Navigating the New Field of International Health Law, Featuring Gian Luca Burci, Legal Counsel for WHO

This lecture, “Navigating the New Field of International Health Law,” will explore the intersection of health and international law and the emergence of International Health Law as a practice area. Featuring Gian Luca Burci, Legal Counsel for the World Health Organization, this program will focus on the growing interactions between health policy and various areas of international law, including international business transactions, intellectual property, international security, and human rights law. The program is sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

The event will take place at Seton Hall Law, Newark, NJ, on Wednesday, February 22, 6 to 7 p.m.  There is no charge. 1 New Jersey CLE credit will be available. Click here to make your reservation or for more information, please contact Sara Simon, Director, Healthcare Compliance Certification Program, at sara.simon@shu.edu or call 973-642-8190.

Update Report, Africa Surgery, Inc., Tom Johnson, Jr., Sierra Leone, December, 2011.

[Ed. note: I had the honor of meeting Tom Johnson a few years back, here at Seton Hall Law when I was still a student and he held a fundraiser through the school. AfricaSurgery, Inc. does God's work-- and I'm well pleased to publish his updates here on HRW. With the help of others, he does a lot-- with very little.]

Because they had intestinal worms and the hemoglobin level of their blood was low, two of the four children we wanted to send from Sierra Leone to Ghana for spinal surgery had to be held back.   I learned of this shortly before I was to depart for Sierra Leone myself on October 25.  I was able to replace one child with an eight-year-old girl in danger of paralysis just in time for her to join the other two patients, a boy and a girl, and two escorts as they left for Ghana on October 28.  I was able to fill the other slot with a young man who was also in danger of paralysis due to the deterioration of some vertebrae by an infection.  We sent him alone on a plane to Ghana in time for surgical treatment by the team from the Foundation of Orthopedics and Complex Spine (FOCOS) in November.  The fifth surgical candidate, a young woman with a severe scoliosis, decided not to have surgery and so was not sent at that time.  The two boys who were held back have had their worms treated and are currently being built up with medications and a nutrient-rich dietary supplement so that they might be able to go for surgery in February, if funds will be available.

All four patients who were operated on are now out of pain and the danger of paralysis.  They are all reported to be walking although one is still having some difficulty moving one leg; hopefully this will clear up with time and physical therapy.

While I was in New Jersey this past year, Foday, one of my Sierra Leonean counterparts, continued to bring people suffering with eye ailments to the Baptist Eye Hospital.  Six of these patients received cataract surgeries which preserved and in some cases restored their vision.  Others were treated medically for infections or as a routine after-surgery follow-up.  Foday and I have so far brought 13 new cases to the eye hospital.  Six of these have undergone surgeries for cataracts, two of these were also surgically treated for pturygiums, a growth-like condition that causes the outside of the eye to be slowly covered with a mesh of over-grown blood vessels which block the vision.  The other five patients are being treated for eye infections.  Two of these, a man 26 years old, and a boy 12 years old, have already lost one eye each to infection.  The goal now is to protect their remaining eyes.

We brought Zinab Sherif, a girl age six, to be seen by Dr. Fritjof, an orthopedic surgeon, and his team who were in Sierra Leone in November on a working visit from Germany.  A bone in Zinab’s right forearm was infected, causing puss to drain out through orifices that would open up after painful periods of swelling.  Needless to say Zinab was making little use of the arm.   Dr. Fritjof cleaned out the infected bone twice and the wound was closed up by a plastic surgeon member of his team.  Zinab was discharged from the hospital on November 28 and her prognosis is good.

A team of plastic surgeons were here at the Holy Spirit Hospital-Catholic Mission in late November.  In five days they preformed 32 procedures.  Because the team included two surgeons who are members of the British Society for Surgery of the Hand (BSSH),  we provided them with: a young boy whose fingers on his left hand are restricted with scar tissue from an accidental scalding, a three-year-old girl with the toes of her right foot contracted due to a burn by fire ashes, and a girl, age six, whose head, face, arms, hands, and one ankle were burnt when a mosquito net caught fire and fell upon her.   We also brought to the team a woman and a young man, both having deep ulcerated sores on their lower legs that required skin grafts.  All five of these cases are still having their dressings changed by nurses at the hospital.  Two will require some physical therapy.

Yabu Kanu, the girl who suffered the multiple burns, and her mother are staying with us at our two houses in Masongbo village because they are from a distant village and are very poor.  There are now 21 spinal surgery children also staying with us at Mansongbo.  We have almost finished the Christmas shopping for them.  They will each be getting a new set of used clothes and new shoes and some items I brought over or had shipped from America including coloring books, used crayons, and drawing paper.  They will each get a pen, a pencil, a note book, and a few hard candies.   There will be dolls for the younger girls costing about $2.00 each, and used toy cars for the younger boys each costing about 45 cents.  There will be a couple soccer balls to be shared by the middle and older boys.  My used National Geographic magazines will go to those not physically able to play ball and for the older girl who is quite bright.  The girls will get little sewing kits and some finger nail sticker-art donated by a friend in New Jersey.  I keep telling them all that “Christmas no go day for bad pikin dem.” (there will be no Christmas for naughty children).   Their behavior has been pretty good lately.

Thank you for all of your help with this work. We have a new website that you might want to visit: www.africasurgery.org.  May you and yours all have a Merry Christmas and a Blessed New Year.

Tom

For Vietnam, Sharp Increase in Infant Fatalities by Hand, Foot, and Mouth Disease

[Ed. Note: We are pleased to welcome Clarissa Gomez to HRW. She is a first year student at Seton Hall University School of Law and graduated in December, 2010 from The College of New Jersey with a B.A. in English and Women and Gender Studies, and a minor in Law, Philosophy and Politics. While she is fairly new to the world of health law, she is currently a representative for the SHU Health Law Forum. Being well-traveled and witnessing the healthcare disparities throughout the world, she has high interest in international healthcare regarding access to treatment and disease prevention, as well as those issues regarding womens' health.]

The World Health Organization (WHO) recently reported information regarding the current outbreak of Hand, Foot and Mouth Disease (HFMD) in Vietnam. While Avian influenza and Severe Acute Respiratory Syndrome (SARS) have been the two leading outbreak diseases in Vietnam over the past eight years, HFMD is the topic of the country’s current health concerns.  Traditionally, HFMD has been common in Vietnam and there have been reports of larger-scale outbreaks from time to time, but so far this year the infection and death toll statistics are already significantly higher than usual. More than 42,000 individuals have been sickened this year, a vast increase from the 10,000 to 15,000 cases that have been reported on average per year since 2008. The main targets of HFMD have been children three years old or younger, and so far 98 children have died from the disease– that is already about triple the  average annual number of chidren’s deaths.

Earlier this year I had the privilege of traveling the dusty, motorcycle-infested streets of Vietnam. After witnessing first-hand the severe lack of sanitary rules to govern sidewalk phở eateries and other food vendors, along with the knowledge that HFMD is most often spread from person to person through contact with virus-contaminated surfaces like unwashed hands, the recent report by WHO is not shocking. The virus can survive for a long period of time in the environment or sewage, which adds to the difficulty in preventing and controlling its spread. Children have the highest risk for infection since they lack the protection of antibodies that are developed within a person’s body with age. While no vaccine or specific treatment exists, the disease has generally been described as mild and quickly recoverable. So, then, what is surprising is the drastic increase in deaths from previous years; it is unclear what may account for this, and the Vietnamese Ministry of Health further warns that the number of cases will likely increase even more in the coming months as children most at risk resume preschool and kindergarten.

I had quite the experience traveling on the train called the “Reunification Express”;  it allows one to travel from north to south Vietnam and vice versa. I was told, and to my surprise, that the train had been modernized and had seen many improvements over the past few years. Suffice it to say, it was no Amtrak. The bathroom consisted of a toilet bowl with a hole that led directly to the train tracks and ground. I could only imagine where the goods of those who used it for relief ended up. Issues of personal hygiene and sanitary practices are at the forefront of the outbreak of HFMD, which is why I mention the train facilities above. The WHO report attributed the spread of HMFD to contact with fluid in blisters or infected feces. As disgusting as it sounds, encountering bodily waste on the street is not a terribly rare or shocking event in rural Vietnam. Perhaps it is a lack of — or disregard for– these everyday public health lifestyle practices that can, and most likely does, account for the statistics being reported by WHO.

Fortunately, the Ministry of Health is closely monitoring the situation and precautionary measures have already been implemented throughout the country in order to reduce further spread of the disease. All health care facilities have received guidelines for surveillance, prevention and treatment of the disease; training courses are being conducted for preventive medicine staff as well as pre-school teachers, and a nation-wide public awareness campaign on television and other means of media are relaying preventative measures to the citizens.

Increased standards of both personal hygiene and environmental care are crucial to the prevention of HFMD, as there is no specific medication administered to combat the disease. It is hopeful, then, that the campaign for heightened awareness will not only prevent the further spread of the virus and lessen the number of casualties due to HFMD, but that Vietnam as a country will benefit as well. Despite the numerous public health issues I encountered, it is, among the countries I’ve visited, one of my favorites.  And since my most recent trip, I hold Ho Chi Minh and Hanoi as two must go-to cities that I desire to travel back to in the future…but I just may not plan my trip between the months of March to May and September to December. Why? Southern Ho Chi Minh city has been one of the hardest hit by HFMD and these months are when the rates of infection are highest.

As tourism accounts for a relatively small but steadily increasing and significant portion of Viet Nam’s economy, it is not hard to believe that the institution of increased sanitary and public health measures, which one might presume will lessen the occurrence and spread of infectious diseases, will ultimately help Viet Nam from both a substantive health and an economic perspective.

Photo Credit: 1, by anjči via Flickr; 2 & 3, Clarissa Gomez

Of Pain and Suffering, Morphine and Global Shortages

In recovery for more than 18 years, up until yesterday I had little good to say about narcotics. Having seen over the years at close quarters what drug and alcohol abuse can do to people and families, I could be considered almost virulently anti-drug. I have no patience for abuse– which may well have spilled over into use. The constant barrage of Pharma commercials which promise that I can avoid any of the discomfort associated with daily life has only added to my distaste. I receive dozens of spam messages through this blog each day promising me cheap oxycontin and the like through internet clearing houses. We are a Pharma Nation. But yesterday, as is so often the case, born of personal experience, I came to appreciate the pain relief that properly administered drugs can bring– and to also appreciate the gravity of the lack of such medicines across the globe.

I woke up and broke out in a cold sweat and quickly began writhing around and wailing in pain like a wild animal caught in a bear trap. The pain came in excruciating waves radiating as though I had just been punched below the belt– repeatedly. Afraid it may have been appendicitis or something equally as dire, I had my son call 911. The police showed up immediately, but the all volunteer ambulance squad took close to 40 minutes to get here. I cursed, hollered, moaned, pled– and even shrieked, the whole time. I did the same even after we reached the Emergency Room, though there I peppered my plaints with apologies.

Convinced it was a kidney stone, the nurse and doctor insisted I take something for the pain. Explaining my recovery status I  protested, but ultimately relented asking if they could make the drug/dose “as little as possible.” They gave me morphine and Toradol. Moments later I became human again. It stopped the pain, it didn’t get me “high.”

The CT scan showed the stone to be making its may down to my urinary tract– all 4 painful millimeters of it. It would need to be 5 millimeters, however, for it to be surgically removed. As such, I longingly wait for it to pass.

Over the years, because I’ve seen so many alcoholics and addicts relapse after using prescription drugs, despite severe pain I’ve eschewed the use of prescription pain relief– always risky to wake a sleeping dragon. But this was something else entirely.

So what does this all have to do with health reform and law? Outside the U.S. there are severe shortages of morphine. Although a dose costs only pennies, the “War on Drugs” is said to have rendered the drug largely unavailable for medical use. In India, morphine is said to be “almost impossible” to get. In the video below,  Diedrick Lohman of Human Rights Watch asserts that “freedom from medical pain should be a basic human right.” I’m not sure how that would be defined legally, but conceptually, I agree. If you ever find yourself within the grips of an unrelenting pain– a pain so great you no longer even feel human–you may too. The video below details the problem, in excruciating terms.

AfricaSurgery, Inc., Update Report, Tom Johnson, Jr., July, 2011

[Ed. note: I had the honor of meeting Tom Johnson a few years back, here at Seton Hall Law when I was still a student and he held a fundraiser through the school. AfricaSurgery, Inc. does God's work-- and I'm well pleased to publish his updates here on HRW. With the help of others, he does a lot-- with very little.]

Dear Friends,

After a baby was born with a hydrocephalous head, the unknown mother kept the boy for about one year before abandoning him in the bushes near the latrine at a hospital-clinic in Sierra Leone.  A nurse named Adema found the child and, despite his deformity, took him in as her own.  She named him Samuel, and gave him her-and-her-husband’s family name of Sesay.  We sent Samuel and Adema to Ghana on March 3, 2011.  Dr. Akoto, a neural surgeon from FOCOS, implanted a shunt in Samuel that will allow excess fluids to drain from his brain into his abdomen.  Samuel is already developmentally and cognitively impaired, but the shunt will prevent water pressure from causing any further damage to Samuel’s brain and will allow him to advance to his greatest level.

In January, 2010 we sent Abdul Kamara from Sierra Leone to Ghana, where Dr. Akoto removed the very large tumor which had displaced up to one-third of his brain.  Abdul recovered and showed no signs of any damage to his brain.  Sadly, however, this past April Abdul passed away unexpectedly after a-day-and-a-night of headache.  We can take some comfort in the knowledge that, after his surgery, Abdul enjoyed 15 months of normal life.

On November 1, 2010 Wusum Koroma, age 28, came to us because he had a hard, bony bump on his head that had started out small but was continuing to grow.  It had already become about the size of a grade-A-jumbo egg.   I feared that this kind of a tumor would eventually bore through Wusum’s skull and invade his brain, as the one had done with Abdul Kamara.  On May 31, 2011 we sent Wusum Koroma to Ghana where he underwent surgery by Dr. Akoto to remove the bone tumor.  Fortunately, the tumor had not yet entered into Wusum’s skull cavity, and he returned to Sierra Leone on July 3.  His prognosis is very good.

ASI field agent Foday Tarawalie has been chartering taxies to take the 18 persons already diagnosed with cataracts to the Baptist Eye Hospital in Lunsar, Sierra Leone, where three of them have already had surgeries to save their vision.  Four others, whose cataracts have matured, are scheduled to be surgically treated during July.  Foday has also been bringing patients who have already had eye surgeries back for check-ups and follow-up treatment with medications.   He reports that more people whose vision is lost or fading from what might be cataracts have approached him.  He has told them to wait until he has finished with our current list and to hope that we can get the funding needed to help them.  A cataract surgery now costs about $85 per eye.  Foday has even more work to do now.  I have just released funds for him to bring to the hospital six more men who have come to him because they are in dire need of hernia surgeries.

Over the past two years, ASI has had nine persons with serious abscess infections of their jaws surgically treated by Dr. Davies, the only oral surgeon in Sierra Leone.  All had hugely swollen faces.  One of these, a young man named Santigi Sesay, had both sides of his lower jaw infected.  Two of the patients had large portions of their lower jaws protruding through an orifice in the sides of their faces where their bodies were dispelling the infected bone material.  All of them were admitted into the government hospital in Freetown for two-to-four months where strong antibiotics were administered before-and-during treatment.  Dr. Davies is now having Foday bring each of these patients back so that he can examine them and treat any who might need further care.

Seven-year old Mahawa Timbo Kamara underwent spinal surgery by a FOCOS team in Ghana in May, 2010 because her small spine was already fractured as a result of a tuberculosis infection, a painful condition known as Pott’s disease.  In December, 2010, Mahawa’s mother passed away, and Mahawa was sent to live with her grandmother in a remote village.  In January, 2011 we brought Mahawa in to stay with us because she had developed on her incision line a small, oozing sore which we began to have treated with antibiotics and topical meds at the Holy Spirit Hospital.  In February, Dr. Harry Akoto, the neural surgeon who was visiting Sierra Leone with two other FOCOS team members to examine patients, determined that Mahawa’s infection was deep.  We sent Mahawa along with another girl, Kadiatu Bangura, age 12, whose implants were working lose from her spine, back to Ghana on March 3.  Mahawa had a procedure known as a “wash out.”  Kadiatu had a revision surgery to remove the detaching portion of implants which were no longer needed because her spine had healed since her first surgery in November, 2009.  Both girls are now back in Sierra Leone and are recovering well.  They have joined the 17 other spinal surgery children living with ASI field agent Foday Tarawalie and his family in a village about four miles from the Holy Spirit Hospital.   Mahawa’s destitute father has asked us to keep his daughter indefinitely because he cannot care for her properly nor provide for her education.  Kadiatu will be returned to her family once we determine that her revision-spinal surgery has completely healed.  Until then, we are keeping her in the vicinity of the hospital where doctors, X-ray and ultra-sound equipment are available.

When Alimamy Sesay was brought to us in December, 2008, he was nine-years old and was in great pain because a tuberculosis infection had caused his spine to fracture.  His father carried him on his back because Alimamy’s legs were paralyzed.   We started Alimamy on anti-TB medications and secured a wheelchair for him.  When I visited Alimamy’s village about one year later, I found that he had recovered much use of his legs.  He was using the wheelchair as a walker and seemed to be out of pain as he visited some neighbors.   But his condition is still serious.  Alimamy’s fractured spine is still exerting pressure on his spinal cord, causing his legs to be spastic.  He could become paralyzed again.  Alimamy is one of the 16 patients now being considered by FOCOS for surgery in Ghana this November.  He is one of the ten of these who have just gotten cat scans this month in the capital city, Freetown.   The scans are expensive, but they will help Dr. Boachie, the head surgeon of FOCOS, determine which candidates need surgery the soonest.

Kadiatu Kanu was six-years old when I was brought to see her on November 26, 2008.  Her spine was fractured from a tuberculosis infection, and her legs were becoming paralyzed.  She was started on a six-month regimen of anti-TB medications which eventually cured her of the tuberculosis.  As the pressure on her spinal cord was relieved, she gradually regained the use of her legs.  But this respite was not permanent; and as her spine continues to collapse, Kadiatu is again becoming paralyzed.  A spine surgeon visiting Sierra Leone from Germany, Dr. Zsolt Fekete, has seen Kadiatu and her X-rays.  As soon as he can work out the details, Dr. Fekete wants us to get Kadiatu to Switzerland to receive emergency treatment, by a specialist in pediatric spinal surgery.  Dr. Fekete is also working out the details for the required hospitalization.  Meanwhile, one of ASI’s helpers in Freetown has gotten Kadiatu a passport and is working on getting her a visa.

On behalf of all of the many Sierra Leoneans whom your generosity is enabling ASI to help — including: 62 who have had successful spinal surgeries; well over 300 men, boys, and some women, treated for debilitating hernias; 52 women surgically treated for various gynecological conditions; over 60 people who have had their sight saved or restored through cataract and other eye surgeries and treatments (one of these was a woman who had been blind for 13 years); eight children who have had clubfeet made straight; the 13 people have had severe abscesses of their jaws drained and surgically treated; and over 100 recipients of reconstructive plastic surgeries for such conditions as cleft lips and cleft pallets, burns and burn-scar contractures, tumors and growths, over 50 children being sponsored for their schooling, and more — I want to thank you for your support and for your prayers.  We at ASI are resolved to continue our work in Sierra Leone to the extent that our funds will allow.

If you are able to join us in this effort at this time (or anytime), checks can be made out to Africa Surgery, Inc., or to ASI, and mailed to me at our new address:

ASI

c/o Tom Johnson

70 Macculloch Ave.

Morristown, NJ 07960

You can also donate on-line at our website:  africasurgery.org (no www. in front).

Whether you can donate at this time or not, please remember our work and our patients in your prayers.

Tom

The Right to Life, Liberty… and the Internet?

This month, the United Nations (UN) Human Rights Council recognized access to the Internet as a human right. The report was written by UN Special Rapporteur on the Promotion and Protection of the Right to Freedom of Opinion and Expression, Frank La Rue, and it separately considers access to Internet content and access to the infrastructure required for Internet access. The report cites over 2 billion Internet users worldwide and notes that the Internet has becomes a key means through which individuals can exercise their right to freedom of opinion and expression. La Rue concludes that “there should be as little restriction as possible to the flow of information via the Internet, except in few, exceptional, and limited circumstances prescribed by international human rights law.”

The report seems motivated by recent episodes of political unrest such as the Arab Spring uprisings. La Rue states that the Internet is “one of the most powerful instruments of the 21st century for increasing transparency in the conduct of the powerful, access to information, and for facilitating active citizen participation in building democratic societies.” He notes that countries have been increasingly censoring online information through 1) arbitrary blocking or filtering of content, 2) criminalization of legitimate expression, 3) imposition of intermediary liability, 4) disconnecting users from Internet access, and 5) inadequate protection of the right to privacy and data protection. La Rue recognizes some legitimate reasons to restrict Internet access, like in the case of cyber- attacks, but focuses on how countries often abuse their power and infringe on the rights of their citizens:

In many instances, States restrict, control, manipulate and censor content disseminated via the Internet without any legal basis, or on the basis of broad and ambiguous laws, without justifying the purpose of such actions… Such actions are clearly incompatible with States’ obligations under international human rights law, and often create a broader “chilling effect” on the right to freedom of opinion and expression.

La Rue specifically notes his concern with the “three- strikes-law” in France and the UK’s Digital Economy Act of 2010. Both of these proposals are anti-piracy measures that would impose penalties against Internet users for illegal file sharing and violation of intellectual property rights. The end result could be suspension of Internet service if copyright infringers disregard warnings. La Rue considers that

Cutting off users from Internet access, regardless of the justification provided, including on the grounds of violating intellectual property rights law, to be disproportionate and thus a violation of article 19, paragraph 3, of the International Covenant on Civil and Political Rights.

Article 19 of the ICCPR concerns the right to freedom of expression.

The fundamental human rights doctrine, the Universal Declaration of Human Rights (UDHR), was penned in 1948 just after the end of WWII. In part based on Franklin Delano Roosevelt’s Four Freedoms, the document was largely a response to the atrocities seen in the war. Article 19 of the UDHR states that

“Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.”

The drafters left the definition of ‘media’ open in anticipation of new technologies, and the Internet and its extraordinary proliferation in recent years is the most relevant form of media in our time.

La Rue, however, does not just depend on this as a basis for his claim that removing Internet access is a deprivation of the basic human right of freedom of expression. He elaborates on how the Internet facilitates the realization of other human rights-

The right to freedom of opinion and expression is as much a fundamental right on its own accord as it is an “enabler” of other rights, including economic, social and cultural rights, such as the right to education and the right to take part in cultural life and to enjoy the benefits of scientific progress and its applications, as well as civil and political rights, such as the rights to freedom of association and assembly. Thus, by acting as a catalyst for individuals to exercise their right to freedom of opinion and expression, the Internet also facilitates the realization of a range of other human rights.

But even if Internet access constitutes a human right, many countries lack access to basic commodities such as electricity, let alone the necessary infrastructure and technologies to access the Internet. La Rue rests on the positive obligation of countries to work towards promoting or facilitating freedom of expression. He encourages countries to develop a “concrete and effective policy… to make the Internet widely available, accessible and affordable to all segments of population.”

La Rue’s report remains the first recommendation in a series of negotiations on how to adopt access to the Internet as a fundamental right. As La Rue concludes, “given that the Internet has become an indispensable tool for realizing a range of human rights, combating inequality, and accelerating development and human progress, ensuring universal access to the Internet should be a priority for all States.”

La Rue is right to understand the internet as a means to effectuate development. The implications for healthcare can, of course, be staggering. An internet connection is no substitute for bread or medicine but that connection  makes widely available medical techniques and public health information and makes “remoteness” a somewhat antiquated concept. If global health is to substantially  improve, internet access will ultimately be key.

Missing Care, Missing Drugs: Canaries in the Medical Coal Mine

While Washington has been focusing on repealing or rolling back parts of the Affordable Care Act, persistent embarrassments of the American health system show how untenable the status quo is. Both lower and middle class families are facing serious problems as they contend with providers’ and insurers’ cost constraints.

I’ll first address the familiar issue of health disparities. According to a recent news report, Lauren E. Wisk of the School of Medicine and Public Health at University of Wisconsin, Madison “examined data from the 2001-2006 Medical Expenditure Panel Surveys on 6,273 families with at least one child.” Wisk’s study shows that excessive financial burdens from cost-sharing are keeping many children from getting the care they need:

Families aren’t choosing to spend their money on going to the doctor when someone is sick because of how much it cost them to see the doctor last time. They’re sacrificing their health because it costs too much to be healthy. . . . We expect that if people aren’t getting the care they need, they’ll be sicker as a result. When you put this all together and look at the big picture, the cost of health care in the U.S. could actually be causing Americans to be sicker.

We might wonder: how can this be? Isn’t the economy in recovery? But we’ve seen this picture before, in the developing world. Growth does not help everyone. India, for example, has had astonishing economic growth, but it “is home to about a third of the world’s underweight and stunted children under the age of 5,” and “the impressive economic growth of the past decade has made only a modest dent into the obstinately high incidence of severe underweight and stunting of children in the country.” As Amartya Sen has shown, not only China, but also Bangladesh, are ahead of India in reducing the number of underweight children, despite the fact that “GNP per capita of $1,170″ in India, “compared with $590 in Bangladesh.” The critical number really is median GNP, and beyond that, real allocation to the sectors and concerns that matter. As the US surpasses Ivory Coast and Pakistan in inequality, don’t count on gains from growth to go to the people who need it.

It’s not just poor patients who need to worry about misplaced priorities in the health care system. We are increasingly seeing shortages of important drugs in the US. (Apparently this issue first caught mass media attention when prisons had a difficult time finding a key barbiturate used in executions.) Given that Congress is busy planning to cut funding for the statistical abstracts of the US and energy research (adding to prior DOJ cuts to studies of industrial concentration in the US), we shouldn’t be surprised to learn that “no one is systematically tracking the toll of the shortages.” Not many journalists are left to report on the government’s failure to report, either. But the head of FDA’s Drug Shortages Program is worried: “This is affecting oncology drugs, critical-care drugs, emergency medicine drugs.” It turns out that much-ballyhooed globalization has some downsides, too:

“We’ve certainly reached a very global supply chain for drug products, with the active ingredients typically made outside of the United States,” said [a] vice president for regulatory sciences at the Generic Pharmaceutical Association. “It could be Europe, India — some cases China. If there’s a problem at a facility in Italy or India, it leads to disruption of the drug supply in the United States.”

And a whole new triage system has developed to address an entirely avoidable crisis:

“We have heard some horror stories where patients are really begging to get the drugs from other sources and where practices or institutions are forced to kind of triage patients and save the drugs for those — quote — most curable, where they have the best prognosis and using substitutes where there isn’t a cure possibility,” [said the] president-elect of the American Society of Clinical Oncology.

A moving piece by Hagop M. Kantarjian describes the dilemmas facing some leukemia doctors:

Recently I sent out a plea on this national crisis to 8,000 oncologists who subscribe to a monthly e-mail newsletter published by the leukemia department at the MD Anderson Cancer Center. Within 12 hours, my in-box was jammed with replies from doctors in more than 25 states, each with his or her own horror story. . . . Take, for example, the 43-year-old Kentucky father who got a substandard dose of cytarabine because his doctor used all the doses he could find but still didn’t have enough. “I don’t know what I’ll do next,” the doctor told me.

Or the 45-year-old retired Air Force lieutenant colonel from Colorado, father of an incoming Air Force Academy cadet, whose leukemia came back after six months. His doctor looked all over the state for cytarabine with no luck and so was forced to give his patient second-line therapy. Or the 15-year-old boy from Florida who is in remission but can’t get the therapy that will cure him.

I see two takeaways from this sad situation. First, the next time someone says that generic “health care costs” are too high, consider whether they really mean we need to reallocate funds from less productive sectors to this, life-threatening crisis. Second, we need to reconsider the wisdom and necessity of far-flung, fragile supply chains for critical products. Barry Lynn has been making this point for some time. His book Cornered argues that “the drive to reduce costs has led to several competing manufacturers relying on a single overseas supplier for certain components and that this makes the whole system vulnerable to an event like an earthquake, a strike, or a war that might put the single supplier temporarily out of business.” Even for those skeptical of Lynn’s thesis in, say, the automotive or computer sector, his warnings should be salient for the food and health care industries. Too many lives have been put at risk by supply chains that are not robust enough to handle predictable challenges.

Hans Rosling, Stats Guru: Income/Health in 200 Countries Over 200 Years in 4 Amazing Minutes

Just too good to pass up: via TPM and the BBC, Hans Rosling, Professor of International Health at Karolinska Institute and Director of the Gapminder Foundation, looks at the relationship between income and health in 200 countries over a span of 200 years– in a few clear and amazingly animated minutes.

Secretary of State Hillary Clinton on the Global Health Initiative

This C-SPAN report is worth considering: “Secretary of State Hillary Clinton spoke at Johns Hopkins University’s School of Advanced International Studies on the Obama Administration’s Global Health Initiative. She discussed the six-year, $63 billion investment that focuses on improving the health of women, children and newborns throughout the world.”

You can see the video (or the transcript) by clicking on the picture.

Recommended Reading: Recent Legal Scholarship on Issues in Global Public Health

Redressing the Unconscionable Health Gap: A Global Plan for Justice (published in the Harvard Law & Policy Review). In this article Lawrence Gostin brings a big picture issue — the vast global health gap between rich and poor — into perfect focus. Professor Gostin reminds us of an “uncomfortable truth” — “that closing the health gap is well within the means of the international community” — and he proposes a simple (in concept if not execution) plan to do just that.  No international treaty would be required; Professor Gostin’s Global Plan for Justice would take the form of a World Health Assembly resolution.  No new organization or governance structure would be required either; rather, the World Health Organization would “assume its place as the global health leader.”  States would be asked to contribute a small percentage — Professor Gostin suggests 0.25% — of their Gross National Income each year to a Global Health Fund.  The WHO would then allocate the Fund’s resources based on “the health needs of developing countries measured by poverty, morbidity, and premature mortality.”  Professor Gostin suggests that the mission of the Fund be threefold: “(1) ensure the fair allocation of essential vaccines and medicines, with particular attention to low- and middle-income countries in a public health emergency; (2) meet basic survival needs [e.g. food, water, sanitation, and vector controls] and create the conditions in which people can be healthy; and (3) help countries that will suffer most to adapt to the health impacts of climate change.”  Existing efforts, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, demonstrate the power of voluntary collective action; unlike the proposed Global Health Fund, however, they are too narrowly-targeted and inconsistent to close the global health gap.  Professor Gostin’s article is short (it’s based on the text of a speech), straightforward, and provocative in the best sense of the word.  I highly recommend it.

I also highly recommend Kevin Outterson’s The Legal Ecology of Resistance: The Role of Antibiotic Resistance in Pharmaceutical Innovation (published in the Cardozo Law Review) in which he uses proprietary sales and volume data for the important hospital antibiotic vancomycin to test a number of widely-propounded theories about the interplay between antibiotic resistance and intellectual property law.  The vancomycin case study fails to support the hypothesis that a patent holder is likely to zealously market an antibiotic with an eye to the drug’s dwindling patent term, without regard for the risk that increased uptake could accelerate the evolution of antibiotic-resistant bacteria.  It also fails to support the hypothesis that if patent terms for antibiotics were extended, patent holders would better manage the sales and use of their drugs to forestall the development of resistance.  By contrast, the story of vancomycin is consistent with the hypothesis that antibiotic resistance stimulates innovation — as bacteria evolve that are resistant to an existing antibiotic a market for a new antibiotic arises.  All of this suggests that “tinker[ing] with the patent system” is unnecessary and could even backfire.  Professor Outterson concludes that a more direct and potentially more effective approach to preserving the antibacterial effectiveness of our antibiotics would be to fix our broken health care reimbursement system, under which infection control is an unreimbursed cost and “hospitals and doctors have generally gained revenues from additional infections[.]“

Developments In Domestic and Global HIV/AIDS Strategies

The White House recently released its HIV/AIDS strategy to reduce the number of new infections in the United States by 25% over the next five years.  During a press conference, President Obama observed that “[t]he question is not whether we know what to do, but whether we will do it.  Whether we will fulfill those obligations… to prevent a tragedy.”  Those obligations primarily concern reducing the number of new infections through HIV prevention programs, increasing access to and quality of care for those living with HIV, and decreasing HIV-related health disparities.  Right now there are 56,000 new infections in the United States every year.  Approximately 1.1 million Americans are living with HIV, but 1 in 5 don’t know it.

Advocates have criticized both the administration and Congress for failing to adequately fund HIV/AIDS efforts at home and abroad.  A recent AIDS Healthcare Foundation (AHF) “Who’s Better on AIDS?” advocacy advertisement unfavorably compared President Obama’s track record to that of President Bush.  (In 2003, the Bush administration implemented the President’s Emergency Plan for AIDS Relief (PEPFAR), a multibillion dollar initiative which has proved successful in lowering the AIDS death rate in Africa, though not the rate of HIV infection).   Michael Weinstein, President of AHF, told CNN that:

“when you see what this administration has done on AIDS, you have to give them very low grades.”

Obama has “consistently underfunded AIDS” programs, Weinstein said.  The president “did not mention the word AIDS for the first five months of his administration.  This national AIDS strategy has been worked on for 15 months, [and] I think it could have been done in 15 minutes.  There’s nothing new in it.”

Weinstein [also] criticized the administration’s intention to redirect money to those groups at greatest risk of contracting HIV/AIDS.  “It’s not good to pit one group against another and it’s unnecessary,” he said.  “The bottom line is that we should be seeking to get all sexually active people to get an HIV test.”

Some recent Canadian research also suggests another bottom line: treating people with HIV reduces the number of new infections.  And there the treatment is free.

The Center for Disease Control (CDC) recently presented its findings that heterosexuals living below the poverty line ($10,000 or less) in American cities were twice as likely to be infected with HIV as their higher-income neighbors.  The statistics translate to 1 in 42 people (the national average is 1 in 222 people).  Most studies focus on sexual orientation, race, and/or intravenous drug use.  None of those factors were included here though.  Kevin Fenton, a CDC HIV/AIDS expert, said that “HIV clearly strikes the economically disadvantaged in a devastating way.”  Researchers found that the risk of spreading HIV came from a lack of access to medical care and unawareness of infection.  Dr. Carlos del Rio, Chair of Global Health at Emory University’s Rollins School of Public Health, frames the issue differently as “[y]ou can talk about ‘Can we decrease the HIV burden in the United States?’  I would say, ‘What can we do to decrease poverty in the United States?’”

The 18th International AIDS Conference took place last week in Vienna, Austria.  Policymakers, researchers, advocates, and persons living with HIV met to draw attention to the epidemic and assess the global response to it.  According to the Associated Press, Julio Montaner, President of the International AIDS Society and Chairman of the Conference, opened the event by pointing to how:

the G-8 group of rich nations has failed to deliver on a commitment to guarantee so-called universal access and warned this could have dire consequences.

“This is a very serious deficit,” Montaner said.  “Let’s rejoice in the fact that today we have treatments that work … what we need is the political will to go the extra mile to deliver universal access.”

With the global economic crisis in full swing, AIDS activists are concerned about developed countries reducing their foreign aid, including funding for AIDS assistance.

In its annual report released last week, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the Kaiser Family Foundation found that global AIDS spending has “flattened.”  Although public and private sources contributed $15.9 billion in 2009, the amount was $7.7 billion short of the estimated $23.6 billion needed to combat AIDS in low and middle-income countries.  Contributing governments included the U.S. (58%), United Kingdom (10.2%), Germany (5.2%), the Netherlands (5%), France (4.4%), and Denmark (2.5%).  The report noted that “without U.S. funding, international AIDS assistance from donor governments would have significantly declined between 2008 and 2009.”

Global Inequality & Access to Health Care

According to a recent study in The Lancet, “The world’s wealthiest two billion people get 75 percent of all the surgery done each year, while the poorest two billion get only 4 percent and often die or live in misery as a result.” It’s a striking fact; how are we to interpret it?

There are two metanarrative accounts of the relationship between inequality and health care. On a Whiggish, optimistic view, vast inequality can generate the capital necessary to fund investment in innovative health care technologies. Scholars like Richard Epstein have celebrated both general economic inequality and unequal access to health care particularly because, they claim, buying power at the top promotes investment in medical advances. On this view, innovations in the wealthy world can diffuse throughout lesser developed regions. Moreover, the rich can also subsidize the poor locally, paying for infrastructure that serves a broader community.

Interpreted less charitably, inequality enables the well-off to bid away resources and opportunities from the poor. Richer nations and persons may snap up limited resources; for instance, in 2009, Jeanne Whalen at the Wall Street Journal wrote an article entitled “Rich Nations Lock In Flu Vaccine as Poor Ones Fret:”

A scramble among wealthy nations to guard against a swine-flu pandemic is raising concerns that billions of people in poorer countries could be left without adequate supplies of vaccine. . . . The emerging battle between the haves and have-nots underscores a major weakness in the global health system: Pharmaceutical companies have severely limited capacity to produce flu vaccines in emergencies.

Inequalities can be even more stark at the R&D phase. If an anti-baldness cure can generate billions of dollars in revenue while a new therapy for tuberculosis only generates hundreds of millions, for-profit pharmaceutical companies may well have a fiduciary duty to invest scarce research dollars in the unhirsute rather than the truly unhealthy.

Lawrence Gostin’s recent article “Redressing the Unconscionable Global Health Gap” offers some practical ways of addressing these disparities:

The international community is deeply resistant to taking bold remedial action — more concerned with their geostrategic interests than the health of the poor. The scale of foreign aid is both insufficient and unsustainable and fails to address the key determinants of health. As a result, the world’s distribution of the “good” of human health remains fundamentally unfair, causing enormous physical and mental suffering by those who experience the compounding disadvantages of poverty and ill health.

Lest we dismiss such inequalities as “not our problem,” Thomas Pogge’s sobering new book elaborates on his earlier argument that wealthier nations are responsible for the plight of the poorest:

[P]olitical and economic inequalities are rising dramatically both intra-nationally and globally. The affluent states and the international organizations they control knowingly contribute greatly to these evils — selfishly promoting rules and policies harmful to the poor while hypocritically pretending to set and promote ambitious development goals.

Both Pogge and Gostin’s work should guide policy responses to the extraordinary disparities exemplified in the Lancet story. As I continue to study fractal inequality in access to medicine, I will be sure to consult their proposals for a more just world. I also hope to see proposals for taxation of “medical tourism” that would redirect at least some of the funds from overseas patients to infrastructure that would support underserved patients in the regions they visit.

Mirror, Mirror on the Wall–Who Has the Most Free Market Health Care System of them All?

At least since legal realist Robert Hale published his Freedom through Law, the question of what constitutes state “intervention” in the market has been complex. For example: at what point does licensing of doctors move from being a natural aspect of any competent health system to being termed a suspect “intervention”? If there is to be free trade in services, don’t we at least need some information about what constitutes genuine medical care? “Perfect information” is a cornerstone of idealized markets—isn’t some baseline of information necessary to any actual market?

In health policy circles, the United States health care system is often seen as the most “free market” system internationally. But even the US would appear to be more interventionist than China, on a cursory reading of Blumenthal and Hsiao’s 2005 article in the NEJM:,

in the early 1980s, China virtually dismantled its apparently successful health care and public health system overnight, putting nothing in its place. In retrospect, this startling and almost inexplicable event seems to have been collateral damage from a much more carefully planned and successful policy strike: the privatization of China’s economy and a general effort to reduce the role of Beijing’s central government in China’s regional and local affairs. Only recently have Chinese authorities recognized the pain and the massive disruption in health care that they have caused.

By contrast, by some calculations, “the current tax-financed share of health spending is . . . 59.8 percent.” Very recent Chinese stimulus spending may be reversing prior privatizations there. But it’s clear that Chinese savings rates are still high, largely because so many citizens are scared of being sick and broke in a market-driven health care system.

Of course, it’s hard to develop any clear metric of private/public here; Blumenthal & Hsiao’s piece may only speak to financing and not other practices. Nevertheless, if Americare fails, the US and Chinese health care systems may be en route to superfusion.

Ethical Marketing Measures in Access to Medicines Index: An Important First Step

Earlier this week, the Access to Medicine Foundation released its 2010 Access to Medicine Index, “a ranking of the world´s largest pharmaceutical companies on their efforts to increase access to medicine for societies in need.”

In a change from the 2008 Index, which was the first to be issued, the 2010 Index includes measures designed to assess companies’ commitment to, and practice of, ethical marketing behavior.  Per the report accompanying the Index, “[t]he marketing and promotion of drugs can have a significant influence on the type of medicines that patients receive.  Particularly in Index Countries [88 countries with low or medium levels of development] with less robust regulatory enforcement and consumer protection, the marketing behavior of pharmaceutical companies can shape access to both appropriate and affordable medicines.  Unethical marketing can lead to suboptimal clinical decisions, prescription of more expensive drugs and irrational use of medicines by consumers, which can result in reduced treatment efficacy and other complications, such as adverse drug reaction and drug resistance.”

The Index ranks pharmaceutical companies’ marketing behavior along three axes: (1) commitments, (2) transparency, and (3) performance.  In the commitments category, companies are assigned points for the marketing codes and standards they have adopted and that they require their local third party sales agents to adopt.  For example, “originators,” i.e., research-based pharmaceutical companies, receive 5 points on a scale of 1-5 for committing to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Pharmaceutical Marketing Practices, the WHO Ethical Criteria for Medicinal Drug Promotion, “or an equivalent industry code.”  Originators that have not committed to any external codes but that have an internal code which covers the same core principles receive 2.5 points.  (The scoring is different for generics on this measure because they do not have a “viable up to date and auditable external code.”)  With regard to third party sales agents, both originator and generic companies can receive all 5 points if they make “specific ethical marketing demands” of their sales agents and then audit the agents’ practices to ensure compliance.

For transparency, the Index gives points to companies that “publicly disclose[] detailed information regarding [their] marketing and promotional programs in the Index Countries, such as payments to physicians or other key opinion leaders and also its promotional activities for other healthcare providers, distributors, etc.”  None of the companies earned any points in this category.  While some have started to disclose payments made in the United States, no company has disclosed payments made in any of the Index Countries.  According to the report, three companies — GlaxoSmithKline, Merck, and Roche — have pledged to disclose payments made in the Index Countries soon.  Companies can also earn disclosure points for revealing breaches of marketing codes and marketing-related litigation in the Index Countries.

For the third category, performance, companies lose points if they breach the IFPMA Code or if they are sued or subjected to fines for marketing behavior.  Companies can earn points for including binding ethical marketing requirements in their agreements with their sales agents and by establishing employee codes of conduct in the Index Countries equivalent to the codes they have in place in other markets.  Despite the fact that issues have been raised “about pharmaceutical marketing practices in the Index Countries, especially regarding clear mention of … adverse side effects,” none of the companies studied lost any points in this category.

As the title of this post suggests, I think that the Index’s attempt to rank companies’ commitment to and practice of ethical marketing practices is important.  Anyone who works in a law school knows how influential rankings can be — for better or for worse.  It is easy to imagine the Access to Medicine rankings providing an additional nudge to companies to begin disclosing payments to healthcare providers around the world not just here in the United States.  At the same time, there is ample room for refinement.  In the performance category, for example, measures, in addition to breaching the IFPMA Code/being sued/ being fined, are needed to expose differences that surely exist in companies’ approaches to marketing in the Index Countries.

Medical Care for Haitians: US Announces Funding

This past Sunday, the White House resumed military airlift of injured Haitians into the United States.  The halt on incoming Haitian patients had happened just days earlier, springing from the economic and logistic fears of many state officials of Florida, where the majority of patients from Haiti were being sent for care.  After finding a solution to the hospital capacity issue in Florida,  and fully knowing that they could not keep certain patients in the medically hazardous environment which is Haiti, White House officials reopened U.S. hospital doors to  badly injured patients.  Yet, the resounding question “who is going to pay for this emergency care?” remains.

The costs are not insignificant.  One Florida hospital executive estimates costs to her hospital alone to be in the millions, and while she hopes some of this cost will be lessened through federal government assistance, other hospitals have already started to initiate reimbursement for the costs themselves through private donations.  In addition, many doctors and nurses are volunteering their services to help reduce the high cost of the care.

The U.S. Department of Health and Human Services announced on Monday that they would supply funding for the emergency care through the National Disaster Medical System, which is usually accessed only in times of domestic emergencies. As described in the announcement, “activation will allow U.S. hospitals that treat Haitian patients evacuated with life-threatening injuries due to the earthquake, to receive federal reimbursement for the costs they incur.”  The reimbursement for the care to Haitians is equal to 110% of Medicare rates.

Since the announcement of aid through the National Disaster Medical System, hospitals in other areas, such as Atlanta, are agreeing to treat patients.  Hospitals in the Atlanta and Florida area are able to provide assistance due to their proximity to Haiti and their “extensive medical resources.”  Other hospitals in the New York, New Jersey, Philadelphia, and Boston areas have been notified that their medical centers may also be tapped  for help in treating the Haitian patients.

Because some of the patients that are being treated at American hospitals are American citizens who were in Haiti when the earthquake hit, some of the medical care can be reimbursed through the insurance coverage that those patients may already have or be eligible to receive.  Interestingly, Haitians who are not legal residents of the United States might also qualify for insurance through Medicaid, but to qualify, the patients would have to be granted “Humanitarian Parole” by U.S. Citizenship and Immigration Services.  Up until this point, Humanitarian Parole visas, which last for a year, have mostly been granted to orphans who were already in the process of being adopted before January 12^th.  Only 50 Humanitarian Parole visas have been granted to those who were sent to the United States for health care; due to the difficulty in tracking patients after their care is complete, the Immigration Services is hesitant to grant more such visas.

While the federal government appears to have systems in place to aid Haitians who are in dire need of medical care for now, questions about long term help still linger.  International aid experts want to see systems of sustainability put into place so that Haiti can once again stand on its own after the foreign aid ends.  Maybe our nation’s leaders will be able to give to Haiti the health care reform it needs, even if they can’t give it to America itself.

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