Latest Drugwonks' Blog
Straight shooting from the Washington Post editorial page. And we concur.
Some snippets:
"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."
We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.
"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."
It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.
"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."
Yup.
Here's a link to the complete editorial:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html
It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.
Now.
Some snippets:
"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."
We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.
"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."
It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.
"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."
Yup.
Here's a link to the complete editorial:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html
It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.
Now.
The National Vaccine Injury Compensation Program (NVIP) board voted to award a family monetary compensation in a case where the reviewers determined that the family was able to show -- not prove, not demonstrate on the basis of scientific evidence -- that it was not impossible to rule out that vaccines aggravated a rare mitochonrial disease (MD). MD is associated with systemic toxicity and nutrient starvation issues at the cellular level that can lead to developmental delays, brain damage and behaviors consistent with those found on the autism disorder spectrum.
Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.
Now the facts, ignored by the media and, it appears, the special masters reviewing the case:
1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.
2. Autistic features are associated with MD. So are developmental delays.
3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)
4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)
5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.
But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?
So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health.
Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.
Now the facts, ignored by the media and, it appears, the special masters reviewing the case:
1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.
2. Autistic features are associated with MD. So are developmental delays.
3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)
4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)
5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.
But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?
So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health.
Can ignorance be bliss when it comes to information about your health? Is knowledge always power -- and can that power be abused? And what about the need for more robust FDA oversight of 21st centuty diagnostics?
Have a look at this article from today's edition of USA Today:
Companies cash in on checking your DNA for disease
By Rita Rubin, USA TODAY
Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.
Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.
Q&A: What to know about testing your genes
The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.
TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?
The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?
In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.
Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.
Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.
"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate."
Have a look at this article from today's edition of USA Today:
Companies cash in on checking your DNA for disease
By Rita Rubin, USA TODAY
Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.
Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.
Q&A: What to know about testing your genes
The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.
TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?
The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?
In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.
Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.
Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.
"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate."
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.
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.
