Sunder on Patents and Access to Medicine

Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here.  The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:

Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.

The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS.   “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.”  ”I know that I’m going to die,” she said, but “who is going to look after my children?”  Her story appears in this video.

Mkhosana’s plight raises difficult interpretive issues.  Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws?  Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.

Sunder acknowledges the importance of patent law to incentivizing the development of new drugs. However, as she wisely notes, one can’t squeeze blood from a stone, however important the “skin in the game” ideology has become to advocates of “free-market” healthcare.  According to Sunder, “creation of generic drug markets for the poor ought not significantly impact the bottom line of Big Pharma, which derives only 5 to 7 percent of its profits from this part of the world.”  It may well be possible to make up for some of that figure by cutting back on promotional budgets in the developed world. It’s also a rather trivial figure compared to tax avoided or evaded on the tens of trillions now hidden away in tax havens.

On the other hand, Big Pharma has a number of justifications and excuses for aggressive assertion of their patents. Spokesmen aver that they are only concerned about what would happen to their profit margins if drugs circulated in an uncontrolled manner. They claim that, if poor countries are permitted to manufacture vast quantities of their drugs, those countries may sell them on the black or grey markets. That, in turn, would reduce the return on such drugs in the developed world, leaving less money for research in the future. Sunder responds that, “The grey-markets concern is a valid one—but . . .the World Trade Organization has begun to craft creative solutions to this problem (requiring generic drugs made for developing world markets to be distinctively labeled, for example).”  As surveillance of both people and goods is better perfected by state security apparatuses and RFID technology, the grey market concern should also become more technologically manageable, enabling finer-grained and more effective price discrimination.

Access to drugs is a key area where ordinary markets simply can’t be expected to achieve humane and rational results.  In 2008, the purchasing power of the average American dog was higher than that of forty percent of the world’s population. Given the extensive extant involvement of the U.S. government both in the domestic pharmaceutical industry and in the international negotiations determining its powers and duties abroad, there is a special moral obligation for U.S. citizens and politicians to assure the widespread and equitable distribution of lifesaving drugs. As Sunder states:

Economists call the millions of people who need a drug but cannot afford it “dead weight loss.” But the millions who die needlessly because of the patent system—a number that some scholars calculate as nine million in the developing world annually—are more than an inefficiency in the system. . . . We must both adopt alternative mechanisms for developing and distributing medicines to the poor (including prizes), and fully support the use of compulsory licenses by developing countries to treat their sick poor. Patent law cannot draw the line at rectifying market failure. Our law must contend with moral failure as well.

Sunder’s eloquent case for access to drugs commends respect and admiration for the Health Impact Fund, Knowledge Ecology International, Medecins sans Frontieres, and other groups for trying to close this gap.

X-Posted at Bill of Health.

Kidney Sales, a Free-Market Approach

Recent events in New Jersey have served to highlight deficiencies in the Kidney Market.

The impoverished of the world, at present, freely considering their options in a market economy, have taken to selling their kidneys, valued at roughly $160,000 on the less than open market, to kidney brokers for the approximate sum of, give or take, $10,000.

At present one may sell a body part legally only in Iran. Thus, as anyone steeped in the strict virtues of Chicago School economics would tell you, the Market in Kidneys suffers at present from “distortions.” The problem, of course, is two fold: the almost universal illegality has added risk to the cost; and limited access to the market has allowed the brokers, through government interference and lack of open competition, to exclude others from their fair share of the profit.

The Kidney Exchange

Patterned after the stock exchange (or perhaps the commodity exchange is a more apt analog), I propose we create, as part of a market driven health reform initiative, a Kidney Exchange. Value maximization will ensure the free flow of kidneys into the most appropriate markets and the most appropriate recipients.

In the interest of fairness and transparency, full reports on each putative “donor” will be submitted to the exchange by medical clinicians who (as is the current practice among medical device researchers) will be paid in stock options in the subjects of their examinations. This stake in the endeavor will ensure commitment to the process. These reports will function as the basis for prospectus and, in the case of those not yet ready for immediate harvest, ongoing quarterly reports.

We would not, of course, limit the purchase of kidneys to those who “need” the actual kidneys, as that too would tend to skew the market. “Need” must be determined through the time-tested criteria of the market: availability of, and a willingness to use, investment capital.

Because, however, even with the most thorough information that money can buy, things can on occasion go awry, we will need a market instrument to ensure protection in the event of failure. Kidney Default Swaps (KDS), an insurance of sorts keyed to whether or not the putative “donor” ultimately tenders a viable kidney. Further, KDS could be patterned after the Credit Default Swap–in that we can allow investors with no connection or insurable interest in the transaction to wager freely on the ultimate outcome–thus creating another lucrative market.

Of course, to combat inefficiencies, a wholesale market will ultimately develop, procurement and development syndicates will be set up, and branded groups of similar subjects will be packaged together for large investors like collateralized mortgage securities.

This investor/market driven approach will further ensure the development of a “Pipeline” to enhance quality and dismiss with the vagaries of procurement.

And lest we forget the benefit to the “donor,” the market too will provide for it. Obviously, anyone who has invested a handsome sum in 4 year old boys from Pakistan (“Pak-Neph B4, b. type O+, trading at…”) will have great interest in safeguarding his investment–nourishing well those kidneys until they are ready for harvest upon demand.

Considering the environmental risks involved for the “free range” donor in many prime but impoverished areas, “harvest banks” to house homegrown investments will, of course, be built. Within the sterile confines of such banks, subjects will grow, watered and fed and exercised to ensure sufficient blood flow and proper kidney function. Subjects kept thus would of course demand a premium on the open market.

Furthermore, upon harvest and release into world, such harvest bank subjects can also readily be expected to breed. Uneducated and untrained in any vocation (market contraindicated) one can reasonably expect them to turn over for modest profit the products of their breeding to the market for eventual harvesting–thus ensuring a steady supply of prime kidneys for generations to come. Naturally, the best genetic lines of kidneys will be identified–arrangements can be made (“Pak-Neph B14/Braz-NephG16, b. type AB+, trading at…), profits in accord.

The addition to one’s portfolio of such financial instruments as “Kidney Futures” or “Kidney Options,” will, I believe, prove a handsome reward to savvy holders. And a thriving business in Kidneys could well be just the market innovation that this economy needs to pull it out of its current doldrums. A Kidney Exchange will provide a swift feast of employment and real wealth.  And of course, we need not be limited to kidneys, there are many other organs that the poor do not, and cannot, use to best advantage.

Conclusion

280 years have passed since Jonathan Swift offered his “Modest Proposal” for solving the pangs of poverty in Catholic Ireland through the sale and eating of Irish babies.[1] Consider this an update of sorts.

There is, however, one distinction between the Swift model that is worth noting: considering the high market value of Irish babies, Swift proposes a preference in procurement for ravenous English Landlords:

I grant this food will be somewhat dear, and therefore very proper for landlords, who as they have already devoured most of the parents, seem to have best title to the children.

A Kidney Exchange, less sentimental but more modern, would, of course, put the preference where the invisible hand of the market deems it best (though under Swift’s criteria the  IMF, and World Bank would seem to be the  sentimental favorites). In this way it would allow, as we do now with private health insurance, that most efficient of instruments, the market, to decide who lives or dies.

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[1] Swift notes that before the age of 12, Irish children were  not particularly saleable or employable, and that “They can very seldom pick up a livelihood by stealing till they arrive at six years old.” His solution stems from the following:  “I have been assured by a very knowing American of my aquaintance in London that a young healthy child well nursed is at a year old a most delicious, nourishing, and wholesome food, whether stewed, roasted, baked, or boiled; and I make no doubt that it will equally serve in a fricassee or a ragout.” His modest proposal: “I do therefore humbly offer it to public consideration that of the hundred and twenty thousand children, already computed, twenty thousand may be reserved for breed…. That the remaining hundred thousand may at a year old be offered in sale to persons of quality and fortune through the kingdom, always advising the mother to let them suck plentifully in the last month, so as to render them plump and fat for a good table.”

The full title of the piece is “A Modest Proposal For Preventing The Children of Poor People In Ireland From Being A Burden To Their Parents Or Country, And For Making Them Beneficial To The Public.” Though most noted for his relatively benign Gulliver’s Travels, Swift’s Modest Proposal helped make him a hero among the Irish.

Benefit Concert for Africa Surgery in Morristown, NJ

Dicey Riley Band

To present a BENEFIT concert for Surgical Efforts in Sierra Leone, West Africa

Featuring Traditional Irish and Celtic Music and Song, Plus the

Bethel AME and Assumption Children’s Choirs

Singing selected choral works

Refreshments donated by parishioners

Saturday, May 12, 2012, 7:30-9:30 pm

Assumption Church

91 Maple Ave., Morristown, NJ 07960

Suggested donation: $15 per adult, Children Free

All proceeds go directly to procuring badly needed medical care and surgical

Treatment for poor farmers and villagers in Sierra Leone.

For more information call, 973-539-2141

[Ed. Note: I've said it before and I'll say it again: Africa Surgery does God's work. They accomplish a great deal with very little.]

Trip Report, Sierra Leone, Tom Johnson, Jr., Africa Surgery, Inc. (ASI)

[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.]

October 27, 2011 – February 15, 2012

Umu Sesay was brought to us by a Catholic missionary priest in 2007.  Her small, seven-year-old spine was so deformed by a tuberculosis infection that I could hardly believe she was still able to stand and to walk around.  We had Umu complete a six-month medical regimen to cure her TB, and we sent her to Ghana in April of 2008 for surgery by a team from the Foundation of Orthopedics and Complex Spine (FOCOS).   Unfortunately, Umu’s chest cavity was so compressed that she was unable to reach the minimum breathing required by the anesthesiologist before she could be cleared for surgery.   But Umu held onto the small plastic device used to measure her inhalation capacity, and she practiced breathing through it after her return to Sierra Leone.  By January, 2010 her persistence had paid off.   She was finally able to make all four of the small plastic balls rise up to the top of a plastic tube, when she inhaled through the testing device.  Umu was one of the four patients ASI sent from Sierra Leone to Ghana for spinal surgery by a FOCOS team in November, 2011.   All four surgeries were successful, and Umu and her three “surgery-mates” are out of pain and the danger of paralysis.  They all can now stand up quite straight.

Umu, whose parents are both deceased, is staying for one month at the ASI base in Freetown where she is receiving nutrient enriched food.  She is being tutored by an ASI helper who is himself a college student and who is a former school teacher.  Umu surprised us with how knowledgeable she is for an 11 year-old girl from a farming village.  Umu will soon be placed with the Cluny Sisters (Catholic missionaries) where she will live at their boarding school for the hearing impaired.  She will attend a primary school for hearing children, until the school year ends in July.  We expect that her spine will have healed by then so that she can be returned to her aunt in their home village.  Umu will no doubt be required to perform many chores, but hopefully she will be able to continue to attend school.

In November, a friend took me to a small village a couple of miles beyond his own to see a six-year-old boy with a “swelling and a sore in his mouth” which turned out to be a fast-growing tumor.  We took little Alimamy Kamara, along with his father, to be seen by the German orthopedic surgeons who were visiting Sierra Leone at that time and who had a reconstructive-plastic surgeon on their team.  The tumor was determined to be inoperable.  The team supplied us with palliative pain medication in the form of suppositories and a liquid formulation that could still be swallowed by the boy whose throat was closing up.   Alimamy died 13 days later. But our visit to his small village turned out to be a blessing for a young man who was also suffering with a painfully swollen face.

Alusine Kamara, age 20, had an abscess in his lower left jaw.  At first reluctant to accept our offer of help, Alusine’s increasing pain eventually forced him to allow us to take him 100 miles down to Freetown.  There the only oral surgeon in the country began what turned out to be a three-month-long process involving admission to the government hospital, heavy doses of intravenous and oral antibiotics and pain meds, and two surgeries.  Two more men completed similar treatments for abscessed jaws while I was in-country, and another man and one woman are to be admitted for oral surgery before the end of this month (Feb. 2012).  This will bring to 18 the number of persons for whom ASI has provided this rather expensive treatment.  The average cost is about $450.  Such abscess can be avoided by simply having decayed teeth pulled in time, saving much pain for the patient, and expense for us.  ASI did have the rotten molars of 55 persons pulled, between March, 2011, and February, 2012, at a cost of about $3.00 each.

While I was in-country, one of my helpers, Foday Tarawalie, brought 38 new patients with eye problems and 21 old cases in need of follow-up medications to the Baptist Eye Hospital in Lunsar.  Nine of the new cases received surgeries to regain their eyesight which was being obstructed by cataracts and/or pterygiums.   The 29 other new cases were medically treated for a variety of conditions including glaucoma and potentially-blinding infections.  ASI is continuing to fund Foday who is continuing to bring old and new patients to the hospital for sight-saving treatments.

Before I arrived in Sierra Leone, 48 surgeries to treat persons with hernias had already been done with funds provided by ASI since February, 2011.   While I was in country 11 more hernia repair surgeries were arranged and funded by ASI, including one for a seven-year-old boy.   Hernias remain a very prevalent health problem in Sierra Leone preventing thousands of men, boys and women from living productive lives.

New Jersey was well represented in Sierra Leone this year.  Dr. Nina Seigelstein returned to the Holy Spirit Hospital with a team including another gynecological surgeon, a scrub nurse, and a midwife.  They preformed 22 major surgeries on women brought to them by ASI, as well as for others who came on their own.   A detailed account can be found at the website: www.oneworldwomenshealth.org.

A member of the ASI board of directors, Sergio Burani, made a nine-day visit to Sierra Leone for the purpose of making a photo documentary of our work.  Sergio fell into stride with the ASI team.  At one point Sergio asked a vendor in an open-air market in the capital city, Freetown, if he could photograph him and his produce.  The man refused but was overheard by the market head-man who, after we explained our mission, insisted that Sergio “snap” away with his camera as much as he wanted to.  All the fuss caught the attention of a passerby who told us of his mother who was in the main government hospital.  Her family could not afford to pay for the medications needed to treat her badly-infected foot which had suffered a wound when a large mortis fell on it.  The young man explained that the entire congregation of their church had decided to pray for his mother to be healed as the only solution at hand.  We paid a visit to the hospital where we heard that the foot might have to be amputated.  We ended up transporting the woman and her daughter 100 miles up-country to our base near the Holy Spirit Hospital.  The woman is being treated as an out-patient for the infection and for a low hemoglobin blood count.  She is scheduled to receive a skin graft by the next reconstructive plastic surgery team that will visit the hospital in early March.  She will not have to lose her foot.

While there, Sergio also instructed six disabled students, three with severe hearing loss, and three post-operative spinal surgery secondary school boys, in the principles of photography and the use of six non-automatic, non-digital cameras which he donated.  One of the hearing-impaired students has already set off on his own, photographing students at their graduation ceremony.   He now is trying to scrape together the money to have his film developed in the hope that he will be able to reap a small profit selling his prints.

On behalf of all of the many Sierra Leoneans whom your generosity is allowing ASI to help, I want to thank you for your support and for your prayers.   I wish to extend special thanks to the Knights of Columbus George Washington Council 359, which gave ASI $3,000 last year.  This more than covered my personal travel and living expenses, enabling all of your donations to go directly to providing medical, surgical, and health care.  We at ASI will continue our work in Sierra Leone to the extent that our funds will allow.  If you are able to join us in this effort, checks can be made out to Africa Surgery, Inc., or to ASI, and mailed to:

Tom Johnson

Africa Surgery, Inc.

70 Macculloch Ave.

Morristown, NJ 07960

You can also donate on line at our website:  www.africasurgery.org

Podcast: Distinguished Guest Practitioner Gian Luca Burci Lectures on the New Field of International Health Law

On Wednesday, February 22, 2012, Distinguished Guest Practitioner Gian Luca Burci, the General Counsel to the World Health Organization (WHO) in Geneva, Switzerland, gave a fascinating talk at Seton Hall Law School on “Navigating the New Field of International Health Law.” The program was sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

Mr. Burci emphasized at the outset that if one defines international health law narrowly, to encompass only international law created “for public health purposes … within a public health environment,” the field is very small indeed.  If one looks more broadly, though, health concerns impact many international law areas, including international environmental law, human rights law, intellectual property law, national security law, and trade law.

The WHO, which is the public health arm of the United Nations, is the source of much or all of what little “hard” international health law there is.  Like other international bodies, the WHO can adopt treaties, but it can also promulgate regulations which do not need to be ratified by its member countries.  Adopted by the WHO’s World Health Assembly, these regulations come into force for all member countries on a specified date.  States that do not wish to be bound by them must affirmatively opt out.

As Mr. Burci put it, the expectation was that the WHO would be a “powerful, normative organization” but “the record is poor, at least in terms of hard law.”  In its 65 years of existence, the WHO has adopted just one treaty, the 2003 Framework Convention on Tobacco Control, and two regulations, the Nomenclature Regulations, which address the classification of, and compilation and publication of statistics on, diseases and causes of death, and the International Health Regulations (IHRs), which aim to limit the international spread of disease.

On the other hand, Mr. Burci explained, the WHO has been “very successful” in introducing rules of a “recommendatory nature,” so-called “soft law.”  The agency is a source of a plethora of technical standards, guidelines, and best practices, including, for example, its non-binding codes on Marketing of Breast-milk Substitutes and on International Recruitment of Health Personnel.

The interplay between soft and hard law is complex and the line between the two can be blurred.  Mr. Burci offered as an example the case of the Codex Alimentarius, which is a collection of non-binding recommendations governing food safety.  If the steps a country takes to protect its food supply conform to the Codex Alimentarius, the country benefits from a presumption that it is in compliance with the General Agreement on Tariffs and Trade (GATT) and the Agreement on the Application of Sanitary and Phytosanitary Measures, both binding treaties. Concomitantly, if a country takes measures that do not comply with the Codex Alimentarius, it exposes itself to the possibility of legal challenge on the grounds that the measures are too trade restrictive.  The ostensibly soft Codex Alimentarius, then, is harder than it seems.

Might we see more hard law from the WHO?  Mr. Burci noted that there has been a strong call for a convention on alcohol control, but opined that such a convention is unlikely to be adopted.  Tobacco, he explained, is different from alcohol in that there is no level of use that is harmless.  Mr. Burci suggested that the problems of illicit trade in medicines and of counterfeit medicines might be amenable to a hard law solution, as might the failure of the market to produce medicines for certain diseases.  With regard to the latter, Seton Hall Law Professor Carl Coleman notes here that a WHO working group recently recommended “the adoption of a binding international convention to promote research and development related to diseases predominantly affecting developing countries.  The proposal is expected to be on the agenda for the May 2012 meeting of the World Health Assembly…, where it is likely to generate significant discussion.”

Listen to Gian Luca Burci’s lecture by clicking on the radio.

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[.]“

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