WHO’s 2013 Global TB Update: Good News and Bad

November 6, 2013 by · Leave a Comment
Filed under: Bioethics, Drugs & Devices, Global Health 

coleman_carl_lg2At last week’s 44th Union World Conference on Lung Health in Paris, one of the main topics of discussion was the World Health Organization’s recently released 2013 Global Tuberculosis Report.  On the bright side, the report confirms a steady decline in the prevalence, incidence, and mortality of TB.  The world is on track to meet the 2015 target of a 50% reduction in the TB mortality rate by 2015, as compared to 1990.

Yet, despite this good news, many aspects of the report remain disturbing.  Of particular concern is the limited progress achieved in diagnosing and treating multi-drug resistant (MDR) TB.  WHO estimates that, worldwide, 3.6 percent of newly diagnosed TB cases and 20 percent of previously diagnosed TB cases involved drug-resistant strains.  But these averages hide considerable regional variation.  In some countries, MDR-TB is estimated to be present in more than 20% of new TB cases and more than half of previously diagnosed cases.

These numbers, however, are just estimates.  A pervasive concern is that national detection systems fail to identify about 1 in 3 people who develop TB.  The percentage of missed cases is even greater among persons with MDR-TB: WHO estimates that less than a quarter of those with MDR-TB have ever been diagnosed.

WHO has called on the international community to scale up efforts at TB detection, as the first step in a comprehensive process of global TB care.  Ideally, detection will be accompanied by access to appropriate treatment, both for the benefit of the individuals who are detected and to reduce the further development of drug-resistant strains.  But, unfortunately, this is not always the way things work.  In 2012, of the 94,000 TB patients detected with MDR-TB, only 77,000 were started on second-line treatments.  In some countries, the treatment gap was even greater; in the African region, only half of those detected with MDR-TB were provided with second-line treatment.  According to WHO, ensuring that a diagnosis of MDR-TB is routinely accompanied by access to high-quality treatment “will require high-level political will and leadership and more collaboration among partners, including drug regulatory authorities, donor and technical agencies, civil society and the pharmaceutical industry.”

In the meantime, what are the ethics of diagnosing individuals with MDR-TB if treatment will not be forthcoming?  From the perspective of the individual being tested, the diagnosis comes with a host of potential harms, including stigmatization, discrimination, and even detention.  If access to treatment – or even humanely administered isolation – cannot be assured, individuals who are given the choice to be tested might reasonably refuse.

At a minimum, persons who are offered MDR-TB testing should be informed of the potential consequences, both positive and negative, as they should be for any other non-trivial medical procedure.   If an individual refuses to undergo testing, the burden should be on those seeking to administer the tests to show that overriding the objection is necessary for legitimate public health objectives.  In settings where persons who test positive for MDR-TB are not given access to treatment, such a showing could very well be impossible to make.

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Sunder on Patents and Access to Medicine

September 30, 2012 by · Leave a Comment
Filed under: Global Health 

pasquale_frank_lg11Last 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.

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Kidney Sales, a Free-Market Approach

September 3, 2012 by · 3 Comments
Filed under: Global Health 
Photo by ed100 via Flickr

CNBC, NASDAQ, Photo by ed100 via Flickr

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

J. Pierpoint Morgan, 1901 via google/LIFE

J. Pierpoint Morgan, 1901 via google/LIFE

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.

trying_new_kidneys1This 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

Gulliver Exhibited to the Brobdingang Farmer, Richard Redgrave (1804-1888)

Gulliver Exhibited to the Brobdingang Farmer, Richard Redgrave (1804-1888)

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.


[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.

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Benefit Concert for Africa Surgery in Morristown, NJ

May 10, 2012 by · Leave a Comment
Filed under: Global Health 

Dicey Riley Band

asiTo 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.]

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

March 13, 2012 by · Leave a Comment
Filed under: Global Health 

[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

When Umu Sesay was brought to us in 2007, she could not stand erect. Her spine was already fractured due to a tuberculosis infection.

When Umu Sesay was brought to us in 2007, she could not stand erect. Her spine was already fractured due to a tuberculosis infection.

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 is finally able to stand straight thanks to surgery done in November, 2011, by the Foundation of Orthopedics and Complex Spine (FOCOS).

Umu is finally able to stand straight thanks to surgery done in November, 2011, by the Foundation of Orthopedics and Complex Spine (FOCOS).

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, before treatment for an abscess in his lower left jaw.

Alusine Kamara, age 20, before treatment for an abscess in his lower left jaw.

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.

asi-tarawallie-sidu-rresized-img_8545-copy1

Sidu Tarawallie, age 60 plus, sees the world clearly now after surgeries to remove a pterygium growth from each eye.

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.

Rokro Kanu, age seven, recovering from surgery to repair his hernia.

Rokro Kanu, age seven, recovering from surgery to repair his hernia.

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.

Boi Woody, was despondentbefore we moved her to the Holy Spirit Hospital.  There visiting  teams of reconstructive surgeons from Great Britain will be able to save her from losing her infected foot.

Boi Woody, was despondentbefore we moved her to the Holy Spirit Hospital. There visiting teams of reconstructive surgeons from Great Britain will be able to save her from losing her infected foot.

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

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