Veterans Choice Act Needs to Get Its Act Together

In Spring 2016, a report from the Veterans Administration (VA) Office of the Inspector General revealed that 21 of 38 VA medical facilities investigated were using improper scheduling for appointments. This is similar to a practice uncovered two years prior. In 2014, forty veterans died while waiting to be treated by the VA. In an investigation that culminated in Phoenix, Arizona, it was discovered that VA medical facility staff created secret waitlists instead of entering veterans into the actual scheduling system, and thereby hid actual wait times. The scandal exposed a pattern of practice used in VA medical facilities nationwide.

In response to the scandal, Congress passed The Veterans Access, Choice and Accountability Act (“Veterans Choice”) in 2014, with hopes it would improve veterans’ access to and quality of healthcare. Essentially, the law requires the VA to authorize veterans registered in the VA health care system as of August 1, 2014 to receive non-VA care if they live more than forty miles from the nearest VA medical facility or if the treatment they need has a wait time of more than thirty days.

Most VA patients do not have war wounds; they have “worn-out knees and [backs] from lugging heavy gear up and down,” according to Irvin Bishop Small, who served in the U.S. Navy for ten years and lives forty-five miles from the nearest VA medical facility. The Veterans Choice program was created to help veterans like him. When the doctor prescribed physical therapy and acupuncture to Small, he reached out to the nearest Choice private medical facility. He was told he would get a call back, but it was him who ended up calling back, over and over again. Because of the lack of necessary treatment, Small’s chronic pain sometimes drove him into deep depression. Legislators that created the program now admit that thousands of veterans are in the same situation.

According to a June 2016 report released by the Commission on Care, the unit Congress charged with implementing the program, Veterans Choice is thoroughly flawed in its design and operation. The report showed some racial and ethnic health care disparities and private medical facilities refusing to treat veterans because of delayed reimbursements, if any at all. It also showed aggravated wait times in some VA medical facilities. Still, it has produced some positive results. A survey showed that 90 percent of veterans were satisfied with the appointments’ timeliness. Still, VA Secretary Robert A. MacDonald said that, “until all veterans say they are satisfied…nobody at VA will be satisfied.”

Meanwhile, presidential candidates are making promises to solve the problem. Republican Nominee Donald Trump pledged that he would expand the Veterans Choice program to allow veterans to choose their doctor and medical facility, regardless of whether they are affiliated with the VA. J. David Cox, president of the American Federation of Government Employees, and a spokesman for opposing candidate Hillary Clinton, disputes that Trump’s proposed plan would lead to the VA’s privatization and private corporations making profit off of veterans suffering.

Many oppose increasing privatization because they believe that VA staff, which are largely made up of veterans themselves, will understand veterans’ needs better than a private caretaker. Bill Breeden, a Vietnam veteran, said that veterans “talk the same language…same issues, [and are] concerned about veterans’ issues.” It is curious to see if promises will be fulfilled and whether this time, the VA will create a system that actually gives each veteran a choice.

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FDA’s New Nutritional Label and the Not So Sweet Impact on Sugar

On May 27th, the FDA released its much anticipated new nutritional labeling requirements. This will be the first time the FDA has revamped its nutritional labeling requirements since they were first created under the Nutritional Labeling and Education Act of 1990.  The new label will make a number of big changes, but none got more attention than the inclusion of “added sugar” on the label. The F.D.A. defines “added sugar” as “sugars that are added during the processing of foods, or are packaged as such, and include sugars (free, mono-and disaccharides), syrups, naturally occurring sugars that are isolated from a whole food and concentrated so that sugar is the primary component (e.g. fruit juice concentrates), and other caloric sweeteners.” The F.D.A.’s inclusion of “added sugar” on the label is seen as a health win by some and a misleading and unhelpful piece of information by others.

Attempts by the government, both local and federal, to curb Americans consumption of sugar has been on the rise over the past few years. In 2013, Mayor Bloomberg attempted to ban sodas and other sugary drinks that were more than 16 oz., but the law received vehement backlash and was eventually overturned. However, Philadelphia last month passed a law that would tax soda at 1.5 cents an ounce. Unlike the New York law, which was seen as an overbearing paternalistic measure to control what citizens eat and drink, the Philadelphia law was framed as a revenue generating tax. So is the Philadelphia law and the new “added sugar” labeling mandate a changing of the tide? Will added sugar become a minimal part of the American diet?

According to some, including George Mason professor and food lawyer, Baylen Linnekin, the new F.D.A. label requirement is a “stinker” and won’t do anything to change sugar consumption in America. Linnekin finds the label of “added sugar” misleading because it “creates a deceptive health halo around products like orange juice and apple juice, which are high in naturally occurring sugar, but contain no added sugar.” He also states that indicating added sugar will not suddenly change the habits of those who eat sugar in unhealthy amounts.

Linnekin is not the only one making these arguments. For the past two years the sugar industry and many food manufacturers have been fighting the “added sugar” component of the new label. The American Baker’s Association, American Beverage Association, Corn Refiners Association, National Confectioners Association, were among the companies and associations that fought for two years to keep “added sugar” off the new labels. Campbell Soup, the parent company to Pepperidge Farm and V8, stated that the new “added sugar” would confuse consumers.  Manufacturers may fear that added sugar could soon go the way of trans fat and become a minuscule part of the American diet. Trans fat is now nearly eliminated from the American diet because of a coordinated effort between scientist, the American Heart Association, and the F.D.A. to make consumers aware of their intake of the dangerous fat. Even if sugar is headed in that direction, many in the healthcare field think that might not be such a bad thing, given the link between sugar and increasing cases of diabetes and obesity in America.

The outcome of the new nutritional label on companies and consumers alike probably will not be fully realized for some time, but the new labeling will certainly have an impact on both groups. It cannot be ignored that consumers are becoming more and more aware of what they eat, with increased attention to labeling of foods with GMOs and consumers going out of their way to eat organic. It also should not be ignored that this will have an impact on the American sugar industry, which is one of the largest in the world. Either way, it was clear that F.D.A. needed to update the nutritional labeling requirements. That realization came because Americans consume food differently than we did twenty-six years ago, sometimes in very detrimental ways, and our food labels should reflect those patterns and needs.

Companies will have until July 26th, 2018 to start complying with the new regulations.

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An Undue Burden, Indeed

Note: This blog is a follow-up from a previous post discussing the potential effects of the Whole Women’s Health v. Hellerstedt case. That post can be found here.

Roughly four months after hearing oral arguments, the Supreme Court of the United States handed down its 5-3 decision in Whole Women’s Health v. Hellerstedt on June 27,, 2016. Justice Breyer wrote the majority opinion on behalf of himself and Justices Kennedy, Ginsburg, Sotomayor, and Kagan. Justice Ginsburg also wrote a concurring opinion on the case. Justice Alito wrote the dissent on behalf of himself, Justice Thomas, and Chief Justice Roberts. Justice Thomas also wrote a separate dissenting opinion. This decision is the most significant victory for abortion rights in a generation.

Just one year ago, the United States Court of Appeals for the Fifth Circuit overturned the trial court and upheld the provisions of the Texas law saying it did not place an undue burden on the right to obtain an abortion. Had the Supreme Court’s decision resulted in a 4-4 ruling, that verdict would have remained in place. However, the majority of the Court said that the appeals court did not properly apply the undue burden standard.

The Court decided that two provisions of the Texas House Bill 2 were unconstitutional as interpreted in Planned Parenthood v. Casey (1992). The Texas bill was signed into law in July 2013 by then-governor, Rick Perry. The first of those provisions was a requirement that physicians performing surgical or medical abortions have active admitting privileges at a hospital within 30 miles. The second provision stated that clinics performing previability abortions meet extensive licensure standards applicable to ambulatory surgical centers (ASCs). The majority opinion reaffirmed the balancing test from Casey; the test calls for thorough judicial review of abortion-related legislation whose stated purpose is to protect women’s health but is allegedly unnecessary. When the legislation presents a substantial obstacle to women seeking abortions, it therefore imposes an undue burden on that right. Justice Breyer, writing for the majority, struck down provisions of the anti-choice law in Texas stating, “each places a substantial obstacle in the path of women seeking a previability abortion, each constitutes an undue burden on abortion access, and each violates the Federal Constitution.”

As of March 2016, Texas was among four other states with laws requiring abortion-providing physicians to have admitting privileges at nearby hospitals, and 21 states with the ambulatory surgery center standards. The Texas law was the only law before the Supreme Court, but these other states will likely have their laws overturned as well. The ruling is a significant step in restoring abortion access for women in Texas and keeping high-quality clinics open. Though the fight is far from over, this decision reaffirmed and strengthened constitutional protections for abortion rights.

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The End of Antibiotics?

Antibiotic resistance is upon us and affects both human and animal health. In a May 2016 report commissioned by United Kingdom (UK) Prime Minister David Cameron, Jim O’Neil, economist most widely known for coining the term BRICs for the emerging economies of Brazil, Russia, India and China and Commercial Secretary to Her Majesty’s Treasury in the UK, pointed out that 700,000 people each year die from bacterial infections that do not respond to antibiotics, and even more recently a new National Academy of Medicine (NAM) paper, conducted by six experts, outlines the evidence that there is a connection between antibiotic use in food animals and antibiotic resistance in people.

For almost fifty years, antibiotics have been approved for use in animal agriculture and human medicine to treat illness, and they have had a remarkable impact on our ability to improve the health of humans and animals alike. However, there are real concerns about the overuse of antibiotics in human and animal medicine, specifically as it relates to the development of antibiotic-resistant strains of bacteria in the US and around the world. The use of antibiotics has been the center of discussion in the US, European Union (EU), and other public forums, such as the World Economic Forum (WEF). In September 2016, there will be a United Nations high-level meeting on antimicrobial resistance at the General Assembly in New York. Global leaders will meet to commit to leading the fight against antimicrobial resistance. The EU has even proposed to include an article on Anti-Microbial Resistance within the SPS Chapter of the Trans-Atlantic Trade and Investment Partnership (TTIP), a trade agreement between the US and EU representing more than forty percent of global trade, addressing steps to mitigate resistance.

In recent years, the animal agriculture industry has placed a high importance on antibiotic stewardship to ensure these critical drugs continue to be effective at fighting bacterial diseases. The Food and Drug Administration (FDA) has issued guidance on the use of antibiotics in food-producing animals, with the goal to phase out the use of antibiotics for growth promotion. All of the affected drug sponsors have committed in writing to making the changes described in the guidance by the end of 2016. Additionally, the FDA wants to ensure the judicious use of antibiotics when used to treat and prevent animal diseases by requiring that antibiotics be administered under the supervision of a veterinarian.

Even with the changes made by the FDA and industry, there is a call to introduce legislation that would more stringently regulate the use of antibiotics in animal agriculture and allow only the use of antibiotics to treat illnesses and not for prevention. California passed the first law in the nation in October 2015 that will require a veterinarian’s prescription for therapeutic antibiotic uses in livestock, ban other uses (including low-dosage levels used to prevent diseases), and require that data be collected on antibiotic use. With the issue on the global stage, it is possible that we will see more advances in both state and federal legislatures to regulate the use of antibiotics in either animal or human health.

 

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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.

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