Latest Drugwonks' Blog
Are we devoid of any sense of irony?
Rob Stein of the Washington Post pens an article that begins:
One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk.
And then two days ago writes with a surge of certainty and finality...
"A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems.
In addition to casting doubt on notions such as lowering cholesterol to prevent heart disease and normalizing blood sugar to protect diabetics, the studies involving well-known drugs such as Avandia and Vytorin have also rekindled concern about whether new medications are being tested adequately before being allowed on the market."
Diabetes and cholesterol drugs are the most widely and heavily studied drugs on the planet next to blood pressure meds. Should every one of those studies been done in clinical trials prior to market? And does Stein see the difference in how he covers the diabetes story --government studies -- and the Vytorin and Avandia cases? I bet he doesn't. What about the Avastin story, the drug left for dead by the FDA and Wall Street only to become a blockbuster?
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
Science is full of surprises...that is the essence of it's enterprise. What's changed is we now have a Tabloid medicine industry comprised of the media, Congress, instant experts like Steve Nissen and nut cases on the Net that seizes on every surprise and turns it into a scandal that was deliberately "hidden" by those conflict-ridden types who conducted the experiment and by the FDA who knew but are too cozy with industry to care.
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021801942.html
Rob Stein of the Washington Post pens an article that begins:
One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk.
And then two days ago writes with a surge of certainty and finality...
"A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems.
In addition to casting doubt on notions such as lowering cholesterol to prevent heart disease and normalizing blood sugar to protect diabetics, the studies involving well-known drugs such as Avandia and Vytorin have also rekindled concern about whether new medications are being tested adequately before being allowed on the market."
Diabetes and cholesterol drugs are the most widely and heavily studied drugs on the planet next to blood pressure meds. Should every one of those studies been done in clinical trials prior to market? And does Stein see the difference in how he covers the diabetes story --government studies -- and the Vytorin and Avandia cases? I bet he doesn't. What about the Avastin story, the drug left for dead by the FDA and Wall Street only to become a blockbuster?
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
Science is full of surprises...that is the essence of it's enterprise. What's changed is we now have a Tabloid medicine industry comprised of the media, Congress, instant experts like Steve Nissen and nut cases on the Net that seizes on every surprise and turns it into a scandal that was deliberately "hidden" by those conflict-ridden types who conducted the experiment and by the FDA who knew but are too cozy with industry to care.
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021801942.html
Anna Mathews puff piece on Bart Stupak paints him as a sometimes overzealous crusader seeking to right wrongs at an out of control FDA...Good thing she didn't include this stirring Stupak statement -- from an LA Times article -- about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA's cafeteria guy should resign...
"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."
Is there such a thing as laissez faire regulation?
Last time I checked, drug approvals were at an all-time low and the percentage of IND getting through the FDA had gone from 11 percent to 8 percent over a ten year period. The percent of drugs withdrawn has remained the same over that same time period. Laissez faire?
Oh and has anyone given one tenth of the coverage to the fact that the NIH pulled the plug on the ACCORD study that killed people compared to the ENHANCE trial that did not? In both cases the protocols were changed midstream and ACCORD even had a data safety monitoring board.
I don't see Stupak holding a hearing on that. Maybe it's not a case of laissez faire regulation. Or maybe it's just that you get less media coverage.
http://online.wsj.com/article/SB120347636748679131.html?mod=home_health_right
"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."
Is there such a thing as laissez faire regulation?
Last time I checked, drug approvals were at an all-time low and the percentage of IND getting through the FDA had gone from 11 percent to 8 percent over a ten year period. The percent of drugs withdrawn has remained the same over that same time period. Laissez faire?
Oh and has anyone given one tenth of the coverage to the fact that the NIH pulled the plug on the ACCORD study that killed people compared to the ENHANCE trial that did not? In both cases the protocols were changed midstream and ACCORD even had a data safety monitoring board.
I don't see Stupak holding a hearing on that. Maybe it's not a case of laissez faire regulation. Or maybe it's just that you get less media coverage.
http://online.wsj.com/article/SB120347636748679131.html?mod=home_health_right
No, not a new horror movie, a new op-ed from today's edition of The Detroit News:
Bureaucrats threaten personalized medical breakthroughs
American health care has come to a fork in the road.
On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.
Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.
Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.
And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.
Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."
Here's the rest of the story:
http://www.detnews.com/apps/pbcs.dll/article?AID=/20080220/OPINION01/802200397/1008
And to further entice you, here's the concluding paragraph:
We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.
Bureaucrats threaten personalized medical breakthroughs
American health care has come to a fork in the road.
On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.
Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.
Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.
And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.
Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."
Here's the rest of the story:
http://www.detnews.com/apps/pbcs.dll/article?AID=/20080220/OPINION01/802200397/1008
And to further entice you, here's the concluding paragraph:
We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.
The Tufts Center for Drug Development -- enemy territory for drugwonks because of its concentration of RedSox rooters -- held a session on business models to improve R and D productivity recently...The takeaway point:
“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US.
“Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added.
Read More
Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet?
Read More
“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US.
“Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added.
Read More
Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet?
Read More
At a recent London policy conference on parallel trade, Heinz Kobelt (Secretary General of the European Association of Euro-Pharmaceutical Companies – EAEPC) discussed his association’s credo of “know your customer.†This was during a discussion of how parallel trade can actually help to enhance drug safety and security. (More on that absurd canard in a moment.)
But, during the ensuing Q&A it turns out that “know your customer†actually means “don’t ask/don’t tell†when it comes to one of their most important and largest category of customers – wholesalers, specifically those shady entrepreneurs who go beyond legal EU parallel trade into the clearly illegal realm of marketing non-approved drugs to North America.
Case in point: Rimonabant.
Licensed and legally marketed in the EU under the brand name “Acomplia,†this medicine is not approved for use in the United States. But type “Acomplia†into any US search engine and you’ll find no shortage of Canadian internet pharmacies ready, willing, and able to sell it to any American with a credit card.
How is this possible? Because these pharmacies are buying their supplies from European wholesalers – wholesalers who are getting their supplies (legally) from within the EU and then selling them (illegally) outside the confines of the Treaty of Rome.
When confronted with this shady behavior, Mr. Kobelt was at a loss for words, finally saying that it was an issue that should be brought up with the wholesalers.
Heinz – you can’t have 57 flavors of “know your customer,†choosing to "know them" only when it's convenient is a policy that is neither sound nor honest.
As to parallel trade enhancing safety and security, here’s how Heinz spins that one.
During his presentation he pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention is that those same products had already passed through three other parallel traders without being found.
Some victory for drug safety and parallel trade.
Something else that Heinz didn’t share was that, when the parallel trader found the counterfeits, rather than calling the UK authorities as required (the MHRA in this instance), he called the company whose drug had been counterfeited – so that he could get his supplies replaced.
Parallel trade and altruistic commitment to drug safety? Sure.
But, during the ensuing Q&A it turns out that “know your customer†actually means “don’t ask/don’t tell†when it comes to one of their most important and largest category of customers – wholesalers, specifically those shady entrepreneurs who go beyond legal EU parallel trade into the clearly illegal realm of marketing non-approved drugs to North America.
Case in point: Rimonabant.
Licensed and legally marketed in the EU under the brand name “Acomplia,†this medicine is not approved for use in the United States. But type “Acomplia†into any US search engine and you’ll find no shortage of Canadian internet pharmacies ready, willing, and able to sell it to any American with a credit card.
How is this possible? Because these pharmacies are buying their supplies from European wholesalers – wholesalers who are getting their supplies (legally) from within the EU and then selling them (illegally) outside the confines of the Treaty of Rome.
When confronted with this shady behavior, Mr. Kobelt was at a loss for words, finally saying that it was an issue that should be brought up with the wholesalers.
Heinz – you can’t have 57 flavors of “know your customer,†choosing to "know them" only when it's convenient is a policy that is neither sound nor honest.
As to parallel trade enhancing safety and security, here’s how Heinz spins that one.
During his presentation he pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention is that those same products had already passed through three other parallel traders without being found.
Some victory for drug safety and parallel trade.
Something else that Heinz didn’t share was that, when the parallel trader found the counterfeits, rather than calling the UK authorities as required (the MHRA in this instance), he called the company whose drug had been counterfeited – so that he could get his supplies replaced.
Parallel trade and altruistic commitment to drug safety? Sure.
Despite those who believe that the government should control what medical journal articles doctors can read, some courageous sanity from the FDA.
FDA to Guide Off-Label Drug Marketing
By MATTHEW PERRONE AP Business Writer
© 2008 The Associated Press
WASHINGTON — The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.
The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.
Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.
Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.
"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.
But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.
Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.
Here’s a link to the FDA statement:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
And here’s a link to the complete AP story:
http://www.chron.com/disp/story.mpl/ap/fn/5545881.html
Knowledge is power. And information saves lives.
FDA to Guide Off-Label Drug Marketing
By MATTHEW PERRONE AP Business Writer
© 2008 The Associated Press
WASHINGTON — The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.
The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.
Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.
Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.
"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.
But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.
Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.
Here’s a link to the FDA statement:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
And here’s a link to the complete AP story:
http://www.chron.com/disp/story.mpl/ap/fn/5545881.html
Knowledge is power. And information saves lives.
Here's Bart Stupak, head of the Health subcommittee on Energy Commerce, who is running the series of show trials on the FDA and the pharmaceutical industry (only anti-industry and FDA malcontents need testify) on the "link" between SSRIs and suicide:
"SSRI’s have not been proven effective in treating adolescent
depression. To the contrary their use may actually increase the suicide rate of its young
patients. In response to these reports of increased suicide rates with SSRI use, FDA
officials suppressed their own post marketing surveillance, prohibited FDA employees
from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient."
Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.
Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is:
And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable?
Here's Bart Stupak on the "link" between SSRI's and suicide
"SSRI’s have not been proven effective in treating adolescent
depression. To the contrary their use may actually increase the suicide rate of its young
patients. In response to these reports of increased suicide rates with SSRI use, FDA
officials suppressed their own post marketing surveillance, prohibited FDA employees
from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient."
Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.
Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is:
And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable?
Here's Bart Stupak on the "link" between SSRI's and suicide
Like they say, everything you read in the newspaper is true – except for those things you know about personally.
Case in point: the Wall Street Journal reporting that, regardless of which of the remaining three amigos gets elected in November, “drugs from Canada†is a done deal.
Nope. Here’s why not:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.†That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.â€
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RXâ€program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way†Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?†Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
So while the candidates may opt for “drugs from Canada†as a useful political talking point – a way to say “look how tough I can be on those bad drug companies. The real issue lies elsewhere.
When it comes to health care reform, there’s one major policy difference that sets Senator McCain apart from Senators Obama and Clinton – Senator McCain believes in the strengths of a market economy. He sees drug importation as an access issue. The other side sees it as a way to import price controls and a first step towards government-run health care.
Don’t get fooled by the importation rhetoric. It’s nothing but a side-show. And it ain’t gonna happen. It's more dangerous as a smoke screen.
Case in point: the Wall Street Journal reporting that, regardless of which of the remaining three amigos gets elected in November, “drugs from Canada†is a done deal.
Nope. Here’s why not:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.†That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.â€
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RXâ€program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way†Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?†Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
So while the candidates may opt for “drugs from Canada†as a useful political talking point – a way to say “look how tough I can be on those bad drug companies. The real issue lies elsewhere.
When it comes to health care reform, there’s one major policy difference that sets Senator McCain apart from Senators Obama and Clinton – Senator McCain believes in the strengths of a market economy. He sees drug importation as an access issue. The other side sees it as a way to import price controls and a first step towards government-run health care.
Don’t get fooled by the importation rhetoric. It’s nothing but a side-show. And it ain’t gonna happen. It's more dangerous as a smoke screen.
Rhetoric counts.
People seem to like the idea of "universal care" but don't much cotton to "government care." That's why you don't hear any of the remaining presidential candidates talking about the latter. But here's one term that nobody seems to like -- health care rationing.
Unfortunately, though, health care rationing is a direct consequence of government-run health care throughout Europe. It's a truth that's, well, universal -- although entirely absent from SiCKO and stump speeches.
Consider the recent report by the British House of Commons Health Committee. They made a total of 38 recommendations -- here are two:
* Wider debate on rationing in the healthcare system across all stakeholders: in particular, NICE must communicate more clearly the reasons for a negative appraisal to patients and clinicians. The Committee also highlighted the scope for disinvestment in some areas to free up resources for more "cost-effective" treatments.
Typical centralized approach -- costs first, patients last. That's one thing that is universal about top-down government-run health care.
But here's some good news. The Committee also recognized the need for additional research into a more "societal-friendly" (aka: long-term and patient-centric) view of HTA. Specifically, the Committee wants to know more about the Swedish Pharmaceutical Benefits Board (LFN) and its wider societal perspective on reimbursement assessments.
Maybe there's something to be said for the Stockholm Syndrome after all.
All things considered, a free-market approach to health care is the best solution since, by definition, it combines the needs of the consumer (aka: the patient) with those of the service provider (in this instance, payers). Part D is only the most recent manifestation of this Economics 101 phenomenon.
And amazingly (if not surprisingly) discussion of Part D seems to have evaporated from the presidential debate. Why? Because it reinforces the proposition that free-market health care (in the case of Part D in combination with a behemoth government program) gets the job done with excellence and under budget.
There's a lesson there not only our transatlantic cousins -- but for our presidential candidates.
Will reality triumph over rhetoric? Stay tuned.
People seem to like the idea of "universal care" but don't much cotton to "government care." That's why you don't hear any of the remaining presidential candidates talking about the latter. But here's one term that nobody seems to like -- health care rationing.
Unfortunately, though, health care rationing is a direct consequence of government-run health care throughout Europe. It's a truth that's, well, universal -- although entirely absent from SiCKO and stump speeches.
Consider the recent report by the British House of Commons Health Committee. They made a total of 38 recommendations -- here are two:
* Wider debate on rationing in the healthcare system across all stakeholders: in particular, NICE must communicate more clearly the reasons for a negative appraisal to patients and clinicians. The Committee also highlighted the scope for disinvestment in some areas to free up resources for more "cost-effective" treatments.
Typical centralized approach -- costs first, patients last. That's one thing that is universal about top-down government-run health care.
But here's some good news. The Committee also recognized the need for additional research into a more "societal-friendly" (aka: long-term and patient-centric) view of HTA. Specifically, the Committee wants to know more about the Swedish Pharmaceutical Benefits Board (LFN) and its wider societal perspective on reimbursement assessments.
Maybe there's something to be said for the Stockholm Syndrome after all.
All things considered, a free-market approach to health care is the best solution since, by definition, it combines the needs of the consumer (aka: the patient) with those of the service provider (in this instance, payers). Part D is only the most recent manifestation of this Economics 101 phenomenon.
And amazingly (if not surprisingly) discussion of Part D seems to have evaporated from the presidential debate. Why? Because it reinforces the proposition that free-market health care (in the case of Part D in combination with a behemoth government program) gets the job done with excellence and under budget.
There's a lesson there not only our transatlantic cousins -- but for our presidential candidates.
Will reality triumph over rhetoric? Stay tuned.
I'm in London at a conference on the European parallel trade experience. And it is, indeed, quite an expereince.
Consider first the topic I have been assigned to address: "What a potential Democratic victory will mean for parallel trade in the USA." Well, first of off, I certainly intend to share with my European colleagues my belief that ALL elections in the United States are democratic ones. And next I will tell them why, when it comes to parallel trade (aka "drug importation") it won't make any difference whatsoever.
But I'll report on my own remarks tomorrow. For now, let me share with you some insights from Mr. W. Neil Palmer of RTI Health Solutions. (By way of bona fides, Neil has served as a senior official with the Canadian Patented Medicine Prices Review Board -- the dreaded PMPRB -- as well as with the Health Division of Health Canada, and the Kellogg Centre for Advanced Studies in Primary Care in Montreal.)
His take on the European experience with parallel trade:
* It is not the policy of EU governments to use parallel trade to deliver savings to their individual health care systems.
* Because savings are not passed on to consumers and payers.
* Patient care may be jeopardized because of quality, supply chain integrity and reguatory compliance issues -- as well as potential shortages occuring in exporting nations.
* Increased parallel trade results in decreased competitivenes of the pharmaceutical industry in local markets. And, since the profits of the parallel traders aren't reinvested into R&D, opportunities are lost for the patient, the local health care system, and the economy.
Other than that, it's been a terrific experience.
Consider first the topic I have been assigned to address: "What a potential Democratic victory will mean for parallel trade in the USA." Well, first of off, I certainly intend to share with my European colleagues my belief that ALL elections in the United States are democratic ones. And next I will tell them why, when it comes to parallel trade (aka "drug importation") it won't make any difference whatsoever.
But I'll report on my own remarks tomorrow. For now, let me share with you some insights from Mr. W. Neil Palmer of RTI Health Solutions. (By way of bona fides, Neil has served as a senior official with the Canadian Patented Medicine Prices Review Board -- the dreaded PMPRB -- as well as with the Health Division of Health Canada, and the Kellogg Centre for Advanced Studies in Primary Care in Montreal.)
His take on the European experience with parallel trade:
* It is not the policy of EU governments to use parallel trade to deliver savings to their individual health care systems.
* Because savings are not passed on to consumers and payers.
* Patient care may be jeopardized because of quality, supply chain integrity and reguatory compliance issues -- as well as potential shortages occuring in exporting nations.
* Increased parallel trade results in decreased competitivenes of the pharmaceutical industry in local markets. And, since the profits of the parallel traders aren't reinvested into R&D, opportunities are lost for the patient, the local health care system, and the economy.
Other than that, it's been a terrific experience.
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.
