Latest Drugwonks' Blog
Days before the advisory committee hearing on Ketek's risk/benefit profile guess who sends a letter to the NEJM claiming that the FDA's use of post market safety data in approving the drug was inappropriate?
David Graham.
But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.
I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.
I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.
He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...
If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.
David Graham.
But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.
I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.
I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.
He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...
If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.
Let me remind everyone that Dr. Graham's famous memo on Vioxx did not adequately control for prior cardiovascular illness, obesity, hypertension or mixture thereof and that notwithstanding Grahama found a 1.47 relative risk of a significant cardiac event for low-dose Vioxx usage and 3.58 for high-dose Vioxx usage compared to current use of celecoxib, though the smaller number was not statistically significant, and relative risk compared to other populations was not statistically significance.
Further, it should be pointed that two advisory committees, one conducted by the FDA and another in Canada determined that Vioxx be returned to market. Dr. Graham's presentation at the FDA advisory committee was not as warmly received as the posterior polishing he received during his Senate presentation.
Do I apologize for logging on to our site to see the fake Graham posting and then responding from Israel and then rushing out to spend time with my family without reading the subsequent correction? Absolutely. Do I apologize for calling him a sad sick individual for equating the FDA with Nazi's when in fact he did nothing of the sort. Of course and it sickens me that someone would write some that disgusting using his name or anyone elses. While I strongly disagree with Graham and his approach, no one deserves such treatmen.
Does it bother me that Graham's lawyer implies that I had reckless disregard for the facts and didn't take the time to see if there were an explanation instead of posturing like an aggrieved victim...kind of. Will the threat of a lawsuit stop me from criticizing Dr. Graham in the future if that was the goal?
You be the judge.
Further, it should be pointed that two advisory committees, one conducted by the FDA and another in Canada determined that Vioxx be returned to market. Dr. Graham's presentation at the FDA advisory committee was not as warmly received as the posterior polishing he received during his Senate presentation.
Do I apologize for logging on to our site to see the fake Graham posting and then responding from Israel and then rushing out to spend time with my family without reading the subsequent correction? Absolutely. Do I apologize for calling him a sad sick individual for equating the FDA with Nazi's when in fact he did nothing of the sort. Of course and it sickens me that someone would write some that disgusting using his name or anyone elses. While I strongly disagree with Graham and his approach, no one deserves such treatmen.
Does it bother me that Graham's lawyer implies that I had reckless disregard for the facts and didn't take the time to see if there were an explanation instead of posturing like an aggrieved victim...kind of. Will the threat of a lawsuit stop me from criticizing Dr. Graham in the future if that was the goal?
You be the judge.
Just received this letter from David Graham's attorney:
Dear Center for Medicine in the Public Interest:
First, thank you for acknowledging on DrugWonks.com that the opinion piece entitled “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†was not, in fact, authored by Dr. David Graham.
Having so acknowledged this fact, we would assume that DrugWonks.com would take the honorable and, we believe, legally mandated step of removing all the postings related to this matter that defame Dr. Graham. Not only did this not happen, DrugWonks.com actually posted an item, “My PS to David Graham†by Robert Goldberg, describing Dr. Graham, among other things as “a sad, sick individual,†after acknowledging that Dr. Graham was not the author of the aforementioned opinion piece.
In our view this Goldberg posting, and the failure to remove the prior postings by Peter Pittts related to this matter, exhibit actual malice toward Dr. Graham and an intentional or reckless disregard for the truth or falsity of these postings. Bluntly, they meet the legal standard of defamation.
Therefore, we must demand that, by 4 pm EST today (Tuesday, November 21, 2006):
(1) DrugWonks.com remove all postings associating Dr. Graham with “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†and any negative insinuations about Dr. Graham related to this matter;
(2) Publish, at the top of the home page of DrugWonks.com, a bold-face, unqualified apology to Dr. Graham as follows: “DrugWonks.com, the Center for Medicine in the Public Interest, Peter Pitts and Robert Goldberg apologize to Dr. David Graham for posting intemperate and insulting comments about Dr. Graham, wrongly attributing to him the authorship of “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity.†We regret any inconvenience or harm this has caused Dr. Graham.â€
Well, we want to do the right thing. And we certainly want Dr. Graham and his lawyers to think we're honorable. And, of course, we'd never want to be intemperate and insulting! Furtherest thing from our minds. But, David, you were also clearly inflamed by the article , so we hope you can see where we were coming from.
Please accept our most sincere apologies. And we regret any inconvenience this has caused you.
And, here's an open offer -- please send us your thoughts on the article that you didn't write and we will run it on drugwonks.com. Since it evidently caused you such grief, we'd like to give you the opportunity to set the record straight.
Your lawyer knows how to reach us.
Dear Center for Medicine in the Public Interest:
First, thank you for acknowledging on DrugWonks.com that the opinion piece entitled “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†was not, in fact, authored by Dr. David Graham.
Having so acknowledged this fact, we would assume that DrugWonks.com would take the honorable and, we believe, legally mandated step of removing all the postings related to this matter that defame Dr. Graham. Not only did this not happen, DrugWonks.com actually posted an item, “My PS to David Graham†by Robert Goldberg, describing Dr. Graham, among other things as “a sad, sick individual,†after acknowledging that Dr. Graham was not the author of the aforementioned opinion piece.
In our view this Goldberg posting, and the failure to remove the prior postings by Peter Pittts related to this matter, exhibit actual malice toward Dr. Graham and an intentional or reckless disregard for the truth or falsity of these postings. Bluntly, they meet the legal standard of defamation.
Therefore, we must demand that, by 4 pm EST today (Tuesday, November 21, 2006):
(1) DrugWonks.com remove all postings associating Dr. Graham with “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†and any negative insinuations about Dr. Graham related to this matter;
(2) Publish, at the top of the home page of DrugWonks.com, a bold-face, unqualified apology to Dr. Graham as follows: “DrugWonks.com, the Center for Medicine in the Public Interest, Peter Pitts and Robert Goldberg apologize to Dr. David Graham for posting intemperate and insulting comments about Dr. Graham, wrongly attributing to him the authorship of “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity.†We regret any inconvenience or harm this has caused Dr. Graham.â€
Well, we want to do the right thing. And we certainly want Dr. Graham and his lawyers to think we're honorable. And, of course, we'd never want to be intemperate and insulting! Furtherest thing from our minds. But, David, you were also clearly inflamed by the article , so we hope you can see where we were coming from.
Please accept our most sincere apologies. And we regret any inconvenience this has caused you.
And, here's an open offer -- please send us your thoughts on the article that you didn't write and we will run it on drugwonks.com. Since it evidently caused you such grief, we'd like to give you the opportunity to set the record straight.
Your lawyer knows how to reach us.
While we are certainly drugwonks, it's important not to forget that one of the most important ways to achieve and maintain good health is through proper diet and nutrition.
Remember, it's the FDA.
I was proud to have been a part of the FDA's Task Force on Consumer Health Information for Better Nutrition. One of our recommendations was that the agency move more swiftly and aggressively to approve qualified health claims for food -- making their value to America's health more transparent and potent from a labeling perspective.
Today's news is that CFSAN (the Center for Food Safety and Applied Nutrition) has received OMB approval for a study on how to best communicate qualified health claims to consumers.
After all, information that isn't properly understood by the consumer isn't worth the label its written on.
Remember, it's the FDA.
I was proud to have been a part of the FDA's Task Force on Consumer Health Information for Better Nutrition. One of our recommendations was that the agency move more swiftly and aggressively to approve qualified health claims for food -- making their value to America's health more transparent and potent from a labeling perspective.
Today's news is that CFSAN (the Center for Food Safety and Applied Nutrition) has received OMB approval for a study on how to best communicate qualified health claims to consumers.
After all, information that isn't properly understood by the consumer isn't worth the label its written on.
USA Today reported yesterday that Medicaid spending as a whole actually declined for the first time since 1965. I have not looked at the data yet and plan to but at first glance it would seem to me that increased utilization of medications -- particularly among the dually eligible population and those in nursing homes -- might be saving money in the more labor intensive parts of the health care system.
ere's a link to the article.
http://www.usatoday.com/printedition/news/20061127/1a_lede27.art.htm
The article notes: "The changes include shifting the elderly from nursing homes to less-costly home health care, cracking down on fraud, refining the management of high-cost patients (such as those with AIDS or hemophilia) and cutting some payments to hospitals and doctors. " Unstated is the fact that such changes rely upon increased drug utilization via disease management programs. At the same time, the question has to be raised as to whether states are simply cutting costs by simply denying care in isolated instances. But then again, the Part D experience has moved control of the drug benefit into the hands of consumers and advocates, albeit with some initial bumps and disruptions which CMS and a motivated crew of stakeholders has promised to rectify this enrollment period. All the more reason to shift resources from providers to consumers...
If so, and I promise to follow up on this premise, it is yet another reason why restricting seniors choice of drugs to fill the dough nut hole for rich seniors makes no sense at all. And why the Part D experiment should be expanded to include Medicaid as a common sense coalition of Ds and Rs are proposing in Congress. The link to this article can be found here.
http://www.jsonline.com/story/index.aspx?id=535435
H
ere's a link to the article.
http://www.usatoday.com/printedition/news/20061127/1a_lede27.art.htm
The article notes: "The changes include shifting the elderly from nursing homes to less-costly home health care, cracking down on fraud, refining the management of high-cost patients (such as those with AIDS or hemophilia) and cutting some payments to hospitals and doctors. " Unstated is the fact that such changes rely upon increased drug utilization via disease management programs. At the same time, the question has to be raised as to whether states are simply cutting costs by simply denying care in isolated instances. But then again, the Part D experience has moved control of the drug benefit into the hands of consumers and advocates, albeit with some initial bumps and disruptions which CMS and a motivated crew of stakeholders has promised to rectify this enrollment period. All the more reason to shift resources from providers to consumers...
If so, and I promise to follow up on this premise, it is yet another reason why restricting seniors choice of drugs to fill the dough nut hole for rich seniors makes no sense at all. And why the Part D experiment should be expanded to include Medicaid as a common sense coalition of Ds and Rs are proposing in Congress. The link to this article can be found here.
http://www.jsonline.com/story/index.aspx?id=535435
H
At what point will Democrats realize that the pledge to force government to negotiate directly with drug AND biotech companies will rob seniors of their choice of medicines and re-run of Hillarycare when biotech stocks lost 40 percent of their market value?
Interesting how the media is already laying the groundwork for this angle as this series of quotes suggest:
"From a rhetorical perspective, Democrats may feel like they gain a lot with this issue, but there are many substantive hurdles that the government faces in trying to negotiate prices. … If you look historically at the government's experience in trying to regulate prices, it's poor." (Ricardo Alonso-Zaldivar, "On Drug Prices, Are Democrats In A Fix?" Los Angeles Times, 11/26/06)
Marilyn Moon, Health Program Director, The American Institutes For Research: Negotiating Drug Prices Is "A Feel-Good Kind Of Answer, But It's Not One That Is Easy To Imagine How You Put Into Practice." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
The Wall Street Journal: "It Isn't Clear That A Government-Run Drug Insurance Plan Would Push Prices Down." "Private plans often rely on pharmacy benefit managers, or PBMs, to obtain rebates and discounts with manufacturers and contain costs. But Medicare has traditionally been a fee-for-service program, without much experience in price negotiation." (Jane Zhang, "Why Medicare Drugs May Be Sticking Point," The Wall Street Journal, 11/24/06)
"Leslie Norwalk, acting administrator of the Centers for Medicare & Medicaid Services, the agency that manages Medicare, says she doubts Medicare would do a better job than private insurers in negotiating drug prices. Indeed, the agency probably would contract with PBMs to do the work. 'They are doing that already,' she said at a recent meeting with The Wall Street Journal." (Jane Zhang, "Why Medicare Drugs May Be Sticking Point," The Wall Street Journal, 11/24/06)
Urban Institute President Robert D. Reischauer: "At Some Point You Have To Ask: What Are We Looking For Here?" "Initially, he said, people were worried no private plans would participate. 'Then too many plans came forward,' Reischauer said. 'Then people said it's going to cost a fortune. And the price came in lower than anybody thought. Then people like me said they're low-balling the prices the first year and they'll jack up the rates down the line. And, lo and behold, the prices fell again. And the reaction was, "We've got to have the government negotiate lower prices." At some point you have to ask: What are we looking for here?'" (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
"The cost of the program has been lower than expected, about $26 billion in 2006, according to the nonpartisan Congressional Budget Office. The cost was projected to rise to $45 billion next year, but Medicare has received new bids indicating that its average per-person subsidy could drop by 15 percent in 2007, to $79.90 a month." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
Polls Show More Than 80 Percent Of Medicare Drug Plan Participants Are Satisfied. "Polls indicate that more than 80 percent of enrollees are satisfied, even though nearly half chose plans with no coverage in the doughnut hole, a gap that opens when a senior's drug costs reach $2,250 and closes when out-of-pocket expenses reach $3,600." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
Interesting how the media is already laying the groundwork for this angle as this series of quotes suggest:
"From a rhetorical perspective, Democrats may feel like they gain a lot with this issue, but there are many substantive hurdles that the government faces in trying to negotiate prices. … If you look historically at the government's experience in trying to regulate prices, it's poor." (Ricardo Alonso-Zaldivar, "On Drug Prices, Are Democrats In A Fix?" Los Angeles Times, 11/26/06)
Marilyn Moon, Health Program Director, The American Institutes For Research: Negotiating Drug Prices Is "A Feel-Good Kind Of Answer, But It's Not One That Is Easy To Imagine How You Put Into Practice." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
The Wall Street Journal: "It Isn't Clear That A Government-Run Drug Insurance Plan Would Push Prices Down." "Private plans often rely on pharmacy benefit managers, or PBMs, to obtain rebates and discounts with manufacturers and contain costs. But Medicare has traditionally been a fee-for-service program, without much experience in price negotiation." (Jane Zhang, "Why Medicare Drugs May Be Sticking Point," The Wall Street Journal, 11/24/06)
"Leslie Norwalk, acting administrator of the Centers for Medicare & Medicaid Services, the agency that manages Medicare, says she doubts Medicare would do a better job than private insurers in negotiating drug prices. Indeed, the agency probably would contract with PBMs to do the work. 'They are doing that already,' she said at a recent meeting with The Wall Street Journal." (Jane Zhang, "Why Medicare Drugs May Be Sticking Point," The Wall Street Journal, 11/24/06)
Urban Institute President Robert D. Reischauer: "At Some Point You Have To Ask: What Are We Looking For Here?" "Initially, he said, people were worried no private plans would participate. 'Then too many plans came forward,' Reischauer said. 'Then people said it's going to cost a fortune. And the price came in lower than anybody thought. Then people like me said they're low-balling the prices the first year and they'll jack up the rates down the line. And, lo and behold, the prices fell again. And the reaction was, "We've got to have the government negotiate lower prices." At some point you have to ask: What are we looking for here?'" (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
"The cost of the program has been lower than expected, about $26 billion in 2006, according to the nonpartisan Congressional Budget Office. The cost was projected to rise to $45 billion next year, but Medicare has received new bids indicating that its average per-person subsidy could drop by 15 percent in 2007, to $79.90 a month." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
Polls Show More Than 80 Percent Of Medicare Drug Plan Participants Are Satisfied. "Polls indicate that more than 80 percent of enrollees are satisfied, even though nearly half chose plans with no coverage in the doughnut hole, a gap that opens when a senior's drug costs reach $2,250 and closes when out-of-pocket expenses reach $3,600." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)
In a new report from London's School of Pharmacy, Professor David Taylor (a contributor to the new CMPI/CNE book “Coincidence or Crisisâ€) points out: "The present system encourages traders to buy modern medicines cheaply in parts of Europe where governments impose low prices, and sell them on in new packages in EU member states where government controlled prices are higher. People think this saves money. But the evidence explored in our report indicates that it is in fact undermining European economic interests and may, on occasions, have created a pharmacy culture that increases counterfeit medicine hazards."
The report calls for stronger legal penalties for medicine counterfeiting and say they also support reform in other areas, from greater freedom of regulated medicines information provision in Europe to better controls over internet pharmacy and medicines trading. Importantly, the School of Pharmacy backs a strong patent system to fund medicines research and says without assets such as the research-based pharmaceutical industry "Europe's economic future will be bleak."
If you would like a copy of "Coincidence or Crisis," please send an email to ppitts@cmpi.org.
The report calls for stronger legal penalties for medicine counterfeiting and say they also support reform in other areas, from greater freedom of regulated medicines information provision in Europe to better controls over internet pharmacy and medicines trading. Importantly, the School of Pharmacy backs a strong patent system to fund medicines research and says without assets such as the research-based pharmaceutical industry "Europe's economic future will be bleak."
If you would like a copy of "Coincidence or Crisis," please send an email to ppitts@cmpi.org.
Here's a great example of how medicine and the private sector are transitioning to prospective and personalized care...with BG Medicine (called Beyond Genomics in this article) a company that was involved in the FDA task force I chaired when I was at the Manhattan Institute, helping build the foundation with bioinformatics...
Drug and device firms invest in study of plaque to find trigger for heart attacks (11-26-06)
The International Herald Tribune
New York, 11/27/2006 - Most people have a clear image of how atherosclerosis, popularly known as hardening of the arteries, causes a heart attack: fatty deposits called plaque build up in a coronary artery until the day the blood flow that sustains the heart is blocked.
If only they were right. In reality, coronary artery blockages almost always cause chest pain known as angina and other symptoms as they form. But half of the men and two-thirds of the women who suffer heart attacks never experience warning symptoms.
And autopsies of such victims frequently show blood clots jammed into arteries that have been only modestly narrowed.
Standard atherosclerosis therapies include bypass surgery to route blood around blockages, angioplasty and stenting to clear blockages from inside the artery and drugs like statins that reduce cholesterol levels to slow the formation of plaque. But they have not been enough to prevent as many as 500,000 deaths a year in the United States alone from what doctors call coronary artery disease.
As a result, many researchers have turned their attention from atherosclerosis in general to the tendency of some patients to develop a form of plaque prone to inflammation and rupture, which can spill a stew of cells into the bloodstream that can incite rapid clotting.
Such plaques have been called "vulnerable" plaque." But little is known about how such plaques form and even less about how long they last or what makes them rupture.
"Figuring out who is going to have plaque rupture would be the Holy Grail of cardiology," said Deepak Bhatt, a leading research cardiologist at the Cleveland Clinic Foundation.
The broadest effort yet to do that was to be announced Monday by a consortium pledging to invest $30 million over the next four years in an international plaque research program that will be overseen by Valentin Fuster, a cardiologist at Mount Sinai Medical Center in New York.
The initial sponsors include Humana, a leading manager of health plans; AstraZeneca and Merck, from the drug industry; Philips Electronics, which makes diagnostic machines widely used to scan the heart, the arteries that supply it with blood and other parts of the circulatory system; and BG Medicine, a start-up in Waltham, Massachusetts, formerly known as Beyond Genomics.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope that the profiles that emerge from the study will show patterns pointing to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create therapeutic products.
The payoff could be enormous for health care companies. Coronary stents, which limit the symptoms of atherosclerosis and the damage from heart attacks, but do not reduce the likelihood of future attacks, make up a $6 billion market for device makers and produce some of the biggest profit margins the industry has ever seen.
Drug makers have fared even better with statins, which partially reduce the risk of new attacks and top $20 billion in worldwide sales.
"How we treat the disease is up for grabs," said Andrew Plump, who monitors early-stage research on new cardiovascular medicines at Merck's research center in Rahway, New Jersey.
The initiative spotlights the growing lineup of research projects and technology investments that reflect competition between drug makers and device companies to develop the safest, most effective and cheapest products to combat atherosclerosis.
Drug and device firms invest in study of plaque to find trigger for heart attacks (11-26-06)
The International Herald Tribune
New York, 11/27/2006 - Most people have a clear image of how atherosclerosis, popularly known as hardening of the arteries, causes a heart attack: fatty deposits called plaque build up in a coronary artery until the day the blood flow that sustains the heart is blocked.
If only they were right. In reality, coronary artery blockages almost always cause chest pain known as angina and other symptoms as they form. But half of the men and two-thirds of the women who suffer heart attacks never experience warning symptoms.
And autopsies of such victims frequently show blood clots jammed into arteries that have been only modestly narrowed.
Standard atherosclerosis therapies include bypass surgery to route blood around blockages, angioplasty and stenting to clear blockages from inside the artery and drugs like statins that reduce cholesterol levels to slow the formation of plaque. But they have not been enough to prevent as many as 500,000 deaths a year in the United States alone from what doctors call coronary artery disease.
As a result, many researchers have turned their attention from atherosclerosis in general to the tendency of some patients to develop a form of plaque prone to inflammation and rupture, which can spill a stew of cells into the bloodstream that can incite rapid clotting.
Such plaques have been called "vulnerable" plaque." But little is known about how such plaques form and even less about how long they last or what makes them rupture.
"Figuring out who is going to have plaque rupture would be the Holy Grail of cardiology," said Deepak Bhatt, a leading research cardiologist at the Cleveland Clinic Foundation.
The broadest effort yet to do that was to be announced Monday by a consortium pledging to invest $30 million over the next four years in an international plaque research program that will be overseen by Valentin Fuster, a cardiologist at Mount Sinai Medical Center in New York.
The initial sponsors include Humana, a leading manager of health plans; AstraZeneca and Merck, from the drug industry; Philips Electronics, which makes diagnostic machines widely used to scan the heart, the arteries that supply it with blood and other parts of the circulatory system; and BG Medicine, a start-up in Waltham, Massachusetts, formerly known as Beyond Genomics.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope that the profiles that emerge from the study will show patterns pointing to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create therapeutic products.
The payoff could be enormous for health care companies. Coronary stents, which limit the symptoms of atherosclerosis and the damage from heart attacks, but do not reduce the likelihood of future attacks, make up a $6 billion market for device makers and produce some of the biggest profit margins the industry has ever seen.
Drug makers have fared even better with statins, which partially reduce the risk of new attacks and top $20 billion in worldwide sales.
"How we treat the disease is up for grabs," said Andrew Plump, who monitors early-stage research on new cardiovascular medicines at Merck's research center in Rahway, New Jersey.
The initiative spotlights the growing lineup of research projects and technology investments that reflect competition between drug makers and device companies to develop the safest, most effective and cheapest products to combat atherosclerosis.
According to a WSJ.com/Harris Interactive health-care poll U.S. adults are divided on whether doctors should be allowed to prescribe drugs to treat diseases or conditions other than those for which they have been approved.
45% of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.
Frighteningly, nearly two-thirds say they would agree to prohibit off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations. Attention must be paid – this is the slippery slope that the Apostles of Evidence-based Medicine would have us follow – to disastrous consequences.
Fortunately, when put into the appropriate perspective, Americans don't want to hamper innovation. 55% believe that if doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases vs. 35% who disagree.
More than two-thirds believe drug companies shouldn't be “allowed to encourage†off-label use vs. 12% who disagree and 20% who aren't sure. Perhaps a better way to have framed that question would have been to have asked if drug companies should be “allowed to share valid clinical information†about off-label use?
One wonders if the pollsters screened out as respondents patients with cancer, multiple sclerosis, etc. and their family members. And, if not, how that segment answered the questions.
For that we do not need a research project – we need a robust Critical Path program.
45% of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.
Frighteningly, nearly two-thirds say they would agree to prohibit off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations. Attention must be paid – this is the slippery slope that the Apostles of Evidence-based Medicine would have us follow – to disastrous consequences.
Fortunately, when put into the appropriate perspective, Americans don't want to hamper innovation. 55% believe that if doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases vs. 35% who disagree.
More than two-thirds believe drug companies shouldn't be “allowed to encourage†off-label use vs. 12% who disagree and 20% who aren't sure. Perhaps a better way to have framed that question would have been to have asked if drug companies should be “allowed to share valid clinical information†about off-label use?
One wonders if the pollsters screened out as respondents patients with cancer, multiple sclerosis, etc. and their family members. And, if not, how that segment answered the questions.
For that we do not need a research project – we need a robust Critical Path program.
"The newly empowered Democrats' vow to cut healthcare costs might spell bad news for the brand-name pharmaceutical industry, but could provide new momentum for generic drug rivals, the Wall Street Journal reported on its Web site on Tuesday. "
.How could more competition be bad? Unless of course Dems want to protect generic companies from competition in the process,.,,If the GOP is smart, they will respond with measures to accelerate and encourage development of new drugs too -- as well as protect authorized generics -- since new drugs are the source of generic profits in the final analysis and authorized generics ultimately promote more price competition!
.How could more competition be bad? Unless of course Dems want to protect generic companies from competition in the process,.,,If the GOP is smart, they will respond with measures to accelerate and encourage development of new drugs too -- as well as protect authorized generics -- since new drugs are the source of generic profits in the final analysis and authorized generics ultimately promote more price competition!
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.
