Lilly Overtakes Pfizer as Biggest DTC Advertising Spender!

Lilly Overtakes Pfizer as Biggest DTC Advertising Spender!

According to cegedim Strategic Data, Lilly overtook Pfizer in total direct-to-consumer (DTC) spending in April, 2012. The chart below shows the top 10 DTC spenders between July 2011 and April 2012.

Pfizer spent nearly $900 million in DTC advertising in 2011. $220 million of that was for Lipitor. I predicted that Lipitor would hold the "Key to DTC Ad Spending in 2012" (see here) and this chart proves it.

Lilly's Cymbalta and Cialis were the #2 and #3 highest in DTC ad spending in 2011. It looks like they will be #1 and #2 in 2012.

Positive or Not, Pediatric Drug Trials Pay Off: Cymbalta and Oxycontin Case Studies

Positive or Not, Pediatric Drug Trials Pay Off: Cymbalta and Oxycontin Case Studies

Very few people may know that drug companies can get an additional six months of market exclusivity from FDA as an inducement for them to study the efficacy and safety of drugs in children. Fewer people realize that no matter what the outcome of such tests, FDA will still grant the additional 6 months of exclusivity before generic copies of the tested drug can be introduced.

A case in point is Cymbalta, an antidepressant marketed by Lilly.

As reported in the Wall Street Journal (here), Cymbalta will have an additional six months of U.S. market exclusivity -- through December 2013 -- because the company studied the drug's effects on children. "Lilly said, however, that it won't seek regulatory approval to market Cymbalta for pediatric use because study results were inconclusive regarding Cymbalta's efficacy in children."

Cymbalta is the "duct tape" of drugs; i.e., it has many approved indications for use in adults.

Cymbalta was originally approved in 2004 for adults with major depression. Later the FDA granted Lilly approval to market Cymbalta for treating nerve pain in diabetics, GAD (ie, "generalized anxiety disorder"; see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!") and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain.

With each new indication comes the potential to increase sales significantly. In 2010, for example, Cymbalta was approved for chronic lower back and knee pain, an indication that may have increased sales by $500 Million, a 16% increase over the $3.07 Bn in sales for Cymbalta in 2009 (read, for example, "Cymbalta: A Sweet ROI for Chronic Pain Indication").

But a 16% increase in sales is paltry compared with a 50% increase in sales that is possible when the FDA approves a drug for use in children under the Best Pharmaceuticals for Children Act, a statute that created the incentive for drug makers to test the products in young patients. For Lilly, a 6-month extension of market exclusivity for Cymbalta could give Lilly more than a $2 Billion windfall (in April, 2012, Lilly reported that first-quarter sales of Cymbalta rose 23% to $1.11 billion).

I'm sure the intent of the law was to make it possible for physicians to prescribe drugs for children based on evidence that the drugs worked in children. To offset the cost to drug companies to run trails to prove efficacy, Congress allowed 6 months of additional exclusivity during which those costs could be recouped. In the case of Cymbalta, children do not benefit and Lilly more than recoups the cost of pediatric trials, which involve perhaps only a few hundred subjects.

Purdue Pharma, however, claimed it lacked resources in 2004 when it abandoned a pediatric Oxycontin clinical trial requested by the FDA. Only now -- when Oxycontin is a mere year away from losing market exclusivity -- is Purdue pursing such a trial (see "After Delay, OxyContin’s Use in Young Is Under Study"). Sales of Oxycontin reached $1.7 billion (in the U.S.?) in 2004.

It is too soon to know if the Oxycontin pediatric trial will demonstrate any effectiveness in treating children under 12. One thing that is certain, however, is that street use of Oxycontin by children and young adults is deadly. If extended market exclusivity can help prevent illegal diversion of even cheaper generic versions of Oxycontin, then I am all for it no matter what the clinical trail results!

Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year

Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year

The pharmaceutical industry has been very generous in making payments to physicians. Last year (2010), for example, a mere dozen pharmaceutical companies paid $760 million to physicians and other health care providers for consulting, speaking, research and expenses, according to ProPublica's "Dollars for Docs" project. ProPublica has taken "translucent" -- ie, difficult to analyze -- data reported by pharmaceutical companies and created a single database that makes comparisons simple (see here).

The database contains information about payments made to about 500,000 doctors. That's about half of ALL doctors in the US (including Peurto Rico). That works out to about $1,520 per doctor (or about $760 per EVERY doctor in the US), on average.

Of course, some doctors were paid MUCH more than this -- eg, pain specialist Gerald M. Sacks raked in $270,825 from Pfizer, Johnson & Johnson, Lilly and Cephalon in 2010, up from $225,575 in 2009. And some doctors received only $50 for lunch. At least 20 doctors, however, received "meals worth $2000 or more from Pfizer between July 2009 and March of this year," said ProPublica reporter Charles Ornstein.

According to the ProPublica database, Pfizer paid my doctor -- Catherine Spratt-Turner -- $388 for meals and $1,500 for speaking in 2010. This worries me because she wants me to come in and discuss my high cholesterol. Apparently, generic pravastatin is not doing the job and I suspect she wants to switch me to another anti-cholesterol medication. Will she suggest Pfizer's LIPITOR? I'll let you know when I see her. Previously, she was hot to get me on AstraZeneca's CRESTOR, which I resisted because of its published side effects. BTW, Spratt-Turner did NOT get any money from AZ last year.

This is exactly what worries some physicians who receive payments from pharmaceutical companies. As more and more searchable data becomes easily available to the public, they fear that patients will rebel and resist their advice if it appears that payments are influencing that advice. Oh, well! Welcome to the social media age!

The table above shows physician payments made by some pharma companies compared to sales. Surprisingly, Lilly spent about 2 times as much as did Pfizer despite having only about half Pfizer's sales volume. Perhaps Pfizer is more efficient than Lilly in targeting influential physicians? Nah! Viagra sales don't need much physician goosing to prescribe, whereas Lilly's Cialis needs as much help as money can buy. [I suspect, however, from the fees paid to pain docs like Dr Sacks, that Lilly is more concerned with promoting Cymbalta for pain.]

Overall, it appears that pharma companies tend to spread payments among physicians such that there is a more or less direct correlation between the number of physicians in a state and the amount of payments made to physicians in that state (see chart below).

Of course, $760 (or $1,520) per every physician is not going to improve a physician's lifestyle very much (although I am sure YOU and I would be happy to have an extra thou to spend every year!).

No, this money is central to what I call pharma's "prescribing recovery act" designed to grease the drug prescribing economy.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Cymbalta: A Sweet ROI for Chronic Pain Indication

Cymbalta: A Sweet ROI for Chronic Pain Indication

One new indication for pain = $500 Million in additional sales!

Once a drug is developed for a single indication, gaining approval for additional indications can be sweet icing on the profit cake.

As an example, take Cymbalta, which was originally approved in 2004 for adults with major depression. Later the FDA granted Lilly, the company that manufactures Cymbalta, approval to market Cymbalta for treating nerve pain in diabetics, GAD (ie, "generalized anxiety disorder"; see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!") and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain.

Now, as reported in this Bloomberg article ("Lilly’s Cymbalta Helps Chronic Pain in U.S. Review"), Cymbalta may be approved for chronic lower back and knee pain, an indication that would increase sales by $500 Million, a 16% increase over the $3.07 Bn in sales for Cymbalta in 2009.

Currently, it is estimated that 7% (about $215 Million) of Cymbalta sales comes from "off-label" prescribing for "diseases of the musculoskeletal system, including arthritis and back pain." No doubt this is due in part to stories published two years ago with these headlines:

* "Cymbalta Found To Reduce Chronic Lower Back Pain"
* "Patients Taking Cymbalta Experienced Reduced Chronic Low Back Pain in New Study"
* "Anti-depressant drug shown to help people with low back pain"

For more on that, see "The Cymbalta Buzz Machine is at Full Throttle!"

Getting a 7% in sales from off-label prescribing is sweet, but sweeter still is getting an additional 17% from being able to market the drug for a new indication.

This got me to thinking about how much it costs to get a drug approved for a new indication. First of all, it has to be lot less expensive than getting the first indication because no new safety trials have to be run. Of course, new efficacy trials have to be run to "prove" that the drug works to treat the new condition. But these trials are much smaller -- hundreds of patients -- compared to the initial trials that involved thousands of patients.

As I learned when I wrote "The Cymbalta Buzz Machine is at Full Throttle!" the the back pain study, which Lilly may have submitted to the FDA to support Cymbalta's use for chronic pain, involved ONLY 236 patients. That's a pretty small study compared to the size of clinical trials needed for initial approval of a drug for marketing.

Searching Google, I found the cost per patient of running a clinical trial to range from $5,000 to $26,000. I suspect the former number is closer to what Lilly paid for its back pain trial. That would mean that Lilly paid only $1.3 Million to run this trial, for which it stands to gain $500 Million in additional sales.

Now that's some sweet ROI icing!