Posts tagged ‘NAMI’
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.
Some of you may be aware of the recent efforts of Senator Chuck Grassley (R- Iowa, for those who care). He has been probing the ties between the pharmaceutical industry and doctors, organizations like the APA and AMA, and so-called patient advocacy groups like NAMI.
Touting themselves as a grassroots organization while getting the bulk of their funding from pharma, NAMI’s loyalties have come into question. There is a growing sense among its members that to be involved with NAMI is to be sold on, even bullied into the idea that there is one true approach to what is considered mental illness and that approach is the medical model and its line of drugs. Even their attempts at reducing stigma center primarily on the idea of embracing diagnoses rather than valuing diversity in thought. Let’s face it — there’s not a lot of money in the diversity of thought. There is however plenty of money to be had promoting a social norm and a singular approach to maintaining (or trying to maintain) your standing within that norm — and when you’re taking that much money from the makers of the fix, it’s a safe bet you’re in agreement as to the approach.
That fact was not lost on Dr. H. Richard Lamb who resigned from his position on the board at NAMI citing the pharma connection. As there is no sign of NAMI’s ship sinking any time soon, it appears to be a genuine move on Lamb’s part to separate himself from the mouthpiece-for-pay system that NAMI has worked out with these companies — a move toward acting in the best interest of the very people NAMI has positioned themselves to reach. While it may take a lot more than one resignation to change the face and, more importantly, the heart of advocacy, it is certainly a step in the right direction. People tend not to walk away from such positions within such organizations without a firm nudge. Sometimes that nudge comes in the form of conscience and good judgement. Maybe that sort of thing could catch on. One can only hope. From the NY Times: (emphasis mine)
… [H]e was “shocked to learn that approximately half of NAMI’s income comes from the large pharmaceutical companies,” he wrote in a resignation letter that Mr. Grassley made public… In an interview, Dr. Lamb said that NAMI’s dependence on the drug industry made some actions impossible. For instance, Dr. Lamb said that NAMI should consider warning against the use of some mental health drugs with life-threatening side effects. But Dr. Lamb said the organization could not consider such a move because it could threaten much of its financing.
When you call things what they are, it’s very clear. NAMI is essentially sponsored by drug companies and what’s true in television and radio certainly holds true in large organizations — Never go against the sponsors. It is the one golden rule that governs all other rules. That’s fine when you’re selling sneakers and dish soap but we’re talking about actual human lives and wellness. It takes a lot of nerve to call your organization a patients’ advocacy group when half to two-thirds of your funding comes from companies that are constantly facing class action lawsuits, federal lawsuits or both for not disclosing adverse findings in clinical trials, lying about known health risks, directly causing death and chemical injury and illegally marketing their most powerful and unpredictable drugs off label. NAMI could hardly be more blatant in aligning their methods with the commercial interests of these companies. If that’s advocating, I’d hate to see their idea of throwing people to the wolves.
It should be said that while Lamb appears to be a man of conviction, his convictions and mine are far from lining up in other respects as he is on the board of directors for the Treatment Advocacy Center, a group unparalleled in their efforts to extend the reach of forced psychiatry through involuntary commitment and drugging. It’s likely that, like many, he acts with good intentions but forced treatment has killed and injured millions with good intentions. I say this not to detract from the spirit of his resignation but to point out the importance of being conscious of the vision and motives of those speaking for you.
The National Alliance on Mental Illness (NAMI) calls itself the “nation’s largest grassroots mental health organization.” If they are a grassroots organization, then the soil is tainted and the land bought and paid for — largely by pharmaceutical companies. Over half of their funding in the just the past five years has been in the form of pharma money. That’s several million dollars. Their list of major contributors reads like a who’s who of psych drug peddlers — all of whom have their own ethics problems lately, including everything from paying doctors to promote for them to lying about adverse clinical trials findings and illegally promoting the off label drugging of children.
The latest glimpse into the NAMI’s affair with pharma is the report that, in light of the fact the drug companies can’t directly market their product for off-label use, Pfizer paid NAMI hundreds of thousand of dollars in exchange for their promotion of Geodon, an atypical antipsychotic, for use on children and the elderly, for which there is no FDA approval and the dreaded black box warning in some cases. All of this is also in conflict with the group’s own professed policy against promoting drugs. When more than half of your money comes from drug manufacturers, you tend to keep it a bit less obvious.
”Drug manufacturers have developed relationships with front organizations – industry-funded grass-roots, consumer advocacy, research and educational organizations whose primary goal is to promote marketing, influence regulations or advance other industry interests,” according to the suit.
The Arlington, Va.-based National Alliance for the Mentally Ill… has received at least $1.3 million from Pfizer over the years, according to the suit.
What’s more, its former president, James McNulty, during his time as NAMI’s leader, “received thousands of dollars for regularly speaking on behalf of Pfizer and other drug makers,” the suit said. “McNulty’s relationship with Pfizer was particularly cozy,” the suit said, and the group’s Web site “goes so far as to promote the off-label use of Geodon in children and the elderly, as well as for long-term use in the treatment of bipolar disease.”
The promotion of Geodon goes against the group’s stated policy of not endorsing products, according to the suit. What’s more, the suit said, such uses of the drug have not been approved by the FDA, and the prescription of Geodon for dementia has received a black-box warning from the agency.
It may seem to some as though it is of little import but NAMI isn’t a just some group out to offer help and reduce stigma related to mental illness, although that is part of their claim. When government policy is enacted, when information is needed, when decisions are made about the treatment of people with mental health diagnoses, NAMI has a seat at the table — so much so that they refer to themselves as “the preeminent voice on Capitol Hill and in state houses across the country for the millions of Americans living with serious mental illness.” They are the loudest voice claiming to come from the corner of those diagnosed as mentally ill and often the only voice that is sought. They’ve presented themselves as an authority on mental illness and the buying public in this arena as with any other is desperately seeking an authority.
… the off-label marketing of Geodon was all about money. And it may have paid off: According to the suit, initial sales of Geodon eight years ago were a disappointing $150 million, leading the company to offer sales incentives to boost the drug to the $1 billion blockbuster category, which it reached last year for the first time – three years behind schedule.
”Pfizer has engaged in a deliberate pattern of false and misleading promotion,” the suit said. “Off-label promotion of Geodon … became ingrained in the sales force and Pfizer management.”
It is harmful enough when drug manufacturers are more about profits than actually offering tools for care. It’s unconscionable when doctors and so-called grassroots groups are doing it, all while claiming to be a voice for the mentally ill. Dangerous things happen when a cash fueled machine teams up with the smiling face of an organization banded together to speak for you — and over you.