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King Pharmaceuticals: Upon Kadian Settlement; Embeda Addiction Questions Remain
King Pharmaceuticals seems to be very good at flying very high above the radar, while its popular morphine sulfate pain medications fly very low under it. This is the perfect place for the 39th largest pharmaceutical company in the world with an annual revenue of $2 billion. That seems like a lot of money, but it is a drop in the bucket compared to big hitting household names like Johnson & Johnson, Bayer, and GlaxoSmithKline.
King Pharmaceuticals just finalized a civil settlement with the United States Department of Justice (DOJ) and the Office of the United States Attorney for the District of Maryland resolving a previously disclosed investigation into Alpharma’s sales and marketing activities. The settlement was announced to be for $42.5 million.
Whistle Blower
This civil suit was a result of the information given by a “whistle blower” within the organization who brought to the attention of authorities in 2006.
The whistle blower’s name is Debra Parks and she charged that King Pharmaceuticals misrepresented Kadian by overstating the benefits and understating some of the very dangerous side effects.
Specifically the lawsuit found, “A co-pay assistance program brochure for Kadian Capsules, an extended-release morphine formulation for the treatment of moderate to severe pain when an around-the-clock opioid analgesic is needed, omitted and minimized serious risks, broadened the indication and failed to present limitations, and presented unsubstantiated superiority claims,” the agency said.
Kadian is not widely advertised except to healthcare providers. So when the healthcare provider shows a consumer one of the few pieces of information in language that patients can understand, that brochure is essentially all of the information the consumer has to go on barring complicated and often confusing labeling.
“Specifically, the back cover includes the boxed warning and some information from the adverse reactions section of the PI,” said a letter proceeding the settlement. “However, these serious, potentially fatal risks are presented in highly complex, medically technical language that is not likely to be understood with consumers.”
It goes on to say, [A Q&A] “suggests that patients with broader types of chronic pain than the drug is indicated for are appropriate candidates for Kadian therapy,” which the DOJ deemed “particularly concerning considering the serious and potentially fatal risks associated with the drug.”
“Illegal marketing of pharmaceutical drugs jeopardizes the public’s confidence in our health-care system,” said Tony West, assistant attorney general for the Justice Department’s civil division.
The money will be split among the federal government, states and Debra Parks, the person who filed the lawsuit in 2006. Ms. Parks will receive $5.33 million.
What is Kadian?
The most obvious dangerous side effect was that Kadian is that it’s highly addictive because its active ingredient is morphine sulfate. Yes, morphine, the same drug that thousands of soldiers have been getting addicted to during wars since its implementation in the American Civil War.
Morphine Sulfate (Opioid) – Morphine is administered by needle, but Morphine sulfate is administered orally. Morphine is the same as it always has been, a powerful opiate based narcotic. Kadian is taken orally 2x a day to relieve pain. The fact that it is taken orally doesn’t make it any less addictive and as it is taken more over time the addiction rises and the body adjusts needing more and more.
Morphine Sulfate Side Effects:
Minor:
- Anxiety
- Constipation
- Depressed or irritable mood,
- Dizziness
- Drowsiness
- Exaggerated sense of well-being
- Light-headedness
- Nausea
- Sedation
- Sweating
- Vomiting
Major:
- Addiction
- Lowered Immune System
- Overdose
What are not mentioned on the warning label of Kadian is the side effects of a lowered immune system, otherwise known as secondary side effects. Though a patient may not get addicted right away, their ailment may make them susceptible to respiratory infections such as pneumonia or tuberculosis. These ailments are deadly to an otherwise weak patient recovering from another ailment.
Embeda, Acurox, Remoxy: Curbing the Addiction, but Not the Side Effects
This multimillion dollar Kadian settlement is just the icing on a very awkward year for King Pharmaceuticals. Two of their top selling drugs, Altace and Skelaxin, a combined 54% of their revenue, just painfully went generic. This is projected to lower the revenue from those two drugs by 75%. Ouch!
Historically King Pharmaceuticals’ business model has been to buy up older drugs, do a little polishing and rebranding, and ride them into generic land where they produce a generic brand and go on to find the next drug. Unfortunately drugs over the past decade have outpaced the companies revenue and left them unable to buy any more profitable workhorse drugs. So King has gone into Research and Development.
The company has laid its stakes on pain killers, staying with the morphine model. They have a drug they introduced recently called Embeda. This time though they are combining Morphine Sulfate with Naltrexone (a powerful anti addiction drug) to create a both kills pain and makes the body want to reject the addictive side.
With this triumph they have moved on to creating their next two generations of pills, Acurox and Remoxy.
King Pharmaceuticals: The Pioneers of Non-Addictive Opiates
Along with Embedia, King is looking to dominate the non-addictive opioid market, basically reinventing pain killers using the old model that opium and heroine addicts have been utilizing for centuries, but instead, they took the addiction out of it.
Acurox is taken orally and contains oxycodone HCl as an active analgesic ingredient, niacin as an active ingredient in low doses, and an ingenious combination of other ingredients. It is touted as the next non-addictive oxycodone (oxycodone is otherwise known on the street as “hillbilly heroine”). It has pending FDA approval and is still in study phase.
Remoxy is Kings most recent research project. They acquired the drug in 2005 and are almost to a close on testing. This too is an oxycodone HCI based drug, but this one resists being ground up and snorted or boiled on a spoon to be injected…unlike their other products. Very exciting stuff.
Defective Drugs
All drugs come with side effects. Combining two drugs, one to counteract the other’s side effects has been a trend in the pharmaceutical industry for decades, but not so much as now when there is so much money on the line.
The bottom line for the patients is that it helps ease the pain from their ailment be it a recent surgery to a sports injury. But if a patient is taking a pain killer for the pain of a chronic disease that lowers their immune system, the use of an opioid, regardless of how non-addictive they make it, is going to create numerous other complications from the effects of lower immune system.
If you or a loved one are on a pain medication, talk to your doctor and look further into the side effects. If you find that the pain medication has worsened your symptoms or caused an addiction it is important that you find experienced legal council to seek the proper compensation for you pain and suffering and future medical bills. Call Phillips Webster for a consultation.
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