Category Archives: Healthcare-Sciences

Who’s Going to Pay for Gene Therapy?

While gene therapy has the potential to save countless people from genetic disorders, only a select few will be able to take advantage of the technology without a price reduction. The cheapest gene therapy treatment on the market today is Yescarta, which ranges from two to four hundred thousand dollars. On the high end, Glybera comes in a whopping $1 million for a single treatment. In terms of eligible patients, Yescarta has approximately 7,500 whereas Glybera has fewer than 10. In an article published by MIT Technology Review, they examined the relationship between the cost of the treatment and the number of eligible patients. In summary, the fewer number of potential patients, the higher the cost of the treatment. This math makes sense because if the R&D is roughly equal for two drugs, but one drug can only be sold to half as many people, the pharmaceutical company needs to get more revenue from each patient. The unfortunate truth is that economics makes no concessions for patients in need of treatment.

Gene therapy treatments are expensive for several reasons, one of which is the age of the technology. In any market, the first products are always the most expensive. When the newest iPhone comes out, they never lower the price. In the pharmaceutical industry especially, the first products to market are often the most expensive to produce. While a new iPhone might have a new screen or a better camera, new medicine is the product of countless hours of research and development, which can be quite costly. FDA regulations also add to the time and cost associated with developing a new medicine or treatment, this is for good reason, but expensive nonetheless.

Sure, the first to market can command high prices, but one of the largest factors affecting the price of new medicines and treatments is the deregulation of the pharmaceutical industry. Pharmaceutical companies are given a lot of liberty in terms of pricing new drugs and they tend to charge immense premiums. In most markets, the supply is somewhat proportionate to the demand, however in specific medical treatments, the target markets are very small, meaning small demand. Companies often depend on wide customer bases to distribute the cost of development. However, the market for Glybera, the most expensive gene therapy treatment to date, consists only of patients with lipoprotein lipase deficiency, limiting the target market to less than 10 people. Since the entire cost of developing Glybera is borne by only 10 people, the price tag is astronomical. In fact, it is probably safe to assume that the developer of Glybera still lost money charging $1 million per treatment.

One of the most outspoken defenders of deregulated pricing in the pharmaceutical industry is Martin Shkreli. Infamous for buying a one of one Wu-Tang album and his smug face, Shkreli perfectly exemplifies the dangers of deregulation. In most industries, absurdly high prices simply means that customers will find cheaper alternatives, but in the pharmaceutical industry, options are limited, giving all of the power to the select few companies that produce a certain drug. Martin Shkreli took advantage of this power when he raised the price of Daraprim, a life-saving immune-system drug used to treat parasitic infection as well as AIDS and Cancer patients, by 5,000%. He raised the price of the drug from $13.50 $750 for a single pill, leaving those who depended on the drug and many others outraged. His defense for the price increase was to fund future drugs that will better help the patients. He explained that the pharmaceutical company was not profitable at $13.50 a pill and that in order to grow the company, they had to become profitable to fund research and development. His defense makes sense from a business perspective, but there are many more factors to consider when determining the cost of a life saving medicine. If pharmaceutical companies are still loosing money charging $750 a pill and $1 million per treatment while countless people can’t afford the treatments they need, how can gene therapy and the pharmaceutical industry move forward and who will pay for it?

 

Dr. Mark McClellan, former FDA commissioner and current leader of the Duke-Margolis Center for Health Policy, organized a consortium at Duke to analyze gene therapy treatments and to brainstorm ways to help patients pay for treatments. Through their research, the consortium concluded that the healthcare system is far behind the medical industry and the advances it has made. Generally speaking, there are three parties involved in gene therapy, the patients seeking treatment, the companies developing and pricing the treatments, and insurance companies. It is in the patient’s best interest to pay as little as possible for medicine, it is in the company’s best interest to charge the patient enough to be profitable and to pay off the development of the drug, and it is the insurance company’s job to make sure they don’t pay for any of it. Since the three major parties involved have mutually exclusive interests, it is impossible for everyone to win. Another factor to consider is the fact that patients respond differently to the treatment, meaning there is a chance that a $1 million treatment is completely ineffective. McClellan explained what is essentially a refund policy for gene therapy treatments in which patients that do not experience any relief or remission of their disease within one month are entitled to a refund. That leaves many things open to interpretation such as the definition of relief or progress, and it still does not account for the possibility of a relapse outside of the refund-window. This makes things infinitely more challenging for not only the companies administering the treatments and the patients receiving them, but it also complicates the pricing structure for insurance companies. If a patient needs coverage for a $1 million dollar one-time treatment, they have to pay out an enormous sum all at once, the one thing that keeps insurance agents up at night.

With all of the factors working against the success of gene therapy, it is hard to predict what a successful implementation will look like on a grand scale. There are countless industries that are light-years ahead of their respective regulating entities. In medicine, that disconnect prevents patients from receiving what could be a life-altering, even life-saving procedures.

Despite the current odds, Nick Leschly, CEO of Bluebird Bio, re-assures us that he’s “confident we can figure it out because if someone has a very serious disease, and we can cure it, the system will find a way to reward that.”

 

Virtual Reality: Ethical Issues, Global Impact, and Impact on your Career

Virtual and Augmented Reality Ethical Issues:

There are a few ethical issues in regard to virtual environments which need to be addressed. These are related to human behavior, motivations, and inappropriate/ uncensored content in open sourced VR worlds. There are also physical and physiological health concerns in regard to the virtual reality experience.

As the researchers point out, there are good reasons to be especially concerned about the influence of virtual reality on the human brain, as opposed to television or non-immersive video games. Concerns have been raised about a possible relationship between virtual reality and desensitization. This refers to virtual reality games in which there are high levels of violence or training exercises for the military in which soldiers engage in simulated combat scenarios which include killing. Desensitization means that the person is no longer affected by extreme acts of behavior such as violence and fails to show empathy or compassion as a result. This has been noticed with gamers, especially those who play first person shooters or role playing games which involve a high degree of immersion. Unlike other forms of media, VR can create a situation in which the user’s entire environment is determined by the creators of the virtual world.

The VR experience can introduce a number of opportunities for new and powerful forms of mental and behavioral manipulation. Virtual Reality is just like any other experience in the real world in the sense that it can hurt people in the same way that real-world situations can affect people in a psychological sense. To avoid an ethical dilemma in regards to VR, it is important to remember:

  1. Experiments using virtual reality should make sure that they do not cause lasting or serious harm to the subject.
  2. Those participating in the experiment should be made aware of possible psychological and physical effects from VR.
  3. Create awareness about the many ways VR can be used for something other than its original intention.
  4. Adopting procedures through policy and law that ensure a user’s privacy and safety is protected and maintained.

Virtual reality is a form of technology that is continuously developing, because of this continuous progression VR may cause some problems that many of us have not encountered before. There will be problems that include poor ergonomics and then there are psychological issues. These issues are moral and ethical concerns that need to be looked upon with these technological advancements. There are physical effects and time constraints. Due to a person’s perception being distorted VR can provide users motion sickness. Some people are affected by this after spending only 30 minutes in a virtual environment whereas others can go several hours before they notice any ill effects. This is also known as cybersickness. These virtual realities and their devices unfortunately take a very long time to create and maintain, and as we should all know, time is money. Wasted time causes many issues within the surface of a company, the products it produces for the customers, the customer service, the research, the future technological advances, and so on. Researchers are attempting to create a balance between hyper-realism and production time but the equation is yet to be solved at this point.

How Virtual Reality Will Impact Businesses In The Next Five Years:

  1. We’ll Experience Our Reality Through Virtual Reality
    • AR and VR will be tools for our future to capture knowledge. The educational world and the way we will learn will dramatically change 5 years from now. VR will truly become an essential tool in the workforce. These technology-driven tools are getting better, more realistic, and are already accepted by those entering the workforce.
  2. Prototyping Will Go to the Next Level
    • VR and AR will allow companies to present their project in newer and better ways than ever before. These virtual prototypes will allow the customers, builders, and developers to have better planned designs and models which will lead to a higher rate of sales and a higher quality of goods sold as every minute detail of a project can be shown. Decision makers and end-users will be able to provide better and more valuable feedback early in the game. This will allow business to focus and spread out their timing more throughout the company and waste less money holistically.
  3. Certain Niche Markets Will Be Impacted
    • These devices will provide happiness and ease to travel around the world without flying or spending thousands of dollars to enjoy simple moments. However, these devices will be extremely expensive to purchase and most likely maintain.
  4. Advanced VR Will Become the Social Laboratory of the Elite
    • VR and AR will be simulating business strategies, assist government policies, and so on. These choices and devices are supported by billions of dollars in capital which makes this an audience and a market to dive into rather than to ignore.

VR and AR on a Global Level:

The insurgence of VR and AR has massive global implications. International Data Corporation (IDC) has projected that in just four years, the VR/AR market will reach sales up to $162 billion. More and more 360o videos have been showing up on video channels such as Youtube, subtly reminding viewers that they could be getting a better experience via a VR device. VR and AR are by no means constrained to video gaming. As mentioned in a previous blog post, VR is already having an impact in the medical industry, education, social media, and business. Surgeons could be using VR for surgeries, and patients for therapy sessions. Education could become much cheaper if entire courses begin to be taught by one teacher embedded into an immersive software. Social media platforms will become entirely new realities with virtual social spaces and avatars. Mark Zuckerberg has created a plan to do something like this in combining Facebook and VR.

So VR is not restricted to gaming; gaming is simply the gateway to people’s interest in VR. But the “gods of technology” seem to have greater plans for Augmented Reality. Virtual Reality will forever be an experience that takes us away from the present and physical world around us. AR, however, could potentially become an everyday part of our lives.

 

Having trouble believing this could be a close representation of our future? Samsung has already put in patents for smart contact lenses. Get ready world!

Healthcare-Sciences Cohesive Research Findings

After researching the various technologies disrupting the healthcare and science industry, a video has been made to compile all of the findings of the healthcare-sciences team. The technologies discussed in the final presentation video are IBM Watson, 3D printing, tissue engineering, and genetic modification. Each new piece of technology offers a different way in how people’s lives will be impacted, however all bring about changes to the social system society has set in place. Changes include how long people are now able to live for, an increased ability to detect diseases, reduce risk during organ transplants, and assist those struggling with disease. The video is posted above but please refer here to discover the team’s research findings.

When IP laws hinder healthcare

In my last blog post, I discussed the development of intellectual property law within the trade industry. With TRIPS (the Trade-Related Aspects of Intellectual Property Rights) as a minimum standard for IP protection, the United States has broadened IP laws even further through a combination of bilateral and multilateral free trade agreements (FTAs). This protection is specifically crucial for the pharmaceutical industry, considering that 10-30% of drugs in developing states are counterfeit. But the balancing act of enacting IP protection is especially important in these nations because too stringent of laws may serve as a great obstacle to growth.

The Trans-Pacific Partnership (TPP), which is currently the largest U.S. FTA to date, was just agreed upon by 12 Pacific Rim nation states. In addition to eliminating barriers to free trade and heightening environmental standards between and across these nations, the TPP calls for stricter standards for intellectual property. The United States government claims that, “TPP’s Intellectual Property (IP) chapter will help Americans take full advantage of our country’s innovative strengths and help to promote trade and innovation, as well as to advance scientific, technological and creative exchange throughout the region.” This statement is accurate, as existing United States’ intellectual property law is used as a foundation for the agreed-upon provisions in the TPP. However, many of the nations that are parties to the agreement are unlikely to be able to execute the high standards set by the U.S. This is especially true for Vietnam, the weakest and poorest party to the partnership.

The TPP sets a 5-8 year data exclusivity standard for biologics and allows for the process of evergreening, which occurs when drug companies request patents for new uses of old drugs. These are only a few of the strict IP provisions presented in the TPP. Judit Rius Sanjuan, a legal adviser to Médecins Sans Frontières has said, “I am sure it will increase the prices of medicine. It will take components of US law and export them to other countries, and create a new global norm that will change the way the TRIPS agreement was negotiated.” This was exactly the case in Guatemala after the Central American Free Trade Agreement was ratified. Whereas many drugs in the US had already become available in generic forms, Guatemalans were still paying high prices for name brands.

Because it controls the majority of intellectual property worldwide, there is great incentive for the United States to require heightened IP standards. And actually, in many fields such as the tech and film industries, these strict standards are satisfactory. But where human health is involved, it has for a long time been common practice to loosen IP laws. The U.S. has previously relaxed IP requirements in bilateral FTAs with Colombia, Panama and Peru, even including the use of compulsory licensing. If the TPP is ratified, drug prices will likely surge throughout developing nations around the globe, at which point the US will be called upon to help pick up the pieces. This should have been of consideration within negotiating the TPP, among other pitfalls that will come to light if the agreement is approved by Congress.

 

Read the full text of the TPP at the USTR website here.

 

A video from June, 2013 that speaks to more issues within the IP chapter of the TPP:

How will medical advancements impact society?

This video discusses the social implications of disruptive technologies such as IBM Watson. Will there be less of a need for people going to medical school and a greater need for people knowing how to operate machinery used within a particular industry? Perhaps that is where the future is heading. Within healthcare and sciences, technologies with cognitive capabilities and sophisticated AI systems are capable of assisting doctors in diagnosing patients, comparing statistics of how people will react to medications, searching for clinical trials within a designated area, monitoring the progression of a patient, and unanimously reporting a patients diagnostics into a cloud based computing system. All of these tasks are things IBM Watson is doing and it is paving the way for treatment within hospitals and treatment centers.

Several articles are discussed in the video regarding statistics on how population is increasing in the future and what that means for an economic system. Within the United States, the average age of retirement for people born after 1960 is now 67 years old compared to 65 years according to the New York Times. Part of the reason people are living longer is due to technologies increasing the ability to detect disease, treat disease, and develop new ways of prevention. If people live longer, what type of impact will that lead to the workforce? Social Security? These questions are topics discussed in the video with the conclusion that the age in which people can receive their benefits from Social Security will increase, causing people to hold their jobs for longer and displacing those searching for available job opportunities. Furthermore technology is currently displacing people out of jobs, however in the future this problem may become more serious if cognitive computing systems such as IBM Watson develop in more industries.

To read more on social implications of disruptive technologies please follow the links below to the news articles discussed in the video. What are your thoughts on this issue?

https://www.nia.nih.gov/research/publication/global-health-and-aging/humanitys-aging

http://www.nytimes.com/2013/01/06/opinion/sunday/social-security-its-worse-than-you-think.html

http://www.livescience.com/10458-immortality-social-burden-longer-lives.html

https://hbr.org/2014/12/what-happens-to-society-when-robots-replace-workers

http://www.politico.com/agenda/story/2015/07/americans-are-living-longer-what-if-thats-a-disaster-000144

http://www.mercatornet.com/articles/view/living-longer-a-bonus-or-a-burden/17015

 

 

The Future of 3D Printing and its Societal Impacts

This blog post is about the ways in which 3D printing technology will advance and the overall societal impact that it will have. I discuss the ways in which nanotechnology and 3D printing are coming together to produce object such as nano-robots and complex circuit architecture. I continue by discussing the ways in which the theoretical creation of nano/molecular assemblers will change the way humanity relates to matter and with each other. An organization called the Open Source Nano Replicator Initiative is planning on creating a molecular assembler that will build molecules from atomic raw materials, and then chemically bond these molecules together on top of each other to create an object. They believe that this will have effects on humanity that are unprecedented because molecular assemblers in the hands of everyone would theoretically end scarcity of matter in our reality. Additionally, I discuss the ways in which 3D printing can currently be used for consumers and manufacturers to corroborate on objects to “debug” and perfect them similarly to the way a software company releases a beta of their product to be tested by consumers.

Sources:

The Societal Impacts of 3D Printing

http://www.forbes.com/sites/ricksmith/2015/07/07/5-incredible-trends-that-will-shape-our-3d-printed-future/

http://www.nanowerk.com/spotlight/spotid=34275.php

http://www.nanowerk.com/spotlight/spotid=37541.php

Legal Requirements for Innovation

In theory tissue engineering sounds like a great advancement for the healthcare industry, so what could possibly go wrong you may ask? Well like everything else in healthcare there is always some kind of risk that needs to be addressed.  Tissue engineering will eventually dissolve the need for organ transplants and in the process save millions of people’s lives. Like I stated in my previous two posts, tissue engineering will eliminate the need to wait for a transplant because a new organ will be created in only a short amount of time with that individuals cells. But before we start to sign our lives away in the process let’s look at what could go wrong and the legal issues that occur.

With new innovation comes new laws and regulations that have to be put into play to insure that someone will be held liable if something tragic occurs. In this case, tissue engineering is still new so there has not been many clinical trials to ensure that this procedure is safe and effective. Since tissue engineering is not in full effect in the healthcare industry quite yet the legal issues first have to start out in the trail stage.  In the journal “Liability Versus Innovation,” Keren-Paz, a student at Keele University School of Law in the United Kingdom discusses the legal process that has to be done to ensure that malpractice is not occurring in the clinical trial period. Keren-Paz states that their ultimate goal is to guarantee that both the “innovation is done responsibly” and that the “legal outcome is fair to the patients.” In order for clinicians to hold trials every patient much first be informed about the treatment they are receiving and the risks that could occur. With new innovation happening in healthcare the patient must know that the specific procedure is new and there are still uncertainties. By receiving an informed consent from the patient the clinician can now continue with the treatment. Next, even if the doctor informs the patient about all the risks and benefits of the treatment they can still be held liable for negligence if something goes wrong. Before a doctor can be labeled as negligent a court must first decide if the doctor was actually negligent or if they did everything correct and the procedure itself was negligent. Along with defining the negligent act the courts must also determine if the “unforeseeable risks to the patients are foreseeable benefits to the third party.” Lastly, Keren-Paz poses the question of whether these laws restrict the innovation of regenerative medicine.

Tissue engineering will one day save millions of people’s lives and the hope is one day people will not have to die waiting for a transplant. Since this innovation is still new it has to be tested and in the clinical trials meet the legal requirements above. Once that is done and the treatment is on the market, humans will then be able to live longer and healthier lives.

 

How Does the Law Combat Genetic Modification?

How does the law adjust for genetic modification. If we look at how it combats it now we might be terrified for how the future might look. Monsanto is the world’s largest GMO seed company and uses its wealth to harass and bully farmers into using their product indefintely. However, farmers aren’t the only ones tricked into succeeding into Monsanto’s plans. Congress has just passed a bill alleviating Monsanto of any liability if people get sick from their modified seeds.
What does this mean for human gene editing? Right now the big issue is patent infringement. The CRISPR/Cas9 is the only type of tool like it out there. But, as history has shown, a successful invention is a copied invention. But if a couple have a child who has received modified genes from one parent, does one company own those genes? The video above shows my thoughts and feelings on the subject. Up next on the blog is how does this tool affect how our society will interact, react, and live in the future…

Sources:
http://www.forbes.com/sites/jonentine/2013/04/02/exposing-the-anti-gmo-legal-machine-the-real-story-behind-the-so-called-monsanto-protection-act/
http://www.nature.com/nbt/journal/v33/n3/full/nbt.3160.html
http://www.usatoday.com/story/money/business/2013/06/04/farmer-monsanto-genetically-engineered-wheat/2388957/

Legal Issues of the 3D printing of Organs

The main legal issues that I focused on are over the ownership of the artificially created organs as well as the implications that 3D printing has on the black market sale of organs. The main conclusions that I found were that there is a possibility that the data file of a person’s organ could have split ownership between the subject is came from and the doctors/scientists that transformed it into a data file. The other conclusion that I found pertained to the possible effect that it would have on the black market for organs. The unlimited replication potential will help cause the supply to increase of organs, which will lower the incentive for people to head to the black market in the first place to get an organ. Currently, people wait on donation lists- but some people decided that the black market sale and transplant is more worth their time. The increased supply of organs would alleviate some of demand on the black market because people will be less desperate, but there still remains an issue of getting the organ transplanted by a professional doctor.

Sources:

http://www.techrepublic.com/article/the-dark-side-of-3d-printing-10-things-to-watch/

http://www.eurekalert.org/pub_releases/2014-02/hm-nlp020614.php

http://www.organovo.com/

https://sites.google.com/site/3dprintingorgans/legal-ethical-and-security-issues

https://www.skadden.com/insights/intellectual-property-issues-stacking-3-d-printing