Latest Drugwonks' Blog
In the spirit of bi-partisanship or whatever I am going to reach out to those eager to have the government negotiate directly with drug companies and show them how it's done: all involve the creation of a whole new bureaucracy
Here is the Canadian approach
it reviews factory-gate prices of individual products to determine if they are excessive. To do this, the board has instituted a set of processes, including review of individual drug prices, conduct of investigations, and application of enforcement mechanisms. The PMPRB process is based on the following classification scheme for all patented drugs: Category 1: a new drug product that is an extension of existing or comparable dosage form of an existing medicine, usually a new strength of an existing drug ( line extensions ); Category 2: the first drug to effectively treat a particular illness or that provides a substantial improvement over existing drug products, often referred to as breakthrough or substantial improvement ; and Category 3: a new drug or dosage form of an existing drug that provides moderate, little, or no improvement over existing drugs ( me-toos ).[6]
The board uses several criteria to classify a product. A manufacturer has to submit data (including price) to the PMPRB for classification of any drug. For a drug that is to be considered a breakthrough, the manufacturer al o ha to include reviews of the product in recognized journals (where available), results of two to five well-controlled trials, and results of a complete Medline search of articles and reviews of the drug. Once a drug is classified, its price is reviewed to determine if it is excessive.
Excessive is interpreted based on the following guidelines: (1) The price of an existing patented drug cannot increase by more than the Consumer Price Index (CPI). (2) The price of a new drug (in most cases) is limited so that the cost of therapy with the new drug is in the range of the costs of therapy with existing drugs in the same therapeutic class. (3) The price of a breakthrough drug is limited to the median of its prices in France, Germany, Italy, Sweden, Switzerland, Britain, and the United States. In addition, no patented drug can be priced above the highest price in this group of countries.
Want to know how the VA does it...here's a GAO ruling to determine whether a VA decision to exclude one drug was fair....A Peter Pitts Genius Award (a box of Cracker Jacks) will be bestowed upon the individual who can explain what the hell a GAO lawyer is doing making a clinical decision....
http://www.gao.gov/decisions/bidpro/295888.htm
or this gem....
http://
www.gao.gov/decisions/bidpro/2949442.htm
Or they can go President Clinton's route and set up a breakthrough drug price commission that would have subpoena power to investigate whether the price for a breakthrough was "reasonable."
Just trying to be helpful
Now on to the real future of medicine...
The headlines are full of stories of biomarkers in development to predict drug response and disease risk in new areas...The question is, why are we ignoring this, the ultimate approach to comparative effectiveness and drug safety in favor of the IOM approach of using outdates claims databases to help decide who gets what drug.
Over-_expression Of Cox-2 Can Predict Prostate Cancer Outcome (November 9, 2006) — Researchers say an over-_expression of COX-2 in men with prostate cancer is associated with an increase in PSA after radiation treatment and the spread of the cancer outside of the prostate. That is the result of the first study linking COX-2 with prostate cancer radiation treatment outcomes.
Here are some other exciting developments reported in this month's edition of Drug Discovery and Development
Heading off Lung Transplant Rejection
Using proteomics, mass spectrometry, and bioinformatics, researchers at the University of Minnesota, Minneapolis, identified three proteins that are highly predictive of lung transplant rejection up to 20 months before the rejection occurs. In addition to early identification, the researchers hope to eventually develop a preventative treatment.
Blood Test to Diagnose Alzheimer's?
Groundbreaking research at the Institute of Psychiatry, King's College London, demonstrates that proteins found in the blood can indicate an increased risk of Alzheimer's disease. It is the first time markers for the development of Alzheimer's have been identified in blood and is a step toward developing a blood test to diagnose and measure progression of the disease.
Gene Variant May Explain Antidepressant Failure
Investigators at Weill Medical College of Cornell University, New York, say their work could lead to the first diagnostic test to guide depression treatment. It would involve sampling the patient's DNA seeking a variant of the gene coding a protein called "Brain Derived Neurotrophic Factor" that may indicate that the patient would not respond to treatment with the most commonly used class of drugs.
Yeah, I guess Bruce Psaty who was on the IOM committee and uses claims databases when he consults to HMOs wasn't too self serving and was right when he told the Star Ledger that personalized medicine is 20 years away....
ScienceNewsDaily is always full of interesting articles that cause one to ponder the meaning of life and our place in the universe.....
Decoded Sea Urchin Genome Shows Surprising Relationship To Humans (November 9, 2006) — The Sea Urchin Genome Sequencing Project consortium, led by the Human Genome Sequencing Center at Baylor College of Medicine in Houston, announced today the decoding and analysis of the genome sequence of the sea urchin, Strongylocentrotus purpuratu.
What's surprising is in fact my great-great grandmother's maiden name on my mother's side was in fact "Purpuratu." We are still figuring out how it turned into Goldberg...
Moon's Escaping Gasses Expose Fresh Surface (November 9, 2006) — A fresh look at Apollo-era images combined with recent spectral data leads researchers to re-examine conventional wisdom. Several lines of evidence suggest that the moon may have seen eruptions of interior gasses as recently as one million years ago, rather than three billion years ago -- the date that has been most widely accepted.
Can you imagine having gas for a milion years, let alone 3 billion?
Here is the Canadian approach
it reviews factory-gate prices of individual products to determine if they are excessive. To do this, the board has instituted a set of processes, including review of individual drug prices, conduct of investigations, and application of enforcement mechanisms. The PMPRB process is based on the following classification scheme for all patented drugs: Category 1: a new drug product that is an extension of existing or comparable dosage form of an existing medicine, usually a new strength of an existing drug ( line extensions ); Category 2: the first drug to effectively treat a particular illness or that provides a substantial improvement over existing drug products, often referred to as breakthrough or substantial improvement ; and Category 3: a new drug or dosage form of an existing drug that provides moderate, little, or no improvement over existing drugs ( me-toos ).[6]
The board uses several criteria to classify a product. A manufacturer has to submit data (including price) to the PMPRB for classification of any drug. For a drug that is to be considered a breakthrough, the manufacturer al o ha to include reviews of the product in recognized journals (where available), results of two to five well-controlled trials, and results of a complete Medline search of articles and reviews of the drug. Once a drug is classified, its price is reviewed to determine if it is excessive.
Excessive is interpreted based on the following guidelines: (1) The price of an existing patented drug cannot increase by more than the Consumer Price Index (CPI). (2) The price of a new drug (in most cases) is limited so that the cost of therapy with the new drug is in the range of the costs of therapy with existing drugs in the same therapeutic class. (3) The price of a breakthrough drug is limited to the median of its prices in France, Germany, Italy, Sweden, Switzerland, Britain, and the United States. In addition, no patented drug can be priced above the highest price in this group of countries.
Want to know how the VA does it...here's a GAO ruling to determine whether a VA decision to exclude one drug was fair....A Peter Pitts Genius Award (a box of Cracker Jacks) will be bestowed upon the individual who can explain what the hell a GAO lawyer is doing making a clinical decision....
http://www.gao.gov/decisions/bidpro/295888.htm
or this gem....
http://
www.gao.gov/decisions/bidpro/2949442.htm
Or they can go President Clinton's route and set up a breakthrough drug price commission that would have subpoena power to investigate whether the price for a breakthrough was "reasonable."
Just trying to be helpful
Now on to the real future of medicine...
The headlines are full of stories of biomarkers in development to predict drug response and disease risk in new areas...The question is, why are we ignoring this, the ultimate approach to comparative effectiveness and drug safety in favor of the IOM approach of using outdates claims databases to help decide who gets what drug.
Over-_expression Of Cox-2 Can Predict Prostate Cancer Outcome (November 9, 2006) — Researchers say an over-_expression of COX-2 in men with prostate cancer is associated with an increase in PSA after radiation treatment and the spread of the cancer outside of the prostate. That is the result of the first study linking COX-2 with prostate cancer radiation treatment outcomes.
Here are some other exciting developments reported in this month's edition of Drug Discovery and Development
Heading off Lung Transplant Rejection
Using proteomics, mass spectrometry, and bioinformatics, researchers at the University of Minnesota, Minneapolis, identified three proteins that are highly predictive of lung transplant rejection up to 20 months before the rejection occurs. In addition to early identification, the researchers hope to eventually develop a preventative treatment.
Blood Test to Diagnose Alzheimer's?
Groundbreaking research at the Institute of Psychiatry, King's College London, demonstrates that proteins found in the blood can indicate an increased risk of Alzheimer's disease. It is the first time markers for the development of Alzheimer's have been identified in blood and is a step toward developing a blood test to diagnose and measure progression of the disease.
Gene Variant May Explain Antidepressant Failure
Investigators at Weill Medical College of Cornell University, New York, say their work could lead to the first diagnostic test to guide depression treatment. It would involve sampling the patient's DNA seeking a variant of the gene coding a protein called "Brain Derived Neurotrophic Factor" that may indicate that the patient would not respond to treatment with the most commonly used class of drugs.
Yeah, I guess Bruce Psaty who was on the IOM committee and uses claims databases when he consults to HMOs wasn't too self serving and was right when he told the Star Ledger that personalized medicine is 20 years away....
ScienceNewsDaily is always full of interesting articles that cause one to ponder the meaning of life and our place in the universe.....
Decoded Sea Urchin Genome Shows Surprising Relationship To Humans (November 9, 2006) — The Sea Urchin Genome Sequencing Project consortium, led by the Human Genome Sequencing Center at Baylor College of Medicine in Houston, announced today the decoding and analysis of the genome sequence of the sea urchin, Strongylocentrotus purpuratu.
What's surprising is in fact my great-great grandmother's maiden name on my mother's side was in fact "Purpuratu." We are still figuring out how it turned into Goldberg...
Moon's Escaping Gasses Expose Fresh Surface (November 9, 2006) — A fresh look at Apollo-era images combined with recent spectral data leads researchers to re-examine conventional wisdom. Several lines of evidence suggest that the moon may have seen eruptions of interior gasses as recently as one million years ago, rather than three billion years ago -- the date that has been most widely accepted.
Can you imagine having gas for a milion years, let alone 3 billion?
Yesterday I had the pleasure of debating Jamie Love on the issue of replacing pharmaceutical patents with a “prize†system wherein the government pays an innovator a lump sum amount for its innovation that is then placed in the public domain.
No, really, he’s serious.
The “prize†model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketryâ€) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.
Certainly not what Schumpeter had in mind when he wrote about “spectacular prizes … thrown to a small minority of winners.†Creative destruction indeed!
Jamie wants to replace a patent system that has allowed the average American lifespan to increase, over the past 50 years, by almost a full decade with a prize program that has a solid record of complete failure.
My argument to Jamie was that, as Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
In other words (and to paraphrase Winston Churchill) our pharmaceutical patent system is the worst way to stimulate and support health care innovation – except for every other system. On a list of 100 ideas for ways to improve innovation and access, Jamie’s prize program isn’t even on the list.
Is it a crackpot idea? Well, consider the fact that Mr. Love’s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerry’s, Bernie Sanders.
Who could support such an idea? Nobody? Wrong! Dangerously wrong. Again, as DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."
Sound familiar? Correct. Europe.
Remember these three words: Evidence-based medicine.
There are, to be sure, other unworkable, ill-considered, and precarious aspects of Mr. Love’s child – but we’ll save that for later. Suffice it to say that a prize system is not a Crackerjack idea. In the meantime, I did tell Jamie that I would gladly comment in detail on the Sanders legislation via a thoughtful and considered edit.
I await the attachment.
No, really, he’s serious.
The “prize†model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketryâ€) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.
Certainly not what Schumpeter had in mind when he wrote about “spectacular prizes … thrown to a small minority of winners.†Creative destruction indeed!
Jamie wants to replace a patent system that has allowed the average American lifespan to increase, over the past 50 years, by almost a full decade with a prize program that has a solid record of complete failure.
My argument to Jamie was that, as Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
In other words (and to paraphrase Winston Churchill) our pharmaceutical patent system is the worst way to stimulate and support health care innovation – except for every other system. On a list of 100 ideas for ways to improve innovation and access, Jamie’s prize program isn’t even on the list.
Is it a crackpot idea? Well, consider the fact that Mr. Love’s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerry’s, Bernie Sanders.
Who could support such an idea? Nobody? Wrong! Dangerously wrong. Again, as DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."
Sound familiar? Correct. Europe.
Remember these three words: Evidence-based medicine.
There are, to be sure, other unworkable, ill-considered, and precarious aspects of Mr. Love’s child – but we’ll save that for later. Suffice it to say that a prize system is not a Crackerjack idea. In the meantime, I did tell Jamie that I would gladly comment in detail on the Sanders legislation via a thoughtful and considered edit.
I await the attachment.
Rumor has it that the WH is fed up with the Republican holds on Andy's nomination and will seek to pressure Senators Demint and Vitter to drop their craven and politically motivated opposition during the lameduck session. Demint will never get the GAO study he wants looking RU-486 and Vitter will get his importation vote anyways because the Dems are interested in spending billions to turn the FDA into a parcel inspection service for European wholesalers while letting the agency infrastructure for evaluating new medicines fall apart....
Businessweek's John Carey has a nice article describing the hell awaiting drug companies come January when the Democrats take control of both ends of Congress...the question is, do the companies have what it takes to use meet this challenge and actually exploit the inherent weaknesses and contradictions in the Democrat proposals...
USA, 11/9/2006 - For drugmakers, the Democratic congressional election triumph means a return to the political crosshairs.
Nancy Pelosi (D-Calif.), widely expected to be the new Speaker of the House, has vowed to give the government the power to negotiate—and thus, she hopes, drive down—drug prices for Medicare patients. Henry Waxman (D-Calif.) and John Dingell (D-Mich.), now that they are back in power, "are licking their chops at the prospect of having hearings" on topics such as the sky-high price of some cancer drugs, says analyst Ira S. Loss of Washington Analysis, which assesses the impact of public policy on investors. The industry also may face a higher bar for drug approvals at the Food & Drug Administration.
So it's no surprise that, on the day after the Nov. 7 election, pharmaceutical stocks went down. The AMEX pharma index sank nearly 2%. Losers included everyone from Pfizer and Schering-Plough to Eli Lilly and Merck.
The scrutiny could be intense. In the next Congress, expect hearings—and well-publicized outrage—over the price of drugs like Genentech's cancer treatment Avastin, which can cost more than $50,000 per year. Expect the Pelosi-led House to quickly act on her promise by passing a measure aimed at driving down the cost of drugs in the Medicare program. Expect more talk about importing cheaper drugs from Canada, and more rhetoric about how the FDA may have moved too fast in the past, allowing risky drugs like Merck's Vioxx on the market. "
Well, we will see. The word is that the D's know the vaunted savings can't be had unless you rob seniors of the choice of drugs they do have. And the "third way" Democrats are likely to propose, requiring comparative effectiveness studies and driving prescribing to the drugs of most "value" will be caught up in methodological, biological and clinical disputes and leave them open to charges that they want to government to practice medicine.
I can see a funny ad around seniors trying to get their medicines from the government supply depot or a costco type place where you have to buy your one drug by the caseload...
"In the meantime, the pharmaceutical industry is raking in the profits that are coming from the Medicare drug benefit. One big winner: Lilly, whose third-quarter sales rose 7%, with profits up 10%, in part on the strength of Medicare prescriptions for its mental illness drug Zyprexa. "
"Raking in?" More seniors are using more medicines. Meanwhile the actual price of Zyprexa (not the retail or manufacturer price) has fallen as a result of price competition. Why shouldn't Lilly prosper? If you sell more, you make more. Check the profit margins of genetic drug firms since Medicare came online, particularly Teva and Mylan, generic drug manufacturers that have had about a 50 percent jump in earnings as a result of patent expirations and a switch away from brand drugs.
Why not make a big stink about those margins or the big profits PBMs and pharmacists will make by selling generic drugs at markup?
If the Democrats want eliminate profit from the prospect of increasing sales volume (sell more, don't increase profits) then the road ahead will be rocky indeed.
If I were "Big Pharma" I would run ads pairing patients with Parkinson's, juvenile diabetes and spinal cord injury with scientists from their companies and with scientists from the small money losing biotech firms they are now investing billions with that are doing work in stem cells and Parkinsons. The scientists would disappear one by one as a narrator talks about how Medicare price controls will make future cures disappear.
Drug companies have a lot at stake. If they don't have the backbone to defend their mission, we will all suffer.
USA, 11/9/2006 - For drugmakers, the Democratic congressional election triumph means a return to the political crosshairs.
Nancy Pelosi (D-Calif.), widely expected to be the new Speaker of the House, has vowed to give the government the power to negotiate—and thus, she hopes, drive down—drug prices for Medicare patients. Henry Waxman (D-Calif.) and John Dingell (D-Mich.), now that they are back in power, "are licking their chops at the prospect of having hearings" on topics such as the sky-high price of some cancer drugs, says analyst Ira S. Loss of Washington Analysis, which assesses the impact of public policy on investors. The industry also may face a higher bar for drug approvals at the Food & Drug Administration.
So it's no surprise that, on the day after the Nov. 7 election, pharmaceutical stocks went down. The AMEX pharma index sank nearly 2%. Losers included everyone from Pfizer and Schering-Plough to Eli Lilly and Merck.
The scrutiny could be intense. In the next Congress, expect hearings—and well-publicized outrage—over the price of drugs like Genentech's cancer treatment Avastin, which can cost more than $50,000 per year. Expect the Pelosi-led House to quickly act on her promise by passing a measure aimed at driving down the cost of drugs in the Medicare program. Expect more talk about importing cheaper drugs from Canada, and more rhetoric about how the FDA may have moved too fast in the past, allowing risky drugs like Merck's Vioxx on the market. "
Well, we will see. The word is that the D's know the vaunted savings can't be had unless you rob seniors of the choice of drugs they do have. And the "third way" Democrats are likely to propose, requiring comparative effectiveness studies and driving prescribing to the drugs of most "value" will be caught up in methodological, biological and clinical disputes and leave them open to charges that they want to government to practice medicine.
I can see a funny ad around seniors trying to get their medicines from the government supply depot or a costco type place where you have to buy your one drug by the caseload...
"In the meantime, the pharmaceutical industry is raking in the profits that are coming from the Medicare drug benefit. One big winner: Lilly, whose third-quarter sales rose 7%, with profits up 10%, in part on the strength of Medicare prescriptions for its mental illness drug Zyprexa. "
"Raking in?" More seniors are using more medicines. Meanwhile the actual price of Zyprexa (not the retail or manufacturer price) has fallen as a result of price competition. Why shouldn't Lilly prosper? If you sell more, you make more. Check the profit margins of genetic drug firms since Medicare came online, particularly Teva and Mylan, generic drug manufacturers that have had about a 50 percent jump in earnings as a result of patent expirations and a switch away from brand drugs.
Why not make a big stink about those margins or the big profits PBMs and pharmacists will make by selling generic drugs at markup?
If the Democrats want eliminate profit from the prospect of increasing sales volume (sell more, don't increase profits) then the road ahead will be rocky indeed.
If I were "Big Pharma" I would run ads pairing patients with Parkinson's, juvenile diabetes and spinal cord injury with scientists from their companies and with scientists from the small money losing biotech firms they are now investing billions with that are doing work in stem cells and Parkinsons. The scientists would disappear one by one as a narrator talks about how Medicare price controls will make future cures disappear.
Drug companies have a lot at stake. If they don't have the backbone to defend their mission, we will all suffer.
How is the French government cutting national health care costs? Why by asking doctors to prescribe fewer medicines of course. In other words, deny patients the medicines they need in order to save the State a few euros in the short-term.
Don’t you love socialized medicine?
Time for a revival of Le Medecin malgre lui.
The full story can be found at:
http://www.reuters.com
Don’t you love socialized medicine?
Time for a revival of Le Medecin malgre lui.
The full story can be found at:
http://www.reuters.com
So now what happens?
Post-election it’s all about the letter “P.â€
I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive tools, and the participatory Critical Path†...
… and we will move to a House of Representatives that is focused on payback and partisan politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.†And that’s deleterious and particularly dangerous right now because of PDUFA.
On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours†to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).
You can also bet we’ll see more rhetoric over plans for phony importation schemes.
It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.
Which means we must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.
America's health is too important to be about partisanship or about profits. It must be about progress, about patients.
We must keep our eyes on the prize and persevere.
Post-election it’s all about the letter “P.â€
I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive tools, and the participatory Critical Path†...
… and we will move to a House of Representatives that is focused on payback and partisan politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.†And that’s deleterious and particularly dangerous right now because of PDUFA.
On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours†to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).
You can also bet we’ll see more rhetoric over plans for phony importation schemes.
It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.
Which means we must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.
America's health is too important to be about partisanship or about profits. It must be about progress, about patients.
We must keep our eyes on the prize and persevere.
If the D's take control of both the House and Senate expect legislation to rollback Medicare reforms enacted in 2003 to pass with Republican support. If they do, they will find that such proposals will require robbing seniors of the choice of essential medicines now and in the future and starve biotech firms that are already losing money of markets. If the pharma and biotech industry were politically smart they would link the Democrat support of embryonic stem cell research with the fact funding for the enabling technologies comes from private firms that would be bled to death by Democrat part D proposals. That's a big if....
Gail Wilensky, who ran the Health Care Finance Administration under Bush I (that's CMS now) has an article today calling for a new public-private agency to evaluate the comparative-effectiveness of medical technologies.
Gail is smart and thoughful on health care matter so I can't figure out what she was thinking here. Maybe she thought she could tame the CE crowd which has an agenda.
http://
As the ALLHAT and CATIE studies show, even well funded comparative effectiveness studies will fall into dis-use for every good reasons. They are poorly designed, they are superceded by studies or personalized medicines that are based on a better mechanistic understanding of disease pathways. Applying ALLHAT recommendations to African Americans will kill them for example. And notice that people who promote C-E never talk about genetic testing to determine which medicine works best? That would be like Tower records talking about Itunes...
Indeed, since most C-E are underpowered they do not capture the genetic variations that explain and cause differences in response to medicines or other intereventions so of course "they all look alike" and regress to cheaper is better. Meta analysis only reinforces this one size fits all conclusion. Which is why for example, NICE has never caught an increased survival benefit from any new cancer drug since 1970. Then again, if you post your QALY at 50K survival doesn't mean very much either.
All of which translates into reimbursement decisions and the comparative effectiveness crowd knows it.
Take UK, Germany, Australia and Canada. All take their sweet time reviewing studies. All deny and limit access to new medicines and have fail first policies based on C-E. Have you read any of the VA off-formulary guidances? Take someone who has non-hodgkins's lymphoma. In the private sector, Rituxan is standard therapy. But not in the countries you cite and not in the VA.. Why? According to the comparative effectiveness studies, the reimbursing agencies want you to go through more painful and more toxic treatments first.
Finally, the entire field of medicine is moving toward the molecular and the personalized. Comparative effectiveness in the 21st century boils down to the right treatment for the right person at the right time. The agency Gail proposes is totally unsuited for arriving at that answer. I have read everyone of the AHQR comparative effectiveness studies...They are not usable in the clinical setting for docs because they are one size fits all and retrospective.
We need to invest in developing personalized treatment strategies that are preventive and prospective in nature. All this C-E will make the foundations and liberals that hate drug companies -- who by the way -- are not developing the next generation of new medicines (biotech firms that make no money are, ) happy. But it will hurt patients by delaying access and giving bureaucrats who know nothing about the practice or science of medicine control over care.
Gail is smart and thoughful on health care matter so I can't figure out what she was thinking here. Maybe she thought she could tame the CE crowd which has an agenda.
http://
As the ALLHAT and CATIE studies show, even well funded comparative effectiveness studies will fall into dis-use for every good reasons. They are poorly designed, they are superceded by studies or personalized medicines that are based on a better mechanistic understanding of disease pathways. Applying ALLHAT recommendations to African Americans will kill them for example. And notice that people who promote C-E never talk about genetic testing to determine which medicine works best? That would be like Tower records talking about Itunes...
Indeed, since most C-E are underpowered they do not capture the genetic variations that explain and cause differences in response to medicines or other intereventions so of course "they all look alike" and regress to cheaper is better. Meta analysis only reinforces this one size fits all conclusion. Which is why for example, NICE has never caught an increased survival benefit from any new cancer drug since 1970. Then again, if you post your QALY at 50K survival doesn't mean very much either.
All of which translates into reimbursement decisions and the comparative effectiveness crowd knows it.
Take UK, Germany, Australia and Canada. All take their sweet time reviewing studies. All deny and limit access to new medicines and have fail first policies based on C-E. Have you read any of the VA off-formulary guidances? Take someone who has non-hodgkins's lymphoma. In the private sector, Rituxan is standard therapy. But not in the countries you cite and not in the VA.. Why? According to the comparative effectiveness studies, the reimbursing agencies want you to go through more painful and more toxic treatments first.
Finally, the entire field of medicine is moving toward the molecular and the personalized. Comparative effectiveness in the 21st century boils down to the right treatment for the right person at the right time. The agency Gail proposes is totally unsuited for arriving at that answer. I have read everyone of the AHQR comparative effectiveness studies...They are not usable in the clinical setting for docs because they are one size fits all and retrospective.
We need to invest in developing personalized treatment strategies that are preventive and prospective in nature. All this C-E will make the foundations and liberals that hate drug companies -- who by the way -- are not developing the next generation of new medicines (biotech firms that make no money are, ) happy. But it will hurt patients by delaying access and giving bureaucrats who know nothing about the practice or science of medicine control over care.
Today the New York Times invokes the myth that drug prices went up an average of 6 percent last year. I think that number comes from an AARP study conducted by the PRIME Institute which used manufacturer prices posted from July 2005 and June 2006.
Well, a little research goes a long way. Going to plans in my home state of NJ, If you look at some of the changes in Medicare part D prices for the Top 25 Brand Name Prescription Products over the same time period, you find that the retail prices have actually gone up slower (4.5 percent) under the AARP than manufacturer prices reported by its own study and out out of pocket share during the initial coverage level has declined by 12 percent! That suggests actual price concessions were deep and that therefore the 6 percent manufacturer price increase (the sticker price) was wishful thinking at best. Prices during the gap under the Humana plan decreased by 4 percent a year and the out of pocket costs during coverage have dropped as well.
And in all cases the retail price of the drug is cheaper than what seniors could get a drugstore.com.
Moving over to the VA model is to see that drugs such as Aricept, Abilify, Evista, Fosamax, Lipitor and Xalatan are not on the VA formulary while they are on the Medicare Part D formulary.
That's just for starters. Which explains why nearly 35 percent of VA seniors tried to join Medicare part D.
Well, a little research goes a long way. Going to plans in my home state of NJ, If you look at some of the changes in Medicare part D prices for the Top 25 Brand Name Prescription Products over the same time period, you find that the retail prices have actually gone up slower (4.5 percent) under the AARP than manufacturer prices reported by its own study and out out of pocket share during the initial coverage level has declined by 12 percent! That suggests actual price concessions were deep and that therefore the 6 percent manufacturer price increase (the sticker price) was wishful thinking at best. Prices during the gap under the Humana plan decreased by 4 percent a year and the out of pocket costs during coverage have dropped as well.
And in all cases the retail price of the drug is cheaper than what seniors could get a drugstore.com.
Moving over to the VA model is to see that drugs such as Aricept, Abilify, Evista, Fosamax, Lipitor and Xalatan are not on the VA formulary while they are on the Medicare Part D formulary.
That's just for starters. Which explains why nearly 35 percent of VA seniors tried to join Medicare part D.
Good morning class and I hope you had a relaxing and refreshing weekend.
To welcome you back, Professor Drugwonk has decided on a pop quiz. Please do not turn over your paper until I say "go!"
Question: Which article appeared in today's New York Times?
As drug prices climb, Democrats find fault with Medicare plan
For big drug companies, the new Medicare prescription benefit is proving to be a financial windfall larger than even the most optimistic Wall Street analysts had predicted. But those gains may come back to haunt drug makers if Democrats take control of Congress this week.
or ...
Antidepressants tied to lower suicide rates in kids
In US counties with the highest rates of prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, the rate of suicide among children ages 5 to 14 is lower than that observed in counties with lower rates, according to a new report.
First person to get the answer correct wins the new edition of Sid Wolfe's "Worst Pills, Best Pills."
Second person to get the correct answer wins two copies.
To welcome you back, Professor Drugwonk has decided on a pop quiz. Please do not turn over your paper until I say "go!"
Question: Which article appeared in today's New York Times?
As drug prices climb, Democrats find fault with Medicare plan
For big drug companies, the new Medicare prescription benefit is proving to be a financial windfall larger than even the most optimistic Wall Street analysts had predicted. But those gains may come back to haunt drug makers if Democrats take control of Congress this week.
or ...
Antidepressants tied to lower suicide rates in kids
In US counties with the highest rates of prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, the rate of suicide among children ages 5 to 14 is lower than that observed in counties with lower rates, according to a new report.
First person to get the answer correct wins the new edition of Sid Wolfe's "Worst Pills, Best Pills."
Second person to get the correct answer wins two copies.
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.
