According to a new study in Health Affairs, more than half of the 354 million doctor visits made each year for acute medical care, like for fevers, stomachaches and coughs, are not with a patient’s primary physician, and that more than a quarter take place in hospital emergency rooms.

The authors of the study pose a significant question about what we’re calling “healthcare reform” --  how can access to primary care be improved when an already stressed system with a dearth of primary care physicians takes on millions of new patients?

More than half of acute care visits made by patients without health insurance were to emergency rooms. That poses a heavy workload and financial burden on the system and means that basic care is provided in an expensive setting.

According to Dr. Stephen R. Pitts (no relation), the lead author and an associate professor of emergency medicine at Emory University, “More and more patients regard the emergency room as an acceptable or even proper place to go when they get sick.”

The study can be found here.

In theory, the new federal law is designed to enhance primary care by increasing reimbursement for practitioners, luring students into the field with incentives.

The real-world reality is, as we know, quite different.  I recently went to my Upper West Side Jewish GP (just to give you an idea of the non-Tea Party demographic).  She asked me, “So, how bad is it?”  When I asked what she was referring to she said, “This new health care law – for me.”  The concept that you can improve primary care by (1) restricting the independence a physician has to practice both the art and the science of medicine and (2) sending very mixed signals about the inevitability of a permanent “doc fix,” (3) increasing case loads, and (4) doing absolutely nothing about tort reform – certainly makes a dubious case for “luring students into the field,” let alone keeping those already in place in practice.

The authors issue a critical warning, “If history is any guide, things might not go as planned.”

And those who do not learn from history ...

And speaking of tort reform, another article in Health Affairs illuminates addresses the issue head on.

The paper by three Harvard professors and a colleague at the University of Melbourne in Australia estimates that the medical-liability system added $55.6 billion to the cost of American medicine in 2008, equal to 2.4 percent of total health spending.

More than 8 of every 10 of those dollars — $45.6 billion — was attributed to defensive medicine by physicians who order unnecessary tests and procedures to protect themselves from malpractice claims. Not decimal dust.

That study can be found here.

Attention must be paid.  Whoever has the gavel for the 112^th Congress has a lot of work to do.

Can consumers really understand what clinical trials have to say about comparative risk and benefit?  And what are the rammifications?

The FDA is studying whether/how to add comparative and numeric information describing benefit and risk data to the brief summary in direct-to-consumer print advertising.

The agency is looking at various presentations of quantitative and qualitative information in a boxed format and determine how consumers perceive drug efficacy and risk as well as measure their understanding of the benefit and risk information.

FDA's summary of the study proposal notes that evidence indicates formatting can impact consumer comprehension of information, and using bullet points or section headings can make the information more readable.

"It is not known whether simply adding efficacy rate information to a consumer-friendly brief summary would be sufficient to enable consumers to understand a product's efficacy, or whether qualitative summations are necessary as well," the agency said in the Federal Register.

Well – duh.  No news there.  All of this is pursuant to the media-friendly (but poorly designed) Dartmouth University study.

One thing that requires no additional study is, shall we politely say, the relative user-unfriendly nature of the current brief summary.  The joke inside the FDA (if a joke it can be called) is that the brief summary is like the Holy Roman Empire – neither brief nor a summary.

Nor of tremendous utility.

According to the FDA’s 2002 study, 65 percent of doctors believed that the DTC ads their patients saw confused them about the relative risks and benefits of prescription drugs—and that is a problem. In a 1999 FDA study, 56 percent of patients who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73 percent—an increase of seventeen percentage points. During that same three-year span, those saying they read “almost all” or “all” fell from 26 percent to 16 percent— these ten percentage points are not decimal dust by any stretch of the imagination.

In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.

For more on why the current long format brief summary doesn’t work see this article from Health Affairs.

As to the idea of a risk “window” – it’s already part of the FDA lexicon (see the January 2004 draft guidance on alternative presentations of the brief summary).

For more on that topic (as well as the variable nature of consumer comprehension and alternate solutions) see this paper from the Drug Information Journal.

In otherwords,  the drug is safe and effective as prescribed for the vast majority of patients but since we never know if everyone who gets it will learn about their risk of heart disease we should take the medicine off the market. 

Is it possible that the NEJM thinks doctors who are prescribing Meridia are too stupid or uninterested in potential medical malpractice suits to determine if someone might be at risk?  I don’t think so.  If every medicine that carries a CV risk was yanked from the market for that reason, you would have to take hundreds of drugs out of commission, including every pain killer.      The editorial's authors also assert that "the heart risk associated with Meridia is not justified by the weight loss seen in the study -- about 9.5 pounds (or 4.5 percent of initial body weight) after one year, on average," CNN /Health.com (9/2, Harding) reports.

And of course Steve Nissen has an informed judgment on the issue..

Steve Nissen, MD, "a cardiologist at the Cleveland Clinic Foundation who has been a vocal critic of recent FDA handling of drug safety concerns, agrees," according to Time (9/2, Park). "We've got a drug here that shows little benefit -- a few pounds of weight loss -- and we trade that for a 28% increased risk of heart attack and 36% increased risk of stroke."

Actually the study concluded: "nonfatal heart attacks occurred in 4.1% of sibutramine users and 3.2% of the placebo group, and nonfatal strokes occurred in 2.6% of sibutramine users and 1.9% of the placebo group,"  

That’s actually a relative risk of 22 percent and 27 percent – or increase in risk of about 1 in 100000 --  but who’s counting? 

 http://www.diahome.org/DIAHome/Home.aspx

When you come up with a conglomerate of conclusions that suggest testing is not necessary for different reasons and medicines it would make sense to suggest that you might want to do testing to get it right.   But all studies conclude that genetic testing is not necessary in most cases. 

Let’s take a look at the NEJM article that compared bleeding events in patients treated with  warfarin vs placebo to see why that might not be the best clinical approach:

“Results are presented only for patients of European or Latin American ancestry. Patients with other ancestries were excluded because of small numbers (99 patients in the next largest group) and concern about the potential for population stratification.” 

“Only 18.0% of patients in the CURE population included in our study underwent PCI, and only 14.5% underwent PCI with placement of a stent, as compared with more than 70% in previous studies.”

So the study --  truly a one size fits all approach – excludes African Americans and people undergoing PCI

Further:

"Carriers had a more pronounced reduction in cardiovascular events with clopidogrel treatment as compared with placebo than did noncarriers (hazard ratio with clopidogrel among carriers, 0.55; 95% CI, 0.42 to 0.73; hazard ratio among noncarriers, 0.85; 95% CI, 0.68 to 1.05; P=0.02 for the interaction). A similar interaction was observed with respect to the second composite primary outcome (hazard ratio with clopidogrel among carriers, 0.66; 95% CI, 0.54 to 0.82; hazard ratio among noncarriers, 0.90; 95% CI, 0.76 to 1.06; P=0.03 for heterogeneity)."

Isn’t finding out who  benefits more a good reason for testing?   Eric Topol thinks so:

“Genomics expert Dr Eric Topol (Scripps Research Institute, La Jolla, CA) told heartwire: "Both TRITON and PLATO reinforce the CYP2C19 story . . . that loss-of-function variants lead to diminished clinical impact for clopidogrel. PLATO takes this a step further to now show that the gain-of-function allele *17 is associated with more bleeding."

http://www.theheart.org/article/1114619.do

The rush towards headline grabbing instant analysis undermines a more systematic analysis in the Meridia and genetic testing issues and ignores the fact that RCT’s have limitations.

As another editorial noted with respect to gene testing:

“Besides genetic profiles, the evaluation of the best management should also take into account the clinical determinants of platelet reactivity—from age and sex to body-mass index, diabetes, and inflammation—that modulate platelet function, while also considering the timing from the acute event, she adds. "Prospective studies evaluating different antiplatelet treatments tailored according to the individual characteristics of patients are urgently needed to identify therapeutic strategies that will provide the best benefit for the single patient in this high-risk clinical setting."

Too bad CER funding is not available for such research.

Allergan has agreed to pay $600 million to settle charges that it illegally promoted and sold Botox through 2005 for unapproved uses like treating headaches.

In addition to the monetary fine, Allergan has agreed to a five-year corporate integrity agreement requiring the company to publish information about its payments to doctors.

The agreement also requires Allergan to drop its First Amendment lawsuit against the F.D.A., in which it had claimed free speech protections when giving doctors information about unapproved uses of Botox.

Whether or not DDMAC dodged a bullet on this one is debatable -- but the core issue is clear -- if it's off label you can't promote it. And calling off-label promotion "physician education" is just way too cute.

A new poll shows that public support for healthcare reform dropped sharply in August. 

The Kaiser Health Tracking Poll has support for the bill dropping 7 percentage points in August — down to 43 percent — while opposition rose 10 points to 45 percent.

Respondents listed healthcare as the third most important factor in deciding how they’ll vote this fall — behind the economy and “dissatisfaction with government.”

Forty-two percent of respondents said healthcare reform will play an “extremely important” role in their ballot-box decisions, on par with the 41 percent who said the same thing in June.

A series of insurance industry reforms, including a ban on lifetime or annual caps on insurance coverage and free preventive care on new insurance plans, have proved popular in polls, but the popularity of the overhaul on the whole hasn’t improved. Plus, opposition to other provisions — namely, the requirement that nearly all Americans buy insurance coverage — has increased. The so-called “individual mandate” was opposed by 70 percent of the Kaiser poll’s respondents.

I have to take slight exception to Peter.   I am afraid that while better post market data is needed to inform product development in  ways that accelerate the targeting of treatment and enrich clinical trials, the JANUS warehouse is not the place FDA should go shopping.  

First it is important to know what’s in JANUS and what is not:

“The JANUS warehouse was populated with sample synthesized human trial data related to two oncology studies. This data was furnished in standard STDM format and data load scripts were developed to import the data. A sample caCORE application was developed to demonstrate the analytical capabilities of such an application accessing the underlying JANUS repository. The application was modeled against SDTM domain views of the Janus warehouse instead of the warehouse schema itself to alleviate complexity and improve data access efficiency. The sample application was successful in that you could authenticate the users at signon using CSM authentication and then review the clinical trial data in the following ways:

• View patient enrollment by study
• View patient retention by study
• Efficacy reporting by study
• Safety reporting by study

Note the absence of genomic data.

To be sure, according to HHS, “there is a JANUS pharmacogenomics pilot study to identify gaps in the RIM and suggest further improvement for the import of genomics data into the database. “

But the FDA contract does not fund such research.  Moreover, HHS under the Obama Administration is interested in using personalized medicine to save money above other goals. 

“The molecularly informed comparative effectiveness research (NCI) was set up to determine whether molecular information can inform quality, efficacy and cost-effectiveness in health care…The MI-CER project also requires the integration of health care financial data to examine cost-effectiveness."

SO how does the PACES use of Janus fit into all this?

According the FDA solicitation: “The Contractor shall develop innovative clinical trial design strategies for prospective CER clinical trials and analyses of healthcare data including providing formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons. These strategies and recommendations shall be documented in reports and manuscripts suitable for publication in scientific journals.”

·     Evaluate comparator groups, populations studied, study designs, endpoints, statistical analysis methods, and trial conduct.

·     Include an evaluation of the capability of each study to distinguish differences in effectiveness and safety among different populations, subpopulations and individuals.

·     Provide formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons.  http://tinyurl.com/2fb4fng

 
While a long term goal of analyzing JANUS data is identify robust data standards to capture and exchange clinical genomic data, that goal is not addressed or funded. 

understood.”

Not understood?  Or does he mean not subject to the sort of one size fits all comparison of treatment A to treatment B that he would conduct as a consultant for reimbursement purposes?

Here’s more:

“Many patients, oncologists and other clinicians, payers and policy makers are dependent on these compendia, yet compendia often are viewed as being “too lenient” in terms of the quality of evidence required for compendia listing. Some studies have raised questions about the rigor and consistency of the compendium process. A 2006 analysis of 14 off-label indications concluded that current compendia “lack transparency, cite little current evidence, and lack a systematic method to review and update generated evidence.”

Let’s set aside the fact that the 2006 analysis was conducted by yet another member of the IOM/CER panel (Harold Sox) who is not an oncologist.  Does the fact that the decline in the rate of death and increase in five year survival rates for most cancers matter to Tunis?  Or how about the fact that by definition “off-label” use is based on clinical insights and forms the basis of common use and further research?  Or that research by Frank Lichtenberg shows about “one-fourth of the mortality decline in cancer is attributable to drug innovation, and 40% of the decline is attributable to (lagged) imaging innovation. ( Life expectancy at birth may have been increased by almost three months between 1996 and 2006 by the combined effects of cancer imaging and cancer drug innovation.)”

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1586687

Not at all. 

Does he really care about personalized medicine?

“Off-label oncology CERs should be designed to be generalizable in that they include sociodemographic diverse patient populations as well as patients with common comorbidities that exist among cancer patients and/or are positively or negatively associated with the use of oncology drug.”

http://www.cmtpnet.org/cmtp-research/Off_label_Overview.pdf

Generalizable.  Common.   But off-label use is treating the patient.  CER is used to make a generalization for purpose of coverage and reimbursement.   Tunis calls for prospective studies using clinical data to compare different drugs, not target treatment.  And he would use the JANUS data to advance his agenda. 

The current PACES project can be skewed to carry out such studies and has the potential to do so because of the lack of specific requirements to advance personalized medicine and integrate genomic analysis with clinical data.  

To give a large contract to an organization that has a vested interest in advancing it’s own approach to CER and has a bias towards using CER and consistently avoids establishing whether CER actually improves clinical outcomes.  Rather,  CER and Tunis focus on process and the creation of “Effectiveness Guidance Documents (EGDs)”  that would become the gold standard for CER research throughout the federal government and would include the FDA.

JANUS should be straightforward, not two-faced about personalized medicine.  Given the potential for bias and manipulation of the existing dataset, the FDA should impose additional requirements and different goals on contractors and itself.

Take a breath.  Some news about the FDA and comparative effectiveness.  Relax – it’s not what you think (or what the people at Consumer’s Union want).

The new efforts will not affect product approvals and instead focus on simply answering a slew of outstanding questions by leveraging the abundance of collected data stored at the agency.  And it’s about time.  The FDA sits at the nexus of vast amount of untapped and highly important data. And while data is great, knowledge is power. 

The American Recovery and Reinvestment Act (aka, “the stimulus package”), the FDA received funding (via AHRQ) to develop a CER infrastructure with outside assistance.

The agency's multi-step CER approach that includes creating the Janus data repository and developing at least one external center through the Partnership in Applied Comparative Effectiveness Science (PACES) initiative to examine the collected data, assess the information and make recommendations to answer questions on different therapies and patient groups. The data will include information from new product submissions and previously submitted product applications.

In parallel to the creation of the Janus data repository, the agency will also convert legacy data into a standardized format that can be inputted into the system. Agency officials acknowledged that the data retrofit will be costly, and the ARRA funding will focus on piloting the initiative to determine whether the program's benefits outweigh its costs. But that depends, largely, on how the agency chooses to define "benefits" -- and over what period of time?

Instead, she said the program will address the real world impact of therapies, help improve consistency and transparency in the approval process and identify healthcare gaps. For example, the examination of data could identify sub-populations that are not impacted by certain classes of drugs, with those patients potentially obtaining improved health outcomes from different therapies, such as certain devices.

Pulse check – this is not CER as part of the PDUFA process.

Janet Woodcock: "I think the science is still too early to be able to really design comparative trials that stand much chance of being conducted, at least pre-approval.”

Personalized medicine?  Well, yes – if you consider the use of outcomes data to be personalized medicine.  And it is.  It’s certainly an important first step towards realizing the “four rights” (right medicine in the right dose for the right patient at the right time).

FDA Chief Scientist Jesse Goodman: "In the long run for FDA and the sponsors, this will make everything more efficient. … Moving towards identifying what's the right way to do it does take some maturation of technology.”

Oh yes. And to that end the FDA will strive to implement “modern analytical tools” to examine the data. Easier said than done – but it’s money well spent.

"Bad science conducted to support litigation."

Via the AP -- and without mincing words ...

A federal appeals court on Friday upheld a ruling that vaccines are not to blame for autism.

The U.S. Court of Appeals for the Federal Circuit upheld a decision last year by a special vaccine court, which concluded there's little if any evidence to support claims of a vaccine-autism link.

Scientist years ago reached that conclusion, but more than 5,500 families sought compensation through the government's Vaccine Injury Compensation Program.

Friday's ruling came in the case of Michelle Cedillo of Yuma, Ariz., who is disabled with autism, inflammatory bowel disease and other disorders that her parents blame on a measles vaccine given at 15 months.

In the 2009 ruling Special Master Denise Vowell wrote that the evidence "is weak, contradictory and unpersuasive. Sadly, the petitioners in this litigation have been the victims of bad science conducted to support litigation rather than to advance medical and scientific understanding" of autism.

In the belief that facts drive guidance and oversight on behalf of the public health, some interesting and important data on attitudes towards risk and benefit in DTC ads.

(Note – key word is “ads” – not social media.)

Attitudes toward Risk/Benefit Info in DTC Ads

TV       Magazine      Online

 Risk

Seen/heard                                            79%         48%              37%

Seen/heard                                           73%           52%              54%

Pay a lot/some attention                        63%           63%              57%

With “utility” almost even across the board (76%/75%/75%), it’s the risk stats that give pause for reflection. 

While 79% have “seen/heard” risk information on TV ads (not surprising since the viewer passively receives it whether they want to or not), and print (48%) out-strips online (37%). 

But the race tightens in the “pays a lot/some attention" – where TV still leads (we are, after all, glued to the couch), but online (69%) out paces print (66%).  Among other conclusions, this points to (1) the well-documented inadequacies of the brief summary (i.e., neither brief nor a summary) and (2) the greater desire of the online ad viewer to click to risk information.  Put another way –nearly 70% of online ad viewers actively click-through to risk information.  Pretty impressive – and even more so considering this data was collected well after the November 2009 FDA letters on sponsored Google links.

Food for thought.

Hello Muddah.  Hello Faddah.

A new study in the August issue of the Journal of Applied Communication Research (conducted by researchers at the Universities of Pennsylvania and Georgia) shows that direct-to-consumer ads that make mention of family history as a significant risk factor for a disease resonates strongly with their target audiences.

Those who viewed the ads indicated a stronger intent to adopt healthy behaviors as well as a stronger intent to seek the medications that were advertised. The researchers concluded consumers were willing to mix pharmaceutical and behavioral changes to minimize their risks to diseases that could be related to genetics.

The study involved a group of 395 adults who viewed four magazine ads, including three for drugs: Bayer aspirin for heart disease, Vytorin (ezetimibe/simvastatin) for high cholesterol, and Actonel (risedronate sodium) for osteoporosis. The fourth was a "masking" ad for ThermaCare , an over-the-counter product for joint and muscle pain.

All participants who saw the ads with familial risk cues, regardless of the level of family disease history, showed a strong intent to purchase medications. The results also indicated that that the consumers who saw the ads with familial risk cues had stronger intentions to engage in healthy lifestyles than those who did not.

"Exposure to familial risk cues in DTC prescription drug ads enhanced behavioral intentions for both healthy lifestyles and for pharmaceutical choices," the article states.

In a 33-page opinion, Judge Emmet Sullivan of U.S. District Court in Washington, D.C., declined to issue a preliminary injunction blocking the sales of the generic Lovenox.

sanofi-aventis sued the FDA after the agency granted Sandoz approval to make enoxaparin (the generic form of the special heparin).

He said, the FDA had presented "a satisfactory explanation for its decision." Judge Sullivan noted that none of the parties had challenged the safety of the generic enoxaparin.

Yesterday the FDA released a preliminary draft of the restaurant menu labeling rules that will go into effect on March 23, 2011. A section of the health care legislation passed in March mandates that restaurants clearly display calorie information on menus, including sit down and drive through menus.

The new rules will apply to many different types of eateries. The general rule is that any restaurant with twenty or more locations is required to label products with calorie information.  The rule also includes vending machines.

Senator Tom Harkin (D-IA) and Congresswoman Rosa DeLauro (D-CT) co-authored the legislation upon which the draft guidelines are based back in 2003.

"This is a great step forward towards ensuring that Americans will be able to make more informed choices about the food they are eating, which will help to combat obesity, cut health care costs, and improve and enhance our lives. The FDA's efforts in making this a reality are admirable, as is the cooperation and participation of the restaurant industry as we move forward," said DeLauro in a press release from her office. "With childhood obesity rates tripling over the last 30 years, this legislation is absolutely imperative to the health of our nation."


Well – except that the research to back up the childhood obesity claims is, well shall we say – inconclusive.


"The issuance of today's guidance regarding menu labeling is an important step in efforts to empower consumers by giving them the information necessary to make sound decisions about their health," said Harkin in a statement.  

Well – except that the research to back up the claim that people alter their habits after reading such labeling (if they, in fact, read them at all) is, shall we say – inconclusive.

We shall see. Stay tuned for the open public comment period.

The draft guidelines can be found here.

Suddenly end-of-life care is back in vogue.

Here’s the New York Times explaining why: 

In a study that sheds new light on the effects of end-of-life care, doctors have found that patients with terminal lung cancer who began receiving palliative care immediately upon diagnosis not only were happier, more mobile and in less pain as the end neared — but they also lived nearly three months longer.

The findings, published online Wednesday by The New England Journal of Medicine, confirmed what palliative care specialists had long suspected. The study also, experts said, cast doubt on the decision to strike end-of-life provisions from the health care overhaul passed last year.

“It shows that palliative care is the opposite of all that rhetoric about ‘death panels,’ ” said Dr. Diane E. Meier, director of the Center to Advance Palliative Care at Mount Sinai School of Medicine and co-author of an editorial in the journal accompanying the study. “It’s not about killing Granny; it’s about keeping Granny alive as long as possible — with the best quality of life.”

 
Here’s what the study found and what the New York Times conveniently ignores: People with end stage lung cancer who were given palliative care at diagnosis and  simultaneously with standard cancer care  “had a significantly better quality of life and significantly lower rates of depression than those who received only standard care.

They also lived longer — median survival for patients in the simultaneous-care group was 11.6 months and in the standard-care group was 8.9 months (P = .02). This survival benefit of 2.7 months is similar to that achieved with standard chemotherapy regimens.”  (www.nejm.org)

The New York Times  reporting makes it seem that palliative care alone was better and that it was therefore wrong to eliminate end of life counseling from Obamacare by calling it a death panel.

In fact, end of life counseling in the original version of Obamacare was not about  “keeping Granny alive longer” or even palliative care.

Section 1233 of the health-care bill drafted would have paid doctors to give Medicare patients end-of-life counseling “every five years -- or sooner if the patient gets a terminal diagnosis.” 

And the counseling was to include advanced care planning, including key questions and considerations, important steps, and suggested people to talk to about” living wills and durable powers of attorney, and their uses …a list of national and State-specific resources to assist consumers and their families."   Not a word about living longer. To suggest now that’s what Democrats meant is absurd: If spending more money to let Granny live longer after a terminal diagnosis  why keep reminding people every five years about “living wills”?

Because it’s a way of telling seniors as they get older that living longer is not very valuable.  Here’s Victor Fuchs, an Obamacare advocate, economist and long time consultant to Donald Berwick and Obama’s health policy adviser Ezekiel Emanuel on technologies that extend life:

“..further gains in life expectancy will mostly mean keeping more Americans alive while they are retired and dependent on indirect transfers of funds from younger workers for much of their living expenses, health care, and social services.”   Because keeping people alive longer is so…wasteful Fuchs suggests government discourage “ innovations that increase life expectancy”  in favor of innovations, such as joint replacement, that improve the quality of life for both the elderly and the near-elderly.”

This is ideology masquerading as science.  In fact, advances that improve quality of life also tend to improve survival especially when it comes to diseases associated with aging.  And it winds up reducing or slowing the cost of treatment.   Since 1996, the average per patient costs for cancer, heart disease and mental illness have declined in inflation adjusted dollars.  And life expectancy continues to increase as well. 

But that’s not good enough for Fuchs,Berwick and others.   And just because of end of life counseling is gone, Obamacare has other tools to shorten life.  One way to do it is to have the government not pay for any new technology that doesn’t meet this goal.  Another is to not count spending on such innovations when determining if a health plan spent the federally required 80-85 percent of it’s premiums on medical care.   Still another is paying doctors to discourage people from using new technologies by discussing their risks and lack of value.   

Fuchs states: Obamacare should only pay for   “innovations whose main effect is to substantially decrease cost while holding quality constant or reducing it only slightly.”   Many Obamacare advocates endorse his view with enthusiasm.  Yet by that standard, a combination of palliative and standard care that increases well-being and extends lives would be discouraged by government.   Maybe the term “death panel” understates the problem.

According to three new studies in the latest issue of the American Journal of Hypertension, almost half of the 50 million Americans with hypertension haven't been prescribed the drug that would work best for them.

From the pages of the Wall Street Journal:

By Katherine Hobson

consumers who were skeptical.

Cleveland Plain Dealer reported yesterday. In response to a question after a speech, Toby Cosgrove said he wanted to ensure that manufacturers and investors would still be willing to make financial bets on unproven devices and drugs. He used the example of a heart valve, saying it now takes two decades to bring a new valve product to market and then assess the effectiveness.

(Cosgrove knows of which he speaks; his bio says he has 30 patents filed, including heart valves and surgical instruments.)

might present some tough obstacles for cancer research.