A Nice Pair of Legs

03/10/2010 07:47 AM |

The FDA stands on two firm legs -- safety and efficacy.  Now there's a hue and cry (from people who should know better) that the agency should embrace comparative effectiveness as a third measure.  Wrong.

Do doctors need more and better information on how to get the right dose of the right drug to the right patient at the right time.  Yes!  But denying FDA approval to one drug because, in a large randomized controlled clinical trial, it may not be "as effective" as another is not only meaningless -- it's counterproductive.  How can care be improved if physicians are denied access to new drugs that work?  Hm.

What we DO need are more and better molecular diagnostics and more adaptive clinical trials to show what drugs work best in specific subpopulations.  That's not comparative effectiveness, it's clinical effectiveness.  And it's crucial to the advancement of 21st century medicine.

Here's the NPR story on the NEJM articles:

http://www.npr.org/templates/story/story.php?storyId=124516838

Watch for the issue of an FDA "third leg" to come up during the upcoming debate over PDUFA reauthorization.  Watch "comparative" effectiveness morph into "cost" effectiveness.  And remember  -- what we need to discuss is "clinical" effectiveness.
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Reality Check on Health Care Reform

03/09/2010 07:07 PM |

The President's proposal states:  "As the numbers of Americans without insurance falls, the Act saves taxpayer dollars by keeping people healthier before they join the program and reducing Medicare’s need to pay to hospitals to care for the uninsured. And to make sure that the quality of care for seniors drives all of our decisions, a group of doctors and health care experts, not Members of Congress, will be tasked with coming up with their best ideas to improve quality and reduce costs for Medicare beneficiaries."

http://www.whitehouse.gov/health-care-meeting/proposal/titleiii

Fast forward to the present.  The RAND Corporation reviewed the ability of Britain's National Health Service -- the ultimate public option with centralized control over health spending, treatment practices, reimbursement levels and performance standards -- to keep people healthier and make sure qualiity of care drives all decisions.  RAND looked at the NHS ability to deliver high quality care after increasing spending on health care during that time at a rate faster than spending in the US. 

Here's what the study found:

A damaging rift between doctors and managers: “The GP and consultant contracts are de-professionalising, and have had the peculiar effect of simultaneously demoralising and enriching doctors. We’ve lost the volitional work of the doctors and far too many of us are now just working to rule.”

Pointless new structures. “Stop the restructurings. The only thing they generate is redundancy payments.” One body responsible for improving standards reported to five different ministers and had three different names in the space of 30 months.

A culture of fear and slavish compliance. “The risk of consequences to managers is much greater for not meeting expectations from above than for not meeting expectations of patients and families.”

http://www.timesonline.co.uk/tol/news/uk/health/article7052606.ece

RAND notes that the NHS has implemented all manner of quality commissions, practice guidelines, performance standards, value-based reimbursement contracts with doctors, etc.   Sounds a lot like the Senate and House bills right?   The RAND study noted that comparative effectiveness studies came in for particular criticism by everyone within the NHS:

"NICE is too focused on fiscal issues: This concern likely arises because NICE is simultaneously considering clinical effectiveness and cost effectiveness. Implementation of NICE technology appraisals is mandatory which underscores the focus on fiscal issues. Concerns were also raised about whether the thresholds are adequate (£30,000 per quality adjusted life year) and about the limited and somewhat weaker economic evidence relative to clinical evidence. This led some observers to suggest that the UK needed guidelines development that would not account for resource issues."

This concern about NICE --  the "group of doctors and health experts" President Obama refers to -- is related directly to the feeling among NHS managers and and GPs that they are simply instruments for carrying out the fiscal goals of the NHS at the expense of the needs and health of patients.   And meanwhile, none of the new structures, measurements or studies have improved care.   Instead, as the RAND study notes:

"Concerns have been raised about perverse incentives for treating multimorbidity patients imbedded in the financial incentives." 

Or as the President said: "And to make sure that the quality of care for seniors drives all of our decisions, a group of doctors and health care experts, not Members of Congress, will be tasked with coming up with their best ideas to improve quality and reduce costs for Medicare beneficiaries."



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The Avandia Wars

03/09/2010 08:03 AM |

In advance of a second FDA’s advisory committee on Avandia and Deputy Commissioner Josh Sharfstein’s testimony on drug safety (this Wednesday in front of a House Energy and Commerce subcommittee on drug safety) comes this front page missile from BioCentury:  “End the War.”

Here’s a taste:

The firestorm over GlaxoSmithKline’s Avandia (rosiglitazone), which was rekindled two weeks ago with an incendiary Senate report, shows why people who live outside the Beltway are convinced that Washington is broken, and why they are right.

The politico-media outburst exemplifies the worst aspects of the American regulatory environment. It also exemplifies why business as usual in Washington must stop, and why the responsibility rests directly at the feet of the politicians and regulators who are failing their responsibility to put the public’s health before politics.

As with previous rounds in the Avandia circus, grandstanding members of Congress played gotcha with FDA, releasing their report to the agency and to the media simultaneously. Citing data from disgruntled FDA employees, Committee Chair Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) said in a Feb. 20 press release that “the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.” The release gave the false impression that this represents FDA’s official position.

Unless the political leadership at HHS and FDA acts quickly and decisively, decision-making based on external political pressure and a paralyzing precautionary philosophy will become institutionalized.

Instead of being occasionally blown off course by recurring squalls, the very real risk is that permanent climate change will forever degrade FDA’s science-based over-sight process, eroding the public’s confidence in the agency and placing a stop sign on the path of biomedical innovation.

Avandia is the poster child for a culture that has evolved at FDA — encouraged by publicity-seeking politicians — in which agency employees who dislike a regulatory decision are able to keep raising the issue, and if they don’t like the results, to go outside established agency procedures for resolving scientific disputes to enlist support from members of Congress and their enabling lapdogs in the media.

There’s more.  A lot more.  Names are named.  And punches aren’t pulled.

The complete BioCentury commentary can be found here.

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Wisdom of Temple to Temple of Wisdom

03/08/2010 08:47 AM |

At a recent debate on clinical trials for Pulmonary Arterial Hypertension (sponsored by the Drug Information Association and the Pulmonary Vascular Research Institute) Bob Temple (CDER Deputy Director for Clinical Science) commented that the distribution of positive results for individual patients (as well as a drug's mean benefit across the population of treated patients in a clinical trial) can be useful in assessing efficacy for pulmonary arterial hypertension.

The issue is – the few versus the many.

"It really isn't the average that matters to people most. For various reasons - analytical, historical and others - we use mean results. But that's not what happens to individual people. ...Of greater interest, this is true for a lot of situations, are the effects on individuals or the distribution of those effects, which we are not so used to measuring."

Even if a drug only has a 10 percent effect, Temple said, "it might have a rather large effect in a fraction of the population," so a look at distribution is useful. "We do think about that, mostly though," he conceded, "when you have context that has a safety problem or the effect is particularly important."

There are increasing opportunities in early studies to identify the responders and incorporate that information into the design of later-phase trials, Temple noted. If sponsors find a likely response predictor, "genomic or some other kind of finding, there's nothing that stops the later trials from stratifying that predictor and analyzing the groups separately or even making the result in the responder subgroup the primary analysis."

Temple's remarks came during a debate on whether clinical trials for PAH drugs should be required to show that patients in the treatment arm improve their distance by a minimum amount during the six-minute walk.

The question, he noted, is what is a big enough improvement? The answer can come from the patients themselves, in how they feel about walking or their life activities, he suggested, "We're very interested in looking more at well-validated patient reported outcomes."

Let's remember and embrace that last comment, "well-validated patient reported outcomes."

Bob’s comments, coming on the heels of the FDA’s recent documents regarding clinical trial designs (Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics), seem to reinforce the agency’s Critical Path philosophy of broadening decision-making criteria about a drug based strictly on generalized results from large scale RCTs. Trial designs that focus on patient selection for ideal response is a key tenet of the personalized medicine approach that industry and FDA are hoping to create and for which the Critical Path’s Reagan Udall Foundation was created to foster.

That being the case, perhaps we should take the Wisdom of Temple to our nation’s Temple of Wisdom and suggest to Congress that a certain percentage of PDUFA fees be used to fund the FDA’s Critical Path program.

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Welch's Jape Juice

03/08/2010 08:12 AM |

61 House members (led by Peter Welch, D/VT) have introduced a bill calling for direct Part D price negotiations -- despite the fact that health care reform legislation is moving ahead in Congress without such a provision (due in no small part to the “deal” cut by the White House and PhRMA).

The bill is essentially the same as the amendment, also sponsored by Welch, included in the health care reform legislation passed by the House last summer. However, a price negotiation provision is not part of the Senate bill on health reform, which has become the primary vehicle for passing health reform through Congress.

The Welch bill does not provide HHS with the authority to establish a national formulary. The Congressional Budget Office has consistently concluded that empowering HHS to negotiate prices, without also providing the secretary with authority to set up a national formulary, would not produce savings to the government.

As Stanford economists Alain Enthoven and Kyna Fong have explained, when discussing Medicare Part D, “Government price negotiation could leave people without drugs that manufacturers decide aren’t sufficiently profitable under the plan.”

That’s exactly what has happened under the health insurance program run by the Department of Veterans Affairs, which is already empowered to directly negotiate prices with drug producers.

Of the 300 most prescribed drugs among Americans 65 and older, the VA only covers 65 percent of them, according to a study from the Lewin Group. By contrast, the two most popular plans in the Medicare Part D drug benefit — where private insurers compete for customers — each cover 94 percent of those medicines.

In fact, over a third of retired veterans supplement their VA coverage by enrolling in Part D

The Part D model hasn’t sacrificed cost-savings for choice, either. The competitive pressures among participating insurers have lead to a 17 percent drop in out-of-pocket spending for seniors who enrolled in the program in 2006 — that’s equivalent to 14 extra days of medicine a year.
Moreover, Part D’s total expenses over the next decade are expected to be nearly $120 billion less than originally estimated when the program was created.

Mr. Welch and friends are hoping to have the bill move in tandem with the final push to pass health care reform legislation or be added to the package of "fixes" being planned for the Senate bill.

Add this to the growing list of reasons why “reconciliation” is both phony and dishonest.

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Critical Path GPS

03/05/2010 08:58 AM |

FDA has issued two new draft guidance documents regarding clinical trial designs: Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, and Guidance for Industry: Non-inferiority Clinical Trials.

Adaptive Design Guidance: This draft guidance is designed to provide sponsors and the review staff in both the drugs and biologics divisions with information regarding adaptive design clinical trials when used in drug development programmes, including aspects of adaptive design clinical trials that deserve special consideration and how a sponsor should interact with FDA while planning and conducting such a study.

An "adaptive" design has been described as a clinical study design that allows users to adapt or modify a trial during its progress based on examination of the accumulated data at an interim point without affecting the validity and integrity of the trial.

The FDA defines an adaptive clinical trial design as one that "includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study". By allowing modifications, the FDA states, there is the possibility that one can make the study more efficient (eg, shorter duration, fewer patients), or have the study be more likely to demonstrate an effect of the drug if one exists, or be more informative (eg, by providing broader dose-response information). The regulator adds, "FDA shares the interest of drug developers in these advantages, but is also concerned with several aspects of such approaches, notably the possible introduction of bias and the increased possibility of an incorrect conclusion."

The guidance notes that such prospectively planned modifications can be submitted with the written study protocol, or in a statistical analytic plan, if used.

The FDA has invited comments on some recommended reporting requirements. It has stated that, in the drug development process, it is important to protect study blinding of an adaptive design study. To this end, it recommends that, where the design is modified after examination of unblinded interim data, and to avoid the introduction of bias (and to maintain confidence in the validity of the study's result), sponsors include in the adaptive design protocol written standard operating procedures (SOPs) that define who will implement the interim analyses and adaptation plan, and all monitoring and related procedures to accomplish the plan, providing for strict control of access to unblinded data. Other information to be included in the SOPs: who would perform the interim analyses and would have access to unblinded data; how compliance with SOPs would be documented; and what information, and under what circumstances, would be permitted to be passed from the Data Monitoring Committee to the sponsor or investigators.

In one part of the guidance document, it is stated: "Adaptive design studies may work best, and with least risk, when there truly are just a few issues (eg, dose, population subsets, endpoints) that need to be examined and are built into an adaptive design."

The document also states: "The greatest interest in adaptive design clinical trials has been in the adequate and well-controlled setting intended to support marketing a drug. Because these studies have the greatest regulatory impact, this guidance is generally oriented toward the use of adaptive design methods in adequate and well-controlled studies, where avoiding rates of false positive study results (increased Type 1 error rate) is critical, and introducing bias should be minimised. Many adaptive methods, however, are also applicable to exploratory studies. This guidance encourages sponsors to gain experience with the less well-understood methods in the exploratory study setting."

According to the guidance, the range of possible study design modifications is described as "broad". The guidance includes both familiar and less familiar approaches in the use of such adaptive designs – as the regulators state that "the less familiar design methods incorporate methodological features with which there is little experience in drug development at this time." Early interaction with the FDA is encouraged on any adaptive design.

Non-Inferiority Clinical Trials Guidance: This guidance provides the FDA's view of how a sponsor can use non-inferiority study design to provide evidence of a drug's effectiveness. This includes the agency's advice on how a sponsor can choose an appropriate non-inferiority margin and how to analyse the results. As stated by the agency in the guidance, a non-inferiority trial compares two treatments and seeks to demonstrate that "any difference [between the treatments] is small enough to allow a conclusion that the new drug has at least some effect or, in many cases, an effect that is not too much smaller than the active control." (These trials contrast with the more common superiority trials, specifically a placebo-controlled trial, where the intent is to show that the new drug is more effective than the control.)

The guidance states: "The usual reason for using a non-inferiority active control design instead of a study design having more readily interpretable results (ie, a superiority trial), is an ethical one. Specifically, this design is chosen when it would not be ethical to use a placebo, or a no-treatment control, or a very low dose of an active drug, because there is an effective treatment that provides an important benefit (eg, life-saving or preventing irreversible injury) available to patients for the condition to be studied in the trial."

Part of the guidance includes five examples of successful and unsuccessful efforts to define non-inferiority margins and conduct non-inferiority studies.

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Turning Vermillion

03/04/2010 08:08 AM |

The Wall Street Journal reports:

The Food and Drug Administration plans to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report.

In a letter to Sen. Chuck Grassley (R., Iowa), the FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool."

An FDA official said the agency has the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability." He said the government doesn't have to show intent to defraud in order to get a conviction. He added that the provision is an important tool that hasn't been used much in recent years.

A report set to be released Thursday by the Government Accountability Office, Congress's watchdog arm, says the Office of Criminal Investigations has operated autonomously for years with little or no accountability to top FDA officials. The criminal office doesn't have to explain what it is investigating or how it using funds, according to the report. It said the office's budget rose 73% between 1999 and 2008 to $41 million, and the number of employees increased by about 40%.

But nowhere in the article does it actually discuss what the OCI does. The reporter, Alicia Mundy, is at fault for only telling one side of the story. Let’s correct that bit of shoddy journalism.

OCI pursues cases that present a danger to the public health and have an FDA nexus. The diverse background of OCI agents gives the FDA the ability to aggressively address issues ranging from mail and financial fraud, to smuggling, forfeiture, and counterfeiting.  OCI agents do this with talent, devotion, skill – and success.

OCI is a career destination of choice for the cream of the crop of Federal law enforcement agencies such as the FBI and the Secret Service – and they come to the FDA with an average of 12.5 years of Federal law enforcement investigatory experience.  That’s why Terry Vermillion, the director of OCI and a former Secret Service agent himself, refers to his agents as “a taskforce of talent.” And they play a crucial role in protecting the safety of America’s prescription medicines and food supply.

In a typical year, FDA's Special Agents will investigate about 1,000 criminal cases resulting in the arrests of hundreds of suspected violators of public health laws.

On average, 200 criminal suspects are convicted each year as the result of OCI investigations. From 1993 to present, OCI has made 4,593 arrests that resulted in 3,546 convictions and more than $5.7 billion in fines and restitutions.

The article also takes some cheap shots at Vermillion. I worked with Terry – and no one at the FDA is more committed to protecting the public health.

Consider the words of Teddy Roosevelt:

“It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood, who strives valiantly; who errs and comes short again and again; because there is not effort without error and shortcomings; but who does actually strive to do the deed; who knows the great enthusiasm, the great devotion, who spends himself in a worthy cause, who at the best knows in the end the triumph of high achievement and who at the worst, if he fails, at least he fails while daring greatly. So that his place shall never be with those cold and timid souls who know neither victory nor defeat.”

Terry Vermillion and the agents of the FDA’s Office of Criminal Investigations are the Roughriders of 21st century drug safety.

And they deserve our respect.

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Climategate Comes To Healthcare Reform

03/03/2010 01:11 PM |

"Today, many scientists and opinion leaders think that if an elite consensus in favor of certain “policies” can be generated, the underlying science must be right. The corrupt system of “peer review” will reliably exclude dissenters, and if the naysayers continue making themselves heard they will be called denialists, tools of right-wing talk radio, etc."

That quote, from an Tom Bethell essay about the state of climate science, also applies to statements and studies used by the elite to push for health care reform...  If a consensus for reform exists -- in the form that is currently approved by the NEJM, Health Affairs, the Kaiser Foundation, the Commonwealth Fund, Families USA, AARP, AMA, then the underlying statistics and studies must be right.  RIght?

Lest one needs a refresher course in the demise of the UN clmate change report, let me point you to Andrew Neil's BBC blog. 

The IPCC 2007 report claimed that global warming was leading to an increase in extreme weather, such as hurricanes and floods. Like its claims about the glaciers, this was also based on an unpublished report which had not been subject to scientific scrutiny -- indeed several experts warned the IPCC not to rely on it.

The author, who didn't actually finish his work until a year after the IPCC had used his research, has now repudiated what he sees has its misuse of his work.

His conclusion: "There is insufficient evidence to claim a statistical link between global warming and catastrophe loss."

Yet it was because of this -- now unproved -- link that the British government signed up to a $100 billion transfer from rich to poor countries to help them cope with a supposed increase in floods and hurricanes.

It was also central to many of the calculations in Britain's Stern Report, which might now need to be substantially revised.

Now after Climate-gate, Glacier-gate and Hurricane-gate -- how many "gates" can one report contain? -- comes Amazon-gate. The IPCC claimed that up to 40% of the Amazonian forests were risk from global warming and would likely be replaced by "tropical savannas" if temperatures continued to rise.

This claim is backed up by a scientific-looking reference but on closer investigation turns out to be yet another non-peer reviewed piece of work from the WWF. Indeed the two authors are not even scientists or specialists on the Amazon: one is an Australian policy analyst, the other a freelance journalist for the Guardian and a green activist.

The WWF has yet to provide any scientific evidence that 40% of the Amazon is threatened by climate change -- as opposed to the relentless work of loggers and expansion of farms.

Every time I have questioned our politicians about global warming they have fallen back on the mantra that "2,500 scientists can't be wrong", referring to the vast numbers supposedly behind the IPCC consensus. http://www.bbc.co.uk/blogs/dailypolitics/andrewneil/2010/01/the_dam_is_cracking.html

But it is now clear that the majority of those involved in the IPCC process are not scientists at all but politicians, bureaucrats, NGOs and green activists.  

That should sound familar (and you know who you are) to the self proclaimed healthcare experts who have shaped the consensus with factoids, overstatements and formulas for "bending the health cost curve" by simply eliminating care that actually makes patients sicker....

Most recent case in point.  The resurrection of Obama's big lie, repeated by Senator Dodd and Cong. Debbie Wasserman-Schultz that  uncompensated care is a $1000 tax on every American family...  

First question:  Will our taxes go down by $1000 under Obamacare?  Will we have $1000 more to spend by 2016.  Did CBO score that.  I don't think so.  

Second,  here is the reality behind that mythical number, courtesy of AEI's Tom Miller: 

[ An Urban Institute] study concluded that attributing increased private health insurance premiums to any expanded costs of treating the uninsured is a misperception; particularly when a net balance of only about $14.5 billion was arguably financed by the privately insured in the form of higher (cost-shifted) private payments for care and, ultimately, higher insurance premiums. Indeed, they estimated that the amount of uncompensated care potentially available for private cost-shifting is most likely even lower, at about $8 billion in 2008, which was less than 1 percent of private health insurance costs ($829.9 billion).
http://www.american.com/archive/2009/july/healthcare-dreams-healthcare-realities

The $1000 lie is just part of the patchwork of falsehoods stitched together to push through a government takeover of healthcare.   It is hard to follow them all. But we will try.
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Storm Warning

03/03/2010 07:15 AM |

Police seized more than 20 million packs of counterfeit medicines, arrested at least 33 people and closed more than 100 illegal pharmacies in a series of raids in eight Southeast Asian nations coordinated by Interpol.

Counterfeit versions of Pfizer Inc.’s Viagra for erectile dysfunction, Bristol-Myers Squibb Co.’s blood thinner Plavix and Teva Pharmaceutical Industries Ltd.’s morning-after pill Plan B were among the products seized, an Interpol officer who coordinated the raids, said Jan. 26 in an e-mail from Jakarta. The haul also included fake aspirin, antibiotics, malaria treatments and hair-loss medicines, she said.

The seizures and arrests, part of an investigation called Operation Storm II, are the second round of raids in two years in Asia as international and local police crack down on widening sales of fake medicines. Sales in the counterfeit-drug industry will jump more than 90 percent to $75 billion this year from 2005 levels, according to the New York-based Center for Medicine in the Public Interest.

Asia is the world’s biggest producer of all counterfeit products, the Organization for Economic Cooperation and Development said in 2007 report. About 40 percent of 1,047 arrests related to fake drugs worldwide in 2008 were made in Asia, according to the Washington-based Pharmaceutical Security Institute.

Counterfeits can account for more than 30% of all drugs sold in developing nations and less than 1 percent of all medicines in developed nations such as the U.S., the International Medical Products Anti-Counterfeiting Taskforce, or IMPACT, said in 2006.

The complete story can be found here:

http://www.latinamericanpost.com/index.php?mod=seccion&secc=5&conn=5950

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Center for American Progress: Con Job on Healthcare Job Growth

03/03/2010 01:02 AM |

I have great respect and admiration for David Cutler.  His work on the value of medical innovation and how different risk perceptions affect how people value health insurance (and price sensitivity) is pathbreaking. 

But his recent "research" report --  "New Jobs Through Better Health Care" explaining how health care reforms pushed by the Obama administration will save billions and create nearly 3 million jobs (as a result) is nothing short of hack work.  I am waiting for  his next study:  "How Obamacare Will Turn The NJ Nets Into A Playoff Contender"

http://www.americanprogress.org/issues/2010/01/new_jobs_health.html

I won't go through chapter and verse -- yet -- on what a shoddy cut and paste piece of propaganda Cutler lent his name to.  And  I will ignore the fact that there is no methodology section that allows someone to look at how Cutler arrived at his conclusion or explains how 1)  premiums will actually decline by 12 percent by 2019 (without subsidies) and how, assuming that is the case, even with higher taxes on business, earnings and income, that decline alone will bring back the 26 percent of American workers who just leave the work force altogether.   Let me just focus on one amazing statement and deconstruct: 

"we demonstrate a less emphasized point about the health care reform legislation  currently before Congress—if successful, its provisions can lower the costs of business and increase both the number of jobs by 250,000 to 400,000 annually over the next decade and increase wage growth. "

Really?  An analysis of the premium and tax burden imposed by the provisions David says will save money reveals:

• An average family who receives health insurance through a small employer and earning between $20,000 and $200,000 would be paying, on average, a range of $82 to $892 more. In the large group market, an average family making between $30,000 and $200,000 would be paying, on average, a range of $116 to $724 more.
• An average head of household who receives health insurance through a small employer and earning between $20,000 and $200,000 would be paying, on average, a range of $383 to $1,587 more. In the large group market, an average head of household also making between $20,000 and $200,000 would be paying, on average, a range of $185 to $1,419 more.

http://keithhennessey.com/2009/12/10/reid-bill-middle-class/

There is also "a payroll tax increase that will permanently sever the link between the Medicare Payroll tax and its contributions to Medicare. This payroll tax increase of .5% on earnings above $200,000 for singles and $250,000 for joint couples will contribute money to the general fund for health care instead of directly for Medicare payments." 

That would affect nearly 80 percent of all small businesses and somehow that provision lowers business costs....


http://www.heritage.org/research/taxes/bg2203.cfm


What is David Cutler thinking?  More to the point, was he thinking?   Certainly there are many factors that influence job creation apart from health care costs, especially if someone is claiming the jobs created are replacing those eliminated for reasons having nothing to do with health care costs!!   Cutler knows that from his own research and from a quick scan of the research on labor economics.  One thing is certain, adding mandated coverage to the cost of being an American or running a business is a tax just as providing a subsidy or third party payment of health care services is a non-cash form of income (tax free) that substitutes for income or lower taxes.   However the effect of each will differ.   A one size fits all approach to providing health care does not work.  And trying to prove that the one size fits all approachh solves every problem is intellectually dishonest.  Americans know a con job when they see it.  And the Center for American Progress study on how better healthcare will create jobs that were destroyed during the recession is exactly that. 





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An Office with Windows

03/02/2010 09:44 AM |

From the Wall Street Journal:

You probably wouldn’t put Microsoft on the list of companies in the market to hire former FDA officials, but the software giant snagged a top medical-device regulator today.

Donna-Bea Tillman, head of the office of device approvals, says her jump to Microsoft isn’t as unusual as it may seem. She told colleagues in a memo she has long had “a love for all things computer.”

Tillman elaborated in an interview with the Health Blog, saying she moonlighted writing software programs for engineering and biomedical experiments when she was in graduate school at Johns Hopkins doing biomedical engineering. “This is a match made in heaven,” she said of her new job.

Microsoft, Google and other technology companies are trying to get in on the medical information-technology bonanza, which was given a boost with $20 billion in last year’s economic stimulus package. Microsoft is also trying to get its Washington health group a higher profile.

IT can play a big part in comparative effectiveness research for medical treatments, Tillman said, adding, “If you want to buy a car, you can get information comparing everything in Consumer Reports, but I can’t get that if I get a disease.”

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Project Hope

03/02/2010 07:49 AM |

Jim Pinkerton (one of the smartest --- and tallest – players in the healthcare policy arena) has penned some very nice words about CMPI’s second annual Odyssey Awards dinner on his blog Serious Medicine Strategy.

And his focus is on one of our favorite four-letter words:  Hope.

Hope in New Jersey

The Center for Medicine in the Public Interest (CMPI) held its second annual Odyssey Award Gala Thursday night, and amidst all the discussion of health policy and medicine, here was one mega-topic on the program: Hope.

Sadly, hope is in short supply in Washington these days. On healthcare, which was supposed to be the signature agenda item of the Obama administration, as well as the Democratic majority in Congress, we now see that both the executive and legislative branches are thoroughly bogged down in unpopular bureaucratese. Leaders on both ends of Pennsylvania Avenue are still trying to pass healthcare "reform" that the American people manifestly do not want. What the American people do want health, but health is not what Washington is interested in advancing. Yes, that seems strange, but Washington is a strange town.

Jim’s complete post can be found here:

http://seriousmedicinestrategy.blogspot.com/2010/02/httpwww.html

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Online and On point

03/01/2010 03:42 PM |

In the continuing saga of social media guidance ...

AstraZeneca (NYSE: AZN) today asked the U.S. Food and Drug Administration (FDA) to adopt guidance that will enable AstraZeneca and others to fully engage in real-time, social media conversations that responsibly provide accurate, balanced information on medicines from a known, identifiable and reliable source. 

            AstraZeneca’s proposal was in response to the FDA's September 2009 Call for Comments on their public notice: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

 “AstraZeneca understands the value of social media to engage key stakeholders in today’s technology-driven world,” said Bob Perkins, Vice President, Public Policy and Promotional Affairs. “While we have developed a corporate presence in the digital space, we believe it is increasingly important to participate in online channels to provide accurate and regulated information about our branded products in conversations with patients, caregivers, and health care providers.”

AstraZeneca believes that five principles should be at the core of any company engagement in social media:

• Truth and Accuracy: Content must be created, developed, or made available that is truthful, balanced, accurate, and not misleading.
  

• To Be Respectful:  Encourage product sponsor participation that respects the interests of patients, caregivers, and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationship.
  

• Protect and Advance Patient Health: Facilitate patient access to quality information for use with their physician to improve their health and protect patients through encouraging accurate and timely reporting on medicine safety.
  

• Transparency: Any product sponsor participation should be accomplished in a manner that, at all times, is entirely transparent to other participants as to the role of product sponsors as participants in online discussion.
  

• Respect the Views of Others: Acknowledge that patients, caregivers, clinicians and others who participate in social media have their own opinions and that, when they differ from those of the product sponsor, it is not the role of a product sponsor to censor or limit these views but to add the product sponsor’s own views to the discussion.
  

In its comments to the FDA, AstraZeneca proposed a regulatory framework that is consistent with these principles and defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media:

• Company-controlled, hosted online communications 
• Company-controlled communications 
• Real-time, social media participation communications
  

The company also noted that, “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making.  In our absence, consumers will turn to information sources that are not regulated and not always well informed.”

AstraZeneca believes the company has an obligation to participate in social media in a responsible way to help educate and empower patients, caregivers and prescribers to make informed decisions about its products.

Click here to view AstraZeneca’s full submission: http://www.astrazeneca-us.com/_mshost795281/content/media/FDA-2009-N-0441.pdf

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An AARP for all seasons

03/01/2010 01:15 PM |

Does silence connote assent? And, if so, assent to what?

On 2/25, AARP announced that it would refrain from further public advocacy of healthcare reform to help, "lower the external political pressure."

Hm.

Please sir, may I have (Sir Thomas) more.
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This is a recording

03/01/2010 08:48 AM |

Whatever happened to “there’s no place for politics at the FDA?” Steve Nissan’s shades-of-Watergate “secret tapes” notwithstanding, the debate over Avandia must be decided based on science and the best judgment of FDA career professionals. 

Secret tapes?  David Graham?  We’ve been down this road before. Let’s get real here folks and let the FDA do its job without political interference.

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The Necessity of Needless Treatments

02/26/2010 11:13 AM |

Jonathan Cohn on why Democrats should just impose an unpopular health care bill on Americans:

"And what about making medical care less expensive? The Democrats' approach is to try a combination of approaches: Eliminating waste, redirecting Medicare payments so that they reward efficiency, altering the tax treatment of insurance, and so on. They admit it will take time and that they are not sure which approaches will work best. But these efforts get at the root causes of rising medical costs--not just profit or administrative inefficiency, but also the tendency towards unnecessary over-treatment."

The liberal logic is that unnecessary treatment is at the heart of rising medical costs (conservatives tend to nod in agreement) and that government regulation can change behavior to eliminate "waste."   The Torah for the Left in implementing this grand scheme is the Dartmouth Atlas. 

But it is increasingly clear that the Dartmouth Atlas is to healthcare reform what the UN Climate Report is to Cap and Trade...  a mass of data and assumptions reinforced by people who believe in the same thing but not in actual biological or clinical facts.   If anything, the effort to eliminate over treatment will make people sicker and undermine innovation, which is the real source of disease prevention and better health.  

Meanwhile,  the Left is also willing to gloss over their willingness to shove 15 million people into Medicaid and what the implications of that will be, on top of cuts to Medicare reimbursement on the supply of hospital and physician services.   Apparently, it thinks that paying little more than half of the going rate is a good way to eliminate "waste."    Does the Left believe that Medicaid delivers great care or can deliver even better care for what it currently pays providers?   Yes it does.  

Finally, Cohn and others lack the guts to admit they are cutting Medicare to pay for an expansion of Medicaid and a tax break for unions.   The "savings"  which may  not materialize are not plowed back into the system.  Oh no, there will be higher taxes for that on top of the new taxes for more expensive,  mandated coverage, which -- the President insists -- is only more expensive because people will want to pay more once they can actually get better coverage.   So you see people really were never concerned about rising premiums after all, they were just waiting for the government to mandate more expensive health care, raise taxes and limit subsidies to a small portion of Americans.  Or more to Cohn's authoritarian purpose, we really shouldn't have a choice because we are too stupid to really appreciate just how great the new health care order will be. 

As I have written before, I hope the Left persists in this strategy.  It will be decimated at the polls come November and health care reform will be better off for it.  

http://www.tnr.com/article/politics/summited-out?page=0,1&utm_source=TNR%20Daily&utm_campaign=26cab0e92c-TNR_Daily_022610&utm_medium=email
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Live from Blair House: Olympic Curling

02/26/2010 06:48 AM |

The much ballyhooed White House summit on healthcare created no “aha” moments or Daily Show-worthy gaffes and was about as interesting to watch as Olympic curling.

President Obama was hoping, by force of will, intelligence and gravitas to both sway Republican lawmakers to his point of view (aspirational at best) while simultaneously demonstrating to the American people (and particularly American voters) that his proposal was a moderate one (arguable at worst).

From a communications perspective, he was presented with a classic  Nick Naylor moment. The president didn’t realize the odds were 2-1 against. Not only did he have to prove he was right, he had to demonstrate the other side was wrong.

The GOP had an easier task — to have something constructive to offer, not get shrill (and yell “liar!”) or look at their watches. They succeeded.

House Minority Leader, John Boehner, rather than coming across as “Dr. No,” was the man with a plan – an easy-to-explain 6-point plan. Communications 101. The GOP were combative but collegial. Their sound bites were designed to generate nodding “me toos” across America. The Democrats were uncoordinated and visibly unhappy they were unable to paint themselves as the white knights of healthcare reform.

Obama and the Democratic leadership needed a dynamic event that would galvanize public opinion behind their call for immediate and comprehensive healthcare reform legislation. They needed a hard-hitting Olympic hockey game. But there were no stand-up body checks. Instead, the president looked like a professor grading papers and the whole enterprise looked and sounded like C-SPAN – the American equivalent of Olympic curling. Let the spinning begin.

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AZ on co-pays

02/25/2010 10:36 AM |

Not AstraZeneca -- Arizona.

It seems the issue of co-pays getting in the way of care and compliance is catching on.  Have a look at this television news report:

http://www.azfamily.com/news/consumer/Sky-rocketing-co-pays-having--85270547.html

This issue is catching fire because it's that rare combination of facts and common sense working together.
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Opie Deepee

02/25/2010 08:24 AM |

So long DDMAC.  Hello OPDP.

Under a new proposal, DDMAC will be renamed the Office of Prescription Drug Promotion and have two divisions, one to review direct-to-consumer content and the second focusing on professionally directed promotions. In terms of structure, it would remain directly under the Office of Medical Policy within the Center for Drug Evaluation and Research (CDER).

According to Rachel Behrman, the proposed change would take several months to implement, adding the suggested move “does not signal a change in philosophy or attitude” in DDMAC, but rather reflects the importance of the division within the agency and its overall size.

And, as we all know, Opie springs eternal.

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A rose by any other name

02/24/2010 09:16 AM |

Thorns are another matter.

Is DDMAC getting a new moniker?  Buzz is that, at this week's DIA marketing meeting, Dr. Rachel Behrman (Associate Commissioner for Clinical Programs) will reveal both a new name and that Tom's Posse will be elevated to an "Office" within CDER. 

Does a new name mean a new attitude?

Just yesterday, Tom Abram's called upon industry to adopt increased self-regulation and restraint.  Thanks Tom.

"We do what we must, and call it by the best name."

-- Ralph Waldo Emerson
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