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Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
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Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
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TortsProf
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11/13/2006 06:28 AM |
Now about those "safe" drugs from Europe ...
According to a new report in the Times of India, over half a million packets of fake medicines, most of them from India, were seized by European customs officials during 2005.
The fake medicines include Viagra, antibiotics, medicines to treat cancer
and high cholesterol and condoms. A sample that was investigated revealed
that what was being passed off as a cardiovascular drug contained a mixture
of brick dust.
"A secret wave of dangerous fakes is threatening the people in Europe," said
Laszlo Kovacs, the EU Taxation Commissioner.
The latest European customs statistics released Saturday said that in 148
operations last year, customs officers intercepted 560,598 packets of fake
medicines. The seizures were double the 2004 rate, but there are fears that
even more counterfeit products may have entered the EU undetected.
Three quarters of the cases involved fake medicines imported from India,
with seven percent from Egypt and six percent from China. Other sources
included Thailand, Argentina, Switzerland, Hong Kong and Indonesia.
The statistics revealed that customs officers across Europe uncovered 26,700
consignments of counterfeit and pirated goods, seizing more than 75 million
items.
"The key is to be faster than the counterfeiters," Kovacs said. "We must
quickly identify, and act to deal with, new routes of fraud and constantly
changing counterfeit patterns to protect our health, safety and the
economy."
Coincidence or Crisis?
(Hint -- There is no such thing as a coincidence.) Read More & Comment...
According to a new report in the Times of India, over half a million packets of fake medicines, most of them from India, were seized by European customs officials during 2005.
The fake medicines include Viagra, antibiotics, medicines to treat cancer
and high cholesterol and condoms. A sample that was investigated revealed
that what was being passed off as a cardiovascular drug contained a mixture
of brick dust.
"A secret wave of dangerous fakes is threatening the people in Europe," said
Laszlo Kovacs, the EU Taxation Commissioner.
The latest European customs statistics released Saturday said that in 148
operations last year, customs officers intercepted 560,598 packets of fake
medicines. The seizures were double the 2004 rate, but there are fears that
even more counterfeit products may have entered the EU undetected.
Three quarters of the cases involved fake medicines imported from India,
with seven percent from Egypt and six percent from China. Other sources
included Thailand, Argentina, Switzerland, Hong Kong and Indonesia.
The statistics revealed that customs officers across Europe uncovered 26,700
consignments of counterfeit and pirated goods, seizing more than 75 million
items.
"The key is to be faster than the counterfeiters," Kovacs said. "We must
quickly identify, and act to deal with, new routes of fraud and constantly
changing counterfeit patterns to protect our health, safety and the
economy."
Coincidence or Crisis?
(Hint -- There is no such thing as a coincidence.) Read More & Comment...
11/12/2006 02:49 PM |
The grass is always greener, right?
Some US politicians are advocating the adoption here at home of a Euro-style, deny-and-delay health care system -- but, as P.J. O'Rourke has famously quipped, "If you think health care is expensive now, just wait until it's free."
It's never as simple as some politicians make it sound. And that's as true for price controls as it is for things like drug importation.
It's important to remember, as the debate over revoking the non-interference clause gets under way within the "first 100 hours," that price controls = choice controls. Just ask our British cousins how nice NICE is or the Germans about IQWIG or the French about their government's initiative to get their docs to prescribe fewer medicines for the sake of the budget -- and patients be damned (see the November 11, 2006 drugwonks blog "L'Etat C'est Moins)".
And of course, when it comes to the Italians -- you can see for yourself in today's Washington Post what Alberto Mingardi of The Instituto Bruno Leoni has to teach us about wistfully contemplating the adoption of a Euro-style health care system without understanding the significant unintended consequences.
The title says it all.
A Drug Price Path To Avoid
By Alberto Mingardi
Sunday, November 12, 2006; Page B07
The next speaker of the House, Rep. Nancy Pelosi (D-Calif.), has let it be known that within her first 100 hours on the job, she will move to allow the government to negotiate directly with pharmaceutical companies to obtain lower drug prices for Medicare patients.
Her plan would create a Medicare drug program that looks a lot like the system we have in my country, Italy, where drug prices are among the lowest in Europe. And that's pretty low, considering that drugs in Europe average about 60 percent less than in the United States. Even as U.S. prices rose, Italian drug prices decreased by 5 percent last year.
At first glance, this might seem an enviable model for America to follow. But before Pelosi rushes down the road to Italian-style health care, allow me to offer a word of caution. Italy is hardly a health-care paradise. In fact, it's more like a quagmire of red tape.
For the most part, Italy's lower drug prices are the product of government price controls. The state purchases nearly 60 percent of the nation's prescription drugs. And it supposedly negotiates prices directly with pharmaceutical companies. But since the Italian government controls such a disproportionate share of the market, it in effect dictates drug prices.
In Italy, these price controls have created a number of problems.
First, they distort the laws of supply and demand. Because of the country's artificially low drug prices, demand for pharmaceuticals is artificially high -- higher than it would be under free-market conditions.
The point is that the government's attempt to force down drug prices has not reduced overall health-care spending. Rather, it has resulted in a spike in demand -- which is one reason why Italy's health-care spending has skyrocketed, growing nearly 68 percent between 1995 and 2003.
As for the quality of Italy's care, that, too, is suffering. With demand for drugs rising, the Italian government has attempted to save money by adopting reimbursement policies that favor certain drugs over others. Unfortunately, the most innovative products often aren't considered reimbursable by the government precisely because they are the most expensive.
It's a great system if you just need an antibiotic. But if you're hoping to avoid open-heart surgery through access to a miracle drug, it can be a nightmare.
And Italians are lacking more than just choice in cutting-edge drugs. They also lack information. According to a recent survey, more than 50 percent of Italy's patients believe that the national health service cannot even supply adequate information about treatments and drugs.
The economy is also harmed. Because it's simply not profitable for companies to invent cures in Italy, price controls have decimated Italy's pharmaceutical industry. Today not one of the world's 50 largest drug manufacturers has its headquarters in Italy, even though the country is the world's seventh-largest economy. Because most drug and biotechnology companies are outside Italy's borders, there are only 84,000 pharmaceutical workers in Italy's entire drug industry. The industry has become a perfect target for Italy's politicians, because they can rail against it with little political downside. The more we follow this path, the less likely it is for Italian companies to develop valuable innovations -- at great risk for both our economy and our health.
So by attempting to hold down drug prices, the Italian government has deprived its citizens of the best care without reducing health-care spending. And it has deprived the country of what could be a vibrant sector of the economy. In their rush to revamp Medicare, U.S. policy leaders should be careful not to make the same mistake.
The writer is a director of the Istituto Bruno Leoni, an Italian free-market think tank. Read More & Comment...
Some US politicians are advocating the adoption here at home of a Euro-style, deny-and-delay health care system -- but, as P.J. O'Rourke has famously quipped, "If you think health care is expensive now, just wait until it's free."
It's never as simple as some politicians make it sound. And that's as true for price controls as it is for things like drug importation.
It's important to remember, as the debate over revoking the non-interference clause gets under way within the "first 100 hours," that price controls = choice controls. Just ask our British cousins how nice NICE is or the Germans about IQWIG or the French about their government's initiative to get their docs to prescribe fewer medicines for the sake of the budget -- and patients be damned (see the November 11, 2006 drugwonks blog "L'Etat C'est Moins)".
And of course, when it comes to the Italians -- you can see for yourself in today's Washington Post what Alberto Mingardi of The Instituto Bruno Leoni has to teach us about wistfully contemplating the adoption of a Euro-style health care system without understanding the significant unintended consequences.
The title says it all.
A Drug Price Path To Avoid
By Alberto Mingardi
Sunday, November 12, 2006; Page B07
The next speaker of the House, Rep. Nancy Pelosi (D-Calif.), has let it be known that within her first 100 hours on the job, she will move to allow the government to negotiate directly with pharmaceutical companies to obtain lower drug prices for Medicare patients.
Her plan would create a Medicare drug program that looks a lot like the system we have in my country, Italy, where drug prices are among the lowest in Europe. And that's pretty low, considering that drugs in Europe average about 60 percent less than in the United States. Even as U.S. prices rose, Italian drug prices decreased by 5 percent last year.
At first glance, this might seem an enviable model for America to follow. But before Pelosi rushes down the road to Italian-style health care, allow me to offer a word of caution. Italy is hardly a health-care paradise. In fact, it's more like a quagmire of red tape.
For the most part, Italy's lower drug prices are the product of government price controls. The state purchases nearly 60 percent of the nation's prescription drugs. And it supposedly negotiates prices directly with pharmaceutical companies. But since the Italian government controls such a disproportionate share of the market, it in effect dictates drug prices.
In Italy, these price controls have created a number of problems.
First, they distort the laws of supply and demand. Because of the country's artificially low drug prices, demand for pharmaceuticals is artificially high -- higher than it would be under free-market conditions.
The point is that the government's attempt to force down drug prices has not reduced overall health-care spending. Rather, it has resulted in a spike in demand -- which is one reason why Italy's health-care spending has skyrocketed, growing nearly 68 percent between 1995 and 2003.
As for the quality of Italy's care, that, too, is suffering. With demand for drugs rising, the Italian government has attempted to save money by adopting reimbursement policies that favor certain drugs over others. Unfortunately, the most innovative products often aren't considered reimbursable by the government precisely because they are the most expensive.
It's a great system if you just need an antibiotic. But if you're hoping to avoid open-heart surgery through access to a miracle drug, it can be a nightmare.
And Italians are lacking more than just choice in cutting-edge drugs. They also lack information. According to a recent survey, more than 50 percent of Italy's patients believe that the national health service cannot even supply adequate information about treatments and drugs.
The economy is also harmed. Because it's simply not profitable for companies to invent cures in Italy, price controls have decimated Italy's pharmaceutical industry. Today not one of the world's 50 largest drug manufacturers has its headquarters in Italy, even though the country is the world's seventh-largest economy. Because most drug and biotechnology companies are outside Italy's borders, there are only 84,000 pharmaceutical workers in Italy's entire drug industry. The industry has become a perfect target for Italy's politicians, because they can rail against it with little political downside. The more we follow this path, the less likely it is for Italian companies to develop valuable innovations -- at great risk for both our economy and our health.
So by attempting to hold down drug prices, the Italian government has deprived its citizens of the best care without reducing health-care spending. And it has deprived the country of what could be a vibrant sector of the economy. In their rush to revamp Medicare, U.S. policy leaders should be careful not to make the same mistake.
The writer is a director of the Istituto Bruno Leoni, an Italian free-market think tank. Read More & Comment...
11/10/2006 05:34 PM |
Here is a draft of the Jamie Love/Prize vs. Patent legislation I discussed below ("There's a prize in every box," November 10, 2006):
Download file
As I promised to Jamie, I am going to give it a comprehensive redline edit.
Also -- here is Jamie's blog on my visit to his office yesterday. (Do I really look that threatening?)
http://www.cptech.org/blogs/drugdevelopment/2006/11/peter-pitts-on-prizes.html Read More & Comment...
Download file
As I promised to Jamie, I am going to give it a comprehensive redline edit.
Also -- here is Jamie's blog on my visit to his office yesterday. (Do I really look that threatening?)
http://www.cptech.org/blogs/drugdevelopment/2006/11/peter-pitts-on-prizes.html Read More & Comment...
11/10/2006 04:53 PM |
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? Read More & Comment...
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? Read More & Comment...
11/10/2006 01:26 PM |
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. Read More & Comment...
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. Read More & Comment...
11/09/2006 01:31 PM |
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.... Read More & Comment...
11/09/2006 11:31 AM |
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. Read More & Comment...
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. Read More & Comment...
11/09/2006 11:11 AM |
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 Read More & Comment...
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 Read More & Comment...
11/08/2006 09:37 AM |
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. Read More & Comment...
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. Read More & Comment...
11/08/2006 12:30 AM |
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.... Read More & Comment...
11/07/2006 09:26 AM |
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. Read More & Comment...
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. Read More & Comment...
11/06/2006 12:45 PM |
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. Read More & Comment...
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. Read More & Comment...
11/06/2006 09:24 AM |
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. Read More & Comment...
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. Read More & Comment...
11/06/2006 09:18 AM |
Yawn?
According to today's edition of the Wall Street Journal, The U.S. Centers for Disease Control and Prevention is aiming to boost awareness of chronic fatigue syndrome.
Chronic fatigue syndrome "is a terrible illness that prevents many people from taking part in everyday activities and participating in the things they enjoy," CDC Director Dr. Julie Gerberding said at a news conference Friday. Early diagnosis and treatment of the disease are important for recovery -- even though it isn't clear what the best treatments are, CDC officials said.
Currently, there is no cure for the syndrome, which is estimated to affect around one million Americans.
Symptoms of the illness, including fatigue, short-term memory impairment, joint and muscle pain, are treated with medications that target the pain or fatigue. Antidepressants are also used.
Although the syndrome was officially recognized by the government in the late 1980s as a medical condition, many people still question whether the condition is a true physical illness.
The lack of knowledge on the causes and treatment of the disease has caused drug companies to stay away from research in the area. Information on the disease can be found at the CDC's Web site, www.cdc.gov/cfs/.
Philadelphia-based Hemispherx Biopharma Inc. plans to seek Food and Drug Administration approval to market Ampligen as a chronic fatigue treatment by the end of the year. If approved, it would be the first drug directly targeted to treat the syndrome. Read More & Comment...
According to today's edition of the Wall Street Journal, The U.S. Centers for Disease Control and Prevention is aiming to boost awareness of chronic fatigue syndrome.
Chronic fatigue syndrome "is a terrible illness that prevents many people from taking part in everyday activities and participating in the things they enjoy," CDC Director Dr. Julie Gerberding said at a news conference Friday. Early diagnosis and treatment of the disease are important for recovery -- even though it isn't clear what the best treatments are, CDC officials said.
Currently, there is no cure for the syndrome, which is estimated to affect around one million Americans.
Symptoms of the illness, including fatigue, short-term memory impairment, joint and muscle pain, are treated with medications that target the pain or fatigue. Antidepressants are also used.
Although the syndrome was officially recognized by the government in the late 1980s as a medical condition, many people still question whether the condition is a true physical illness.
The lack of knowledge on the causes and treatment of the disease has caused drug companies to stay away from research in the area. Information on the disease can be found at the CDC's Web site, www.cdc.gov/cfs/.
Philadelphia-based Hemispherx Biopharma Inc. plans to seek Food and Drug Administration approval to market Ampligen as a chronic fatigue treatment by the end of the year. If approved, it would be the first drug directly targeted to treat the syndrome. Read More & Comment...
11/06/2006 08:41 AM |
Important new paper by, among others, my friend and former colleague, Randy Lutter, FDA's Associate Commissioner for Policy & Planning, on why personalized medicine saves lives and saves money.
Here's the executive summary:
Progress towards realizing a vision of personalized medicine—drugs and drug doses that are safer and more effective because they are chosen based on an individual’s genetic makeup—has been slower than once forecast. The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs. Here we evaluate one example of how using genetic information in drug therapy may improve public health and lower health care costs.
Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases. We estimate the health benefits and the resulting savings in health care costs by using personalized warfarin dosing decisions based on appropriate genetic testing. We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually. We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion.
Did that last bit get your attention? Good! Here's a link to the entire paper:
http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337&PHPSESSIS=2b0284fa8e8d5t08bd4e1515ac971482 Read More & Comment...
Here's the executive summary:
Progress towards realizing a vision of personalized medicine—drugs and drug doses that are safer and more effective because they are chosen based on an individual’s genetic makeup—has been slower than once forecast. The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs. Here we evaluate one example of how using genetic information in drug therapy may improve public health and lower health care costs.
Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases. We estimate the health benefits and the resulting savings in health care costs by using personalized warfarin dosing decisions based on appropriate genetic testing. We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually. We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion.
Did that last bit get your attention? Good! Here's a link to the entire paper:
http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337&PHPSESSIS=2b0284fa8e8d5t08bd4e1515ac971482 Read More & Comment...
11/03/2006 02:12 PM |
Since there's a general belief that the pharmaceutical industry invents new diseases, we thought we'd get in on the fun with Part D Denial Disorder or PD3.
The unfortunate symptoms of PD3 are easy to spot: feelings of inadequacy when it comes to the private sector, the irrational belief that senior citizens have no cognitive abilities and, non-dietary aversion to donut holes. A less severe but related condition has been identified as Pelosian Ideation Syndrome (PIS) -- which can manifest itself through both disorientation and lack of balance.
If you feel you may suffer from PD3 stop reading this blog immediately and log onto the Public Citizen website for immediate relief.
A new study, funded by PhRMA and conducted by the Amundson Group, shows (among other interesting things) that in 2005 the average Medicare beneficiary filled 2.5 prescriptions per month -- but in 2006 (and with Part D coverage) that number jumped to 4.0 prescriptions per month. (The study found that the increase was consistent across all ages.)
The study also measured the average out-of-pocket cost for each day's supply of medication. And to those PD3-free readers, the findings should come as no surprise -- a per unit measure shows a 74% reduction in patients' out-of-pocket costs from $1.58 BPD (Before Part D) to 40 cents APD (After Part D).
More access at lower cost. Pretty sweet double play.
As for positive patient outcomes, the study measured the impact of Part D on access to drugs for specific chronic conditions that are highly prevalent in the Medicare population: Alzheimer's disease, high cholesterol, diabetes, hypertension, and osteoporosis -- all conditions that are often undertreated.
For each of these chronic conditions, the study found that there was a significant increase in the number of prescriptions filled per month -- suggesting that patients with these conditions are getting treatment under Part D that they were not previously receiving.
Note: In rare but advanced cases of PD3, symptoms can also include the belief that chronic disease should not be treated early and aggressively and the inability to differentiate between Santa Claus and the Non-Interference Clause.
If, after reading this blog, you are experiencing feelings of guilt and inadequacy, please consult a specialist -- Dr. Mark McClellan.
To view the complete study, click on the link below:
http://www.phrma.org/files/Amundsen_Study.pdf Read More & Comment...
The unfortunate symptoms of PD3 are easy to spot: feelings of inadequacy when it comes to the private sector, the irrational belief that senior citizens have no cognitive abilities and, non-dietary aversion to donut holes. A less severe but related condition has been identified as Pelosian Ideation Syndrome (PIS) -- which can manifest itself through both disorientation and lack of balance.
If you feel you may suffer from PD3 stop reading this blog immediately and log onto the Public Citizen website for immediate relief.
A new study, funded by PhRMA and conducted by the Amundson Group, shows (among other interesting things) that in 2005 the average Medicare beneficiary filled 2.5 prescriptions per month -- but in 2006 (and with Part D coverage) that number jumped to 4.0 prescriptions per month. (The study found that the increase was consistent across all ages.)
The study also measured the average out-of-pocket cost for each day's supply of medication. And to those PD3-free readers, the findings should come as no surprise -- a per unit measure shows a 74% reduction in patients' out-of-pocket costs from $1.58 BPD (Before Part D) to 40 cents APD (After Part D).
More access at lower cost. Pretty sweet double play.
As for positive patient outcomes, the study measured the impact of Part D on access to drugs for specific chronic conditions that are highly prevalent in the Medicare population: Alzheimer's disease, high cholesterol, diabetes, hypertension, and osteoporosis -- all conditions that are often undertreated.
For each of these chronic conditions, the study found that there was a significant increase in the number of prescriptions filled per month -- suggesting that patients with these conditions are getting treatment under Part D that they were not previously receiving.
Note: In rare but advanced cases of PD3, symptoms can also include the belief that chronic disease should not be treated early and aggressively and the inability to differentiate between Santa Claus and the Non-Interference Clause.
If, after reading this blog, you are experiencing feelings of guilt and inadequacy, please consult a specialist -- Dr. Mark McClellan.
To view the complete study, click on the link below:
http://www.phrma.org/files/Amundsen_Study.pdf Read More & Comment...
11/03/2006 11:51 AM |
I know that lots of reporters are on leave or had very little time to go through the Family USA report. And FUSA knows that. The media was manipulated and used by FUSA and reporters should not be happy about it....The Family USA report continues to astound me...Here's a group that has been in favor of generic drug approvals and use and then turns around and claims that generic coverage is not meaningful, which is a weasel word for not having 100 percent of all drug costs covered for all seniors regardless of income or ability to pay. So much for means testing, right?
Another weasel word....generic equivalent instead of generic alternative. FUSA claims that most of the commonly used drugs have no generic equivalent, which means an exact copy. There are however, generic alternatives which might be cheaper and as effective (or not depending on the person) for all but 6 of the drugs FUSA lists. There are generic beta blockers, calcium channel blockers, pain relievers, anti-depressants, proton pump inhibitors, etc that FUSA ignored to paint a dire picture.
Finally, FUSA ignored the fact that many of the drugs on the Medicare formulary they regard as meaningul such as Aricept, Lipitor, Nexium, Prevacid, Evista, Celebrex...are not on the wonderful VA formulary it would use instead of the horrible private sector PBM model which by the way FUSA endorsed in 2000 when proposed by President Clinton and the Dems.
Another Media Miss....
Anti-Depressants Linked to Lower Suicide Rates
Researchers report an inverse relationship between antidepressant prescriptions and the rates of suicide in children and adolescents -- a finding that contradicts the Food and Drug Administration's "black box" warning for selective serotonin reuptake inhibitor medications, also known as SSRI drugs.
The University of Illinois at Chicago epidemiologic study appears in the November issue of the American Journal of Psychiatry.
The researchers examined suicide rates of children ages 5-14 in each county of the United States from 1996 to 1998 and county-level data on SSRI prescriptions. The results were adjusted for sex, race, income, access to quality mental health care and variations in county-to-county suicide rates.
"We found that counties with the highest prescription rates for SSRI drugs had the lowest suicide rates in children and adolescents," said the lead author Robert Gibbons, director of the Center for Health Statistics and professor of biostatistics and psychiatry at UIC. "This is just the opposite of what you would predict if SSRI's were producing suicide."
Yeah, which comports with meta-analyses of randomized clinical trials and other epidemiological studies. So in light of the media's reporting on the opposite -- based on a handful of questionably conducted small studies -- where's the coverage?
So what are reporters looking at? Drug marketing practices...what a shock.
Med schools warn of drug sales pitches
By David Caruso (AP)
No point giving you the whole article since it is such a time worn theme....the pizza, the prizes, it corrupts.
The punchline of course is delivered once again by Jerome Kassirer who of course is beyond reproach on all things medical....
"Dr. Jerome Kassirer, a professor at the Tufts School of Medicine and a frequent critic of the doctor-pharmaceutical relationship, said schools need to do more than just lecture.
"The question to ask yourself about these programs is: What are the faculty doing? Because if the students walk away from those sessions and find out their faculty are off speaking for Pfizer, what are they going to think?"
My answer: I can't wait till I get a crack at that too.....
Or better yet how about a universal ban on speaking fees for everyone. Why should Kassirer get paid to spout his views. Isn't that a conflict? If he was really comitted to his cause, he would do it for nothing. How do I know that the money given to him by a group is causing him to shade or shape his view?
Similarly, reporters give talks for money on their views of the world? Doesn't that make them appear less objective and blur the distinction between their obligation as journalists to inform and simply being paid to give their opinion. How do I know that a reporter is truly being objective when they are receiving outside income to provide their opinion?
Sorry, no hits this week. Let's see what election week brings.
PS. Here's a photo of my son Zach doing urban combat training in the Negev.. (He is the one on the left) Can I repeat again how proud I am of him? Anyone who knows John Kerry's email please forward... Read More & Comment...
Another weasel word....generic equivalent instead of generic alternative. FUSA claims that most of the commonly used drugs have no generic equivalent, which means an exact copy. There are however, generic alternatives which might be cheaper and as effective (or not depending on the person) for all but 6 of the drugs FUSA lists. There are generic beta blockers, calcium channel blockers, pain relievers, anti-depressants, proton pump inhibitors, etc that FUSA ignored to paint a dire picture.
Finally, FUSA ignored the fact that many of the drugs on the Medicare formulary they regard as meaningul such as Aricept, Lipitor, Nexium, Prevacid, Evista, Celebrex...are not on the wonderful VA formulary it would use instead of the horrible private sector PBM model which by the way FUSA endorsed in 2000 when proposed by President Clinton and the Dems.
Another Media Miss....
Anti-Depressants Linked to Lower Suicide Rates
Researchers report an inverse relationship between antidepressant prescriptions and the rates of suicide in children and adolescents -- a finding that contradicts the Food and Drug Administration's "black box" warning for selective serotonin reuptake inhibitor medications, also known as SSRI drugs.
The University of Illinois at Chicago epidemiologic study appears in the November issue of the American Journal of Psychiatry.
The researchers examined suicide rates of children ages 5-14 in each county of the United States from 1996 to 1998 and county-level data on SSRI prescriptions. The results were adjusted for sex, race, income, access to quality mental health care and variations in county-to-county suicide rates.
"We found that counties with the highest prescription rates for SSRI drugs had the lowest suicide rates in children and adolescents," said the lead author Robert Gibbons, director of the Center for Health Statistics and professor of biostatistics and psychiatry at UIC. "This is just the opposite of what you would predict if SSRI's were producing suicide."
Yeah, which comports with meta-analyses of randomized clinical trials and other epidemiological studies. So in light of the media's reporting on the opposite -- based on a handful of questionably conducted small studies -- where's the coverage?
So what are reporters looking at? Drug marketing practices...what a shock.
Med schools warn of drug sales pitches
By David Caruso (AP)
No point giving you the whole article since it is such a time worn theme....the pizza, the prizes, it corrupts.
The punchline of course is delivered once again by Jerome Kassirer who of course is beyond reproach on all things medical....
"Dr. Jerome Kassirer, a professor at the Tufts School of Medicine and a frequent critic of the doctor-pharmaceutical relationship, said schools need to do more than just lecture.
"The question to ask yourself about these programs is: What are the faculty doing? Because if the students walk away from those sessions and find out their faculty are off speaking for Pfizer, what are they going to think?"
My answer: I can't wait till I get a crack at that too.....
Or better yet how about a universal ban on speaking fees for everyone. Why should Kassirer get paid to spout his views. Isn't that a conflict? If he was really comitted to his cause, he would do it for nothing. How do I know that the money given to him by a group is causing him to shade or shape his view?
Similarly, reporters give talks for money on their views of the world? Doesn't that make them appear less objective and blur the distinction between their obligation as journalists to inform and simply being paid to give their opinion. How do I know that a reporter is truly being objective when they are receiving outside income to provide their opinion?
Sorry, no hits this week. Let's see what election week brings.
PS. Here's a photo of my son Zach doing urban combat training in the Negev.. (He is the one on the left) Can I repeat again how proud I am of him? Anyone who knows John Kerry's email please forward... Read More & Comment...
11/03/2006 09:45 AM |
Anybody else had enough of the AARP’s regular “Trends†reports on prescription drug pricing? I’d been tuning them out since the only difference from one report to the next was the date -- but Henry Waxman has reignited both my interest and my ire.
Let’s start with the actual report.
The first thing to note is that the AARP report relies on a measure of wholesale cost from a proprietary dataset – not the actual prices paid by cash customers. Patients with insurance (yes – like Part D) don’t ever see these prices. America’s insured focus their attention and anger on ever-rising co-pays (which increase many times-fold the price of the prescription medicines they are, in theory, linked to).
I think the folks over at Big Insurance (yes – like the AARP) have some ‘splaining to do.
Here's a link to the rest of the story ...
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=382532 Read More & Comment...
Let’s start with the actual report.
The first thing to note is that the AARP report relies on a measure of wholesale cost from a proprietary dataset – not the actual prices paid by cash customers. Patients with insurance (yes – like Part D) don’t ever see these prices. America’s insured focus their attention and anger on ever-rising co-pays (which increase many times-fold the price of the prescription medicines they are, in theory, linked to).
I think the folks over at Big Insurance (yes – like the AARP) have some ‘splaining to do.
Here's a link to the rest of the story ...
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=382532 Read More & Comment...
11/03/2006 08:36 AM |
One hundred years ago today, on November 3 1906, Alois Alzheimer, psychiatrist and pathologist, presented the first case of the disease that later came to bear his name in Tubingen Germany. The patient, Auguste D, developed dementia in her 50s and was so restless and confused that doctors prescribed balneotherapy - day long immersion in a lukewarm bath - to soothe her. When she was at her worst they knocked her out with chloroform.
According to an article in today's edition of The Independent (London), "A cure remains a distant dream."
Here is a link to that article:
http://news.independent.co.uk/world/science_technology/article1951233.ece
We must not allow the walls that stymie progress towards finding better treatments (and, ultimately, cures) to stand. President Bush, Dr. von Eschenbach, Dr. Zerhouni, members of Congress: Tear down these walls.
Aggressive measures are required and one important way we can help advance this agenda is to forcefully support, fund, debate, and participate in the FDA's Critical Path agenda. This is a core function of the Center for Medicine in the Public Interest (CMPI), the think tank home of drugwonks.com.
We invite you to join our crusade. Read More & Comment...
According to an article in today's edition of The Independent (London), "A cure remains a distant dream."
Here is a link to that article:
http://news.independent.co.uk/world/science_technology/article1951233.ece
We must not allow the walls that stymie progress towards finding better treatments (and, ultimately, cures) to stand. President Bush, Dr. von Eschenbach, Dr. Zerhouni, members of Congress: Tear down these walls.
Aggressive measures are required and one important way we can help advance this agenda is to forcefully support, fund, debate, and participate in the FDA's Critical Path agenda. This is a core function of the Center for Medicine in the Public Interest (CMPI), the think tank home of drugwonks.com.
We invite you to join our crusade. Read More & Comment...
11/02/2006 02:39 PM |
Medical schools train doctors to resist marketers' siren songs
The Associated Press By David B. Caruso
2 November 2006
NEW YORK (AP) - Medical schools in several states are strengthening programs that warn doctors and students not to be dazzled by drug company marketing practices.
DRUGWONKS TRANSLATION: Put on these sunglasses and place a wreath of garlic cloves in all examination rooms.
The Mount Sinai School of Medicine announced Wednesday that it would use a $400,000 grant to remind doctors to question sophisticated sales presentations and rely on solid science when deciding which medications to give patients.
DRUGWONKS TRANSLATION: So tell me, is your new product really more effective? Wow – did you see that shot! These are great seats.
The program is one of five receiving $1.9 million from the Attorney General Consumer and Prescriber Education Grant Program, which has awarded $11 million to 28 institutions interested in cautioning health care workers about pharmaceutical sales techniques.
DRUGWONKS TRANSLATION: Pharmaceutical sales representatives are really minions of Satan.
The Center for Evidence Based Policy at Oregon Health & Science University administers the grants.
DRUGWONKS TRANSLATION: When it comes to “evidence-based policy†we don’t really need evidence – and if you don’t agree you can give us back the check. That’s our policy.
One of the programs being implemented at Mount Sinai will be a new type of class at its Morchand Education Center, famous for training exercises in which actors play patients. For these new sessions, though, the actors will be playing pharmaceutical company sales representatives.
DRUGWONKS TRANSLATION: STELLAAAAA!!!!!!
Another part of Mount Sinai's program will advise health care providers how to tactfully deal with patients who see a drug on television and demand a prescription.
DRUGWONKS TRANSLATION: Hey – did you go to medical school too?
Money for the education programs comes from a $430 million settlement that resolved charges that pharmaceutical giant Pfizer Inc. illegally paid doctors to prescribe its drug Neurontin for uses that had not been approved by the U.S. Food and Drug Administration.
DRUGWONKS TRANSLATION: Providing better medical education is Job One. Actually, that’s wrong, sorry – demonizing the pharmaceutical industry is Job One. My bad.
The next $6.5 million in grants will be used to inform consumers on how drugs are prescribed and marketed, said the Center for Evidence Based Policy
DRUGWONKS TRANSLATION: And the third traunch will be used to fund a program on better health outcomes through collective farming. Read More & Comment...
The Associated Press By David B. Caruso
2 November 2006
NEW YORK (AP) - Medical schools in several states are strengthening programs that warn doctors and students not to be dazzled by drug company marketing practices.
DRUGWONKS TRANSLATION: Put on these sunglasses and place a wreath of garlic cloves in all examination rooms.
The Mount Sinai School of Medicine announced Wednesday that it would use a $400,000 grant to remind doctors to question sophisticated sales presentations and rely on solid science when deciding which medications to give patients.
DRUGWONKS TRANSLATION: So tell me, is your new product really more effective? Wow – did you see that shot! These are great seats.
The program is one of five receiving $1.9 million from the Attorney General Consumer and Prescriber Education Grant Program, which has awarded $11 million to 28 institutions interested in cautioning health care workers about pharmaceutical sales techniques.
DRUGWONKS TRANSLATION: Pharmaceutical sales representatives are really minions of Satan.
The Center for Evidence Based Policy at Oregon Health & Science University administers the grants.
DRUGWONKS TRANSLATION: When it comes to “evidence-based policy†we don’t really need evidence – and if you don’t agree you can give us back the check. That’s our policy.
One of the programs being implemented at Mount Sinai will be a new type of class at its Morchand Education Center, famous for training exercises in which actors play patients. For these new sessions, though, the actors will be playing pharmaceutical company sales representatives.
DRUGWONKS TRANSLATION: STELLAAAAA!!!!!!
Another part of Mount Sinai's program will advise health care providers how to tactfully deal with patients who see a drug on television and demand a prescription.
DRUGWONKS TRANSLATION: Hey – did you go to medical school too?
Money for the education programs comes from a $430 million settlement that resolved charges that pharmaceutical giant Pfizer Inc. illegally paid doctors to prescribe its drug Neurontin for uses that had not been approved by the U.S. Food and Drug Administration.
DRUGWONKS TRANSLATION: Providing better medical education is Job One. Actually, that’s wrong, sorry – demonizing the pharmaceutical industry is Job One. My bad.
The next $6.5 million in grants will be used to inform consumers on how drugs are prescribed and marketed, said the Center for Evidence Based Policy
DRUGWONKS TRANSLATION: And the third traunch will be used to fund a program on better health outcomes through collective farming. Read More & Comment...
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