INdiana Systemic Thinking

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 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.”

January 26, 2008

Lilly’s Cymbalta Sales Grow

From a Bloomberg report, via the Indianapolis Star
INDIANAPOLIS — Eli Lilly and Co.‘s antidepressant Cymbalta exceeded $2 billion in global saleslast year, Chief Executive Officer Sidney Taurel said. That would represent at least a 52 percent increase from the $1.32 billion reported in 2006, when Cymbalta was Lilly’s third-best-selling product globally. The drug is intended to replace revenue lost to generic competitors for the antipsychotic Zyprexa, Lilly’s top-selling drug, when it loses patent protection in 2011. “Cymbalta is growing very, very fast,” Taurel said Friday in Davos, Switzerland, where he is attending the World Economic Forum. “It will be bigger than Zyprexa before Zyprexa loses its patent.” (Bloomberg)

The Blogmeister agrees with Mr. Taurel.  They just keep finding new uses for this drug.  I recently heard some physicians have found it very useful in the treatment of pain managment.  New uses equal more prescriptions which equal more sales.

January 24, 2008

Lilly Settles 900 Suits Involving Zyprexa

Here is a blurb buried deep in the business page of the Indianapolis Star:

INDIANAPOLIS — Eli Lilly and Co.has settled another 900 personal-injury claims against its antipscyhotic drug Zyprexa, including five set to go to court next month, thus avoiding what would have been the first trial in the U.S. The Indianapolis drug maker confirmed the settlement Wednesday but declined to reveal the amount. With the latest agreements, Lilly has settled more than 25,000 claims, leaving about 1,100 unsettled. Many of the plaintiffs have claimed Lilly underplayed the drug’s side effects, including weight gain and elevated blood sugar. Lilly has set aside $1.2 billion to pay claims.

December 9, 2007

Marketing and Big Pharma

Last night I had finished all the posting work for the blog and decided to do some web surfing.  It dawned on me I hadn’t done much of that since installing the RSS feed software.  So there I went.

However, I was drawn to a memory I had earlier in the day when I was posting this about Eli Lilly hiring a firm to do “damage control” [my phrase] for the drug Zyprexia.  I remember the story quoted a Psychiatrist who ran a blog.  I decided to check it out. 

I don’t know about anyone else, but things tend to trend for me.  What I mean is certain topics come up in different situations a few times over a few days.  This was one of those occasions.  As I looked through Dr. Carlat’s blog I was struck by the number of unflattering posts about the marketing practices of the major pharmaceutical companies.  What was strange, in a Jungian synchronicity way, was I remembered reading a post on Dr. Mike Schatzlein’s blog (titled, Is This Thing On), about the same topic, but more related to physical medicine.  I wasn’t going to post about it, because it didn’t really have anything to do with mental health, but once I read Dr. Carlat’s article, I decided big-pharma’s marketing tactics were relevant to everyone in healthcare and systemically undermining the patients right to trust his/her physician, despite the area of practice, with making the best medical decision, based on the patients’ needs.

Indeed, in Dr. Schatzlein’s blog, he makes the point that by advertising directly to the consumer, big pharma is, in a sense, undermining the physician who, because they may not prescribe a specific drug, is not, in the patient’s view,  giving the patient the best care.  In fact, the opposite is probably more true, that not prescribing a heavily advertised drug will more than likely, cost the patient less, and is more tailored to their specific situation.  Dr. Schatzlein also mentions a well know heart researcher who is currently hawking the prescription drug Lipitor.  While this researcher did graduate from medical school, he has spent his entire life developing high risk artificial hearts that, while not really successful, garnered him a high degree of fame.  According to Schatzlein, this researcher, after medical school, never sought a license to practice medicine and went straight into research.  So we have this researcher who has never written a prescription, telling consumers this is the best drug for them.  In the Blogmeister’s opinion, it appears that after a life of research (he’s getting up there), this researcher is “selling out” to big pharma to pad his retirement account.

It is exactly this “selling out” to big pharma that Dr. Carlat addresses in an article he wrote for New York Magazine.  The Blogmeister was enthralled with this article which describes the insidious way a good Psychiatrist was turned into a pawn for the drug companies through lavish ego stroking and, of course, cash.  He outlines how his conscience eventually caught up with him and his search to reconcile how he may have misled other physicians and possibly hurt patients, with wanting to be an ethical Physician.

The point of all this is the public needs to trust their Physicians.  They need to know their Physician is prescribing what is best for the patient, despite what  a drug representative just bought them for lunch.  By the same token, patients need to realize, while sometimes the best drug for them is the one with the best marketing campaign, sometimes it is not.  The person to determine that difference is your unbiased Physician.

[Post-script:  As I was fininishing this post, my 10 year old Daughter looked over my shoulder.  She saw the word “Lipitor” and commented, “Oh, I’ve heard of that, it’s on T.V.]

December 8, 2007

Lilly Hires Firm to Soothe Psychiatrists’ Concerns

According to the Indianapolis Star, Eli Lilly’s antipsychotic drug Zyprexia is the target of thousands of legal claims.   Lilly is attempting to reassure psychiatrists they do not face higher malpractice risk for prescribing the best selling drug.

“The company has hired a medical education company, Professional Risk Management Services of Virginia, to help spread the message that psychiatrists can manage risk.

The company recently mailed a 14-page brochure to psychiatrists across the U.S. with the message that the best way to avoid malpractice claims is to provide good care and document it carefully.

The program includes a 21-minute online slide show. The program does not mention Zyprexa or other drugs by name.

Lilly acknowledged Friday that some psychiatrists are concerned about being dragged into lawsuits.

“Psychiatrists have an increasing level of anxiety about malpractice and medication prescribing, and a lot of this is heightened by all the plaintiffs’ lawyers running everywhere,” said Lilly spokeswoman Marni Lemons.

The drug maker has paid more than $1 billion to settle tens of thousands of patient claims that it hid or downplayed the side effects of Zyprexa. Many patients said the drug gave them diabetes symptoms, including weight gain and higher blood sugar levels. Lilly has steadfastly denied that, despite agreeing to several rounds of settlements.

Lemons declined to say how much Lilly spent to hire the medical education company.

Lilly faces lawsuits from several states, including Alaska, Mississippi, Louisiana and West Virginia, that seek to recoup Medicaid money spent caring for Zyprexa patients.

The antipsychotic is Lilly’s top-selling drug, generating $4.2 billion in sales last year. But sales growth has been slowing, and Lilly executives told analysts this week that the company’s dependence on Zyprexa will diminish gradually as other products grow faster.

Lilly and the National Council for Community Behavioral Healthcare announced in June the results of a survey of 400 psychiatrists. The survey showed that more than half had patients who stopped taking antipsychotic medication or reduced their dosages based on fears raised by law firm advertising.

Lemons said initial feedback from psychiatrists who have participated in the program has been “overwhelmingly positive.”

But not all psychiatrists are sold. Dr. Daniel Carlat, a Massachusetts psychiatrist, criticized the program on his blog this week as “one of the more devious drug marketing campaigns in recent memory.”

“No psychiatrist who sees this is foolish or naive enough not to realize that the reason Lilly is doing this is because they’re having serious trouble with Zyprexa,” he said in an interview. “It’s obvious Lilly is just trying to do some damage control.”

December 6, 2007

Cymbalta to overtake Zyprexa as top seller

In a story published by the Indianapolis Star, drug maker and Indiana based Eli Lilly will continue to downsize in an effort to boost profits. 

“In a sweeping overview, the Indianapolis-based company also said it expects 2008 to deliver earnings of $3.85 to $4 per share and that next year should see the emergence of antidepressant Cymbalta to overtake Zyprexa as top seller in the U.S.”

In the Blogmeister’s view, this is not a comment on the state of depression in Indiana and the U.S., but all the “off-label” uses for Cymbalta (such as pain management).

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