INdiana Systemic Thinking

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 16, 2008

FDA: Allowing Big Pharma’s Off Label Advertising

According to the Indianapolis Star this morning, the Food and Drug Administration will continue allowing pharmaceutical companies efforts to market a drug’s “off-label” uses, as long as the companies adhere to certain guidelines.  This “marketing” includes giving physicians articles describing “off-label” use.  In the past this practice has come under fire as the companies themselves sponsored the research and the articles were not published in peer reviewed journals.  According to the new guidelines;

Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating that the FDA has not reviewed them.
Drug industry advocates said the proposal firmly establishes FDA’s role as a regulator of medicine — not information.

However, these “advocates” have a lot to gain by the ruling.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.

February 9, 2008

Inside H.B. 1288: Certified Behavior Analysts

H.B. 1288 requires the state to establish the State Board of Behavior Analysts.  Behavior Analysis, as defined by the bill “means the design, implementation, and evaluation of instructional and environmental modifications to produce socially significant improvements in human behavior through skill acquisition and the reduction of problematic behavior”.  It allows for two levels of Analysts, one requires a Bachelor’s degree, while the other requires a Master’s degree, although the degree can be in any area.  Both certifications require a test and supervised hours.  The requirements mimic the requirements of the Behavior Analyst Certification Board, a non-profit Florida Corporation.

Background

This legislation was first requested at an Indiana Commission on Autism meeting.  Specifically, the commission was asked by Michelle Trivedi, “parent of an autistic child, for the commission to support legislation to be introduced in the 2008 session of the General Assembly that would require board certification for applied behavior analysts.”  The commission heard from Ms. Trivedi, but had many significant questions and did not recommend the legislation be pursued in it’s final report.  However, Rep. Vanessa Summers and Rep. Phil Hinkle, both commission members, introduced the legislation in the 2008 session.

Legislative Progress

Upon introduction, the legislation became very controversial for several reasons.  First, it did not exempt any professionals currently licensed to practice medicine, psychology, mental health counseling, social work, and marriage and family therapy.  Because the definition of what behavior analysis is, it would require all of those professions to become certified as behavior analysts to continue to practice with the licenses they already have.  Thankfully, the authors of the bill agreed to amend the bill to effectively state no-one could use the title Certified Behavior Analyst, unless they are certified.  With this amendment, the concerns of the already licensed professionals were satisfied and they did not oppose the bill in the house.  The bill passed the House last week and is now awaiting a hearing in the Senate Corrections, Criminal, and Civil Matters Committee.

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.

February 2, 2008

Lilly to Reach Deal with Feds?

Maybe, but no one is talking, according to the Fort Wayne Journal Gazette, citing the New York Times.  Here is the background:

Zyprexa was Lilly’s top selling drug last year. It rang up $4.8 billion and accounted for 25 percent of the company’s total sales, but it also has brought the company many legal headaches.

Beginning in late 2006, a series of articles in the Times said Lilly downplayed the drug’s risks and marketed it for uses unapproved by the Food and Drug Administration.

Attorneys general from 30 states have subpoenaed documents detailing Lilly’s sales, marketing and promotional practices for Zyprexa as part of a civil investigation under state consumer protection laws.

The drug also has faced thousands of product liability claims from patients, many alleging the company did not adequately warn patients taking the medication of a heightened diabetes risk.

And here is what is being said:

Lilly spokeswoman Tarra Ryker declined to elaborate on the possibility of a settlement when reached by phone.

“We are cooperating with the government in these investigations, and the discussions around those are confidential,” she said. “We’ve said pretty much all we’re going to be able to say on this.”

She also declined to comment on the payment amount.

“We don’t know where the information came from,” she said.

The Times reported that federal prosecutors in Philadelphia are leading the settlement talks for the government, in consultation with Justice Department headquarters in Washington.

The amount being bantered around is 1 Billion dollars.

January 31, 2008

“Dr. Phil Show”: How’s That Working Out For You?

According to WTHR, Dr. Phillip McGraw “regrets” discussing his “visit” with pop singer Brittany Spears.  Here is the background:

Spears, 26, was hospitalized in Los Angeles after a child custody dispute with ex-husband Kevin Federline resulted in an hours-long standoff with police January 3. Federline has sole physical and legal custody of their two sons, Sean Preston, 2, and Jayden James, 1.

McGraw said he visited the pop singer as a family friend, and rejected critics who accused him of practicing psychology without a license.

This is what Dr. Phil has to say:

“I regret making the statement. It didn’t help. It didn’t work,” the syndicated TV psychologist said Wednesday on ABC’s “Good Morning America.”

“I did not go there to diagnose her. I did not go there to treat her,” said McGraw, who showed up at Cedars-Sinai Medical Center on January 5 as Spears was about to be discharged.

McGraw said he retired his Texas license after 25 years of private practice because of the demands of his “Dr. Phil” daytime talk show.

The Spears family has accused McGraw of betraying their trust by making an “inappropriate” public statement about the singer’s hospitalization.

McGraw had told celebrity news TV shows that Spears was in “dire” need of medical and psychological help.

In an appearance on NBC’s “Today” show Wednesday, McGraw said his public comments after visiting Spears were intended to prevent rumors and misinformation.

“I wanted to stop speculation about what may have gone on in there,” he said.

OK, whatever.  We all know he went there to get ratings for his pseudo-psychological show.  Anytime a person in the therapy, or psychological, field puts their needs in front of a person or family, in a professional situation, they act unethically.  Speaking of which, a formal complaint was filed in California over the incident.  The California Board of Psychology treats complaints as confidential, so we don’t know what will happen with this yet.  Interestingly, the complaint also alleges Dr. Phil violated Ms. Spears confidentiality rights under HIPA.  While the California complaint is a felony, the HIPA violation could result in federal charges.

January 30, 2008

Lilly Changing Marketing Payment Scheme?

The only authority for this is Dr. Daniel Carlat, who publishes the Carlat Psychiatry Blog.  Rather than try to summarize, here is his article:

Eli Lilly “Slashes” Hired Gun Payments in Response to Dr. Drug Rep

One of my moles in the upper echelons of the pharmaceutical industry informed me that officials at Eli Lilly are changing some payment policies to hired guns in response to the article, Dr. Drug Rep.

Prepare to be underwhelmed.

The officials involved were apparently discussing the negative publicity generated by the article, and decided to put a more stringent cap on their payments to physicans who hawk their drugs to other doctors. In the past, there was a $100,000/year maximum for regular talks, with an option of tacking on an extra $50,000 for certain “brand-specific” talks, such as talks specifically relating to Zyprexa or Cymbalta. So the maximum was $150,000 per year, and many doctors were happily maxing out at that figure. Reportedly, Lilly is worried that allowing physicians to make “6 figures” for whoring themselves appears unseemly, so as of 2009, the total cap will be slashed to…drum roll please…$75,000/year. That’s only 5 figures.

The physicians affected are unlikely to be hitting the welfare rolls soon, however, as they might be able to make up this lifestyle-threatening shortfall by engaging in a novel professional activity–treating patients.

January 29, 2008

Zyprexa, Cymbalta Fuel Growth for Lilly

From the Indianapolis Star:

Driven by solid sales of its antidepressant Cymbalta, Indianapolis drugmaker Eli Lilly and Co. today said fourth-quarter profits grew to $854.4 million and 78 cents per share, beating many analysts’ estimates.

Earnings jumped six-fold from the same period in 2006, when Lilly recorded income of $132.3 million and 12 cents per share as it took a big charge to settle claims with patients who said they were harmed by Lilly’s Zyprexa schizophrenia drug.

But showing how little harmed it was by that publicity, Lilly said Zyprexa sales were again No. 1 in its sales lineup, accounting for $1.27 billion. Cymbalta was next up with $628.3 million. Overall, its sales increased 16 percent to $5.19 billion.

“Lilly completed a very successful year by continuing to deliver strong financial results to our shareholders in the fourth quarter,” said CEO and chairman Sidney Taurel. “Our additional investment in sales and marketing helped fuel accelerated double-digit sales growth.”

Mental Health: Fourth Most Expensive Condition to Treat

Wow, I was really surprised when I read this today.  It’s a study estimating the top 10 most expensive health conditions.  It has the usual…heart conditions and cancer are numbers 1 and 3, respectively, but “Mental disorders, including depression”  came in at number 4 with an estimated cost of 56 billion.  I found that hard to believe because Therapists, Psychologists, and Psychiatrists don’t make anything near what a cardiologist or oncologist does.  Then I saw this:

The money paid for visits to doctor’s offices, clinics and emergency departments, hospital stays, home health care and prescription medicines [were included].

Okay, I get it now.  Most of the money in Mental Health care goes to hospitals, emergency departments and prescription medications.  This is due to the public perception they can handle any situation, or take a pill,  and do not seek help early.  When people figure out this strategy is usually ineffective, they usually end up in an emergency room or hospital, where the costs are astronomical.  This “solution” is vastly more expensive than outpatient therapy.  As an aside, most therapists, this one included, do not consider ER and hospital admissions treatment, but crisis management.  With those factors included, the numbers make sense.  If costs for “mental disorders including depression” are ever reduced, a correlating change in perception among the public would also have to occur.  In that regard, Mental Health is no different from any of the other conditions cited, where prevention and early detection is paramount to decreasing costs.

Pfizer Lays Off 660

According to the Indianapolis Star, Pfizer Inc. is eliminating 660 jobs at it’s plant near Terre Haute, Indiana.  This is due to poor sales of Pfizer’s inhaled insulin drug, Exubera.  Apparently this should come as no surprise to workers who have been on paid leave since production was halted in October.

Pfizer also makes the following psychotropics, or closely related drugs:  Dilantin, Navane,  and Xanax, which are not effected by the shut down.

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