Imagine No Fair Balance

• 08.29.2008

“Disease Awareness” ads are, by definition, advertisements for prescription drugs that discuss a disease, but not a specific medicine.  They educate the consumer about important health issues such as … how to quit smoking.

But here’s how Alicia Mundy, in today’s Wall Street Journal, begins her story about a disease awareness campaign on just this public health issue:

“Pfizer Inc. has found a way to encourage the use of its antismoking drug Chantix without detailing serious potential side effects through a commercial that doesn't mention Chantix at all.”

Okay class, is this going to be a story that praises Pfizer (the world’s largest pharmaceutical company) for educating people about how to quit smoking? Or is it a story about how Big Pharma is trying to hide the fact that (gasp!) drugs have risks?

Ms. Mundy continues:

“Under Food and Drug Administration rules, if an ad doesn't directly name the drug, it doesn't have to include the reading of possible side effects that can chew up expensive television time.”
True.  But consider the phrasing.  For Ms. Mundy, “disease awareness” is just another clever ploy to avoid fair balance/adequate provision.

And she lumps all disease awareness ads together:

“This unbranded approach has been used in the past to promote disease awareness and build markets for treatments for those disease. Bob Ehrlich of DTC Perspectives, which monitors direct to consumer advertising by drug makers, says the Ambien and Chantix promotions may be clever, but ‘There's a risk they could rouse congressional ire over cute commercials that don't emphasize medicine.’ “

Bob, there’s a difference between these two campaigns.  Check them out and judge for yourself.  One has to assume that Ms. Mundy did – and that she’s decided that all disease awareness ads are the same – meaning that they are equally devious.

But, in fairness, she gives Pfizer the chance to comment:

“Pfizer says it isn't pushing Chantix in its ads, or trying to circumvent FDA rules. "The goal of the My Time to Quit campaign is to encourage people to quit smoking," said company spokeswoman Sally Beatty. "My Time to Quit is designed to encourage people who are thinking about quitting to speak to their healthcare provider about the benefits of quitting smoking and available treatment options," she said.”

Isn't it refreshing when Big Pharma stands up for itself?

Perhaps the most astounding and important paragraph in the article is the following:

"With unbranded ads, you don't have the 'fair balance' requirement," said Rich Gagnon of the ad agency DraftFCB, part of Interpublic Group of Companies Inc., in New York. "Imagine paying millions to run that ad campaign, and having to use up 30 seconds to list all the problems," said Mr. Gagnon, who has several pharmaceutical clients.”

“Imagine” paying millions to talk about risk?  I should say its money well spent. Does Mr. Gagnon really believe that disease awareness ads are just a slick way to sidestep providing fair balance?  If he was misquoted or if his comment was taken out of context, he should strive to correct the record a pleine vitesse.

Ms. Mundy also goes to Ruth Day – with whom we often disagree on DTC issues:

“Ruth Day of Duke University, a frequent critic of direct to consumer ads, gave the commercial and website high marks for useful information. An expert in how medical ads work on consumers, Dr. Day said mytimetoquit.com is relatively easy and gets to lists of side effects quickly.”

And we’ll leave it at that.

The Strange Silence of Complete Response

• 08.28.2008

Do “complete response” letters offer more clarity or ambiguity?  It depends who you ask.

If you are privy to what the letters say, they offer greater clarity as to what needs to be done to gain FDA approval.  (At least that’s the theory.)

If you are a reporter or a financial analyst or a patient or a physician, you only know what the sponsor tells you.  And that’s not much.

But it never has been and a lot of people find that frustrating.

Well, life is full of frustrations.

Consider the media.  They have a job to do.  Will complete response letters help them write a more complete story?  No, because the letters are not public and it is highly unlikely (for many good reasons) that "commercial confidential" communications with the FDA will be shared with anyone outside the confines of the sponsor.  (For more on the issue of complete response letters and commercial confidentiality, see, “Public or Private,” from the Journal of Life Sciences.)  

Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.”  Hogwash.

Here it is straight from the Bob Temple:

“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’  That’s what I would say.”

Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency. Easier said than done? Sure. But let’s stop with the lame “We’ll make FDA angry” excuses.

The strange silence that generally accompanies FDA communications is a tough nut to crack.  If “more” is desirous by the media, but problematic from the legitimate viewpoint of the sponsor, what can be done?

One incremental step forward is to help clarify what is not in a complete response letter.  Recently Johnson & Johnson received a complete response letter for paliperidone palmate.  In addition to the usual and customary, “We’re looking forward to working with the FDA to bring this important new product to market,” J&J also added one important piece of information – that the FDA had not asked for any additional studies.

Rather than sharing what was in the letter, J&J shared what was not in the letter.  Smart.

For more discussion of the complete response issue have a look at this excellent article from the July/August 2008 issue of the RPM Report.

Don't be Bob

• 08.27.2008

Much discussion about 47 million uninsured.  Very little discussion about who they are. 

Always included in that much touted number are scores of healthy young people — close to 20 million, by some accounts — who elect not to buy health insurance even though they can afford it. They voluntarily choose not to have health insurance — which is quite different from not being able to get health insurance.

Invulnerable?  Not always.

Check out the new website, "don't be bob,"  that is trying to attract this segment of the uninsured population.  It's good for these uninsured adults.  It's good for the overall risk pool.

And it's a good start towards solving the problem with smart and savvy free-market solutions.

For more on that same sane notion of free-market solutions, have a look at the op-ed in today's Wall Street Journal by Grace-Marie Turner, president of the Galen Institute.  She writes:

"A new study by University of Minnesota economists Stephen Parente and Roer Feldman shows that Congress could boost by more than 12 million the number of people who have health insurance without spending taxpayer dollars.  The change required is to allow people to buy health insurance across state lines, so they can shop for less expensive policies ... For example, a typical health-insurance policy in heavily regulated New York costs more than three times as much as in less regulated Iowa ($388 a month versus $98 a month for the same coverage)."

But you won't hear any of that free-market hooey coming out of Denver.

Stanford's Sad CME Shakedown

• 08.26.2008

Ironic that Stanford Medical School is located at 300 Pasteur Drive.  Ironic, because Pasteur's transformational research on bacteria was financed largely by the beer and wine industry as were most of his writings, lectures and travels on the subject. 

Which  means that Dr. Pasteur would have been been banned from doing such research and promoting it's value by Stanford.  Instead, the funding would have gone to the dean of the medical school and a group of bureaucrats more interested in political correctness than medical progress.   According to the new Stanford medical school policy on industry support for medical education,  "the faculty, in conjunction with the office of CME, will decide the choice of topic and content for all Stanford CME activities, and curricula will be chosen based on the educational needs of our learner populations."

http://deansnewsletter.stanford.edu/#1

And as we all know, academics are free of any bias and never seek to steer money away from approaches they don't believe in and funnel cash to their own pet theories. 

Which means that Pasteur, whose original ideas were rejected and ridiculed would have been labeled as "corrupted" by industry funding and would never have seen the light of day.  CME would have gone instead to supporting treatments of disease based on spontaneous generation.  Pasteur's subsequent work on the anthrax and rabies vaccine would be similarily attacked for it too had industry funding.

Pasteur challenged the dogma of the time and challenged his critics to attack him not in terms of circular and self-justifying arguments but by engaging in their own experimental research. 

Attack my experiments," he challenged his critics. "Prove that they are incorrect instead of trying new ones that are merely variants of mine, but into which you introduce errors that then have to be pointed out to you."

Sadly today, that spirit is being extinguished by the new religion of politically correct science.  When the Dean of one of the finest medical schools in the country claims "the historical and traditional models of CME, based largely on lectures and discussion groups, have served a purpose, although their impact on truly enhancing medical knowledge that leads to improvements in health care outcomes is unresolved" he is parroting the catechisms of a anti-science caste who believe, without evidence, that commercial support of research, training and symposium have an adverse impact on public health.  

Simply handing the CME cash over to medical schools  is problematic particularly if the role of CME in health improvement is unresolved.  And if Dean Pizzo and others truly believe that, then they should be not responsible for the nearly $1 billion in industry support for such activities.   For all the prattle about lack of accountability in CME, their is no murkier moral or intellectual stew than an academic department at a major university or no entity better at siphoning dollars for overhead, salaries and indirect expenses. 

The larger issue, that men and women of insight and teaching talent might find themselves barred by universities of promoting ideas and interests they have researched remains.  So does the fact that medical schools have largely failed to serve the primary care and nonphysician workers who treat the  medically underserved, those health care providers who don't have the money or the luxury of an tony academic appointment or CME cash. 

As with all myopic ideological movements, the attack on industry support of CME has casualties.  Public health will be one.  Truth another.  As Pasteur put it, "In each of us there are two men, the scientist and the man of faith or doubt. The two domains are distinct, and woe unto him who seeks to make the one encroach upon the other in the current imperfect state of our knowledge."

http://www.people.fas.harvard.edu/~agoldham/articles/pasteur.htm

How does a Scotsman get his healthcare information?

• 08.26.2008

How does a Scotsman get his healthcare information? With difficulty.

Here's a new article from today's edition of The Scotsman:

Advertising rules stifle free market for prescriptions
By Peter Pitts

IN EUROPE, it is illegal for drug companies to advertise prescription-only drugs to consumers. But the European Commission (EC) recently announced that it will allow pharmaceutical firms to disseminate "information" on their products over the airwaves, on the internet, and in print.

I think this change can't come soon enough. For too long, European bureaucrats have put cost considerations before patient care, keeping patients in the dark about alternatives that may best address their needs. Officials have, I think, paid lip service to the idea of empowering patients with more information on treatment options.

James Copping, a principal administrator of the EC, said in 2006: "We want a system where patients can be empowered to take an equal part in healthcare decisions." But thus far, no such thing has happened.

Consider the European agencies tasked with weighing the effectiveness of various treatments, such as the UK's National Institute for Clinical Excellence (Nice) or Germany's IQWiG. These agencies exist to provide unbiased medical information to government.

But because they are operated by government, I would say they have a vested interest in keeping costs down and have an incentive to conclude that newer, more expensive medicines are no more effective than older, cheaper ones.

Nice offers an instructive example. In 2001, contrary to expert findings by licensing authorities in 65 countries – including Scotland – it cited "insufficient evidence" for recommending the use of Gleevec in leukaemia patients.

In 2002, US authorities approved Gleevec for the treatment of stomach cancer and it was deemed a miracle drug. It wasn't until 21 months later that Nice authorised the use of Gleevec for English victims of the disease.

IQWiG seems similarly set on depriving German patients of vital treatments. The agency has promoted an "efficiency frontier" as its governing methodology for evaluating treatments. But such jargon is smoke and mirrors, designed to cover for the government's preference for established – and generally less expensive – treatments, and by decreeing the most cost-effective option in a treatment category, these agencies effectively determine what a doctor must prescribe, irrespective of a patient's individual characteristics.

Obviously, pharmaceutical companies have products to sell. But, by allowing them to provide Europeans with medical information, they could serve as a counterbalance to the heavy-handed pronunciations of state-run comparative-effectiveness agencies.

Indeed, a great deal of evidence demonstrates that consumers benefit when drug manufacturers participate in healthcare decision-making.

In the US, for example, a 2002 study by the Food and Drug Administration found that direct-to-consumer advertising of pharmaceuticals improved both patient-doctor discussions and compliance with physician recommendations. The study also found that 88 per cent of patients who asked about a specific drug were afflicted with the condition in question.

A 2003 study in US health policy journal Health Affairs arrived at a similar conclusion. According to the study, ad- inspired doctor visits resulted in the advertised medicine being prescribed in only about 47 per cent of cases. Put another way, patients didn't get a prescription for the medicine they came in to discuss on more than half their visits. Even with advertising, doctors exert appropriate judgment when they prescribe drugs.

On other occasions, according to the study, previously undiagnosed medical conditions get treated – a good thing.

For European bureaucrats, there is reason for concern. If consumers can get additional information on drug options thanks to direct-to-consumer efforts, there's a good chance they'll start to ask the state-run health systems why they can't access certain treatments.

As European Parliament member Jorgo Chatzimarkakis recently argued: "Citizens cannot be deprived of information by their own governments on such crucial issues as one's health."

Government-run systems have demonstrated that they're not interested in spending more money, but armed with new information, consumers may be able to make the case to their leaders that the status quo of rationed, controlled care will no longer suffice.

Uncompensated care study: Case of Wishful Arithmetric

• 08.25.2008

Today's study in Health Affairs tries to suggest, once again, that  universal health care of some sort would cost only less than paying out for uncompensated care to the uninsured who receive most of this "free" care. 

The researches argue that neither health care spending or private premiums would go up that much because "hospital spending on uncompensated care has been relative stable.  That is partly because the public hospitals and clinics that most often care for the uninsured often don't have many privately insured patients to absorb the costs."

Translation: most uncompensated care is due to the fact that Medicare and Medicaid don't pay the full cost of medical expenditures.  Uncompensated spending has been stable because Medicare and Medicaid have held reimbursement rates steady and because in many cases the state match (to pay for the care of illegals) has skyrocketed with most of the money going to urgent care and maternal health, not complex medical procedures. 

GIve people a full blue plate entitlement and watch both government expenditures rise and uncompensated care increase as well.  In every state where a single payer plan has been enacted uncompensated care continues to go up.  The best example is the Oregon Health plan which ensures the uninsured by rationing access to cutting edge treatments and raising taxes.  The trend of uncompensated care since 1994 in that state is below.

Statewide Uncompensated Care by Year:
	Year	Charity Care	% Change from Prev. Year	Bad Debt	% Change from Prev. Year	Total Uncomp. Care	% Change from Prev. Year
	1994	74,653,735		90,272,616		164,926,351
	1995	55,645,120	-25.5%	90,262,052	0.0%	145,907,172	-11.5%
	1996	53,036,784	-4.7%	80,387,137	-10.9%	133,423,921	-8.6%
	1997	55,123,781	3.9%	83,974,361	4.5%	139,098,142	4.3%
	1998	58,291,332	5.7%	96,289,876	14.7%	154,581,208	11.1%
	1999	53,994,527	-7.4%	102,732,393	6.7%	156,726,920	1.4%
	2000	64,916,584	20.2%	128,914,104	25.5%	193,830,688	23.7%
	2001	77,772,655	19.8%	138,822,832	7.7%	216,595,487	11.7%
	2002	107,854,204	38.7%	164,629,911	18.6%	272,484,115	25.8%
	2003	183,626,444	70.3%	221,580,947	34.6%	405,207,391	48.7%
	2004	268,333,010	46.1%	269,741,864	21.7%	538,074,874	32.8%
	2005	374,330,244	39.5%	301,574,208	11.8%	675,904,452	25.6%
	2006	445,884,426	19.1%	305,343,908	1.3%	751,228,334	11.1%
	2007	524,707,945	17.7%	351,866,447	15.2%	876,574,392	16.7%

The same thing happened in Tennessee when Tenncare was enacted.  The idea that a single payer system will eliminate uncompensated care is bogus unless the single payer doubles what it pays providers, hospitals, etc.  Just the opposite takes place in a single payer system.   What will reduce uncompensated care -- apart from rationing which will drive up costs elsewhere --  are changes to the financial and technological structure of healthcare that reward saving and investment in personal health and staying healthy.   Indeed, as the percent of people in consumer directed plans increases and includes the uninsured, the amount of out of pocket spending has remained stable and as a RAND study last year shows, the consumer directed plans are associated with reduced hospital and physician visits and increased access to prescriptions.  This does not always "control" costs but does appear to improve quality by encouraging more management of costly chronic illnesses,

http://content.healthaffairs.org/cgi/content/full/hlthaff.27.5.w399/DC1

When is Off-Label not Off-Label?

• 08.25.2008

When is off-label not off-label?  When it's on-formulary and off-patent of course.

At least that seems to be the position of some state Medicaid plans.

Case in point, pregabalin (Lyrica) and Iowa (coincidentally, the state represented in the United States Senate by Charles Grassley).

Iowa Medicaid requires preauthorization for pregabalin -- which is FDA-approved for (among other indications) fibromyalgia.  In Iowa a patient with a diagnosis of fibromyalgia must first fail on at least two  of the State's "preferred" agents -- trycyclic anti-depressants, topical lidocaine, or gabapentin.  None of these three agents are approved by the FDA for the treatment of fibromyalgia.

But they are less expensive than the on-patent, on-indication product.  So what we've got here is step-therapy based on off-label usage.  Not unheard of, certainly , but it does start sending some interesting policy messages about the appropriateness of off-label use in various circumstances.  (And it's more than a little bizarre when you consider that Pfizer, the manufacturer of pregabalin, had to pay a $430 million fine for off-label promotion of gabapentin.)

The actions of the Hawkeye State Department of Human Services are even more peculiar considering that Senator Grassley (R, IA) asked the U.S. Government Accounting Office (GAO) to investigate off-label prescribing -- and not because he thought it was a valuable tool for patient care.

So here's where we stand:  Off-label use of on-patent medications is bad, but off-label use for generics is good.  Translation:  off-label use is good when it saves the payer money.

Is cost-based trial-and-error medicine really the path we want to take in the era of personalized medicine?

What about science?

What about relying on the professional judgment of the physician?

What about what's best for the patient? 

Patient-Centric Care? He knows it when he sees it

• 08.22.2008

John F.P. Bridges, Assistant Professor, Department of Health Policy and Management at the Johns Hopkins School of Public Health and Senior Fellow at the Center for Medicine in the Public Interest, is the featured interview in the current edition of DIA Today.

It's a Q&A.  Here's a sample:

DIA:  Do you think that the general public -- the average "patient on the street" -- would recognize the concept of patient-centered care?

JB:  "I think that if they experience it, they can tell the difference, but at the moment we're setting up barriers to patient-centered care.

To find out what that means, have a look at the compete interview here.  It begins on page 18.

Is It Worth Letting Women Get Cervical Cancer

• 08.21.2008

I guess if you take a "societal" (read government or HMO) perspective it does, especially if you believe that an additional yearl of disease free life for a women 21-26 is only worth $100K, which is an arbitrary numbe developed in 1985 that reflects a "societal perspective" on the cut off or rationing point...

"We adopted a societal perspective, discounted costs and benefits by 3% annually, and expressed benefits as quality-adjusted life-years (QALYs) gained. After eliminating strategies that were more costly and less effective or less costly and less cost-effective than an alternative strategy, incremental cost-effectiveness ratios were calculated as the additional cost divided by the additional health benefit associated with one strategy as compared with the next-less-costly strategy. Although there is no consensus on a cutoff point for good value for resources, we interpreted our results in terms of a commonly cited threshold of $50,000 per QALY gained, as well as an upper-bound threshold of $100,000 per QALY gained."

Hmm, and what does that cover...

"The routine vaccination of 12-year-old girls, in the context of current screening and assuming lifelong vaccine-induced immunity, had an incremental cost-effectiveness ratio of $43,600 per QALY gained, as compared with screening alone (Table 2). The addition of a 5-year catch-up program for girls between the ages of 13 and 18 years cost $97,300 per QALY, and extension to 21 years of age cost $120,400 per QALY. The extension of the catch-up program to 26 years of age cost $152,700 per QALY, as compared with the catch-up program to 21 years of age."

The extra $52 K is really society saying, we have decided after $100K  we will roll the dice and see if we have to pay for all the costs relateded to screening, treatting, etc. cevical cancer.   It does not even address what a 26 year old woman might think a catch up shot is worth....

Oh,  and the additional benefits. like avoiding screening and the worry or other illnesses were never counted either.

"when the potential benefits associated with preventing noncervical HPV-16–related and HPV-18–related cancers and HPV-6–related and HPV-11–related juvenile-onset recurrent respiratory papillomatosis were included, cost-effectiveness ratios were reduced"

So of course the NEJM runs an editorial claiming the vaccine is not cost effective, it's press department hypes that and not the guts of the study and the rest of the media takes the lead and will ikely cite (via misrepresentation) the study as proof that many new products are not worth their cost.  .

Still believe cost-effectiveness will certainily be a patient-centered and objective process taking into account all stakeholder concerns.  

http://content.nejm.org/cgi/content/full/359/8/821

Cost-effectiveness wars

• 08.21.2008

John F. P. Bridges, Assistant Professor at Johns Hopkins Bloomberg School of Public Health, a Senior Fellow at the Center for Medicine in the Public Interest and the Founding Editor of The Patient, comments on the new Hanover Consensus and the future of comparative effectiveness.

Here's what he has to say:

 
Peter Pitts’ depiction of the almost ten year old “cost-effectiveness” wars in Germany (See Uncommon Denominator) is just an introduction to the debate over economic evaluation of medicine in Germany, Europe and beyond. While it is commonly believed that Europe had long ago fallen to the dark forces of cost-effectiveness analysis, the German defiance referred to in Peter’s article has highlighted that this is not really the case (and there are plenty more counter examples out there). 

Two key issues central to the German debate over economic evaluation are, (1) what methods constitute “best practice” in the economic evaluation of health care, and (2) what type of evaluation is needed for a system that is based on a combination of employer and private health insurance, albeit a system that is subjected to an increasing government presence – along with calls for major reforms to create (attention Obama-ites) a national health care system.

The Hanover Consensus Group has consistently taken the line that “everyone else is doing it, so why aren’t we?” (Although a cynic might read “other health economists are profiting from it and we want too as well!”) While cost-effectiveness analysis is a regularly accepted rule, it’s wrong to consider it as accepted best practice.  Even for those who herald its use, it is often understood as a “necessary evil”.  Furthermore, in an evidence base world, there has never actually been a technology assessment performed on cost-effectiveness analysis, hence we don’t know if it does or does not lead to better health care investments or lowers overall expenditures. Anecdotal evidence in Ontario indicates that it failed to decrease -- and potentially increased -- the rate of medical inflation following its implementation.  Based on the experience in Australia, cost-effectiveness analysis can decrease total expenditures -- but by delaying reimbursement decisions -- a de facto shortening patent life on drugs – or through the negotiation of major price discount, and not by weeding out bad practice. 

The more subtle point in this debate relates to the compatibility of cost-effectiveness with the German health care system.  Created by Otto von Bismarck at the end of the 19^th century, the system of Social Health Insurance was based on the principles of solidarity and subsidiarity.  While Angela Merkel’s health care reforms have threatened the latter to promote affordability, the Germany health care system remains essentially employer and employee sponsored, with a limited role for government.  Furthermore, the Social Code Book that defines the German health care system calls for efficiency to maximize within each disease state, which is at odds with the “priority setting” approaches (a more genteel way of referring to health care rationing) implicit in cost-effectiveness analysis. 

Having been a regular IQWiG watcher since its inception, I have to congratulate Dr. Kolominsky-Rabas for his efforts in searching for an alternative approach to cost-effectiveness analysis.  While I might not agree with the current approaches presented by Caro and colleagues, I find it refreshing that we are now entertaining alternatives. American policy makers  should not only pay attention to this robust debate in Germany, but should be active participants given that we too might find ourselves with our own version of IQWiG in the near future.