Prescribing medications is part of the job for nurse practitioners. Most of us write hundreds of prescriptions each month. But does an FDA approval mean these medications are safe? Are they being marketed to medical providers for appropriate uses? The 5 major drug company settlements over the past 5 years indicate we may need to more closely evaluate what we prescribe to our patients- even if these medications are promoted by major pharmaceutical companies.
When new medications are presented to you by pharmaceutical representatives, the natural inclination is to assume they are safe. They have endured extensive testing and have achieved government approval. Based on recent recalls and safety warnings we know this is not always true. Which have been some of the most costly safety and marketing flops?
1. GlaxoSmithKline ($3 Billion)
The largest pharmaceutical fine in history was imposed against GlaxoSmithKline this July. GSK was fined $3 billion for illegally marketing Paxil and Wellbutrin and withholding information regarding the potentially dangerous diabetes drug Avandia. Avandia doubles risk of heart failure after one year of treatment and increases risk of heart attack by up to 43%. Although people died as a result of cardiovascular events in clinical trials while taking Avandia, warnings were not published on the drug’s label. GSK was aware of the drug’s risks but quieted concerns from physicians.
2. Merck ($950 Million)
We all know the infamous story of the painkiller Vioxx. Charged with deceiving the government and prescribers regarding the medication’s safety profile, Merck paid out a $950 million dollar settlement when Vioxx was revealed to increase risk of heart attack and stroke. The drug maker pled guilty to illegally marketing the drug for off label uses and making false statements about it’s safety.
3. Purdue Pharma ($634 Million)
The maker of Oxycontin, Purdue Pharma, originally marketed the drug by promoting it as less addictive and less likely to cause withdrawal symptoms than other opioid painkillers. As a medical provider, you are well aware this is simply not true- in fact the medication is colloquially known as ‘Hillbilly Heroin’. Purdue Pharma was charged with allowing sales representatives to share “fake scientific charts” on the drug’s safety which they showed to providers to validate their claims.
4. AstraZeneca ($520 Million)
In 2010, pharmaceutical company AstraZeneca settled a lawsuit surrounding schizophrenia drug Seroquel for a whopping $520 million. The company was accused of promoting use of Seroquel in children, elderly, veterans and prisoners for unapproved diagnoses. AstraZeneca was charged with misleading medical providers by showing only favorable research on the drug and hiding research indicating it increases the risk of diabetes. The drug caused rapid weight gain in children and increased risk of death in the elderly.
5. Bristol-Myers Squibb ($515 Million)
Charged with illegally marketing it’s drug Abilify to treat elderly patients for dementia and pediatric patients for aggression, Bristol-Myers Squibb settled a lawsuit for $515 million in 2007. The pharmaceutical company illegally recommended that providers prescribe Abilify to children and the elderly, uses for which it was not FDA approved. Providers were also lured to prescribe the medication when the company unlawfully paid medical providers to dispense it’s products and offered kickbacks such as vacations to luxury destinations.
The tales of deceit are endless when it comes to pharmaceutical companies and medical providers. As prescribers, nurse practitioners must be aware that claims made by pharmaceutical companies must be closely evaluated. Just because a drug is marketed to you, does not mean it is safe. If you notice side effects of certain medications among your patients report them and question the drug’s safety profile. It is illegal for you to be bribed to prescribe medications. If you are given gifts or perks, monetary or otherwise, for prescribing medication something is fishy.
Take precaution in prescribing newer, name brand medications to your patients. Drug manufacturer’s do not always have your patient’s best interests in mind.