Latest Drugwonks' Blog
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.
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.
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."
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."
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.
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.
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?
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?
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.
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.
