Commonwealth Fund Flunks Stats 101

12/03/2008 12:38 PM |

Nirit Weiss, MD (a neurosurgeon with a Master of Business Administration and a specialization in healthcare economics) has written a blistering appraisal of heavily reported and oft cited July 2008 Commonwealth Fund report, “Why Not the Best?”

After reading her analysis, perhaps a better title would have been “Why Not the Best Use of Statistics?”

In addition to entirely discrediting the report’s methodologies, the article (in a series of very disturbing sidebars) shows that the mainstream media was either lazy or complicit (or both) in reporting the story.

Weiss’ full exposé can be found here.

Weiss writes:

“On July 17, 2008, the Commonwealth Fund commission published its second Scorecard report, Why Not the Best?: Results from the national scorecard on U.S. Health System Performance, 2008. Its findings that U.S. health care performance had not improved since 2006 and that access to health care significantly declined were again reported widely in the media and in a way that gave wide credence to the Scorecard’s conclusions (see sidebar). As the New York Times noted, The findings are likely to provide supporting evidence for the political notion that the nation’s health care system needs to be fixed.”

However, the 2008 Scorecard must be interpreted with caution. In attempting to diagnose the ills of America’s healthcare system, the Scorecard suffers from serious flaws that challenge the validity of its conclusions – flaws that were, essentially, ignored by the authors of the study and completely missed by the media coverage. These flaws fall into three categories:

   1. The methodology by which the data were collected and the studies were designed to address specific questions.
   2. Arbitrary definitions and metrics used to define the concept of “quality” in health care.
   3. Sweeping, broad conclusions that are unsubstantiated by the findings of the study.

1.    Flawed methodology

The 2008 Scorecard is based upon multiple disparate studies, using various methodologies, non-uniform definitions of “benchmark,” and arbitrary assumptions as to what “logical policy goals” are, and what “adequately insured” actually means. The Scorecard attempts to draw meaningful conclusions based on a summation of individual studies with varying sample sizes, varying performance comparisons, and varying data collection techniques.

In peer-reviewed, scientific literature, it is invalid to lump together the results of multiple studies, using multiple methodologies, in the same charts, graphs, and conclusions, without assigning relative weight to the results of the studies. Adding even more to the confusion, many of the reported data are not directly referenced to published studies, so it is impossible to trace and evaluate the sources of the information. A substantial number of the individual analyses were merely described as “conducted by the authors,” limiting the reader’s ability to evaluate the quality and validity of the studies.

Perhaps more troubling are those data which can be traced back to their source studies, and turn out to be based on patient self-reporting. For example, in its section on “quality,” the Scorecard quantified mistakes made in health care delivery according to patient interpretation and self-reporting! Patients were asked how often they felt mistakes were made in their medical care, such as errors in laboratory testing, or medication errors.

2.    Arbitrary metrics used to define “quality”

The entire premise of the Scorecard, is that “quality” in the U.S. Healthcare System can be quantified by assessing mean scores with respect to 37 “indicators” across five “dimensions” of health system performance. The 37 “indicators” across five “dimensions” are modeled after those used in studies of industry, and focus on health care delivery systems performance, which is indeed one component of value and return-on-investment. But it is not the largest determinant of what most Americans would define as “quality.” Assessing the quality of delivery of goods by studying uniformity, for example, is appropriate when evaluating the transformation of undifferentiated inputs into uniform outputs, each machined to be identical to the other.

In other words, the conclusions of the study are dependent on the authors’ assumption that all patients with a given diagnosis, say diabetes, are otherwise identical, and should have no difference in outcomes. This input/output calculation disregards the fact that all inputs, such as patients with diabetes, have other comorbidities, and cannot be expected to have the same outcome or outputs.

3.    Unsubstantiated conclusions

The authors of the Scorecard present their results in raw form, and then apply these results to reach broad conclusions, which are several steps removed from the data actually being presented; indeed, the data presented often does not directly support or relate to some of the Scorecard’s conclusions. Because there are so many such examples, it is reasonable to summarize them. In general, the authors conclude that universal health insurance in the U.S. would improve quality at substantial cost-savings, that increased primary care and preventative care always improves outcomes at reduced cost, and that “preventable” hospitalizations and outcomes are preventable entirely by policy changes in health care delivery, in the absence of a drastic culture shift in this country. These conclusions may have some validity, but they are not directly supported by the data presented.

Given the potentially far-reaching implications of publications such as the 2008 Scorecard on policy-making and financing of healthcare, the authors and sponsors of these studies must be held to the same high standards as are physicians and scientists when reporting results of their investigations. This responsibility must be shared by the media, who control the dissemination of information, and must present the results of such studies in as objective and informative a manner as their audience deserves.

As Trevor Butterworth comments in a sidebar:

“Both the Washington Post (“U.S. Health Care Still Ill, Survey Finds”) and Forbes (same headline) ran an article by Healthday News, which simply reported the Scorecard's conclusions and cited Karen Davis, the Commonwealth Fund's president, and Cathy Schoen, the Commonwealth Fund's senior vice president for research and evaluation, to explain the significance:

“‘The United States also lags behind other countries in health-care results, Schoen said. ‘Even where the U.S. average improved, other countries have improved much more rapidly,’ she said. ‘As a result, we are falling further behind the leaders.’”

No other expert opinion was offered in either article, but Post readers were invited to visit the Commonwealth Fund's website “To learn more about health care in the United States.”

A half-truth, as my grandmother used to say, is a whole lie.
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Who Moved My Cheese?

12/02/2008 11:50 PM |

Our friend Peter Huber (senior fellow, Manhattan Institute) has a provocative article in the current issue of City Journal, “Curing Diversity.”

Huber discusses, among other things, the current inflection point of innovation vs. cost and how we got to where we are. 

Some of his comments to whet your appetite”

“Pharmacology has found better ways to tame smaller shards of hostile life while dodging friendly molecular bystanders. And in scrambling to do all that, it has revealed that we aren't all the same deep down, neither in sickness nor in health.”

But …

“The Fourteenth Amendment doesn't guarantee equal protection at the pharmacy … So the stage is set for a long battle between radically new medical science and a senescent, unscientific vision of how diseases are cured and what the "health-care system" ought somehow to deliver.”

Huber is the first policy wonk (as far as I know) to compare a restrictive formulary to a cheese wheel:

“Charles de Gaulle once wondered how anyone could govern a nation that had 246 different kinds of cheese. Designer medicine could probably stock that many varieties on just the cholesterol shelf of its fromagerie. The simplest fix: fewer cheeses.”

There's a punchline in there somewhere.

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Kidney Punch to NICE

12/01/2008 05:14 PM |

According to a report in today’s Guardian, the ban on drugs that can give kidney cancer patients many months of extra life is to be lifted. At least two, and possibly all four, of the medicines that had previously been deemed too expensive to prescribe will be approved by the National Institute for Health and Clinical Excellence (NICE) early next year.

What caused the the reversal?  Why evidence, of course.

"A spokeswoman for NICE said the organization was looking again at all the drugs because there was more evidence submitted during a couple of periods of the appraisal process by manufacturers, which needs to be discussed by the [appraisal] committee. We will publish a next draft within four weeks of the committee's meeting in January and issue final guidance in March 2009.”

Couldn't have been anything else, right? Well ...

"The move follows British Health Secretary Alan Johnson's decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue."

For more on this issue, see here.  

And for the complete Guardian article, see here.

Perhaps HHS Secretary/Healthcare Czar-Designate Daschle should give the Honorable Mr. Johnson a call. And maybe he should conference-in Senator Baucus.

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ALLHAT Jazz

12/01/2008 03:02 PM |

Per the renewed interest in ALLHAT -- and the pros and cons of large scale, government-funded comparative effectiveness trials -- some further comment from Michael Weber, MD -- one of the original ALLHAT investigators (and Chairman of the Center for Medicine in the Public Interest):

Using ALLHAT as an example of an “evidence gap” could be misleading, for the issue is not the information produced by ALLHAT, but rather how it’s interpreted and used.

Most experts, myself included, have concluded that diuretics are highly useful drugs in treating hypertension, and may even be underutilized.  But there is no convincing evidence that they are superior to other drug classes.

Admittedly, diuretics are cheap to acquire, though not necessarily cheap to use. Because they cause unwanted changes in such factors as potassium, glucose (which can lead to diabetes) and uric acid ( which can lead to gout), the additional costs of extra laboratory tests, follow-up doctor visits and corrective therapies must be reckoned in.

In fact, the British National Health Service, which is guided in drug selections by its highly cost-sensitive National Institute of Clinical Excellence, favors amlodipine (one of the diuretic’s competitors in ALLHAT) as the usual starting therapy for hypertension. This recommendation is based on the ASCOT study that found that a beta-blocker/diuretic combination (a favored treatment in ALLHAT) was significantly less effective than a combination of newer drugs in reducing fatal and non-fatal cardiovascular events and strokes.

Another powerful study, ACCOMPLISH, was recently presented at the scientific sessions of the AmericanCollege of Cardiology and is expected to be published before year’s end. This much discussed trial has also indicated that diuretics  --  valuable as they are  --  may not be as effective in prolonging life and preventing heart attacks as other choices.

So the claim of an evidence gap is not based on a disregard of evidence, but in fact demonstrates that the opposite is true. Clinicians apparently are aware of the full spectrum of evidence, not just selected portions promoted by a government agency. From the perspective of patients with hypertension, this surely is good news.

(For more on ALLHAT, see here.)

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Hecho en Mexico

11/30/2008 05:22 PM |

Last week I participated in a two-day seminar held by the Consejo de Salubridad General of Mexico. The topic was “Farmacoeconomia: una nueva era en la toma de decisiones,” (“Pharmacoeconomics: a new age for decision making.) The conference’s subtitle was important, “una vision internacional.”

The “internacional” part consisted of myself, Michael Drummond, Professor of Health Economics (University of York), Professor Jacques Lelorier, Chief of the Pharmaco-economics and Pharmaco-epidemiology research unit at the University of Montreal, and Kalipso Chalkidou, Acting Director of Policy Consulting at NICE.

The seminar was designed to debate and discuss Mexico’s new pharmaco-economic guidelines for their national formulary. And there was as much debate as discussion. (The audience was comprised of about 100 members of various Mexican government health authorities – and they were not passive observers.) The opening remarks by Stephano Bertozzi (Instituto Nacional de Salud Publica) set the tone for the event, “We need to spend more and spend more wisely.”

Michael Drummond’s presentation was a primer on the various types of evidence used in healthcare technology assessments. Nothing new – but a valuable view into the soul of HTA. Dr. Drummond’s take-away message was that decisions made via HTA are economic decisions – not necessarily medical ones. He also pointed out that using RCTs as the mainstay of comparative effectiveness measures was a flawed proposition and that other evidence – such as observational studies and real-time outcomes data needed to become part of the broader HTA equation.

I was up next, and the gist of my talk was that decisions should be made on patient-centric rather than cost-based platforms – and that reimbursement choices based on short-term budgetary considerations can have expensive (for the government) and dire (for the patient) consequences. My presentation can be found here.

Third on the agenda was Professor Jacques Lelorier who gave a very provocative presentation on the gaming of the comparator issue in general and by Canadian authorities (CDR) in particular – which does not tell the innovator company what comparator it has chosen and then, once a decision has been made, won’t share the data used in the process. He made the point (echoed by others during the course of the event) that when a particular HTA review finds a product to be outside of the selected cost-effectiveness parameters, “the answer is no,” but when the parameters fall within the selected criteria, “the answer is maybe.”

Kalipso Chalkidou gave an overview of NICE – making a point of the fact that NICE is not a reimbursement agency and does not deny access to pharmaceuticals. She also discussed the pending policy (in the UK) of providing physicians with financial “incentives” if they move patients from on-patent medicines to generic alternatives “Incentive” -- such a nice word when a government uses it. Can you imagine what it would be called if this same technique was used by an innovator company? (Hint – “bribery.”) Dr. Chalkidou also noted this policy is “pending” because it is being challenged in court. She also pointed out (vis-à-vis statins) that if there was “any proof” that an on-patent product was “better” than a generic that NICE would be glad to reconsider its current position on the matter. I will shortly send her a link to the BMJ-published THIN study that shows why switching patients from on-patent atorvastatin (Lipitor) to off-patent simvastatin (generic Zocor) has proven to be very expensive to the British healthcare system because of its disastrous and deleterious impact on patient health. (For more on the THIN study, see here.) 

Day Two of the seminar was comprised of Mexican health officials and academics presenting their views on pharmaco-economics and HTA. Some worthwhile and representative remarks:

“Developing guidelines is one thing -- making disastrous implementation mistakes is something else. We must have confidence in the people doing our HTA reviews and understand the relative strengths and weaknesses of the data. We must have clarity about appeal guidelines. A good economic analysis is not a faultless crystal ball. HTA has threats as well as opportunities.” (Atanacio Valencia, Institudo Nacional de Salud Publica)

“HTA isn’t a decision – it is the evidence to assist in making a decision.” (Maria Cristina Gutierrez Delgado, Secretaria de Salud). Her presentation was on a Mexican HTA analysis of the HPV vaccine – an analysis that showed the vaccine not to be cost-efficient. The Health Minister, however, decided to go against that recommendation.

Stephano Bertozzi spoke about the need to create a formalized training program for those who prepare HTA studies as well as for those who will make the final reimbursement decisions.

Octavio Amancio Chassin (Consejo de Salubridad General), made the excellent point that HTA must go “beyond the QALY,” taking into careful consideration a variety of factors such as the financial impact associated with caregivers.

Being able to participate in this event and to view the Mexican public health community discuss and debate how to set up an HTA authority convinces me of five things:

1. HTA can be a valuable tool when the right tools are used the right way;

2. HTA must be a combined and collegial effort of government officials, trained academics, physicians and pharmaceutical companies;

3. A variety of evidence must be considered – from RCTS to observational studies to outcomes data;

4. HTA must be as much a patient-centric proposition as a cost-effectiveness mechanism;

5. All aspects of HTA – from the design to the decision to the appeals process must be open and transparent

As we in the United States begin to think seriously about HTA we absolutely must remember that it’s more than just “comparative effectiveness.” And a good way to start having a serious conversation about the issue would be to convene experts and discuss the right way to move forward.

I respectfully suggest to Senator Baucus and Senator Conrad, before they offer legislation setting up an American comparative effectiveness body (within AHRQ or anywhere else), that they look at the process being used by our NAFTA neighbors to the South and carefully consider the warning of Professor Atanacio Valencia, “Don’t make the remedy worse than the disease.”

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Why ALLHAT is a Turkey

11/28/2008 09:07 PM |

Andrew Pollack tells the story of ALLHAT the supposed gold standard of comparative effectiveness trials in today's NYT.

CMPI's chairman Michael Weber is quoted:

“There was a feeling there was a political and economic agenda as much as a scientific agenda,” said Dr. Michael Weber, a professor of medicine at the Health Science Center at Brooklyn, part of the State University of New York, who had been an investigator in the study but afterward became one of its leading critics. “They pushed beyond what the data allowed them to say.”

Critics said the rules of the trial had favored the diuretics. If the first drug did not adequately lower blood pressure — as happened in more than 60 percent of cases — a second drug could be added. But that second drug was usually a type that worked better with diuretics than with ACE inhibitors.

FDA's Bob Temple says: “This is the largest and best attempt to compare outcomes we are ever going to see,” he said. “And people are extremely doubtful about whether it has shown anything at all.”

So who is in favor of this big trials?

Those who want the government to dictate to doctors what to prescribe based on cost-driven clinical trial designs or think they will spit out precise answers that health plans can use to save money. But in fact such trials themselves have a political edge and often lead by people who themselves have a bias: Which is why Curt Furberg, the man who played fast and loose with the data to claim calcium channel blockers cause cancer, was forced to resign. Actually not the only reason. The other reason: the design of ALLHAT exposed African Americans to an excess risk of stroke and stroke related death. President-Elect Obama and his health advisers should bear that in mind in considering Furberg for any position.

So what's the verdict on comparative effectiveness research? Clinical trials of the size, scope and design of ALLHAT are inconclusive and often outdated, if not politically motivated. So what's the alternative that everyone is seeking to spend billionns on?

"Dr. Clancy (Carolyn Clancy director of the federal Agency for Healthcare Research and Quality) said that her agency was now mainly using insurance records to judge how treatments perform. While clinical trials are the gold standard, she said, they are costly and time-consuming.

And, she added, “You might be answering a question that by the time you are done, no longer feels quite as relevant.”

And that's going to save the US health system billions?

Research on how to achieve the best outcomes for patients is possible. But neither the ALLHAT approach or the review of insurance records is the way to do it.

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Tastes Like Chicken

11/26/2008 10:55 PM |

As we prepare to think "turkey" -- let's first talk "chicken."

As in "Chicken Little."

I share this because, having just landed in Mexico City for a conference on HTA and pharmacoeconomics, I can attest to the fact that the sky is not falling – notwithstanding a story in today’s Washington Post that the FDA is teetering on the brink.

Consider the opening paragraph:

“Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”

First of all, the agency already has some very high caliber leadership – but a new Commissioner with vision, guts and communication skills will absolutely make things better. The FDA is a very hierarchical agency. And it’s very true that more money, personnel and technology are must haves. Particularly technology.

But folks, as Pollyanna-ish as it may sound – the agency that parlor game pundits, some of our elected officials and so-called “watchdog groups” are bemoaning as broken – is actually working pretty well considering withering media attacks, internal score-settling and general hand-wringing by people who mostly have no idea what they’re talking about.

And some who do and should know better.

I am surprised by the comments of my former colleague Bill Hubbard who is quoted in the Post as saying, "FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us."

If that’s true today, then it must have been true when Bill and I were at Parklawn together. And it wasn’t true then. Bill wants the best for the agency – but tacking to the political winds is bad strategy.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

It’s important to read what Dr. Kessler said – that there’s a general “perception” – that’s a lot different from it being true. But minus a smart and robust communications strategy – perception becomes reality. And the FDA has been minus a smart and robust communications strategy for too long.

And then there are those with personal agendas.

"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.

Funny the article should quote David Ross – who has a chip on his shoulder the size of Gibralter. It’s kind of like asking Hillary Clinton to write a job recommendation for Monica Lewinsky. It’s also poor reporting that Ross’ conflicts weren’t noted.

Sloppy journalism and bad editing.

And then there are those who point out how well the FDA was run when they were running it:

"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

Let’s face it -- Jane will not go down in history as one of the great FDA Commissioners. And shame on her for saying the agency isn’t using science, first, last and always as it’s decision-making compass.

The article makes one excellent point that needs to be repeated and repeated and repeated, “While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.”

That’s change we can believe in – lots of change.

And, according to Mark McClellan – already considered by many to be one of the FDA’s Hall of Fame Commissioners -- "There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources. The most important thing is overall effective leadership that leads in a way that establishes public trust."

Amen.

And Happy Thanksgiving.

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On the BMJ-Low

11/25/2008 04:27 PM |

Last March (March 4^th to be exact) drugwonks.com commented on the hypocritical disconnect between what medical journals were writing about medical journalism conflict-of-interest and what they were practicing (“New Realism Redefined”) -- “There seems to be a lot of "do as I say not as I do" going on these days.”

A few months later (August 25^th), Steve Usdin of BioCentury weighted in on the same topic.  His article, “Sacred vs. Profane,” began as follows:

“Medical journal editorials routinely attack the pharmaceutical industry, alleging drug companies corrupt the practice of medicine through inappropriate and overly aggressive marketing, while also criticizing doctors for allowing themselves to be influenced.  The journal publishers themselves, however, play a key role in encouraging the behaviors their editors criticize via advertising, sponsored subscriptions and the promotion of reprints of company-sponsored clinical trials.”

(It should also be noted that both JAMA and NEJM declined Usdin’s requests for interviews.)

So it comes as somewhat of a surprise (Really?  No.) that in the current edition of the British Medical Journal (19 November 2008, doi:10.1136/bmj.a2535), much of the same ground is covered – but minus any mention of the sins of medical journals!  Why does this seemingly obvious issue of transparency fail to gain any traction?  Maybe the new Chairman of Energy and Commerce will look into it?

Maybe not.

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Biederman Bashing Part 2

11/25/2008 03:22 PM |

Did Joe Biederman do anything unethical or wrong by asking Johnson and Johnson to support a research center to develop gene and imaging based diagnostics to more accurately screen for child and adolescent bipolar disorder and then use risperidone (and other drugs) to conduct open label and randomized clinical trials to establish if treatment based on new screening criteria produced better results?

Yes. Biederman should have been more transparent or more promotional about it. Because in this day and age if you don't let your enemies know what you are doing by definition you are hiding something. And if you are hiding something you are by definition conspiring to poison people (particularly children) with drugs that are "powerful" but somehow also "ineffective" and dangerous.

Should J and J not have decided to spend $6 million promoting awareness of bipolar conditions in kids, support CME with unrestricted grants and seek ideas on the appropriate way to design studies for pediatric labeling?

It should have been more open, more willing to give up control and let the science and consensus go where it might instead of letting marketing people try to micromanage.

It's the secrecy stupid. You have nothing to be afraid of. Or ashamed of. If you are transparent that will leave your enemies as the only ones skulking around, conspiring, feeding and feeding off trial attorney dough for fear and profit.

Read More
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Grassley Stains

11/24/2008 04:28 PM |

Here's how Chuck Grassley conducts "investigations"

1.  He sends a letter like this one to Roger Meyer of Best Practice which is a private for profit company that receives no federal grant money.   But that's beside the point since the crime is now simply conducting and publishing research on any observation of any post market benefit of any drug for mental illness in peer reviewed publications such as JAMA.  Which is what Fred Goodwin and Roger Meyer did along with authors from Kaiser Permanente and Group Health of Puget Sound.

(Suicide Risk in Bipolar Disorder During Treatment With Lithium and Divalproex Frederick K. Goodwin, MD; Bruce Fireman, MA; Gregory E. Simon, MD; Enid M. Hunkeler, MA; Janelle Lee, MHA, DrPH; Dennis Revicki, PhD

JAMA. 2003;290:1467-1473.) 

The subject of Grassley's investigation is the following: " A Population-based sample of 20 638 health plan members aged 14 years or older who had at least 1 outpatient diagnosis of bipolar disorder and at least 1 filled prescription for lithium, divalproex, or carbamazepine between January 1, 1994, and December 31, 2001. Follow-up for each individual began with first qualifying prescription and ended with death, disenrollment from the health plan, or end of the study period."

The results?

In both health plans, unadjusted rates were greater during treatment with divalproex than during treatment with lithium for emergency department suicide attempt (31.3 vs 10.8 per 1000 person-years; P<.001), suicide attempt resulting in hospitalization (10.5 vs 4.2 per 1000 person-years; P<.001), and suicide death (1.7 vs 0.7 per 1000 person-years; P = .04). After adjustment for age, sex, health plan, year of diagnosis, comorbid medical and psychiatric conditions, and concomitant use of other psychotropic drugs, risk of suicide death was 2.7 times higher (95% confidence interval [CI], 1.1-6.3; P = .03) during treatment with divalproex than during treatment with lithium. Corresponding hazard ratios for nonfatal attempts were 1.7 (95% CI, 1.2-2.3; P = .002) for attempts resulting in hospitalization and 1.8 (95% CI, 1.4-2.2; P<.001) for attempts diagnosed in the emergency department.

Conclusion  Among patients treated for bipolar disorder, risk of suicide attempt and suicide death is lower during treatment with lithium than during treatment with divalproex.

See how dangerous this is.  No wonder Pharmalot rushed to blog on the Grassley "probe"

Worst Practice? Senate Probes NPR Host’s Firm

Of course, engaging in such activities in identifying risks is ok and individuals with such information should contact Grassley's office or the Church of Scientology or both. (Something tells me that either way the one will get the info to the other. 

2.   How did Phamalot find out.  Turns out that Grassley, well before Roger Meyer even responded to the Grassley "probe" send what his missive to  to the media in advance of sending the letter to Roger Meyer as well as bloggers such as pharmalot whose blog is an oasis for the anti-psycho-pharm crowd.  Pharmalot then trumpets that Best Practice is being investigated by Grassley.  Did Pharmalot contact Roger Meyer or Fred Goodwin or read the JAMA article in question.  Of course not.  Is such behavior defamatory.  To my mind it is.   When I have gone over the top -- and I have -  I have at least apologized or issued a retraction.  We will see what happens to Pharmalot in the days ahead.  Even bloggers should abide by a code of moral decency. 

3.  But don't hold your breath.  The pharmalot blog along with others will generate more mainstream media headlines and articles.  And a press release from Grassley that is already to go. 

Will this have a chilling effect on the publication of off-label effects of medications.  Of course it will.  Will that harm patients and undermine innovation.  Of course.  Along with the assault on any tie between industry and academia.  

The hijacking of science for fear and profit continues apace.
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Term of Endearment

11/24/2008 01:35 PM |

The U. S. Food and Drug Administration prides itself on being, first and foremost, all about science. So, how did the agency that regulates upwards of 30 percent of the U.S. economy get so caught up in tacking against biting political crosswinds? As a veteran of the regulatory wars, my argument is that the rocky seas began to roil when the position of FDA Commissioner was converted from a career position to a political position in the late 1960s. Prior to that time, the FDA chieftain was generally someone who had advanced through the ranks of the agency gaining experience and seasoning along the way. When the Commissioner’s position became Senate confirmable in the late 1980s, some believe an adverse change took place. Others believe that politics is just more contentious than ever before. Both of these notions are correct.

When one considers the mission of FDA—to independently protect and advance the public health—it is not at all clear whether the Commissioner should be a Senate-confirmed political appointee “serving at the pleasure of the President.” I think that the American people would prefer he or she be nominated by the President for a fixed 6-year term—similar to that of the Director of the FBI. Think about it—why should the safety of food additives, the integrity of the blood and vaccine supply, and decisions on drug labeling indications (to name only a few FDA responsibilities) be considered Democratic or Republican issues? The boss of the FDA Commissioner is and should continue to be the Secretary of Health and Human Services—a politically appointed, Senate-confirmed cabinet officer. This is enough. More politics just leads to regulatory paralysis and discord—neither which protects or advances America’s health. 

Having had the honor to serve our country as an FDA Associate Commissioner, I can unequivocally state that the unwelcome infusion of politics into science makes an already difficult job virtually impossible. To have the job of Commissioner open and only partially filled for extended lengths of time grinds progress to a halt. Low morale, lengthy delays, and even postponements often characterize an open Commissionership. This is not acceptable.

Who becomes the next FDA Commissioner is important. But an important indication of the seriousness with which President-Elect Obama takes that post is how soon in his administration a nomination is made. Let’s hope it’s done swiftly and smartly.

For more on this, have a look at the Journal of Life Sciences.

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Quantum of Shamelessness

11/21/2008 07:36 PM |

More info that the New York Times left out of its story on Fred Goodwin:

The Times writes:

"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias."

“These companies compete with each other and cancel each other out,” he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments."

Here are the facts:

Goodwin consistently studied the effects of lithium a drug that lost it's patent nearly a half century ago and continues to lecture about it's benefits as a front line treatment for manic depression.

Read More

Goodwin also pioneered the use of light therapy to treat season affect disorder.

Meanwhile the Grassley witch hunt continues apace, now "investigating" Goodwin's private consulting business for promoting "off-label" use of lithium. Translation: Publishing an article in JAMA comparing the effect of lithium in reducing suicide among manic depressive patients to marketed products - in partnership with managed care plans and other research organizations -- is now a reason to investigate. And of course just being investigated by Grassley is a crime because taking money from any drug company for any reason at any time makes all of one's research suspect and you a criminal.

Got that?

I can hear the hatchets being sharpened. Shannon Brownlee and Jeanne Lenzer must not be far behind.
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Expert Witness

11/21/2008 06:39 PM |

Per today's article in the New York Times on my friend and colleague Fred Goodwin ... why was there no mention of stature in the field of psychiatry?

Here are (only) some of Dr. Goodwin's particulars:

*  Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society;

*  Former Director of the National Institute of Mental Health

This was not relevant to the story, why?

Looks like that "all the news that's fit to print" window is getting narrower all the time.  Talk about a lack of fair balance and adequate provision.

Time to contact the Ombusdman.
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Generic Attack on Fred Goodwin

11/21/2008 05:10 PM |

Fred Goodwin is one of the leading psychopharmacologists of this century. He is also a practicing psychiatrist. That is reason alone for those bent on driving down the use of medications for mental illness to target Goodwin for being paid to advise pharmaceutical companies who develop products for the treatment of such conditions. Goodwin -- who is my friend and a CMPI board member -- is a pioneer in the successful treatment of schizophrenia and manic depression. His radio show, "The Infinite Mind" covered a wide variety of subjects ranging from dreams, to aging, to depression over the 15 years he was the host.

He is being slimed by the same small-minded group that wants to savage science and replace it with a contorted combination of anger, unmedicated anecdotes and trial lawyer inspired opportunism.

Goodwin will continue to publish, lecture and research, adding value and knowledge to patients lives.

Here's the difference between Goodwin and his attackers:

Fred has helped reduced the number of suicides among the mentally ill. They have helped increase them.

They have to live with their legacy. I am sure Fred will be content with his.

Read New York Times article
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Adding the Fuel of Interest to the Power of Genius

11/21/2008 01:45 PM |

Day II of the IFPMA Assembly offered a pastiche of pithy policy pensées.

John Lechleiter (President and CEO, Eli Lilly & Company) spoke on the urgency of making healthcare more personal. A few points from his remarks:

* “The free market hasn’t failed — it just hasn’t been given a chance to work as it should.”

* “With critics of the U.S. system pointing to Europe and other countries for reform guidance — in the past decade, nearly every European country has introduced market-oriented reforms — and has turned to the private sector in their efforts to reduce the health costs of treatments.”

* “We need to build a consumer-driven system — one that instills a sense of personal ownership … and puts the individual consumer in charge of how health care dollars are spent — through such mechanisms as health savings accounts.”

* “Transparency is the lubrication that makes consumer-driven healthcare work.”

* "We need to restructure the system so it is patient-centered … where health care providers, payers, regulators, and innovators work together to answer a single question: What is best for the individual patient?”

* “In a patient-centered system, individuals bear primary responsibility for their own health. And physicians help patients recognize incentives for healthier living … and act as agents on their behalf. In this system, providers compete on value and are measured on quality.”

* “We must build a system that promotes universal access, not by mandate but through free-market solutions that maximize coverage and improve access.”

* “In 2007 — for the first time — we offered U.S. employees consumer-driven options: HSA/HRA. About one-third of employees opted for a health savings account or a health reimbursement account.”

* “This year, roughly two-thirds of enrolled employees — including moi — and dependents chose one of these options. By 2010, our company will offer only consumer-driven options for our active employees.”

Lechleiter’s full remarks can be found here.

In his keynote address, IFPMA President Fred Hassan (whose day job is Chairman and President of Schering-Plough), shared that the IFPMA will commence a global communications effort on the value of IP. And while he didn’t say that IP is a human right, he came very close – pointing out all of the good that solid intellectual property right protection affords civil society. He also quoted Abraham Lincoln (a popular thing in Washington, DC these days), saying that intellectual property rights “add the fuel of interest to the passion of genius.”

Bravo.

Hassan also noted that the IFPMA is going to field a study to determine its image and level of influence in Geneva. (Note to Fred: If you have to ask …)

Rich Bagger (SVP, Worldwide Public Affairs & Policy, Pfizer) was the only speaker to consistently refer to his company as being in the “life sciences” business. Why is this so hard for everyone else to remember ?

One of Rich’s themes was “new roads to access.” And he offered a very early yet tantalizing example – Pfizer’s partnership with the Grameen Bank of Bangladesh (yes – the one run by Nobel Laureate Muhammad Yunus). Pfizer and Grameen are developing a “micro health insurance model” along the lines of Grameen’s well-known micro-credit programs. According to Bagger, a policy might cost $20/month of which $3 would go towards pharmaceutical coverage. That’s consumer-driven healthcare LDC style – and a program that the world’s largest life sciences company should talk about publicly, proudly and often.

Ladies and Gentlemen – the frost is on the pumpkin and it’s time to get to work.

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Hello Tom. Goodbye Steve.

11/20/2008 02:37 PM |

Tom Daschle is a terrific choice for HHS for many reasons.  Most importantly, he’s a grown-up. 

Daschle's sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.

His other role in the Obama White House, that of Health “Czar,” poses some interesting questions.  Specifically, how will he approach the issue of the Part D Non-Interference Clause – which he (along with Senator Kennedy) drafted in the first place?

Yesterday, at Day II of the IFPMA Assembly, the luncheon speakers were former Senators John Breaux and Trent Lott.  Neither thinks there will be a strong Congressional effort to reverse the Non-Interference Clause.

I am not as phlegmatic.

And to that point, a few things worthy of consideration:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong

"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause.  Consider:

* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.

Why?  Marketplace competition.

* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.

Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.

We shouldn’t interfere with success.

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Connections That Count

11/19/2008 09:36 PM |

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Of Budget Shortfalls and Snake Oil

11/19/2008 11:32 AM |

As our current financial meltdown forces state governments to consider ugly budget cutbacks, some foolish ideas often get undeserved airtime.

Specifically, drug importation.

It’s worth restating the facts.

State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ 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.

And what of Minnesota’s RxConnect? 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 what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA” (Hamptons.com Sept 30, 2008, reported by Aaron Boyd).

Shameful.

This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources 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.

PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.

Oh – and by the way, such programs don’t even save any money. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation 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.

We’re all in deep enough fiscal trouble.  We shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that make for good soundbites -- but bad public policy.
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Sachs Appeal

11/19/2008 12:19 AM |

Sorry for the late evening post, but I've been at 24th IFPMA Assembly in Washington, DC. all day.

Some highlights:

The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?

The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.

Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)

Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.

More from the IFPMA Assembly tomorrow.
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Pharma's Margin Call

11/17/2008 06:35 PM |

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