Government Run Healthcare Harms Our Health

10/22/2009 12:06 PM |

CMPI hosted a roundtable discussion with health policy leaders about the real impact of health care proposals being considered by Congress. We released new findings developed by Richard Cooper, MD a professor of medicine at U Penn challenging the claim made about every bill: that a public option or a “trigger”, health exchanges and Medicare commissions can cut “unnecessary” care, reduce spending on health by 30 percent of the total and pay for universal coverage.

Dr. Cooper's research (which can found on his blog buzcooper.com/2009/07/29/what-if-the-problem-is-poverty/ ) clearly shows that proposals to have government penalize doctors who use more services than the lowest ten percentile (or reward those who use less services), reimburse according to evidence-based guidelines which are skewed to the less is best bias inherent in comparative effectiveness research, cut back payments to doctors in Medicaid and Medicare based on this mindset, limit the introduction of new technologies where government payment predominates, and envision increasing the number of Americans receiving care under this framework will mean cutting back drastically on access to medical treatment for poor people in urban areas.

Our panel of experts, moderated by CMPI senior fellow and former Congressman Mike Ferguson observed that central features of the current bills in Congress will guarantee that health care gets worse for minorities and the chronically ill, not better.

Michael Cannon, who runs health policy studies at Cato Institute (www.cato.org/people/michael-cannon ) noted that because Medicare and Medicaid are already the largest single source of payment, expanding the model will make it even harder to shift resources or change thinking in ways to focus on illness or disease prevention. The political culture will simply reorganize around the larger bureaucracy.

Joe Antos, the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute (www.aei.org/antos) pointed out that health care is a series of choices about care, cost, coverage and behavior. The issue is who should make these choices. The current proposals are hell-bent in centralizing such important decisions into the hands of a few government planners. Choices made by many to allocate resources thereby become rationing.

Jim Frogue , who is deputy director of Newt Gingrich's Center for Health Transformation (www.healthtransformation.net/cs/jim_frogue) emphasized that behavior is the key to health status for most chronic illnesses. Reforms that fail to focus on health improvement in a signficant way, or fail to free people to pursue prevention will make matters worse. While best practices are not one size fits all, Frogue noted that prevention approaches can be shared, adapted and refined for specific populations.

Finally, Gary Puckrein, President of the National Minority Quality Forum noted that advances in medical technology explain a considerable amount of the increase in life expectancy and survival over the last 50 years. The forum www.nmqf.org has identified by zip code where the greatest incidence of the most serious and costly chronic disease exists. It has tracked to the patient level who will cost the most in terms of Medicare expenditures and why. The failure to prevent diabetes explains much of the growing cost of Medicare and it can be traced to specific urban areas, areas that will see money cut because it is defined as "wasteful" when it could be transformed into more effective forms of care.

The battle of health care then is not "yes" or "no" but "how." Medical innovation is and should continue to be an American growth industry and a source of productivity. The current approach to reform undermines and discourages transformation, drives up cost and slows the development of the next generation of technologies.

More importantly, the mass of regulation assures that the health care equivalent of a Bill Gates or Eric Schmidt will not emerge to lead and transform a critical and competitive American industry.    Read More & Comment...

Emissions Impossible

10/22/2009 08:48 AM |

Ad Age reports:

 U.S. Senator Al Franken (D-Minn.), along with co-sponsors Sens. Sherrod Brown (D-Ohio) and Sheldon Whitehouse (D-R.I.), have introduced legislation (S. 1763) to disallow the federal tax deduction for all advertising and marketing expenses for prescription drugs. There are rumblings that the senators would like to have the proposal added to the health-care reform legislation, and the possibility exists that they may offer it as an amendment when the proposed bill is considered by the full Senate.

Former Food and Drug Administration associate commissioner Peter Pitts, now the president of the Center for Medicine in the Public Interest, said the proposed legislation to cut the ad tax deductibility endangers more than just the health-care reform bill.

"What this endangers is the public health, as every survey -- including those done by the FDA -- show that DTC advertising, beyond helping to sell product, actually increases the health literacy of the American health consumer," he said. "Such a move is actually an anti-health reform amendment and is nothing more than grandstanding by a long-time opponent of the pharmaceutical industry [Mr. Brown] and a 'Saturday Night Live' alum [Mr. Franken]. Painting pharmaceutical marketing as an 'enemy' of health reform is like saying automotive advertising is the enemy of emissions control."

The full Ad Age article can be found here:

 http://adage.com/article?article_id=139826

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Katy Bar(code) the Door

10/21/2009 08:36 AM |

SCRIP World Pharmaceutical News reports that, “The European pharmaceutical industry association, EFPIA, today launched its anti-counterfeiting pilot project in Sweden, raising concerns among parallel traders that should it be rolled out across the EU, the scheme's central database may be misused by manufacturers to curb sales to certain wholesalers.”) This follows up on the commission's legislative proposal for some sort of authentication process, but which stopped short of recommending an actual type.

The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.

The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.

The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.

Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."

Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.

The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.

The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.

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Total Ellipse of the Sum

10/20/2009 10:42 AM |

The Senate Finance bill is over 1500 pages long.  But when it comes to the infamous “Doc Fix” (and its nearly 10 year $250 billion price tag), there’s only a one-year patch – with the cost offset by taxes and reduced spending elsewhere.

What about the other nine years?

That, it seems, is the purview of S.1776 and, according to the New York Times, “Congressional Democrats have no plans to offset the cost of S. 1776, which is why they are eager to keep it separate from the broader health care legislation and avoid breaking the president’s promise.”

That promise again, “I will not sign a plan that adds one dime to our deficits — either now or in the future. Period.”

Well, it seems that many in Congress are looking at the “period” and seeing an ellipse.

The Times continues, “Congressional Democrats insist that fixing the doctor payment formula should not count toward the cost of the big health care legislation, because it is a problem they inherited.”

Unlike the problem of the uninsured?  Unlike the problem of preexisting conditions?  Unlike the problem of the donut hole?  Unlike the problem of (FILL IN THE BLANK)?

Sounds like a total ellipse of the sum.

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Outrage - Government Attempts Takeover of Cable Industry!

10/19/2009 05:09 PM |

Please help CMPI create a viral buzz with our new web ad. Share this video with your social networks and email lists.

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Galen Poll Cuts To The Heart of Healthcare Debate

10/19/2009 02:02 PM |

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%
###

 

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Warts and All

10/19/2009 08:40 AM |

On September 29^th, 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 16^th):

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. 

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FDA's Public Citizen

10/17/2009 07:58 PM |

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?

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One Witt. Two Errors.

10/16/2009 10:22 AM |

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Witt Picking

10/16/2009 09:52 AM |

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.

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Doctor, Lawyer and (Acting) Indian Chief

10/15/2009 09:04 AM |

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.

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Clinical Trials and Tribulations

10/14/2009 09:51 AM |

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.

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Snowe Job

10/13/2009 06:40 PM |

 
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. )

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Atonal Melody

10/12/2009 08:48 AM |

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

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Veritas? No Mas!

10/09/2009 09:07 AM |

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.

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Doctors Don't Count

10/08/2009 08:37 AM |

When it comes to healthcare reform, doctors don’t count … when it comes to cost analysis that is.

The Senate Finance approach to healthcare includes upwards of $245 billion to adjust Medicare payments for physicians. But -- for reasons that defy logic – that number is excluded from the Congressional Budget Office’s scoring.  It’s the same political legerdemain that refuses to call a tax a tax.

The so-called “doc fix” would ensure that physician pay isn't cut. Some say the payment is a political carrot designed to ensure doctors' support of health care overhaul. Maybe so, but it is real money and should be included in the CBO scoring of any healthcare reform bill.

Honestly – a healthcare bill that doesn’t include Medicare payments to physicians?

As my kids would say, "word."

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Of "Interest"

10/07/2009 08:56 AM |

Last week I sat on the final panel of the Fourth National FDA Regulatory Symposium.  The topic for discussion was “Striking the Right Balance:  How to Manage Conflicts of Interest in the Wake of the IOM Report and Congressional Reform Proposals. 

Moderated by Wayne Pines (APCO), my fellow panelists were Eric Campbell (Associate Professor Harvard University) and Marc Wilenzick (Assistant General Counsel, Pfizer – and a former Assistant Chief Counsel at the FDA).

Some commentary:

• We should all pay attention to our nomenclature.  It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.”  And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.

• Dr. Campbell, who sat on the IOM’s COI committee, said that the Institute’s report was “bipartisan.” I corrected him – pointing out that it’s “non-partisan.” Or at least it’s supposed to be.  He graciously accepted the point.

• Dr. Campbell acknowledged the importance of physicians (both practicing and those in the realms of both clinical and academic research) working with industry.  That’s nice.  But when I pointed out to him that physicians who do so (and particularly in the great Commonwealth of Massachusetts) are increasingly viewed as tainted – if not as outright criminals – he had no answer.

• My point to Dr. Campbell (and to all members of the COI Polloi) is that actions (often ones with political intent) often have unintended consequences (often on the public health).

In my concluding remarks I made the point that, when it comes to “transparency,” we need to weigh “interest versus benefit." That, as with drugs and devices, we must consider the “safe use” of transparency.

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Byron the "Brandjacker?"

10/06/2009 09:57 AM |

Word on the street (or, more precisely, on the Hill) is that Senator Dorgan is going to offer an importation amendment to the forthcoming (maybe) Big Kahuna health reform legislation.  Bad idea.  It’s time to introduce the Senior Senator from North Dakota to “brandjacking.”

According to an article in Pharma Times,  “A new report has highlighted the rise of pharmaceutical “brandjacking” for popular drugs, which is causing health concerns and damaging the reputation of the sector.” The analysis, published by MarkMonitor, highlights “a parallel online system of pharmaceutical supply and demand” which is being fuelled by continued growth in listings for medicines on business-to-business exchange sites as well as increased traffic to illicit pharmacies.”

As a result, consumers are turning to the internet, says the report, with people visiting both legal and illicit online pharmacies. Also, offshore manufacturers “increasingly embrace B2B exchange sites to sell bulk quantities of branded prescription drugs, often of suspicious quality.” Therefore, cost savings and efficiencies of e-commerce “become even more attractive, presenting a tempting opportunity for online fraud and brand abuse."

MarkMonitor chose six leading prescription drugs and examined nearly 20,000 instances of cybersquatting, the practice of abusing trademarks within the domain name system, a rise of 9%.

The report noted that of the 2,930 online pharmacies found in the study, only four were certified in the VIPPS program by the National Association of Boards of Pharmacy. Furthermore, the non-VIPPS sites offered discounts as high as 90% from the prices offered by certified websites, which indicate, “that the products are of suspicious quality.”

Importation anyone?

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Gems on REMS: A Cool and Refreshing Draft (Guidance)

10/06/2009 09:46 AM |

I was pleased to be both a co-chair and a speaker at this year’s Drug Safety Summit. (And particularly so, since we were joined by Sir Alasdair Breckenridge, Chairman of Great Britain’s MHRA -- the Medicines and Healthcare Products Regulatory Agency.)

My panel was ably moderated by Brian Harvey (Sanofis-Aventis and a former colleague from my FDA days). The other panelists were Meredith Manning (Hogan & Hartson) and Florence Ho (Celgene – and another former FDA colleague). 

The topic was “Achieving Predictability and Transparency in REMS.  Some of the discussion points:

* REMS must be viewed as a “win/win” situation for the agency (it can now move forward and approve drugs with higher risk profiles and have a more direct path for post-market surveillance), for sponsors (who can have their drugs approved with greater alacrity), physicians (who will – at least in theory) have a more complete view of risks and benefits, and patients (who will have additional therapeutic options and will now – at least in certain circumstances – become more complete part of the compliance/adherence proposition).

* Much discussion over where in the drug development process REMS should surface.  Acknowledgement that this cannot be done in the absence of data – and confusion as to how to deal with early (even Phase II information) that might be REMS relevant.  And “confusion” meaning both scientific uncertainty and internal confusion and discomfort.

* Evident frustration about validated tools (the absence thereof).  But this was at least somewhat assuaged by the timely release of the FDA’s draft guidance on “Format and Content of Proposed REMS Assessments, and Proposed REMS Modifications.”  And it was a cool and refreshing draft indeed.

* And, speaking of draft guidance and validated tools – what about timeliness and the potential for (are you sitting down) – user fees for REMS. Yes, of course REMS development and approval is part of the NDA process.  And, yes, they should (at least in theory) be covered under PDUFA fees. But, hey, just thought I’d mention it.

* The issue of both “class” REMS and REMS for generics – the latter combined with the important issue of the intellectual property and patent rights of the innovator.

* Continued discussion as to whether or not companies should wait until the agency asks – or if sponsors should preemptively (you should excuse the expression) provide an outline of a potential REMS plan.  This is important not just as an issue of timeliness (as opposed to having the agency introduce the topic in a complete response letter), but also of responsibility.  If, as we all want to believe, the FDA must be both regulator of and colleague to industry, then what are the responsibilities of a sponsor relative to (among many other things) surfacing the REMS issue – and at what point in the process. 

Nobody said it was going to be easy.

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Wisdom. Common Sense. And a Sense of Humor.

10/05/2009 05:12 AM |

Last Wednesday I chaired the Fourth National FDA Regulatory Symposium. Being the chair gave me the privilege to introduce the event’s keynote speaker, FDA Commissioner Peggy Hamburg.

By way of introduction, I pointed out that everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible.
Every specific action the agency takes is an opportunity to speak to a larger public health issue. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. The FDA must be seen as leading rather than simply participating in the process.

As a former New York City Health Commissioner, Dr. Hamburg has the opportunity to bring to the FDA the ability to view regulatory issues from the viewpoint of the man on the street, the patient -- the consumer.  And there are issues aplenty:

•    There’s the question of REMS plans.
•    And complete response letters.
•    And the transparency of complete response letters.
•    And biomarkers.
•    And guidance on off-label promotion.
•    And “net impressions” of DTC materials
•    And oversight of social media.
•    And of clinical trials.
•    And of adaptive clinical trials.
•    And follow-on biologics.
•    And bioequivalence for generics.
•    And GMPs
•    And drug importation.
•    And counterfeiting.
•    And companion diagnostics.
•    And the regulation of diagnostics.
•    And 510(k) reform.
•    And food safety and security.
•    And dietary supplements.
•    And nutritional health claims.
•    And tobacco.
•    And early safety signal communications.
•    And pandemic preparedness.
•    And greater international harmonization.
•    And the balance of predictability vs. ambiguity.
•    And food from the progeny of cloned animals.
•    And the FDA’s working relationships with industry and academia.
•    And the Reagan/Udall Foundation – wither the agency’s Critical Path program?

As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”

The Commissioner began her remarks by commenting, “It’s a lot easier to ask the questions then to answer them.”  Zing,

Some additional thoughts from Dr. Hamburg:

* Concerned that the agency “is under-appreciated by the public”  (a recent poll shows that, among government agencies, the FDA ranks just one notch above the IRS) “and under-resourced.” In fact, she mentioned that she was going to OMB on Friday (October 2) to defend the FDA’s budget proposal for the coming fiscal year.  I promised to pray for her.

* The FDA’s most valuable assets are the “extraordinary public servants” who work at the FDA.  Can’t repeat that too many times.

* That to be FDA Commissioner requires “wisdom, common sense, and a sense of humor.”  Well said.

* The urgency of the FDA’s Critical Path program and “the urgency to fund robust 21st century regulatory science. “ She aptly defined the agency’s role as “Reviewer, Approver – and Catalyst. And, “We must advocate for it.”

* “Success is not measured in warning letters.” Amen – and courageous of her to say so.

* Similarly, and relative to foreign drug manufacture, “The FDA will never be able to assure safety all on our own.” And that there must be “shared responsibility for global drug inspections.”

* During the Q&A she was asked whether or not the FDA would add comparative effectiveness as a third leg to the approvals process.  Her smart response was that the FDA should find ways to share its data with researchers in order to “enrich understanding.” Short answer to direct question – no third leg.

* Per the FDA’s initiative on transparency (led by Deputy Commissioner Josh Sharfstein), Dr. Hamburg said she hoped to have some initial (“incremental”) recommendations by November.  Stand by on that one.

Thank you Commissioner.


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