Latest Drugwonks' Blog
Grassley, EPA clash on dust limit
Whenever the FDA doesn't do exactly what Senator Charles Grassley thinks is right or issues a ruling on a drug he disagrees with that seems to favor a drug company, he is quick to claim it is another example of how the FDA is sacrificing public health because it has a "cozy" relationship with industry.
So I guess that means when the EPA does not make a special exception to a particular industry in enforcing a public health-type rule and a Senator tries to carve out an exemption, that relationship would be defined as....how? I am sure the EPA has some very good scientific data to support it's position. So I am sure Senator Grassley was not criticizing the integrity or intelligence of EPA scientists when he called the ruling "idiotic" because he has made preserving the intellectual independence of people like David Graham a keystone of his career in the Senate. He would never try to bully or cajole an agency into changing it's stance...that wouuld be inconsistent and political and undermine his morally insufferable position on FDA issues and drug safety...
DES MOINES, Iowa Senator Charles Grassley is clashing with the Environmental Protection Agency.
The dispute comes after the agency reversed its course on exempting agriculture operations from dust regulations.
The Bush Administration says it decided against the exemption because officials could not legally exempt specific industries.
Grassley, a Republican, disagrees with the opinion. He says it is -- quote -- "such an idiotic move for the EPA to take" -- end quote.
The senator has sent a letter to the E-P-A's top administrator inviting him to visit Grassley's farm in Iowa.
He has asked for a response within 24 hours.
Whenever the FDA doesn't do exactly what Senator Charles Grassley thinks is right or issues a ruling on a drug he disagrees with that seems to favor a drug company, he is quick to claim it is another example of how the FDA is sacrificing public health because it has a "cozy" relationship with industry.
So I guess that means when the EPA does not make a special exception to a particular industry in enforcing a public health-type rule and a Senator tries to carve out an exemption, that relationship would be defined as....how? I am sure the EPA has some very good scientific data to support it's position. So I am sure Senator Grassley was not criticizing the integrity or intelligence of EPA scientists when he called the ruling "idiotic" because he has made preserving the intellectual independence of people like David Graham a keystone of his career in the Senate. He would never try to bully or cajole an agency into changing it's stance...that wouuld be inconsistent and political and undermine his morally insufferable position on FDA issues and drug safety...
DES MOINES, Iowa Senator Charles Grassley is clashing with the Environmental Protection Agency.
The dispute comes after the agency reversed its course on exempting agriculture operations from dust regulations.
The Bush Administration says it decided against the exemption because officials could not legally exempt specific industries.
Grassley, a Republican, disagrees with the opinion. He says it is -- quote -- "such an idiotic move for the EPA to take" -- end quote.
The senator has sent a letter to the E-P-A's top administrator inviting him to visit Grassley's farm in Iowa.
He has asked for a response within 24 hours.
Is is my imagination or is the AP Kevin Freking the only journalist in America who refuses to accept that Medicare Part D is a resounding success. See his most recent article entitle Seniors to Get More Medicare Drug Choices. Freking stands alone -- actually with the only person in Washington who can't say anything good about the Part D benefit, Families USA Godfather Ron Pollack -- in asserting that the rollout of more Medicare Part D plans with lower premiums, fewer restrictions, more drug choices and better tools for managing costs is a terrible thing because it's confusing:
"Seniors who complained this year about a dizzying array of choices for a Medicare drug plan may find themselves even dizzier when they shop around for next year.
Federal officials announced Friday that 17 companies have been approved to provide Medicare drug coverage nationally. This year, there were nine."
Actually, since 90 percent of all seniors signed up for the program and a small percentage who hit the donut hole really had a problem after doing so, Freking had to scrape around for a quote from -- who else -- the Don of Part D Doom himself, Ron Pollack to underscore just how crappy the program really is:
"The incredible confusion that persisted throughout this year is about to get considerably worse," said Ron Pollack, executive director of Families USA, an advocacy group. "This is because there will be quite a few more plans to choose from, they will all be different from each other, and seniors will have a much shorter time period to make decisions about enrollment."
Similarly, Freking reaches down to another well paid malcontent, Deanne Beebe," a spokeswoman for the Medicare Rights Center, said that seniors won't be won over by all the additional options.
"They don't want dozens of choices," she said. "They want one affordable drug benefit they can count on when it comes time to fill their prescription."
Yes, Ron annd Deanne compared to the one size fits all system where seniors would wait five years to get many of the newest medicines while the government negotiates prices and restricts access there will be quite a few more plans to choose from. As for seniors not wanting dozens of choices, I propose that Beebe rollout a the VA style approach and try to sell it with the longer waits for drug approvals, fewer drug choices and in some cases, higher out of pocket costs..
The triumph of ideology over compassion and common sense.
"Seniors who complained this year about a dizzying array of choices for a Medicare drug plan may find themselves even dizzier when they shop around for next year.
Federal officials announced Friday that 17 companies have been approved to provide Medicare drug coverage nationally. This year, there were nine."
Actually, since 90 percent of all seniors signed up for the program and a small percentage who hit the donut hole really had a problem after doing so, Freking had to scrape around for a quote from -- who else -- the Don of Part D Doom himself, Ron Pollack to underscore just how crappy the program really is:
"The incredible confusion that persisted throughout this year is about to get considerably worse," said Ron Pollack, executive director of Families USA, an advocacy group. "This is because there will be quite a few more plans to choose from, they will all be different from each other, and seniors will have a much shorter time period to make decisions about enrollment."
Similarly, Freking reaches down to another well paid malcontent, Deanne Beebe," a spokeswoman for the Medicare Rights Center, said that seniors won't be won over by all the additional options.
"They don't want dozens of choices," she said. "They want one affordable drug benefit they can count on when it comes time to fill their prescription."
Yes, Ron annd Deanne compared to the one size fits all system where seniors would wait five years to get many of the newest medicines while the government negotiates prices and restricts access there will be quite a few more plans to choose from. As for seniors not wanting dozens of choices, I propose that Beebe rollout a the VA style approach and try to sell it with the longer waits for drug approvals, fewer drug choices and in some cases, higher out of pocket costs..
The triumph of ideology over compassion and common sense.
This is news?
Well, since it's true it's worth repeating, and since it's based on "a new study" it's worth reporting on. Still, I'm surpised that it even made the UPI wire. So much the better.
Here goes ...
"Patients who leave the doctor's office with a prescription may be leaving something important behind."
Car keys? No, they're leaving, brace yourself, without "the information they need to take their medicines correctly."
In fact, according a new study (see, told you) from UCLA (go Bruins!) doctors only give their patients 62% of five "key pieces" of information:
* Patients were told the name of a new medication only 74% of the time.
* Patients were told why they were taking a new medication only 87% of the time.
* Only 30% of patients were told how long to take the new prescription.
* Only 55% of patients were told how many tablets to take.
* Only 58% for both frequency and appropriate timing (with food, etc.)
And the winner is:
* Doctors told patients about potential adverse events of a new medication only 35% of the time.
To be fair this was a study based on data collected from 185 outpatient visits to 44 physicians, so draw your own "margin of error" conclusions.
(I wonder how are they going to pin this one on the pharmaceutical industry?)
Well, since it's true it's worth repeating, and since it's based on "a new study" it's worth reporting on. Still, I'm surpised that it even made the UPI wire. So much the better.
Here goes ...
"Patients who leave the doctor's office with a prescription may be leaving something important behind."
Car keys? No, they're leaving, brace yourself, without "the information they need to take their medicines correctly."
In fact, according a new study (see, told you) from UCLA (go Bruins!) doctors only give their patients 62% of five "key pieces" of information:
* Patients were told the name of a new medication only 74% of the time.
* Patients were told why they were taking a new medication only 87% of the time.
* Only 30% of patients were told how long to take the new prescription.
* Only 55% of patients were told how many tablets to take.
* Only 58% for both frequency and appropriate timing (with food, etc.)
And the winner is:
* Doctors told patients about potential adverse events of a new medication only 35% of the time.
To be fair this was a study based on data collected from 185 outpatient visits to 44 physicians, so draw your own "margin of error" conclusions.
(I wonder how are they going to pin this one on the pharmaceutical industry?)
Ceasefire Event with David Kendall and Peter Pitts
I'm very excited to participate in the October 11th Ceasefire on Healthcare debate with David Kendall who served on President Clinton's Task Force for Health Care Reform. As you probably know, the forum (led by former Senator John Breaux) seeks to find “common ground†for meaningful, bipartisan change to the nation’s health care system.
I hope you can attend or tune in for the podcast. Here are the details:
Professor James A. Thurber, Director, American University’s Center for Congressional and Presidential Studies, invites you to join him and former Senator John Breaux at a Lunch Forum on Health Care Reform, featuring David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute, and Peter Pitts, Director of the Center for Medicine in the Public Interest (CMPI).
October 11, 2006
12:00pm - 1:30pm
Butler Boardroom, American University
Speakers:
David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute
Peter Pitts, Director, Center for Medicine in the Public Interest (CMPI)
For more information about the Ceasefire on Healthcare Series, please visit www.ceasefireonhealthcare.org.
Please RSVP to the center (ccps@american.edu) by October 6, 2006.
Contact Melissa Castle, (202) 885-3491, mcastle@american.edu, for more information.
I'm very excited to participate in the October 11th Ceasefire on Healthcare debate with David Kendall who served on President Clinton's Task Force for Health Care Reform. As you probably know, the forum (led by former Senator John Breaux) seeks to find “common ground†for meaningful, bipartisan change to the nation’s health care system.
I hope you can attend or tune in for the podcast. Here are the details:
Professor James A. Thurber, Director, American University’s Center for Congressional and Presidential Studies, invites you to join him and former Senator John Breaux at a Lunch Forum on Health Care Reform, featuring David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute, and Peter Pitts, Director of the Center for Medicine in the Public Interest (CMPI).
October 11, 2006
12:00pm - 1:30pm
Butler Boardroom, American University
Speakers:
David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute
Peter Pitts, Director, Center for Medicine in the Public Interest (CMPI)
For more information about the Ceasefire on Healthcare Series, please visit www.ceasefireonhealthcare.org.
Please RSVP to the center (ccps@american.edu) by October 6, 2006.
Contact Melissa Castle, (202) 885-3491, mcastle@american.edu, for more information.
In one week the FDA has been pilloried as being to ineffectual in the effort to make medicines safer and now, in a New York Times article, described as an agency under seige too afraid to approve any new medication in a timely fashion. Has anyone ever written an article commending FDA employees for just doing a good job on behalf of the public health?
The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.
The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.
The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.
Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.
On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...
Many Americans benefited from last year’s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicine’s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.
Highlights for 2005 include:
* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).
* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).
* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).
* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.
* 10 “orphan†medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.
* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.
* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.
The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.
The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.
The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.
Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.
On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...
Many Americans benefited from last year’s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicine’s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.
Highlights for 2005 include:
* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).
* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).
* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).
* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.
* 10 “orphan†medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.
* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.
* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.
Scott Hensley's article in today's WSJ underscores both the hypocrisy and inherent limitations of so-called evidence based medicine. J&J is hoping to launch a form of risperidal called paliperidone that is described only as being released over a 24-hour period of time and is therefore more tolerable to the liver in some people. One potentially important point Hensley left out of the story is that the form of risperidal JJ seeks to market is known to have a lower concentration of transmembrane transporter P-glycoprotein (P-gp) P-gp potentially limits access to brain tissue of psychoactive substrate which means that the lower concentration could make it more valuable to patients who don't respond well to Risperdal because of they way they metabolize the products. In other words, paliperidone could be a medicine for a small but clinically underserved group of schizophrenics. But JJ is going to have to do to the heaving lifting to demonstrate that is the case.
Meanwhile, Hensley cites the example of the HMO that simply decided it would stop paying for Medium because they are cheaper versions that are as effective. Where are the media skeptics demanding the source of the data for this decision? Isn't this a conflict of interest? What about the fact that the Roche Amplichip allows MDs to distinguish how well patients metabolize difference proton pump drugs? What if you can't handle Prevacid or Protonix? My daughter couldn't take either and she had to be prescribed Nexium. Why should she or anyone else be forced to pay out of pocket because she genetically unable to metabolize other PPIs? Isn't this a form of genetic discrimination?
So much for evidence based medicine. It's evidence when the HMO decides to dump a drug, but conflicted propaganda to promote a me-too drug when a drug company decides to bring a new medicine to market?
Meanwhile, Hensley cites the example of the HMO that simply decided it would stop paying for Medium because they are cheaper versions that are as effective. Where are the media skeptics demanding the source of the data for this decision? Isn't this a conflict of interest? What about the fact that the Roche Amplichip allows MDs to distinguish how well patients metabolize difference proton pump drugs? What if you can't handle Prevacid or Protonix? My daughter couldn't take either and she had to be prescribed Nexium. Why should she or anyone else be forced to pay out of pocket because she genetically unable to metabolize other PPIs? Isn't this a form of genetic discrimination?
So much for evidence based medicine. It's evidence when the HMO decides to dump a drug, but conflicted propaganda to promote a me-too drug when a drug company decides to bring a new medicine to market?
Disturbing news that the EU may be eating our continental breakfast in the effort to make drug development more effective and efficient. Innomed, the European Platform on Innovative Medicines, is looking to hammer out a deal in which pharma companies and the EU kick in about $750 million a year over ten years towards process improvements in drug development and regulatory reforms. Meanwhile, back home we squabble about spending more to collect an increasing amount of paper about post market safety, shutting down PDUFA and imposing criminal penalities on companies that refuse to complete post market studies that most patients don't want to enroll in. At the same time, FDA has a grand total of 6 million for Critical path and its overall budget is cut in the House.
Note to all those who posture on stem cell funding. It won't do a damn bit of good if we have a 19th century drug development infrastructure for testing products based on such research.
Note to all those who posture on stem cell funding. It won't do a damn bit of good if we have a 19th century drug development infrastructure for testing products based on such research.
Hurrah for a David Leonhardt and his superb article “The Choice: A Longer Life or More Stuff†(New York Times, September 27, 2006).
It’s a very thoughtful and provocative essay about what we, as a society, receive for what many pundit, pols, and MSM savants derisively refer to as “spiraling health care costs.â€
Mr. Leonhardt writes, “Living in a society that spends a lot of money on health care creates real problems, but it also has something in common with getting old. It’s better than the alternative.â€
As David Cutler (our second favorite health economist) points out in “Your Money or Your Life,†in 1950 the average American spent less than $100 a year ($500 in today’s dollars) on medical care. That number today is $6000.
And, according to Leonhardt, “Most families in the 1950’s paid their bills, but they also didn’t expect much in return. After a century of basic health improvements like indoor plumbing and penicillin, many experts thought that human beings were approaching the limits of longevity.â€
Remember what biologist Rene Dubos wrote in the 1960’s, “Modern medicine has little to offer for the prevention or treatment of chronic and degenerative diseases.â€
As Walter Wriston famously quipped, “The future isn’t what it used to be.†He was wrong. And so was Monsieur Dubos.
Dan Quayle was more on the mark (kind of) when he said, “The future will be better tomorrow.â€
That's turned out to be surprisingly prescient.
Mr. Leonhardt points out that perhaps “spiraling†costs are, well, worth it. “A baby born in the United States this year will live to age 78 on average, a decade longer than the average baby born in 1950 … If you think about this as the return on the investment on medicine, the payoff has been fabulous: Would you prefer spending an extra $5500 on health care every year – or losing ten years of your lifespan?â€
And what do you think the proponents of so-called "rational use of medicine" would have to say about that? Ultimately, they say what Leonhardt points out as both true and frightening -- "that the best way to reduce health care spending is to reduce health care itself."
That is not acceptable in our affluent society. In First World societies health care is precisely how we should spend our money. As David Cutler writes, “We have enough of the basics in life. What we really want are the time and the quality of life to enjoy them.â€
And to do this we must be able to choose the health care (yes – even the pharmaceuticals) that are best suited to our individual needs. Choosing to support spending on health care means choosing life.
Health care: it's where pro-choice meets pro-life.
It’s a very thoughtful and provocative essay about what we, as a society, receive for what many pundit, pols, and MSM savants derisively refer to as “spiraling health care costs.â€
Mr. Leonhardt writes, “Living in a society that spends a lot of money on health care creates real problems, but it also has something in common with getting old. It’s better than the alternative.â€
As David Cutler (our second favorite health economist) points out in “Your Money or Your Life,†in 1950 the average American spent less than $100 a year ($500 in today’s dollars) on medical care. That number today is $6000.
And, according to Leonhardt, “Most families in the 1950’s paid their bills, but they also didn’t expect much in return. After a century of basic health improvements like indoor plumbing and penicillin, many experts thought that human beings were approaching the limits of longevity.â€
Remember what biologist Rene Dubos wrote in the 1960’s, “Modern medicine has little to offer for the prevention or treatment of chronic and degenerative diseases.â€
As Walter Wriston famously quipped, “The future isn’t what it used to be.†He was wrong. And so was Monsieur Dubos.
Dan Quayle was more on the mark (kind of) when he said, “The future will be better tomorrow.â€
That's turned out to be surprisingly prescient.
Mr. Leonhardt points out that perhaps “spiraling†costs are, well, worth it. “A baby born in the United States this year will live to age 78 on average, a decade longer than the average baby born in 1950 … If you think about this as the return on the investment on medicine, the payoff has been fabulous: Would you prefer spending an extra $5500 on health care every year – or losing ten years of your lifespan?â€
And what do you think the proponents of so-called "rational use of medicine" would have to say about that? Ultimately, they say what Leonhardt points out as both true and frightening -- "that the best way to reduce health care spending is to reduce health care itself."
That is not acceptable in our affluent society. In First World societies health care is precisely how we should spend our money. As David Cutler writes, “We have enough of the basics in life. What we really want are the time and the quality of life to enjoy them.â€
And to do this we must be able to choose the health care (yes – even the pharmaceuticals) that are best suited to our individual needs. Choosing to support spending on health care means choosing life.
Health care: it's where pro-choice meets pro-life.
Exciting news from the FDA website ...
FDA and Duke Clinical Research Institute Form Partnership to Collaborate on Cardiac Safety Virtual
'Warehouse' of Electrocardiograms Will Serve as Primary Tool In Cutting-Edge Safety Research
The U.S. Food and Drug Administration (FDA) today announced a partnership, under the agency's Critical Path Initiative, with Duke Clinical Research Institute (DCRI) to develop a new generation of tools to identify, as early as possible, the potential effects that drugs and devices may have on the heart -- one of the more ominous side effects associated with such products.
The research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) amassed by the agency from the clinical trial data submitted as part of new drug applications.
"For years we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patient’s heart," said Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs. "Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005, and this partnership in 2006, we hope to identify patterns that will help to predict which patients are at an increased risk for cardiovascular side effects. This knowledge can guide the development of safer treatments."
FDA and the Duke Clinical Research Institute are developing a consortium with members of academia, patient advocacy groups, other government and non-profit organizations and industry to coordinate and support a variety of research projects involving ECGs obtained in clinical trials. Through the consortium, FDA and DCRI will identify gaps in cardiac biomarkers and prioritize projects based on those needs.
Research shows that women are at higher risk of arrhythmias (abnormal heart beats), but it is not known whether this difference in susceptibility is related to different responses to drugs. Among the first applied projects the consortium will address is a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate the four current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular research study.
"By selecting the most appropriate method for measuring ECGs, we can better assess the impact of a drug or device on patients," said Norman Stockbridge, M.D., Director for CDER's Division of Cardio-Renal Drug Products.
Under the framework of this consortium, Duke and FDA researchers, together with other industry and academic consortium partners, will use the database to identify early indicators for potentially life-threatening cardiac arrhythmias. Strategies will range from the systematic comparison of variants of existing risk-evaluation techniques (to select the most efficient methods) to searching for novel ECG waveform features capable of detecting small adverse drug effects.
"Through its academic mission, the DCRI is committed to identifying and developing more accurate measures of cardiac safety. We will continue to advance the science supporting safety in drug development," said Dr. Robert Califf, Director of DCRI / Vice Chancellor for Clinical Research of the Duke University Medical Center. "This goal is shared with the FDA, and we are proud to be an integral member during the process that will bring a priority area of the Critical Path Initiative from concept to reality."
In October 2005, FDA and the Duke Clinical Research Institute co-sponsored the first in a series of meetings on improving the evaluation of cardiac safety during product development, a high priority under FDA's Critical Path Initiative. The Cardiac Safety and Critical Path Initiative Think Tank brought together representatives of academic research institutions, industry, professional societies, patient advocacy groups, and government agencies as part of a long-term effort to foster the development of tools needed to improve cardiac safety. Another meeting of the group is scheduled for November 3, 2006 at Duke University.
The ECG Warehouse
Following the establishment of an ECG waveform and annotation standard, the FDA partnered with Mortara Instrument Inc., to develop a digital ECG warehouse to support the storage and review of the submitted data. Under the terms and conditions of a Cooperative Research and Development Agreement (CRADA), the FDA's ECG Warehouse was designed and built and contains ECGs submitted as part of submissions to the agency, separated from any personal patient information.
The data standards that enabled this step were a product of Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL-7), organizations in which FDA and industry are cooperating to develop a comprehensive set of standards for clinical trial data. Through such efforts, the agency expects to enable other similar research opportunities across the full range of data collected in clinical trials of new drugs. Proprietary and nonpublic information will only be disclosed in accordance with FDA regulations and appropriate confidentiality agreements.
FDA and Duke Clinical Research Institute Form Partnership to Collaborate on Cardiac Safety Virtual
'Warehouse' of Electrocardiograms Will Serve as Primary Tool In Cutting-Edge Safety Research
The U.S. Food and Drug Administration (FDA) today announced a partnership, under the agency's Critical Path Initiative, with Duke Clinical Research Institute (DCRI) to develop a new generation of tools to identify, as early as possible, the potential effects that drugs and devices may have on the heart -- one of the more ominous side effects associated with such products.
The research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) amassed by the agency from the clinical trial data submitted as part of new drug applications.
"For years we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patient’s heart," said Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs. "Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005, and this partnership in 2006, we hope to identify patterns that will help to predict which patients are at an increased risk for cardiovascular side effects. This knowledge can guide the development of safer treatments."
FDA and the Duke Clinical Research Institute are developing a consortium with members of academia, patient advocacy groups, other government and non-profit organizations and industry to coordinate and support a variety of research projects involving ECGs obtained in clinical trials. Through the consortium, FDA and DCRI will identify gaps in cardiac biomarkers and prioritize projects based on those needs.
Research shows that women are at higher risk of arrhythmias (abnormal heart beats), but it is not known whether this difference in susceptibility is related to different responses to drugs. Among the first applied projects the consortium will address is a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate the four current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular research study.
"By selecting the most appropriate method for measuring ECGs, we can better assess the impact of a drug or device on patients," said Norman Stockbridge, M.D., Director for CDER's Division of Cardio-Renal Drug Products.
Under the framework of this consortium, Duke and FDA researchers, together with other industry and academic consortium partners, will use the database to identify early indicators for potentially life-threatening cardiac arrhythmias. Strategies will range from the systematic comparison of variants of existing risk-evaluation techniques (to select the most efficient methods) to searching for novel ECG waveform features capable of detecting small adverse drug effects.
"Through its academic mission, the DCRI is committed to identifying and developing more accurate measures of cardiac safety. We will continue to advance the science supporting safety in drug development," said Dr. Robert Califf, Director of DCRI / Vice Chancellor for Clinical Research of the Duke University Medical Center. "This goal is shared with the FDA, and we are proud to be an integral member during the process that will bring a priority area of the Critical Path Initiative from concept to reality."
In October 2005, FDA and the Duke Clinical Research Institute co-sponsored the first in a series of meetings on improving the evaluation of cardiac safety during product development, a high priority under FDA's Critical Path Initiative. The Cardiac Safety and Critical Path Initiative Think Tank brought together representatives of academic research institutions, industry, professional societies, patient advocacy groups, and government agencies as part of a long-term effort to foster the development of tools needed to improve cardiac safety. Another meeting of the group is scheduled for November 3, 2006 at Duke University.
The ECG Warehouse
Following the establishment of an ECG waveform and annotation standard, the FDA partnered with Mortara Instrument Inc., to develop a digital ECG warehouse to support the storage and review of the submitted data. Under the terms and conditions of a Cooperative Research and Development Agreement (CRADA), the FDA's ECG Warehouse was designed and built and contains ECGs submitted as part of submissions to the agency, separated from any personal patient information.
The data standards that enabled this step were a product of Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL-7), organizations in which FDA and industry are cooperating to develop a comprehensive set of standards for clinical trial data. Through such efforts, the agency expects to enable other similar research opportunities across the full range of data collected in clinical trials of new drugs. Proprietary and nonpublic information will only be disclosed in accordance with FDA regulations and appropriate confidentiality agreements.
Was it something we said? We hope so. In any event, let me second Peter's sentiments and thank everyone for their words of support and humor in the wake of this attack.
So much to catch up on ...
I see that Families USA released a study showing that many kids without health insurance have parents that work. Lots of these kids are eligible for SCHIP and haven't signed up ten years after the program was initiated by the Clinton administration...Families USA Godfather Ron Pollack never attacked President Clinton in the first two weeks of the program rollout about lack of enrollment as he ceaselessly assaulted President Bush during the Medicare part D rollout about poor enrollment. Partisan. Hypocrite. You pick your terms... And by the way...lots of those parents could afford to insure their kids but are too cheap. Sorry, but that's a fact.
Novartis released promising results about a MS drug. According to an AP report
"80 percent of patients taking the drug were found not to have active inflammation according to medical imaging scans. The company also said that patients who had been given a placebo for the first six months of the study showed a marked improvement after they were switched to the treatment, an improvement that was sustained out to the 24th month of the study."
Now let's see, if we follow the IOM recommendations there would be no advertising about the product and its results for five years, there would be an onerous daisy chain of product handling, patient enrollment criteria and bans on off-label prescribing and any expert in MS who had anything to do with Novartis in the past would be excluded from advising them even if they had a Nobel Prize... And that benefits patients how?
Seems to me that since the IOM panel was full of HMO types who do nothing but write guidelines and make formulary decisions all day -- instead of actually conducting clinical trials and seeing patients -- that perhaps, just perhaps its conclusions were a bit biased, narrow and self serving? What about THAT conflict of interest. The IOM recommendations will definitely keep new medicines off HMO formularies. Anyone in the media think of that when writing their articles slamming the FDA?
Feels good to be back.
Go Yankees and L Shana Tova to everyone!
So much to catch up on ...
I see that Families USA released a study showing that many kids without health insurance have parents that work. Lots of these kids are eligible for SCHIP and haven't signed up ten years after the program was initiated by the Clinton administration...Families USA Godfather Ron Pollack never attacked President Clinton in the first two weeks of the program rollout about lack of enrollment as he ceaselessly assaulted President Bush during the Medicare part D rollout about poor enrollment. Partisan. Hypocrite. You pick your terms... And by the way...lots of those parents could afford to insure their kids but are too cheap. Sorry, but that's a fact.
Novartis released promising results about a MS drug. According to an AP report
"80 percent of patients taking the drug were found not to have active inflammation according to medical imaging scans. The company also said that patients who had been given a placebo for the first six months of the study showed a marked improvement after they were switched to the treatment, an improvement that was sustained out to the 24th month of the study."
Now let's see, if we follow the IOM recommendations there would be no advertising about the product and its results for five years, there would be an onerous daisy chain of product handling, patient enrollment criteria and bans on off-label prescribing and any expert in MS who had anything to do with Novartis in the past would be excluded from advising them even if they had a Nobel Prize... And that benefits patients how?
Seems to me that since the IOM panel was full of HMO types who do nothing but write guidelines and make formulary decisions all day -- instead of actually conducting clinical trials and seeing patients -- that perhaps, just perhaps its conclusions were a bit biased, narrow and self serving? What about THAT conflict of interest. The IOM recommendations will definitely keep new medicines off HMO formularies. Anyone in the media think of that when writing their articles slamming the FDA?
Feels good to be back.
Go Yankees and L Shana Tova to everyone!
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.
