Showing posts with label antidepressants. Show all posts
Showing posts with label antidepressants. Show all posts

How the Placebo Effect & Marketing Can Improve Health & Increase Pharma Profits

Big pharmaceutical companies are drastically cutting back on research and development. The economics just do not support the model that has been the driving force of the drug industry over the past 15 years.

According to a Forbes analysis reported by Matthew Herper, "The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion" (see "The Truly Staggering Cost Of Inventing New Drugs").

Some pundits suggest that lowering the cost of performing clinical trials will help get more drugs to market faster. Andrew von Eschenbach, former FDA Commissioner and now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative, suggested that instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies" (see here).

However, Herper points out that the "main expense is failure. AstraZeneca (AZ) does badly by this measure because it has had so few new drugs hit the market." AZ spent about $59 billion on R&D between 1997 and 2011, but only managed to get 5 new drugs approved. According to simple arithmetic, that means each of these 5 drugs cost about $11.8 billion to develop.

That's an interesting number. A very similar number came up during last night's 60 Minutes segment on "Treating Depression: Is there a placebo effect?" (see it here). It turns out that antidepressants sales in the U.S. bring in $11.3 billion a year to pharmaceutical companies that sell them -- including AstraZeneca!

Could it be that the drug industry is merely "breaking even" in the anti-depressant market?

I suspect they are probably making a pretty good profit -- but that profit may be diminishing as more and more anti-depressants go off patent. In fact, it has been suggested that 60 Minutes dared to air this expose -- four years after the research was first published -- because the "news" can no longer harm the drug companies that CBS depends upon for advertising -- most of the drugs mentioned are off patent (see “You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants).

I did a blog post about antidepressants and the placebo effect two years ago in January 2010 (read "A Common Goal of Research and Marketing: Fool the Doctor"). In that post, it was noted that clinical evidence suggests these drugs are not any more effective than a placebo in patients with less severe depression. But drug company marketing to physicians does not mention this. Thus, physicians are led to believe that the drugs ARE effective for all patients with depression.

As pointed out in the 60 Minutes piece, "a clinician who cares, who takes the time, who listens to you, who asks questions about your condition and pays attention to what you say, that's the kind of care that can help facilitate a placebo effect." That goes double if the clinician actually believes what he or she is prescribing is a drug with proven efficacy.

Consequently, marketing to physicians along with direct marketing to consumers can play a huge role in "facilitating" a placebo effect. Which leads me to this idea: pharmaceutical companies should be in the business of developing placebos rather than dangerous, ineffective chemical compounds. There would be no need for expensive clinical trials and it would be easy for FDA to adopt von Eschenbach's idea to approve these new "drugs" before they are proven effective. It will be up to marketing to make them effective by facilitating the placebo effect!

Of course, to be successful, this new approach to drug development must be done surreptitiously and the FDA must conspire with the drug industry (not too much of a stretch there). After all, if everyone knows that the drug industry is manufacturing placebos, the game is up -- doctors will know that they are prescribing placebos and so would patients. That knowledge will render the placebo ineffective. This is a case where a knowledgeable patient is at a disadvantage.

It should be noted, however, that many physicians in some countries knowingly prescribe placebos. Results of a survey published in the British Medical Journal (BMJ) indicate that "about half of the surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis. Furthermore," say the researchers, "physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition; only rarely do they explicitly describe them as placebos" (read this).

Antidepressants: Top Advertised & 3rd Most Commonly Used Rx Drug

According to a recent CDC Data Brief (find it here), antidepressants were the third most common prescription drug taken by Americans of all ages in 2005–2008 and the most frequently used by persons aged 18–44 years. From 1988–1994 through 2005–2008, the rate of antidepressant use in the United States among all ages increased nearly 400%.

Key findings (2005–2008):

  • Eleven percent of Americans aged 12 years and over take antidepressant medication.
  • Females are more likely to take antidepressants than are males, and non-Hispanic white persons are more likely to take antidepressants than are nonHispanic black and MexicanAmerican persons.
  • About one-third of persons with severe depressive symptoms take antidepressant medication.
  • More than 60% of Americans taking antidepressant medication have taken it for 2 years or longer, with 14% having taken the medication for 10 years or more.
  • Less than one-third of Americans taking one antidepressant medication and less than one-half of those taking multiple antidepressants have seen a mental health professional in the past year
Here's a chart that breaks it down by age group and males vs. females:

Click the image for an enlarged view

Perhaps not so coincidentally, antidepressants are among the TOP advertised Rx category in 2010, according to the recent AdAge analysis I summarized in a previous post (see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!" and pie chart below). 



Of the TOP 25 advertised drugs in 2010, DTC ad spends for antidepressants was 20% of the total (24% if you include Lyrica, which is not indicated for depression but is often prescribed for depression off-label).



The CDC data covers the time period 2005-2008, which is somewhat prior to when the full effects of the recession were felt by the recently unemployed. 


Women are twice as likely to take anti-depressants than men (Overall, 40% of females and 20% of males with severe depressive symptoms take antidepressant medication says CDC). Actually, for all degrees of symptoms, women are 2,5 times more likely to take antidepressants than men (see data in chart above).


Why are proportionately more women taking antidepressants than men? The CDC News brief doesn't say, but news reporters have suggested that more women are caregivers and therefore subject to depression linked to that.


Or could it be the DTC advertising of antidepressants that lead more women to ask their doctors about antidepressants (see, for example, "Women Need More Love, Less Drugs")?


Actually, practically every DTC ad (except ads for Viagra) "speaks" to women -- the ads most often focus on the woman as the sufferer of the indicated condition or the caregiver. 


This is part of an issue that I will discuss with several experts in an upcoming LIVE podcast titled "How to Score With Women (as a Marketer) via Social Media." One question I'd like to ask the experts is this: Do pharma marketers focus on women because they are the majority of the audience or because they buy more products (including drugs) than men (ie, are more prolific consumers than are men)? I tend to favor the latter over the former. What do you think?

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!