Abbott Laboratories fined $1.6bn for Depakote marketing
US pharmaceutical company Abbott Laboratories has been fined a total of $1.6 billion for the marketing of Depakote, an anti-seizure medication.
The company pleaded guilty to a violation of the Food, Drug and Cosmetic Act for misbranding Depakote, which is also a mood-stabiliser.
The drug has been approved for the treatment of epilepsy, migraines and bipolar, but according to the US Justice Department, Abbott Laboratories encouraged its sales team to market the drug as being a suitable treatment for dementia and autism.
It is thought to be the biggest settlement ever involving just one single drug.
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Abbott Laboratories will now pay $800 million to federal and state governments, $700 million as a criminal penalty and $100 million to states to resolve consumer protection matters.
The company reportedly had a team of sales representatives that specifically sold the drug to nursing homes.
There have also been allegations made claiming Abbott Laboratories used financial bribes to persuade healthcare professionals to prescribe the drug to their patients.
Although doctors themselves can prescribe medication to a patient in the way that they see fit, pharmaceutical manufacturers are only permitted to market products as they have been approved by the FDA (US Food and Drug Administration).
Following today’s ruling, Abbott Laboratories has agreed to undergo a probationary period of five years, during which its operations will be overseen by the US government to ensure no other misdemeanours take place.
Commenting on the settlement, Laura J. Schumacher, Executive Vice President of the Abbott General Counsel, said: “We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement.
“The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements.”
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Dexcom: changing the lives of people with type 1 diabetes
It is estimated that 9.3% of adults around the world are living with type 1 diabetes, which amounts to a total of 463 million people. A further 1.1 million children and adolescents under the age of 20 are living with the condition.
Unlike the more prevalent type 2 diabetes, where the body still produces insulin and symptoms develop slowly, people with type 1 diabetes need regular insulin injections or pumps, and must monitor their sugar levels frequently.
In recent years a number of remote glucose monitoring systems have become available that patients can use at home. These work with a sensor, usually placed under the skin, that measures glucose levels every few minutes. This information is then transmitted wirelessly to a device like a smartphone or tablet, which can then be shared with their clinician.
British actress Nina Wadia's son Aidan, 14, has type 1 diabetes, and has been managing his condition using Dexcom, a glucose monitoring system used by patients all over the world. Here Wadia explains how Dexcom has improved their lives.
As a parent of someone with type 1 diabetes, what is your day-to-day life like?
Being able to take a breath, think and pivot constantly without getting frustrated becomes an essential mindset because sometimes it feels like each day is determined to be different from the day before. Whatever worked yesterday is going to misfire today.
Which areas of yours and Aidan’s life are most impacted by diabetes?
The one thing that you have to fight hard to reclaim is spontaneity, especially when it comes to food and exercise. It’s only when this is taken do you realise how essential each one is. You can be flexible and there are no real limits, but only in the sense that a great athlete can be flexible without limits because they’ve trained super hard to be that way. So we’ve all had to become athletes when it comes to being spontaneous.
How has Dexcom helped you and Aidan?
Dexcom has brought future science fiction to real life today. The continuous glucose monitoring system is tiny, sits discreetly on his body and gives him a ten-day breather between sensor changes, so it's goodbye finger-pricking seven times daily.
Dexcom is totally active at a grass roots level and for Diabetes Awareness has pledged to donate £2,000 if #DexcomDiabetesStories and/or #DexcomWarriorStories is shared 200 times! I’ll be sharing more on social media and would love to hear how other families are winning their fights.
Maybe most importantly Dexcom is trying to introduce a reimbursement programme for type 1 diabetes patients which will give greater access to modern, life changing hi-tech. I want to spread the word on the importance of accessing it through this campaign.
If you compared your life today with how it was before Aidan was using Dexcom, what has changed?
It's always working, which lets him take his mind off diabetes for longer stretches. It also lets me get off his back. We both receive alerts so I no longer have to pester him by asking him what his number is, and especially importantly, I don’t have to wake him at night to prick his finger if I’m worried. Dexcom gave us back our sleep!