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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.
The Senate version of the stimulus package has excised the House’s proposal for a $1.1 billion “Federal Coordinating Council on Comparative Effectiveness.”
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.
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).
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.
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.
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.
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
"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.
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.
And just what caused the the reversal? Why evidence, of course.
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.”
Is the Sutent decision a NICE breaker?
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
