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01/10/2008 07:16 AM |
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. Read More & Comment...
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. Read More & Comment...
01/09/2008 09:53 AM |
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 Read More & Comment...
"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 Read More & Comment...
01/09/2008 07:10 AM |
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. Read More & Comment...
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. Read More & Comment...
01/08/2008 11:25 AM |
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. Read More & Comment...
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. Read More & Comment...
01/08/2008 09:43 AM |
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. Read More & Comment...
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. Read More & Comment...
01/08/2008 07:16 AM |
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. Read More & Comment...
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. Read More & Comment...
01/07/2008 10:30 PM |
... 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
Read More & Comment...
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
Read More & Comment...
01/07/2008 01:49 PM |
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 Read More & Comment...
“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 Read More & Comment...
01/07/2008 01:01 PM |
From the WSJ Health Blog ...
Claiming he popped Merck’s former painkiller “like it was Skittles†(sic), the pitcher expressed his concerns about the potential impact of the drug on his health. “Now these people who are supposedly regulating it tell me it’s bad for my heart. I don’t know what the future holds because of the medicine I’ve eaten, but I trusted that it was not harmful,†Clemens told Mike Wallace.
I may be wrong here, but I do not believe the FDA-approved label for Vioxx included any mention of either stupidity or hanging fastballs. Read More & Comment...
Claiming he popped Merck’s former painkiller “like it was Skittles†(sic), the pitcher expressed his concerns about the potential impact of the drug on his health. “Now these people who are supposedly regulating it tell me it’s bad for my heart. I don’t know what the future holds because of the medicine I’ve eaten, but I trusted that it was not harmful,†Clemens told Mike Wallace.
I may be wrong here, but I do not believe the FDA-approved label for Vioxx included any mention of either stupidity or hanging fastballs. Read More & Comment...
01/07/2008 12:20 PM |
U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted†the law by saying the FDA’s approval of a drug label is only a “first step.†He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.â€
The Solicitor General’s full opinion can be viewed at
http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf
Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case." Read More & Comment...
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted†the law by saying the FDA’s approval of a drug label is only a “first step.†He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.â€
The Solicitor General’s full opinion can be viewed at
http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf
Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case." Read More & Comment...
01/07/2008 11:42 AM |
Doing its best Emily Litella impersonation, Congress has increased the amount of federal dollars available to fund FDA review of DTC ads -- rather than go with the previous (and legislated) idea for user fees designed to speed up the review process.
That's right -- "Never mind."
According a House staffer (as told to the Pink Sheet), this action "reflects House members' concern that user fees give the impression drug makers are buying FDA approval."
Well that impression needs to be changed and there's no time like the present. User fees don't buy anything except review. Nothing else. And, when it comes to DTC ads, review isn't even required by law (although it is by the PhRMA Marketing Code).
Any one who says the FDA is "in industry's pocket" is entirely ignorant of what really happens. Unfortunately, that group seems to contain a lot of our elected representatives -- including some who are running for President. Read More & Comment...
That's right -- "Never mind."
According a House staffer (as told to the Pink Sheet), this action "reflects House members' concern that user fees give the impression drug makers are buying FDA approval."
Well that impression needs to be changed and there's no time like the present. User fees don't buy anything except review. Nothing else. And, when it comes to DTC ads, review isn't even required by law (although it is by the PhRMA Marketing Code).
Any one who says the FDA is "in industry's pocket" is entirely ignorant of what really happens. Unfortunately, that group seems to contain a lot of our elected representatives -- including some who are running for President. Read More & Comment...
01/07/2008 06:27 AM |
During Saturday night’s Republican debate, Senator McCain continued his benighted attack on the pharmaceutical industry – the usual half-truth talking points – and then something really unusual happened – another candidate decided that it was time for a dose of reality. Governor Romney said, “Don’t make the pharmaceutical companies into the big bad guys.â€
Senator McCain thinks they are. He should talk to patients rather than listening to pollsters.
Looking at the world – and particularly the world of health care – through a “good guy/bad guy†lens is simplistic, wrong, and deleterious to real reform. But it does play well in the media. Senator John "Every Man a King" Edwards is trying the same thing. Some call it “the politics of hate.†And the fact that Michael Moore has decided endorse Edwards is an interesting addition to the divisiveness some candidates are adopting out of desperation.
Joining Governor Romney in the courageous camp of sanity is Senator Obama, who recently told a group of citizens that health care reform will not be easy and that anyone who says there’s a simple solution doesn’t know what they’re talking about.
Romney isn’t playing the easy and risk-free “blame Big Pharma†gambit and Obama isn’t opting for simple solutions -- such as drug importation (once again being embraced by both McCain and Edwards).
You mean real reform is going to be hard? That’s the truth – but will it sell? Read More & Comment...
Senator McCain thinks they are. He should talk to patients rather than listening to pollsters.
Looking at the world – and particularly the world of health care – through a “good guy/bad guy†lens is simplistic, wrong, and deleterious to real reform. But it does play well in the media. Senator John "Every Man a King" Edwards is trying the same thing. Some call it “the politics of hate.†And the fact that Michael Moore has decided endorse Edwards is an interesting addition to the divisiveness some candidates are adopting out of desperation.
Joining Governor Romney in the courageous camp of sanity is Senator Obama, who recently told a group of citizens that health care reform will not be easy and that anyone who says there’s a simple solution doesn’t know what they’re talking about.
Romney isn’t playing the easy and risk-free “blame Big Pharma†gambit and Obama isn’t opting for simple solutions -- such as drug importation (once again being embraced by both McCain and Edwards).
You mean real reform is going to be hard? That’s the truth – but will it sell? Read More & Comment...
01/04/2008 10:00 AM |
Everyone is coming out with snap judgments on what caused Hillary to crash and burn in Iowa. Here's my take: her effort to paint herself as the Mother Courage of Universal Healthcare is falling flat. The more she talks about it and her ability to deliver, the less people seem to trust her and her leadership.
Senator Clinton claims she will make health care her defining issue in New Hampshire. Is that a good thing? We shall see. Read More & Comment...
Senator Clinton claims she will make health care her defining issue in New Hampshire. Is that a good thing? We shall see. Read More & Comment...
01/04/2008 08:57 AM |
FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.
The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.
The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.
The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.
"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.
"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."
The full FDA announcement can be found at
http://www.fda.gov
TAG -- you're it. Read More & Comment...
The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.
The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.
The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.
The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.
"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.
"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."
The full FDA announcement can be found at
http://www.fda.gov
TAG -- you're it. Read More & Comment...
01/03/2008 12:18 PM |
Where are you likely to receive better cardiac care, your hospital's ER or the men's department at Nordstrom's?
A recent study from the NEJM suggests that the refusal of hospitals -- perhaps out of litigation fear -- to allow the use of automatic defibrillators -- might be a reason thousands die of heart attacks who would otherwise still be alive.
Automatic defibrillators that have come into use in public places like airports and casinos during the last decade or so are meant to be used by laymen: trained employees or even bystanders. Connected to the chest of someone who has collapsed, the machine senses electrical activity in the heart and delivers a shock only if it is needed. These devices are designed to be essentially foolproof, making it impossible to harm someone by firing off an unnecessary shock. But so far they have not been used much in the care of hospitalized patients.
Dr. Saxon said the automatic defibrillators should be used more, along with the type of heart monitoring now given mostly to cardiac patients. Not everyone needs such monitoring, she said, but it may be in order for those who are very ill with kidney problems, diabetes or pneumonia, even if they have no history of heart problems. Their information would be transmitted to a computer network that would send out an alert if needed. In addition, she said, automatic defibrillators could be installed in every hospital room.
“You can get them for $500 on eBay,†she said. “It wouldn’t even take a nurse. You could train the cafeteria workers if you wanted to.â€
Speaking on her cellphone, Dr. Saxon said, “You’re better off having your arrest at Nordstrom, where I’m standing right now, because there are 15 people around me.â€
What's the hold up? My guess is fear of lawsuits. It would only take one idiot represented by John Edwards to sue a hospital for being shocked improperly by a hospital aide instead of the chief of cardiology for that nobel experiment to end.
The Precautionary Principle is killing common sense in health care. And people.
http://www.nytimes.com/2008/01/03/health/research/03heart.html?_r=2&ref=us&oref=slogin&oref=slogin Read More & Comment...
A recent study from the NEJM suggests that the refusal of hospitals -- perhaps out of litigation fear -- to allow the use of automatic defibrillators -- might be a reason thousands die of heart attacks who would otherwise still be alive.
Automatic defibrillators that have come into use in public places like airports and casinos during the last decade or so are meant to be used by laymen: trained employees or even bystanders. Connected to the chest of someone who has collapsed, the machine senses electrical activity in the heart and delivers a shock only if it is needed. These devices are designed to be essentially foolproof, making it impossible to harm someone by firing off an unnecessary shock. But so far they have not been used much in the care of hospitalized patients.
Dr. Saxon said the automatic defibrillators should be used more, along with the type of heart monitoring now given mostly to cardiac patients. Not everyone needs such monitoring, she said, but it may be in order for those who are very ill with kidney problems, diabetes or pneumonia, even if they have no history of heart problems. Their information would be transmitted to a computer network that would send out an alert if needed. In addition, she said, automatic defibrillators could be installed in every hospital room.
“You can get them for $500 on eBay,†she said. “It wouldn’t even take a nurse. You could train the cafeteria workers if you wanted to.â€
Speaking on her cellphone, Dr. Saxon said, “You’re better off having your arrest at Nordstrom, where I’m standing right now, because there are 15 people around me.â€
What's the hold up? My guess is fear of lawsuits. It would only take one idiot represented by John Edwards to sue a hospital for being shocked improperly by a hospital aide instead of the chief of cardiology for that nobel experiment to end.
The Precautionary Principle is killing common sense in health care. And people.
http://www.nytimes.com/2008/01/03/health/research/03heart.html?_r=2&ref=us&oref=slogin&oref=slogin Read More & Comment...
01/03/2008 06:01 AM |
A few years back, at a Senate hearing on DTC issues, Senator Debbie Stabenow (D, MI) asked an FDA official, "Why do drug companies only advertise new drugs?" My colleague's sage and savvy reply to the Senator from Michigan, "Senator, for the same reason that Detroit only advertises new cars."
Okay folks, once again into the abyss ...
Does John Edwards know more than your doctor?
These are two questions that ought to be posed to the Democratic candidate for president — who has been banging the kettle drums on the campaign trail lately demanding that laws be passed limiting what information about new drugs and treatments may fall before your eyes.
He wants to ban — or at least, heavily regulate and limit — the way that medicines can be advertised.
Instead of commercials that let people know of the existence of a newly developed drug or treatment, only doctors would be allowed to convey that information for at least two full years.
After that point, if elected, Edwards might permit some word to get out.
Maybe.
Here's the rest of the story ...
http://article.nationalreview.com/?q=ZWVmZDQ5ZTRhMGUxMDc4YTA5Y2JmNTIxYTU2Zjk4Yjk=
Cost of a shave and a haircut? Why two bits of course. Read More & Comment...
Okay folks, once again into the abyss ...
Does John Edwards know more than your doctor?
These are two questions that ought to be posed to the Democratic candidate for president — who has been banging the kettle drums on the campaign trail lately demanding that laws be passed limiting what information about new drugs and treatments may fall before your eyes.
He wants to ban — or at least, heavily regulate and limit — the way that medicines can be advertised.
Instead of commercials that let people know of the existence of a newly developed drug or treatment, only doctors would be allowed to convey that information for at least two full years.
After that point, if elected, Edwards might permit some word to get out.
Maybe.
Here's the rest of the story ...
http://article.nationalreview.com/?q=ZWVmZDQ5ZTRhMGUxMDc4YTA5Y2JmNTIxYTU2Zjk4Yjk=
Cost of a shave and a haircut? Why two bits of course. Read More & Comment...
01/02/2008 03:11 PM |
Previously uninsured adults who received Medicare coverage reported improvements in health, especially those with cardiovascular disease or diabetes, according to a study in the JAMA.
Uninsured near-elderly adults, particularly those with cardiovascular disease or diabetes, experience worse health outcomes and use more health services as Medicare beneficiaries after age 65 years than insured near-elderly adults. Because chronic diseases are prevalent and insurance coverage is often unaffordable for older uninsured adults, the impact of near-universal Medicare coverage at age 65 years on the health of previously uninsured adults may be substantial, according to researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston.
The researchers conclude that providing earlier health insurance coverage for uninsured adults, particularly those with cardiovascular disease or diabetes, may have considerable social and economic value for the United States by improving health outcomes. Read More & Comment...
Uninsured near-elderly adults, particularly those with cardiovascular disease or diabetes, experience worse health outcomes and use more health services as Medicare beneficiaries after age 65 years than insured near-elderly adults. Because chronic diseases are prevalent and insurance coverage is often unaffordable for older uninsured adults, the impact of near-universal Medicare coverage at age 65 years on the health of previously uninsured adults may be substantial, according to researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston.
The researchers conclude that providing earlier health insurance coverage for uninsured adults, particularly those with cardiovascular disease or diabetes, may have considerable social and economic value for the United States by improving health outcomes. Read More & Comment...
01/02/2008 02:06 PM |
My mother-in-law hates George W. Bush. That doesn't make her special -- but it has made her impossible to talk to about Part D. She thinks it's "Bush's thing" and has refused to even consider signing up for coverage.
Over the holidays, as she was complaining about her prescription medicine expenses, I went to the well one more time and advised her to check into signing up for Medicare drug coverage.
And you know what? She did.
She may still hate the President, but she sure loves her Part D.
Oh yes -- she lives in California. Read More & Comment...
Over the holidays, as she was complaining about her prescription medicine expenses, I went to the well one more time and advised her to check into signing up for Medicare drug coverage.
And you know what? She did.
She may still hate the President, but she sure loves her Part D.
Oh yes -- she lives in California. Read More & Comment...
01/02/2008 11:30 AM |
What do Jamie-Lynn Spears and Steve Nissen have in common? While only one looks good with a partially exposed tummy, both are dubious sources of advice in their chosen fields of expertise. At least Jamie-Lynne has the good sense not to move forward with her book about parenting -- while Steve Nissen will continue to find products to make people afraid about using meta-analysis as his weapon of choice.
http://www.chicagotribune.com/entertainment/chi-lynn-spears,1,3749621.story Read More & Comment...
http://www.chicagotribune.com/entertainment/chi-lynn-spears,1,3749621.story Read More & Comment...
01/02/2008 07:18 AM |
Here's a house editorial from today's edition of the Wall Street Journal.
Stopping Medicine's Machines
The Vioxx panic seems to have subsided, but the same kind of alarmism is beginning to wash over health-care fields other than pharmaceuticals. The most recent is medical technology. Now Congress is ready to intervene, so let's try to separate good sense from exaggeration.
On the front-burner for Congressional action is Medtronic, a major medical-device maker, and the controversy surrounding a component of its heart defibrillators. Surgically implanted near the shoulder, these devices treat cardiac arrest by electrically shocking the heart back into regular rhythm. In October, in the face of escalating criticism over safety concerns, Medtronic voluntarily withdrew from the market a type of the complex wires -- called leads -- that connect a defibrillator to the heart muscle and tell it when to deliver therapy.
These Sprint Fidelis leads have a smaller diameter than most others available. Cardiologists have been calling for narrower models because they are easier to thread through the veins during surgery. Once implanted, they are less likely to lead to blood clots or obstructions, or distort heart valves.
While all leads break or "fracture," some evidence began to emerge this year that the Fidelis line, which was made available in the U.S. in 2004 and rapidly adopted, was more prone to early malfunction compared to older alternatives. A fracture can cause painful misfires, or a failure to deliver effective shocks to a dying patient.
Medtronic at first maintained the data weren't conclusive. After further internal studies and advice from its outside panel of heart doctors, it pulled the product. About 268,000 people have the implants world-wide; fractures may have contributed to five deaths. According to the company's composite estimates, 97.7% of the leads will still operate properly after 30 months in the body. The rate for Medtronic's older lead is 99.1%, a difference that isn't statistically meaningful but will be if trends remain constant.
Medtronic CEO Bill Hawkins told us that pulling Fidelis was ultimately "a judgment call." No doubt the medical side of the ledger is vastly complex. Researchers only have a limited understanding of why the leads may be less reliable. Because they were thinner, they may be more vulnerable to stress. Failures may be due to a surgeon's implant technique, or simply due to complications in patients with chronic medical conditions.
But Medtronic's withdrawal may also have been driven by legal and political calculations. Post-Vioxx, companies are under pressure to get out in front of even modest health risks. All therapies carry some risk, so these withdrawals strip choices from patients and their doctors. Mr. Hawkins notes that "society's tolerance for any risks associated with medical technology is nearing zero." The trial bar is a main offender. The first lawsuits against Medtronic were filed literally the morning after the withdrawal announcement, with many to come.
Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.
The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.
The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.
Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.
Devices undergo extensive laboratory "bench tests" to simulate how they'll behave under the stresses of the human body. Requiring premarket clinical trials wouldn't even detect the rare or long-term problems like the one that brought down Fidelis, and refinements of existing designs don't need square-one scrutiny. Postmarket surveillance, of the kind Medtronic and other makers conduct with their products, is a better way to monitor safety.
As with so many other medical scandals, the real danger to public health is overreaction to medical risk. Several cardiologists we spoke with (some affiliated with Medtronic) offered anecdotal evidence of high-risk patients refusing care due to the "anxiety-ridden environment," as one electrophysiologist called it. Not having a device is far worse for them than the possibility of malfunction. It might be fatal. That might not be the intent of the politicians and trial lawyers, but it is a consequence of their opportunism. Read More & Comment...
Stopping Medicine's Machines
The Vioxx panic seems to have subsided, but the same kind of alarmism is beginning to wash over health-care fields other than pharmaceuticals. The most recent is medical technology. Now Congress is ready to intervene, so let's try to separate good sense from exaggeration.
On the front-burner for Congressional action is Medtronic, a major medical-device maker, and the controversy surrounding a component of its heart defibrillators. Surgically implanted near the shoulder, these devices treat cardiac arrest by electrically shocking the heart back into regular rhythm. In October, in the face of escalating criticism over safety concerns, Medtronic voluntarily withdrew from the market a type of the complex wires -- called leads -- that connect a defibrillator to the heart muscle and tell it when to deliver therapy.
These Sprint Fidelis leads have a smaller diameter than most others available. Cardiologists have been calling for narrower models because they are easier to thread through the veins during surgery. Once implanted, they are less likely to lead to blood clots or obstructions, or distort heart valves.
While all leads break or "fracture," some evidence began to emerge this year that the Fidelis line, which was made available in the U.S. in 2004 and rapidly adopted, was more prone to early malfunction compared to older alternatives. A fracture can cause painful misfires, or a failure to deliver effective shocks to a dying patient.
Medtronic at first maintained the data weren't conclusive. After further internal studies and advice from its outside panel of heart doctors, it pulled the product. About 268,000 people have the implants world-wide; fractures may have contributed to five deaths. According to the company's composite estimates, 97.7% of the leads will still operate properly after 30 months in the body. The rate for Medtronic's older lead is 99.1%, a difference that isn't statistically meaningful but will be if trends remain constant.
Medtronic CEO Bill Hawkins told us that pulling Fidelis was ultimately "a judgment call." No doubt the medical side of the ledger is vastly complex. Researchers only have a limited understanding of why the leads may be less reliable. Because they were thinner, they may be more vulnerable to stress. Failures may be due to a surgeon's implant technique, or simply due to complications in patients with chronic medical conditions.
But Medtronic's withdrawal may also have been driven by legal and political calculations. Post-Vioxx, companies are under pressure to get out in front of even modest health risks. All therapies carry some risk, so these withdrawals strip choices from patients and their doctors. Mr. Hawkins notes that "society's tolerance for any risks associated with medical technology is nearing zero." The trial bar is a main offender. The first lawsuits against Medtronic were filed literally the morning after the withdrawal announcement, with many to come.
Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.
The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.
The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.
Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.
Devices undergo extensive laboratory "bench tests" to simulate how they'll behave under the stresses of the human body. Requiring premarket clinical trials wouldn't even detect the rare or long-term problems like the one that brought down Fidelis, and refinements of existing designs don't need square-one scrutiny. Postmarket surveillance, of the kind Medtronic and other makers conduct with their products, is a better way to monitor safety.
As with so many other medical scandals, the real danger to public health is overreaction to medical risk. Several cardiologists we spoke with (some affiliated with Medtronic) offered anecdotal evidence of high-risk patients refusing care due to the "anxiety-ridden environment," as one electrophysiologist called it. Not having a device is far worse for them than the possibility of malfunction. It might be fatal. That might not be the intent of the politicians and trial lawyers, but it is a consequence of their opportunism. Read More & Comment...
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