Month: June 2016

Cancer’s Cure: Within us all along

In a call to action at his final State of the Union Address last January, President Barack Obama charged Vice President Joe Biden with the duty of overseeing a new initiative to cure cancer “as we know it,” called the Cancer Moonshot. This comes exactly one year after the death of the Veep’s eldest son, former Delaware Attorney General Beau Biden, who lost his battle with cancer in January 2015 at the age of 46.

According to the American Cancer Society, the International Agency for Research on Cancer (IARC) projected a surge of new cancer cases in the decade to come. In 2012, 14.1 million people worldwide were diagnosed with some form of the disease, resulting in 8.2 million deaths. By the year 2030, that number is expected to rise over fifty percent, to 21.7 million, with 13 million cancer-related deaths worldwide.

For decades, Western medicine has relied on limited means of treating malignant growths, primarily using chemo (a blood cell growth-inhibiting poison) and radiation therapies to prolong patients’ lives, if not placing them into permanent remission. However, these efforts often prove futile as patients endure severe side effects, decreased quality of life, and sometimes shortened lifespans due, not just to the disease state, but to the consequences of treatment itself.

With the proliferation of advancements in computer technology and science beginning in the second half of the twentieth century, modern medicine too saw major progress. In the 1970s, Genentech Incorporated emerged out of the San Francisco Bay Area, becoming the world’s first biotechnology company, synthesizing insulin in order to treat diabetes. Since then, the biotech industry has continued to utilize the human immune system, called immunotherapy, to combat disease in hopes of treating a host of illnesses – one of the most urgent being cancer.

In essence, immunotherapy is “designed to produce immunity to a disease or enhance the resistance of the immune.” In May 2016, researchers at Duke University made a “breakthrough” discovery –  according to the United States Food and Drug Administration –  identifying properties within the poliovirus which triggered the immune system, and effectively creating a promising new, safe method of destroying glioblastoma, a particularly aggressive form of brain cancer. After introducing a synthetic version of poliovirus into the body, the virus automatically infects the tumor. Scientists found that it subsequently signaled to the immune system to attack and destroy those cells. Furthermore, initial tests indicate that this method could be successful for treating several more types of cancers, including breast, colorectal, prostate cancers, pancreatic, liver, and renal cancers. Of course, this is not the only significant development to come out of immunotherapy. Similar clinical trials have been done on lung cancer, bladder cancer, and many more forms of the disease.

In recent years, start-up biotech companies like Gilead, Amgen, BioMarin, and Medivation have surfaced, capitalizing on this approach, and making great strides in the development of immunotherapies for an array of malignancies. Likewise, other well-established pharmaceutical giants like Pfizer, Roche, Johnson & Johnson, and Glaxosmithkline have begun efforts to acquire and/or develop their own immunotherapies and targeted treatments.

Better Breastfeeding Laws for a New Normal

Malnutrition causes about one-third of deaths among children under five. More than half of these deaths are because of inappropriate feeding practices during the first year of life. As a way to improve young children’s health and nutrition, the World Health Organization (WHO) recommends that mothers breastfeed their children within the first hour of life. Evidence shows that exclusive breastfeeding for the first six months up to two years has the single largest impact on a child’s likelihood to survive and thrive.

In 1981, WHO adopted the International Code of Marketing of Breast-Milk Substitutes (the Code). The Code prohibits promotion of breast-milk substitutes including advertisements, gifts to health workers, and distribution of free samples. It also requires that breast-milk packages contain a message about the superiority of breast-feeding over formula. The Code does not absolutely prohibit breast-milk substitutes. WHO’s recently released resolution in June 2016 guides governments and companies on how to better handle breast-milk substitutes: “they should be readily available, but not promoted.” However, out of the 194 WHO member states, only 39 countries have laws executing all provisions of the Code; only six have allocated budget or funding for monitoring and enforcement.

The WHO, United Nations Children’s Fund (UNICEF), and the International Baby Food Action Network (IBFAN) say breast milk is safe, clean, and contains antibodies that help protect against many common childhood illnesses. Breastfed children perform better on intelligence tests, and are less likely to be overweight, obese, or diabetic. Mothers also benefit from reduced risks of breast and ovarian cancer. UNICEF Chief of Nutrition, Werner Schultink, emphasized that mothers should be aware of the “readily available means to protect the health and well-being of their children.”

According to the United Nations’ most recent report on nutrition, breastfeeding has the potential to save lives of more than 820,000 children and 20,000 women. Additionally, the global economy can gain up to $300 billion if every infant is exclusively breastfed for at least six months. Still, the more developed countries are plagued with breastfeeding controversies. In March, earlier this year, a woman in D.C. was fired for pumping breast-milk for her newborn child during her break at a desk job. A federal judge ruled in March that the D.C. police officer could sue the city. Also earlier this year, at the London Heathrow Airport, security threw out a mother’s two weeks worth of breast-milk. Several airports have long had equipment to securely check large amounts of liquid such as milk for young children.

Lancet, a UK medical journal, suggests some ways to improve protection and promotion of breastfeeding. Increased provisions for paid maternity leave and Affordable Care Act provision for protected nursing breaks and insurance coverage for breast pumps could increase breastfeeding by up to 25%. However, there is concern on whether breastfeeding can transmit infectious diseases such as the Ebola Virus and AIDS. Researchers from the University of Cambridge and Wellcome Trust Sanger Institute published case studies in the Virus Evolution journal, stating that a mother may have transmitted Ebola to her baby by breastfeeding. Previously, WHO advised that HIV-positive mothers to refrain from breastfeeding. However, on November 2009, WHO revised its recommendations. HIV-positive mothers risk less than 1% chance of transmission if they also take antiretroviral drugs throughout the period of breastfeeding.

Advocacy groups such as the United States Breastfeeding Committee are driving collaborative efforts for policy and practices that could protect and promote breastfeeding in the U.S. Still, the U.S. has yet to create laws that mirror the Code.

 

 

DIGITALIZATION OF HEALTH CARE INFORMATION: HADOOP

A major push has been under way by medical service providers and their technology outsourcing companies to digitalize electronic records and the attendant Personal Health Information (PHI) that is generated every time we get medical care. In fact, digitalizing healthcare records is widely thought of as one of the best available avenues of obtaining savings and holding back the United States’ rapidly ballooning healthcare costs. However, beyond the immediate savings, digitalization of medical records holds out the promise of running analytics on those records, and thus uncovering precious new information on the trends hidden in our PHI.

One example of a domain where this effort is starting to bear fruit is analytic efforts regarding episodes of care. Let us say that State X analyzes all of the instances where its citizens were treated for a particular disease. Next, after isolating those cases, it normalizes for age, race, gender and other demographic variables, and then analyzes the data for cost per patient for the treatment of these diseases. Once that’s done, the state could then compile and rank all the medical providers providing medical treatment to its population, in order of least expensive to most expensive. It could then provide a financial reward to, say, the five medical providers who are providing this treatment at the lowest risk, while penalizing those medical providers who are costing their patients the most money for getting the same treatment. Or it could try to pick either the best or the worst medical providers, and try to find out why one group is performing so much differently than the other group.

Two recent trends in modern healthcare have accelerated the potential for deriving greater benefits from the PHI analytics. One is the emergence of Cloud technology. Due to the ever-tightening budgets, states are increasingly finding it more and more convenient to move their healthcare operation and applications from dedicated data centers to the Cloud environment. The more security-conscious of these entities are opting for some variation of private clouds. Either way, they are depending on the protection provided by the breach requirements of the Healthcare Insurance Portability and Accountability Act (HIPAA), which allows them to shift the liability of these breach incidents to the business associates rather than the covered entities.

The second trend worth paying attention to is the emergence of Hadoop. Hadoop is an open-source software language developed by the non-profit Apache Foundation. Due to its open-source nature, it can be used without having to incur any commercial licensing costs. Hadoop allows users to process very large data sets on a group of different computers, by splitting up the data, sending it to different computers to be processed, and then putting all the processed data back together in the correct order. This feature allows it to produce results similar to what would be achieved through a supercomputer but by using a group of less-powerful computers.

Entities using the Cloud are becoming increasingly comfortable with allowing their data to reside in external servers. This then allows this data to be analyzed by analytics suites running Hadoop. The result is increasing clarity and decreasing cost. This happy convergence of more powerful analytics and cloud computing should ultimately accrue greater benefit to the healthcare community and the patients they serve.

Ransomware: The Cyber-Crime Spree Against Hospitals

By: Alexis Rose

Ransomware attacks have become an increasing plague on a number of industries, but there is special concern for the targeting of hospitals and other healthcare providers. Ransomware is a type of malware that infects computers and networks, typically through infected e-mails or advertisements. The malware locks users out of key files or an entire network and the infected computer will display a screen with a ransom demand. The owner of the system is told the network can only be unlocked with a key that must be provided by the hacker, and the key can only be acquired once the ransom is paid. The high value of healthcare files and the vulnerability of hospital computer systems makes the healthcare industry an increasing target for ransomware attacks.

A number of hospitals have paid ransom demands and the demands are only getting bolder. The largest ransom paid was on February 5th by the Los Angeles area hospital, Hollywood Presbyterian Medical Center, which paid $17,000 in bitcoin (a type of online currency that allows cyber criminals to demand larger untraceable amounts of money) to have its system unlocked. The attack on Hollywood Presbyterian was the beginning of a slew of ransom attacks through the months of March and April. In March, three hospitals were hit by ransomware attacks within a few days of each other and in early April MedStar’s system was hit, putting at risk its ten-hospital network. On May 23rd, Kansas Heart Hospital was hit with the boldest attack yet, when the hackers demanded a second ransom. The Wichita-based hospital was hacked and paid a “small amount” of ransom, according to the hospital’s president. However, after the ransom was paid the hospital was not provided with the key to unlock their data. Kansas Heart did not pay the second ransom, but it makes clear a frightening fact that these attacks will likely get worse before a comprehensive cyber-security solution can be found.

The large uptick of ransomware attacks has sparked concern amongst many security experts and the government. The Senate Judiciary Committee held a hearing on May 28th about the broader issue of ransomware attacks across industries, but the discussion was largely focused on the healthcare industry. Adam Meyers, an expert who has worked in the cyber-security field for over fifteen years, testified in front of the Committee and urged the medical industry to train its personnel in spotting suspicious e-mails and links. He also highly encouraged hospitals to have a separate back-up network, which allows the hospital to more easily recover files that may otherwise be lost forever.

The College of Healthcare Information and Management Executives (CHIME) also provided a statement to the Committee with their recommendations for combatting ransomware attacks.  In the statement made by CHIME, the group pointed out that much of the IT money and resources in the medical industry have focused on HIPPA regulations and patient file privacy, rather than network security. CHIME recommended that policymakers give the health industry incentives that will encourage investment in IT. CHIME also recommended that Congress reduce the complexity of the regulation that commands the healthcare industry. By having more uniformed and less complicated security regulations healthcare providers can spend more time and money monitoring against daily threats. Alisa Walker, a partner at Baker Donelson, a top health law firm, wrote last month about the importance of a comprehensive preparedness plan. She recommends that hospitals (as well as other industries) treat ransomware threats similar to any other physical security threat.

It is clear that ransomware attacks will continue to climb and both the healthcare industry and lawmakers will have to make significant changes in how these threats are handled. Lawmakers have to create serious cyber-security regulations and the healthcare industry will have to use significant time and resources to comply.

NAS Study on GMOS: End of Debate?

NAS Study on GMOS: End of Debate?

Agricultural biotechnology (commonly referred to as “GMOs,” “genetic engineering,” or “biotech”) has been the topic of much debate over the past few years, and most of the discussion has been about whether companies should be required to label products containing GMOs. Congress is currently working to create bipartisan legislation that would require mandatory nationwide labeling, fixing the issue of patchwork individual state labeling laws, such as the one going into effect in July in Vermont, which requires labels on products containing genetically engineered ingredients. The Vermont law – Act 120 –will take effect July 1, 2016. Consumers and legislators have pushed for a GMO label on foods made through biotechnology due to fear of unknown health and environmental effects and the right to know what is in our food, such as infertility or cancer in humans and resistance in plants.

In order to address some concerns and rhetoric around biotechnology, the National Academy of Sciences (NAS) released a report, “Genetically Engineered Crops: Experiences and Prospects,” on May 17. The NAS conducted a retrospective examination of the alleged positive and adverse effects of biotech crops in order to anticipate what emerging genetic-engineering holds for the future. The NAS panel, which was comprised of 200 independent experts with no direct ties to the agriculture industry, reviewed 900 studies comparing the US and EU and found that there is no evidence to suggest  GMOs pose any adverse risks to human health or the environment. The report discusses several uncertainties about the economic, agronomic, health and safety impacts of biotech crops and food, while also making recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GMO technology.

While the NAS found no adverse environmental or health risks, the study is not meant to end the discussion about biotechnology or its effects on the environment and human health. While there are a couple of varieties of GMOs currently in the marketplace, such as corn, soybeans, and papayas, many biotech traits have not yet left the laboratory. The NAS study stated that, “available in fewer than 10 crops as of 2015, varieties with G.E. herbicide resistance, insect resistance, or both were grown on about 12 percent of the world’s planted cropland.”  The NAS, Food and Drug Administration (FDA), US Department of Agriculture (USDA), and other research agencies will need to continue to conduct and review studies regarding the health impact of food biotechnology, as well as its impact on the ecosystem.

As the world population and obesity continue to increase and water supply and farmable land further decrease, researchers and companies will look towards science to help us solve some of these monumental issues. However, it is essential that systems and regulations are put in place to help us continue to assess the safety of scientific innovations, such as food biotechnology, and help consumers better understand what is in their food and help them make informed choices.