Latest Drugwonks' Blog
Let's restrict access out of cost considerations and use safety as the excuse!!!
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/09/19/ncancer219.xml
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/09/19/ncancer219.xml
PRINCIPLES FOR REAUTHORIZATION OF sCHIP
From the Health Policy Consensus Group
* The primary focus of the State Children’s Health Insurance Program should be to cover children in families with incomes at or below 200 percent of poverty. States that wish to expand sCHIP to cover children and adults in higher-income families are free to do so with their own state funds.
For those above 200 percent of poverty, the appropriate federal mechanism for support is through a combination of tax reform and direct financial subsidies to help families purchase the private health insurance of their choice.
* The program’s subsidies should be re-structured to encourage the purchase of private health insurance. sCHIP subsidies could be used to allow parents to purchase the health coverage that they believe is best for their children, including adding them to policies that may be offered at their workplaces. Research shows that children and their parents benefit if the whole family is covered.
* The federal-state matching ratio for sCHIP funding should be changed to eliminate the distortions that exist in today’s system. States receive a higher federal matching rate for covering sCHIP recipients (which today include many adults) than they receive for covering children eligible for Medicaid, even though these Medicaid children are in families with lower incomes. Congress should focus on fixing the perverse incentives that reward states at a higher level for enrolling higher-income sCHIP children over poorer Medicaid children. The current funding formulas also mean more federal sCHIP dollars will go to wealthier states that can afford to expand the program than to poorer states that do not have sufficient state funds to expand their programs.
* sCHIP must not be turned into another entitlement program modeled after Medicaid, with unlimited federal funds matching state spending on benefits. That would add to the taxpayers’ already-overwhelming burden of tens of trillions of dollars in unfunded entitlement liabilities. It also would encourage states to use accounting tricks to inappropriately increase federal payments, as they have done for years in the Medicaid program. sCHIP must remain as a capped funding program to the states, and Congress must require states to live within their allocations.
Here is the complete Consensus Group statement:
Download file
Two-thirds of uninsured children are eligible for either sCHIP or Medicaid under current law, including many children under 200 percent of poverty who are not yet enrolled. Expanding sCHIP to children in higher-income families would mean shifting the focus away from these children who most need help and would grow the program into a middle-class entitlement that goes far beyond its current mission of helping near-poor children. Reauthorization of sCHIP should concentrate on reducing the number of near-poor children who are eligible for coverage.
From the Health Policy Consensus Group
* The primary focus of the State Children’s Health Insurance Program should be to cover children in families with incomes at or below 200 percent of poverty. States that wish to expand sCHIP to cover children and adults in higher-income families are free to do so with their own state funds.
For those above 200 percent of poverty, the appropriate federal mechanism for support is through a combination of tax reform and direct financial subsidies to help families purchase the private health insurance of their choice.
* The program’s subsidies should be re-structured to encourage the purchase of private health insurance. sCHIP subsidies could be used to allow parents to purchase the health coverage that they believe is best for their children, including adding them to policies that may be offered at their workplaces. Research shows that children and their parents benefit if the whole family is covered.
* The federal-state matching ratio for sCHIP funding should be changed to eliminate the distortions that exist in today’s system. States receive a higher federal matching rate for covering sCHIP recipients (which today include many adults) than they receive for covering children eligible for Medicaid, even though these Medicaid children are in families with lower incomes. Congress should focus on fixing the perverse incentives that reward states at a higher level for enrolling higher-income sCHIP children over poorer Medicaid children. The current funding formulas also mean more federal sCHIP dollars will go to wealthier states that can afford to expand the program than to poorer states that do not have sufficient state funds to expand their programs.
* sCHIP must not be turned into another entitlement program modeled after Medicaid, with unlimited federal funds matching state spending on benefits. That would add to the taxpayers’ already-overwhelming burden of tens of trillions of dollars in unfunded entitlement liabilities. It also would encourage states to use accounting tricks to inappropriately increase federal payments, as they have done for years in the Medicaid program. sCHIP must remain as a capped funding program to the states, and Congress must require states to live within their allocations.
Here is the complete Consensus Group statement:
Download file
Two-thirds of uninsured children are eligible for either sCHIP or Medicaid under current law, including many children under 200 percent of poverty who are not yet enrolled. Expanding sCHIP to children in higher-income families would mean shifting the focus away from these children who most need help and would grow the program into a middle-class entitlement that goes far beyond its current mission of helping near-poor children. Reauthorization of sCHIP should concentrate on reducing the number of near-poor children who are eligible for coverage.
Additional thoughts on warfarin, genetic testing and personalized medicine courtesy of Dr Caroline Wright of the Foundation for Genomics and Population Health (a charitable company registered in England and Wales) …
“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug (see previous news article), the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.
Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.
The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.
FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicineâ€
Remember – PDUFA page 182. Working together we can accomplish great things for the public health.
“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug (see previous news article), the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.
Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.
The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.
FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicineâ€
Remember – PDUFA page 182. Working together we can accomplish great things for the public health.
Alison Bass (a former Boston Globe reporter with a long hate the industry bias) is the latest apologist for the increase in suicides as a result of the fearmongering over SSRIs. In an editorial called "Suicide Rates as a PR Tool" she attributes better mental health care and gun control (!) Really? So how are kids killing themselves now in the wake of better mental health care and stricter gun controls if SSRIs have nothing to do with it. The idiocy of zealot courtesy of another anti-medication fanatic, Univ of Maryland researcher Julie Zito.
Oh, Bass is the author of a forthcoming book entitled, "Side Effects: A Best-selling Drug on Trial." How about fearmongering and demeaning those who have struggled to combat suicide as a PR tool. Where does a suicide denier stack up next to a Holocaust denier.
http://www.boston.com/news/globe/editorial_opinion/
Others like Alex (I stole the documents) Berenson dismiss the number of suicides as so small as to really merit concern. Funny, when Steve (I want to cause people's hands to tremble a little bit before they write that prescription," )Nissen and Curt Furberg were foaming at the mouth about 25 'unexplained' heart attacks among kids taking ADHD drugs over a ten year period that was enough to demand a black box an entire class of drugs and for the NY Times to run story after story validating as opposed to questioning the concerns.
http://www.nytimes.com/2006/02/10/health/policy/10drug.html
http://www.nytimes.com/2006/02/21/health/21psyc.html?fta=y
Keep it coming. Every time these whack jobs and their apologists take a run at the work of Robert Gibbons -- which has been verified by Greg Simon at Group of Health Puget Sound and J. John Mann and many others -- the most extreme and dangerous they appear.
Oh, Bass is the author of a forthcoming book entitled, "Side Effects: A Best-selling Drug on Trial." How about fearmongering and demeaning those who have struggled to combat suicide as a PR tool. Where does a suicide denier stack up next to a Holocaust denier.
http://www.boston.com/news/globe/editorial_opinion/
Others like Alex (I stole the documents) Berenson dismiss the number of suicides as so small as to really merit concern. Funny, when Steve (I want to cause people's hands to tremble a little bit before they write that prescription," )Nissen and Curt Furberg were foaming at the mouth about 25 'unexplained' heart attacks among kids taking ADHD drugs over a ten year period that was enough to demand a black box an entire class of drugs and for the NY Times to run story after story validating as opposed to questioning the concerns.
http://www.nytimes.com/2006/02/10/health/policy/10drug.html
http://www.nytimes.com/2006/02/21/health/21psyc.html?fta=y
Keep it coming. Every time these whack jobs and their apologists take a run at the work of Robert Gibbons -- which has been verified by Greg Simon at Group of Health Puget Sound and J. John Mann and many others -- the most extreme and dangerous they appear.
In PDUFA, that is. Page 182. That's where the language creating the Reagan/Udall Foundation begins. And if you want to talk about real FDA reform -- its really the most important part of the whole package.
But what's been written about it can be summed up in two words -- almost nothing.
All the more reason to watch this space.
But what's been written about it can be summed up in two words -- almost nothing.
All the more reason to watch this space.
Steve Galson is a man of honor, integrity, passion, and intelligence -- and he's a terrific choice for Acting U.S. Surgeon General.
Drugwonks will be closed and will not be updated until after Yom Kippur is over.. We leave you with a story that reflects the essence of Rabbi Israel Salanter, a leader of the Mussar (Orthodox Jewish values and ethics) movement in Vilna..
Two unforeseen developments rocked Reb Yisroel's stay in Vilna. The first was related to Reb Yisroel's attitude toward matters of health. He accepted doctor's orders as halachah (Torah law), implicit in the command of ''V'Nishmarsem M'od L'Nafshoseihem", "And you shall guard your lives" (Devarim 4:15). When health concerns conflicted with other halachos, he usually decided with a consistent leniency as far as the latter was concerned. He seemed to share Reb Chaim Brisker's view: "I am not lenient in regard to Shabbos or Yom Kippur; rather I am stringent in the laws of preservation of life!"15
Since Reb Yisroel never rendered any halachic decisions in Vilna, not even for his own household,16 he must have experienced enormous personal conflict during the peak of a cholera epidemic that devastated Vilna in late summer 1848. Reb Yisroel had committed himself to the city's welfare - renting hospital quarters with five hundred beds, while his own talmidim nursed the stricken around the clock, seven days a week, with patient care on Shabbos no different than on the other days of the week. As Yom Kippur approached, he feared that the fast would weaken the people and make them dangerously susceptible to the often-fatal disease. Reb Yisroel hung placards throughout Vilna urging all who felt weak to eat on the fast day, to stave off any threat. He did this without consulting others because he apparently realized that he would not gain a consensus for such a radical, yet - in his view - essential move. Immediately after Shacharis on Yom Kippur, he himself rose to the bimah, and according to some accounts, publicly made Kiddush and ate some cakes to encourage all those in need to follow suit. Needless to say, there were great protests, but Reb Yisroel ignored them and reportedly made his way to other shuls as well, to urge others to join him.
We join with others in wishing everyone "gmar khasime tova" ... That everyone should be enscribed for a good year.
Two unforeseen developments rocked Reb Yisroel's stay in Vilna. The first was related to Reb Yisroel's attitude toward matters of health. He accepted doctor's orders as halachah (Torah law), implicit in the command of ''V'Nishmarsem M'od L'Nafshoseihem", "And you shall guard your lives" (Devarim 4:15). When health concerns conflicted with other halachos, he usually decided with a consistent leniency as far as the latter was concerned. He seemed to share Reb Chaim Brisker's view: "I am not lenient in regard to Shabbos or Yom Kippur; rather I am stringent in the laws of preservation of life!"15
Since Reb Yisroel never rendered any halachic decisions in Vilna, not even for his own household,16 he must have experienced enormous personal conflict during the peak of a cholera epidemic that devastated Vilna in late summer 1848. Reb Yisroel had committed himself to the city's welfare - renting hospital quarters with five hundred beds, while his own talmidim nursed the stricken around the clock, seven days a week, with patient care on Shabbos no different than on the other days of the week. As Yom Kippur approached, he feared that the fast would weaken the people and make them dangerously susceptible to the often-fatal disease. Reb Yisroel hung placards throughout Vilna urging all who felt weak to eat on the fast day, to stave off any threat. He did this without consulting others because he apparently realized that he would not gain a consensus for such a radical, yet - in his view - essential move. Immediately after Shacharis on Yom Kippur, he himself rose to the bimah, and according to some accounts, publicly made Kiddush and ate some cakes to encourage all those in need to follow suit. Needless to say, there were great protests, but Reb Yisroel ignored them and reportedly made his way to other shuls as well, to urge others to join him.
We join with others in wishing everyone "gmar khasime tova" ... That everyone should be enscribed for a good year.
We don't want people living too long now, do we? Not cost-effective. Thank goodness we have the know it alls at CMS who can quickly come up with the optimal lifespan. Once you have the optimal dose for ESAs down pat why stop there? Something for Herb Kuhn and co to think about as they defend their decision and peddle their brilliance to congressional staff in the weeks ahead....
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070920005089&newsLang=en
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070920005089&newsLang=en
As Scott Gottlieb's piece in the WSJ demonstrates, FDA reform is now all about legal pork, not public health. But what Scott didn't note is how our good friends Nissen and Furberg have played and will play a pivotal role in greasing this greed machine.
It all comes together.
The Dems -- under orders from Nancy Pelosi -- have inserted a legal loophole into the FDA reform bill that would give trial lawyers the right to sue drug companies if they don't provide additional information about the risks of drugs independent of what the FDA tells them to provide to the public. This is way to undermine the sole authority -- upheld by courts -- to determine if a drug is safe and effect. It is part of this general trend toward drug safety vigilantism which is being aided and abetted by free lancers inside and outside the FDA who leak and release hastily produced studies to Congress and to the media -- before and after duly constituted FDA review periods.
This shameful assault on the public health is fueled and funded by the trial bar who have pressured and paid for Democrats to slip this last minute provision into a bill that is required to keep the FDA operating.
Now where in the world will the trial bar get the evidence that a drug is unsafe independent of FDA decisions.
Enter Nissen, Furberg, Graham, Avorn, et. al who with the help of the nutroots on the internet (some whom are funded by the trial bar) stoke fear and provide story ideas for the media and copy for an eternally bent over medical journal establishment that is willing to receive what ever they deliver about how dangerous drugs are. No surprise that the "studies" of Furberg -- the 'unpaid' advisor to the trial bar figure prominently in the argument for what the Dems are calling a rule of construction that would allow lawyers to sue companies for not including warnings (based on studies generated by people like Nissen and Furberg) even when the FDA prohibits a company from including warnings without it's consent. The FDA does not engage -- with the exception of a handful of cranks -- in fearmongering. Guys like Nissen do it because it increases their power. And Trial Lawyer Inc. has allied with them because their fearmongering fertilizes the ground from which they reap profits.
The result? Fewer new drugs, fewer new uses, less innovation and less medical benefit.
http://online.wsj.com/article/SB119025325354433415.html?mod=opinion_main_commentaries
It all comes together.
The Dems -- under orders from Nancy Pelosi -- have inserted a legal loophole into the FDA reform bill that would give trial lawyers the right to sue drug companies if they don't provide additional information about the risks of drugs independent of what the FDA tells them to provide to the public. This is way to undermine the sole authority -- upheld by courts -- to determine if a drug is safe and effect. It is part of this general trend toward drug safety vigilantism which is being aided and abetted by free lancers inside and outside the FDA who leak and release hastily produced studies to Congress and to the media -- before and after duly constituted FDA review periods.
This shameful assault on the public health is fueled and funded by the trial bar who have pressured and paid for Democrats to slip this last minute provision into a bill that is required to keep the FDA operating.
Now where in the world will the trial bar get the evidence that a drug is unsafe independent of FDA decisions.
Enter Nissen, Furberg, Graham, Avorn, et. al who with the help of the nutroots on the internet (some whom are funded by the trial bar) stoke fear and provide story ideas for the media and copy for an eternally bent over medical journal establishment that is willing to receive what ever they deliver about how dangerous drugs are. No surprise that the "studies" of Furberg -- the 'unpaid' advisor to the trial bar figure prominently in the argument for what the Dems are calling a rule of construction that would allow lawyers to sue companies for not including warnings (based on studies generated by people like Nissen and Furberg) even when the FDA prohibits a company from including warnings without it's consent. The FDA does not engage -- with the exception of a handful of cranks -- in fearmongering. Guys like Nissen do it because it increases their power. And Trial Lawyer Inc. has allied with them because their fearmongering fertilizes the ground from which they reap profits.
The result? Fewer new drugs, fewer new uses, less innovation and less medical benefit.
http://online.wsj.com/article/SB119025325354433415.html?mod=opinion_main_commentaries
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.
