Latest Drugwonks' Blog
Since death is a surrogate for advancing to the next stage of Man's destiny, Senator Grassley should ask the GAO to investigate whether Pharma, in conspiracy with the FDA, is thwarting God's plan.
So now Senator Grassley wants the GAO to determine whether or not using surrogate markers is sound science?
This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.
And the patient shall inherit the wind.
This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.
And the patient shall inherit the wind.
MA Senate President Therese Murray wants to ban all gifts, grants and honoraria to physicians. You can go to jail and be fined $5000 for giving a talk sponsored by the biotech or drug company. Take a pen and go to the pen. Two years max.
All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.
I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...
And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..
" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.
Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html
No potential for conflict there.... I wonder who contributed to her campaign?
But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/
The conflict of interest movement is morphing into a lynch mob..
All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.
I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...
And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..
" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.
Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html
No potential for conflict there.... I wonder who contributed to her campaign?
But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/
The conflict of interest movement is morphing into a lynch mob..
Senators Baucus and Conrad have introduced the “The Comparative Effectiveness Research Act of 2008â€. It has all of the conflicts and biases towards cost containment that other similar entities have.
1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.
1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.
On the heels of my article discussing McCain's market-driven views on health comes his statement to the effect that credible scientists believe that vaccines cause autism.
I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.
If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:
"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."
My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.
And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence.
I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.
If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:
"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."
My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.
And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence.
We strongly support the free and fair sharing of legitimate scientific information. That's why we're in favor of both the use of reprints as an important way to share cutting-edge medical information with physicians and the FDA's draft rule on the appropriate ways to do so.
That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.
Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:
"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."
Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?
Some verbatim verbiage from the JAMA sales aid:
"Designed to be turn-key for rep delivery, mail, and distribution at conventions"
"Stimulates physician"
"Serves as an innovative, new offering for sales representatives and as a meeting premium"
The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:
"I use them as a sales tool and patient education material."
"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."
JAMA also quotes research showing the efficacy of such reprints:
"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."
There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.
Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.
Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."
Yeah, New Realism. It must be Dr. DeAngelis' favorite.
There's a lot of that going around these days.
That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.
Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:
"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."
Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?
Some verbatim verbiage from the JAMA sales aid:
"Designed to be turn-key for rep delivery, mail, and distribution at conventions"
"Stimulates physician"
"Serves as an innovative, new offering for sales representatives and as a meeting premium"
The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:
"I use them as a sales tool and patient education material."
"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."
JAMA also quotes research showing the efficacy of such reprints:
"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."
There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.
Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.
Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."
Yeah, New Realism. It must be Dr. DeAngelis' favorite.
There's a lot of that going around these days.
According to an article in the Connecticut Post:
"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."
Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation.
"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."
Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation.
Previously we commented on the WHO sending a team to Bangkok to discuss compulsory licensing in the broader context of TRIPS flexibiltiies ("WHO to WIPO: Having wonderful time. Glad you're not here").
Here's a link to those comments:
http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html
Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:
Download file
To give you a hint as to the direction of the study, here are the final 14 words of the report:
"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."
And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."
However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:
"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."
But it's only a brief shining moment. Here's the end of that paragraph:
"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."
This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.
What would John Calvin say?
Here's a link to those comments:
http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html
Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:
Download file
To give you a hint as to the direction of the study, here are the final 14 words of the report:
"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."
And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."
However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:
"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."
But it's only a brief shining moment. Here's the end of that paragraph:
"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."
This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.
What would John Calvin say?
According to a report in the International Herald Tribune (via the Associated Press), the recently appointed head of Thailand's Food and Drug Administration resigned Monday "amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs."
Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.
Here's a link to the complete article:
http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft.
Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.
Here's a link to the complete article:
http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft.
Although HTAs seem not to have hit my home country yet, because of socialized medicine this appears generally without giving its name.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests.
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.
