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 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 13, 2008

Health Blog Roundup: Step-dads, Chelsea Clinton, Statins Make Women Stupid, etc…

Here are some of the posts I found interesting this morning from the list of national health blogs I keep track of:

From the Wall Street Journal Health Blog:

Do statins “make women stupid“?

Blue Cross of California wants doctors to help them cancel patient policies.

Dr. Grohol’s World of Psychology:

Making sense of suicide and drugs.

On the Radar:

Chelsea Clinton hates her health insurance.

Hidden Agenda in CDHPs

From MSNBC:

It’s tough being a step-dad!

February 6, 2008

Big Pharma Hates McCain: and that’s a bad thing why???

There are two ways of determining where a politician stands on healthcare; read their platform statements, and/or follow the money.  If you choose the first, read carefully.  The language is as carefully crafted as your insurance policy, probably because it was written by the same people.  For example, something like “I want to reduce healthcare costs by implementing money saving technology” (which is common to several candidates) translates to:  I want to save insurance companies money by forcing providers of all sizes to spend money on updating computers and software.  So, sometimes following the second path is better.  Look at where a candidate is getting their money.  If it is from insurance and pharmaceutical companies, chances are they hope to make money if the candidate wins.  How do these companies make money?  In the case of insurance, either from charging the consumer more, or getting the provider to take less.  In the case of pharmaceuticals, continued law allowing them to sell overpriced medication in the United States and placing restrictions on generics.

So, how does all this get us to McCain?  Well, the Wall Street Journal’s Health Blog has a good post on his relationship with the pharmaceutical industry.  According to the Blog,

McCain opposes Big Pharma on two hotly contested issues: the re-importation of drugs from countries where they cost less and giving Medicare the clout to negotiate drug prices directly. McCain has long stumped for re-importation to save money. And he voted against the expansion of Medicare to include a drug benefit because it didn’t allow direct price negotiations by the government and because the program covers too many people.

His health-care plan also calls for drug companies to reveal prices of their drugs and to develop a straightforward path for the creation of generic biologics, two other ideas that wouldn’t do much for the bottom line of the industry leaders.

So there is the rhetoric.  Now how does that match up with the dollars?  Surprisingly well.  Again, according to the WSJ Health Blog:

The Center for Responsive Politics reports that McCain has received $39,797 in donations from pharmaceutical manufacturers. That puts him behind Obama ($154,710), Clinton ($140,544), Mitt Romney ($103,825), Rudy Giuliani ($91,550) and even Chris Dodd ($68,200)

 If we turn contributions around and see who is giving to McCain, we find:

…The most generous group is the retired, with more than $5 million in donations. And who wants cheap drugs more than the retired? No. 2: Lawyers and law firms, which have given $2.5 million, according to the CRP. (No. 6 on the list are health professionals with $713,952 in contributions.)

So the numbers appear to match the rhetoric, when it comes to pharmaceuticals.  However, the Blogmeister took a look at McCain’s healthcare plan.  It is very nonspecific and difficult to tell what he wants to do overall.  It would be interesting to apply the same analysis as above to his overall healthcare plan.  Still, it seems McCain has popular support for at least half the healthcare problem.  I’d really like to know, in non legal language, what he wants to do about the other half,  insurance companies.

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.

Big Insurance: “and throw a little sand in there too…”

I don’t know if everyone will get the reference in the title, but I thought it was fitting.  In another example of Big Insurance trying to prop up their already fat bottom line, comes this from the Wall Street Journal’s Health Blog.  By the way, this is what happens when MBA’s make medical decisions instead of MDs.

Aetna is about to cut back on its coverage of a popular but expensive form of anesthesia for patients undergoing colonoscopies, the AP reports. Docs aren’t pleased.

Doctors say the fast-acting drug propofol makes colonoscopies more comfortable (or at least less uncomfortable). But its use often requires that an anesthesiologist be present, and boosts the cost of the procedure by $200 to $1,000. Insurers argue that “moderate sedation,” which combines painkillers and a sedative, works equally well for most patients and doesn’t require the presence of an additional specialist.

WellPoint cut back on its coverage of propofol a few years back. As of April 1, Aetna will pay for an anesthesiologist to be present during a colonoscopy only in cases where the patient would be at high risk without one. UnitedHealthcare covers propofol during colonoscopy, according to the AP.

Some gastroenterologists and anesthesiologists are working with lawyers to fight the change. “To the extent litigation is an option, we’re looking at all options,” said John Fanburg, counsel for the New Jersey State Society of Anesthesiologists and the New Jersey Gastroenterology and Endoscopy Society.

I have an idea, lets have the “insurers” who made this decision undergo the procedure the way they want everyone else to.  Wonder if that would change their mind. 🙂

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 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.”

Next Page »

Blog at WordPress.com.