Directed ‘HIT,’ the center of the precision medicine bullseye

The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing titled “Continuing America’s Leadership: Realizing the Promise of Precision Medicine for Patients.” The hearing discussed the reality that, with innovative approaches, physicians may no longer need to make treatment recommendations based upon outcomes for an average patient. Instead, precision medicine could be utilized to account for individual differences in patients’ genes, environments, and lifestyles in order to enhance the quality and effectiveness of health care. The hearing covered ways that health information technology (HIT) could be advanced to make precision medicine the norm in order to achieve goals like those set out in President Obama’s Precision Medicine Initiative.

HIT

Dr. Karen DeSalvo the National Coordinator of the HHS Office of the National Coordinator for Health for Health Information Technology (ONC) testified before the Senate committee that “health information technology is the foundation required to bring precision medicine to operational life.” To achieve broad utilization of precision medicine, DeSalvo testified that the nation needs to continue to move forward with plans like the ONC’s interoperability roadmap. To develop the HIT infrastructure, the ONC believes three goals need to be met: (1) develop consistent use of applicable standards for application programming interfaces, health care terminology, implementation, and security; (2) foster an environment of trust and security around individual’s data; and (3) incentivize interoperability.

Testimony

Jeffrey Shuren, Director, Center for Devices and Radiological Health (CDRH) at the FDA, testified that technology will also play a key role in precision medicine through technological medical advancements like Next-Generation Sequencing (NGS). According to Shuren, “An NGS test is capable of detecting the billions of bases in the human genome, and in doing so identify the approximately 3 million genetic variants an individual may have.” As a result, a single use of an NGS test could help diagnose and even predict patient’s risks for countless conditions. Francis S. Collins, the Director of the National Institutes of Health (NIH) added that technology can increase biomedical understanding through “widespread adoption of electronic health records, the recent revolution in mobile health technologies, and the emergence of computational tools for analyzing large biomedical data sets.”

Senators

Senator Lamar Alexander (R-Tenn) criticized what he called the “failed promise” of the EHR incentive program as a barrier to the advancement of precision medicine. Alexander said that the $28 billion drive to increase EHR utilization has not been worth the effort due to complaints of disrupted workflow. Alexander did say that interoperability should remain a goal. Senator Patty Murray (D-Wash) commented that Republicans and Democrats need to work together and invest in “priorities like the President’s precision medicine initiative.” Murray added that while it is important to promote precision medicine, the protection of privacy needs to remain a top concern in light of “serious security breaches impacting families’ personal health information.”

New isn’t always better: Old medicinal tricks useful in the modern age

With all of the emphasis on development of new drugs and medical techniques, it seems that the momentum is always pushing forward. Although the practice of medicine from centuries past seems ancient, beyond outdated, and at most, useless considering high mortality rates and short lifespans, some of these old techniques are proving to be valid, even breakthrough options when modern science fails.

Sharper than a knife

Blades made from obsidian (volcanic glass) were used in questionable surgical procedures in the Stone Age. However, some doctors recognize that while the surgeries themselves were often unnecessary and misguided, the tools used are still the best that can be found. When properly cut, obsidian has a continuous edge cleaner than steel. Because steel scalpels can have a rough cutting edge on a microscopic level, they can cause additional tissue damage.

Dr. Lee Green, a professor at the Department of Family Medicine at the University of Alberta, says that the reduction of tissue damage by using obsidian blades during procedures allows cuts to heal faster with less scarring. While helping documentarians produce a film on ancient surgical technology, he compared the use of steel and obsidian scalpels by making incisions in cultured-skin burn dressing and placing them under a microscope. Dr. Green said that the results were evident, to the point where “the steel scalpel incision looked like it had been made by a chainsaw.”

Although Dr. Green personally uses obsidian scalpels, he warns that they will not likely be used broadly due to some marked drawbacks. These scalpels are not FDA approved. Because they are more brittle, they are prone to breaking and could cause more injury. Dr. Green warns that these scalpels feel very different during use than steel counterparts, and that doctors who are interested in using them must practice before attempting a procedure. Even so, these blades have proven useful for patients who may have a steel or metal allergy and cannot tolerate regular scalpels.

Superbugs, meet your match

MRSA (methicillin-resistant Staphylococcus aureus) are bacteria with resistance to typically used antibiotics. These infections, commonly known as staph infections, can be fatal and are difficult to treat. These “superbugs” are often found in hospitals, but have become more common in community settings.

Dr. Christina Lee, an Anglo-Saxon expert at the University of Nottingham, translated Bald’s Leechbook, one of the oldest known medical texts. During her translation efforts, she came across an “eyesalve” remedy for eye infections. She was intrigued by its inclusion of garlic, which is already being studied for possible antibiotic properties. Additionally, it was described as the “best of leechdoms.” Lee approached microbiologists at the university to see if they would be willing to try it.

The ingredients, including garlic and onion or leek, wine, and bile from a cow’s stomach were left to stand in a brass vessel for nine days, then strained through a cloth according to the directions. The scientists had little hope that the potion would work. But when applied to a population of billions of cells, the remedy left only a few thousand alive.

The scientists asked a U.S. team of researchers to do a study involving a live organism. The results from biopsies of mice wounds showed that  90 percent of MRSA bacteria were killed. These results were replicated multiple times. Researchers are not completely sure how it all works, but theorize that either steeping the ingredients in alcohol forms a potent new molecule or that the active properties of each ingredient combine to attack bacteria.

Deceptive Practices Spotted Among Marketers of Melanoma Detection Apps

Marketers of mobile apps claiming the ability to detect symptoms of melanoma are being challenged for deceptive marketing techniques by the Federal Trade Commission (FTC). The FTC charged that no scientific evidence supported the claims of the ability to detect early stage melanoma. The FTC reached settlements with some marketers of MelApp and Mole Detective, while charges are being pursued against two additional Mole Detective marketers who refused to settle.

Users were instructed to submit a photograph and other information about moles found on their body. The apps used this information to calculate melanoma risk. Although the apps suggested that users see a physician over melanoma concerns, the FTC’s associate director for advertising practices, Mary Engle, said that marketing gave the impression that the apps were diagnosis tools. In 2013, the Journal of the American Medical Association published the results of a study on the classification of melanomas by various apps conducted by dermatologists. Although the apps were not named, three of the apps were found to incorrectly classify at least 30 percent of melanomas as low risk.

Mole Detective was created and first marketed by Kristi Kimball’s company New Consumer Solutions, LLC in January 2012. Avrom Lasarow’s company L Health Ltd. oversaw marketing from August 2012 forward. The Kimball settlement prohibits the company from claiming that an app can detect or diagnose melanoma unless this statement is supported by scientific evidence obtained by clinical testing, and the company must disgorge $3,930. Lasarow and his company did not settle, and the FTC will pursue litigated judgment.

MelApp was marketed by Health Discovery Corporation in 2011. A proposed settlement contains prohibitions similar to the Mole Detective settlement on claims regarding the app’s reliability. The company must disgorge $17,963.

Who Will Pay the Bill After the Medical Device Tax Repeal?

The Patient Protection and Affordable Care Act (ACA) (P.L.  111-148) Medical Device Excise Tax has returned to headlines in light of renewed efforts to repeal the tax. The controversial ACA provision— a fundamental financial support of health reform—is projected to bring in $29 billion over the next 10 years. According to a New York Times article, the apparent legitimacy of the tax repeal effort is being given unusual bi-partisan support due to “liberal Democrats in states with large concentrations of device manufacturers.”  Amidst the reintroduction of legislation to repeal the tax—H.R. 160, the “Protect American Innovation Act”—opinions are divided as to who ultimately bears the cost of the 2.3 percent tax and whether the tax produces harm or supports positive industry reform.

Impact

The ACA provision imposes a 2.3 percent tax on the sale of medical devices. The tax is paid by manufacturers and importers. According to the New York Times, trade groups have brought strong opposition to the tax, indicating that it has already led to reduced spending and will lead to a loss of “195,000 jobs among manufacturers and suppliers and in the general economy over the next five years.” The Congressional Research Service (CRS) plainly disagrees with the industry’s analysis. The CRS estimated in a January 2015 report that the tax will have “fairly minor effects, with output and employment in the industry falling by no more than two-tenths of 1 percent.” Additionally, the CRS analysis concluded that most of the cost of the tax would fall on consumers, and not on the profits of medical device companies. The CRS also indicated that the subsequent effect on the price of healthcare would be negligible.

Response

Steven Ubl, chief executive of the Advanced Medical Technology Association (AdvaMed), and Gail Rodriguez, executive director of the Medical Imaging and Technology Alliance, responded critically towards the tax and the ACA in the form of a letter to the editor in the New York Times.  Primarily, Ubl and Rodriguez took issue with the assertion that, in the aggregate, pharmaceutical and medical device companies benefit from expanded insurance coverage under the ACA, regardless of the excise tax. The letter critiqued the argument in light of what the letter referred to as an “essentially nonexistent” growth in the demand for medical devices.  To support their position that the ACA tax is damaging the industry, UBL and Rodriguez pointed to a study conducted by AdvaMed—a medical device trade association. According to the study, which contradicted sharply with the CRS findings, the tax was responsible for 8,500 job losses and will lead to 20,500 less new jobs in the next five years. The study also indicated that 53 percent of companies participating in the survey indicated that research and development spending was cut as a result of the tax.

Future of the Tax

What the future holds for the ACA and its device tax remains unclear. Although opinions could hardly differ more significantly with respect to the tax’s actual effect, there are some facts that are less contested. For example, it is seldom disputed that the purpose of the tax was to generate revenue to support the expansive reforms of the ACA. The CRS indicates that although the tax is small, if it were repealed, “no revenue replacement has been proposed and it may be difficult to find.” Additionally, repeal efforts are raising other concerns. For example, both the CRS report and a New York Times opinion page have expressed concerns that success with medical device repeal may lead to industry challenges of other health care revenue provisions.   The worry is that without adequate revenue, already significant budget deficits will increase and struggling health care programs will be forced to face damaging cuts. The President and Congress will be asked to decide, in the near future, what should become of this particular tax. However, this issue once again poses the outstanding question about how we, as a country, should go about paying our health care bills.