Gertrude Stein on Reimportation

03/02/2009 03:07 PM |

The budget outline released by the Obama administration Feb. 26 "supports" FDA's "new efforts to allow Americans to buy safe and effective drugs from other countries."

In a background briefing, an official with the White House Office of Management and Budget explained the funding will "begin to lay the basis for safe and effective reimportation at FDA. But we think we need to put some infrastructure and build some processes there to do that."

What’s “reimportation?” If it means bringing back into the US drugs manufactured within our borders and then sent abroad (which is what most people think it means) then there’s no there there.

If, on the other hand, the unnamed official means “importation,” then Katie bar the door on safety, intellectual property rights, and the importation of foreign price controls.

Did President Obama discuss this plan when he met with Canadian Prime Minister Stephen Harper? 

Probably not.
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Equal but Separate

03/02/2009 01:28 PM |

Courtesy of today's Washington Times Commentary section: 

Getting it right with modern drugs

Congress and President Barack Obama should be commended for expressing a strong commitment to modernize the Food and Drug Administration.

The FDA needs funding, resources, and the support of our leaders in Washington if the agency is to get it right in confronting our most urgent health challenges - especially if they want to ensure patients receive the safest, most effective generic medications.

As a top priority, the FDA must move to modernize its standards for approving generic versions of "controlled release" drugs. Controlled release drugs are a new generation of medication. They are engineered to deliver a precise amount of a medicine, at precise intervals, over a period of hours, without losing potency or effectiveness. This controlled release mechanism helps treat patients suffering from some of the most chronic and debilitating conditions - pain, depression, Parkinson's, Alzheimer's or hypertension.

The good news is that more than 20 generic controlled release drug formulations are poised to be released to the market, pending FDA approval. The bad news is that the FDA is using dated generic approval standards to evaluate these modern medications. This is critical considering any deviation from how a controlled release drug is delivered to the body can lead to unbearably painful, harmful or even fatal patient consequences.

For the FDA to approve a generic drug it must, in part, be identical in strength, dosage form, and route of administration to the original, branded drug. But the FDA's tests for controlled release generics are not measuring the very element that makes the original drugs so valuable to patients: the safe, controlled delivery of a specific amount of medication over an extended time. Measurements that don't include time variables simply cannot assure bioequivalence for this class of drugs.

One remedy to the bioequivalence testing shortfall will only require FDA to use multiple time-based measurements of active ingredient concentration. This will allow regulators to compare the complete performance and equivalence of a generic to the original controlled release medication. This is just a small alteration in the testing standards and only requires generic controlled release applicants to submit more data.

Those who would decry this tweak of the measurements miss the bigger picture. Controlled release drugs are only one class in a whole emerging generation of medications - follow-on biologics are another example - that the FDA will need to adapt to and address if it hopes to keep patients safe. There must be no public doubt that all new classes of generic drugs are exactly bioequivalent to branded versions that have been validated by clinical trials and years of use.

By no means is this a call for the FDA to scrap its standards for bioequivalence - not at all. Rather, this is a call to make them more robust and stringent in order to honestly assess a new generation of drugs. Evidence supporting that conclusion is mounting - a host of complaints and reports from patients losing effectiveness after switching from a branded, controlled release anti-depressant to a generic led the FDA to review whether the generic was bioequivalent and therapeutically equivalent to the brand. The review board gave the generic its vote of confidence, but noted its sensitivity to the bioequivalence issue, saying:

"The question is whether the reported lack of efficacy and/or new onset side effects in these patients who switched suggests a problem with the generic product, i.e., lack of bioequivalence to the branded product, or have some other explanation."

Simply put, the generics industry cannot flourish, innovate and compete if it does not inspire the confidence of American patients. For the FDA to continue to ignore the controlled release regulatory oversight is to invite disaster on two fronts: the complete erosion of the generic industry's reputation in the eyes of patients, and, unthinkable, widespread patient harm caused by ineffective controlled release generics.

Many of the health and food incidents over the last few years were hard for the FDA to predict or prevent, given its resources and funding. There will be no excuse, however, if the FDA ignores the potential for harm waiting in this regulatory gap. Pretending there is no risk in changing formulations is not science-based regulation. In the real world, there are no shortcuts to patient safety.

Peter Pitts is president and co-founder of the Center for Medicine in the Public Interest and was a Food and Drug Administration associate commissioner from 2002-04. Robert Goldberg is vice president and co-founder of the Center for Medicine in the Public Interest.

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Health Care Tax Credits Look Better and Better

03/01/2009 05:09 PM |

The COBRA tax credit is another example of why  government solutions to the problem health care coverage will fail and probably add to the  government created problem.    COBRA is simply a way of giving people who are laid off the "opportunity" to pay for the gold plated employer based health plan out of their own pocket, a health plan that would not be so gold plated if not for the third party approach to coverage and the rich tax subsidies supporting such a system and the political interests sustaining it.   Would people pay for such a turkey in the free market?  Of course not.  Not even at half the cost.

Uncertainty over new health safety net for jobless

WASHINGTON – The Obama administration rushed to include a health care safety net for laid-off workers in the recently signed stimulus bill, but has not told employers exactly how to make it work.

As a result, tens of thousands of jobless people could wait months before getting help paying for health insurance that their employers previously had covered.

"Too many people are still trying to figure this out," said Heath Weems, director of human resources policy at the National Association of Manufacturers. "There is a lot of confusion."

At issue is the program called COBRA, the acronym for the law that allows workers to keep their company's health insurance plan for 18 months after they leave their job, if they pay the premiums.

The policies are so expensive that only a minority of eligible workers sign up, often those with medical conditions that demand attention. Costs for a family of four can top $1,000 per month."

You betcha.

As Peter has noted, divide $700 billion by the real number of the uninsured -- 20 million --  over ten years or better, $70 billion a year by 20 million you get $3500 per person.  So why not give people a tax credit  and let insurers, health care agents, etc provide a product from scratch that offers insurance coverage that automatically enrolls people, is universal, portable guaranteed issue of some sort, incentives for healthy behavior, a rider that people would pay that would cover out of catatstrophic out of pocket expenses and encourage pre-funding of deductibles via HSAs through employers, direct deposit. etc.    Compare that to the unworkable effort to extend COBRA and all it's complexities....and COBRA is so expensive precisely because the health plan it is "replacing" is unfairly subsidized by lower income Americans in favor of health care plans like those that are bankrupting GM and Chrysler.  

How to pay for it?  End the system that creates the COBRA like plans in the first place and give people a chance to design plans that they truly value with their own money.   Encourage more personal responsibility for health.  Provide doctors and patients with information on real comparative effectiveness information, information on what health technologies and treatments are best for them, not guidelines twisted by any one interest as Roy Poses of the www.hcrenewal.blogspot.com/  has noted.  (Yes, I agree with Roy on this emphatically!)   More on this in future post.   
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Profiles In Courage

02/28/2009 01:11 AM |

Winston Churchill once noted: "This is no time for ease and comfort. It is the time to dare and endure." 

Last night Peter and I were surrounded by people who celebrated Dr. Sol Barer, CEO of Celgene for his leadership and vision in transformational medicine.  They and we were graced by the warmth and wit of John Stossel, Rich Bagger, Mike Ferguson, myleoma survivor Elijah Alexander, and Dr. Jules Hirsch -- individuals who are leaders in their respective fields of journalism, the pharmaceutical industry, politics, professional football and academic research.  Their charge to us, at the First Annual CMPI Odyssey Dinner, was to dare and endure as they have, on behalf of medical innovation.  We were called upon to speak out,  to make biomedical innovation a personal and passionate cause -- and to battle against those who vilify its capitalist origins.

I can't thank enough those who gathered with us to begin this new movement -- friends old and new --  for their support, generosity, warmth and participation. Above all, I am left with a memory of your kindness, the appreciation of which I look forward to repaying in the months and years ahead!

Thank you.
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Rahm's Part D Sleight of Hand

02/27/2009 08:57 PM |

OMB Budget Document:

"The Budget supports the Food and Drug Administration’s (FDA’s) new efforts to allow Americans to buy safe and effective drugs from other countries ..."

Don't kid yourself by thinking this has anything to do with lowering costs for seniors (because even the AARP says Part D is a better deal) or "broadening access" for the uninsured (which is what pharmaceutical patient assistance programs are for). Importation is yet another stealth strategy towards a straight up price control regime for medicines. If importation goes forward, you don't need to revoke the Non-Interferene Clause.  This has been Rahm Emanuel's strategy for the past few years and now he's an agent in place.

If you like "universal care" provided by Uncle Sam, MD -- you're going to love importation.

Here we go again.  Read More & Comment...

Sol's Trophy and Elijah's Cup

02/27/2009 01:41 PM |

Sing in me, Muse, and through me tell the story
of that man skilled in all ways of contending,
the wanderer, harried for years on end,
after he plundered the stronghold
on the proud height of Troy.

So begins Homer's Odyssey.  And so began last night's first annual Center for Medicine in the Public Interest Odyssey Award gala dinner.

The dinner (held at the posh Short Hills Hilton) honored Sol Barer, PhD, CEO and Chairman of Celgene, for his lifetime of dedication to the cause of medical innovation.  (Watch this space soon for his complete remarks.)  Sol is a visionary and the evening was all about him -- but he is all about innovation in the service of patient care.

And while Dr. Barer got the trophy, the hero of the evening was Elijah Alexander, ex-NFL linebacker, husband, father of two -- and survivor of multiple myeloma. (For more on Alexander's fight against multiple myeloma, visit the "Tackle Multiple Myeloma Foundation" website here.)

Elijah talked about his cancer, about the impact it had on his family -- and how innovation saved his life (specifically via Revlimid).  He cried.  Everyone cried.  Even John Stossel, Mr. "Give Me A Break" (and the evening's emcee), misted over.

The evening was all about the importance and urgency of innovation.

Yes -- even innovation via the resurrection of thalidomide.

President Obama says he want to "cure cancer."  He should talk with Sol Barer.

But first he should listen to Elijah Alexander.

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Deja Vu All Over Again in Healthcare Reform

02/26/2009 06:39 PM |

Here's my take on the Obama healthcare "downpayment"

1.   I don't like tax increases.  However capping the deductibility of health care expenses at some point does make sense.  So does taxing benefits beyond a certain dollar value or income level (inflation adjusted).  Obama got that half right.
2.   Requiring HMOs to bid using the Medicare actuary's estimate was something President Bush proposed in 2003.  Most people don't remember that.  Now Obama is proposing the same thing in lieu of the bonus.  Will seniors pay more or less?  Will they be better off?  Hard to predict.
3.  No price controls on part D which rewards use of market forces and preventive technologies.  Cuts to medical imaging and home health which will likely not stand or will be adjusted. 
4.  The administration proposes a bundled hospital payment that includes 30 days for post discharge care.  Can we say DRG-based capitation?  Nothing new here...just another reimbursement code to exploit.

The Obama team did as little as prescriptively possible to come up with $700 billion for universal health care.   More -- about a trillion more (at least) will be needed and even then not everyone will be enrolled.  And of course enrollment does not equal better health or outcomes.   Where will the rest of the money come from?  A tax on employers in lieu of providing coverage.  

So for the most part the health care reforms are nothing new and the cost is very high.   Still, the down payment does little to move us towards "government run" health care.    If free market types want to come up with a way to provide people with a choice of health plans that eliminates penalties for pre-existing conditions and a range of insurance products that are affordable that does not involve government control over medical decisions, now is the time.   It can't be HSAs alone, which are still a confusing and difficult benefit to provide.   It has to protect people from financial catastrophe, reward healthy behavior, reward better outcomes, encourage more personal responsibility.     And the proposal has to be bold and big. 

Nothing else will compete or do. 
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Sasquatch Care

02/26/2009 02:02 PM |

According to a story in today’s Washington Post, “President Obama is proposing to begin a vast expansion of the U.S. health-care system by creating a $634 billion reserve fund over the next decade, launching an overhaul that most experts project will ultimately cost at least $1 trillion.”

Key words, “vast expansion.”  That means a “vast expansion” of the medical practice of Uncle Sam, MD.

And, says House domestic policy adviser Melody C. Barnes, “It serves as a footprint for something bigger."

The complete Washington Post story can be found here.

The AP reports that, “The health care provisions are meant to start a dialogue with Congress over how to provide coverage for an estimated 48 million uninsured.”

Um, there’s some double counting going on here.  First of all, what about the 4.1 million person expansion of SCHIP (funded through a 61-cent increase in the federal excise tax on tobacco) and the 12 million Americans who already qualify for government benefits – but haven’t signed up for them.  That’s 16.1 millions worth of double counting.

And then there’s the thorny issue of counting 10 million uninsured illegal aliens as part of the 48 million.  If there’s raucous contention over allowing illegals to have New York State drivers’ licenses – you can’t expect acquiescence on the issue of providing this group healthcare paid for by the American tax payer.

What is the President’s position on this issue? Enquiring minds want to know.

So, 4.1 million + 12 million + 10 million = 26.1 million.  That leaves us with 22 million.

Of the remaining 22 million uninsured, there are many millions of Americans (many of them between the ages of 18-25) who opt not to buy health insurance even though they could afford to do so.  Some estimate this cohort to be as large as 20 million. But let’s say, for matter of discussion, that it’s only half that.

Pull out your calculators:  4.1 million via expanded SCHIP + 12 million already eligible for government programs but not signed up + 10 million illegal aliens, + 10 million Americans “opting out” = 32 million.

That leaves 16 million Americans who make too much to receive government benefits and too little to afford private coverage. 16 million divided by the President’s “down payment” of $634 billion is $39,625 per person.

(And this isn't counting the unemployment insurance-eligible Americans and their families who now qualify for government benefits as part of their unemployment benefits.)

This is a footprint for “something bigger?”

Maybe we should call it “Sasquatch Care.”

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Healthcare Reform via Contextual Analysis

02/25/2009 01:57 PM |

Good speech.  Liked the overall tone.  Pleased to report that the Vice President's hair is holding up nicely (which is more than I can say for my own).

Not surprisingly (in advance of the budget) light on details.  No surprises.

Per healthcare reform, two words that may serve as tea leaves -- "down payment" and "affordable."

"Down Payment" = incremental.

"Affordable" = insurance reform.

Relative to "affordable," here's are a few paragraphs from the recent Robert Pear story in the New York Times:

Since last fall, many of the leading figures in the nation’s long-running health care debate have been meeting secretly in a Senate hearing room. Now, with the blessing of the Senate’s leading proponent of universal health insurance, Edward M. Kennedy, they appear to be inching toward a consensus that could reshape the debate.

Many of the parties, from big insurance companies to lobbyists for consumers, doctors, hospitals and pharmaceutical companies, are embracing the idea that comprehensive health care legislation should include a requirement that every American carry insurance.

While not all industry groups are in complete agreement, there is enough of a consensus, according to people who have attended the meetings, that they have begun to tackle the next steps: how to enforce the requirement for everyone to have health insurance; how to make insurance affordable to the uninsured; and whether to require employers to help buy coverage for their employees.

The ideas discussed include a proposal to penalize people who fail to comply with the “individual obligation” to have insurance.

“There seems to be a sense of the room that some form of tax penalty is an effective means to enforce such an obligation, though only on those for whom affordable coverage is available,” said the memorandum, prepared by David C. Bowen, a neurobiologist who is director of the health staff at the Senate Committee on Health, Education, Labor and Pensions.

The full New York Times story can be found here.

Another question worth pondering is wither Medicare Advantage?

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Plain Vanilla? Not So Fast.

02/24/2009 08:35 PM |

  Read More & Comment...

Transparency Where the Sun Don' t Shine

02/24/2009 04:01 AM |

In yet another example of how when you seek a "seat at the table" in Washington politicians take it as a sign that you can't stand on your own two feet or you would be willing to lie under the next bus they throw you under ...

http://www.ama-assn.org/amednews/2009/02/23/prsa0223.htm

"Sunshine" bill sets $100 trigger for disclosing drug industry pay to doctors

The proposal would let states regulate such income even further. Reflecting a growing trend, two universities and a specialist group announce new conflict-of-interest policies.

"Physicians who receive $100 or more from drugmakers or device manufacturers over the course of a year would have those payments posted to the Web under bipartisan Senate legislation introduced in January.

The new bill is stricter than a version of the measure circulated last year that received support from industry and organized medicine groups, including the Pharmaceutical Research and Manufacturers of America and the American Medical Association.

The reintroduced legislation, known as the Physician Payments Sunshine Act, came amid another round of disclosure and conflict-of-interest policies announced by doctors and academic health systems."

Note that none of these disclosure or conflict of interest policies or limits on marketing announced by academic health systems restrict the ability of academic health systems to uh..market to the public, pay doctors out of central funds, receive and transfer money from insurance companies, hospitals, the for-profit arms of the health systems themselves, the lobbying or law firms that might retain the physicians from the academic health systems for expert legal work.  Oh no.  That exemption is about a wide as the part on Senator Grassley's scalp.  

And since we have no regard for the civil liberties of physicians and their family members...."The bill also would require drug companies or device makers that are not publicly traded to disclose any ownership interest held by physicians or their immediate family members. "  Does that mean if Dr. Berkowitz invests his son's Bar Mitzvah money in a hedge fund that also holds a position in a start up seeking to cure cancer that it is the responsibility of the start up to track down that investment? 

Some university health systems have gone to idiotic lengths to prove to Grassley how pure they are..."University of Iowa Health Care, a 1,420-physician health system, also announced a stricter financial-conflict plan in January. Among other things, the new policy bars faculty, staff and trainees from seeking, accepting or giving patients product samples under the theory that the free drugs improperly influence prescribing habits."  Nice theory.  But is it true?  And what if samples allow doctors to monitor if patients actually respond well to drugs without burdening patients with out of pocket costs?  Doesn't that improperly influence prescribing habits?  Since co-pays seem to drive down compliance in many cases isn't this policy harmful to patient health in order to appease Grassley?  And meanwhile it hasn't stopped UI from boosting the amount of dough it spends marketing itself to the various insurance providers in the area.

In any event,  I agree with Senator Grassley tha "Shedding light on industry payments to physicians would be good for the system.  Transparency fosters accountability, and the public has a right to know about financial relationships."  So with that, the Sunshine Act should be amended to include any payment to physicians and any financial relationships in the health care industry.  That includes when foundations and law firms pay physicians to travel to cushy locations to pontificate about drug and devicemaker influence in Bermuda and when the same pay doctors to conduct studies, publish reports and hold conferences.  That includes when doctors are paid as expert witnesses and or receive any sort of gift, food, compensation of any value over $100 to advise, consult on policy or legal matter.  That includes when academic health centers and hospitals pay for CME curriculum, as well as travel, food and lodging.  That includes any time a physician is paid to conduct research, participate on a panel or advice a government agency, insurance company, benefit manager, HMO, etc that can influence a cilnical decision, guideline development, etc.  And why stop at $100.  Why not $50 or $25?  Why stop at doctors?  Why not nurse practitioners, pharmacists, home health workers, infusion specialist, lab technicians? 
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Outliers Anyone?

02/20/2009 06:54 PM |

Very important editorial by Janet Woodcock and Larry Lesko in the current NEJM.  The title, "Pharmacogenetics -- Tailoring Treatments for Outliers."

Here's the beginning to whet your appetite:

If it were not for the great variability among individuals, medicine might as well be a science and not an art.

— Sir William Osler (1892)

Over the past half century, biomedical science has developed randomized, controlled clinical-trial methods that can distinguish treatment effects from the noise of human variability. Positive results from tests of a treatment in a randomized, controlled trial provide great confidence that an intervention improves a prespecified outcome in a population defined by explicit entry criteria. These methods are rightly venerated because they have helped move medicine from anecdote to science and have largely brought about the therapeutic advances of the past 50 years. However, although population-based, randomized, controlled trials of drugs control for disease variability, they generally do not reveal why some people do not have a response to treatment, others have excessive pharmacologic responses, and still others have side effects that occur in a distinctive pattern for a given drug. Addressing this question is our next challenge.

Currently, medicine is addressing this challenge through the lens of genomic technologies. There is considerable debate about the quality, quantity, and type of evidence that would be needed to change clinical practice by introducing pharmacogenetic testing for a given drug. What methods should be used to understand individual responses once an overall population benefit has been shown in randomized, controlled trials?

The full editorial can be found here. It's a timely and important read.

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Woe Is AHRQ

02/19/2009 03:43 AM |

What will $1.1 billion buy in terms of medical evidence?  A lot more work for consultants who do nothing but review other reviews of clinical trials and practice guidelines to produce what else, an easily digestible guideline that everyone can follow -- particularly the HMOs and the research organizations set up by the HMOs that will do the reviews for AHRQ that will dictate to doctors what to do:

"As a result of this increase in the quantity of relevant information, synthesized information such as systematic reviews, clinical guidelines, and resources (e.g., The Cochrane Library), have become essential tools for the users of the evidence (Druss and Marcus, 2005). However, the number of these products has also grown substantially. For example, as of September 2007, the Agency for Healthcare Research and Quality’s (AHRQ’s) National Guideline Clearinghouse (2007b) listed 54 clinical practice guidelines under the heading “antihypertensives.” In this situation, end users need a mechanism to determine which summaries are the most relevant, valid, and reliable."  This is according to an Institute of Medicine study:

Knowing What Works in Health Care: A Roadmap for the Nation (2008)  Board on Health Care Services (HCS)

So the key to improving the practice of medicine is to rely on the summaries which are -- according to the HMO-run and beholden institutes that do most of the work for AHRQ and their HMO heavy stakeholder group -- the most relevant, valid and reliable....

Or is it about cost?

Jean Slutsky, who will essentially be in charge of the billion or so that AHRQ spends compares her agency favorably to NICE in the UIK among others:

"Health care expenditures are growing faster than incomes for most developed countries, jeopardizing the stability of health care systems globally.¹ This trend has led to interest in knowledge about the most effective use of health care worldwide. To increase the value of health care services, many countries have established programs or independent agencies that inform health care decisionmaking through systematic reviews of technologies, pharmaceuticals, and other health care interventions. A few examples include the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, the Haute Autorité de Santé (HAS) in France, and the Canadian Agency for Drugs and Technologies in Health (CADTH)"

As I have  mentioned here  and here AHRQ has a cozy relationship with NICE analogues established by HMOs:

"We have something that looks somewhat analogous in many of the domains in which NICE is working," says Joseph Newhouse, Ph.D., professor of health care policy at Harvard Medical School and a former member and vice-chair of the Medicare Payment Advisory Commission (MedPAC). It's just not "pulled together in one agency with a crisp mandate."

Starting with the private sector, there are a number of technology assessment groups that analyze drugs, devices, and procedures—the most well known of which is the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). "It has been around for about 10 years and is definitely considered the most rigorous of the groups," says Barbara J. McNeil, M.D., Ph.D., a professor and head of the Department of Health Care Policy at Harvard Medical School who is a member of TEC Medical Advisory Panel.

TEC completes 20 to 25 assessments of drugs, devices, and procedures each year, usually for treatments with increasing requests for coverage but unclear value. A recent example is the use of electron beam CT (computed tomography) for the evaluation of patients with suspected cardiac disease. The TEC staff completes a detailed review and the Medical Advisory Panel uses this information to make a judgment about its clinical effectiveness. 

Kaiser Permanente and the Centers for Medicare and Medicaid Services (CMS) are among TEC's clients. Similar groups include ECRI (formerly the Emergency Care Research Institute) and Hayes Inc. Many health plans, including CIGNA HealthCare, have their own internal medical technology assessment groups.

Read more here

It should be noted that ECRI and Hayes Inc. helped write the IOM report on comparative effectiveness and ECRI has also done work on the use of CT scans for heart disease...  And I will save my analysis of how TEC and ECRI systematically ignored the predictive value of CT scans in detecting early onset of heart disease better than other treatments for another time.  Suffice to say that ARHQ is hell-bent on the summarizing of the "available" evidence as selected by a select few of individuals whose computers seem to have tunnel vision when it comes to searching for the truth. 

I have heard the rhetoric of the AHRQ folks in various settings.  Some of it sounds good.  And some of the studies they have sponsored with respect to alternative evaluation methodologies are valuable but too few to make a difference.  

CMPI has even offered to help fund and sponsor conferences to promote patient-centered approaches to comparative effectiveness research.  No response from either Clancy or Slutsky.  I guess they are content to publish reports that continually claim that there is insufficient evidence for....etc.  That disclaiimer is just enough to let health plans say no to any number of existing or new treatments. 
It will kill innovation and hurt millions without saving money...

"NICE has earned a well-deserved reputation for methological rigor, transparency and an ability to learn."
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Symbiosis not Schism

02/18/2009 08:26 PM |

Timely and honest editorial (penned by Richard Horton) in the February 7 (Volume 373) edition of The Lancet.  He points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst.  Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.

In discussing detailing and CME Horton writes, "Still, industry has an important voice in medicine, one that under the right arrangements doctors should be aware of and hear at all stages of their career."

His main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism."  It's what's in the best interest of the patient.

Horton's editorial can be found here.  It's worth a read.
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From THE House to Our House

02/18/2009 07:41 PM |

Today, the Center for Medicine in the Public Interest the public policy home of drugwonks.com) is proud to announce the appointment of former Congressman Mike Ferguson as a Senior Fellow and Director of its new Odyssey Initiative for Biomedical Innovation and Human Health. 

Ferguson is chairman and CEO of Ferguson Strategies LLC, a government affairs and business consulting firm based in Washington, D.C.  Ferguson served in the House for nearly a decade, representing New Jersey's 7th District.

Peter Pitts, the Center's President and former Associate FDA Commissioner, said Ferguson's appointment demonstrates CMPI's commitment to broaden its scope and influence.

“Congressman Ferguson was a strong advocate in Washington for key health care initiatives during the last decade, and he helped to shape the debate about the future of important reform proposals,” Pitts said.  “Congressman Ferguson brings to CMPI his compassion for and commitment to those suffering from illnesses, as well as his wealth of experience on Capitol Hill, and that combines to represent a real value-added for CMPI.”

Robert Goldberg, PhD, will help guide the Center's new initiative, and he said Ferguson will be helpful in advancing the deployment biomedical innovation.

“Under Mike's leadership, the Center will show how medical innovations are the ‘green technologies' that can solve our country's most pressing health care problems and help point out when policies and positions are choking off the entrepreneurship and investment that sustain such progress,” Goldberg said.

Ferguson completed four two-year terms in Congress in January, when he also started Ferguson Strategies.

“I'm looking forward to continuing my efforts to accelerate the translation of medical knowledge into better and more effective ways to prevent and treat disease,” Ferguson said.  “Medical innovation is the key to making health care more effective, efficient and affordable.  We plan to make this case and develop policies that reward innovation in every part of the health care system.”

In Congress, Ferguson served as vice chairman of the House Energy and Commerce Subcommittee on Health, and he was instrumental in securing passage of the Medicare Part D prescription drug benefit.  He also led opposition to efforts that would have allowed drug importation and imposed government-mandated price controls for prescription drugs and rationing of health care services.

Ferguson successfully led the congressional effort to secure House and Senate passage of the Lifespan Respite Care Act – legislation he authored – that authorizes $289 million for states to train volunteers to help an estimated 50 million families caring at home for adults and children with special needs. President Bush signed Congressman Ferguson's bill into law in 2006.

Ferguson was the recipient of the 2006 Legislator of the Year Award from the National Visiting Nurses Association, and the 2007 Congressional Award from the Leukemia & Lymphoma Society.

In addition to the Health Subcommittee, Congressman Ferguson also served on the Telecommunications and the Internet Subcommittee, and the Oversight and Investigations Subcommittee.

A graduate of Delbarton School in Morristown, New Jersey, Ferguson attended the University of Notre Dame in South Bend, Indiana, where he received a bachelor's degree in government. He earned a master's degree in public policy from Georgetown University in Washington, D.C.
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CE = Caveat Emptor

02/17/2009 01:46 PM |

The words are nice -- now let's see if the actions lead to NICE.

Here's the House/Senate report language that accompanied the $1.1 billion for a Federal Coordinating Council on Comparative Effectiveness:

"The conferees to not intend for the comparative effectiveness research funding ...to be used to mandate coverage, reimbursement, or other policies for any public or private payers,” and that funding shall be used to evaluate “the clinical outcomes, effectiveness, risk, and benefits of two or more medical treatments and services.” The conferees “further recognize that a ‘one-size-fits-all’ approach to patient treatment is not the most medically appropriate solution to treating various conditions.”

"CE" can mean so many things.  It can also mean "Caveat emptor."

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510(k) for a Tricorder?

02/17/2009 01:37 PM |

Saw this article online (courtesy of Google and the Press Association), and thought it worthy to share:

Doctors could soon be using a Star Trek-style device the size of a BlackBerry to check patients' genetic suitability to different medicines. A prototype of the hand-held device is already being tested by British scientists, who say it could be on the market in two years. The SNP (pronounced snip) Doctor is the kind of gadget that might by have used by Dr Leonard McCoy in the original Star Trek TV series.

From a drop of saliva or cheek swab it can analyse DNA to tell if a patient has the right genetic fit for a particular drug.

The Snip Doctor looks for known single nucleotide polymorphisms (SNPs) - single letter changes in the genetic code - that can affect an individual's response to medical treatment. Each year the NHS spends around £460 million dealing with the 250,000 patients who are admitted to hospital suffering adverse reactions to prescribed drugs. The unwanted side effects can vary in severity from dizziness and nausea to heart palpitations or loss of consciousness. The finished product will be an all-in-one device that can rapidly analyse a sample placed in its cartridge and flash the result up on a screen.

Being able to predict bad responses to drugs such as antidepressants or cholesterol-lowering statins would allow doctors to tailor dosages and types of medication to individual patients. Scientists at Imperial College London and its spin-out company DNA Electronics are now carrying out trials of the Snip Doctor's effectiveness.

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Where You Stand Depends on Where You Sit

02/16/2009 03:03 PM |

Front-page article in today’s New York Times on the $1.1 billion for comparative effectiveness.

The complete article (by Robert Pear) can be found here.

Pear writes, “Under the legislation, researchers will receive $1.1 billion to compare drugs, medical devices, surgery and other ways of treating specific conditions. The bill creates a council of up to 15 federal employees to coordinate the research and to advise President Obama and Congress on how to spend the money.”

Let’s not kid ourselves.  This is really about head-to-head drug trials.  Is anyone even paying lip service to anything else?

According to Pear, “The program responds to a growing concern that doctors have little or no solid evidence of the value of many treatments.”

Really?  No solid evidence?  What about all those journal articles?  What about professional guidelines?  What about the growing availability of outcomes data?

“Little or no solid evidence.”  In other words, evidence generated by the pharmaceutical industry doesn’t count  -- but government research (like CATIE and ALLHAT) does.  Talk about politics trumping science!

Pear reports that, “Women and members of minority groups expressed concern about that approach. Drugs and other treatments can affect different patients in different ways, they said, but researchers often overlook the differences because their studies do not include enough women, blacks or Hispanics … The final bill says that the research financed by the federal government shall include women and members of minority groups.”

That’s nice.  But when you use the same 20th century tools for clinical trial design – you get the same 20th century data.  It’s important to note that not one cent of the stimulus bill went towards the development of 21st century drug development and regulatory tools – precisely what the FDA’s Critical Path program is designed to address. 

Here are a couple of other important issues that are rarely mentioned:

(1) Pharmaceuticals represent about 11.5% of our national healthcare spend – about the same as the rest of the developed world. 7% of that expense is for on-patent drugs.

(2) Generic drugs represent 56% of the volume and 4.5% of the spend.  And both of those numbers are growing.

(3) The way to “save lives” is to make sure that the right patient gets the right medicine in the right dose at the right time. Whether or not they save money depends on where you sit and who you ask.

“The new research will eventually save money and lives,” said Representative Pete Stark (D, CA), chairman of the Ways and Means Subcommittee on Health.

Really Congressman?  In that order?

Where you stand often depends on where you sit.  If you’re a payer (either public or private), saving money can often mean denying expensive end-of-life care.  If you’re a patient, well, you might have another view.

Pear writes, “Britain, France and other countries have bodies that assess health technologies and compare the effectiveness, and sometimes the cost, of different treatments.”

“Sometimes?”  Come on.  As Aldous Huxley wrote, “Facts do not cease to exist because they are ignored.”

Pear repeats what drugwonks.com shared on February 12, that the House Appropriations Committee (in a report accompanying its version of the economic recovery bill) said that research comparing different treatments could “yield significant payoffs” because less effective, more expensive treatments “will no longer be prescribed.” For more on this see “The UnCERtainty Principle.”)

If we want to provide excellent care and save money, there are two crucial public health issues that are being ignored by our elected representatives:

(1) Early diagnosis/prevention.  No monies for either of these two items in the stimulus package.

(2) Compliance programs.  According to a Harris survey, one in three (33%) U.S. adults who have been prescribed drugs to take on a regular basis report that they are often or very often noncompliant with their treatment regimens for any number of reasons. 

Early diagnosis, prevention programs, and compliance issues are huge pieces of the healthcare cost pie – but not, it seems, sexy enough from a political talking point perspective.

No doubt members of Congress will say that such things will be addressed when we debate health care reform.

But isn’t that what we’re doing now?

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Do We Need More Quality Measures?

02/16/2009 02:55 PM |

You can't be against quality.  And I'm not. Any more than I am against cost-effective medicine or comparative effectiveness. Peter and I have posted and written much on the the CMPI model for measuring quality and approach comparative effectiveness from the patient perspective and using tools that promote predictive, prospective care. And we will have a lot more to say and do in the months ahead. (Too bad John Mack couldn't get the wax and other debris out of his ears when I was talking about that in my opening remarks at the epharma conference. Then again, some people only hear what they want to hate instead of walking 5 feet and say "Hello, my name is John, what did you mean when you said ..." ) But I digress.

Having said all that, I applaud Janet Corrigan and Nancy Nielsen for trying to bring order to the quality chaos. But I wonder if the problem is not the orgy of objects to measure but the lack of focus on creating measures that are derived from clinical, as opposed to claims data, biomarkers instead of randomized clinical trials, meaningfully designed systems that help doctors in their daily practice instead of top down systems like the one being conceived by the billion dollar slush fund?

www.ama-assn.org/amednews/2008/12/29/prsd1229.htm
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1.1 vs. 0.0

02/16/2009 02:45 PM |

Dean Vernon Wormer: Mr. Kroger: two C's, two D's and an F. That's a 1.2. Congratulations, Kroger. You're at the top of the Delta pledge class. Mr. Dorfman?

Flounder: Hello!

Dean Vernon Wormer: Zero point two... Fat, drunk and stupid is no way to go through life, son. Mr. Hoover, president of Delta house? One point six; four C's and an F. A fine example you set! Daniel Simpson Day... HAS no grade point average. All courses incomplete. Mr. Blu - MR. BLUTARSKY... ZERO POINT ZERO.

Now let's go to the Stimulus Bill

* Various health IT computer systems of unknown use and impact: $19 billion

* Spending on basic biological research including vaccines, HIV, cancer, etc: $6 billion

* Spending on ways to reduce access to new technologies and treatments chosen by a stakeholder group made up of people from the insurance industry and at the sole discretion of the Secretary of HHS unless there is demonstrable proof as established by a handful of "stakeholders" from those from the insurance industry and those trained at NICE (including Steve Pearson):  $1.1 billion

* New spending for the FDA's Critical Path institute, food safety research, collaborations with European, Asian or African partners to harmonize drug safety standards:

Zero point zero.
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