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Government Policy

A Complicated System

by Jen Jenkins, Market Analyst

In this article, Dr. Aaron E. Carroll, a professor of pediatrics at Indiana University School of Medicine, provides an anecdotal reference to something that is too often overlooked within the American health care system. Issues about the affordability of obtaining insurance and the quality of care are constantly highlighted and debated, but how care is actually delivered is an issue all on its own.

The Affordable Care Act was passed in an effort to ensure a significant decrease in the number of people who did not have insurance. Regardless of where you stand on the topic, the fact is that having insurance is only one access point within the American health care system. What happens after you have insurance? What is the process of receiving care actually like?

In the aforementioned article, Dr. Carroll describes his difficult journey with ulcerative colitis and the obstacle of every three months obtaining the only medicine that has ever worked for him. Just reading his account is frustrating and confusing. He ends this anecdote with wonder at how the majority of people, especially anyone suffering worse problems than his, could possibly manage the often dizzying twists and turns of correlating insurance protocols, with doctor’s visits, with lab testing, with pharmaceutical companies, and more.

Reform in the medical world is long, difficult road. The Affordable Care Act was  a vehicle to get more people health insurance and it is still being vehemently argued. Once that piece of the puzzle is solved in some capacity then maybe we can look further into reforming the actual system and access to the care that is delivered.

The Great Sugar Anomaly

by Jen Jenkins, Market Analyst

Sugar is a familiar substance to all of us, but the history of its unnatural counterpart may be less so. The first artificial sweetener, saccharin, was discovered by accident in 1879; due to sugar rationing during WWI and WWII the artificial sweetener found fame. It wasn’t until 1965 that Aspartame, the second major artificial sweetener, was developed.

Controversy began when Canada banned saccharin in 1977 because of studies indicating it caused cancer in rats. The FDA considered banning the sweetener as well but due to large demand a moratorium was placed on the ban and then extended seven different times. In 1991 Congress withdrew the ban completely. The bottom line in that decision: numerous studies have been done on these artificial sweeteners since questions were first raised in 1977 and none have been able to prove a correlation between human consumption and cancer. Thus, artificial sweeteners remain prevalent in the diet of many Americans today.

For a long time, since sugar was deemed “bad,” diet enthusiasts touted artificial sweeteners to be the holy grail of dieting without giving up a sweet tooth. However, as is the tendency with many fads, the tables turned and a new battle has been waged. Which is worse: Sugar or its artificial equivalent? Opinions are vast and varied. This article by a professor of pediatrics at Indiana University School of Medicine argues that despite having been attacked for decades as “harmful chemicals” there is no scientific link showing humans are harmed by consuming artificial sweeteners, whereas there has been significant scientific evidence that sugar is harmful to humans and their health.

No matter where you stand in the debate it is interesting to scroll through the comments section of these articles to view the different stances people are taking (many of them volatile). Due to an overwhelming response to the article mentioned above, the author responded to some questions here. Whether you are team sugar or team artificial sweetener the key word seems to be moderation, or not at all, so what’s with all the hostility?

The Physician Who Saved Countless Babies from Birth Defects

Dr. Frances Oldham Kelsey, who died last week at the age of 101, became a 20th-century North American heroine for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States  from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.

In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she was one of only seven full-time and four young part-time physicians reviewing drugs for the FDA. One of her first assignments there was to review an application for the drug thalidomide as a tranquilizer and painkiller for pregnant women for morning sickness. Even though it had already been approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested further studies. Despite pressure from thalidomide’s manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.

After  the story received press coverage in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation. Companies were required to demonstrate the efficacy of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies. Read more about Dr. Kelsey…

DNA Dilemmas

by Jen Jenkins, Market Analyst, MCN

DNA, or deoxyribonucleic acid, contains the genetic blueprint that distinguishes each and every human being. Since its advent in 1985, and with a 99% accuracy rate, DNA testing has emerged as the most reliable physical evidence available, particularly at crime scenes. The TV show CSI popularized the science behind forensic testing but over the years it has also become widely accessible for many other purposes. Disturbingly, as the tests have become more accurate and less expensive, we are also seeing evidence of discrimination that has arisen due to having this type of information so readily available.

Laws have indeed come about to specifically protect people from discrimination due to genetic testing. The most newsworthy example of this was seven years ago when Congress prohibited employers and insurers from discriminating against people with genes that showed an increased risk for developing diseases that may be costly to treat. A more recent article in The New York Times, “‘Devious Defecator’ Case Tests Genetics Law,” is an interesting, albeit bizarre, example of the serious issues and concerns surrounding this topic. Two men accused of defecating publicly outside a warehouse where they worked were subjected to a DNA test in order to compare their DNA with that of the feces. Both men, fearing the possibility of losing their jobs, agreed to the testing and were subsequently cleared. Following the debacle the men sued the company on the grounds that the genetics law in place made it illegal for the employer to have requested or required genetic information under any circumstances.

“Anyone in the future thinking about using a genetic test in ways that can embarrass or harm an individual will have to confront the fact that it violates federal law,” stated a Georgetown University law professor regarding the case. Nevertheless, although the United States justice system has many existing laws when it comes to awarding damages for other types of discrimination, there are no laws or guidelines in place specifying how judges may award justly for discrimination due to genetic testing misconduct.

Making (Common) Sense out of HIPAA

by Brian L. Grant MD

That HIPAA is misunderstood is an understatement. As this article in The New York Times describes, HIPAA is used as an excuse for absurd interpretations and ultimately a denial of rights to communicate by non-covered entities, a refusal to receive information from family members, churches who erroneously believe they can no longer share the fact that a congregant may be ailing, and other forms of nonsense.

If I had a quarter for every person who made declarative but incorrect statements about HIPAA, it would buy a lot of coffee, and some pastries to boot!

The goal of HIPAA is to maintain the privacy of medical information. But many questions remain. For example, why is unencrypted email apparently unacceptable but a fax is OK, though many senders or recipients of faxes send the faxed documents as Internet attachments? Is an email less secure than the US mail, which could result in a piece of paper lying on a desk in plain sight of the wrong people? I imagine that if the NSA or North Korea has an interest in the files of a medical practice, they may view them with minor effort. But does encrypting email actually solve a problem of files being compromised? The reality is that unencrypted email use is not prohibited. What is prohibited is accessing and reading such information by an individual or more who are not authorized. That raises the theoretical concern that people with time on their hands at Yahoo or Google are opening and viewing emails containing PHI (protected health information).

Protecting medical privacy is important and HIPAA is well-intended and to the degree it compels the profession to establish guidelines, training and evaluating of who and how one shares medical information, it is a good thing. But we have a ways to go to achieve clarity, reduce barriers to good care, and maintain compassion along with common sense.

Beating Back Opioids – Now What?

WorkComp Central published a new report,“We’re Beating Back Opioids — Now What?” this past June, by Peter Rousmaniere in cooperation with CompPharma. It narrates a 20-year story and poses some provocative recommendations, noting that we are at a turning point in treating chronic pain though the statistics remain daunting. Every workday, some 5,000 workers sustain injuries which disable them for at least a week; on any given day in the U.S. 500,000 injured workers are treated for chronic pain. The majority of treatments includes opioids, and for individuals with chronic pain, care and wage replacement can reach $1,000,000 in cost per claim.

Per the study’s author: “This report does two things. First, it chronicles the two decade-long story of how opioid use greatly expanded in workers’ comp, then halted and began to retreat in the face of fierce criticism. Workers’ comp professionals can use this story to tell their friends about a war they still are fighting.”

Rousmanier also credits several organizations in the detection and reporting on trends and solutions. They include the California Workers’ Compensation Institute, CompPharma, the National Council for Compensation Insurance, Washington State, and the Workers’ Compensation Research Institute. Read more…

 

Hepatitis C: Who Can Afford to Be Cured?

In October U.S. Food and Drug Administration approved a new pill, Harvoni, that can cure hepatitis C, which afflicts about 170 million people worldwide and annually kills 350,000 people.

The price on the new treatment will be a hard pill to swallow for most: $94,500 for a 12-week treatment course with Harvoni, manufactured by Gilead Sciences.

Hepatitis C is a chronic blood-borne infection that attacks the liver, eventually causing cirrhosis or liver cancer and leading to death if not treated. The US Centers of Disease Control and Prevention believes 3.2 million people in the United States could be infected.

Patients who receive these treatments almost never see the total cost, but their insurers do. More than two dozen state Medicaid programs for low-income patients, as well as for-profit insurers, have restricted coverage for the treatment to only those with severe liver damage. While researching the subject for this blog post, we found such distressing – and sadly accurate – soundbites as “The $84,000 Cure – Cheaper than a Liver Transplant.” Last July two members of the Senate Finance Committee, including Ron Wyden, Committee Chair, Democrat from Oregon, asked the manufacturer to defend the cost. They are not alone.

“Never before have drugs been priced so high to treat such a large population,” says Steve Miller, chief medical officer at Express Scripts, the country’s largest manager of drug benefits for employers and insurers. In December, Express Scripts announced it would reject coverage for one-pill-a-day Harvoni and instead steer patients to a less pricey rival drug that requires four to six pills a day.

Just how profitable are drugs like Harvoni and Sovaldi, a Hepatitis C medication released last year? In 2014 Sovaldi, also manufactured by Gilead,  generated $10.3 billion in sales, making it one of the most lucrative pharmaceutical launches ever. Harvoni sales totaled more than $2.1 billion in the last 3 months of the year. Gilead’s market capitalization has soared from $29 billion to $167 billion in five years. The net worth of its chief executive officer, John Martin, exceeds $1 billion. “For a long time we’ve had innovation after innovation,” Martin noted. For many patients, Gilead’s drugs are indeed miraculous. But is the U.S. health-care system paying too much for them? And with 170 million carriers worldwide, what will the impact of this transmittable disease be on governments and citizens with much less spending power?

The Problem of Unnecessary, No-Value Care

By Brian L. Grant MD

Atul Gawande, MD once again hits a bull’s eye in this incisive New Yorker article on the massive problem and challenge of unnecessary “no-value” care.

In truth, “no value” is generous, since care with no value removes value from the system by diverting resources from the economy that could be creating value, and by increasing morbidity and occasional mortality that is inherently part of health care but is accepted as part of the risk benefit calculation.

When there is no benefit, one only encounters risk. Gawande cites a 2010 Institute of Medicine Report that 30% of health care spending, or 750 billion per year in the US, is wasted. Spread across the population of patients, this would mean that 30% of the care received offers no value (while carrying risk), and 30% of the care provided by hospitals, doctors, pharmaceutical manufacturers, physical therapists and so on, are wasted. Of course, human nature being what it is, the average patient likely thinks that it is someone else receiving such wasted care and the average health professional may believe, or at least profess publicly, that all which they do or prescribe on behalf of patients is necessary and appropriate.

If we were to accept this 30% statistic and were somehow able to curtail waste without shifting or increasing costs we would not be in the crisis of cost that we find ourselves in. Our 18% or so of GDP spent on health care would be a more moderate, but a still substantial, 12%. By any reasonable standard, Gawande is describing a situation that ought to outrage every citizen. How much of our many other crises could be abated if 750 billion dollars were allocated to them? Education, poverty, social justice, homelessness, child abuse, and neglect? Or for those with more libertarian views, if this money were redistributed to the 319 million Americans for their own spending, we would each by richer by $2,351.00 per year! What would such wealth unleashed on the economy accomplish?

Why does this problem exist? I believe it is a combination of factors including ignorance, greed, and indifference. The ignorance is preventable but is largely driven by the indifference of a consuming population who have little economic motivation to be mindful of what they receive since others are paying the costs via private and public insurance. Greed speaks for itself and takes the form of deliberately doing the unnecessary or a deliberate denial of the potential that a particular intervention is not needed by ignoring the evidence or not asking the right questions. The patient population in the presence of motivation is capable of making informed decisions by asking tough questions of their physicians and doing their own research.

Fortunately, as the article describes, there are systemic alternatives that can lead to change in this pattern of behavior when one is willing to acknowledge and confront the problem.

An Environmental Activist’s Thoughts on GMOs (and How He Was "Converted")

There’s a lot of talk these days about eating genetically modified organisms (GMOs). GMOs are any organism whose genetic material has been altered using genetic engineering techniques.

For about 14,000 years humans have been using selective breeding, a form of genetic modification, in our raising of domesticated plants and animals. So, basically everything we eat has been selectively bred, thus modifying the genes over time.

How are GMOs intrinsically different? They may or may not be: whereas selective breeding depends on choosing among naturally occurring genetic variation within a population or species, genetic engineering can, but does not necessarily, involve the intentional introduction of genes from different species, a technology first developed in 1972.

And is this intrinsically “good” or “bad”? Mark Lynas, researcher at the Cornell Alliance for Science, mulls this over in “How I Got Converted to G.M.O. Food.” Lynas, a self-described lifelong environmental activist, notes that though he was initially opposed to GMOs, he now believes that genetically modified foods are safe, and points out a major gap between scientists’ and the public’s perception on the issue: per the Pew Research Center and the American Association for the Advancement of Science, while 88 percent of association scientists agreed it was safe to eat genetically modified foods, only 37 percent of the public did. Lynas, through his research at Cornell, tries to bring a more informed context to this gap. In sum he notes:

No one claims that biotech is a silver bullet. The technology of genetic modification can’t make the rains come on time or ensure that farmers in Africa have stronger land rights. But improved seed genetics can make a contribution in all sorts of ways: It can increase disease resistance and drought tolerance, which are especially important as climate change continues to bite; and it can help tackle hidden malnutritional problems like vitamin A deficiency.

What Are Nanoparticles – and Why Should You Care?

Per this article in Fortune, Nanoparticles “touch nearly every Fortune 500 company and aspect of our lives”; the Project on Emerging Nanotechnologies estimates that it’s $20 billion industry.

Nanoparticle are between 1 and 100 nanometers in size (a billionth of a meter). They’re not particularly well understood but they’re present all around us in the environment – and in many of the products we buy and ingest. The interesting and sometimes unexpected properties of nanoparticles stem from the large surface area of the material relative to their overall size.

They’re not a new discovery – nanoparticles were used by artisans as far back as the ninth century in Mesopotamia for generating a glittering effect on the surface of pots. In 1857 Michael Faraday provided the first description, in scientific terms, of the optical properties of nanometer-scale metals. But their applications have changed considerably in the past few years.

Arturo Keller of the University of California, Santa Barbara has been studying nanoparticles, in particular titanium dioxide, in common products such as cosmetics, sunscreens, and lotions. It’s important to note that titanium dioxide is chemically inert and has been around humans for decades, and its practical applications includes use in joint replacements.

But at the nanosize, per Dr. Keller’s research the particles “can also cross the blood-brain barrier or enter cells and destroy genetic material,” leading to increased rates of cancer, heart disease, and neurological disorders.  The Environmental Working Group, a research organization based in Washington, D.C., estimates that nano titanium dioxide is in about 10,000 over-the-counter products, including food, a trend which started over a decade ago.

As research such as Keller’s is completed, many companies and the US government are paying close attention to their use and safety and the FDA is discussing regulations. Their small size allows for many positive uses such as highly targeted drug delivery at the molecular level, and a more targeted delivery of pesticides to crops. As Fortune notes, “perhaps the most concerning and harmful aspect of heightened fears about nanoparticles is the potential for a broad, ill-informed backlash.” Read more…