Latest Drugwonks' Blog
Robert Goldberg
Ray Woosley's pioneering collaboration with the FDA to move drug safety in to the 21st century are paying off...Let's see who objects...
From the San Francisco Chronicle....
The Food and Drug Administration is poised to throw its support behind a powerful new method of predicting the safety of experimental drugs, a step that could help pharmaceutical companies bring treatments to market more quickly - and reduce patients' risk.
The process being considered uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects.
"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," said Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development.
Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals' reactions aren't always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.
"Using current tests, you have lost about 70 percent of the kidney function before you pick it up," says William Mattes, director of toxicology at the Critical Path Institute in Tucson.
The new biomarker process has the potential to save a patient's kidneys.
The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol- Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Co. and Pfizer. The companies contribute their expertise but, according to Woosley, the institute does not accept commercial funding.
Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.
"This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials," said Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology.
Goodsaid is responsible for the development of the FDA's biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.
Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park's SRI International to break a worrying trend within the pharmaceutical industry: In the past decade the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically.
Meanwhile, scares like the one associated with the painkiller Vioxx, which turned out to cause heart attacks and strokes, have further fueled this trend.
Unique for the Critical Path Institute is that FDA is a cofounder. Today, the European Medicines Agency - an agency similar to the FDA - also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA.
"This is the first time they have coordinated their decisions," Mattes said.
Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA's attitude toward present drug safety tests.
"Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said.
He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication.
"Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used," says Wolfe.
The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day.
"It is in a very advanced stage of that process," Goodsaid said. "We should have some news soon."
Posted by Robert Goldberg on April 17, 2008 4:40 PM
Ray Woosley's pioneering collaboration with the FDA to move drug safety in to the 21st century are paying off...Let's see who objects...
From the San Francisco Chronicle....
The Food and Drug Administration is poised to throw its support behind a powerful new method of predicting the safety of experimental drugs, a step that could help pharmaceutical companies bring treatments to market more quickly - and reduce patients' risk.
The process being considered uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects.
"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," said Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development.
Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals' reactions aren't always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.
"Using current tests, you have lost about 70 percent of the kidney function before you pick it up," says William Mattes, director of toxicology at the Critical Path Institute in Tucson.
The new biomarker process has the potential to save a patient's kidneys.
The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol- Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Co. and Pfizer. The companies contribute their expertise but, according to Woosley, the institute does not accept commercial funding.
Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.
"This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials," said Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology.
Goodsaid is responsible for the development of the FDA's biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.
Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park's SRI International to break a worrying trend within the pharmaceutical industry: In the past decade the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically.
Meanwhile, scares like the one associated with the painkiller Vioxx, which turned out to cause heart attacks and strokes, have further fueled this trend.
Unique for the Critical Path Institute is that FDA is a cofounder. Today, the European Medicines Agency - an agency similar to the FDA - also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA.
"This is the first time they have coordinated their decisions," Mattes said.
Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA's attitude toward present drug safety tests.
"Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said.
He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication.
"Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used," says Wolfe.
The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day.
"It is in a very advanced stage of that process," Goodsaid said. "We should have some news soon."
Posted by Robert Goldberg on April 17, 2008 4:40 PM
Robert Goldberg
From his speech in Pittsburgh...
Americans also worry about stagnant wages, which are caused in part by the rising cost of health care. Each year employers pay more and more for insurance, leaving less and less to pay their employees. As president, I will propose and relentlessly advocate changes that will bring down health care costs, make health care more affordable and accessible, help individuals and families buy their health insurance with generous tax credits, and enable you to keep your insurance when you change jobs.
Many retired Americans face the terrible reality of deciding whether to buy food, pay rent or buy their prescriptions. And their government should help them. But when we added the prescription drug benefit to Medicare, a new and costly entitlement, we included many people who are more than capable of purchasing their own medicine without assistance from taxpayers who struggle to purchase their own. People like Bill Gates and Warren Buffet don't need their prescriptions underwritten by taxpayers. Those who can afford to buy their own prescription drugs should be expected to do so. This reform alone will save billions of dollars that could be returned to taxpayers or put to better use.
Posted by Robert Goldberg on April 17, 2008 4:21 PM
From his speech in Pittsburgh...
Americans also worry about stagnant wages, which are caused in part by the rising cost of health care. Each year employers pay more and more for insurance, leaving less and less to pay their employees. As president, I will propose and relentlessly advocate changes that will bring down health care costs, make health care more affordable and accessible, help individuals and families buy their health insurance with generous tax credits, and enable you to keep your insurance when you change jobs.
Many retired Americans face the terrible reality of deciding whether to buy food, pay rent or buy their prescriptions. And their government should help them. But when we added the prescription drug benefit to Medicare, a new and costly entitlement, we included many people who are more than capable of purchasing their own medicine without assistance from taxpayers who struggle to purchase their own. People like Bill Gates and Warren Buffet don't need their prescriptions underwritten by taxpayers. Those who can afford to buy their own prescription drugs should be expected to do so. This reform alone will save billions of dollars that could be returned to taxpayers or put to better use.
Posted by Robert Goldberg on April 17, 2008 4:21 PM
Peter Pitts
What ever happened to dialogue and ... ethics?
In it's reporting/editorializing on the recent "what-did-Merck-know-and-when-did-it-know-it" saga, JAMA accuses some pretty high-powered healthcare professionals of shilling for shillings.
Now it comes to light that the folks JAMA denounced weren't even given the chance by the Sultans of Science to defend themselves.
Here's what the Washington Post says,
"Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them. Several of those people yesterday called the conclusions incorrect, incomplete or unfair."
Don't "real" journalists" seek out both sides of the story? Don't real scientists?
Posted by Peter Pitts on April 17, 2008 7:15 AM
What ever happened to dialogue and ... ethics?
In it's reporting/editorializing on the recent "what-did-Merck-know-and-when-did-it-know-it" saga, JAMA accuses some pretty high-powered healthcare professionals of shilling for shillings.
Now it comes to light that the folks JAMA denounced weren't even given the chance by the Sultans of Science to defend themselves.
Here's what the Washington Post says,
"Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them. Several of those people yesterday called the conclusions incorrect, incomplete or unfair."
Don't "real" journalists" seek out both sides of the story? Don't real scientists?
Posted by Peter Pitts on April 17, 2008 7:15 AM
Peter Pitts
We've been saying it for years -- when it comes to FDA reform, the descant is "Show me the money!" And we're glad to say that the chorus has picked up some new members.
“To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the FDA’s spending.
The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely.
If lawmakers decide that the White House “was wrong and you needed to add another $100 million, just to pull a number completely out of the air, could you handle that?” Mr. Bennett asked.
Dr. von Eschenbach said he would “welcome an opportunity to present a scenario of portfolio options” for levels of financing.
That's a nice way to put it.
Posted by Peter Pitts on April 16, 2008 6:59 AM
We've been saying it for years -- when it comes to FDA reform, the descant is "Show me the money!" And we're glad to say that the chorus has picked up some new members.
“To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the FDA’s spending.
The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely.
If lawmakers decide that the White House “was wrong and you needed to add another $100 million, just to pull a number completely out of the air, could you handle that?” Mr. Bennett asked.
Dr. von Eschenbach said he would “welcome an opportunity to present a scenario of portfolio options” for levels of financing.
That's a nice way to put it.
Posted by Peter Pitts on April 16, 2008 6:59 AM
Robert Goldberg
From the ever interesting http://fiercehealthcare.com
A new study has drawn a conclusion that flies in the face of the core assumptions most planners make about healthcare. At least for some patients, shorter hospital stays aren't better, according to the study, which was published in this month's Archives of Internal Medicine. The researchers, who studied 15,531 Pennsylvania patients diagnosed with a pulmonary embolism, found that those who were discharged sooner were at greater risk of death. Specifically, patients discharged after four or fewer dies were much more likely to die than those remaining in the hospital for five or more days.
This definitely proves Wennberg's point about regional variation: There are cheaper ways to die. I guess he left figuring out the most effective ways to prolong life to others....
Posted by Robert Goldberg on April 15, 2008 1:17 PM
From the ever interesting http://fiercehealthcare.com
A new study has drawn a conclusion that flies in the face of the core assumptions most planners make about healthcare. At least for some patients, shorter hospital stays aren't better, according to the study, which was published in this month's Archives of Internal Medicine. The researchers, who studied 15,531 Pennsylvania patients diagnosed with a pulmonary embolism, found that those who were discharged sooner were at greater risk of death. Specifically, patients discharged after four or fewer dies were much more likely to die than those remaining in the hospital for five or more days.
This definitely proves Wennberg's point about regional variation: There are cheaper ways to die. I guess he left figuring out the most effective ways to prolong life to others....
Posted by Robert Goldberg on April 15, 2008 1:17 PM
Robert Goldberg
According to the conflict of interest kapos, academics should have no industry money since it is corrupting. Imagine what venture capital which showers profs with options and seeks 50 percent returns will do!!
According to FasterCures...it leads to robust commercialization of of important new technologies...
"Partnerships between venture capitalists and inventors from academia may be an effective way to commercialize drug and medical-device research. This approach is exemplified by the success of Polaris Venture Partners, whose collaboration with Robert Langer, an expert affiliated with the Massachusetts Institute of Technology, has produced 13 companies over the past 15 years."
Money supporting important medical ideas. As in the Cystic Fibrosis Foundation and VC firms funding academics to find cures for CF who themselves might profit from the companies they set up. Sickening...to the conflict of interest connect the dot capos at http://pharmalot.com, http://healthcarerenewal.com, etc., etc.
Posted by Robert Goldberg on April 15, 2008 1:10 PM
According to the conflict of interest kapos, academics should have no industry money since it is corrupting. Imagine what venture capital which showers profs with options and seeks 50 percent returns will do!!
According to FasterCures...it leads to robust commercialization of of important new technologies...
"Partnerships between venture capitalists and inventors from academia may be an effective way to commercialize drug and medical-device research. This approach is exemplified by the success of Polaris Venture Partners, whose collaboration with Robert Langer, an expert affiliated with the Massachusetts Institute of Technology, has produced 13 companies over the past 15 years."
Money supporting important medical ideas. As in the Cystic Fibrosis Foundation and VC firms funding academics to find cures for CF who themselves might profit from the companies they set up. Sickening...to the conflict of interest connect the dot capos at http://pharmalot.com, http://healthcarerenewal.com, etc., etc.
Posted by Robert Goldberg on April 15, 2008 1:10 PM
Robert Goldberg
For those who think that real time reporting of how drugs work in people will lead to a mass of lawsuits, one size fits all drug switching and drug withdrawals think again. From a WSJ article on a Wellpoint-FDA drug data sharing program:
"Contrary to the meta-analysis, WellPoint's initial findings didn't necessarily indicate a higher heart-attack risk linked to Avandia than to Actos and other diabetes medications. Now the company is broadening the data search to examine the safety question further. (The insurer says the study wasn't sponsored by Glaxo or another drug company.)"
Any comment Dr. Nissen or are you too busy offering protection to companies with what will be yet another outdated approach to drug safety?
And HMOs will find it harder to shove patients into drug silos...so much for comparative effectiveness....
"Kaiser also has performed its own safety and efficacy tests on FDA-approved drugs before placing them on its formulary. Within the past six months, for example, for instance, it studied whether a particular generic version of the blood-thinner warfarin was as safe and effective as other versions. David Campen, medical director of Kaiser's Northern California pharmacy operations, said it took the precaution before price negotiations with the generic's maker, given that even slight dosing changes in warfarin can cause harsh side effects."
Wait till genetic tests are broadly available.
Reality bites, especially when you are trying to use one size fits all studies to squeeze savings out of health care....
http://online.wsj.com/article/SB120822459568214991.html?mod=health_home_stories
PS...The FDA should be applauded for leading the way in this effort.
Posted by Robert Goldberg on April 15, 2008 12:58 PM
For those who think that real time reporting of how drugs work in people will lead to a mass of lawsuits, one size fits all drug switching and drug withdrawals think again. From a WSJ article on a Wellpoint-FDA drug data sharing program:
"Contrary to the meta-analysis, WellPoint's initial findings didn't necessarily indicate a higher heart-attack risk linked to Avandia than to Actos and other diabetes medications. Now the company is broadening the data search to examine the safety question further. (The insurer says the study wasn't sponsored by Glaxo or another drug company.)"
Any comment Dr. Nissen or are you too busy offering protection to companies with what will be yet another outdated approach to drug safety?
And HMOs will find it harder to shove patients into drug silos...so much for comparative effectiveness....
"Kaiser also has performed its own safety and efficacy tests on FDA-approved drugs before placing them on its formulary. Within the past six months, for example, for instance, it studied whether a particular generic version of the blood-thinner warfarin was as safe and effective as other versions. David Campen, medical director of Kaiser's Northern California pharmacy operations, said it took the precaution before price negotiations with the generic's maker, given that even slight dosing changes in warfarin can cause harsh side effects."
Wait till genetic tests are broadly available.
Reality bites, especially when you are trying to use one size fits all studies to squeeze savings out of health care....
http://online.wsj.com/article/SB120822459568214991.html?mod=health_home_stories
PS...The FDA should be applauded for leading the way in this effort.
Posted by Robert Goldberg on April 15, 2008 12:58 PM
Peter Pitts
From today's Washington Times ...
"Evidence-based" Rx miscues
Hillary Clinton, Barack Obama and John McCain have been traveling the country laying out their solutions to the problem of escalating health-care costs. One plan they all favor is ramping up federal funding for so-called "evidence-based" medicine.
The theory behind evidence-based medicine is simple: If the government were to run clinical trials testing the effectiveness of drugs and medical technologies, and then use the results to determine what to cover, taxpayers would avoid paying for treatments that aren't effective enough to justify their price tag.
Sounds great, right? Too bad that in practice, evidence-based programs are largely driven by the political imperative to cut costs — not the medical imperative to give patients the best care possible.
That was certainly the case for CATIE, or the Clinical Antipsychotic Trials in Intervention Effectiveness. This federally funded, $40 million study concluded new "atypical" nonpsychotic drugs are no more effective at treating schizophrenia symptoms than are older drugs. Because this finding flatly contradicted psychiatrists' real-world observations, CATIE had no impact on which drugs were prescribed for schizophrenia.
Like most large-scale trials, CATIE took a one-size-fits-all approach to medicine. Evidence-based programs encourage this approach. The underlying assumption is that the same care can be applied to every patient suffering from the same disease.
Modern science disproves that notion. Everyone has a unique biological makeup. Health-care professionals need to be given the autonomy to tailor their treatments to the specific needs of their patents.
Evidence-based programs rarely provide that autonomy. In the long run, this often results in higher costs.
Consider an overweight man who is forced to take a cheaper, less effective anti-cholesterol drug. If he ends up in the emergency room because of undertreated cardiovascular disease, this could end up costing the health-care system significantly more money.
All too often, denying patients access to the right medicines early on means paying for more invasive and expensive procedures later.
The evidence confirms this. A study from the University of Utah examined the relationship between cost-containment programs and the total cost of health care for a number of medical conditions. It found that the tighter the restrictions on which treatments a physician could administer, the higher the overall cost of care.
Medical treatment should be based on the specific genetic, clinical and demographic factors of an individual patient. That's how you keep people healthy. In an era of personalized medicine, one-size-fits-all health-care strategies are dangerously outdated.
Choosing short-term savings over long-term results has a pernicious effect on the public purse and public health. Strenuous cost controls compromise patient care.
The theory behind and the practice of evidence-based medicine just don't match up. And until politicians can show how they'll resolve that tension, they need to look elsewhere in their quest to find politically palpable solutions to the country's health-care woes.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.
Posted by Peter Pitts on April 15, 2008 8:07 AM
From today's Washington Times ...
"Evidence-based" Rx miscues
Hillary Clinton, Barack Obama and John McCain have been traveling the country laying out their solutions to the problem of escalating health-care costs. One plan they all favor is ramping up federal funding for so-called "evidence-based" medicine.
The theory behind evidence-based medicine is simple: If the government were to run clinical trials testing the effectiveness of drugs and medical technologies, and then use the results to determine what to cover, taxpayers would avoid paying for treatments that aren't effective enough to justify their price tag.
Sounds great, right? Too bad that in practice, evidence-based programs are largely driven by the political imperative to cut costs — not the medical imperative to give patients the best care possible.
That was certainly the case for CATIE, or the Clinical Antipsychotic Trials in Intervention Effectiveness. This federally funded, $40 million study concluded new "atypical" nonpsychotic drugs are no more effective at treating schizophrenia symptoms than are older drugs. Because this finding flatly contradicted psychiatrists' real-world observations, CATIE had no impact on which drugs were prescribed for schizophrenia.
Like most large-scale trials, CATIE took a one-size-fits-all approach to medicine. Evidence-based programs encourage this approach. The underlying assumption is that the same care can be applied to every patient suffering from the same disease.
Modern science disproves that notion. Everyone has a unique biological makeup. Health-care professionals need to be given the autonomy to tailor their treatments to the specific needs of their patents.
Evidence-based programs rarely provide that autonomy. In the long run, this often results in higher costs.
Consider an overweight man who is forced to take a cheaper, less effective anti-cholesterol drug. If he ends up in the emergency room because of undertreated cardiovascular disease, this could end up costing the health-care system significantly more money.
All too often, denying patients access to the right medicines early on means paying for more invasive and expensive procedures later.
The evidence confirms this. A study from the University of Utah examined the relationship between cost-containment programs and the total cost of health care for a number of medical conditions. It found that the tighter the restrictions on which treatments a physician could administer, the higher the overall cost of care.
Medical treatment should be based on the specific genetic, clinical and demographic factors of an individual patient. That's how you keep people healthy. In an era of personalized medicine, one-size-fits-all health-care strategies are dangerously outdated.
Choosing short-term savings over long-term results has a pernicious effect on the public purse and public health. Strenuous cost controls compromise patient care.
The theory behind and the practice of evidence-based medicine just don't match up. And until politicians can show how they'll resolve that tension, they need to look elsewhere in their quest to find politically palpable solutions to the country's health-care woes.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.
Posted by Peter Pitts on April 15, 2008 8:07 AM
Peter Pitts
In April of 2006, James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:
“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”
Copping continued as to possible ways to achieve that goal:
“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”
Well, almost two-years to the day, the controversial EU-wide ban on pharmaceutical advertising may soon end – although what this means, precisely, is unclear, as is what kind of information may become available.
The European commission plans to allow drug companies to give "information" about their drugs to the public on TV, the internet and in print.
The consultation document from the enterprise and industry directorate-general says: "It should be possible for the pharmaceutical industry to disseminate information on prescription-only medicines through TV and radio programmes, through printed material actively distributed, through information in printed media or through audiovisual and written material provided to patients by healthcare professionals." The consultation period closed on April 7. An earlier Commission report had found unequal access to health and medicines information throughout the EU, which it said could be harmful to public health.
Leaders of the European pharmaceutical industry have once again stressed that they are not seeking, and have never sought, direct-to-consumer advertising for prescription medicines to be permitted within the European Union. However, according to Arthur Higgins (EFPIA president and chief executive of Bayer HealthCare AG.), “After years of debate, we call on all European institutions to develop a patient-centered EU framework for information provision without further delay.”
EFPIA is also concerned at the EU proposals for a governance system for monitoring the information provided by the industry. The Commission suggests that the structure of enforcement could take place on three different levels – an EU advisory committee, the EU national authorities and national “co-regulatory” bodies – but EFPIA believes that this could potentially lead to a “patchwork” of very different interpretations and implementations in national laws, as it is currently the case, and thus fail to adequately address the European dimension of the current shortcomings.
Instead, the industry proposes an alternative system based on an EU-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) and robust enforcement procedures in case of breaches including sanctions as well as fines. Such a Code could work alongside and complement the legislative change envisaged by the European Commission later this year.
Posted by Peter Pitts on April 15, 2008 7:18 AM
In April of 2006, James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:
“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”
Copping continued as to possible ways to achieve that goal:
“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”
Well, almost two-years to the day, the controversial EU-wide ban on pharmaceutical advertising may soon end – although what this means, precisely, is unclear, as is what kind of information may become available.
The European commission plans to allow drug companies to give "information" about their drugs to the public on TV, the internet and in print.
The consultation document from the enterprise and industry directorate-general says: "It should be possible for the pharmaceutical industry to disseminate information on prescription-only medicines through TV and radio programmes, through printed material actively distributed, through information in printed media or through audiovisual and written material provided to patients by healthcare professionals." The consultation period closed on April 7. An earlier Commission report had found unequal access to health and medicines information throughout the EU, which it said could be harmful to public health.
Leaders of the European pharmaceutical industry have once again stressed that they are not seeking, and have never sought, direct-to-consumer advertising for prescription medicines to be permitted within the European Union. However, according to Arthur Higgins (EFPIA president and chief executive of Bayer HealthCare AG.), “After years of debate, we call on all European institutions to develop a patient-centered EU framework for information provision without further delay.”
EFPIA is also concerned at the EU proposals for a governance system for monitoring the information provided by the industry. The Commission suggests that the structure of enforcement could take place on three different levels – an EU advisory committee, the EU national authorities and national “co-regulatory” bodies – but EFPIA believes that this could potentially lead to a “patchwork” of very different interpretations and implementations in national laws, as it is currently the case, and thus fail to adequately address the European dimension of the current shortcomings.
Instead, the industry proposes an alternative system based on an EU-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) and robust enforcement procedures in case of breaches including sanctions as well as fines. Such a Code could work alongside and complement the legislative change envisaged by the European Commission later this year.
Posted by Peter Pitts on April 15, 2008 7:18 AM
Robert Goldberg
Prescription drugs are 10 percent of our total health care spend. And cancer drugs, despite the hoopla, the coverage, the furor are...less than five percent of that 10 percent. Other biologics are an even small percentage.
So leave it to the HMOs, the ones that want to focus on that teeniest, tiniest part of the health care dollar when it comes to comparative effectiveness, the one part that demonstrably displaces and slows the use of more expensive medical services, to impose a 50 percent co-pay on the average (or as Obama would say, the "ordinary") American for these most expensive meds.
Here's Gina Kolata writing about in the NY Times...
"With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month....
The system, often called Tier 4, began in earnest with Medicare drug plans and spread rapidly. It is now incorporated into 86 percent of those plans. Some have even higher co-payments for certain drugs, a Tier 5."
How about a Tier 20 where you beg the HMO to give you the drug in exchange for your first born?
Here's a story growing more typical by the day:
In January, shortly after Ms. Steinwand renewed her insurance policy with Kaiser Permanente, she went to refill her prescription for Copaxone. She had been insured with Kaiser for 17 years through her husband, a federal employee, and had had no complaints about the coverage.
She had been taking Copaxone since multiple sclerosis was diagnosed in 2000, buying a 30 days’ supply at a time. And even though the drug costs $1,900 a month, Kaiser required only a $20 co-payment.
Not this time. When Ms. Steinwand went to pick up her prescription at a pharmacy near her home in Silver Spring, Md., the pharmacist handed her a bill for $325.
There must be a mistake, Ms. Steinwand said. So the pharmacist checked with her supervisor. The new price was correct. Kaiser’s policy had changed. Now Kaiser was charging 25 percent of the cost of the drug up to a maximum of $325 per prescription. Her annual cost would be $3,900 and unless her insurance changed or the drug dropped in price, it would go on for the rest of her life.
“I charged it, then got into my car and burst into tears,” Ms. Steinwand said.
After all the studies demonstrating that increased co-pays are associated with a rise in sickness, hospitalization, etc...what on earth are HMO's thinking?
_http://www.nytimes.com/2008/04/14/us/14drug.html?hp=&adxnnl=1&adxnnlx=1208192535-86G/GZlEluwU6N3fpEUaig
Prescription drugs are 10 percent of our total health care spend. And cancer drugs, despite the hoopla, the coverage, the furor are...less than five percent of that 10 percent. Other biologics are an even small percentage.
So leave it to the HMOs, the ones that want to focus on that teeniest, tiniest part of the health care dollar when it comes to comparative effectiveness, the one part that demonstrably displaces and slows the use of more expensive medical services, to impose a 50 percent co-pay on the average (or as Obama would say, the "ordinary") American for these most expensive meds.
Here's Gina Kolata writing about in the NY Times...
"With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month....
The system, often called Tier 4, began in earnest with Medicare drug plans and spread rapidly. It is now incorporated into 86 percent of those plans. Some have even higher co-payments for certain drugs, a Tier 5."
How about a Tier 20 where you beg the HMO to give you the drug in exchange for your first born?
Here's a story growing more typical by the day:
In January, shortly after Ms. Steinwand renewed her insurance policy with Kaiser Permanente, she went to refill her prescription for Copaxone. She had been insured with Kaiser for 17 years through her husband, a federal employee, and had had no complaints about the coverage.
She had been taking Copaxone since multiple sclerosis was diagnosed in 2000, buying a 30 days’ supply at a time. And even though the drug costs $1,900 a month, Kaiser required only a $20 co-payment.
Not this time. When Ms. Steinwand went to pick up her prescription at a pharmacy near her home in Silver Spring, Md., the pharmacist handed her a bill for $325.
There must be a mistake, Ms. Steinwand said. So the pharmacist checked with her supervisor. The new price was correct. Kaiser’s policy had changed. Now Kaiser was charging 25 percent of the cost of the drug up to a maximum of $325 per prescription. Her annual cost would be $3,900 and unless her insurance changed or the drug dropped in price, it would go on for the rest of her life.
“I charged it, then got into my car and burst into tears,” Ms. Steinwand said.
After all the studies demonstrating that increased co-pays are associated with a rise in sickness, hospitalization, etc...what on earth are HMO's thinking?
_http://www.nytimes.com/2008/04/14/us/14drug.html?hp=&adxnnl=1&adxnnlx=1208192535-86G/GZlEluwU6N3fpEUaig
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.
