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The Costly Treatment for HCV

FDA has now approved Hepatitis C (HCV) drugs for children ages 12 to 17, which speed recovery and treatment. HCV is a blood-borne infection, causing inflammation to the liver, which can lead to liver failure, cancer and ultimately death. While HCV is attributed to sharing needles, which results in transferring contaminated blood, 20% of children get it from drug use. With HCV, one can become infected and not notice the symptoms until much later.

Research indicates that around 23,000 to 46,000 children are infected with HCV.  A baby only has a 6% chance of getting it while in their mother’s womb, and most children can clear the virus on their own by the age of 7. Those who do not clear the virus by the time they are two years old are chronically infected with HCV. Two drugs that the FDA has approved, and which have been highly effective thus far, are Harvoni and Solvadi. Harvoi and Solvadi are direct anti-acting antiviral drugs that prevent the virus, HCV, from multiplying, basically curing HCV. In clinical trials used on affected children, the two drugs have managed to eliminate all traces of the virus in the time frame of twelve weeks. Initially, the drugs were not even meant for children, causing doctors to be very hesitant in prescribing them before FDA approval.

As great as this may seem, the price for the drugs are costly. When the drugs first came out, the price was up to 100,000 dollars in the course of treatment. Medicaid restricted access to the drugs, and approved access to only those who had liver damage before treatment. Luckily, federal law states that Medicaid programs must cover “early and periodic screening, diagnostic, and treatment services” for children under 21.

HCV drugs treat a large population and there should be better access to expensive treatments. Because President Trump advocates for lowering drug prices, patients affected with HCV get the chance to access the otherwise expensive treatment. In 2015 alone, federal health programs spent more money on drugs for HCV than for any other drug. The Center for Medicaid and Medicare reported that Medicare Part D spent at least 7 billion dollars on the drug Harvoni, and Medicaid spending 2.2 billion.

The American Liver Foundation states that children with HCV should be receiving hepatitis A and B vaccinations, along with an annual influenza vaccine. Because children with HCV don’t usually exhibit obvious symptoms, their pediatricians should continue to monitor their growth and nutrition, and should have periodic screening of liver function through blood tests. Approving the drugs that cure HCV will significantly help children who might otherwise end up suffering from it; however, it’s important to keep in mind that the cost for the drugs are still expensive, and it cannot be given to children under the age of 12.

 

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Planning Trumped: Prepare for Parenthood

In October 2016 before leaving office, former President Barrack Obama issued a final rule to bar states from withholding federal family-planning funds from Planned Parenthood affiliates and other health clinics that provide abortions. The measure took effect two days before the inauguration of current President Donald Trump, and required that states pass along family-planning grants – regardless of whether the groups they’re passing them along to offer abortion services.

Now, however, President Trump has signed a law which gives states the option to deny funding for Planned Parenthood and other groups that perform abortions, thus invalidating Obama’s rule that “effectively barred state and local governments from withholding federal funding for family planning services related to contraception, sexually transmitted infections, fertility, pregnancy care, and breast and cervical cancer screening from qualified health providers…” To push the measure through Congress, Republicans relied on the Congressional Review Act, a law enacted by the United States Congress in 1996, which “empowers Congress to review, by means of an expedited legislative process, new federal regulations issued by government agencies and, by passage of a joint resolution, to overrule a regulation.” The law barely passed the Senate requiring a tie-breaking vote from Vice President Pence. President Trump’s new law allows states to block Planned Parenthood, along with other abortion providers, from receiving funds associated with the Title X Family Planning program. Title X is a federal grant program for family-planning and reproductive health services for low-income and uninsured patients. Title X provides about $60 million annually to Planned Parenthood. In states that directly control Title X money, the law could embolden legislatures to strip that funding from Planned Parenthood. However, in states like Pennsylvania and New Jersey, independent nonprofits distribute Title X funds, and those nonprofits have pledged to continue funding local Planned Parenthoods.

Prior to taking office, President Trump voiced support for Planned Parenthood’s health-related services, other than abortion. He says that Planned Parenthood may keep its federal funding if it no longer provides abortion services. Although this proposal was never formally made, Planned Parenthood has sternly rejected any such proposal. In any case, federal law already prohibits the use of federal tax money to pay for abortions, except in cases of rape or incest, or to save a woman’s life. The executive vice president of the Planned Parenthood Federation of America, Dawn Laguens, stated, “Offering money to Planned Parenthood to abandon our patients and our values is not a deal that we will ever accept. Providing critical health care services for millions of American women is nonnegotiable.” A healthcare crisis would arise, according to the President of Planned Parenthood Federation of America, Cecile Richards, if Planned Parenthood were to be defunded. She does not believe the national health care system would be able to handle the 2.5 million patients that Planned Parenthood sees annually. Republicans in Congress and legislatures will likely to continue targeting Planned Parenthood because its network is the largest provider of abortions, even though about half of its affiliates do not perform them.

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Henrietta Lacks Lives On

Before viewing HBO’s recent release of The Immortal Life of Henrietta Lacks, it is appropriate to gain an understanding of the true story that give rise to the film. The story begins with Henrietta Lacks, a poor black tobacco farmer from Virginia who reported to Johns Hopkins Hospital in 1951 with complaints of a “knot in her womb” and abnormal bleeding following the birth of her fifth child. After shuffling her to the segregated colored ward for treatment, Lacks’ physician gave her a devastating diagnosis: advanced cervical cancer. Less than a year later, just months after her 31st birthday, the malignant cells coursing throughout Lacks’ body caused her early death.

Yet unbeknownst to Henrietta or her family, she would continue to live on for decades following her death. During the course of her treatment, Henrietta’s physician, Dr. George Gey, received a sample of her cells. Dr. Gey incorporated the cells into his research, which involved an ongoing search for “immortal” cells, or cells that would continuously divide and grow after removal from a patient. Dubbed HeLa cells, Henrietta’s cells turned out to be the miraculous cells Dr. Gey sought; they would go on to revolutionize modern medical research. The cells played an integral role in the development of the polio vaccine, and their use was included in cancer, AIDS, radiation, and gene mapping research over the decades following Henrietta’s death. HeLa cells were also the first human cells to survive the cloning process in 1955.

Despite the widespread use of Henrietta’s cells, her family possessed no knowledge of their circulation until more than 20 years after her death. The Lacks’ family first learned about HeLa cells in the 1970s, when a scientist contacted the family to request their blood samples and other genetic materials. The family followed up on these requests with multiple inquiries about the status of HeLa cells and further information about their uses and distribution, but their questions remained unanswered until the late 1990s and early 2000s. During that period, the release of an award-winning documentary by the BBC and a bestselling book by Rebecca Skloot started to peel back the layers of the HeLa cell story.

Throughout their long and controversial history, HeLa cells raised a number of legal questions relating to the notions of informed consent and property rights. First, researchers all over the world used Lacks’ cells for medical research without her knowledge or consent (or her family’s). A landmark decision in the Supreme Court of California addressed a similar issue in the 1990 case Moore v. Regents of the University of California. In that case, John Moore argued that personal ownership of his cells continued after their removal from his body during a course of leukemia treatment. But the court disagreed, and denied Moore’s claim for conversion. The court’s weariness of Moore’s argument stemmed from fears that including bodily tissues under the umbrella of property rights would have a chilling effect on medical research. Based on this case, it appears there is little chance that a tort liability suit over the use of Lacks’ cells would have much success.

Yet other violations of Lacks’ personal information occurred as well. In 1976, Science Magazine published the article Genetic Characteristics of the HeLa Cell. Without seeking consent from the Lacks family, the article contained private information about the genetic markers contained in the DNA of Henrietta and her family members. Because DNA reveals the most fundamental makeup of a person’s body, and reveals private information about abnormalities and/or predispositions to disease, this publication constituted another circumstance where the Lacks’ family’s private information was put on public display without their consent. In a similar vein, Johns Hopkins released Henrietta’s private medical records to journalist Michael Gold in 1985 for use in his book A Conspiracy of Cells: One Woman’s Immortal Legacy and the Medical Scandal It Caused.

Some might call Henrietta’s story and its legacy a perfect storm of privacy violations. It is important to remember that the concept of informed consent barely existed in the 1950s, and statutory privacy protections such as HIPAA were still decades away from existence when her cells were first taken and used for research. Though it is now an extensive field providing comprehensive protections, the topic of medical privacy still faces some significant obstacles. One of the most difficult issues for researchers in the medical field to overcome is their inability to prospectively determine biospecimen uses and research. As HeLa cells displayed, sometimes the range of possibility connected to a specific cell or tissue sample is not determined until after scientists conduct further research on the sample. Patients are understandably weary of signing over samples for any and all uses, creating strict limitations on researchers and the ways they may use human samples. Other significant obstacles to informed consent include lack of understanding on behalf of the patient, questions surrounding the life of the consent, and ethical considerations regarding the proper time and scenario to ask patients for consent.

As the fabric of American healthcare continues to grow and change on a regular basis, these obstacles pose concrete challenges to healthcare professionals and legal practitioners in the healthcare field. Henrietta Lacks’ contentious cells may continue to teach us new lessons about privacy and informed consent for decades to come.

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The Debate Over Wrongful Birth Suits in Texas

The Texas Senate may soon decide on a bill that would prohibit parents from filing “wrongful birth” suits.  Wrongful birth suits allow parents of a child born with a genetic disability to sue their doctor if they say they were not properly warned about the potential for the disability or counseled on their options, including the parents’ choice to have an abortion based on the severity of the condition.  Nine states have enacted bans on wrongful birth lawsuits, including Arizona, South Dakota, and Indiana.

Wrongful birth lawsuits are different than wrongful pregnancy cases, in which women can sue physicians if they become pregnant after receiving an operation to prevent them from having children.  They are also different from wrongful life suits, which are brought on behalf of disabled children and are not recognized in Texas.

The wrongful birth legal issue in Texas dates back to a 1975 Texas Supreme Court caseJacobs v. Theimer, 519 S.W.2d 846 (1975).  Dortha Jean Jacobs, the plaintiff in that case, contracted rubella during her first trimester, giving birth to a child with defective organs.  Consequently, the Jacobs’ medical bills totaled more than $21,000 by 1973.  Jacobs and her husband sued Dr. Louis M. Theimer on grounds that she failed to diagnose the rubella and inform them of potential long-term risks to the fetus.  The Texas Supreme Court sided with Jacobs, awarding her family the funds needed to care for the child’s disability.  Since the Jacobs case, wrongful birth lawsuits in Texas have been very rare.  In fact, medical malpractice attorneys in Texas say they rarely, if ever, see wrongful birth lawsuits.

Lawmakers brought the bill before the Texas Senate Committee on State Affairs last week in a hearing with dramatic and emotional public debate.  Senator Brandon Creighton, who authored the bill, said allowing the lawsuits could encourage doctors to seek out every possible disability and even promote abortions to avoid litigation.  Creighton said the bill would send a message that Texas “does not believe that a life in and of itself is an injury in which parents need a damage payment.”  “The presence of a disability in a child should not be grounds for a lawsuit,” Creighton said at a Senate State Affairs Committee hearing on February 27.

Proponents of the bill say that it is needed to protect doctors from wrongful birth lawsuits and to protect the rights of the disabled.  Proponents also argue that parents will still be able to sue doctors for negligence if needed.

Opponents called it another attempt by the state to infringe upon a woman’s right to choose to have an abortion and that it essentially allows doctors to withhold information from patients, and impose their religious beliefs upon them.  “It seems to be axiomatic that we should have to stand up and say that it shouldn’t be policy for the state of Texas to excuse doctors from lying to their patients, and that’s what this bill does,” said Blake Rocap, legislative counsel for National Abortion Rights Action League / Pro-Choice Texas.  He said doctors should not be held liable for disabilities “they did not cause,” and that doctors “may overcautiously seek out all potential disabilities and promote abortions in order to avoid liability.”  Despite the objections, the committee voted unanimously to send the bill to the full Senate.

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Steak With A Side Of…Salt Warnings?

In September, 2015, the New York City Board of Health approved a new sodium warning measure. The law requires chain New York City restaurants with 15 or more locations nationwide to display a salt shaker symbol next to menu offerings that contain more than 2,300 mg of sodium. Shortly following the regulation’s announcement, the National Restaurant Association sued NYC, arguing that the law was arbitrary and capricious because the science regarding sodium’s health effects remains unsettled. On February 10, a New York appeals court allowed the rule to remain in force by affirming the trial court’s rejection of the National Restaurant Association’s arguments.

A stay was initially placed on the regulation shortly following its creation, preventing its enforcement until May, 2016. At that time, the Appellate Division of the New York State Supreme Court lifted the stay, and allowed enforcement of the rule throughout New York City. Health Commissioner Dr. Mary T. Bassett publicly applauded the decision, stating that the ruling “allows New Yorkers to make informed and better decisions about their diets and their health.” The Manhattan Appellate Division of the State Supreme Court then affirmed the 2016 decision in last month’s holding.

In the court’s opinion, Justice Ellen Gesmer pointed out the health risks of high-sodium foods and dishes: “Excess consumption of sodium, the primary ingredient of salt, can cause high blood pressure, which is in turn correlated with a higher risk of cardiovascular disease, congestive heart failure and kidney disease, according to the overwhelming consensus among scientists and the federal agencies charged with protecting the nation’s health.” Justice Gesmer continued by clarifying the reasoning behind the court’s decision, and pointing out that this mandate differed from other NYC dietary restrictions that came before it because it did not interfere with citizens’ personal autonomy when making individual food choices. Bloomberg’s big-soda ban, for example, entirely prohibited consumers from purchasing large sodas. The salt warnings, on the other hand, merely inform the consumer about the levels of salt rather then restricting them from purchasing such dishes altogether.

The mandate was opposed by the New York State Restaurant Association, an ardent advocate against governmental regulation of dietary information and regulation. The association fought a similar law in 2009. In that case, New York State Restaurant Association v. New York City Board of Health, the association asserted that a city law requiring chain restaurants with 15 or more locations nationwide to post calorie content information on menus and menu boards was both preempted by federal law and unconstitutional. Meeting a similar demise to the argument in the recent salt warning case, the NYC calorie warning regulation was upheld in the Second Circuit Court of Appeals on the grounds that the city law was reasonably related to its goal of reducing obesity.

The regulation (and the NY Court’s decision to uphold it) is increasingly relevant as local, state, and federal legislatures consider similar dietary warnings and regulations, and courts at all levels grapple with what constitutes an appropriate amount of government involvement (if any) in private citizens’ dietary decisions. What remains to be seen is how these and other regulations actually influence consumer decisions. American University Washington College of Law Professor Lindsay Wiley wrestles with these important questions in her 2014 research about the impact of product configuration bans. Wiley suggests that, despite the fact that such regulations are subject to a great deal of public discourse, their high visibility might lead to long-term decreases in portion size and increases in the availability of balanced meals. Despite such research, this field continues to be largely unchartered territory as the United States attempts to mitigate the nation’s growing obesity and health care epidemic.

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