Andrew Francesco was a rambunctious, athletic and joyful child, but also a handful. When he was 5 years old, a psychiatrist prescribed Ritalin. As he grew older, he disrupted classes and was given a growing number of potent antipsychotic and other medications.
These didn’t work, so he was prescribed more. Pushed out of one school after another, Andrew grew frustrated, unhappy and sometimes alarming. 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 he suffered a rare complication from one of them, Seroquel. One Friday he was well enough to go to school; on Sunday he was brain-dead.
That’s the story that Steven Francesco, a longtime pharmaceutical industry executive and consultant, tells in “Overmedicated and Undertreated,” his harrowing memoir of raising Andrew, his son. He makes clear that the larger problem — even from his view as an industry insider — is a sector that sometimes puts profits above public well-being.
Here’s the central issue: Children with emotional or mental disorders have become a gold mine for the drug industry. Psychiatric medicines for children account for billions of dollars in sales annually, and the market has boomed.
Between the mid-1990s and the late 2000s, prescriptions of antipsychotics for children rose about sevenfold.
And now the industry is getting even greedier. It is pushing for a First Amendment right to market its drugs for off-label uses, a path that would leave children like Andrew with mental-health issues particularly vulnerable. You may think of free speech as a citizen’s right to dissent; pharmaceutical executives see it as a tool to market drugs for unapproved uses.
Two courts have ruled for the drug companies. That’s the triumph of an ideology that sees corporations as virtuous players endowed with individual freedoms, and regulators as untrustworthy Luddites.
“The recent court decisions could erode the FDA approval process — put in place to protect the public — and threaten public health and patient safety,” warns Dr. Margaret Hamburg, until recently the Food and Drug Administration’s commissioner.
Experts on mental health fear that these rulings could lead to “terrible trouble by confounding science with marketing,” says Dr. Steven E. Hyman, a Harvard expert on psychiatry and former director of the National Institute of Mental Health.
Already, 80 percent of the psychiatric medicine administered to children is “off label,” Francesco estimates, meaning that the FDA hasn’t approved its use for that purpose. Sometimes, off-label use makes sense, but it must be done with care, not just as a result of aggressive marketing by pharmaceutical companies simply aiming to boost quarterly profits.
“Children, because their brains are still developing, are not just small adults,” Hyman notes.
The pharmaceutical industry repeatedly has shown why “regulation” shouldn’t be a dirty word in American politics:
• In the early 1960s, many countries allowed the “wonder drug” thalidomide to treat morning sickness in pregnant women. A heroic female doctor at the FDA, Frances Kelsey, resisted industry pressure to approve thalidomide in the United States, thus averting thousands of horrific birth defects like those it caused abroad.
• In the mid-1990s, pharmaceutical companies argued that doctors systematically under-treated pain, and as a solution the manufacturers aggressively marketed opioids. The companies’ behavior was sometimes criminal (executives of the company that made OxyContin pleaded guilty to criminal charges), but also hugely profitable. This helped lead to a crisis of addiction to prescription painkillers and heroin; today, drug overdoses kill more Americans than guns or cars do.
• In a recent column, I recounted how Johnson & Johnson deceptively marketed an antipsychotic medicine called Risperdal, concealing for example 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 paid more than $2 billion in penalties and settlements — but also registered $30 billion in Risperdal sales. The executive who oversaw this illegal marketing effort was Alex Gorsky, who then was promoted to chief executive of J&J. If you’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 while one drug killed Andrew, another seemed to help him, although he also says that animal therapy, in the form of a dog, seemed to help him more. Children’s mental health in particular is complicated, with difficult trade-offs, requiring oversight.
Think of cars: They, too, offer a huge benefit but still require careful regulation.
So if you agree with today’s politicians thundering against regulation, or if you think that pharmaceutical companies should enjoy a free speech right to peddle drugs, then talk to a family fighting opiate addiction. Or a parent of a thalidomide child. Or consult the grieving family of Andrew Francesco.