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The Opinion Pages | OP­ED COLUMNIST

Drugs, Greed and a Dead BoyNOV. 5, 2015

Nicholas Kristof

Andrew Francesco was a rambunctious, athletic and joyful child, but also ahandful. When he was 5 years old, a psychiatrist prescribed Ritalin. As hegrew older, he disrupted classes and was given a growing number of potentantipsychotic and other medications.

These didn’t work, so he was prescribed more. Pushed out of oneschool after another, Andrew grew frustrated, unhappy and sometimesalarming. His parents hid the kitchen knives. Then his mother died at 54;the family believes that the stress of raising Andrew was a factor.

When Andrew was 15, the medications caught up with him and hesuffered a rare complication from one of them, Seroquel. One Friday he waswell enough to go to school; on Sunday he was brain­dead.

That’s the story that Steven Francesco, a longtime pharmaceuticalindustry executive and consultant, tells in “Overmedicated andUndertreated,” his harrowing memoir of raising Andrew, his son. He makesclear that the larger problem — even from his view as an industry insider —is a sector that sometimes puts profits above public well­being.

Here’s the central issue: Children with emotional or mental disordershave become a gold mine for the drug industry. Psychiatric medicines forchildren account for billions of dollars in sales annually, and the market has

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boomed.

Between the mid­1990s and the late 2000s, prescriptions ofantipsychotics for children rose about sevenfold.

And now the industry is getting even greedier. It is pushing for a FirstAmendment right to market its drugs for off­label uses, a path that wouldleave children like Andrew with mental health issues particularlyvulnerable. You may think of free speech as a citizen’s right to dissent;pharmaceutical executives see it as a tool to market drugs for unapproveduses.

Two courts have ruled for the drug companies. That’s the triumph ofan ideology that sees corporations as virtuous players endowed withindividual freedoms, and regulators as untrustworthy Luddites.

“The recent court decisions could erode the F.D.A. approval process —put in place to protect the public — and threaten public health and patientsafety,” warns Dr. Margaret Hamburg, until recently the Food and DrugAdministration’s commissioner.

Experts on mental health fear that these rulings could lead to “terribletrouble by confounding science with marketing,” says Dr. Steven E. Hyman,a Harvard expert on psychiatry and former director of the NationalInstitute of Mental Health.

Already, 80 percent of the psychiatric medicine administered tochildren is “off label,” Francesco estimates, meaning that the F.D.A. hasn’tapproved its use for that purpose. Sometimes, off­label use makes sense,but it must be done with care, not just as a result of aggressive marketing bypharmaceutical companies simply aiming to boost quarterly profits.

“Children, because their brains are still developing, are not just smalladults,” Hyman notes.

The pharmaceutical industry repeatedly has shown why “regulation”shouldn’t be a dirty word in American politics:

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In the early 1960s, many countries allowed the “wonder drug”thalidomide to treat morning sickness in pregnant women. A heroic femaledoctor at the F.D.A., Frances Kelsey, resisted industry pressure to approvethalidomide in the United States, thus averting thousands of horrific birthdefects like those it caused abroad.

In the mid­1990s, pharmaceutical companies argued that doctorssystematically under­treated pain, and as a solution the manufacturersaggressively marketed opioids. The companies’ behavior was sometimescriminal (executives of the company that made OxyContin pleaded guilty tocriminal charges), but also hugely profitable. This helped lead to a crisis ofaddiction to prescription painkillers and heroin; today, drug overdoses killmore Americans than guns or cars do.

In a recent column, I recounted how Johnson & Johnson deceptivelymarketed an antipsychotic medicine called Risperdal, concealing forexample the fact that it can cause boys to grow large, pendulous breasts(one boy developed a 46DD bust). J&J got caught, pleaded guilty and paidmore than $2 billion in penalties and settlements — but also registered $30billion in Risperdal sales. The executive who oversaw this illegal marketingeffort was Alex Gorsky, who then was promoted to chief executive of J&J. Ifyou’re a pharmaceutical company, crime sometimes pays.

It’s true of course that pharmaceuticals are, literally, lifesavers; indeed,they may have saved my life from malaria. Steven Francesco says that whileone drug killed Andrew, another seemed to help him, although he also saysthat animal therapy, in the form of a dog, seemed to help him more.Children’s mental health in particular is complicated, with difficult trade­offs, requiring oversight.

Think of cars: They, too, offer a huge benefit but still require carefulregulation.

So if you agree with today’s politicians thundering against regulation,or if you think that pharmaceutical companies should enjoy a free speechright to peddle drugs, then talk to a family fighting opiate addiction. Or a

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parent of a thalidomide child. Or consult the grieving family of Andrew

Francesco.

Gail Collins is off today.

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A version of this op­ed appears in print on November 5, 2015, on page A27 of the New Yorkedition with the headline: Drugs, Greed and a Dead Boy.

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