The Fine Line between Pharmaceutical Marketing and Medical Education

There was another article in today’s New York Times lamenting the marketing practices utilized by drug companies to inform physicians about their products. While these practices may be troubling to legislators and the American public, everybody who works in the life sciences industry including regulatory agencies like the US Food and Drug Administration (FDA) understands the “rules of the game” and how it is played. However,

over the past three years, there has been a full frontal assault on direct-to-consumer advertising and marketing and sales practices used by drug makers to hawk their products to physicians and the American public. This has largely been an over reaction to the lack of regulatory oversight of drug manufacturers during the Bush administration. The new regulations have severely limited what sales representatives can offer physicians e.g. gifts and free lunches and dinners, for more face time to sell their products. Consequently, the only means left available to drug makers to reach large numbers of physicians is marketing through medical education.

This is how it works. Companies annually budget monies to pay highly recognized physicians aka key opinion leaders (KOLs) to give lectures to physicians that might influence their prescribing habits. These lectures often take the form of informational seminars that focus on treatment options for certain therapeutic indications which often times subliminally highlight the advantages of the sponsor’s product over its competitors. Not surprisingly, the effectiveness and success of these programs is usually directly proportional to the sums of money invested in them. For example, in 2004, Forrest Laboratories (the subject of the NY Times article) planned on spending “$34.7 million to pay 2000 physicians to deliver 15,000 marketing lectures about Lexapro (an antidepressant) to their peers in one year.” The investment appears to have paid off; sales Lexapro reached $2.3 billion in 2008 even though a lower cost generic version of the drug is available. And, while the Forrest investment in medical education may appear to be a large one, it pales in comparison to the sums invested in medical education programs by much larger companies like Pfizer, Merck and others.

While certain members of Congress may be “shocked and outraged,” these practices are sanctioned by FDA. And, as long as drug makers are compliant and adhere to the rules they shouldn’t be faulted or penalized for their efforts. The point that I am trying to make is that drug makers, like all other for-profit entities, must maximize sales to generate sufficient profits remain in business. Therefore, it should come as no surprise to legislators or the American public for that matter, that drug makers use all legally available means to maximize the sale of their products. If Congress doesn’t like what drug makers are doing, then they ought to stop complaining and legislate changes to the rules. Put simply, it’s time for Congress to “put up or shut up.”

Until next time...

Good Luck and Good Job Hunting!!!!

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Direct-to-Consumer Drug (DTC) Pharmaceutical Advertising Really is Big Business!

No doubt that many of you already know that DTC advertising is an effective way for pharmaceutical companies to “push” their drugs. However, when I saw the amount of money that was spent on DTC in 2007 I was shocked! In 2007 alone, drug companies spent $5,375,117,382 on advertising. Yes, that's $5.375 billion dollars (think of how many research grants could have been funded or how much money could have been spent on universal healthcare!).  The aggregate ROI for 25 pharma companies examined was impressive–totaling about $32 billion or roughly 7-fold!

A table published by Consumer Reports AdWatch highlights 25 of the biggest spenders along with their sales, giving an indication of how much their ad spending has paid off —or not! The drugs that received the biggest bang for the buck are bolded. Despite the conflict of interest and false advertising DTC flap over Lipitor, it still managed to have the third best return among the 25 products analyzed.

Drug

Approved for1

DTC advertising
20072

Retail sales
20073

Sales per ad dollar spent

Lunesta

Insomnia

$294,180,616

$712,740,000

$2.42

Ambien CR

Insomnia

$204,065,972

$876,028,000

$4.29

Cymbalta

Anxiety, depression, diabetic neuropathy pain

$183,336,687

$1,732,827,000

$9.45

Lipitor

High cholesterol

$180,866,960

$6,165,531,000

$34.09

Plavix

Stroke risk reduction

$174,942,656

$3,082,712,000

$17.62

Rozerem

Insomnia

$171,466,210

$116,658,000

$0.68

Cialis

Erectile dysfunction

$151,649,663

$453,233,000

$2.99

Vytorin

High cholesterol

$140,715,035

$1,938,882,000

$13.78

Nasonex

Seasonal allergies

$131,220,183

$892,534,000

$6.80

Advair Diskus

Asthma

$121,197,100

$3,390,766,000

$27.98

Boniva

Osteoporosis

$112,958,755

$404,109,000

$3.58

Zetia

High cholesterol

$110,357,144

$1,405,066,000

$12.73

Requip

Restless Legs Syndrome, Parkinson's disease

$106,271,994

$407,665,000

$3.84

Abilify

Bipolar disorder and schizophrenia

$105,768,412

$1,781,562,000

$16.84

Flomax

Enlarged prostate

$100,969,013

$1,002,163,000

$9.93

Nexium

Heartburn and GERD

$96,960,417

$4,355,901,000

$44.92

Valtrex

Herpes and shingles

$88,409,332

$1,395,313,000

$15.78

Spiriva

Chronic obstructive pulmonary disease

$84,002,514

$868,226,000

$10.34

Yaz

Contraceptive pill

$83,566,746

$254,592,000

$3.05

Viagra

Erectile dysfunction

$83,064,378

$824,946,000

$9.93

Lyrica

Fibromyalgia and neuropathic pain

$70,663,685

$1,000,069,000

$14.15

Chantix

Smoking cessation

$63,979,755

$764,723,000

$11.95

Singulair

Asthma and seasonal allergies

$63,289,786

$2,863,326,000

$45.24

Celebrex

Pain from conditions like osteoarthritis

$55,230,236

$1,416,084,000

$25.64

Zyrtec

Seasonal allergies

$38,476,595

$1,302,807,000

$33.86

1Consumer Reports Consumer Drug Reference, 2008.
2Data compiled by Nielsen Media research, March 2008.
3Data provided by Drug Topics and Verispan, March 2008.


No wonder why everybody wants to work for a pharmaceutical company–despite the downsizing there is still substantial money to be made!

Until next time….

Good Luck and Good Job Hunting!!!!!!

Ho-Hum--Another Direct-to-Consumer Television Ad is Under Fire

The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a cardiac stent called Cypher that is manufactured by the company. The television ad is the first ever to market a medical device. Nevertheless, according to an article published in this week’s New England Journal of Medicine, the ad overstates the benefits of the stent without mentioning possible adverse effects that can include heart attack and stroke.

The current brouhaha is nothing new in the ongoing battle between drug manufacturer (and now, medical device companies) and regulators over DTC advertising. As some of you may know, the US is one of a few industrialized countries in the world that allows DTC advertising.  Further, DTC ads don’t require FDA review or approval before they are aired or printed–although in some instances, companies do request FDA review. 

Because of growing problems with DTC ads (especially television spots), there is mounting pressure on FDA to limit consumer medical advertising or, at the very least, increase regulatory oversight of it. To that end, on Friday, an FDA advisory panel will convene to discuss whether television ads for prescription medications ought to include a statement encouraging consumers to report any adverse side effects via a toll free number to the agency. At present, this type of disclaimer is only required for DTC print ads.

For those of you who don’t know, FDA has (by law) a post marketing surveillance network in place to allow consumers to report any side effects (big or small) that they may experience after taking prescription or over the counter medications. Further, companies are required by FDA regulations to immediately report any and all side effects associated with their products.

Of interest, in a hearing last week on drug advertising (being conducted by the House Energy and Commerce Committee), several drug company representatives in attendance were asked whether or not they would support a toll free number on television ads to encourage viewers to report adverse side effects. Surprisingly (perhaps not) they could or would not directly answer the question. According to John D. Dingell, chair of the committee and advocate of greater regulatory oversight of DTC advertising, “Some ads appear to be misleading and others appear to be downright deceptive.” Imagine that!

What is particularly disturbing about the DTC controversy is that government officials and legislators are frequently incredulous when they learn about DTC advertising abuses. As I have stated time and time again, there are larges sums of money at stake here. This coupled, with little or no regulation, and mounting pressures to keep company stock price shares high, is a sure recipe for disaster (as we have begun to witness over the past 5 years or more). In my opinion, there is only a single solution to the problem–craft more stringent regulations and greater FDA oversight for DTC advertising. Asking drug and medical devices companies to regulate themselves in any area is tantamount to allowing a fox to live in a hen house—the pickings are easy and only the fox gets fat!

Until next time….

Good Luck and Good Job Hunting!!!!!