Technology Triple Trivia

TTT123 Questions. 3 Hints. 3 Answers.

July 7, 2015

1. What do 1/3 of Americans try to avoid?

Hint:

Answer: gluten free this, gluten free that.  One third of Americans try to dodge the potentially misunderstood protein found in wheat, barley and rye because it has been tied to certain gastro-intestinal diseases and plain old feeling lousy.  However, could it be that we’re the bad guys and not these innocent cereal grains?  According to one geneticist, “[i]f eating wheat was so bad for us, it’s hard to imagine that populations that ate it would have tolerated it for 10,000 years.”  By now, at first blush, humans should have evolved where any persisting genetic intolerance to gluten should have been naturally eradicated over time.  In fact, the opposite seems to hold true.  But why?  In the Middle East, where wheat was first domesticated, people began developing, not eliminating genetic variations now associated with adverse gluten-related responses.  But, again, why?  It may simply be a matter of cost/benefit.   Potential susceptibility to one thing may protect us against something much worse.  It’s a case of perhaps getting sick versus the alternative, dying — that somehow gluten sensitive genes protected us from something that could have killed us in a certain environment.  However, when potential sensitivity evolves into intolerance, it becomes a problem.  For some reason, sensitivities in general have escalated over the years, becoming more serious.  We don’t have an answer as to why that is.  It could be many things but instead of blaming wheat, rye and barley, we should maybe look more closely at our habits, environment and diet.  Read more here.

2. What recent event ought to give Andrew Wakefield many sleepless nights?

Hint:

Answer: a young woman whose immune system was compromised due to medication she was taking died recently.  From measles.  The woman allegedly contracted measles from another patient who happened to be attending the same health clinic around the same time.  A person may catch the measles even if previously vaccinated.  Basically, anyone with a suppressed immune system, regardless of vaccination history, is susceptible, as in the case of the aforementioned deceased.  So are children under the age of 12-15 months (recommended age for the first installment of the MMR vaccine) and, of course, those who remain unvaccinated.  Unfortunately, “one child in 12 in the United States is not receiving their first dose of MMR vaccine on time, underscoring considerable measles susceptibility across the country.”  That’s a scary statistic considering how easily measles are spread:  via breathing, coughing or sneezing.  “If you’re not protected, you can get measles just by walking into a room where someone with the disease has been in the past couple of hours.”  With so many unpreventable illnesses out there, why take a chance with those that are preventable?  Read the story here.

3. What newly-launched health study potentially reads like a tennis game in terms of advantages and disadvantages?

Hint:

Answer: the NIH-funded BabySeq Project “is the first randomized, controlled trial to measure the harms and benefits of newborn genomic sequencing.”  The study will specifically consider the pros and cons of providing genetic information to parents and pediatricians.  Eventually, by screening for 1,700 variants of genes implicated with childhood-onset diseases, researchers hope to answer many questions.  For instance,  whether the information will result in better, more timely or beneficial health interventions?  Will it cause risky or unnecessary treatments? Will it cause discrimination on a parental or broader, societal level?  Will it affect parental bonding in cases where a child carries a variant associated with a poor prognosis?  At the end of the day, as part of the ballooning concept of population-wide genomic sequencing, the issue is whether it is beneficial to mainstream sequencing the DNA of newborns as opposed to other members of society.  Read the details here.

The Cost of Living

As if the average healthy American’s housing, transportation, grocery and tax payments aren’t high enough, the average sick American also has to contend with the escalating cost of prescription cancer medications.  A recently published 60 Minutes script highlights that a cancer diagnosis carries with it the fear of not only the disease but also the fear of not being able to financially survive disease treatment.   In our country, both the disease and treatment costs are killers.  In the United States, pharmaceutical companies set the price for drugs.  Often, when pharmaceutical costs are challenged, the drug companies cite the cost of innovation — approximately one billion dollars to bring a drug to market.  Getting a drug to a patient typically involves a doctor purchasing the drug at cost from the manufacturer and then selling and billing it at retail – a set percentage of the wholesale cost.  The more expensive the drug, the more money lining the doctor’s pocket and a huge incentive for using more expensive drugs — albeit the doctor also has to shell out more in up-front costs.  However, behind the scenes, drug companies are finding other ways of providing financial incentives to physicians to prescribe high-cost drugs to already financially-struggling patients.  When one drug company, Sanofi, was called out by concerned physicians for charging an exorbitant amount for a certain cancer drug, it responded by reducing doctor’s costs while keeping patients’ and insurance companies’ costs sky-high.  The company offered to charge doctors $10,000 for the drug which the doctors would then bill to a patient’s insurer.  Medicare, for instance, is required to pay what a drug manufacturer charges and recoup part of that cost through a patient’s co-pay — a couple thousand dollars of that original $10,000.   This may not be news to many.  But, what many are not aware of is that after charging a doctor $10,000 for a drug, Sanofi opted to issue a check back to the doctor, worth thousands of dollars, as a way of saying “thank you for prescribing our drug.”  So, while Sanofi claims it is charging $10,000 for a particular drug because R&D costs allegedly demand it, it is also sending the message that it really doesn’t cost $10,000 because the company can afford to lose thousands of dollars in incentive payments to physicians to promote its product(s).   A win-win for both physician and big pharma.  Some doctors, appalled by drug company practices in general, are raising their voices to promote patients’ well-being and quality of life.  One drug company official’s response to those concerned:  the insurer should just lower the patient’s co-pay.  Things that make one go hmmmmmm.  This is a very important issue, and one that we at the Center for Law, Science & Innovation are following closely, especially as one third of Americans can expect a cancer diagnosis in their lifetime.

Worldwide Web Watch

WWWearth

In an excerpt¹ published by Salon entitled, Killer robots are coming next:The next military-industrial complex will involve real-life Terminators, Yale University’s Wendell Wallach, asks us to consider whether we, as a society, are ready and capable of navigating competently through the expected robot-entrenched and drone infested war zones of the near future.  Competent navigation, importantly, requires addressing the question of limitations on “smart” weapons systems.   Following in the footsteps of a proposed presidential executive order, Wallach suggests a ban, and short of a ban, “an international humanitarian principle that machines should not be making decisions about killing humans.”  Time is of the essence because, as Wallach explains, “more and more functions are being turned over to computerized systems,” leaving humans out of the loop.  The idea of an international ban on fully autonomous killing systems has gained international support but as with other humanitarian concerns, a continuous public voice, pushing for a ban, is required to keep the momentum going.  Wallach appeals to our ethical selves, noting that “delegating life-and-death decisions to machines is immoral because machines cannot be held responsible for their actions.”  However, with the proviso that robotic moral advancements should not be tested with autonomous lethal weapons, Wallach additionally provides, “[i]f and when robots become ethical actors that can be held responsible for their actions, we can then begin debating whether they are no longer machines and are deserving of some form of personhood” — perhaps opening the door, at that time (and not before), for such systems to become ethically qualified and eventually accepted as proxy military soldiers.

¹Excerpted from “A Dangerous Master: How to Keep Technology From Slipping Beyond Our Control” by Wendell Wallach. Published by Basic Books.

Technology Triple Trivia

TTT13

3 Questions. 3 Hints. 3 Answers.

1. What seemingly greedy tactics by some for-profit labs are hurting a valuable scientific undertaking?

Hint:

Answer: many doctors wouldn’t think twice about participating in a pharmacogenomics study to ensure their patients are taking the right medication, dose or experience fewer side effects.  Pharmacogenomics, which involves assessment of an individual’s DNA and its relationship and response to certain drugs, is a booming industry.  However, without adequate standards and oversight, it is one that can get out of control.   One company currently being investigated for out of control practices is Renaissance RX.   Looking to grow fast and furious, Renaissance is alleged to have encouraged physicians to conduct genetic testing on thousands of patients, regardless of eligibility, and engaged in improper billing practices in connection with those patients.  The problem, aside from financial greed and lack of uniform participation and payment standards, is one of fast growth in an area where gatekeepers are scrambling to catch up and impose safeguards.  Personalized genetic medicine has bestowed many benefits — patients and science have prospered.  However, when fraud and shady tactics taint the industry, progress for all is halted.  Read more here.

2. What do a QTip and a couple million dollars have in common?

Hint:

Answer: the federal Genetic Information Nondiscrimination Act (GINA) provides, among other things, that employers are not allowed to collect employees’ genetic information.  In the first ever GINA case to go to trial, two men, whose genetic information was unlawfully collected, were awarded $2.2 million in damages.  The moral of the story: watch who you swab.  Read the details here.

3. From winning Jeopardy! to treating cancer, is there anything this guy can’t do?

Hint:

 

Answer: among other projects, IBM is training Watson to be an AI cancer specialist.  Watson has a great advantage over humans: being able to expertly sift through vast amounts of medical data, including genetic information, in seconds.  It is hoped that using and perfecting Watson in this area will enable doctors and patients from all over the world to have access to the “best” treatment specialist — with little wait time for results.   Will Watson and similar AI eventually replace human doctors? It’s possible say some but others believe Watson & Co., are simply tools that enhance the physician and his or her skills.  Read the details here.

GET 2015: Anti-aging Treatments

GET 2015GET Highlights

Anti-Aging Treatments: Scientific Progress Needs to Be Accompanied with Regulatory Advances

BY GARY E. MARCHANT (Professor of Law, ASU)

One of the many cutting-edge sessions at the 3rd Annual Governance of Emerging Technologies conference focused on anti-aging technologies. There has been a long history of unproven life-extension claims and bogus anti-aging products. But in recent years, significant progress has been made in developing scientifically- based approaches for extending the quality and length of life. However, there are serious legal and practical obstacles impeding the regulatory pathways for such agents.

Dr. James Kirkland, Director of the Mayo Clinic’s Robert and Arlene Kogod Center on Aging in Rochester, MN, kicked off the session with an overview presentation on “The Basic Biology of Aging: New Interventions and Therapeutic Opportunities.” Dr. Kirkland emphasized that aging biology is at the core of a large number of chronic diseases, including cancer, cardiovascular disease, stroke, sacrcopenia (muscle wasting), diabetes, and neurodegenerative disease. Attacking these chronic diseases one-by-one is not a viable anti-aging strategy, since preventing the onset of just one of these diseases will only extend life a year or two until the next disease on the list sets in. Rather, the strategy needs to target fundamental mechanisms shared by chronological aging and age-related chronic diseases, such as Inflammation, cellular senescence, macromolecular dysfunction, and stem cell or progenitor dysfunction. Fortunately, we now have a growing list of over 35 potential interventions that increase lifespan and/or healthspan in animal studies that are now candidates for human trials. Dr. Kirkland ended his presentation by listing some of the practical challenges in conducting human trials on these exciting new potential anti-aging agents, such as the potentially long duration of such trials and the need for surrogate biomarkers. He suggested some innovative approaches for overcoming these challenges, such as focusing on research subjects with “accelerated aging” conditions.

Next, Dr. Lewis Gruber, CEO of the biotechnology company Siwa, reported on a specific approach to anti-aging therapy that his company is pursuing. Siwa is targeting senescent cells, which accumulate in tissue over time and secrete substances that impede the proliferation of stem cells and other healthy cells. Cell senescence has been associated with all of the chronic diseases associated with aging, including cancer, Alzheimer’s disease, atherosclerosis, chronic obstructive pulmonary disease, hypertension, and sarcopenia. Siwa has developed a momoncolonal antibody therapy called NeaVira™ that targets a cell surface marker found on senescent cells. The potential of this agent has been demonstrated in animal studies targeting sarcopenia in which statistically significant increases in muscle mass were observed in treated aged mice compared to controls, with no adverse effects and no regression after cessation post treatment. This potential anti-aging agent is now being prepared for human trials.

Well-known author Joel Garreau then addressed the social consequences of anti-aging therapies, presenting four possible scenarios for 2030, which he referred to as “small change,” “drooling on their shoes,” ”live long and prosper,” and “immortality.” These four scenarios and their implications were previously described by Garreau in a Slate article.

Finally, I (Gary Marchant) discussed the regulatory impediments to regulatory approval of anti-aging therapies. Our current regulatory system is geared towards single-disease therapeutics, and is not a good fit for oversight of new health-based interventions such as preventive treatments, human enhancements, and anti-aging therapies. With the recent progress in anti-aging treatments, there is an urgent need for new regulatory pathways for anti-aging treatments, which may be part of a transition from a disease-focused model to a health-focused model. A vigorous discussion closed the session, with some people focusing on changes within the existing statutory framework, and others calling or innovative new governance approaches. Many of the audience members agreed to work together to pursue a more viable regulatory pathway for ant-aging therapies. Send me an email at gary.marchant@asu.edu if you would like to be part of this search for a solution.