By now you’ve likely heard that drug maker GlaxoSmithKline must shell out $3 billion for the fraudulent sale and marketing of drugs including the popular antidepressant Wellbutrin (also sold as the smoking cessation drug Zyban). In the Big Bertha of healthcare fraud settlements, the British pharmaceutical giant has admitted to playing fast and loose in its branding of Wellbutrin and marketing it for uses not approved by the U.S. Food and Drug Administration.
Wellburtin (generic name: bupropion) has been approved to treat depression, and many claim to have been helped by it. As Zyban it has been deemed useful as an anti-smoking drug. It is not illegal for a doctor to prescribe a drug for off-label uses. But it is certainly illegal for a company to go around marketing a drug for such purposes. Department of Justice documents show that Glaxo marketed Wellubtrin for off-label use to treat a wide range of conditions, including anxiety, biopolar disorder, obesity, sexual dysfunction, weight loss, and more, despite the fact that it was not approved to treat any of them and lacked appropriate research findings to justify those uses. Consumer Reports notes that “Wellbutrin was even promoted to treat bulimia and alcohol withdrawal, two treatments that the label specifically warns against.”
Glaxo continued its marketing-on-steroids despite warnings about possible safety risks from the FDA. A favorite tactic was to lure doctors with anything from free spa treatments to outright bribes to get on board with campaigns.
Dr. Drew Pinsky, the host of TV shows including “Lifechangers” and “Celebrity Rehab with Dr. Drew,” was one of the doctors who threw medical ethics to the wind, hauling in $275,000 in March and April 1999 to push Wellbutrin as an antidepressant that was different from the others in not killing sex drive. The federal complaint says that Glaxo’s PR firm Cooney Waters “hired Dr. Drew Pinsky from MTV and Loveline as a spokesperson to deliver messages about WBSR [Wellbutrin] in settings where it did not appear that Dr. Pinsky was speaking for WBSR.”
Recently unsealed court records reveal that Pinsky claimed on his “Loveline” radio show that the active substance in Wellbutrin “could explain a woman suddenly having 60 orgasms in one night.” Really!
The Daily Beast reports that Paul Thacker, a former staffer for Senator Charles Grassley who participated in the lawmaker’s investigation into Glaxo and later worked for the Project on Government Oversight, said that like many, he grew up listening to Dr. Drew’s advice: “Dr. Drew was how kids in college in California learned about sex, drugs and mental-health issues.”
His abuse of the public trust should shame Pinsky forever, but what about the health and safety of all those people who were listening to his show?
You’d be hard-pressed to find a person who doesn’t want to be skinny, happy and have great sex. Which is why Glaxo put together amarketing campaign in 1999 called – incredibly — “Operation Hustle.” The DOJ complaint reveals that this was Glaxo’s full-court-press to market Wellbutrin as the “happy, horny, skinny pill.”
The FDA never said that Wellbutrin should be used for weight loss or as a libido booster. But let’s take a closer look at what the FDA does say about the drug Pinsky was touting at the Orgasmatron. Warnings issued in 2009 for bupropion point to a dark side of the medication that is not widely known. (For a complete list of possible side effects, you’ll want to peruse the FDA Web site.)
-All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide.
-Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.
The suicide risks associated with antidepressants have been getting most of the attention in the Glaxo scandal, particularly because the company deliberately marketed its antidepressant Paxil to young people despite a known risk of suicide. Suicidal thinking and behavior is linked to the class of drugs known as SSRIs or serotonin reuptake inhibitors, and also to Effexor, a selective serotonin norepinephrine inhibitor, and Wellbutrin, a monoamine oxidase inhibitor.
But there’s something just as shocking – if not more so – in the FDA warnings about bupropion. And it has to do with that item called “homicidal ideation.” In plain English, that means thinking about killing someone. That’s quite an alarming potential side effect, and one many people would be unlikely to accept in a drug if they were aware of it. If you combine “homicidal ideation” with the other list of potential side effects, such as “aggression, psychosis and delusions,” it’s not hard to figure out what you might come up with: violence.
Bupropion is not the only antidepressant with this risk. In fact, a recent study conducted by the Public Library of Science showed that nine out of 10 of the most popular psychiatric drugs are associated with violence, including fluoxetine (Prozac), alprazolam (Xanax) and our friend bupropion (Wellbutrin/Zyban).
Ann Blake Tracy, executive director of the International Coalition for Drug Awareness, would like to see certain drugs, including Wellbutrin, banned for this reason. In a report from the Toledo Blade on tragic events associated with their use, including murder and attempted murder, she explains her view:
“Since when is [homicidal ideation] an accepted side effect? It’s OK to kill somebody?” said an incredulous Ms. Tracy…”I think this would probably be the first time I can think of in the history of this country that we’ve allowed a drug on the market that causes homicide.”
The story of Eric Attwood, an 83-year-old from a small town near Seattle with no previous history of violence, is a case in point. He tried to kill his wife by stabbing her in February 2006. He had been taking Wellbutrin for 12 days. Defense lawyer Jeffery P. Robinson blamed the drug, and the judge was inclined to agree, ruling that he was insane at the time of the stabbing, possibly because of a reaction to medication.
According to the Associated Press report:
The couple had been married for 60 years without any domestic violence before the attack, which Robinson blamed on a sample of the prescription medication Wellbutrin that a doctor had prescribed for Attwood because his family was concerned about symptoms of depression.
There is an interesting word in the report: “sample.” Samples of drugs often seem to be hanging around in doctors’ offices and their use – popular particularly in times of economic hardship – often flies under the radar. This is yet another example of aggressive marketing that can go awry when doctors give patients free samples left by drug company reps during launches and marketing campaigns. Such samples are known to influence doctors’ prescription habits and have beencriticized as potentially harmful to patients, difficult to monitor and a source of inflated costs in healthcare (the promotion of samples is expensive).
Bupropion, along with other antidepressants, has long been associated with potential dangers to people suffering from mood disorders, particularly the various forms of bipolar disorder, which is notoriously difficult to diagnose. A patient may be treated for depression, for example, when bipolar disorder, especially the less well-known and less dramatic forms such as “soft bipolar” or “bipolar II,” is the real underlying problem. If such a patient is given bupropion or an SSRI, there is a danger of what’s called a “manic flip.”
The Livestrong Web site describes this risk:
Wellbutrin can trigger manic episodes in patients that are actually suffering from bipolar disorder (manic depression) rather than clinical depression. This is a potential side effect of similar anti-depressant medications as well. Paranoid feelings, suicidal behavior and hallucinations may also be experienced by certain users. Patients experiencing these types of effects while using Wellbutrin are urged to cease product use and consult their prescribing doctors immediately.
And then there’s the problem of potential “psychosis,” which may be associated with risk factors like bipolar disorder or the simultaneous use of other drugs like benzodiazepines.
The use of more than one drug to treat mental health conditions is common. A patient suffering from anxiety and depression may be prescribed something like bupropion to treat the depression and also given benzodiazepines (Xanax, Valium, Ativan, etc.) to combat occasional bouts of anxiety. But the benzodiazepines may work to lower inhibition and inadvertently increase the potential effects of the bupropion. If those effects happen to be things like aggression, hostility, or homicidal ideation, well, you can see a potential tragedy in the making. The patient may have little understanding of such risk factors and may not know what is happening to him or her. The behavior is then often blamed on the depression or anxiety rather than the medication.
The Web site SSRI Stories (which includes other meds like Wellbutrin, which is not an SSRI), lists thousands of news reports of suicide and violent acts associated with the use of antidepressants, and includes a sortable database. To read through the list is to get a shocking glimpse into an ocean of human tragedy the illegal marketing of these drugs has likely exacerbated.
Murder / Wellbutrin / 1998-12-02, Michigan / 18-Year-Old Kills 5 Family Members
Murder / Wellbutrin / 2010-06-13, North Carolina / Husband Told Dr. that Wellbutrin Gave Him Violent Thoughts: Then Killed Wife
There have also been reports of teenagers crushing and snorting the drug, as well as abuse in prison populations. It is not difficult to imagine the results that might come such unsupervised use. Add a dose of alcohol, or a history of aggression, and the potential for harm only increases.
All of this is not to say that Wellbutrin and other antidepressant drugs do not benefit many patients. But the illegal marketing by Glaxo and the pushing by paid doctors like Drew Pinsky suggest a concerted effort to dupe the public about the safety and efficacy of such medications. People certainly want to be skinny and sexy and happy. But most of them don’t want to wind up hurting themselves or someone else. As long as drug companies like Glaxo and ethically deficient doctors like Pinksy get away with putting profits over health, the potential for tragedy will only grow.
At the very least, doctors must exercise great caution in prescribing these medications and closely monitor their use (a situation which, given the inadequate coverage of psychiatric visits under most health insurance plans, is unlikely). Above all, we need to rethink the ways these drugs are marketed, and stop slapping the wrists of companies that behave illegally and doctors who abuse their office. Jail time and the revocation of medical licenses would be a start.