Latest Drugwonks' Blog
Two articles in the Wall Street Journal regarding the use, misuse and theft of drug patents...Of course all the drugs made by Thai-government run companies will be used for the poor and be of top quality....And none of them will ever make it onto the black market because there are SO many limits placed on selling inferior or bogus drugs to unsuspecting people in poor countries...
http://online.wsj.com/article/SB120515886199824251.html?mod=djempersonal
http://online.wsj.com/article/BT-CO-20080310-706680.html?mod=djempersonal
http://online.wsj.com/article/SB120515886199824251.html?mod=djempersonal
http://online.wsj.com/article/BT-CO-20080310-706680.html?mod=djempersonal
The House Energy and Commerce Committee's health subcommittee is scheduled to pick up Tuesday where it left off Thursday, discussing and possibly amending the tobacco-control legislation before certain passage. The full committee would then take up the bill, and passage there appears certain as well.
Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So for now, thank you for not regulating.
FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry.
Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So for now, thank you for not regulating.
FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry.
Leave it to the mainstream media to pump out the ultimate scare: Big Pharma pollutes the water supply!!!!
AP probe finds drugs in drinking water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."
What no Viagra? What about OTC products? Is this some off-label use conspiracy?
"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."
Trillion? How about gazillion?
"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."
Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.
"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."
Yes, truly alarming, especially when you claim we don't know the risks.
"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."
Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.
The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:
"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."
Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?
The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:
"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."
Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...
Read Article Here
AP probe finds drugs in drinking water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."
What no Viagra? What about OTC products? Is this some off-label use conspiracy?
"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."
Trillion? How about gazillion?
"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."
Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.
"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."
Yes, truly alarming, especially when you claim we don't know the risks.
"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."
Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.
The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:
"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."
Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?
The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:
"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."
Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...
Read Article Here
What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane.
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane.
Here's Sir Michael Rawlins, the director of NICE, exposing comparative effectiveness as a back of the envelope calculation that has hardened into a tool for rationing:
" It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. There is no known piece of work which tells you what the threshold should be. There have been ex cathedra statements. For example, the World Health Organisation says it should be somewhere around your GDP per person, but why the GDP per capita? It is elusive."
Who do you trust, your doctor or the collective judgment of health economists and their ex cathedra statements..... Policymakers who support comparative effectiveness as evidence-based are engaging in Orwellian Newspeak.
Read more of the sloppy methodology deployed by cost containers....
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/uc27-i/uc2702.htm
" It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. There is no known piece of work which tells you what the threshold should be. There have been ex cathedra statements. For example, the World Health Organisation says it should be somewhere around your GDP per person, but why the GDP per capita? It is elusive."
Who do you trust, your doctor or the collective judgment of health economists and their ex cathedra statements..... Policymakers who support comparative effectiveness as evidence-based are engaging in Orwellian Newspeak.
Read more of the sloppy methodology deployed by cost containers....
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/uc27-i/uc2702.htm
Straight shooting from the Washington Post editorial page. And we concur.
Some snippets:
"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."
We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.
"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."
It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.
"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."
Yup.
Here's a link to the complete editorial:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html
It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.
Now.
Some snippets:
"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."
We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.
"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."
It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.
"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."
Yup.
Here's a link to the complete editorial:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html
It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.
Now.
The National Vaccine Injury Compensation Program (NVIP) board voted to award a family monetary compensation in a case where the reviewers determined that the family was able to show -- not prove, not demonstrate on the basis of scientific evidence -- that it was not impossible to rule out that vaccines aggravated a rare mitochonrial disease (MD). MD is associated with systemic toxicity and nutrient starvation issues at the cellular level that can lead to developmental delays, brain damage and behaviors consistent with those found on the autism disorder spectrum.
Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.
Now the facts, ignored by the media and, it appears, the special masters reviewing the case:
1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.
2. Autistic features are associated with MD. So are developmental delays.
3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)
4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)
5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.
But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?
So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health.
Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.
Now the facts, ignored by the media and, it appears, the special masters reviewing the case:
1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.
2. Autistic features are associated with MD. So are developmental delays.
3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)
4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)
5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.
But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?
So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health.
Can ignorance be bliss when it comes to information about your health? Is knowledge always power -- and can that power be abused? And what about the need for more robust FDA oversight of 21st centuty diagnostics?
Have a look at this article from today's edition of USA Today:
Companies cash in on checking your DNA for disease
By Rita Rubin, USA TODAY
Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.
Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.
Q&A: What to know about testing your genes
The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.
TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?
The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?
In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.
Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.
Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.
"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate."
Have a look at this article from today's edition of USA Today:
Companies cash in on checking your DNA for disease
By Rita Rubin, USA TODAY
Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.
Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.
Q&A: What to know about testing your genes
The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.
TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?
The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?
In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.
Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.
Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.
"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate."
Since death is a surrogate for advancing to the next stage of Man's destiny, Senator Grassley should ask the GAO to investigate whether Pharma, in conspiracy with the FDA, is thwarting God's plan.
So now Senator Grassley wants the GAO to determine whether or not using surrogate markers is sound science?
This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.
And the patient shall inherit the wind.
This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.
And the patient shall inherit the wind.
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.
