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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Let's Hope Don Berwick Has A Tax Problem

02/03/2009 09:30 PM |

Don Berwick of the Institute for Healthcare Improvement is being mentioned to head up CMS.  He is a single payer who believes that we can cut 40 percent health care spending no prob by following the Commonwealth Fund manifesto....which reads like a 200 page endorsement of NICE

Here is Berwick claiming that the US can ratchet down cost to UK levels and be just fine.....

"..... It is manifestly possible for a Western democracy to give all the care its population needs for about 10 percent of GDP. It is possible. You can't say it's not possible because it's being done. We're at 16 percent or 17 percent. We're wasting probably 40 percent or 30 percent of the dollars we're putting into health care. That's true and I don't understand, Michael I know will come at me on this, why we just don't target that as an aim, reduce the total cost. Thirty percent waste easily in our system. I think he wants to get there by working on quality and value and that's probably right, but don't take your eye off the ball. "

"...integrated care for chronic illness and the gaps there in. The Commonwealth Fund is now our lead, I guess, scrutinizer of that problem. Seventy percent of costs go into chronic illness care. Probably half of it is pure waste. And a lot of it happens because we don’t have the integrated flows that we need for a restructured care system.
"The third really might be American exceptionalism. It’s our inability to learn from successful models outside of this country. Countries that function with better care than we have; we are 19th out of 19. That’s OECD data, that’s what Senator Baucus said and he’s right, compared to countries that are functioning at 60 or 70 cents on our health care dollar.
"We’ve got to learn from these other models and not throw them away because we assume that stuff like that doesn’t work here. It will. It’s our decision, what we choose we can choose to change."

So we should ration access to new drugs and treatments?  Is there any evidence that care -- where waiting times are longer and primary care is vastly overused -- is more "integrated?" 

 "My wife is Under Secretary for Energy in Massachusetts and she has taught me about decoupling in the energy world where utilities now in at least 20 states or so, aren’t paid for volume. They can make as much money by saving a kilowatt as by making one. We need to do that with care. You ought to be able to somehow treat an empty bed as an asset. Right now we don’t do that at all. "

An empty bed as an asset?  What does that mean?  Should we fill beds to make money? 
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mcclellan for HHS?

02/03/2009 07:00 PM |

Good for the administration and health care....
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Daschle Packs It In

02/03/2009 06:41 PM |

How fast did President Obama go from being strongly behind Daschle to telling him to head back to South Dakota?  One thing is now certain: the inevitability of health care reform Obama or Baucus style is no longer.... Is there is an opening here for patient-centered provision of coverage? 
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Comparative Effectiveness Slush Fund

02/03/2009 03:12 PM |

The focus on Senator Daschle's failure to pay taxes in a timely fashion should shift to examining who controls and gets the $1.1 billion in comparative effectiveness money that goes to Agency for Healthcare Research and Quality.  That cash will be doled out  in large part on the sole discretion of Daschle  himself who wants NICE-like comparative effectiveness rulings to determine tax benefits for insurance deductibilty.  The rest is under the control of Carolyn Clancy and a handful of "stakeholders" largely beholden to to HMOs and ties to think tanks with funding from trial attorneys and foundations that support attacks on medical innovation and want a government take over of healthcare.  In addition, the institutes carrying out the work are creatures of the HMOs themselves or contractors thereof. 

No media scrutiny whatsoever and yet more than $1 billion of tax dollars to be spent in the stimulus....

Way to go.  The media is complicit in the creation of a slush fund for Daschle that pales in comparison to whatever tax filing mistake he may have made. 
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Those Pesky Facts about Healthcare Reform

02/03/2009 12:36 PM |

"I believe for the first time in American history, health care reform will be done."

That's the incoming Secretary for Health and Human Services, Tom Daschle, speaking at a national conference on health care reform in December.

Daschle is right to be optimistic. Too many Americans lack health insurance, and there are many opportunities for reform.

Unfortunately, his reform ideas center on the government's playing a larger role in the health care market. This concept is popular among voters, as there's a widespread perception that health care systems abroad are a runaway success. The media tends to present those systems in the best light possible, highlighting their apparent benefits and ignoring their downsides. As a result, many Americans have overly positive visions of what life is like under universal health care -- and so support its creation here at home.

The truth is that government-controlled health care is not free. It comes at a great cost in the form of high taxes, long waiting lines and frequent denials of coverage.

French citizens pay about 20 percent more in income tax than Americans, according to the Organization for Economic Cooperation and Development.

The Fraser Institute reports that Canadians face an average wait of almost 18 weeks between a general practitioner's referral and actual treatment by a specialist.

In the United Kingdom, the national health care agency won't cover treatments with a yearly cost of more than $46,000. British citizens pay 11 percent to 12 percent of their weekly income to finance the country's health care system. Many popular pharmaceutical drugs aren't covered by public insurance.

It's estimated that about one- fifth of taxes collected in Canada go toward funding the country's health system.

So much for "free" health care.

Most universal health care systems also impose strict price controls on pharmaceutical drugs. But, as a new study from the Rand Corp. finds, introducing similar price regulations in the U.S. would stifle drug innovation, resulting in reduced average life expectancy.

The costs of universal health care are real and substantial. It's imperative that voters and legislators see the other side of the story before any reforms are implemented.

For the rest of the story, have a look at this op-ed from the Chicago Sun-Times.

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Something rotten in Denmark?

02/03/2009 10:11 AM |

When I was working on the issue of DTC and patient information a couple of years back (my report may be downloaded here) , I sometimes wondered why a European firm didn’t simply take out an ad to say : "We have many drugs that could help you, but we are not allowed to tell you about them."

The other day, some oncologists in Denmark did a similar thing. According to some new authority, there is no evidence that the benefit from the cancer medicine Avastin outweighs the negative impact of side-effects. This would justify the decision not to make this product the first choice when treating lung cancer.

The oncologists begged to differ, and circulated a letter to the concerned patients to inform them of their view.

According to the Swedish website Dagens Medicin, the central authority Danske Regioner will now stop this letter from being sent.

Said the politician in charge : "It would be very unethical to distribute such letters now that we have done so much to build confidence in Danish cancer treatments."

Really ? Is it more "ethical" to silence doctors who actually believe in the benefits of a certain treatment ? Probably not; but this is about saving money, sorry, rational use of drugs.



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Decommissioning Darvon

02/02/2009 02:47 PM |

Here's the black box warning that has been attached to Darvon and it's generic version's for years:

"Darvon should not be used by people who are suicidal or who easily become addicted to medicines, alcohol, or other substances. Do not take more of Darvon than the dose your doctor prescribed. Taking excessive doses of Darvon by itself, with other medicines, or with alcohol may cause serious side effects and could be fatal. Limit the amount of alcohol you drink while you are taking Darvon . Tell your doctor if you have a history of any substance abuse, mood or mental disorders, suicidal thoughts or attempts, or if you take any medicines that cause drowsiness such as tranquilizers, sleep medicines, muscle relaxers, or antidepressants."

And here is an Time Magazine article about Darvon and the efforts of Sid Wolfe, now an offical pain the you know what as a member of the Risk Benefit advisory committee for the FDA, to ban the drug:

"... Wolfe asked for an immediate ban on the sale of the widely prescribed pain reliever propoxyphene, best known as Darvon. He claimed not only that Darvon is an ineffective painkiller, but also that in excessive doses it produces a euphoric high, which he says, "makes it attractive as a drug of abuse. This is tantamount to legalized dope." Further, said Wolfe, Darvon-related deaths in the U.S. have been increasing, rising in major cities to about 600 last year and making the compound "the deadliest prescription drug in the United States." Eli Lilly and Co., of Indianapolis, the principal manufacturer, promptly branded Wolfe's charges "irresponsible and clearly not supported by the facts."

Darvon-related deaths have often involved intentional misuse, either by overdosing or mixing with alcohol and other drugs. Lilly notes that the average person would have to take 30 large-size Darvon capsules at one time (the usual dose is one every four hours) to cause death, 15 if he were intoxicated. Further, the drug is a controlled substance—a prescription is good for only five refills within six months. (If HEW will not ban Darvon, Wolfe wants the drug reclassified so that prescriptions cannot be refilled.)

Lilly also says that Wolfe's claim about Darvon's effectiveness is misleading because it is largely based on studies of single, rather than multiple, doses of the drug. Doctors prefer Darvon for some patients because, unlike aspirin, it does not cause gastrointestinal bleeding or lower the body temperature. Concludes Lilly's Dr. Robert Furman: "Used as directed, Darvon is really very safe. The fact that some people are intent on abusing it shouldn't be used to indict it."

Read More

That article was written 40 years ago. Wolfe was petitioning the FDA then.

I can't say I totally disagree with Wolfe's motives. Darvon and Darvocet were and are the drug of choice for people who seek to commit "peaceful suicide' and is pushed as such by pro-suicide groups and chat rooms. The problem is, banning the drug will remove another effect medicine for menstrual cramps that does not cause internal bleeding and if the UK is any guide those seeking to commit suicide or use painkillers recreationally will use medicines that are stronger or have worse side effects than liver toxicity.

Wolfe's persistence is an example of ideology overriding science and the doctor-patient relationship. The Sid Wolfe fan club (Alicia Mundy, President) might delight in his longstanding effort to drive drugs he detests off the market but for many people, including me and family members, his personal choices would come at the expense of our very lives.

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