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…
There’s no precise way to measure calorie consumption across a general population, but according to several major data sources which track trends in the United States, American calorie consumption is declining.
Barry Popkin, a University of North Carolina professor who has studied food data extensively, described the development as a “turning point.” There is no single moment when American attitudes toward eating changed, but researchers point to a 1999 study as a breakthrough. That year, researchers from the Centers for Disease Control and Prevention published a paper in The Journal of the American Medical Association that turned into something of a blockbuster.
In the intervening years the anti-obesity public health campaigns have focused on one subject more than any other: beverages. This seems to be working. Soda consumption in the US has fallen from an average of 40 gallons per year per American in 1998 to 30 gallons/person/year in 2014. Interestingly, that 30 gallon average is the same rate of soda consumption in 1980, when the obesity rates started to climb. Though food trends haven’t radically changed — the drop in soda consumption isn’t accompanied by a rise in vegetable consumption, for instance — this is a clear stop in the right direction. Read more…
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.
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.
Start-ups and doctors are in zealous pursuit of new and sometimes controversial ways to prevent, detect and treat concussions, as noted in this article.
A growing industry has developed around concussions, with entrepreneurs, academic institutions and doctors scrambling to find ways to detect, prevent and treat head injuries. An estimated 1.7 million Americans are treated every year after suffering concussions from falls, car accidents, sports injuries and other causes.
While the vast majority quickly recover with rest, a small percentage of patients experience lingering effects a year or longer afterward. Along with memory issues, symptoms can include headaches, dizziness and vision and balance problems.
Since 2007 research spending has increased dramatically. At that time Congress, facing criticism that the military had ignored the psychological and physical toll on soldiers of serving in the Afghanistan and Iraq conflicts, allocated $600 million for research and treatment on traumatic brain injury and post-traumatic stress disorder (PTSD), two major conditions faced by many returning soldiers. In turn much of the traumatic brain injury research has included a look at treating concussions. Many highly publicized cases in the NFL of concussed football players have added to the call for more research and treatment options.
The search for ways to treat and prevent concussions has spawned screening tools, helmet sensors, electronic mouthpieces, diagnostic blood tests and brain imaging devices. Start-ups are marketing their products to the military, schools, hospitals, sports teams and parents, and controversial therapies like hyperbaric oxygen are being promoted to patients. But as the industry booms, medical experts are raising concerns that it is a business where much of the science is sketchy, belief frequently outruns fact, and claims of technological breakthroughs evaporate soon after they are made. Read more…
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…
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?