Eventually, whistleblowers helped state and federal authorities to investigate illegal drug company promotion, especially in cases where expensive new mental health drugs were promoted for uses that had not been approved by the FDA. When a medication is approved by the FDA, it is usually approved to treat only one illness, which is listed on the label—at least initially. Once approved, however, it may be tried by physicians to see if it will work for other illnesses.
But drug companies are not allowed to actively promote this “off-label” use, or even to nudge the word-of-mouth. They are supposed to, instead, pay to have the drug tested for those other uses and apply for additional “indications” on the label. Some of these off-label experimentations lead doctors to discover a much more important use for a medication than the one it was originally approved for—some antiepilepsy drugs, for example, have turned out to have much broader applications in treating bipolar disorder. However, because these off-label uses have not yet been thoroughly tested, they can easily lead to problems.
For example, there is a class of medications called atypical antipsychotics—which began when Clozaril (clozapine) proved there was a more effective way to treat schizophrenia, schizoaffective disorder, and the psychotic symptoms of severe bipolar disorder. Clozaril was revolutionary and effective but since it carried a small risk of blood disease and required regular blood testing, drug companies set out to create other atypical antipsychotics that might not require blood testing—and they came up with Risperdal, Seroquel, and several others. While perhaps not quite as effective as Clozaril, they were much easier to take—which meant more patients who needed them might stay on them. And if these drugs had primarily been prescribed for patients with severe mental illnesses who needed them, they would likely have been pretty successful and probably largely uncontroversial.
However, after the runaway success of Prozac—which dovetailed with the relaxing of FDA rules that had all but prevented medications from being advertised on television—mental health drugs started to be prescribed and advertised more aggressively. Physicians—some trained in mental healthcare, many just primary care docs—began trying them on patients with different diagnoses, with varying success. And pharmaceutical company sales reps started spreading the news of physicians who claimed to have good results, even though those results were anecdotal and had not been verified in clinical trials.
This kind of off-label promotion is illegal, and it can be dangerous. Many adults were tried on the drugs who didn’t need a medication that powerful, and then many children with behavioral problems were tried on them, under the mistaken assumption they had an adolescent form of bipolar disorder and needed a baby dose of these medications (which would be a little bit like giving baby doses of skin cancer chemotherapy to kids with acne). With more of the drugs being given to more people, more patients were exposed to potential side effects—which turned out to include early onset diabetes and, in some males, growth of breasts.
Now, if you had schizophrenia and these drugs were the only ones that dampened your severe symptoms, you might actually consider the possibility of diabetes and male breasts to be a risk worth taking. Treatment-resistant schizophrenia is one of the most debilitating diseases known to man. But, certainly, those risks were not worth taking for the much larger group of people without such severe illnesses.
However, that isn’t why the companies were prosecuted. They were prosecuted for illegally promoting these off-label uses. And these whistleblower prosecutions would lead to some of the largest multibillion-dollar settlements in history.
While there have been illegal promotion guilty pleas involving other drugs for other diseases, these prosecutions have clearly had the greatest effect on mental health care. The headlines from the cases have fed a social prejudice that mental health drugs are haphazardly and over-zealously prescribed. They have served to compound stigma. I am very concerned about the health and economic impact of overprescribing and illegal promotion of medications. But I am also concerned about the millions of Americans with mental illnesses who need medication and refuse to take it, or won’t even go get evaluated or diagnosed because of stigma and discrimination.
These prosecutions are also part of the reason that many drug companies have cut back or eliminated their research and development programs for new mental health medications; the other reason is that drugs for central nervous system conditions have generally taken longer to get approved than drugs for other body systems, and a smaller percentage of them are approved at all. So, only a handful of companies are still trying to develop new drugs for brain diseases, and there is a shortage of new drug “targets” for their research. The situation is so dire that the Institute of Medicine held a symposium recently just to discuss how to get the pharmaceutical industry interested again in the broad unmet needs in central nervous system medications.
You may have issues with big business–like companies. A lot of people do. But you should have even bigger issues with those companies getting out of the business of trying to treat or cure your medical problems.
Chapter 13
In mid-November of 1998, I was summoned to the office of Steve Elmendorf, who was chief of staff for my House mentor, Dick Gephardt. I walked over to his office, which was in the back of the Minority Leader’s suite, and he ushered me in and closed the door.
He told me how much Dick loved me and appreciated what I had done for the party. And he said Dick wanted me to become the chairman of the Democratic Congressional Campaign Committee, the party’s political and fund-raising arm for the House. It was a proposition beyond my wildest dreams: a leadership position rarely offered to someone so young. I had just turned thirty-one, and this would make me the fifth-ranking Democrat in the House.
There was, however, one catch.
“If you do this,” he said, “you can’t drink.”
Amazingly, I do not recall feeling freaked out by this in the least, which gives a pretty good indication of how little insight I had into my illness; the level of self-delusion and pretending that goes on with these diseases is really astonishing. I didn’t feel exposed or scared, and I didn’t see this for what it was—my first-ever intervention, by someone who held my professional future in his hands.
My reaction was to say to him, and to myself, “Okay, I got it.”
It was as if he had told me I had to lose a few pounds or shave off a bad mustache. I never for one minute thought, I must have a pretty serious problem if the House Minority Leader is this worried about it. I just had no concept of how much my bipolar disorder and my drinking had impacted my life.
I also didn’t know if Gephardt knew, or if his younger chief of staff had heard the gossip and was trying to run interference for him. I understood that the word must have been out that “Patrick really ties one on.” Of course, I already realized that in Washington everyone knows everything. I just, somehow, believed that was true for everyone else but me. I had grown up in a family culture where we continued to deny, even to ourselves, what everyone else seemed to already know.
But, in all honesty, this had little to do with being a Kennedy and much more to do with being an addict. This is how all addicts are. The denial is so huge, the self-perception so skewed. And the problem worsens so gradually that it’s like being in water and you don’t notice the temperature is rising a degree at a time until you realize, Oh my god, it’s boiling, and I’m cooked!
So, at a moment when many people might have been scared straight, shocked into some kind of self-realization—and would have considered taking immediate action, getting serious help—I just matter-of-factly agreed to stop drinking. As if that meant I could, or that the underlying reasons I was self-medicating with alcohol would just go away.
—
THIS WAS ALL HAPPENING, in part, because the Democrats had done well enough in the midterm election that Newt Gingrich stepped down as Speaker of the House. Dick decided tha
t he would not challenge Al Gore for the Democratic nomination for President, but instead dedicate all his efforts to winning back the House and becoming Speaker. Since we were now only eleven seats behind, we would only need six more seats in the next election to retake the majority—an ambitious but not impossible goal. Besides the amount of money I raised, I would be judged by whether or not we won back those six seats.
There was also another incentive to do well. I was being given a new committee assignment, the most coveted committee assignment: Appropriations. But in order to make sure nobody screamed about my being too low on the seniority ladder to get that assignment, I agreed to suspend my membership in the new committee until after I had finished my two years at the DCCC.
So, in January of 1999 I became the chairman of the DCCC, overseeing a staff of 126 and spending all my free time—and some of my not-free time—traveling all over the country raising money for Democratic congressional candidates to win back the House.
This was a job I was born to do. When the task was stoking Democratic pride and filling party coffers, that’s when the power of this name I inherited, which elevated me in ways I have spent my life trying to fully understand, was perfectly clear. We dramatically increased the levels of donations we sought. Before I took over the DCCC, the highest donation we asked for was $15,000 in “hard money” to join our “Speaker’s Club.” I initiated “Team 2000,” a “soft money” campaign for those who donated at least $100,000. They would be rewarded with special events, including the opportunity to attend a special clambake and tour at our family compound in Hyannis Port. Democrats were still trying to legislate against the growth of soft money in elections, but we just couldn’t let the Republicans keep killing us in that area while awaiting campaign finance reform.
We raised a lot of money and helped a lot of candidates. And because of that, everyone was willing to ignore that I periodically didn’t look so well. Mostly, I kept my illness to myself. But, looking back, it is amazing how much people were willing to ignore or explain away.
—
IN MY OWN MIND, of course, I hadn’t agreed to stop drinking so much as to stop drinking in public. For the most part, I kept that promise for the two years I ran the DCCC. But that was also when I started abusing prescription narcotic painkillers.
I was not alone. While narcotic painkillers were not new, the FDA recently had approved OxyContin, a new, more powerful time-release pill version of oxycodone, the compound found in Percocet and other medications. The drug was approved in 1995 for serious pain management of cancer and the worst cases of arthritis—and labeled as a dangerous, highly addictive Schedule II drug. But as soon as it started being marketed in 1996, OxyContin began being used off-label for other types of pain management and being abused as a street drug.
The risk of abuse was especially high with the larger-dose pills. The drug was available in ten-, twenty-, forty-, and eighty-milligram pills—and, in 2000, they briefly added a one-hundred-sixty-milligram pill (which was quickly forced off the market because of absurd levels of abuse). What made Oxy so effective as a painkiller was exactly what made it so addictive: it was very powerful and remained that way for up to twelve hours. For those who couldn’t wait for the time release, they would chew the pills before swallowing them to break up the coating, or smash the pills and snort them.
Like most people with chronic back pain, I was no stranger to pain medicine. And it’s not like I didn’t need pain relief. My back had never been quite right after the surgery to remove that tumor, and I shared chronic back pain with almost every male member of my family. I just didn’t need quite as much pain relief as I was starting to give myself.
—
FOUR MONTHS AFTER I was put in charge of the DCCC, I was on Air Force One with President Clinton, Dick Gephardt, and others, heading to a major fund-raiser in Massachusetts, where we would meet my father and John Kerry. The event was at the home of Alan Solomont, a longtime family friend and former healthcare company director who was very active in philanthropy and had recently served as the finance chair of the DCCC. (He was later the US Ambassador to Spain.) It was a very important fund-raiser, very close to home in a lot of ways.
I had taken OxyContin for my back pain that morning. Among its other effects, Oxy really diminishes your motor skills—and I am a little uncoordinated to begin with. But it doesn’t make you appear intoxicated, so I had the false impression that I seemed okay.
During the flight, I went to the bathroom. And as I was washing up, I stuffed a paper towel too far into the disposal bin, which had a lid that popped up on a spring. So my left hand got stuck in there. And since I was feeling no pain, I tried to yank it out.
In the process, I ripped off the whole top of my middle finger.
That I felt. But mostly I shrieked because I looked down and saw there was blood all over the bathroom. I wrapped my finger with a paper towel and it was still bleeding like crazy. My heart was pounding; I couldn’t believe this was happening. But since I wasn’t in pain—I could barely feel anything—it was like I was a third-party witness to my own disaster.
So I quietly went up to some of the Secret Service and showed them my hand. They brought me to this room on the plane that got repurposed for major medical emergencies. When I walked in it didn’t look like anything but a little room, but then they started pulling out shelves and operating tables and pulling down lights, and suddenly it was transformed into a surgical suite in a trauma center.
The physician who accompanied the President was there, and he didn’t miss a beat. He turned on the lights, held my hand down, and all the injections were ready in a split second. Next thing I knew they were suturing me up. And, of course, I was pretending like this was really hurting me. Because I knew that in the closet they had lots of narcotics.
Soon President Clinton looked in on me. He couldn’t believe what was going on; he’d never seen anything like this before on Air Force One. He teased me a little bit, and I said, “Mr. President, now I can say I was operated on at thirty thousand feet on Air Force One.”
And he just said, “Oh my god, this is really something . . .”
They finished sewing me up, bandaged me, and handed me a jar of Percocets. The physician said, “Be sure not to take too many of these.”
And as I did with every other doctor who said that to me—and, over the years, there were many—I responded, “Okay.” I couldn’t wait to get out of his line of sight so I could take even more.
In Boston we were met by a big motorcade. We got to the event, and my dad and John Kerry and others were already there; my escapade getting my hand sewn up was all the buzz.
And then I collapsed.
I was taken to a side room in the house and when I came to, the advance people told me that if I didn’t feel up to speaking, the president said it was okay. This was probably their polite way of telling me to sit this one out. And I completely ignored them.
So, when everyone was supposed to go on, I got up and walked to the stage with them. My job was to introduce Dick Gephardt and do my stump speech.
Instead I got up there with my bandaged middle finger—I was really flying by then, I had taken a few more pills—and I said, “It’s good to be here. Some of you may have learned I had a mishap on Air Force One and had to get stitches.”
And then I showed my hand, with the bandaged middle finger.
“As you know,” I continued, “one of our jobs is to come up with effective messaging to take back the House from the Republicans and their right-wing agenda. But sometimes you can’t deliver the message in any other way but to give them, y’know, a hand signal.”
The mere notion I would do this in front of the President, my father, the top donors for the party, is appalling, frightening. But I was feeling no pain at the time. I remember thinking it was all pretty funny.
And, regardless of my behavior, the dinner was a great su
ccess and raised $800,000. And the next morning we got back on the road to do more fund-raising.
—
DURING THE WINTER AND SPRING of 1999, the world of brain diseases was preparing for the first-ever White House Conference on Mental Health, to be held in June. It was, as much as anything, an acknowledgment that the Decade of the Brain was almost over, as was the Clinton presidency—and for all their ambitious goals for improving the care of mental illness and increasing research into its treatment and cure, they hadn’t made enough progress.
The conference was also meant to introduce the important role mental health would play if Al Gore were elected president. And the timing of the conference—just before the official announcement that he was running—was no coincidence.
But there was no mistaking that this was primarily a labor of love for Tipper Gore, who wanted to make it clear that mental health would be her primary concern if she got to be First Lady but also wanted to make a difference right away just in case there wasn’t a Gore presidency. The planning was elaborate, because Tipper held many regional meetings as a warm-up to the national conference and also insisted that the main event be simulcast by satellite—which, back in 1999, was a considerable undertaking—to six thousand locations across the country. The President was also arranging to announce a broad array of executive orders at the conference, which would attempt to make a significant impact on the main issues being addressed.
If it was not already clear that such a conference was long overdue, a major tragedy made the point horrifically and poignantly. On April 20, thirteen students and faculty were killed, and more than twenty were injured, at Columbine High School in Littleton, Colorado, by two heavily armed students who then took their own lives. The assault did not immediately instigate a discussion about mental illness, as more recent shootings have—it took a longer time to figure out what had happened and why.
A Common Struggle: A Personal Journey Through the Past and Future of Mental Illness and Addiction Page 15