Survey That Rewarded NYC Physicians with $100 Gift Card Concludes Physicians View Pharma Gifts Positively. Duhhh!

I don't know whether to laugh or cry about all the brouhaha regarding results of a survey of NYC physicians just reported in Archives of Surgery.

The survey finds that 72 percent of the 590 physicians and medical students at the Mount Sinai School of Medicine who responded "have positive attitudes toward various marketing overtures, including small gifts and lunches" (see this Pharmalot post with the headline: "Most Docs Remain Positive About Pharma Marketing").

Not mentioned in the Pharmalot post is the fact that "participants who completed the survey were able to submit their names and e-mail addresses separately for the opportunity to receive 1 of 2 gift cards worth $100 each" (you have to access the METHODS section of the paper to see this; it's not in the abstract, which Pharmalot cited).

To which I say: DUHhh! Whaddaya (NYC-speak) expect from physicians who are offered not just one, but maybe TWO $100 gift cards?

Nevertheless, expect to see many more headlines like "Most Docs Remain Positive About Pharma Marketing" in the future.

Should J&J's CEO Weldon Take His Medicine Like a Man and Appear Before Congress as Requested?

Johnson & Johnson CEO William Weldon was asked yesterday to appear before the House Committee on Oversight and Government Reform for a second time to testify on product recalls at its McNeil Consumer Healthcare subsidiary in Fort Washington, Pa. The hearing is scheduled for June 30 in Washington.

Recall that Weldon declined to testify previously claiming he was recovering from back surgery and could not make the trip (see "JNJ's CEO Weldon May Send Underling to Congress. The Aching Back Excuse"). Instead, he sent Colleen A. Goggins, Worldwide Chairman, Consumer Group, Johnson & Johnson, in his place. Ms. Goggins looked like a deer caught in the headlights as she faced lawmakers at that hearing (see "Parallels Between BP and J&J").

This time, Weldon should take notice of the attachment to the invitation that says "Witnesses with disabilities should contact Committee staff to arrange any necessary accommodations." [See "The Video Option" at end of this post.]

I think that Weldon should take his medicine like a man and testify in person. What do you think? Please take my little poll and let me know:

Should J&J's CEO William Weldon Appear Before Congress as Requested?
	Yes
	No

The Video Option
Aileen Katcher (@AKatcher), a healthcare PR specialist, tweeted me: "You don't give the option of appearing via video feed should his condition require." Maybe that would be an option, but I am afraid Weldon might emulate Clinton and respond to inquires about McNeil's "phantom recall" with "It depends on what you mean by 'recall'". [For more on the phantom recall, see "Parallels Between BP and J&J".]

Finally, A Google Drug Search Ad Format That Has All FDA Could Want... But Pharma Can't Use It!

Google just launched a NEW Rx drug ad format that includes everything FDA requires that a drug company include in its direct-to-consumer advertising: fair balance, and direct links to side effects, precautions, dietary information, etc. It even includes a logo that identifies it as a special ad sanctioned by a trusted authority! Unfortunately, the new format is only for the National Institutes of Health (NIH) and NOT available to pharmaceutical advertisers.

Below is the result shown on Google after a search on "Lipitor" (click on image for an enlarged view):

At the very top is the typical AdWord that Pfizer paid for. It's puny and uninformative and does not mention what medical condition Lipitor is approved for. Just below it is the NIH ad, which has all the required and interesting information. It even includes a little colorful pill that draws your attention to the ad and marks it as special. When you click on the NIH ad [actually, it's not technically an ad, but a natural search result that ALWAYS appears at the top of the natural search results; in that sense it's an UNPAID ad]. although not a paid ad] you are taken to a page on the NIH site set up especially for atorvastatin, the active ingredient in Lipitor.

This new drug ad format is the latest initiative of Google Health, which last year launched "Health OneBox" that offered easy-to-read details on illnesses and conditions with a single search.

Will these NIH ads compete with drug company's paid search drug ads, not to mention natural search results? Or can the two work in concert to increase the clickthrough rate on the paid ads?

Either way, Google stands to increase revenue from pharma paid ads. The NIH ads are just another instance of pharma losing share of voice on search engines. They must counteract that with even more advertising. Hopefully, Google's new ad format specifically designed for pharma (see here) will win FDA approval. That format can compete more effectively with the NIH ads. Not that there's anything wrong with the NIH ads!

Humana's iPhone/iPad "Games for Health": Would You Pay $2.99 to Play?

My Twitter pal @skypen (aka Fabio Gratton) keeps me up to date regarding innovative health apps and games developed by pharmaceutical and other healthcare companies. Today he tweeted:

"Humana develops health game for iPhone http://bit.ly/biQKlQ"

"Besides developing original games for health," said Paul Puopolo, leader of Humana’s Games for Health, "[we] partner with game developers who are open to new business models to offer unique video games that can improve health and wellness."

That's an interesting goal for an iPhone app worthy of further investigation. So I went to the Humana Games for Health Web site and found this promo for the Humana iPhone game app called "Colorfall":

This is a game similar to Tetris. The objective is to arrange and eliminate cascading color squares before the screen fills up. How does this game "improve health and wellness?" Well, you are prompted to get up off your behind and use the iPhone to photograph colorful objects such as a butter dish (shown below):

The app uses the dominant color in the photo to alter the color of squares, which can help you win the game.

In other words, this game improves health and wellness by encouraging you to move around. Huh? Usually, I play games when I'm stuck in the middle seat of an airplane and not able to move around. If I were at home and went into my fridge looking for colorful foods, I might just pause the game and have a snack. Butter, hmmmmm...

Anyway, Colorfall looks like a game worth trying. But I will never download it because Humana has the nerve to charge $2.99! I asked Fabio: "Why would I pay $2.99 for these games from Humana - an insurance company with $bn in assets????" To which Fabio replied: "i agree. Should be free. Who will pay? Probably Pharma cos and competitors to learn/see what others are doing."

If you are working for a pharma company and thinking of developing iPhone or iPad game apps, I doubt you would want to charge people $2.99. People hate the pharma industry about as much as they hate insurance companies and are sure not to pay. So it's a mystery to me why Humana charges people a fee for this game, especially if they believe it will improve the health of the people covered by their plans and thus lower their costs.

A better business model for game apps is to offer free games that include motivational messages or links to useful information as part of the game.

"You Never Had Coffee Like This Before!": FDA Wants to Keep It That Way

FDA is warning consumers not to use "Magic Power Coffee," an instant coffee product marketed as a dietary supplement for sexual enhancement. FDA says Magic Power Coffee contains the drug ingredient hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. The Website is shown below:

If it weren't for this FDA warning I may never have HEARD of Magic Power Coffee, much less had it. It looks delicious and could solve two of my biggest problems: staying alert AND staying erect! I almost forgot to mention that Magic Power Coffee can also make me rich if I participate in an online multi-level marketing scheme! Wow! I might sign up even if all I get out of it is FREE Magic Power Coffee!

This is only one of several products sold over the Internet containing a Viagra-like substance that the FDA has warned consumers about. Frankly, none of the other products even tempted me. One other such product was "Stud Capsule For Men," which the FDA found to be "adulterated with sildenafil" (ie, Viagra). Unlike Magic Power Coffee, a "stud capsule" does not appeal to me. For one thing, the marketing is atrocious! "Stud Capsule" as a brand name is weak -- it accurately reflects what it is supposed to achieve, but does not conjure up the type of image I'd like to be associated with. "Magic Power Coffee," on the other hand, sounds much more intriguing. Plus, it's also recommended for women!

"Imagine an incredible coffee that not only tastes great," says the Magic Coffee marketing blurb, "but magically has an effect on both men & women! With Magic Power Coffee, your 'special moments' can increase to a level you only dreamed."†

There's even a foot note on the Website reminiscent of side effect warnings seen on drug.com sites:

"Individual results may vary. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. The information on this Website or in emails is designed for educational purposes only and is not intended to be a substitute for informed medical advice or care. Do not use this information to diagnose or treat any health problems or illnesses without consulting your doctor. Magic Power Coffee is not intended or to be used to treat any type of medical condition."

Can the FDA seize this product? I'm not sure. It contains a derivative of sildenafil, an FDA-approved drug, but it is not "counterfeit" Viagra. Also, the marketing does not make any claim that it is Viagra or has a medical use.

Of course, Magic Power Coffee could still contain other dangerous chemicals such as rat poison (for more on that, see "Was a Rat Harmed in the Filming of This Pfizer Commercial?").

I Predicted It: Social Media Guidance Likely To Be Split Into Multiple Documents

"What had been envisioned as a massive, all-encompassing guidance on Internet promotion is being retooled as multiple guidances to address specific issues in the online realm," Tom Abrams, head of the Center for Drug Evaluation and Research's Division of Drug Marketing, Advertising and Communications (DDMAC) said during a panel discussion at the Drug Information Association's annual meeting in Washington, D.C., June 15. (Picked up from a "FDA Library Alert" email -- "DDMAC: Social Media Guidance Likely To Be Split Into Multiple Documents" -- I just received.)

Either I can see into the future, or FDA reads Pharma Marketing Blog and takes my advice. In November, 2009, I said "If FDA decides to bite off more than it can chew, it will take a long time to issue any guidance and whatever it comes up with will be out of date as soon as it is published. A much better approach would be to tackle a few issues at a time" (see "FDA Social Media Guidelines Best Done in Baby Steps").

More from "FDA Library Alert":

Abrams said the planned move from a single document covering all forms of online promotion -- such as social media, webpages and videos -- to multiple, targeted guidances will help future-proof DDMAC's oversight of the web. It would give DDMAC greater flexibility in the event that new technologies emerge to supplant today's online media.

"Technology is evolving so much, we don't want the guidance to become quickly outdated," Abrams explained.

He emphasized that this shift is not set in stone, but is simply the division's "current vision" for the guidance. "It could change at any time," he noted.

If the division does adopt this approach, the guidances will not be rolled out all at once, but over the course of time, Abrams said. He added that the first of these guidances will likely be released this year.

During the conference, Abrams also revealed that the Internet guidances likely would address specific issues or circumstances -- such as the posting of unprompted data on off-label use of a product or the question of responsibility when off-label information is posted on a third-party site -- rather than specific platforms -- such as websites or Twitter.

Abrams declined to give a complete breakdown of the guidance topics envisioned or the number of guidances expected under this approach.

For more details, see the August edition of the FDA Advertising and Promotion Manual.

Sex, Pharmaceuticals, and Selling Sickness: I'm Looking Forward to a Great Time In Amsterdam!

This October I will be in Amsterdam enjoying the sights and pleasures that city has to offer. But I am not planning to buy sex or to smoke pharmaceutical substances. I do plan, however, to attend and make a presentation at the Selling Sickness conference hosted by Healthy Skepticism (Netherlands), assisted by the Dutch Institute for Rational Use of Medicine and Healthy Skepticism (International). The sponsors include the Dutch Ministry of Health and the Dutch Health Care Inspectorate. You can find the program here.

I look forward to this conference because "Female sexual dysfunction will be used as a case study to explore problems with disease promotion as well as policy options." Ray Moynihan, journalist, co-author of the book "Selling Sickness: How The World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients" and author of "Sex, Lies & Pharmaceuticals," is a featured speaker.

In preparation for the conference, I am following closely the news about flibanserin, a new drug developed by the German pharma company Boehringer Ingelheim (BI) for "hypoactive sexual desire disorder" (HSDD) in pre-menopausal women. Today, an FDA advisory committee will meet to review this drug's application for marketing approval. BI must answer the question FDA always asks: is the drug safe and effective. The FDA’s own review, out yesterday, says the overall response rate in clinical trials isn't "particularly compelling," reports the WSJ Health Blog.

Perhaps an even more interesting question is whether or not hypoactive sexual desire disorder is a real medical condition. FDA does not consider that question when approving drugs. Whatever compound comes their way for which a drug company has clinical data, FDA's only duty is to consider if it is safe and effective for whatever "condition" it is designed to treat. A drug company is free to invent a medical condition and FDA can't say a word about that.

Do pharma companies "invent" medical conditions in order to sell drugs? Is hypoactive sexual desire disorder an "invented" medical condition?

One case where there is "smoking gun" evidence of a medical condition being invented by a pharma company is "overactive bladder," another condition affecting mostly women. "Pharmacia instrumental in creating new disease," said a marketing VP in the notes to his PowerPoint presentation made at an industry conference in October, 2002 (see Overactive Bladder: "Pharmacia instrumental in creating new disease" says Former VP).

My fellow blogger, Rich Myer, reviewed all the PR that BI is doing to create awareness of hypoactive sexual desire disorder: "In the last month, Boehringer has been trying to lay the consumer groundwork with a promotional campaign about women’s low libido, including a Web site, a Twitter feed, a Discovery Channel documentary and a publicity tour by Lisa Rinna, a soap opera star and former Playboy model, who describes herself as someone who has suffered from a disorder that Boehringer refers to as a form of 'female sexual dysfunction.'" In his post Rich quotes Dr. Adriane Fugh-Berman, an associate professor at Georgetown University’s medical school: "This is really a classic case of disease branding,” said Fugh-Berman. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient."

Oh, Oh, Rich! You are not in command of the facts. You should have read BI's "Key Facts on HSDD and Flibanserin". One fact cited is this: "HSDD is a medical condition – not simply 'low libido.'"

Anyway, this is sure to be a BIG topic for discussion at the Selling Sickness conference in Amsterdam. I wonder if people from BI will be there or invited to speak? Hope so.