Merck may have one of the most popular vaccines on the market in its human papilloma vaccine Gardasil, but the drug giant is banking that the product can do more than help just young women.

News broke on Monday that Merck has asked FDA to review new Phase III data demonstrating the positive effects of vaccinating men with Gardasil-data that were first presented in November at the annual meeting of EUROGIN (the European Research Organisation on Genital Infection and Neoplasia). 

“We found a robust reduction in infection and disease in men,” said Anna Giuliano, a scientist at the H. Lee Moffitt Cancer Center in Tampa, and a lead investigator on the trial. “This was really exciting because it opens the door to a method of prevention that men can benefit from as well as women.”


  According to Giuliano, data showed that men were not just passive carriers and transmitters of the disease, as previously thought, but actually suffer consequences from the infection. 

“There is a significant cancer burden in men-men get cancer as a consequence of HPV infection-particularly in the anal cavity and penis,” Giuliano told 

 “And in some cases, the incidence of these cancers is approaching what we see for cervical cancer in the United States.”

It turns out that a high proportion of these cancers are caused by the same strains of HPV that Gardasil is designed to prevent. The vaccine was also found to be helpful in lowering the incidence of genital warts by 90 percent.

“It’s almost an equity issue,” Giuliano said. “If you have a vaccine and it shows that it reduces infectious disease in males, shouldn’t they have access to the vaccine as women do?”

Side effects in men are the same as in women, including a small amount of pain around the injection area and a small number of people who develop a low-grade fever. 

But the big question remains: If the vaccine is approved, how do you market it to men?

Giuliano agrees that it will be a challenge. “It’s hard enough to teach doctors about treating men with the vaccine,” she said. “Merck will have to start a major public service educational program about the importance of vaccination. It’s going to take some time, but I think once people understand what the issues are, they will get excited about it.”

Articles

News Analysis

Merck isn't bragging about the positive data it received regarding the use of its landmark HPV vaccine in men. But the pharma giant also isn't wasting time submitting the info to FDA. Pharm Exec talked to the lead investigator behind the trials to find out why this could be another milestone for Merck.

Merck Submits Request to Market Gardasil to Men

The advertising industry, which went into the holidays suffering less from the struggling economy than many other industries, got bad news this week when the British newspaper 

 reported that WPP, the advertising and communications mega-company, would eliminate thousands of jobs (out of about 100,000 worldwide) as a result of the recession. 

While WPP denied the rumors, a flurry of stories began circulating through legitimate press organizations including AdAge and BNET, which reported that WPP subsidiary Ogilvy & Mather will shed up to 100 employees. Omnicom, like WPP a member of the “big six” advertising holding companies, announced that it will lay off between two and five percent of its global workforce.

So what does this mean for pharma and it agencies of record?

According to most of the ad professionals 

asked, the outlook is better than it may sound. Companies with major accounts in consumer products—particularly automobiles—are in for a rough 2009, said one creative director. But smaller firms that deal primarily in drug ads should be safe—at least until patents start expiring.

“The worst layoffs I ever saw were the ones during the dot-com bust—I have never seen anything like that,” said Mel Sokotch, a veteran of Grey Advertising and Foote Cone & Belding. “But what drove that was the extraordinary money being spent by dot-coms. This time, I have a sense that [layoffs] will line up with the economy and the industries that are hurting.

“If you have an auto account, you are going to be hurting. On the other hand, if your client is Procter & Gamble or Kraft…packaged goods and healthcare hold up in down economies. It’s always been a good thing for an agency to have a lot of healthcare and packaged goods because they are more recession proof.”

One week into the new year, and word is trickling out that some large advertising firms are gearing up for heavy cuts. First out the gate is WPP, which is expected to be cutting thousands of jobs.

Ad Agencies Feel the Crunch as WPP Readies Layoffs

Healthcare agency veteran Ahnal Purohit is stepping out on her own, shedding two-thirds of healthcare agency Donahoe Purohit Miller and rebranding her own organization as Purohit Navigation. The goal: to be a one-stop-shop for small to mid-size pharmas looking to promote their brands.

Last week, the newly christened company announced that it will promote the fact that it handles far more than just market research (its bread-and-butter service). President and CEO Purohit is banking on an all-in-one multitasking approach to promotion that includes branding, sales education, and public relations.

At a time when some large agencies are struggling to stay ahead, independents such as Purohit Navigation are becoming popular alternatives. The company is currently working with new drug firm Proumis Pharma to help launch three new brands.

“For the size of the brands that we have, large consumer-type advertising campaigns don’t make sense,” said Purohit. “We need to be much more targeted, and really look outside of the box with our campaigns.”

Purohit calls her approach “guerrilla direct-to-patient marketing.” For example, a few years back, Donahoe Purohit Miller was hired to promote Sanofi-Aventis’ nail fungus drug Penlac. Rather than hit the competition head-on with television ads, the company bought a truck (nicknamed “The Toe Truck”), loaded it with a pair of podiatrists, and sent it to marathons around the country to educate runners about the disease. The campaign worked, and a shot of the truck even ended up on one of the 

So what happened to the rest of Donahoe Purohit Miller? 

Ed Donahoe is recently retired and Mark Miller has started his own company, branching off from DPM’s CME business.

According to Purohit, the split was amicable. With recent regulations prohibiting medical education firms from partnering with advertising agencies, Purohit and Miller felt that it would be better to break into two separate companies, rather than maintaining firewalls between the two divisions. 

“We wanted to be one of the first companies to demonstrate that we will comply with the guidelines,” Purohit said. “We felt that it made more sense to separate than build firewalls. So Mark will start a company with the clients we had on the CME side, and I decided to keep the promotional side of the business with our existing customers.”

With the departure and retirement of two-thirds of Donahoe Purohit Miller, the middle child has rebranded itself Purohit Navigation and is going after the pharma market as a one-stop-shop for all its branding needs.

Pharmaceutical Executive-01-08-2009

Merck Submits Request to Market Gardasil to Men

Ad Agencies Feel the Crunch as WPP Readies Layoffs

Purohit Takes Center Stage