Latest Drugwonks' Blog
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
MarkMonitor that is.
Congress may soon consider legislation that would allow Americans to buy prescription drugs from foreign countries. Lawmakers who plan to vote for it should first read a new report on online pharmacies published by the respected Internet fraud expert MarkMonitor.
Published in August while Congress was on vacation, it found that of the 3,160 online pharmacies it studied, almost all of them were likely selling fake medicine.
This shocking finding should cause the congressional supporters of drug importation to change their minds, as many of their constituents will be turning to such websites for their prescriptions if the bill becomes law.
Here's a taste:
"The FDA has caught a number of pharmacies that claimed to be based in Canada -- but were operated out of China and sold medicine that was manufactured there. It's not clear how many online pharmacies are doing this, but anecdotal evidence suggests that the number is large. MarkMonitor found that 18 percent of the Web sites it evaluated were based in China, and that 12 percent were in the former Soviet Union."
And here's a link to an op-ed from today's Detroit News ...
http://www.detnews.com/apps/pbcs.dll/article?AID=/20070920/OPINION01/709200323/1008
Unsafe online pharmacies would be among the first to capitalize on legalized importation. If Americans care about their safety, they ought to log off online pharmacies. And lawmakers ought to shut down their push for drug importation.
Congress may soon consider legislation that would allow Americans to buy prescription drugs from foreign countries. Lawmakers who plan to vote for it should first read a new report on online pharmacies published by the respected Internet fraud expert MarkMonitor.
Published in August while Congress was on vacation, it found that of the 3,160 online pharmacies it studied, almost all of them were likely selling fake medicine.
This shocking finding should cause the congressional supporters of drug importation to change their minds, as many of their constituents will be turning to such websites for their prescriptions if the bill becomes law.
Here's a taste:
"The FDA has caught a number of pharmacies that claimed to be based in Canada -- but were operated out of China and sold medicine that was manufactured there. It's not clear how many online pharmacies are doing this, but anecdotal evidence suggests that the number is large. MarkMonitor found that 18 percent of the Web sites it evaluated were based in China, and that 12 percent were in the former Soviet Union."
And here's a link to an op-ed from today's Detroit News ...
http://www.detnews.com/apps/pbcs.dll/article?AID=/20070920/OPINION01/709200323/1008
Unsafe online pharmacies would be among the first to capitalize on legalized importation. If Americans care about their safety, they ought to log off online pharmacies. And lawmakers ought to shut down their push for drug importation.
Last night, on the CNBC program "On the Money, Betsey McCaughey (Hudson Institute) and me were interviewed by Melissa Francis on "the drug dilemma" -- whether or not drug companies are doing enough to explain potential side-effects of their products.
Here's the video link:
http://www.cnbc.com/id/15840232?video=522416099&play=1
On the money? You decide.
Here's the video link:
http://www.cnbc.com/id/15840232?video=522416099&play=1
On the money? You decide.
Peter and I received inquiries about where CMPI received our funding from a nice young man from Senator Byron Dorgan's office name Ben Klein. We both spoke to him and told Ben as we have told everyone that CMPI receives the bulk of our support -- proudly -- from pharmaceuetical and biotech firms that do the heavy lifting in the search for better medicines and search for cures. We are forthright and transparent in that respect. We offered to send a 990 once it's complete... a real one made in the USA, not imported from Canada.
We believe in disclosure and transparency and in that spirit, here's where Senator Dorgan got his money for his 2004 campaign....
Agribusiness $127,180
Communic/Electronics $442,767
Construction $26,300
Defense $57,998
Energy/Nat Resource $181,266
Finance/Insur/RealEst $458,100
Health $161,400
Lawyers & Lobbyists $562,214
Transportation $148,864
Misc Business $303,683
Labor $345,000
Ideology/Single-Issue $211,255
Other $83,360
http://www.opensecrets.org/races/sector.asp?ID=NDS1&cycle=2004&special=N
So the next time Dorgan talks issues someone should question his integrity by asking him if he gets support from such and such industry first.....
And here is where he spreads the pork... earmarks include $350,000 for leafy-spurge eradication efforts and $200,000 for the International Peace Gardens. In North Dakota? How about my backyard to replace the poison sumac?
And just so we know what the Dorgan standard for disclosure is, let's go back to 2005 when he was holding court on the Abramhoff scandal and "forgot" to disclose how he used Jack's corporate box as a fundraiser and pocketed campaign contributions that, while legal, gave the appearance of a conflict of interest...
From the Boston Globe in 2005...
The Democrat helping to lead the Senate investigation into Jack Abramoff's Indian lobbying had his own connections to the controversial lobbyist's team and clients, including using his sports arena skybox to raise money.
Senator Byron Dorgan, a North Dakota Democrat, acknowledges he got Congress in fall 2003 to press government regulators to decide, after decades of delay, whether the Mashpee Wampanoag tribe of Massachusetts deserved federal recognition.
Dorgan met with the tribe's representatives and collected at least $11,500 in political donations from Abramoff partner Michael D. Smith, who was representing the Mashpee, around the time he helped craft the legislation, according to interviews and documents obtained by the Associated Press.
The senator also didn't reimburse another tribe, the Mississippi Choctaw, for the use of Abramoff's skybox in 2001, when the tribe held a fund-raiser for him there, instead treating it as a tribal contribution. He only recently reimbursed the tribe for the box, four years later, after determining it was connected to Abramoff.
Dorgan, who is vice chairman of the Senate Indian Affairs Committee that is investigating Abramoff, says he sees no reason to step down from the probe, which he and Senator John McCain, an Arizona Republican, are leading. He said he had no idea at the time that any of the transactions were connected to Abramoff or the alleged fleecing of tribes.
''I never met Jack Abramoff, but I am appalled by what we have learned about his actions," Dorgan said Thursday. ''So I have never felt there was any conflict in my helping to lead that investigation. I think Senator McCain would agree our investigation has been relentless and that neither of us will be diverted."
Dorgan's contacts, donations, and fund-raisers involving Abramoff tribal clients and lobbying associates, as well as those of other lawmakers, have not been examined during the Senate hearings into the lobbyist's roughly $80 million in charges to the tribes.
The senator didn't volunteer the information, although he did disclose his donations in campaign reports over the years.
Larry Noble, the government's former chief election enforcement lawyer, said Dorgan should have considered stepping aside from the inquiry and should have disclosed all his own intersections with Abramoff's associates and tactics.
''I think any way you look at it, he had an obligation to disclose," Noble said. ''It is hard for anyone not to see a conflict when you're investigating the same activity you yourself were involved with."
Over the past month, the AP has reported that about four dozen lawmakers, Republicans and Democrats, collected donations from Abramoff's tribal clients and firm around the time they wrote letters to the Bush administration or Congress favorable to the tribes.
Congressional ethics rules require lawmakers to avoid even the appearance of a conflict of interest in performing official duties and accepting political money. The Justice Department is investigating whether Abramoff, already charged with fraud in a Florida case, won any undue influence through donations and favors.
Dorgan on Monday sharply criticized the AP for reporting last week that he collected $20,000 from Abramoff's firm and tribes in the period when he wrote a letter urging the Senate Appropriations Committee to fund a school construction program that Abramoff's clients and other tribes wanted.
The senator, who has Indian tribes in his state, said he long supported the program and the letter and donations had no connection.
He asserted that he never took any action or received campaign help that knowingly involved Abramoff.
Dorgan's office acknowledged he met in 2003 with representatives of the Mashpee, the Massachusetts tribe that Abramoff signed as a client and Smith represented.
The senator used his position as a member of the joint House-Senate committee that approved the final Interior Department spending bill for 2004 to craft a provision that pressed the agency to ''complete its review of the Mashpee petition as expeditiously as possible."
http://www.boston.com/news/nation/washington/articles/2005/12/03/abramoff_prober_had_ties_to_lobbyist/
Hope we've been helpful Senator. Let's have lunch soon.
We believe in disclosure and transparency and in that spirit, here's where Senator Dorgan got his money for his 2004 campaign....
Agribusiness $127,180
Communic/Electronics $442,767
Construction $26,300
Defense $57,998
Energy/Nat Resource $181,266
Finance/Insur/RealEst $458,100
Health $161,400
Lawyers & Lobbyists $562,214
Transportation $148,864
Misc Business $303,683
Labor $345,000
Ideology/Single-Issue $211,255
Other $83,360
http://www.opensecrets.org/races/sector.asp?ID=NDS1&cycle=2004&special=N
So the next time Dorgan talks issues someone should question his integrity by asking him if he gets support from such and such industry first.....
And here is where he spreads the pork... earmarks include $350,000 for leafy-spurge eradication efforts and $200,000 for the International Peace Gardens. In North Dakota? How about my backyard to replace the poison sumac?
And just so we know what the Dorgan standard for disclosure is, let's go back to 2005 when he was holding court on the Abramhoff scandal and "forgot" to disclose how he used Jack's corporate box as a fundraiser and pocketed campaign contributions that, while legal, gave the appearance of a conflict of interest...
From the Boston Globe in 2005...
The Democrat helping to lead the Senate investigation into Jack Abramoff's Indian lobbying had his own connections to the controversial lobbyist's team and clients, including using his sports arena skybox to raise money.
Senator Byron Dorgan, a North Dakota Democrat, acknowledges he got Congress in fall 2003 to press government regulators to decide, after decades of delay, whether the Mashpee Wampanoag tribe of Massachusetts deserved federal recognition.
Dorgan met with the tribe's representatives and collected at least $11,500 in political donations from Abramoff partner Michael D. Smith, who was representing the Mashpee, around the time he helped craft the legislation, according to interviews and documents obtained by the Associated Press.
The senator also didn't reimburse another tribe, the Mississippi Choctaw, for the use of Abramoff's skybox in 2001, when the tribe held a fund-raiser for him there, instead treating it as a tribal contribution. He only recently reimbursed the tribe for the box, four years later, after determining it was connected to Abramoff.
Dorgan, who is vice chairman of the Senate Indian Affairs Committee that is investigating Abramoff, says he sees no reason to step down from the probe, which he and Senator John McCain, an Arizona Republican, are leading. He said he had no idea at the time that any of the transactions were connected to Abramoff or the alleged fleecing of tribes.
''I never met Jack Abramoff, but I am appalled by what we have learned about his actions," Dorgan said Thursday. ''So I have never felt there was any conflict in my helping to lead that investigation. I think Senator McCain would agree our investigation has been relentless and that neither of us will be diverted."
Dorgan's contacts, donations, and fund-raisers involving Abramoff tribal clients and lobbying associates, as well as those of other lawmakers, have not been examined during the Senate hearings into the lobbyist's roughly $80 million in charges to the tribes.
The senator didn't volunteer the information, although he did disclose his donations in campaign reports over the years.
Larry Noble, the government's former chief election enforcement lawyer, said Dorgan should have considered stepping aside from the inquiry and should have disclosed all his own intersections with Abramoff's associates and tactics.
''I think any way you look at it, he had an obligation to disclose," Noble said. ''It is hard for anyone not to see a conflict when you're investigating the same activity you yourself were involved with."
Over the past month, the AP has reported that about four dozen lawmakers, Republicans and Democrats, collected donations from Abramoff's tribal clients and firm around the time they wrote letters to the Bush administration or Congress favorable to the tribes.
Congressional ethics rules require lawmakers to avoid even the appearance of a conflict of interest in performing official duties and accepting political money. The Justice Department is investigating whether Abramoff, already charged with fraud in a Florida case, won any undue influence through donations and favors.
Dorgan on Monday sharply criticized the AP for reporting last week that he collected $20,000 from Abramoff's firm and tribes in the period when he wrote a letter urging the Senate Appropriations Committee to fund a school construction program that Abramoff's clients and other tribes wanted.
The senator, who has Indian tribes in his state, said he long supported the program and the letter and donations had no connection.
He asserted that he never took any action or received campaign help that knowingly involved Abramoff.
Dorgan's office acknowledged he met in 2003 with representatives of the Mashpee, the Massachusetts tribe that Abramoff signed as a client and Smith represented.
The senator used his position as a member of the joint House-Senate committee that approved the final Interior Department spending bill for 2004 to craft a provision that pressed the agency to ''complete its review of the Mashpee petition as expeditiously as possible."
http://www.boston.com/news/nation/washington/articles/2005/12/03/abramoff_prober_had_ties_to_lobbyist/
Hope we've been helpful Senator. Let's have lunch soon.
That's Bridges as in John FP Bridges, CMPI Senior Fellow and Assistant Professor, Department of Health Policy & Management at the Johns Hopkins Bloomberg School of Public Health.
John has co-authored a very timely, important and intriguing new paper in The Expert Review of Pharmaceoeconomic and Outcomes Research, "Promoting patient empowerment in the healthcare system: highlighting the need for patient-centered drug policy."
Timely because it coincides with many Presidential candidates releasing their plans for revitalizing the American health care system.
Important because the paper seeks to define precisely what "empowerment" means and identify its constituent variables.
And intriguing because, well, it is.
Here's what Bridges, et al consider the "Antecedents to Empowerment" ...
* Knowledge
* Health Literacy
* Patient Initiative
* Access to Services and Drugs
And "Activities for Empowerment" ...
* Information Sharing
* Doctor-Patient Communication
* Choice
* Shared Decision Making
And, as a result, the "Outcomes of Empowerment" ...
* Health Status
* Patient Satisfaction
* Self-Efficacy
* Adherence
Here is a link to the complete article:
Download file
Viva Bridges!
John has co-authored a very timely, important and intriguing new paper in The Expert Review of Pharmaceoeconomic and Outcomes Research, "Promoting patient empowerment in the healthcare system: highlighting the need for patient-centered drug policy."
Timely because it coincides with many Presidential candidates releasing their plans for revitalizing the American health care system.
Important because the paper seeks to define precisely what "empowerment" means and identify its constituent variables.
And intriguing because, well, it is.
Here's what Bridges, et al consider the "Antecedents to Empowerment" ...
* Knowledge
* Health Literacy
* Patient Initiative
* Access to Services and Drugs
And "Activities for Empowerment" ...
* Information Sharing
* Doctor-Patient Communication
* Choice
* Shared Decision Making
And, as a result, the "Outcomes of Empowerment" ...
* Health Status
* Patient Satisfaction
* Self-Efficacy
* Adherence
Here is a link to the complete article:
Download file
Viva Bridges!
There are some bloggers anxious to absolve themselves of responsibility for the jump in suicides because of SSRI related fearmongering who are claiming that the 2004 data is just a blip.
Nice try with incomplete data. The jump in suicides was pronounced among youths but increased across ages 10-64 from 2003-2004. The jump in 2004 came after a 15 year decline among kids. And if the suicide rate decline in 2005 -- which I hope is the case -- holds up among kids specifically it only goes to show that the fearmongering was the principal factor not the other way 'round.
At least such pundits like Phil Dawdy of Furious Season with whom I rarely agree but whose trenchant style I admire are seeking to offer an alternative and plausible data-driven explanation. http://www.furiousseasons.com
They are not claiming -- like David Healy -- that the jump is a result of treating kids with atypicals. Healy, who is now a paid consultant to the trial bar suing Lilly and other companies who make such drugs has no shame. What a tool.
Nice try with incomplete data. The jump in suicides was pronounced among youths but increased across ages 10-64 from 2003-2004. The jump in 2004 came after a 15 year decline among kids. And if the suicide rate decline in 2005 -- which I hope is the case -- holds up among kids specifically it only goes to show that the fearmongering was the principal factor not the other way 'round.
At least such pundits like Phil Dawdy of Furious Season with whom I rarely agree but whose trenchant style I admire are seeking to offer an alternative and plausible data-driven explanation. http://www.furiousseasons.com
They are not claiming -- like David Healy -- that the jump is a result of treating kids with atypicals. Healy, who is now a paid consultant to the trial bar suing Lilly and other companies who make such drugs has no shame. What a tool.
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.
