By twenty-first century American standards, Stu Dolin’s medical care was close to ideal. That’s a hard idea to swallow, given what happened to him in the end, but it’s true. The real paradox is why it wasn’t enough to save him – and how his doctor became a victim as well.
In June 2010, while taking a generic version of the antidepressant Paxil, Dolin jumped in front of an oncoming subway train in downtown Chicago. His family was convinced that the medication had caused his suicide. Last month, a federal jury agreed. They found GlaxoSmithKline (GSK) liable for Dolin’s death, and awarded $3 million to his widow Wendy – two million for her own loss, and one million for Stu Dolin’s own suffering in his last week of life.
Few people succeed in suing the drug company when a loved one dies from the effects of his medication. It’s far more common to sue the prescribing doctor. Plenty of lawyers are willing to take on a malpractice insurer with limited loyalty to the doctor, and a lively interest in a reasonable settlement. To face off against a multinational corporation with an unlimited war chest, which will fight like hell for the reputation of its product, is something else entirely.
An even bigger barrier is something called the Learned Intermediary Doctrine. Under American law, drug companies have no obligation to level with you, the patient, about the potential hazards of the drug. Their only obligation is to tell your doctor about those risks. He or she is then expected to function as a “learned intermediary” – a sort of educated bodyguard who will tell you what you need to know, in language you can understand, and see to it that no harm comes to you. The drug’s official label (that enormous, technical document folded up and stuffed into the drug package) is written with your doctor, not you, in mind.
But what if that official label does not tell the whole truth about the drug’s hazards? That was the situation faced by Martin Sachman, M.D., Stu Dolin’s family doctor, who became a key witness in the Dolin lawsuit.
Marcus Welby M.D. – the old-school family doctor
That’s not Martin Sachman in the picture at the top of today’s blog – it’s Robert Young in the title role of Marcus Welby, M.D., the popular prime-time TV drama from the 1970’s. To most of us, Dr. Welby represents the family doctor we wish we could have – the one our parents had in the good old days. He was a settled presence in the neighborhood; he’d known you and your family for years. You could go to him for advice on just about anything, and you tended to trust what he told you.
For Dolin, Marty Sachman was that kind of doctor. Since about 2005, Sachman has had what’s known as a “concierge” practice. For an annual fee of about $2,000 (over and above their usual insurance costs), patients can get something close to a Marcus Welby level of care from a doctor of this type. They can be reached on weekends, may even make house calls from time to time, and you’re almost never limited to a ten-minute appointment.
Sachman had been Stu Dolin’s doctor for at least ten years. He was also a close personal friend. (That’s unusual enough these days that attorneys rushed to assure the jury there was nothing “unethical” about it. A generation or two ago it was fairly common, especially in small towns.) Often, faced with a difficult medical decision, there’s one question we really want to ask the doctor: Would you give the same advice to a loved one or a best friend, if they were in my shoes? Mostly, we don’t have the nerve to ask. Stu Dolin was lucky enough to know the answer would be yes.
A Job For A General Practitioner
Most family doctors take that Learned Intermediary business fairly seriously. It’s one reason why they refrain from handling “specialty” drugs for complex or serious conditions, which may require expert management. Chemotherapy for cancer; biologic drugs for Crohn’s disease, MS and other autoimmune disorders – those are best left to specialists.
When he began practicing medicine in the 1980’s, Sachman explained, antidepressants were in that category. The older ones were more problematic, with more side effects, and were reserved for people with relatively severe symptoms. Rather than try to treat such patients himself, he’d refer them to a psychiatrist.
This changed when Paxil, Prozac and the other SSRI drugs came out in the early 1990’s. They were depicted as being safe enough to be handled by general practitioners, and a reasonable option for patients whose troubles didn’t warrant seeing a psychiatrist. By the mid-2000’s, this had become the first-line option for dealing with both depression and anxiety.
As Dr. Sachman saw it, if a patient had mild to moderate depression in response to some trouble or stress in his life that was a “reactive” depression for which he could prescribe SSRI’s. If they had serious problems with sleep and appetite, a slowed-down or unusually agitated appearance, and an inability to function in daily life, that was true “clinical depression,” and they should see a psychiatrist.
Dr. Sachman knew Stu Dolin well, and the anxiety he complained of in June 2010 did not alarm him. Stu was just going through “one of his stress periods, on account of his work responsibilities. He seemed to be getting through it like he did the other times.” Dr. Sachman’s diagnosis was situational anxiety. A drug like Paxil could help people get through a rough period like this. The condition was fairly benign—and like the overwhelming majority of his colleagues, he considered Paxil to be a fairly benign drug.
A “Warning Label” that failed to warn
By 2010, the official label for Paxil gave physicians no reason to doubt that assessment – at least for adult patients. It warned that any antidepressant could trigger agitation and suicidal impulses in children and youth up to the age of 24. However, it also stated that “short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24,” and showed lowered suicidality in those over 65.
The warning added two more crucial sentences:
“Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality or unusual changes in behavior.”
As psychiatrist Joseph Glenmullen told the jury, this label effectively blinded doctors to the risks faced by adults: “What this tells me as a practicing psychiatrist is that if I’m treating a 57-year-old patient, and I put them on Paxil, Paxil couldn’t make them worse. Paxil couldn’t make them suicidal.” If they did feel worse, said Glenmullen, “it would be, and it says explicitly, their depression or other underlying psychiatric condition.”
Worst of all, he said, “if the patient gets worse and it might be the drug, what do you do? You take them off the drug to see. If they get worse and it couldn’t be the drug but it’s the depression, what do you do? You increase the drug, which is going to worsen the risk. So it’s very dangerous.”
The regulatory history of Paxil and the other SSRI’s was almost Byzantine. For years they carried no warnings of a risk for suicide. In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents. A number of medical experts felt the warning should apply with equal urgency to adults.
However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new. This was the “24 and under” label attached to both brand-name and generic Paxil in 2010. This suited GSK just fine. The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.
More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product. In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide. The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty.
A Doctor Taken Hostage
Thanks to GSK, that information never reached Marty Sachman. If it had, he testified, he would never have prescribed Paxil for Stu Dolin. There were plenty of other options—other drugs, and non-drug strategies – for treating situational anxiety. Because of the warning label, he said, he had never prescribed Paxil to a patient under 25; the benefits didn’t seem worth the risk. He had a few adult patients who seemed to do well on Paxil; if they had been on it for several years and wanted to continue, he would refill it. However, in the seven years since Stu Dolin’s death he had not written a single new Paxil script: “I don’t trust the labeling,” he said. “I don’t trust the company, to be honest.”
Marty Sachman’s anguish—and his sense of betrayal—was apparent to everyone in the courtroom. Physicians like himself, he said, “rely on truth and honesty from pharmaceutical companies, and to falsify information or hold back information is totally criminal. How can we treat people effectively and safely if we can’t depend on that?” They couldn’t. Instead, he had prescribed a drug, and a patient had died. That alone would have been traumatic for any honest doctor; that the patient was his best friend made it devastating. It was not like being a Learned Intermediary; it was more like being a hostage.
So what about the average Joe?
Dr. Sachman never got the chance for a follow-up visit with Stu Dolin; within six days of starting Paxil, he was dead. If he had, it’s just possible he could have spotted his longtime patient’s real problem. Maybe even stopped the Paxil. We’ll never know.
In 2010, the year Stu Dolin died, doctors wrote 259 million antidepressant prescriptions. For most patients, who don’t have access to anyone remotely resembling Dr. Welby, the situation is even scarier. They may get a script for an SSRI in a ten-minute encounter with an overworked stranger, based on a checklist left in the waiting room so that every patient can be “screened” for depression. The potential number of doctors taken hostage – and patients tossed overboard – is hard to imagine.
I have to think genial old Marcus Welby, M.D. wouldn’t stand for it. What about us?