Latest Drugwonks' Blog
According to the Wall Street Journal (and other media) "Congressional Democrats began a push for more Food and Drug Administration funding, saying the agency lacks the resources to deal with risks to consumers and pressing the agency's head to endorse more spending."
Now as far as Andy tin cupping -- that's not going to happen. Not that it isn't justified -- it's just not how the system works. That's the job of Andy's boss -- and his boss' boss.
But increased funding is required -- and it ain't gonna come from PDUFA fees.
Time to step up to the plate, Mr. President.
Now as far as Andy tin cupping -- that's not going to happen. Not that it isn't justified -- it's just not how the system works. That's the job of Andy's boss -- and his boss' boss.
But increased funding is required -- and it ain't gonna come from PDUFA fees.
Time to step up to the plate, Mr. President.
Talk about a report that's dated before it gets printed. A just released GAO study reports that ... ready ... sitting down ... here it comes ... the FDA is under-staffed and under-funded. Gasp.
What? You thought FDA reform was a done deal. Er, no.
Consider this factoid, over the last 14 years, the FDA has lost 1311 employees and nearly $300 million in appropriations -- while Congress has lathered on additional mandates and responsibilities.
And they have the chuzpah to accuse FDA of not doing its job. Shameful but, unfortunately, not surprising.
And you know who you are.
Okay -- once more with feeling -- those four little words that mean real FDA reform ...
Show me the money!
What? You thought FDA reform was a done deal. Er, no.
Consider this factoid, over the last 14 years, the FDA has lost 1311 employees and nearly $300 million in appropriations -- while Congress has lathered on additional mandates and responsibilities.
And they have the chuzpah to accuse FDA of not doing its job. Shameful but, unfortunately, not surprising.
And you know who you are.
Okay -- once more with feeling -- those four little words that mean real FDA reform ...
Show me the money!
While we are on the subject of conflicts, I am still waiting for the Pharmaceutical Purity Priesthood to connect the dots between those who comment on pharmaceutical funding and their funding from George Soros. While doing so, here's a great piece by Michael Fumento in the Weekly Standard on how the Lancet continues to ignore and coverup the Soros funding of the now deeply discredited 2006 Lancet study of Iraqi war deaths. Not only did the Lancet hide the Soros funding and not ask the authors to disclose the funding, it timed the release of the highly inflated numbers to the weeks running up to the 2006 mid-term election where of course it received maximum coverage.
Fumento writes:
"Horton spoke at a rally in 2006 sponsored by Stop the War Coalition, a British group set up on September 21, 2001, which is to say its purpose was to oppose punishing and defeating the perpetrators of the 9/11 attack. At the rally, Horton shouted about the "mountain of violence and torture" in Iraq--and no, he wasn't talking about Saddam. "This axis of Anglo-American imperialism extends its influence through war and conflict, gathering power and wealth as it goes, so millions of people are left to die in poverty and disease," he angrily added. This is not your father's medical journal editor.
As National Journal revealed, Lancet's 2006 study was about half funded by antiwar billionaire George Soros, who in a November 2003 Washington Post interview said that removing President Bush from office was the "central focus of my life" and "a matter of life and death." This no doubt explains the release of the Lancet study four weeks before the 2006 midterm elections, just as Lancet's 2004 study was released days before the presidential election. Even the magazine's ardent defenders don't claim the timing was a coincidence.
The 2006 Lancet report states only, "Funding was provided by the Massachusetts Institute of Technology and the Center for Refugee and Disaster Response of the Johns Hopkins Bloomberg School of Public Health." Soros is known for concealing his massive political donations, and the Lancet was complicit on this occasion."
As I have noted before, there are many sources of bias and conflict in publications. Financial conflict is but one. I would say political and ideological bias looms larger and is more problematic. As I will argue in future posts, a new pseusdscience of pseudocertainty is forming around meta-analysis to feed into the desire of trial attorneys to usurp FDA control over drug labeling authority. My guess is that much of the leftist and purist blogosphere will fall into line around using meta-analysis to challenge the FDA's right of pre-emption on the subjective grounds that it is a "captive" of the industry it regulates. Again, this challenge ignores outcomes and risks and arrogates the framing of those risks to trial attorneys and "their" experts who are funded by....George Soros, trial attorney backed groups, etc.
Not coincidentally, though this is entirely speculation on my part, the Lancet was the source of the article that claimed the MMR vaccines caused autism.
http://www.fumento.com/military/lancet2008.html
Fumento writes:
"Horton spoke at a rally in 2006 sponsored by Stop the War Coalition, a British group set up on September 21, 2001, which is to say its purpose was to oppose punishing and defeating the perpetrators of the 9/11 attack. At the rally, Horton shouted about the "mountain of violence and torture" in Iraq--and no, he wasn't talking about Saddam. "This axis of Anglo-American imperialism extends its influence through war and conflict, gathering power and wealth as it goes, so millions of people are left to die in poverty and disease," he angrily added. This is not your father's medical journal editor.
As National Journal revealed, Lancet's 2006 study was about half funded by antiwar billionaire George Soros, who in a November 2003 Washington Post interview said that removing President Bush from office was the "central focus of my life" and "a matter of life and death." This no doubt explains the release of the Lancet study four weeks before the 2006 midterm elections, just as Lancet's 2004 study was released days before the presidential election. Even the magazine's ardent defenders don't claim the timing was a coincidence.
The 2006 Lancet report states only, "Funding was provided by the Massachusetts Institute of Technology and the Center for Refugee and Disaster Response of the Johns Hopkins Bloomberg School of Public Health." Soros is known for concealing his massive political donations, and the Lancet was complicit on this occasion."
As I have noted before, there are many sources of bias and conflict in publications. Financial conflict is but one. I would say political and ideological bias looms larger and is more problematic. As I will argue in future posts, a new pseusdscience of pseudocertainty is forming around meta-analysis to feed into the desire of trial attorneys to usurp FDA control over drug labeling authority. My guess is that much of the leftist and purist blogosphere will fall into line around using meta-analysis to challenge the FDA's right of pre-emption on the subjective grounds that it is a "captive" of the industry it regulates. Again, this challenge ignores outcomes and risks and arrogates the framing of those risks to trial attorneys and "their" experts who are funded by....George Soros, trial attorney backed groups, etc.
Not coincidentally, though this is entirely speculation on my part, the Lancet was the source of the article that claimed the MMR vaccines caused autism.
http://www.fumento.com/military/lancet2008.html
Antibiotic research is drying up because of a politically inspired demand for larger clinical trials and a push for placebo controlled trials where they need not be required. Congress tosses money at the problem when reform is needed. So I agree with Sid Wolfe when he says: “I’m tired of all these lures to an industry making so much money today that they can’t even see straight,â€
The lures are to biotech start ups mostly. But mostly they need regulatory help and money for Critical Path. Two weeks ago the FDA, academics and industry held a workshop on clinical trial design in cooperation with the Infectious Disease Society of America. The key issue was when to use adaptive trials and other approaches. This is like returning to "GO" in Monopoly. We should be much farther ahead in our approach to drug development in infectious diseases. Kudos to Helen Boucher, David Shlaes and FDAer Ed Cox who have been nurturing this working relationship. It needs -- via support for Reagan Udall -- support from unusual suspects such as hospital groups, private foundations, food companies, as well as FDA senior leadership, from HHS and Congress. Oh wait, this might lead to conflicts. So forget it, let a thousand bugs multiply. What's a thousands deaths and disease when the real disease we are trying to contain is the corruption of our medical research establishment at the hands of BIg Pharma?
http://blogs.wsj.com/health/2008/01/28/new-antibiotics-grow-scarce-as-bad-bugs-multiply/
The lures are to biotech start ups mostly. But mostly they need regulatory help and money for Critical Path. Two weeks ago the FDA, academics and industry held a workshop on clinical trial design in cooperation with the Infectious Disease Society of America. The key issue was when to use adaptive trials and other approaches. This is like returning to "GO" in Monopoly. We should be much farther ahead in our approach to drug development in infectious diseases. Kudos to Helen Boucher, David Shlaes and FDAer Ed Cox who have been nurturing this working relationship. It needs -- via support for Reagan Udall -- support from unusual suspects such as hospital groups, private foundations, food companies, as well as FDA senior leadership, from HHS and Congress. Oh wait, this might lead to conflicts. So forget it, let a thousand bugs multiply. What's a thousands deaths and disease when the real disease we are trying to contain is the corruption of our medical research establishment at the hands of BIg Pharma?
http://blogs.wsj.com/health/2008/01/28/new-antibiotics-grow-scarce-as-bad-bugs-multiply/
Article published Jan 29, 2008 The Washington Times
Health care spending
January 29, 2008
By Robert Goldberg - What do Hillary Clinton and the recent government data on prescription drug spending have in common? In both cases, the mainstream media got it wrong. Just days ago every reporter and pundit were predicting that Mrs. Clinton was on the verge of a major blowout in New Hampshire and that Barack Obama's nomination was virtually assured. We know what happened. Now of course, the media is furiously spinning in the other direction, calling her victory "historic" and the election a "horserace." Until the next primary.
With prescription drug spending, the media of course reported that it increased in 2006 by about 8.5 percent, more than last year because of increased Medicare drug spending. Health care spending went up overall too, by about 6.7 percent about the same as last year. So all the headlines and stories claimed that "drug spending fueled rising health care costs" "Drug benefit fuels Medicare spending" and so on.
But the press got that wrong too. And unlike electoral politics, the pundits didn't have to rely solely on exit polls and recycled "experts" for the intelligence estimates. They were all working from the same study, which was published in Health Affairs.
Drug spending for Medicare did increase. But that's not news because when you give 39 million people a new drug benefit that's going to happen. Apart from the fact that the Medicare Part D program is running at 20 percent under budget estimates, it is not fueling Medicare spending overall. Quite the opposite.
Even as drug spending has increased by nearly 9 percent as a percentage of total health care spending its share remains about the same. If it's fueling the rise in spending it is very efficient fuel. Indeed, the increase in drug spending corresponds nationally with a decline in the rate of increase in spending in hospitals, nursing homes and visits to the doctor.
Could it be that more drug spending is driving down the rate of increase in other health care spending, particularly in Medicare? Public money (mostly Medicare and Medicaid) pays for about half of those other expenses. The surge in drug spending, which includes a shift of the Medicaid drug population to Medicare coincides with this decline in spending in other areas.
What's more, the goal of the Medicare Part D program was to reduce the cost of prescription drugs for people with limited incomes and chronic illnesses. It has accomplished that. Studies have shown, most recently another study in health affairs, that by eliminating the co-payments for prescription drugs, people use more medicines. When that happens their chronic illnesses such as diabetes, blood pressure and depression improve. They use other, more expensive health care services, less often. They are happier and healthier. Which is the real value of medicine in the first place.
Does this relationship apply for seniors in general? It would be great to see more research done using current Medicare beneficiary data. According to earlier work by my colleague Frank Lichtenberg, Courtney Brown Professor of Economics at Columbia University's School of Business, it does. Access to newer drugs costs more money but is offset by a reduction in hospital, home health care and physician costs according to Dr. Lichtenberg's research.
In other words, the value of the Part D program is not just that it makes drugs affordable but that it makes new medicines rapidly available as well. Efforts to restrict access to new drugs through co-pays and formularies would not only discriminate against the poor and chronically ill, it would actually drive up spending across the board. (Dr. Lichtenberg has also found that Medicare Part D has increase drug usage by less than 5 percent nationally. So much for claims that it created a huge windfall for drug firms. ) What's news is that the media, which was so quick to bill the Medicare prescription drug program as a failure two weeks into it's existence, once again rendered a snap judgment so far from reality that it should have used Narnia as its dateline.
James Q. Wilson has observed that journalism, like so much scholarship, now dwells in a postmodern age in which truth is hard to find and statements merely serve someone's interests. Health care will be an important issue in the coming campaign. Accuracy is always a casualty of electioneering. Too bad journalists are increasingly part of the problem whether it's coverage of candidates or the concerns that shape our vote in the first place.
Robert Goldberg is vice president of the Center for Medicine in the Public Interest.
Health care spending
January 29, 2008
By Robert Goldberg - What do Hillary Clinton and the recent government data on prescription drug spending have in common? In both cases, the mainstream media got it wrong. Just days ago every reporter and pundit were predicting that Mrs. Clinton was on the verge of a major blowout in New Hampshire and that Barack Obama's nomination was virtually assured. We know what happened. Now of course, the media is furiously spinning in the other direction, calling her victory "historic" and the election a "horserace." Until the next primary.
With prescription drug spending, the media of course reported that it increased in 2006 by about 8.5 percent, more than last year because of increased Medicare drug spending. Health care spending went up overall too, by about 6.7 percent about the same as last year. So all the headlines and stories claimed that "drug spending fueled rising health care costs" "Drug benefit fuels Medicare spending" and so on.
But the press got that wrong too. And unlike electoral politics, the pundits didn't have to rely solely on exit polls and recycled "experts" for the intelligence estimates. They were all working from the same study, which was published in Health Affairs.
Drug spending for Medicare did increase. But that's not news because when you give 39 million people a new drug benefit that's going to happen. Apart from the fact that the Medicare Part D program is running at 20 percent under budget estimates, it is not fueling Medicare spending overall. Quite the opposite.
Even as drug spending has increased by nearly 9 percent as a percentage of total health care spending its share remains about the same. If it's fueling the rise in spending it is very efficient fuel. Indeed, the increase in drug spending corresponds nationally with a decline in the rate of increase in spending in hospitals, nursing homes and visits to the doctor.
Could it be that more drug spending is driving down the rate of increase in other health care spending, particularly in Medicare? Public money (mostly Medicare and Medicaid) pays for about half of those other expenses. The surge in drug spending, which includes a shift of the Medicaid drug population to Medicare coincides with this decline in spending in other areas.
What's more, the goal of the Medicare Part D program was to reduce the cost of prescription drugs for people with limited incomes and chronic illnesses. It has accomplished that. Studies have shown, most recently another study in health affairs, that by eliminating the co-payments for prescription drugs, people use more medicines. When that happens their chronic illnesses such as diabetes, blood pressure and depression improve. They use other, more expensive health care services, less often. They are happier and healthier. Which is the real value of medicine in the first place.
Does this relationship apply for seniors in general? It would be great to see more research done using current Medicare beneficiary data. According to earlier work by my colleague Frank Lichtenberg, Courtney Brown Professor of Economics at Columbia University's School of Business, it does. Access to newer drugs costs more money but is offset by a reduction in hospital, home health care and physician costs according to Dr. Lichtenberg's research.
In other words, the value of the Part D program is not just that it makes drugs affordable but that it makes new medicines rapidly available as well. Efforts to restrict access to new drugs through co-pays and formularies would not only discriminate against the poor and chronically ill, it would actually drive up spending across the board. (Dr. Lichtenberg has also found that Medicare Part D has increase drug usage by less than 5 percent nationally. So much for claims that it created a huge windfall for drug firms. ) What's news is that the media, which was so quick to bill the Medicare prescription drug program as a failure two weeks into it's existence, once again rendered a snap judgment so far from reality that it should have used Narnia as its dateline.
James Q. Wilson has observed that journalism, like so much scholarship, now dwells in a postmodern age in which truth is hard to find and statements merely serve someone's interests. Health care will be an important issue in the coming campaign. Accuracy is always a casualty of electioneering. Too bad journalists are increasingly part of the problem whether it's coverage of candidates or the concerns that shape our vote in the first place.
Robert Goldberg is vice president of the Center for Medicine in the Public Interest.
Attacking the "conflicts" and "coverups" of companies and affiliated researchers in an attempt to discredit the commercialization of medical research comes at a price: undermining confidence in the science and the use of products themselves. As with all Ad Hominem attacks, particularly circumstancial, the fact that a researcher may stand to benefit from the acceptance of their research does not affect the validity of the research itself, since scientifically established evidence can stand or fall on its own merits. The failure to challenge such research in this fashion is of course, intellectually dishonest and manipulative. The consequence and object of such manipulation is to "frame" the choice or perspective of research as a risk to be avoid and as not relying on the research and its results as a place of certainty..
Which lead us to the spike in whooping cough cases triggered by the decline in the number of kids being immunized:
"Before the development of a vaccine, whooping cough was a major public health threat, particularly from the 1920s to the '40s, when it infected as many as 265,000 Americans a year and killed as many as 9,000 a year, said Dr. Mary Healy, director of the Texas Children's cocoon-strategy program.
Since the vaccine, she said, its annual incidence dropped to around 30,000 in the 1950s and as low as about 1,000 in 1976. It began creeping up in the 1980s and 1990s."
Click Here for More Info
Parents are convinced vaccines are unsafe not because of any evidence they are dangerous but because critics claim that the people pushing vaccines like Paul Offit are "conflicted" and therefore should not be trusted. ....Ditto the decline in SSRI and rising suicide rates because of "conflicts" and "coverups". This is now the new standard for determining whether or not research or a scientist is acceptable. Truth is now function of political correctness and adherence to the view that the commercialization of medical research is inherently corrupting. Can someone say Lysenko?
Pseudoscience leads to pseudocertainty which leads to a decline in the public health.
Those who claim that it "seems that negative studies are suppressed" are substituting emotion and bias for the scientific method. So too are those who change the subject from the outcomes to the studies to the character of those who sponsored them. Or as Saul Bellow once said: "A great deal of intelligence can be invested in ignorance when the need for illusion is deep."
Which lead us to the spike in whooping cough cases triggered by the decline in the number of kids being immunized:
"Before the development of a vaccine, whooping cough was a major public health threat, particularly from the 1920s to the '40s, when it infected as many as 265,000 Americans a year and killed as many as 9,000 a year, said Dr. Mary Healy, director of the Texas Children's cocoon-strategy program.
Since the vaccine, she said, its annual incidence dropped to around 30,000 in the 1950s and as low as about 1,000 in 1976. It began creeping up in the 1980s and 1990s."
Click Here for More Info
Parents are convinced vaccines are unsafe not because of any evidence they are dangerous but because critics claim that the people pushing vaccines like Paul Offit are "conflicted" and therefore should not be trusted. ....Ditto the decline in SSRI and rising suicide rates because of "conflicts" and "coverups". This is now the new standard for determining whether or not research or a scientist is acceptable. Truth is now function of political correctness and adherence to the view that the commercialization of medical research is inherently corrupting. Can someone say Lysenko?
Pseudoscience leads to pseudocertainty which leads to a decline in the public health.
Those who claim that it "seems that negative studies are suppressed" are substituting emotion and bias for the scientific method. So too are those who change the subject from the outcomes to the studies to the character of those who sponsored them. Or as Saul Bellow once said: "A great deal of intelligence can be invested in ignorance when the need for illusion is deep."
Fresh from his victory in the drivers’ licenses for illegal aliens campaign, Governor Spitzer is turning his attention to reforming health care in the Empire State.
Here's the lay of the land, status quo ante:
Prior to any actions, New York will spend approximately $1.9 billion in State funds on prescription drugs in 2008-09 through the Medicaid and EPIC programs. The 2008-09 Executive Budget recommends actions that would control these costs and generate $172 million in State savings.
But these "savings" come at a cost -- the cost of quality health care for low income New Yorkers. And, considering that prescription medicines represent but 4 percent of the New York State health care spend (4 cents on the NY health care dollar), it's a penny wise/pound foolish proposition. "Seven and a half cents," the famous "Pajama Game" song tells us, "doesn't mean a hell of a lot." But when it comes to prevention, life saving interventions, and chronic care, four cents does.
The sampling of ideas below all save money for Albany in the short term -- and will result in a lower quality of care for New York's Neediest and a higher taxpayer burden for expensive hospital stays and other high cost health care interventions. Governor Spitzer's plan is a perfect examples of a cost-based, "government first" paradigm --when what we really need is more cost-efficient and humane patient-centric, "people first," health care policy.
* High Cost Drugs. A Specialty Pharmacy Program will be created within Medicaid to lower the price of high cost drugs, which have increased dramatically in number and cost. Specialty drugs typically require specific handling and have a limited distribution.
Translation: Rationing.
* Clinical Drug Review Program. The Executive Budget reflects the addition of new drugs to the Clinical Drug Review Program (CDRP) to generate additional savings while continuing to ensure proper usage of certain high-risk drugs.
Translation: Rationing through questionable evidence-based medicine schemes.
* Physician Education. A program will be started to provide prescribes with unbiased clinical information about medications and to balance marketing efforts by manufacturers. This will improve patient outcomes and reduce unnecessary expenditures by providing objective information to prescribers.
.
* Translation: Rationing. Anyone care to wager what these "unbiased" studies will recommend? Echoes of CATIE and ALLHAT. It's the battle between 20th century practice variation and 21st century patient variation/personalized medicine.
* Pharmacy Reimbursements. Pharmacy reimbursement will be reduced from Average Wholesale Price (AWP) less 14 percent to AWP less 17 percent for brand name drugs to more closely reflect the actual wholesale price to pharmacies. This reduction will be offset by a one dollar increase in the dispensing fee for generics and brand name drugs in the PDP. In addition, co-payments for brand name drugs in the Medicaid PDP will be reduced from $3.00 to $1.00. These changes will encourage the use of lower cost and preferred products.
Translation: Bribe pharmacists to switch their customers to generic drugs -- even if that switch is from an on-patent medicine recommended by a patient's physician to an entirely different molecule. Savings first. Patients last.
What’s most peculiar is that Governor Spitzer offers only a few small initiatives to deal with the most important health care issue in New York State (and, for that matter, every state) – chronic disease. This is, perhaps, the most explicit example of sins of omission and the Gov’s focus on short term vs. long term savings. It’s an ignorant and dangerous omission. Sins of omission, the saying goes, are seldom fun. And, while this particular omission may be politically expedient – it’s also dangerous and short-sighted.
Here's a link to the full health care section of the Governor’s executive budget:
http://publications/budget.state.ny.us/eBudget0809/fy0809littlebook/HealthCareMedicaid.html
In "The Pajama Game," the union boss "Prez" sings, "With a pencil and a pen I figured it out." Governor Spitzer (who some say would like to play Prez himself some day) needs to return to the drawing board and figure out a way to put patients first -- before he prepares for his own second act.
Here's the lay of the land, status quo ante:
Prior to any actions, New York will spend approximately $1.9 billion in State funds on prescription drugs in 2008-09 through the Medicaid and EPIC programs. The 2008-09 Executive Budget recommends actions that would control these costs and generate $172 million in State savings.
But these "savings" come at a cost -- the cost of quality health care for low income New Yorkers. And, considering that prescription medicines represent but 4 percent of the New York State health care spend (4 cents on the NY health care dollar), it's a penny wise/pound foolish proposition. "Seven and a half cents," the famous "Pajama Game" song tells us, "doesn't mean a hell of a lot." But when it comes to prevention, life saving interventions, and chronic care, four cents does.
The sampling of ideas below all save money for Albany in the short term -- and will result in a lower quality of care for New York's Neediest and a higher taxpayer burden for expensive hospital stays and other high cost health care interventions. Governor Spitzer's plan is a perfect examples of a cost-based, "government first" paradigm --when what we really need is more cost-efficient and humane patient-centric, "people first," health care policy.
* High Cost Drugs. A Specialty Pharmacy Program will be created within Medicaid to lower the price of high cost drugs, which have increased dramatically in number and cost. Specialty drugs typically require specific handling and have a limited distribution.
Translation: Rationing.
* Clinical Drug Review Program. The Executive Budget reflects the addition of new drugs to the Clinical Drug Review Program (CDRP) to generate additional savings while continuing to ensure proper usage of certain high-risk drugs.
Translation: Rationing through questionable evidence-based medicine schemes.
* Physician Education. A program will be started to provide prescribes with unbiased clinical information about medications and to balance marketing efforts by manufacturers. This will improve patient outcomes and reduce unnecessary expenditures by providing objective information to prescribers.
.
* Translation: Rationing. Anyone care to wager what these "unbiased" studies will recommend? Echoes of CATIE and ALLHAT. It's the battle between 20th century practice variation and 21st century patient variation/personalized medicine.
* Pharmacy Reimbursements. Pharmacy reimbursement will be reduced from Average Wholesale Price (AWP) less 14 percent to AWP less 17 percent for brand name drugs to more closely reflect the actual wholesale price to pharmacies. This reduction will be offset by a one dollar increase in the dispensing fee for generics and brand name drugs in the PDP. In addition, co-payments for brand name drugs in the Medicaid PDP will be reduced from $3.00 to $1.00. These changes will encourage the use of lower cost and preferred products.
Translation: Bribe pharmacists to switch their customers to generic drugs -- even if that switch is from an on-patent medicine recommended by a patient's physician to an entirely different molecule. Savings first. Patients last.
What’s most peculiar is that Governor Spitzer offers only a few small initiatives to deal with the most important health care issue in New York State (and, for that matter, every state) – chronic disease. This is, perhaps, the most explicit example of sins of omission and the Gov’s focus on short term vs. long term savings. It’s an ignorant and dangerous omission. Sins of omission, the saying goes, are seldom fun. And, while this particular omission may be politically expedient – it’s also dangerous and short-sighted.
Here's a link to the full health care section of the Governor’s executive budget:
http://publications/budget.state.ny.us/eBudget0809/fy0809littlebook/HealthCareMedicaid.html
In "The Pajama Game," the union boss "Prez" sings, "With a pencil and a pen I figured it out." Governor Spitzer (who some say would like to play Prez himself some day) needs to return to the drawing board and figure out a way to put patients first -- before he prepares for his own second act.
Just a matter of time before the juggernaut switched gears from Vioxx to Vytorin. (How cool that they go in alphabetical order, it will make life easier for the paralegals at least.)
Now we at drugwonks get to play our version of connect the dots as the purists line up on the side of the bottom feeders offering their services as consultants, their opinions in the media, white papers, policy support through web sites and groups like the Soros funded Prescription Project and the Institute on Medicine as Profession. We already have two"dots": Susan Wood, recipient of silicone breast implant settlement cash (where no evidence of wrongdoing or harm existed)
Read More
"Schering says there were problems with the way the data from the study were collected and analyzed, and that it needed all this time to fix those problems. Susan Wood, a professor at George Washington University and former Food & Drug Administration official, doesn't buy that. "You can't just say, 'Wait, we'll fix it,'" she says. "You have to get it out and let people decide."
The other dot is Steve Nissen who of course has been conducting (for pay) his own set of studies to determine whether increase HDL (regardless of genetic variation) can lead to plaque reversal and can correlate with a reduction in death using his own imaging studies. According to Matt Herper he is gunning for Zetia. (Here's a link to an article where Nissen gushes over the plaque reversing power of a drug he was working on but has never, ever made it into human trials.)
Read Full Article Here
The lesson here: Don't you dare do a plaque reversal study with imaging as your surrogate endpoint without using Steve Nissen. Oh, another lesson: Steve Nissen does no work on genetic sensitivity to statins or personalized medicine, the real future. The ENHANCE study in its backhanded way essential demonstrated that Vytorin is the drug which can lower cholesterol for a small genetic subset but not reduce plaque.
In any event, what people think about this matter -- and what to do about it -- will be shaped by their views of capitalism and medicine, not by the science. Will every large clinical trial of a drug on the market now become an opportunity to attack, expose, sue and investigate.
I think so. The "dots" profit from it in terms of publicity, consulting fees, foundation grants, their cut from class action suits and consolidation of control over the conduct of clinical trials, prescribing patterns, etc.
Now we at drugwonks get to play our version of connect the dots as the purists line up on the side of the bottom feeders offering their services as consultants, their opinions in the media, white papers, policy support through web sites and groups like the Soros funded Prescription Project and the Institute on Medicine as Profession. We already have two"dots": Susan Wood, recipient of silicone breast implant settlement cash (where no evidence of wrongdoing or harm existed)
Read More
"Schering says there were problems with the way the data from the study were collected and analyzed, and that it needed all this time to fix those problems. Susan Wood, a professor at George Washington University and former Food & Drug Administration official, doesn't buy that. "You can't just say, 'Wait, we'll fix it,'" she says. "You have to get it out and let people decide."
The other dot is Steve Nissen who of course has been conducting (for pay) his own set of studies to determine whether increase HDL (regardless of genetic variation) can lead to plaque reversal and can correlate with a reduction in death using his own imaging studies. According to Matt Herper he is gunning for Zetia. (Here's a link to an article where Nissen gushes over the plaque reversing power of a drug he was working on but has never, ever made it into human trials.)
Read Full Article Here
The lesson here: Don't you dare do a plaque reversal study with imaging as your surrogate endpoint without using Steve Nissen. Oh, another lesson: Steve Nissen does no work on genetic sensitivity to statins or personalized medicine, the real future. The ENHANCE study in its backhanded way essential demonstrated that Vytorin is the drug which can lower cholesterol for a small genetic subset but not reduce plaque.
In any event, what people think about this matter -- and what to do about it -- will be shaped by their views of capitalism and medicine, not by the science. Will every large clinical trial of a drug on the market now become an opportunity to attack, expose, sue and investigate.
I think so. The "dots" profit from it in terms of publicity, consulting fees, foundation grants, their cut from class action suits and consolidation of control over the conduct of clinical trials, prescribing patterns, etc.
The New York Times "breaks" the story that the American Heart Association receives support from Schering and Merck. The implication is that the AHA came out with a statement as a result of that connection. Let's assume for argument's sake that this is correct. And let's forgive the AHA for putting Donny Osmond on their website.
Here is the gist of the AHA statement:
Because Vytorin does not appear to be unsafe, lipid-lowering therapy with simvastatin is of proven benefit, and some patients have been prescribed Vytorin because a statin alone may not have been sufficiently effective in lowering their LDL or was not appropriate for them because of other medical conditions, we do not believe patients should stop taking the drug on their own,†said Dr. Jones. “However, patients on this combination drug should check with their doctor to see if they should stay on the drug, be switched to a statin alone, or take another combination of drugs for their cholesterol.â€
Does anyone have a problem with that statement. If I were a Schering or Merck handler I would not think I got my money worth.
Or maybe the critics are not thinking conspiratorially enough. AHA also gets money from Novartis, GSK, Pfizer and other companies. Maybe they used their financial clout to water down what was going to be a hearty endorsement of the drug. Or maybe the money went to the millions AHA gives out in research grants to academic medical centers for CME and other reasons. Which is it? We don't know. And of course the rest of the pontificators have rushed to judgment based on the NY Times without regard to the essence of the AHA ENHANCE statement.
The next point of course is that if the AHA is simply a paid for mouthpiece for Big Phama, it goals, views, tactics, etc by virtue of receipt of financial support, then that cause and effect relationship must apply equally to organizations and individuals who receive support from organizations. So therefore, physicians, researchers, etc who receive money from foundations such as Commonwealth, the Open Society Institute, Pew, Josiah Macy, etc to share its biases and ideology. Similarly, people from HMOs, insurance companies, CMS, Medicaid who share a cost cutting view will reflect that bias and particular view of technology.
Finally, there is the so what question? As Ezekiel Emanuel as stated regarding for-profit IRBs: "What we should really focus on then is not the ideology of profit status but these substantive outcome data."
No one has proven that the purist approach will produce better health, better drugs, safer medicines. The movement against so-called conflict of interest is all based on a revulsion towards the profit motive in health. It is more like the Taliban trying to purify the planet than a systematic effort to make medicine more patient centered based on an mechanistic undestanding of how to predict and prevent illness. The purists skip right past personalized medicine because it is not part of the grand scheme to rid medicine of the corruption.
Quite the opposite, the evidence that expelling "commercial interests" from CME (I guess that would mean Danny Carlat and Howard Brody since they make money off books and lectures), academic detailing, state formularies based on so-called evidence based medicine, conflict free FDA advisory committees, the application of the precautionary principle to the development and use of medicine (don't use any new medicine for 7 years according to Public Citizen), turn over all drug development to government and shorten patents and of course a single payer system would improve health.
Academic detailing according to CATIE and ALLHAT? One size fits all medicine? Paying doctors to prescribe generic when will have genetic tests and algorithms that indicate otherwise? The attempt to discredit researchers who have worked or have received funding from pharma is an intellectually dishonest and weak way to simply not engage in discussion or consider important, mechanistically valid research. It is the new Lysenkoism.
You wouldn't know from all the rapid pharma hating that mortality and morbidity has been declining worldwide in direct proportion to the rate of introduction of new drugs, devices and surgical techniques. Medical technology has done more to advance and enhance humanity than anything else we could have come up with. Check that, the commercialization of medical technology.
Rather, the piling on is just an expression of a hatred of capitalism. To paraphrase Aaron Wildavsky, my critics see medical technology as part of the apparatus by which corporate capitalism maintains inequalities that harm society and the public health.
The piling on is a product of a particular view of how the world works. These are angry, fearful people who have a utopian plan to take medicine back to a pristine time that never existed. The disturbance is, in fact, in their psyche and souls. Their success in enacting their plan comes at the expense of the reputation of good scientists everywhere, trust in science generally and medical progress. To make themselves right, they would destroy others and rule over the rest.
Here is the gist of the AHA statement:
Because Vytorin does not appear to be unsafe, lipid-lowering therapy with simvastatin is of proven benefit, and some patients have been prescribed Vytorin because a statin alone may not have been sufficiently effective in lowering their LDL or was not appropriate for them because of other medical conditions, we do not believe patients should stop taking the drug on their own,†said Dr. Jones. “However, patients on this combination drug should check with their doctor to see if they should stay on the drug, be switched to a statin alone, or take another combination of drugs for their cholesterol.â€
Does anyone have a problem with that statement. If I were a Schering or Merck handler I would not think I got my money worth.
Or maybe the critics are not thinking conspiratorially enough. AHA also gets money from Novartis, GSK, Pfizer and other companies. Maybe they used their financial clout to water down what was going to be a hearty endorsement of the drug. Or maybe the money went to the millions AHA gives out in research grants to academic medical centers for CME and other reasons. Which is it? We don't know. And of course the rest of the pontificators have rushed to judgment based on the NY Times without regard to the essence of the AHA ENHANCE statement.
The next point of course is that if the AHA is simply a paid for mouthpiece for Big Phama, it goals, views, tactics, etc by virtue of receipt of financial support, then that cause and effect relationship must apply equally to organizations and individuals who receive support from organizations. So therefore, physicians, researchers, etc who receive money from foundations such as Commonwealth, the Open Society Institute, Pew, Josiah Macy, etc to share its biases and ideology. Similarly, people from HMOs, insurance companies, CMS, Medicaid who share a cost cutting view will reflect that bias and particular view of technology.
Finally, there is the so what question? As Ezekiel Emanuel as stated regarding for-profit IRBs: "What we should really focus on then is not the ideology of profit status but these substantive outcome data."
No one has proven that the purist approach will produce better health, better drugs, safer medicines. The movement against so-called conflict of interest is all based on a revulsion towards the profit motive in health. It is more like the Taliban trying to purify the planet than a systematic effort to make medicine more patient centered based on an mechanistic undestanding of how to predict and prevent illness. The purists skip right past personalized medicine because it is not part of the grand scheme to rid medicine of the corruption.
Quite the opposite, the evidence that expelling "commercial interests" from CME (I guess that would mean Danny Carlat and Howard Brody since they make money off books and lectures), academic detailing, state formularies based on so-called evidence based medicine, conflict free FDA advisory committees, the application of the precautionary principle to the development and use of medicine (don't use any new medicine for 7 years according to Public Citizen), turn over all drug development to government and shorten patents and of course a single payer system would improve health.
Academic detailing according to CATIE and ALLHAT? One size fits all medicine? Paying doctors to prescribe generic when will have genetic tests and algorithms that indicate otherwise? The attempt to discredit researchers who have worked or have received funding from pharma is an intellectually dishonest and weak way to simply not engage in discussion or consider important, mechanistically valid research. It is the new Lysenkoism.
You wouldn't know from all the rapid pharma hating that mortality and morbidity has been declining worldwide in direct proportion to the rate of introduction of new drugs, devices and surgical techniques. Medical technology has done more to advance and enhance humanity than anything else we could have come up with. Check that, the commercialization of medical technology.
Rather, the piling on is just an expression of a hatred of capitalism. To paraphrase Aaron Wildavsky, my critics see medical technology as part of the apparatus by which corporate capitalism maintains inequalities that harm society and the public health.
The piling on is a product of a particular view of how the world works. These are angry, fearful people who have a utopian plan to take medicine back to a pristine time that never existed. The disturbance is, in fact, in their psyche and souls. Their success in enacting their plan comes at the expense of the reputation of good scientists everywhere, trust in science generally and medical progress. To make themselves right, they would destroy others and rule over the rest.
Here’s how the Wall Street Journal story, “FDA Procedures Draw Scrutiny†begins, “Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar.â€
This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry†bandwagon. And it’s neither true nor accurate. It seems odd that one day the media is writing, pundits and pronouncing and politicians are orating about a parched pipeline and over-zealous regulators while in the next breath about the need for the agency to "raise the bar." Consistency? We don't need no stinking consistency.
And then there’s the bit about proxy markers.
Here’s what the Journal story has to say about that:
“ … proxy markers can be misleading. Sometimes a drug works on a proxy but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side effects that don't surface during initial proxy-marker studies but end up outweighing its benefit.â€
What? You mean using markers doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – there is no perfect predictor of either risk or benefit. And if we allow ourselves to poo-poo the significant advances that biomarkers deliver than we are heading down the slippery slope of the Precautionary Principle that warns us to “do nothing until we know everything.†Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB120122452254515507.html
The best way to help the FDA to “raise the bar†is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.
This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry†bandwagon. And it’s neither true nor accurate. It seems odd that one day the media is writing, pundits and pronouncing and politicians are orating about a parched pipeline and over-zealous regulators while in the next breath about the need for the agency to "raise the bar." Consistency? We don't need no stinking consistency.
And then there’s the bit about proxy markers.
Here’s what the Journal story has to say about that:
“ … proxy markers can be misleading. Sometimes a drug works on a proxy but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side effects that don't surface during initial proxy-marker studies but end up outweighing its benefit.â€
What? You mean using markers doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – there is no perfect predictor of either risk or benefit. And if we allow ourselves to poo-poo the significant advances that biomarkers deliver than we are heading down the slippery slope of the Precautionary Principle that warns us to “do nothing until we know everything.†Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB120122452254515507.html
The best way to help the FDA to “raise the bar†is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
