'Deadly Monopolies:' An Excerpt From Harriet A. Washington's New Book

This is an adaption from "Deadly Monopolies" Harriet A. Washington's new book, which explores how the corporate takeover of the medical industry is affecting the healthcare system and the future of medicine. This excerpt examines the role of medical patents in slowing U.S. research and inflate drug costs. The book was released on Oct. 4 by Doubleday.

Expensive medicines are always good: if not for the patient, at least for the druggist.

-- Russian proverb

"Could you say that again?" Heather managed to croak weakly. What she thought she heard had so stunned her she was surprised she could produce any soundat all. Robin, the benefits manager, hesitated a moment. "I said that despite the
changes to the insurance plan, your medication costs will continue to be covered," she replied. "However, there is a deductible, and you will be responsible for the out-of-pocket costs of your medication until the deductible is met."

"And the deductible is $2500?" demanded Heather incredulously. Not waiting for an answer, she continued, "So I have to pay for my meds until I have bought $2500 worth?"

"Yes."

"I was in shock," recalls Heather, 35. "I had walked into the HR conference room for what I thought would be a routine benefits meeting and I was going to leave not knowing how I would pay for my pills. I felt clueless and confused. But I knew I needed my medication." Her medication is called Mysoline, and Heather needs it to function because she suffers from epilepsy. She is also a strong, vibrant woman who volunteers at a food bank and holds down a high-energy position as a publicist for a small New York
City publisher.

But she well remembers being a delicate child beset by allergies and wracked by frequent seizures until her neurologist finally discovered that Mysoline quelled them without triggering her numerous sensitivities. For 24 years she has never missed a pill or a doctor's appointment, and she has been rewarded with a seizure-free life.

After receiving the bad news in January 2008, Heather quickly discovered that area pharmacies only sold the 250mg Mysoline tablets she needs in a three-month supply, for $1200, which she had to borrow. After that, she ordered a one-month bottle online
and subsequently traveled from pharmacy to pharmacy in search of the drug. But:

Suddenly, one day in June, I could not find a pharmacy that carried it anywhere. I called the drug's maker in California and the representative informed me a casual voice that they had stopped manufacturing it, and he didn’t know if or when it would be back on the shelves. He said it like he was saying 'It's sunny outside.' He also said something about it being off-patent or the patent changing hands; I was so nervous, I don't remember. I asked, 'What am I supposed to do? I need it,' and he said airily, 'Oh, there must be a generic.' No, he didn't know the name. No, he didn't know where I could get it. No details or advice: That was it.

Heather's doctor found the generic, which worked safely for her. "Then," Heather recalled, "in the summer of 2009, the company called to tell me that the medication would be back on the shelves in mid-July. I was glad to get it, but I resent the indifference that the drug maker and my employer showed toward my life and health." Heather suffered no physical harm from her ordeal, but it has changed her outlook. "This wasn't elective; this was a necessity, and I was shaken to think that my medical lifeline could be snatched away just like that. I don't think I'll ever see drug companies the same way again."

Mysoline, Heather's medical lifeline, is not a novel "blockbuster" -- usually defined as a drug with annual revenues of over US $1 billion. It is an unfashionable drug introduced in 1950 by a company that is now known as AstraZeneca, and it has been surpassed by many more modern anticonvulsives, although it is less toxic and triggers fewer side effects than most newer drugs.

Mysoline is not even very profitable despite its substantial price tag, because relatively few people buy it. It had vanished from store shelves in 2008 after its maker determined that it failed to meet "certain commercial criteria": it simply wasn't profitable enough. But its sudden, unannounced withdrawal had put Heather and others who depend on it at risk for more than isolated seizures: As its label clearly warns, abruptly discontinuing Mysoline can cause status epilepticus, a life-threatening condition in which the person's body is wracked by repeated, frequent seizures that can kill.

The right to profits

At first blush, one may be tempted to brush aside complaints about profit-driven marketing decisions and argue that a nongovernmental for-profit company has the right to abandon any product that fails to meet its commercial criteria. Ours is an unapologetically capitalist society and 'profit' is not a dirty word. Yet Heather's situation dramatizes how in the absence of sufficient countervailing factors, the weighing of profits over patient welfare has generated American nightmares that arise largely because the US government allows drug companies to set prices without the regulation and controls employed by some countries, such as Brazil and Canada.

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