A New/Old Perspective on Risk

02/13/2009 08:20 PM |

As we continue to furrow our collective brows pondering the eternal quandary of risk/benefit, I thought you’d enjoy the comments below (which I received this afternoon via e-mail from a respected physician who shall remain nameless):

TO ALL THE KIDS WHO SURVIVED THE 1930s, 40's, 50's, 60's & 70's

First, we survived being born to mothers who smoked and/or drank while they were pregnant.

They took aspirin, ate blue cheese dressing, tuna from a can, and didn't get tested for diabetes.

Then after that trauma, we were put to sleep on our tummies in baby cribs covered with bright colored lead-based paints.

We had no childproof lids on medicine bottles, doors or cabinets and when we rode our bikes, we had no helmets. Not to mention the risks we took hitchhiking.

As infants & children, we would ride in cars with no car seats, booster seats, seat belts or air bags.

Riding in the back of a pick up on a warm day was always a special treat.

We drank water from the garden hose and NOT from a bottle.

We shared one soft drink with four friends, from one bottle and NO ONE actually died.

We ate cupcakes, white bread and real butter and drank Kool-Aid made with sugar, but we weren't overweight because we were always outside playing.

We would leave home in the morning and play all day, as long as we were back when the streetlights came on.

No one was able to reach us all day. And we were O.K.

We would spend hours building our go-carts out of scraps and then ride down the hill, only to find out we forgot the brakes. After running into the bushes a few times, we learned to solve the problem.

We did not have Playstations, Nintendo's, X-Boxes, no video games at all, no 150 channels on cable, no video movies or DVD's, no surround-sound or CD's, no cell phones, no personal computers, no Internet or chat rooms.

We had friends and we went outside and found them!

We fell out of trees, got cut, broke bones and teeth and there were no lawsuits from these accidents.

We ate worms and mud pies made from dirt, and the worms did not live in us forever.

We were given BB guns for our 10th birthdays, made up games with sticks and tennis balls and, although we were told it would happen, we did not put out very many eyes.

We rode bikes or walked to a friend's house and knocked on the door or rang the bell, or just walked in and talked to them!

Little League had tryouts and not everyone made the team. Those who didn't had to learn to deal with disappointment.  Imagine that!

The idea of a parent bailing us out if we broke the law was unheard of. They actually sided with the law!

These generations have produced some of the best risk-takers, problem solvers and inventors ever!

The past 50 years have been an explosion of innovation and new ideas. We had freedom, failure, success and responsibility, and we learned HOW TO DEAL WITH IT ALL!

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Another One Bites the Dust

02/13/2009 06:50 PM |

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SAEC-O -- Better than SiCKO

02/13/2009 06:03 PM |

FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events

The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions.
 
Both skin conditions appear as allergic-like skin reactions associated with blistering and peeling, and are considered life-threatening. Medications causing these serious allergic reactions should be discontinued; and if such signs and symptoms are not quickly recognized, these reactions can be fatal.

“The SAEC has fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event.”

The SAEC is a nonprofit partnership of pharmaceutical companies, the Wellcome Trust, and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. The samples from the initial serious skin rash cases and matched controls were collected by GlaxoSmithKline plc, London, U.K., and donated to the consortium for this research.

By pooling these samples, the SAEC has identified numerous genetic associations that may contribute to an individual’s risk of developing serious drug-induced skin reactions. The data was compiled and analyzed just 16 months after the consortium was launched.

“We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. “We continue to believe the application of genomics to research the genetic basis of serious adverse events will prove to be one the most productive early applications of this technology.”

The consortium will publish its initial research results later this year.

Researchers who enter in to a data use agreement can obtain free access to the data to generate custom data inquiries and obtain immediate results on the genetic basis of adverse drug events.

For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org.

For information on the FDA’s Critical Path Initiative see http://www.fda.gov/oc/initiatives/criticalpath/

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Bloviation on Comparative Effectiveness

02/13/2009 05:40 PM |

Steve Pearlstein is a Pulitizer Prize winning columnist for the Washington Post who writes winningly and smartly about economics and health care.  He believes that Treasury can rebuild the banks and that the stimulus package can create jobs and by extension the whole shebang will rebuild the economy.  Whatever.   He also believes that "there is no reason we cannot set up reasonable procedures, overseen by independent health professionals, to protect patients who can demonstrate a special need for a treatment that is not normally cost-effective."

Hmm, I guess the doctor-patient relationship doesn't quite cut it for Mr. Pearlstein.  Or put another way, if Mr. Pearlstein's doctor had access to 21st century tools that made medicine predictiive and prospective -- which is increasingly possible -- he would still opt for cookbook decisions rendered by researchers who are largely selected from HMO sponsored research institutions using research methods that by definition exclude the variations in treatment effect and response that his doctor can detect...or could detect if those said researchers would ever get around to evaluating the value of those 21st century tools...

Pearlstein asserts that critics of comparative effectiveness don't have "any shred of evidence that the professionals who do this research are incompetent or have any but the best intentions in trying to figure out what treatments are the most effective for patients. There is no reason to believe that once this clinical research is completed, it cannot be used in a disciplined, scientific way by physicians, economists and medical ethicists to determine whether there are drugs, tests, surgical procedures or devices that simply don't deliver enough benefit to justify their cost."

He is quick to claim that England is special and doesn't count.  What about Canada, or Australia or Germany?  How about Netherlands or Italy or Israel?  Is there any entity that uses comparative effectiveness that does not restrict access to new technologies based on what it is worth to the institution without regard to the consumer?   What about the VA which restricts access to new drugs?  Or the Medicaid formularies that restrict access to cancer medicines and drugs for mental illness based on the comparative effectiveness research churned out by the Drug Effectiveness Research Project which is paid for by the Agency for Health Care Research and Quality and is conducted by HMO supported institutes?  Forget about intentions. In healthcare, it's the outcomes that matter.   It's not belief, it's evidence.  And the best evidence is biological and mechanistic, not probability. 

Pearlstein then introduces a straw man when he writies:

"But ours is an economy that is sinking under the weight of a health-care system that costs twice as much as any in the world while delivering poorer health outcomes. The cost of health care has crippled entire industries, disadvantaged our companies in international competition and brought millions of families into bankruptcy. Worst of all, in denying vital medical services to the 40 million Americans without health insurance, we engage in the most immoral kind of medical rationing imaginable -- rationing by the ability to pay. "

The reasons for our rate and intensity of health care spending has little do with medical device and drug expenditures, the smallest part of the health care budget.  It is multifactorial.  And the assertion that our outcomes are poorer is wrong in any event.  In any event, health systems that ration have done little to control the rate of health expenditures.  They merely shift spending into other categories.  Ultimatley the solution to health care problems, including spending, is innovation, which comparative effectiveness is used to kill.

Pearlstein tries to slime those who criticize comparative effectiveness as political arsonists supported by drug and medical devicemakers.  So be it.   If those fires had been quenched decades ago where would society be.    And where will it go if Pearlstein fails to fully understand the consequences of the approach being proposed the comparative effectivenesss zealots.

See his article here.
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Sayonara to Quality Healthcare

02/13/2009 12:03 AM |

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AAJ Ambulance Chasers Down On Pre-emption

02/12/2009 10:28 PM |

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The UnCERtainty Principle

02/12/2009 01:06 PM |

It is becoming increasingly un-PC (“Pharma Correct”) to say that $1.1 billion earmark for a “Federal Coordinating Council for Comparative Effectiveness Research” is a bad idea.

Well, it’s a bad idea.

And cozying up to the powers-that-be isn’t going to change the fact that this is a giant first step towards a U.S. version on NICE.

Whether or not you agree that such a notion is a bad idea, we should ALL agree that it’s important enough to debate on its merits – and not become law through legislative legerdemain; hidden deep within the bowels of the stimulus package.

Wither transparency?

Senator Feinstein says that, “the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.”

Senator Baucus promises that, “Its charge should not go beyond that.”

Indeed, Senate Finance Committee documents detailing health provisions in the Senate's economic stimulus package say that the bill "specifically prohibits the government from making any coverage decisions based on this research, or even from issuing guidelines that would suggest how to interpret the research results."

But the House language has no such limitations in mind:

“By knowing what works best and presenting this information more broadly to patients and health care professionals, those items, procedures and interventions that are most effective to prevent, control and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”

 

The problem is that “comparative effectiveness,” as it is currently designed, places into conflict the short-term budgeting dilemmas of governments elected for relatively short periods of time with the ever-lengthening life spans of their electorates.  Us.

 

Those in favor of comparative effectiveness favor large scale randomized trials to "compare" drugs. The problem is that randomized trials tend to ignore differences in clinical outcomes due to side effects or genetic variations. So whether you analyze them together or individually, researchers will most always find no difference in the effect of medicines, a result that is biased in favor of older, cheaper drugs. 

As currently organized, comparative effectiveness will be used to increase government control over the practice of medicine and introduce price controls.

Let's get real folks.  All rhetoric to the contrary -- this is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans. Step Two is to do away with the Non-Interference Clause so that comparative effectiveness measures can be used to offer a VA-style formulary.  And Step Three is to make that the model for the "universal care" we'll all be paying increased taxes to support.

(Note: The VA formulary offers 1,300 drugs, compared with 4,300 available under the average Part D plan -- prompting more than one-third of retired veterans to enroll in Medicare drug plans.)

 

Broader access to mediocre care? “Just like in Europe?” What a victory.

 

We need a new model. We need to develop proposals that modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA Critical Path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, we must establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.

 

For instance, the FDA, in cooperation with many interested parties, has developed a Critical Path opportunities list that provides 76 concrete examples of how new scientific discoveries in fields such as genomics and proteomics, imaging, and bioinformatics could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.

 

We need a Critical Path for Comparative Effectiveness to begin the process of developing a similar list of ways new discoveries and tools (such as electronic patient records) can be used to improve the predictive and prospective nature of comparative effectiveness.

 

It’s a complicated proposition—but such a goal is as simple as it is essential—cost must never be allowed to trump care, and short-term savings must not be allowed to trump long-term outcomes. Just as we need new and better tools for drug development, so too do we need them for comparative effectiveness measurements.

 

A comparative effectiveness model for the 21st Century should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new healthcare paradigm capable of providing for its needs in the 21st Century. Equality of care must be matched with quality of care. 

 

In an era of personalized medicine, one-size-fits-all treatments and reimbursement strategies are dangerously outdated. We are early in this debate, but at least we can all agree that this is not, and must not be exclusively, a debate about saving money. It must be about patient care. 

And it must be openly and robustly debated. 

For more on this issue, have a look at this new policy paper from the Washington Legal Foundation.

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Uncle Sam, MD -- the Movie

02/11/2009 02:39 PM |

Universal care?  Government care?  47 million uninsured?  The VA "model?"  Healthcare "like in Europe?"  Who better to address these questions than Uncle Sam, MD?  (That's a rhetorical question.)

If you like the legislation -- you'll love the movie.

Have a look at our new 16 minute documentary, "Off Label:  Universal Healthcare."  Just click here and then click on the picture of our very own Uncle Sam.

Please share this video with all your contacts, friends, relations -- and elected representatives.  And send along your comments as well.
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Comparatve Effectiveness Slush Fund is Shovel Ready....

02/10/2009 02:49 PM |

Let it not be said that high paying economists on the HMO dole are not shovel ready.....

Increasing choices, decreasing costs

The Medicare Prescription Drug Savings and Choice Act of 2009 proposes increasing beneficiary choice and driving down costs by creating a Medicare-administered drug plan as an alternative to privately administered Part D plans. Additional provisions include:

• The Medicare-operated drug plan or plans would be available nationwide with a uniform monthly premium.
• The Agency for Healthcare Research and Quality would assess clinical effectiveness and safety of drugs and recommend medications that should be included on the plan formulary.
• Drugs cannot be removed from a formulary during the plan year except in the case of safety concerns.
• An advisory committee would review petitions and make recommendations on whether to add drugs to the formulary.
• For drugs that provide similar benefits, the formulary would use incentives to encourage Medicare beneficiaries to choose the drug for which the HHS secretary was able to negotiate the lowest price.

http://www.ama-assn.org/amednews/2009/02/09/gvsc0209.htmBack to top.

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"Clarification in Conference"

02/10/2009 11:16 AM |

Sometimes the Congressional Record is worth reading.

Here’s a colloquy that includes Senators Baucus, Enzi, Hatch, Roberts, and Feinstein.  The date, February 6, 2009.  The topic, $1.1 billion for a “Federal Coordinating Council on Comparative Effectiveness.” The highlights are mine.  The words are their own.

Mr. BAUCUS. I understand Senator ENZI has comments regarding the provisions for comparative clinical effectiveness research included in The American Recovery and Reinvestment Act of 2009 which is being considered in the Senate this week. 

Mr. ENZI. I am pleased to see that in its consideration of this bill, the Appropriations Committee made sure this research will evaluate comparative clinical effectiveness, not comparative cost-effectiveness. In addition, the committee’s report language references provisions of the existing comparative effectiveness research program at HHS that ensure that the agency developing comparative information does not use it to set national practice standards or coverage restrictions. I also believe that comparative effectiveness research must be conducted using an open and transparent process, and must consider differences in how people respond to treatment. It is my understanding that the Comparative Effectiveness Research Act of 2008, which you introduced with Senator CONRAD last Congress, is consistent with these principles. I would like to see the $1.1 billion used consistently with these principles, and ask that you advocate for these principles in conference.

Mr. HATCH. I agree that the primary focus of comparative effectiveness research should be clinical effectiveness not cost. We can all agree that the ‘‘one size fits all’’ approach is the wrong approach for the American health care system. Based on our own personal experiences we all know that what works best for one person, does not always work the same for another. I look forward to working in a bipartisan and inclusive manner to come up with prudent legislation that will not only help us realize the true potential of comparative effectiveness but also preserve patient choice and innovation—the two hallmarks of our health care system.

Mr. ROBERTS. I would associate myself with the remarks of Senator ENZI, and would underscore that it is very important to require full openness, transparency and accountability in how research priorities are set and how studies are conducted and communicated. Without this openness, patients have no assurance that their voice will be heard in the process, and no ability to understand how results are being used in decisions that directly affect their health. I look forward to working with my colleagues to ensure that strong provisions for openness, transparency, and accountability are put in place.

Mrs. FEINSTEIN. I thank my colleagues for their efforts on this issue. I agree that comparative effectiveness research holds great promise to improve medical care by giving physicians and patients valuable information on treatment options. It is my understanding that the new Federal coordinating council included in the language is intended to coordinate the comparative effectiveness research efforts taking place across Federal agencies and with funds we are providing in this bill. However, there is some concern that the language, as currently written, allows the council to expand its activities beyond mere coordination. I think my colleagues would agree that the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.

Mr. BAUCUS. I thank Senator FEINSTEIN for pointing that out. I agree. The coordinating council should look across agencies to coordinate resources and activities of the federal government with respect to comparative effectiveness research. Its charge should not go beyond that. The language of the bill could be clarified to make that point clear. And I will support clarification of it in conference.

(Here’s the complete colloquy.)

$1.1 billion to “coordinate” resources and activities?  That’s a lot of mazuma.  And not a single job created.  Well, maybe one coordinator and a few assistants.  And at $1.1 billion, they’ll be earning more than any GS-14 I ever met.

And that’s with benefits.

And speaking of $1.1 billion, that also happens to be the mid-range savings projected for what implementation of FDA-recommended genetic testing for warfarin will deliver in one year.  (The savings will be realized through the prevention of 85,000 serious bleeding events and 17,000 strokes annually.) Yet FDA is not slotted to receive a single shekel from the stimulus package.

“Clarification in conference,” indeed. 

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Hope Springs Eternal

02/09/2009 04:29 PM |

You know what they say -- everything you read in the newspapers is true except for those things you know about personally.

Well, I read in a major US daily that the $1.1 billion for comparative effectiveness research (via AHRQ) had been stripped from the Senate version of the stimulus package. And opined on this accordingly.

Wrong. The monies are indeed in the Senate version.

Apologies for the mistake. But a bigger mistake would be for Congress to pass a stimulus package with this earmark for cost-effectiveness.

Once again with feeling -- here's why:

1. The additional spending does not stimulate the economy. The money would be spent on consulting contracts for health care economists.

2. The way the money would be spent is neither transparent nor clearly defined. Indeed, nearly a half a billion dollars would be spent at the discretion of the HHS secretary without outside review, establishment of research goals or methodologies.

3. The rest of the money ($700 million) is a slush fund payoff to insurance companies and health plans. The group advising the government on which research organizations should get the money is made up mostly of HMOs, insurers and Medicaid directors. And the entities that would conduct the research are run by either by the health plans themselves or by consultants who work for them directly and who want the government to take over the job of deciding what technologies consumers should get and what doctors should get paid. This is a cost-based crowd.

Giving over a billion dollars for a small cadre of appointees who could dictate and determine medical practice and the future of the life sciences industry is a risky and unwise use of tax payer dollars under any circumstance. To suggest that it would stimulate the economy only adds insult to injury.

And again, please excuse the earlier mistake. Hope springs eternal.

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A "Stimulus" Earmark for Cost-Based Care

02/09/2009 01:57 PM |

The Senate version of the stimulus package has excised the House’s proposal for a $1.1 billion “Federal Coordinating Council on Comparative Effectiveness.” 

Bravo.

Here’s why such “stealth healthcare reform should not be part of the final stimulus bill.

1.  The additional spending does not stimulate the economy.  The money would be spent on consulting contracts for health care economists.

2.  The way the money would be spent is neither transparent nor clearly defined.  Indeed, nearly a half a billion dollars would be spent at the discretion of the HHS secretary without outside review, establishment of research goals or methodologies.

3. The rest of the money ($700 million) is a slush fund payoff to insurance companies and health plans. The group advising the government on which research organizations should get the money is made up mostly of HMOs, insurers and Medicaid directors. And the entities that would conduct the research are run by either by the health plans themselves or by consultants who work for them directly and who want the government to take over the job of deciding what technologies consumers should get and what doctors should get paid. This is a cost-based crowd.

Giving over a billion dollars for a small cadre of appointees who could dictate and determine medical practice and the future of the life sciences industry is a risky and unwise use of tax payer dollars under any circumstance.  To suggest that it would stimulate the economy only adds insult to injury.

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Minefield Get's a Mansfield

02/09/2009 01:38 PM |

Liz Mansfield has been tapped to be the FDA’s point person on coordinating and upgrading the agency’s activities involving genomics and related fields (including the analysis of complex DNA, protein and small molecular expression platforms).

She has an enviable title, “Senior Genomics Advisor” and her task is to focus on the agency’s goal of providing the agency’s physician and scientists with the tools and personnel capable of high level analysis of complex genetic data. Liz will reside within the Office of the Chief Scientist.

The title is nice.  The function is crucial.  Now all FDA needs is the funding to aggressively address the issue. 

Fund the Reagan/Udall Center now!

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Drain the Comparative Effectiveness Slush Fund

02/06/2009 08:30 PM |

As the Senate seeks to slash billions from the spending bill many legislators have focused on the $1.1 billion that would go to the Agency for Healthcare Research and Quality for "comparative effectiveness research" for elimination and future consideration in a more timely and deliberative fashion.  This would be a wise move for the following reason:

1.  The additional spending does not stimulate the economy.  The money would be spent on consulting contracts for health care economists.
2.  The way in which the money would be spent is neither transparent or clearly defined.  Indeed, nearly a half a billion dollars would be spent at the discretion of the HHS secretary without outside review, establishment of research goals or methodologies:

Directs $400 million to be made  available for comparative effectiveness research to be allocated at the discretion of the Secretary of HHS. Funds appropriated shall be used to accelerate the
development and dissemination of research assessing the comparative  effectiveness of healthcare treatments and strategies, including efforts that 1)
conduct, support, or synthesize research that compares the clinical outcomes,  effectiveness, and appropriateness of items, services, and procedures that are used
to prevent, diagnose, or treat diseases, disorders, and other health conditions; and 2) encourage the development and use of clinical registries, clinical data
networks, and other forms of electronic health data that can be used to generate or obtain outcomes data:

3.   The rest of the money is a payoff to insurance companies and health plans who want the government to take over the job of deciding what technologies consumers should get and what doctors should get paid.  The group advising AHRQ on what research organizations should get the money is made up mostly of insurers and Medicaid directors and the entities that would conduct the research are run by health plans themselves or consult for them directly.  Another $700 million would go directly to AHRQ to be allocated by it's comparative effectiveness research "stakeholders" group to a  group of "technology evaluation centers" that do most of the comparative effectiveness research for the agency.   This is akin to giving the EPA money to evaluate air quality standards and turning the decision of which research to fund over to car makers and limiting the pool of research organizations to those supported by or consulting to the Big Three auto companies.  

4.  In other countries comparative effectiveness has has the effect of hurting patients and killing biotechnology, a leading source of economic growth and jobs.   The National Institute of Clinical Excellence (NICE) in Britain is the  model for the "coordinating council."   It has been recently cited by patients in Britain for denying access to cancer drugs.  The UK's BioIndustry Association recently noted: "an independent inquiry is necessary to assess NICE's long-term impact on the cost, access to, and uptake of medicines in the UK. As you know, NICE has been aggressive about rejecting expensive medicines that it says don't offer sufficient advantages over older, less costly drugs."  This announcement came after it was discovered that the British health system had a $3 billion surplus and biotech companies were going broke. 

http://www.bioindustry.org/biodocuments/BIGTR2/BIGT_Review_and_Refresh.pdf
http://www.fiercebiotech.com/story/uk-biotechs-ask-tax-breaks/2009-01-22


Giving over a billion dollars for a small cadre of self-interested appointees who could dictate and determine medical practice and the future of the biotechnology industry is a risky and unwise use of tax payer dollars under any circumstance.  To suggest that it would stimulate the economy is to only add insult to injury. 
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A Teaching Moment

02/06/2009 02:46 PM |

At the recent Cardiovascular and Renal Drugs Advisory Committee meeting (the "prasugrel meeting") there was much discussion over appropriate dosing in specific patient populations.  It was in the midst of this confabulation that Marvin Konstam, MD (the acting chair) commented that,  "We need to practice personalized medicine.  We just don't know how."

Joining Dr. Konstam on the rostrum were Dr. Bob Temple and Dr. John Jenkins -- two FDAers whose job it is to help advance the practice of personalized medicine.

Yes we can.
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Smoke - Do It For The Children!

02/05/2009 11:33 PM |

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Be Careful What You Wish For....

02/05/2009 08:14 PM |

The comparative effectiveness crowd thinks that data will deliver them from the clutches of evil drug companies.  Yet all the studies using patient level information continue to suggest that limiting access to new drugs drives down compliance and increases total health care spending by making people sicker....  The most recent research comes from the records of the Geisinger Health System often lauded as a model for how to use EHRs to increase efficiency...

One Diabetic in Three Doesn't Follow Doctor’s Med Orders

Newswise — About one diabetic in three never fills the doctor’s prescription for antidiabetic medication, according to a study based on a new method of capturing a comprehensive picture of pharmaceutical compliance data.

Appearing in the February issue of the Journal of General Internal Medicine, the study is the first to link physician medication orders from Geisinger Health System’s robust electronic health record with insurance claims to show that far more diabetics than previously estimated choose not to fill their prescriptions. The findings point to the importance - in terms of long-term wellness and cost-savings - of engaging patients in their diabetes care.

While previous studies have relied only on insurance claims for estimates of diabetic patients who fill antidiabetic (antihyperglycemic) prescriptions, the Geisinger study is the first to capture actual physician prescription orders as well as prescription insurance claims to link data to patient diagnosis and history.

For the estimated 1.5 million newly diagnosed diabetics in the United States each year, unwillingness to fill antihyperglycemic prescriptions is a costly problem. The estimated 35 percent non -fill rate corresponds to 400,000 new diabetic patients each year. Untreated for early-stage diabetes, many of these patients will become candidates for more costly second-line medications that are more likely to cause adverse side effects.

According to the study’s lead author, Nirav Shah, MD, senior investigator, Geisinger Center for Health Research, the findings provide valuable insight into patient preferences and behaviors that can help healthcare providers as well as pharmaceutical researchers develop treatment regimens that patients are more likely to follow. Specifically, this would involve addressing why patients choose not to fill prescriptions and the significance of pursuing mutually acceptable options.

“Despite the perception that healthcare providers must intensify treatment over time to manage diabetic patients, our study shows the equally important and often underestimated role of engaging patients in their care,” said Dr. Shah.

About the Study
The retrospective cohort study from 2002 to 2006 analyzed 1,132 patients over the age of 18 who sought care from the Geisinger Clinic, had Geisinger Health Plan pharmacy benefits and were prescribed an antihyperglycemic medication. The authors analyzed the prescription fill rates within 30 days of the prescription order date.

The study found that copays less than $10 and baseline A1c greater than 9 percent were associated with improved first-fill rates; gender, age and co-morbidity score appeared to have no association. Not surprisingly, significant reductions in A1c rates were seen in patients who filled their diabetic medication prescriptions, although some decreases in A1c also were seen in non-filling patients, possibly due to increased adherence to diet and exercise guidelines.

In addition, the study found that patients who were prescribed first line diabetics medications such as biguanides and sulfonylureas were more likely to fill their prescriptions compared with patients who were prescribed second line oral agents or insulin.

The study authors suggest that future research should utilize electronic health record data to quantify medication adherence at each interval of the prescription cycle.

So much for tierd formularies that try to steer people away from  newer drugs to save money....  Seems as though they and those who push them are just saving money by making consumers sicker....  I wonder if the folks who are in control of the comparative effectiveness slush fund over at HHS are listening. 



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Peanuts for CFSAN

02/05/2009 02:42 PM |

We all want better, more robust food safety.  And there’s lots of Congressional rhetoric to that effect.

That's nice -- but rhetoric won’t put more inspectors on the street.  That takes the do-re-mi.

Representative Rosa DeLauro says she will introduce a bill that would take food safety away from the FDA and place those duties at a new Food Safety Administration within HHS.

But it's not where the responsibilities reside – it’s the budget available to do the job.  And if you think the drug side of the FDA is under-funded (and it is) then get ready for this – the food side is even worse off.  

(One former top FDA food safety official, when told he would have to “do more with less,” replied, “How about this – how about we do less with less.”  He resigned shortly thereafter.)

When you fund CFSAN with peanuts -- you reap what you sow.

Check please.

Ms. DeLauro’s proposal (along with most of the others being offered) would give the FDA authority to order recalls, which are now voluntary.

Nice rhetorical flourish.  But here’s the real deal – all recalls are “voluntary” (note quotation marks) but the companies being “asked” (note quotation marks) are always – like 100% of the time always -- compliant.

Change the verbiage, sure.  But write the check.

And since Congress is paying attention to the FDA and the food side of the business, here’s something else to think about – dietary supplements.

In May 2007, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.

Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.

A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.

"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs,"

That ruling was good news for the public health -- but it raises urgent concerns as to why so-called "supplements" are regulated as food in the first place.

If Congress is looking at how the FDA regulates food (or even if it should continue to do so), our elected representatives should (indeed must!) debate significant reforms to DSHEA.

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Health Care, Chicago Style

02/04/2009 08:56 PM |

The Edmund Burke Institute has launched a new magazine called Reflections.  The purpose of the magazine is "to launch a conservative moral and intellectual revival. We will bring together the finest minds and writers to defend the eternal principles of God, country and family. We seek to forge a reinvigorated conservative movement for the 21st century-one that champions a new nationalism, rooted in a culture of life, small government, a restoration of federalism and victory over Islamist terrorism. The time has come for a one-nation conservatism that reaches out to minorities and women, the unborn and the poor, workers and students. The movement must go beyond its traditional base or else suffer a slow, agonizing death."

Well the editors made an exception with regard to finest minds and allowed me to contribute to the inaugural edition.  Here is my article, written before the "stimulus" bill was rammed through the House, on how health care would become a bailout boondoggle.

Have a look here.
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NICE Breaker?

02/04/2009 06:19 PM |

The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has reversed it’s earlier decision to deny payment for (sunitinib malate) and will pay for it as a first-line treatment for patients with metastatic renal cell carcinoma mRCC (advanced kidney cancer). 

According to NICE, “Sutent provided a step-change in the first-line treatment of advanced and/or metastatic RCC and [NICE] noted that more than 20% of the public and patients that responded in consultation highlighted this impressive benefit from sunitinib.”

(More than 7,000 people are diagnosed with kidney cancer in the UK each year and approximately 3,600 people die from the disease.)

This reversal is effectively an acknowledgment that the agency hasn’t worked as intended.
 
And just what caused the the reversal?  Why evidence, of course.

A spokeswoman for NICE said the organization was reevaluating Sutent because "there was more evidence submitted during a couple of periods of the appraisal process by manufacturers, which needs to be discussed by the [appraisal] committee.”

Couldn't have been anything else, right? Well, according to a report in The Guardian,

“The move follows British Health Secretary Alan Johnson's decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue."

Here's what NICE Chairman, Sir Michael Rawlins had to say, "We must be fair to all the patients in the National Health Service, not just the patients with macular degeneration or breast cancer or renal cancer. If we spend a lot of money on a few patients, we have less money to spend on everyone else. We are not trying to be unkind or cruel. We are trying to look after everybody."

As Robert Jones (a retired Glaxo Wellcome executive and former member of EFPIA's economic policy committee from 1994 to 2006, and its chairman from 1994 to 2001) writes:

“At the root of NICE’s operations is a Benthamite approach to health benefits. For NICE, value equates to social utility, the optimisation of which informs all of its judgments. Some of NICE's decisions may seem cruel in human terms, and ill-advised in public relations terms, but there is an arid logic to them which can usually be seen at work.”

Utilitarianism isn’t a one-dimensional worldview.  Consider Bentham’s comment that,

“It is vain to talk of the interest of the community, without understanding what is the interest of the individual.”

Is the Sutent decision a NICE breaker?

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