Latest Drugwonks' Blog
The GAO report on DTC is so chock-full of half-truths that it is breathtaking to behold.
Consider this subhead (page 14 of the report), "Research Suggests DTC Advertising Increases Drug Spending and Utilization." Now to the casual observer (read here "politician" or "many journalists") that means the same thing as "DTC Advertising Increases the Cost of Drugs."
Not so.
It's a GAO solipsism.
A more accurate statement would be that DTC advertising drives patients to their doctors who, in turn, reach a diagnosis and then appropriately prescribe. That DTC helps patients and their physicians diagnose an existing medical condition earlier than might otherwise occur is a tremendously positive and potent public health service.
Is that statement in the GAO report? Nope.
Also, if more people are being appropriately prescribed more medicines -- then , indeed, we will as a nation be spending more on pharmaceuticals. But the GAO report makes this sound like a nepharious scheme. And don't be surprised if this theme is taken up by the usual suspects.
What's interesting is that the GAO doesn't report that, if you look at the "list" price of all the on-patent drugs within a given therapeutic category (which almost nobody pays) and then look at their individual advertising spends, what you will not find is a causal relationship. Oops.
And it's very disturbing that the GAO report didn't even consider FDA's research on DTC and physician prescribing patterns. What the FDA found was that physicians are NOT inappropriately prescribing medicines just because their patients ask for them.
But why worry about facts when you've got rhetoric on your side.
Consider this subhead (page 14 of the report), "Research Suggests DTC Advertising Increases Drug Spending and Utilization." Now to the casual observer (read here "politician" or "many journalists") that means the same thing as "DTC Advertising Increases the Cost of Drugs."
Not so.
It's a GAO solipsism.
A more accurate statement would be that DTC advertising drives patients to their doctors who, in turn, reach a diagnosis and then appropriately prescribe. That DTC helps patients and their physicians diagnose an existing medical condition earlier than might otherwise occur is a tremendously positive and potent public health service.
Is that statement in the GAO report? Nope.
Also, if more people are being appropriately prescribed more medicines -- then , indeed, we will as a nation be spending more on pharmaceuticals. But the GAO report makes this sound like a nepharious scheme. And don't be surprised if this theme is taken up by the usual suspects.
What's interesting is that the GAO doesn't report that, if you look at the "list" price of all the on-patent drugs within a given therapeutic category (which almost nobody pays) and then look at their individual advertising spends, what you will not find is a causal relationship. Oops.
And it's very disturbing that the GAO report didn't even consider FDA's research on DTC and physician prescribing patterns. What the FDA found was that physicians are NOT inappropriately prescribing medicines just because their patients ask for them.
But why worry about facts when you've got rhetoric on your side.
The Government Accountability Office’s new report on DTC states the obvious -- the FDA lacks an effective way to screen, review and track pharmaceutical advertising.
Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.
Once again drugwonks says, “show me the money.â€
In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.
''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.
Hello PDUFA!
Letter Imperfect
On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.
Indeed, Waxman Redux.
But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance†means. Not precise enough – but better than before.
GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.
Unfortunately, there are a lot of fools out there. Fools on the Hill.
Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.
Once again drugwonks says, “show me the money.â€
In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.
''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.
Hello PDUFA!
Letter Imperfect
On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.
Indeed, Waxman Redux.
But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance†means. Not precise enough – but better than before.
GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.
Unfortunately, there are a lot of fools out there. Fools on the Hill.
Excellent article in Scientific American.......
Special Report: 10 Promising Treatments for World's Biggest Health Threats
Cutting-edge pharmaceuticals now being tested could revolutionize the fight against cancer, Alzheimer's, HIV, diabetes, nicotine addiction and other devastating diseases
By Charles Q. Choi
Treatments for diabetes, smoking, Alzheimer's disease and lung cancer are just a few of the potentially lifesaving cures Scientific American has chosen to highlight in this year's roundup of drugs you've never heard of, despite their potentially huge impact on global health.
These 10 treatments, all of which could significantly impact global health and wellness, are currently running the last gauntlet a pharmaceutical must run before it becomes available to the public--the clinical trial. During this trial researchers test the drug on humans, carefully observing its side effects as well as its overall effectiveness.
All of the following substances have already passed phase I safety trials and are proceeding into phase II or III efficacy and toxicity trials. (One caveat: any therapy in development runs a risk of failure, even after passing phase III.)
A number of these trials represent completely novel classes of therapy, such as employing fragments of RNA that interfere with problem genes or developing vaccines meant to quell drug addiction.
Some of this year's candidates target the usual rogues' gallery of killers, such as malaria, lung cancer and HIV.
Many of the disorders targeted by the following treatments are becoming increasingly widespread. These disorders include diabetes, which the Centers for Disease Control and Prevention projects will someday afflict one in three children born today; Alzheimer's, which has become more common as life expectancy has increased; and the dengue viruses, which are causing larger and more frequent epidemics, especially in the tropics.
One of this year's drugs even has the potential to serve as a safer replacement for the painkiller Vioxx.
The link to the entire article and the list of all the drugs in development (until price controls or IOM like FDA reform proposal kill them off) here
http://www.sciam.com/print_version.cfm?articleID=7271FB84-E7F2-99DF-38227214BDE0DE78
Special Report: 10 Promising Treatments for World's Biggest Health Threats
Cutting-edge pharmaceuticals now being tested could revolutionize the fight against cancer, Alzheimer's, HIV, diabetes, nicotine addiction and other devastating diseases
By Charles Q. Choi
Treatments for diabetes, smoking, Alzheimer's disease and lung cancer are just a few of the potentially lifesaving cures Scientific American has chosen to highlight in this year's roundup of drugs you've never heard of, despite their potentially huge impact on global health.
These 10 treatments, all of which could significantly impact global health and wellness, are currently running the last gauntlet a pharmaceutical must run before it becomes available to the public--the clinical trial. During this trial researchers test the drug on humans, carefully observing its side effects as well as its overall effectiveness.
All of the following substances have already passed phase I safety trials and are proceeding into phase II or III efficacy and toxicity trials. (One caveat: any therapy in development runs a risk of failure, even after passing phase III.)
A number of these trials represent completely novel classes of therapy, such as employing fragments of RNA that interfere with problem genes or developing vaccines meant to quell drug addiction.
Some of this year's candidates target the usual rogues' gallery of killers, such as malaria, lung cancer and HIV.
Many of the disorders targeted by the following treatments are becoming increasingly widespread. These disorders include diabetes, which the Centers for Disease Control and Prevention projects will someday afflict one in three children born today; Alzheimer's, which has become more common as life expectancy has increased; and the dengue viruses, which are causing larger and more frequent epidemics, especially in the tropics.
One of this year's drugs even has the potential to serve as a safer replacement for the painkiller Vioxx.
The link to the entire article and the list of all the drugs in development (until price controls or IOM like FDA reform proposal kill them off) here
http://www.sciam.com/print_version.cfm?articleID=7271FB84-E7F2-99DF-38227214BDE0DE78
The Commonwealth Fund -- why don't they just call themselves the Single Payer Society and get it over with? -- claims there are only 1 million people in consumer directed health plans, that most of them were forced into them at gunpoint and all of them just hate being in them (as opposed to be in a Canadian paradise or something like Medicaid). The Fund ignores data from various plans including UnitedHealth Group showing patients under high-deductible health plans with a health savings account (HSA) are more likely to seek preventive care and are far less likely to visit emergency rooms for non-emergency care.
Moreover, it turns out that half of all people without insurance have chosen to go without despite having been offered it by their employers or by a state run health program. Now that's really consumer directed health care.
Moreover, it turns out that half of all people without insurance have chosen to go without despite having been offered it by their employers or by a state run health program. Now that's really consumer directed health care.
On the heels of the hysteria about anti-depressant, suicide and black boxes....
Genes May Alter Antidepressant Effects
Study May Help Find Way to Select Antidepressant Most Effective for Patient
By Miranda Hitti
WebMD Medical News Reviewed By Louise Chang, MD
on Wednesday, December 06, 2006
Dec. 6, 2006 -- Variations in certain genes may affect how well depressed people respond to different antidepressants, new research shows.
The report comes from Francis McMahon, MD, of the National Institute of Mental Health (NIMH).
"Medications to treat depression are widely available, but no one treatment works for everyone," McMahon says in a news release
There is no test to predict which of the various antidepressants will work best for a particular patient. It can take trial and error over weeks or months to find the right one.
"We are seeking to better understand why this is the case, and, using genetic markers, develop personalized treatments that give patients the best chance at remission," McMahon says.
"Ultimately, our goal is to put together a panel of genetic markers that can guide treatment decisions and help doctors choose an antidepressant that will work best for an individual patient," he says.
That panel of genetic markers isn't complete yet. But McMahon's findings may help."
And there is this comment....
"There is a heritable component to suicidal behaviour, encouraging the search for the associated risk alleles. Given the putative role of the 5-HT (5-hydroxytryptamine; serotonin) system in suicidal behaviour, serotonergic genes are leading candidates. "
Psychol Med. 2003 Jul;33(5):775-83. Links
Deliberate self-harm is associated with allelic variation in the tryptophan hydroxylase gene (TPH A779C), but not with polymorphisms in five other serotonergic genes.
Genes May Alter Antidepressant Effects
Study May Help Find Way to Select Antidepressant Most Effective for Patient
By Miranda Hitti
WebMD Medical News Reviewed By Louise Chang, MD
on Wednesday, December 06, 2006
Dec. 6, 2006 -- Variations in certain genes may affect how well depressed people respond to different antidepressants, new research shows.
The report comes from Francis McMahon, MD, of the National Institute of Mental Health (NIMH).
"Medications to treat depression are widely available, but no one treatment works for everyone," McMahon says in a news release
There is no test to predict which of the various antidepressants will work best for a particular patient. It can take trial and error over weeks or months to find the right one.
"We are seeking to better understand why this is the case, and, using genetic markers, develop personalized treatments that give patients the best chance at remission," McMahon says.
"Ultimately, our goal is to put together a panel of genetic markers that can guide treatment decisions and help doctors choose an antidepressant that will work best for an individual patient," he says.
That panel of genetic markers isn't complete yet. But McMahon's findings may help."
And there is this comment....
"There is a heritable component to suicidal behaviour, encouraging the search for the associated risk alleles. Given the putative role of the 5-HT (5-hydroxytryptamine; serotonin) system in suicidal behaviour, serotonergic genes are leading candidates. "
Psychol Med. 2003 Jul;33(5):775-83. Links
Deliberate self-harm is associated with allelic variation in the tryptophan hydroxylase gene (TPH A779C), but not with polymorphisms in five other serotonergic genes.
According to a report in today's New York Times, "Public health officials, psychiatrists, grieving parents and outraged former patients will fill a hotel ballroom in Silver Spring, Md., this morning to argue the most bitterly divisive question in psychiatry: do the drugs that doctors prescribe to relieve depression make some people more likely to attempt suicide?"
I was at the agency the last time this debate took place. Very emotional. But emotions mustn't get in the way of the facts. Politicians love emotions. The media loves emotions. But science demands facts. Hard facts. Facts that may not tell people what they want to hear.
And anecdotes, even terrible ones, are not science. In June we blogged on a major new study, the first of its kind, finds that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.
And before you ask, no, the study was not funded by a pharmaceutical company. The funding came from the NIH and the Dana Foundation. The full study appears in the June issue of the journal PLos Medicine.
For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.
Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.
Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.
Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.
With that in mind, moves to restrict the use of SSRI antidepressantscould have a harmful effect, the authors stated.
“I don’t think these claims that antidepressants increase suicide have a solid base,†said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.
“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.â€
While this new science will provide little solice to those who have suffered through a suicide, it will help mental health professionals, their patients — and their patients’ loved ones — better understand the value of available therapies.
I grieve, I truly do, for the parents and spouses, friends, and relatives who have lost loved ones to suicide. And their grief is beyond my comprehension. But warping the science to fit anyone's emotional needs is just plain wrong. Hopefully this hearing will be held and reported on based on the science.
But I doubt it. Let's see what tomorrow's news stories focus on. Will the reports focus on the anecdotes of families or the science of anti-depressants? We shall see.
I was at the agency the last time this debate took place. Very emotional. But emotions mustn't get in the way of the facts. Politicians love emotions. The media loves emotions. But science demands facts. Hard facts. Facts that may not tell people what they want to hear.
And anecdotes, even terrible ones, are not science. In June we blogged on a major new study, the first of its kind, finds that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.
And before you ask, no, the study was not funded by a pharmaceutical company. The funding came from the NIH and the Dana Foundation. The full study appears in the June issue of the journal PLos Medicine.
For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.
Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.
Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.
Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.
With that in mind, moves to restrict the use of SSRI antidepressantscould have a harmful effect, the authors stated.
“I don’t think these claims that antidepressants increase suicide have a solid base,†said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.
“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.â€
While this new science will provide little solice to those who have suffered through a suicide, it will help mental health professionals, their patients — and their patients’ loved ones — better understand the value of available therapies.
I grieve, I truly do, for the parents and spouses, friends, and relatives who have lost loved ones to suicide. And their grief is beyond my comprehension. But warping the science to fit anyone's emotional needs is just plain wrong. Hopefully this hearing will be held and reported on based on the science.
But I doubt it. Let's see what tomorrow's news stories focus on. Will the reports focus on the anecdotes of families or the science of anti-depressants? We shall see.
Pete (Raving) Stark has announced that Democrats will seek a middle ground on pharma and biotech price controls in Medicare Part D next year. No government run plan to compete with private plans says the Stark. That would be perceived as too radical.
"That might draw a veto and then get us accused -- which I don't mind, but most of my colleagues do -- of price-setting and all that. … There's a hesitancy to seem too radical."
Instead, the D's will just instruct the HHS Sec'y to squeeze companies for the VA price and then run and tell Congress what a bunch of price gougers they are relative to what they are charging seniors in the private plans. Drugwonks is sure there won't be any penalties or punishments available for not bringing companies to heel....
And in the hypocrite department...
Stark said he also wanted to reduce the number of private plans available to seniors.
There are now 40 or more plans operating in many markets; Stark would like to reduce that to 15 or 20.
Let's travel back in time to January 2003 and listen to Minority Leader Pelosi on the issue of choice in Medicare:
"In his State of the Union Address last night, President Bush emphasized the importance 'choice.' I agree. Choice is important.
"However, under the President’s plan, our senior citizens may no longer have the choice to go to their own doctor. Seniors may no longer have the choice to fill their prescriptions at their local drug stores. This is particularly harmful to seniors who live in our rural communities."
Drugwonks notes that the reason there are so many plans is that particularly in rural areas you need lots of plans competing to include networks of local pharmacies. But apparently Raving Stark thinks he knows exactly what amount of choice is just right for seniors -- now and in the future, along with what prices will bring forth the appropriate medicines.
"That might draw a veto and then get us accused -- which I don't mind, but most of my colleagues do -- of price-setting and all that. … There's a hesitancy to seem too radical."
Instead, the D's will just instruct the HHS Sec'y to squeeze companies for the VA price and then run and tell Congress what a bunch of price gougers they are relative to what they are charging seniors in the private plans. Drugwonks is sure there won't be any penalties or punishments available for not bringing companies to heel....
And in the hypocrite department...
Stark said he also wanted to reduce the number of private plans available to seniors.
There are now 40 or more plans operating in many markets; Stark would like to reduce that to 15 or 20.
Let's travel back in time to January 2003 and listen to Minority Leader Pelosi on the issue of choice in Medicare:
"In his State of the Union Address last night, President Bush emphasized the importance 'choice.' I agree. Choice is important.
"However, under the President’s plan, our senior citizens may no longer have the choice to go to their own doctor. Seniors may no longer have the choice to fill their prescriptions at their local drug stores. This is particularly harmful to seniors who live in our rural communities."
Drugwonks notes that the reason there are so many plans is that particularly in rural areas you need lots of plans competing to include networks of local pharmacies. But apparently Raving Stark thinks he knows exactly what amount of choice is just right for seniors -- now and in the future, along with what prices will bring forth the appropriate medicines.
Gottlieb is leaving.
Expanded access growing.
Hello PDUFA.
Expanded access growing.
Hello PDUFA.
Editorial from today's edition of the New York Times:
Editorial
Fighting Drug Fakes
Published: December 12, 2006
Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.
In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.
In Panama, dozens of people died after taking counterfeit drugs made with an industrial solvent. Often counterfeiters put in real ingredients for their smell or taste, but heavily diluted. This has sped the emergence of resistant strains of infections, and is probably a big reason some malaria drugs and antibiotics have lost their power.
Drug counterfeiting can be fought. Five years ago, the majority of Nigeria’s drugs were fakes, and the country was a major source of counterfeits abroad. When the Nigerian government donated 88,000 doses of meningitis vaccine to Niger during an epidemic in 1995, the vaccine turned out to be a fake — causing more than 2,500 children to die.
Now the possibility that a drug is fake in Nigeria has dropped to 17 percent, according to the World Health Organization. The country’s drug control agency is informing people through radio and TV jingles about fake medicines. It has also fired corrupt officials, hired a fleet of inspectors to drop in on pharmacies, banned imports from some 30 companies, and begun prosecuting counterfeiters.
One of the problems Nigeria still faces is that the penalty for counterfeiting medicine is as little as a $70 fine — a small price to pay for a crime that can reap a fortune. All over the developing world, governments treat falsifying medicines as a mere copyright infringement, rather than potential murder.
The W.H.O. has recently set up a task force that brings together many groups that work on counterfeit drugs. It is a start. Multinational drug companies — which have been reluctant to report fakes lest they erode consumer confidence in all drugs — need to do more. An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.
Wonder if Senator Vitter will put a "hold" on his subscription to the Gray Lady?
All the news that's fit to print. Amen.
Editorial
Fighting Drug Fakes
Published: December 12, 2006
Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.
In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.
In Panama, dozens of people died after taking counterfeit drugs made with an industrial solvent. Often counterfeiters put in real ingredients for their smell or taste, but heavily diluted. This has sped the emergence of resistant strains of infections, and is probably a big reason some malaria drugs and antibiotics have lost their power.
Drug counterfeiting can be fought. Five years ago, the majority of Nigeria’s drugs were fakes, and the country was a major source of counterfeits abroad. When the Nigerian government donated 88,000 doses of meningitis vaccine to Niger during an epidemic in 1995, the vaccine turned out to be a fake — causing more than 2,500 children to die.
Now the possibility that a drug is fake in Nigeria has dropped to 17 percent, according to the World Health Organization. The country’s drug control agency is informing people through radio and TV jingles about fake medicines. It has also fired corrupt officials, hired a fleet of inspectors to drop in on pharmacies, banned imports from some 30 companies, and begun prosecuting counterfeiters.
One of the problems Nigeria still faces is that the penalty for counterfeiting medicine is as little as a $70 fine — a small price to pay for a crime that can reap a fortune. All over the developing world, governments treat falsifying medicines as a mere copyright infringement, rather than potential murder.
The W.H.O. has recently set up a task force that brings together many groups that work on counterfeit drugs. It is a start. Multinational drug companies — which have been reluctant to report fakes lest they erode consumer confidence in all drugs — need to do more. An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.
Wonder if Senator Vitter will put a "hold" on his subscription to the Gray Lady?
All the news that's fit to print. Amen.
As Jennifer Corbett Doore of Dow Jones reports, "The Food and Drug Administration proposed new regulations Monday that the agency hopes will provide broader access to experimental drugs for seriously ill people who have exhausted all other commercially available treatments."
""This proposed reform is carefully designed to balance several objectives," said FDA Commissioner Dr. Andrew C. von Eschenbach. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."
Janet Woodcock, the FDA's deputy commissioner for operations, explained that large patient groups with cardiovascular diseases, cancer and HIV have long been able to access drugs that are currently being developed and are in clinical trials. However, outside of clinical trials, FDA regulations have been confusing and potentially a barrier to small groups and individual
patients who want to receive access to experimental treatments. The new regulations will explain how patients can receive access to such drugs, even though the patients don't fit the exact criteria for participating in the trial.
"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Woodcock said.
The proposed rules are open for public comment for 90 days.
Here's the link:
http://www.fda.gov/cder/regulatory/applications/IND_PR.htm
We will certainly be commenting.
""This proposed reform is carefully designed to balance several objectives," said FDA Commissioner Dr. Andrew C. von Eschenbach. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."
Janet Woodcock, the FDA's deputy commissioner for operations, explained that large patient groups with cardiovascular diseases, cancer and HIV have long been able to access drugs that are currently being developed and are in clinical trials. However, outside of clinical trials, FDA regulations have been confusing and potentially a barrier to small groups and individual
patients who want to receive access to experimental treatments. The new regulations will explain how patients can receive access to such drugs, even though the patients don't fit the exact criteria for participating in the trial.
"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Woodcock said.
The proposed rules are open for public comment for 90 days.
Here's the link:
http://www.fda.gov/cder/regulatory/applications/IND_PR.htm
We will certainly be commenting.
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.
