INdiana Systemic Thinking

April 29, 2010

Seroquel Slap-down

Filed under: Healthcare,Legal/Law,Pharmacology,psychiatry,schizophrenia,Seroquel — kurtglmft @ 10:28 am

According to the Associated Press, via the Fort Wayne Journal Gazette, drugmaker AstraZeneca will have to pay 520 million in fines to resolve “allegations of illegal marketing of the company’s antipsychotic drug Seroquel.”

“AstraZeneca allegedly marketed Seroquel for off-label uses — those not approved by federal drug regulators — including insomnia and psychiatric conditions other than schizophrenia and bipolar disorder.”

In addition,

“U.S. Attorney Michael Levy of Philadelphia, where the settlement was filed, said that the company had “turned patients into guinea pigs in an unsupervised drug test.”

AstraZeneca, which has its U.S. headquarters in Wilmington, Delaware, faces more than 25,000 product liability lawsuits over Seroquel, with most alleging that the drug caused diabetes. Seroquel has been on the market since 1997.

The government said AstraZeneca paid kickbacks to doctors recruited to serve as authors of articles by Astra Zeneca and the company’s agents about the unapproved uses of Seroquel.

The company also made payments to doctors to travel to resort locations to advise AstraZeneca about marketing messages for unapproved uses of the drug, the government stated.

AstraZeneca denied the allegations leveled by the government in the civil case settled Tuesday, saying it wanted to avoid the delay, uncertainty and expense of a protracted legal battle.”

The story goes on to state the drug is the second best seller for the company, generating sales of 4.9 Billion dollars.

February 19, 2008

Mental Health: Meds, Therapy, or Both?

In a story by the UPI, the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services in Washington, said consumers spent 17 billion dollars on Anti-depressants and anti-psychotic drugs.  Accounting for just over 13 percent of the 127 billion U.S. consumers spent on prescription drugs in 2005.

However, in another UPI story today;

In a speech at the annual meeting of the American Association for the Advancement of Science in Boston, Jason Robert of Arizona State University said that while understanding biology is crucial to the understanding of psychosis, “there is more to psychosis than mere biology.”

Robert said claims that genetics and neuroscience will revolutionize medicine and elaborate predictions about new diagnostic tools and new treatments are not being borne out “because they fail to grapple with the complexity of human beings — as brains, bodies, and, embedded in culture, steeped in history, and dynamically creating their own worlds. If we’re really going to have personalized medicine, we have to be focusing not just on the genome, but the person.”

Rather that having a caricature of culture in mind, “what’s really critically important is understanding cultures dynamically, as complex, historic, social and political structures that dramatically influence people’s lives.”

Ignoring all except biology may mean never having the capacity “to actually influence the well-being of the patient,” he said.

Mental health professionals have long known of their patients propensity to want an easy way out of their difficulties by just taking a pill to address their mental health needs.  However, while medication is a wonderful way to feel better and treat the biology of a disorder, almost no one recommends pharmacology alone in the treatment of mental health difficulties.

When I was in school, the prevailing thought about how one develops some of these biologically based disorders was some people are more than likely born with the predisposition to develop these disorders, BUT it was an individual’s life experiences that brought these predispositions out.  Of course, I’m not including things like adjustment disorders (where the environment, social and otherwise, are to blame) or Developmental Disabilities (which are entirely biologically based).

Medication does not address any of the underlying experiences leading to a disorder.  Nor does it help develop new coping mechanisms for situations affecting the disorder.  Americans need to see psychotherapy as they do physical, occupational, speech, and/or other therapies that work in conjunction with medicine.   For example, if one breaks their leg, they would see a physician to set the leg, then begin working with a physical therapist to teach them how to use the newly set leg now and in the future.  They would probably also address what may have happened in the past to cause the fracture.  If Americans used this same rationale with psychiatrists and mental health therapists, we would probably see dramatic “cure” rates for those afflicted with mental health issues.

However, because of stigma, time constraints, or whatever else, we see more people taking medications to feel better about what is going on in their life, which never really seems to change.  Conversely, we also see people who spend years in therapy never getting better either, because, for one reason or another, they don’t want to see a psychiatrist.  However, the people who, in my experience, seem to get better faster and go on to live well adjusted lives are those who employ the services of both professionals.

February 5, 2008

More Trouble for Zyprexa

In what is becoming more and more common, Eli Lilly’s Schizophrenia drug Zyprexa has run into a little more trouble.  From the Reuters, via the Indianapolis Star:

Excessive sedation is a “serious safety concern” with an experimental, long-acting form of Eli Lilly and Co.’s blockbuster Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released Monday.

Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia, Reuters and Bloomberg both reported.

But risks include excessive sleepiness.

The analysis was released ahead of a meeting by a panel of outside advisers who will evaluate the drug Wednesday.”Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence – 0.07% of injections and 1.3% of patients,” FDA staff said.

Lilly officials, in a separate summary, said they thought the benefits of the long-acting formulation outweighed the risks.

“Although there are important additional safety considerations associated with the injection, they are manageable with appropriate labeling and risk-minimization activities,” the company said, Reuters reported.

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