Latest Drugwonks' Blog
"And what about making medical care less expensive? The Democrats' approach is to try a combination of approaches: Eliminating waste, redirecting Medicare payments so that they reward efficiency, altering the tax treatment of insurance, and so on. They admit it will take time and that they are not sure which approaches will work best. But these efforts get at the root causes of rising medical costs--not just profit or administrative inefficiency, but also the tendency towards unnecessary over-treatment."
The liberal logic is that unnecessary treatment is at the heart of rising medical costs (conservatives tend to nod in agreement) and that government regulation can change behavior to eliminate "waste." The Torah for the Left in implementing this grand scheme is the Dartmouth Atlas.
But it is increasingly clear that the Dartmouth Atlas is to healthcare reform what the UN Climate Report is to Cap and Trade... a mass of data and assumptions reinforced by people who believe in the same thing but not in actual biological or clinical facts. If anything, the effort to eliminate over treatment will make people sicker and undermine innovation, which is the real source of disease prevention and better health.
Meanwhile, the Left is also willing to gloss over their willingness to shove 15 million people into Medicaid and what the implications of that will be, on top of cuts to Medicare reimbursement on the supply of hospital and physician services. Apparently, it thinks that paying little more than half of the going rate is a good way to eliminate "waste." Does the Left believe that Medicaid delivers great care or can deliver even better care for what it currently pays providers? Yes it does.
Finally, Cohn and others lack the guts to admit they are cutting Medicare to pay for an expansion of Medicaid and a tax break for unions. The "savings" which may not materialize are not plowed back into the system. Oh no, there will be higher taxes for that on top of the new taxes for more expensive, mandated coverage, which -- the President insists -- is only more expensive because people will want to pay more once they can actually get better coverage. So you see people really were never concerned about rising premiums after all, they were just waiting for the government to mandate more expensive health care, raise taxes and limit subsidies to a small portion of Americans. Or more to Cohn's authoritarian purpose, we really shouldn't have a choice because we are too stupid to really appreciate just how great the new health care order will be.
As I have written before, I hope the Left persists in this strategy. It will be decimated at the polls come November and health care reform will be better off for it.
http://www.tnr.com/article/politics/summited-out?page=0,1&utm_source=TNR%20Daily&utm_campaign=26cab0e92c-TNR_Daily_022610&utm_medium=email
The much ballyhooed White House summit on healthcare created no “aha” moments or Daily Show-worthy gaffes and was about as interesting to watch as Olympic curling.
President Obama was hoping, by force of will, intelligence and gravitas to both sway Republican lawmakers to his point of view (aspirational at best) while simultaneously demonstrating to the American people (and particularly American voters) that his proposal was a moderate one (arguable at worst).
From a communications perspective, he was presented with a classic Nick Naylor moment. The president didn’t realize the odds were 2-1 against. Not only did he have to prove he was right, he had to demonstrate the other side was wrong.
The GOP had an easier task — to have something constructive to offer, not get shrill (and yell “liar!”) or look at their watches. They succeeded.
House Minority Leader, John Boehner, rather than coming across as “Dr. No,” was the man with a plan – an easy-to-explain 6-point plan. Communications 101. The GOP were combative but collegial. Their sound bites were designed to generate nodding “me toos” across America. The Democrats were uncoordinated and visibly unhappy they were unable to paint themselves as the white knights of healthcare reform.
Obama and the Democratic leadership needed a dynamic event that would galvanize public opinion behind their call for immediate and comprehensive healthcare reform legislation. They needed a hard-hitting Olympic hockey game. But there were no stand-up body checks. Instead, the president looked like a professor grading papers and the whole enterprise looked and sounded like C-SPAN – the American equivalent of Olympic curling. Let the spinning begin.
It seems the issue of co-pays getting in the way of care and compliance is catching on. Have a look at this television news report:
http://www.azfamily.com/news/consumer/Sky-rocketing-co-pays-having--85270547.html
This issue is catching fire because it's that rare combination of facts and common sense working together.
So long DDMAC. Hello OPDP.
Under a new proposal, DDMAC will be renamed the Office of Prescription Drug Promotion and have two divisions, one to review direct-to-consumer content and the second focusing on professionally directed promotions. In terms of structure, it would remain directly under the Office of Medical Policy within the Center for Drug Evaluation and Research (CDER).
According to Rachel Behrman, the proposed change would take several months to implement, adding the suggested move “does not signal a change in philosophy or attitude” in DDMAC, but rather reflects the importance of the division within the agency and its overall size.
And, as we all know, Opie springs eternal.
Is DDMAC getting a new moniker? Buzz is that, at this week's DIA marketing meeting, Dr. Rachel Behrman (Associate Commissioner for Clinical Programs) will reveal both a new name and that Tom's Posse will be elevated to an "Office" within CDER.
Does a new name mean a new attitude?
Just yesterday, Tom Abram's called upon industry to adopt increased self-regulation and restraint. Thanks Tom.
"We do what we must, and call it by the best name."
-- Ralph Waldo Emerson
Then Peter Bach in his NEJM article revealed that the entire enterprise, the foundation not only of the entire liberal effort to bend the curve on health care through government rationing but of a billion dollar business designed to "coach" people out of treatments for back pain, breast cancer, prostate cancer, etc... all to the financial benefit of hospitals and health plans, is medically bankrupt and statistically corrupt...
Here's Buzz Cooper putting the Atlas through the document shredder:
An important article appeared in today’s NYT, describing a new paper by Peter Bach, which is in today’s NEJM. Peter’s paper (“A Map to Bad Policy“) debunks the Dartmouth Atlas and cautions against its use. As I said in the Wash Post in September, the Dartmouth Atlas is the ”Wrong Map for Health Care Reform.”
More damning even than Peter’s analysis was Elliott Fisher’s reply: “Dr. Fisher agreed that the current Atlas measures should not be used to set hospital payment rates, and that looking at the care of patients at the end of life provides only limited insight into the quality of care provided to those patients. He said he and his colleagues should not be held responsible for the misinterpretation of their data.” Really? It was someone else’s interpretation? OK, Elliott, you’re not responsible. Just stand in the corner.
Peter is not the only leading epidemiologist to debunk Dartmouth in recent days. There’s also the report this week from the U of Wisconsin and RWJ by Pat Remington (another leader), showing that people who have the poorest health (and, therefore, the highest health care costs) live in the poorest counties (see my blog report and an earlier discussion of poverty and health care). And there’s the recent paper by Ong and Rosenthal (co-authored by Jose Escarce, editor of HSR, the leading health services research journal), showing that, when all care is measured (not simply end-of-life care, as measured by Dartmouth), hospitals that provide more have lower mortality, which was confirmed in the current issue of Medical Care by Barnato and associates at the U of Pittsburgh. When it rains, it pours.
What’s doubly important about the death of the Dartmouth Atlas is that it was the cornerstone of health care reform. Right from the start, Peter Orszag, director of OMB and the administration’s architect of health care reform, accepted Dartmouth’s ideological principles that health care spending was driven by doctors and hospitals who over-treated and over-charged, to no benefit. The funds for health care reform were readily available by simply getting rid of geographic differences. That alone would save 30% of health care spending ($700B). And that could be accomplished by making everything look like Mayo (white, middle class and efficient) and by having more primary care physicians (which Mayo doesn’t). And best of all, it could assure that no new taxes would be needed, just as President Obama had promised.
And here's Peter Bach explaining why cost driven health care policy is, well, bad for patients...
Say Hospital A and Hospital B each has a group of patients with a fatal disease. Hospital A gives each patient a $1 pill and cures half of them; Hospital B provides no treatment. An Atlas analysis would conclude that Hospital B was more efficient, since it spent less per decedent. But all the patients die at Hospital B, whereas only half of the patientsdo at Hospital A, where the cost per life saved is a bargain at $2. Although $1 cures are rare, changing the price or efficacy of the pill does not alter the fundamental problem with examining costs alone when cost differences are sometimes associate with outcome differences.
And finally Bach challenges what, until recently, the media, most foundation types, the underachieving liberal health bloggers drank as daily Kool-aid, that the Dartmouth Atlas controlled for severity of illness by looking at only dead people.
Another methodologic problem is that Atlas analyses assess hospital efficiency overall on thebasis of costs incurred for nonrepresentative patients — decedents who were enrolled in fee-forservice Medicare. This group varies among hospitals in terms of severity of illness and is notrepresentative of a given hospital’s overall spending pattern. Regarding illness severity, Atlas researchers note on their Web site (www.dartmouthatlas.org/faq/ hospital.shtm) that they focus on “patients who died so that [they can be sure] that patients were similarly ill across hospitals,” further explainingthat “by definition, the prognosis of all patients[who died was] identical — all were dead . . . therefore, variations [in resource use] cannot be explainedby differences in the severity of illness.” But since some hospitals take care of sicker patients than others, the average severity of illness of patients who die also varies among hospitals. This fact is being ignored when all spending differences are attributed to differences in efficiency.
"Dr. Peter Bach of Memorial Sloan-Kettering argues against using the Dartmouth measures to financially reward and penalize hospitals. There is a healthy and vital debate about how best to change hospital incentives. None of this, however, calls the Dartmouth researchers’ decades of highly respected work—or their fundamental findings—into question. If anything, the debate reinforces the importance of their research."
http://www.newyorker.com/online/blogs/newsdesk/2010/02/the-cost-conundrum-persists.html#ixzz0gOWwIFNc
Meanwhile Elliott Fisher sought the refuge of the Dartmouth student newspaper to set the record straight:
“There’s a pretty good correlation between treatment of patients over 65 and under 65,” Fisher said.
In a response published in the New England Journal of Medicine, Fisher wrote that Medicare data is closely associated with a single hospital, making it a good measure of hospital effectiveness.
Bach’s final criticism of the Atlas data focused on the variation of illness severity between hospitals. Because of this variation, hospitals that care for patients with very severe illnesses could appear less efficient than those that take care of patients with less severe cases, even if they actually operate with the same level of efficiency, he said.
Fisher responded in the interview that the Dartmouth Atlas data is “carefully adjusted” for variations such as illness severity, poverty and price differences.
Talking to a college student, admittedly, a very smart college student, Fisher can get away with a mixture of evasion and distortions.1. There is no correlation between health care spending between people age 65 and over vs people who are younger unless you truly control for severity of illness which the Atlas fails to do because it never looks at two people from baseline with the same disease over time and compare outcomes. The Medicare/ non Medicare variance is wide as the Bach article shows.
2. Dartmouth and Fisher claim to limit who they analyze to those with a list of common chronic diagnoses. All together, that is about 90% of all people who die in Medicare. Then they adjust for a few things like primary diagnosis and age and sex and stuff. They have never shown that they can capture the variability between hospitals in severity of illness and they cannot, even using far more sophisticated measures. But they do not think they need to risk-adjust for the regional variations stuff. When MedPac did that, most of the variations went away.
Despite all this, both Gawande and Fisher persist in claiming: "that Bach’s criticism does not undermine the main finding of the Atlas data: regional variations in health care spending show that higher costs associated with specialized procedures do not necessarily lead to better health outcomes. Costs can be lowered by creating more accountable hospitals and moving away from a “toxic payment system” that creates incentives for unnecessary tests, according to Fisher."
http://thedartmouth.com/2010/02/22/news/atlas
Why would they say that when the entire methodology is shot to hell?
Because both (and not just them) make big money off of speeches, consulting and businesses that push the less is more approach.
And the commercialization of the Dartmouth Atlas -- coaching people to ration their own care in my opinion -- culiminated in the formation of a company called Health Dialog by the Dartmouth folks. HD was purchased by a British concern for $750 million. And HD has lobbyists in Washington pushing the adoptiong of its products in the current health care reform bill.
http://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=2
I am sure that Nissen was waiting for the climactic scene when the CEO either tries to bribe him or have him poisoned in his hotel room.
Unfortunately, the response he received from the GSK higher-ups was suggestion to do an analysis about when people actually had their heart problems since other studies did not show CV side effects in the short time frame he was showing (See below). And the worst thing about that response was the fact that GSK did not offer to pay him tens of millions of dollars to do such a study, a study Nissen has gladly done before using his ultrasound measurement of heart problems..
Of course there is no mention of Nissen secretly sending a copy of his NEJM paper to Congress in violation of the embargo requirement and not sharing it with the FDA.
Nor is there any mention of what NHLBI said in light of the RECORD study... "NHLBI staff reviewed the scientific findings and arranged for Data Safety and Monitoring Board (DSMB) meetings for both trials. The BARI 2D and ACCORD DSMB meetings reviewed in-depth analyses of cardiovascular disease rates in patients receiving rosiglitazone versus other diabetes drugs in the two trials. The DSMBs also conducted a thorough review of the recently published data on heart attacks and deaths in patients receiving rosiglitazone.
Each DSMB provided recommendations to the NHLBI on how the totality of evidence on rosiglitazone should affect the conduct of BARI 2D and ACCORD. The NHLBI carefully reviewed the DSMBs' recommendations and also thoroughly reviewed the recently published meta-analysis of rosiglitazone and the RECORD trial, along with the accompanying editorials published online May 21 and June 5 by the New England Journal of Medicine. "
http://www.nhlbi.nih.gov/new/press/07-rosi-qa.htm
Oh...
The NHLBI concurs with the DSMBs' recommendation that both the BARI 2D and ACCORD data, viewed in the context of the recent publications, contain no observations that would justify a recommendation to terminate rosiglitazone treatment in the research setting of either study.
The New York Times claims that the RECORD study was poorly designed. In fact, the interim RECORD analysis done to follow up on Nissen's claim was had limited statistical power because of an unexpectedly low event rate and incomplete follow-up (a mean of 3.7 years instead of the planned median of 6 years). Still the interim analysis had the same internal statistical reliability as Nissen's analysis: What the Times fails to note is that when Nissen lumped in all 42 studies, he glossed over the fact that the individual studies he looked at were not conducted the same way, with patients with the same disease or drug dose. Further, the 42 studies were small and overall event rates were low, partially because trial durations were relatively short ranging from 24 to 52 weeks, about 25 to 50 percent shorter than RECORD. As anyone who does statistics for a living will tell you, adding up a bunch of underpowered and short term studies does not give you a well-powered study with long term predictive effects.
Here's what one article -- written by Sanjay Kaul and colleagues said about the study: "The investigators' own subgroup analyses, which were limited to the small trials alone or to the 2 large trials (DREAM [Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication] and ADOPT [A Diabetes Outcome Progression Trial]), did not demonstrate statistically significant associations (1). Furthermore, one might reasonably question whether results from the 3 trials that targeted patients with Alzheimer disease (n = 1) or psoriasis (n = 2) who did not have diabetes should be combined with results from other trials that included patients with diabetes or prediabetes. Because rosiglitazone is already contraindicated in patients with heart failure, one might also reasonably limit the assessment of risk to patients without that contraindication and not combine data from the single study in patients with diabetes who had congestive heart failure with data from other studies. Incidentally, this trial exhibited the highest number of myocardial infarctions (n = 5) and cardiovascular deaths (n = 3) among all the small trials in the rosiglitazone treatment group (1).
Read Article
Some people can't handle not being FDA commissioner.... Meanwhile we will keep a running count of the media types who fail to put Nissen, Avandia and other studies about the medicine in context and simply write stories based on the narrative of the insider exposing (once again) the evil drug company.
Jim Pinkerton over at Serious Medicine Strategy does a great job at undermining the assertion of those who claim we spend too much on expensive new technologies and bleating about why prices of technologies go up, not down:
"The price of a CT scanner rose about 55 percent in 30 years, from an inflation-adjusted $1.4 million to $2.2 million. That’s a big increase, but, as Goetz notes, the number of X-ray “slices” a machine can perform has risen from four to 64. That’s a 16-fold increase, or 1600 percent. Which is to say, the increase in the quality of CT machines has risen almost 30 times faster than the increase in the cost. If that’s not a Moore’s Law-level increase, it’s pretty close. "
Moreover, as I noted in a post to Jim's blog the increase in the use of PET/CT scans is not profit driven, it is a function of what new technologies, contrast agents and science can do, particularly in prediction, staging and diagnosing a wide variety of cancers. And the cost of a scan in inflation adjusted terms has declined while the accuracy has increased. These two factors explain diffusion, consistent with Jim's observation.
"...they are highly effective in staging, detecting and personalizing all types of cancer. Moreover, the information from imaging has been critical to the next wave of personalized medicine: development of -- guess what? -- to predict the path of each cancer tumor by linking a CT report to the rearrangement of the genetic code for the tumor. Why is this possible, because of a rapid decline in the cost of sequencing along with an increase in speed and precision. Moore's Law. And this approach could replace CT scans when they become price competitive. Why low cost? A greater increase in use, a further fall in production costs and competition. "
But only if government doesn't get in the way of it's use.
Anyone want a government agency to determine whether this new "fingerprinting" of cancers should be used?
seriousmedicinestrategy.blogspot.com/2010/02/can-we-afford-ct-scans.html
Scientists Spot Genetic 'Fingerprints' of Individual Cancers
THURSDAY, Feb. 18 (HealthDay News) -- Researchers have found a way to analyze the "fingerprint" of a cancer, and then use that fingerprint to track the trajectory of that particular tumor in that particular person.
"[This technique] will allow us to measure the amount of cancer in any clinical specimen as soon as the cancer is identified by biopsy," said study co-author Dr. Luis Diaz, an assistant professor of oncology atJohns Hopkins University. "This can then be scanned for gene rearrangements, which will then be used as a template to track that particular cancer."
Diaz is one of a group of researchers from the Ludwig Center for Cancer Genetics and Therapeutics and theHoward Hughes Medical Institute at Johns Hopkins Kimmel Cancer Center that report on the discovery in the Feb. 24 issue of Science Translational Medicine.
This latest finding brings scientists one step closer to personalized cancer treatments, experts say.
"These researchers have determined the entire genomic sequence of several breast and colon cancers with great precision," said Katrina L. Kelner, the journal's editor. "They have been able to identify small genomic rearrangements unique to that tumor and, by following them over time, have been able to follow the course of the disease."
One of the biggest challenges in cancer treatment is being able to see what the cancer is doing after surgery, chemo or radiation and, in so doing, help guide treatment decisions.
"Some cancers can be monitored by CT scans or other imaging modalities, and a few have biomarkers you can follow in the blood but, to date, no universal method of accurate surveillance exists," Diaz stated.
Almost all human cancers, however, exhibit "rearrangement" of their chromosomes.
"Rearrangements are the most dramatic form of genetic changes that can occur," study co-author Dr. Victor Velculescu explained, likening these arrangements to the chapters of a book being out of order. This type of mistake is much easier to recognize than a mere typo on one page.
But traditional genome-sequencing technology simply could not read to this level.
Currently available next-generation sequencing methods, by contrast, allow the sequencing of hundreds of millions of very short sequences in parallel, Velculescu explained.
For this study, the researchers used a new, proprietary approach called Personalized Analysis of Rearranged Ends (PARE) to analyze four colorectal and two breast cancer tumors.
First, they analyzed the tumor specimen and identified the rearrangements, then tested two blood samples to verify that the DNA had been shed into the blood, sort of like a tumor's trail of bread crumbs.
"Every cancer analyzed had these rearrangements and every rearrangement was unique and occurred in a different location of genome," said Velculescu. "No two patients had the same exact rearrangements and the rearrangements occurred only in tumor samples, not in normal tissue," he noted.
"This is a potentially highly sensitive and specific tumor marker," Velculescu added. Levels of the biomarkers also corresponded with the waxing and waning of the tumor.
"When the tumor progresses, the relative amount of the rearrangement increases in the blood and goes down after chemotherapy," Diaz said. "It tracks very nicely with the clinical history of the tumor."
The method would not be used for cancer screening and more research needs to be done to make sure PARE doesn't detect low-level tumors that don't actually need any treatment.
Although this approach is currently expensive (about $5,000 versus $1,500 for a CT scan), the authors anticipate that the cost will come down dramatically in the near future, making PARE more cost-effective than a CT scan.
Under the terms of a licensing agreement, three of the study authors, including Velculescu, are entitled to a share of royalties on sales of products related to these findings.
Maine lawmakers are debating a bill that would require pharmaceutical companies to retrieve unused prescription drugs from households across the state. The measure is designed to prevent those medicines from ending up in Maine’s water supply.
Protecting Maine’s drinking water is of paramount importance. But the bill won’t make Maine’s water any cleaner. And it could raise the price of medicines and stifle biopharmaceutical research.
(The bill is LD 821, “An Act to Support Collection and Proper Disposal of Unused Drugs”)
For starters, more than 90 percent of the drugs that find their way into tap water comes from the waste products of those who have ingested their medicines correctly — not from folks improperly flushing their meds down the toilet. So this “take back” program would do nothing to prevent the main source of pharmaceutical chemicals in water.
Moreover, the safest and most effective way to dispose of drugs is to toss them in the household trash, in sealed plastic bags to keep them away from children and pets. That waste is eventually held in secure landfills, preventing any chemicals from leaking into surface waters.
A secondary function of the bill, according to its supporters, is to get pharmaceuticals out of the hands of those who might abuse them.
Any legislation that takes the issue of drug abuse seriously, however, needs to provide communities with the resources to teach their citizens about the dangers of prescription drugs. This bill does not.
Even if the Maine Legislature went back to the drawing board and attempted to design a bill that actually improved residents’ health, lawmakers still would be hard-pressed to create effective regulations. That’s because water quality, by its very nature, isn’t a state issue — it’s a national issue.
The Mississippi River Watershed runs through 31 states. The Chesapeake Bay Watershed serves 17 million people in seven states plus the District of Columbia. There’s no doubt that water safety deserves serious attention from the government. And Maine lawmakers should do their best to ensure that the local water supply remains free of pollutants. But this bill would be ineffective at the state level.
The problems with this bill go beyond its inefficacy. It actually could jeopardize the health care of patients across the country.
Creating the complex and expansive network required to regularly collect unused drugs from resident homes would be a very costly enterprise. Consequently, this bill would dramatically drive up the operating costs for medical research firms, leaving less money for scientists to develop new drugs. That’s particularly bad news for those suffering from conditions like cancer and Parkinson’s, whose lives depend on future medical innovation.
What’s more, drug makers likely will try to recoup dollars lost on recovery programs by raising prices on their products. So folks would see higher pharmacy bills at a time of great economic instability.
Maine lawmakers have crafted a bill that fails to address the important issues of water purity and prescription drug abuse, and actually harms people’s health care.
They can do better.
http://www.nytimes.com/2010/02/19/opinion/19krugman.html?em
"What would work? By all means, let’s ban discrimination on the basis of medical history — but we also have to keep healthy people in the risk pool, which means requiring that people purchase insurance. This, in turn, requires substantial aid to lower-income Americans so that they can afford coverage.
And if you put all of that together, you end up with something very much like the health reform bills that have already passed both the House and the Senate.
What about claims that these bills would force Americans into the clutches of greedy insurance companies? Well, the main answer is stronger regulation; but it would also be a very good idea, politically as well as substantively, for the Senate to use reconciliation to put the public option back into its bill."
Maybe the Krug forgets that the it was the very prescriptions he is pushing that helped contribute to the rise in premiums. That, and the fact that insurance companies tried to hold the line on premium increases in 2008. In any event, he ignores the fact that individual premiums under Obamacare will increase by up to 35 percent in 2016 as all these regulations kick in (that's according to CBO). And a pubiic option will not be less expensive according to both CBO and CMS unless there is some drastic price controls. That will keep prices in check in the short term, but not overall spending..
Buying across state lines is not a panacea and would likely have unintended consequences (as with any health care policy). But there are a lot of things that could be done to keep premium costs down and predictable, starting with allowing people to buy catastrophic coverage. However leftists like Krugman would never allow that choice.
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.
