NY Times Finds Medical Fear in the Wrong Places

02/07/2011 03:46 PM |

Virginia Heffernan’s article (Prescription for Fear www.nytimes.com/2011/02/06/magazine/06FOB-Medium-t.html) claims WebMD is a less trustworthy health info than Mayo because it (in her words) shills for drug companies. 

She should be less concerned about drug advertising and more about how online health sites are used to shape public perception.  If she did, she would have focused on all the sites that spread anti-vaccine fear.  Most of them are not in it for the money.  Those that are hawking their own products. 

Moreover, she ignored how mainstream coverage, relying on such sources, spread panic and misinformation.  The media perpetuated the anti-vaccine ideology, overstated the risks of anti-depressants and recently called a 1 in 3 million occurrence of a rare lymphoma in women with breast implants a “link.”

 

Ms. Heffernan is right to be wary about many online health sites.  But her concern with WebMD is misplaced.  WebMD’s medical reporting copies other news outlets.  She should have focused on her own industry’s mangling of medical information.

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Regulatory Race Relations

02/07/2011 08:02 AM |

Peggy Hamburg’s letter to the editor (Washington Post, February 4, 2011)

Drug approval isn't a race between the U.S. and the E.U.

In his Jan. 24 op-ed, "Finding a strategy for growth," Fareed Zakaria missed the mark regarding the speed of drug approvals in the United States and Europe. The facts show that the Food and Drug Administration's review times are somewhat shorter and that approval of new drugs generally occurs sooner in the United States, compared with Europe.

The FDA compared marketing approval of 57 novel drugs approved by both FDA and European Union regulators between 2006 and 2010. Of these, 43 were approved first in the United States and 14 were approved first by the E.U. Twenty-seven of these 57 drugs were FDA-designated priority review drugs that provide a therapeutic advance, and all but three of the 27 were approved first by FDA. The median time from marketing submission to FDA approval was 183 days for priority review products, and 396 days for standard review products. In the E.U., those times were 403 days and 449 days, respectively.

The review and approval of new drugs is not a race between FDA and EU regulators, with whom we collaborate and whom we see as colleagues. But we do operate under different laws and procedures. Finally, we note that apart from the FDA's regulatory climate, there are many reasons why industry chooses to work overseas, including reduced labor and production costs.

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Empty Expertise and Obamacare

02/04/2011 05:57 PM |

To get a sense of how divorced from real experience most healthcare policy experts are let me share with you some recent examples.. 

Here's Jonathan Cohn:

"The idea behind the Affordable Care Act is to strengthen health insurance and give it to more people, which will cost the government money. At the same time, though, it will make the health care system as a whole more efficient, which will save the government money. Over the course of a decade, the costs and savings should be about equal, which means the net cost to the government would be roughly zero -- even as we'd made insurance both more reliable and much more available. That would be a pretty good deal...

Now, if you're worried about the government's long-term fiscal future -- and you should be! -- the key question is what happens after those 10 years. The big worry is that the budgetary burden of health care will become staggeringly heavy in 2030, 2040 and beyond. The only way to avoid that scenario is to slow down the growth of federal health care spending -- that is, to make sure it doesn't keep going up as fast as it's been for the last few decades."

But it begs the question: haven't we been making health care more efficient over the past 20 years?  Following Cohn's argument, doing so would have prevented federal health care spending and spending overall not to go up as fast as it's been for the last few decades.

www.kaiserhealthnews.org/Columns/2011/February/020311cohn.aspx

Applying that timeline what do we see?

The rate of increase in healthcare spending is three times slower in the last few years compared to what it in 1970.

Assuming government wasn't doing anything to help, what was?   I have some ideas but the point is,  health care debates that don't start with accepting the facts as they are instead of some narrative we "feel" is right will go nowhere fast.

In the interest of fairness, here's an example of empty expertise from the conservative perspective:

Here's John McCain on Rx drug costs:

"Americans salaries are being cut, household budgets are slim and millions of Americans are struggling to make their monthly mortgage payment.  For these reasons and so many more, Americans should not be forced to wait another day to purchase safe and affordable prescription drugs from outside the United States.  But, while Americans all over the country and having to choose between their next meal and their necessary prescriptions, the large pharmaceutical companies continue to pressure Congress to delay consideration of any legislation to allow the importation of safe and lower priced prescription drugs."

The reality?

"Canadians (on average) spent 2.5% of their per capita PDI on prescription drugs in 2007, compared to 2.6% in 2009. Americans spent less of their per capita after-tax income (2.3%) on prescription drugs than Canadians in both 2007 and 2009. Comparable results were found when prescription drug spending as a share of per capita GDP was ana- lyzed. Canadians (on average) spent roughly 1.5% of their per capita GDP on prescription drugs in 2007, compared to 1.7% in 2009 (figure 1). Americans spent the same percentage of their per capita GDP on prescription drugs in 2007 as they did in 2009—roughly 1.7%."

tinyurl.com/4f7x94y

www.fraserinstitute.org/.../fraser.../prescription-drug-spending-Canada-and-US.pdf - Canada

People can have their own opinions, but not their own facts....

 

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Getting the Biggest Bang for the Regulatory Buck

02/04/2011 08:48 AM |

Getting the biggest bang for the regulatory buck doesn't mean that the FDA needs fewer bucks.

According to a story on today’s AP wire:

“House Republicans are seeking to keep their campaign promise to cut $100 billion from domestic programs … The hardest hit agencies would include the Food and Drug Administration …”

This is a crucial debate at a time when the agency needs more, not less funding and PDUFA is up for reauthorization.  Both the Congressional determination to spend more wisely and the pharmaceutical industry’s desire that PDUFA V returns to first principles are not mutually exclusive.  What both groups want is a properly funded FDA that spends its money in a responsible and predictable manner.

For more on the urgent need for smart and timely PDUFA reauthorization, see here, here, here, and here.

“Money is better than poverty, if only for financial reasons”

-- Woody Allen

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Pregnant Pause

02/03/2011 10:06 AM |

Here’s the headline:

 

WASHINGTON — The Obama administration is examining whether the new health care law can be used to require insurance plans to offer contraceptives and other family planning services to women free of charge.

 

The article by Robert Pear is more about the continuing and hypersensitive debate over contraception than anything else – but there’s another issue.

According to the Patient Protection and Affordable Care Act, insurers must cover “preventive health services” and cannot charge for them. Without getting into the myriad and highly political issues surrounding contraception, an obscured, undiscussed but highly important question relative to the PPACA is – just what is “preventive medicine?”

With dynamic advances in diagnostics, we can now determine (with ever-greater degrees of accuracy and certainty) if someone, say, is prone to develop Alzheimer’s Disease.  A recent article in the New York Times, “Two Tests Could Aid in Risk Assessment and Early Diagnosis of Alzheimer’s,” discusses a diagnostic scan that can help physicians determine whether a patient’s dementia is actually Alzheimer’s – allowing earlier and more aggressive treatment. The article also points out that, “… a large study sponsored in part by the National Institute on Aging is scanning healthy people and following them to see if the scans predict the risk of developing Alzheimer’s disease.”

If such a predictive test does become available, would this fall under the codicils of the PPACA’s call for “no-cost preventive screenings?” The impact on payers would be significant.  Such a diagnostic would cost significantly more than a prescription for the Pill.  And if Alzheimer’s was indeed the diagnosis – treating it is expensive.

The question then arises, is it cheaper to identify and aggressively treat a patient in the early stages of Alzheimer’s (even before there is a significant manifestation of symptoms) or to wait until the late stages – where the real costs lie not only in therapeutics, but in the related expenses of care-giving?

As the Center for Medicine in the Public Interest demonstrated in the paper, “Alzheimer’s Disease and Cost-effectiveness Analyses:  Ensuring Good Value for Money or Indirect Price Controls”, early intervention saves significant dollars over the course of the disease – even by delaying disease progression.  This is a crucial point as there is, at present, no “cure” for Alzheimer’s Disease.

Where you stand often depends on where you sit. Will the PPACA demand that insurance providers provide free “preventive care” for a drug that doesn’t lead to prevention of a disease (like Alzheimer's) but delays its progression (like Aricept)? What about diagnostic screenings that can significantly lower the long-term costs of a non-preventable disease? If you are a payer, it’s a question of short-term costs versus long-term savings. And then, of course, whether the disease state is Alzheimer's Disease or breast cancer -- there’s what’s best for the patient.

And that’s a consideration particularly germane for our nation’s largest payer – Uncle Sam.

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CMPI Senior Fellow J. Rick Turner named new Editor-in-Chief of the Drug Information Journal

02/02/2011 11:55 AM |

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Grover on the Florida ruling

02/02/2011 11:50 AM |

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Globalizing Regulatory Oversight

02/02/2011 06:38 AM |

As a follow-up to my comments on combating counterfeits on a global level (“Peggy’s Regulatory Marshall Plan”), let me share some comments from the Commissioner’s speech Monday at Council on Foreign Relations.

(The speech – as delivered – will be available shortly on the FDA’s website.)

 

It’s a pleasure to be back in New York and at the Council on Foreign Relations. I have admired this organization for many years and am proud to be a longstanding member.

 

Some here may have been surprised to see that CFR is focusing on issues of food and drug regulation. But it is highly appropriate, much needed, and very timely. 

 

Our scope and responsibilities are enormous. But it hasn’t always been that way. As you can imagine the world in which FDR created the modern FDA in 1938 was very different from ours.

 

Back then, most products FDA regulated were domestically manufactured and the data supporting them came from American investigators. And for years, when it came to importation of foreign products, our authority to ensure safety and quality and to protect public health focused on catching problems at the border and then limited overseas inspections. But times have changed.

 

Today the world in which FDA-regulated products are discovered, developed, processed, and distributed is much bigger. FDA’s traditional model of manufacturing site inspections and border examinations is simply not adequate in today’s transformed world.

 

In 2010 alone, FDA estimates that more than 20 million import lines of food, devices, drugs, cosmetics, and tobacco arrived at U.S. ports of entry—more than a three-fold increase in regulated imports from a decade ago. Regulated products come from 300,000-plus facilities in more than 150 different countries all over the world. And they come through over 300 ports of entry into the United States. 

 

The numbers are staggering. In the food realm, about 40 percent of fresh fruit and produce and over 70 percent of seafood we eat in the United States come from other countries. And for medical products, a stunning 80 percent of the active pharmaceutical ingredients in our drugs come from outside our borders and about 40 percent of the drugs themselves. 

 

The global supply chain has led to the distribution of unsafe or ineffective products and harm caused by economic adulteration and intentional fraud. You will hear directly from others the tragic toll that the counterfeit trade is taking in many parts of the world. And for all of us, the global supply chain presents many new national and international security threats.

 

In recent years in this country, we have experienced events—some clearly deliberate and some unintended—with serious implications for health and safety, as well as for trade, commerce, and the economy: ranging from contaminated heparin (a blood thinning drug), counterfeit glucose monitor strips and surgical mesh, to melamine-tainted vegetable protein and dairy products, salmonella in peppers, to name just a few.

 

This is a moment for leaders around the world to create a new vision of how we regulate. We have a shared interest in ensuring the safety and quality of food and medical products and a shared responsibility for safety and quality. By working together to monitor and improve safety and quality globally, we will benefit all the citizens of the world.

 

What I envision for the future is a public health safety net for consumers around the world that is created, supported, and maintained by a global alliance of regulators. Some of the work for this is already underway and has been for several years, as regulators around the world have begun to collaborate. But these efforts need to be taken to the next level. We must ask ourselves how we can weave our various efforts into a coherent global system of oversight and safety.

As part of these efforts, regulatory authorities, especially those with the greatest experience and resources, must work together to help build regulatory capacity in those countries that are more resource poor and with still developing systems so that they can produce food and commodities that are safe, wholesome and meet international safety standards. This is surely in America’s vested interest, but it will have broader benefits for public health and economic development within those countries.

 

In addition to creating a global coalition of regulators, we must create a modern means to share data globally. And, we must use those data and advanced analytics to proactively prevent and identify problems. Detecting and preventing global problems demands global intelligence- sharing and data-mining. 

 

Also, as the new food safety law recognizes and requires, we must also enlist public and private third parties, as well as industry and other organizations, to increase the global safety net. We must do this for foods and medical products. Regulators cannot do it alone. 

 

Finally, we must create the momentum in the U.S. and in the global community to make these changes real—and sustainable. These changes must begin now, but they will take time and the support of many people to fully implement. A strong global safety net will be challenging to weave. But, we can do it together.

 

So let us continue the conversation today and—as regulators, consumers, academics, industry leaders, and others with expertise—find new ways to ensure the safety and quality of food and medical products and promote the health and well being of the American people and our fellow citizens around the globe.

 

These issues affect us all and we all must contribute to solutions. Thank you.

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Sensationalized Online Health Info Can Be Deadly

02/01/2011 01:16 PM |

www.psychologytoday.com/blog/baffled-numbers/201101/overcoming-tabloid-medicine-uphill-battle
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Obamacare's Final Chapter

02/01/2011 12:46 PM |

As seen in The American Spectator ...

Obamacare's Final Chapter
By:  Robert Goldberg

Judge Roger Vinson's summary  judgment declaring the Patient Protection and Affordable Care Act unconstitutional goes beyond providing legal basis for overturning the requirement to buy healthcare. He demonstrates that the individual mandate is merely a means to solve a political problem created by the faulty drafting of Obamacare. In doing so, he forces the administration and the Supreme Court to overturn his decision by expanding the power of Congress in capricious ways neither the Founders intended or voters will be happy with.

The first part of Vinson's brief rejects the complaint made by the 26 states opposing Obamacare that the required expansion of Medicaid is coercive because it forces hard choices on states it did not agree to. Vinson (citing another court opinion) notes, "The difficulty if not the impropriety of making judicial judgments regarding a state's financial capabilities renders the coercion theory highly suspect as a method for resolving disputes between federal and state governments." Governments cannot use the Constitution to solve a problem created by bad policy.

In making this argument Vinson invokes the original Tea Party. He notes: "It is difficult to imagine that a nation which began, at least in part, as the result of opposition to a British mandate giving the East India Company a monopoly and imposing a nominal tax on all tea sold in America would have set out to create a government with the power to force people to buy tea in the first place."

This is more than a rhetorical flourish. Vinson is setting the stage for shredding the constitutionality and reasoning behind the individual mandate: The American Revolution was started in part by outrage against the tea tax. How greater would that reaction be if citizens were also forced by any government not only buy tea but also to purchase a specific kind of tea from specific companies or risk a penalty.

Under Obamacare, not only is a decision not to buy healthcare against the law, so too is the voluntary purchase of a product other than that specified under Obamacare would trigger a penalty.

Stephanie Cutter, Obama's health care advisor, blogged: "People who make an economic decision to forgo health insurance do not opt out of the healthcare market. As Congress found, every year millions of people without insurance obtain healthcare they cannot pay for, shifting tens of billions of dollars in added cost onto those who have insurance and onto taxpayers." The White House goes further and argues that because other parts of Obamacare might encourage people to postpone getting insurance until they need to, the individual mandate is "necessary and proper." Without it, the healthcare market would collapse.

Which leads Vinson to his second argument: The administration's claim that without the mandate costs and taxes would rise is no better a reason for judicial intervention than the claims of states that Obamacare is forcing them into a lousy financial position. It would be a huge overreach of judicial power to compel people to buy a specific product to rectify a situation created by previous policies. Congress enacted laws requiring hospitals that receive Medicaid dollars to treat all individuals and ask about cost later.

Congress has many options to address the "free-rider" problem just as the states have a range of choices in addressing rising Medicaid costs. (It could impose a healthcare tax on everyone to pay for insurance for the uninsured or bailout states. Or it could change laws to eliminate uncompensated care.)

Hence, Vinson notes: "it should be emphasized that while the individual mandate was clearly 'necessary and essential' to the Act as drafted, it is not 'necessary and essential' to health care reform in general." In fact, the mandate and penalties a prescribed actually reward businesses and individuals for dropping coverage and enrolling in Medicaid. That would -- in Cutter's words -- shift tens of billions of dollars in added cost onto those who have insurance and onto taxpayers.

If Congress can compel purchase of specific products from only government-approved health plans under the Commerce Clause to deal with financial challenges in the healthcare market created by previous policies or compensate with Obamacare's imperfections, nothing can stop it from dictating the terms and conditions of other economic decisions that have a fiscal consequence to a particular market.

Vinson has done more than overturn Obamacare. He's raised the political stakes for Obamacare supporters. Overturning his ruling would force the Supreme Court to "authorize Congress to reach and regulate far beyond the currently established 'outer limits' of the Commerce Clause and effectively remove all limits on federal power." The political response would lead to Obama's defeat or congressional action eliminating the individual mandate. Either way, it is increasingly unlikely Obamacare will be enacted.

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Discussion of Tabloid Medicine

02/01/2011 12:40 PM |

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Peggy's Regulatory Marshall Plan

02/01/2011 10:25 AM |

Yesterday the Council on Foreign Relations held a conference on the issue of global counterfeiting of both food and drugs.  Appropriately, the U.S. Commissioner of the Food & Drug Administration, Peggy Hamburg, was the keynote.  And she had some interesting and important things to say.

A few pearls from Peggy:

* The new reality of food and drug regulation is that it’s global. In fact, it should be a topic for conversation at the next meeting of the G20.

* The recent crises in both food and drug safety will only repeat themselves unless regulatory agencies from around the world work in closer and more regular partnership.

* There is a responsibility on the part of the FDA and other more developed regulatory agencies around the world. (MHRA certainly comes to mind.) to help build “regulatory capacity” for those nation’s that want and need assistance. (Nigeria comes to mind.

* Part of a closer working relationship means a more regular and robust sharing of global intelligence on issues of counterfeiting. (And, for that matter – many other things too.)

* And lastly, “We can’t inspect our way out of this problem."

All good things – progressive things -- but, short of a regulatory Marshall Plan, things that will have to rely (at least initially) on personal relationships between senior officials at various regulatory agencies and a focus on what’s best for global public health writ large is convergent with what’s best for any given nation.

It’s not as easy as it sounds.

Beyond the generally difficult nature of international regulatory harmonization (yes friends, it is a lot harder than it looks) is the profoundly difficult issue of domestic economic interests and trade.

For example, every nation (from the United States to Nigeria) is concerned about counterfeit drugs and unsafe food coming across its borders.  That’s obvious. But are all nations equally concerned about controlling the export of counterfeit, unsafe, and substandard products to other nations?  That’s trade.

Principles aren’t principles, as my father used to say, until they hurt.

Paul Orhii, Director-General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), was on the event’s first panel and he shared a chilling story – not of children dying from imported Chinese cough syrup laced with diethylene glycol, but of the Chinese government’s view on where it’s responsibility for quality control begins and ends.

The Chinese, it seems, believe their responsibilities end when a product leaves the borders of the Middle Kingdom.

According to Orhii, when he complained to the SFDA (the Chinese drug regulatory agency) that many of the counterfeit medicines in Nigeria (where, according to the NAFDAC DG, 40% of the drug supply is counterfeit) were coming from China, he was bluntly told that Beijing was not responsible for the quality of medicines in Nigeria – that was his problem.

So much for regulatory fraternity.

And, when it comes to counterfeit medicines there’s the definitional problem – largely driven by (yep) domestic and international trade concerns.  You can talk TRIPS all day long, but at the end of the day it’s about money.

If we can’t even agree on the definition of “counterfeit medicines,” how are we ever going to start, methodically and cross-nationally, measuring its size and scope? And while the war of words rages within the Byzantine confines of the WHO, people continue to die and the problem continues to grow.

As a next step, how about a coordinated international effort to measure the infiltration of counterfeit medicines into national drug supplies. After all, if you can’t measure it, then it doesn’t really count.

We cannot continue to combat counterfeit medicines through the power of horrific anecdotes.

“Man is the measure of all things.”

-- Protagoras

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AD Hoc

01/31/2011 07:12 AM |

We should all pay attention to our nomenclature.  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." Case in point:  so-called “academic detailing” (AD).

 

According to the Big Daddy of AD, Jerry Avorn (Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology ), “Academic detailing is when healthcare professionals (usually pharmacists) meet with healthcare professionals to provide them with information and educational tools on various treatment options and optimal care, to improve provider knowledge of medical treatment effectiveness, encouraging alignment of practices with established evidence.”

 

(PS/ for the sake of transparency, it’s important to note that Dr. Avorn has his own for-profit academic detailing business that has a contract with the state of Pennsylvania.)

 

Left unsaid, but clearly implicit, is that such detailing is required to offset the devilish doings of the pharmaceutical industry. That’s why the more common appellation for academic detailing is counter detailing.

 

Why should anyone care?  Well – not to put too fine a point on it – it’s now the law of the land.  (That is to say that significant government funding has been provided to develop and roll-out academic detailing programs.)

 

As of October 2010, AHRQ has awarded five grants for a program on academic detailing and the “communication of CER results to physicians”.  This program to disseminate CER findings is supported by $29.5 million from the American Recovery and Reinvestment Act (aka, “the stimulus package”).

Where is the money going? Good question.

* One contract, for $11.7 million, went to Total Therapeutic Management (TTM) and is specifically intended for physician outreach and education

(TTM is a company that focuses on chart abstraction, data mining, and physician and patient education for a predominantly commercial client base -- health plans, pharmacy benefit managers, employers, and pharmaceutical companies, etc.)

The goal of this contract is to integrate AHRQ’s comparative effectiveness research, products, and tools into clinical practice through 9,000 on-site, face-to-face visits with clinicians, nurses, health plan formularies, benefit managers, and other healthcare professionals. 

Other recipient organizations under the overall program:

* $18 million to Ogilvy Public Relations Worldwide, Healthcare Division to create a publicity center and another contract for $8.6 to create regional dissemination centers.

* A $4 million “continuing education award” to Prime Education (an educational design and accreditation company focused on continuing medical education programs).

* $2.4 million to IMPAQ International (a social science research and consulting firm that specializes in impact evaluations for a client base of predominantly U.S. government agencies) to evaluate the impact of the other four contracts.

But there are some problems.

* Only a few small studies demonstrate that academic detailing reduces overall healthcare costs (direct and/or indirect) – and most only demonstrate reduced prescription drug expenditures.

To that point:

* Reducing the amount of money spent on drugs without improving the quality of care significantly limits the impact of detailing programs on overall healthcare costs. In fact, it just reinforces the concept of “fail first” – a strategy that’s good for payers (including our nation’s biggest payer – Uncle Sam) – but bad for patient outcomes.

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 out-of-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.

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.

One study of schizophrenia drugs used in Georgia's Medicaid program showed that, while step therapy saved the state close to $20 a month on drugs for every patient, the savings were more than offset by increased costs in other services. Indeed, the program saw a monthly increase of nearly $32 per patient in outpatient care.

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." Access to care must be matched with quality of care.

There is little information on why so few AD programs attempt to measure overall healthcare cost reductions.  This is likely due to the fact that measuring changes in prescription drug costs is a more manageable analysis than determining changes in overall healthcare spending. It also (in the calling a spade a spade department) fits into the general cognitive mapping of those who believe that pharmaceutical costs are the main driver of health care costs. (FYI – on-patent drug costs represent less than a dime on the American healthcare dollar.)

If the goal is better outcomes and lower costs – the problem isn’t the cost of pharmaceuticals, it’s the costs of non-compliance.

The New England Healthcare Institute estimates that $290 billion in healthcare expenditures could be avoided if medication adherence were improved.

A new study in Health Affairs demonstrates that people with four common chronic illnesses saved themselves – and the healthcare system – significant dollars by being medication adherent.

The CVS Caremark-funded report is based on an analysis of 135,000 patients with congestive heart failure, diabetes, hypertension and high cholesterol. The study found that people who took their meds made fewer visits to the emergency room and spent fewer days in the hospital. Specifically:

* Patients with congestive heart failure who took all their prescribed drugs saved $7,832 per year compared with those who didn’t.

* Patients with diabetes saved $3,756 by taking all of their meds.

* Patients with high blood pressure saved $3,908 when they filled all their prescriptions.

* Patients with high cholesterol saved $1,258 when they got the full benefit of pharmaceuticals.

The study concludes:

“Our findings indicate that programs to improve medication adherence are worth consideration by insurers, government payers, and patients, as long as intervention costs do not exceed the estimated health care cost savings.”And according to a report from the Center for Technology and Aging (CTA), "Medication non-adherence is responsible for up to 33 percent to 69 percent of medication-related hospital admissions and 23 percent of all nursing home admissions."

Adding new meaning to the words "penny wise, pound foolish."

The CTA recommends a robust program of medical optimization (“med-ops”) via information technology as an important element to improving medication-related errors and improving medication adherence among older adults.

The report says "widespread use" of technology aimed at this population could save thousands of lives and billions of dollars.

"More widespread use of technologies that reduce the cost and burden of medication-related illness among older adults is urgently needed," said David Lindeman, the center's director.

AHRQ funding for such programs:  zero.

The worst part about rushing headlong into academic detailing is that there is no clear articulation or transparency regarding the specific rules and regulations that will govern the behavior and activities of AHRQ-funded detailers.

Some of those unanswered (and, alas, unasked) questions:

Q: What safe guards are in place to certify that physicians are being presented information that is unbiased? Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low cost therapies.

Asked another way – how can an “academic detailing” program funded by our nation’s largest payer be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent.  But “academic” it ain’t.

Q: What information is worthy of being detailed by these programs?  Who decides and on what basis?

Q: What can they say or not say?  Who decides? Will they have to play by the same rules as pharmaceutical representatives?  And, importantly, what is the oversight mechanism?  If academic detailers stray into off-label conversations, to whom does DDMAC send a letter?  Whom does the Department of Justice investigate? Who pays the fine?

All this to say that, if academic detailing is the answer – what’s the question?

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CBS Drops Charlie Sheen, Supports Wakefield

01/30/2011 04:10 PM |

While CBS is cancelling Two and Half Men while Charlie Sheen enters rehab, it is still sticking with Andrew Wakefield.   Specifically CBS Evening News producer Sharyl Attkison – who works for Katie Couric – continues to carry on the anti-vaccine crusade of Andrew Wakefield and others who believe that Wakefield is a misunderstood martyr.   Atkinson, who in the past sought to smear Paul Offit and other scientists for promoting the safety and importance of immunizations remains Wakefield’s staunchest support among the mainstream media outlets.  After Wakefield’s fraud was exposed and many journalists began to acknowledge that they had provided him and anti-vaccine groups with an “evidence free pass” over the past decade, CBS News came out with this fearmongering headline:

Child Flu Vaccine Seizures?

Posted by Sharyl Attkisson9 comments

More confusing news for parents trying to do the best, safest things for their children when it comes to vaccination.

According to a Vaccine Safety "update" issued by the FDA on Jan. 20, there's been an increase in reports of febrile seizures among infants and children following this year's flu vaccine. Febrile seizures are seizures associated with fever.

According to the FDA: "FDA and CDC have recently detected an increase in the number of reports to VAERS of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc.). Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age."

The FDA says 42 more seizures than usual were reported through Dec. 13; most within a day of the child receiving the flu vaccine. The FDA recommends parents take no action based on this information. They should, the FDA says, continue getting their children vaccinated against flu, as usual. (It should be noted that non-government medical experts differ on the issue of whether flu shots should be given to children.

The FDA points out that data from VAERS, the Vaccine Adverse Event Reporting System, is preliminary and serves as a sign that further investigation is warranted. The maker of the flu vaccine in question, Sanofi Pasteur, has issued a statement saying that no clear link has been established between the flu shot and the seizures, and the cases may be nothing more than coincidence.

 

And CBS concludes:

Even with "no clear link established," the mere suggestion of a link may be troubling to parents.

Not content to stop there, CBS adds a link to another study that has nothing  to do with flu shots:

 

http://www.cbsnews.com/htdocs/pdf/Molecula.pdf

 

But the study says nothing about kids, vaccines, seizures, autism.. The study merely points out that in animals early life seizures can result in cellular and molecular changes that could contribute to learning and behavioral disabilit

 

As  the LeftBrainRightBrain blog (points out):  “Attkisson has either not read the study she cites, does not understand it, or has a very dark agenda. The paper discusses patients with early life seizures and epilepsy. Attkisson gloms on to the findings and applies them, with no credible reason, to the general population.

 

The 42 extra cases of febrile seizure reported in the VAERS database do not come close to establishing causality. Instead of telling readers the FDA report is no cause for alarm, Attkisson does the exact opposite.

 

And Attkisson has been a stalwart in using CBS News to flack for and support anti-vaccine causes:

 

http://lizditz.typepad.com/i_speak_of_dreams/2008/07/sharyl-attkisso.html

Where are the health care journalists and watchdog types when it comes to CBS News as a platform for anti-vaccine rhetoric?  It’s time to demand that CBS both explain this troubling pattern and seek to ensure it’s coverage of vaccine safety issues – as well as other medical news – is science-based.

 

It should worry about the lives of kids more than it does the future of one of it’s sit-coms.

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Stent Gent

01/28/2011 08:54 AM |

As the saying goes, the plural of “anecdote” isn’t “data” -- that is unless the anecdote supports your theory.  Here’s a personal anecdote -- a story of how the system works.

Being adopted, I have no family history, so when I suffered through some late night chest pains I figured I’d better act on the warning signals. I called my GP and got a same-day consultation, resulting in a next-day referral to a cardiologist and a stress test.  Diagnosis – arterial blockage and an immediate referral to NYU Medical Center for an angiogram. 48 hours later I had two stents and was home – writing this report.

My situation is not unique but, being in the business of healthcare policy, some of the things that happened to me are indicative of some broader themes.

1. Facts vs. Fear

After being admitted into the cardiac unit, getting my wrist ID and giving some blood, my first visit was with a nurse practitioner who began her explanation of stents as follows, “You might have read some newspaper articles about how stents are over-used and dangerous.  That’s crap.  They save lives, they’re safe and it’s a lot more pleasant than open-heart surgery.”

This before she asked me what I did for a living.

2. The Evils of Pharmaceuticals

After the obligatory (and important!) lecture about the need to eat more healthfully and exercise more regularly, one of the resident’s said to me, “And we’re big believers in pharmaceutical intervention – don’t believe everything you read in the newspaper.” 

This before he asked me what I did for a living.

3. Problems with the FDA

When I told the interventional cardiologist that I was a former FDA associate commissioner and was at the agency when the first drug eluting stent was approved, his comment was, “That’s something you should be proud of.”

That, despite all the middle-of-the-night poking and prodding (and my roommate’s bed-rattling basso profundo snoring) made my visit a more meaningful and memorable experience.

4. The Cost of Innovation

As I walked in my own front door a mere 26 hours after surgery, full of piss and vinegar and ready for action, I remembered my father.  His first heart attack (at an age only slightly older than mine today) landed him in the hospital where his sternum was split open and a bypass performed. A dangerous operation followed by a lengthy hospital stay and a prolonged, home-bound period of recovery. That was then. The best there was at the time.  Top-notch 20^th century surgical technique and pharmaceutical therapy.  It was very expensive and left him with a scar the size and shape of a Sonoran Gopher Snake.

Over 20 years later, all I have to remember my surgery by is a small catheter incision and a handful of booklets on heart-healthy nutrition.

Which I plan to read and act on.

Tennis anyone?

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Friday reading

01/28/2011 01:35 AM |

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The phony connection between thimerosal and autism

01/28/2011 01:23 AM |

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Breast Implant Cancer Panic: Wakefieldism Rises Again

01/27/2011 04:05 PM |

Here is what the FDA concluded about a possible association between breast implants and a rare form of non-Hodgkins lymphoma called anaplastic large cell lymphoma (ALCL). Read more here.
 

It is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.

The FDA also noted 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast.  As in 0.000003% of women. 
 

There were 60 reported cases of ALCL in women with breast implants worldwide from 1997-2010.   The average time women between getting implants and a ALCL diagnosis was 8 years.   
 

Should women with implants be concerned?  The FDA suggests follow up for any persistent swelling or fluid build up.  And    cautions that over-reaction could lead to even worse problems for women:
 

“..if we biopsy every abnor­mality – such as a minor thick­ening or fluid accu­mu­lation adjacent to a breast implant – we’ll hike up the costs and, more impor­tantly, the com­pli­ca­tions asso­ciated: With every needle stick there’s a risk of infection, addi­tional scar for­mation and more. On the other hand, you wouldn’t want to overlook a treatable, early-stage lym­phoma. Women need to know of the risks of implants, which can only be deter­mined if doctors thor­oughly inves­tigate these sorts of complications.”
 

And the risk of dying?  Early diagnosis and treatment for all forms ALCL is essentially a cure.  And relative to the risks of dying from heart disease and diabetes the risks seem fairly insignificant. 
 

But if you read most of the media outlets and websites in the last couple of days you would have thought that implants were “linked” conclusively to an increased risk of cancer for every woman who has them:
 

Breast implants could put women at increased risk of rare cancer

Chicago Sun-Times - Monifa Thomas -

FDA looks for cancer link to breast implant patients

Boston Globe - Deborah Kotz -

Breast Implants May Be Linked to Rare Cancer

Wall Street Journal - Jennifer Corbett Dooren, Alicia Mundy -

Breast Implants Linked to ALCL, a Form of Blood Cancer, According to FDA

ABC News - Lara Salahi 

Breast Implant Link to Cancer Probed by US FDA After 34 Cases Reported

Bloomberg - Catherine Larkin

AP’s Matt Perrone did a great job reporting the real risk-benefit bottom line but the Huffington Post managed to turn his account inside out with this headline:
 

Breast Implants Cancer Link Found, Says FDA

MATTHEW PERRONE

Blogs were not much better for the most part:
 

Well: Breast Implants Linked to Rare Cancer

New York Times (blog) - Toby Bilanow 

Breast implants may cause rare cancer

CNN (blog)
 

WebMD FDA announced that there is a link between breast implants and a very rare form of blood cancer. Read more here 

Actually WebMD the FDA used the term “a possible association”
 

The rare exceptions:

FDA Reports on Association of Breast Implants and a Rare Form of Lymphoma

By Elaine Schattner, M.D., on January 27th, 2011

Read more here
 

and

About that Breast Implant/Cancer Risk … - Health Blog - WSJ

5 hours ago by Katherine Hobson
 

Even assuming 60 cases among 5 million women, that's about one case per 83333 women. http://blogs.wsj.com/health/
 

(Actually it is 60 cases among 5 million over 10 years but we should get the point)

Last week the media was congratulating itself for reporting that Andrew Wakefield was a fraud after giving him an evidence free pass for over a decade.  But as Gary Schweitzer warned:
 

“Unfortunately, journalism played a key role in promoting Wakefield's claims. The "Respectful Insolence" blog referred to one journalist as CBS' resident anti-vaccine propagandist. Around the world there were many other examples of journalists' unquestioning acceptance of the vaccine scares.
 

The BMJ reminds us that "the damage to public health continues, fuelled by unbalanced media reporting and an ineffective response from government, researchers, journals, and the medical profession."

 

Read more here

Didn’t take long for mainstream outlets to go back to their unhealthy habits…

 

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Franken Sense

01/27/2011 11:41 AM |

The Senator from SNL, Al Franken, has introduced legislation that would allow the federal government to negotiate lower drug prices for Medicare beneficiaries.

In other words, legislation that would abolish the Non-Interference Clause.

Franken says that his Prescription Drug and Health Improvement Act would cut prescription drug costs for seniors in Minnesota and across the country.

“When I travel around Minnesota, I always hear from seniors that they’re still paying far too much for prescription drugs,” Franken said.

That’s Franken nonsense.

Some things to consider:

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

Stanford Business School's Alain Enthoven and Kyna Fong

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

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

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

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

Why?  Marketplace competition.

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

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

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

We shouldn’t interfere with success.

By revoking the Non-Interference clause, Uncle Sam will be able to "negotiate" prices for Part D drugs.  That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head.  There's also the potential for Uncle to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.

“Direct negotiations” means price controls.  And price controls = choice controls.

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The Ryan health care message

01/26/2011 06:33 PM |

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