Latest Drugwonks' Blog
According to a Page One story in the March 3rd edition of The Wall Street Journal, "The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself."
But what is entirely missing from the story (by the generally excellent reporter Anna Mathews) is that the FDA has never been given a budget to build a new system.
Want better adverse event reporting? Want better post-marketing surveillance? Want better data mining opportunities?
Show me the money!
But what is entirely missing from the story (by the generally excellent reporter Anna Mathews) is that the FDA has never been given a budget to build a new system.
Want better adverse event reporting? Want better post-marketing surveillance? Want better data mining opportunities?
Show me the money!
The NHS (the British National Health Service) is taking the threat of counterfeit drugs seriously. Health officials have warned that patients are being put at risk by counterfeiters targeting the UK's NHS supply chain.
According to Naem Ahmed the head of intelligence at the MHRA (the Medicines and Healthcare Products Regulatory Agency), counterfeiters have become more confident and bolder in their illegal activities. "If you trade over the internet the risk of detection is low, but you only sell a pack here and a pack there. If you penetrate the supply chain, there is a higher risk, but you can make a lot of money."
And the weak link in the chain? Parallel trade.
According to Naem Ahmed the head of intelligence at the MHRA (the Medicines and Healthcare Products Regulatory Agency), counterfeiters have become more confident and bolder in their illegal activities. "If you trade over the internet the risk of detection is low, but you only sell a pack here and a pack there. If you penetrate the supply chain, there is a higher risk, but you can make a lot of money."
And the weak link in the chain? Parallel trade.
Just returned from Italy where (as a guest of the Bruno Leoni Institute) I spoke in Rome, Genoa, and Milan on the issue of Evidence Based Medicine. Why Italy? Because, as in many other EU nations, the issue of "saving" money by restricting formularies has reached epidemic proportions. Patients are unhappy. Doctors are unhappy. And officials (both elected and career) are frightened -- as they should be after watching what's going in the UK and Germany --that denying health care will, inevitably, become a political hot potato. After all, as one Italian official said to me, "Why should the Heath Minister behave like the junior Finance Minister?"
Why indeed?
Here is how the Italian media reported on both my visit and this urgent transatlantic public health issue:
From Il Giornale:
http://www.ilgiornale.it/a.pic1?ID=161202
And Il Tempo:
http://www.iltempo.it/approfondimenti/index.aspx?id=1146342&Sectionid=8&Editionid=8
And, yes, the food was magnificent.
Why indeed?
Here is how the Italian media reported on both my visit and this urgent transatlantic public health issue:
From Il Giornale:
http://www.ilgiornale.it/a.pic1?ID=161202
And Il Tempo:
http://www.iltempo.it/approfondimenti/index.aspx?id=1146342&Sectionid=8&Editionid=8
And, yes, the food was magnificent.
Very disturbing article about how the new CBO direct appears to be pulling together a panel to apply evidence based medicine (EBM) and cost-effectiveness measures to decide how to squeeze spending out of the the federal health care budget. In essence he is proposing a CBO version of the the UK's National Institute for Clinical Excellence (NICE) with the added feature that unlike NICE, CBO will be in the business of making both clinical and budgetary decisions....
CBO Forming Panel to Examine Slowing
Health Care Cost Growth, Director Says
The Congressional Budget Office is forming a health care advisory group to help CBO craft options for slowing health care growth, with a first meeting set for May, CBO Director Peter R. Orszag said March 2.
In an interview with BNA reporters and editors, Orszag said the panel would be comprised of health care experts such as visiting fellows who will be charged with helping find options to limit health care cost growth.
Orszag in the past has said the advisory panel would be patterned after the CBO's current panel of economics advisers, and also would aid the agency in improving scoring of complicated health care proposals.
Orszag told BNA that rapidly rising health care spending is the biggest threat to the nation's fiscal health. The advisory group will help produce analytical papers on options for curbing rising spending in ways that will not adversely affect Americans' health, he said.
Rising Costs
"We have to take the cost growth out of health care without harming health," he said.
Rising health care costs are more of a threat to the nation's fiscal health than the expected influx of baby-boomers into federal health care programs such as Medicare, he added.
For example, the panel likely will examine such options as the benefits that health information technology and the comparative effectiveness information on medical procedures could have in slowing cost growth, Orszag said.
Orszag said there is a "substantial amount of evidence" that the health care spending has reached "the flat part of the curve" in which increased health care spending is not necessarily producing increased health care benefits.
Which evidence is that? Added quality of life from new drugs for cancer? Alzheimer's? HIV? New vaccines for HPV?
Orszag said he will spend "a very substantial share of my time helping to bend that curve."
How? By using an arbitrary cut of a 50K for a quality of life year like they do in the UK?
Reducing spending in Medicare and Medicaid likely will only shift costs to other parts of the health care system, doing little to sustain the overall health care system or those federal health care programs, he added.
In a budget options paper released Feb. 23, CBO put forward numerous options for trimming federal health care spending. For example, the report said paying Medicare managed care plans the same rate as fee-for-service plans could save $65 billion over five years.
Meaning, we can cut risk adjusted payments for the sickest seniors that are designed to treat them and keep them healthy and integrate their care....
I can't wait to see how many of the panel from from the left wing funded Prescription Project or IMAP. Any bets that Jerry Avorn, supporter of ALLHAT (the modern day Tuskegee experiment) will be annointed?
CBO Forming Panel to Examine Slowing
Health Care Cost Growth, Director Says
The Congressional Budget Office is forming a health care advisory group to help CBO craft options for slowing health care growth, with a first meeting set for May, CBO Director Peter R. Orszag said March 2.
In an interview with BNA reporters and editors, Orszag said the panel would be comprised of health care experts such as visiting fellows who will be charged with helping find options to limit health care cost growth.
Orszag in the past has said the advisory panel would be patterned after the CBO's current panel of economics advisers, and also would aid the agency in improving scoring of complicated health care proposals.
Orszag told BNA that rapidly rising health care spending is the biggest threat to the nation's fiscal health. The advisory group will help produce analytical papers on options for curbing rising spending in ways that will not adversely affect Americans' health, he said.
Rising Costs
"We have to take the cost growth out of health care without harming health," he said.
Rising health care costs are more of a threat to the nation's fiscal health than the expected influx of baby-boomers into federal health care programs such as Medicare, he added.
For example, the panel likely will examine such options as the benefits that health information technology and the comparative effectiveness information on medical procedures could have in slowing cost growth, Orszag said.
Orszag said there is a "substantial amount of evidence" that the health care spending has reached "the flat part of the curve" in which increased health care spending is not necessarily producing increased health care benefits.
Which evidence is that? Added quality of life from new drugs for cancer? Alzheimer's? HIV? New vaccines for HPV?
Orszag said he will spend "a very substantial share of my time helping to bend that curve."
How? By using an arbitrary cut of a 50K for a quality of life year like they do in the UK?
Reducing spending in Medicare and Medicaid likely will only shift costs to other parts of the health care system, doing little to sustain the overall health care system or those federal health care programs, he added.
In a budget options paper released Feb. 23, CBO put forward numerous options for trimming federal health care spending. For example, the report said paying Medicare managed care plans the same rate as fee-for-service plans could save $65 billion over five years.
Meaning, we can cut risk adjusted payments for the sickest seniors that are designed to treat them and keep them healthy and integrate their care....
I can't wait to see how many of the panel from from the left wing funded Prescription Project or IMAP. Any bets that Jerry Avorn, supporter of ALLHAT (the modern day Tuskegee experiment) will be annointed?
Hillary takes credit for starting the health IT revolution at the VA. Given recent reports of health records being stolen and then showing up again unannounced, it sure looks like
it...
Last month, as the following article from computerworld.com shows, " a portable hard drive with information on up to 1.8 million veterans and doctors had been reported missing from its medical center in Birmingham, Ala., on Jan. 22."
VA slow to strengthen IT security
it...
Last month, as the following article from computerworld.com shows, " a portable hard drive with information on up to 1.8 million veterans and doctors had been reported missing from its medical center in Birmingham, Ala., on Jan. 22."
VA slow to strengthen IT security
Churchill defined a fanatic as someone who can't change his mind and won't change the subject.
Submitted for your consideration Henry Waxman, who continually grinds out studies showing that when government sets drug prices the prices will be lower because it is a monopoly buyer and who endlessly trots out the the case study against academic tenure, Gerard Anderson of Johns Hopkins, to say that other countries negotiate lower prices so we can too, ignoring how other countries systematically starve their systems of new medicines.
So what else is new? We can have low prices and fewer choices..just vote for it. But didn't Democrats scatter like pollen when it came time to put real teeth into a direct negotiation for Medicare?
Drain profits out of drug companies. No problem. Just watch capital flow out of biotech firms including stem cell investment.
I think Waxman might point out that drug companies warned of a loss of investment before generic drug competition and Medicaid rebates and R and D spending has done up. But he ignores the fact the companies were able to increase market prices to offset government policies and many new drugs came on to the scene during the 1990's that were first in class. In otherwords, pricing freedom and innovative products saved the day. What he's talking about now is capping prices and profits on breakthrough drugs now and in the future. And introducing patent stripping legislation with watered down safety standards that mandate generic biologics as 100 percent interchangeable to help them gain market share.
Now that's a fanatic.
Submitted for your consideration Henry Waxman, who continually grinds out studies showing that when government sets drug prices the prices will be lower because it is a monopoly buyer and who endlessly trots out the the case study against academic tenure, Gerard Anderson of Johns Hopkins, to say that other countries negotiate lower prices so we can too, ignoring how other countries systematically starve their systems of new medicines.
So what else is new? We can have low prices and fewer choices..just vote for it. But didn't Democrats scatter like pollen when it came time to put real teeth into a direct negotiation for Medicare?
Drain profits out of drug companies. No problem. Just watch capital flow out of biotech firms including stem cell investment.
I think Waxman might point out that drug companies warned of a loss of investment before generic drug competition and Medicaid rebates and R and D spending has done up. But he ignores the fact the companies were able to increase market prices to offset government policies and many new drugs came on to the scene during the 1990's that were first in class. In otherwords, pricing freedom and innovative products saved the day. What he's talking about now is capping prices and profits on breakthrough drugs now and in the future. And introducing patent stripping legislation with watered down safety standards that mandate generic biologics as 100 percent interchangeable to help them gain market share.
Now that's a fanatic.
Spreading fear for profit:
Media, lawyers and interest groups gang up on vaccinations
By JOHN STOSSEL
We can scare ourselves stupid.
Consider vaccines. Robert F. Kennedy Jr. says the mercury in them has "poisoned an entire generation! It's causing IQ loss, mental retardation, speech delay, language delay, ADD, hyperactivity!"
The news media love this kind of story. They repeatedly invite Barbara Loe Fisher, who heads the Vaccine Information Center, to tell parents about vaccine risks. She warns of "seizures, brain inflammation, collapse shock, and, of course ... death."
Causing autism is the biggest accusation. "Before kids received so many vaccines," says Fisher, "you didn't see autistic children. ... We can't build the special-education classrooms fast enough now to accommodate all these sick and disabled children."
Do vaccines cause autism?
Almost certainly not. Dr. Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia, told me, "It's perfectly reasonable to be skeptical about anything you put into your body, including vaccines. And vaccines do have side effects. But vaccines don't cause autism."
He speaks with confidence because the National Academy of Sciences recently reviewed the research and concluded that 19 major studies tracking thousands of kids show no link between vaccines and autism: www.iom.edu/ CMS/3793/4705/20155.aspx "The question has been raised; it's been answered," Offit says.
Then why are so many kids diagnosed as autistic today? As March of Dimes researchers put it, "Changes in diagnosis account for the observed increase in autism." Sure enough, California data show the rise in autism diagnoses almost exactly matches a drop in retardation cases.
"People that we once called quirky or geeky or nerdy are now called autistic," Offit said, "because when you give that label of, say, autistic spectrum disorder, you allow that child then to qualify for services."
Imagine that. A trendy diagnosis being driven by government-paid services.
Vaccine opponents are unconvinced. After my recent TV program "Scared Stiff," they told me they "know" that vaccines caused their child's autism. "Nothing else could have done it."
My heart goes out to parents struggling to help their autistic children, but I fear they have been misled by another anti-drug-industry scare campaign.
I know something about those from personal experience. Twenty years ago, "20/20" interviewed Allen McDowell, a lawyer who said the whooping-cough vaccine was defective. After our alarming report, many parents told their kids' pediatricians they didn't want the vaccine. Some doctors became vaccine-shy.
When my daughter got a fever after one of the vaccines, her doctor decided not to give her the final shot. He said my being a "20/20" correspondent made him even more anxious about the vaccine.
And a short time afterward, my daughter got whooping cough. Luckily, she recovered.
But after media reports like "20/20's" and well-publicized lawsuits, many people refuse to vaccinate their children. And America now sees more cases of whooping cough, mumps, and measles.
Says Offit: "Watch a child come into the hospital and die of measles, knowing that it can be safely and easily prevented by vaccines. It's very hard to live with that."
But Barbara Fisher of the Vaccine Information Center is unmoved. When I asked if vaccines have done more good than harm, she said the matter is "complex."
Lawyer McDowell claims his lawsuits made the vaccine safer. "I'm doing a service for the public," he says.
Nonsense, Offit says. Lawyers didn't make the vaccines better: "There was always an interest in trying to make that vaccine safer, but the science had to catch up to that." He added, "There's a certain profiteering that comes with fear."
Lawyers, the media, and interest groups do profit from spreading fear.
McDowell is now considering new lawsuits claiming that vaccines cause autism. I said to him, "You scare people and make money off it!" After a pause, he replied, "True."
Media, lawyers and interest groups gang up on vaccinations
By JOHN STOSSEL
We can scare ourselves stupid.
Consider vaccines. Robert F. Kennedy Jr. says the mercury in them has "poisoned an entire generation! It's causing IQ loss, mental retardation, speech delay, language delay, ADD, hyperactivity!"
The news media love this kind of story. They repeatedly invite Barbara Loe Fisher, who heads the Vaccine Information Center, to tell parents about vaccine risks. She warns of "seizures, brain inflammation, collapse shock, and, of course ... death."
Causing autism is the biggest accusation. "Before kids received so many vaccines," says Fisher, "you didn't see autistic children. ... We can't build the special-education classrooms fast enough now to accommodate all these sick and disabled children."
Do vaccines cause autism?
Almost certainly not. Dr. Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia, told me, "It's perfectly reasonable to be skeptical about anything you put into your body, including vaccines. And vaccines do have side effects. But vaccines don't cause autism."
He speaks with confidence because the National Academy of Sciences recently reviewed the research and concluded that 19 major studies tracking thousands of kids show no link between vaccines and autism: www.iom.edu/ CMS/3793/4705/20155.aspx "The question has been raised; it's been answered," Offit says.
Then why are so many kids diagnosed as autistic today? As March of Dimes researchers put it, "Changes in diagnosis account for the observed increase in autism." Sure enough, California data show the rise in autism diagnoses almost exactly matches a drop in retardation cases.
"People that we once called quirky or geeky or nerdy are now called autistic," Offit said, "because when you give that label of, say, autistic spectrum disorder, you allow that child then to qualify for services."
Imagine that. A trendy diagnosis being driven by government-paid services.
Vaccine opponents are unconvinced. After my recent TV program "Scared Stiff," they told me they "know" that vaccines caused their child's autism. "Nothing else could have done it."
My heart goes out to parents struggling to help their autistic children, but I fear they have been misled by another anti-drug-industry scare campaign.
I know something about those from personal experience. Twenty years ago, "20/20" interviewed Allen McDowell, a lawyer who said the whooping-cough vaccine was defective. After our alarming report, many parents told their kids' pediatricians they didn't want the vaccine. Some doctors became vaccine-shy.
When my daughter got a fever after one of the vaccines, her doctor decided not to give her the final shot. He said my being a "20/20" correspondent made him even more anxious about the vaccine.
And a short time afterward, my daughter got whooping cough. Luckily, she recovered.
But after media reports like "20/20's" and well-publicized lawsuits, many people refuse to vaccinate their children. And America now sees more cases of whooping cough, mumps, and measles.
Says Offit: "Watch a child come into the hospital and die of measles, knowing that it can be safely and easily prevented by vaccines. It's very hard to live with that."
But Barbara Fisher of the Vaccine Information Center is unmoved. When I asked if vaccines have done more good than harm, she said the matter is "complex."
Lawyer McDowell claims his lawsuits made the vaccine safer. "I'm doing a service for the public," he says.
Nonsense, Offit says. Lawyers didn't make the vaccines better: "There was always an interest in trying to make that vaccine safer, but the science had to catch up to that." He added, "There's a certain profiteering that comes with fear."
Lawyers, the media, and interest groups do profit from spreading fear.
McDowell is now considering new lawsuits claiming that vaccines cause autism. I said to him, "You scare people and make money off it!" After a pause, he replied, "True."
For those who want to spend more on filling the donut hole...here's a reminder of what we face unless we make Medicare more market driven, prospective and patient centered..(from the Drudge Report)
U.S. COMPTROLLER: PRESCRIPTION DRUG BILL 'MAY BE THE MOST FINANCIALLY IRRESPONSIBLE LAW IN 40 YEARS'; Bill Will Add $8 Trillion to Long-Term Medicare Obligations
Thu Mar 1 2007 13:41:11 ET
That Could Already Bankrupt the U.S.
The U.S. government's top accountant says the law that added a prescription drug benefit to Medicare may be the most financially irresponsible legislation passed since the 1960s. U.S. Comptroller General David Walker says Medicare -- barring vast reform to the program and the nation's healthcare system -- is already on course to possibly bankrupt the treasury and adding the prescription bill just makes the situation worse. Walker appears in a Steve Kroft report to be broadcast on 60 MINUTES Sunday, March 4 (7:00-8:00 PM, ET/PT) on the CBS Television Network.
"The prescription drug bill is probably the most fiscally irresponsible piece of legislation since the 1960s," says Walker, "because we promise way more than we can afford to keep." He argues that the federal government would need to have $8 trillion today, invested at treasury rates, to cover the gap between what the program is expected to take in and what it is expected to cost over the next 75 years à and that is in addition to more than $20 trillion that will be needed to pay for other parts of Medicare. "We can't afford to keep the promises we've already made, much less to be piling on top of them," he tells Kroft.
The problem is the baby boomers. The 78 million people born between 1946 and 1964 start becoming eligible for Social Security benefits next year. "They'll be eligible for Medicare just three years later and when those boomers start retiring en masse, then that will be a tsunami of spending that could swamp our ship of state if we don't get serious," says Walker.
As life expectancies increase and the cost of health care continues to rise at twice the rate of inflation, radical reform in health care will be necessary, Walker says. He says the federal government is also going to have to find ways to increase revenue and reduce benefits. The alternative is ugly. Walker shows Kroft General Accounting Office long-term projections that assume the status quo continues, with the same levels of taxation, spending, and economic growth. By the year 2040, Walker says, "If nothing changes, the federal government is not going to be able to do much more than pay interest on the mounting debt and some entitlement benefits. It won't have money left for anything else...."
Sen, Kent Conrad (D-N.D.), chairman of the Senate Budget Committee, tells Kroft that this problem is well known among members of Congress: "Yes, they know in large measure, Republicans and Democrats, that we are on a course that doesn't add up." And he acknowledges nobody is addressing the matter. Why? "Because it's always easier not to," Conrad says, "because it's always easier to defer, to kick the can down the road to avoid making choicesÉYou get in trouble in politics when you make choices."
Walker believes the biggest problem may be that everything seems okay now, so people don't have the sense of urgency that's needed to make tough choices. But the longer we wait, he argues, the harder it's going to be to solve the problem. "The fact is that we don't face an immediate crisis and so people say, ÔWhat's the problem?' The answer is, we suffer from a fiscal cancer...and if we do not treat it, it could have catastrophic consequences for our country," he tells Kroft.
U.S. COMPTROLLER: PRESCRIPTION DRUG BILL 'MAY BE THE MOST FINANCIALLY IRRESPONSIBLE LAW IN 40 YEARS'; Bill Will Add $8 Trillion to Long-Term Medicare Obligations
Thu Mar 1 2007 13:41:11 ET
That Could Already Bankrupt the U.S.
The U.S. government's top accountant says the law that added a prescription drug benefit to Medicare may be the most financially irresponsible legislation passed since the 1960s. U.S. Comptroller General David Walker says Medicare -- barring vast reform to the program and the nation's healthcare system -- is already on course to possibly bankrupt the treasury and adding the prescription bill just makes the situation worse. Walker appears in a Steve Kroft report to be broadcast on 60 MINUTES Sunday, March 4 (7:00-8:00 PM, ET/PT) on the CBS Television Network.
"The prescription drug bill is probably the most fiscally irresponsible piece of legislation since the 1960s," says Walker, "because we promise way more than we can afford to keep." He argues that the federal government would need to have $8 trillion today, invested at treasury rates, to cover the gap between what the program is expected to take in and what it is expected to cost over the next 75 years à and that is in addition to more than $20 trillion that will be needed to pay for other parts of Medicare. "We can't afford to keep the promises we've already made, much less to be piling on top of them," he tells Kroft.
The problem is the baby boomers. The 78 million people born between 1946 and 1964 start becoming eligible for Social Security benefits next year. "They'll be eligible for Medicare just three years later and when those boomers start retiring en masse, then that will be a tsunami of spending that could swamp our ship of state if we don't get serious," says Walker.
As life expectancies increase and the cost of health care continues to rise at twice the rate of inflation, radical reform in health care will be necessary, Walker says. He says the federal government is also going to have to find ways to increase revenue and reduce benefits. The alternative is ugly. Walker shows Kroft General Accounting Office long-term projections that assume the status quo continues, with the same levels of taxation, spending, and economic growth. By the year 2040, Walker says, "If nothing changes, the federal government is not going to be able to do much more than pay interest on the mounting debt and some entitlement benefits. It won't have money left for anything else...."
Sen, Kent Conrad (D-N.D.), chairman of the Senate Budget Committee, tells Kroft that this problem is well known among members of Congress: "Yes, they know in large measure, Republicans and Democrats, that we are on a course that doesn't add up." And he acknowledges nobody is addressing the matter. Why? "Because it's always easier not to," Conrad says, "because it's always easier to defer, to kick the can down the road to avoid making choicesÉYou get in trouble in politics when you make choices."
Walker believes the biggest problem may be that everything seems okay now, so people don't have the sense of urgency that's needed to make tough choices. But the longer we wait, he argues, the harder it's going to be to solve the problem. "The fact is that we don't face an immediate crisis and so people say, ÔWhat's the problem?' The answer is, we suffer from a fiscal cancer...and if we do not treat it, it could have catastrophic consequences for our country," he tells Kroft.
Drugwonks and CMPI has always been open (why should hide it) about the fact we receive support from pharmaceutical and biotech firms. The last time we looked, there are few industries that actually spend time and money making things that actually heal people and save lives and I have said and wrote in countless settings when called a tool of Big Pharma or some other tired compliment, it is a personal passion of mine to speak up for the scientists and researchers who dedicate their time and effort to discovering and developing and commercializing new medicines. The last time I looked, the critics of industry -- and some criticisms are valid -- haven't developed a new drug, nor have the models they propose -- killing off drug companies in favor of drug discovery/development combines that they would run or would have their own hand-picked people run that in turn would have the standards for approving, prescribing and paying for medicines set by a similar bunch of "untainted" experts would be a disaster, the equivalent of the outpatient unit at Walter Reed.
But that debate is for another day. The point here is the aura of objectivity the critics tend bask in because they are given a free pass by the media. Has the media ever explored the financial and ideological conflicts of the critics? For instance, David Blumenthal, a integral part of the IOM Drug Safety committee has been both a recipient of Commonwealth grants and a reviewer to decide who gets what for the liberal health foundation. Blumenthal is also head of an organization called The Institute on Medicine as a Profession (IMAP) which according to it's website "aims to set forth a vision for professionalism in the 21st century and to promote that vision through research and policy initiatives. "
IMAP received a $7.5 million grant from George Soros who made his money in part from wrecking currencies. IMAP is part of a new venture called The Prescription Project, which is funded by Community Catylst, which in turn is funded by the same group that funds the liberal Families USA which also receives money from Soros. The Prescription Project is being funded by the Pew Charitable Trust to the tune of $6 million but is also linked to the Prescription Access Litigation Project through its affiliation with Community Catalyst. That project is comprised of the largest tort lawyers suing drug companies for a variety of reasons.
The Prescription Project is designed to end companies from having any contact with doctors or patients whatsoever. As the project notes: "Public and private payers spend billions of dollars a year on prescription drugs. When these payers rely on information from industry marketing campaigns rather than unbiased scientific studies, the result is higher cost and poorer quality."
I guess the unbiased scientific studies they have in mind are ALLHAT, CATIE, and the NICE study recommending that the UK's health system not pay for Alzheimer's drugs and new cancer drugs...but that is for another day too
Now guess who is on the board of The Prescription Project: I have done the work for you.
* Jerry Avorn, M.D. Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital
* Patrick J. Brennen, MD, Chief of Clincial Effectiveness and Quality Improvement of the University of Pennsylvania Health System
* David L. Coleman, MD, Chairman, Department of Medicine of Boston University
* Cathy DeAngelis, MD, Editor-in-Chief of JAMA
* Sharon Levine, MD, Associate Executive Director of Kaiser Permanente
* John E. McDonough, Ph.D. Executive Director, Health Care For All, Massachusetts
* Steven Nissen, MD, President of the American College of Cardiology
* Philip A. Pizzo, MD, Dean of the Stanford School of Medicine
PS. Health Care For All is affiliated with Community Catalyst and Families USA
Levine is probably best known for appearing, with her co-star, Jerry Avorn, in the ABC Special hosted by the late Peter Jennings (HMO companies, executive producers) to argue that the rise in the use of new medicine was completely the result of drug ads and added nothing to health.
And Nissen still believes that it is ok to hype the cardiovascular risks associated with drugs for ADHD are dangerous because there is no way so many kids are really ADHD
The fact is, these groups want to advance an agenda. They are receiving funding from liberal foundations to support this agenda. With respect to Blumenthal, it is sad that he was allowed to be on the IOM committee but Nobel Prize winners with real experience in drug development were not by the committee's chair because of conflicts. It is apparent that only one type of relationship is considered wrong: an association with a pharmaceutical firm. I
guess you can take money from currency wreckers who want to de-Nazify America (Soros) and that's ok or liberal foundations and not be conflicted. If history tells us anything the people who are driven by ideology are more willing to twist the truth (e.g. Marcia Angell still claiming that all drugs in a class are equally effective) to advance a political agenda. That is what the Prescription Project and the rest really are. How do we know that Blumenthal's judgment as an IOM member wasn't influenced by his ideology? What about the fact that both of his projects could benefit from the IOM recommendations including the recommendation for lots of evidence based medicine type studies?
But that debate is for another day. The point here is the aura of objectivity the critics tend bask in because they are given a free pass by the media. Has the media ever explored the financial and ideological conflicts of the critics? For instance, David Blumenthal, a integral part of the IOM Drug Safety committee has been both a recipient of Commonwealth grants and a reviewer to decide who gets what for the liberal health foundation. Blumenthal is also head of an organization called The Institute on Medicine as a Profession (IMAP) which according to it's website "aims to set forth a vision for professionalism in the 21st century and to promote that vision through research and policy initiatives. "
IMAP received a $7.5 million grant from George Soros who made his money in part from wrecking currencies. IMAP is part of a new venture called The Prescription Project, which is funded by Community Catylst, which in turn is funded by the same group that funds the liberal Families USA which also receives money from Soros. The Prescription Project is being funded by the Pew Charitable Trust to the tune of $6 million but is also linked to the Prescription Access Litigation Project through its affiliation with Community Catalyst. That project is comprised of the largest tort lawyers suing drug companies for a variety of reasons.
The Prescription Project is designed to end companies from having any contact with doctors or patients whatsoever. As the project notes: "Public and private payers spend billions of dollars a year on prescription drugs. When these payers rely on information from industry marketing campaigns rather than unbiased scientific studies, the result is higher cost and poorer quality."
I guess the unbiased scientific studies they have in mind are ALLHAT, CATIE, and the NICE study recommending that the UK's health system not pay for Alzheimer's drugs and new cancer drugs...but that is for another day too
Now guess who is on the board of The Prescription Project: I have done the work for you.
* Jerry Avorn, M.D. Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital
* Patrick J. Brennen, MD, Chief of Clincial Effectiveness and Quality Improvement of the University of Pennsylvania Health System
* David L. Coleman, MD, Chairman, Department of Medicine of Boston University
* Cathy DeAngelis, MD, Editor-in-Chief of JAMA
* Sharon Levine, MD, Associate Executive Director of Kaiser Permanente
* John E. McDonough, Ph.D. Executive Director, Health Care For All, Massachusetts
* Steven Nissen, MD, President of the American College of Cardiology
* Philip A. Pizzo, MD, Dean of the Stanford School of Medicine
PS. Health Care For All is affiliated with Community Catalyst and Families USA
Levine is probably best known for appearing, with her co-star, Jerry Avorn, in the ABC Special hosted by the late Peter Jennings (HMO companies, executive producers) to argue that the rise in the use of new medicine was completely the result of drug ads and added nothing to health.
And Nissen still believes that it is ok to hype the cardiovascular risks associated with drugs for ADHD are dangerous because there is no way so many kids are really ADHD
The fact is, these groups want to advance an agenda. They are receiving funding from liberal foundations to support this agenda. With respect to Blumenthal, it is sad that he was allowed to be on the IOM committee but Nobel Prize winners with real experience in drug development were not by the committee's chair because of conflicts. It is apparent that only one type of relationship is considered wrong: an association with a pharmaceutical firm. I
guess you can take money from currency wreckers who want to de-Nazify America (Soros) and that's ok or liberal foundations and not be conflicted. If history tells us anything the people who are driven by ideology are more willing to twist the truth (e.g. Marcia Angell still claiming that all drugs in a class are equally effective) to advance a political agenda. That is what the Prescription Project and the rest really are. How do we know that Blumenthal's judgment as an IOM member wasn't influenced by his ideology? What about the fact that both of his projects could benefit from the IOM recommendations including the recommendation for lots of evidence based medicine type studies?
Another fine piece by Marilyn Chase (with Jacob Goldstein) in the WSJ on new HIV drugs...
http://online.wsj.com/article/SB117263482927121688-search.html?KEYWORDS=marilyn+chase&COLLECTION=wsjie/6month
The WSJ article (and other media reports) describe the performance of new HIV drugs as "a really remarkable development". Left unsaid is that all these drugs are highly targeted with respect to the mutations of the HIV virus they either attack or block. In particular, Pfizer Inc.'s maraviroc will be launched in combination with a diagnostic called Trofile made by Monogram Biosciences. According to Monogram, the " Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients." Doctors and patieents used the assay throughout the clinical development of maraviroc a patient's likelihood for response and avoid side effects. If approved the combination will help determine if someone will benefit from the drug. (It will be hard for the UK or Canada to deny paying for this drug on any other grounds than to say we don't want to spend the money on saving lives..)
But the FDA will get little additional money to support expanding this approach to development relative to what the fear mongers want to spend on post market clinical trials.....
The WSJ article (and other media reports) describe the performance of new HIV drugs as "a really remarkable development". Left unsaid is that all these drugs are highly targeted with respect to the mutations of the HIV virus they either attack or block. In particular, Pfizer Inc.'s maraviroc will be launched in combination with a diagnostic called Trofile made by Monogram Biosciences. According to Monogram, the " Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients." Doctors and patieents used the assay throughout the clinical development of maraviroc a patient's likelihood for response and avoid side effects. If approved the combination will help determine if someone will benefit from the drug. (It will be hard for the UK or Canada to deny paying for this drug on any other grounds than to say we don't want to spend the money on saving lives..)
But the FDA will get little additional money to support expanding this approach to development relative to what the fear mongers want to spend on post market clinical trials.....
http://online.wsj.com/article/SB117263482927121688-search.html?KEYWORDS=marilyn+chase&COLLECTION=wsjie/6month
The WSJ article (and other media reports) describe the performance of new HIV drugs as "a really remarkable development". Left unsaid is that all these drugs are highly targeted with respect to the mutations of the HIV virus they either attack or block. In particular, Pfizer Inc.'s maraviroc will be launched in combination with a diagnostic called Trofile made by Monogram Biosciences. According to Monogram, the " Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients." Doctors and patieents used the assay throughout the clinical development of maraviroc a patient's likelihood for response and avoid side effects. If approved the combination will help determine if someone will benefit from the drug. (It will be hard for the UK or Canada to deny paying for this drug on any other grounds than to say we don't want to spend the money on saving lives..)
But the FDA will get little additional money to support expanding this approach to development relative to what the fear mongers want to spend on post market clinical trials.....
The WSJ article (and other media reports) describe the performance of new HIV drugs as "a really remarkable development". Left unsaid is that all these drugs are highly targeted with respect to the mutations of the HIV virus they either attack or block. In particular, Pfizer Inc.'s maraviroc will be launched in combination with a diagnostic called Trofile made by Monogram Biosciences. According to Monogram, the " Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients." Doctors and patieents used the assay throughout the clinical development of maraviroc a patient's likelihood for response and avoid side effects. If approved the combination will help determine if someone will benefit from the drug. (It will be hard for the UK or Canada to deny paying for this drug on any other grounds than to say we don't want to spend the money on saving lives..)
But the FDA will get little additional money to support expanding this approach to development relative to what the fear mongers want to spend on post market clinical trials.....