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In September I participated in a conference of French health care regulators, pharmaceutical firms and members of the Assemblée Nationale. The keynote of the event was a speech by the French Minister of Health, Madame Roselyne Bachelot. She gave a thoughtful presentation on the need for all concerned to work together for the public good.
Recently she showed that she meant what she said with these comments in front of the French Parliament:
"Je suis enfin défavorable à ce que l'on intègre,à l'instar du NICE, la notion de quality-adjusting life-years dans les indicateurs d'éfficience médico-économique. Cela ne correspond pas à la culture dont la HAS doit s'inspirer."
For those of you who took Spanish in high school, here's the translation:
"I am not in favor, as it is done by NICE, to integrate the notion of quality-adjusting life-years among the indicators for medico-economic efficiency. It does not correspond to the culture which should inspire the HAS."
(HAS = La Haute Autorité de Santé. HAS roughly corresponds to NICE in the UK or CMS in the US -- not precisely, but you get the idea.)
Well, amen to French culture and a big "Bon Courage!" to Madame Bachelot.
Recently she showed that she meant what she said with these comments in front of the French Parliament:
"Je suis enfin défavorable à ce que l'on intègre,à l'instar du NICE, la notion de quality-adjusting life-years dans les indicateurs d'éfficience médico-économique. Cela ne correspond pas à la culture dont la HAS doit s'inspirer."
For those of you who took Spanish in high school, here's the translation:
"I am not in favor, as it is done by NICE, to integrate the notion of quality-adjusting life-years among the indicators for medico-economic efficiency. It does not correspond to the culture which should inspire the HAS."
(HAS = La Haute Autorité de Santé. HAS roughly corresponds to NICE in the UK or CMS in the US -- not precisely, but you get the idea.)
Well, amen to French culture and a big "Bon Courage!" to Madame Bachelot.
David Kessler was fired as dean of Univ of California SanFran Medical School. I have no love for Kessler's reign as FDA commissioner -- at least when Clinton was prez and the Dems controlled Congress. Kessler left the FDA to become dean of Yale medical school where most everyone agreed he did a great job. He took on the UCSF job because it is supposed be a world leader in translational medicine, that is, a powerhouse in doing the sort of work that drug companies are supposed to do and don't according to the Soros funded types.
But Kessler found that UCSF, instead of having about $70 million to build up the integrated translational programs he came to establish was deep in the financial toilet. His efforts to clean things up lead to a slimy charge that he was pocketing dough, a charge that was baseless.
Kessler is stepping down. But his inability to institute changes to make the medical school financially accountable raises troubling questions about the ability of the academic medical institutions to properly oversee clinical trials, drug development, practice guidelines, etc. Academic institutions are less transparent and less accountable than most entities. And now we see with UCSF and other universities financial irregularities if not outright corruption as a result of direct manipulation by politicians. I am thinking specifically of the University of Medicine and Dentistry of NJ where the med school's political overseers have nearly ran that fine institution into the ground with self dealing and indifference.
We now see that Congress has no problem calling members of FDA advisory committees if they don't like a particular decision. Imagine how academics would buckle if their every study was under congressional scrutiny. This is how science should be conducted? This is new order the Reformers would impose on us? The Kessler departure raises serious questions about the ability of academic institutions to handle the serious responsibility of transforming scientific insights into preventive and proactive treatments. They cannot be trusted or asked to do so. And neither can the arrogant leaders of the Hate Pharma movement who have tried to seize the dollars and power to determine the course of medicine for themselves and cronies.
http://www.usatoday.com/news/education/2007-12-14-california-dean_N.htm
But Kessler found that UCSF, instead of having about $70 million to build up the integrated translational programs he came to establish was deep in the financial toilet. His efforts to clean things up lead to a slimy charge that he was pocketing dough, a charge that was baseless.
Kessler is stepping down. But his inability to institute changes to make the medical school financially accountable raises troubling questions about the ability of the academic medical institutions to properly oversee clinical trials, drug development, practice guidelines, etc. Academic institutions are less transparent and less accountable than most entities. And now we see with UCSF and other universities financial irregularities if not outright corruption as a result of direct manipulation by politicians. I am thinking specifically of the University of Medicine and Dentistry of NJ where the med school's political overseers have nearly ran that fine institution into the ground with self dealing and indifference.
We now see that Congress has no problem calling members of FDA advisory committees if they don't like a particular decision. Imagine how academics would buckle if their every study was under congressional scrutiny. This is how science should be conducted? This is new order the Reformers would impose on us? The Kessler departure raises serious questions about the ability of academic institutions to handle the serious responsibility of transforming scientific insights into preventive and proactive treatments. They cannot be trusted or asked to do so. And neither can the arrogant leaders of the Hate Pharma movement who have tried to seize the dollars and power to determine the course of medicine for themselves and cronies.
http://www.usatoday.com/news/education/2007-12-14-california-dean_N.htm
You mean that thing about counterfeit drugs is for real! (After all, if it's on the front page of the New York Times it must be important.)
Here's a link to Walt Bogdanich's story in today's Gray Lady:
http://www.nytimes.com/2007/12/17/world/middleeast/17freezone.html?hp
To whet your appetite, here's how it begins ...
DUBAI, United Arab Emirates — Along a seemingly endless row of identical gray warehouses, a lone guard stands watch over a shuttered storage area with a peeling green and yellow sign: Euro Gulf Trading.
Three months ago, when the authorities announced that they had seized a large cache of counterfeit drugs from Euro Gulf’s warehouse deep inside a sprawling free trade zone here, they gave no hint of the raid’s global significance.
But an examination of the case reveals its link to a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, Britain and the Bahamas, ultimately leading to an Internet pharmacy whose American customers believed they were buying medicine from Canada, according to interviews with regulators and drug company investigators in six countries.
The seizure highlights how counterfeit drugs move in a global economy, and why they are so difficult to trace. And it underscores the role played by free trade zones — areas specially designated by a growing number of countries to encourage trade, where tariffs are waived and there is minimal regulatory oversight.
And yet some members of Congress want to decrease regulatory oversight of counterfeiting. Go figure.
Here's a link to Walt Bogdanich's story in today's Gray Lady:
http://www.nytimes.com/2007/12/17/world/middleeast/17freezone.html?hp
To whet your appetite, here's how it begins ...
DUBAI, United Arab Emirates — Along a seemingly endless row of identical gray warehouses, a lone guard stands watch over a shuttered storage area with a peeling green and yellow sign: Euro Gulf Trading.
Three months ago, when the authorities announced that they had seized a large cache of counterfeit drugs from Euro Gulf’s warehouse deep inside a sprawling free trade zone here, they gave no hint of the raid’s global significance.
But an examination of the case reveals its link to a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, Britain and the Bahamas, ultimately leading to an Internet pharmacy whose American customers believed they were buying medicine from Canada, according to interviews with regulators and drug company investigators in six countries.
The seizure highlights how counterfeit drugs move in a global economy, and why they are so difficult to trace. And it underscores the role played by free trade zones — areas specially designated by a growing number of countries to encourage trade, where tariffs are waived and there is minimal regulatory oversight.
And yet some members of Congress want to decrease regulatory oversight of counterfeiting. Go figure.
An op-ed, from the International Herald Tribune, by Dr. Howard Zucker, assistant director-general of the World Health Organization and chairman of the International Medical Products Anti-Counterfeiting Taskforce.
A plague of bad medicine
There is a silent killer loose in the streets of every major city from Beijing to New York. Each day this menace brings the threat of greater illness and even death to sick patients living on farms in Africa and in the bungalows of South America. The source of this global epidemic is
counterfeit medicines.
Unlike counterfeit purses or watches, there is no demand by consumers for fake drugs. No one - rich or poor, Chinese, American or African - seeks them out; their victims are always duped into believing they have the real thing.
The motivation is simple: counterfeiting drugs is big business today, and quite likely the fastest growing criminal activity on earth. According to the U.S.-based Center for Medicine in the Public Interest, counterfeit drug trafficking will be a $75 billion enterprise by 2010.
Here's the rest of Dr. Zucker's commentary:
http://www.iht.com/articles/2007/12/14/opinion/edzucker.php
An important read.
A plague of bad medicine
There is a silent killer loose in the streets of every major city from Beijing to New York. Each day this menace brings the threat of greater illness and even death to sick patients living on farms in Africa and in the bungalows of South America. The source of this global epidemic is
counterfeit medicines.
Unlike counterfeit purses or watches, there is no demand by consumers for fake drugs. No one - rich or poor, Chinese, American or African - seeks them out; their victims are always duped into believing they have the real thing.
The motivation is simple: counterfeiting drugs is big business today, and quite likely the fastest growing criminal activity on earth. According to the U.S.-based Center for Medicine in the Public Interest, counterfeit drug trafficking will be a $75 billion enterprise by 2010.
Here's the rest of Dr. Zucker's commentary:
http://www.iht.com/articles/2007/12/14/opinion/edzucker.php
An important read.
In the spirit of the season, some thoughts on how 2008 can be the year when we all decide to "just get along" and focus on the public health and personalized medicine rather than, well, more personalized agendas.
As far as a "more effective" FDA is concerned, consider this -- effective regulation can’t happen in a vacuum. Unlike in the movies, the best new ideas, be they scientific or otherwise, rarely spring fully-grown from the head of anyone -- even our elected representatives. That means industry and Congress and academia and patient groups and physicians ... and the FDA must have close ties. Ties that bind rather then cut, with relationships built on trust and mutual respect. That's the only way to achieve anything worthwhile. "The beatings will continue until morale improves" isn't working. And while there will always be tension between regulator and regulated, between agency and oversight authority, such tension can be productive, creative tension.
Diamonds, after all, are the result of pressure.
As far as a "more effective" FDA is concerned, consider this -- effective regulation can’t happen in a vacuum. Unlike in the movies, the best new ideas, be they scientific or otherwise, rarely spring fully-grown from the head of anyone -- even our elected representatives. That means industry and Congress and academia and patient groups and physicians ... and the FDA must have close ties. Ties that bind rather then cut, with relationships built on trust and mutual respect. That's the only way to achieve anything worthwhile. "The beatings will continue until morale improves" isn't working. And while there will always be tension between regulator and regulated, between agency and oversight authority, such tension can be productive, creative tension.
Diamonds, after all, are the result of pressure.
10-2 against. So it doesn't look like we'll be seeing OTC statins any time soon. All the more reason to carefully watch the FDA's words and actions viz BTC. If all this is giving you heartburn -- well at least those medications you can get without a prescription.
How did steroids spread through MLB. It started in college and high school where coaches and parents looked the other way. And it continued in The Show where management from the GMs to the owners knew about it and did nothing. Retired players who I know realize that 'roids were and are illegal but have said that a clear no tolerance policy would have wipe them out a long time ago.
Meanwhile Senator Mitchell's report has some very interesting things to say about how easy it is for players -- or anyone -- to get steroids and HGH through internet pharmacies and Canada. What sort of signal does it send when Congress handcuffs the federal law enforcement agencies and the FDA from intercepting such products in it's stupid pursuit of drug importation. The same signal MLB ownership sent to players when it said it wanted to crack down on steroid use but never really got tough.
Here's a link to the Yahoo sport site that in turn has a link to the report.
http://sports.yahoo.com/
Meanwhile Senator Mitchell's report has some very interesting things to say about how easy it is for players -- or anyone -- to get steroids and HGH through internet pharmacies and Canada. What sort of signal does it send when Congress handcuffs the federal law enforcement agencies and the FDA from intercepting such products in it's stupid pursuit of drug importation. The same signal MLB ownership sent to players when it said it wanted to crack down on steroid use but never really got tough.
Here's a link to the Yahoo sport site that in turn has a link to the report.
http://sports.yahoo.com/
Just participated on a "blogger conference call" with Mark Fendrick (University of Michigan) and Michael Chernew (Harvard University). They are the co-directors of the Center for Value-Based Insurance Design.
The VBID Center sounds like an interesting proposition. For more detail check out their website:
http://www.sph.umich.edu/vbidcenter/
Many interesting points were brought up -- not the least of which was the issue of whether or not -- considering the relatively truncated lifespan of any individual's relationship with a given private payer -- Big Insurance can be convinced to offer more efficient programs that incent aggressive preventative and chronic care.
And, since the VBID program is based in the Wolverine State, I asked if they thought the new GM/Union agreement over health care would result in more patient-centric programs. Both Dr. Fendrick and Dr. Chernew demurred from making a prediction. Typical academics!
I think it will. Because (1) These are union employees who (at least in theory) will be with the insurance plan for an extended period -- so additional up-front costs (aka "investments") can be recouped over a longer period of time via enhanced productivity and fewer acute health care events and (2) Unions exist to serve their members rather then themselves (I know -- at least in theory) and should, therefore, be more willing to spend more money upfront.
Whether or not my prediction turns out to be correct -- it's a good initial litmus test for the general theory.
The VBID Center also said all the right things about the value of reimbursing for appropriate diagnostics (genomic and otherwise) -- specifically giving the thumbs up to genetic tests for Warfarin and the BRCAs.
The call lasted about an hour with many intelligent questions from the blogger audience. Strangely though, the VBID folks said their "consultant" had told them to expect a blogger call to last for only 20-25 minutes. Peculiar. But, in any event, it was time well spent.
The VBID Center sounds like an interesting proposition. For more detail check out their website:
http://www.sph.umich.edu/vbidcenter/
Many interesting points were brought up -- not the least of which was the issue of whether or not -- considering the relatively truncated lifespan of any individual's relationship with a given private payer -- Big Insurance can be convinced to offer more efficient programs that incent aggressive preventative and chronic care.
And, since the VBID program is based in the Wolverine State, I asked if they thought the new GM/Union agreement over health care would result in more patient-centric programs. Both Dr. Fendrick and Dr. Chernew demurred from making a prediction. Typical academics!
I think it will. Because (1) These are union employees who (at least in theory) will be with the insurance plan for an extended period -- so additional up-front costs (aka "investments") can be recouped over a longer period of time via enhanced productivity and fewer acute health care events and (2) Unions exist to serve their members rather then themselves (I know -- at least in theory) and should, therefore, be more willing to spend more money upfront.
Whether or not my prediction turns out to be correct -- it's a good initial litmus test for the general theory.
The VBID Center also said all the right things about the value of reimbursing for appropriate diagnostics (genomic and otherwise) -- specifically giving the thumbs up to genetic tests for Warfarin and the BRCAs.
The call lasted about an hour with many intelligent questions from the blogger audience. Strangely though, the VBID folks said their "consultant" had told them to expect a blogger call to last for only 20-25 minutes. Peculiar. But, in any event, it was time well spent.
Per Dr. Bob's post below on vaccines, let me relate what my pediatrician buddy says to parents who don't want their children vaccinated --
"It's your choice. But if you choose not to have your child vaccinated then you cannot be my patient."
This is serious business folks. Voodoo science that scares parents away from accepting childhood vaccinations (and the lawyers who would fan those false flames for profit) is one of the most serious public health risks our nation faces.
And certainly one of the most avoidable.
"It's your choice. But if you choose not to have your child vaccinated then you cannot be my patient."
This is serious business folks. Voodoo science that scares parents away from accepting childhood vaccinations (and the lawyers who would fan those false flames for profit) is one of the most serious public health risks our nation faces.
And certainly one of the most avoidable.
In her excellent piece about the Merck vaccine recall Linda Johnson anticipates -- correctly -- the coming storm from the crazies who believe that we should really be scared and angry about how the fact that kids don't even need vaccines to begin with:
"The recall is likely to heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection. "
Sad but true. And Johnson forgot to mention the barrage of bottom feeding trial lawyers who will try to sue Merck in the wake of the recall.
http://news.yahoo.com/s/ap/20071213/ap_on_he_me/vaccine_recall
"The recall is likely to heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection. "
Sad but true. And Johnson forgot to mention the barrage of bottom feeding trial lawyers who will try to sue Merck in the wake of the recall.
http://news.yahoo.com/s/ap/20071213/ap_on_he_me/vaccine_recall
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.
