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Regulatory Issues

Limiting Opioids for Patients with Chronic Pain

By Jen Jenkins

Pain is one of the main reasons people go see their doctor. Although it was once overlooked or often dismissed, it is now a standard vital sign in a patient’s work-up. However, unlike other tests administered in a medical setting, pain is difficult to measure because among other factors, pain tolerance is highly individual. The United States has had a long and complex history with chronic pain management. In the 1990s, doctors were reproached for under-treating pain and were told that opioids, including OxyContin, could not only bring unmitigated relief to patients but do so in a safe way. Today, doctors are again being admonished but for a very different reason. Politicians and policy makers continue to publicly denounce what has been labeled as the “opioid crisis,” due in part to doctors over-prescribing medication, namely opioids.

A growing number of states are enacting measures to limit prescription opioids and the federal government has issued the first national guidelines to help reduce the use of these highly addictive medicines. Dr. Robert L. Wergin, chairman of the board of the American Academy of Family Physicians, said he doesn’t want to stop prescribing opioids altogether but that he can see why some doctors have gotten to that point. Dr. Wergin has taken professional and personal risks in prescribing opioids. Closely monitored by state and federal officials, he must go through an elaborate prescription checklist. He has also been threatened by addicts, desperate for pills. His patients now sign “pain management contracts” and must agree to random drug tests before receiving an opioid prescription. “You don’t want to become so jaded that you assume everyone in the E.R. is a drug-seeker,” Dr. Wergin said, but he has seen firsthand a growing number of overdoses and opioid-related deaths during his emergency room shifts.

Collectively, primary care physicians write the greatest volume of opioid prescriptions and these same doctors are now scrambling to find alternatives for their patients dealing with chronic pain. Prosecutors and medical review boards closely scrutinize physicians who prescribe controlled substances. Many medical associations now offer doctors training about chronic pain, urging the use of other remedies such as physical therapy, acupuncture, anti-inflammatories, antidepressants, or counseling before prescribing opioids. Unfortunately, alternatives are unrealistic for some patients for a variety of reasons: physical therapy may be too expensive; anti-inflammatories cannot be taken by those with a compromised liver.

Some state medical boards have recommended limiting the number of opioid doses per month while others have recommended limiting the strength of daily dose. Dr. Wergin is careful not to promise patients a prognosis of being “pain-free” and chooses instead to talk with them about setting realistic goals to manage their pain. Although opioids help to alleviate severe pain, they are highly addictive. The epidemic of overdoses and death is real and the responsibility of monitoring patients for potential abuse falls largely on prescribing doctors.

Take a moment to read the following New York Times article and learn more about Dr. Wergin and what he is doing for his patients.

Measuring Medicine and Evaluating Education

by Jen Jenkins

The ability to measure quality in nearly every industry has proven to be a powerful and important component for success. In both healthcare and education, metrics and measurements are no less significant, but over time has this number gathering trend spun out of control?

According to Robert Wachter, a professor and chairman of the Department of Medicine at UC San Francisco and the author of this New York Times blog post, in healthcare and education “the focus on numbers has gone too far.” In medicine, the constant measuring that takes place has become more a matter of being included on a “top 100” or “best hospitals” list, rather than a chance to improve patient care. A significant amount of a doctor’s precious time is now being spent entering information into a computer system instead of having quality conversations with patients. A study done in 2013 found that during a 10-hour shift, emergency room doctors were clicking a mouse 4,000 times. That is an immense amount of time spent entering information and being away from patients, all in the name of producing numbers.

It’s true that spending time on metrics is not as much of an issue in industries where the focus and care of another person doesn’t possibly mean life or death.  The issue isn’t whether or not to get rid of measurement in healthcare–it does play an important role–but to instead scale it back. Allowing time for more research could help produce a better understanding of what to measure and ensure that what is being measured really matters in terms of the betterment of the industry. Overall, according to Robert Wachter, one should fully appreciate that measurement does place a burden on professionals in the medical field. We need to learn how to minimize that burden so that measuring for quality does not mean a decline in the actual quality of care that patients receive from doctors.

In his post, Robert Wachter goes on to explore this phenomenon of metrics and measurement in another industry where the cons may outweigh the pros. As in medicine, measurement in education comes at an expense. According to educators, that expense is actual learning and a loss of some important subjects that are not as easily measured by tests – examples include art, music, and physical education. Is a preoccupation with test scores really worth the demise of a well-rounded education?

Avedis Donabedian, a professor at the University of Michigan’s School of Public Health, had a surprising answer regarding the secret behind quality. After a lifetime spent in the field of quality measurement, this data-driven scientist said, “The secret of quality is love.” It’s clear that we cannot let the business side of either healthcare or education dissuade people from becoming doctors or educators; these are both fields that should be able to adopt measurement without losing the compassion and altruism that exists at their core.

Denialism vs. Skepticism

by Angela Sams

“You’re entitled to your own opinion, but not your own facts.” A common phrase indicating that everyone can have their opinion on any variety of matters, but when it comes to clear, objective facts, there’s really no point in arguing. Needless to say, there are plenty of opinionated people out there, and sometimes having an unsubstantiated opinion on unarguable facts can come at price.

Political arguments overwhelm our country as we read about the Paris climate change conference and prepare for elections next year. It takes a well-informed and discerning individual to separate fact from fiction (or, opinion), when sometimes one may be presented as the other.  As a recent Op-Ed article in New York Times points out, “disbelieving science isn’t skepticism, it’s a form of willful ignorance.” Skepticism is something that is evidence-based. For example, we may read about a topic, but are not convinced enough by the facts to believe that whatever the article states is true. Denialism, on the other hand, is more about believing what we want to believe (“I don’t want climate change to exist, so I just won’t believe in it,”), pushing aside obvious evidence, and focusing on so-called “facts” that would help support our own opinions on the matter.

In order to avoid denial, it’s important to understand science. Science does not mean that there is only one answer, and it does not mean that if new evidence comes along it will not change the current understanding of something. Rather, it’s something that’s always evolving, something that is never “settled.” And while it may turn out that a theory is false, science’s “successful track record suggests that there is no superior competitor in discovering the facts about the empirical world.” Rejecting the current scientific evidence on a topic such as global warming is not just being in denial—it could also come at a price. Instead of pretending that something doesn’t exist, wouldn’t it be smarter instead to prepare for it or try to prevent it, until further evidence suggests that this is not necessary?

Sugar – Our #1 Food Villain

by Jen Jenkins, Market Analyst

Over the past several months we have often blogged on the topic of sugar and soda consumption and the possible detrimental effects both may have on human health. Sugar is quickly claiming the spotlight as the most villainous of foods that we consume, due to soaring rates of diabetes, obesity, and heart disease — all sugar-related disorders. Up until now, however, there has not been a study that truly proves sugar is a lone culprit in the rise of these chronic diseases. Dr. Robert Lustig is the reason we may now have, in his words, “hard and fast data that sugar is toxic irrespective of its calories and irrespective of weight.”

A new study developed by Dr. Lustig, out of the University of California, San Francisco, tested the effects of removing sugar from the diet of 43 children while keeping their weight and the amount of calories consumed exactly the same. Previous studies argued that it couldn’t be proven that removing sugar alone creates positive outcomes, since removing sugar also lowers calorie consumption and induces weight loss. To overcome this argument, Dr. Lustig made sure the children weighed themselves daily. If the children were losing weight, he had them eat more of the foods provided, to keep their weight the same. According to Dr. Lustig, after only 9 days “everything got better.”

Overall, their fasting blood sugar levels dropped by 53%, along with the amount of insulin their bodies produced since insulin is normally needed to break down carbohydrates and sugars. Their triglyceride and LDL levels also declined and, most importantly, they showed less fat in their liver. – Time

The main goal of this study was to look at sugar and how its negative effect on the body isn’t correlated with other diet concerns, calorie consumption, or weight loss. In fact, Dr. Lustig admitted that the diet the children were fed was far from ideal and still loaded with processed foods. Despite that, there were very noticeable improvements in the children’s health. Dr. Lustig is hoping these findings, along with new ones that continue to emerge, will encourage the U.S. Department of Agriculture to consider this new information on sugar when finalizing the updated Dietary Guidelines for 2016.

For more information on why not everyone is convinced by this new study and for other concerns expressed by experts, see this Time article.

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.

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?

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…

Eating Sawdust Will Not Make You Smarter

Eating sawdust will not make you smarter. Nor, likely, will eating powdered houseplants or a mixture of dried rice, mustard, wheat and radish, no matter how the product is labeled. And yet millions of Americans apparently are eating just that: As it turns out, testing announced by the state of New York this week found that the Ginkgo biloba sold by Walmart, for example, contained no Ginkgo biloba DNA — it was a mixture of rice, mustard, wheat and radish.

“Supplements” are not considered by the Food and Drug Administration to be drugs or food and therefore are not subjected to rigorous testing and related laws regarding product labeling. The results of multiple tests have shown that many supplements don’t contain much, if any, of what they’re labeled as being (though to be clear, nothing has been found so far that does contain sawdust). Ginkbo biloba may or may not be good for your health, but you might never find out – because the product you’ve bought might not actually contain any.

One in four dollars in the supplement market passes though Utah, the home stage of Senator Orrin Hatch, whose son is a longtime lobbyist for the supplement industry and who was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market.

“There’s a lot of wrong information out there,” warns the American Cancer Society, in its tutorial on these products. “Even for those who are usually well informed, it can be hard to find reliable information about the safe use and potential risks of dietary supplements.”

Read more…