Latest Drugwonks' Blog
Merrill Matthews and I don't see eye-to-eye on everything when it comes to Medicare reform, but there's one thing we do agreed on ... it's working.
Have a look:
http://www.mercurynews.com/search/ci_5537368/nclick_check=1
As always, looking forward to all your thoughts and comments.
Have a look:
http://www.mercurynews.com/search/ci_5537368/nclick_check=1
As always, looking forward to all your thoughts and comments.
To: Gilbert Ross, M.D.
Executive and Medical Director
American Council on Science and Health
New York
Dear Gil,
you did not read my oped carefully,
you have mischaracterized my argument for the benefit of your argument.
I never said that mortality wasn't a worthy endpoint warranting further study, i said it shouldn't be a "solo" endpoint.
I am also not alone among the thousands of internists and pulmonologists who use screening chest ct as part of a strategy for early detection, and then together with a team of top level radiologists, figure out what to do with the results. This is very clearly described in my oped, and you have distorted it.
You also should have admitted to the Journal that you know me personally, that I have done consulting work for your organization, and that this may have affected your motivation in writing this letter.
I have heard from many practicing physicians and top level researchers who have agreed with me and praised my oped. Everyone agrees that the great advances in CT technology have let to a situation where it is capable of diagnosing cancers before they leave the lung, and in the right hands, are much less likely to cause unmanageable false positives.
we can see the advantage of advanced technological screening of breast cancer, a less aggressive cancer, with the current news about MRI.
My core premise is that a practicing clinical physician like myself needs diagnostic tools like this in his arsenal that can be used in conjunction with a proper knowledge of the medical literature.
I always welcome debate with you, and appreciate your invitation for further debate, but i feel that should have occurred before you published an inaccurate letter.
Marc Siegel MD
Executive and Medical Director
American Council on Science and Health
New York
Dear Gil,
you did not read my oped carefully,
you have mischaracterized my argument for the benefit of your argument.
I never said that mortality wasn't a worthy endpoint warranting further study, i said it shouldn't be a "solo" endpoint.
I am also not alone among the thousands of internists and pulmonologists who use screening chest ct as part of a strategy for early detection, and then together with a team of top level radiologists, figure out what to do with the results. This is very clearly described in my oped, and you have distorted it.
You also should have admitted to the Journal that you know me personally, that I have done consulting work for your organization, and that this may have affected your motivation in writing this letter.
I have heard from many practicing physicians and top level researchers who have agreed with me and praised my oped. Everyone agrees that the great advances in CT technology have let to a situation where it is capable of diagnosing cancers before they leave the lung, and in the right hands, are much less likely to cause unmanageable false positives.
we can see the advantage of advanced technological screening of breast cancer, a less aggressive cancer, with the current news about MRI.
My core premise is that a practicing clinical physician like myself needs diagnostic tools like this in his arsenal that can be used in conjunction with a proper knowledge of the medical literature.
I always welcome debate with you, and appreciate your invitation for further debate, but i feel that should have occurred before you published an inaccurate letter.
Marc Siegel MD
April 1st 60 Minutes will do an "expose" timed to the release of a Center for Public Integrity report showing that the pharmaceutical industry spent nearly $900 million on lobbying and campaign contributions over the past decade. Sounds like a lot right?
But the industry doesn't come close to many others in trying to push their point in a political system that frankly requires money to move messages around. Case in point, Phrma the trade group is way down the list when it comes to spending on lobbying comparrd to many DC trade groups according to CPI.
Using CPI data (1998-2004), pharma (and I don't know if they count biotech in that mix) is about even when it comes to lobbying compared to the aggregated spending of other health care interests that have been under less scrutiny and attack. Both have spent about $650 million on lobbying during that time. Add insurance companies (life and health) and the whole health care financing and delivery system has spent twice as much on lobbying as drug companies and it trade group. Electric utilities alone spent $500 million. Add in all energy related lobbying and you are close to a $ 1 billion. Banking, financing, credit concerns spend as much as pharma. So do defense and aerospace companies.
And so do all manner of government, government officials, public unions,city, county, state, sewer authorities, foreign, you name it.
Lobbying has a Jack Abrahamoff taint to it. And granted there are there are plenty of folks who set up shop and sell themselves and justify a large monthly retainer because they are able to get that all important "ask" from an important member of Congress. But ultimately how we feel about lobbying depends on our opinion on a political issue. Those who claim that the "Israel Lobby" has "too much influence" based on campaign contributions do so because they have a problem with American support for Israel. Those who claim that "Big Pharma" has "too much influence" similarly are likely to support price controls, drug importation, more FDA regulation.
So let's be honest. If you attack the Israel Lobby, you are not a Zionist.
If you attack Big Pharma's lobbying effort, you do not believe free markets are the best way to make new drugs available.
In or out. Simple as that.
But the industry doesn't come close to many others in trying to push their point in a political system that frankly requires money to move messages around. Case in point, Phrma the trade group is way down the list when it comes to spending on lobbying comparrd to many DC trade groups according to CPI.
Using CPI data (1998-2004), pharma (and I don't know if they count biotech in that mix) is about even when it comes to lobbying compared to the aggregated spending of other health care interests that have been under less scrutiny and attack. Both have spent about $650 million on lobbying during that time. Add insurance companies (life and health) and the whole health care financing and delivery system has spent twice as much on lobbying as drug companies and it trade group. Electric utilities alone spent $500 million. Add in all energy related lobbying and you are close to a $ 1 billion. Banking, financing, credit concerns spend as much as pharma. So do defense and aerospace companies.
And so do all manner of government, government officials, public unions,city, county, state, sewer authorities, foreign, you name it.
Lobbying has a Jack Abrahamoff taint to it. And granted there are there are plenty of folks who set up shop and sell themselves and justify a large monthly retainer because they are able to get that all important "ask" from an important member of Congress. But ultimately how we feel about lobbying depends on our opinion on a political issue. Those who claim that the "Israel Lobby" has "too much influence" based on campaign contributions do so because they have a problem with American support for Israel. Those who claim that "Big Pharma" has "too much influence" similarly are likely to support price controls, drug importation, more FDA regulation.
So let's be honest. If you attack the Israel Lobby, you are not a Zionist.
If you attack Big Pharma's lobbying effort, you do not believe free markets are the best way to make new drugs available.
In or out. Simple as that.
The Institute of Medicine As a Profession may not accept money from big money but it does get loot from Haliburton via it's patron George Soros.....I guess hypocrisy goes down easy when it's followed by a lot of zeroes....
Here's the background.....
http://blog.foreignpolicy.com/node/3776
Soros buys Halliburton
Home » blogs » Mike Boyer
Tue, 02/27/2007 - 3:22pm.
Normally, I'm willing to overlook the hypocrisy of the liberal elite. If Al Gore and his Hollywood cronies want to fly around on gas-guzzling, atmosphere-polluting private jets while railing against global climate change, I'm willing to overlook it.
But the latest move by globe trotting, hyper-liberal billionaire George Soros borders on being too much. According to papers filed with the SEC, in the fourth quarter of 2006 Soros purchased nearly 2 million shares of ... hold your breath ... Halliburton. The Halliburton shares reportedly went for an average purchase price of $31.30 a share. That puts Soros' total investment in Halliburton at around $62.6 million, or about 2 percent of his total portfolio.
Soros, of course, is the dean of Democratic money giving. And Halliburton, of course, is the company that embodies everything the Democrats see as evil. Dick Cheney is its former chief, for goodness' sake. But Soros is also a man of contradictions. He supported campaign finance reform for years, only to declare that defeating President George W. Bush was the "central focus" of his life. To prove it, he sunk $24 million of his own "soft" money into the 2004 campaign, helping make that election one of the most divisive in modern history.
Soros' position in Halliburton is reported to be his first, which means he bought it with a full understanding of Halliburton's reputation. Soros may not see a problem with profiting from a company that has been accused of everything from sweatheart deals to cooking the books to serving U.S. troops lousy food in Iraq. The real question, however, is whether MoveOn.org, the Center for American Progress, and other organizations that have benefitted from Soros' charity will see a problem with accepting money earned off Halliburton shares?
Here's the background.....
http://blog.foreignpolicy.com/node/3776
Soros buys Halliburton
Home » blogs » Mike Boyer
Tue, 02/27/2007 - 3:22pm.
Normally, I'm willing to overlook the hypocrisy of the liberal elite. If Al Gore and his Hollywood cronies want to fly around on gas-guzzling, atmosphere-polluting private jets while railing against global climate change, I'm willing to overlook it.
But the latest move by globe trotting, hyper-liberal billionaire George Soros borders on being too much. According to papers filed with the SEC, in the fourth quarter of 2006 Soros purchased nearly 2 million shares of ... hold your breath ... Halliburton. The Halliburton shares reportedly went for an average purchase price of $31.30 a share. That puts Soros' total investment in Halliburton at around $62.6 million, or about 2 percent of his total portfolio.
Soros, of course, is the dean of Democratic money giving. And Halliburton, of course, is the company that embodies everything the Democrats see as evil. Dick Cheney is its former chief, for goodness' sake. But Soros is also a man of contradictions. He supported campaign finance reform for years, only to declare that defeating President George W. Bush was the "central focus" of his life. To prove it, he sunk $24 million of his own "soft" money into the 2004 campaign, helping make that election one of the most divisive in modern history.
Soros' position in Halliburton is reported to be his first, which means he bought it with a full understanding of Halliburton's reputation. Soros may not see a problem with profiting from a company that has been accused of everything from sweatheart deals to cooking the books to serving U.S. troops lousy food in Iraq. The real question, however, is whether MoveOn.org, the Center for American Progress, and other organizations that have benefitted from Soros' charity will see a problem with accepting money earned off Halliburton shares?
As we noted The Prescription Project is " an initiative of the Boston-based nonprofit healthcare advocacy group Community Catalyst, which made headlines a little over a year ago when it sued Pfizer over its marketing claims for Lipitor. The Prescription Project is being conducted in partnership with the Institute on Medicine as a Profession (IMAP) and is funded by a USD 6 million, two-year grant from The Pew Charitable Trusts and money from George Soros.
In addition, the group has assembled a prestigious advisory committee whose members include Cathy DeAngelis, the editor-in-chief of JAMA; Steven Nissen, the president of the American College of Cardiology; and Philip A Pizzo, the dean of the Stanford School of Medicine."
Part of this campaign includes class action lawsuits initiated by the Prescription Action Litigation Project which in turn is comprised of Trial Lawyers Inc (large trial firms that seek huge monetary damages by suing corporations) and their public advocacy front, Public Citizen and various state organizations.
For instance, one mainstay of the PALP is the law firm Hagens Berman Sobol Shapiro (HBSS) which has been going after Pfizer for what is alleges are "false marketing claims by pharmaceutical giant, Pfizer. We are investigating claims made for its cardiovascular disease drug Lipitor, that encouraged doctors to prescribe the drug for patients when it was not necessary or healthy to do so." The firm is claiming that Pfizer encouraged doctors to prescribe the cholesterol drug for hypertension, chronic kidney disease, and many other unapproved illnesses besides the prevention of cardiovascular disease. ...
Hagens, Berman is famous for suing Starbucks for unbridled competition and being slapped with a $10 million penalty for violating their ".. duty of loyalty to three small water bottlers that in 2003 were close to settling a claim with Nestle Waters North America, the owner of Poland Spring Water Co." "Seattle law firm told to pay $10.8 million", Seattle Post-Intelligencer, Mar.24; Lattman, Mar. 24).
Public Citizen and the U.S. Public Interest Research Group (PIRG) works closely with Hagens Berman and other tort firms through Community Catalyst and TPP and other conduits to attack off label prescribing via fishing expeditions, testimony and now legislation at the state level to force doctors to either disclose or disgorge any money obtained from drug or biotech firms for any purpose.
This is not an effort to 'clean up' medicine. This is a witch hunt, a Stalinist effort to purge medicine of any relationship between academia, private industry and clinicians. And it is an effort to presume that off-label prescribing is both hurtful and possibly criminal behavior. Let's be clear: the goal is to create another opportunity for shaking down the drug industry and physicians. All you need are RiskMaps that prohibits and limits off-label prescribing and you have a whole new source of revenue for tort lawyers.....
Sort of like shorting currencies and buying them up. No wonder Soros is involved.
In addition, the group has assembled a prestigious advisory committee whose members include Cathy DeAngelis, the editor-in-chief of JAMA; Steven Nissen, the president of the American College of Cardiology; and Philip A Pizzo, the dean of the Stanford School of Medicine."
Part of this campaign includes class action lawsuits initiated by the Prescription Action Litigation Project which in turn is comprised of Trial Lawyers Inc (large trial firms that seek huge monetary damages by suing corporations) and their public advocacy front, Public Citizen and various state organizations.
For instance, one mainstay of the PALP is the law firm Hagens Berman Sobol Shapiro (HBSS) which has been going after Pfizer for what is alleges are "false marketing claims by pharmaceutical giant, Pfizer. We are investigating claims made for its cardiovascular disease drug Lipitor, that encouraged doctors to prescribe the drug for patients when it was not necessary or healthy to do so." The firm is claiming that Pfizer encouraged doctors to prescribe the cholesterol drug for hypertension, chronic kidney disease, and many other unapproved illnesses besides the prevention of cardiovascular disease. ...
Hagens, Berman is famous for suing Starbucks for unbridled competition and being slapped with a $10 million penalty for violating their ".. duty of loyalty to three small water bottlers that in 2003 were close to settling a claim with Nestle Waters North America, the owner of Poland Spring Water Co." "Seattle law firm told to pay $10.8 million", Seattle Post-Intelligencer, Mar.24; Lattman, Mar. 24).
Public Citizen and the U.S. Public Interest Research Group (PIRG) works closely with Hagens Berman and other tort firms through Community Catalyst and TPP and other conduits to attack off label prescribing via fishing expeditions, testimony and now legislation at the state level to force doctors to either disclose or disgorge any money obtained from drug or biotech firms for any purpose.
This is not an effort to 'clean up' medicine. This is a witch hunt, a Stalinist effort to purge medicine of any relationship between academia, private industry and clinicians. And it is an effort to presume that off-label prescribing is both hurtful and possibly criminal behavior. Let's be clear: the goal is to create another opportunity for shaking down the drug industry and physicians. All you need are RiskMaps that prohibits and limits off-label prescribing and you have a whole new source of revenue for tort lawyers.....
Sort of like shorting currencies and buying them up. No wonder Soros is involved.
my book review in NY Post Opinion books on Sunday speaks to the need to retain the patient contact, caring, and deep involvement with patients that is at the heart of good medicine.
This essential quality will be the first thing to be further jeopardized if government mandates for expanded coverage don't take "quality of care" into account. Dr. Chen directs these issues to the essential need to care for dying patients, but it is a universal concern for all health care.
http://www.nypost.com/seven/03252007/postopinion/postopbooks/dying_for_compassion_postopbooks_marc_k__siegel.htm
This essential quality will be the first thing to be further jeopardized if government mandates for expanded coverage don't take "quality of care" into account. Dr. Chen directs these issues to the essential need to care for dying patients, but it is a universal concern for all health care.
http://www.nypost.com/seven/03252007/postopinion/postopbooks/dying_for_compassion_postopbooks_marc_k__siegel.htm
Drugs watchdog faces legal review
The NHS drugs watchdog is to face a judicial review in court for the first time over the guidance it offers.
Two firms have been granted the review over the way the National Institute for Health and Clinical Excellence reached its conclusion on Alzheimer's drugs.
NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.
Eisai and Pfizer said the process was unfair, but NICE said the claims were without foundation.
NICE guidance in 2001 recommended donepezil, rivastigmine and galantamine - which can make it easier to carry out everyday tasks - should be used as standard.
But in November the watchdog announced people with newly diagnosed, mild Alzheimer's were exempt.
Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.
Neil Hunt, chief executive of the Alzheimer's Society, which will give evidence in the case, said: "Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical.
Why should we care about how the Brits choose care for Alzheimer’s patients Over There? Because their “evidence-based†model is being touted by many Over Here as the right path.
Consider what’s happening Down Under where a similar (although by no means identical) system is also used to limit available treatment for Australians who suffer from Alzheimer’s Disease. The particulars are different – but the message is the same: when government acts to limit therapeutic choices, patients suffer the consequences.
Australia limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.†In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.â€
Restrictive formularies (yes, like the VA system) and health care systems (such as in the United Kingdom, Australia, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.
The NHS drugs watchdog is to face a judicial review in court for the first time over the guidance it offers.
Two firms have been granted the review over the way the National Institute for Health and Clinical Excellence reached its conclusion on Alzheimer's drugs.
NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.
Eisai and Pfizer said the process was unfair, but NICE said the claims were without foundation.
NICE guidance in 2001 recommended donepezil, rivastigmine and galantamine - which can make it easier to carry out everyday tasks - should be used as standard.
But in November the watchdog announced people with newly diagnosed, mild Alzheimer's were exempt.
Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.
Neil Hunt, chief executive of the Alzheimer's Society, which will give evidence in the case, said: "Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical.
Why should we care about how the Brits choose care for Alzheimer’s patients Over There? Because their “evidence-based†model is being touted by many Over Here as the right path.
Consider what’s happening Down Under where a similar (although by no means identical) system is also used to limit available treatment for Australians who suffer from Alzheimer’s Disease. The particulars are different – but the message is the same: when government acts to limit therapeutic choices, patients suffer the consequences.
Australia limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.†In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.â€
Restrictive formularies (yes, like the VA system) and health care systems (such as in the United Kingdom, Australia, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.
Please join CMPI and Old Dominion University for a robust conversation with Carolyn Clancy, Gail Wilensky, Scott Gottlieb, Stephen Spielberg (no, the one from Dartmouth), Dr. Bob (Goldberg) and distinguished others for a half-day seminar on the role of comparative effectiveness research.
Yes, Senator Baucus was invited.
It's on March 29, from 9am to 2pm at the National Press Club. Full program details can be found at http://www.cmpi.org
To RSVP, please contact Connie Davis, csdavis@odu.com
Hope you can attend.
Yes, Senator Baucus was invited.
It's on March 29, from 9am to 2pm at the National Press Club. Full program details can be found at http://www.cmpi.org
To RSVP, please contact Connie Davis, csdavis@odu.com
Hope you can attend.
Re-reading the Dorgan-Snowe drug importation legislation in the wake of the laundry list of drugs found in Anna Nicole's blood at time of death leads me to this interesting clause in the bill which takes the definition of the doctor-patient relationship with respect to internet prescribing to Hollywood levels:
(3) QUALIFYING MEDICAL RELATIONSHIP-
`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--
`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; or
`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.
`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.
`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.
And the loophole that will make it easy for any criminal, kiddie-porn site operator or terrorist to set up shop in Canada and source drugs from anywhere:
"An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B)."
Please note that Canada does not vouch for what happens in the scores of export houses up north that import commercial quantities of drugs from Pakistan, Iran, Turkey, etc under a personal use exemption. So all you have to do to comply with the Anna Nicole import bill is be a Rx chop shop in Canada.
(3) QUALIFYING MEDICAL RELATIONSHIP-
`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--
`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; or
`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.
`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.
`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.
And the loophole that will make it easy for any criminal, kiddie-porn site operator or terrorist to set up shop in Canada and source drugs from anywhere:
"An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B)."
Please note that Canada does not vouch for what happens in the scores of export houses up north that import commercial quantities of drugs from Pakistan, Iran, Turkey, etc under a personal use exemption. So all you have to do to comply with the Anna Nicole import bill is be a Rx chop shop in Canada.
The next time someone who knows nothing about drug development or medicine blathers on about why drug companies don't just focus on breakthrough drugs should read the article in the NEJM about the quest to find a drug that actually reverses atherosclerosis. The statin focused pathway makes a lot of sense and it not dead despite what you will hear because of the complexity that has been discovered in large part because of the huge wager Pfizer made on the torcetrapib molecule.
The "failure" has, as Dr. Nissen and colleagues, article demonstrates, advanced our understanding. I have been a severe critic of Nissen with respect to his pronouncements on the safety of ADHD drugs, but as this article suggests, his handling of the torcetrapib issue has been thoughtful, responsible and in some respects visionary.
http://content.nejm.org/cgi/content/full/NEJMoa070635v1
More needs to be written about this unfolding saga -- as well as other struggles to understand the intimate connection between disease, body, molecule, genetics. It might promote the growth of something lack among those eager to issue pronouncements about how companies should run their businesses: humility. As Derek Lowe of www.corante.com has noted, on a good day scientists walk into a lab not knowing what to expect, The NEJM shows that real money is invested on this proposition every.
The "failure" has, as Dr. Nissen and colleagues, article demonstrates, advanced our understanding. I have been a severe critic of Nissen with respect to his pronouncements on the safety of ADHD drugs, but as this article suggests, his handling of the torcetrapib issue has been thoughtful, responsible and in some respects visionary.
http://content.nejm.org/cgi/content/full/NEJMoa070635v1
More needs to be written about this unfolding saga -- as well as other struggles to understand the intimate connection between disease, body, molecule, genetics. It might promote the growth of something lack among those eager to issue pronouncements about how companies should run their businesses: humility. As Derek Lowe of www.corante.com has noted, on a good day scientists walk into a lab not knowing what to expect, The NEJM shows that real money is invested on this proposition every.