Category Archives: Government/Research

Another Obamacare?

On December 13, 2016 President Obama signed H.R.34 and so, the 21st Century Cures Act became law. Sponsored by Rep. Suzanne Bonamici* (D-OR) and co-sponsored in a bipartisan manner, many say this is the biggest legislation of Obama’s presidency, after the Affordable Care Act.  However, just like the Affordable Care Act, the bill has its detractors.

H.R. 34 first was introduced on January 6, 2015, “to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes,” as the bills synopsis states.  The 21st Century Cures Act addresses mental (neurological) disorders, such as Alzheimer’s, trys to find a cure for cancer and pays special attention on America’s current opioid epidemic.  Though many articles do not mention that H.R. 34 specifically supports tbi research, an overview of the bill shows that of the $6.3 billion allocated to medical research, $1.5 billion are alloted to the Brain Research Through Advancing Innovative Neurotechnologies Initiative (BRAIN Initiative).  (As I note in a previous article, BRAIN is associated with tbi research.)  “Congressman Frank Pallone, Jr. (D-NJ), ranking member on the House Energy and Commerce Committee, applauded President Obama for signing the 21st Century Cures Act into law… [as he says] the 21st Century Cures Act will advance medical research, fund the fight… towards mental health reform. As a leader in medical innovation, New Jersey and [medical] institutions… stand to benefit from 21st century cures investments in medical research.”

Beyond research, though, the bill focuses on pharmaceuticals.  It is with this that many take issue.  Currently, the FDA has to approve the efficacy and safety of all medications or medical devices before they go on market.  Going through the government’s red tape can take years.  “Under the Cures Act, companies will be allowed to submit observational data and ‘in house’ registry data as evidence for the safety and efficacy of a new product.”  The bill’s proponents attest that this will significantly reduce the cost of medication, thereby promoting research and development.  Detractors, like myself, worry that getting rid of the “safety and efficacy” red tape may mean less safe and ineffective drugs.

*Another bill, also called the 21st Century Cures Act (H.R. 6), was introduced by Rep. Fred Upton (R-MI) on May 19. 2015.  In Uptons words, “21st Century Cures is an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today.”  The last action on this bill was on July 13, 2015, when it was referred to the Committee of Health, Education, Labor, and Pensions by the Senate.  (Word-for-word, H.R.34 and H.R.6 have the same synopsis, so they essentially seem to be the same bill.)

Readying for the Red Planet

In 2015, Matt Damon was part of a team that traveled to Mars.  Specifically, in the film The Martian, he starred in the story of an astronaut who traveled to Mars and was left behind by his fellow astronauts.  The film had a budget of about $100 million and grossed over $225 million at the box office.  It was nominated for 172 awards, including 7 Academy Awards, and won 33 awards.  Essentially, The Martian played on the fantasy that many humans have: to travel to another planet.  With new technology continually being developed, this fantasy has become much more likely to happen in recent years.  However, the 2015 film, based on a 2011 book of the same name, discounts one of the probable issues when traveling to and from the Red Planet: radiation exposure.

According the National Aeronautics and Space Administration (NASA), “The Martian highlights the neurological, radiation-related dangers that could occur on a round trip to Mars.”  However, simply showing the astronauts living in a radiation-shielding habitat, does not really show why radiation-shielding would be of upmost importance.  The Guardian notes the inaccuracies of the film, such as, “Everyone would die… due to excessive radiation.”  Broadly defined, radiation is “the emission or transmission of energy in the form of waves or particles through space or through a material medium.”  While rare on Earth, it can be emitted by things as televisions and x-rays. It is, however, prevalent in space and the Mayo Clinic confirms that “radiation sickness is serious and often fatal.”

If they travel to another planet, “The astronauts are not going to come back with full-blown Alzheimer’s… but… there will be some mild cognitive impairment,” says Charles Limoli, professor of radiation oncology at the University of California. To prevent these cognitive impairments, which may lead to problems seen in other neurological disorders, such as impaired decision-making and depression, NASA is looking for a way to protect the neural circuitry of the body in space.  In fact, “Researchers hope that the initiatives in place to help send humans on deep space missions will also help those on Earth suffering from diseases like Alzheimer’s and Parkinson’s, as well as depression or traumatic brain injury.”  Currently, they have exposed mice to similar amounts of radiation that the astronauts will receive and found, “their learning, memory, multitasking, cognitive flexibility in changing situations and even behavioral adaptation were altered or negatively impacted.”  As the study notes, humans are not mice and our brains are different; however, they do believe this is a good example of the effects radiation will have on our brains.

People and the media rarely want to think of any negatives related to the possibility of doing something that has always been a mythical dream.  Travel to Mars will happen.  NASA is working on technology to eliminate radiation exposure and to prevent the negative effects of the radiation exposure that will occur during the trip to the Red Planet and on the surface of the planet.  (Mars has three ozone layers, but still less ozone protection than the Earth.)  NASA has already set a manned mission to Mars for the 2030’s.  People just need to let the scientists, and their mice, at NASA find a way to make this international orbital journey to Mars safe for all those aboard.  In the meantime, their research can help humans on Earth, astronauts or not, who suffer from brain injury and other neurological issues.

* Some have proposed that the first trip to Mars be a one-way trip, meaning that astronauts would travel to Mars to permanently inhabit the planet.  While this may be the most cost-effective way for people to travel to the Red Planet, proponents of this idea do not consider many of the risks involved in an interplanetary trip.  For example, the organization Mars One, led by Dutch billionaire Bas Lansdorp, has promised to colonize Mars by 2026.  On the Project’s website, there is a page that answers the question: How safe is the journey?  According to the site, the following risks are conceivable: accident(s) during launch, vital components could malfunction during the journey there, a number of issues might present themselves when entering Mars’ atmosphere, and there could be problems when landing.  The page does not mention the certainty of radiation absorption while on the trip to the planet.

“Hearing” Concussions

Though they are quite different on the surface, soldiers and college athletes both function in roles that can result in physical injury.  Unfortunately, this commonality means that both soldiers and college athletes have a higher likelihood of getting a mild traumatic brain injury (mTBI), also known as a concussion.  Because of this, the U.S. Army Medical Materiel Agency (USAMMA) and the National Collegiate Athletic Association (NCAA) joined forces in a search to find a better way of detecting mTBI, which may not be immediately recognizable.  The project, known as the “Grand Alliance”, is being conducted at the Massachusetts Institute of Technology’s government-funded Lincoln Laboratory (MIT LL), with the goal of creating “a U.S. Food and Drug Administration-cleared, real-time mild TBI screening app and hardware device which can be used throughout the echelons of care from point of injury to rehabilitation,” said Brian Dacanay, USAMMA product manager.  Essentially, they are in the process of creating “a computer algorithm to identify vocal biomarkers” to be used on a portable smartphone-size device that could help identify when someone needs medical help for a concussion.  MIT LL hopes to have the device ready for FDA approval by 2018.

America’s BRAIN May Increase In 2017

In 2009, President Obama told the press that his administration will “restore science to its rightful place.”  A list of 100 examples of this “restoration”, called the IMPACT REPORT, was published on June 21, 2016 by the White House press office.  Example #45 on this list is the April 2013 launch of the BRAIN (Brain Research through Advancing Neurotechnologies) Initiative, which was begun in order “to develop neuro-technologies [to] uncover new ways to treat, prevent, and cure brain disorders such as Alzheimer’s, Parkinson’s, schizophrenia, autism, epilepsy, and traumatic brain injury.”  This Initiative, funded jointly by the Federal government and private enterprises, was news when it first was started, but since then there have been few stories in the news and few statements from Obama himself discussing the Initiative’s studies or its findings.

Despite the lack of discussion about the program in the media, online you can find the benefits of the Initiative and its recent, but limited, successes.  In March of this year, Obama proposed to increase the “Federal investment in the BRAIN  Initiative from $300 million in fiscal year 2016 to $434 million in fiscal year 2017.”  (In fiscal year 2013, when program started, BRAIN’s budget was $100 million.)  Though the 2016 budget of $300 million seems high already, for the extensive studies the Initiative does, $434 million may be more appropriate.  This funding for BRAIN has been provided by 5 federal agencies, DARPA, NIH, NSF, IARPA, and FDA, who also run the studies.  In 2017, the President plans to increase this to 6 federal agencies, by adding the Department of Energy.

In looking through the National Institute of Mental Health, a subset of the NIH, BRAIN Initiative’s Science News page, I found only 4 press releases for 4 studies completed since 2013.  Presumptively, that is because comprehensive medical studies often take years to complete and/or more completed study results can be found on other government websites.  More financing may mean that the program can start and eventually complete additional studies, perhaps more quickly because it can add more manpower.

The study I found most intriguing was a study funded both by BRAIN and the Human Connectome Project, and completed in 2015, titled “Our Brain’s Secrets to Success”.  This study examines the cortex of 461 volunteers to see “how the human brain contributed to our success.”

As of July 7, the program has reported the results of one study in 2016, “Ketamine Lifts Depression via a Byproduct of its Metabolism,” with the purpose of finding a new, more effective anti-depressant by using metabolite, a byproduct of ketamine.  (Ketamine is already being used for this purpose in many hospitals.)  The results of this study, published in May, found that ketamine’s use as an antidepressant worked well in rats, but, while human trials with ketamine quickly relieved patient’s depression, it did not have lasting effects.

Targeting TBI Pain

Earlier this week, Lpath, Inc. was awarded a $1.45 million grant by the Department of Defense to conduct further preclinical studies of a medication intended to ease the pain associated with traumatic brain injury.  The pill, Lpathomab, “is a first-in-class, humanized monoclonal antibody targeting lysophosphatidic acid”.   To date, Lpathomab has only been tested in animals and humans who have not suffered a TBI, both with positive results.  Presumptively, these new funds will help them test its effects in the people that it is intended to help.  This new government grant, with its potentially positive implications, resulted in the Lpath stock rising by 62% earlier this week.

VA Recognizes TBI Mistake: Positive, But Possibly Too Late

According to the Defense and Veteran’s Brian Injury Center (DVBIC), a cooperative between the Department of Defense and Veteran’s Affairs, “Traumatic brain injury (TBI) is a significant health issue which affects service members and veterans during times of both peace and war.”  Given that the military recognizes that traumatic brain injury (TBI) is a major problem, it is a shock that, since 2007, 25,000 veterans who are now known to suffer from traumatic brain injury were not initially diagnosed and treated for TBI.  (Tested by doctors who have been found to be unqualified, these veterans were diagnosed with post-traumatic stress disorder (PTSD).  PTSD is terrible, yes, but more treatable than TBI.)

Through this major error, tens of thousands of veterans were not given the appropriate medical and financial help they needed and deserved.  Fortunately, the military now realizes its mistakes and can rectify them and prevent them from happening again.  For many veterans, who have struggled for years to get the military to recognize its difficulties, though, is it too little, too late?

(To learn more about TBI and the military from past service members, visit http://www.disabledveterans.org/.)

Restoring or Remodeling (?) Your Memory

Since the launch of the BRAIN Initiative in 2013, DARPA, the Pentagon’s Defense Advanced Research Projects Agency, has been researching the functionality of the brain though the Restoring Active Memory (RAM) program.  With a $40 million grant, the program, led by UCLA and UPenn, has been trying to “develop a neural prosthesis” to help restore the memories of the 1.7 million American civilian and 270,000 military personnel who suffer from (rather than afflicted by, as they term it) memory loss as the result of a head injury each year.   “Through the Restoring Active Memory (RAM) program, DARPA seeks to accelerate the development of technology able to address this public health challenge and help service members and others overcome memory deficits by developing new neuroprosthetics to bridge the gaps in the injured brain,” states Dr. Justin Sanchez, Director of the Biological Technologies Office at DARPA.

Initially tested on lab rats with positive results, the program then tested it with human patients.  On May 11, 2016, at DARPA’s Demo Day, the research of RAM was presented to select officials.  These patients underwent brain surgery in which a wireless neural interface devices were implanted in brain regions that are involved in the development of declarative memory, the section of the brain that remembers how to do basic tasks, such as remembering appointments (though a calendar can do that too).

Many articles related to this project include a photo of Arnold Schwarznegger in Total Recall, but people need not worry.  Brain implants will not give you memories of living on Mars.  (However, they may allow veterans to return to war and be more skilled soldiers.)  While the example given by Total Recall is a bit extreme, the concern is founded, as according to James Giordano, a neuroethicst at Georgetown University, “[Surgical implants in the brain] could involve alteration in cognitive and emotional function, including a change in personality.”  Rick Weiss, the director of strategic communications at DARPA, counters this statement with his own question, “How is someone going to have a livelihood if they can’t remember how to do simple tasks [as happens to some brain injury patients]?”

Dr. Sanchez says, “If you have a traumatic brain injury and lost the ability to form and recall memories, if you had a medical device that could help you with that it can be transformative.”  I believe that yes, brain implants could be helpful in certain circumstances, but, when related to doing some activities, such as going to the grocery store and then shopping, a GPS and/or a paper and pen could be just as helpful and do not require brain surgery.

The ability to restore memories would be a groundbreaking scientific accomplishment.  However, choosing to undergo surgery that could essentially turn you into someone else, is a very difficult decision.