Land of the Free?

09/26/2008 10:38 AM |

No doubt you've heard the old saw, "If you think healthcare is expensive now -- wait until it's free."

People in the US generally equate "universal" healthcare with "free" healthcare, "like in Europe."

Let's examine that proposition.

In America this year, a family of four with an employer-based PPO will face about $15,609 total in healthcare costs. Of this amount, the employer will pay on average $9,442, and the employee will contribute $3,492 in premiums and $2,675 for co-pays and other expenses. Employee premiums are about 6 percent of the median family’s annual income — less than what that family spends on food.

In Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected went to the health system in 2004. Several provinces, including Quebec, Ontario, Alberta, and British Columbia, also charge additional premiums. Canadians may spend their own money to receive private treatment for procedures or drugs that are not covered by the government system.

Citizens of the United Kingdom pay 11 percent of each pound they make in weekly income between $198 and $1,326 for care through the state-run National Health Service, plus an additional one percent of income over $1,326 per week. That’s nearly double what Americans pay.

The co-pay for drugs is low, but many drugs are not covered, often because they are not considered cost-effective enough to justify inclusion in the government’s plan.

But what if you need one of those drugs? Well, you can kiss your NHS benefits good-bye. Anyone who uses his or her own money to buy drugs outside the NHS will find him or herself shut out of the system. (The NHS is considering becoming more benevolent by letting patients "top-off.  We'll see.)

In Germany, coverage from a public sickness fund currently can range significantly in cost, from around 12.2 to 16.7 percent of income, with the employee paying a bit under half. This coming fall, premiums are set to be standardized — and healthcare experts anticipate that they will be set around 15.5 percent. Private patients can generally expect to pay more than they would in the public system.

In France, employees contribute only 0.75 percent of their salaries towards medical care, but they also pay a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the bulk of costs for doctor visits and for a portion of the costs of medications. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, which costs approximately 2.5 percent of salary.

When compared to the U.S., the fact is that the health care systems in Europe and Canada don’t save citizens much at all.

Health reform is urgently needed in this country, and cost-cutting will be a critical component of any reform efforts. Despite its supporters’ claims to the contrary, government control of the healthcare marketplace is anything but a ticket to a lower-cost healthcare paradise.

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CMS Morphing Into NICE

09/25/2008 01:31 PM |

Is CMS using the process of National Coverage Determination to sneak comparative effectiveness into the back door?  That might be an overstatement.  Probably fairer to say that CMS is putting it right on the table.  It will control the methodologies and when it will be used and under what conditions unless a more transparent and consumer focused approach is quickly developed.   And CMS, much like NICE is aiming straight for the most innovative technologies that allow more personalized and preventive treatment of diseases such as cancer.  Here's an example of a technology CMS worries might not be comparatively effective:

"A limited body of evidence informs gene expression profiling tests to inform cancer therapy decisions.  It is unclear if the widespread addition of such testing to the evaluation of patients with would result in a meaningful change in disease management and improved health outcomes."

Yes, and it was unclear if the widespread addition of taxol to breast cancer patients would result in a meaningful change either.  But it did.  But only after we had a widespread addition through clinical use. 

The larger issue is how  CMS  sticks approaches to evaluation that are outdated and fail to incorporate the same science used to develop the technologies they want to measure.  This includes biological m markers of disease, disease progression, differences in treatment response and effects.  This was and is the rate limiting factor that led the FDA to launch the Critical Path.  

The Personalized Medicine Coalition has offered to meet with CMS to encourage a more patient-centered approach in evaluation, which is a great first step.  But we need a Critical Path for Personalized Medicine to insure that the old tools and methods of evaluation are not used to exclude and delay access to innovations but instead help guide appropriate use from the outset and learn from how clinicians optimize care. 

Here's a laundry list of some of the new technologies (and a few old ones) that CMS wants to apply outdated comparative effectiveness evaluation as NICE does in the UK
http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19

Contact PMC for a copy of the letter it sent to CMS.  It lays out a set of common sense set of patient-centered principles for evaluating new medical technologies.  
http://www.personalizedmedicinecoalition.org/
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The Canard of Academic Purity

09/25/2008 12:53 PM |

Those who decry industry-sponsored continuing medical education often propose, as a solution, that CME be provided by "conflict-free" academic medical centers.

Well, "conflict-free" is in the eye of the beholder. And conflict-free many academic medical centers are not.

To this point, consider the remarks that Roger Meyer, MD (Clinical Professor of Psychiatry, Georgetown University, Adjunct Professor of Psychiatry, University of Pennsylvania) offered at the recent conference held on the subject of industry-sponsored CME by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com). Dr. Meyer points out that the same accusations of conflict being leveled at industry are equally true for academic medical centers.

To view Dr. Meyer's slides (particularly slide #9, "The Impact of Commerce") along with other presentations from the CMPI event, click here.
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The Exceptional NHS

09/24/2008 01:09 PM |

Britain’s National Health Service is preparing to allow its loyal subjects to pay for some top-up drugs.  

“Topping off” is when a patient pays for drugs that the NHS will not provide because NICE (The National Institute for Health and Clinical Excellence) has determined that a given medicine’s “cost-effectiveness” isn’t up to snuff.

Key point – the government is getting ready to allow private citizens to spend their own money on healthcare. 

According to an article in the Times of London, opponents of this reform feel it will  “spell the end of the National Health Service.”

The complete Times story can be found here.

Further reforms are planned to the system under which local NHS committees decide which patients are exceptional cases and can receive drugs not yet approved by NICE.

If you are not “exceptional,” please take two steps forward … over the cliff.

Ministers were forced to review the ban after an outcry over the death in March of Linda O’Boyle, a grandmother who was denied free NHS treatment after buying a drug to treat her bowel cancer.

According to some at the NHS, patients must be made to understand what might happen if they ran out of cash before finishing their treatment.

Indeed.  But what about never getting a chance at treatment in the first place?

Attention must be paid -- particularly by those who deem "health care like in England," as the "universal" solution to health care reform in the United States.

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Sunshine Superman

09/24/2008 12:06 PM |

A little sunshine is always welcome in central Indiana.

Starting next year, Eli Lilly and Co. will reveal how much money it pays physicians for speeches and consulting. According to a report in the Indianapolis Star, Lilly  president and chairman, John Lechleiter, will announce the new policy in an address to the Economic Club of Indiana today.

"Lilly is striving to be a leader in improving transparency across our industry," Lechleiter said in a statement. "As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Under Lilly's registry of physician payments, they will list fees to physicians who serve the company as speakers and advisers. That information, which likely will include physicians' names and hometowns, will be posted starting in the second half of 2009 on a publicly accessible Internet database, Lilly said.

In 2011, Lilly plans to expand the database to include payments, updated annually, for clinical research and other provisions called for in the Physician Payments Sunshine Act pending in Congress.

For a big drug company to be the first to disclose its payments to doctors "takes a lot of courage," said Sen. Herbert Kohl, D-Wis., a co-sponsor with U.S. Sen. Charles Grassley, R-Iowa, of the Sunshine Act.

In 2004, Lilly became the first drug maker to voluntarily make public data on its clinical trials of new drugs. Last year it began publicly reporting its educational grants and charitable contributions, becoming the first in its industry to do so.

The complete story can be found here.

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Damn Yankees

09/23/2008 03:12 PM |

In my recent post ("Battling the COI Polloi") I made a mistake that only a Yankee (meaning someone from north of the Mason-Dixon line -- not one of the pinstripe variety) could make -- I confused Louisiana with Alabama.  I misquoted Dr. George Lundberg who referred to "LA."  To me that means "Louisiana" -- but what Dr. Lundberg meant was "Lower Alabama."

I have amended the blog and will now head out for a lunch of grits and crow.

Damn Yankees.
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Hollow Healthcare Coverage

09/23/2008 01:31 PM |

Obama is accusing McCain of destroying healthcare with deregulation?  Obama's National Health Exchange is a carbon copy of the Massachusetts Plan.

In the case of the Mass Health Connector for instance, it's insurance coverage without access to primary care.  And by the way, the Commonwealth of MA refuses to allow retail clinics into the state.  The result, newly enrolled folks are waiting a 100 days to see a doctor at Medicaid rates.   And the plan  is already $1 billion over budget. 

http://www.boston.com/news/health/articles/2008/09/22/across_mass_wait_to_see_doctors_grows/

Obama's "plan" to extend coverage to 210,000 people in Illinois was accompanied by regs to force doctors and health plans to accept patients regardless of condition and reimburse at 30 percent lower rates than private plans.   Years later people are still waiting to see doctors and the state of Illinois owes physicians nearly $2 billion in Medicaid payments.

Government financed and run healthcare is looking more and more like Fannie Mae and Freddie Mac backed mortgages,  owners without assets, homes without homeowner as more and more people flood into a zone where they are encourage -- free of normal risk and responsibility and market controls -- to purchase and consume a good at an artificially reduced price in order to hit a hollow target.  In the case of Freddie Mac it was home ownership.   Government subsidized solutions to increasing health care coverage are largely focused on getting as many people covered as possible, burying the costs and paperwork and worrying about the impact on people and providers later.  The result, over the past 15 years and as state efforts to create single payer systems have shown, has been a run up in costs and a decrease in access to care, particularly among minorities, children and the mentally ill.   
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Battling the COI Polloi

09/23/2008 01:24 PM |

Yesterday’s CMPI conference on the current state of continuing medical education addressed the single most important issue relative to industry-sponsorship of CME – it works.

It’s really telling that this is the great unspoken secret.

Well, yesterday it was spoken about – a lot.

George Lundberg, MD (editor-in-chief of the Medscape Journal and former JAMA editor) spoke of “government by consent of the governed” – his point being that physicians overwhelmingly support industry support of CME. Lundberg commented that, "As we say in LA (that's Lower Alabama), if it ain't broke, don't fix it."

Tom Stossel, MD (Professor of Medicine, Harvard Medical School) spoke of “an inquisition of disclosure.”  Tom is always so subtle.

Jack Lewin, MD (President, American College of Cardiology) reassured the audience that none of the members of Congress he’s spoken with are considering an industry tithe for CME (which would then be distributed by some high-minded and entirely conflict-free government-anointed body).

Jack's pretty plugged in, but if such a legislative program ever was enacted, perhaps it could be dubebd “PDUFuss."

Dr. Lewin also spoke of the current “run-and-hide” environment of the CME sponsorship debate.  How helpful. The denizens of conflict of interest (the so-called “COI-Polloi”) have once again put their own private/political interests in front of the public health.  And the result may very well be devastating.

At the end of the day, the most important message coming out of this event was that there are two sides to every story (often more) -- and that all the current  binary/good guy-bad guy debate achieves is is to hide the tremendous nuances in how physicians learn (and, ultimately, how patients benefit) from industry-sponsored CME.

The full proceedings of this event (full audio and video, along with all PowerPoint presentations) will be available shortly at www.cmpi.org.

Jack Lewin’s opening slide really summed everything up. Here’s what it said:

 “The best interest of the patient is the only interest to be considered.”

                                                            William Mayo, MD

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CME Education on The Hill

09/23/2008 02:21 AM |

CMPI and the Healthcare Communications Coalition of America held a Capitol Hill briefing on continuing medical education today.   It was likely the first time that people who actually provide CME (or serve as partipants and attendants) presented both the facts and their viewpoint in Washington. 

We made no bones about the fact that the briefing would make the case for CME and thanks to our panelists, we did not fail in this task.   George Lundberg, the Editor in Chief of Medscape, made the point that most doctors like CME because they learn things from it that allow them to be better doctors, a theme restated by other participants. 

Moreover,  it became clear that the charges of bias-because-of-commercialism were being leveled by interests who themselves are mired in commercialism and stand to gain from and elimination of the commercial provision of CME.   Further,  the assaults on industry support of CME has discouraged investment according those in the trenches (Marissa Seligman Chief of Clinical Regulatory Affairs for Pri-Med, the largest commercial provider of CME for primary care physicians,  Jack Lewin, president of the American College of Cardiology).  Also discussed are the risk of undermining primary care and underserved populations.   Data was presented by Dr. Leonard Bielory, Tom Sullivan of Rockpointe, and Jeff Drezner, CEO of Clinical Care Options in support of the claim that CME does improve clinical practice.  Dr. Lundberg referenced a JAMA study showing that online CME is  highly effective compared to CME workshops.   And more data is widely available in medical journals underscoring this point. 

CME should be part of an overall approach to making medicine more patient-centered, increasing access to health care in medically underserved communities and improving health outcomes.  None of this achievable by banning or discouraging industry support for CME.  On the contrary we need more CME, not less. 

That was (and is) our message. 
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SiCKO in Real Life

09/22/2008 11:13 PM |

MSNBC journalist Brinley Bruton has accomplished something precious few in the mainstream media have even attempted -- a balanced story about accessing health care in both Great Britain and the United States.

It’s a fair, honest – and personal account and it’s called:

A tale of 2 sickbeds: Health care in UK vs. US: A journalist's treatment for same condition in two countries is worlds apart

Here is a link to the complete story.

And here are some sample paragraphs to whet your appetite:
   
"LONDON - A few weeks ago I found myself curled up in a hospital here in London, my feverish body shaking violently back and forth. The pain in my side and back made it hard to straighten my torso, and I’d thrown up in a friend’s car on the way to the hospital.

"The hospital couldn’t find an extra hospital bed, so I spent my first night hooked up to an IV on a gurney in the middle of a row of men and women, my sweaty skin sticking to the plastic. A shriveled woman in the bed to my right issued loud and largely unintelligible commands to nobody in particular. A steady flow of patients visited the bathroom right in front of my bed. A shouting match broke out between some of the nurses and nurses aides until a man at the other end of the room yelled, “Could you please take it outside? I’m trying to rest.”

Sometime in the midst of this I was diagnosed with pyelonephritis, a severe urinary tract infection that had spread to a kidney, and ended up in the hospital for three nights. I had already been on two courses of antibiotics, but that hadn’t cleared up the initial infection. Finding myself sick and alone thousands of miles away from my mom was bad enough, but scarier still was just how familiar the illness felt.

I’d been sick with the same thing almost 10 years ago when I was in my 20s and still living in the United States, where I’m from. In both cases, my side and back hurt and fever shot up. And each time, I recovered after serious doses of antibiotics and lots of bed rest. But apart from that, my experiences were a world apart.

The biggest difference: Money. Getting sick in New York City decimated my bank account. In London, I didn’t pay a penny. I should note, however, that a full 9 percent of my gross pay goes towards the equivalent of a health tax. (For comparison’s sake, according to the Commonwealth Fund, in 2007 about half of working-age Americans spent 5 percent or more of their income on out-of-pocket medical costs and premiums.)

And while I recovered fully in both cases, the care I received felt quite different. In New York, I never feared that I would be overlooked. At my doctor’s office in upscale Gramercy Park, he and his nurses took their time seeing me, and were always at pains to reassure me. On my first visit, the receptionist let me sit in an empty consulting room so that I wouldn’t have to weep in the waiting room. She checked in on me and brought me water.

But unlike the personal care I received in the US, in London, I felt like I was on a vast and often creaking conveyor belt, and there was a big risk of falling through the cracks. British care is socialized — and feels that way."

Alas, there are no simple solutions to America’s health care woes.  But there is significant danger in those who promise an “EU-style” panacea.

We look forward to the forthcoming debate between Senator McCain and Senator Obama (the one on October 15th at Hofstra) to see how they address the tough, perplexing – and crucial issue of American health care reform.

In the meantime, please visit www.biggovhealth.org to learn more about the problems inherent in government-run health care.

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The Death of Importation

09/19/2008 08:53 PM |

As I've said again and again and again -- importation is not going to happen.

Now maybe people will start listenng.

Both campaigns, it seems, have come to their senses. The issue is safety.

And:

(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.

(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.

The important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”

(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.

And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.

And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.

(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.

The next canard, that of "universal" care is even more dangerous. It's government care -- and it ain't free.

"Universal" care is the new importation.

But we'll bask in the demise of importation until Monday.

(And, hopefully, reports of its death have not been greatly exaggerated.)
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Political Reality Check on Drug Importation

09/19/2008 02:56 PM |

I wonder if Rahm Emanauel or Charles Grassley have any second thoughts....

http://www.reuters.com/article/politicsNews/idUSN1842642120080918

McCain, Obama rethink drug reimportation: aides

Thu Sep 18, 2008 3:26pm EDT

By Susan Heavey

WASHINGTON (Reuters) - U.S. presidential candidates Barack Obama and John McCain are reviewing their support for allowing individuals to import cheaper prescription drugs in light of tainted medicines and other goods made in other countries, their advisers said on Thursday.

Reimportation, as the practice is known, has been controversial for years, even as some supporters have arranged trips to Canada and Mexico for patients to stock up on cheaper medications.

But recent scares involving chemical-laced batches of baby formula and the blood thinner heparin -- both made in China -- have raised new concerns that safely bringing in additional medical products from overseas could be tougher than expected.

"Both candidates were in favor of reimportation and sort of subsequent to the heparin incident (there's) a lot less enthusiasm," said Dora Hughes, a health policy adviser to Democratic candidate Obama.

"We have a better understanding of the challenges that go along to support the importation," she said, speaking before the Generic Pharmaceutical Association's (GPhA) annual conference in Washington .

Neither adviser said their candidate had abandoned reimportation, but had realized it would be more difficult.

"We now realize the challenges for doing that are greater than before," Douglas Holtz-Eakin, a senior policy adviser to Republican candidate McCain, told reporters at the conference.

Groups representing brand-name and generic drugmakers, including GPhA, oppose reimportation, saying it could allow more unsafe products into the country.

Canada and some other countries have lower prices for many prescription drug because of government price controls. Several U.S. bills have proposed allowing some importation for personal use but have never become law.

Since then, problems with numerous foreign products have raised new questions about how to import medications safely.

Most recently, more than 6,000 infants in China have fallen ill and at least three have died so far from milk powder contaminated with the chemical melamine, in a widening scandal that erupted earlier this month.

Sales of Chinese-made formula are banned in the United States , but U.S. officials have said some formula may have slipped into the country.

In February, the U.S. Food and Drug Administration reported the first deaths in U.S. patients given heparin made by Baxter International Inc. The agency later acknowledged it had failed to inspect the Chinese facility where the drug's raw ingredient was made.

Pet food, toothpaste and other Chinese-made products have also drawn U.S. warnings. Critics have chided the FDA for its inability to properly inspect overseas manufacturers.

FDA officials have said they lack enough staff and money to regularly inspect such facilities.

(Reporting by Susan Heavey; Editing by Tim Dobbyn)

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Mental Health Parity Makes Sense

09/19/2008 12:33 PM |

I don't support the idea of additional mandates but the notion that mental illness should be treated as a second class illness or, worse, that consumers should not have a choice about how their illness should be treated flies in the face of both science and consumer choice.   The legislation before the House and Senate would require simply that coverage for eating disorders or schizophrenia be treated the same a sinus infections.  In most cases they are not.  And in most cases the rationing imposed on the former has lead to a revolving door of care that complicates treatment and drives up total costs overall.   

In a consumer driven world, we could shift our dollars to what ails us most and find the best sources of care.  But we are not there yet.  In the meantime, the efforts of Congressmen Patrick Kennedy and Jim Ramstead should be commended along with those of Senator Pete Domenici to eliminate disparities in how mental illness is regarded by many health plans. 
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The Conflict of Interest Priesthood is Defrocked

09/19/2008 02:22 AM |

Danny Carlat, the self-annointed, holier than the rest of , high priest of what passes for bias and conflict of interest in medicine doesn't like it when someone suggests that the assertion that pharmaceutical support for CME is corrupting is simply an biased assertion that survives only in an evidence free zone.... This exchange, which shows the practicing psychiatrist becoming unhinged by my fairly mild post, shows what happens when a self-righteous gasbag is punctured:

Getting Slimed by the Slime Specialists

"I must be doing something right. Yesterday, after I provided some free publicity for an upcoming "evidence-based" evaluation of industry funding of CME, I received the following comment from the Vice President of CMPI, Robert Goldberg:

Apparently you are the only pure one left on the planet. You have no biases or opinions that color your judgment or clinical practice. And of course your opinion about the negative pharmaceutical industry's impact on research -- none of which can be demonstrated through the traditional scientific methods but only appeals to emotion -- are right and everyone else is wrong. But that's not bias. Apart from the fact that the Sourcewatch material is three years old and outdated (which means you didn't even bother to check the facts since our 990 is readily available) you don't even have the intellectual or moral courage to engage on the merits of the issue CME or more generally the relationship between industry and academia. Rather, you resort to the oldest rhetorical trick in the book: attacking the character or motives of a person who has stated an idea, rather than the idea itself. That's the sign of a bully and a coward. If you had any integrity or guts at all you would show up at our session (the very thought of it must give be keeping you up nights!!) engage in reasoned discussion. But I doubt you will.

In this response, Mr. Goldberg demonstrates exactly why his organization and his blog have become notorious for perfecting the art of personal-attack-as-policy-discussion. Those who want to find example after example of Mr. Goldberg's and Mr. Pitt's inimitable rhetorical style should read this expose recently published in opednews.com.    Here Danny links to the ravings of Evelyn Pringle....a most reliable and objective source of information...

Some of their pit bull (sans lipstick) pronouncements:

--"Sidney Wolfe, Public Citizen’s General Secretary of Junk Science..."

--"Not the real FDA - a Grahamatization" (referring the David Graham, the FDA analyst who revealed the extent of the Vioxx health risks)

--"That's the sign of a bully and a coward," describing me. We've descended to that level of name-calling now?

If Mr. Goldberg would like to engage in the merits of the CME discussion, he merely has to read dozens of my prior postings, in which I comment ad nauseum on the innumerable developments, debates, and policy pronouncements in the world of CME. If he would like concrete examples of commercially biased CME, I have provided them in spades.

Unlike the speakers at his conference, I don't have Fortune 500 companies standing in line ready to pony up for a trip to Washington D.C. at a moment's notice. If CMPI really wanted to engage in an "evidence-based" discussion, they would have invited speakers with alternative points of view, but they didn't, and because of that, the conference is a charade and is merely an opportunity for networking among those who profit mightily from industry-sponsored CME. "


And here's the psychiatrist's temperate posting of the previous day....

Wednesday, September 17, 2008

Jurassic CME Park comes to Capitol Hill

Look out, congressmen and senators. The dinosaurs are stampeding the Hill.

That reactionary unthink tank, Center for Medicine in the Public Interest (CMPI), is sponsoring what they are calling an "Evidence-Based Evaluation" of industry support of continuing medical eduation. You can view their invitation here.

For those who have not yet learned about CMPI, go to Sourcewatch for as much information about them as you can stomach. Essentially, they are a front group for the pharmaceutical industry, the CME industry, and whatever other stakeholding company is willing to fund them according to this menu of donating options. For example, $10,000 buys you a "corporate sponsorship" and up to four meals with "CMPI research scholars," $25,000 nets you a seat in the "Chairman's Circle" and an invitation to a "summit," and big spenders can go whole hog with a $100,000 membership in the "President's Club," and a "personal briefing."

Joining with this den of integrity will be none other than George Lundberg, M.D., editor-in-chief of Medscape. Dr. Lundberg embarrassed Medscape and the entire medical community recently with this video editorial in which he responded to the CME concerns of the nation's top medical organizations by saying: "We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”

Other participants, all of whom will examine the issue from a balanced and "evidence-based" perspective, are:

 

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Passing of a Health Insurance Pioneer

09/17/2008 10:39 PM |

I had the pleasure of talking with and meeting J. Patrick Rooney. He was the man who launched the HSA movement and saw the approach expand from an idea to a fixture in the health care firmament. He died two days ago and his energy and intellect -- as well as his impatience -- will be missed. This article from the Indianapolis Business Journal captures much of Mr. Rooney's unique charm, character and vision. It mentions that he once wrote: “When I die, I would like God to welcome me."

Mission accomplished.


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Oh Brother, Where Art Thou?

09/17/2008 09:44 PM |

A question I get asked a lot these days is – Who should be on the short-list for FDA Commissioner?

Henry Waxman isn’t on my list – but he sure sounds like he wants the job.

According to Alicia Mundy at the Wall Street Journal, “In a letter sent today, Waxman, a California Dem who chairs the House oversight committee, demanded that the agency explain its priorities and accused it of carrying water for the drug and device industry."

His specific accusations surround the issues of pre-emption and the dissemination of medical journal articles that discuss off-label use. (For more on pre-emption, see here and here. And on the issue of off-label, see here and here.)

This most recent episode of the Waxman Inquisition really goes beyond the pale. In his letter, America’s Oversighter-in-Chief comments that Deputy HHS Secretary Tevi Troy isn’t to be trusted because:

(1) He once worked at, among other places, Hudson Institute and (2) Because his brother is Dan Troy.

Well, I worked with Tevi at Hudson – and during our joint tenure there we received exactly zero funding from the pharmaceutical industry. But, hey, why let the facts get in the way when the rhetoric of personal attack provides such florid opportunity? Did Mr. Waxman’s office even bother to check the facts? Facts? Facts? Who needs facts when you’ve got friction.

As to Dan Troy, I can personally attest from confidential knowledge that they are, in truth and in fact, brothers. So what? What is Mr. Waxman implying?

Shameful. Cowardly.

It’s also disappointing (but not surprising) that Mr. Waxman chose to release the letter to the media before it arrived at the FDA.

Maybe next time Mr. Waxman should ask one of his interns to hand-deliver the letter – since it’s so urgent.

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Out of the "Ordinary"

09/17/2008 12:07 PM |

From the Financial Times:

“A legal battle between GlaxoSmithKline and Greek wholesalers over parallel trade in drugs – which could have implications for the price of medicine - ended with a mixed result on Tuesday morning at Europe’s top court.

The European Court of Justice ruled that if a dominant company refused to meet “ordinary” orders for medicinal products, because it wanted to put a stop to parallel exports, it was breaching EU competition law.

But the judges said that it was up to individual countries’ courts to decide whether orders were “ordinary”. They would need to look at both the previous business relations between the drug company and the wholesalers concerned, and the size of the orders in relation to market needs in the country concerned.

Drug prices in Greece are among the lowest in Europe. GSK’s lawyers had argued that wholesalers there were placing ever-larger orders for certain drugs, mainly so that they could export the products and enjoy the benefit of higher prices in other EU states.

As a result, in 2000, GSK changed its Greek distribution system, and supplies to wholesalers were interrupted. The wholesalers complained that this amounted to anti-competitive conduct and an abuse of a dominant position.

In April, a senior legal adviser at the ECJ largely ruled against the company. Tuesday’s full court decision significantly qualifies that position.”

And via Bloomberg, this add:

“The court ``has confirmed that companies must be able to take reasonable and proportionate steps to protect their own commercial interests, even if they hold a dominant position and such steps must be assessed in the light of the ordinary requirements of the markets,'' London-based Glaxo said in a e-mailed statement.”

Is this the beginning of the end of pharmaceutical parallel trade in the EU?  It depends.  But one thing is certain, if nations such as the US decide to start draining the European medicines supply through some sort of importation scheme, many EU nations may see this as, well, out of the “ordinary.”

No matter -- if the EU decides to act in its own best interests perhaps the next Congress can design a plan where we import cheaper drugs from ... India.

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Caste of Characters

09/16/2008 09:40 PM |

The House Energy & Commerce Committee needs to help fix the problem, not the blame.

Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.

But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right.  The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.

But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”

That’s not true.  It’s not fair.  And it’s not helpful.

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Panic Over Plastics

09/16/2008 06:36 PM |

You gotta love the media ...

FDA backs BPA as study links it to heart disease, diabetes  Read More & Comment...

FDA Inks Penn

09/16/2008 12:42 PM |

FDA and the University of Pennsylvania have signed a five-year MOU to work on advancing (among other things) drug/device co-development, companion diagnostics, translational medicine and new clinical trial models.

All good things.

The issue of companion diagnostics is particularly crucial or, more appropriately, critical (yes -- like in Critical Path) -- and not just for existing medications (warfarin and Herceptin come to mind) -- but also for pipeline programs.  Are we approaching a time when the FDA might consider asking for companion diagnostics to be developed as part of the approval process for some products?  That would be a 21st century personalized partnership, adding a whole different dimension to both safety and efficacy.

The FDA/Penn agreement also will faciliate interaction between the FDA and Penn students -- an important next step in the agency's urgent need to expand its recruitment efforts.

Particular congrats go out  to Mary Poos, the FDA's Sultana of MOUs, for yet another job well done.
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