A Preemptive Strike: US Medical Devices DTC Advertising Comes Under Fire

Just when the medical device industry is gaining steam and poised to challenge pharma and biotech companies for market share and profits, some lawmakers have begun to question the medical devices industry’s direct-to-consumer (DTC) advertising practices. Last year, the medical device industry spent about $193 million for DTC advertising on television and the Internet—a mere fraction of what was spent on DTC consumer advertising for prescription drugs sold by pharmaceutical and biotechnology companies.

One reason given by lawmakers to justify its current scrutiny of medical devices DTC advertising practices is that “medical devices can have more of an impact on a patient’s well-being than a drug because devices often require surgery to implant and may remain inside the body for years.” However, in response, a representative from the Advanced Medical Technology Association, a medical devices trade group said, “While an advertisement may stimulate a patient to ask a doctor about device, the process of receiving one involves a discussion of its benefits and risks.” He went on to say “You may take a pill because it doesn’t involve very much. But you don’t undergo surgery unless you think you have a serious need for it.” 

Another reason cited by Herb Kohl, a Democrat from Wisconsin is “The medical device industry is just beginning to get into the game.” Yes, Mr Kohl’s assertion is absolutely correct. Unlike most pharma and biotechnology companies, which have engaged in unregulated DTC advertising for the past 10 years or so—and literally made billions— the medical devices industry was slow to recognize that DTC advertising could be used to effectively hawk its products. I guess the thought here is: “to head ‘em off at the pass!”

The current call for an investigation into the DTC practices of some medical devices companies raises several interesting questions. First, is the investigation simply a red herring to distract FDA from crafting new regulations to rein in and more tightly control DTC advertising by pharmaceutical and biotechnology companies? (While FDA has recently revised some of its DTC advertising guidelines, the changes are still not rigorous enough). Second, could the call for increased scrutiny of the medical devices industry simply be an attempt (by pharma and biotech lobbyists) to stifle the recent, explosive growth of the medical devices industry?  Finally, why are lawmakers rather than the agency (which oversees the device industry) investigating the DTC advertising practices of medical devices companies?

On a personal note, I support tighter regulations and increased scrutiny of the DTC advertising practices for all  life sciences companies. Although DTC ads are directly aimed at consumers, their real purpose is to influence prescribing practices of physicians by inducing patients to ask questions about whether or not the drugs or devices that they “saw on TV” are appropriate for them. That said, I believe that it is up to FDA to insure that all DTC ads are fairly balanced (risks vs. benefits) and medically accurate before they are viewed by the American public.

Until next time…

 

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

A Different Slant on Direct-to-Consumer (DTC) Advertising

I previously posted a piece on BioJobBlog about direct-to-consumer advertising that is used by many pharma and biotech companies to induce people who see the ads to ask their physicians about a “ drug that they heard about on TV.” John Heubusch who runs Writing Frontier.com, read the post and pointed me in the direction of a piece that he wrote on the same topic. His slant on the topic is different than mine but we both reach similar conclusions—DTC advertising needs to be better regulated by FDA.

Until next time… 

Good Luck and Good Job Hunting!!!!

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!!!!!!

Pfizer and Jarvik Part Company Over Heart-Wrenching Television Ad

I am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

Until next time….

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