Latest Drugwonks' Blog
Remember the media assault on Eli Lilly for suspending it's study of prasugrel last year, assuming malfeasance, substandard results, etc? Let's roll the tape from Matt Herper's dark commentary entitled "Lilly's Scary Silence":
"It's hard to see how that could be any comfort to investors. As is often true, there is a big downside risk to investors ahead of the data release on Nov. 4. But investors should be equally concerned about whether or not Lilly is giving straight answers about its data. If these studies do bode badly for prasugrel, investors have a right to know now. If they don't, Lilly still needs to give a clearer explanation. If the company can't do that, the safest thing is probably to assume the worst and sell the stock."
http://www.forbes.com/sciencesandmedicine/2007/10/25/pharmacuticals-prasugrel-lilly-biz-sci-cx_mh_1026lilly1.html?boxes=relstories
Science doesn't just snap to the whims of investors and reporters...but in case anyone cares here's an update from http://www.fiercebiotech.com
Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel
March 29, 2008
Reductions seen as soon as three days and out to 450 days in patients who received either bare metal or drug-eluting stents
CHICAGO, March 29, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- The investigational antiplatelet drug prasugrel plus aspirin produced a marked and highly statistically significant reduction in the risk of coronary stent thrombosis (ST) - a major concern for physicians and patients with potentially fatal consequences - in patients who received a stent as compared to standard therapy with clopidogrel (Plavix®) plus aspirin (1.13 percent vs. 2.35 percent, p<0.0001), according to a stent analysis from the head-to-head TRITON-TIMI 38 trial.
The findings were presented today by Dr. Stephen Wiviott, an assistant professor of medicine at Harvard Medical School and investigator with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, at the Society for Cardiovascular Angiography and Interventions Scientific Sessions with the American College of Cardiology's Innovation in Intervention: i2 Summit, in Chicago. In addition, the manuscript was simultaneously published online by the British medical journal, The Lancet.
In the TRITON-TIMI 38 trial, whose overall results were previously published, 12,844 of the 13,608 enrolled patients received at least one intracoronary stent. Of those patients, 6,461 received a bare metal stent (BMS), 5,743 patients received a drug-eluting stent (DES), and 640 patients received both BMS and DES at the time of enrollment. Stent thrombosis was a pre-defined secondary endpoint in the trial.
Prasugrel reduced the relative risk of coronary stent thrombosis (a new clot at the implanted stent site) over clopidogrel by 52 percent (1.13 percent vs. 2.35 percent, p<0.0001). In patients who received drug-eluting stents (DES), treatment with prasugrel reduced relative risk by 64 percent over clopidogrel (0.84 percent vs. 2.31 percent, p<0.0001), and by 48 percent in patients who received bare metal stents (BMS) (1.27 percent vs. 2.41 percent, p=0.0009).
In the analysis, prasugrel was consistent in reducing stent thrombosis, compared to clopidogrel, whether assessment occurred early or late (<30 days and greater than or equal to 30 days, out to 450 days, the median duration of therapy), regardless of the type of stent used (bare metal or drug-eluting), and regardless of which academic research consortium (ARC) definition of stent thrombosis was used - definite/confirmed stent thrombosis, definite/confirmed plus probable stent thrombosis, and definite/confirmed plus probable plus possible stent thrombosis. Definite/probable stent thrombosis was reduced by 59 percent in prasugrel-treated patients within 30 days of stent placement (0.64 percent vs. 1.56 percent, p<0.0001), and by 40 percent after 30 days (out to 450 days, 0.49 percent vs. 0.82 percent, p=0.03).
"Stent thrombosis is very serious, given the high risk of mortality. In TRITON, among 210 patients with definite or probable stent thrombosis, 186 (89 percent) either died or experienced an MI as a result of the event," said Francis Plat, M.D., vice president, clinical development, Daiichi Sankyo Company, Limited. "We were excited by the results of this study and the possibility that prasugrel may someday provide an alternative treatment for ACS patients undergoing PCI and receiving coronary stents."
A 19 percent reduction in risk was observed with prasugrel compared with clopidogrel among all patients receiving a stent (9.7 percent vs. 11.9 percent, p=0.0001) in TRITON's primary endpoint of cardiovascular death, non- fatal heart attack, or non-fatal stroke. A 20 percent relative reduction favoring prasugrel was observed in the primary endpoint in patients who received only a bare metal stent (10.0 percent vs. 12.2 percent, p=0.003), and in patients who received only a drug-eluting stent, results showed an 18 percent relative reduction in the primary endpoint favoring prasugrel (9.0 percent vs. 11.1 percent, p=0.019). Fatal stent thrombosis occurred in 18 (0.28 percent) patients treated with prasugrel and 29 (0.46 percent) patients treated with clopidogrel (p=0.10). Of note, of the 210 patients with stent thrombosis, 89 percent either died or had a myocardial infarction associated with the event.
The rate of major bleeding was higher in all patients receiving a stent treated with prasugrel vs. clopidogrel (2.4 percent vs. 1.9 percent, p=0.06). Major bleeding in both DES and BMS prasugrel-treated groups when compared to clopidogrel-treated patients was 3 percent vs. 2 percent (p=0.34 DES) and 2 percent vs. 2 percent (p=0.09 BMS).
In addition to a reduction in the primary endpoint (CV death, non-fatal heart attack, or non-fatal stroke), a significantly lower rate of the composite endpoint of cardiovascular death, heart attack or urgent target vessel revascularization (UTVR) was observed with prasugrel vs. clopidogrel for both bare metal stents (10 percent vs. 12 percent, p=0.009) and for drug- eluting stents (9 percent vs. 11 percent, p=0.004). A significant reduction was also seen in heart attack alone (8 percent vs. 10 percent, p=0.003, BMS and 7 percent vs. 9 percent, p=.006, DES). In DES-implanted patients, regardless of those receiving only sirolimus-eluting or paclitaxel-eluting stents, there was a similar magnitude of event reduction with prasugrel compared to clopidogrel.
For the entire cohort, sub-acute stent thrombosis (24 hours to 30 days) was 0.36 percent in prasugrel-treated patients vs. 1.19 percent in clopidogrel-treated patients (p<0.0001). DES-implanted patients had lower rates of stent thrombosis compared to BMS-implanted patients, and prasugrel was shown to significantly reduce stent thrombosis in DES-implanted patients within the first three days compared to clopidogrel (0.14 percent vs. 0.63 percent, p=0.003) as well as for thromboses that occurred >30 days following the DES implantation (0.42 percent vs. 0.91 percent, p=0.04).
"The reduction in risk seen in patients in this analysis treated with prasugrel over patients treated with clopidogrel is encouraging for high-risk patients with acute coronary syndrome being managed with PCI," said J. Anthony Ware, M.D., Lilly vice president for cardiovascular/acute care.
"It's hard to see how that could be any comfort to investors. As is often true, there is a big downside risk to investors ahead of the data release on Nov. 4. But investors should be equally concerned about whether or not Lilly is giving straight answers about its data. If these studies do bode badly for prasugrel, investors have a right to know now. If they don't, Lilly still needs to give a clearer explanation. If the company can't do that, the safest thing is probably to assume the worst and sell the stock."
http://www.forbes.com/sciencesandmedicine/2007/10/25/pharmacuticals-prasugrel-lilly-biz-sci-cx_mh_1026lilly1.html?boxes=relstories
Science doesn't just snap to the whims of investors and reporters...but in case anyone cares here's an update from http://www.fiercebiotech.com
Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel
March 29, 2008
Reductions seen as soon as three days and out to 450 days in patients who received either bare metal or drug-eluting stents
CHICAGO, March 29, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- The investigational antiplatelet drug prasugrel plus aspirin produced a marked and highly statistically significant reduction in the risk of coronary stent thrombosis (ST) - a major concern for physicians and patients with potentially fatal consequences - in patients who received a stent as compared to standard therapy with clopidogrel (Plavix®) plus aspirin (1.13 percent vs. 2.35 percent, p<0.0001), according to a stent analysis from the head-to-head TRITON-TIMI 38 trial.
The findings were presented today by Dr. Stephen Wiviott, an assistant professor of medicine at Harvard Medical School and investigator with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, at the Society for Cardiovascular Angiography and Interventions Scientific Sessions with the American College of Cardiology's Innovation in Intervention: i2 Summit, in Chicago. In addition, the manuscript was simultaneously published online by the British medical journal, The Lancet.
In the TRITON-TIMI 38 trial, whose overall results were previously published, 12,844 of the 13,608 enrolled patients received at least one intracoronary stent. Of those patients, 6,461 received a bare metal stent (BMS), 5,743 patients received a drug-eluting stent (DES), and 640 patients received both BMS and DES at the time of enrollment. Stent thrombosis was a pre-defined secondary endpoint in the trial.
Prasugrel reduced the relative risk of coronary stent thrombosis (a new clot at the implanted stent site) over clopidogrel by 52 percent (1.13 percent vs. 2.35 percent, p<0.0001). In patients who received drug-eluting stents (DES), treatment with prasugrel reduced relative risk by 64 percent over clopidogrel (0.84 percent vs. 2.31 percent, p<0.0001), and by 48 percent in patients who received bare metal stents (BMS) (1.27 percent vs. 2.41 percent, p=0.0009).
In the analysis, prasugrel was consistent in reducing stent thrombosis, compared to clopidogrel, whether assessment occurred early or late (<30 days and greater than or equal to 30 days, out to 450 days, the median duration of therapy), regardless of the type of stent used (bare metal or drug-eluting), and regardless of which academic research consortium (ARC) definition of stent thrombosis was used - definite/confirmed stent thrombosis, definite/confirmed plus probable stent thrombosis, and definite/confirmed plus probable plus possible stent thrombosis. Definite/probable stent thrombosis was reduced by 59 percent in prasugrel-treated patients within 30 days of stent placement (0.64 percent vs. 1.56 percent, p<0.0001), and by 40 percent after 30 days (out to 450 days, 0.49 percent vs. 0.82 percent, p=0.03).
"Stent thrombosis is very serious, given the high risk of mortality. In TRITON, among 210 patients with definite or probable stent thrombosis, 186 (89 percent) either died or experienced an MI as a result of the event," said Francis Plat, M.D., vice president, clinical development, Daiichi Sankyo Company, Limited. "We were excited by the results of this study and the possibility that prasugrel may someday provide an alternative treatment for ACS patients undergoing PCI and receiving coronary stents."
A 19 percent reduction in risk was observed with prasugrel compared with clopidogrel among all patients receiving a stent (9.7 percent vs. 11.9 percent, p=0.0001) in TRITON's primary endpoint of cardiovascular death, non- fatal heart attack, or non-fatal stroke. A 20 percent relative reduction favoring prasugrel was observed in the primary endpoint in patients who received only a bare metal stent (10.0 percent vs. 12.2 percent, p=0.003), and in patients who received only a drug-eluting stent, results showed an 18 percent relative reduction in the primary endpoint favoring prasugrel (9.0 percent vs. 11.1 percent, p=0.019). Fatal stent thrombosis occurred in 18 (0.28 percent) patients treated with prasugrel and 29 (0.46 percent) patients treated with clopidogrel (p=0.10). Of note, of the 210 patients with stent thrombosis, 89 percent either died or had a myocardial infarction associated with the event.
The rate of major bleeding was higher in all patients receiving a stent treated with prasugrel vs. clopidogrel (2.4 percent vs. 1.9 percent, p=0.06). Major bleeding in both DES and BMS prasugrel-treated groups when compared to clopidogrel-treated patients was 3 percent vs. 2 percent (p=0.34 DES) and 2 percent vs. 2 percent (p=0.09 BMS).
In addition to a reduction in the primary endpoint (CV death, non-fatal heart attack, or non-fatal stroke), a significantly lower rate of the composite endpoint of cardiovascular death, heart attack or urgent target vessel revascularization (UTVR) was observed with prasugrel vs. clopidogrel for both bare metal stents (10 percent vs. 12 percent, p=0.009) and for drug- eluting stents (9 percent vs. 11 percent, p=0.004). A significant reduction was also seen in heart attack alone (8 percent vs. 10 percent, p=0.003, BMS and 7 percent vs. 9 percent, p=.006, DES). In DES-implanted patients, regardless of those receiving only sirolimus-eluting or paclitaxel-eluting stents, there was a similar magnitude of event reduction with prasugrel compared to clopidogrel.
For the entire cohort, sub-acute stent thrombosis (24 hours to 30 days) was 0.36 percent in prasugrel-treated patients vs. 1.19 percent in clopidogrel-treated patients (p<0.0001). DES-implanted patients had lower rates of stent thrombosis compared to BMS-implanted patients, and prasugrel was shown to significantly reduce stent thrombosis in DES-implanted patients within the first three days compared to clopidogrel (0.14 percent vs. 0.63 percent, p=0.003) as well as for thromboses that occurred >30 days following the DES implantation (0.42 percent vs. 0.91 percent, p=0.04).
"The reduction in risk seen in patients in this analysis treated with prasugrel over patients treated with clopidogrel is encouraging for high-risk patients with acute coronary syndrome being managed with PCI," said J. Anthony Ware, M.D., Lilly vice president for cardiovascular/acute care.
And speaking of vapid coverage, an accompanying article in the NEJM that claims the higher use of Vytorin in the US was due to DTC provides no evidence of cause and effect or association. Rather, it does put it's finger on the real reason: Canada health system delayed and restricted access:
"Vytorin has been available in the United States since July 2004 but is still not available on the Canadian market. The use of ezetimibe-containing products in the United States increased sharply with the introduction of Vytorin. Some U.S. clinicians may have adopted the combination cholesterol-lowering product to improve adherence to dual therapy, but this option was not available in Canada. Third, in Canada, publicly funded provincial drug formularies have been conservative in their coverage of ezetimibe. Two of the three provincial government-funded formularies that serve three provinces (Ontario, Quebec, and British Columbia), in which approximately 75% of Canada's population lives, list ezetimibe with prescribing criteria that limit its use to patients in whom the target level of LDL cholesterol has not been achieved with a statin and patients who cannot tolerate or have a contraindication to statins; a third formulary does not even list ezetimibe as a benefit, although it is currently under review. These formulary criteria appear to be consistent with guideline recommendations that favor medication classes for which data on outcomes are available. Public formulary listings often influence medication coverage in private Canadian drug plans.
Oh.
But watch how many media articles cite DTC as the culprit. This is typical of the the quality of the case against DTC.
http://content.nejm.org/cgi/content/full/NEJMsa0801461
"Vytorin has been available in the United States since July 2004 but is still not available on the Canadian market. The use of ezetimibe-containing products in the United States increased sharply with the introduction of Vytorin. Some U.S. clinicians may have adopted the combination cholesterol-lowering product to improve adherence to dual therapy, but this option was not available in Canada. Third, in Canada, publicly funded provincial drug formularies have been conservative in their coverage of ezetimibe. Two of the three provincial government-funded formularies that serve three provinces (Ontario, Quebec, and British Columbia), in which approximately 75% of Canada's population lives, list ezetimibe with prescribing criteria that limit its use to patients in whom the target level of LDL cholesterol has not been achieved with a statin and patients who cannot tolerate or have a contraindication to statins; a third formulary does not even list ezetimibe as a benefit, although it is currently under review. These formulary criteria appear to be consistent with guideline recommendations that favor medication classes for which data on outcomes are available. Public formulary listings often influence medication coverage in private Canadian drug plans.
Oh.
But watch how many media articles cite DTC as the culprit. This is typical of the the quality of the case against DTC.
http://content.nejm.org/cgi/content/full/NEJMsa0801461
It would great if, just once, coverage about clinical trials focused on the unpredictability of science and the inherent difficulty of designing "real world" studies of the effect of drugs that produce desired results, particularly a measurable reversal in biochemistry that contributes to death.
That will not happen with Vytorin, except in the breach. To be sure the original:" these findings plus future biologic and clinical evidence could confirm that the benefits of lowering LDL cholesterol may depend not only on "how low you go" but also on "how you get there."
http://content.nejm.org/cgi/content/full/NEJMe0801608
This is a point that Eric Topol has been making since the first wave of ENHANCE data was released. See Eric's video on his blog:
http://blogs.theheart.org/posts/temple-of-the-ldl-cholesterol
In the end, Vytorin use will fall but for the wrong reasons. Absent information about "how to get there" before prescribing, LDL treatment will still be hit or miss. That's all the ENHANCE study showed. We know that reducing LDL is important but we still lack targeted treatments.
That will not happen with Vytorin, except in the breach. To be sure the original:" these findings plus future biologic and clinical evidence could confirm that the benefits of lowering LDL cholesterol may depend not only on "how low you go" but also on "how you get there."
http://content.nejm.org/cgi/content/full/NEJMe0801608
This is a point that Eric Topol has been making since the first wave of ENHANCE data was released. See Eric's video on his blog:
http://blogs.theheart.org/posts/temple-of-the-ldl-cholesterol
In the end, Vytorin use will fall but for the wrong reasons. Absent information about "how to get there" before prescribing, LDL treatment will still be hit or miss. That's all the ENHANCE study showed. We know that reducing LDL is important but we still lack targeted treatments.
As many in this country are calling for a ban on the sharing of physician prescribing data -- our regulatory cousins in the United Kingdom are moving aggressively in precisely the opposite direction.
According to a report in the Financial Times,
The government is considering making public the full details of 700m prescriptions issued by general practitioners each year.
Publication could provide valuable new statistics to help improve treatment, fight "postcode prescribing" and hold GPs more accountable.
The proposal is sensitive, however, following embarrassing losses of personal information by government agencies in recent months. Medical specialists warn that detailed prescription data could also threaten patient confidentiality and undermine existing research databases.
The aim was "to determine whether it would be possible to make practice-level prescribing data more accessible to the private sector", the government said in an answer to a recent parliamentary question.
Sue Sharpe, head of the Pharmaceutical Services Negotiating Committee, which represents pharmacists, said, "I have concerns about patient and prescriber confidentiality" if the data were released more widely. She also commented that it could also lead to "aggressive promotion of prescriptions" by drug companies.
Here's a link to the complete article:
http://www.ft.com/cms/s/0/dea53df6-feba-11dc-9e04-000077b07658.html?nclick_check=1
Same issues as here at home, but a completely antipodal policy design.
According to a report in the Financial Times,
The government is considering making public the full details of 700m prescriptions issued by general practitioners each year.
Publication could provide valuable new statistics to help improve treatment, fight "postcode prescribing" and hold GPs more accountable.
The proposal is sensitive, however, following embarrassing losses of personal information by government agencies in recent months. Medical specialists warn that detailed prescription data could also threaten patient confidentiality and undermine existing research databases.
The aim was "to determine whether it would be possible to make practice-level prescribing data more accessible to the private sector", the government said in an answer to a recent parliamentary question.
Sue Sharpe, head of the Pharmaceutical Services Negotiating Committee, which represents pharmacists, said, "I have concerns about patient and prescriber confidentiality" if the data were released more widely. She also commented that it could also lead to "aggressive promotion of prescriptions" by drug companies.
Here's a link to the complete article:
http://www.ft.com/cms/s/0/dea53df6-feba-11dc-9e04-000077b07658.html?nclick_check=1
Same issues as here at home, but a completely antipodal policy design.
Dr. Marc Siegel, a senior fellow at the Center for Medicine in the Public Interest, is a practicing internist, an Associate Professor at the New York University School of Medicine and a fellow in the Master Scholars Society at New York University. Dr. Siegel is also a columnist for The Los Angeles Times and a frequent contributor to the Washington Post, USA Today, Slate, and many other publications. He is the author of False Alarm; the Truth About the Epidemic of Fear (top 20 books of 2005 - Discover Magazine) and Bird Flu: Everything You Need to Know About the Next Pandemic. Dr. Siegel appears regularly on CNN, the NBC Today Show, and the Fox News Channel. Dr. Siegel was a contributor to the U.S. Senate Finance committee investigation of the 2001 bioterror crisis.
In his essay, "The Virtual House Call," Dr. Siegel discusses many of the challenges facing the 21st century physician in the United States. Here is a free sample (yes, we here at drugwonks are still giving away free samples) of his discourse:
"I have a litmus test to check on my humanity. I call it the virtual house call. It isn’t an actual house call but it relies on similar notions of inconvenience in order to help a patient. Rarely do we have time these days to travel to a patient’s home. We must extend ourselves beyond our offices and our blackberries in caring for our patients in order to become truly empowered as physicians. This extension of self is the virtual house call.
Here is my litmus test: Every day I leave my office for a cup of coffee when I get restless. The coffee shop is one block south of where I practice. I ask myself what I would do if one of my patients, on his or her way to see me, suddenly collapsed right outside that same coffee shop I frequent and called my office from his cell phone while gasping for air.
Would I instruct my nurse to call 911, or would I run the same block I always walked?
Would I at least show as much commitment to my patient as I show to my caffeine habit?
I’ve never had to face this particular litmus test, but I certainly hope I would pass it. And each time I pick up the phone to check in on one of my patient, I’m conscious of a similar kind of litmus test. As I listen over the phone to the telling sounds of fast breathing or nervous coughing, I make determinations that my nurse or secretary could never make. I try to remain available, to not set strict limits. I’m convinced that continuity of care makes me a better doctor.
Dr. Siegel's entire composition can be found at both at the top of this page and at http://www.cmpi.org under the "Report" heading. The larger paper is titled, "The Hazards of Harassing Doctors."
In his essay, "The Virtual House Call," Dr. Siegel discusses many of the challenges facing the 21st century physician in the United States. Here is a free sample (yes, we here at drugwonks are still giving away free samples) of his discourse:
"I have a litmus test to check on my humanity. I call it the virtual house call. It isn’t an actual house call but it relies on similar notions of inconvenience in order to help a patient. Rarely do we have time these days to travel to a patient’s home. We must extend ourselves beyond our offices and our blackberries in caring for our patients in order to become truly empowered as physicians. This extension of self is the virtual house call.
Here is my litmus test: Every day I leave my office for a cup of coffee when I get restless. The coffee shop is one block south of where I practice. I ask myself what I would do if one of my patients, on his or her way to see me, suddenly collapsed right outside that same coffee shop I frequent and called my office from his cell phone while gasping for air.
Would I instruct my nurse to call 911, or would I run the same block I always walked?
Would I at least show as much commitment to my patient as I show to my caffeine habit?
I’ve never had to face this particular litmus test, but I certainly hope I would pass it. And each time I pick up the phone to check in on one of my patient, I’m conscious of a similar kind of litmus test. As I listen over the phone to the telling sounds of fast breathing or nervous coughing, I make determinations that my nurse or secretary could never make. I try to remain available, to not set strict limits. I’m convinced that continuity of care makes me a better doctor.
Dr. Siegel's entire composition can be found at both at the top of this page and at http://www.cmpi.org under the "Report" heading. The larger paper is titled, "The Hazards of Harassing Doctors."
The FDA is ramping up it's effort to monitor the safety of drugs through its Early Alert and REMS program. It could be that the constant release of information on safety will do two things:
First neutralize the fear mongering and it's impact of people like Steve Nissen (more on him later) by getting ahead of the curve early and often. Second, get people and doctors to think more generally about the risks and benefits of medicines as well as their proper use. Finally, maybe it will prod companies and insurers to offer genetic tests to increase safer and more tailored dosing and drug selection right off the bat...
Genomas for instance is developing a genetic test to predict and compare an individual's risk of getting muscle pain among atorvastatin, simvastatin and rosuvastatin. I have used the protoype for my statin selection. http://www.genomas.net
I was pretty critical about the Early Alert program at first, regarding it as not being science based. But maybe (is it possible?) I was wrong. I think that flooding the safety zone with information is useful. It would be great as part of the Alerts to note that incidence of safety problems as a percentage of total scrips to put things into perspective. Along those lines, we encourage everyone who cares about the safety and impact of their meds to sign up for Iguard.org, a patient community that shares information about the benefits and side effects of their drugs. You can enroll at www.iguard.org
First neutralize the fear mongering and it's impact of people like Steve Nissen (more on him later) by getting ahead of the curve early and often. Second, get people and doctors to think more generally about the risks and benefits of medicines as well as their proper use. Finally, maybe it will prod companies and insurers to offer genetic tests to increase safer and more tailored dosing and drug selection right off the bat...
Genomas for instance is developing a genetic test to predict and compare an individual's risk of getting muscle pain among atorvastatin, simvastatin and rosuvastatin. I have used the protoype for my statin selection. http://www.genomas.net
I was pretty critical about the Early Alert program at first, regarding it as not being science based. But maybe (is it possible?) I was wrong. I think that flooding the safety zone with information is useful. It would be great as part of the Alerts to note that incidence of safety problems as a percentage of total scrips to put things into perspective. Along those lines, we encourage everyone who cares about the safety and impact of their meds to sign up for Iguard.org, a patient community that shares information about the benefits and side effects of their drugs. You can enroll at www.iguard.org
No, really.
Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.
“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,†Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.
Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.
Good luck Susan.
Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.
“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,†Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.
Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.
Good luck Susan.
Why even bother having an FDA reporter when writing an FDA “expose†story is as easy as, well, Mad Libs.
New Report by (proper noun) Accuses FDA of (adjective) Oversight
Today (adjective) Citizens for (adjective) Health, a not-for-profit organization, released a (adjective) meta-analysis that (adverb) concludes the FDA, “is in the (noun) of (adjective) Pharma.â€
“Our research of (number) concerned (plural noun) points (adverb) to an agency that has once again (verb past tense) the American public. It’s a (adjective) indication that the FDA places (noun) over (noun) and cannot be trusted to (verb) or (verb) – and certainly not (verb) in the public interest,†said the author’s report Dr. Sidney (type of animal).
“I find this new report both (adjective) and (adjective) – but (adverb) not (adjective),†commented Representative Henry (proper name).†“And I intend to hold televised (plural noun) on the matter.â€
“This is just another (adjective) example of the FDA’s lack of (adjective) (noun), added Dr. Steven (name of automobile company). If I were the FDA Commissioner this (adjective) circumstance would never have occurred.â€
In an embargoed editorial, the New (place name) Journal of Medicine opined that the (adjective) problem “is caused by the Prescription (noun) User-Fee Act and made even (adjective) by the agency’s continued (verb) of direct to (noun) advertising.†The editorial also points to the need for (adjective) importation of prescription (plural noun) from (name of country).
Supporting this notion, the AAR(letter) added that (adverb) high (plural noun) for drugs are a result of the (type of shrub) Administration's (adjective) program known as Part (letter) and supports (adjective) government (verb).
The FDA had (adjective) comment.
New Report by (proper noun) Accuses FDA of (adjective) Oversight
Today (adjective) Citizens for (adjective) Health, a not-for-profit organization, released a (adjective) meta-analysis that (adverb) concludes the FDA, “is in the (noun) of (adjective) Pharma.â€
“Our research of (number) concerned (plural noun) points (adverb) to an agency that has once again (verb past tense) the American public. It’s a (adjective) indication that the FDA places (noun) over (noun) and cannot be trusted to (verb) or (verb) – and certainly not (verb) in the public interest,†said the author’s report Dr. Sidney (type of animal).
“I find this new report both (adjective) and (adjective) – but (adverb) not (adjective),†commented Representative Henry (proper name).†“And I intend to hold televised (plural noun) on the matter.â€
“This is just another (adjective) example of the FDA’s lack of (adjective) (noun), added Dr. Steven (name of automobile company). If I were the FDA Commissioner this (adjective) circumstance would never have occurred.â€
In an embargoed editorial, the New (place name) Journal of Medicine opined that the (adjective) problem “is caused by the Prescription (noun) User-Fee Act and made even (adjective) by the agency’s continued (verb) of direct to (noun) advertising.†The editorial also points to the need for (adjective) importation of prescription (plural noun) from (name of country).
Supporting this notion, the AAR(letter) added that (adverb) high (plural noun) for drugs are a result of the (type of shrub) Administration's (adjective) program known as Part (letter) and supports (adjective) government (verb).
The FDA had (adjective) comment.
If I were a Carpenter or a Zucker or an Avorn, -- the three amigos who penned “Drug-Review Deadlines and Safety Problems†(NEJM, 2008; 358: 1354-61) – I’d be greasing up the old spin machine.
Consider the following from BioCentury Extra:
FDA refutes PDUFA safety study
FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.
The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.
Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.
And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.
Well, as they say in Harvard Yard, "veritas."
We look forward to the FDA’s review … and hopefully to an apology from the authors and a retraction from NEJM.
Yeah, right.
Consider the following from BioCentury Extra:
FDA refutes PDUFA safety study
FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.
The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.
Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.
And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.
Well, as they say in Harvard Yard, "veritas."
We look forward to the FDA’s review … and hopefully to an apology from the authors and a retraction from NEJM.
Yeah, right.
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs
and Biologics
New FDAAA requirements being implemented
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.
Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA’s authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.
“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,†said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.â€
In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.
The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.
The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
One of the named products is Mifepristone -- the infamous "abortion pill." So now we'll see if "safety" and "choice" can live side-by-side.
and Biologics
New FDAAA requirements being implemented
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.
Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA’s authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.
“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,†said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.â€
In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.
The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.
The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
One of the named products is Mifepristone -- the infamous "abortion pill." So now we'll see if "safety" and "choice" can live side-by-side.
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.
