Healthcare Does Not Have a Problem With Silos

August 3, 2017

Healthcare does not have a problem with silos.

In fact, there are no silos in healthcare; there are only boundaries.

If we truly want to change healthcare, we need to break boundaries.

Read the rest of this entry »

Advertisements

#IrishMed Chat – Patients and Caregivers Involvement in Research

July 19, 2017

The Research Loop made made its first tweetchat debut on #IrishMed last Wednesday, July 12, 2017.  Dr. Liam Farrell from Ireland founded and moderates this tweetchat every Wednesday at 10pm BST and 5pm EST, bringing together an international group of patients, caregivers, providers, researchers, and many more to discuss a range of healthcare topics.  For this tweetchat, Liam was kind enough to have me as the co-host to talk about patient and caregiver involvement in research.

Read the rest of this entry »


How will our medical history be written?

April 1, 2013

I read a lot of books on medical history.  I can’t get enough of them.  I find them so incredibly fascinating – the people behind the case studies, the innovators with their extraordinary imaginations, new discoveries challenging institutions of old.

Read the rest of this entry »


Sharing Clinical Trial Data

March 30, 2013

While Big Data is a buzzword thrown about as a promise to change health and healthcare, the reality is we still have many barriers in realizing what our health data can really do.  Big Data is the concept of really large data sets.  As part of Obama’s Open Government Initiative, the government has posted an enormous amount of data sets generated by the federal government at Data.gov.  And they’ve released data specific to health at HealthData.gov clinical care provider quality information, nationwide health service provider directories, databases of the latest medical and scientific knowledge, consumer product data, community health performance information, government spending data.

But this data does not include data held by private companies or research institutions who conduct clinical trials.  This leaves data sitting in repositories that could improve public health, enhance patient safety, and spur drug development if shared more widely both within and across sectors.  But the tides are changing.

Read the rest of this entry »


Askimo TV Interviews on Health Law and Policy

March 30, 2013

I was recently asked to give a series of expert interviews for Askimo on various subjects in health law and policy.  Askimo provides three main services:  it is a free library of 4-10 minute interviews with experts from around the globe, speaking on issues about which they are most knowledgeable. It could be a tax law or a medical disease — knowledge that is practical and can help in daily life.

“I like knowledge,” said David Butnaro, owner of Askimo, based in Tel Aviv, Israel, and soon to have an office in Maryland.  He describes Askimo as “a cross between Wikipedia and TED.”  Currently, the platform has close to 3,000 videos in its library in languages ranging from English to Hebrew to French; 60 percent are in English.

I really enjoyed this opportunity to translate complicated health law and policy subjects and introduce some new ideas like ePatients (I hope I did all ePatients justice) to the world.  Who knows how this knowledge will impact someone’s life.

Below are links to these interviews.

Note – I look forward to the Supreme Court’s decision in FTC v. Actavis after oral arguments this Monday, March 25, 2013, exploring the legality of Pay-For-Delay Settlements.

I also look forward to the Supreme Court’s Decision in Myriad Genetics which will discusses the patentability of the BRCA-1 and-2 genes and the processes to test for them as discussed in “Genetic Patenting” above.


The Costs to Live – Part 4

April 20, 2011

In wrapping up this series (for now), I would like to present an international view of the effects of the high prices of medications and the high cost to live by discussing both economics and human rights laws.

As I mentioned in the first post, pharmaceutical companies today, enjoy the benefits of patents, meaning that another company cannot produce generic equivalents until the patent expires. This leaves the pharmaceutical company who invented the medicine with a monopoly on the market – meaning they can charge whatever price they want (as long as the market will bear it). Again, as I previously introduced, the goal of patents is to sustain inventing incentives and continue to attract investors – helping firms recuperate their extraordinary R&D costs by allowing it to impose prices for their medicines that might be higher than the market value considering the current supply and demand.

The Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement, developed as part of the 1994 General Agreement on Tariffs and Trade Uruguay Round Agreement by the World Trade Organization, established international recognition of patents (along with copyrights, trademarks, and others). Article 27 of the TRIPS Agreement specifically states that “patents shall be available for any inventions, whether products or processes, in all fields of technology,” establishing patent protection for pharmaceuticals for 20 years To maximize profits in this period of monopoly, pharmaceutical companies often set high prices for their medicines. They not only set high prices for their medicines, but they are able to increase prices, as they are currently doing in anticipation of patent expirations in the next few years.

Patents are not inviolable though, limited exceptions may be made “provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner.” Some countries allow others to use a patented invention for research purposes where the aim is to understand more fully the invention as a basis for advancing science and technology. Canadian permits generic producers to use patented products, without authorization and prior to the expiration of the patent, in order to seeking regulatory approval from public health authorities for the marketing of their generic version as soon as the patent expires.

The Agreement also allows Members to authorize compulsory licenses or for government use without the authorization of the patent owner. If a country experiences a “national emergency”, “other circumstances of extreme urgency,” or “government use” or anti-competitive practices, there is no need to try for a voluntary license before issuing a compulsory license. And in these instances, and others of compulsory licensing, the patent owner still has to be paid and the prices are still high.

Patented drug sales in Africa and the Indian sub-continent were only 2.3% of global sales. This might not only be due to high prices. Between 1975 and 1999, only 0.1% of new chemical entities produced were for tropical disease and tuberculosis – the medicines needed most in these areas. (For I’m fairly certain when you have tuberculosis, you are not as worried about erectile dysfunction). Noting the low sales and the trifling research and development on medicines to meet the needs of these populations, patents aren’t incentivizing innovation or drawing in investors.

Under Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) states must “recognize the right of everyone to enjoyment of the highest attainable standard of physical and mental health.” Assisting with implementation of the ICESCR, the Committee on Economic, Social, and Cultural Rights (CESCR) provides guidance and has interpreted that the provision of essential drugs as defined by the WHO is a core obligation of states under the right to health. The World Health Organization (WHO) lists essential medicines and recommends they be available within the context of a functioning health system at all times, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.

The ICESCR also requires, in Article 2, “each State party to the present Covenant undertakes to take steps individually and through international assistance and cooperation…” In assisting and cooperating, countries must then protect human rights in their actions and must “take measures to prevent non-state entities under their jurisdiction from interfering with the enjoyment of… rights abroad.” Non-state entities include private corporations… such as pharmaceutical companies. Furthermore, countries have a duty to facilitate, provide, and promoting human rights in other countries.

Unfortunately, the United States (home to many pharmaceutical companies, and patent issuer to many of the medications they produce) has not taken steps to fulfill these obligations. In fact, the US has placed countries that attempt to exercise compulsory licensing on the US Trade Representative Watch List, effectively pressuring them to act as the US would like – which is to protect patents. Nor has the US taken action against pharmaceutical companies for interfering with the right to health by such actions as their pricing mechanisms.

In her article, “Rights” and wrongs: what utility for the right to health in reforming trade rules on medicines, Lisa Forman, argues that “factors like infrastructure (and poverty) are less of a bar to access than is commonly believed, and that political willingness to address other access factors may be fundamentally linked to removing financial barriers. Thus, addressing economic (price) factors may facilitate action on all other access fronts.

From the discussion I lay out, we can begin to understand advancing the right to health, part of a much bigger human rights movement, focuses heavily on economics including the effects of costs and the barriers they create to realizing this right.

What then can we do to address the inequities in the right to health and particularly the access to pharmaceuticals? Social movement to engage others in discussing and debating the right to health can have a huge impact.  According to Forman, “…rights in concert with social movement offer a powerful tool for raising the priority of the health needs of the global poor, particularly when these are deemed to conflict with free trade and commercial interests.” But social movement alone may not be enough, we also must encourage our leaders in government to embrace international agreements which they signed by ratifying these agreements and enforcing them legally. Even more so, across the world we (individually and through government and private industry) have to change our priorities trading in profits for life.

Vast disparities of wealth and opportunity divide us… Nowhere are the disparities more shocking than when it comes to health. Infectious diseases that have been banished from the most fortunate nations continue to kill millions among the poorest people on the plant – illnesses that can easily be prevented with a vaccine or a safe drug. Infant mortality is a rare and tragic event in the developed world; in the developing world it remains an everyday occurrence. In some places, one in five children dies before the age of five… The wonders and promise of modern medicine must reach everyone, not just a privileged few.[1]


Note: I will address other social determinants of health in a future post as the right to health is interdependent and inextricably linked with other rights and must be addressed not just by attacking pharmaceutical pricing but by considering issues such as clean water, quality food, education, and shelter.

The Costs to Live – Part 3

April 17, 2011

Previously, I introduced you to many of the big pharmaceutical companies and factors influencing the high prices they charge for their medications. The effects of the high costs are highlighted below.

As many as 2 billion people (1/3rd of the world’s population) lack access to essential medicines. As I pointed out above, in America more than 25% of those prescribed a medication don’t take it and 23% cut their pills in half or skipped doses because of the high price of their medications. In developing countries the median prices for drugs are on average 2.7 times higher than international reference prices in the public health-care sector and 6.3 times higher in the private sector. Thus, you can imagine that in a place in developing countries where the prices are higher and income is lower, the even greater barrier to affording medications.

The inability to afford medication (meaning that people don’t take the right dose, skip doses, or don’t take their medicines) has an incredible cost to society. In the US alone, $100-300 billion is lost in decreased productivity from those who do not have access to medications. This does not account for the increased burden on households who may lose income to sick days. Nor does this account for the increased burdens on the health care system (especially if those who cannot afford their medicines end up in the Emergency Room). We cannot even begin to estimate the loss in productivity throughout the world.

Consider the impact of such medications:

– Life expectancy increased 40% with the introduction of medications for cancer and heart disease.
– From 1995 to 2002 medications for HIV/AIDS decreased deaths from 16.2 per 100,000 to 4.9 per 100,000.
– Antihypertensive medicines reduced deaths by 89,000 annually
– Vaccinations eradicated smallpox and nearly eradicated polio

I could go on and on. Let’s not underestimate the amazing contributions pharmaceutical companies make to society by bringing these medicines to market – saving lives. On the other hand, we cannot forget that these companies are not completely altruistic. They have other interests at heart, including (and perhaps primarily?) reaping profits. So while they contribute substantially to our health, they also create huge barriers through their pricing.

For instance, insulin used to treat type 1 diabetes was created in 1922, saving children from slow starvation. To supply 1 bottle of regular insulin costs roughly $10 per bottle of 1,000 units. However, retail price in the United States runs about $191. Granted, insulin today is better than insulin in 1922, there are synthetic insulins on the market now. Even then, the pricing is exorbitant.

Such high prices leave people desperate to save their lives. In the United States, this might mean going to Canada to get cheaper medications. In the other parts of the world, people turn to counterfeit medicines. Counterfeit drug sales alone will reach $75 billion globally in 2010, an increase of more than 90 percent from 2005. And who could blame someone for buying a cheaper counterfeit medicine wanting only to be healthy or to help their sick family members?

Unfortunately, these counterfeit medicines can actually make everyone worse off by cultivating resistance to treatments. Tuberculosis (TB) is the primary example of this, a disease that kills 1.8 million people each year, or 4,500 each day. This disease is the leading killer of people with HIV and is a disease of poverty. When TB is improperly treated because of low quality medications or skipped doses, drug resistance develops leading to (aptly named) multidrug-resistant TB (MDR-TB) and even extensively drug-resistant TV (XDR-TB). The World Health Organization (WHO) estimated 440,000 new cases of MDR-TB were reported last year in 60 countries. Again, who would blame someone for skipping medications they cannot afford or seeking cheaper drugs which may be counterfeit? And while we may think of TB (regular, MDR or XDR) as only affecting developing countries, this highly contagious disease affects the world.

(I may question though whether there might be confusion between drugs illegally imported or generics produced vs. how many are truly poor quality)

The costs of medicines aren’t just impressive when you think about the incredible profits pharmaceutical companies make and their incredible waste. The cost of medicines is most remarkable when you consider the costs of actual lives – people dying from chronic diseases, diseases that can be prevented through vaccinations, and diseases that could be treated with good quality medications.

To their credit, pharmaceutical companies will contribute to a deal between countries to share flu virus samples in exchange for access to affordable vaccines derived from them with the hope of saving lives if another flu pandemic arises. However, they’ve only agreed to provide about one-half of the vaccines needed. What will the other half of the world do?

A bit more remains to be discussed including some economics (in particular, the Trade Related aspects of Intellectual Property Rights) and human rights discourse (including how to ensure accountability). Domestically and internationally, much more remains to be done to ensure the right to health through access to affordable medications.

Continue the series:
The Costs to Live – Part 4