Articles

Archive for Politics and Regulation

What does a new drug cost? Part II: The productivity problem

A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.

The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted.  Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?

(more…)

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

Leave a Comment (20) →

Oregon Naturopaths v. Evidence-Based Medicine

Like every state, Oregon is struggling with the unsustainable costs of taxpayer-funded health care programs. In an attempt to tame this beast, Oregon recently established a system of coordinated care organizations, or CCOs, to (as the name suggests) coordinate medical, mental health, and dental care for residents enrolled in Oregon Health Plan, the state’s Medicaid program. The new system requires supervision of this coordinated effort by the participant’s primary care physician (PCP). Not one of the 15 newly-minted CCOs has credentialed a naturopath as a PCP even though naturopaths are licensed as such by the state. Needless to say, the naturopaths are not pleased by this development.

The big stumbling block appears to be the state’s requirement that CCOs practice evidence-based medicine as a cost control measure. Unfortunately for naturopaths, evidence-based medicine is not their strong suit. Apparently scientific plausibility is not much of a concern either.

As one chief medical officer of a CCO explained in a news report,

We have an obligation to the state and to the community that the providers on our panel will deliver the evidence-based care required by the Oregon Health Plan. . . . We need to make sure that all of the providers who are empanelled meet those basic standards of care.

(more…)

Posted in: Legal, Naturopathy, Politics and Regulation, Vaccines

Leave a Comment (35) →

“Moneyball,” the 2012 election, and science- and evidence-based medicine

Regular readers of my other blog probably know that I’m into more than just science, skepticism, and promoting science-based medicine (SBM). I’m also into science fiction, computers, and baseball, not to mention politics (at least more than average). That’s why our recent election, coming as it did hot on the heels of the World Series in which my beloved Detroit Tigers utterly choked got me to thinking. Actually, it was more than just that. It was also an article that appeared a couple of weeks before the election in the New England Journal of Medicine entitled Moneyball and Medicine, by Christopher J. Phillips, PhD, Jeremy A. Greene, MD, PhD, and Scott H. Podolsky, MD. In it, they compare what they call “evidence-based” baseball to “evidence-based medicine,” something that is not as far-fetched as one might think.

“Moneyball,” as baseball fans know, refers to a book by Michael Lewis entitled Moneyball: The Art of Winning an Unfair Game. Published in 2003, Moneyball is the story of the Oakland Athletics and their manager Billy Beane and how the A’s managed to field a competitive team even though the organization was—shall we say?—”revenue challenged” compared to big market teams like the New York Yankees. The central premise of the book was that that the collective wisdom of baseball leaders, such as managers, coaches, scouts, owners, and general managers, was flawed and too subjective. Using rigorous statistical analysis, the A’s front office determined various metrics that were better predictors of offensive success than previously used indicators. For example, conventional wisdom at the time valued stolen bases, runs batted in, and batting average, but the A’s determined that on-base percentage and slugging percentage were better predictors, and cheaper to obtain on the free market, to boot. As a result, the 2002 Athletics, with a payroll of $41 million (the third lowest in baseball), were able to compete in the market against teams like the Yankees, which had a payroll of $125 million. The book also discussed the A’s farm system and how it determined which players were more likely to develop into solid major league players, as well as the history of sabermetric analysis, a term coined by one of its pioneers Bill James after SABR, the Society for American Baseball Research. Sabermetrics is basically concerned with determining the value of a player or team in current or past seasons and with predicting the value of a player or team in the future.
(more…)

Posted in: Clinical Trials, Politics and Regulation, Science and Medicine, Science and the Media

Leave a Comment (47) →

It’s time for true transparency of clinical trials data

What makes a health professional science-based? We advocate for evaluations of treatments, and treatment decisions, based on the best research methods. We compile evidence based on fair trials that minimize the risks of bias. And, importantly, we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result in a trial, especially when it’s sloppily done or biased.  And there are many ways to design a trial to demonstrate positive results in some subgroup, as Kimball Atwood pointed out earlier this week. And even when a trial is well done, there remains the risk of error simply due to chance alone. So to sort out true treatment effects, from fake effects, two key steps are helpful in reviewing the evidence.

1. Take prior probability into account when assessing data. While a detailed explanation of Bayes Theorem could take several posts, consider prior probability this way: Any test has flaws and limitations. Tests give probabilities based on the test method itself, not on what is being tested. Consequently, in order to evaluate the probability of “x” given a test result, we must incorporate the pre-test probability of “x”. Bayesian analysis uses any existing data, plus the data collected in the test, to give a prediction that factors in prior probabilities. It’s part of the reason why most published research findings are false.

2. Use systematic reviews to evaluate all the evidence. The best way to answer a specific clinical question is to collect all the potentially relevant information in a structured way, consider its quality, analyze it according to predetermined criteria, and then draw conclusions. A systematic review reduces the risk of cherry picking and author bias, compared to non-systematic data-collection or general literature reviews of evidence. A well-conducted systematic review will give us an answer based on the totality of evidence available, and is the best possible answer for a given question.

These two steps are critically important, and so have been discussed repeatedly by the contributors to this blog. What is obvious, but perhaps not as well understood, is how our reviews can still be significantly flawed, despite best efforts. In order for our evaluation to accurately consider prior probability, and to be systematic, we need all the evidence. Unfortunately, that’s not always possible if clinical trials remains unpublished or are otherwise inaccessible. There is good evidence to show that negative studies are less likely to be published than positive studies. Sometimes called the “file drawer” effect, it’s not solely the fault of investigators, as journals seeking positive results may decline to publish negative studies. But unless these studies are found, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention. How bad is the problem? We really have no complete way to know, for any particular clinical question, just how much is missing or buried. This is a problem that has confounded researchers and authors of systematic reviews for decades. (more…)

Posted in: Clinical Trials, Politics and Regulation

Leave a Comment (18) →

The Trial to Assess Chelation Therapy: Equivocal as Predicted

The ill-advised, NIH-sponsored Trial to Assess Chelation Therapy (TACT) is finally over. 839 human subjects were randomized to receive Na2EDTA infusions; 869 were randomized to receive placebo infusions. The results were announced at this weekend’s American Heart Association meeting in Los Angeles. In summary, the TACT authors report a slight advantage for chelation over placebo in the “primary composite endpoint,” a combination of five separate outcomes: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina:

 

Although that result may seem intriguing, it becomes less so when the data are examined more carefully. First, it barely achieved the pre-ordained level of statistical significance, which was P=.036. Second, none of the individual components of the composite endpoint achieved statistical significance, and most of the absolute difference was in coronary revascularization–which is puzzling:

(more…)

Posted in: Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (8) →

Weak drug regulation and patient tragedies: We’ve seen this story before

Plenty of new drugs, but few that are truly innovative. Growing costs from their use. Physicians deemed “Dupes of Big Pharma” for their interactions with the pharmaceutical industry. A call to produce better information on which drugs work best. Finally, shoddy drug manufacturing is injuring and even killing patients. These stories could be lifted from today’s headlines — but they’re actually from 1962. Problems with the behavior of the pharmaceutical manufacturing industry, and our relationship with it, are not new. Nor are they restricted to one country. Every developed country’s health-care system is different, but one feature is near-universal: none have a public pharmaceutical industry. Ever nation relies on for-profit, private companies to supply its population with drug products.

Blog posts here can get pretty wonkish about health policy, as many of the substantial challenges to science-based medicine have their roots in regulation — whether it’s DSHEA which implemented a regulatory double-standard for supplements, or the state-by-state legislative alchemy that Jann Bellamy has documented, which transforms magical thinking and pseudoscientific practices into registered and regulated health practitioners. Federal food and drug regulations have also come under some scrutiny (and praise). The FDA’s under fire again; this time over its responsibility to oversee pharmaceutical manufacturing. But in this case, it’s not Big Pharma that’s the villan — it’s pharmacies. (more…)

Posted in: Pharmaceuticals, Politics and Regulation

Leave a Comment (20) →

Obamacare and CAM III: Great Expectations

In a previous post, we looked at how so-called “complementary and alternative medicine” (or “CAM”) might fit into the definition of “essential health benefits,” which must be covered by insurers pursuant to the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA”). In another, we contemplated what it might mean for insurers to “discriminate” against CAM providers, which is prohibited by the ACA. In both posts, the conclusion reached was that these provisions of Obamacare might not incorporate CAM practices into health care at the level CAM providers were hoping for. Here again we examine how the great expectations of CAM promoters may not be met in health care reform.

This time, we take a look at some additional provisions of the ACA that CAM lobbyists and their friends in Congress managed to insert into the healthcare overhaul. Of course, whether the ACA is around for much longer will depend on the outcome of the November elections, although Gov. Romney’s promise to “repeal Obamacare” if elected president will happen only if his party wins a majority in both the House of Representatives and Senate.  (more…)

Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

Leave a Comment (9) →

Mortality and lack of health insurance

The 2012 election campaign is in full swing, and, for better or worse, health care is one of the major defining issues of the election. How can it not be, given the passage of the Patient Protection and Affordable Care Act (PPACA), also colloquially known as “Obamacare,” was one of the Obama administration’s major accomplishments and arguably the largest remaking of the American health care system since Medicare in 1965? It’s also been singularly unpopular thus far, contributing to the Republican takeover of the House of Representatives in the 2010 elections, as well as the erosion of Democratic control of the Senate. Given that this is a medical blog dedicated to discussing the scientific basis of medicine and not a political or health policy blog, I am not going to go into the reasons for a lot of this. What I am going discuss is a recent eruption of the central problem that led President Obama to make the PPACA one of the central policy initiatives, if not the central policy initiative, of his first term. That problem is the issue of people without health insurance, who number roughly 50 million, with a further estimate that 86.7 million people were uninsured at some point during the two year period from 2007 to 2008, representing about 29% of the total U.S. population under 65.

The question that bubbled to the surface last week in the form of a statement by Republican challenger Mitt Romney, and a tear-inducing op-ed piece published yesterday in the New York Times by Nicholas Kristof entitled A Possibly Fatal Mistake, is what the health impact of not having insurance is for those millions of people. This is a question that can be addressed scientifically and is, despite its politically charged nature, correctly within the purview of science-based medicine. What to do about it, in contrast, is a matter for politics and public policy. So first let’s examine the question.
(more…)

Posted in: Politics and Regulation, Public Health

Leave a Comment (300) →

Obamacare and CAM II: Discrimination (or not) against CAM

Supporters of science-based medicine have expressed concern over this provision in the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA.”):

SEC. 2706. NON-DISCRIMINATION IN HEALTH CARE.

(a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

Section 2706 (now codified as 42 U.S.C. Sec. 300gg-5) goes into effect in 2014 and covers virtually all individual and group insurance market policies, although it is not clear whether it will apply to existing policies “grandfathered” in 2010 by the ACA.

Section 2706 was not part of the U.S House of Representatives version of the ACA but was included in the Senate version (which ultimately passed) under the guidance of (surprise!) Sen. Tom Harkin (D-Iowa). It was heavily lobbied by the American Chiropractic Association and other “CAM” providers, as well as some “conventional” providers like nurse anesthetists and optometrists. The legislative history (reports, committee minutes, floor debates and the like which precede a vote on a bill) indicates it was specifically included to prevent discrimination against CAM providers.  This is of obvious concern to anyone who supports science-based, or for that matter evidence-based, medicine, as there is nothing to indicate that scientific plausibility or evidence (or the lack thereof) actually affects CAM practices. It should also concern insurers and those who pay for insurance (employers and individuals) to the extent it might require payment for CAM treatments, as ineffective treatments will negatively affect their bottom line. The U.S. Departments of Health and Human Services (HHS) and Labor and the Treasury Department, which are charged with issuing regulations implementing the ACA, have not yet promulgated regulations for Section 2706. The American Medical Association House of Delegates has already passed a resolution seeking its repeal.

(more…)

Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

Leave a Comment (20) →

Antivaccine versus anti-GMO: Different goals, same methods

Countering ideologically motivated bad science, pseudoscience, misinformation, and lies is one of the main purposes of this blog. Specifically, we try to combat such misinformation in medicine; elsewhere Steve and I, as well as some of our other “partners in crime” combat other forms of pseudoscience. During the nearly five year existence of this blog, we’ve covered a lot of topics in medicine that tend to be prone to pseudoscience and quackery. Oddly enough, there’s one topic that we haven’t really written much about at all, and that’s genetically modified organisms (GMOs). GMOs, as you know, are proliferating, and it’s quite worth discussing the potential and risks of this new technology, just as it is worthwhile to discuss the potential benefits versus the risks of any new technology that can impact our health, not to mention the health of the planet. Unfortunately, GMOs have become a huge political issue, and, I would argue, they have become just as prone to pseudoscience, misinformation, and bad science as vaccines, with a radical group of anti-GMO activists who are as anti-science as any antivaccinationist or quack.

Leave it to that quackery promoter to rule all quackery promoters, Mike Adams, to give me just the opportunity to show you what I mean. Over the last couple of weeks, Mike has been in a fine lather about GMOs, with multiple posts with titles such as The GMO debate is over; GM crops must be immediately outlawed; Monsanto halted from threatening humanity and The evil of Monsanto and GMOs explained: Bad technology, endless greed and the destruction of humanity. In other words, it’s a series of post with Adams’ typical hyperbole. If you were to believe him, GMOs are the product of a plot by Satan, Monsanto, big pharma, and the government, and he’s not sure which one of these is the most evil of the bunch.
(more…)

Posted in: Cancer, Genetically modified organisms (GMOs), Politics and Regulation, Public Health

Leave a Comment (100) →
Page 11 of 38 «...910111213...»