New hospital safety scores were released this week, and around the country, those that scored well are crowing (see e.g., here and here). The data is provided by a nonprofit called Leapfrog Group, which compiles survey-responses and CMS data on a website called hospitalsafetyscore.org. Check out your own hospitals. The Leapfrog Group includes several leaders in the hospital safety movement, including Peter Pronovost (of checklist fame) and Lucian Leape (author of the seminal 1994 JAMA article on the topic). Is anyone aware of an empirical study that looks at the relationship between these scores and medical malpractice liability claims or payouts? Any attorneys that use this sort of data in the litigation of individual cases?
As is well known ACA § 3025 (§1886(q) Social Security Act) established the Hospital Readmissions Reduction program. This is operationalized through deductions built into the Hospital IPPS (Inpatient Prospective Payment Systems) Rule which sets the Medicare reimbursement amounts, here. The excess readmissions ratio initially only applies to readmissions based on MI, Heart Failure, and Pneumonia. Initially the maximum deduction is 1% but that rises to 2% in October 2013 and 3% in October 2015.
A parallel program for Medicaid designed to reduce hospital-acquired infections was introduced in the 2005 Deficit Reduction Act, here. However, Lee and colleagues, here, found no change in infection rates. Nevertheless, the dollars associated with readmissions reduction may give that program greater traction.
Jordan Rau in the New York Times, here, notes that 307 hospitals are already facing the maximum reduction involving many millions of dollars. Not surprisingly some hospitals view the penalties as a distraction while others blame their patients for everything from their level of sickness and poverty to non-compliance. Overall, however, Rau’s article and Amy Boutwell’s recent post at Health Affairs, here, suggest that CMS is succeeding in getting the industry’s attention.
By Casey Thomson
Don’t just read the summaries – check out the tweets themselves! From now on, links to the original tweets will be included in our round-up. Additionally, as a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet. With that, read on for this week’s round-up…
- Arthur Caplan (@ArthurCaplan) posted an article about the growing trend of paying for convenience in healthcare with privacy, sometimes without formal consent. The latest example (and the subject of this article) is palm-scanning at New York University Langone Medical Center. (11/11) [Note: Dan Vorhaus also tweeted this the next day.]
- Frank Pasquale (@FrankPasquale) linked to a post on the potential valuables (medicines, solvents, chemical treatments) hidden amongst newly-discovered marine micro-organisms. With regulations hefty on land but largely non-existent for water, there are concerns that damage from harvesting could result in ecosystem damage or exploitation of water resource-rich developing nations. (11/11)
- Dan Vorhaus (@genomics lawyer) brought up a link describing the “particularized consent approach” of the website my46, meant to facilitate the process of helping people decide what results of genetic testing to see and when to see such results. Combining this with his post about the direct-to-consumer genomics of 23andMe, it is clear that this is an area to watch. (11/12)
- Daniel Goldberg (@prof_goldberg) exclaims his love for the term “empathotoxin” in conjunction with the link for this blog post. The post talks about the declining sense of empathy correlated with medical training as according to a research review by American Medicine, with results based on self-reporting. (11/12)
- Kevin Outterson (@koutterson) tweeted an article about the oncoming scrutiny likely to hit Congress in the throngs of the current meningitis outbreak. While state boards and the F.D.A. are receiving much of the onslaught as a result of their lax oversight, Congress has hindered stronger regulation for drug compounders particularly in regards to defining the F.D.A.’s policing authority – and thus, say some, is partly deserving of blame. (11/14)
- Daniel Goldberg (@prof_goldberg) also linked to an article that talked of lessening the gaps between the mainstream views concerning disability (the “outside” view) and those within the disability community (the “inside” view) when considering law. By proposing a certain set of “framing rules” facilitated by input from the inside view, nondisabled people can make more informed decisions regarding the relationship to disability. (11/14)
- Dan Vorhaus (@genomicslawyer) posted an article that followed up on an earlier tweet from our weekly round-ups detailing China’s new draft regulation for human genetic materials, including but not limited to organs. (11/15)
- Frank Pasquale (@FrankPasquale) included a link to the The New York Times piece on the massive drug shortages plaguing the nation’s healthcare system. Pasquale noted in his tweet that organizations which purchase on behalf of groups, often for hospitals, may be contributing to this shortage. (11/17)
Until recently, most ordinary people had never heard of “pharmacy compounding.” Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).
Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug. See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002). For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)). A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).
However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion. The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year. These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.
If you’ve been following the fungal meningitis outbreak and wondering about the legal implications, take a listen to this audio interview with Glenn Cohen and personal injury lawyer Michael F. Barrett, hosted by Legal Talk Network’s Lawyer2Lawyer. They discuss the litigation likely to stem from this outbreak (and some already pending), as well as the role of FDA and CDC in regulation.
by Brendan Abel, JD
Countless regulations have been enacted over the past 35 years to protect children from unnecessary clinical testing. Federal regulations, the Belmont Report, and professional guidelines all state that children should be enrolled in clinical trials only when the research is a high imperative. Federal research regulations insist that absent a potential for direct benefit to the participating child, research should take place only if there is “minimal risk” or “minor increase over minimal risk.”
Thus, it was surprising that one year ago, the National Biodefense Science Board (NBSB), an advisory panel to the Secretary of Health and Human Services, recommended that HHS develop and implement a study of pre-exposure anthrax vaccine in pediatric populations. Such a vaccine would subject children to risks with little potential for therapeutic benefit. The matter is now in front of the President’s Commission for the Study of Bioethical Issues, at the request of Secretary Kathleen Sebelius, who in May visited the Commission to ask for advice regarding the ethical issues raised by this potential study. The Commission’s recommendation is expected early next year.
Much of the controversy surrounding anthrax-vaccine testing in the pediatric population relates to the issue of timing. Since the vaccine can be used either prophylactically or as a post-exposure treatment, the government is considering whether children should be tested now to determine safety, efficacy, and dosing levels in a structured, controlled environment, or whether it is best to avoid subjecting children to the risks of the testing and to face an (unlikely) anthrax attack without the knowledge that would be gained from such a study.
On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva. Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter). A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .” Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year. A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.
The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days. The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.” (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.” Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.” The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.
The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.
In his latest MSNBC column, Art Caplan addresses a different angle of the fungal meningitis outbreak:
The quest for relief from pain has now resulted in the deaths of 19 people and a total of 247 confirmed infections of fungal meningitis from tainted steroid injections. Thousands more who got the injections, made by the New England Compounding Center in Massachusetts, are worried that they too may wind up sick or dead.
The horrific outbreak has resulted in the outrage about a lack of oversight of the compounding pharmacy.
But, this tragedy has another aspect that is not getting sufficient attention. Why are so many Americans getting spinal injections?
A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no matter how powerful or well funded, could deliver on that expectation, and the reality is that FDA operates under a variety of limitations, both fiscal and legal.
The current deadly meningitis outbreak linked to contaminated injections made by a Massachusetts compounding pharmacy shocks us and upsets our expectation that the drugs we take to get better will not, at the very least, cause us harm. Responding reflexively to this crisis, many in the media and in Washington have already started to call for greater federal oversight. This is a natural impulse, but one that merits cool-headed consideration. FDA is an agency that already has a broad statutory mandate and limited resources. Enforcement resources are slim enough that the agency’s response to an HHS report this month finding rampant violation of dietary supplement-labeling laws was simply to say that the agency would “address the recommendations as its resources and priorities allow.” Before we add still further to FDA’s crowded plate at a time when it is already facing a potential budget crisis (and it is worth noting that according to at least one former FDA chief counsel and congressional testimony by agency officials, FDA already possesses the authority to regulate pharmacies like the one involved in the outbreak and historically has done so), it is worth asking whether FDA enforcement is the only or best solution to the problem.
Fifty years ago on Wednesday, President Kennedy signed into law the US Food and Drug Amendments. The amendments radically overhauled the way in which manufacturers brought drugs to market. Most importantly, the amendments instituted the four-phase review process and the requirement that manufacturers get informed consent from people receiving experimental drugs. If the past fifty years is any indication, though, its unlikely that FDA’s current regulations are well suited to deal with the changing context of medicine, including clinical trials of stem-cell therapies forecasted with the Nobel Prize Committee’s awarding of their prize in Physiology or Medicine earlier this week.
The amendments’ supporters had good intentions and the regulations have had positive effects overall. Yet the US government is still trying to redress many of their negative consequences. The rules have proven to be outmoded for new circumstances that policymakers did not have in mind when they created the amendments five decades ago.
The four-phase review process requires that manufacturers apply to the FDA and submit drugs for agency review three times—at least. One consequence of the four-phase review system is that it extended the time until consumers could access new therapies. This can seem a small price to pay to assure that drugs are safe and effective, a phrase that has become the slogan for the Amendments. People with new, fast-moving diseases, however, have seen the delay as a death sentence. For example, sociologist Steven Epstein has written extensively and carefully about the response to drug delays in the 1980s and 1990s among the HIV/AIDS activist community. The FDA has responded with changes, such as a fast-track approval system, but these shifts tend to come only in response to dire crises.