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The organization formerly known as the Association of Trial Lawyers of America (ATLA) -- the NewSpeak-named American Association for Justice -- doesn’t like our study on the dangers of Internet health care information.
We must be doing something right.
According to the president of the association, Kathleen Flynn Peterson, “How can anyone take these groups seriously when they release studies based on a methodology of Google searches?â€
Kathy -- it was a study about Internet searches. Google -- get it?
Since we're asking questions, here's one for Ms. Peterson -- Why are tort lawyers masquerading as health care advocates on Google in the first place?
We must be doing something right.
According to the president of the association, Kathleen Flynn Peterson, “How can anyone take these groups seriously when they release studies based on a methodology of Google searches?â€
Kathy -- it was a study about Internet searches. Google -- get it?
Since we're asking questions, here's one for Ms. Peterson -- Why are tort lawyers masquerading as health care advocates on Google in the first place?
The recent article in the NEJM has the results of a carefully researched genomic analysis that included scientists from several institutes. The study was elegant -- comparing families and children with autism spectrum disorder (all independently adjudicated) with controls that did not along with those that had a bipolar diagnosis and therefore shared a genetic duplication and deletion on Chromosome 16p11.2 The analysis was run a three platforms and cross referenced to assure inter-reliabiity of results The consortium found that "a region of chromosome 16p11.2 influences susceptibility to autism when it is either deleted or duplicated" in about 1 percent of all cases. This adds to the growing body of knowledge that autism has multiple genetic sources
But that won't stop the fanatics and their propagandists like David Kirby who claim that it is something else, even if it isn't thimerasol, just as long as it is something that corporations are pushing in a dark conspiracy with the government:
"All that said, thimerosal may well not be a factor in a single case of autism. But what if one day, we discovered it had caused, say, one percent of all cases? With estimates of autism as high as 1.5 million in the country, that would mean 15,000 Americans who were ravaged by thimerosal (not to mention everyone overseas).
But if thimerosal is vindicated, or shown to be a very minor player, then what about other vaccine ingredients? And what about the rather crowded vaccine schedule we now impose upon families of young children? And what about reports of unvaccinated children in Illinois, California and Oregon who appear to have significantly lower rates of autism? Shouldn't we throw some research dollars into studying them?
You can answer that, no, we shouldn't, because the vaccine-autism debate is over.
But I am willing to wager that it has only just begun."
I hear the black choppers whirling overhead.
http://content.nejm.org/cgi/content/full/NEJMoa075974
But that won't stop the fanatics and their propagandists like David Kirby who claim that it is something else, even if it isn't thimerasol, just as long as it is something that corporations are pushing in a dark conspiracy with the government:
"All that said, thimerosal may well not be a factor in a single case of autism. But what if one day, we discovered it had caused, say, one percent of all cases? With estimates of autism as high as 1.5 million in the country, that would mean 15,000 Americans who were ravaged by thimerosal (not to mention everyone overseas).
But if thimerosal is vindicated, or shown to be a very minor player, then what about other vaccine ingredients? And what about the rather crowded vaccine schedule we now impose upon families of young children? And what about reports of unvaccinated children in Illinois, California and Oregon who appear to have significantly lower rates of autism? Shouldn't we throw some research dollars into studying them?
You can answer that, no, we shouldn't, because the vaccine-autism debate is over.
But I am willing to wager that it has only just begun."
I hear the black choppers whirling overhead.
http://content.nejm.org/cgi/content/full/NEJMoa075974
The FDA sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.
The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.
FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
The complete FDA announcement can be found here:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html
The FDA also responded today to a citizen petition from Wyeth, Madison, NJ, asking FDA to take regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs. Other stakeholders, including health care providers and consumer groups, have also raised concerns about "BHRT" drugs.
The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.
FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
The complete FDA announcement can be found here:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html
The FDA also responded today to a citizen petition from Wyeth, Madison, NJ, asking FDA to take regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs. Other stakeholders, including health care providers and consumer groups, have also raised concerns about "BHRT" drugs.
Great minds think alike.. From today's Chicago Tribune by Bruce Japsen:
"After a rocky start, Medicare's drug benefit appears to be delivering a lower prescription tab for seniors, along with a whopping bill for the federal government, new research shows.
The Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
The savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage, according to a study released Tuesday on the Web site of the Annals of Internal Medicine ( http://www.annals.org ). A print edition will be published Feb. 5.
The study, considered by its authors to be the first in-depth examination of the impact of Part D, does not reveal shocking surprises in usage, considering the desire of seniors to have drug coverage. But its authors said the program was clearly working, reflecting the experiences of millions of Americans.
"We found that it had a modest but significant effect on both savings and drug use," said Dr. G. Caleb Alexander, assistant professor of medicine at University of Chicago Medical Center and one of the study's authors. "Despite extensive debate, it was not clear to what extent Part D would save people money or allow them to obtain drugs they might not otherwise be able to afford."
That debate is over. Now the question is, to what extent will we use incentives and new technology to match people to the right drug to promote the best outcome and quality of life. Or will we use one size fits all studies to drive people to the cheapest drug? Cost containment is just another word for profiteering if it doesn't add value to people's lives.
http://www.chicagotribune.com/news/chi-wed_medicare01.09jan09,0,4354066.story
"After a rocky start, Medicare's drug benefit appears to be delivering a lower prescription tab for seniors, along with a whopping bill for the federal government, new research shows.
The Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
The savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage, according to a study released Tuesday on the Web site of the Annals of Internal Medicine ( http://www.annals.org ). A print edition will be published Feb. 5.
The study, considered by its authors to be the first in-depth examination of the impact of Part D, does not reveal shocking surprises in usage, considering the desire of seniors to have drug coverage. But its authors said the program was clearly working, reflecting the experiences of millions of Americans.
"We found that it had a modest but significant effect on both savings and drug use," said Dr. G. Caleb Alexander, assistant professor of medicine at University of Chicago Medical Center and one of the study's authors. "Despite extensive debate, it was not clear to what extent Part D would save people money or allow them to obtain drugs they might not otherwise be able to afford."
That debate is over. Now the question is, to what extent will we use incentives and new technology to match people to the right drug to promote the best outcome and quality of life. Or will we use one size fits all studies to drive people to the cheapest drug? Cost containment is just another word for profiteering if it doesn't add value to people's lives.
http://www.chicagotribune.com/news/chi-wed_medicare01.09jan09,0,4354066.story
Offering lower drug co-payments to people with diabetes, high blood pressure and other chronic diseases could increase use of preventive medicines, suggests a new study led by University of Michigan and Harvard University researchers.
Higher co-payments that took effect Jan. 1 are designed to help American employers cope with the rising costs of health insurance by making workers and retirees pay more out of their own pockets. But does it help health care outcomes for patients? No.
The study, funded by GlaxoSmithKline and Pfizer Inc., suggests that some drug co-payments should be reduced for some people with chronic diseases. Reducing the amount of co-payments by a few dollars would increase the use of preventive drugs by these patients. And properly treated, these chronic conditions can be managed effectively and cost -efficiently -- keeping patients out of the hospital or other more, er, horizontal places.
The researchers looked at a major private employer that made some medications free to employees and slashed co-pays for other drugs by 50 percent. This led to a significant increase in employees' use of preventive medicines.
The study authors also looked at another employer that kept co-payments at the same levels and found it didn't show the same increase in employee use of preventive medicines.
The findings were published in the January/February issue of Health Affairs.
"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," senior study author Dr. Mark Fendrick, of the University of Michigan Medical School and School of Public Health, said in a prepared statement. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."
Treating chronic disease via appropriate pharmaceutical intervention saves both money and lives -- benefiting both the public purse and the public health. And isn't that what health care is all about.
Higher co-payments that took effect Jan. 1 are designed to help American employers cope with the rising costs of health insurance by making workers and retirees pay more out of their own pockets. But does it help health care outcomes for patients? No.
The study, funded by GlaxoSmithKline and Pfizer Inc., suggests that some drug co-payments should be reduced for some people with chronic diseases. Reducing the amount of co-payments by a few dollars would increase the use of preventive drugs by these patients. And properly treated, these chronic conditions can be managed effectively and cost -efficiently -- keeping patients out of the hospital or other more, er, horizontal places.
The researchers looked at a major private employer that made some medications free to employees and slashed co-pays for other drugs by 50 percent. This led to a significant increase in employees' use of preventive medicines.
The study authors also looked at another employer that kept co-payments at the same levels and found it didn't show the same increase in employee use of preventive medicines.
The findings were published in the January/February issue of Health Affairs.
"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," senior study author Dr. Mark Fendrick, of the University of Michigan Medical School and School of Public Health, said in a prepared statement. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."
Treating chronic disease via appropriate pharmaceutical intervention saves both money and lives -- benefiting both the public purse and the public health. And isn't that what health care is all about.
You can be the judge and become a better consumer of online health care information after reading our report. Much of what passes for "information" is propaganda placed by trial attorneys, so-called public interest groups and alternative health sites to steer people away from taking certain drugs, making them feel they should sue if they did take them or replace them with things that are expensive because they are natural. In specific cases, which we provide, the information on the Web has contributed to a decline in public health and death.
The Web has become an organizing tool for those seeking to politicize science. Ironically, for all the concern about DTC the biggest and most dangerous source of disinformation is often provided by organizations that are the biggest critics of drug ads. When, for example, will Public Citizen and Consumers Reports do the responsible thing and take down all the inaccurate links to their sites about statins and liver damage? When will these organizations stop associating with the same trial attorneys that front load the Web with sites that scare people about the risks of drugs relative to their benefits?
Misinformation and disinformation regarding health issues could be a huge public health problem in the years ahead. We hope this study gives people an insight into how big and a common sense way of how to solve it: consider the source and consult your doctor before taking action.
The Web has become an organizing tool for those seeking to politicize science. Ironically, for all the concern about DTC the biggest and most dangerous source of disinformation is often provided by organizations that are the biggest critics of drug ads. When, for example, will Public Citizen and Consumers Reports do the responsible thing and take down all the inaccurate links to their sites about statins and liver damage? When will these organizations stop associating with the same trial attorneys that front load the Web with sites that scare people about the risks of drugs relative to their benefits?
Misinformation and disinformation regarding health issues could be a huge public health problem in the years ahead. We hope this study gives people an insight into how big and a common sense way of how to solve it: consider the source and consult your doctor before taking action.
We are truly confounded by Senator Charles Grassley's "suggestion" that anyone inside the FDA with a beef about the safety of a drug simply vet it in front of an Advisory Committee.
Where could he have gotten such an idea? Perhaps from David Graham, who mixed and matched methodologies and half-baked studies to trash conclusions he disagreed with.
Here's a suggestion: Why not let other Senators from committees other than Finance weigh in with their own opinions, studies and comments during markups and in front of the cameras to trash and second guess the work of staff. Or better yet, let every buck private who disagrees with a procurement policy or a military tactic attack the decision after it's been debated and made. That's just a recipe for chaos.
The benighted effort to move decision making out of the realm of well-established processes of collegial review is an attempt to make all questions disputed and therefore political matters. To do so increases the amount of conflict around the issue of acceptable risk at a time when the FDA is developing and adopting tools that can define risk at the individual level and is creating systems to that can respond to risk quickly through personalized medicine.
It seems that Senator Grassley and Dr. Graham believe the risk of drugs flows from a conspiracy of silence between the FDA and industry. This is a naive and romantic view of safety that sells well but ultimately places the public health in grave danger by demoralizing scientists and discouraging innovation.
Leadership and courage will be required to stand up to his attempt at scientific McCarthyism.
Where could he have gotten such an idea? Perhaps from David Graham, who mixed and matched methodologies and half-baked studies to trash conclusions he disagreed with.
Here's a suggestion: Why not let other Senators from committees other than Finance weigh in with their own opinions, studies and comments during markups and in front of the cameras to trash and second guess the work of staff. Or better yet, let every buck private who disagrees with a procurement policy or a military tactic attack the decision after it's been debated and made. That's just a recipe for chaos.
The benighted effort to move decision making out of the realm of well-established processes of collegial review is an attempt to make all questions disputed and therefore political matters. To do so increases the amount of conflict around the issue of acceptable risk at a time when the FDA is developing and adopting tools that can define risk at the individual level and is creating systems to that can respond to risk quickly through personalized medicine.
It seems that Senator Grassley and Dr. Graham believe the risk of drugs flows from a conspiracy of silence between the FDA and industry. This is a naive and romantic view of safety that sells well but ultimately places the public health in grave danger by demoralizing scientists and discouraging innovation.
Leadership and courage will be required to stand up to his attempt at scientific McCarthyism.
Under the signature of Chairman Dingell and Mr. Stupak, the Energy and Commerce Committee is charging that Dr. Robert Jarvick isn’t qualified to speak on issues of cardiovascular disease since he’s not a "practicing physician with a valid license in any state."
As Peter Rost over at BrandweekNRX writes, “He's an M.D. but he never actually practiced medicine. Instead he changed the course of medicine, through his work."
Did Jonas Salk ever practice medicine -- or was he too busy saving mankind?
“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,†Mr. Dingell said in a press release.
Congress imitates the Colbert Report. Except their writers aren't on strike.
Rost writes. “This is grossly unfair. He clearly went through fire to get his medical degree and had more motivation than most. He then continued a career which led to one of the most notable breakthroughs in medicine. To get on his case and the fact that Pfizer is using him as a spokesperson is simply wrong.â€
"Dr. Jarvik,†Pfizer responds, “ is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well."
Here’s a copy of the Dingell/Stupak letter.
Download file
It's Mad Libs for legislators. Insert NAME OF DRUG COMPANY. Insert NAME OF CEO. Insert ACCUSATION. Its fun for the whole family – and the media loves it!
Until it makes you look foolish.
As Peter Rost over at BrandweekNRX writes, “He's an M.D. but he never actually practiced medicine. Instead he changed the course of medicine, through his work."
Did Jonas Salk ever practice medicine -- or was he too busy saving mankind?
“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,†Mr. Dingell said in a press release.
Congress imitates the Colbert Report. Except their writers aren't on strike.
Rost writes. “This is grossly unfair. He clearly went through fire to get his medical degree and had more motivation than most. He then continued a career which led to one of the most notable breakthroughs in medicine. To get on his case and the fact that Pfizer is using him as a spokesperson is simply wrong.â€
"Dr. Jarvik,†Pfizer responds, “ is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well."
Here’s a copy of the Dingell/Stupak letter.
Download file
It's Mad Libs for legislators. Insert NAME OF DRUG COMPANY. Insert NAME OF CEO. Insert ACCUSATION. Its fun for the whole family – and the media loves it!
Until it makes you look foolish.
... other, more expensive parts of the health care equation.
Prescription drug spending increased from 2005-2006 by 8.5 percent, the biggest jump in two years. But it corresponds with the sharpest drop in spending on nursing home, hospital and doctor services. This is what we who supported Part D had argued all along.
The article can be found in the latest edition of Health Affairs..
http://content.healthaffairs.org/content/vol27/issue1/?etoc
">http://content.healthaffairs.org/content/vol27/issue1/?etoc
Prescription drug spending increased from 2005-2006 by 8.5 percent, the biggest jump in two years. But it corresponds with the sharpest drop in spending on nursing home, hospital and doctor services. This is what we who supported Part D had argued all along.
The article can be found in the latest edition of Health Affairs..
http://content.healthaffairs.org/content/vol27/issue1/?etoc
">http://content.healthaffairs.org/content/vol27/issue1/?etoc
Teresa Lee, vice president of payment and policy for AdvaMed, opines in The Journal of Life Sciences ...
“The advent of personalized medicine will not only mean better outcomes for patients, but for the health care system as a whole, as diseases will be detected earlier when they are less expensive to treat and when there is a greater chance for complete recovery. Eliminating the expense associated with latter stages of disease will save the healthcare system untold billions and allow more resources to be devoted to areas such as preventive services, to help combat disease before they even start.
Unfortunately, the promise of molecular diagnostics and personalized medicine might not be realized because of Medicare reimbursement policies that were devised for diagnostics technologies of 1984, back when a cell phone was the size of a brick and cost $4,000.â€
Here’s a link to the entire article:
http://www.tjols.com/article-487.html
Lee’s conclusion?
"In order to address these issues and encourage innovation that will enable personalized medicine to fulfill its promise, it is important for Congress to pass the Medicare Advanced Laboratory Diagnostics Act, which will reform many of the outdated Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests.
Momentum is growing to enact this needed reform to modernize Medicare’s outdated reimbursement policies that will finally let the full potential of innovative molecular diagnostics and personalized medicine thrive. “
For more information on this issue, please see our earlier blog, "Chuck and Cover" at
http://drugwonks.com/2007/12/chuck_and_cover.html
“The advent of personalized medicine will not only mean better outcomes for patients, but for the health care system as a whole, as diseases will be detected earlier when they are less expensive to treat and when there is a greater chance for complete recovery. Eliminating the expense associated with latter stages of disease will save the healthcare system untold billions and allow more resources to be devoted to areas such as preventive services, to help combat disease before they even start.
Unfortunately, the promise of molecular diagnostics and personalized medicine might not be realized because of Medicare reimbursement policies that were devised for diagnostics technologies of 1984, back when a cell phone was the size of a brick and cost $4,000.â€
Here’s a link to the entire article:
http://www.tjols.com/article-487.html
Lee’s conclusion?
"In order to address these issues and encourage innovation that will enable personalized medicine to fulfill its promise, it is important for Congress to pass the Medicare Advanced Laboratory Diagnostics Act, which will reform many of the outdated Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests.
Momentum is growing to enact this needed reform to modernize Medicare’s outdated reimbursement policies that will finally let the full potential of innovative molecular diagnostics and personalized medicine thrive. “
For more information on this issue, please see our earlier blog, "Chuck and Cover" at
http://drugwonks.com/2007/12/chuck_and_cover.html
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.
