… in the Real World

This Washington Monthly blog post, “The Affordable Care Act in the Real World,” frames the question in ways that should matter most, in terms of how people’s lives are actually affected by the health reform law.

A priest I knew many years ago once said to me, “Turning real human suffering into an abstraction is among the greatest sins.” .

My children now have health coverage through mine, and our family’s health will now sustain itself through my children’s 26th birthdays. A mouth full of cavities was treated, and vision has been a godsend, and my daughters have the ability to go to the doctor at $20 a pop, instead of the $150 a pop uninsured rate, and they don’t have to go willy-nilly to a clinic setting!

A dear friend of mine skirted death with a ruptured colon, had surgery to the tune of over $80,000 because they were uninsured. and worried about preexisting conditions when it came to reversing the colostomy, qualified for insurance so he doesn’t have to carry around a bag for the rest of his life.

Amen.

 

What Will Change if the Supreme Court Overturns Obamacare’s Individual Mandate?

Ezekiel Emmanuel’s op-ed in the New York Times addresses some of the changes that will and will not be affected, if the individual mandate to buy health insurance is overturned as unconstitutional.

The very substantial downside is that 16 million people who would have been insured will not be. This number will rise to 32 million if Medicaid expansion is also deemed unconstitutional. According to Emmanuel, this would also trigger a downward spiral threatening to substantially increase insurance premiums for everyone.

On the other hand, changes such as bundling of payments, which have already begun, lead to better coordinated care and lower costs. These changes will continue apace regardless of what the Supreme Court’s decides.

Tens of thousands of Americans die because of hospital-acquired infections every year, and far more are harmed by medical errors. Last year, authorized by the Affordable Care Act, the Obama administration announced a $500 million program called Partnership for Patients aimed at reducing hospital-acquired infections, errors and other preventable complications. The act also requires Medicare to begin posting online each hospital’s rate of certain medical errors and infections, and to cut payments to hospitals with the highest rates.

Consequently, hospitals across the country are working to reduce preventable hospital errors. Once it’s clear that this is a major priority, significant progress can be made. A few years before the health care reform act was passed, the Hospital of the University of Pennsylvania, where I work, started paying attention to reducing preventable errors, and it managed to reduce infections from intravenous lines to 1 or fewer per month from 30 to 40 per month. All it took was removing intravenous lines whenever they weren’t necessary, changing them regularly and using a more vigorous sterilizing technique when inserting them. Many other institutions are making similar progress now. All of this has nothing to do with the constitutionality of the individual mandate and will continue no matter what the Supreme Court rules.

The same goes for the problem of hospital readmissions. Right now, nearly 20 percent of Medicare patients who are discharged from a hospital are readmitted within 30 days. Some are scheduled readmissions; others occur for completely unrelated health problems, like falls and accidents. But many could be prevented by paying more attention to the coordination of care between physicians and hospitals and by better follow-up after patients are discharged. Beginning this year, the health care reform act will penalize hospitals that have high readmission rates for three conditions: pneumonia, heart failure and heart attacks. This list will later be expanded. As a result, all hospitals are now scrambling to figure out how to create “the perfect patient discharge” so patients don’t become hospital “frequent fliers.”

If the Supreme Court rules that the individual mandate is unconstitutional — in my opinion, an improbable and legally indefensible decision — it will not end health care reform. Hospitals and doctors will continue to work to improve care and control costs. But tens of millions of Americans will continue to be excluded from the health care system, which is hardly an optimal outcome.

 

Why Adjust the Dosage on a Useless Drug?

Merrill Goozner is among our nation’s best health policy reporters. His concern about this FDA decision is one that makes a great deal of sense.

Professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice are raising alarms about a recent Food and Drug Administration decision to approve a new dosage for the  best-selling Alzheimer’s drug Aricept (donepezil). The decision “breached the FDA’s own regulatory standard” and has led to “incomplete and distorted messages” about the drug, they warned in the latest British Medical Journal.

Aricept has become a $2 billion-a-year blockbuster in large part because people caring for elderly patients with dementia are desperate for something, anything to slow their loved ones’ inexorable decline. The original dose for the drug, which was approved in 1996, provided a short-term improvement in memory that faded to insignificance within six months. With its patent due to expire, the companies behind the drug — Eisai and Pfizer — went to the FDA with a clinical trial in 1,400 patients claiming a higher dosage showed better results. The FDA agreed, which gave the companies another three years of marketing exclusivity based on a use patent for that new, higher dose.

Here’s the medical problem with that higher dosage, according to Schwartz and Woloshin. While the clinical trial showed that patients did slightly better in cognition (like recognizing numbers), the drug had no impact whatsoever on their actual functioning in day-to-day life, at least none that their caregivers could notice. Yet the major side effects of the drug — nausea and vomiting — increased significantly. The article claimed that the FDA had said specifically to the trial sponsors that the higher dose had to have an impact that caregivers could notice to win approval. Schwartz and Woloshin charged the FDA with violating its own standards.

Supreme Court Unanimously Rules Against Patenting “Laws of Nature”

This is a most promising development. The biotech companies’ willy-nilly rush to patent everything in sight had to end somewhere. It’s important not to generalize too broadly from this ruling, but it does seem to be a line in the sand that even this corporate-friendly Court felt compelled to draw. Good for them!

The unanimous Supreme Court decision said, “Laws of nature, natural phenomena and abstract ideas are not patentable” under provisions of the US Patent Act.

To be covered by a patent, “an application of a law of nature… must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law,” said the decision written by Justice Stephen Breyer.

“The claims are consequently invalid,” said the court’s decision, which reversed an earlier ruling of the US Court of Appeals for the Federal Circuit.

The patents covered a method developed by Prometheus Laboratory for adjusting dosages of thiopurine treatment for patients with immune system diseases, such as Crohn’s disease, a chronic intestinal inflammation.

The unanimous Supreme Court decision said, “Laws of nature, natural phenomena and abstract ideas are not patentable” under provisions of the US Patent Act.

To be covered by a patent, “an application of a law of nature… must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law,” said the decision written by Justice Stephen Breyer.

“The claims are consequently invalid,” said the court’s decision, which reversed an earlier ruling of the US Court of Appeals for the Federal Circuit.

The patents covered a method developed by Prometheus Laboratory for adjusting dosages of thiopurine treatment for patients with immune system diseases, such as Crohn’s disease, a chronic intestinal inflammation.

FDA Panel Urges Studies on Pain Drugs Known to Have Severe Side Effects

Somehow I suspect this will not end well.

Particularly because the conditions listed as potential indications for prescription of these clearly dangerous drugs are so common — chronic low back pain, osteoarthritis, and diabetic peripheral neuropathy — this has all the hallmarks of a trainwreck in slow motion.

Few if any people would want to rule out the use of even dangerous painkillers for people with, say, intractable cancer pain. But to jump from that potentially appropriate use (as the pharmaceutical companies always do) to using them from low back pain or arthritis, is breathtakingly irresponsible.

An FDA advisory committee has voted 21-0 that the investigational anti-nerve growth factor (anti-NGF) drug class should continue to be developed for pain treatment, despite the drug class’s link to joint-related adverse events.

There are no anti-NGF drugs currently approved, but three companies are deep into their development programs, testing the safety and efficacy of the drug class to treat a variety of pain, including pain associated with osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer.

For Monday’s meeting of the Arthritis Advisory Committee, FDA researchers reviewed data from the three drug companies and concurred with earlier findings that anti-NGF drugs do appear to cause rapid joint destruction. In patients who already had osteoarthritis, the joint deterioration was more severe than if their disease had progressed naturally, and, in some cases, patients who did not have osteoarthritis developed rapidly progressing joint deterioration during the trial.

Lower doses and less frequent administration of anti-NGF agents as well as placebo were both associated with naturally progressing osteoarthritis, while higher doses of anti-NGF drugs and use of an NSAID was linked to rapidly-progressing osteoarthritis as well as osteonecrosis.

An FDA reviewer and an outside academic reviewer performed separate analyses on 355 cases where patients receiving anti-NGF drugs underwent joint replacement surgery. Of those cases, 21% were determined to be rapidly-progressing osteoarthritis, and 7% were determined to be osteonecrosis.

For those not familiar with the terms, osteonecrosis is death of bone tissue and osteoarthritis is joint degeneration.

The ironic fact that the nonsteroidal anti-inflammatory drugs (ibuprofen, Advil, Motrin, etc.) routinely used for arthritis yield short-term pain relief but also cause long-term joint deterioration due to thinning of cartilage, is little known to the public. The FDA panel’s report on these anti-nerve growth factor drugs indicates that these, too, are known in advance to involve similar (and perhaps far more severe) trade-offs.

Not exactly what the doctor should order.

How Should Tobacco Be Regulated?

A new survey published in the American Journal of Public Health finds the following:

Knowledge of current public opinion is important as the Food and Drug Administration (FDA) applies the best scientific evidence available to tobacco product regulation. Based on a nationally representative survey of the US adult population, we report 43% support for banning of cigarettes, 65% for reducing nicotine, and 77% for reducing nicotine if such an action could cause fewer children to become addicted to cigarettes. The FDA should consider protecting children by removing all but nonaddictive cigarettes from the marketplace.

Only recently has the Food and Drug Administration had the power to regulate tobaccoproducts. How it will use that power remains to be seen. The Family Smoking Prevention and Tobacco Control Act of 2009 does not allow the agency to outlaw cigarettes but confers upon it the power to set standards that can reduce nicotine content and regulate chemicals in cigarette smoke.

Short of a ban, what tobacco control measures are justified based on public health benefits while also being defensible regarding concerns about limiting corporate speech? That appears to be where the rubber is hitting the road at this juncture.

What these Harvard School of Public Health researchers have done in their study is to artfully frame the issue in terms of a few specific choices. With 77% support in this survey for “removing all but nonaddictive cigarettes from the marketplace,” there now appears to be strong majority support for a major new form of regulation, though I hasten to add that the tobacco industry and its allies have not yet waged a major anti-regulation ad campaign. If and when they do, the percentages currently favoring stronger regulation may decline. That said, 77% is a strong starting point.

Crafting effective policy to regulate harmful and addictive substances requires evidence, courage and subtlety. There are no easy answers and the politics are complicated. This was underscored by a recent temporary injunction issued by Judge Richard J. Leon of United States District Court in Washington (a George W. Bush appointee), which blocked new FDA rules requiring that all cigarette packs include graphic warnings about cigarettes, similar to those required in Canada and Australia. While Judge Leon’s ruling (which he based largely on the free speech rights of tobacco companies) runs contrary to other judicial rulings on FDA tobacco policy, and may not survive appeal, it raises significant questions as how much maneuvering room is available to the FDA.

Because cigarettes are legal, the severity and wide ranging effects of cigarette addiction are under-appreciated. Lung cancer and heart disease are only two of the diseases tobacco can cause. Several years ago, when I compiled lists of risk factors for all major chronic degenerative diseases to use in the clinical nutrition course I teach, smoking was a risk factor for every single disease.

Years ago, I heard a talk by Dr. Andrew Weil of the University of Arizona Medical School, in which he asserted that a cigarette habit is harder to kick than an addiction to heroin. The massive damage that cigarettes cause to individuals and society as a whole has been amply documented and widely publicized for over 50 years (the landmark Surgeon General’s report was released in 1964), and the case against cigarettes continues grows ever stronger.

It’s time for the FDA to significantly strengthen its tobacco regulations and for the courts to recognize that public health should outweigh tobacco company profits.

Lead Plaintiff in Anti-Reform Case Declares Bankruptcy, Partly Due to Medical Bills

File under irony, along with genuine sympathy for this family’s plight.

Mary Brown, a 56-year-old Florida woman who owned a small auto repair shop but had no health insurance, became the lead plaintiff challenging President Obama‘s healthcare law because she was passionate about the issue.

Brown “doesn’t have insurance. She doesn’t want to pay for it. And she doesn’t want the government to tell her she has to have it,” said Karen Harned, a lawyer for the National Federation of Independent Business. Brown is a plaintiff in the federation’s case, which the Supreme Court plans to hear later this month.

But court records reveal that Brown and her husband filed for bankruptcy last fall with $4,500 in unpaid medical bills. Those bills could change Brown from a symbol of proud independence into an example of exactly the problem the healthcare law was intended to address.

The central issue before the Supreme Court is whether the government can require people to buy health insurance. Under the law, those who fail to buy insurance after 2014 could face a fine of up to $700.

The business federation, along with other critics of the law, calls the insurance mandate a “threat to individual liberty” that violates the Constitution.

Obama administration lawyers argue that the requirement is justified because everyone, sooner or later, needs healthcare. Those who fail to have insurance are at high risk of running up bills they cannot pay, sticking the rest of society with the cost, they argue. Brown’s situation, they say, is a perfect example of exactly that kind of “uncompensated care that will ultimately be paid by others.”

Decision to Include Pink Slime in School Lunches Shines Spotlight on Fundamental Conflicts at USDA

I wish could say that this is fiction, but it’s not.

Pink slime — that ammonia-treated meat in a bright Pepto-bismol shade — may have been rejected by fast food joints like McDonald’s, Taco Bell and Burger King, but is being brought in by the tons for the nation’s school lunch program.

The U.S. Department of Agriculture is purchasing 7 million pounds of the “slime” for school lunches, The Daily reports. Officially termed “Lean Beef Trimmings,” the product is a ground-up combination of beef scraps, cow connective tissues and other beef trimmings that are treated with ammonium hydroxide to kill pathogens like salmonella and E. coli. It’s then blended into traditional meat products like ground beef and hamburger patties.

We originally called it soylent pink,” microbiologist Carl Custer, who worked at the Food Safety Inspection Service for 35 years, told The Daily. “We looked at the product and we objected to it because it used connective tissues instead of muscle. It was simply not nutritionally equivalent [to ground beef]. My main objection was that it was not meat.”

Custer and microbiologist Gerald Zernstein concluded in a study that the trimmings are a “high risk product,” but Zernstein tells The Daily that “scientists in D.C. were pressured to approve this stuff with minimal safety approval” under President George H.W. Bush’s administration. The USDA asserts that its ground beef purchases “meet the highest standard for food safety.”

USDA school lunch policy is fundamentally conflicted, as is all USDA policy. In essence, the agency serves two masters whose agendas are frequently at odds with each other — (1) the physical health of the public and (2) the financial health of agribusiness.

This pink slime, aka “lean beef trimmings,” is just one example of a policy decision that benefits the corporation selling the product while harming kids from homes poor enough to qualify for the federally-funded school lunch program.

This pink slime story has made the rounds on the Internet the past few days, and we discussed it yesterday in the clinical nutrition class I teach for upper division chiropractic students. Everyone in class, needless to say, considered the slime a major gross-out.

A couple of students said they thought the solution might be to transfer school lunch programs to the states, which they believed were more likely to make better decisions.

My response was that the pink slime story made it a particularly difficult day for me to be defending the federal government. However, I added that in my experience, state governments are also fully capable of making terrible decisions. And that furthermore, agriculture and food industry lobbyists operating at the state level are often better able to achieve their goals (although they clearly do quite well for themselves at the federal level, too), because people and organizations supporting policies for enhanced health or environmental protection usually don’t have the capacity to lobby effectively in 50 separate states. Corporations, of course, do have the wherewithal to do this, and thus we often see an especially un-level playing field at the state level.

Regarding the school lunch program, one point I did not think to mention to my students is that if left to their own devices, I think it is likely that some states (perhaps many) would just drop the school lunch program altogether. I live in Kansas. I frankly do not know whether, given the choice, the state would decide to save money by dropping or substantially cutting back on school lunches. Recent budgetary decisions involving resdistribution of resources from those with less (via elimination of tax credits and decreased levels of social services) to those with more (via lower taxes) lead me to assume the worst.

As a result, I am glad that there is a federal program to feed students from poor families. I just wish they would keep the pink slime off the menu.

Blunt-Rubio “Contraception” Amendment: A Stealth Attack on Essential Health Services?

Press coverage this week on the Blunt-Rubio amendment to a Senate highway spending bill focused to a large extent on its sponsors’ stated goal of allowing employers to deny contraceptive coverage in health plans offered to their employees, based on religious or moral objections. Republicans sought to frame the issue as freedom of religion while for Democrats, it was primarily an attack on contraception and, more broadly, on women’s rights.

It is important to realize that impact of Blunt-Rubio, were it to be enacted into law, extends far beyond contraceptives, sex, and religion, taking aim squarely (if quietly) at the entire idea of requiring insurance plans to cover what are deemed “essential services.” It is no exaggeration to say that this proposal has the potential to thoroughly undermine the long-established process of requiring insurers to cover a defined set of health services.

This amendment, which only failed by a 51-48 vote, would allow all employers to determine whether or not to deny coverage for contraceptive services, regardless of whether the Institute of Medicine, Department of Health and Human Services, or state insurance regulators judged these to provide substantial health benefits. But more signifcantly, what it would also do is to allow any employer to eliminate coverage for any health care service, based on the religious or moral beliefs of the CEO or other decision makers.

How do we define moral beliefs? Our morals may be based on religious teachings (Catholic, Protestant, Jewish, Hindu, Buddhist, Muslim, Scientologist, Wiccan, etc.). Or, they may be based on anything else we choose to believe. Morals are quite personal and American society is exceptionally diverse in the range of moral beliefs professed by its citizens. Your moral beliefs may be based on deep philosophical inquiry and meditation, or they may be based on the last thing you heard on your favorite talk radio station.

If you are a CEO who strongly believes that vaccination is immoral because it violates the sanctity of the body as a temple, or any other reason), should you be able to eliminate that coverage from your employees’ list of covered services? How about a CEO who has joined the Church of Scientology and decides as a result to eliminate psychiatric benefits from his employees’ coverage? Should a corporate leader who considers sex outside of marriage to be immoral be permitted to eliminate not only coverage for abortion or contraception but also prenatal care for those who transgress his moral code?

Where does this stop? Blunt-Rubio is silent on that question, with its advocates preferring to limit the discussion to contraception. Did they not think it through? Or is this a stealth attack on government’s ability to define essential services and require insurance policies to cover them?

The implications are truly breathtaking in their comprehensiveness. Any employer can deny any health service for any reason, as long as he or she states that their objection is “moral.”  This is philosophically consistent with the conservative philosophy of governance that judges democratically elected officials to be the worst imaginable source to depend on for health care policy, choosing instead to vest that power in the hands of the private sector, specifically corporate CEOs or those to whom they delegate their power.

Is that the kind of health policy you favor?