Latest Drugwonks' Blog
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
Maybe someone can explain the difference between the risks of off-label use of drug-eluting stents -- which CMS will still cover -- and the risks of appropriate ESA use -- which CMS will is banning. In both cases there is no evidence from randomized controlled trials demonstrating safety or quality of life benefit which CMS claims is the standard for reimbursing things these days.
Last time I checked there was no randomized placebo controlled study of aspirin with safety being the primary endpoint. Maybe Medicare should not pay for that either.
http://online.wsj.com/article/SB119318921736669347.html?mod=health_home_stories
Last time I checked there was no randomized placebo controlled study of aspirin with safety being the primary endpoint. Maybe Medicare should not pay for that either.
http://online.wsj.com/article/SB119318921736669347.html?mod=health_home_stories
Gee, I wonder who leaked this to the WSJ...Let's see, when you don't have the science or the facts on your side, presenting the sort of observational data in public to defend your position that you derided as evidence in support of the safety of other drugs and when everyone else in the agency is pretty much responsible...my guess is David Graham and that it is part of a well-orchestrated effort. We know it's not the European Medicine Agency which just tighted prescribing data. Let's hope with better post market data we won't have this hysteria in the future. My guess is, with tort lawyers and web-based interest groups profiting from fear we will see more of this, not less.
http://online.wsj.com/article/SB119318921736669347.html?mod=health_home_stories
http://online.wsj.com/article/SB119318921736669347.html?mod=health_home_stories
Andy von Eschenbach comments on the issue of "legacy drugs" via a letter in today's edition of the New York Times ...
To the Editor:
The Food and Drug Administration thanks you for emphasizing our continued efforts to protect the public and raising consumers’ awareness that certain drugs are marketed without F.D.A. approval. In June 2006, the F.D.A. announced its renewed emphasis on solving the problem that many drugs lack F.D.A. approval, often because they were introduced into the market long before the F.D.A. had its current regulatory authority.
To deal with the unapproved drugs that remain in use, we give highest priority to drugs that have safety concerns, lack evidence of effectiveness or are health frauds. This approach is carried out without imposing undue burdens on health care and is applied uniformly against all companies, large and small, that market these drugs.
The F.D.A. is committed to proactive action to assist companies with finding opportunities to legally market their products. As part of this commitment, the F.D.A. appointed an unapproved drugs coordinator and conducted a full-day workshop in January 2007 to educate companies about the drug approval process, the over-the-counter monograph process and user fee waivers. Our unapproved drugs coordinator consults frequently with companies, and many of them have begun the approval process for their products.
Some refer to these unapproved marketed drugs as “legacy drugs.†A legacy is not a substitute for drug approval. Individual experience, anecdotal evidence and marketing history are insufficient bases for concluding that a drug is safe and effective. In fact, experience demonstrates that unapproved drugs are often unsafe, ineffective, inappropriately labeled and poorly manufactured. This is not the legacy that we want for our families.
I, and the entire F.D.A., remain committed to ensuring that safe and effective drugs are available to protect and promote the health of the American people.
Andrew C. Von Eschenbach, M.D.
Commissioner of Food and Drugs, Food and Drug Administration
Washington, Oct. 22, 2007
To the Editor:
The Food and Drug Administration thanks you for emphasizing our continued efforts to protect the public and raising consumers’ awareness that certain drugs are marketed without F.D.A. approval. In June 2006, the F.D.A. announced its renewed emphasis on solving the problem that many drugs lack F.D.A. approval, often because they were introduced into the market long before the F.D.A. had its current regulatory authority.
To deal with the unapproved drugs that remain in use, we give highest priority to drugs that have safety concerns, lack evidence of effectiveness or are health frauds. This approach is carried out without imposing undue burdens on health care and is applied uniformly against all companies, large and small, that market these drugs.
The F.D.A. is committed to proactive action to assist companies with finding opportunities to legally market their products. As part of this commitment, the F.D.A. appointed an unapproved drugs coordinator and conducted a full-day workshop in January 2007 to educate companies about the drug approval process, the over-the-counter monograph process and user fee waivers. Our unapproved drugs coordinator consults frequently with companies, and many of them have begun the approval process for their products.
Some refer to these unapproved marketed drugs as “legacy drugs.†A legacy is not a substitute for drug approval. Individual experience, anecdotal evidence and marketing history are insufficient bases for concluding that a drug is safe and effective. In fact, experience demonstrates that unapproved drugs are often unsafe, ineffective, inappropriately labeled and poorly manufactured. This is not the legacy that we want for our families.
I, and the entire F.D.A., remain committed to ensuring that safe and effective drugs are available to protect and promote the health of the American people.
Andrew C. Von Eschenbach, M.D.
Commissioner of Food and Drugs, Food and Drug Administration
Washington, Oct. 22, 2007
Here's the bottom line reason pediatricians love the decision to ban cough medicines: fewer 2 AM phone calls from parents about dosing, less anxiety about lawsuits...
Benjamin Brewer MD who blogs for the WSJ on medicine:
The dose provided some relief — the boy’s sniffles and cough abated long enough for the Brewers to get some shuteye. “I have found that the advice to hold off on a kid’s cold medicine is much easier to give than it is to heed,†Brewer writes.
The crackdown on cold medicines for kids may have an unintended benefit for the doctor. “With infant cold medications off the market, I won’t miss the parents calling in the middle of the night for recommendations on how much to use,†he writes. “I won’t miss meticulously documenting how many tenths of a milliliter I advised a person to give or the liability risks associated with my advice.â€
Thanks for the dose of honesty doc.
I just wish the FDA experts were as freaked out about MRSA and diminishing antibiotics to treat them as they were about cough medicines. Ironically, the "safety uber alles" movement has made it likely kids will see fewer antibiotics for killer bugs or coughs. Reminds me of when I was a kid. It would make me feel a little bit better if Mickey Mantle were still batting clean up for the Yankees.
http://blogs.wsj.com/health/2007/10/23/a-taste-of-his-own-medicine/
For those who want to see Mantle's stats as opposed to the number of kids who died from infectious diseases in the 1960s...
http://www.baseball-reference.com/m/mantlmi01.shtml
Benjamin Brewer MD who blogs for the WSJ on medicine:
The dose provided some relief — the boy’s sniffles and cough abated long enough for the Brewers to get some shuteye. “I have found that the advice to hold off on a kid’s cold medicine is much easier to give than it is to heed,†Brewer writes.
The crackdown on cold medicines for kids may have an unintended benefit for the doctor. “With infant cold medications off the market, I won’t miss the parents calling in the middle of the night for recommendations on how much to use,†he writes. “I won’t miss meticulously documenting how many tenths of a milliliter I advised a person to give or the liability risks associated with my advice.â€
Thanks for the dose of honesty doc.
I just wish the FDA experts were as freaked out about MRSA and diminishing antibiotics to treat them as they were about cough medicines. Ironically, the "safety uber alles" movement has made it likely kids will see fewer antibiotics for killer bugs or coughs. Reminds me of when I was a kid. It would make me feel a little bit better if Mickey Mantle were still batting clean up for the Yankees.
http://blogs.wsj.com/health/2007/10/23/a-taste-of-his-own-medicine/
For those who want to see Mantle's stats as opposed to the number of kids who died from infectious diseases in the 1960s...
http://www.baseball-reference.com/m/mantlmi01.shtml
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.
