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September 23, 2016 0

The worst part of the Zika story we know so far, is that we do not know nearly enough to combat it in a meaningful way. First it was just an exotic STD from South America. Then it turns out to be a virus that could cause severe disability in newborns. As of August 2016, the CDC has reported that there are 2,722 Zika cases across the United States, another 14,110 in the US Territories (not counting the sexually transmitted cases), active mosquito-borne transmission in every country from Mexico, south through the Caribbean and Central America, to Ecuador, Colombia and Brazil in South America.  New studies indicate the virus is associated with brain disorders in adults, for example Guillain-Barré syndrome.  According to Florida State University researchers, the Zika virus directly targets the development of brain cells, in as little as three days after exposure, effectively stunting the cells’ growth.

The United Nations Health Agency noted in its new warning on the virus that “the more we know, the worse things look,” while World Health Organization’s Director-General Dr. Margaret Chan said that in under a year, the status of Zika has changed from ‘a mild medical curiosity’ to a disease with severe public health implications. Meanwhile, the CDC reported just a few days ago that they are almost out of money to fight this growing epidemic, which is unfortunate for many states and Puerto Rico which heavily rely on Federal help.

We still do not know what type of global impact on the spread of Zika the past Olympic games will play, but with the fast approaching annual rainy season in South America we are in for a perfect storm of factors that could become the tipping point to spreading the virus globally, unless concrete steps are taken now.

Clinical trials to make vaccines are still in process, and won’t progress anytime soon for that matter, if the stock market is any indicator.  Companies like Sanofi (NYSE:SNY), Inovio Pharmaceuticals (NASDAQ:INO), Intrexon Corp (NYSE:XON), and others have announced Zika vaccines initiatives, but the investors are clearly not impressed.

That leaves us with the next most logical option: detection.  Making easy to use, rapid, reliable, and cost-effective testing tools widely available across the affected region will help slow the spread and is a key preventative measure for this global epidemic.

Dr. Yelena Budovskaya, Ph. D., whose company Xnsion is at the cutting edge of rapid testing development, explains the difficulty labs face when tackling the problem with traditional methods. According to Dr. Budovskaya, “Most new technologies target the development of an instrument or adapting already existing instruments to allow rapid detection of one or few potential causes of infection. These instruments are expensive and would require significant investments for a diagnostic lab to adapt and adopt these instruments for the detection of various disease and infections; and in this case – Zika. Combined with the high cost of tests and limited testing availabilities, very limited information is available about the epidemiology of Zika: from its geographic origin, patterns, down to the possibility of health impacts and studies regarding Zika co-infections with other mosquito- or tick-borne viruses. The other fundamental problem with current Zika testing technologies is that they heavily rely on antibodies against the Zika virus. However, the Zika virus is very similar to other mosquito-borne viruses which makes those test unspecific. “

Yet, while, companies like Xnsion do appear to have the answer, it has yet to reach the market. The stalemate seems to be in the partnership that should have been a fertile ground for growth and innovation: between the public and the private sectors. One is in the business of advancement of public health, while the other is in the business of offering effective solutions for a profit. Inertia of one, causes inertia in the other, and rightfully so.

Big corporations do exist for the ultimate goal of enriching their shareholders, and they simply cannot afford to invest into solutions that will not have the backing of the public sector. Right now the “best” (CDC recommended) test costs ~$20-25 per sample that makes it out of reach in many struggling economies, which also happens to be the countries most affected by the virus at the moment.

Public health experts say that a viable test should utilize standard molecular laboratory equipment, be simple enough to be performed by any laboratory technician without necessity for in-depth knowledge in molecular biology, and should cost below $10 per test.

I believe we could get there, and the price will be driven down by normative market laws of supply and demand through increased competition if the private sector sees a serious commitment from the Federal government here at home, the World Health Organization, and of course local governments across the region.

Combating the Zika virus falls out of the normative boundaries of global responsibility. It is not about more affluent countries providing aid to developing nations. The threat to global health is real, and is a joint responsibility of the leading nations and each individual government in the affected region to step up to the plate. One cannot expect the private sector to go at it alone, although one can expect them to deliver, if the other side does their job, as opposed to the ongoing jockeying currently happening in the US Congress, such as blocking President Obama’s request for the necessary funds.

It is easy to call out the pharma industry for being the bad guys. But maybe, now is the perfect opportunity for the public sector to show them what good guys look like, and help create the market conditions for an affordable, accurate, scalable, adaptable and, most importantly, rapid Zika diagnostics.

Givi Topchishvili

June 22, 2016 0

Givi_2The necessity of clinical trials as a means of assessing potentially life-saving interventions is widely accepted by healthcare providers and medical researchers alike.  Also generally agreed upon is the difficulty of finding patients who meet the necessary inclusion criteria to participate in these clinical trials. In part, this challenge can be attributed to the administrative burden of having to match potential patients to specific selection criteria. Additionally, the traditional patient pool is further limited by geographical proximity to the clinic or laboratory where the trial takes place. I asked my colleague and the CEO of Prime Access, Chip Weinstein, for his thoughts on what could be done to help recruitment. Here is Chip’s response:

“Brian Clark’s TrialMatch hack, revealed at the TechCrunch Disrupt SF Hackathon, seeks to jump the administrative hurdle by extracting the inclusion and exclusion criteria from existing studies posted on, and matching those criteria to the user profiles of potential clinical patients.  Meanwhile, Apple’s new open source platform, ResearchKit, aims to circumvent the physical distance barrier between patient and research facility by using the already standard iPhone features to measure and record patient data. ResearchKit’s launch introduced five new apps to the platform, each of which focuses on a different health issue. Within days of the initial launch, the studies drew thousands of new participants, who were able to use their phones to take basic physical tests without traveling to a laboratory.

“While both of these platforms are certainly steps in the right direction, neither TechCrunch nor ResearchKit quite answer the question of how to persuade people to sign up in the first place, nor do they address the full range of barriers preventing willing volunteers from participating in clinical trials. By relying solely on medical records and clinical inclusion and exclusion criteria, both Apple and Clark are overlooking a major determinant of health behaviors: cultural identity.

“According to the 2010 U.S. Census, the population of Hispanic Americans increased by 43% and now comprises 16% of the U.S. population; African Americans make up 12.6% of the total U.S. population, and the Asians American population increased by 43.3%, and now comprises 4.8% of the U.S. population. There is no Census data on LGBT individuals, but the Williams Institute estimates that 3.5% of the U.S. population identifies as LGBT. These are not insignificant numbers in a population of approximately 320 million, yet minority groups consistently report lower satisfaction with their medical care, and have lower health outcomes than their Caucasian counterparts. Numerous studies have attributed these disparities in access to and use of health services to socioeconomic factors and health insurance coverage.  While these are certainly material observations, it is also important to give weight to the pertinent cultural factors.

153831142“We at Prime Access understand that a discussion about health cannot be separated from its cultural context, which is why we utilize a Total Market approach to reach a demographically diverse audience. As of 2014, the Selig Center reports that the Hispanic market holds the highest minority group buying power, at $1.3 trillion, with the African American market not far behind at $1.1 trillion. Asian American buying power is expected to reach $1 trillion by 2019, and Witeck Communications estimates the current buying power of LGBT identifying individuals at $884 billion. To maximize revenue-generating potential in a complex and multicultural world, it is imperative to understand the unique identities and interests of target consumers.

“It is equally important to recognize that while cultural groups do have shared experiences, they each have their own singular needs. For example, Hispanic and LGBT patient groups both face obstacles when accessing healthcare. However, whereas for Hispanic patients these barriers appear rooted in a lack of understanding of their cultural needs, LGBT patients are more likely to experience institutional stigma in response to their identity. Consequently, the lack of access to health services manifests in different health outcomes for each group: Hispanic patients tend to suffer more from cardiovascular disease, diabetes, and asthma, whereas LGBT patients tend to have a higher prevalence of depression, anxiety, suicidal ideation, eating disorders, and substance abuse. Therefore, marketers must employ different approaches to engage each group and meet its specific needs.

“To that end, mobile phones provide an accessible and versatile vehicle which can be used to reach multiple demographic groups simultaneously. According to a Pew Research Center, 90% of American adults own a cell phone, and 63% of adult mobile phone owners use their phone to access the Internet, which makes cell phones the perfect platform for the development of a patient-friendly mobile app or service.  Moreover, separate apps can be developed to target different groups with demographic-specific material, and thus capture potential clinical trial patients in studies most relevant to their needs.

“In a diverse and increasingly industrialized global community, it would be wise to allocate resources to advancing technology that can be used to target specific patient needs. Because health care decisions are so deeply entwined with cultural identity, it is necessary to address every facet of prospective consumers when seeking to engage their participation. Through Total Market strategy, marketers will be able to understand and provide for the specific needs of a wider, more diverse audience.”

Givi Topchishvili

March 28, 2016 0

Givi_2 In a recent article in Time’s Money Magazine, Kara Brandeisky put forward a number of ways Americans can save money on prescription medication. 13 to be exact. The solutions are interesting and creative. They range from substituting brand names for generics, asking your physician for combined pills, and pleading with your insurance provider, to changing your insurance policy altogether.

While each individual piece of advice is correct, the complete list strikes me as wrong. This column assumes that we have surrendered to a reality that’s simply unsustainable. As Ms. Brandeisky herself points out in her article, a staggering “43% of those in fair or poor health say it’s somewhat, or very, difficult to afford their medications, and 37% say they’ve skipped out on filling a prescription because of cost, according to the Kaiser Family Foundation (KFF).”

What happened to demanding action, finding ways to help, or even feeling good old outrage? Instead, we are now being conditioned to update the status and move on.

In the late ‘80s and early ‘90s New York newspapers were full of articles with practical tips on how to avoid becoming a victim in the dangerous city. But once again, the bottom line was that people had to live with violence and learn to adjust. Thankfully not everyone agreed, and now most New Yorkers enjoy their city without fear. But making change requires action, not adaptation. Settling for the status quo and losing hope never ends well. Which brings me back to Ms. Brandeisky’s article.

We have a choice: learn how to further yield to constantly rising costs of medication or take a stand and become agents of change. Let’s begin by shifting the discourse. It’s time to stop telling our fellow Americans to request double dosage pills just to split them in two, and focus our attention on things that will actually drive the costs down: fostering fair competition; reforming an outdated patent system that hinders it; demanding transparency in insurance billing; and coming up with innovative technologies that improve compliance and enhance the patient journey.

We have to understand that change will come one way or another. If European companies that make superb alternatives cannot get past the FDA red tape, they will shift their efforts to East Asia, which welcomes competition at a regulatory level. If the Europeans sense that American manufacturers are unfairly undercutting pricing in Europe by using their privileged positions in the States, the companies will start suing in American courts. If businesses in the US continue to be burdened with high employee-insurance costs because of cost-shifting insurance companies, they will escalate the lobbying efforts to avoid the rising expenses. And if institutional players don’t develop innovative technologies through grassroots and crowdfunding, they will be left behind.

I would rather play a role in driving that change than clip pharmacy coupons, which happens to be tip #12 on the Money list.

Givi Topchishvili

February 24, 2016 0

By Givi Topchishvili of 9.8 Group

Topchishvili-Feb2016artworkLet me begin by admitting that I haven’t watched a Congressional Hearing since Michael Corleone had to stare down angry lawmakers in the Godfather Part II. Little did I know how accurately a 1974 Hollywood scene portrayed the reality I saw on 2016 CSPAN airing of the Congressional Hearing on the Prescription Drug Market. The theatrics, the drama, and emotions were so perfectly done, I had a hard time seeing the fine line between fiction and the reality. And that to me is a problem.

The policies relating to public health are highly consequential to governance and should not be taken lightly even by those of us who believe in a smaller government. Quality, access, and affordability of healthcare are vital to a society. It effects individuals and businesses. It effects government spending. It effects innovation and a major slice of the economy.

That’s why I found it perplexing that everything I saw boiled down to a show. There was a lot of self-righteous indignation, moralizing, and finger-pointing. On the other side of the isle was a perfect lineup of the worst examples of corporate greed and speculation, that happened to end up in the pharma business. It was a well-orchestrated show, evidently deeply steeped in traditions. Is that what we call leadership?

As I write this, major changes are happening in different parts of the world with regards to cost of pharmaceutical drugs. Japan, facing an aging population and a massive government debt burden, now has Prime Minister Shinzo Abe’s government insisting on price cuts on branded drugs and pushing for a speedier transition to generics. The government has said that in the next few years it would like to see generics make up about 80 percent of prescriptions in Japan from about 50 percent now. It also makes friendlier business environment for smaller companies like Israel’s Teva Pharmaceutical and India’s Sun Pharmaceutical, among others. The Japanese government identified a tangible problem and found a tangible solution.

In the UK, under pressure from consumer advocates, the government is considering overriding a patent for one major branded medication, pay its developer a compensation – process known as compulsory licensing – and authorize a company to make cheap generic copies. The case is still pending, but in a sign that the pressure is real the maker was already forced to slash pricing on the drug, although it wouldn’t disclose by how much.

Meanwhile back home in the United States, we get great reality TV of a group of lawmakers beating down on Martin Shkreli without offering any real solutions. The anticipated FDA review time for new drugs is still at least 10 to 15 months, officially, while in reality it could take years. The border to entry is still prohibitively complex and expensive. There is no mechanism in place to open the market up to more competition, or ways to expedite approval of medicines that are proven to be effective in other parts of the world.

At the same time, legal loopholes in the tax code and complex offshore schemes allow multinational entities to facilitate tax evasion. The structure of our insurance compensation policies and conjunction with HIPPA rules make it easy for some companies to charge double or triple the price as they do in other parts of the world for the same medication. That leverage is then used to undercut competition in other parts of the world, compensating for the losses at the expense of American patients and insurance companies.

Yes, there are many problems in the pharma industry, but whatever problems might exist will be easier to resolve if the government actually focused on their responsibilities and made the regulatory environment more open to transparent business practices and scientific innovation. But that takes real leadership, which is a lot more difficult than beating down on caricatures of the worst elements in any industry.

Givi Topchishvili