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If It Ducks Like A Quack (Part 1 of 2)

Yale has many impressive graduates, including Eli Whitney, who declared, "Keep your cotton-pickin' hands off my gin."  The university has also wrapped sheepskin around less admirable characters, including a father and son who conned first America and then Britain into trusting their wrongheaded but likely heartfelt beliefs.  We are, of course, referring to Elisha and Benjamin Perkins, doctors who promoted quack medical apparatus.  Their saga shows what a minefield medicine can be, even for a great institution like Yale.  And then there's the colchicine story.  Dr.  Watson of IBM, mind the gaps!

Quackery
A Quack, Immortalized
Quacks seem to have always been present on the medical scene, as The Charlatan (1857),
by Pietro Longhi, painted while Elisha Perkins was alive, illustrates

The former fame and subsequent notoriety of Perkins père and fils have long since faded from public awareness, but from about 1796 until about 1809 the Yalie healers built a profitable practice on a theory involving metal rods, one steel and one brass, they called "tractors" that they said allowed them to guide the flow of electricity within a patient's body.

Their notion was inspired by the work of the Italian physician Luigi Galvini, who famously used electricity to get frogs' legs to kick.

Elisha Perkins was in his late fifties when he began promoting his exotic cure.  Until that time he had built up a substantial medical practice and an international reputation based on what were apparently very real accomplishments.  His fame was enhanced by his heritage: His father, Joseph Perkins, was also a well-regarded physician and a proud graduate of Yale.  Thus, by the time Benjamin's career, the third stage of the Perkins quackery rocket was launched, the family was very well established in medical and social circles in the United States, in Great Britain, and elsewhere in Europe.

By the time Perkins died at age 59 in 1799 he had become rich, to a considerable extent as a result of his theory about tractors and galvanic currents in the human body.  The fact that the Connecticut Medical Society had tossed him out in 1797 for violating its ethical rules had little immediate effect on his practice, a growing cadre of followers and the growing fame of his son Benjamin.

Benjamin couldn't stand the heat in Connecticut, so he moved his practice to Europe, principally to England.  While he was apparently quite popular and successful, he, like his father, caught the attention of doctors who felt the tractor notion was just plain hogwash.

tractors
Perkins Tractors
Useless except as a placebo, these quack devices were said to guide
the flow of electric currents in a patient's body

In the early 1800s, a skeptical British doctor developed a simple scientific proof to show that the Perkins tractors didn't work the way Perkins avowed, although, like placebo medicine, they may have helped patients who believed in them actually feel better.  Dr.  Haygarth of Bath, England, made replica tractors out of wood, painted them to look like the metal Perkins models, and demonstrated that any effect attributed to Perkins' devices was strictly the result of psychological factors.  Believers could be cured by the wooden tractors, patients who didn't buy the Perkins story weren't affected at all by the wooden or real metal versions.

By the time Haygarth's work was widely understood by medical practitioners and Perkinism, as the tractor theory had become known, was generally discredited, Benjamin had returned to America with a pile of money he made in England.

Although the Perkins tractors didn't actually help anyone for medical reasons, they apparently made some patients feel better and, perhaps more importantly, they didn't hurt anyone either.  Of course it is possible that some of Perkins's patients who relied on his quackery might have suffered because they didn't seek help from a more legitimate physician.  But it appears that Perkins's patients were seeking remedies for maladies that led to discomfort and not hoping for a therapy that would address life-threatening diseases or conditions.  This distinction is very important in the practice of medicine, which often involves some uncertainty but which nevertheless emphasizes the importance of protecting the patient.

For the past couple thousand years and then some, medical doctors embark on their careers under the guidance of an ethical oath that can be traced back to the Greek Hippocrates, who lived from about 460 to about 370 BC.  Hippocrates and the school that unfolded from his life and work created a body of writing that even today provides an excellent foundation for anyone studying medicine and particularly its history.  In addition to its philosophical content, the Corpus, as the work is called, also included notes on medicines and therapies known by the Greeks of the Golden Age.  This knowledge was absorbed by and enhanced by the Romans, and from there it grew into the knowledge bases of the universities of Europe and their medical schools.

The initial tenet of the Hippocratic Oath in most of the interpretations, variations, and derivations that have sprung from it during the past nearly twenty-five hundred years is approximately this admonition to the would-be healer:  First, do no harm.

The Perkins family with their quack tractors may have been passing off nonsense as medicine, but the accounts of their seemingly harmless though not helpful activities suggest they at least conformed to the first principle of Hippocratic medicine.  But they didn't follow Hippocratic philosophy very far, because that fundamental code of medical practice called for a lot of cautious observation and record-keeping.  Consequently, the ancient Greeks or at least the ones who followed the work of Hippocrates and his students supported the use of some medicines and therapies that are still with us today.

Hippocrates
Hippocrates
This physician and philosopher taught his students medical ethics
as he developed a body of empirical knowledge that included the administration
of medicines such as colchicine that are still in wide use today

If this seems quite advanced for science that is so ancient, that is in part because we have lost track of many beliefs that long preceded those of the classic Greeks.  Across the Mediterranean Sea, more than a thousand years before Hippocrates was born, the culture of medicine and medical education was very highly developed.  Egyptians, by 1,500 BC, had catalogued a vast number of medical therapies.  One of the most famous reference documents is called the Ebers Papyrus, and it is generally held that it came from a tomb where it had been stored along with one or more mummies.  The scroll, more than 100 pages long, is a pretty extensive catalog of the materia medica of its day.

From the records left by the Egyptians and Greeks it has become clear that healers and, one supposes, quacks as well knew or at least two medicines that remain in wide use: aspirin and colchicine.

Aspirin, or at least its natural precursors in the form of willow bark and, in Europe at least, the herb meadowsweet, were used by the ancients to relieve pain and for other purposes along the lines we use aspirin and other NSAIDS today.  Modern aspirin was created in 1897 in the laboratories of Bayer, which is still a leader in the marketing of the drug.  The modern version was created by treating the active ingredient in willow bark, salicylic acid, with acetyl chloride in a way that yielded a chemical that provided the benefits of willow bark without the severe side effects it often produced, particularly the intense gastric irritation.

Aspirin is a remarkably effective and usually safe pharmaceutical and it remains cheap and plentiful today, in part because political and cultural developments kept Bayer from totally controlling its production, and in part because these days it can be made for next to nothing by chemical factories in China and elsewhere far from Germany.  Inside that Bayer bottle in your medicine cabinet the pills or at least the powder later pressed into pilule form may well have originated in China.

Colchicine is a treatment for gout, which is caused by the build-up of uric acid crystals in joints, famously the joints of the big toes of the afflicted.  It comes from the bulb of a crocus plant that is related to the species whose flowers yield saffron.  It was known in ancient Egypt and written up in the Ebers Papyrus.  It was also used by the Greeks, the Romans, and pretty much every civilization since.

Not long ago colchicine was not only widely used but also widely available.  It cost only a few cents a pill, possibly as much as a dime.  Today, in the USA but nowhere else, it can cost five dollars or more a pill, and until earlier this year it was only dispensed as the specific medicine Colcrys, although currently it is also available as a generic.  In Europe, Asia, and elsewhere colchicine remains an inexpensive generic, but those places don't have to live under the quirky laws that govern the availability and therefore the cost of colchicine.

The key chapter in the recent story of colchicine involves an FDA activity called the Unapproved Drugs Initiative that sought to bring grandfathered medicines into the same testing regime used for newly developed drugs.  A company called, without regard to Internet slang, URL, said it would do the testing the FDA wanted for colchicine if it could get in return patent protection that allowed it to recover its research costs and then some.  In 2009 URL, in return for following FDA testing guidelines and paying the agency $45 million in fees, got what it had asked for.

Papyrus
Ebers Papyrus
A scroll found in an Egyptian tomb shows that physicians compiled records of materia medica
more than 3500 years ago and that the Egyptians used some of the same natural remedies
prescribed by Hippocrates a thousand years later

This is because the tests it ran or reviewed showed that colchicine worked the way doctors and patients knew it would for the past 3,500 years.  The upshot: URL got exclusive patents.  It then shut down all the competing suppliers of generic colchicine to the America market as it offered its newly named and radically more expensive Colcrys pills to gout sufferers.  About three years later, in 2012, URL, suddenly taking in more than $400 million a year from colchicine sales, sold itself to Takeda, the biggest of Japan's big pharma companies.  Takeda kept the price up and by now may have farmed out manufacturing to a very substantial outfit in India called Sun.  Takeda had already flipped the rest of URL, selling right to all its pharmaceuticals other than Colcrys to Sun.

Earlier this year, with the possibility of a critical FDA review of the colchicine situation in the wings and a rival's litigators chipping away at its legal defenses, Takeda began licensing its colchicine patents to other suppliers.  Immediately, the price for the drug declined at the wholesale level and soon after at retail pharmacies across America.  The situation is still changing; the pendulum continues swinging back.  The retreat provides a bit of financial relief to gout sufferers unable to pay big bucks for small pills.

The situation outside the USA is quite different.  Chemists at pharma companies in India, Turkey, and elsewhere already know how to make colchicine, as have their predecessors for 3,500 years.  The pharmaceuticals game is a global business.  Manufacturers and their distributors sell medicine to privately owned pharmacies and government health authorities.  When a generic drug is allowed to be sold in the USA, it will be available at big name chains and small independent drug stores, too.  The same companies, either directly of via distributors, sell the same medicines to web-based pharmacies.  All these Internet pharmacies offer a lot more than colchicine, which even with sales of a half billion dollars a year across America is not one of the biggies.

With big pharma and big medicine in general now huge and still growing, it's easy to see the IBM might look at this business segment as it searches for opportunity.  But notwithstanding the cases in which powerful companies have exploited the market, and despite the seemingly limitless growth in the costs of hospitalization, diagnosis, treatment and medication, the health business still clings to its ethical roots and, more often than skeptics might appreciate, ultimately reverts to the ideas of Hippocrates and his followers.

In America right now and possibly to an extent the world over medicine is in a boom or perhaps a bubble.  The USA is adjusting to its move towards treating basic health care as a right, something that has long since been the case elsewhere.  Sure the availability of medicine and care are limited by social and economic resources, but the intention of most countries' health authorities is to improve the well-being of every person.

As a result, the big players in the medical world can be subject to considerable scrutiny and criticism.  If IBM ever becomes a significant provider of medical care (including sophisticated technological support for such care) in a way that puts it in public view, it might have to undergo a lot of adjustment.

If IBM can in fact really improve the quality of care and its delivery, it stands to become a cultural hero and to reap considerable financial rewards.  But in medicine practice comes with the risk of malpractice, with the urge to succeed and tell the world about that success comes with the lure to not merely reach but to overreach.  The kinds of bold claims IT companies, including IBM, make about their goods and services might be a bit excessive in the realm of medicine.  Very aggressive pricing practices, such as the ones that made Takeda gigantic profit margins in the colchicine market, may not be consistent with IBM's broader goals, which might require a positive image and which would certainly be undermined by ridicule.  IBM wouldn't want Watson to be lampooned as a quack, the way Perkins was, nor pressed by authorities and the force of public opinion into price-cutting and other reversals of business course the way Takeda was.

So, IBM, we wish you good luck in the world of medicine.  Remember, please, to first be sure to do no harm, including to you and your shareholders as well as to medical patients who might depend on Watson's advice.

— Hesh Wiener June 2015


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