About Daniel Redwood

Daniel Redwood, DC, is Director of the Master of Science in Human Nutrition and Functional Medicine program at the University of Western States. He is Associate Editor of Topics in Integrative Healthcare and a member of the American Chiropractic Association's editorial advisory board. He lives in Portland, Oregon.

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.

 

What About the Uninsured?

Ron Brownstein’s article in the National Journal goes straight to the heart of why health reform is needed.

But the debate over health care reform—which will intensify again next week as the Supreme Court hears oral arguments on challenges to the law’s mandate on individuals to buy insurance—involves more than competing philosophies or political strategies. At its core, it raises an irreducibly tangible question: what, if anything, to do about the nearly 50 million Americans who today lack health insurance?

Those millions of uninsured rarely intrude into the promises from GOP congressional leaders and the party’s presidential field to defend liberty by repealing Obama’s plan. But ignoring them doesn’t make them go away. If the 2012 election rewards Republicans with enough leverage in Washington to erase Obama’s initiative, they will face the choice of finding an alternative means to expand coverage or allowing the number of those without insurance to grow, with far-reaching consequences not only for the uninsured but for those with insurance as well.

Without some policy intervention, there’s little question that access to health insurance will continue to decline. Since 2000, the number of the uninsured has jumped from 36.6 million to 49.9 million, about one-sixth of all Americans.

That number would have been even higher if an additional 20 million people over that period had not obtained coverage through Medicaid and the Children’s Health Insurance Program. This growth partially offset the unrelenting erosion in employer-based care: The share of Americans obtaining coverage from their employer has declined every year since 2000, in good times and bad.

Earlier this month, the Congressional Budget Office forecast that, absent the new health care law, the number of uninsured would rise to 60 million by 2020.

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.

Interesting Findings But at What Cost? How Massage Heals Sore Muscles

This study is revealing on more than one level.

First, it clearly documents for the first time that a specific anti-inflammatory process is triggered by massage, involving suppression of pro-inflammatory cytokines and stimulation of the mitochondria, which play a role in cellular repair. For the researchers and the New York Times writer reporting the story, that’s the bottom line.

But after reading it through twice, I find myself appalled at the protocol they used. Taking muscle biopsies on healthy people in order to understand a bodiliy mechanism goes against the grain for me. In essence, what’s being done is to intentionally injure the body in order to understand how it responds to injury. From my perspective, it’s a strange set of bioethics that considers this par for the course. I don’t like this when it’s done to animals and I don’t like it any better when it’s done to consenting humans.

Tiffany Field of the University of Miami Medical School, who is quoted in the article, has for decades been the acknowledged leader in massage research. She’s quite happy with the findings. Much as I would like to be, I find the method through which they were gained to override the benefits they represent.

Their experiment required having people exercise to exhaustion and undergo five incisions in their legs in order to obtain muscle tissue for analysis. Despite the hurdles, the scientists still managed to find 11 brave young male volunteers. The study was published in the Feb. 1 issue of Science Translational Medicine.

On a first visit, they biopsied one leg of each subject at rest. At a second session, they had them vigorously exercise on a stationary bicycle for more than an hour until they could go no further. Then they massaged one thigh of each subject for 10 minutes, leaving the other to recover on its own. Immediately after the massage, they biopsied the thigh muscle in each leg again. After allowing another two-and-a-half hours of rest, they did a third biopsy to track the process of muscle injury and repair.

Vigorous exercise causes tiny tears in muscle fibers, leading to an immune reaction — inflammation — as the body gets to work repairing the injured cells. So the researchers screened the tissue from the massaged and unmassaged legs to compare their repair processes, and find out what difference massage would make.

They found that massage reduced the production of compounds called cytokines, which play a critical role in inflammation. Massage also stimulated mitochondria, the tiny powerhouses inside cells that convert glucose into the energy essential for cell function and repair. “The bottom line is that there appears to be a suppression of pathways in inflammation and an increase in mitochondrial biogenesis,” helping the muscle adapt to the demands of increased exercise, said the senior author, Dr. Mark A. Tarnopolsky.

State University Veterinary School Adds Acupuncture, Herbs and More

Using complementary and alternative methods with animals substantially defangs the classic skeptic’s complaint that it’s all from the placebo effect. This is a trend that will continue to grow. It’s good to see this happening in a state university program.

The Louisiana State University vet school is profiled in this article:

The LSU Veterinary Teaching Hospital, part of the veterinary school, has broadened its services to include acupuncture, massage therapy and herbal treatments for animals — the large ones for now and dogs and cats soon.

Rebecca McConnico, associate professor of veterinary medicine, said the combination of traditional medicine and newly adopted treatments are referred to as “integrative medicine.” She studied equine acupuncture at the Chi Institute of Chinese Medicine in Reddick, Fla., last year before earning her large animal certification.

“For me and my understanding and experience, (LSU) integrates with — not instead of,” she said, stressing the use of integrative therapies as a complement to traditional Western medicine.

McConnico works mainly with horses — the most common animal to receive this type of treatment. She said horses can benefit from the Eastern-inspired practices, particularly acupuncture.

“We use it in cases where horses have gastrointestinal or neurological disease, chronic pain or non-healing wounds,” McConnico said. “It takes 15 to 20 minutes, and most commonly is performed every four to six weeks for chronic pain.”

If the horse is afraid of needles, the vet staff uses a form of acupuncture called acupressure, wherein pressure is applied to the various points.

McConnico said she has worked with about two dozen animals since her recent certification, including horses, goats and cattle. She said clients are starting to learn about and seek this unique service for their animals.

“It seems to be well-received. Some clients just ask for it and sometimes it’s offered to them. Most are willing to try it.”

 

Possible Junk Food Ad Ban in Scotland

We’re not likely to see anything like this in the U.S. anytime soon. Still, one can dream.

Junk food ads face being banned from prime-time TV in a bid to curb childhood obesity.

The Scottish Government have demanded that adverts for products high in fat, sugar and salt are not shown before the 9pm watershed.

Junk food and sugary snacksads are already banned during children’s TV programmes.

But ministers fear that youngsters are being influenced in their eating habits by adverts shown during talent shows such as The X Factor and soaps.

Westminster Health Secretary Andrew Lansley has been urged by Scottish ministers to introduce a ban across the UK.

But, if he refuses, the Scottish Government will move to introduce a ban north of the border.

Scottish Public Health Minister Michael Matheson said: “Broadcast advertising influences the choices made by children and can shape their attitudes to food as they grow into adulthood.

“Tackling obesity and encouraging people to make healthier life choices is one of the most important things we can do to improve the health of our nation.”

Products banned before the watershed would likely include burgers, chicken nuggets, fries, cereals high in sugar, crisps and chocolate.

White Rice Joins White Bread and Sugar in Increasing Diabetes Risk

Whole, unprocessed foods are best. This is just one example.

Because diabetes is intimately linked to heart disease, hypertension, and obesity (as part of the Metabolic Syndrome), this is really about far more than diabetes.

Patients who ate the greatest amounts of the grain had a 27% greater risk of developing the disease than those who ate the least, and the relative risk was higher among Asian patients, Qi Sun, PhD, of Harvard, and colleagues, reported in BMJ.

“Although rice has been a staple food in Asian populations for thousands of years, this transition [to more sedentary lifestyles and greater availability of food] may render Asian populations more susceptible to the adverse effects of high intakes of white rice, as well as other sources of refined carbohydrates, such as pastries, white bread, and sugar sweetened beverages,” they wrote.

The glycemic index of white rice is higher than that of other whole grains, largely due to processing. It’s also the primary contributor to dietary glycemic load for populations that consume rice as a staple food, such as Asians.

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.