafe or ineffective.
Health care costs are the leading domestic consumer issue. Congressional interference on individual reimbursement decisions at CMS will just feed those health inflation fires while possibly causing harm to patients.
Please reject H.J. Res. 54.
Sincerely,
http://www.gooznews.com
"Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
Regular doctors -- those who are not scientists at our nation's health agencies are, by definition, too stupid, corrupt, tainted by Big Pharma to be trusted and consumers, well, why have consumer groups if you could trusts you and me to act on our own behalf. Thank goodness we have people like Merrill Goozner to lead the way.
Mind you,these are the same consumer groups that were screeching during the run up to PDUFA renewal that the FDA is a tool of Big Pharma and can't be trusted to protect the public.
I guess if you say you are a consumer group you can be as hypocritical all you want.
Here's the the post:
Dr. Congress Makes a House Call
GoozNews: October 17, 2007
As I mentioned yesterday, the Food and Drug Administration wrote a strong letter to Capitol Hill last week backing the Center for Medicare and Medicaid Services' restrictions on the use of erythropoietin-stimulating drugs like Aranesp and Procrit during cancer chemotherapy. The FDA black box warning, the letter pointed out, called on oncologists to use the lowest possible dose for avoiding blood transfusions since higher doses of the drugs to boost energy -- which, of course, results in higher sales for their makers, Amgen and J&J -- leads to more deaths and faster tumor growth in cancer patients.
Despite this evidence, Congress is considering a resolution to overturn the CMS payment decision, which went into effect late last month. It has at least 26 co-sponsors already and the drug companies' lobbyists are out in force trying to get it passed. So is the American Society of Clinical Oncologists, whose members profit from greater sales of the drugs.
Yesterday, a coalition of consumer groups including the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union,
National Research Center for Women & Families, National Women’s Health Network, the TMJ Association and U.S. PIRG wrote every member of Congress asking them to vote no on H.J. Res. 54, which would overturn the CMS decision. I thought it worth reprinting here because of the principles at stake, which are outlined in the letter:
October 16, 2007
Dear Member:
We urge Congress not to interfere in the efforts of the Centers for Medicare & Medicaid Services and the Food and Drug Administration to use the best available science to determine the proper dosing of erythropoietin stimulating agents (ESAs). The safe and proper dosage of this drug in very vulnerable cancer patients is an extremely technical issue. Congress should leave these life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies.
H.J. Res. 54 or similar proposals in the Senate are a direct violation of this principle. The FDA has issued a “black box†label warning against excessive use of ESAs. There is significant evidence that the overuse of ESAs can actually speed tumor growth and early death in cancer patients. After more than a year of study, CMS issued a national coverage decision (NCD) in July that took this latest evidence into account. Congress should not substitute its own judgment for that of CMS and the FDA on these issues.
While it is true that the American Society of Clinical Oncologists, which represents the nation’s cancer physicians, protested the CMS decision, we cannot help but note that companies and physicians make enormous windfall profits from the sale and use of ESAs. Now they are trying to convince Congress that Medicare is denying a needed medical service.
This is not the proper venue for their objections. In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention.
We also must note that some provider groups opposed previous reductions in the windfall profits that came from the reimbursement system of various cancer drugs. They said it would radically reduce treatment options and hurt patients. Those statements have been proven untrue. Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.
Congress should set broad policy objectives and standards for Medicare, but Congressional interference regarding coverage policies for specific medical products would set a terrible precedent. It would encourage companies making medical products as well as medical specialty organizations to constantly ask Members of Congress to override scientific evidence and spend taxpayer dollars needlessly on products whose sale would benefit those companies or specialties more than they benefit patients. In some cases, such overrides could promote the use of medical products in ways that are potentially dangerous to patients because they are unsafe or ineffective.
Health care costs are the leading domestic consumer issue. Congressional interference on individual reimbursement decisions at CMS will just feed those health inflation fires while possibly causing harm to patients.
Please reject H.J. Res. 54.
Sincerely,
http://www.gooznews.com
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.
