Latest Drugwonks' Blog
Mixed news from the 2009 European Society of Cardiology Congress in Barcelona on a new post hoc sub-analysis of patients treated with Lipitor (atorvastatin calcium) in the five-year Treating to New Targets (TNT) study. For patients with established heart disease who were treated with a statin, 18 novel biomarkers including C-reactive protein (CRP) did not predict future cardiovascular events such as heart attack and stroke. By contrast, traditional lipid risk factors were strong predictors of cardiovascular events.
The 18 novel biomarkers were not predictive of risk for future cardiovascular events in patients with stable coronary heart disease already on statin therapy. Higher levels of LDL cholesterol and triglycerides and lower levels of HDL cholesterol, however, were each strongly and significantly predictive of risk for future events.
The complete report can be found here.
Consider value-based insurance design, and then consider Section 224 (c) of HR3200, "Encouraging the Use of High Value Services." The public health insurance option may modify cost sharing and payment rates to encourage the use of services that promote health and value."
The Pink Sheet points out a recent paper sponsored by the National Pharmaceutical Council as "adjust[ing] out-of-pocket costs based on an assessment of the clinical benefit value - not simply the cost - to a specific patient population." The overall goal is "getting more health out of every health care dollar."
And they continue:
“A shift to value-based insurance would provide some interesting opportunities for drug manufacturers to develop and present evidence of their products' value. A permanent comparative effectiveness research program, which is being considered as part of health care reform legislation, also could become an important source of information on value.”
ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)
and his main point is that the devil is in the details.
Lichtenberg believes that incorrect estimates of some or all of these key inputs are often used:
ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated
And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.
Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?” and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing” -- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.
Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:
Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States
Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,” The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.
and
Murphy and Topel: The value of a life year is $373,000.
Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,” Journal of Political Economy, 2006.
Attention must be paid. Hello Senator Baucus.
Uninsured Americans
And while obviously the recession that hit the US beginning last year has worsened the picture, a Gallup poll in June 2009 put the number currently uninsured at around 16 percent of adults. That is higher than in previous years, yes, but not shockingly or dangerously so. It also represents only those uninsured at one point in time and leaves out people under 18, who tend to have a higher rate of being insured, especially with the extension this year of programs like SCHIP.
I’m hardly going to argue that “only” 14-16 percent uninsured is a reason to leave the US health care system as is. However, both honesty and well-researched information have been lacking, on all sides, of the health care debate. The myth of the rising uninsured is yet another example of this.
In Sunday's edition of the New York Times, Robert Pear reported that:
“Medicare beneficiaries would often have to pay higher premiums for prescription drug coverage, but many would see their total drug spending decline, so they would save money as a result of health legislation moving through the House, the Congressional Budget Office said in a recent report.”
The "but" is at the very end of the article:
“But, Mr. Elmendorf said, the averages conceal the fact that beneficiaries would be affected in different ways.”
(That’s Doug Elmendorf, director of the CBO.)
And when you consider the, um, facts …
“Those who use a relatively small amount of prescription drugs would pay more in additional premiums than they would save, he said, while those who use a large amount of drugs would gain more from lower cost-sharing than they would pay in higher premiums.”
The CBO study was undertaken at the request of Representative Dave Camp (R, MI), the senior Republican on the
Mr. Pear ends by reporting that, “The budget office did not estimate how many Medicare beneficiaries might see an increase in their spending for prescription drugs and drug coverage, and how many would see a reduction, under the House bill. Mr. Camp said “the vast majority of seniors” would pay more, and he said House Democrats should scrap their bill and “start over with open, bipartisan talks.”
The complete New York Times article can be found here.
What’s the problem with higher co-pays? They reduce usage and compliance. Great if you’re trying to save money in the short-term. Not so great if you’re trying to enhance patient outcomes over the long-term. Short-term-savings (a political objective) vs. long-term patient health (which is also much more cost-effective in the long-term).
Short-term (political) thinking delivers long-term (public health) problems.
According to a recent study by Wolters Kluwer Health, fewer Americans are filling their drug prescriptions. In the fourth quarter of 2008,
Why?
Drug prices. It's not that the cost of prescription drugs is rising - it's patients' out-of-pocket costs, or co-pays. One of the reasons for this is that insurance companies, reluctant to foot the bill for brand-name medications, have been refusing to cover more brand-name prescriptions.
In the fourth quarter of 2008, in fact, health insurers denied coverage for 10.8 percent of brand-name drugs - a jump of 21 percent from the first quarter of 2007.
And it's not because the medicines themselves are becoming more expensive. Between 1998 and 2003, prescription drug costs increased by $22.48 per person. Meanwhile during that same period, the average health insurance premium went up by $104.62 per person.
When co-pays go up, more people see the need to abandon their prescription drug regimen. At least that's what a study from
As health care costs continue to rise, it's understandable that insurance companies (including the nation’s biggest payer – Uncle Sam) are looking to save money wherever possible. Passing off the cost of prescription drugs to patients, however, will only drive up overall costs while resulting in dramatically poorer health for more Americans.
Industry and Professional communication is very important for overall development of technology. The users have to be told what tools they have. Once we are out of school those opportunities are limited. There is just too much to do than just browse every single medical journal to see what’s new out there.
Every single day the fast food companies advertise on television and ask our children to eat cholesterol laden food which will make them obese. Every single day marketeers are ruthlessly selling a lot more harmful stuff to everyone including us. We should focus on that, rather than just be trapped in our own world of medicine and to cut communications inside it.
Last year, the British Association of Pharmaceutical Wholesalers (BAPW) warned about a risk of severe drug shortages over the winter as wholesalers ran down stocks in advance of price cuts on January 1st, 2009. It also noted that the problem could be made worse by parallel trading from the
In July this year, the problem of shortages was raised again, with claims that they were being caused by changes in
While it is wholesalers that are responsible for most parallel trade, it appears that in the
The industry is not alone in drawing attention to this situation.
According to a report in PharmaTimes:
“A study has found that over 80% of on-line advertisements for Internet pharmacies accepted by the search engine Yahoo were in violation of US federal and state laws.The researchers were able to buy prescription drugs without a prescription from Yahoo Internet pharmacy advertisements, and in one case the drugs were imported from India, which is prohibited by US law, says the survey, which was conducted by research firms LegitScript.com and KnujOn.com.”
“Moreover, the researchers acquired prescription drugs without a prescription from an Internet pharmacy approved by PharmacyChecker – the service by which Yahoo, Google and Microsoft require their Internet pharmacy advertisers to be verified as legitimate - and listed on PharmacyChecker.com. Those drugs were also imported from India."
The complete report can be found here.
In other cases, bureaucracy intrudes so that even those who meet the definition of live birth may not end up in statistics. In France, in order for the baby to be given a birth certificate as a live birth, one must have “a medical certificate [that] attests that the child was born ‘alive and viable’.” On the other hand, “[i]n the absence of a medical certificate attesting that the child was born ‘alive and viable,’ the civil service officer only establishes a certificate of a child without life,” in lieu of a birth certificate. Overall, “this procedure applies, on one hand, to children born alive but not viable, and on the other, to children stillborn after a term of 22 weeks…or with a weight of at least 500 grams.” Thus, there is ample opportunity for babies to not be counted either because they are considered nonviable or because a certificate that they were born alive and viable could not be obtained. The scale of the resulting impact on mortality rates is implied by statistics that show that under a sixth of recorded infant deaths in France take place in the initial twenty-four hours after birth, versus one-third in both the US and Canada.
Another such case is Canada. Like that US, Canada uses the WHO definition of live birth but bureaucratic complexities may mean that not every baby born alive makes it into the register of live births. One such baby is Sonja Stefnovic, born January 6, 2006 in Ontario and who, though she lived a mere 35 minutes, more than met the criteria for a live birth. Yet, when her parents asked for a birth certificate they were told none existed. The paperwork had been filed to register her death but not her birth, which, unbeknownst to her parents, had to been registered separately. As far as Ontario was concerned, Sonja had never been alive at all.
While such cases are unusual in most of Canada, they are endemic in Ontario where in the last ten years there have been over 30,000 cases of unreported births due to bureaucratic delays, confusing procedures, and a substantial fee for registering births. That adds up to thousands of missing birth records each year and constitutes 30 percent of records of babies who lived less than a year. And Ontario makes up 40 percent of births in Canada. Ontario has also consistently been late in reporting births to federal statisticians. Arne Ohlsson, director of evidence-based neonatal care and outcomes research at the University of Toronto has said that, "[b]ecause such a large proportion of the population is born in Ontario and those vital statistics are not accurate, the country's statistics are not accurate and comparisons with other countries will be inaccurate." Whether the flawed records are used in calculating national statistics or whether Ontario is omitted, the result is nonetheless a number that does not cover all the babies born in the country.
Even if you can overcome the statistical problems, there are other factors that make infant mortality rates an inaccurate tool for comparing the quality of care in different health systems. Access to and quality of care are certainly influential in determining death rates but elements related only partially, tangentially, or not at all to the medical system are critical as well. Many are cultural, like delayed childbearing, use of fertility treatment, multiple births, or a high percentage of teen births, since these trends come with higher prematurity rates. Further, mortality rates are affected by ethnic factors that differ widely –and cannot be dismissed merely as reflections of access or socio-economics.
Culture may also trickle into medical care in another realm, in influencing the willingness of doctors and hospitals to pull out all the stops to try to save even the smallest and most premature babies. In the US, the expectation is that doctors will do everything possible to keep preemies alive unless the parents object. But in the Netherlands, premature babies below 25 weeks gestation are no longer to be resuscitated because the chance of survival without serious disabilities is considered low and they are instead given palliative treatment. Other nations fall somewhere in between and in countries like the UK and Canada, the enormous cost of intensive intervention and shortages of pediatric nurses and spaces in NICUs have played a significant role in the debate over when and how to intervene.
What the ‘correct’ policy may be is beyond the scope of my present post –and the answer is probably neither singular nor fixed. But it is something that needs to be taken into account when comparing statistics.
All of these issue show why international statistics should be interpreted with extreme caution, at least until we know where the number come from, how they are derived, and what other factors are simultaneously in play. And although it may be frustrating to know that, as in this case, the answer may be that the statistics cannot tell us much about the strengths and weaknesses of health care systems and their relation to one another, it is better to know we are in the dark than to clutch at false illumination.
Are these products foods or medicines? Well, to quote the great Hoosier poet James Whitcomb Riley, "If it walks like a duck and swims like a duck and quacks like a duck, I call that bird a duck."
To those who would peddle dietary supplements as medicine, the message must be that FDA has the authority to stop you if and when you cross the line. And to Congress, the message is that if FDA is to embrace a "safety first" philosophy, then DSHEA needs to be reformed—because the line has been crossed too many times. This oversight must be corrected immediately.
For the rest of the story, check out this piece from Pharmaceutical Executive Magazine.
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.
