Latest Drugwonks' Blog
When news articles (as opposed to op-eds) offer opinions, they are supposed to be between quotation marks.
When a reporter slips in his own opinion, it’s sloppy editing at best and inappropriate bias at worst. Consider this paragraph of unattributed reportage from today’s New York Times article, “F.D.A. Commissioner and Other Top Health Officials Plan to Step Down” --
“If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug’s safety.”
FDA has put speed of approval over safety? Says who? The New York Times? If that’s the opinion of the editorial page, then they should say so. If this is Gardiner Harris’ opinion, he’s entitled to it – personally, but this isn't where it belongs. Not ever.
Also, what’s all this about “certainty of a drug’s safety.” Is the New York Times calling for a Precautionary Principle approach to drug regulation?
When a reporter slips in his own opinion, it’s sloppy editing at best and inappropriate bias at worst. Consider this paragraph of unattributed reportage from today’s New York Times article, “F.D.A. Commissioner and Other Top Health Officials Plan to Step Down” --
“If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug’s safety.”
FDA has put speed of approval over safety? Says who? The New York Times? If that’s the opinion of the editorial page, then they should say so. If this is Gardiner Harris’ opinion, he’s entitled to it – personally, but this isn't where it belongs. Not ever.
Also, what’s all this about “certainty of a drug’s safety.” Is the New York Times calling for a Precautionary Principle approach to drug regulation?
Do I sense a growing social consensus around the concept of collaborative healthcare reform? I do.
And that’s a good thing – because real reform cannot happen otherwise. Top-down efforts don’t cut it. That’s a lesson we can learn from our transatlantic cousins. Consider “High Quality Care for All,” (aka, “the Darzi report”) -- the recently released NHS “next stage review” document. It calls for, as one of its “key steps,” “ A Coalition for Better Health, with a set of new voluntary agreements between the Government, private and third sector organisations on actions to improve health outcomes.”
Jolly good -- and something our new healthcare czar/HHS Secretary should consider.
(If you’re interested in reading where the NHS is going – or at least planning to, here’s a link to the complete Darzi Report.)
Among other things, this means all stakeholders must have a seat at the table. Yes, even industry. And this has particular resonance when it comes to FDA and the Critical Path initiative. What we need is a consensus (especially among members of Congress like Representative Rosa DeLauro) that the agency can and indeed must be both regulator and colleague -- and that collaboration on developing the tools for 21st century drug development and regulatory science are too important to remain mired in the treacle of politics and posturing.
But there’s a caveat – all too familiar to our friends at the NHS -- that of using the costs of sickness “as a means of turning benevolence to power.”
That last quote comes from Paul Starr’s “The Social Transformation of American Medicine,” and it’s worth quoting in its entirety:
“Whoever provides medical care or pays the cost of illness stands to gain the gratitude and good will of the sick and their families. The prospect of these good-will returns to the investment in healthcare creates a powerful motive for government and other institutions to intervene in the economics of medicine. Political leaders since Bismarck seeking to strengthen the state or to advance their own or their party’s interests have used insurance against the costs of sickness as a means of turning benevolence to power.”
In other words, healthcare reform must be about healthcare – and not politics. Easier said than done? Certainly. But a truth we must, er, hold self-evident.
And that’s a good thing – because real reform cannot happen otherwise. Top-down efforts don’t cut it. That’s a lesson we can learn from our transatlantic cousins. Consider “High Quality Care for All,” (aka, “the Darzi report”) -- the recently released NHS “next stage review” document. It calls for, as one of its “key steps,” “ A Coalition for Better Health, with a set of new voluntary agreements between the Government, private and third sector organisations on actions to improve health outcomes.”
Jolly good -- and something our new healthcare czar/HHS Secretary should consider.
(If you’re interested in reading where the NHS is going – or at least planning to, here’s a link to the complete Darzi Report.)
Among other things, this means all stakeholders must have a seat at the table. Yes, even industry. And this has particular resonance when it comes to FDA and the Critical Path initiative. What we need is a consensus (especially among members of Congress like Representative Rosa DeLauro) that the agency can and indeed must be both regulator and colleague -- and that collaboration on developing the tools for 21st century drug development and regulatory science are too important to remain mired in the treacle of politics and posturing.
But there’s a caveat – all too familiar to our friends at the NHS -- that of using the costs of sickness “as a means of turning benevolence to power.”
That last quote comes from Paul Starr’s “The Social Transformation of American Medicine,” and it’s worth quoting in its entirety:
“Whoever provides medical care or pays the cost of illness stands to gain the gratitude and good will of the sick and their families. The prospect of these good-will returns to the investment in healthcare creates a powerful motive for government and other institutions to intervene in the economics of medicine. Political leaders since Bismarck seeking to strengthen the state or to advance their own or their party’s interests have used insurance against the costs of sickness as a means of turning benevolence to power.”
In other words, healthcare reform must be about healthcare – and not politics. Easier said than done? Certainly. But a truth we must, er, hold self-evident.
Healthcare "like in Europe?" Bad idea.
According to new study (published in a five-paper special report on drug pricing in Health Affairs), imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows.
The report suggests that lowering insurance co-payments would be a better way of attacking the problem of rising prescription drug prices in the United States.
"We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime," said Darius Lakdawalla of the nonprofit Rand Corporation. (This paper was funded by a grant from Pfizer and the National Institute on Aging.)
Lakdawalla and colleagues used computer models of price regulation in 19 countries to simulate the impact of price controls that cut drug company revenues by 20 percent.
They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.
"We found longevity declines on the order of about a half of year for people at the age of 55 when you look out to people who are alive in 2050 and 2060," he said.
A team of researchers that included Harvard economist David Cutler, a health policy adviser for President-elect Barack Obama, suggested in the same journal that drug spending growth rates had reached a "turning point."
They noted that while drug prices tripled from 1997 through 2007, spending in 2007 grew just 1.6 percent, the slowest rate since 1974, as many brand-name drugs lose patent protection.
Cutler and colleagues noted that prescription drug spending trends have changed dramatically in the past five years, and assumptions based on older trends no longer apply.
The Health Affairs special issue can be found here.
And Reuters coverage can be found here.
According to new study (published in a five-paper special report on drug pricing in Health Affairs), imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows.
The report suggests that lowering insurance co-payments would be a better way of attacking the problem of rising prescription drug prices in the United States.
"We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime," said Darius Lakdawalla of the nonprofit Rand Corporation. (This paper was funded by a grant from Pfizer and the National Institute on Aging.)
Lakdawalla and colleagues used computer models of price regulation in 19 countries to simulate the impact of price controls that cut drug company revenues by 20 percent.
They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.
"We found longevity declines on the order of about a half of year for people at the age of 55 when you look out to people who are alive in 2050 and 2060," he said.
A team of researchers that included Harvard economist David Cutler, a health policy adviser for President-elect Barack Obama, suggested in the same journal that drug spending growth rates had reached a "turning point."
They noted that while drug prices tripled from 1997 through 2007, spending in 2007 grew just 1.6 percent, the slowest rate since 1974, as many brand-name drugs lose patent protection.
Cutler and colleagues noted that prescription drug spending trends have changed dramatically in the past five years, and assumptions based on older trends no longer apply.
The Health Affairs special issue can be found here.
And Reuters coverage can be found here.
Another sign that we have gone crazy...
Now who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...
I found this post from FiercePharma said it best...
1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
FDA panel votes down two asthma meds
See Full StoryNow who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...
I found this post from FiercePharma said it best...
1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
Wow. Healthcare reform.
President-Elect Obama, in officially introducing Tom Daschle as his HHS Secretary-designate, said (in effect) "if not now, when?"
Okay, got that. But many questions remain unanswered, like ... how.
One item that will be at the core of the agenda (even though the administration won't explicitly call it by its real name) will be pharmaceutical price controls.
There will be three immediate bites at the price control apple:
The first is the revocation of the Non-Interference Clause. By so doing the government will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
Bite #2 is importation. Even though such a program won't save any money (less than .1% of drug spending according to OMB) and is fraught with safety issues, it does present the opportunity to import de facto price controls. Would a Secretary Daschle provide Secretarial Certification? Do the ends justify the means?
Bite #3 is comparative effectiveness. Senator Baucus has this as an integral part of his package and it would be surprising if others (specifically Senator Kennedy) wouldn't do the same. While comparative effectiveness isn't, per se, a price control mechanism -- it's the HOV lane to that destination a la healthcare technology assessment and a NICE-like proposition.
(Senator Baucus' legislation -- at least the 2008 version -- says the work of this new AHRQ-based body couldn't be used for CMS reimbursement decisions. Sure. And if you believe that one, I've got a Senate seat to sell you.)
And it's important to note that all three of these "bites" can happen simultaneously, separately, before, during, or as part of a more comprehensive Administration-reform initiative.
Let threedom ring -- but remember for whom the bell tolls.
President-Elect Obama, in officially introducing Tom Daschle as his HHS Secretary-designate, said (in effect) "if not now, when?"
Okay, got that. But many questions remain unanswered, like ... how.
One item that will be at the core of the agenda (even though the administration won't explicitly call it by its real name) will be pharmaceutical price controls.
There will be three immediate bites at the price control apple:
The first is the revocation of the Non-Interference Clause. By so doing the government will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
Bite #2 is importation. Even though such a program won't save any money (less than .1% of drug spending according to OMB) and is fraught with safety issues, it does present the opportunity to import de facto price controls. Would a Secretary Daschle provide Secretarial Certification? Do the ends justify the means?
Bite #3 is comparative effectiveness. Senator Baucus has this as an integral part of his package and it would be surprising if others (specifically Senator Kennedy) wouldn't do the same. While comparative effectiveness isn't, per se, a price control mechanism -- it's the HOV lane to that destination a la healthcare technology assessment and a NICE-like proposition.
(Senator Baucus' legislation -- at least the 2008 version -- says the work of this new AHRQ-based body couldn't be used for CMS reimbursement decisions. Sure. And if you believe that one, I've got a Senate seat to sell you.)
And it's important to note that all three of these "bites" can happen simultaneously, separately, before, during, or as part of a more comprehensive Administration-reform initiative.
Let threedom ring -- but remember for whom the bell tolls.
According to the AP's Matt Perrone:
The AP (12/12, Perrone) (courtesy of the DIA briefing) the Food and Drug Administration (FDA) stated that it "will add the sternest safety warnings available" -- the so-called black-box warning -- "to prescription drugs used to cleanse the bowel before colonoscopies." The FDA was spurred into action after it "received more than 20 reports of a rare, but serious form of kidney failure among patients taking the drugs, known as oral phosphate products." Therefore, Salix Pharmaceuticals' Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous ) and OsmoPrep (sodium biphosphate, sodium phosphate) will now include a label that "warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease, or those that take medications that affect the kidneys."
Wait there's more.
Oral sodium phosphate drugs, "sold with and without a prescription, have been associated with acute phosphate nephropathy, the kidney injury," and it "may lead to permanent kidney damage," Bloomberg News (12/12, Blum) adds. According to Joyce Korvick, M.D., deputy director of the agency's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, "one reason for the risk might be that some people may be dehydrated and not drinking enough fluid when they use oral sodium phosphate products for bowel cleansing, despite the instructions on the products," WebMD (12/11, Hitti) reported. Meanwhile, the FDA is also recommending "that consumers not use over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, for bowel cleansing."
Those "treatments also shouldn't be used for bowel cleansing, and will get new warnings" as well, HealthDay (12/11, Reinberg) added. "At lower doses, however, they are safe for use as laxatives, the FDA said." But there "are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep," Dr. Korvick pointed out. Meanwhile, Hemant K. Roy, M.D., of Evanston-Northwestern Healthcare in Illinois, who wrote an editorial in the Archives of Internal Medicine that accompanied a study on "the risks of oral sodium phosphate" solutions, "stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening." The (NC) Triangle Business Journal (12/11, Coletta) and MedPage Today (12/11, Gever) also covered the story, as did the Los Angeles Times (12/11, Maugh) in its Booster Shots blog.
Doesn't the FDA have better things to do with it's time? Or put another way: has the regulatory apparatus of the nation state evolved to the point where it now has to tell people how to cleanse it's collective bowels safely and effectively? Apparently a manufacturer, in response to the black box put on the label because 20 people are too stupid to follow directions or not drink a case of beer before undergoing a colonoscopy, has pulled it's product. And thank goodness the media is there to cover this story.....
There's always my grandmother's recipe for fruit compote....
The AP (12/12, Perrone) (courtesy of the DIA briefing) the Food and Drug Administration (FDA) stated that it "will add the sternest safety warnings available" -- the so-called black-box warning -- "to prescription drugs used to cleanse the bowel before colonoscopies." The FDA was spurred into action after it "received more than 20 reports of a rare, but serious form of kidney failure among patients taking the drugs, known as oral phosphate products." Therefore, Salix Pharmaceuticals' Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous ) and OsmoPrep (sodium biphosphate, sodium phosphate) will now include a label that "warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease, or those that take medications that affect the kidneys."
Wait there's more.
Oral sodium phosphate drugs, "sold with and without a prescription, have been associated with acute phosphate nephropathy, the kidney injury," and it "may lead to permanent kidney damage," Bloomberg News (12/12, Blum) adds. According to Joyce Korvick, M.D., deputy director of the agency's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, "one reason for the risk might be that some people may be dehydrated and not drinking enough fluid when they use oral sodium phosphate products for bowel cleansing, despite the instructions on the products," WebMD (12/11, Hitti) reported. Meanwhile, the FDA is also recommending "that consumers not use over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, for bowel cleansing."
Those "treatments also shouldn't be used for bowel cleansing, and will get new warnings" as well, HealthDay (12/11, Reinberg) added. "At lower doses, however, they are safe for use as laxatives, the FDA said." But there "are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep," Dr. Korvick pointed out. Meanwhile, Hemant K. Roy, M.D., of Evanston-Northwestern Healthcare in Illinois, who wrote an editorial in the Archives of Internal Medicine that accompanied a study on "the risks of oral sodium phosphate" solutions, "stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening." The (NC) Triangle Business Journal (12/11, Coletta) and MedPage Today (12/11, Gever) also covered the story, as did the Los Angeles Times (12/11, Maugh) in its Booster Shots blog.
Drugmaker recalls over-the-counter bowel cleansing solutions. In a separate article, Bloomberg News (12/12, Pollack, Blum) reports that "C.B. Fleet Co., a closely held maker of laxative products, said it was voluntarily withdrawing its oral, over-the-counter bowel cleansing solutions after U.S. health regulators warned such drugs may harm the kidneys." Specifically, the drugmakers are recalling "Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy," a "decision [that] was made because the Food and Drug Administration said...that this class of drugs should be available only by prescription."
Doesn't the FDA have better things to do with it's time? Or put another way: has the regulatory apparatus of the nation state evolved to the point where it now has to tell people how to cleanse it's collective bowels safely and effectively? Apparently a manufacturer, in response to the black box put on the label because 20 people are too stupid to follow directions or not drink a case of beer before undergoing a colonoscopy, has pulled it's product. And thank goodness the media is there to cover this story.....
There's always my grandmother's recipe for fruit compote....
But then again the girl couldn't bring herself to report that when Scott Gottlieb was at FDA -- and before -- he still saw patients in the ER. Her reporting in this piece, particularly her backhanded slap at Janet Woodcock as someone who hasn't or couldn't reform the FDA is short of slander....
"People close to the industry have been floating the names of other candidates to run the FDA -- including Janet Woodcock, a senior official at the agency -- who are seen as less likely to carry out a thorough overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock as a possible interim chief while a permanent leader is vetted."
Disgusting. And it just so happens that with the possible exception of Steve Nissen whose own conflicts, skeletons and yet to be revealed corrupt behavior while at Cleveland Clinic (most notably his not so veiled threats against companies that did not use him to conduct research), most of the other serious candidates for FDA commissioner have great respect for Dr. Woodcock. But then again, they are actual physicians, not journalists who failed to reveal they were at the same time working for left wing think tanks like Mundy...
Read article here
"People close to the industry have been floating the names of other candidates to run the FDA -- including Janet Woodcock, a senior official at the agency -- who are seen as less likely to carry out a thorough overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock as a possible interim chief while a permanent leader is vetted."
Disgusting. And it just so happens that with the possible exception of Steve Nissen whose own conflicts, skeletons and yet to be revealed corrupt behavior while at Cleveland Clinic (most notably his not so veiled threats against companies that did not use him to conduct research), most of the other serious candidates for FDA commissioner have great respect for Dr. Woodcock. But then again, they are actual physicians, not journalists who failed to reveal they were at the same time working for left wing think tanks like Mundy...
Read article here
Word is from that some in healthcare policy land are upset that Peter wrote a piece critical of the Baucus proposal to examine the comparative effectiveness of new drugs the way NICE does which could lead to rationing. Note to Peter's critics -- our focus is on people and innovation, not a particular Beltway interest or position. No one tells us what to say or do.
Let’s be honest --the fundamental assumption behind the push for a comparative effectiveness agency in the US is that high drug prices are the primary reason American healthcare costs are on the rise. That's simply not true. Drug prices went up less than 1 percent last year, well below the rate of inflation. Pharmaceuticals are about 11% of our national healthcare spend – with on-patent medications representing only about 7 percent. (Something to remember when we debate the non-interference clause and drug importation.)
In theory, properly designed comparative effectiveness studies can be a valuable tool in patient care. In theory. But in practice, in an increasingly personalized world, do large scale studies such as ALLHAT and CATIE really help? Marginally – at best. But all they really end up accomplishing is reaffirming the outdated methodologies of a cost-based system, when what we really need are the proper tools for patient-centric medicine.
While it’s true that comparative effectiveness and healthcare technology assessment (HTA) aren’t the same thing – the question on the table is whether one inevitably leads to the other. And with all the attention being paid to the “need for a US NICE,” the answer is “yes.”
To read more on this topic – and why Senator Baucus needs to go back to the drawing board, click here.
In theory, properly designed comparative effectiveness studies can be a valuable tool in patient care. In theory. But in practice, in an increasingly personalized world, do large scale studies such as ALLHAT and CATIE really help? Marginally – at best. But all they really end up accomplishing is reaffirming the outdated methodologies of a cost-based system, when what we really need are the proper tools for patient-centric medicine.
While it’s true that comparative effectiveness and healthcare technology assessment (HTA) aren’t the same thing – the question on the table is whether one inevitably leads to the other. And with all the attention being paid to the “need for a US NICE,” the answer is “yes.”
To read more on this topic – and why Senator Baucus needs to go back to the drawing board, click here.
The out of touch editorial board of the NY Times writing from the only valuable asset left in the Sulzburger empire (the superfluous new building on 8th Avenue) tries to explain would use generic drugs but for the advertising efforts of brand name drug companies.
Which is sort of like saying the NYT readership should continue to decline as people just pick up the news from any old source even in the face of those annoying and relentless ads the paper keeps running...
What I find interesting is that there are actually still 40 pages in the paper's section A...
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Which is sort of like saying the NYT readership should continue to decline as people just pick up the news from any old source even in the face of those annoying and relentless ads the paper keeps running...
What I find interesting is that there are actually still 40 pages in the paper's section A...
Read More
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.
