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Drugwonks
Latest News!Written By Comment Count Comment Last Three February 26, 2010
Dr. Robert Goldberg
Jonathan Cohn on why Democrats should just impose an unpopular health care bill on Americans:
"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 -
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February 26, 2010
Peter Pitts
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. -
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February 25, 2010
Peter Pitts
Not AstraZeneca -- Arizona.
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. -
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February 25, 2010
Peter Pitts
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. -
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February 24, 2010
Peter Pitts
Thorns are another matter.
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 -
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February 23, 2010
Dr. Robert Goldberg
First Buzz Cooper systematically shredded the underlying assumptions of the Dartmouth Atlas with his studies showing that sickness and poverty, not stupid doctors over-treating people who coincidentally all died within two years, explained most of the variation in health care spending.
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. "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. -
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February 22, 2010
Dr. Robert Goldberg
Steve Nissen secretly recorded conversations he had with Glaxo SmitkKline execs about his meta-analysis of 42 studies showing an increased risk of CV events.
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. -
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February 22, 2010
Dr. Robert Goldberg
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: 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. -
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February 20, 2010
Peter Pitts
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. -
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February 19, 2010
Dr. Robert Goldberg
Paul Krugman once again has the simple solution to the Wellpoint premium increases:
http://www.nytimes.com/2010/02/19/opinion/19krugman.html?em 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." -
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February 19, 2010
Peter Pitts
Terrific and timely new article by John Bridges (Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health and a senior fellow at the Center for Medicine in the Public Interest), et. al. It appears in the journal Pharmacoeconomics under the title, “Healthcare Rationing by Proxy Cost-Effectiveness Analysis and the Misuse of the $50,000 Threshold in the US.”
Here’s the abstract: The application of cost-effectiveness analysis in healthcare has become commonplace in the US, but the validity of this approach is in jeopardy unless the proverbial $US50,000 per QALY benchmark for determining value for money is updated for the 21st century. While the initial aim of this article was to review the arguments for abandoning the $US50,000 threshold, it quickly turned to questioning whether we should maintain a fixed threshold at all. Our consideration of the relevance of thresholds was framed by two important historical considerations. First, cost-effectiveness analysis was developed for a resource allocation exercise where a threshold would be determined endogenously by maximizing a fixed budget across all possible interventions and not for piecemeal evaluation where a threshold needs to be set exogenously. Second, the foundations of the $US50,000 threshold are highly dubious, so it would be unacceptable merely to adjust for inflation or current clinical practice. Upon consideration of both sides of the argument, we conclude that the arguments for abandoning the concept for maintaining a fixed threshold outweigh those for keeping one. Furthermore, we document a variety of reasons why a threshold needs to vary in the US, including variations across payer, over time, in the true budget impact of interventions and in the measurement of the effectiveness of interventions. We conclude that while a threshold may be needed to interpret the results of a cost-effectiveness analysis, that threshold must vary across payers, populations and even procedures. ‘‘Cost-effectiveness analysis can skirt life valuation by relying instead on the premise that we want our limited resources to achieve maximal benefits (which may be set in units that we prefer not to value monetarily).’’ [Thompson and Fortress, 1980, p. 555[1]] The complete article can be found here. -
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February 18, 2010
Peter Pitts
In the January 2010 issue of Academic Medicine (Acad Med. 2010; 85:80–84.), four researchers from the Cleveland Clinic published a paper entitled, “The Effect of Industry Support on Participants of Bias in Continuing Medical Education.”
The purpose of the study: “To obtain prospective evidence of whether industry support of continuing medical education (CME) affects perceptions of commercial bias in CME activities.” The method: “The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multispecialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support.” CME conflicts of interest! The Cleveland Clinic! A study with zero industry funding or researcher connections! Speed dial to Senator Grassley, right? Not so fast. The study’s conclusion: “This large, prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present.” Could this be the reason there was no mainstream media coverage or press releases from Congress? You be the judge. The study can be found here. -
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February 17, 2010
Peter Pitts
It's that time again. PDUFA reauthorization. And the question on everyone's mind is, 'How high is up?"
Steve Usdin (scribe extraordinare of BioCentury) offers up some intriguing PDUFA pensées under the seasonally appropriate headline, "PDUFA Blizzard." The article can be found here. Once again proving the point that, when it comes to matters PDUFA, the best din is Usdin. -
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February 16, 2010
Peter Pitts
“Podium policy” (when regulators give speeches or media interviews that announce new regulatory expectations), is never a good idea. And least of all when the policy implicates First Amendment values and involves potential criminal enforcement. The issue at hand is pharma and social media – an issue where there is already significant confusion. And now, unfortunately, there’s more. Consider the comments of Jean-Ah Kang (special assistant to DDMAC director Tom Abrams) in her recent interview with Ignite Health: “The bottom line is this is a regulated industry, and if you choose to do promotion in that area just make sure that at the end of the day what we’re looking at is in the best interest of public health.” Dr. Kang then defines what she meant by “the public health”:
“Meaning, is this prescription drug promotion truthful? Is it balanced? Is it accurate? Is it false or misleading? That’s the big picture at the end of the day.”
And then she offers some qualifications:
“Several things come to mind with use of intent. We have regulations and again, they’re not black and white per se, but they exist … Even though someone may not have intended something, if the end result is that the public is misled then it’s a problem.”
And finally, “I mean people have gone to jail over these serious public health issues. So just be aware of the regulatory environment.”
“Intent” to promote against the “best interest of the public health” via regulations that are “not black and white” and over which “people have gone to jail.” Talk about "net impressions." The implications of her remarks are chilling. Chilling, frustrating and disappointing – but not necessarily surprising. After all, it’s all about ambiguity.
Ambiguity is power. That’s why interpretation of FDA regulations (on social media and a host of other issues) is such a vibrant cottage industry. Regulated industry, on the other hand, seeks clarity. Industry wants bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA. “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.” And nowhere is this truer or more dangerous than at DDMAC.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than vague, ever-changing expectations based on undefined notions of what serves “the public health,” is a distinctly more challenging proposition.
If the FDA wants to remain relevant (and out of court), they should develop clear rules that safeguard the important First Amendment values at stake. And this is about more than just the speech rights of companies. It’s about the rights of the Internet user (yes, you) to obtain information from a full range of sources – not just the government and plaintiffs lawyers and snake oil salesmen.
Dr. Kang is a smart person and a real believer in the potential of social media to advance the public health and she does her best to portray the FDA process as thoughtful and deliberative. It is. But, at a bare minimum, we are entitled to something more (or perhaps it would be better to say something less) than Jean-Ah’s remarks. After all, the FDA doesn’t have the authority to regulate or even define what is “bad” for the public health writ large. That’s regulatory creep of the first order. (Her complete interview can be found here.)
When I served at the FDA, we struggled with how to both regulate and advance the new field of pharmacogenomics. As Commissioner McClellan said at the time, “pharmacogenomics is a new field, but we intend to do all we can to use it to promote the development of medicines. By providing practical guidance on how to turn the explosion of pharmacogenomic information into real evidence on new drugs, we are taking an important step toward that goal.” The same philosophy of “regulator as colleague” should also be true for the new dynamic of social media. It’s like a game of chutes and ladders. FDA should act as a guide to the ladders and a sentry against the chutes – rather than an as the ogre at the foot of the bridge.
“I know it when I see it” as an approach to social media regulation doesn’t cut it. Predictability is power in pursuit of the public health. And social media is as powerful tool for advancing the public health today as any medical breakthrough you care to name. In 2010, healthcare begins at search.
Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity. And it’s never easy, because swimming against the tide of an entrenched bureaucracy never is. But as Commissioner Hamburg and other agency change agents (Drs. Sharfstein, Woodcock and Goodman to name three) demonstrate, it is possible.
As Winston Churchill said, “Ease is relative to the experience of the doer.”
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February 15, 2010
Peter Pitts
If it’s unlikely that Washington will pass meaningful health care reform any time soon. Yet health care costs are still exploding — making quality care unaffordable for too many Americans and putting a financial burden on us all. Surprisingly, though, there’s a smart move that health insurers can make that will lower costs for consumers and insurers alike, and improve patient health: Reduce co-pays on prescription drugs. High drug prices lead many Americans to skip doses or quit prescriptions entirely. Yet prescription drug prices aren’t rising — it’s patients’ out-of-pocket costs, or co-pays. Over the past several years, insurance companies have become increasingly reluctant to foot the bill for brand-name medications. Indeed, since 2000, co-pays have increased four times faster than prescription drug prices. Patients respond to higher co-pays by skipping their meds more often. In 2003, researchers at the University of Oregon studied the effects of introducing a $2 to $3 co-pay for prescription meds among 17,000 patients. Adherence to treatment dropped by 17 percent. Some insurers are even refusing to cover new prescription drugs. According to a study from Wolter Kluwer Health, insurers’ denial rate for brand-name meds was 10.8 percent at the end of 2008 — a 21 percent jump from the year before. Abandoning treatment — a practice known as "non-adherence” — has serious consequences for patient health. For instance, people with hypertension who neglect their meds are more than five times more likely to experience a poor clinical outcome than those who don’t. Heart disease patients are 1.5 times more likely. It also results in higher medical costs, as patients who go off their meds often end up in the hospital. Minor conditions that might have been controlled by inexpensive medications can sometimes balloon into life-threatening illnesses that require surgery or other costly treatments. This makes sense. After all, a daily cholesterol-lowering drug is far less expensive than emergency heart surgery. As Congress figures out what to do next on health care reform, private insurers can act now to control their own costs and vastly improve medical outcomes, all while making health care more affordable for average Americans. Reducing drug co-pays is the way to do it. -
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February 12, 2010
Peter Pitts
A new blemish on the tort bar.
Last week, over-ruling a lower court and obvious logic, a New Jersey appeals court ruled that a trial court should reconsider allowing a so-called “expert” to testify in Palazzolo v. Hoffman La Roche, Inc, a lawsuit alleging that Accutane causes depression. The issue involves whether an expert should be allowed to offer testimony on a study that was (1) considered flawed and (2) was funded by plaintiffs and lawyers involved in the litigation. The trial court in New Jersey ruled that Doug Bremner, an Emory University professor, should not be allowed to offer expert testimony on his “flawed study.” Now the appeals court has remanded the case to the trial court "to consider whether Bremner should be allowed to testify on causation, without reference to the study.” (The trial judge decided the study was central to his opinion and dismissed the case.) To quote that well-known legal expert, Madonna – not! There are two main problems, one scientific and other ethical. Problem #1 is Bremner’s reliance on PET scans to find metabolic changes in the brains of acne patients treated with Accutane (the problem being that all parties agreed that that PET scans could not diagnose depression). The second, as already mentioned, is that Bremner’s study was commissioned specifically for use in the litigation by plaintiffs and lawyers involved in the litigation. Can you imagine the hue and cry if a pharmaceutical company had done this? Since sunshine is always the most potent disinfectant, how about a Sunshine Act for the tort bar? To quote the English social reformer, William Ellery Channing, “It is far more important to me to preserve an unblemished conscience than to compass any object however great.” -
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February 11, 2010
Dr. Robert Goldberg
Former Prez Bill Clinton was "admitted to the Columbia Campus of New York Presbyterian Hospital after feeling discomfort in his chest. Following a visit to his cardiologist, he underwent a procedure to place two stents in one of his coronary arteries."
By doing so Clinton and his doctors flouted the conclusion of what the WSJ's Keith Winstein's lovingly calls "a simple concept: Study different medical treatments and figure out which delivers the best results at the cheapest cost, giving patients the most effective care." That comparative effectiveness research. And Winstein is the muse to those who insist that people like the former POTUS should been given old drugs for 4 months rather than having a stent procedure:
Yet, an examination of one of the best-known examples of a comparative-effectiveness analysis shows how complicated such a seemingly straightforward idea can get. The study, known as "Courage" and published in the New England Journal of Medicine in 2007, shook the world of cardiology. It found that the most common heart surgery—a $15,000 procedure that unclogs arteries using a small scaffold or stent—usually yields no additional benefit when used with a cocktail of generic drugs in patients suffering from chronic chest pain. The Courage trial was led by William Boden, a Buffalo, N.Y., cardiologist, and funded largely by the Department of Veterans Affairs. It tracked 2,287 patients for five years and found that trying drugs first, and adding stents only if chest pain persisted, didn't affect the rate of deaths and heart attacks, although stents did produce quicker pain relief." But what did this study really say? And should one study shape how every doctor treats every patient? Winstein ignores the fact that even the COURAGE study shows that 1 in 4 patients with chest pain need a stent and drugs to survive as long as others who just received drugs. And it ignores the fact that the tools in the study used to identify which patients would benefit most from specific clot busting approaches and medicines -- a PET stress test and gene test for drug response -- are not widely reimbursed yet because they have not undergone the same kind of comparative effectivenesss research your article swoons over. In otherwords, it's ok to use new technologies to make the case not to pay doctors, but not to pay for those technologies when doctors want to use them. That is comparative effectiveness simply put. Even worse, when quoting Eric Topol in the article Winstein makes it seem that Topol is in favor of the one size fits all approach: It's certainly remarkable that nothing has been done to put some checks and balances," into the stenting decision after Courage, says Eric Topol, the chief academic officer of Scripps Health, a hospital operator in San Diego. "I have a very strong disagreement with cardiologists who see no reason to do the stress test." Winstein fails to note what he likely knew if he interview Topol at length, that Topol is also doing gene-testing prior to drug selection for eluting PCI and is a leader in personalized medicine in cardiology. But that didn't fit the narrative that one study can decide what treatment is good in all cases vs the judgment of doctors and their clinical experience. Good thing Clinton's doctors didn't drink the COURAGE kool-aid. In the future it would be an act of leadership and consistency for all supporters of CER and its methods to ask their doctors to treat them according what CER studies supported by the government say. Their could even be a health plan for such people. Keith should be the first enrollee. -
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February 11, 2010
Dr. Robert Goldberg
From Jacob Goldstein's WSJ healthblog:
By Jacob Goldstein
The latest proposal comes from the state’s governor, Deval Patrick, who yesterday proposed a bill that would give the state the power to review — and, in some cases, reject — rate increases by doctors and hospitals. Here’s a key paragraph from the bill:
The bill would also allow the state to prevent health-insurance plans sold to small businesses from raising premiums by more than 1.5 times the rate of medical inflation, and impose a two-year moratorium on lawmakers mandating new health benefits that plans must cover (those mandates drive up costs). The Boston Globe said reaction “was mixed, with small business groups expressing cautious optimism, insurers saying the measures do not go far enough, and health care providers worrying that smaller hospitals could be disproportionately harmed and that some might have to lay off caregivers.” -
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February 11, 2010
Peter Pitts
Pleased to report that the “Health Expert Blog” has named drugwonks.com to its “Top 50 Medical Ethics Blogs” list.
According to that blog: “Medicine is fraught with ethical dilemmas. The very nature of health care, medicine and biology offer insights into humanity. Additionally, issues of medical ethics delves into the most intimate parts of our lives, focusing on our bodies — sometimes at a cellular level. The state of health care, and the technology that is coming to medicine offer new challenges to the idea of what is right and wrong. Here are 50 medical ethics blogs that can offer insight on the debate.” We are pleased to be in such esteemed company. The complete list can be found here. (See, life really does begin at 50.) -
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February 10, 2010
Dr. Robert Goldberg
The autocrats persist in a policy of polarization when it comes to health care.. Henry Aaron restates the elitist case that the problem with health care reform is that is hasn't been explained simply enough to we the little people and that popular will be damned Democrats should use reconciliation to ram through the existing Senate bill...
"Meanwhile, supporters have spent most of their time on seemingly endless debates with one another about specific legislative provisions — whether to include a public option in the reform legislation, whether to have a single national insurance exchange or separate state exchanges, how to enforce a mandate that everyone carry insurance and how much to spend on subsidies to make that mandate acceptable, how to enforce a mandate on all but small employers to sponsor and pay for basic coverage for their workers, and scores of other complex and bewildering technical provisions. Health care reformers in the administration and Congress have a powerful case to make and, on an issue of such enormous importance, a duty to make it. In addition to reminding Americans that reform will protect, not jeopardize, coverage by preventing insurance companies from canceling coverage or jacking up premiums for the sick, reform advocates should remind them that the proposed legislation will bring coverage to tens of millions of currently uninsured Americans and protect it for scores of millions of others. Reform advocates should explain the legislation’s legitimate promise of cost control and quality improvement. President Barack Obama has announced a bipartisan meeting on moving the reform process forward. It is an opportunity for all sides to present ideas for improving the bills that already have been passed by both houses of Congress. If modifications are identified that will command the support of simple majorities in both houses, they should be adopted through reconciliation. Then the House should pass the Senate bill."Read more here The pursuit of health care reform is a manifestation -- indeed it is the ultimate mission of liberal elitists one on side of a culture war that James Q. Wilson characterized with regard to the national split over the Iraq war. That divide exists on healthcare. Wilson wrote of a "linkage between ideology, on the one hand, and congressional polarization, media influence, interest-group demands, and education on the other are easily read in the commentary surrounding the 2004 election. In their zeal to denigrate the president, liberals, pronounced one conservative pundit, had "gone quite around the twist." According to liberal spokesmen, conservatives with their "religious intolerance" and their determination to rewrite the Constitution had so befuddled their fellow Americans that a "great nation was felled by a poisonous nut." If such wholesale slurs are not signs of polarization, then the word has no meaning. To a degree that we cannot precisely measure, and over issues that we cannot exactly list, polarization has seeped down into the public, where it has assumed the form of a culture war. The sociologist James Davison Hunter, who has written about this phenomenon in a mainly religious context, defines culture war as "political and social hostility rooted in different systems of moral understanding." Such conflicts, he writes, which can involve "fundamental ideas about who we are as Americans," are waged both across the religious/secular divide and within religions themselves, where those with an "orthodox" view of moral authority square off against those with a "progressive" view. To some degree, this terminology is appropriate to today's political situation as well. We are indeed in a culture war in Mr. Hunter's sense, though I believe this war is itself but another component, or another symptom, of the larger ideological polarization that has us in its grip. Conservative thinking on political issues has religious roots, but it also has roots that are fully as secular as anything on the Left. By the same token, the liberal attack on conservatives derives in part from an explicitly "progressive" religious orientation--liberal Protestantism or Catholicism, or Reform Judaism--but in part from the same secular sources shared by many conservatives." Wilson goes on to ask and answer:"But what, one might ask, is wrong with having well-defined parties arguing vigorously about the issues that matter? Is it possible that polarized politics is a good thing, encouraging sharp debate and clear positions? Perhaps that is true on those issues where reasonable compromises can be devised. But there are two limits to such an arrangement. -
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Now that it’s expanded health-insurance coverage to nearly all of its citizens, Massachusetts is trying to figure out what to do about the rapid rise of health costs.