The Dartmouth Atlas In Tatters and Disgrace

02/23/2010 04:21 PM |

First Buzz Cooper systematically shredded the underlying assumptions of the Dartmouth Atlas with his studies showing that sickness and poverty, not stupid doctors over-treating people who coincidentally all died within two years, explained most of the variation in health care spending. 

Then Peter Bach in his NEJM article revealed that the entire enterprise, the foundation not only of the entire liberal effort to bend the curve on health care through government rationing but of a billion dollar business designed to "coach" people out of treatments for back pain, breast cancer, prostate cancer, etc... all to the financial benefit of hospitals and health plans, is medically bankrupt and statistically corrupt...

Here's Buzz Cooper putting the Atlas through the document shredder:

An important article appeared in today’s NYT, describing a new paper by Peter Bach, which is in today’s NEJM. Peter’s paper (“A Map to Bad Policy“) debunks the Dartmouth Atlas and cautions against its use. As I said in the Wash Post in September, the Dartmouth Atlas is the ”Wrong Map for Health Care Reform.”

More damning even than Peter’s analysis was Elliott Fisher’s reply: “Dr. Fisher agreed that the current Atlas measures should not be used to set hospital payment rates, and that looking at the care of patients at the end of life provides only limited insight into the quality of care provided to those patients. He said he and his colleagues should not be held responsible for the misinterpretation of their data.” Really? It was someone else’s interpretation? OK, Elliott, you’re not responsible. Just stand in the corner.

Peter is not the only leading epidemiologist to debunk Dartmouth in recent days. There’s also the report this week from the U of Wisconsin and RWJ by Pat Remington (another leader), showing that people who have the poorest health (and, therefore, the highest health care costs) live in the poorest counties (see my blog report and an earlier discussion of poverty and health care). And there’s the recent paper by Ong and Rosenthal (co-authored by Jose Escarce, editor of HSR, the leading health services research journal), showing that, when all care is measured (not simply end-of-life care, as measured by Dartmouth), hospitals that provide more have lower mortality, which was confirmed in the current issue of Medical Care by Barnato and associates at the U of Pittsburgh. When it rains, it pours.

What’s doubly important about the death of the Dartmouth Atlas is that it was the cornerstone of health care reform. Right from the start, Peter Orszag, director of OMB and the administration’s architect of health care reform, accepted Dartmouth’s ideological principles that health care spending was driven by doctors and hospitals who over-treated and over-charged, to no benefit. The funds for health care reform were readily available by simply getting rid of geographic differences. That alone would save 30% of health care spending ($700B). And that could be accomplished by making everything look like Mayo (white, middle class and efficient) and by having more primary care physicians (which Mayo doesn’t). And best of all, it could assure that no new taxes would be needed, just as President Obama had promised.

And here's Peter Bach explaining why cost driven health care policy is, well, bad for patients...

Say Hospital A and Hospital B each has a group of patients with a fatal disease. Hospital A gives each patient a $1 pill and cures half of them; Hospital B provides no treatment. An Atlas analysis would conclude that Hospital B was more efficient, since it spent less per decedent. But all the patients die at Hospital B, whereas only half of the patientsdo at Hospital A, where the cost per life saved is a bargain at $2. Although $1 cures are rare, changing the price or efficacy of the pill does not alter the fundamental problem with examining costs alone when cost differences are sometimes associate with outcome differences.

And finally Bach challenges what, until recently, the media, most foundation types, the underachieving liberal health bloggers drank as daily Kool-aid,  that the Dartmouth Atlas controlled for severity of illness by looking at only dead people. 

Another methodologic problem is that Atlas analyses assess hospital efficiency overall on thebasis of costs incurred for nonrepresentative patients — decedents who were enrolled in fee-forservice Medicare. This group varies among hospitals in terms of severity of illness and is notrepresentative of a given hospital’s overall spending pattern. Regarding illness severity, Atlas researchers note on their Web site (www.dartmouthatlas.org/faq/ hospital.shtm) that they focus on “patients who died so that [they can be sure] that patients were similarly ill across hospitals,” further explainingthat “by definition, the prognosis of all patients[who died was] identical — all were dead . . . therefore, variations [in resource use] cannot be explainedby differences in the severity of illness.” But since some hospitals take care of sicker patients than others, the average severity of illness of patients who die also varies among hospitals. This fact is being ignored when all spending differences are attributed to differences in efficiency.

The Dartmouth group has circled the wagons.  Atul Gawande tries to explain how Bach's article, which directly attacks the Dartmouth methodology, reaffirms how brilliant his story about McAllen, based on the Dartmouth Atlas, really was:

"Dr. Peter Bach of Memorial Sloan-Kettering argues against using the Dartmouth measures to financially reward and penalize hospitals. There is a healthy and vital debate about how best to change hospital incentives. None of this, however, calls the Dartmouth researchers’ decades of highly respected work—or their fundamental findings—into question. If anything, the debate reinforces the importance of their research."

http://www.newyorker.com/online/blogs/newsdesk/2010/02/the-cost-conundrum-persists.html#ixzz0gOWwIFNc

Meanwhile Elliott Fisher sought the refuge of the Dartmouth student newspaper to set the record straight:

“There’s a pretty good correlation between treatment of patients over 65 and under 65,” Fisher said.

In a response published in the New England Journal of Medicine, Fisher wrote that Medicare data is closely associated with a single hospital, making it a good measure of hospital effectiveness.

Bach’s final criticism of the Atlas data focused on the variation of illness severity between hospitals. Because of this variation, hospitals that care for patients with very severe illnesses could appear less efficient than those that take care of patients with less severe cases, even if they actually operate with the same level of efficiency, he said.

Fisher responded in the interview that the Dartmouth Atlas data is “carefully adjusted” for variations such as illness severity, poverty and price differences.

Talking to a college student, admittedly, a very smart college student, Fisher can get away with a mixture of evasion and distortions. 

1.  There is no correlation between health care spending between people age 65 and over vs people who are younger unless you truly control for severity of illness which the Atlas fails to do because it never looks at two people from baseline with the same disease over time and compare outcomes.  The Medicare/ non Medicare variance is wide as the Bach article shows.

2.  Dartmouth and Fisher claim to limit who they analyze to those with a list of common chronic diagnoses.  All together, that is about 90% of all people who die in Medicare.  Then they adjust for a few things like primary diagnosis and age and sex and stuff.  They have never shown that they can capture the variability between hospitals in severity of illness and they cannot, even using far more sophisticated measures.  But they do not think they need to risk-adjust for the regional variations stuff.  When MedPac did that, most of the variations went away.

Despite all this, both Gawande and Fisher persist in claiming: "that Bach’s criticism does not undermine the main finding of the Atlas data: regional variations in health care spending show that higher costs associated with specialized procedures do not necessarily lead to better health outcomes. Costs can be lowered by creating more accountable hospitals and moving away from a “toxic payment system” that creates incentives for unnecessary tests, according to Fisher."

http://thedartmouth.com/2010/02/22/news/atlas

Why would they say that when the entire methodology is shot to hell?

Because both (and not just them) make big money off of speeches, consulting and businesses that push the less is more approach. 

And the commercialization of the Dartmouth Atlas -- coaching people to ration their own care in my opinion --  culiminated in the formation of a company called Health Dialog by the Dartmouth folks.  HD was purchased by a British concern for $750 million.  And HD has lobbyists in Washington pushing the adoptiong of its products in the current health care reform bill. 

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Nissen P.I.

02/22/2010 10:57 PM |

Steve Nissen secretly recorded conversations he had with Glaxo SmitkKline execs about his meta-analysis of 42 studies showing an increased risk of CV events. 

http://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=2

I am sure that Nissen was waiting for the climactic scene when the CEO either tries to bribe him or have him poisoned in his hotel room. 

Unfortunately, the response he received from the GSK higher-ups was suggestion to do an analysis about when people actually had their heart problems since other studies did not show CV side effects in the short time frame he was showing (See below).  And the worst thing about that response was the fact that GSK did not offer to pay him tens of millions of dollars to do such a study, a study Nissen has gladly done before using his ultrasound measurement of heart problems.. 

Of course there is no mention of Nissen secretly sending a copy of his NEJM paper to Congress in violation of the embargo requirement and not sharing it with the FDA.  

Nor is there any mention of what NHLBI said in light of the RECORD study... "NHLBI staff reviewed the scientific findings and arranged for Data Safety and Monitoring Board (DSMB) meetings for both trials. The BARI 2D and ACCORD DSMB meetings reviewed in-depth analyses of cardiovascular disease rates in patients receiving rosiglitazone versus other diabetes drugs in the two trials. The DSMBs also conducted a thorough review of the recently published data on heart attacks and deaths in patients receiving rosiglitazone.

Each DSMB provided recommendations to the NHLBI on how the totality of evidence on rosiglitazone should affect the conduct of BARI 2D and ACCORD. The NHLBI carefully reviewed the DSMBs' recommendations and also thoroughly reviewed the recently published meta-analysis of rosiglitazone and the RECORD trial, along with the accompanying editorials published online May 21 and June 5 by the New England Journal of Medicine. "

http://www.nhlbi.nih.gov/new/press/07-rosi-qa.htm

Oh...

The NHLBI concurs with the DSMBs' recommendation that both the BARI 2D and ACCORD data, viewed in the context of the recent publications, contain no observations that would justify a recommendation to terminate rosiglitazone treatment in the research setting of either study.

The New York Times claims that the RECORD study was poorly designed.  In fact, the interim RECORD analysis done to follow up on Nissen's claim was had limited statistical power  because of an unexpectedly low event rate and incomplete follow-up (a mean of 3.7 years instead of the planned median of 6 years).  Still the interim analysis had the same internal statistical reliability as Nissen's analysis:  What the Times fails to note is that when Nissen lumped in all 42 studies, he glossed over the fact that the individual studies he looked at were not conducted the same way, with patients with the same disease or drug dose.  Further, the 42 studies were small and  overall event rates were low, partially because trial durations were relatively short ranging from 24 to 52 weeks, about 25 to 50 percent shorter than RECORD.   As anyone who does statistics for a living will tell you,  adding up a bunch of underpowered and short term studies does not give you a well-powered study with long term predictive effects.

Here's what one article -- written by Sanjay Kaul and colleagues said about the study:  "The investigators' own subgroup analyses, which were limited to the small trials alone or to the 2 large trials (DREAM [Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication] and ADOPT [A Diabetes Outcome Progression Trial]), did not demonstrate statistically significant associations (1). Furthermore, one might reasonably question whether results from the 3 trials that targeted patients with Alzheimer disease (n = 1) or psoriasis (n = 2) who did not have diabetes should be combined with results from other trials that included patients with diabetes or prediabetes. Because rosiglitazone is already contraindicated in patients with heart failure, one might also reasonably limit the assessment of risk to patients without that contraindication and not combine data from the single study in patients with diabetes who had congestive heart failure with data from other studies. Incidentally, this trial exhibited the highest number of myocardial infarctions (n = 5) and cardiovascular deaths (n = 3) among all the small trials in the rosiglitazone treatment group (1).

Read Article

Some people can't handle not being FDA commissioner.... Meanwhile we will keep a running count of the media types who fail to put Nissen, Avandia and other studies about the medicine in context and simply write stories based on the narrative of the insider exposing (once again) the evil drug company. 

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Mass Production of Medical Progress

02/22/2010 02:02 AM |

Jim Pinkerton over at Serious Medicine Strategy does a great job at undermining the assertion of those who claim we spend too much on expensive new technologies and bleating about why prices of technologies go up, not down:

"The price of a CT scanner rose about 55 percent in 30 years, from an inflation-adjusted $1.4 million to $2.2 million. That’s a big increase, but, as Goetz notes, the number of X-ray “slices” a machine can perform has risen from four to 64. That’s a 16-fold increase, or 1600 percent. Which is to say, the increase in the quality of CT machines has risen almost 30 times faster than the increase in the cost. If that’s not a Moore’s Law-level increase, it’s pretty close. "

Moreover, as I noted in a post to Jim's blog the increase in the use of PET/CT scans is not profit driven, it is a function of what new technologies, contrast agents and science can do, particularly in prediction, staging and diagnosing a wide variety of cancers.  And the cost of a scan in inflation adjusted terms has declined while the accuracy has increased.  These two factors explain diffusion, consistent with Jim's observation. 

"...they are highly effective in staging, detecting and personalizing all types of cancer. Moreover, the information from imaging has been critical to the next wave of personalized medicine: development of -- guess what? --  to predict the path of each cancer tumor by linking a CT report to the rearrangement of the genetic code for the tumor.   Why is this possible, because of a rapid decline in the cost of sequencing along with an increase in speed and precision.  Moore's Law.  And this approach could replace CT scans when they become price competitive.   Why low cost?  A greater increase in use, a further fall in production costs and competition. "

But only if government doesn't get in the way of it's use.  

Anyone want a government agency to determine whether this new "fingerprinting" of cancers should be used?

seriousmedicinestrategy.blogspot.com/2010/02/can-we-afford-ct-scans.html

Scientists Spot Genetic 'Fingerprints' of Individual Cancers

By Amanda Gardner
HealthDay Reporter Thu Feb 18, 11:49 pm ET

THURSDAY, Feb. 18 (HealthDay News) -- Researchers have found a way to analyze the "fingerprint" of a cancer, and then use that fingerprint to track the trajectory of that particular tumor in that particular person.

"[This technique] will allow us to measure the amount of cancer in any clinical specimen as soon as the cancer is identified by biopsy," said study co-author Dr. Luis Diaz, an assistant professor of oncology atJohns Hopkins University. "This can then be scanned for gene rearrangements, which will then be used as a template to track that particular cancer."

Diaz is one of a group of researchers from the Ludwig Center for Cancer Genetics and Therapeutics and theHoward Hughes Medical Institute at Johns Hopkins Kimmel Cancer Center that report on the discovery in the Feb. 24 issue of Science Translational Medicine.

This latest finding brings scientists one step closer to personalized cancer treatments, experts say.

"These researchers have determined the entire genomic sequence of several breast and colon cancers with great precision," said Katrina L. Kelner, the journal's editor. "They have been able to identify small genomic rearrangements unique to that tumor and, by following them over time, have been able to follow the course of the disease."

One of the biggest challenges in cancer treatment is being able to see what the cancer is doing after surgery, chemo or radiation and, in so doing, help guide treatment decisions.

"Some cancers can be monitored by CT scans or other imaging modalities, and a few have biomarkers you can follow in the blood but, to date, no universal method of accurate surveillance exists," Diaz stated.

Almost all human cancers, however, exhibit "rearrangement" of their chromosomes.

"Rearrangements are the most dramatic form of genetic changes that can occur," study co-author Dr. Victor Velculescu explained, likening these arrangements to the chapters of a book being out of order. This type of mistake is much easier to recognize than a mere typo on one page.

But traditional genome-sequencing technology simply could not read to this level.

Currently available next-generation sequencing methods, by contrast, allow the sequencing of hundreds of millions of very short sequences in parallel, Velculescu explained.

For this study, the researchers used a new, proprietary approach called Personalized Analysis of Rearranged Ends (PARE) to analyze four colorectal and two breast cancer tumors.

First, they analyzed the tumor specimen and identified the rearrangements, then tested two blood samples to verify that the DNA had been shed into the blood, sort of like a tumor's trail of bread crumbs.

"Every cancer analyzed had these rearrangements and every rearrangement was unique and occurred in a different location of genome," said Velculescu. "No two patients had the same exact rearrangements and the rearrangements occurred only in tumor samples, not in normal tissue," he noted.

"This is a potentially highly sensitive and specific tumor marker," Velculescu added. Levels of the biomarkers also corresponded with the waxing and waning of the tumor.

"When the tumor progresses, the relative amount of the rearrangement increases in the blood and goes down after chemotherapy," Diaz said. "It tracks very nicely with the clinical history of the tumor."

The method would not be used for cancer screening and more research needs to be done to make sure PARE doesn't detect low-level tumors that don't actually need any treatment.

Although this approach is currently expensive (about $5,000 versus $1,500 for a CT scan), the authors anticipate that the cost will come down dramatically in the near future, making PARE more cost-effective than a CT scan.

Under the terms of a licensing agreement, three of the study authors, including Velculescu, are entitled to a share of royalties on sales of products related to these findings.

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Trash Talk

02/20/2010 11:13 AM |

Maine lawmakers are debating a bill that would require pharmaceutical companies to retrieve unused prescription drugs from households across the state. The measure is designed to prevent those medicines from ending up in Maine’s water supply.

Protecting Maine’s drinking water is of paramount importance. But the bill won’t make Maine’s water any cleaner. And it could raise the price of medicines and stifle biopharmaceutical research.

(The bill is LD 821, “An Act to Support Collection and Proper Disposal of Unused Drugs”)

For starters, more than 90 percent of the drugs that find their way into tap water comes from the waste products of those who have ingested their medicines correctly — not from folks improperly flushing their meds down the toilet. So this “take back” program would do nothing to prevent the main source of pharmaceutical chemicals in water.

Moreover, the safest and most effective way to dispose of drugs is to toss them in the household trash, in sealed plastic bags to keep them away from children and pets. That waste is eventually held in secure landfills, preventing any chemicals from leaking into surface waters.

A secondary function of the bill, according to its supporters, is to get pharmaceuticals out of the hands of those who might abuse them.

Any legislation that takes the issue of drug abuse seriously, however, needs to provide communities with the resources to teach their citizens about the dangers of prescription drugs. This bill does not.

Even if the Maine Legislature went back to the drawing board and attempted to design a bill that actually improved residents’ health, lawmakers still would be hard-pressed to create effective regulations. That’s because water quality, by its very nature, isn’t a state issue — it’s a national issue.

The Mississippi River Watershed runs through 31 states. The Chesapeake Bay Watershed serves 17 million people in seven states plus the District of Columbia. There’s no doubt that water safety deserves serious attention from the government. And Maine lawmakers should do their best to ensure that the local water supply remains free of pollutants. But this bill would be ineffective at the state level.

The problems with this bill go beyond its inefficacy. It actually could jeopardize the health care of patients across the country.

Creating the complex and expansive network required to regularly collect unused drugs from resident homes would be a very costly enterprise. Consequently, this bill would dramatically drive up the operating costs for medical research firms, leaving less money for scientists to develop new drugs. That’s particularly bad news for those suffering from conditions like cancer and Parkinson’s, whose lives depend on future medical innovation.

What’s more, drug makers likely will try to recoup dollars lost on recovery programs by raising prices on their products. So folks would see higher pharmacy bills at a time of great economic instability.

Maine lawmakers have crafted a bill that fails to address the important issues of water purity and prescription drug abuse, and actually harms people’s health care.

They can do better.

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Krug Spiral

02/19/2010 01:55 PM |

Paul Krugman once again has the simple solution to the Wellpoint premium increases: 

http://www.nytimes.com/2010/02/19/opinion/19krugman.html?em

"What would work? By all means, let’s ban discrimination on the basis of medical history — but we also have to keep healthy people in the risk pool, which means requiring that people purchase insurance. This, in turn, requires substantial aid to lower-income Americans so that they can afford coverage.

And if you put all of that together, you end up with something very much like the health reform bills that have already passed both the House and the Senate.

What about claims that these bills would force Americans into the clutches of greedy insurance companies? Well, the main answer is stronger regulation; but it would also be a very good idea, politically as well as substantively, for the Senate to use reconciliation to put the public option back into its bill."

Maybe the Krug forgets that the it was the very prescriptions he is pushing that helped contribute to the rise in premiums.  That, and the fact that insurance companies tried to hold the line on premium increases in 2008.   In any event, he ignores the fact that individual premiums under Obamacare will increase by up to 35 percent in 2016 as all these regulations kick in (that's according to CBO).   And a  pubiic option will not be less expensive according to both CBO and CMS unless there is some drastic price controls.  That will keep prices in check in the short term, but not overall spending..

Buying across state lines is not a panacea and would likely have unintended consequences (as with any health care policy).    But there are a lot of things that could be done to keep premium costs down and predictable, starting with allowing people to buy catastrophic coverage.   However leftists like Krugman would never allow that choice. 

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QALYwood Squares

02/19/2010 07:06 AM |

Terrific and timely new article by John Bridges (Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health and a senior fellow at the Center for Medicine in the Public Interest), et. al.  It appears in the journal Pharmacoeconomics under the title, “Healthcare Rationing by Proxy Cost-Effectiveness Analysis and the Misuse of the $50,000 Threshold in the US.”

Here’s the abstract:

The application of cost-effectiveness analysis in healthcare has become commonplace in the US, but the validity of this approach is in jeopardy unless the proverbial $US50,000 per QALY benchmark for determining value for money is updated for the 21st century. While the initial aim of this article was to review the arguments for abandoning the $US50,000 threshold, it quickly turned to questioning whether we should maintain a fixed threshold at all. Our consideration of the relevance of thresholds was framed by two important historical considerations. First, cost-effectiveness analysis was developed for a resource allocation exercise where a threshold would be determined endogenously by maximizing a fixed budget across all possible interventions and not for piecemeal evaluation where a threshold needs to be set exogenously.

Second, the foundations of the $US50,000 threshold are highly dubious, so it would be unacceptable merely to adjust for inflation or current clinical practice. Upon consideration of both sides of the argument, we conclude that the arguments for abandoning the concept for maintaining a fixed threshold outweigh those for keeping one. Furthermore, we document a variety of reasons why a threshold needs to vary in the US, including variations across payer, over time, in the true budget impact of interventions and in the measurement of the effectiveness of interventions. We conclude that while a threshold may be needed to interpret the results of a cost-effectiveness analysis, that threshold must vary across payers, populations and even procedures.

‘‘Cost-effectiveness analysis can skirt life valuation by relying instead on the premise that we want our limited resources to achieve maximal benefits (which may be set in units that we prefer not to value monetarily).’’

[Thompson and Fortress, 1980, p. 555[1]]

The complete article can be found here.

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Ignore this study!

02/18/2010 04:10 PM |

In the January 2010 issue of Academic Medicine (Acad Med. 2010; 85:80–84.), four researchers from the Cleveland Clinic published a paper entitled, “The Effect of Industry Support on Participants of Bias in Continuing Medical Education.”

The purpose of the study: “To obtain prospective evidence of whether industry support of continuing medical education (CME) affects perceptions of commercial bias in CME activities.”

The method: “The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multispecialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support.”

CME conflicts of interest!  The Cleveland Clinic!  A study with zero industry funding or researcher connections!  Speed dial to Senator Grassley, right? 

Not so fast.

The study’s conclusion: “This large, prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present.”

Could this be the reason there was no mainstream media coverage or press releases from Congress?

You be the judge.

The study can be found here.

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Getting High

02/17/2010 04:43 PM |

It's that time again.  PDUFA reauthorization.  And the question on everyone's mind is, 'How high is up?"

Steve Usdin (scribe extraordinare of BioCentury) offers up some intriguing PDUFA pensées under the seasonally appropriate headline, "PDUFA Blizzard."

The article can be found here.

Once again proving the point that, when it comes to matters PDUFA, the best din is Usdin.
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Podium Police

02/16/2010 09:16 AM |

“Podium policy” (when regulators give speeches or media interviews that announce new regulatory expectations), is never a good idea. And least of all when the policy implicates First Amendment values and involves potential criminal enforcement.

The issue at hand is pharma and social media – an issue where there is already significant confusion.  And now, unfortunately, there’s more.

Consider the comments of Jean-Ah Kang (special assistant to DDMAC director Tom Abrams) in her recent interview with Ignite Health:

 

“The bottom line is this is a regulated industry, and if you choose to do promotion in that area just make sure that at the end of the day what we’re looking at is in the best interest of public health.”

 

Dr. Kang then defines what she meant by “the public health”:

 

“Meaning, is this prescription drug promotion truthful?  Is it balanced?  Is it accurate? Is it false or misleading? That’s the big picture at the end of the day.”

 

And then she offers some qualifications:

 

“Several things come to mind with use of intent. We have regulations and again, they’re not black and white per se, but they exist … Even though someone may not have intended something, if the end result is that the public is misled then it’s a problem.” 

 

And finally, “I mean people have gone to jail over these serious public health issues. So just be aware of the regulatory environment.”

 

“Intent” to promote against the “best interest of the public health” via regulations that are “not black and white” and over which “people have gone to jail.”  Talk about "net impressions." The implications of her remarks are chilling. Chilling, frustrating and disappointing – but not necessarily surprising.  After all, it’s all about ambiguity.  

 

Ambiguity is power. That’s why interpretation of FDA regulations (on social media and a host of other issues) is such a vibrant cottage industry. Regulated industry, on the other hand, seeks clarity. Industry wants bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA. “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.” And nowhere is this truer or more dangerous than at DDMAC.

 

Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than vague, ever-changing expectations based on undefined notions of what serves “the public health,” is a distinctly more challenging proposition.

 

If the FDA wants to remain relevant (and out of court), they should develop clear rules that safeguard the important First Amendment values at stake.  And this is about more than just the speech rights of companies.  It’s about the rights of the Internet user (yes, you) to obtain information from a full range of sources – not just the government and plaintiffs lawyers and snake oil salesmen.  

 

Dr. Kang is a smart person and a real believer in the potential of social media to advance the public health and she does her best to portray the FDA process as thoughtful and deliberative.  It is. But, at a bare minimum, we are entitled to something more (or perhaps it would be better to say something less) than Jean-Ah’s remarks.  After all, the FDA doesn’t have the authority to regulate or even define what is “bad” for the public health writ large.  That’s regulatory creep of the first order. (Her complete interview can be found here.)

 

When I served at the FDA, we struggled with how to both regulate and advance the new field of pharmacogenomics. As Commissioner McClellan said at the time, “pharmacogenomics is a new field, but we intend to do all we can to use it to promote the development of medicines. By providing practical guidance on how to turn the explosion of pharmacogenomic information into real evidence on new drugs, we are taking an important step toward that goal.”  The same philosophy of “regulator as colleague” should also be true for the new dynamic of social media. It’s like a game of chutes and ladders.  FDA should act as a guide to the ladders and a sentry against the chutes – rather than an as the ogre at the foot of the bridge.

 

“I know it when I see it” as an approach to social media regulation doesn’t cut it. Predictability is power in pursuit of the public health. And social media is as powerful tool for advancing the public health today as any medical breakthrough you care to name. In 2010, healthcare begins at search.

 

Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity. And it’s never easy, because swimming against the tide of an entrenched bureaucracy never is. But as Commissioner Hamburg and other agency change agents (Drs. Sharfstein, Woodcock and Goodman to name three) demonstrate, it is possible. 

 

As Winston Churchill said, “Ease is relative to the experience of the doer.”

 

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Do not pass "Co"

02/15/2010 08:58 AM |

If it’s unlikely that Washington will pass meaningful health care reform any time soon. Yet health care costs are still exploding — making quality care unaffordable for too many Americans and putting a financial burden on us all.

Surprisingly, though, there’s a smart move that health insurers can make that will lower costs for consumers and insurers alike, and improve patient health: Reduce co-pays on prescription drugs.

High drug prices lead many Americans to skip doses or quit prescriptions entirely. Yet prescription drug prices aren’t rising — it’s patients’ out-of-pocket costs, or co-pays. Over the past several years, insurance companies have become increasingly reluctant to foot the bill for brand-name medications. Indeed, since 2000, co-pays have increased four times faster than prescription drug prices.

Patients respond to higher co-pays by skipping their meds more often. In 2003, researchers at the University of Oregon studied the effects of introducing a $2 to $3 co-pay for prescription meds among 17,000 patients. Adherence to treatment dropped by 17 percent.

Some insurers are even refusing to cover new prescription drugs. According to a study from Wolter Kluwer Health, insurers’ denial rate for brand-name meds was 10.8 percent at the end of 2008 — a 21 percent jump from the year before.

Abandoning treatment — a practice known as "non-adherence” — has serious consequences for patient health. For instance, people with hypertension who neglect their meds are more than five times more likely to experience a poor clinical outcome than those who don’t. Heart disease patients are 1.5 times more likely.

It also results in higher medical costs, as patients who go off their meds often end up in the hospital. Minor conditions that might have been controlled by inexpensive medications can sometimes balloon into life-threatening illnesses that require surgery or other costly treatments.

This makes sense. After all, a daily cholesterol-lowering drug is far less expensive than emergency heart surgery.

As Congress figures out what to do next on health care reform, private insurers can act now to control their own costs and vastly improve medical outcomes, all while making health care more affordable for average Americans. Reducing drug co-pays is the way to do it.

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A Tort Blemish

02/12/2010 07:02 AM |

A new blemish on the tort bar.

Last week, over-ruling a lower court and obvious logic, a New Jersey appeals court ruled that a trial court should reconsider allowing a so-called “expert” to testify in Palazzolo v. Hoffman La Roche, Inc, a lawsuit alleging that Accutane causes depression. The issue involves whether an expert should be allowed to offer testimony on a study that was (1) considered flawed and (2) was funded by plaintiffs and lawyers involved in the litigation.

The trial court in New Jersey ruled that Doug Bremner, an Emory University professor, should not be allowed to offer expert testimony on his “flawed study.” Now the appeals court has remanded the case to the trial court "to consider whether Bremner should be allowed to testify on causation, without reference to the study.” (The trial judge decided the study was central to his opinion and dismissed the case.)

To quote that well-known legal expert, Madonna – not!

There are two main problems, one scientific and other ethical. Problem #1 is Bremner’s reliance on PET scans to find metabolic changes in the brains of acne patients treated with Accutane (the problem being that all parties agreed that that PET scans could not diagnose depression). The second, as already mentioned, is that Bremner’s study was commissioned specifically for use in the litigation by plaintiffs and lawyers involved in the litigation.

Can you imagine the hue and cry if a pharmaceutical company had done this? Since sunshine is always the most potent disinfectant, how about a Sunshine Act for the tort bar?

To quote the English social reformer, William Ellery Channing, “It is far more important to me to preserve an unblemished conscience than to compass any object however great.”

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Bill Clinton vs Comparative Effectiveness

02/11/2010 06:52 PM |

Former Prez Bill Clinton was "admitted to the Columbia Campus of New York Presbyterian Hospital after feeling discomfort in his chest. Following a visit to his cardiologist, he underwent a procedure to place two stents in one of his coronary arteries."

By doing so Clinton and his doctors flouted the conclusion of what the WSJ's  Keith Winstein's lovingly calls "a simple concept: Study different medical treatments and figure out which delivers the best results at the cheapest cost, giving patients the most effective care."

That comparative effectiveness research.  And Winstein is the muse to those who insist that people like the former POTUS should been given old drugs for 4 months rather than having a stent procedure:

"Even before Congress took up the now-stalled health-care overhaul, it appropriated $1.1 billion to fund these studies. Both the Senate and the House included it in their versions of the bill. President Barack Obama backed it.

Yet, an examination of one of the best-known examples of a comparative-effectiveness analysis shows how complicated such a seemingly straightforward idea can get.

The study, known as "Courage" and published in the New England Journal of Medicine in 2007, shook the world of cardiology. It found that the most common heart surgery—a $15,000 procedure that unclogs arteries using a small scaffold or stent—usually yields no additional benefit when used with a cocktail of generic drugs in patients suffering from chronic chest pain.

The Courage trial was led by William Boden, a Buffalo, N.Y., cardiologist, and funded largely by the Department of Veterans Affairs. It tracked 2,287 patients for five years and found that trying drugs first, and adding stents only if chest pain persisted, didn't affect the rate of deaths and heart attacks, although stents did produce quicker pain relief."

http://online.wsj.com/article/SB10001424052748703652104574652401818092212.html?KEYWORDS=stents

Winstein notes (with regret): " Without a way to keep insurers from covering procedures that studies find ineffective, projects like Courage face an uphill climb. The health-care bills passed by the House and Senate have provisions to disseminate study results, but wouldn't require private insurers or Medicare to adjust coverage or payments to doctors in response to findings."

But what did this study really say?  And should one study shape how every doctor treats every patient? 

Winstein ignores the fact that even the COURAGE study shows that 1 in 4 patients with chest pain need a stent and drugs to survive as long as others who just received drugs.  And it ignores the fact that the  tools in the study used to identify which patients would benefit most from specific clot busting approaches and medicines -- a PET stress test and gene test for drug response -- are not widely reimbursed yet because they have not undergone the same kind of comparative effectivenesss research your article swoons over.   In otherwords,  it's ok to use new technologies to make the case not to pay doctors, but not to pay for those technologies when doctors want to use them.  That is comparative effectiveness simply put.

Even worse, when quoting Eric Topol in the article Winstein makes it seem that Topol is in favor of the one size fits all approach:

It's certainly remarkable that nothing has been done to put some checks and balances," into the stenting decision after Courage, says Eric Topol, the chief academic officer of Scripps Health, a hospital operator in San Diego. "I have a very strong disagreement with cardiologists who see no reason to do the stress test."

Winstein fails to  note what he likely knew if he interview Topol at length, that Topol is  also doing gene-testing prior to drug selection for eluting PCI and is a leader in personalized medicine in cardiology.

But that didn't fit the narrative that one study can decide what treatment is  good in all cases vs the judgment of doctors and their clinical experience. 

Good thing Clinton's doctors didn't drink the COURAGE kool-aid.   In the future it would be an act of leadership and consistency for all supporters of CER and its methods to ask their doctors to treat them according what CER studies supported by the government say.   Their could even be a health plan for such people.   Keith should be the first enrollee.



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MassCare Death Spiral Begins

02/11/2010 05:59 PM |

From Jacob Goldstein's WSJ healthblog:

By Jacob Goldstein

Now that it’s expanded health-insurance coverage to nearly all of its citizens, Massachusetts is trying to figure out what to do about the rapid rise of health costs.

The latest proposal comes from the state’s governor, Deval Patrick, who yesterday proposed a bill that would give the state the power to review — and, in some cases, reject — rate increases by doctors and hospitals.

Here’s a key paragraph from the bill:

Any contract under which provider payments increase by an amount in excess of the applicable Consumer Price Index for Medical Care Services shall be presumptively disapproved. The division may conduct a hearing on any contract that is presumptively disapproved and will approve or disapprove the contract based on its findings following the hearing.

The bill would also allow the state to prevent health-insurance plans sold to small businesses from raising premiums by more than 1.5 times the rate of medical inflation, and impose a two-year moratorium on lawmakers mandating new health benefits that plans must cover (those mandates drive up costs).

The Boston Globe said reaction “was mixed, with small business groups expressing cautious optimism, insurers saying the measures do not go far enough, and health care providers worrying that smaller hospitals could be disproportionately harmed and that some might have to lay off caregivers.”

http://blogs.wsj.com/health/2010/02/11/mass-governor-wants-to-cap-hospital-doctor-rate-increases/

Mixed?  I wonder what insurers will say when their rates are capped.  In any event,  price controls will only worsen the shortage of primary care in the Bay State and reduce the availability of services.  

Here is something else Republicans can bring up in their summit:  Government regulation of health care reduces employment and investment.. 

 

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Fabulous 50

02/11/2010 05:42 PM |

Pleased to report that the “Health Expert Blog” has named drugwonks.com to its “Top 50 Medical Ethics Blogs” list.

According to that blog:

“Medicine is fraught with ethical dilemmas. The very nature of health care, medicine and biology offer insights into humanity. Additionally, issues of medical ethics delves into the most intimate parts of our lives, focusing on our bodies — sometimes at a cellular level. The state of health care, and the technology that is coming to medicine offer new challenges to the idea of what is right and wrong. Here are 50 medical ethics blogs that can offer insight on the debate.”

We are pleased to be in such esteemed company.

The complete list can be found here.

(See, life really does begin at 50.)

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Health Care Autocrats Are Paving The Way For Their Own Demise

02/10/2010 10:09 PM |

The autocrats persist in a policy of polarization when it comes to health care..  Henry Aaron restates the elitist case that the problem with health care reform is that is hasn't been explained simply enough to we the little people and that popular will be damned Democrats should use reconciliation to ram through the existing Senate bill...

"Meanwhile, supporters have spent most of their time on seemingly endless debates with one another about specific legislative provisions — whether to include a public option in the reform legislation, whether to have a single national insurance exchange or separate state exchanges, how to enforce a mandate that everyone carry insurance and how much to spend on subsidies to make that mandate acceptable, how to enforce a mandate on all but small employers to sponsor and pay for basic coverage for their workers, and scores of other complex and bewildering technical provisions.

 Health care reformers in the administration and Congress have a powerful case to make and, on an issue of such enormous importance, a duty to make it. In addition to reminding Americans that reform will protect, not jeopardize, coverage by preventing insurance companies from canceling coverage or jacking up premiums for the sick, reform advocates should remind them that the proposed legislation will bring coverage to tens of millions of currently uninsured Americans and protect it for scores of millions of others. Reform advocates should explain the legislation’s legitimate promise of cost control and quality improvement.

President Barack Obama has announced a bipartisan meeting on moving the reform process forward. It is an opportunity for all sides to present ideas for improving the bills that already have been passed by both houses of Congress. If modifications are identified that will command the support of simple majorities in both houses, they should be adopted through reconciliation. Then the House should pass the Senate bill."

Read more here

The pursuit of health care reform is a manifestation -- indeed it is the ultimate mission of liberal elitists one on side of a culture war that James Q. Wilson characterized with regard to the national split over the Iraq war. That divide exists on healthcare. Wilson wrote of a "linkage between ideology, on the one hand, and congressional polarization, media influence, interest-group demands, and education on the other are easily read in the commentary surrounding the 2004 election. In their zeal to denigrate the president, liberals, pronounced one conservative pundit, had "gone quite around the twist." According to liberal spokesmen, conservatives with their "religious intolerance" and their determination to rewrite the Constitution had so befuddled their fellow Americans that a "great nation was felled by a poisonous nut."

If such wholesale slurs are not signs of polarization, then the word has no meaning. To a degree that we cannot precisely measure, and over issues that we cannot exactly list, polarization has seeped down into the public, where it has assumed the form of a culture war. The sociologist James Davison Hunter, who has written about this phenomenon in a mainly religious context, defines culture war as "political and social hostility rooted in different systems of moral understanding." Such conflicts, he writes, which can involve "fundamental ideas about who we are as Americans," are waged both across the religious/secular divide and within religions themselves, where those with an "orthodox" view of moral authority square off against those with a "progressive" view.

To some degree, this terminology is appropriate to today's political situation as well. We are indeed in a culture war in Mr. Hunter's sense, though I believe this war is itself but another component, or another symptom, of the larger ideological polarization that has us in its grip. Conservative thinking on political issues has religious roots, but it also has roots that are fully as secular as anything on the Left. By the same token, the liberal attack on conservatives derives in part from an explicitly "progressive" religious orientation--liberal Protestantism or Catholicism, or Reform Judaism--but in part from the same secular sources shared by many conservatives."

Wilson goes on to ask and answer:

"But what, one might ask, is wrong with having well-defined parties arguing vigorously about the issues that matter? Is it possible that polarized politics is a good thing, encouraging sharp debate and clear positions? Perhaps that is true on those issues where reasonable compromises can be devised. But there are two limits to such an arrangement.

"....many Americans believe that unbridgeable political differences have prevented leaders from addressing the problems they were elected to address. As a result, distrust of government mounts, leading to an alienation from politics altogether. The steep decline in popular approval of our national officials has many causes, but surely one of them is that ordinary voters agree among themselves more than political elites agree with each other--and the elites are far more numerous than they once were."

Read more here

The misguided effort to push through the current health care bill will deepen the divide as well as the distrust.  As Wilson notes, since they are so many elites (the so-called stakeholders and people like me who follow them with blogs, white papers and Hill briefings) the ability of government to serve as a connective tissue to public opinion is dampened.  The push for health care is leading to an outright rejection of the very politicians themselves.  But importantly it is not leading to the alienation from politics.  It is fueling an awakening. 

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Is It Harder To Stop Smoking Than To Stop Being Stupid?

02/10/2010 06:39 PM |

Smoking cessation with and without assistance: a population-based analysis.

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SPA Treatment

02/10/2010 04:58 PM |

A thoughtful and provocative piece by Matt Herper over at Forbes.

FDA Agreement Should Be Public

One of the biggest initiatives Margaret Hamburg has announced since she became head of the Food and Drug Administration is a new push to make FDA's doings more transparent to the outside world. Yesterday's bad news for Seattle-based Cell Therapeutics represents one way in which the regulator fails to  make sure investors have information they need.

Cell Therapeutics (CTI) shares  fell 40% to 60 cents  yesterday after an briefing document prepared by the FDA raised multiple problems with the company's drug, pixantrone, and the quality of the clinical trials Cell Therapeutics is using to argue for its approval as a treatment for non-Hodgkin's Lymphoma. The biggest shocker, though, related to an agreement called a "special protocol assessment" which the company had told investors it had but which the FDA now says is no longer valid.

Special protocol assesments, or SPAs, are important for every drug company, from the tiniest fleaspeck biotechnology company all the way up to Pfizer. They are agreements between a company and the FDA that a clinical trial, if conducted as planned and successful, should produce enough data for a drug to be approved. This reassures companies that they are not going to pour $40 million into a late-stage study only to have the FDA say it did the wrong trial. SPAs also ease investor fears, helping smaller companies raise money.

Unfortunately, they are treated by FDA as confidential communications between the agency and companies. What is said to investors about the SPA is entirely up the the company. Between March 28, 2008, and September 16 2009, CTI reference the SPA in five press releases. But in the briefing documents released yesterday, the FDA stated: "On March 28, 2008, CTI notified the FDA of an early halt to enrollment for PIX301. The study was not stopped at a planned interim analysis and early study stopping invalidated the applicant’s Special Protocol Assessment." A CTI spokesman did not comment when asked why investors were not informed of this change.

This is not the first time this sort of thing has happened. In 2008, it was revealed at an FDA advisory committee meeting that GPC Biotech had misrepresented the SPA for its prostate cancer drug, causing shares to drop 60% in a day.

It might take an act of Congress to allow the FDA to make SPAs public, but that should happen. This would increase their value to biotechnology firms who are trying to raise money and prevent run-of-the-mill stock buyers from getting fleeced.

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Liberal Condescension On Display

02/09/2010 03:27 PM |

EJ Dionne the doyen of liberal lecturing down to the masses explains -- through a charming parable told to him by a member of Congress -- why it is ok for Democrats to ram through the current health bill --  Cornhusker kickback and all:  because we the dumb schmucks are too stupid to understand what's good for us until it is put in front of us in the fashion liberals have established:

"On health care: 'Finish the kitchen'
By E.J. Dionne Jr.
Monday, February 8, 2010; A15

If President Obama gets to sign a health-reform bill, as I believe he will, one reason may be Rep. Jay Inslee's difficult experience renovating his kitchen.

He told his kitchen story at a House Democratic caucus after Republican Scott Brown's victory in Massachusetts sent Inslee's colleagues into paroxysms of dismay, chaos and fear. Brown's triumph reduced the Democrats' majority in the Senate to "only" 59, and this led many in both houses to want to give up on health reform altogether. Even Obama was sounding an uncertain trumpet.

This made no sense to Inslee, a Democrat from Washington state. First elected to the House in 1992, he was swept out of office in the 1994 Republican landslide that followed the collapse of Bill Clinton's health-care efforts. Four years later, Inslee returned to Congress.

"I introduced myself as a fella who was defeated in 1994, the last time we didn't pass meaningful health-care reform," Inslee recalls saying. "I said it was a painful event, and I didn't want them to go through that pain." In politics, he told his colleagues, assuming the "fetal position" can be the most dangerous thing to do.

And then he recounted all the grief he and his family went through while work on their kitchen renovation dragged on and on and on. "During that time, I had blood lust against my contractor," Inslee said. "Six months went by, and he was still arguing with the plumber. Eight months went by, and there were still wires hanging down everywhere, and he was having trouble with the building inspector."

But eventually, the job got done. "And now I love that kitchen," Inslee recalls saying. "I bake bread in that kitchen. My wife cooks great meals in that kitchen. The contractor's now a buddy of mine, and I've had beers with him in that kitchen."

Inslee looked at his colleagues and declared: "We've got to finish the kitchen." His point was that Americans won't experience any of the benefits of health-care reform until Congress puts a new system in place.

I called Inslee about his kitchen oration after Rep. David Wu (D-Ore.) told me it was one of the turning points in calming Democrats' nerves. "Now," Wu says, "people run into him in the hallway, smile and say, 'Finish the kitchen.' "


Dionne is in LOVE with this analogy... I hope he and his fellow autocrats continue to spread the message. 

Here's how is condescending disregard for the public sounds to the rest of us simple folk:

"Some paradox of our natures leads us, when once we have made our fellow men the objects of our enlightened interest, to go on to make them the objects of our pity, then of our wisdom, ultimately of our coercion. "   Lionel Trilling, The LIberal Imagination (1950)

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Forget the TV Summit: Obamacare is Being Implemented

02/09/2010 10:26 AM |

Through AHRQ and Medicare (and with the explicit editorial support of the NEJM) CER is being used to slow down the development and access to new medical technologies without regard to or understanding about the impact to individuals.   CER or HTA is the operating system of Obamacare.  And as I noted in my previous blogs, AHRQ has more money to slow down the use of new technologies than FDA's Center for Drug Evaluation and Research has for review new products. 

Apart from the dangerous and bizaare indulgence of the whims of anti-vaccine and anti-science groups, AHRQ's role in developing studies and evidence standards for use of personalized medicine, targeted therapies, nanotechnology, drug/diagnostic combinations, etc.. (studies conducted by a small group of organizations that include those controlled by HMOs who also control the funding decisons made by AHRQ) for HMOs, Medicare, Medicaid, etc will impose significant costs on innovation and well-being.  

Most recently the FDA approved the use of Crestor as a preventive treatment for heart disease using hsCRP tests to identify those specific patients who might benefit.  Clearly a step towards targeted and prudent use of statins.  Women were found to benefit more than men from early intervention.  Yet ARHQ's recommendation to the US Preventive Services Task Force was to NOT use hsCRP tests in primary care settings until there were more randomized trials..  

Continuing to impose the barrier of randomized trials on all new individualized technologies is tantamount to creating Jim Crow laws for personalized medicine.  And indeed, the impact of using expensive randomized trials to test everything new will be to make fewer new things available without knowing which are valuable to who.  

Which is the point of bending the curve:  slowing consumption of new technologies across the board to free up money for bigger entitlements.  Unfortunately,  the use of older and cheaper more often does not translate into better health and lower costs.  

Republicans and Democrats who truly want a serious American effort to improve health care should shun the White House offer of media exposure and concentrate on getting better information on what my colleague Peter Pitts calls the four health care rights of the 21st century:  the right medicine for the right person for the right reason at the right time.   Such rights increase wellbeing and improve value.   Scrapping AHRQ's agenda and conflicted approach to pursuing it is the first step in that healthy direction
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ARSI Coda

02/08/2010 08:32 AM |

Over a billion dollars for CER @ AHRQ ... but only $25 million to advance FDA's regulatory science. 

The Pink Sheet Reports:

Gaining the expertise and infrastructure needed to assess products of the future - such as biosimilars and those based on stem cells and nanotechnology - is the goal of a $25 million scientific modernization effort proposed in the fiscal 2011 FDA budget.

The Advancing Regulatory Science Initiative (ARSI) is a cross-center program whose ultimate objective is to provide FDA scientists with the skills to evaluate the safety, effectiveness and quality of products developed with new and emerging technologies, as well as give industry the standards by which such products will be judged.

The agency bills the initiative as the first major effort to address a 2007 FDA Science Board report that cited FDA's inability to keep up with scientific advances, such as those in biology and bioinformatics.

The Center for Drug Evaluation and Research plans to "establish regulatory guidance to provide a scientifically sound and safe pathway to better characterize and develop biosimilars," the agency says in supporting documentation for its budget.

ARSI, which FDA characterizes as a new program and an increase in budget authority, provides $2 million for the biosimilar effort. Another $3.7 million in carry-over balances from user fees will be used for the program.

As part of a $15.55 million increase for infrastructure, workforce and collaboration, ARSI includes money to prepare for reviewing products that utilize stem cells and nanotechnology.

With the removal in 2009 of the ban on federal funding for embryonic stem cell research, FDA "anticipates a significant increase in investigational new drug applications and biologics license applications for stem cell products during the next few years," the agency says.

In anticipation of that, ARSI gives the Center for Biologics Evaluation and Research $950,000 and five full-time equivalents to prepare for reviewing stem cell products (i.e., a therapy comprised of, or derived from, human cells, tissues or cellular or tissue-based products, and gene therapy products) as novel biologic therapies.

The FY '11 funds will allow CBER to develop and communicate guidance that provides agency expectations for pre-clinical studies, clinical trial design and regulatory policy. CBER also will work with the scientific community to develop analytic tests for characterizing stem cell products.

The largest chunk of ARSI is $7.3 million for nanotechnology regulatory science across the agency. CBER and CDER each will receive $475,000 and one FTE to participate in the effort.

The intent is to build laboratory testing capacity, develop and train staff in nanotechnology and conduct research into the character and safety of products. The latter will help FDA scientists as they review the benefits and risks of products, such as drugs delivered by nanoparticles to cancer cells.

Included in ARSI is a $4.45 million increase in funding for the Critical Path Initiative. The money will enable FDA to launch new projects for validating biomarkers, modernize and increase the efficiency of clinical trials; improve tools to predict product safety and effectiveness, including the use of information technology; and modernize toxicology studies.

FDA's documents do not provide a baseline figure for CPI, but includes it under the Office of the Chief Scientist (OCS), which is budgeted at a total of $29.59 million. Funding for CPI in the current fiscal year is $16 million.

The money also will enable OCS to staff the Office of Science and Innovation, which is being set up to serve as a core resource of scientific expertise in emerging areas. OSI was created in a reorganization implemented by Commissioner Margaret Hamburg in mid-2009 to improve the agency's scientific capabilities.

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