Two weeks ago, Shire received a warning letter for posting a sponsored testimonial on YouTube without including risk information. Shire was very open when I called them up and admitted that the video was posted by accident and immediately removed when it was brought to the company’s attention.

While I’m not 100 percent positive, it looks like this might have been the first time FDA actually name-dropped a social networking service in a warning letter. Which poses the question: Is FDA watching YouTube, and what does this mean for pharma?

Ignite Health’s Fabio Gratton told me that this ramification could go one of two ways. Pharma could view it as the feds are now treating YouTube with the same degree of importance as television and other media outlets, thereby validating the online service. Or it could scare pharma away from posting videos on YouTube, because that could warrant a warning letter.

So where does FDA stand?

I sent an email to FDA spokesperson Felicia Stewart with one question: Are you guys watching YouTube for pharma ads?

She missed the deadline for the article, but lo and behold, this morning I got a nice, concise answer from the feds.

DDMAC has been and continues to monitor the many vehicles that companies use to promote their prescription drug products. Our monitoring includes magazine ads, TV ads, promotional exhibits at medical conferences, Internet, sales brochures, journal ads, and consumer mailers and brochures. Internet monitoring includes promotion done by or on behalf of drug companies such as companies’ own product Web sites and their placement of promotion on others Web sites. The action addressing promotion by the company on YouTube is one example. Another example is the action addressing Pfizer’s promotion on cnn.com for Viagra.

There you have it. FDA is watching YouTube, and boy, do I wish I was the guy or gal being paid to troll the Web all day looking for errant pharma ads or remixes of the Rozerem beaver singing the Tay Zonday classic “Chocolate Rain.”

It’s Nobel Prize season again, and Monday morning delivered news of the first gold medal and wad of dough. The 2008 Nobel Prize for Medicine went to three virus hunters, one who discovered the human papilloma virus (HPV), the cause of many cervical cancers, and two who isolated the human immunodeficiency virus (HIV), the source of the AIDS scourge.

For anyone concerned with sexual health, it’s gratifying that science’s top honor has gone to researchers who devoted their careers to tracking the most deadly sexually transmitted diseases—in the early ‘80s, at a time when professional stigma was virulent. And it may not be stretching advocacy to see the choice as a subtle slapdown of governments worldwide, including the US and others acting at its behest, that persist in promoting an abstinence-only approach to HIV prevention. It may also increase acceptance of, and demand for, the HPV vaccines recently developed and marketed by Merck and GSK.

But the big news, of course, is that neither of the two virologists honored for nabbing HIV was Robert Gallo, who has long been recognized, in official histories, as the “co-discoverer,” with France’s Luc Montagnier. No, the judges at the Karolinska Institute tapped Montagnier and his former colleague Françoise Barré-Sinoussi, snubbing Gallo in their own attempt at revisionist history. The AP titled its coverage “Nobel Is Postscript to Bitter 1980s HIV Dispute”; Reuters chose “Nobel Medicine Prize Reopens Old AIDS Wounds”. Newsweek went with “The Shocking Nobel Prize”. [Read more →]

Lilly broke the news Monday morning that ImClone had accepted its offer to acquire the biotech firm for $6.5 billion or $70 per share—Lilly’s largest acquisition ever.

With this purchase Lilly gains control of ImClone’s blockbuster, targeted cancer agent Erbitux, which is marketed for second- and third-line colon cancer and refractory head and neck cancer.

ImClone also has five monoclonal antibodies in clinical development—including one in Phase III and two currently moving out of Phase II trials. The acquisition will help Lilly meet the challenge of patent expiration that it will see in the next decade and bolster its 13 oncology drugs currently in development.

One sticking point will be how the deal affects ImClone’s co-marketing pact with Bristol-Myers Squibb in the United States. BMS currently pays a 39 percent distribution fee to ImClone for Erbitux and owns 17 percent of ImClone stock. In an investor call this morning, Lilly said it could not comment on the situation. [Read more →]

Promotions and hires for September 26, 2008:

• Merck named Barry J. Goldstein, M.D., vice president of clinical development for diabetes and obesity

• Sanofi-Aventis announced that Chris Viehbacher will succeed current CEO Gerard Le Fur in December

• GlaxoSmithKline named Ellen Strahlman chief medical officer

• Questcor Pharmaceuticals appointed Gary Sawka CFO

• Encorium appointed David Ginsberg president and CEO

• Wyeth named Daniel J. McIntyre vice president, corporate communications

• Genesis Pharmaceuticals appointed John Yang Wang to its board of directors

• Zosano Pharma appointed Gail Schulze chair and CEO

• Lilly named John Lechleiter its board of directors chairman

• Merz Pharmaceuticals named Jack Britts president and CEO

• Ferring Pharmaceuticals appointed Paul Korner, M.D., vice president, medical affairs

• Zafgen appointed Thomas Hughes the company’s first CEO

Click here to view a slideshow from Prix Galien 2008

The 2008 Prix Galien USA is in the books, and Pharm Exec was in attendance at New York’s Museum of Natural History to take in all the festivities. Pfizer, Merck, Alexion, Wyeth, and Celgene were all recognized for their work in advancing science in both the biotech and pharma industries. Charlie Rose played master of ceremonies to a packed house featuring a who’s who of the science elite and a handful of Nobel Laureates. [Read more →]

When 5,742 physicians opt in voting for their favorite medical journal ads over utilizing spare time that never comes, you know it’s a big deal. And yesterday at The Doctor’s Choice awards luncheon sponsored by the Association of Medical Media (AMM), their input was not only showcased on a most refined level but also indicative of what they want pharma marketing to deliver.

It became quite clear to me early in the ceremony that physicians weren’t selecting ads based on how fun and fancy they were, but rather on how they delivered a message straight and to the point. William Castagnoli, director of The Doctor’s Choice awards, echoed my thoughts. [Read more →]

The UBS meeting’s annual Global Life Sciences Conference this week in Manhattan confronted a unique nexus of Wall Street’s manic behaviors resulting from the nation’s financial crisis and the heavy presence of security on the streets and at the conference hotel as the Sept. 22-25 meeting coincides with nearby UN sessions. These events heightened the pre-existing concerns among health care investors and company executives about the closed IPO window, lack of VC funding for start ups and emerging companies and credit crunch. There was a “Black Monday” mood of resignation and humor heard among the attendees as they shared their reactions to the unfolding Wall Street and governmental drama that seemed impossible not long ago. [Read more →]

Pharma sales forces were out, well, in force for a two-day leadership summit put on by the Center for Business Intelligence this week in Philadelphia. As a newbie on the pharma reporting scene, I eagerly await these conference opportunities…especially the ones that deal with important sales management topics. This conference, in particular, presented sessions on just about every topic under the sales force sun—from cool new ways to reach physicians to interactive detailing and closed-loop promotion. In particular, I appreciated Matt Pammer’s presentation on examining the benefits and challenges of a rep-facilitated e-detailing program, and how it can complement a sales force strategy. [Read more →]

King Pharmaceuticals sweetened its offer to purchase Alpharma this morning. The drug firm boosted the bid price to $37 per share or $1.6 billion from the initial of $33 a share it presented in early August. If Alpharma refuses, King is prepared to get down and dirty.

In a pointed letter to Alpharma’s board, King President and CEO Brian A. Markison stated that every effort to negotiate terms and costs with Alpharma has been ignored.

“While we would prefer to work cooperatively with you and your Board to complete a negotiated transaction, our Board of Directors has authorized management to commence a tender offer to purchase all of the outstanding shares of Class A Common Stock of Alpharma for $37 per share in cash, which we intend to do promptly.”

On August 22, Alpharma President and CEO Dean J. Mitchell rejected King’s initial offer stating, “the proposal is inadequate and does not reflect the Company’s inherent value.” Mitchell accused Markison of publicly commenting on negotiations without a confidentiality agreement and noted that the offer was not up to snuff because of potential earnings of Alpharma’s pain drug Embeda, currently under review by FDA.

In a statement to the press today, ImClone Chairman Carl Icahn said that the review committee overlooking Bristol-Myers Squibb’s offer to purchase the biotech company for $60 per share $4.5 billion just isn’t good enough.

He not only accused BMS of lowballing, but also admitted that the company has been in talks with the head of another mysterious pharma company, which has resulted in an offer of $70 per share in cash.

“The special committee has determined, subject to the execution of a confidentiality agreement, to allow this company to conduct due diligence for a two week period, subject to extension by mutual consent,” the release stated. “No determination has been made as to whether $70 per share would be adequate.”

BMS has yet to release statement in reaction to Icahn’s comments. BMS is a 17 percent stakeholder in ImClone and worked with ImClone to bring the head/neck cancer treatment Erbitux to the US market. ImClone is mum about the new suitor.

Photo by Jenn Jenn