Latest Drugwonks' Blog
The first thing that needs to be said about medical devices is that we should stop calling them medical devices. They are, in every sense, medical technology.
And technology, as we all know, is what makes the world go ‘round.
That being said, we must take medical technology as seriously as we do pharmaceuticals.
And, as the use of medical technology (from stents to scans) becomes ever more important and more pervasive, so too must we focus on safety.
But we must not fall into the false security of the Precautionary Principle which warns us to do nothing until we know everything. Why is this a bad idea? Because we can never “know everything.†And when it comes to FDA regulated products, be they drugs or devices or combination products – there will always be risk that comes along with benefit.
Can we do a better job regarding medical technology safety? Yes. Must we? Absolutely. Are we?
Here’s what Dan Schultz, director of CDRH had to say in today’s Wall Street Journal on that point:
"Are there ways to identify problems more quickly? I think the answer is yes. But if you require a clinical trial for every design change, what does that do to the ability of bringing new technologies to market?"
What, you mean there's no easy answer? Sorry Senator Grassley.
Here’s a link to the article:
http://online.wsj.com/article/SB119370397918375690.html?mod=hps_us_pageone
Vigilance must not supplant progress. They must advance together and learn from each other.
And technology, as we all know, is what makes the world go ‘round.
That being said, we must take medical technology as seriously as we do pharmaceuticals.
And, as the use of medical technology (from stents to scans) becomes ever more important and more pervasive, so too must we focus on safety.
But we must not fall into the false security of the Precautionary Principle which warns us to do nothing until we know everything. Why is this a bad idea? Because we can never “know everything.†And when it comes to FDA regulated products, be they drugs or devices or combination products – there will always be risk that comes along with benefit.
Can we do a better job regarding medical technology safety? Yes. Must we? Absolutely. Are we?
Here’s what Dan Schultz, director of CDRH had to say in today’s Wall Street Journal on that point:
"Are there ways to identify problems more quickly? I think the answer is yes. But if you require a clinical trial for every design change, what does that do to the ability of bringing new technologies to market?"
What, you mean there's no easy answer? Sorry Senator Grassley.
Here’s a link to the article:
http://online.wsj.com/article/SB119370397918375690.html?mod=hps_us_pageone
Vigilance must not supplant progress. They must advance together and learn from each other.
Seems as though John Edwards must have been absent during the law school lecture on the US Constitution – specifically the part that relates to Freedom of Speech. In a speech the other day he called for, among other things, mandatory FDA approval before drug companies launch major ad campaigns.
Must have tested well in focus groups.
Similar bloviation during debate over FDA reform was quickly dismissed because of some more educated members of Congress familiarity with the First Amendment.
But, as we all know, facts and reality have very little to do with Presidential campaigns.
Further proof of this was Senator Edwards’ remark that drug advertising misleads patients and drives up health care costs.
Neither of these statements is true. As to “misleads patients,†what DTC does do is send patients (aka – consumers) into the offices of their physicians were they have important dialogue about their health. In many of these DTC-initiated visits a previously undiagnosed condition is diagnosed. And earlier diagnosis and treatment decreases health care costs.
As to whether or not DTC increases the cost of medicines, consider this – when you compare the prices of medicines within a given therapeutic category along with their spending on DTC, there is no correlation. Also, when you compare the amount of money spent on DTC versus research and development – they don’t even have the same number of zeroes.
According to Edwards, "The excessive costs of prescription drugs are straining family budgets and contributing to runaway health care costs.â€
Another nice sound bite that belies the truth. Only 11.5% of the US health care spend is on pharmaceuticals – the same pharmaceuticals that keep people out of the hospital (over 30% of our health care expense). Proper medication keeps people healthy, at work, and paying taxes.
But that’s not as popular a sound bite in Iowa and New Hampshire (where Senator Edwards shared his comments with primary voters).
"With such aggressive and often misleading drug company marketing, it's too easy for advertising -- instead of doctors or proven results -- to influence families' health decisions," Edwards' campaign quoted him as saying.
Often misleading? Really? Does he even know about “fair balance†and “adequate provision?†Does he even know about the research that shows how few people actually even try to read various brief summaries?
Probably not. And that would explain why the “Edwards Plan†also calls for drug advertising to disclose more information about side effects and comparisons of drugs against placebos and alternatives.
Someone should ask him about this during the next candidate debate. (And speaking of “comparisons,†someone should also ask him about his understanding of comparative effectiveness.)
Further, the Edwards plan would institute a two-year delay on consumer advertising of all new drugs.
So, not only do we not really need Freedom of Speech – we also don’t need new and timely information about new and timely medicines.
Gevalt.
Must have tested well in focus groups.
Similar bloviation during debate over FDA reform was quickly dismissed because of some more educated members of Congress familiarity with the First Amendment.
But, as we all know, facts and reality have very little to do with Presidential campaigns.
Further proof of this was Senator Edwards’ remark that drug advertising misleads patients and drives up health care costs.
Neither of these statements is true. As to “misleads patients,†what DTC does do is send patients (aka – consumers) into the offices of their physicians were they have important dialogue about their health. In many of these DTC-initiated visits a previously undiagnosed condition is diagnosed. And earlier diagnosis and treatment decreases health care costs.
As to whether or not DTC increases the cost of medicines, consider this – when you compare the prices of medicines within a given therapeutic category along with their spending on DTC, there is no correlation. Also, when you compare the amount of money spent on DTC versus research and development – they don’t even have the same number of zeroes.
According to Edwards, "The excessive costs of prescription drugs are straining family budgets and contributing to runaway health care costs.â€
Another nice sound bite that belies the truth. Only 11.5% of the US health care spend is on pharmaceuticals – the same pharmaceuticals that keep people out of the hospital (over 30% of our health care expense). Proper medication keeps people healthy, at work, and paying taxes.
But that’s not as popular a sound bite in Iowa and New Hampshire (where Senator Edwards shared his comments with primary voters).
"With such aggressive and often misleading drug company marketing, it's too easy for advertising -- instead of doctors or proven results -- to influence families' health decisions," Edwards' campaign quoted him as saying.
Often misleading? Really? Does he even know about “fair balance†and “adequate provision?†Does he even know about the research that shows how few people actually even try to read various brief summaries?
Probably not. And that would explain why the “Edwards Plan†also calls for drug advertising to disclose more information about side effects and comparisons of drugs against placebos and alternatives.
Someone should ask him about this during the next candidate debate. (And speaking of “comparisons,†someone should also ask him about his understanding of comparative effectiveness.)
Further, the Edwards plan would institute a two-year delay on consumer advertising of all new drugs.
So, not only do we not really need Freedom of Speech – we also don’t need new and timely information about new and timely medicines.
Gevalt.
By now you will have heard about the most recent in a series of FDA leaks. I refer specifically to the Wall Street Journal's "people with knowledge of the matter" -- the matter at hand being Avandia.
I will not speak to the specifics of the leak -- I will not give illegal and unethical behavior one inch of additional space -- nor will I spend any time or energy playing the "I wonder who the leaker is?"game. (Not that I don't have my own suspicions.)
What I do want to address is the growing trend within the FDA of "leaking" internal discussions to the media in order to try to force the agency's hand. If "politicizing" the agency is bad (and it is -- very much so) than it is bad writ large. The ends does not justify the means.
The FDA is an organization of health care professionals. An organization of many. Organizations have hierarchies. And organizations have rules. And rules are meant to be followed. The alternative is chaos -- a state into which the agency mustn't spin. When rogue employees choose to take the law into their own hands -- even when they believe their position is the correct one -- bad things ensue and stakeholder trust erodes. And, yes, one stakeholder is the pharmaceutical industry. Another is the American citizen.
Anonymous leaks are not the acts of whistleblowers -- they are the acts of cowards.
An "FDA of One" is one very bad idea.
I will not speak to the specifics of the leak -- I will not give illegal and unethical behavior one inch of additional space -- nor will I spend any time or energy playing the "I wonder who the leaker is?"game. (Not that I don't have my own suspicions.)
What I do want to address is the growing trend within the FDA of "leaking" internal discussions to the media in order to try to force the agency's hand. If "politicizing" the agency is bad (and it is -- very much so) than it is bad writ large. The ends does not justify the means.
The FDA is an organization of health care professionals. An organization of many. Organizations have hierarchies. And organizations have rules. And rules are meant to be followed. The alternative is chaos -- a state into which the agency mustn't spin. When rogue employees choose to take the law into their own hands -- even when they believe their position is the correct one -- bad things ensue and stakeholder trust erodes. And, yes, one stakeholder is the pharmaceutical industry. Another is the American citizen.
Anonymous leaks are not the acts of whistleblowers -- they are the acts of cowards.
An "FDA of One" is one very bad idea.
Matt Herper and Robert Langreth have a good column about Lilly's hurry up and wait approach to releasing the results of a dosing study about prasugrel, which would not compete with but be an alternative to people who do not respond well to Plavix or aspirin.
Again, it's not the data so much as how it is presented to investors and the clinical community. The rules of the road have changed. People demand more data. And the genetic underpinnings that cause differences in drug response and dose response -- which is what at issue here -- are pretty much like open source software or operating systems.
I don't think anything nefarious is going on. If the science types have control of the process -- and Steve Paul who runs RD at Lilly is a straight shooter -- they are probably retooling and re-examining the data to see which dose works for which groups.
But that is not the end of the matter. Matt and Robert should know that Lilly is likely trying to figure how all this tailored treatment info pans out and whether or not -- in the safety uber alles environment -- even a drug that has diagnostic or gene-specific dosing limits ala warfarin could even get through the FDA these days.
Maybe Lilly is compiling a list of drug safety vigilantes it needs to hire as consultants to ensure they don't trash the drug to the trial attorneys and the media. Drug safety? More like a protection racket.
http://www.forbes.com/2007/10/25/pharmacuticals-prasugrel-lilly-biz-sci-cx_mh_1026lilly1.html?partner=alerts
Again, it's not the data so much as how it is presented to investors and the clinical community. The rules of the road have changed. People demand more data. And the genetic underpinnings that cause differences in drug response and dose response -- which is what at issue here -- are pretty much like open source software or operating systems.
I don't think anything nefarious is going on. If the science types have control of the process -- and Steve Paul who runs RD at Lilly is a straight shooter -- they are probably retooling and re-examining the data to see which dose works for which groups.
But that is not the end of the matter. Matt and Robert should know that Lilly is likely trying to figure how all this tailored treatment info pans out and whether or not -- in the safety uber alles environment -- even a drug that has diagnostic or gene-specific dosing limits ala warfarin could even get through the FDA these days.
Maybe Lilly is compiling a list of drug safety vigilantes it needs to hire as consultants to ensure they don't trash the drug to the trial attorneys and the media. Drug safety? More like a protection racket.
http://www.forbes.com/2007/10/25/pharmacuticals-prasugrel-lilly-biz-sci-cx_mh_1026lilly1.html?partner=alerts
Sometimes life and politics provides their own punchlines... From the KaiserNet's First Edition: these two headlines cluelessly linking a tobacco tax expansion of SCHIP to health plans covering smoking cessation....
TODAY'S NEWS
House Passes Revised SCHIP Bill, Still Lacks Enough Votes To Override President Bush's Threatened Veto
AP/Houston Chronicle
Businesses Pay for Worker Smoking Cessation Programs as Part of Effort To Reduce Health Care Costs
New York Times
http://www.kaisernetwork.org/daily_reports/rep_firstedition.cfm
TODAY'S NEWS
House Passes Revised SCHIP Bill, Still Lacks Enough Votes To Override President Bush's Threatened Veto
AP/Houston Chronicle
Businesses Pay for Worker Smoking Cessation Programs as Part of Effort To Reduce Health Care Costs
New York Times
http://www.kaisernetwork.org/daily_reports/rep_firstedition.cfm
Seems simple enough. Get rid of samples, pens, pizza. But then let's see just how much information about new medicines flow to doctors and whether that affects patients. Right now the claim that freebies adversely influence prescribing patterns and do not advance patient health is unsubstantiated. And who would decide who gets what information and how? The same group that supports government run comparative effectiveness trials? And the proposal to eliminate all private industry involvement in academic medicine will undermine medical progress. As if academic medicine would be free of bias, conflict, error and devious behavior if money was not involved. Right. See the piece from The Scientist below...
http://www.the-scientist.com/news/home/53709/
http://www.the-scientist.com/news/home/53709/
I was on a terrific panel this morning (hosted by DTC Perspectives Magazine) on the influence on blogging in pharmaland. Hosted by Pharmalot's Ed Silverman, my fellow panelists were Scott Hensley (of the Wall Street Journal and the Wall Street Journal Health Blog) and Christiane Truelove of MedAd News (or as we like to refer to her because of her pithy Friday blog recaps, "Christiane CliffNotes").
Scott Hensley wins for most thought-provoking soundbite ...
"If we don't post, nothing happens."
Amen brother.
Scott Hensley wins for most thought-provoking soundbite ...
"If we don't post, nothing happens."
Amen brother.
In the spirit of full and open dialogue, here are two letters-to-the-editor from today's on-line edition of the New York Times ...
Opinion
LETTERS
Testing New Drugs
Published: October 25, 2007
Re “A Test of Bad Health†(Op-Ed, Oct. 18):
To the Editor:
Peter Pitts’s criticism of the proposed Center for Comparative Effectiveness exemplifies the scare tactics used by the pharmaceutical industry to protect its interests.
While he cites one example of delayed drug approval in Britain, he doesn’t mention the many cases in which comparative effectiveness studies have fostered timely and appropriate decisions to adopt or not adopt new drugs and other medical advances.
The use of government-sponsored studies to inform drug coverage decisions by government agencies is not “an inherent conflict of interest,†but rather the judicious exercise of government resources to serve the public interest.
Sadly, the casualties of President Bush’s veto of the State Children’s Health Insurance Program bill include not only the millions of children left uninsured, but also the hundreds of millions of Americans and their doctors who need better information to make the best possible decisions about their health care.
Alan B. Cohen
Boston, Oct. 18, 2007
The writer is a professor of health policy and management and the executive director of the Boston University Health Policy Institute.
To the Editor:
Peter Pitts warns that a proposed Center for Comparative Effectiveness to test new drugs would be dangerous because “conducting these studies is so tricky, their findings are regularly overturned or modified by further research.†Yet he would have us accept the company’s clinical trials showing the drug to be safe and effective?
One wonders why it is so tricky for the government to do this research, yet so simple for his pharmaceutical financiers to do the same.
Kevin Carlsmith
Hamilton, N.Y., Oct. 18, 2007
After all, everyone's entitled to their opinion.
Opinion
LETTERS
Testing New Drugs
Published: October 25, 2007
Re “A Test of Bad Health†(Op-Ed, Oct. 18):
To the Editor:
Peter Pitts’s criticism of the proposed Center for Comparative Effectiveness exemplifies the scare tactics used by the pharmaceutical industry to protect its interests.
While he cites one example of delayed drug approval in Britain, he doesn’t mention the many cases in which comparative effectiveness studies have fostered timely and appropriate decisions to adopt or not adopt new drugs and other medical advances.
The use of government-sponsored studies to inform drug coverage decisions by government agencies is not “an inherent conflict of interest,†but rather the judicious exercise of government resources to serve the public interest.
Sadly, the casualties of President Bush’s veto of the State Children’s Health Insurance Program bill include not only the millions of children left uninsured, but also the hundreds of millions of Americans and their doctors who need better information to make the best possible decisions about their health care.
Alan B. Cohen
Boston, Oct. 18, 2007
The writer is a professor of health policy and management and the executive director of the Boston University Health Policy Institute.
To the Editor:
Peter Pitts warns that a proposed Center for Comparative Effectiveness to test new drugs would be dangerous because “conducting these studies is so tricky, their findings are regularly overturned or modified by further research.†Yet he would have us accept the company’s clinical trials showing the drug to be safe and effective?
One wonders why it is so tricky for the government to do this research, yet so simple for his pharmaceutical financiers to do the same.
Kevin Carlsmith
Hamilton, N.Y., Oct. 18, 2007
After all, everyone's entitled to their opinion.
Sanofi's conduct in the testing of Ketek underscores the importance of trust in shaping perceptions of risk. The relationship between drug companies and consumers must change. It will have to be more honest, more transparent, more individualized and enduring. It can't end after the FDA approves a product either.
According to the WSJ the FDA said it was "unable to find evidence" that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.
These problems are rare and will happen. However when they are detected they should be reported promptly and the unqualified investigators should be barred from participating in clinical trials as a matter of industry policy.
http://online.wsj.com/article/SB119328145497070973.html?mod=googlenews_wsj
According to the WSJ the FDA said it was "unable to find evidence" that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.
These problems are rare and will happen. However when they are detected they should be reported promptly and the unqualified investigators should be barred from participating in clinical trials as a matter of industry policy.
http://online.wsj.com/article/SB119328145497070973.html?mod=googlenews_wsj
Who says sorry seems to be the hardest word? Here's a sample of some a Pete Stark's other gentle musings about those who differ with him on healthcare policy issues... From Jonathan Weisman of the Washington Post (get a look at the photo the WP selected for the article..)
2003: As Stark belittled House Ways and Means Chairman Bill Thomas (R-Calif.), then-Rep. Scott McInnis (R-Colo.) told him to "shut up."
"You think you are big enough to make me, you little wimp?" Stark taunted. "Come on. Come over here and make me, I dare you. You little fruitcake."
2001: At a Ways and Means subcommittee hearing on abstinence promotion, Stark referred to then-Rep. J.C. Watts (R-Okla.) as the "current Republican Conference chairman, whose children were all born out of wedlock."
1995: In a private meeting, Stark called then-Rep. Nancy L. Johnson (R-Conn.) a "whore for the insurance industries."
"He didn't call her a 'whore,' " defended Stark press secretary Caleb Marshall. "He called her a 'whore of the insurance industry.' "
1991: Stark singled out "Jewish colleagues" for blame for the Persian Gulf War, referring to then-Rep. Stephen Solarz (D-N.Y.) as "Field Marshal Solarz in the pro-Israel forces."
1990: Stark called then-Health and Human Services Secretary Louis Sullivan, who is African American, "as close to being a disgrace to his race as anyone I've ever seen."
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/23/AR2007102302165.html
2003: As Stark belittled House Ways and Means Chairman Bill Thomas (R-Calif.), then-Rep. Scott McInnis (R-Colo.) told him to "shut up."
"You think you are big enough to make me, you little wimp?" Stark taunted. "Come on. Come over here and make me, I dare you. You little fruitcake."
2001: At a Ways and Means subcommittee hearing on abstinence promotion, Stark referred to then-Rep. J.C. Watts (R-Okla.) as the "current Republican Conference chairman, whose children were all born out of wedlock."
1995: In a private meeting, Stark called then-Rep. Nancy L. Johnson (R-Conn.) a "whore for the insurance industries."
"He didn't call her a 'whore,' " defended Stark press secretary Caleb Marshall. "He called her a 'whore of the insurance industry.' "
1991: Stark singled out "Jewish colleagues" for blame for the Persian Gulf War, referring to then-Rep. Stephen Solarz (D-N.Y.) as "Field Marshal Solarz in the pro-Israel forces."
1990: Stark called then-Health and Human Services Secretary Louis Sullivan, who is African American, "as close to being a disgrace to his race as anyone I've ever seen."
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/23/AR2007102302165.html
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.
