Finally -- real health reform legislation

06/30/2010 08:48 AM |

Bravo.

Medicare and Medicaid patients with a chronic condition will be able to review all their medications in one-on-one sessions with pharmacists under a bill introduced Tuesday by Sen. Kay Hagan (D-N.C.). The Medication Therapy Management (MTM) Expanded Benefits Act would also reimburse pharmacists to follow up and educate patients about their medication regimen.

"This bill will allow seniors with one chronic condition, such as diabetes or heart disease, to bring all of their medications to the pharmacy and ensure they are following doctor's orders," Hagan said in a statement. "If more seniors properly follow their medication regimens, we can save lives and Medicare dollars."

Currently 12.9 percent of seniors in the Medicare prescription drug program — all of whom have multiple chronic illnesses — are eligible to participate in MTM programs. Hagan's bill would allow seniors with only one chronic illness to participate in the program at pharmacies, hospitals and other entities that distribute pharmaceutical drugs and provide MTM services.

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AHRQ Angel

06/30/2010 08:42 AM |

Wither comparative effectiveness?

"We are now right on the cusp of an era where we can get all the data we want," but getting the research methods and analytics right "is going to be quite critical," said Carolyn Clancy, director of the Agency for Healthcare Research and Quality.

But data, as the saying goes, is like a bikini – what it shows you is interesting, but what it conceals is essential.

Clancy believes (and appropriately so) that data could help, say, a newly diagnosed cancer patient  who wants to know, "What happens to people like me if I choose this path, that path or another path?"

They don’t call it the Critical Path for nothing.

Clancy: "Increasingly we're seeing in legislation the opportunity to inform policy with science, but the details really matter in getting it right."

Indeed.  And those details need to lead us towards the “four rights” – the right medicine in the right dose at the right time for the right patient.

And that’s not comparative effectiveness – that’s clinical effectiveness.

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For self-inflicted wounds, press 6

06/29/2010 07:48 AM |

Canada’s solution to ever-longer hospital queues: “Technowait” -- a program that allows patients to register at the front desk, then through a phone line, check in periodically to determine when the doctor is “really” ready to see them.

Is this about improving wait times or improving the quality of wait times?

Alas – the latter. 

According to a story in the Toronto Star, “In the most general sense, it improves the relationship between care providers and patients … Even patients without kids can go back to work or rest at home if they are feeling unwell. They can go to a restaurant or to the mall. They don’t have to feel trapped and fearful that they will lose their place in line.”

The complete Toronto Star can be found here.

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Much Ado About Avandia

06/28/2010 02:55 PM |

You can stop reading the JAMA article about the dire risks of Avandia when you come to this seemingly innocuous line:

"Several unplanned, post hoc analyses were performed to evaluate the failure of some Cox proportional hazards models to meet the proportional hazards assumption. These unplanned analyses included those restricted to patients who entered the study before or after publication of a widely publicized meta-analysis of rosiglitazone randomized trials on May 21, 2007,¹ and partitioning of follow-up time into intervals of 0 through 2 months, more than 2 through 4 months, and more than 4 months."

Read the full JAMA article here.

Translation:

"Post-hoc analysis, in the context of design and analysis of experiments, refers to looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is sometimes called by critics data dredging to evoke the sense that the more one looks the more likely something will be found. More subtly, each time a pattern in the data is considered, a statistical test is effectively performed. This greatly inflates the total number of statistical tests and necessitates the use of multiple testing procedures to compensate. However, this is difficult to do precisely and in fact most results of post-hoc analyses are reported as they are with unadjusted p-values. These p-values must be interpreted in light of the fact that they are a small and selected subset of a potentially large group of p-values. Results of post-hoc analysis should be explicitly labeled as such in reports and publications to avoid misleading readers.

In practice, post-hoc analysis is usually concerned with finding patterns in subgroups of the sample."

In other words,  Graham, et. al. tortured the data to get it to say what it wanted.  And even then it found a slightly elevated risk for those on Avandia over a year period, a difference so slight that it could be easily explained by, say, severity of illness or blood sugar levels, neither of which Graham and company cared to measure.

What they did do was, after discovering no difference in risk, a post hoc subgroup analysis to find risk.  That's cheating by their own admission since in the entire group they studied their were only 15,000 people on Avandia compared to 100,000 or so on Actos.   But they still subdivided the two groups into two smaller groups (2-4 months on each drug and 4-6 months) and finally found what they claimed were "significant differences" in hazard ratios but only in composite scores.. And even then it was a difference of 20 percent or so.   Not really statistically significant.   Hey, why not test in between trips to  the bathroom?  It would be more fitting giving the quality of the research. 

I can't believe JAMA published this nonsense with an accompanying editorial warning against use of Avandia instead of an editorial tearing about the questionable data mining.  

My guess is the FDA will see right through the charade.  

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No Such Thing As A Perfect Drug

06/28/2010 10:31 AM |

An excellent piece in The Boston Globe by VC Chris Westphal about the hyperventilation about drug safety absent a science-based discussion of benefits...

http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/06/28/the_myth_of_the_perfect_drug/
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www.badplanemeal.gov

06/28/2010 09:56 AM |

FDA report reveals airline food could pose health threat:

http://www.usatoday.com/travel/flights/2010-06-28-1Aairlinefood28_ST_N.htm

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Make Mine a Double

06/28/2010 08:03 AM |

As the saying goes, "A joy that's shared is a joy made double."  And that may now be the case via more coordinated FDA and CMS actions. 

A June 23 memorandum of understanding on data sharing (signed by FDA Commissioner Peggy Hamburg and CMS Acting Administrator Marilyn Tavenner), could serve as a first step toward parallel reviews by FDA and CMS. CDRH Health Director Jeff Shuren announced the pact at a June 24 public workshop on device innovation.

The memorandum "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions," commented Shuren.

As part of the new effort, the two agencies are "seriously exploring the ability to start, at a manufacturer's request, a Medicare national coverage determination process while the medical device is still under pre-market review at FDA," for example, Shuren explained at the meeting. "Such an approach could reduce the time from FDA approval to CMS coverage and payment for some devices."

He also noted that the agencies may eventually consider defining certain circumstances when an FDA determination on safety and effectiveness is adequate for CMS to pay for a new technology "without additional evidence."

Shuren stressed, however, that only expanded information sharing has been agreed upon at this point. Parallel review is "not a done deal," he said

CMS' coverage-with-evidence-development policies, for instance, could help with FDA post-market data collection, he explained. FDA is already exploring use of Medicare claims data as a post-market surveillance tool as part of its Sentinel initiative.

Some worry about the potential for trade secret data held by FDA to seep out if it is shared with CMS, since the latter agency does not have the same statutory obligations for confidentiality. But Shuren stressed that if the agencies move forward with parallel reviews, such reviews would be voluntary and it would be up to the sponsor to initiate the process.  Read More & Comment...

Failure is not an option -- almost

06/25/2010 09:23 AM |

In California, failure is not an option -- almost.

Pending legislation AB 1826, which prohibits “fail first” practices by insurers, has been steadily moving through the California Assembly and will go for a vote in the Health Committee on Wednesday, June 30.

According to the legislative language, “This bill would require a health care service plan or contracts and health insurer covering insurance policies that cover outpatient prescription drug benefits to provide coverage for a drug that has been prescribed for the treatment of pain without first requiring and would prohibit those contracts and policies from requiring the subscriber, enrollee, or insured to first use another drug or product as specified.”

CMS has already issued a 2010 Call Letter to limit step therapy in health plans for Medicare patients.

AB 1826 will help physicians do what they do best practice the art and science of medicine.

The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.

As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted, "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

In California -- indeed across the entire United States -- access to care must be matched with quality of care.

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What's the best place in Dallas to eat crow?

06/24/2010 04:17 PM |

Update on AHA Scientific Sessions Regarding ACCME Discussions

DALLAS, June 23, 2010 –The AHA has long believed in the integrity of science that is rigorously peer reviewed by content experts, and is absolutely independent in the positioning and delivery of its content. As noted in the ACCME statement of 6/23/10, in which they stated their belief in the value of constructive debate and input about their policies and all issues related to managing conflict of interest in accredited CME, the ACCME is committed to setting fair and reasonable standards that support education about scientific research and developments, while ensuring that accredited CME is independent and free of commercial influence. During in-depth discussions with the AHA, and after thoughtful deliberation, the ACCME agreed that AHA’s extensive internal controls assure independence, and are appropriate for CME accreditation for a scientific meeting.

Thus, there will be no variance from past Scientific Sessions and CME will be available for all presentations within the scientific program. This will insure that the flow of science will remain unfettered as it always has been and as would be in keeping with the mission of the AHA.

For those submissions that were withheld, we will reopen abstract submissions shortly and enter the newly submitted material into our ongoing peer review process.

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COI Polloi in Gray

06/24/2010 10:09 AM |

There’s an article in today’s edition of the New York Times headlined “Debate Over Industry Role in Educating Doctors.” 

Yes – there is a debate.  And it’s an important one.  But the article doesn’t report on the debate – it takes a stance.  Consider the first 17 words of the reportage:

 “In the latest effort to break up the often cozy relationship between doctors and the medical industry …”

That’s not an article – that’s an editorial.

The article throws around a lot of big numbers.  For example;

“Continuing medical education has become a big business in the United States, with more than 700 accredited providers. Total spending on such courses peaked at $2.5 billion in 2007, including a record $1.2 billion paid by companies, according to the Accreditation Council for Continuing Medical Education, a nonprofit regulatory group.”

But these are numbers out of context.  Statistics, as the saying goes, is like a bikini – what it shows you is interesting but what it conceals is essential.  Here’s a statistic mysteriously absent from the Times story: 42 percent of CME activities have no industry support at all. Two-thirds of providers get less than 10 percent of their total revenue from drug and device companies.

Citation for that last bit of information – ACCME.

Selective reporting of the facts is unworthy of our national newspaper of record.  As my grandmother used to say, “A half-truth is a whole lie.”

The complete New York Times article can be found here.

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Commonwealth's Latest Work of Fiction

06/24/2010 08:45 AM |

 Commonwealth comes to it's usually conclusion...

U.S. scores dead last again in healthcare study

Wed Jun 23, 2010

A patient waits in the hallway for a room to open up in the emergency room at a hospital in Houston, Texas, July 27, 2009.

Credit: Reuters/Jessica Rinaldi

WASHINGTON (Reuters) - Americans spend twice as much as residents of other developed countries on healthcare, but get lower quality, less efficiency and have the least equitable system, according to a report released on Wednesday.

How could the media allow the bogus, made to order, results of the Commonwealth Funds survey of health systems remain unexamined? Laziness, bias and just too busy? Here is the gist of the study:

The report looks at five measures of healthcare -- quality, efficiency, access to care, equity and the ability to lead long, healthy, productive lives. Britain, whose nationalized healthcare system was widely derided by opponents of U.S. healthcare reform, ranks first in quality while the Netherlands ranked first overall on all scores, the Commonwealth team found.

 

U.S. patients with chronic conditions were the most likely to say they gotten the wrong drug or had to wait to learn of abnormal test results.

 

"The findings demonstrate the need to quickly implement provisions in the new health reform law," the report reads.

 

Critics of reports that show Europeans or Australians are healthier than Americans point to the U.S. lifestyle as a bigger factor than healthcare. Americans have higher rates of obesity than other developed countries, for instance.

 

"On the other hand, the other countries have higher rates of smoking," Davis countered. And Germany, for instance, has a much older population more prone to chronic disease.

 

Some thoughts:

 

It is easy in any health system to find people who are happy with their health care, in Europe particularly.  That permits Commonwealth from avoiding the real analytical work or confronting the reality that Britain’s NHS has severe structural problems or, that despite the market-based reforms Netherlands has instituted (oops, Commonwealth ignores that) significant health disparities between urban and rural, rich and poor, immigrants and citizens persist.   The British medical journals and media are awash with studies showing that disparities are widening.  Sir Michael Rawlins of NICE told me as much last year.   Somehow, somewhere Commonwealth Foundation the 200 people in Britain who think the NHS is great. Maybe Karen Davis just interview Donald Berwick 200 times. 

 

Of course the findings lead to the conclusion that Obamacare should be adopted.  This is the same organization that claimed comparative effectiveness research based on the Dartmouth Atlas would save over a trillion dollars between 2010-2020.    It’s easy if you use survey data instead of carefully designed studies that rely on data sets, including biomarkers, that permit reliable international comparisons over a period of time.   Such as five year survival rates for various forms of cancer by stage,  treatment for asthma,  access to psychiatric care (mental illness is the fastest growing disease), ability for people over 65 to live without disabilities, etc. access to new treatments.    If you don’t do serious research and the media just laps up your claims and findings uncritically you can say anything you want.

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Putney says the FDA girl has got to have soul!

06/23/2010 09:36 AM |

Pursuant to yesterday's discussion of the HHS IG's report on FDA's oversight of non-US based clinical trials, some commentary from Leslie Ball, director, division of scientific investigations, Office of Compliance, FDA Center for Drug Evaluation and Research:

"As a consequence of that report, I think we will be looking, internally, at the quality of data a little bit more critically that's conducted outside the U.S. ...That might result in some additional analysis and soul-searching about whether or not requirements need to be put in place."

A new site-selection model already is under development that will move the agency to a more risk-based approach to determine which sponsors will be inspected, Ball said.

The factors that could trigger an inspection include the drug application and trial design, or site-specific risk attributes like enrollment and drop-out rate. FDA Principal Deputy Commissioner Joshua Sharfstein said in his response to the report geography also is a risk parameter in the formula.

"We are expecting that to be a little more complex," she said. "We also want to say that just when the regulated community figures out what our risk algorithm is, we will change it. So don't get too comfortable."

FDA also already is looking to expand its partnerships with other regulators, as was recommended in the report to maximize its resources. A pilot program with the European Medicines Agency to conduct joint inspections and share other information, if successful, could lead to more collaborations with other foreign regulators.

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Cynical Trials

06/22/2010 10:59 AM |

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When is a REMS not a REMS?

06/21/2010 10:31 AM |

When it's a medguide ... maybe.

FDA is searching for a way out of imposing a REMS when only a medication guide is required.

According to John Jenikns, director of the Office of New Drugs (and the best dressed man at the FDA), having to develop and then assess the impact of medication guides as part of the REMS program is a burdensome administrative task for the agency, as well as for sponsors and pharmacies and society at large.

"We are looking to try and be creative in how we interpret that part of the statute, so stay tuned to see if we're able to find some creative ways around this," he said.

In the meantime, medguides remain a component of a REMS and "until we work through this further, there are a lot of medication guide-only REMS - a lot of burden on us, a lot of burden on you - that we'd like to try to get out of."

As of June 3, FDA had listed 123 REMS on its website. Eighty-four consist only of a MedGuide, while another 25 involve a medguide and communication plan. The other 14 REMS require sponsors to adopt elements to ensure safe use. Five of those also involve a MedGuide; three also have a communication plan; and the other six also require both a MedGuide and a communication plan.

If FDA does not find a solution it can implement itself, the next reauthorization of the Prescription Drug User Fee Act in 2012 offers an opportunity for legislative change. Industry and other stakeholders already have cited REMS as an area for focus during PDUFA V.

(And, hopefully, that's "V" like in "victory.")

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New York Times Exposes Dartmouth Doubletalk, Undermining Don in the Process

06/20/2010 10:03 AM |

http://www.nytimes.com/2010/06/19/business/19dartmouth.html

The NY Times rejoinder to Elliot Fisher is devastating and could have been even more complete if Reed Abelson and Gardiner Harris had not pulled their punches on such aspects of the Dartmouth empire as it's deep involvement in and financial dependency on Health Dialog...

It also raises the stakes on the Berwick nomination since Berwick's love and faith in Dartmouth is well known and has been reciprocated.  From an earlier NPR report"

ROVNER: So at first glance, the person President Obama has chosen, Donald Berwick, seems an unlikely candidate. He's a mild-mannered pediatrician and Harvard Medical School professor. But Dartmouth health policy researcher Elliot Fisher, who's worked with Berwick for years, says he's the perfect choice to implement some of the most sweeping changes to the nation's health care system in generations.

Dr. ELLIOT FISHER (Researcher, Dartmouth Health Policy): Don Berwick is a visionary leader who not only understands health care, but also understands and has shown that he can help physicians, nurses and hospital leaders work together to improve the care that patients receive.

www.npr.org/templates/story/story.php

I can't wait to see how Maggie (too many cancer drugs) Mahar tries to defend Berwick, Dartmouth, et al now.  And how come Maggie hasn't addressed the Health Dialog connection?  Why is money driven medicine wrong when it's doctors and drug companies but not when it's Dartmouth?

I smell hypocrisy and an unwillingess to respond to this important question. 
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Doctor in the Senate

06/18/2010 09:29 AM |

Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.

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NICE Decision on Tarceva: Show Me The Marker

06/17/2010 09:26 AM |

Anyone who follows this site knows I am not a fan of using CER to make coverage decisions and that NICE in general is not a model for any  health system.  However the NICE decision not to recommend Tarceva as maintenance therapy for non-small cell lung cancer, while still framed in terms of quality adjusted life years is really about biomarkers.

Once you get past the wonk talk about Markov estimates and parametric projection models the key considerations were the following:

"no data for the stable disease subgroup were provided to allow separate consideration of the use of erlotinib in squamous and non-squamous disease. Furthermore, no evidence was provided comparing erlotinib with pemetrexed in patients with non-squamous disease who have stable disease after first-line treatment."

And,

"The Committee discussed whether the SATURN study could be generalised to UK clinical practice and noted that there were few UK patients and a high proportion of patients from Southeast Asia in the study. The Committee noted a comment from the ERG that Asian people are known to respond better to lung cancer treatments than other races. The Committee heard from the clinical specialists that there are no significant reasons why the relative benefit of erlotinib in the SATURN trial would not also be seen in the UK population."

And

"It also heard from clinical specialists that patients with EGFR mutations have a longer natural history of disease and a better prognosis than other patients with non-small-cell lung cancer. The clinical specialists also commented that the small proportion of patients with EGFR mutations in the SATURN trial would be similar to the UK population. The Committee noted that no one in the SATURN trial had received first-line treatment with pemetrexed and cisplatin, which is now becoming a commonly used combination chemotherapy regimen for patients with non-squamous disease. It therefore concluded that there was uncertainty about the clinical benefit of erlotinib in patients who had previously received pemetrexed and cisplatin."

Do I think Tarceva should not have been approved.  No.  Because it would make more sense to allow  reimbursement, encourage biomarker development and contribute to personalized medicine. 

But the NICE consultation process reveals a deeper appreciation of the role of biomarkers in evaluating treatment effectiveness than the current bone headed approach being funded by AHRQ.  
www.nice.org.uk/guidance/index.jsp

effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/
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The Nadir of ACCME

06/17/2010 09:02 AM |

Once more into the abyss.

The Accreditation Council for Continuing Medical Education (ACCME), the national body that accredits medical education courses has decided that physicians and researchers who work inside the pharmaceutical industry will not be allowed to make medical education presentations at medical meetings.

That effectively means that America’s physicians will not be able to be instructed by many of the best and the brightest.

And this is where nomenclature becomes important. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.”  And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it. When it comes to “transparency,” we need to weigh “interest versus benefit." Just like with drugs and devices, we must consider the “safe use” of transparency.

But transparency is no longer good enough for the ACCME – now they want purity – whatever that means.

When is a conflict not a conflict?  The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.

Who’s pure and who isn’t?  Here’s the answer – nobody is 100% pure.  Not even Ivory Soap is 100% pure – and it floats!

In the February 7^th edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst.  Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.

Horton’s main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism."  It's what's in the best interest of the patient.

The new dictate by the ACCME is the COI polloi out of control.  Consider the comments of healthcare icon and NIH director Francis Collins:

"It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector.” 

Big Pharma hires the best.  And now America’s physicians are being denied their counsel.

Do we really want to build the foundation of 21^st century CME on the second best and the almost brightest?

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Express Yourself

06/16/2010 08:32 AM |

Interesting story in yesterday’s edition of the St. Louis Post-Dispatch about Express Scripts and its president, George Paz (who is referred to in the article as a “former accountant").

Mr. Paz -- “The cheapest drugs is (sic) where we make our profits.” To that end, the article points out that in 2008, “Express Scripts agreed to pay $9.3 million to 28 states and $200,000 in reimbursement to consumers to settle lawsuits that accused the company of deceptive business practices in allegedly overstating the economic benefits to consumers of switching to certain drugs.”

And yet:

“Express Scripts would like to extend its influence further. Plans are in the works to put information kiosks in doctor's offices to advise patients about cheaper alternatives to brand-name drugs.”

Not “better.”  Not “more effective.”  Not “safer.” “Cheaper.”  Can you imagine what would happen if a pharmaceutical company wanted to try something like this?  Can you say “congressional investigation?”

And just who is “cheaper” better for?

"Our whole model is switching people to lower-cost drugs," Paz said. "The more money my shareholders make, the more money I make."

(According to the Post-Dispatch article, Mr. Paz’s compensation, including bonuses and other incentives, totaled $10.6 million in 2009.)

This is sadly reminiscent of the Blue Care Network of Michigan program (now discontinued) that sent letters out to their participating primary care physicians offering a $100 payment “for each member in their panel with a BCN pharmacy benefit who fills a prescription for a generic lipid lowering agent.”

Per an ABC News investigative report, “Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.” In other words, we’ll pay you $100 to switch your patient to a generic statin that isn’t even a generic version of what they are currently taking.

When asked by the ABC reporter if patients knew their doctors were receiving payments from the insurance company in return for a service that helps to increase the profits of the insurance company, the response from BCN was “not specifically.”

A study fielded by the National Consumers League demonstrated that switching a patient to a generic medicine doesn’t always result in positive outcomes:

• 15% of general Rx users saying that they or a family member experienced therapeutic substitution

–        Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.

–        More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.

–        Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.

Just as no two patients have the same biochemistry, no two medicines are exactly equivalent.  But if your primary goal is to reduce short-term costs, that's an inconvenient truth.

The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.

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Does Personalized Medicine Mean Faster Approvals?

06/15/2010 10:27 PM |

Peggy Hamburg and Francis Collins co-authored an article entitled "The Path to Personalized Medicine" which was published in today's NEJM

http://content.nejm.org/cgi/content/full/NEJMp1006304?query=OF

The key paragraph is:

"The challenge is to deliver the benefits of this work to patients. As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time."

Sadly not everyone shares their commitment.  There are those in the agencies both of them lead who oppose their vision.  I know since I have met and heard them speak.  One of them -- from the NIH -- called the ALLHAT study the "gold standard" of evidence-based medicine.  Must have received his MD from the Rosa Delauro School of Biomarker Science (Merrill Goozner, Dean of Academic Research). 

At the same time, personalized medicine does not automatically translate into faster approvals.  It would be easy to chalk this up to agency risk aversion across the board.  Rather, I think it is more a matter of over time that the regulatory system has been able to become bloated and expensive because the way health care technologies have been paid for allowed both industry and government to pass the cost of oversight on to consumers, inefficiencies and all.  Is the process of developing new medicines risky and expensive?  You bet it is.  But could it be less so and could industry made or demanded more efficiencies in product cycles and manufacturing?  Absolutely.   And will more of the fate and future of a produce be determined in the market rather than in the clinical period.  That will be true as well.  Especially when in comes to finding new uses based on the same pathways in different diseases or disease sites.

So faster approvals will still matter, but faster adoption or approvals for new uses will likely matter more.  Which means getting to "no" faster in the early stages of development and finding multiple uses in the real world.  And both will depend on personalized medicine as defined by Drs. Hamburg and Collins.  

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