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How the Federal Government Shutdown Is Hurting Healthcare: Agency by Agency

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By THCBist

The shutdown could not stop the rollout of the state and federal exchanges.

That’s because the Obama administration, sensing a political fight in the offing with Republicans, wisely prepaid the bill for the insurance exchanges and other key components of the rollout.

On the other hand, the fiscal standoff is having a very real impact on the infrastructure that supports healthcare across the United States.   Agencies from the Centers for Disease and Control to the National Institutes of Health have seen their money turned off. Others have seen their staffing levels sharply reduced with non-essential employees furloughed.

It doesn’t take a wild imagination to imagine potential deadly consequences if something goes wrong. If for example, flu season strikes early or a drug recall  is needed.  Much of the pain will be felt over time.  As the shutdown drags on, you can expect problems that are brewing under the surface to become much more visible …

Here’s a review of what’s happening:

Centers For Disease Control and Prevention
Funding for monitoring of disease outbreaks turned off. Lab operations sharply scaled back. 24/7 operations center to remain online.  With some scientists predicting a severe 2013-2014 flu season, this is cause for concern …

National Institutes For Health
Enrollment in new clinical trials suspended, impacting thousands of patients suffering from serious diseases. No action on grant proposals. Minimal support for ongoing protocols.

Food and Drug Administration
Food safety inspections sharply cut back. Monitoring of imports eliminated.  Oversight of production facilities curtailed, again potentially an issue with flu season on the way.The good news? Because drug approvals are funded by industry “user-fees” FDA approvals of new drugs will continue.

Centers For Medicare and Medicaid Services
Key ACA related operations intact.  The bad news for docs and patients – claims and payment processing expected to continue but with slower service than usual. With purse strings tight, this is likely to become more of a problem as shutdown drags on. In the unlikely event that a shutdown continues for more than a month, the impact on physician practices could be much more serious.

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Regulating Health IT: When, Who, and How?

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By Rebecca L. Jewell, Esq. & Dan Haley

Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.

Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.

Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.

But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.

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Should a Doctor Prescribe Drugs that are Unapproved by the FDA?

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By Juliet Mavromatis, MD

Here’s an interesting clinical dilemma brought to my attention by another physician.

She was asked to refill a prescription for a drug called domperidone to help a patient with lactation. Domperidone is not FDA approved in the United States for any indication. However, in Europe and in Canada it is approved as a promotility agent for patients with a condition called gastroparesis, which causes the stomach to empty very slowly and results in chronic nausea and vomiting. As a side effect the drug is also known to increase the production of prolactin, a hormone that stimulates milk production. In the case of this physician’s patient, she had adopted a child and found that the medication had effectively enabled her to produce milk and nurse, with seemingly no untoward effects. It’s unclear who had initially prescribed the drug, but various online lactation support forums discuss it as an option  for women who have trouble with lactation.

The questions: Is it legal, ethical or good medical practice for a physician in the United States to write a prescription for domperidone for a patient who has been using it for lactation with good results? How about for gastroparesis? Where does one get the drug? Is it even legal to sell the drug in the United States?

I’ve cared for at least two patients who have used domperidone. In both instances it was ordered by prescription from an overseas source by a local gastroenterologist. In these two cases my patients had tried just about everything on the market in the United States for gastroparesis and were still struggling with debilitating symptoms. In one case, my patient had required hospitalizations and ultimately a feeding tube because of intractable vomiting. The drug was ineffective in both patients and it was eventually discontinued.

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Open Research For Open Cures: A Report From Sage Congress

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By Andy Oram

Over four years of Congresses, Sage Bionetworks has drawn together leading thinkers and doers throughout the fields of genetic research and drug development. For two days each year, the conference floor is colonized by clumps of eagerly networking PhDs from academic, pharma, government, non-profits, biotech firms, and patient advocacy groups–people who often glide from one domain to another within this tight-knit cohort.

A cohort, certainly, we can characterize this group of attendees, sharing as they do a mysterious language drawn from years of research most of us will never understand. But is it a community? That will be tested over the following year as Sage Bionetworks lets go of the Congress. Founder Stephen Friend says it is up to others to create the next Congress, and its success or failure will be a measurement of the sweat and passion that Friend and Sage have put into attempts to build a community.

Why should a reader look further at this struggle among a tiny elite, rather than clicking on the next article? Well, first, if you’re one of the 48% of Americans who took a prescription drug this month, you should be concerned about where new breakthrough drugs will emerge. If you visit this web site because you want a more responsive health care system that can match patients to treatments more quickly and cheaply, recognize that new methods are important nowhere as much as at the foundation of the system where new treatments are discovered. And if you are just curious about the potential for global cross-institutional teams and loose networks connecting experts with ordinary members of the public to find creative solutions to old problems, this article will provide insights.

Don’t get too close, you don’t know what I have

The premise on which Friend founded Sage is that research and drug development have stagnated and cannot progress without more collaboration and data sharing. Therefore, with all due regard for the presentations at the recent Sage Congress on cancer research projects and other individual experiments, the real theme of the conference is in the keynotes about open source, the use of social media, and crowdsourcing. The challenge of this community–if we find that it has indeed become a community–is to analyze and deal with the particular challenges that genetic research and drug development inject into trends toward open collaboration.

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Let Them Eat Cupcakes

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By Katie Booth


Can the FDA ban cupcakes?

While this may seem like a silly question, the Center for Science in the Public Interest (“CSPI”) has filed a petition with the FDA urging the agency to regulate the amount of sugar (including high fructose corn syrup) in soft drinks. According to the executive director of CSPI, sugar is a “slow-acting but ruthlessly efficient bioweapon” that causes “obesity, diabetes, and heart disease.”

If soft drinks are a problem, surely cupcakes are too. A twelve-ounce can of Coca-Cola contains 39 grams of sugar. A seasonally-appropriate red velvet cupcake from Sprinkles contains 45 grams of sugar—and who can eat just one? National cupcake consumption increased 52% between 2010 and 2011, and U.S. consumers ate over 770 million cupcakes last year. Sugary soft drink consumption, on the other hand, is down 23% since 1998 and 37% since 2000.

While the FDA can’t regulate sugar as a bioweapon, it probably could regulate sugar as a food additive.

Under the Food, Drug, and Cosmetic Act, a food additive is “any substance the intended use of which results or may reasonably be expected to result—directly or indirectly—in its becoming a component or otherwise affecting the characteristics of any food.” This broad definition would include sugar. The FDA does not, however, regulate food additives that are “generally recognized as safe” (“GRAS”). Presumably the FDA considers sugar to be GRAS—for now. Continue reading…

Tobacco Companies Must Punch Selves in Face, Implement Court Orders

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By Christopher Robertson

The Washington Post covers a new order by DC district court judge Gladys Kessler, arising out of an old RICO case brought by the federal government, requiring that the tobacco companies publish advertisements to confess publicly that they previously lied about the safety of smoking and manipulated cigarettes to make them more addictive.  I have pulled the district court order and posted it, along with this appendix.  The order provides the exact language of the mandated advertisements, but no analysis.  Below the fold, I trace the convoluted path this case and a related case have taken through the compelled speech doctrine around the First Amendment, all thanks to a single judge on the Court of Appeals.

A. Adverse Health Effects of Smoking

A Federal Court has ruled that the Defendant tobacco companies deliberately deceived the American public about the health effects of smoking, and has ordered those companies to make this statement. Here is the truth:

• Smoking kills, on average, 1200 Americans. Everyday.
• More people die every year from smoking than from murder, AIDS, suicide, drugs, car crashes, and alcohol, combined.
• Smoking causes heart disease, emphysema, acutemyeloid leukemia, and cancer of the mouth, esophagus, larynx, lung, stomach, kidney, bladder,and pancreas.
• Smoking also causes reduced fertility, low birthweight in newborns, and cancer of the cervix and uterus.

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A Coming Storm: FDA Regulation of Mobile Medical Applications

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By Ryan Minarovich

I recently had the great fortune of attending Health 2.0 in San Francisco. The conference was abuzz with new medical technologies that are harnessing the power of innovation to solve healthcare problems including many new mobile medical application companies showcasing their potential. As I walked and talked around the exhibit floor, one thing caught my ear, or I should say one thing didn’t catch my ear. Among the chatter about these products, the concern about FDA regulation of this product segment, or even FDA regulation in general was noticeably absent. While many of the application developers are well aware of potential FDA involvement, most would be hard-pressed to outline the impact this would have on their companies and products.

Being labeled a medical device, which is the direction the FDA is leaning, could have a significant impact on business model organization, top-line revenue, and product deployment. For unprepared start-ups, FDA regulation could signal an end for their company. This is in stark contrast to well informed developers who are preparing themselves for the change and would most likely be able to leverage these regulations to their advantage.

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The New Bioterrorism? The Hacked Medical Device

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By Jane Sarasohn-Kahn

A time-and-technology challenged FDA, proliferation of software-controlled medical devices in and outside of hospitals, and growth of hackers have resulted in medical technology that’s riddled with malware. Furthermore, lack of security built into the devices makes them ripe for hacking and malfeasance.

Scenario: a famous figure (say, a politician with an implantable defibrillator or young rock star with an insulin pump) becomes targeted by a hacker, who industriously virtually works his way into the ICD’s software and delivers the man a shock so strong it’s akin to electrocution.

Got the picture?

Welcome to the dark side of health IT and connected health. Without strong and consistently adopted security technology and policies, this scenario isn’t a wild card: it’s in the realm of possibility. This is not new-news: back in 2008, a research team figured out how to program a common pacemaker-defibrillator to transmit a “deadly 830-volt jolt,” according to Barnaby Jack, a security expert.

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Rethinking the Provider Certification Game

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By David Shaywitz, MD

Quality is the new watchword in healthcare; it’s what we seek – and increasingly, what we try to measure.  Medications, devices, care delivery, hospital services – all are now scrutinized as we seek to gauge their benefit, and justify their cost.

The idea of using metrics to evaluate quality make sense, but only if we can trust the metrics themselves.  Otherwise, we risk becoming party to an updated version of craniometry, systematized false-precision that focuses on easily-measurable parameters (such as head circumference) that may not represent meaningful proxies for the assessments we’re really after (i.e. intelligence).

The good news is that the science of testing, of developing evaluation instruments, has improved over time.  We’re now better able to recognize the qualities and properties of good tests – and to identify where they’re likely to fall short.

We’re also getting more comfortable with demanding robust evaluation instruments.  For example, the FDA’s approach to patient-reported outcomes places exceptional (and appropriate) emphasis on the assessment tool chosen, and requires that it demonstrates the appropriate properties before relying on its results.

Unfortunately, one critically important area within our healthcare system that seems to have escaped such careful review is the way the competence of care providers is typically assessed and certified.

Whether you are an X-ray technician, a physical therapist, a registered nurse, or a transplant surgeon, you are required to pass through a gauntlet of costly certification exams.  These tests, already significant, are assuming an even greater importance as the healthcare system increasingly looks to them as proxies for quality.  Certification can be required for employment and for admission privileges, and frequently impacts the reimbursement rate for healthcare providers.

All this makes complete sense – provided the certification tests themselves are sound.

Unfortunately, the world of healthcare worker certification remains a bit like the wild west, as medical organizations and professional societies approach certification testing with profoundly different degrees of rigor — and generally little-to-no transparency.

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Medical Apps: The Next Generation

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By Kenny Lin, MD

Doctors of my generation have experienced dramatic changes in the way we access the information we need to care for patients.

As a medical student 15 years ago, my “peripheral brain” consisted of fat textbooks sitting on office bookshelves or smaller, spiral-bound references stuffed into the bulging pockets of my lab coat. As a doctor-in-training, I replaced those bulky references with programs loaded onto PDAs. Today, smartphone apps allow health professionals at all levels to access the most up-to-date medical resources such as drug references, disease-risk calculators, and clinical guidelines—anytime, anywhere.

Apps have several advantages over traditional medical texts. First, the information is always current, whereas many textbooks are already dated by the time they hit shelves. If I have a question, I can look up the answer on my smartphone without leaving my patient’s side. And unlike textbook chapters, many medical apps have interactive features that help doctors choose appropriate screening tests for patients, recognize when immunizations are due, or calculate a patient’s risk of developing heart problems.

Lastly, apps can enable remote monitoring of high-risk patients and reduce the need for office visits. In a small study published in PLoS ONE, for example, researchers found that patients hospitalized for heart vessel blockages were able to complete “supervised” rehabilitation exercise sessions in their homes with a portable heart monitor and GPS receiver that transmitted real-time data to doctors via smartphone.

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