Of Morals and Smartphones

By Emily Largent

Although many lament that the ubiquity of smartphones has contributed to a recent decline in etiquette, a study published this week in Science suggests that smartphones’ ubiquity may make them a valuable–if surprising–tool for studying modern morality.

Most moral judgment experiments are lab-based and driven by hypotheticals. By contrast, this was a field experiment that focused on the moral judgments people make in their daily lives. The authors recruited 1,252 adults from the U.S. and Canada. Participants were contacted via text message five times each day over a three-day period. Each time, they were asked “whether they committed, were the target of, witnessed, or learned about a moral or immoral act within the past hour.” For each moral or immoral event, participants described via text what the event was about; provided situational context; and provided information about nine moral emotions (e.g., guilt and disgust). Political ideology and religiosity were assessed during an intake survey.

Participants reported a moral or immoral event on 28.9% of responses (n = 3,828). Moral and immoral events had similar overall frequencies.  The authors found political ideology was reliably associated with the types of moral problems people identified.  Liberals mentioned events related to Fairness/Unfairness, Liberty/Oppression, and Honesty/Dishonesty more frequently than did conservatives.  By contrast, conservatives were more likely to mention events related to Loyalty/Disloyalty, Authority/Subversion, and Sanctity/Degradation.  Continue reading

What Is (or Isn’t) a Public Health “Emergency”?

In this week’s issue of New England Journal of Medicine, Michelle Mello, Wendy Parmet, and I write about what constitutes — or should constitute — a “public health emergency”. The law provides for emergency declarations, which suspend ordinary legal standards and processes in order to avoid catastrophe, on many levels (international, federal, state, local) and in public health or more general contexts. We focus our discussion at the state level, using Governor Deval Patrick’s declaration of the opioid-addiction crisis as a public health emergency as an opportunity to explore the appropriate parameters of these powers. My co-authors and I don’t debate the public health significance of opioid addiction in the Commonwealth, nor the specific measures ordered pursuant to this declaration. We do question the expanding use of public health emergency powers beyond the traditional arenas of infectious disease outbreaks, natural disasters, and acts of bioterrorism into new territories, such as injuries and chronic disease.

State laws provide governors and their top health officers with considerable latitude in declaring public health emergencies. But the powers available upon such declarations are extraordinary and should be wielded with care. My co-authors and I identify three key criteria that seem to be enshrined in the spirit of public health emergency laws: “the situation is exigent, the anticipated or potential harm is calamitous, and the harm cannot be avoided through ordinary procedures.” In the absence of these criteria, the invocation of such emergencies may raise heightened concerns — for instance, if ensuing orders involve serious infringements on individual and private business rights — and could result in a loss of public trust in health officials and legitimacy in public health laws. We caution against setting such troubling precedent.

Read more in our Perspective, entitled “What Is a Public Health “Emergency”?“.

Asking the Right Right Question About Football – Why do Some NFL Players Abuse Their Partners?

The national press is buzzing after TMZ released a video of Baltimore Ravens running back Ray Rice’s barbaric assault of his then-fiancee, Janay Rice.  Much of the spotlight of the coverage shined on the NFL’s handling of the abuse, and perhaps even more time was spent yesterday questioning Ms. Rice’s decision to stay in her relationship with her husband.  These are certainly valid questions to ask, and there is something to be said about the raised “awareness” of domestic violence in the aftermath of its players deplorable acts of violence.  I would argue the discussion has been more valuable than any awareness raised by NFL teams wearing pink during breast cancer awareness month.

If we want to best-capitalize on the awareness raised by these acts of violence, however, the conversation needs to shift from harm reduction (“why did she stay?”) to harm prevention.  To illustrate: when faced with the prevalence of lung cancer, do we ask “Why does the cancer patient continue to smoke?”  Yes, to some extent, we do, but we first addressed the causal inquiry, “What causes cancer?”, and in order to prevent the next generation from becoming addicted to nicotine, millions have been invested and continue to be invested in educating the public (and particularly youth) about the harms of tobacco use, and legislative action has been taken to prevent the harms caused by tobacco use.

Domestic violence (or intimate partner violence), like lung cancer, is a public health issue.  This is not a novel or controversial statement.  According to a 2010 CDC report, one in four women and one in seven men have experienced severe physical violence by an intimate partner, and according to a 2003 report, the national costs of health services for intimate partner rape, physical assault, and stalking is nearly $4.1 billion.  The CDC’s website states:  “The goal is to stop IPV [intimate partner violence] before it begins. There is a lot to learn about how to prevent IPV.”

It is time that the health care community take the CDC’s statement seriously and work collaboratively across law, public health, and medicine to research, propose, and implement innovative solutions to this perpetual epidemic, that costs thousands of lives in the United States each year.  Unlike some other organizations aimed at addressing public health issues, organizations whose goal is to prevent domestic violence are often grossly under-funded.  Perhaps the most apropos inquiry or statement to put to the NFL, the NFL Player’s Union, or other public health institutions that agree that domestic violence prevention is important is one capture by a classic football film: “SHOW ME THE MONEY.”

[Ed. Note: This post reflects the author's views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

9/30/14: A Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

To Watch: Rural Enrollment on Exchanges

As we gear up for a second year of exchange marketplace enrollment, one issue to keep an eye on is the success we have at getting people who live in rural areas onto the healthcare rolls.  As pointed out in today’s Kaiser Health News write-up (here), there is potential for the ACA to increase rural health disparities, even while it gets more people insured, because many of the efforts to encourage enrollment–think navigators, enrollment centers, advertising, and outreach–just work better in urban areas.  For some reading on this issue, see the Kaiser Family Foundation’s posting here, the HHS’s Health Resources and Services Administration’s report here, and the Rural Health Foundation’s roundup here.

8 Facts (and some pretty graphs) that explain what’s wrong with American Healthcare

This single webpage (Vox) covers about 80% of what I try to convey during the first day of my health law class.  And the page does it with some nice graphics, which are worth stealing (ahem, “fair using” for educational purposes).  While nothing will be new to health policy scholars, it is a nice synthesis.  Highly recommended.

The Expressive Dimension of Donor Deferral

By Dov Fox

The Guardian and L.A. Times are the latest major news organizations to decry trans-Atlantic restrictions on blood donation by men who have sex with men (MSM). The case against such categorical bans has been reignited by an influential piece that Bill of Health editor Glenn Cohen recently published with co-authors Jeremy Feigenbaum and Eli Adashi in the Journal of the American Medical Association. Cohen, Feigenbaum, and Adashi make a powerful case why sexual orientation should be just one component among others used to assess the risk that blood donors might spread HIV.[i]

But their argument elides exactly what is—and isn’t—wrong with excluding men who have sex with men from donating blood. At times they suggest the longstanding U.S. ban reflects “outdated homophobic perceptions.” Yet they acknowledge that it was “well-intentioned and guided by a need to protect the integrity of the national blood supply.” Indeed, the Food and Drug Administration that enacted the lifetime MSM ban solicited guidance from the National Gay Task Force whose recommendations were adopted into Red Cross blood collection procedures.[ii] It’s unlikely the policy was motivated by animus as opposed to concern for public health.

Elsewhere, the authors imply the policy’s chief offense is that it deprives MSM of a crucial “civic opportunity.” But giving blood, even if it shares the life-saving potential of military service and registration as an organ donor, is not typically regarded as a duty of citizenship tantamount to voting or jury service.[iii] So it’s not its effects on those it excludes that makes the donor ban so bad.

The best reason to let low-risk gay men give blood lies in the demeaning message that excluding them expresses, what I’ve called the expressive dimension of donor deferralContinue reading

9/18/14: Post-Trial Responsibilities Conference

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave.

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

Apple’s mHealth Rules Fear to Tread Where Our Privacy Laws Fall Short

By Nicolas Terry

On September 9 Apple is hosting its ‘Wish We Could Say More’ event. In the interim we will be deluged with usually uninformed speculation about the new iPhone, an iWatch wearable, and who knows what else. What we do know, because Apple announced it back in June, is that iOS 8, Apple’s mobile operating system will include an App called ‘Health’ (backed by a ‘HealthKit’ API) that will aggregate health and fitness data from the iPhone’s own internal sensors, 3rd party wearables, and EMRs.

What has been less than clear is how the privacy of this data is to be protected. There is some low hanging legal fruit. For example, when Apple partners with the Mayo Clinic or EMR manufacturers to make EMR data available from covered entities they are squarely within the HIPAA Privacy and Security Rules triggering the requirements for Business Associate Agreements, etc.

But what of the health data being collected by the Apple health data aggregator or other apps that lies outside of protected HIPAA space? Fitness and health data picked up by apps and stored on the phone or on an app developer’s analytic cloud fails the HIPAA applicability test, yet may be as sensitive as anything stored on a hospital server (as I have argued elsewhere). HIPAA may not apply but this is not a completely unregulated area. The FTC is more aggressively policing the health data space and is paying particular attention to deviance from stated privacy policies by app developers. The FTC also enforces a narrow and oft-forgotten part of HIPAA that applies a breach notification rule to non-covered entity PHR vendors, some of whom no doubt will be selling their wares on the app store. Continue reading

Contraceptive Mandates and Conscience – All Objections Are Not Equal

By Jonathan Will

In the wake of the Hobby Lobby decision, the US Department of Health and Human Services announced on Friday proposed rules regarding exemptions for those objecting to the contraceptive mandate.  Whenever I read about conscientious objections to health care services made by providers, patients, or indeed, employers, I am reminded that all objections are not equal.

As Mark Wicclair, and others, have written, studies show that medical professionals may object to services based on clinically false information.  For instance, certain pharmacists reported that they objected to emergency contraception on the mistaken belief that Plan B was the same thing as RU-486 (mifepristone, or the “abortion pill”).  Similarly, a prominent general practitioner admitted to making decisions regarding the prescription of oral contraception without fully understanding the mechanisms of operation that prevent pregnancy.  If medical professionals make decisions based on ignorance, one can suspect that lay employers and patients do as well.

This suggests that individuals often lack the information necessary to truly assess their stance on morally controversial services.  While the law does (and should) play a role in protecting conscience, it seems unsatisfying when such protection is granted to those holding underdeveloped views, and at the expense of (and detriment to) those seeking legal medical services.

Beneficiaries File Class Action Lawsuit Challenging Medicare Hearing Delays

I have blogged a few times about the current backlog in Medicare’s coverage appeals process, including observations about a lawsuit by providers challenging the backlog in federal court in the District of Columbia.  (See here.)  Yesterday a new lawsuit was filed, this one a class action lawsuit by beneficiaries represented by the Center for Medicare Advocacy.  (See their press release here.)  The case is Lessler et al. v. Burwell, 3:14-CV-1230 (D.Conn.).  I am blocked from accessing the complaint on PACER but am working on getting a copy.

Without access to the complaint it is dangerous to speculate, but I wonder whether this suit may be subject to many of the exhaustion-based arguments that I thought could lead to dismissal of the provider suit.  But the Center for Medicare Advocacy has had success pursuing class action suits on behalf of Medicare beneficiaries before, most notably the Jimmo case that led to a significant change in the standard of qualification for skilled nursing care.  (See here.)

One thing about this suit that may only be interesting to administrative law buffs is the choice of forum.  This case was filed in Connecticut, not the District of Columbia (where the providers filed their suit).  As I have written about elsewhere, there are pros and cons to channeling administrative law cases through DC, among them DC’s expertise in exhaustion and other administrative law issues.

I can’t say whether the Center for Medicare Advocacy chose to file in Connecticut rather than the District solely because that is their home forum, or whether they thought they’d get a more sympathetic judge/more plaintiff-friendly exhaustion doctrine.  And the same goes for the providers’ choice to file in the District rather than some other state.  I can say from experience, though, that the choice can really matter; DC judges’ familiarity with administrative law issues just makes them perceive these cases differently from the start.  So it would not surprise me at all if there are considerations beyond mere location at play here.  (Not that there’s anything wrong with that!)

The Political Economy of Medicaid Expansion

Many health law profs have wondered about how state officials can turn down bucketloads of federal money, without suffering the ire of their local constituents.  In states like Arizona, that frustration was spoken most vocally by the local healthcare industry and their employees, who have the most to gain from the expansion of coverage, even if the Medicaid beneficiaries are unlikely to themselves have political clout.

Well, over at the New Yorker, Sam Wang has now compiled the polling data for the gubernatorial races to ask whether “In Swing States, Is Obamacare an Asset?”  This graphic tells the whole story, focusing on states where Republican incumbents who made Medicaid-expansion decisions are now up for re-election:

Chart09-09-updated[1]

Although voters respond to a mix of positions and personalities, and these are only nine states, it is striking that the governors who declined federal money to cover their most vulnerable are also the most vulnerable at the polls.

The Revival of Phage Therapy to Fight Antimicrobial Resistance (AMR) – Part III: What about patent protection and alternative incentives?

In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).

Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.

One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.

Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part II: What about patent protection and alternative incentives?

Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized”  by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.

Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013)  and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part I: What are the legal implications?

Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report “Phage therapy gets revitalized” by Sara Reardon concentrates on the use of viruses (bacteriophages) to battle bacteria. The idea is not new, but apart from some applications in the former Soviet Union, it never was established as a major research area elsewhere. In particular the paper examines the European Phagoburn project, which is the first large, multi-centre clinical trial of phage therapy for human infections, funded by the European Commission. It involves a phase I-II trial of using viruses for the treatment of bacterial infection following burns. The European Union (EU) is contributing €3.8 million (US$5.2 million) to the Phagoburn study demonstrating that it is taking the approach seriously. Meanwhile, the US National Institute of Allergy and Infectious Diseases announced in March 2014  that it regards phage therapy as one of seven key areas in its strategy to fight antibiotic resistance.

So far Western practice has concentrated on treating complex or unidentified infections with broad-spectrum antibiotics. These antibiotics would typically eliminate multiple types of bacteria, including those who have beneficial effects to the human organism. Despite resulting in direct negative consequences for patients, e.g. gastrointestinal disorders, these “atomic bomb” approaches can result in biological niches where resistant “bad bugs” can prosper. This is the reason why scientists are turning towards more targeted approaches. This is where phage therapy comes into play. Like “guided missiles”, phage-therapy has the ability to kill just species of bacteria or strain. Quoting the US virologist Ryland Young and the head of the scientific council at the Eliava Institute in Tblisi (Georgia), Mzia Kutateladze, the Nature report explains how nature offers an almost unlimited source of different phages and that so far no identical phages have ever been found. For this reason it is fairly simple to identify a particular phage for a bacterial target. If the bacterium should become resistant against that particular phage, researchers would modify the viral cocktails that are used for treatment by adding or substituting phages. At the Eliava Institute such updates occur – according to the report – approximately every 8 months and the scientists would not be fully aware of the precise combination of phages in the cocktail.

In light of these advantages the recent interest of US and EU stakeholders in phage therapy comes as no surprise. However, the scientific and legal challenges confronting these projects are complex. After all we are talking about viruses here, which triggers alarm bells with regard to public perception, safety concerns, and the regulation of relevant research. It also appears questionable if – or under what circumstances – regulatory authorities would be willing to grant market approval for such a rapidly changing product like in the case of e.g. influenza vaccines. Another significant problem for the development of new phage therapies, also addressed in the paper, lies in the reluctance of pharmaceutical companies to invest into the field. The potential obstacles for more private involvement in phage therapy are many and range from considerable risks of failure, reputational damage, and unforeseeable side-effects to insufficient certainty with regard to intellectual property protection and guarantees of a profit.

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The Fight Against Antimicrobial Resistance: Important recent publications

One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.

A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.

This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.

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Serious Risks from New Prescription Drugs

by Donald W. Light

Based on http://www.ethics.harvard.edu/lab/blog/436-new-prescription-drugs-a-major-health-risk

Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.

Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.

Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?

However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.

In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

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