The Problem With Bob

Could it be that someone's finally going to wipe the grin off Smiling Bob's face? As we were putting this issue to bed, the Cincinnati newspapers reported that federal agents had raided the offices of Berkeley Premium Nutraceuticals, a company best known for its "natural male enhancement" pill, Enzyte, and for its repulsive television commercials starring Bob. The US Postal Service led the operation, which also included the FBI, IRS, and FDA. They froze bank accounts, sent employees home, and combed records, attempting to determine whether Berkeley, which has accumulated more than 5,000 complaints with the Cincinnati Better Business Bureau and the Ohio attorney general's office since 2001, had committed mail fraud.

Patrick Clinton

With the Postal Service taking the lead on the investigation, it's too much to expect that the goal is to shut down the Enzyte ads, but we can always hope.

If you haven't seen the ads, you're either extraordinarily lucky or you haven't been paying your cable bill. They've been all over television, with a creaky retro visual style, Bob's trademark pop-eyed rictus, and a voice-over narrative aimed at those with slow-moving mental processes: "This is Bob," one of them starts. "Bob is doing well—very well indeed. . . . [W]hat did he get? Why, a big boost in confidence, a little more self-esteem—and a very happy Mrs. at home."

It's a nasty, leering piece of work, and all the worse because it tarnishes the already less-than-sterling reputation of drug advertising. Enzyte is technically a supplement and not covered by the same advertising regulations that cover drugs. But do viewers know that? I'm sure that for most, an Enzyte commercial is just another drug ad, and just more proof that drug companies are venal, deceptive, and cynical.

That's not fair. Why would consumers (lots, by most accounts) believe that a product like Enzyte will improve their sex lives? In part because, deliberately or not, the ads implicitly suggest that the product is a pharmaceutical—proven, safe, and reliable. The "Bob" ads exploit the trust that pharmaceuticals have earned and then undermine it. At a time when the public is vigorously scrutinizing the finest nuances of legitimate pharmaceutical ads, it's outrageous that they're permitted to continue.

Quick on the Uptake

Speaking of advertising, former FDA commissioner David Kessler was interviewed on that subject by the San Francisco Chronicle a few weeks back. "The way it used to be, if a drug got approval, its use would increase gradually over time," Kessler told reporter Bernadette Tansey. That meant relatively few people would be exposed to unexpected side effects. But now, with advertising, the uptake of drugs in the marketplace is much quicker. "Many more people are going to be exposed," Kessler said. "That's the nightmare."

There's truth in what Kessler says. New drugs used to reach peak sales in year five or so. Now many peak in year two. And that really does mean that more patients receive drugs during the period when doctors, companies, and FDA are still learning important lessons about them. The question is: What should we do about that fact?

Obviously, it would be terribly hard on the industry if advertising was banned in the case of new drugs or, worse yet, if limitations were imposed on how a drug could be used in the first few years post-approval. Accelerating time-to-peak sales is a key element in enhancing the profitability of a drug. But does it benefit patients—or harm them? That's not a traditional safety/efficacy question, but it's the sort we're likely to see more of. The industry needs to find a way to answer these new questions—and soon.

Patrick Clinton is Pharmaceutical Executive's editor-in-chief and can be reached at pclinton@advanstar.com.