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3 posts from May 2016

05/17/2016

Dr. Amy Jessop honored with Public Health Recognition Award

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Dr. Amy Jessop, an associate professor of health policy and public health at University of the Sciences and director of Hepatitis Treatment Research and Education Center, received the Individual Public Health Recognition Award from the College of Physicians of Philadelphia on May 10 for her work with Prevention Point Philadelphia.

Dr. Jessop is a member of the board of directors at Prevention Point Philadelphia (PPP), an organization focused on reducing the risk for those who are at high risk for contracting HIV/AIDS, Hepatitis and other blood-borne diseases.

The organization was founded in 1991 as an underground syringe exchange. It was legalized by Mayor Ed Rendell in 1992 and since the organization has worked to reach the most vulnerable populations who are engaging in the most high-risk behaviors.

Dr. Jessop’s award is an acknowledgement of her tireless work and dedication to ensure that underserved populations such as active drug uses, people who were previously incarcerated, and others without access to healthcare receive primary care, HIV and hepatitis testing, counseling, drug addiction referrals and additional social services.

Dr. Jessop and PPP have developed the appropriate services for these underserved individuals providing valuable community resources, especially during these times of epic opiate use in Philadelphia.

The College of Physicians’ 2016 Public Health Recognition Awards recognize those who contribute to the public health of the greater Philadelphia area. Each year the college honors an individual or organization which has given substantially to the health of the community and a student who has shown leadership and excellence among their peers.

05/10/2016

What is Big Data and how will it revolutionize the health industry? Part III

Big Data has already made an impact in many industries, and is transforming how we think of healthcare and public health. It will continue to revolutionize healthcare, pharmaceuticals, clinical trial management, administration, and all aspects of the health industry. The US has the highest healthcare costs in the world, and our outcomes are often mediocre. The application of Big Data techniques will help reduce these costs and improve outcomes. As the field matures, we will see a cumulative effect, as insights build atop each other.

Big Data is a revolution, but it is still in its infancy. The truth is, we still have not come close to getting maximum value from our traditional methods of data analysis. Big Data makes use of the unbelievable volume, variety, and velocity of data being produced every second, and applies creative querying to make predictions and to make recommendations. It uses an open source architecture called Hadoop, which runs on commodity hardware, meaning that Big Data will be available to all organizations in the future. The challenge will be in asking the data the right questions, and querying the data sources in an appropriate way. These skills will be in very high demand in the near future.

However, there are some major challenges in applying Big Data in healthcare, particularly when it comes to protecting patient privacy. First of all, Health Insurance Portability and Accountability Act (HIPAA) compliance is mandatory, and violating HIPAA is a serious breach of the law and medical ethics. So, how do we integrate patient data while preserving privacy? Yes, data can be de-identified, but sophisticated analysts could determine the identity of individual patients.  In a White House reported on balancing Big Data and privacy, it was noted that policy alone cannot prevent data breaches, and that technology needs to be effectively implemented to prevent breaches.  It also makes the case that policy should focus on the harm caused by specific breaches. 

Breaches in privacy are a serious matter and companies deploying Big Data, just as before, must be vigilant in their use of technologies, such as encryption, to prevent breaches.  With so much data, the consequences of a data breach can be staggering.  It was revealed in 2015 that over 4 million current and former federal employees had their personal data stolen by hackers.  The data were held by the Office of Personnel Management (OPM). Therefore, companies with access to millions of patient records must be especially vigilant.

Breaches of massive datasets can result in more than just identifying information, such as social security numbers and addresses, as was the case in the OPM breach. As devastating as that was for the millions of victims, the potential damage from, for example, stealing patients’ genomic data could be even worse. We’re at the cusp of a new era in data management. The consequences of privacy breaches in this new domain have yet to be fully understood. Vigilance will be the key for all stakeholders.

The data that patients provide allow researchers to conduct extraordinary analyses and tease out information that was invisible under the old paradigm. Big Data analysis requires many people to share their data. So, policies should be in place that protect patients, while still encouraging them to share their personal information. Data encryption will play a role in preventing breaches. But, intelligent policies will be as important. Many times, hackers can bypass encryption and other tools due to a human vulnerability.

If companies do not enforce their policies effectively, then encryption can be neutralized as a deterrent. The STUXNET virus crippled computer systems in Iran’s Nantanz nuclear facility. The Iranians had physically isolated those information systems from other computer networks and the Internet. The virus exploited a vulnerability by introducing a virus onto the thumb drives of employees. Then, when one or more employees inserted the thumb drive into the computer system, STUXNET was able to spread and cripple the network. While this is an extreme case, and it is widely presumed that one or more intelligence agencies designed the virus, it does highlight how a breach in protocol can be exploited. It is not enough to have strong policies—companies must be able to enforce them as well.

Storing and accessing patient data without violating patients’ privacy is going to be a long-term challenge. Companies should have a clear written policy on patient privacy. In addition, they should take steps to ensure that data are not mishandled by mistake. The damage to patients can be serious, and the consequences to the company could possibly be catastrophic. Not only would they be vulnerable to lawsuits, HIPAA violations could actually lead to criminal charges.

Think Big!

Magdi Stino, Health Policy PhD Candidate

05/05/2016

The European Biosimilars Market

In previous blogs, I have written about what biosimilars are and have speculated about the development of the US biosimilars industry. While the US biosimilars market may not fully mature for another decade, the European biosimilars market has been expanding for years. In this blog, I will analyze what the European biosimilars market looks like and whether it is a preview of the US biosimilars market.

The biosimilars market in Europe has existed now for over a decade. The first approved biosimilar was a somatotropin in 2006. Since then, Europe has seen 22 biosimilars emerge in several different drug classes (more information available here). With all the potential savings that biosimilars offer, 22 products may seem like a small number to be developed over a decade. Similar to the US, a barrier for biosimilars in Europe is the development pathway. The European Medicines Agency (EMA)which operates similarly to the FDA, provides the legal pathway for biosimilars. Unlike the FDA however, the EMA has made many different product specific guidelines which may be hindering the adoption of biosimilars. Additionally, the EMA does not provide pricing or reimbursement guidelines. This responsibility instead falls to each individual member state. Some member states like Germany and the UK have made pricing policies favorable to biosimilars. Germany has prescribing quotas and the UK has reimbursements for physicians. Others, like Italy and France, have policies that are less favorable in the form of universal price regulation. This regulation does not offer any incentive for the adoption of biosimilars. This mesh of product specific legal guidelines and member state specific pricing policies has slowed the biosimilars market in Europe.

Despite these challenges, biosimilars still offer great savings in Europe. Biosimilars can be as low as 30% less expensive than the European reference products. Even with the slow adoption, some reports show that biosimilars could save Europe as much as $33 billion by the year 2020. At first glance, it seems as though these savings would create an environment where all European member states would mimic the UK and Germany and embrace biosimilars. One might expect that over the next decade, biosimilar policy and use across Europe will look almost identical. History, however reveals that this may not be the case. It is no secret that biosimilars can bring savings to the health care, so countries that have not already adopted them are not guaranteed to adopt them in the future. What is likely is that biosimilars will continue to bring savings, but only to the handful of member states adopting favorable policies.

The European biosimilar experience is unlikely to be repeated in the US. The FDA may end up with a less cumbersome development pathway than Europe which could then lead to more rapid adoption. Individual states will also not have the same policy and reimbursement variability as European member states. In other words, policies in Pennsylvania will look similar to those in New York, while policies in the UK will continue vary greatly from policies in Italy. With that being said, the US biosimilars market will still be unpredictable. All Europe teaches us is that despite unique road blocks, biosimilars can still bring large saving to health care systems who accommodate them.

Robert Bond, PharmD '18

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