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Finally, a poll that asks Americans specific questions about the actual details of the proposal squirming through Congress....

Galen Institute Releases Poll Showing Overwhelming Opposition to the Individual Mandate and Other Key Components of Congressional Health Reform Proposals

Seventy-one Percent Are Concerned Their Health Insurance Will
Change if Congress Passes Health Reform Legislation

For more information, please contact:
Jeff Lungren, Communications Director
(703) 299-9207 or jeff@galen.org

ALEXANDRIA, VA. OCTOBER 19, 2009 – The Galen Institute today released new survey results showing overwhelming opposition to the individual mandate and other key components of health reform legislation Congress is considering.

“These findings illustrate strong opposition to fundamental aspects of the bills moving through Congress,” said Galen Institute President Grace-Marie Turner. “People don’t want to be forced to buy insurance they can’t afford or that might not fit their needs, yet the proposals would slap a tax on them if they don’t. And people overwhelmingly oppose reducing seniors’ health benefits or raising taxes on the working and middle class in order to expand coverage to some of the uninsured, yet many in Congress continue to push exactly that.”

“What the public does favor is a targeted approach to solving problems in our health sector, but not a complete Washington-style overhaul of one-sixth of our economy. Washington’s failure to listen is causing great apprehension and concern among the public,” added Turner.

The nationwide random survey of 510 adults was conducted October 8-11, 2009 and has a +/- 4.34 margin of error. International Communications Research (ICR), a non-partisan research firm based in Pennsylvania, conducted the survey.

More Than Seven in Ten Oppose the Individual Mandate

Seventy-one percent of those surveyed said they would oppose “a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year.” Only 21 percent said they would support the law. More than half (54 percent) of all respondents indicate a “strong” opposition to the individual mandate, including 58 percent of those 45-54 years of age and 58 percent of those 55 years and older.

More Than Two-Thirds Oppose Reducing Seniors’ Health Benefits to Pay for Covering the Uninsured

More than two-thirds (68 percent) oppose reducing “some health insurance benefits for senior citizens in order to expand health insurance for some people who are uninsured,” while 28 percent support the idea. Opposition is spread across political party lines as 86 percent of Republicans, 66 percent of Independents, and 59 percent of Democrats oppose this idea.

Opposition to Raising Taxes on the Working and Middle Class to Cover the Uninsured

Fifty-eight percent disagree, most of them “strongly” (44 percent), with the following statement: “I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans.” Only 39 percent support the position.

Seventy-one Percent Are Concerned Current Health Insurance Will Change if Congress Passes Health Reform

Seventy-one percent said they were concerned that their current health insurance would change if Congress passes health reform legislation. One-quarter (25 percent) said they were not concerned. Groups with the highest level of concern include: people 55 years and older (84 percent), those aged 45-54 (80 percent), Republicans (82 percent), and Independents (78 percent). Almost half (47 percent) of all respondents indicate they are “very concerned.” Sixty-two percent of people aged 55 years and older are “very concerned,” along with 61 percent of Republicans, 63 percent of those in the South, and 54 percent of Independents.

Support for a Targeted Approach to Addressing Health Care

Forty-nine percent support, “A targeted approach that addresses a few problems at a time.” Forty-one percent support, “A comprehensive approach that makes significant changes to our current health care system.”

_________________________________

Here are Details of the Survey’s Results

Question: Let's say that Congress passed a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year. Would you support or oppose this law?

STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 8%
SOMEWHAT OPPOSE 17%
STRONGLY OPPOSE 54%
DON’T KNOW/REFUSED 8%


Question: Which of the following approaches to health care reform do you favor?

A comprehensive approach that
makes significant changes to our 41%
current health care system?
A targeted approach that
addresses a few problems at a time? 49%
NEITHER 4%
DON’T KNOW 5%

Question: Do you agree or disagree with the following statement? "I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans."

STRONGLY AGREE 18%
SOMEWHAT AGREE 20%
SOMEWHAT DISAGREE 14%
STRONGLY DISAGREE 44%
DON’T KNOW/REFUSED 4%

Question: How concerned are you that your current health insurance will change if Congress passes health reform legislation? Are you ...?

VERY CONCERNED 47%
SOMEWHAT CONCERNED 24%
NOT VERY CONCERNED 9%
NOT CONCERNED AT ALL 17%
NOT APPLICABLE/ I 3%
CURRENTLY DO NOT HAVE
HEALTH INSURANCE
DON’T KNOW 1%

Question: Let's say Congress proposed a bill that would reduce some health insurance benefits for senior citizens in order to provide health insurance for some people who are uninsured. Would you support or oppose this bill?

STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 15%
SOMEWHAT OPPOSE 20%
STRONGLY OPPOSE 48%
DON’T KNOW 4%
###
 

Warts and All

  • 10.19.2009

On September 29th, the New York Times reported:

Former Drug Executive Convicted of Wire Fraud

In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.

(Full story here: http://www.nytimes.com/2009/09/30/business/30drug.html)

There are rules that need to be followed and there are consequences for those who play fast and loose with them.

Except, it seems, if you are the rule-maker.

Here’s an FDA announcement that appeared Friday (October 16th):

FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

(Full FDA release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm)

Wonderful public health news and certainly worth promoting. And kudos to the FDA for using a regulatory action to discuss an important public health issue.

The interesting issue is how the release ends:

“Gardasil product information: www.fda.gov/cber/products/gardasil.htm

That link doesn’t bring you directly to the package insert, but rather to a page where you can access the package insert. 

Would a pharmaceutical company be permitted to forward such an FDA announcement along to others without more detailed risk information?  What about posting the FDA announcement to a commercial website?  What about handing it out to physicians?

In 2002, when I was the FDA's associate commissioner for external relations, Dr. Janet Woodcock (then, as now, CDER Director) came in to my office and she was not smiling. She waved a draft of a new drug approval press release at me and asked, "How is anybody supposed to understand this? It's written for scientists!"

I felt her pain. My answer to Dr. Woodcock was that the press office had written a much more consumer-friendly document, but that the release had, quite literally, been doctored when sent to the Center for Drug Evaluation and Research for review. Rather than focusing on the important public health message intrinsic in the new drug approval, the career science staff insisted on putting in more science. "Well," she said, "that's not going to happen anymore." And that was the beginning of a beautiful relationship.

What that story demonstrates—and why I never tire of retelling it—is that communications at the FDA is a perfect example of the maxim, "It's not what we say that matters—it's what our target audience remembers." All the science in the world—precise and important as it may be—is not going to help the average consumer understand why a new drug is important, why it was approved, or even what it does.

So, this isn’t about FDA needing to add more risk information – their release speaks in plain English to the general population.  Well done.  The question is, shouldn’t pharmaceutical companies be allowed to do the same?  Isn’t a clear message in the best interests of the public health? What’s required is a more titrated approach to communications that -- like DTC TV guidance -- provides a clear pathway for achieving compliance while respecting the inherent space/time limitations of any given medium. 

First the good news:

John M. Taylor, III will occupy a new position at FDA, Counselor to the Commissioner, where he will oversee the agency's crisis response functions as well as advise on a range of policy and regulatory matters.  An attorney, Mr. Taylor served previously with FDA as a staff lawyer, an advisor to previous Commissioners, and as Associate Commissioner for Regulatory Affairs.  He most recently has been Executive Vice President, Health, at the Biotechnology Industry Organization, after serving as a Divisional Vice President for Federal Governmental Affairs at Abbott Laboratories.

I served with John and he is a stand-up guy.  Great hire.

Now the other news:

Peter G. Lurie, MD, MPH, will serve in the agency's Office of Policy, where he will help develop strategies to facilitate medical product availability to meet critical public health needs, reporting to the Assistant Commissioner for Policy.  Dr. Lurie has most recently been Deputy Director of Public Citizen's Health Research Group in Washington, DC and is an adjunct faculty member at Johns Hopkins Bloomberg School of Public Health and the George Washington University School of Public Health and Life Sciences.   

I’ve debated Peter.  Smart guy.  Highly political guy.  Public Citizen’s well-known position on “medical product availability” is that most products are “too dangerous.”  What’s next?  Sid Wolfe as FDA’s Philosopher-in-Residence?


I must apologize for two sloppy (and embarassing) mistakes.  Per my earlier post ("Witt Picking"), I incorrectly attributed Waxman alumni status to two current FDA staffers.
 
Ann Witt -- yes, former Waxmanite.

Josh Sharfstein -- similarly.
 
David Dorsey -- not.  David, as I actuall knew, comes over to the FDA from the late Senator Kennedy's office.
 
And Jeanne Ireland worked for Mr. Dingel before the coup -- in which she lost her job there.
 
My apologies.

Witt Picking

  • 10.16.2009

Ann Witt, health counsel extraordinaire to Representative Henry Waxman(and who previously served as acting director of DDMAC and advisor to the Commissioner), is returning to the FDA to serve in the agency’s Office of Policy, Planning and Budget.  

Does this mean Ms. Witt will fill Jeff Shuren’s shoes?  (Jeff is currently serving as the Acting Director at CDRH.) That would give Ann the platform to address some of her favorite issues such as off-label communications, advisory committee operations, and the medical device review process.  It’s also interesting to note that Ms. Witt was a key player in Dr. Kessler’s (failed) attempt to claim regulatory authority over tobacco.

FDA Principal Deputy Commissioner Josh Sharfstein graced the luncheon dais on the final day (Wednesday) of AdvaMed’s third annual shindig.

Following a video welcome from his boss, FDA Commissioner Peggy Hamburg (who advised the audience they weren’t obligated to laugh at any of Josh’s jokes), Dr. Sharfstein spoke about the five issues driving reform over at CDRH.  They are:

(1) The development of predictable pathways. Good to hear that the corner office understands that predictability is an important public health issue.

(2) 510(k) reform (and the IOM study of same). Josh noted that “not everyone” was unhappy with the status quo. 

(3) Development of a comprehensive compliance strategy.  Urgent since the absence of such a program dilutes credibility for both regulator and regulated.

(4) A total lifecycle approach to post-market safety.  A la REMS – this (at least in theory) gives the agency greater comfort to approve riskier products.

(5) Better communication of why (and how) CDRH reaches its decisions.  This jives with the agency’s broader transparency initiative (which is being coordinated by Sharfstein).

Josh lauded Acting CDRH Director Jeff Shuren, noting that he (Jeff) wasn’t just keeping the seat warm until a permanent director can be appointed, but had the full faith and authority of the Commissioner to drive the above five-pointed program forward.

Jeff Shuren is a serious guy and whip-smart.  An MD and a JD – he now completes the triad as (acting) indian chief.

The European Commission is inviting feedback from stakeholders on how the Clinical Trials Directive (Directive 2001/20/EC) might be improved.

The commission wants to know whether the scope of such community-wide authorization procedures should be optional, with the choice being left to the sponsor. Also, it asks whether such procedures should cover all clinical trials preformed in the EU or whether they should be limited to only some clinical trials (for example multinational trials).

Stakeholders are asked to submit feedback on which option is preferable and on the practical and legal issues that would have to be considered if they were to be adopted.

While ethical issues clearly fall within the remit of member states and would remain there, the commission has several suggestions to ensure better co-operation and exchange among national ethics committees to improve the ethical review of clinical trials.

The consultation document contains several examples of inconsistencies in the current application of the directive in member states.

For example, there are different interpretations of what could be considered a substantial amendment; this has resulted in a situation whereby the company regards something as a substantial change more often than it actually should in order to avoid problems of non-compliance.

Also, problems relating to the reporting of suspected unexpected serious adverse reactions (SUSARs) have led to multiple reporting of the same SUSAR, lack of reporting and unreliability of community data on SUSARs. Moreover, the number of SUSARs received differs disproportionately among some member states.

The consultation document builds on the findings and recommendations of an EU-funded study – the Impact on Clinical Research of European Legislation (ICREL) – that was issued earlier this year. The ICREL project was initiated in January 2008 and it measured the impact of the directive on four key stakeholder groups – commercial and non-commercial clinical trials sponsors, competent authorities and ethics committees – between 2004 and 2007.

All fine and good and important and timely – but what about enhanced harmonization with, among others, the United States?  First things first perhaps, but the transatlantic issue must be addressed – and sooner rather than later.

Snowe Job

  • 10.13.2009
 
The Senate Finance Committee puts a happy face on a horrible health care reform bill that will have to be dumped into the HELP Bill...And Olympia Snowe goes along.to help the process along...  Here are the talking points since no one will read the bill (amended by me)

 

Eight Things to Know about the America’s Healthy Future Act (Amended for honesty and accuracy)

1. Individuals and employers who are satisfied with their current health insurance coverage can keep it and would not be required to change health plans.  (For five years.  And then individuals and employers -note, not employees-  would be forced to buy health plans through exchanges that cost up to three times as much as their previous coverage with benefits they may not want or use.  Poor and working class people will have no choice but Medicaid, which will double in size even as physician  pay is cut.  Good luck trying to keep your own doctor in either case unless you pay cash.) 

2. No American can be denied health insurance or charged more because of a pre-existing health condition.  (But since Americans who are and stay healthy will subsidize those of us who get sick and enroll only when they are seriously ill, the costs of coverage will increase or care will be rationed.   Probably both.  And Americans with pre-existing conditions will be denied coverage of drugs or  tests and be forced to wait to see specialists as health plans, under the threat of a public option trigger, will cut access to care that the Obama administration regards as unnecessary/)

3. Health insurance companies will not be able to discriminate on the basis of gender or health status -- so insurance companies can’t charge more for women or Americans who are sick.

(See above. This is pay for performance in perverse. ) 

 

4. Health insurance companies will no longer receive tax deductions if they give their executives excessive salaries and compensation.  (And this improves health care access and quality how?)

5. Members of Congress will be required to buy their health insurance through the same exchanges that people in their own states will use, instead of having a separate Congressional health plan.  (Yes, but Members of Congress will have their insurance deeply subsidized.)

6. Health insurance companies will no longer be able to limit how much coverage you can use over your lifetime or how many benefits you can use each year.  (Sounds good.  But remember the government will be making those decisions from here on in.   What benefits you use and how much will be decided by a Quality Czar who will issue reimbursement and coverage decisions for health exchanges based on what bureaucrats believe is cost effective.  That’s rationing.)

7. The bill specifically says there will be no Medicare benefit cuts for individuals. In fact, it strengthens Medicare’s finances so the program can continue to provide benefits for years to come.  (Nice try.  The bill specifically cuts Medicare Advantage, the fastest growing program for the most chronically ill seniors.   Score a big one for AARP which , in exchange for shilling for Obamacare, will reap billions as seniors dumped from Advantage have to buy supplemental coverage for what the shuttered program used to pay for.   It specifically reduces what doctors will get under Medicare.  It specifically seeks to reduce how much doctors do based not on how sick people are (see the similar contradiction in point 6) but on the lowest amount of care given per person regardless of burden of disease.  And it micromanages the decision of whether to pay for new technologies to assure that fewer people get innovations more slowly.     Maybe it’s not a cut, but it is denial of care.

8. Low-and middle-income seniors will get 50 percent of their drug costs paid for when they reach the so-called doughnut hole in the Medicare Part D prescription drug program, where no coverage is provided today.  (And what drugs they get will be determined by a government panel that will increasingly delay access to new drugs based on price alone and without regard to individual differences. )




Atonal Melody

  • 10.12.2009

Remember Melody Peterson?  She used to cover the pharmaceutical beat for the New York Times until she was, well – until she didn’t any more.  Now her occasional column inches appear where they belong – on pages designated "opinion." On Saturday (10/10/09) she had an op-ed in the Los Angeles Times. The title of her piece, “Healthcare reform without drug price controls? That's sick.”

Ms. Peterson needs some fact checkers.  Some examples:

“Over the last 30 years, the industry hasn't focused its efforts on discovering those truly amazing innovations that can change the practice of medicine.”

Really?  Cardiologists, oncologists, psychiatrists, endocrinologists, and just about every other specialist – as well as internists would likely disagree – and strongly. Thirty years ago was 1979. Does Ms. Peterson need a list of 30 years worth of pharmaceutical innovation? Looks like it.

She continues:

“When Congress expanded Medicare in 2003 to cover the cost of prescriptions, the industry's lobbyists got language into the bill that made it illegal for the government to negotiate prices and act like a savvy medicine shopper.”

Melody refers to the Non-Interference Clause -- but gets her facts wrong.  That particular codicil was initially drafted not by “industry lobbyists” during the Bush Administration, but during the Clinton years by then Senators Tom Daschle and Ted Kennedy.  Pesky facts!

Relative to government-dictated pharmaceutical price controls, Ms. Peterson writes that, “… studies have shown it would save billions of dollars a year.” She then forgets to cite any studies.

Well, consider this statement from Stanford Business School's Alain Enthoven and Kyna Fong, “Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices.”

And this, according to that mouthpiece of the right-wing conspiracy, USA Today -- "Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector.”

Facts?  They just get in the way when the end justifies the means. 

Melody writes,

“Nearly one of every five dollars that we spend each year goes to the drug companies, doctors, hospitals and the rest of the medical system.”

Yes – but how is this money spent? Well, since her essay is about on-patent pharmaceuticals, it would have been useful (one would think obvious and necessary) to offer a breakdown.  Here’s what she omitted – our national percent spend for on-patent medicines is about 8% of the total. Less than a dime on the dollar.

Towards the end of her, um, opinion piece, Peterson writes, “Congress must pass legislation to ensure that every American has access to medical care. And study after study has shown we can do that without breaking the bank -- if only we reform the system to hold down costs. But the drug companies, which are spending more on lobbying than any other industry, are determined to make sure that doesn't happen.”

So many studies!  Not one listed.  And – last I looked -- the pharmaceutical industry is spending tens of millions of dollars in advertising in support of healthcare reform.

“Facts do not cease to exist because they are ignored.”

-- Aldous Huxley

Veritas? No Mas!

  • 10.09.2009

Whenever my father said something my grandfather didn’t agree with, zayde would shrug and say, “For that you went to Harvard College?”

Yesterday I debated a professor from Harvard College -- John Abramson, MD, professor of clinical medicine and author of "Overdosed America." The venue was Minnesota Public Radio. We debated the issue, “Is Drug Research Biased.” 

Dr. Abramson was, to be polite, ill-informed.  He did, however, come clean and admit he is an occasional witness-for-hire for trial lawyers. Oddly, he kept making peculiar comparisons between comparative effectiveness and ... climate change.  Afterwards, when I visited his web site (www.overdosedamerica.com) it was … all about climate change. 

For this he teaches at Harvard College?

Have a listen and judge for yourself.  The radio program can be found here.

Comic relief?  Not quite ... but almost.  How sad.

CMPI

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.

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