Author: Maya Frazier

New Hope for Eradicating Blood Cancers: Successful T-Cell Trials Provide Possible Alternative to Toxic Treatment Protocols

For years, researchers, survivors, and various interest organizations, have tirelessly sought to develop or fund cutting edge treatment protocols that would help increase survival rates for blood cancers and eventually lead to a much-desired cure.

According to the Leukemia and Lymphoma Society, there are currently 327,520 people in the United States are living with or are in remission from leukemia. Generally, achieving remission has more than quadrupled since the 1960s. The “overall relative survival rate” for all blood cancers was 60.3 percent between 2004 and 2010. More specifically, patients with Chronic Lymphocytic Leukemia (CLL) have a survival rate of 85.3 percent, the highest overall survival rate within the leukemia category; Acute Lymphoblastic Leukemia (ALL) has the highest survival rate for children at about 92 percent, but an overall survival rate of 70 percent. Acute Myeloid Leukemia (AML) has the lowest for adults at 25.4 percent. AML in children under 15 years old has a 66.3 percent survival rate.

In February, researchers from Boston University published a report with promising findings about an innovative treatment for patients with blood cancers. Dr. Hui Feng and her team, Dr. Nicole M. Anderson, Dr. Dun Li, and Dr. Fabrice Laroche, suggest that T-cell leukemia cells can support its growth and survival, leading to more patients achieving remission.

The Boston University team worked with 35 terminally ill leukemia patients, and 94 percent successfully went into remission utilizing genetically modified T-cells. The study suggests that the T-cell therapy has the greatest success with blood cancers, however, oncologists and researches are hopeful that similar results can be achieved with tumors.

Similar trials have been conducted in the United Kingdom, Italy and throughout the United States with great success. How do the oncologists and researchers perform the T-cell process that seems to be drastically changing therapy options for blood cancer patients? In the simplest terms, T-cells are removed from the patient’s body, genetically modified, and the modified T-cells are transfused back into the patient. The study suggests that the CARS (Chimeric Antigen Receptor) molecules “reduce the ability of the cancer to shield itself from the patient’s immune system, allowing the T-cells to attack the cancer.” Given the nature of blood cancers, a treatment that is able to weaken a cancer cell’s ability to fight the immune system is groundbreaking.

Other than the Boston University team, US San Diego announced that it is conducting three T-cell like trials: ZUMA-1, ZUMMA-2 and ZUMMA-3. With several research institutions conducting trials and furthering the research on this groundbreaking protocol, T-cell therapy could provide alternatives to aggressive and toxic therapies that, albeit, stops the cancer cells from rapidly expanding, also kill good cells as well. The Federal government, via the United States Food and Drug Administration (FDA) appears to be supportive of T-cell related trials. In 2014, the FDA granted Breakthrough Therapy status to an Investigation New Drug (IND) application submitted by University of Pennsylvania’s Perelman School of Medicine, focused on T-cell therapy treatments in ALL patients.

While researchers and oncologists posit that T-cell therapy is ground breaking and “extraordinary”, patients and families are also thrilled that a new treatment could potentially become widely available, particularly those patients that have tried traditional treatments and failed to achieve remission.

Election 2016 and the Fate of the Affordable Care Act

Election 2016 and the Fate of the Affordable Care Act

As the 2016 presidential race looms on, candidates, on both sides of the isle, have provided prospective voters with ideas of how health care in America will fair under their presidency. Candidates have adopted policies ranging from complete and utter repeal of every provision of the Affordable Care Act (ACA) to proposed single payer systems. Depending on the outcome this coming November, Americans may see an end to the insurance exchange or changes to established programs like Medicaid and Medicare. Below are brief summaries of Senator Sanders and Senator Cruz’s proposed health plans.

Senator Bernie Sanders: Senator Sanders’ health plan, Medicare For All: Leaving No One Behind, would provide health care coverage to all Americans in a “federally administered single-payer health care program.” Senator Sanders projects that this plan, which would cover the breadth of health care services from preventative care, primary care services and specialty long-term care, will cost an estimated 1.38 trillion dollars a year, according to Sanders’ campaign site. The health care program would be funded primarily by a progressive tax scheme with additional funding from employers and limited premiums for certain households. Sanders suggests that his health care plan will save most Americans $5,000 and will take away the anxiety of wondering if a service is covered or if a desired health care professional is in or out of network. Naturally, there are critics to Sanders’ plan claiming that the numbers proposed by his plan are too good to be true.

Senator Ted Cruz: It seems unclear whether Senator Cruz has officially offered a full health care plan; however, what is clear is that if Ted Cruz is elected president he will not rest until the ACA is repealed. Questioned about his health care plan in a recent Republic national debate, Ted Cruz highlighted three principles that would stand as the cornerstone of his perspective plan: 1) allowing citizens to purchase insurance across state lines; 2) expanding health savings accounts; and 3) severing health insurance from employment, making health insurance individualized and portable. During his debate response, Cruz did not indicate the costs his plan or proposed initiatives carry. Moreover, according to Slate.com, what was more noticeably missing from Cruz’s response was “[a]ny mention whatsoever of how patients with pre-existing conditions, who were routinely denied coverage by insurance companies prior to health reform, would be taken care of.” While removing restrictions of where Americans can purchase health insurance seems practicable; however, as of yet, Cruz has not mentioned how he would deal with the uninsured, underinsured or individuals that explicitly receive coverage because of the ACA. Critics to Cruz’s outlined principles seem to focus on the oversight mentioned by Slate.com, that Cruz’s “plan” does not account for many sectors of the population that the ACA specifically helped.

As the 2016 presidential race is sure to heat up in the coming months, it will be interesting to see how all the candidates plan to change America’s healthcare system.

Even with the ACA, is healthcare in America bankrupting its citizens?

A recent New York Times/Kaiser Family Foundation survey found that 1 in 5 insured American’s struggle to pay medical related expenses. On March 23, 2010, President Obama signed the Affordable Care Act, which enacted comprehensive health care reform. The massive law contains countless provisions, with some of the most controversial and contested being the individual and employer mandates. Due in part to the mandates, decreased costs of yearly/monthly premiums, and restrictions on denying coverage for pre-existing conditions, the uninsured rate has dropped 6 percent, from 15.1 percent to 9.2 percent, since the ACA was enacted. Despite the impressive increase in insured American’s, the new NY Times/Kaiser study suggests that insuring more Americans is only one part of solving America’s mounting healthcare problems.

The study suggests that many Americans are taking second jobs, working longer hours, or cutting back on household expenses to pay the costs of medical treatment not covered by their insurance. Margot Sanger-Katz, in a NY Times article summarizing the study, suggests that although insurance premiums are lower, the lower premiums are offset by higher deductibles. The article highlights several examples of Americans that were blindsided by unexpected medical bills, including one individual who lost her home due to extensive medical costs despite being insured. Is there any solution to this growing problem? President Obama’s administration is constantly battling attacks on the ACA. Given Congress’ recent attempt to repeal portions of the ACA, which President Obama not surprisingly repealed on Friday, January 8th , it seems unlikely that Congress will pass any additional legislation to further regulate the insurance industry. What relief do Americans have when it seems that the only way to avoid medical debt is to stay healthy?

The Huffington Post suggests that the situation is not so bleak for at least some sectors of the population. “The data from the Centers for Disease Control and Prevention show that the number of people in households that faced problems paying medical bills decreased by 12 million from the first half of 2011 through the first six months of this year.” The data further suggests that “among the poor, the share of those with problems fell from 32.1 percent to 24.5 percent,” which is an even more significant decrease in problems than their middle-class counterparts.

With the uninsured rate at historic lows, and still many Americans struggling to make ends meet while receiving needed medical treatments, additional health care reform seems necessary. However, given the current political landscape and Congress’ overwhelming disdain for health care reform introduced by the current administration, it seems unlikely that much-needed change will occur. Where does that leave American’s who are facing the life-changing decision of depleting hard-earned savings to have a fighting chance at treatment, surgery or recovery? A recent article from the Las Vegas Review Journal suggests negotiating upfront with hospitals for fair rates can help control mounting medical expenses. However, more often than not, staying healthy is the best way to avoid medical debt and keep hard-earned money in the bank.

 

Health care’s saving grace: Is Telemedicine the real deal or a privacy nightmare?

Health care professionals are constantly developing and brainstorming innovative ways to increase access to healthcare in an affordable way. Is telemedicine the solution to the health care industry’s problems?

The American Telemedicine Association defines telemedicine as the “use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.” Although telemedicine is considered a recent trend, telemedicine has been utilized for over 40 years and continues to grow in popularity. Today, telemedicine is predicted by many healthcare professionals and public health analysts to drastically cut annual healthcare spending. One report claims that in the coming years, telemedicine will cut annual healthcare spending by $60 billion; $40 billion in eliminating roughly two-thirds of unneeded emergency room visits and $20 billion in by replacing one-third of physician visits. Analysts have also noted that an expansion in Medicare coverage for telemedicine services will further increase annual savings.

Some health care professionals, however, are not sold on telemedicines projected savings. Dr. Jha stated, “You do the telemedicine; it leads to more tests. It leads to more follow-up visits. And, over time, when you look at the data, it turns out that telemedicine overall is not necessarily a big cost saver.” Despite this, the overwhelming message from health care professionals and communication professionals alike is that telemedicine works and will account for unprecedented savings.

Currently, Medicare only covers telemedicine services for rural and medically underserved areas when video conferencing is used. As telemedicine continues to develop public health professionals will keep a watchful eye on the Centers for Medicare and Medicaid Services to see if reimbursement for telemedicine services expands.

Telemedicine seems to be the golden child in healthcare; it cuts costs, increases access to care, and spurs innovation. Despite this, advancements in telemedicine possess major privacy concerns. As telemedicine continues to evolve from its video conference/consultation base to more services are being offered via mobile apps and text messages, how is a patient’s information being managed and protected?

Telemedicine requires developers, consumers, and physicians alike to consider if information from a video consultations will be recorded, or how data collected from a mobile health app will be stored, and whether federal or state privacy law is violated with such practices. The Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC), recognizing the need for guidance in the telehealth arena, provide resources for providers, implementers and consumers to address the many privacy issues related to health and mobile devices. ONC harps on the importance of encryption and being an informed consumer to help decrease privacy violations. Even still, federal, state, and local governments will continue to develop laws and regulations that address the ever-changing privacy landscape in light of continued telehealth innovation.

Warehouse fire highlights importance of EHR

A warehouse fire in the Williamsburg neighborhood of Brooklyn, NY provided yet another compelling argument for the need for protected health information to be accessible through an Electronic Health Record (EHR) system. The federal government, through the Department of Health and Human Services (HHS), among other entities, have released various statements highlighting the importance of developing EHRs. The fire, which burned a Williamsburg warehouse on January 31, 2015, resulted in innumerable pieces of personal health information (PHI) littering the streets of New York. The fire, which began on a Saturday, still burned on Monday.

According to EHR Intelligence, “recovery specialists [continue to] comb the streets and the East River for fragments of papers with personal health information, social security numbers, and bank account details exposed to the public.” Moreover, EHR Intelligence reports that North Shore-Long Island Jewish Health System, New York-Presbyterian Hospital, NYU Langone Medical Center, and Mount Sinai Health System stored records and patient information at the warehouse. Luckily, all the organizations, according to the New York Times, had copies of the patient records within its respective EHR systems.

Fortunately with responsive recovery teams and on the ground personnel the warehouse fire did not result in a massive breach potentially affecting thousands of patients, but it did illustrate the importance of having effective EHR systems and also the need to store patient data in more than one place. Imagine if any of the health care providers storing data at the warehouse did not have an EHR system. Could you imagine mitigating that situation? What would you tell patients? How would HHS deal with the breach?

The Office of the National Coordinator, within HHS, has numerous resources available to providers to help implement an effect EHR system. Moreover, the ONC provides additional information about the importance of EHR systems to improving patient care. Other than helping to reduce potential breaches, EHR systems are so popular because they help further the goal of interoperability. Interoperability is on the national health care agenda and has support from both Congress and the White House. President Obama’s proposed fiscal year 2016 budget allocates $78 million to ONC, which is a $17 million dollar increase since ONC’s inception, to help further the interoperability mission. Having an effective EHR system helps to promote the interoperability message in that, after the initial interoperable framework is laid by the federal government, it will be crucial for providers to be well equipped with systems that can easily interact with one another. EHR systems allow a patient with various providers to receive more coordinated care. Moreover, EHR systems can make it much less burdensome for individual patients to access their personal health records.

While the weekend warehouse fire is a tell tale example of the necessity for electronic record keeping, the federal government is also invested in the electronic systems to help further an even more important goal: increasing the quality and effectiveness of health care services.

FDA “Updates” Its Policy on Blood Donations from Gay and Bi-Sexual Men Engaging in Same-Sex Intercourse

Since 1983, FDA has banned men from donating blood for life if they have had sex with another man, even just once, at any point from 1977 and on, Despite lacking scientific significance, the lifetime ban has remained in effect until this past December. However, organizations like the Red Cross have been pushing for the ban to be revisited since 2006. On December 23, 2014, the FDA announced that it would alter the 31-year old national policy banning males who engage in same sex intercourse from donating blood. The new proposed policy would now allow males who are gay or bi-sexual to donate blood so long as the potential donor has abstained from same-sex intercourse for at least 12 months.

Politicians, gay rights activists, and public health officials have spoken out against FDA’s new policy and some are calling the ban “harmful and offensive.” According to Gay Men’s Health Crisis (GMHC), requiring gay and bi-sexual men to abstain from having sex with other men for a year ”is [still] a de facto lifetime ban.” GMHC went on to note that heterosexual men are not required to remain celibate for a year and therefore, the “step forward” that FDA is attempting to make is still overt discrimination.

Senator Tammy Baldwin (D-Wisc.), who led the charge for the government to end the lifetime ban, noted that although the new proposal was a step in the right direction, she “remain[s] concerned that [the new policy] does not achieve our goal of putting in place a policy that is based on sound science.” Baldwin noted, “[t]he Administration must continue to work toward implementing blood donation policies based on individual risk factors instead of singling out one group of people and turning away healthy, willing donors, even when we face serious blood shortages.”

Despite receiving criticism and concerns, the FDA’s new proposed policy garnered support as well. Steven W. Thrasher, for NPR’s Code Switch, a gay male who has written extensively about FDA’s lifetime blood ban, offered his support for the recently updated policy. Throughout Thrasher’s piece, he explained the technicalities and reasoning behind the ban, from his perspective, noting that because “the act of a man having sex with another man imposes a risk on his potential blood donation on the same level as taking IV drugs, having been incarcerated, or having had sex with someone who is an IV drug user or has been incarcerated, Thrasher is “okay” with the update on the ban.

Thrasher explained that there is a difference between “shaming gay men” and recognizing that the practice of homosexual male sex does have actual risks proven by various demographics. Thrasher cites statistics from the CDC, noting “the overall gay male population of the US is only 2%, according to the CDC, this group “accounted for three-fourths of all estimated new HIV infections annually from 2008 to 2010.” Thrasher said, “A one-year ban, however, would be based on the risk assessments of a practice — the practice of a man having sex with another man — and not unscientifically shaming gay men. This might sound like a fine difference. But it’s an important one.”

Others believe that the government should adopt the approach followed in Italy and Spain, where gay or bi-sexual men, engaging in sex with other men are allowed to donate blood so long as the donor is in a monogamous relationship and whose blood tests are safe. The “individualized risk assessment” approach appears to be successful in Italy, and according to a 2013 study, there is “no evidence of a significant impact on the human immunodeficiency virus epidemic in Italy.”

Whether you view the updated policy as a baby-step, a leap forward, or as no change at all, FDA’s recent announcement has undoubtedly reignited the conversation about blood donations polices and the still stigmatized health concerns of gay and bi-sexual men.