Drug manufacturer GlaxoSmithKlein was hit yesterday with the largest health-care-fraud settlement in U.S. history, a $3 billion fine to settle criminal and civil charges regarding the asthma medication Advair, the diabetes drug Avandia, and the antidepressants Paxil and Wellbutrin. While the details of the charges by the Department of Justice read like a Grisham novel, the complaints are all too serious, and offer important lessons for anyone who takes prescription drugs.
Lesson 1: Find out if a drug prescribed to you is approved to treat your condition and, if not, why your doctor thinks it makes sense for you.
Some of the most eye-brow raising charges against GSK were its promotion of both Paxil (paroxetine and generic) and Wellbutrin (buproprion and generic) for conditions not approved by the Food and Drug Administration. While prescribing a drug "off-label" is legal, promoting it for that use is not. And that's apparently something GSK did, including misrepresenting research data to show benefit and to hide safety problems. For example, the company promoted Paxil for use in children and adolescents though it was not approved for them. In fact, studies had shown it was not effective in kids and was potentially dangerous, even suggesting that it increased the risk suicide and violence. With Wellbutrin, the drug company marketed it for anxiety, attention-deficit hyperactivity disorder, biopolar disorder, obesity, sexual dysfunction, weight loss, and other medical conditions, though it was not approved to treat any of them, and lacked solid research findings to support its use. It was even promoted to treat bulimia and for people who suddenly stopped drinking alcohol, two treatments that the label specifically warns against. According to the Department of Justice's official complain documents, the nickname around the GSK offices for Wellbutrin was the "happy, horny, skinny pill."
Lesson 2: Say 'no' to free samples.
As part of promoting the drugs for off-label use, GSK relied on free samples, given to doctors to be handed out to patients, for both Paxil and Wellbutrin. Companies use free samples, legally, as marketing tools, especially for expensive, brand-name only medications. While that might seem like a good deal, whether its for an off-label or an approved use, it's not. The samples can lead to higher costs over the long-term, because when the samples run out and it's time to fill a prescription, you're stuck paying for the full price of the brand-name drug. So skip samples when possible and ask for a generic drug instead. Generics are usually not only cheaper, but more is known about their safety and effectiveness, too.
Lesson 3. Watch out for drug reps.
To entice doctors to prescribe the asthma medication Advair (fluticasone and salmeterol), along with Paxil, and Wellbutrin off-label, the drug company paid kickbacks to doctors, took them out to dinners, gave them tickets to Madonna concerts and Celtics and Yankees games, and sent them on hunting trips or vacations to spas and resorts in places like Bermuda, Hawaii, and Jamaica. The company also paid doctors million in speaking and consulting fees, and even created sham advisory boards. What matters most is if your doctor can be bought. If you see drug reps loitering in your doctor's office, take note, since the freebies and promotional items drug companies give doctors can influence the drugs they prescribe. Although, thankfully, some drug companies have curtailed those types of practices, and some doctors ban drug reps from their waiting rooms, the practice continues. To find out if a company has paid your doctor for speaking engagements or consulting, see Dollars for Docs. It's a project of ProPublica, a nonprofit group that collects publicly reported data on payments from 12 drug companies.
Lesson 4: Read up on the safety of your medications using unbiased sources. In the case of the type 2 diabetes drug, Avandia (pioglitazone), GlaxoSmithKline was cited for repeatedly not alerting the FDA of various cardiovascular safety problems relating to the drug, although the company was aware of them. While the company did not alerted the FDA in a timely fashion, other organizations, including Consumer Reports, were tracking safety "signals" and data regarding Avandia and reporting on it.
GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data [U.S. Department of Justice]
U.S. District Court Complaint Against GlaxoSmithKline [U.S. District Court for the District of Massachusetts]