Latest Drugwonks' Blog
Here’s how the Wall Street Journal story, “FDA Procedures Draw Scrutiny†begins, “Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar.â€
This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry†bandwagon. And it’s neither true nor accurate. It seems odd that one day the media is writing, pundits and pronouncing and politicians are orating about a parched pipeline and over-zealous regulators while in the next breath about the need for the agency to "raise the bar." Consistency? We don't need no stinking consistency.
And then there’s the bit about proxy markers.
Here’s what the Journal story has to say about that:
“ … proxy markers can be misleading. Sometimes a drug works on a proxy but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side effects that don't surface during initial proxy-marker studies but end up outweighing its benefit.â€
What? You mean using markers doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – there is no perfect predictor of either risk or benefit. And if we allow ourselves to poo-poo the significant advances that biomarkers deliver than we are heading down the slippery slope of the Precautionary Principle that warns us to “do nothing until we know everything.†Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB120122452254515507.html
The best way to help the FDA to “raise the bar†is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.
This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry†bandwagon. And it’s neither true nor accurate. It seems odd that one day the media is writing, pundits and pronouncing and politicians are orating about a parched pipeline and over-zealous regulators while in the next breath about the need for the agency to "raise the bar." Consistency? We don't need no stinking consistency.
And then there’s the bit about proxy markers.
Here’s what the Journal story has to say about that:
“ … proxy markers can be misleading. Sometimes a drug works on a proxy but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side effects that don't surface during initial proxy-marker studies but end up outweighing its benefit.â€
What? You mean using markers doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – there is no perfect predictor of either risk or benefit. And if we allow ourselves to poo-poo the significant advances that biomarkers deliver than we are heading down the slippery slope of the Precautionary Principle that warns us to “do nothing until we know everything.†Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB120122452254515507.html
The best way to help the FDA to “raise the bar†is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.
When I first published my paper on parallel trade of medicines in 2003 (http://www.cne.org/publications2.htm) there were no reported links between this phenomenon and counterfeit drugs in Europe. Today, it seems that this connection is increasingly established, unfortunately.
As pointed out here (http://www.pharmatimes.com/WorldNews/article.aspx?id=12674) the other day, the European Commission is gearing up to legislate on this after the summer. Commissioner Verheugen said before Parliament that packaging and labelling, and indeed product recalls pose a "considerable risk" to patient safety.
How’s that ? Parallel traders, admittedly a legal and legitimate business in the EU, have the right and are often obliged to interfere with the original manufacturer’s packaging (except for the blister packs) by re-boxing and re-labelling the goods, before re-exporting them. Patient leaflets need to be replaced when sending products intended for the Greek market to the UK, for instance. Parallel importers are in principle legally obliged to submit the modified packaging to the original supplier ; in practice, this is hard to enforce and therefore rarely occurs. And here’s the rub : as the supply chain is broken and packages are modified, there is opportunity to introduce both counterfeit, substandard or useless products.
Ultimately, parallel distribution hinges on the paradox by which EU member states set prices but goods are simultaneously free to circulate within the Union : Verheugen announced that solutions will be presented, but until further notice, pricing is not part of the EU’s remit. And free pricing will not be part of the member states' political agenda in the short or medium term; and only this would in effect resolve the issue, but it entails wholesale health care reform to get the government out of the sector.
As pointed out here (http://www.pharmatimes.com/WorldNews/article.aspx?id=12674) the other day, the European Commission is gearing up to legislate on this after the summer. Commissioner Verheugen said before Parliament that packaging and labelling, and indeed product recalls pose a "considerable risk" to patient safety.
How’s that ? Parallel traders, admittedly a legal and legitimate business in the EU, have the right and are often obliged to interfere with the original manufacturer’s packaging (except for the blister packs) by re-boxing and re-labelling the goods, before re-exporting them. Patient leaflets need to be replaced when sending products intended for the Greek market to the UK, for instance. Parallel importers are in principle legally obliged to submit the modified packaging to the original supplier ; in practice, this is hard to enforce and therefore rarely occurs. And here’s the rub : as the supply chain is broken and packages are modified, there is opportunity to introduce both counterfeit, substandard or useless products.
Ultimately, parallel distribution hinges on the paradox by which EU member states set prices but goods are simultaneously free to circulate within the Union : Verheugen announced that solutions will be presented, but until further notice, pricing is not part of the EU’s remit. And free pricing will not be part of the member states' political agenda in the short or medium term; and only this would in effect resolve the issue, but it entails wholesale health care reform to get the government out of the sector.
Aubrey Blumsohn who runs the scientific misconduct blog attacked us recently and I am trying to figure out why.
http://scientific-misconduct.blogspot.com/
Dr. Blumsohn is a researcher who, according to a report by NPR (a known front for Big Pharma), did not like the statistical analysis of the study he did for Proctor and Gamble. Blumsohn found out that 40 percent of the data was tossed out and was not happy, so he went public with the process.
The fact is, many researcher don't do their own analysis and rely on others to do the statistical analysis and select the statistical analysis and study design. This is changing and in many cases investigators do have control of the whole megillah. Indeed in many cases the drug or biotech companies themselves will rely on academics to take the lead. Blumsohn has presented the entire data set by the way though it has not been published as of yet.
I give Dr. Blumsohn credit for sticking to his guns with respect to the integrity of the data as he saw it. His university apparently wanted to give him cash to drop the whole matter and he told them no. You have to admire that sort of tenacity. We need more truth seeking everywhere. And everyone should post their clinical trials. Period.
But to suggest that because more of the clinical trials are funded by the private sector means more misconduct or a dearth of null studies is empirically wrong. The same goes for suggesting that receives pharma funding is corrupt and that only pharma funding is a source of conflict or that it always taints research outcomes. As a JAMA article on the subject noted: "Contrary to the often-voiced concern that major journals do not report null studies, we found that a substantial proportion of the cardiovascular trials published in JAMA, The Lancet, and the New England Journal of Medicine between 2000 and 2005 reported either no significant difference between therapies (34.6%) or a significant difference favoring SOC over newer treatments (6.8%). Furthermore, among trials funded solely by not-for-profit organizations, the proportion of trials not favoring innovation was 51.0% suggesting that, at least for these trials, evidence of publication bias is minimal."
But bias on the part of the scientific misconduct blogosphere does exist. It has constructed a conspiracy theory based on speculation, anecdotes and hubris.
The link to the NPR report, which Dr. Blumsohn seems not to have posted, is here:
http://www.npr.org/templates/story/story.php?
storyId=5234621
It is a balanced account of what happened.
The bias of the blogosphere is showing.
http://scientific-misconduct.blogspot.com/
Dr. Blumsohn is a researcher who, according to a report by NPR (a known front for Big Pharma), did not like the statistical analysis of the study he did for Proctor and Gamble. Blumsohn found out that 40 percent of the data was tossed out and was not happy, so he went public with the process.
The fact is, many researcher don't do their own analysis and rely on others to do the statistical analysis and select the statistical analysis and study design. This is changing and in many cases investigators do have control of the whole megillah. Indeed in many cases the drug or biotech companies themselves will rely on academics to take the lead. Blumsohn has presented the entire data set by the way though it has not been published as of yet.
I give Dr. Blumsohn credit for sticking to his guns with respect to the integrity of the data as he saw it. His university apparently wanted to give him cash to drop the whole matter and he told them no. You have to admire that sort of tenacity. We need more truth seeking everywhere. And everyone should post their clinical trials. Period.
But to suggest that because more of the clinical trials are funded by the private sector means more misconduct or a dearth of null studies is empirically wrong. The same goes for suggesting that receives pharma funding is corrupt and that only pharma funding is a source of conflict or that it always taints research outcomes. As a JAMA article on the subject noted: "Contrary to the often-voiced concern that major journals do not report null studies, we found that a substantial proportion of the cardiovascular trials published in JAMA, The Lancet, and the New England Journal of Medicine between 2000 and 2005 reported either no significant difference between therapies (34.6%) or a significant difference favoring SOC over newer treatments (6.8%). Furthermore, among trials funded solely by not-for-profit organizations, the proportion of trials not favoring innovation was 51.0% suggesting that, at least for these trials, evidence of publication bias is minimal."
But bias on the part of the scientific misconduct blogosphere does exist. It has constructed a conspiracy theory based on speculation, anecdotes and hubris.
The link to the NPR report, which Dr. Blumsohn seems not to have posted, is here:
http://www.npr.org/templates/story/story.php?
storyId=5234621
It is a balanced account of what happened.
The bias of the blogosphere is showing.
What's the difference between "universal" health care and "government" health care? Just who are these 47 million uninsured Americans that everyone's talking about?
Here's a new op-ed (from both the San Francisco Examiner and the Washington Examiner) that addresses both issues.
Commentary
Peter Pitts: Uncle Sam, M.D.?
On both sides of the political aisle, presidential candidates have labeled universal health coverage as the moral challenge of the decade. But is a government-run health care system the best means to bring this about?
Well, that depends on whether you want your health insurance and medical services to be provided by the same folks who run the Department of Motor Vehicles and Federal Emergency Management Agency.
Look abroad and you’ll see the disastrous effects of a government takeover of the health care industry.
In Canada, patients languish on surgical waiting lists for months. In the province of British Columbia, for example, more than 75,000 citizens were waiting for surgery at the end of September 2007. Even for serious procedures such as cardiac surgery, the average wait time is more than nine weeks.
In the single-payer health systems dotting Europe, price controls on prescription drugs have reduced the supply of treatments available to patients. Good news for the bean counters, but bad news for the sick.
What’s more, price controls have caused an atrophy of the European pharmaceutical industry. Fifteen years ago, European firms were responsible for 80 percent of drugs invented worldwide; today, they account for less than 20 percent of new drugs.
So not only have European patients taken a hit, thanks to reduced availability of medicines, so has the European economy.
Such dirty secrets are why most advocates of universal health care harp exclusively on access to insurance, which everyone agrees is important. In doing so, they obscure these insidious aspects of a government-run system.
But the fact is, access to health insurance is not a problem for most Americans.
Among those who work full- time, for instance, the vast majority receive access to either a health maintenance organization or a preferred provider organization through their employer. Older Americans have Medicare, while Medicaid serves the poor. Active and former military personnel are in the insurance system run by the Department of Veterans Affairs. Self-employed people may acquire individual policies or exploit the benefits of high-deductible insurance policies and health savings accounts.
Even for the indigent, care is widely available — at either a heavily subsidized level or often for free. And it’s illegal to turn a patient away from a hospital emergency room for lack of an insurance card.
Vaccinations are often free for children and the elderly, and free or low-cost walk-in clinics have grown in popularity throughout the country.
When it comes to prescription drugs, both manufacturers and retailers have set up programs to provide needed medicines to low-income patients at reduced cost.
So in a very real sense, “universal health care†already exists.
What about the oft-cited 47 million Americans who “lack insurance?†Such a number sounds catastrophic, but an examination of the details reveals that such figures are not always what they seem.
First, included in that number are scores of healthy young people — close to 20 million, by some accounts — who elect not to buy health insurance even though they can afford it. They voluntarily choose not to have health insurance — which is quite different from not being able to get health insurance.
That figure also includes 10 million illegal aliens. None of the politicians currently touting his or her plan for universal coverage has addressed this significant portion of the uninsured pool. And if the government can’t identify who’s here illegally anyway, how can it possibly ensure that they’ve purchased health insurance too?
Finally, the 47-million statistic isn’t static. Most of those who are without insurance are only without it temporarily — as when switching jobs.
When we get down to brass tacks, it turns out that many politicians and media types have created a phony verbal distinction between “universal health coverage†and “government-run health care.†Universal coverage is not possible without government coercion — and all the disastrous side effects that come along with it.
Our current system may be problematic. But the “free lunch†promised by advocates of government-run health care is anything but. Its costs are clear: price controls that stifle medical innovation, and a rationing of medical services that leaves many patients out in the cold.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.
While it's nice having a doctor in the family -- it shouldn't be your Uncle Sam.
Here's a new op-ed (from both the San Francisco Examiner and the Washington Examiner) that addresses both issues.
Commentary
Peter Pitts: Uncle Sam, M.D.?
On both sides of the political aisle, presidential candidates have labeled universal health coverage as the moral challenge of the decade. But is a government-run health care system the best means to bring this about?
Well, that depends on whether you want your health insurance and medical services to be provided by the same folks who run the Department of Motor Vehicles and Federal Emergency Management Agency.
Look abroad and you’ll see the disastrous effects of a government takeover of the health care industry.
In Canada, patients languish on surgical waiting lists for months. In the province of British Columbia, for example, more than 75,000 citizens were waiting for surgery at the end of September 2007. Even for serious procedures such as cardiac surgery, the average wait time is more than nine weeks.
In the single-payer health systems dotting Europe, price controls on prescription drugs have reduced the supply of treatments available to patients. Good news for the bean counters, but bad news for the sick.
What’s more, price controls have caused an atrophy of the European pharmaceutical industry. Fifteen years ago, European firms were responsible for 80 percent of drugs invented worldwide; today, they account for less than 20 percent of new drugs.
So not only have European patients taken a hit, thanks to reduced availability of medicines, so has the European economy.
Such dirty secrets are why most advocates of universal health care harp exclusively on access to insurance, which everyone agrees is important. In doing so, they obscure these insidious aspects of a government-run system.
But the fact is, access to health insurance is not a problem for most Americans.
Among those who work full- time, for instance, the vast majority receive access to either a health maintenance organization or a preferred provider organization through their employer. Older Americans have Medicare, while Medicaid serves the poor. Active and former military personnel are in the insurance system run by the Department of Veterans Affairs. Self-employed people may acquire individual policies or exploit the benefits of high-deductible insurance policies and health savings accounts.
Even for the indigent, care is widely available — at either a heavily subsidized level or often for free. And it’s illegal to turn a patient away from a hospital emergency room for lack of an insurance card.
Vaccinations are often free for children and the elderly, and free or low-cost walk-in clinics have grown in popularity throughout the country.
When it comes to prescription drugs, both manufacturers and retailers have set up programs to provide needed medicines to low-income patients at reduced cost.
So in a very real sense, “universal health care†already exists.
What about the oft-cited 47 million Americans who “lack insurance?†Such a number sounds catastrophic, but an examination of the details reveals that such figures are not always what they seem.
First, included in that number are scores of healthy young people — close to 20 million, by some accounts — who elect not to buy health insurance even though they can afford it. They voluntarily choose not to have health insurance — which is quite different from not being able to get health insurance.
That figure also includes 10 million illegal aliens. None of the politicians currently touting his or her plan for universal coverage has addressed this significant portion of the uninsured pool. And if the government can’t identify who’s here illegally anyway, how can it possibly ensure that they’ve purchased health insurance too?
Finally, the 47-million statistic isn’t static. Most of those who are without insurance are only without it temporarily — as when switching jobs.
When we get down to brass tacks, it turns out that many politicians and media types have created a phony verbal distinction between “universal health coverage†and “government-run health care.†Universal coverage is not possible without government coercion — and all the disastrous side effects that come along with it.
Our current system may be problematic. But the “free lunch†promised by advocates of government-run health care is anything but. Its costs are clear: price controls that stifle medical innovation, and a rationing of medical services that leaves many patients out in the cold.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.
While it's nice having a doctor in the family -- it shouldn't be your Uncle Sam.
Jan 22, 2008 20:58 | Updated Jan 23, 2008 9:48
Oxford Union stages 'farcical' debate
By JONNY PAUL, LONDON
From the Jerusalem Post
Oxford University's debating society is being accused of childishness and sensationalism by Jewish groups after inviting participants with alleged anti-Israel backgrounds to support a motion questioning Israel's right to exist in a debate on Thursday....
Proposing the motion are Norman Finkelstein, formally of De Paul University in Chicago, and Ted Honderich, professor of philosophy at University College London.
Finkelstein's books include The Holocaust Industry: Reflections on the Exploitation of Jewish Suffering and Image and Reality of the Israel-Palestine Conflict. On his Web site, he hosts Brazilian cartoonist Latuff, whose work won second prize in Iran President Mahmoud Ahmadinejad's Holocaust denial art competition in December 2006....
Opposing the motion in the Oxford debate is Palestinian scholar and activist Ghada Karmi, who believes that Jews do not constitute a nation and they lack "biological, racial or national characteristics."
Joining Karmi is Israeli academic Ilan Pappe, currently at Exeter University in the UK.
Last February, Pappe declared his warm friendship with Hamas leader Ismail Haniyeh and suggested that Hizbullah leader Hassan Nasrallah "should be put on the committee to decide the future of Israel."
Emily Partington, president of Oxford University Union told The Jerusalem Post: "The motion was decided upon as it is a current topic of discussion, and people who might not have extensive knowledge about the State of Israel may well question the existence of a state which appears to differ so greatly from others. Much of the interest in the motion derives from the debate about what constitutes Israel, and what Israel does. All of the participants in the debate will be arguing from their own independent perspectives, rather than representing anything or anyone else."
Translation: we excluded people who support Israel from the debate who are "paid" to represent Israel and who therefore are obviously biased in their view of a what a state is and should be is so different (and by our standards, racist.) So our debate is really the fair and balanced one because our participants independently concluded Israel should be wiped off the map.
Excluding scholars because they associate with Israel or disqualifying them because they represent Israel is just plain wrong. The same goes from barring them from engaging in important research, holding faculty positions, sitting on panels, etc? Where does the the game of connect the dots turn into outright persecution?
Isn't it wrong in other areas of intellectual and political life as well?
Read More
Oxford Union stages 'farcical' debate
By JONNY PAUL, LONDON
From the Jerusalem Post
Oxford University's debating society is being accused of childishness and sensationalism by Jewish groups after inviting participants with alleged anti-Israel backgrounds to support a motion questioning Israel's right to exist in a debate on Thursday....
Proposing the motion are Norman Finkelstein, formally of De Paul University in Chicago, and Ted Honderich, professor of philosophy at University College London.
Finkelstein's books include The Holocaust Industry: Reflections on the Exploitation of Jewish Suffering and Image and Reality of the Israel-Palestine Conflict. On his Web site, he hosts Brazilian cartoonist Latuff, whose work won second prize in Iran President Mahmoud Ahmadinejad's Holocaust denial art competition in December 2006....
Opposing the motion in the Oxford debate is Palestinian scholar and activist Ghada Karmi, who believes that Jews do not constitute a nation and they lack "biological, racial or national characteristics."
Joining Karmi is Israeli academic Ilan Pappe, currently at Exeter University in the UK.
Last February, Pappe declared his warm friendship with Hamas leader Ismail Haniyeh and suggested that Hizbullah leader Hassan Nasrallah "should be put on the committee to decide the future of Israel."
Emily Partington, president of Oxford University Union told The Jerusalem Post: "The motion was decided upon as it is a current topic of discussion, and people who might not have extensive knowledge about the State of Israel may well question the existence of a state which appears to differ so greatly from others. Much of the interest in the motion derives from the debate about what constitutes Israel, and what Israel does. All of the participants in the debate will be arguing from their own independent perspectives, rather than representing anything or anyone else."
Translation: we excluded people who support Israel from the debate who are "paid" to represent Israel and who therefore are obviously biased in their view of a what a state is and should be is so different (and by our standards, racist.) So our debate is really the fair and balanced one because our participants independently concluded Israel should be wiped off the map.
Excluding scholars because they associate with Israel or disqualifying them because they represent Israel is just plain wrong. The same goes from barring them from engaging in important research, holding faculty positions, sitting on panels, etc? Where does the the game of connect the dots turn into outright persecution?
Isn't it wrong in other areas of intellectual and political life as well?
Read More
Consider Alex Berenson's coverage of the cholesterol-heart disease risk connection and his mangling of Eric Topol's insights to fit a certain ideology:
“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,†said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.
Makes it sound like he is trashing statins like Vytorin right?
Here's Eric on two different ocassions: First, from his provocative blog on the ENHANCE study which I summarize:
Not all LDLs are the same. There are different ways to lower different LDLs based on the ways they are oxidized. Topol is emphatic in pointing for instance that women do not benefit as much from statins in LDL as men do. Are we not doing enough or have we overcooked the aggregate LDL-heart attack link?
http://blogs.theheart.org/
Previously to that, Topol noted in the wake of the discovery of genes that cause differential response to different statins: "Researchers have known for years that cholesterol, a fatty protein that can cling to the walls of blood vessels and raise heart risk, is linked to the action of enzymes that can be blocked with medicines such as Pfizer Inc.'s Lipitor. The genes open up the possibility of new drugs that can help more patients avoid heart disease"
``Obviously, we only knew part of the story,'' Topol said Jan. 11 in a telephone interview. ``Now we can study whole new pathways and understand how they become deranged in people with blood vessel disease.''
On top of all this come this hasty fix of yet another Berenson boo-boo
"Correction: January 18, 2008
A headline in Business Day on Thursday with an article about research involving two widely used cholesterol-lowering drugs misstated the issue raised by the results. It is whether using drugs to lower cholesterol at all costs is always medically effective, or even safe; there is no question that cholesterol itself can pose dangers."
Rush to judgment or poor reporting or both? And who said the conclusion of ENHANCE was to lower cholesterol at all costs? Roy Poses? That sounds like a pretty ill-informed or biased reading of ENHANCE since the question once again whether or not Vytorin reduced the risk of heart attack caused by atherosclerosis in familial hypercholesterolemia. Nothing more. It did lower LDL more than generic Zocor alone but missed the athero endpoint as measured by the murky imaging marker. As Nissen knows, lots of trials designed to reduce plaque by reducing LDL or even increasing HDL tend to miss their mark. We don't know why, but I put my money with Topol instead of Nissen to come up with new drugs based on new insights and for someone else other than Healthcare Renewal to explain the clinical value in an unbiased matter that would benefit me as a patient.
It would have been nice to have given Topol's insights on personalized medicine more play. But that would have undermine the effort to paint Big Pharma as a bunch of thieves. So here's the point: the failure of the I hate pharma crowd in the media and blogosphere to address the personalized medicine story is not an oversight. It is Lysenkoism and Healthcare Renewal is leading the way.
http://www.newsinferno.com/archives/2418
“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,†said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.
Makes it sound like he is trashing statins like Vytorin right?
Here's Eric on two different ocassions: First, from his provocative blog on the ENHANCE study which I summarize:
Not all LDLs are the same. There are different ways to lower different LDLs based on the ways they are oxidized. Topol is emphatic in pointing for instance that women do not benefit as much from statins in LDL as men do. Are we not doing enough or have we overcooked the aggregate LDL-heart attack link?
http://blogs.theheart.org/
Previously to that, Topol noted in the wake of the discovery of genes that cause differential response to different statins: "Researchers have known for years that cholesterol, a fatty protein that can cling to the walls of blood vessels and raise heart risk, is linked to the action of enzymes that can be blocked with medicines such as Pfizer Inc.'s Lipitor. The genes open up the possibility of new drugs that can help more patients avoid heart disease"
``Obviously, we only knew part of the story,'' Topol said Jan. 11 in a telephone interview. ``Now we can study whole new pathways and understand how they become deranged in people with blood vessel disease.''
On top of all this come this hasty fix of yet another Berenson boo-boo
"Correction: January 18, 2008
A headline in Business Day on Thursday with an article about research involving two widely used cholesterol-lowering drugs misstated the issue raised by the results. It is whether using drugs to lower cholesterol at all costs is always medically effective, or even safe; there is no question that cholesterol itself can pose dangers."
Rush to judgment or poor reporting or both? And who said the conclusion of ENHANCE was to lower cholesterol at all costs? Roy Poses? That sounds like a pretty ill-informed or biased reading of ENHANCE since the question once again whether or not Vytorin reduced the risk of heart attack caused by atherosclerosis in familial hypercholesterolemia. Nothing more. It did lower LDL more than generic Zocor alone but missed the athero endpoint as measured by the murky imaging marker. As Nissen knows, lots of trials designed to reduce plaque by reducing LDL or even increasing HDL tend to miss their mark. We don't know why, but I put my money with Topol instead of Nissen to come up with new drugs based on new insights and for someone else other than Healthcare Renewal to explain the clinical value in an unbiased matter that would benefit me as a patient.
It would have been nice to have given Topol's insights on personalized medicine more play. But that would have undermine the effort to paint Big Pharma as a bunch of thieves. So here's the point: the failure of the I hate pharma crowd in the media and blogosphere to address the personalized medicine story is not an oversight. It is Lysenkoism and Healthcare Renewal is leading the way.
http://www.newsinferno.com/archives/2418
According to today’s Wall Street Journal, “Researchers said they identified a genetic variant that is linked to both an increased risk of a heart attack and a person's chances of preventing such an attack by taking a cholesterol-lowering pill called a statin.â€
“Discovery of the KIF6 variant was announced by Celera Group-Applera Corp., an Alameda, Calif., diagnostics company known for having mapped the human genome in 2000 in a high-profile race with a government-funded project.â€
Details are reported in three studies being published Jan. 29 by the Journal of the American College of Cardiology and now available on the publication's Web site:
http://content.onlinejacc.org/in_press.dtl
“The interaction of KIF6 with statin therapy "is a very interesting and unexpected finding," said Marc Sabatine, a cardiologist at Brigham and Women's Hospital, Boston, and a co-author of one of the papers. While it would be "premature" to base treatment decisions on a patient's KIF6 status, he said, the results "take us one step closer to personalized medicine" in which doctors use genetic data to tailor therapy for patients.â€
Celera plans to launch "in the coming months" a genetic test for about $200 for the KIF6 variant.
"It's quite provocative," said Eric Topol, a cardiologist and director of Scripps Genomic Medicine and a cardiologist at the Scripps Clinic, La Jolla, Calif. "It could be a marker but there are a lot of question marks surrounding it."
Researchers said further study of KIF6 could help identify mechanisms for how heart disease develops and possibly new targets for drugs to treat it.
Here is the link to the story (subscription required):
http://online.wsj.com/article/SB120096559471905225.html?mod=dist_smartbrief&apl=y&r=204309
And personalized medicine marches forward.
“Discovery of the KIF6 variant was announced by Celera Group-Applera Corp., an Alameda, Calif., diagnostics company known for having mapped the human genome in 2000 in a high-profile race with a government-funded project.â€
Details are reported in three studies being published Jan. 29 by the Journal of the American College of Cardiology and now available on the publication's Web site:
http://content.onlinejacc.org/in_press.dtl
“The interaction of KIF6 with statin therapy "is a very interesting and unexpected finding," said Marc Sabatine, a cardiologist at Brigham and Women's Hospital, Boston, and a co-author of one of the papers. While it would be "premature" to base treatment decisions on a patient's KIF6 status, he said, the results "take us one step closer to personalized medicine" in which doctors use genetic data to tailor therapy for patients.â€
Celera plans to launch "in the coming months" a genetic test for about $200 for the KIF6 variant.
"It's quite provocative," said Eric Topol, a cardiologist and director of Scripps Genomic Medicine and a cardiologist at the Scripps Clinic, La Jolla, Calif. "It could be a marker but there are a lot of question marks surrounding it."
Researchers said further study of KIF6 could help identify mechanisms for how heart disease develops and possibly new targets for drugs to treat it.
Here is the link to the story (subscription required):
http://online.wsj.com/article/SB120096559471905225.html?mod=dist_smartbrief&apl=y&r=204309
And personalized medicine marches forward.
Let me respond to the latest tut-tut from Roy Poses who insist he isn’t calling physicians who work for drug companies or consult for them prostitutes but just wants transparency about their funding sources. I see a backtracking big time, much hypocrisy and huge bias. There is no doubt Poses is part of the “I hate Pharma†crowd along with many in the blogosphere. And he presumes that the only source of bias that affects the public health adversely – mostly without empirical evidence – is financial inducements from drug companies. He even uses the pejorative term “collaboration†as in drug companies are “now are the largest collective source of medical research money, they are thus under great pressure to collaborate with these companies. An academic trying to raise research money from one such company might find it hard to resist offers of consulting fees, speaker’s honoraria, advisory board positions, etc from that company. But once the academic thus starts to work part time for the company, who knows where his or her interests lie?â€
So for Poses the mere receipt for pharmaceutical research dollars is like alchemy, transforming the pure, virginal scientist into someone who – along with his or her results – can be twisted into something that reflects the desire for profits, not the public health. By his standards Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses just got one Merck grant back in 1997-1999 (which he never declared on his blog).
He gives two examples
“For the final words, let me quote Dr Stefan Kertesz, who was commenting on the pervasiveness of conflicts of interest affecting the 2004 National Cholesterol Education Panel guidelines that suggested drastic lowering of cholesterol for patients with heart disease and diabetes. (Hat tip for this to DB's Medical Rants.) These controversial guidelines may be one reason physicians feel compelled to use drugs to lower cholesterol which have, like ezetimibe, no proven independent benefits for their patients.â€
Controversial? Most of the people who Poses and Kertesz slime by association did the original work to establish the value of statins in the 1980’s. Does Poses not prescribe statins to people with high LDL and low HDL. And for him to say he won’t prescribe Vytorin because it has not proven independent benefit is shocking. It is both wrong and demonstrates he practices political science, a science driven by his guilt by association mentality.
Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to “natural†cholesterol lowering products that they sell, etc. No conflict there? Is it ok for physicians to promote and consult for companies pushing this approach?
Let us go further. So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind or biased eye towards other sources of conflict. Indeed, he ignores his own position stated in another post: “I think Anaissie et al have demonstrated the glaring need for tough regulations requiring disclosure of all financial (and probably political) conflicts of interest affecting anyone who can make decisions, for individuals or organizations, in health care. Basically similar regulations should apply not only to government agencies and academic medical institutions, but also all other health care organizations, not-for-profit and for-profit included.â€
Indeed, by focusing exclusively on financial conflicts and indeed only one subset of such monetary influences – ignoring funding from foundations, government business grants such as SBIR funds, money from consulting for trial attorneys or tort settlements, -- Poses and others ignore other forms of biases that can be as or more dangerous. As John P. A. Ioannidis wrote in Why Most Published Research Findings Are False:
“Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable].
But let us focus on other forms of bias.
For instance, the Prescription Project, which according to it’s website seek to ensure that “ industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information is essential to promoting sound and cost effective health care.â€
The Prescription Project has advisory committee members that consult for or work for the largest HMOs and the generic lobbying group. It obtains substantial funding from George Soros, as do many other organizations intertwined with The Prescription Project. The PP also “collaborates†with the Community Catalyst Group, another leftist organization that receives support from the Prescription Access Litigation Project. So the Prescription Project benefits indirectly from an organization that receives funding from trial lawyers.
Should Poses be suspicious about the choice of drugs made by The Prescription Project based on their source of funding? Not a peep.
In the end, Poses may be right to be cautious but the caution should be comprehensive or it is simply part of an ideological push or grab for power.
The point is, conflicts are a problem but ideological agendas and professional hubris can be deadly or truly damaging. I have not even touched the human cost of Steve Nissen’s attack on ADHD medicines, Avandia, etc. or the hype surrounding vaccines or SSRIs. I will only quote Marcia Angell who noted:
“Modern history is replete with instances of fervent beliefs or conventional wisdom being proved wrong by scientific research. Only a commitment to evidence can test the hopes, fears and biases that otherwise would have full sway. Science is sometimes messy and slow, but it’s the only method we have to answer questions about the material world and to evaluate the many health scares that recurrently sweep across the country. Like democracy, it’s better than whatever is second best, and we ignore it at our peril.â€
So for Poses the mere receipt for pharmaceutical research dollars is like alchemy, transforming the pure, virginal scientist into someone who – along with his or her results – can be twisted into something that reflects the desire for profits, not the public health. By his standards Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses just got one Merck grant back in 1997-1999 (which he never declared on his blog).
He gives two examples
“For the final words, let me quote Dr Stefan Kertesz, who was commenting on the pervasiveness of conflicts of interest affecting the 2004 National Cholesterol Education Panel guidelines that suggested drastic lowering of cholesterol for patients with heart disease and diabetes. (Hat tip for this to DB's Medical Rants.) These controversial guidelines may be one reason physicians feel compelled to use drugs to lower cholesterol which have, like ezetimibe, no proven independent benefits for their patients.â€
Controversial? Most of the people who Poses and Kertesz slime by association did the original work to establish the value of statins in the 1980’s. Does Poses not prescribe statins to people with high LDL and low HDL. And for him to say he won’t prescribe Vytorin because it has not proven independent benefit is shocking. It is both wrong and demonstrates he practices political science, a science driven by his guilt by association mentality.
Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to “natural†cholesterol lowering products that they sell, etc. No conflict there? Is it ok for physicians to promote and consult for companies pushing this approach?
Let us go further. So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind or biased eye towards other sources of conflict. Indeed, he ignores his own position stated in another post: “I think Anaissie et al have demonstrated the glaring need for tough regulations requiring disclosure of all financial (and probably political) conflicts of interest affecting anyone who can make decisions, for individuals or organizations, in health care. Basically similar regulations should apply not only to government agencies and academic medical institutions, but also all other health care organizations, not-for-profit and for-profit included.â€
Indeed, by focusing exclusively on financial conflicts and indeed only one subset of such monetary influences – ignoring funding from foundations, government business grants such as SBIR funds, money from consulting for trial attorneys or tort settlements, -- Poses and others ignore other forms of biases that can be as or more dangerous. As John P. A. Ioannidis wrote in Why Most Published Research Findings Are False:
“Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable].
But let us focus on other forms of bias.
For instance, the Prescription Project, which according to it’s website seek to ensure that “ industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information is essential to promoting sound and cost effective health care.â€
The Prescription Project has advisory committee members that consult for or work for the largest HMOs and the generic lobbying group. It obtains substantial funding from George Soros, as do many other organizations intertwined with The Prescription Project. The PP also “collaborates†with the Community Catalyst Group, another leftist organization that receives support from the Prescription Access Litigation Project. So the Prescription Project benefits indirectly from an organization that receives funding from trial lawyers.
Should Poses be suspicious about the choice of drugs made by The Prescription Project based on their source of funding? Not a peep.
In the end, Poses may be right to be cautious but the caution should be comprehensive or it is simply part of an ideological push or grab for power.
The point is, conflicts are a problem but ideological agendas and professional hubris can be deadly or truly damaging. I have not even touched the human cost of Steve Nissen’s attack on ADHD medicines, Avandia, etc. or the hype surrounding vaccines or SSRIs. I will only quote Marcia Angell who noted:
“Modern history is replete with instances of fervent beliefs or conventional wisdom being proved wrong by scientific research. Only a commitment to evidence can test the hopes, fears and biases that otherwise would have full sway. Science is sometimes messy and slow, but it’s the only method we have to answer questions about the material world and to evaluate the many health scares that recurrently sweep across the country. Like democracy, it’s better than whatever is second best, and we ignore it at our peril.â€
Should Vytorin continue to advertise? What impact, if any, will this question have on the larger issue of DTC regulation? These and other questions are discussed in a worthwhile article in this week’s edition of Advertising Age.
Here’s a link to the article:
http://adage.com/article?article_id==123228
And a few paragraphs to whet your appetite:
"Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.
Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold, Mr. Pitts said. DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it.
But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. The industry should absolutely explain to the general population where drugs come from and how they're made," he said. “It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."
That being said, it’s good news that, in yesterday’s edition of the New York Times (and elsewhere) there was a Vytorin ad that tried to put the current study into perspective.
Nice start – but more needs to be done. Vioxx was a missed opportunity to talk (soberly and sensibly) about safety (risk/benefit). Let’s not let Vytorin be a missed opportunity to talk about what clinical trials can tell us – and what they cannot.
This is an important teaching moment -- and can show the potency of DTC advertising and, more broadly, DTC² (direct to consumer communications) as a way to educate the public (yes -- politicians too) about the urgency of personalized medicine and 21st century clinical trial design.
Tough and complicated topics? You bet. But (as Tom Hanks said in A League of Their Own) "If it was easy, anyone could do it."
Here’s a link to the article:
http://adage.com/article?article_id==123228
And a few paragraphs to whet your appetite:
"Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.
Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold, Mr. Pitts said. DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it.
But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. The industry should absolutely explain to the general population where drugs come from and how they're made," he said. “It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."
That being said, it’s good news that, in yesterday’s edition of the New York Times (and elsewhere) there was a Vytorin ad that tried to put the current study into perspective.
Nice start – but more needs to be done. Vioxx was a missed opportunity to talk (soberly and sensibly) about safety (risk/benefit). Let’s not let Vytorin be a missed opportunity to talk about what clinical trials can tell us – and what they cannot.
This is an important teaching moment -- and can show the potency of DTC advertising and, more broadly, DTC² (direct to consumer communications) as a way to educate the public (yes -- politicians too) about the urgency of personalized medicine and 21st century clinical trial design.
Tough and complicated topics? You bet. But (as Tom Hanks said in A League of Their Own) "If it was easy, anyone could do it."
Have a look at today’s New York Times editorial,“The Real Price of Fakes.â€
Here’s a link:
http://www.nytimes.com/2008/01/20/opinion/20sun3.html?_r=1&ref=opinion&oref=slogin
And here’s the concluding paragraph:
“Some people in Congress want to tighten penalties on counterfeiters, a good but modest move. More to the point, the Consumer Product Safety Commission and the Food and Drug Administration need more money. And businesses that often avoid acknowledging the fake trade, for fear of damaging their brand, should be more open with consumers about how to tell the difference between real and unreal. Until then, buyer beware.â€
A few points. First is that, absolutely, penalties must be significantly enhanced. Today the risks are too low and the rewards too high – and that will only lead to exponential growth in the counterfeiting of prescription medicines. According to the WHO, “The US based Centre for Medicine in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.â€
Willy Sutton, the depression-era criminal, when asked why he robbed, replied “because that’s where the money is.†If Willy Sutton were alive today, he’s be in the counterfeit drugs business – because that’s where the money is.
Second – and speaking of money – glad to see that the Times is calling on Congress to give the FDA more money to combat prescription medicine counterfeiting. And while they’re at it, the Times editorialists should also call out those members of Congress who want to actually tie FDA’s hands in dealing with this menace.
In 2006, the federal Joint Terrorism Task Force unsealed an indictment charging 19 persons with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, largely through direct consumer shipment from Canada, to Americans seeking cheaper drugs. It, in turn, directed its profits to support of the criminal terrorist group Hezbollah.
Less than four months later, as Hezbollah rockets rained down on Israel, the Senate voted for an amendment offered by David Vitter of Louisiana to ban U.S. Customs and Border Protection agents from seizing prescription drugs that Americans import from Canada. For Mr. Vitter, the passage was a defeat of sorts: He wanted to ban Customs agents from seizing medicines imported from anywhere, which suggests that the politicians who voted for the measure knew that dangerous people were trying to sell fake drugs in America.
Canada is already the favorite port of call for fake medicines. According to customs, most of these drugs are not shipped through wholesale distribution channels but are shipped directly to consumers, with Canada being the major transshipment point because of its access to the U.S. market.
Here’s a link:
http://www.nytimes.com/2008/01/20/opinion/20sun3.html?_r=1&ref=opinion&oref=slogin
And here’s the concluding paragraph:
“Some people in Congress want to tighten penalties on counterfeiters, a good but modest move. More to the point, the Consumer Product Safety Commission and the Food and Drug Administration need more money. And businesses that often avoid acknowledging the fake trade, for fear of damaging their brand, should be more open with consumers about how to tell the difference between real and unreal. Until then, buyer beware.â€
A few points. First is that, absolutely, penalties must be significantly enhanced. Today the risks are too low and the rewards too high – and that will only lead to exponential growth in the counterfeiting of prescription medicines. According to the WHO, “The US based Centre for Medicine in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.â€
Willy Sutton, the depression-era criminal, when asked why he robbed, replied “because that’s where the money is.†If Willy Sutton were alive today, he’s be in the counterfeit drugs business – because that’s where the money is.
Second – and speaking of money – glad to see that the Times is calling on Congress to give the FDA more money to combat prescription medicine counterfeiting. And while they’re at it, the Times editorialists should also call out those members of Congress who want to actually tie FDA’s hands in dealing with this menace.
In 2006, the federal Joint Terrorism Task Force unsealed an indictment charging 19 persons with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, largely through direct consumer shipment from Canada, to Americans seeking cheaper drugs. It, in turn, directed its profits to support of the criminal terrorist group Hezbollah.
Less than four months later, as Hezbollah rockets rained down on Israel, the Senate voted for an amendment offered by David Vitter of Louisiana to ban U.S. Customs and Border Protection agents from seizing prescription drugs that Americans import from Canada. For Mr. Vitter, the passage was a defeat of sorts: He wanted to ban Customs agents from seizing medicines imported from anywhere, which suggests that the politicians who voted for the measure knew that dangerous people were trying to sell fake drugs in America.
Canada is already the favorite port of call for fake medicines. According to customs, most of these drugs are not shipped through wholesale distribution channels but are shipped directly to consumers, with Canada being the major transshipment point because of its access to the U.S. market.
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.
