Latest Drugwonks' Blog
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
A more complete response to the politically motivated, mean spirited, and just plain wrong comments by the so-called Union of Concerned Scientists ...
http://www.tjols.com/article-350.html
Here are some snippets:
* Twenty-five years ago, the success rate for a new drug used was about 14 percent. Today, a new medicinal compound entering early-stage testing – often after more than a decade of pre-clinical screening and evaluation – is estimated to have only an 8 percent chance of reaching the market. For very innovative and unproven technologies, the probability of an individual product's success is even lower.
* Better, more current and predictable scientific research and standards must be developed and devoted to streamlining the critical path. Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle and to lower the cost of research by helping industry identify product failures earlier in the clinical trials process.
* New development tools in these areas will enable better through-put to commercial product development and will act as a productivity multiplier, increasing the returns on public and private investment in basic research. With improved scientific methods and a new, shared effort by all of us, we can develop and improve standards for product characterization and product safety testing, for both traditional and innovative products.
* Today only about 1 percent of the proteins in blood have been identified. Of that 1 percent only a fifth has FDA approved diagnostic utility. These proteins, after we understand them, could help predict disease remission. Currently academics and private companies collect data and establish correlations, but no one is responsible for organizing this information into the broader knowledge that could lead to generalized principles industry and FDA could use for broader, faster, and more accurate product evaluation.
* Think about the millions of dollars that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process. Using the lower end of the Tufts drug development number, a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs. Similarly, shifting 5 percent of clinical failures from late-stage to early-stage trials reduces out of pocket costs by $15-$20 million.
Next up on the Critical Path hit parade -- who will be named to the Reagan/Udall board of directors. Watch this space for more details.
http://www.tjols.com/article-350.html
Here are some snippets:
* Twenty-five years ago, the success rate for a new drug used was about 14 percent. Today, a new medicinal compound entering early-stage testing – often after more than a decade of pre-clinical screening and evaluation – is estimated to have only an 8 percent chance of reaching the market. For very innovative and unproven technologies, the probability of an individual product's success is even lower.
* Better, more current and predictable scientific research and standards must be developed and devoted to streamlining the critical path. Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle and to lower the cost of research by helping industry identify product failures earlier in the clinical trials process.
* New development tools in these areas will enable better through-put to commercial product development and will act as a productivity multiplier, increasing the returns on public and private investment in basic research. With improved scientific methods and a new, shared effort by all of us, we can develop and improve standards for product characterization and product safety testing, for both traditional and innovative products.
* Today only about 1 percent of the proteins in blood have been identified. Of that 1 percent only a fifth has FDA approved diagnostic utility. These proteins, after we understand them, could help predict disease remission. Currently academics and private companies collect data and establish correlations, but no one is responsible for organizing this information into the broader knowledge that could lead to generalized principles industry and FDA could use for broader, faster, and more accurate product evaluation.
* Think about the millions of dollars that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process. Using the lower end of the Tufts drug development number, a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs. Similarly, shifting 5 percent of clinical failures from late-stage to early-stage trials reduces out of pocket costs by $15-$20 million.
Next up on the Critical Path hit parade -- who will be named to the Reagan/Udall board of directors. Watch this space for more details.
A letter from the FDA to Peter Stark and Henry Waxman lies about the benefits of EPO.
It claims that there no quality of life benefits associated with use of EPO among cancer patients undergoing chemotherapy.
That is a lie. Andy von Eschenbach should -- if he is around -- as a cancer patient and oncologist have the guts to squash Richard Padzur's assault on EPO and stand up for the truth.
The FDA has even allowed Amgen to make QOL claims on the label. The current label for EPO allows for QOL benefits. And just because the FDA does not allow them because of Padzur's pique does not make it so. There will likely be revisions but not a total rejection.
So the claim there is no QOL benefit approved by the FDA is also a lie. The fact that the FDA sees no benefit in terms of survival at a biological level does not mean such a correlation fails to exist overall. Cancer death rates are down. They are down because of earlier screening and better drugs. Better drugs can only be used because of a reduction in RBC and a corresponding optimization of hemoglobin levels. Take away ESAs and guess what happens?
Why would the FDA capitulate to Stark and Waxman?
Where is the leadership? Politics as usual should not apply when lives are on the line. Stark, Waxman and Padzur are distorting science and -- working together -- seeking to gain control over regulatory processes for political purposes. Where is the courage to put a stop to it.
Andy, your phone is ringing.
It claims that there no quality of life benefits associated with use of EPO among cancer patients undergoing chemotherapy.
That is a lie. Andy von Eschenbach should -- if he is around -- as a cancer patient and oncologist have the guts to squash Richard Padzur's assault on EPO and stand up for the truth.
The FDA has even allowed Amgen to make QOL claims on the label. The current label for EPO allows for QOL benefits. And just because the FDA does not allow them because of Padzur's pique does not make it so. There will likely be revisions but not a total rejection.
So the claim there is no QOL benefit approved by the FDA is also a lie. The fact that the FDA sees no benefit in terms of survival at a biological level does not mean such a correlation fails to exist overall. Cancer death rates are down. They are down because of earlier screening and better drugs. Better drugs can only be used because of a reduction in RBC and a corresponding optimization of hemoglobin levels. Take away ESAs and guess what happens?
Why would the FDA capitulate to Stark and Waxman?
Where is the leadership? Politics as usual should not apply when lives are on the line. Stark, Waxman and Padzur are distorting science and -- working together -- seeking to gain control over regulatory processes for political purposes. Where is the courage to put a stop to it.
Andy, your phone is ringing.
After Alex Berenson's sob story about the growing dental health crisis in America due to greedy dentists we have this from that health care paradise, Great Britain.
English 'pull own teeth' as dental service decays
Mon Oct 15, 7:19 AM ET
LONDON (AFP) - Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday.
Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday."
Maybe Jon Cohn of TNR wants to nibble on this one. I thought universal coverage made health care more accessible and affordable. (Don't forget the UK has nearly doubled spending on health care in the past decade so don't use the resource problem as an excuse.) When you pay people nothing and make services free you wind up with people expecting everything and getting nothing.
http://news.yahoo.com/s/afp/20071015/wl_uk_afp/britainhealthdentists
English 'pull own teeth' as dental service decays
Mon Oct 15, 7:19 AM ET
LONDON (AFP) - Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday.
Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday."
Maybe Jon Cohn of TNR wants to nibble on this one. I thought universal coverage made health care more accessible and affordable. (Don't forget the UK has nearly doubled spending on health care in the past decade so don't use the resource problem as an excuse.) When you pay people nothing and make services free you wind up with people expecting everything and getting nothing.
http://news.yahoo.com/s/afp/20071015/wl_uk_afp/britainhealthdentists
The Republicans are winning the battle on SCHIP and should not mistake the carpet bombing from the Left as a sign they are in trouble. It used the same tactics to run down Part D and now they see that in politics it is hard to add something, even harder to take it away. More to the point, Americans know when their tax dollars are being wasted. Part D to help seniors and reduce hospital visits, yes. Government subsidies and government run health plans to middle income families who could get insurance on their own, no.
But look at how USA Today tries to spin the war of ideas as a war of attrition against the GOP and Bush....
"Slim majorities back two positions at the core of the president's opposition to the expansion:
•52% agree with Bush that most benefits should go to children in families earning less than 200% of the federal poverty level — about $41,000 for a family of four. Only 40% say benefits should go to such families earning up to $62,000, as the bill written by Democrats and some Republicans would allow.
•55% are very or somewhat concerned that the program would create an incentive for families to drop private insurance. Bush and Republican opponents have called that a step toward government-run health care.
Taken together, the results show that while Bush may be losing the political battle with Democrats, he may be doing better on policy."
Slim majorities? I bet 50 dollars that if the poll was on Iraq and the same numbers signaled for withdrawal the adjective "slim" would nowhere to be found.
How can you lose the policy battle and not the political battle . Who said anything about losing? See how that assumption just...crowds out the reality?
PS
The poll should have asked about the precedent settting $83K with no asset test ripoff and the numbers would have been lower. And all this despite the media painting the contest as one of Bush vs poor kids.
http://www.usatoday.com/printedition/news/20071016/a_chippoll16.art.htm
But look at how USA Today tries to spin the war of ideas as a war of attrition against the GOP and Bush....
"Slim majorities back two positions at the core of the president's opposition to the expansion:
•52% agree with Bush that most benefits should go to children in families earning less than 200% of the federal poverty level — about $41,000 for a family of four. Only 40% say benefits should go to such families earning up to $62,000, as the bill written by Democrats and some Republicans would allow.
•55% are very or somewhat concerned that the program would create an incentive for families to drop private insurance. Bush and Republican opponents have called that a step toward government-run health care.
Taken together, the results show that while Bush may be losing the political battle with Democrats, he may be doing better on policy."
Slim majorities? I bet 50 dollars that if the poll was on Iraq and the same numbers signaled for withdrawal the adjective "slim" would nowhere to be found.
How can you lose the policy battle and not the political battle . Who said anything about losing? See how that assumption just...crowds out the reality?
PS
The poll should have asked about the precedent settting $83K with no asset test ripoff and the numbers would have been lower. And all this despite the media painting the contest as one of Bush vs poor kids.
http://www.usatoday.com/printedition/news/20071016/a_chippoll16.art.htm
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.
