GlaxoSmithKline has withdrawn its application for the use of Avodart in the prevention of prostate cancer. One has to wonder if this is a case of premature ejaculation, because GSK only filed its application with the FDA back on October 1 (see GSK Files on Avodart).
Reuters is reporting that the company pulled the filing because some data “needed updating.” GSK intends to refile soon.
Hate to say it, but it looks like somebody got trigger happy over at GSK. Oops!
Monday, November 23, 2009
Saturday, November 21, 2009
Provenge Gets D-Day
Dendreon received confirmation from the FDA that it’s (re)-submission for prostate cancer vaccine Provenge is complete. The FDA has also given Dendreon a PDUFA action date of May 1, 2010. This is good news for Dendreon because it means the FDA has finally put Provenge on equal footing compared to other drugs and Dendreon/Provenge is no longer being punished for the FDA’s bad publicity. Unfortunate, the bad news for Dendreon is that the FDA has been rather cavalier about PDUFA dates over the last year and half. It’s more like a guideline for them now.
I’m really rooting for Dendreon. I think an additional option for treating prostate cancer is a good thing. But Dendreon’s Provenge is a classic underdog story. A good product torpedoed by a couple of doctors and an FDA insider, all hoping to get rich quick off a competing product. Poor Dendreon. The folks there have been totally sodomized from Washington State to Washington, D.C.
Of course, the scheme couldn’t be kept quiet. Subsequent trials have demonstrated what we all knew the first time – Provenge should have been approved. But along the way, Dendreon has had to publicly battle the FDA. That battle has proved very time consuming and expensive for Dendreon. And it has been extremely embarrassing for the FDA. Over the last six months, I still had a high degree of optimism that the FDA would allow Provenge to be approved.
Despite the PDUFA deadline, my optimism is pretty much gone. I wonder if Provenge will be approved. It should be, but I doubt it. There are still too many FDA insiders that have been embarrassed over this. Shoving Provenge into the back of the desk forever, while being devastating for many men with prostate cancer, is the politically expedient thing to do for government agency ladder climbers. Folks at the FDA don’t want to touch Provenge and have their records saddled with that baggage.
So while Dendreon was receiving its letter from the FDA telling them of the PDUFA date, men who have been impacted by this little scheme continue to battle on. They’ve filed numerous Freedom of Information Act (FOIA) act requests to get access to information within the FDA. Conveniently, the FDA is claiming that records relating to this back-room deal with the devil have been destroyed, e-mails have been deleted and jeez, the dog ate their homework. It’s a federal offense to destroy records relating to a federal lawsuit, but that doesn’t seem to matter when it’s the government committing the crime.
Despite President Barack Obama’s personal assurance that no federal agency would squash FOIA requests, even if they were political embarrassing, it seems that transparency under Obama is still more rhetoric than reality. I wish the gents at Care to Live well. The truth will come out on Provenge – it just might take a very, very long time.
Reference: Provenge Activists Try Again for FDA Documents
I’m really rooting for Dendreon. I think an additional option for treating prostate cancer is a good thing. But Dendreon’s Provenge is a classic underdog story. A good product torpedoed by a couple of doctors and an FDA insider, all hoping to get rich quick off a competing product. Poor Dendreon. The folks there have been totally sodomized from Washington State to Washington, D.C.
Of course, the scheme couldn’t be kept quiet. Subsequent trials have demonstrated what we all knew the first time – Provenge should have been approved. But along the way, Dendreon has had to publicly battle the FDA. That battle has proved very time consuming and expensive for Dendreon. And it has been extremely embarrassing for the FDA. Over the last six months, I still had a high degree of optimism that the FDA would allow Provenge to be approved.
Despite the PDUFA deadline, my optimism is pretty much gone. I wonder if Provenge will be approved. It should be, but I doubt it. There are still too many FDA insiders that have been embarrassed over this. Shoving Provenge into the back of the desk forever, while being devastating for many men with prostate cancer, is the politically expedient thing to do for government agency ladder climbers. Folks at the FDA don’t want to touch Provenge and have their records saddled with that baggage.
So while Dendreon was receiving its letter from the FDA telling them of the PDUFA date, men who have been impacted by this little scheme continue to battle on. They’ve filed numerous Freedom of Information Act (FOIA) act requests to get access to information within the FDA. Conveniently, the FDA is claiming that records relating to this back-room deal with the devil have been destroyed, e-mails have been deleted and jeez, the dog ate their homework. It’s a federal offense to destroy records relating to a federal lawsuit, but that doesn’t seem to matter when it’s the government committing the crime.
Despite President Barack Obama’s personal assurance that no federal agency would squash FOIA requests, even if they were political embarrassing, it seems that transparency under Obama is still more rhetoric than reality. I wish the gents at Care to Live well. The truth will come out on Provenge – it just might take a very, very long time.
Reference: Provenge Activists Try Again for FDA Documents
Politics of Breast Cancer
I’ve been surprised by a number of people that I generally respect in the medical world that have embraced the USPSTF recommendations against breast cancer screening with gusto. Some of these same individuals would pour over a pharmaceutical industry funded study to pick it apart. When it comes to the USPSTF recommendations, they’re willing to blindly accept the results – without ever having even read them.
Here's my position – don’t change the guidelines. There have been two decades of scientific rigor put into the guidelines that came out in 2002. The medical results that screening have led to a decline in breast cancer fatalities speak for themselves. The burden of changing guidelines rests with those who wish to change them.
Here’s the issue with Evidence-based medicine – you need evidence. Where is the well-conducted scientific study that brought about this change in guidelines? Point to it. You can't. These guidelines were issued, not in response to new medical data, but in response to changing political beliefs about an economic one.
The guidelines were last reviewed in 2002. Since that time, there was one actual new study...a study that shows for every 1,904 women you screen in the age group 39-49, you'll save 1 from dying of breast cancer during the study period (not much longitudinal accounting here). This is not a burning bush or a stunning medical breakthrough. Is it enough to throw out all the other studies? I think not.
A number of people are asserting that the USPSTF, AHRQ and HHS are strictly scientific and medical organizations and they do not take cost into account. That’s a political argument. It’s also a lie. There’s a difference between being blind to costs and making a decision based solely on medicine and knowing the costs, but not actively weighing them. It’s like when a guy confesses to murder, but some judge tells the jury to ignore the confession – it’s still out there. For those still operating under the impression that the USPSTF guidelines are totally blind to cost, I recommend you read them and the paper published in the Annals. Cost is taken into account and defined in the recommendations as "resource requirements.” In fact, you'll see references to costs throughout the paper. Economics was a strong driver of these recommendations (and 3 of the 16 panelists work in healthcare economics). The USPSTF members received a financial analysis of mammography spending as part of their deliberation process. So, the USPSTF has, most definitely, taken cost into account.
Much of the anger over the Government’s official guidelines is because of the lower bound: the recommendation that annual screenings be withheld from women age 40-49. What is missing in a lot of the media discussions are the two other parts of the task-forces recommendation: the upper bound and frequently. The task force also recommended that women over age 75 are, essentially, too old and not worth saving/screening (this done through omission – essentially taking the previous recommendation for screening and now saying there is inconclusive evidence to support screening) – essentially, costs do not justify the activity. The task force also recommended screening every other year for women 50-74 - a move not supported in the medical literature (but seems to have some considerable support in the world of healthcare economics). These recommendations trouble me because a woman could easily move from Stage 1 to Stage 3 breast cancer in two years between mammograms. The decision not to recommend screening for women over 75 is really problematic from an ethical standpoint, although it makes strong economic sense.
I think it's nearly criminal that at least one member of this "expert panel" hasn't been in a room with a patient in so long that Clinton was probably President - hardly keeping up on the science (instead they serve in the capacity of rent-a-doc to the government and industry, lending the credentialed title "M.D." to whatever sham science comes their way). And I'm sure the three pediatricians and the one pediatric nurse practitioner (4 of 16 members of the panel - or 25%) added a lot to the discussion on breast cancer in women age 40+. There isn't single, actual expert on this panel: not a radiologist, not an expert in breast cancer, and not even a general oncologist (but I'm sure the three medical economists had a lot to say).
KevinMD asks the question, what if the government commissions an expert panel and nobody follows the results. My question back to KevinMD is even more fundamental – what if the government commissions a panel without any experts, why would anyone follow its recommendations?
The burden of proof for changing medical guidelines lies in those who wish to change it. My recommendation, leave it at 40. Unless there is new clear and compelling evidence to do otherwise (we're talking prospectively designed trials).
All else is just political window dressing. If we want to have a discussion about cost controls and healthcare rationing, let’s have that discussion. But let’s not pretend to have a discussion about medical outcomes when we’re really talking about finances.
Here's my position – don’t change the guidelines. There have been two decades of scientific rigor put into the guidelines that came out in 2002. The medical results that screening have led to a decline in breast cancer fatalities speak for themselves. The burden of changing guidelines rests with those who wish to change them.
Here’s the issue with Evidence-based medicine – you need evidence. Where is the well-conducted scientific study that brought about this change in guidelines? Point to it. You can't. These guidelines were issued, not in response to new medical data, but in response to changing political beliefs about an economic one.
The guidelines were last reviewed in 2002. Since that time, there was one actual new study...a study that shows for every 1,904 women you screen in the age group 39-49, you'll save 1 from dying of breast cancer during the study period (not much longitudinal accounting here). This is not a burning bush or a stunning medical breakthrough. Is it enough to throw out all the other studies? I think not.
A number of people are asserting that the USPSTF, AHRQ and HHS are strictly scientific and medical organizations and they do not take cost into account. That’s a political argument. It’s also a lie. There’s a difference between being blind to costs and making a decision based solely on medicine and knowing the costs, but not actively weighing them. It’s like when a guy confesses to murder, but some judge tells the jury to ignore the confession – it’s still out there. For those still operating under the impression that the USPSTF guidelines are totally blind to cost, I recommend you read them and the paper published in the Annals. Cost is taken into account and defined in the recommendations as "resource requirements.” In fact, you'll see references to costs throughout the paper. Economics was a strong driver of these recommendations (and 3 of the 16 panelists work in healthcare economics). The USPSTF members received a financial analysis of mammography spending as part of their deliberation process. So, the USPSTF has, most definitely, taken cost into account.
Much of the anger over the Government’s official guidelines is because of the lower bound: the recommendation that annual screenings be withheld from women age 40-49. What is missing in a lot of the media discussions are the two other parts of the task-forces recommendation: the upper bound and frequently. The task force also recommended that women over age 75 are, essentially, too old and not worth saving/screening (this done through omission – essentially taking the previous recommendation for screening and now saying there is inconclusive evidence to support screening) – essentially, costs do not justify the activity. The task force also recommended screening every other year for women 50-74 - a move not supported in the medical literature (but seems to have some considerable support in the world of healthcare economics). These recommendations trouble me because a woman could easily move from Stage 1 to Stage 3 breast cancer in two years between mammograms. The decision not to recommend screening for women over 75 is really problematic from an ethical standpoint, although it makes strong economic sense.
I think it's nearly criminal that at least one member of this "expert panel" hasn't been in a room with a patient in so long that Clinton was probably President - hardly keeping up on the science (instead they serve in the capacity of rent-a-doc to the government and industry, lending the credentialed title "M.D." to whatever sham science comes their way). And I'm sure the three pediatricians and the one pediatric nurse practitioner (4 of 16 members of the panel - or 25%) added a lot to the discussion on breast cancer in women age 40+. There isn't single, actual expert on this panel: not a radiologist, not an expert in breast cancer, and not even a general oncologist (but I'm sure the three medical economists had a lot to say).
KevinMD asks the question, what if the government commissions an expert panel and nobody follows the results. My question back to KevinMD is even more fundamental – what if the government commissions a panel without any experts, why would anyone follow its recommendations?
The burden of proof for changing medical guidelines lies in those who wish to change it. My recommendation, leave it at 40. Unless there is new clear and compelling evidence to do otherwise (we're talking prospectively designed trials).
All else is just political window dressing. If we want to have a discussion about cost controls and healthcare rationing, let’s have that discussion. But let’s not pretend to have a discussion about medical outcomes when we’re really talking about finances.
Friday, November 20, 2009
Breast Cancer Recommendations: Feedback Welcome
The Annals of Internal Medicine, publisher of the controversial USPSTF Breast Cancer Recommendations (funded by AHRQ), is inviting feedback. On its website, you can take their survey and give them feedback on whether you will follow their recommendations.
To recap, the recommendations are, no annual screening for women between the ages of 40-49, no screening for women over age 75, and screening every other year for women between the ages of 50-74.
Alternately, if you want to go straight to the survey, just click here.
To recap, the recommendations are, no annual screening for women between the ages of 40-49, no screening for women over age 75, and screening every other year for women between the ages of 50-74.
Alternately, if you want to go straight to the survey, just click here.
Wednesday, November 18, 2009
ACS Stands Firm
Today is the Great American Smokeout, sponsored by the American Cancer Society (ACS). I’m a big fan of the ACS this week – it takes real resolve to stick up for patients in the midst of an HHS-funded initiative to send women’s breast cancer screening back into the 1950’s and a healthcare reform bill that is weak on oncology treatment. Yet the ACS stands firm, so the least I can do is give them a shout out on their Great American Smokeout.
The American Cancer Society has a huge uphill battle on its hands. This is the 34th year the Great American Smokeout and so much progress has been made in anti-smoking and public health initiatives – until this year. The ACS finds itself the partner of the CDC which, under the leadership of Thomas R. Frieden, has been apathetic at best to plight of chronic disease in America caused by smoking. Dr. Frieden lost his will to combat smoking about the time he received his political appointment from President Barack Obama – a smoker (surely this is just a coincidence).
The unfortunate situation is that all of the progress that has been over the last several decades has gone up in one big puff of Presidential smoke – adult smoking rates are increasing for the first time in decades. The CDC is ignoring the issue. Thankfully, the American Cancer Society isn’t willing to buckle to political pressure and is willing to stand firm on anti-smoking measures.
Thank you to the American Cancer Society!
The American Cancer Society has a huge uphill battle on its hands. This is the 34th year the Great American Smokeout and so much progress has been made in anti-smoking and public health initiatives – until this year. The ACS finds itself the partner of the CDC which, under the leadership of Thomas R. Frieden, has been apathetic at best to plight of chronic disease in America caused by smoking. Dr. Frieden lost his will to combat smoking about the time he received his political appointment from President Barack Obama – a smoker (surely this is just a coincidence).
The unfortunate situation is that all of the progress that has been over the last several decades has gone up in one big puff of Presidential smoke – adult smoking rates are increasing for the first time in decades. The CDC is ignoring the issue. Thankfully, the American Cancer Society isn’t willing to buckle to political pressure and is willing to stand firm on anti-smoking measures.
Thank you to the American Cancer Society!
Monday, November 16, 2009
AHRQ: Ration Breast Cancer Screening
The U.S. Preventative Services Task Force (USPSTF) of HHS’ Agency for Healthcare Research and Quality (AHRQ) has launched an all-out jihad on women. The AHRQ and USPSTF are making some pretty radical recommendations: no mammography for women over age 74, a recommendation against mammo for women age 40-49 and mammo only every other year for women age 50-74. It’s not that there isn’t a compelling reason to skip on mammography, it’s that it costs too much. Under the new recommendations, a woman could develop advanced stage breast cancer and die by the time HHS would allow her to get screened.
This measure is nothing more than healthcare rationing. We’ve seen this move from the Administration before – several months ago, CMS decided to ignore scientific evidence and decline payments for virtual colonoscopies. Add to this, HHS’ desire to see prevention, screening and treatment for prostate cancer stripped from the books, I think it’s safe to say that the U.S. Department of Health & Human Services new approach to cancer is: Death is Cheap. To the Government, you are less of a financial burden if you’re dead.
These recommendations are all the more concerning because some would like for AHRQ’s recommendations to become standard. In fact, health reform legislation pending in Congress could mandate AHRQ recommendations as a basis for payment (or denial). I have to wonder if HHS is this willing to engage in care rationing before healthcare reform legislation is passed, how aggressive will they be after? If the Government is not willing to screen and treat for Cancer, what’s next? Childhood leukemia? And who gets to make these decisions?
Thankfully, everyone who supports the rights of women and believes in actually providing healthcare (vs. rationing care) has condemned this. Some of the criticisms include:
The Scientific Advisory Board over at Susan G. Komen opposes these new recommendations, although, for political reasons, they haven’t come out strongly on this issue: “We want to eliminate any impediments to regular mammography screening for women age 40 and older. It is our view, however, that the exact timing of assessments is less important than guaranteeing access to screening. New screening approaches and more individualized recommendations for breast cancer screening are urgently needed. Susan G. Komen for the Cure supports research initiatives designed to improve screening, and we believe that it is imperative that this research move forward rapidly.” I’ve long been a critic of Susan G. Komen and the way they operate. However, I’d like to applaud them for actually talking sense in this situation.
“I’m riled up; this is a giant step backward and a terrible mistake,” said the founder of Breastcancer.org, Dr. Marisa Weiss, an oncologist who practices at Lankenau Hospital in Wynnewood, Pa. “We know mammography overperforms and finds things that will never be life-threatening, and we know it underperforms in some women. But it has no chance to perform in women who don’t get it.” (quoted in the New York Times)
“You’re going to start losing a lot of women,” said Sylvia Moritz, 54, of Manhattan, who learned she had breast cancer at 48 after an annual mammogram. “I have two friends in their 40s who were just diagnosed with breast cancer. One of them just turned 41. If they had waited until she was 50 to do a routine mammogram, they wouldn’t have to bother on her part — she’d be dead.” (quoted in the New York Times)
"The USPSTF recommendations are a step backward and represent a significant harm to women's health. To tell women they should not get regular mammograms starting at 40 when this approach has overwhelmingly been shown to save lives is shocking. At least 40 percent of the lives saved by mammographic screening are of women aged 40-49. These recommendations are inconsistent with current science and apparently have been developed in an attempt to reduce costs. Unfortunately, many women may pay for this unsound approach with their lives," said W. Phil Evans, M.D., FACR, president of the Society of Breast Imaging (SBI).
“These unfounded USPSTF recommendations ignore the valid scientific data and place a great many women at risk of dying unnecessarily from a disease that we have made significant headway against over the last 20 years… These new recommendations seem to reflect a conscious decision to ration care,” said Carol H. Lee, M.D., chair of the American College of Radiology Breast Imaging Commission.
One thing is absolutely certain: it is open season on women’s health and it is open season on preventing cancer deaths.
If you do one thing tonight, call the women in your life – your mothers, your sisters, your grandmothers, your daughters – and tell them that you love them…while you still can.
This measure is nothing more than healthcare rationing. We’ve seen this move from the Administration before – several months ago, CMS decided to ignore scientific evidence and decline payments for virtual colonoscopies. Add to this, HHS’ desire to see prevention, screening and treatment for prostate cancer stripped from the books, I think it’s safe to say that the U.S. Department of Health & Human Services new approach to cancer is: Death is Cheap. To the Government, you are less of a financial burden if you’re dead.
These recommendations are all the more concerning because some would like for AHRQ’s recommendations to become standard. In fact, health reform legislation pending in Congress could mandate AHRQ recommendations as a basis for payment (or denial). I have to wonder if HHS is this willing to engage in care rationing before healthcare reform legislation is passed, how aggressive will they be after? If the Government is not willing to screen and treat for Cancer, what’s next? Childhood leukemia? And who gets to make these decisions?
Thankfully, everyone who supports the rights of women and believes in actually providing healthcare (vs. rationing care) has condemned this. Some of the criticisms include:
The Scientific Advisory Board over at Susan G. Komen opposes these new recommendations, although, for political reasons, they haven’t come out strongly on this issue: “We want to eliminate any impediments to regular mammography screening for women age 40 and older. It is our view, however, that the exact timing of assessments is less important than guaranteeing access to screening. New screening approaches and more individualized recommendations for breast cancer screening are urgently needed. Susan G. Komen for the Cure supports research initiatives designed to improve screening, and we believe that it is imperative that this research move forward rapidly.” I’ve long been a critic of Susan G. Komen and the way they operate. However, I’d like to applaud them for actually talking sense in this situation.
“I’m riled up; this is a giant step backward and a terrible mistake,” said the founder of Breastcancer.org, Dr. Marisa Weiss, an oncologist who practices at Lankenau Hospital in Wynnewood, Pa. “We know mammography overperforms and finds things that will never be life-threatening, and we know it underperforms in some women. But it has no chance to perform in women who don’t get it.” (quoted in the New York Times)
“You’re going to start losing a lot of women,” said Sylvia Moritz, 54, of Manhattan, who learned she had breast cancer at 48 after an annual mammogram. “I have two friends in their 40s who were just diagnosed with breast cancer. One of them just turned 41. If they had waited until she was 50 to do a routine mammogram, they wouldn’t have to bother on her part — she’d be dead.” (quoted in the New York Times)
"The USPSTF recommendations are a step backward and represent a significant harm to women's health. To tell women they should not get regular mammograms starting at 40 when this approach has overwhelmingly been shown to save lives is shocking. At least 40 percent of the lives saved by mammographic screening are of women aged 40-49. These recommendations are inconsistent with current science and apparently have been developed in an attempt to reduce costs. Unfortunately, many women may pay for this unsound approach with their lives," said W. Phil Evans, M.D., FACR, president of the Society of Breast Imaging (SBI).
“These unfounded USPSTF recommendations ignore the valid scientific data and place a great many women at risk of dying unnecessarily from a disease that we have made significant headway against over the last 20 years… These new recommendations seem to reflect a conscious decision to ration care,” said Carol H. Lee, M.D., chair of the American College of Radiology Breast Imaging Commission.
One thing is absolutely certain: it is open season on women’s health and it is open season on preventing cancer deaths.
If you do one thing tonight, call the women in your life – your mothers, your sisters, your grandmothers, your daughters – and tell them that you love them…while you still can.
Sunday, November 15, 2009
Niaspan Beats Zetia in Minor Study
Abbott Lab’s Niaspan beat out Merck’s Zetia (ezetimibe) in concomitant therapy with statins when looking at atherosclerosis. The study, which was presented at the American Heart Association scientific meeting in Orlando, was tiny in scope with only 208 patients participating.
This is bad news for Merck. The company’s Zetia has had negative news in previous trials. Also, sales of Vytorin have stumbled in recent years.
This is bad news for Merck. The company’s Zetia has had negative news in previous trials. Also, sales of Vytorin have stumbled in recent years.
Brilinta Trumps Plavix
AstraZeneca’s Brilinta topples Bristol-Myers Squibb and Sanofi-Aventis’ Plavix in a head-to-head trial – again. Previous trials showed similar results. Brilinta prevented more serious cardiovascular events and deaths than Plavix. Brilinta seems to have an equivalent safety profile.
This study was an analysis of over 8,400 of the sickest patients from the large PLATO trial – which looked at over 18,000 patients internationally.
AstraZeneca will be filing for U.S. approval for Brilinta soon and the company expects approval early next year. This is good news for AstraZeneca as it hopes to steal some of Plavix’s $9 billion in sales.
This study was an analysis of over 8,400 of the sickest patients from the large PLATO trial – which looked at over 18,000 patients internationally.
AstraZeneca will be filing for U.S. approval for Brilinta soon and the company expects approval early next year. This is good news for AstraZeneca as it hopes to steal some of Plavix’s $9 billion in sales.
Thursday, November 12, 2009
Smoking Increases – It’s Cool Again
In addition to acknowledging its underestimated of H1N1 deaths earlier today, the CDC also acknowledged that adult smoking rates have increased for the first time in decades. Adult smokers are now back over the critical 20% threshold.
I all but predicted this in a recent posting Politics and the Failure of Public Health. In that posting I noted that the CDC has all but given up on solving the problems of chronic disease and we know that smoking is at the root of many of those conditions – heart disease, cancer, obesity and a host of others.
In that posting, I also questioned whether the CDC’s lack of efforts in reducing smoking have something to do with our Smoker in Chief – President Barack Obama. Obama has made smoking cool again. There’s a swagger to being a smoker now that hasn’t existed in many years. The CDC’s head Dr. Thomas R. Frieden has made a crusade against smoking – a mission he seems to have promptly abandoned once he received his appointment from President Obama.
Chronic disease is a critical health issue. This is an area calling out for CDC leadership – and leadership from Dr. Thomas Frieden. Hopefully Dr. Frieden and the CDC will take today’s news to heart and begin focusing on fighting chronic disease in America.
Reference: Wall Street Journal
I all but predicted this in a recent posting Politics and the Failure of Public Health. In that posting I noted that the CDC has all but given up on solving the problems of chronic disease and we know that smoking is at the root of many of those conditions – heart disease, cancer, obesity and a host of others.
In that posting, I also questioned whether the CDC’s lack of efforts in reducing smoking have something to do with our Smoker in Chief – President Barack Obama. Obama has made smoking cool again. There’s a swagger to being a smoker now that hasn’t existed in many years. The CDC’s head Dr. Thomas R. Frieden has made a crusade against smoking – a mission he seems to have promptly abandoned once he received his appointment from President Obama.
Chronic disease is a critical health issue. This is an area calling out for CDC leadership – and leadership from Dr. Thomas Frieden. Hopefully Dr. Frieden and the CDC will take today’s news to heart and begin focusing on fighting chronic disease in America.
Reference: Wall Street Journal
H1N1 Death Tolls Soars
The CDC has previously estimated only 1,000 deaths due to H1N1 flu…until today. The CDC has finally begun acknowledging what medical professionals across the country have known for over a month. The CDC has finally come clean indicating that 3,9000 have died from the swine flu. This is the just going to be the tip of the iceberg.
While many have suspected that the CDC’s low-ball assessments were politically motivated, I’m going to cut the agency some slack and assume that they are just completely overwhelmed by the outbreak. Of course, they are also woefully under supported.
However, today’s OpEd on MSNBC really hit the nail on the head – calling the White House’s flu response “dismal at best.” The article states, “The Obama administration bears much of the blame for the fear the public and health care workers have of the swine flu vaccine.”
While President Barack Obama has finally declared a state of emergency and finally started paying attention, many critical months were lost when the country had the opportunity to respond. Clearly, Obama’s trust in HHS Secretary Kathleen Sebelius was misplaced at best.
Hang on, it’s going to get a lot worse before it gets better.
Reference: LA Times and MSNBC
While many have suspected that the CDC’s low-ball assessments were politically motivated, I’m going to cut the agency some slack and assume that they are just completely overwhelmed by the outbreak. Of course, they are also woefully under supported.
However, today’s OpEd on MSNBC really hit the nail on the head – calling the White House’s flu response “dismal at best.” The article states, “The Obama administration bears much of the blame for the fear the public and health care workers have of the swine flu vaccine.”
While President Barack Obama has finally declared a state of emergency and finally started paying attention, many critical months were lost when the country had the opportunity to respond. Clearly, Obama’s trust in HHS Secretary Kathleen Sebelius was misplaced at best.
Hang on, it’s going to get a lot worse before it gets better.
Reference: LA Times and MSNBC
Friday, November 6, 2009
IMS Health Sells Out
As predicted a few weeks ago, IMS Health has sold itself to private equity for $5.2 billion ($4 billion in actual transaction, plus the acquisition of another $1.2 billion in debt). The buyers were private equity firms Texas Pacific Group (TPG) and the Canadian Pension Plan (CPP) Investment Board. The deal works out to $22 a share. I’d look for the new owners to break up the company – slipping the high-profit prescription data business from the consulting organization.
IMS has really struggled since the current CEO, David Carlucci, took over. The company recently lost a very high-profile legal challenge against the State of New Hampshire prohibiting sales of prescription data that identify individual physicians (there’s a little more to it). IMS vigorously defended itself in a costly legal battle that tapped the company of a significant amount of cash and proved to be a considerable distraction with customers.
Already, some law firms are looking into the deal on behalf of shareholders. While the deal represents a nice premium over the last 12 months (IMS’ shares have been in the toilet since long before the recession hit), it is well below the $31.49 of October 2007 – just two short years ago (and the high $20’s where the stock has traded for much of the past 5 years).
This deal is a rather significant windfall for IMS executives who received thousands of shares over the last few years. This deal is also the end of the once-formidable pharmaceutical market research firm. The only remaining question is: which company will take over reins in the industry?
IMS has really struggled since the current CEO, David Carlucci, took over. The company recently lost a very high-profile legal challenge against the State of New Hampshire prohibiting sales of prescription data that identify individual physicians (there’s a little more to it). IMS vigorously defended itself in a costly legal battle that tapped the company of a significant amount of cash and proved to be a considerable distraction with customers.
Already, some law firms are looking into the deal on behalf of shareholders. While the deal represents a nice premium over the last 12 months (IMS’ shares have been in the toilet since long before the recession hit), it is well below the $31.49 of October 2007 – just two short years ago (and the high $20’s where the stock has traded for much of the past 5 years).
This deal is a rather significant windfall for IMS executives who received thousands of shares over the last few years. This deal is also the end of the once-formidable pharmaceutical market research firm. The only remaining question is: which company will take over reins in the industry?
Wednesday, November 4, 2009
A New Look for Pharm Aid
Change is in the air. That holds true for Pharm Aid. We’ve just launched our new logo, both here and on Twitter. Let me know how you like it.
Tuesday, November 3, 2009
Health Reform Fuels Job Losses
Healthcare reform efforts are driving further job cuts in the healthcare, pharmaceutical and medical device industries. What started as a rationalization of sales forces and a response to the global recession has accelerated in response to health finance reform legislation pending before Congress.
As noted in the Wall Street Journal Health Blog, there have been significant cuts. Today, Johnson & Johnson announced 8,000 jobs will be cut. Previous major layoffs include the Pfizer/Wyeth 20,000 cut, Eli Lilly’s decision to cut 5,000 jobs, and AstraZeneca’s 7,000 job elimination. And by adding them up, the Wall Street Journal gets to 40,000 job cuts.
I believe that is underestimated by at least half. And here’s why. These were only the major cuts and the only the ones that caught big headlines. There have been many other more subtle layoffs, including Merck/Schering (16,000) that will materialize soon, Caraco Pharmaceuticals (450), BMS (113 in Indiana), and Charles River (115). Other companies have not quantified their layoffs.
Most bluntly, Boston Scientific CEO Ray Elliott has indicated that Obamacare would cost his company an additional 1,000-2,000 jobs.
Into this fray, countries are stepping in and making a valiant pitch to American and European companies to outsource jobs there. These countries offer compelling financial incentives without any of the entanglements offered by the Obama regime.
One thing is certain, healthcare reform as envisioned by President Obama will accelerate American job losses.
As noted in the Wall Street Journal Health Blog, there have been significant cuts. Today, Johnson & Johnson announced 8,000 jobs will be cut. Previous major layoffs include the Pfizer/Wyeth 20,000 cut, Eli Lilly’s decision to cut 5,000 jobs, and AstraZeneca’s 7,000 job elimination. And by adding them up, the Wall Street Journal gets to 40,000 job cuts.
I believe that is underestimated by at least half. And here’s why. These were only the major cuts and the only the ones that caught big headlines. There have been many other more subtle layoffs, including Merck/Schering (16,000) that will materialize soon, Caraco Pharmaceuticals (450), BMS (113 in Indiana), and Charles River (115). Other companies have not quantified their layoffs.
Most bluntly, Boston Scientific CEO Ray Elliott has indicated that Obamacare would cost his company an additional 1,000-2,000 jobs.
Into this fray, countries are stepping in and making a valiant pitch to American and European companies to outsource jobs there. These countries offer compelling financial incentives without any of the entanglements offered by the Obama regime.
One thing is certain, healthcare reform as envisioned by President Obama will accelerate American job losses.
Obama Promises H1N1 Vaccine - Again
While I previously wrote about the White House Admission of Significant Mistakes on H1N1, things have deteriorated over the last 48 hours. Obama mouthpiece Robert Gibbs noted that President Barack Obama is frustrated with the H1N1 flu vaccine shortage. Gibbs also promised that President Barack Obama is personally tackling this issue “each and every day to fix this.”
That’s terrific, but President Obama needs to take much of the responsibility for the current H1N1 vaccine mess. It’s absolutely negligent that President Obama has waited so long to take H1N1 seriously. While President Obama spent 24 days golfing or taking a lavish vacation on Martha's Vineyard, H1N1 could have been addressed in a meaningful and significant way. Let’s face it – President Obama’s actions have been far too little. Now that Obama has his head out of wherever it was, hopefully it isn’t too late.
Don’t get me wrong, H1N1 isn’t an issue that the President needs to personally solve. Unfortunately, President Obama nominated Kathleen Sebelius to the job of HHS Secretary and that’s when the trouble started, so now Obama needs to compensate for Sebelius' significant shortcomings. Secretary Sebelius looks great in a St. John’s suit, she’s a staunch supporter of abortion and she's a great fundraiser for the Democratic Party. Unfortunately, that’s where Kathleen Sebelius’ qualifications end. She is woefully ignorant of healthcare issues and is in way over her head on public health issues like disease outbreaks. One has to wonder if we had a competent HHS Secretary whether we’d be in the same pickle we’re in.
Unfortunately, the Obama Administration has had yet another misstep with the H1N1 vaccine. While millions of Americans can’t get access to the vaccine, the Defense Department has announced that terrorist detainees at Guantanamo Bay will receive the H1N1 shots. Obama spokesman Robert Gibbs quickly backtracked saying that terrorist suspects won’t receive the vaccine because: 1) there is no vaccine currently in Guantanamo Bay and 2) there is no H1N1 vaccine currently being shipped to Guantanamo. The Pentagon noted that Gibbs is technically correct at this point in time, but immunization of Guantanamo inmates will commence later this month – long before millions of American citizens have access to the vaccine. That’s a huge political embarrassment for President Obama.
I’m glad Obama is finally taking H1N1 seriously, but I resent that thousands of Americans are dying of flu while President Obama has been distracted by his extracurricular activities – golfing, basketball, finding a dog for his daughters and lavish vacations in Martha’s Vineyard. We’re in the middle of a public health crisis and it’s time for President Obama get in the game.
Source: Reuters
That’s terrific, but President Obama needs to take much of the responsibility for the current H1N1 vaccine mess. It’s absolutely negligent that President Obama has waited so long to take H1N1 seriously. While President Obama spent 24 days golfing or taking a lavish vacation on Martha's Vineyard, H1N1 could have been addressed in a meaningful and significant way. Let’s face it – President Obama’s actions have been far too little. Now that Obama has his head out of wherever it was, hopefully it isn’t too late.
Don’t get me wrong, H1N1 isn’t an issue that the President needs to personally solve. Unfortunately, President Obama nominated Kathleen Sebelius to the job of HHS Secretary and that’s when the trouble started, so now Obama needs to compensate for Sebelius' significant shortcomings. Secretary Sebelius looks great in a St. John’s suit, she’s a staunch supporter of abortion and she's a great fundraiser for the Democratic Party. Unfortunately, that’s where Kathleen Sebelius’ qualifications end. She is woefully ignorant of healthcare issues and is in way over her head on public health issues like disease outbreaks. One has to wonder if we had a competent HHS Secretary whether we’d be in the same pickle we’re in.
Unfortunately, the Obama Administration has had yet another misstep with the H1N1 vaccine. While millions of Americans can’t get access to the vaccine, the Defense Department has announced that terrorist detainees at Guantanamo Bay will receive the H1N1 shots. Obama spokesman Robert Gibbs quickly backtracked saying that terrorist suspects won’t receive the vaccine because: 1) there is no vaccine currently in Guantanamo Bay and 2) there is no H1N1 vaccine currently being shipped to Guantanamo. The Pentagon noted that Gibbs is technically correct at this point in time, but immunization of Guantanamo inmates will commence later this month – long before millions of American citizens have access to the vaccine. That’s a huge political embarrassment for President Obama.
I’m glad Obama is finally taking H1N1 seriously, but I resent that thousands of Americans are dying of flu while President Obama has been distracted by his extracurricular activities – golfing, basketball, finding a dog for his daughters and lavish vacations in Martha’s Vineyard. We’re in the middle of a public health crisis and it’s time for President Obama get in the game.
Source: Reuters
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