Latest Drugwonks' Blog
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.
Senator Clinton claims she will make health care her defining issue in New Hampshire. Is that a good thing? We shall see.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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
http://www.chicagotribune.com/entertainment/chi-lynn-spears,1,3749621.story
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.
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.
"VANCOUVER, Wash. -- A McDonald's employee in Vancouver is a new mom after a fast delivery at the fast-food restaurant.
Danielle Miller, 16, was working at the McDonald's on Gher Road and state Route 500 on Dec. 21 when she suddenly felt ill and ran to the bathroom, reported television station KPTV in Portland, Ore.
A friend and co-worker of Miller's followed her into the restroom and asked her if she was pregnant. Miller said no. But moments later, with the assistance of a 911 dispatcher, the friend helped Miller deliver her baby in the McDonald's restroom."
Gives a new meaning to "Do you want fries with that?"
http://www.wesh.com/family/14953330/detail.html
Danielle Miller, 16, was working at the McDonald's on Gher Road and state Route 500 on Dec. 21 when she suddenly felt ill and ran to the bathroom, reported television station KPTV in Portland, Ore.
A friend and co-worker of Miller's followed her into the restroom and asked her if she was pregnant. Miller said no. But moments later, with the assistance of a 911 dispatcher, the friend helped Miller deliver her baby in the McDonald's restroom."
Gives a new meaning to "Do you want fries with that?"
http://www.wesh.com/family/14953330/detail.html
Here's the gift that will keep on giving...
From the LA Times round up of the year's top ten scams...
"Natural" Viagra turned out to be not so natural in some cases.
Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.
The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.
The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.
The FDA forced 4Everon off the market."
As for names...I still like the Chinese rip-off of Viagra name...Big Brother
http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business
From the LA Times round up of the year's top ten scams...
"Natural" Viagra turned out to be not so natural in some cases.
Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.
The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.
The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.
The FDA forced 4Everon off the market."
As for names...I still like the Chinese rip-off of Viagra name...Big Brother
http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business
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.
