Latest Drugwonks' Blog
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.
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.
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.
“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.”
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.
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.”
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:
"Even before Congress took up the now-stalled health-care overhaul, it appropriated $1.1 billion to fund these studies. Both the Senate and the House included it in their versions of the bill. President Barack Obama backed it.
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."
http://online.wsj.com/article/SB10001424052748703652104574652401818092212.html?KEYWORDS=stents
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.
By Jacob Goldstein
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.
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:
Any contract under which provider payments increase by an amount in excess of the applicable Consumer Price Index for Medical Care Services shall be presumptively disapproved. The division may conduct a hearing on any contract that is presumptively disapproved and will approve or disapprove the contract based on its findings following the hearing.
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.”
http://blogs.wsj.com/health/2010/02/11/mass-governor-wants-to-cap-hospital-doctor-rate-increases/
Mixed? I wonder what insurers will say when their rates are capped. In any event, price controls will only worsen the shortage of primary care in the Bay State and reduce the availability of services.
Here is something else Republicans can bring up in their summit: Government regulation of health care reduces employment and investment..
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.)
"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.
"....many Americans believe that unbridgeable political differences have prevented leaders from addressing the problems they were elected to address. As a result, distrust of government mounts, leading to an alienation from politics altogether. The steep decline in popular approval of our national officials has many causes, but surely one of them is that ordinary voters agree among themselves more than political elites agree with each other--and the elites are far more numerous than they once were."
Read more here
The misguided effort to push through the current health care bill will deepen the divide as well as the distrust. As Wilson notes, since they are so many elites (the so-called stakeholders and people like me who follow them with blogs, white papers and Hill briefings) the ability of government to serve as a connective tissue to public opinion is dampened. The push for health care is leading to an outright rejection of the very politicians themselves. But importantly it is not leading to the alienation from politics. It is fueling an awakening.
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.
