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 |

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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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A New/Old Perspective on Risk

02/13/2009 08:20 PM |

As we continue to furrow our collective brows pondering the eternal quandary of risk/benefit, I thought you’d enjoy the comments below (which I received this afternoon via e-mail from a respected physician who shall remain nameless):

TO ALL THE KIDS WHO SURVIVED THE 1930s, 40's, 50's, 60's & 70's

First, we survived being born to mothers who smoked and/or drank while they were pregnant.

They took aspirin, ate blue cheese dressing, tuna from a can, and didn't get tested for diabetes.

Then after that trauma, we were put to sleep on our tummies in baby cribs covered with bright colored lead-based paints.

We had no childproof lids on medicine bottles, doors or cabinets and when we rode our bikes, we had no helmets. Not to mention the risks we took hitchhiking.

As infants & children, we would ride in cars with no car seats, booster seats, seat belts or air bags.

Riding in the back of a pick up on a warm day was always a special treat.

We drank water from the garden hose and NOT from a bottle.

We shared one soft drink with four friends, from one bottle and NO ONE actually died.

We ate cupcakes, white bread and real butter and drank Kool-Aid made with sugar, but we weren't overweight because we were always outside playing.

We would leave home in the morning and play all day, as long as we were back when the streetlights came on.

No one was able to reach us all day. And we were O.K.

We would spend hours building our go-carts out of scraps and then ride down the hill, only to find out we forgot the brakes. After running into the bushes a few times, we learned to solve the problem.

We did not have Playstations, Nintendo's, X-Boxes, no video games at all, no 150 channels on cable, no video movies or DVD's, no surround-sound or CD's, no cell phones, no personal computers, no Internet or chat rooms.

We had friends and we went outside and found them!

We fell out of trees, got cut, broke bones and teeth and there were no lawsuits from these accidents.

We ate worms and mud pies made from dirt, and the worms did not live in us forever.

We were given BB guns for our 10th birthdays, made up games with sticks and tennis balls and, although we were told it would happen, we did not put out very many eyes.

We rode bikes or walked to a friend's house and knocked on the door or rang the bell, or just walked in and talked to them!

Little League had tryouts and not everyone made the team. Those who didn't had to learn to deal with disappointment.  Imagine that!

The idea of a parent bailing us out if we broke the law was unheard of. They actually sided with the law!

These generations have produced some of the best risk-takers, problem solvers and inventors ever!

The past 50 years have been an explosion of innovation and new ideas. We had freedom, failure, success and responsibility, and we learned HOW TO DEAL WITH IT ALL!

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Another One Bites the Dust

02/13/2009 06:50 PM |

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SAEC-O -- Better than SiCKO

02/13/2009 06:03 PM |

FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events

The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions.
 
Both skin conditions appear as allergic-like skin reactions associated with blistering and peeling, and are considered life-threatening. Medications causing these serious allergic reactions should be discontinued; and if such signs and symptoms are not quickly recognized, these reactions can be fatal.

“The SAEC has fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event.”

The SAEC is a nonprofit partnership of pharmaceutical companies, the Wellcome Trust, and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. The samples from the initial serious skin rash cases and matched controls were collected by GlaxoSmithKline plc, London, U.K., and donated to the consortium for this research.

By pooling these samples, the SAEC has identified numerous genetic associations that may contribute to an individual’s risk of developing serious drug-induced skin reactions. The data was compiled and analyzed just 16 months after the consortium was launched.

“We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. “We continue to believe the application of genomics to research the genetic basis of serious adverse events will prove to be one the most productive early applications of this technology.”

The consortium will publish its initial research results later this year.

Researchers who enter in to a data use agreement can obtain free access to the data to generate custom data inquiries and obtain immediate results on the genetic basis of adverse drug events.

For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org.

For information on the FDA’s Critical Path Initiative see http://www.fda.gov/oc/initiatives/criticalpath/

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Bloviation on Comparative Effectiveness

02/13/2009 05:40 PM |

Steve Pearlstein is a Pulitizer Prize winning columnist for the Washington Post who writes winningly and smartly about economics and health care.  He believes that Treasury can rebuild the banks and that the stimulus package can create jobs and by extension the whole shebang will rebuild the economy.  Whatever.   He also believes that "there is no reason we cannot set up reasonable procedures, overseen by independent health professionals, to protect patients who can demonstrate a special need for a treatment that is not normally cost-effective."

Hmm, I guess the doctor-patient relationship doesn't quite cut it for Mr. Pearlstein.  Or put another way, if Mr. Pearlstein's doctor had access to 21st century tools that made medicine predictiive and prospective -- which is increasingly possible -- he would still opt for cookbook decisions rendered by researchers who are largely selected from HMO sponsored research institutions using research methods that by definition exclude the variations in treatment effect and response that his doctor can detect...or could detect if those said researchers would ever get around to evaluating the value of those 21st century tools...

Pearlstein asserts that critics of comparative effectiveness don't have "any shred of evidence that the professionals who do this research are incompetent or have any but the best intentions in trying to figure out what treatments are the most effective for patients. There is no reason to believe that once this clinical research is completed, it cannot be used in a disciplined, scientific way by physicians, economists and medical ethicists to determine whether there are drugs, tests, surgical procedures or devices that simply don't deliver enough benefit to justify their cost."

He is quick to claim that England is special and doesn't count.  What about Canada, or Australia or Germany?  How about Netherlands or Italy or Israel?  Is there any entity that uses comparative effectiveness that does not restrict access to new technologies based on what it is worth to the institution without regard to the consumer?   What about the VA which restricts access to new drugs?  Or the Medicaid formularies that restrict access to cancer medicines and drugs for mental illness based on the comparative effectiveness research churned out by the Drug Effectiveness Research Project which is paid for by the Agency for Health Care Research and Quality and is conducted by HMO supported institutes?  Forget about intentions. In healthcare, it's the outcomes that matter.   It's not belief, it's evidence.  And the best evidence is biological and mechanistic, not probability. 

Pearlstein then introduces a straw man when he writies:

"But ours is an economy that is sinking under the weight of a health-care system that costs twice as much as any in the world while delivering poorer health outcomes. The cost of health care has crippled entire industries, disadvantaged our companies in international competition and brought millions of families into bankruptcy. Worst of all, in denying vital medical services to the 40 million Americans without health insurance, we engage in the most immoral kind of medical rationing imaginable -- rationing by the ability to pay. "

The reasons for our rate and intensity of health care spending has little do with medical device and drug expenditures, the smallest part of the health care budget.  It is multifactorial.  And the assertion that our outcomes are poorer is wrong in any event.  In any event, health systems that ration have done little to control the rate of health expenditures.  They merely shift spending into other categories.  Ultimatley the solution to health care problems, including spending, is innovation, which comparative effectiveness is used to kill.

Pearlstein tries to slime those who criticize comparative effectiveness as political arsonists supported by drug and medical devicemakers.  So be it.   If those fires had been quenched decades ago where would society be.    And where will it go if Pearlstein fails to fully understand the consequences of the approach being proposed the comparative effectivenesss zealots.

See his article here.
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Sayonara to Quality Healthcare

02/13/2009 12:03 AM |

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AAJ Ambulance Chasers Down On Pre-emption

02/12/2009 10:28 PM |

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The UnCERtainty Principle

02/12/2009 01:06 PM |

It is becoming increasingly un-PC (“Pharma Correct”) to say that $1.1 billion earmark for a “Federal Coordinating Council for Comparative Effectiveness Research” is a bad idea.

Well, it’s a bad idea.

And cozying up to the powers-that-be isn’t going to change the fact that this is a giant first step towards a U.S. version on NICE.

Whether or not you agree that such a notion is a bad idea, we should ALL agree that it’s important enough to debate on its merits – and not become law through legislative legerdemain; hidden deep within the bowels of the stimulus package.

Wither transparency?

Senator Feinstein says that, “the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.”

Senator Baucus promises that, “Its charge should not go beyond that.”

Indeed, Senate Finance Committee documents detailing health provisions in the Senate's economic stimulus package say that the bill "specifically prohibits the government from making any coverage decisions based on this research, or even from issuing guidelines that would suggest how to interpret the research results."

But the House language has no such limitations in mind:

“By knowing what works best and presenting this information more broadly to patients and health care professionals, those items, procedures and interventions that are most effective to prevent, control and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”

 

The problem is that “comparative effectiveness,” as it is currently designed, places into conflict the short-term budgeting dilemmas of governments elected for relatively short periods of time with the ever-lengthening life spans of their electorates.  Us.

 

Those in favor of comparative effectiveness favor large scale randomized trials to "compare" drugs. The problem is that randomized trials tend to ignore differences in clinical outcomes due to side effects or genetic variations. So whether you analyze them together or individually, researchers will most always find no difference in the effect of medicines, a result that is biased in favor of older, cheaper drugs. 

As currently organized, comparative effectiveness will be used to increase government control over the practice of medicine and introduce price controls.

Let's get real folks.  All rhetoric to the contrary -- this is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans. Step Two is to do away with the Non-Interference Clause so that comparative effectiveness measures can be used to offer a VA-style formulary.  And Step Three is to make that the model for the "universal care" we'll all be paying increased taxes to support.

(Note: The VA formulary offers 1,300 drugs, compared with 4,300 available under the average Part D plan -- prompting more than one-third of retired veterans to enroll in Medicare drug plans.)

 

Broader access to mediocre care? “Just like in Europe?” What a victory.

 

We need a new model. We need to develop proposals that modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA Critical Path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, we must establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.

 

For instance, the FDA, in cooperation with many interested parties, has developed a Critical Path opportunities list that provides 76 concrete examples of how new scientific discoveries in fields such as genomics and proteomics, imaging, and bioinformatics could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.

 

We need a Critical Path for Comparative Effectiveness to begin the process of developing a similar list of ways new discoveries and tools (such as electronic patient records) can be used to improve the predictive and prospective nature of comparative effectiveness.

 

It’s a complicated proposition—but such a goal is as simple as it is essential—cost must never be allowed to trump care, and short-term savings must not be allowed to trump long-term outcomes. Just as we need new and better tools for drug development, so too do we need them for comparative effectiveness measurements.

 

A comparative effectiveness model for the 21st Century should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new healthcare paradigm capable of providing for its needs in the 21st Century. Equality of care must be matched with quality of care. 

 

In an era of personalized medicine, one-size-fits-all treatments and reimbursement strategies are dangerously outdated. We are early in this debate, but at least we can all agree that this is not, and must not be exclusively, a debate about saving money. It must be about patient care. 

And it must be openly and robustly debated. 

For more on this issue, have a look at this new policy paper from the Washington Legal Foundation.

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