Bitter Pill to Swallow? Try the Shot.
Facing the impending expiration of its bestseller Zyprexa’s patent, Eli Lily has just introduced their newly approved Zyprexa Relprevv, a long acting injectable, for use in adults diagnosed with schizophrenia. While it may be good business, it may prove for many to be bad medicine.
From the Wall Street Journal:
If a classic pharma strategy holds true, the drug may also extend Lilly’s ability to make money from its Zyprexa franchise.
The company is likely to face generic competition on regular-selling Zyprexa in 2011. But a key patent on the extended release version of the drug is valid until 2018, a Lilly spokeswoman told the Health Blog.
Drug makers have long brought out extended-release versions of drugs (often branded XR or CR) as a way to fight generic competition. Antipsychotics were the top-selling class of drugsin the U.S. last year, and they’re losing patent protection left and right these days. Drug makers are bringing out extend-release versions of several drugs in the class, including AstraZeneca’sSeroquel XR and Johnson and Johnson’s Risperdal Consta.
Well, if “classic pharma strategy holds true,” we’ll see this drug touted off label for everything from dementia to depression and to suppress unruly conduct in children. The injectable is geared toward people who are deemed “non-compliant” and appears to have been introduced with more of an eye toward administration than patient health. From the Associated Press:
For the new version, patients will visit their doctors every two or four weeks — depending on their dosage — to receive the injection, spokeswoman Janell Smith said.
She said the longer-lasting version makes it easier for patients to stay on the medication, and it allows doctors to track whether they’re doing that since they have to make office visits for the injections.
Given the list of risks and side effects, I wouldn’t say it makes it easy for patients but it does make it easy for their doctors to monitor and carry out their drug regimen. This effectively clears the hurdle of a person’s choice to discontinue the drug if, for example, the side effects prove too brutal or they choose another path toward their own wellness. While force isn’t the only intended purpose for this drug, you’ll find it’s the perfect companion (from the pro-drug and pro-force perspective) to the growing national trend toward forced outpatient treatment, more kindly termed by its proponents in government and industry as “assisted” outpatient treatment. A term not unlike calling solitary confinement assisted “me time.” AOT laws are currently in place in most states and are in the works in many of the remaining few.
This new injectable appears to be the first of its class approved for “acute agitation” a point laid out in this little fear-blurb from The Medical News.
Acute agitation is a well-recognized behavioral syndrome with a range of symptoms, including hostility, extreme excitement, poor impulse control, tension and uncooperativeness. The syndrome can occur with a number of conditions, including schizophrenia and bipolar disorder. Patients suffering from agitation in its severe forms are usually in an emergency situation and require immediate treatment to alleviate personal distress and to prevent harm to themselves and others.
“Well-recognized” just means “medically baseless but agreed upon” and their idea of agitation is a clear case of pathologizing human behavior. The “symptoms” of acute agitation are just a list of how any person might respond to forced treatment and incarceration. Unfortunately, our system is so tilted in the medical establishment’s favor that once it’s called a disease, a disorder or a syndrome, all bets are off and it can be treated with drugs and your consent is irrelevant. Disease debate aside, approving a long acting injectable for episodic behavior is a bold step toward an increasingly blatant use of drugs as control. No one should be on a month’s worth of drugs for a day’s worth of being hostile and uncooperative, regardless of the cause.
Interestingly but not surprisingly — US News directs readers not to Eli Lily for more information on the drug but to NAMI. That’s some clever positioning for a “grassroots” patients’ advocacy group. They are looking more like a drug makers’ advocacy group every day.