Patrick Clinton

There are whistleblowers who bring wrongdoing to light. But there are also whistleblowers whose main complaint is "I should have won." FDA seems to suffer from a serious oversupply of the second sort.

There are good reasons why we shouldn't permit lifestyle drugs on the market. But as a society, we've already shown that those reasons don't mean much to us.

A new bill says HHS has to negotiate Medicare drug prices with pharma companies. It won't work-but that's not the biggest thing wrong with it.

A new GAO report sets out to explain why drug development is so expensive and what to do about it. What the report says is important, but what it leaves out is a sense of how the world of pharma actually works.

To one major legal scholar, drug safety regulation isn't just about meeting standards, it's about what you take away from one group of patients in order to benefit the rest.

When Arthur Higgins first announced that he was about to take the reins of the healthcare group at Bayer, in 2004, colleagues were surprised.

The US Department of Justice thinks that "Average Wholesale Price" should mean just what the words say-no more, no less. Why? It's never meant that before.

The problem isn't that there's conflict between safety and efficacy or between getting a useful medicine to market and protecting the public from a dangerous one. The problem is that the conflict isn't well structured. That needs to change.

The world according to New Hampshire: Doctors prescribe expensive drugs because pharma reps sell them. Interfere with the selling, and you'll cut down on the prescribing. It's a plan. But for what?

The road forward for both public health and the industry is going to require more trust and intimacy, not less, between patients, physicians, FDA, and pharma. Patients need to see a fully functioning set of checks and balances-not what they're seeing today.

I needed to eat. I even wanted to eat. Instead, I sat in front of my hospital lunch tray, unable to face up to a carton of red Jell-O. When you think of it, that's a situation most of us face (minus the Jell-O) every day in business.

At the rate science is progressing, there may be more new knowledge in the next 25 years than in the past 100. That's great news, but not if you are planning to run your business as you run it today.

Where is pharma going? Toward more science, and more political pressure on science. Toward greater patient responsibility-and more regulation-by-lawsuit. And forward. Let's not forget about forward.

Safety advocates want to make it tougher for new drugs to win FDA approval. Consumer advocates want to make it legal to import drugs from abroad. Put those ideas together, and what have you got?

Understanding how drugs are bought and paid for has always been a bit complicated. People used to say that pharma had two customers-physicians and patients. Only one of them used the drug, and neither of them knew the price. My, how times have changed. Now the industry has so many customers, it needs to stop and get to know them all over again. And that's at a time when drugs worth tens of billions of dollars are going off patent. To map pharma's shifting landscape, Pharm Exec convened a group of top market researchers to discuss the issues shaping an evolving industry. Topics ranged far and wide, from the advent of Medicare Part D, to the new focus on adherence, the role of international markets, even the brave new world of marketing to seniors' children.

The newspapers seem shocked to learn that scientific journals occasionally publish things that aren't true. Where have they been?

Is the public ready for an exciting thriller about terrorism, drug counterfeiting, valiant FDA agents, and glamorous women who invite pharma CEOs to come up and look at their drug patents? Sure. Maybe someone should write one.

Witnessing an industry's wild ride is perhaps the best reason to work for a business magazine. You've given us 25 years of excitement. And we plan to pay you back.

The most salient feature of the Medicare prescription drug benefit is its uncertainties. That was perhaps the key insight at a roundtable conducted by Pharmaceutical Executive in conjunction with the executive summit "Medicare Part D: Can There Be Alignment Between Government Goals and Industry Opportunity?" cosponsored by this magazine and Model N, a revenue management-solution provider. With a panel that included representatives from pharma, the legal community, prescription benefit managers, and data and service providers, the roundtable looked at the goals of Part D, the threats and opportunities it presents to stakeholders, the skills companies need to develop, and the way the playing field is likely to change over the next few years. What follows is an edited version of the conversation.

Think of the role compliance plays in your job. Now imagine that level of concern increased by 25 percent, 50, or even more. That's what pharma has to look forward to in the next few years, as the effects of old regulatory initiatives, such as 21 CFR Part 11 and Sarbanes Oxley, start fully kicking in-and as we experience the as-yet-unknown regulatory fallout of the new concern with drug safety. It's no surprise that a great portion of this volume of Pharm Exec's Successful Product Manager's Handbook series is given over to compliance.

With patients who suffer from poverty, lack of education, and disease, it is incredibly easy to do damage through a marketing tactic that might be acceptable for another group.

If congressmen gathered to work through the nuances of banning ED drugs from reimbursement under Medicare, they'd still back the ban. But the decision would be grounded in lack of faith in prescribing behavior, not disregard for a debilitating condition.

If congressmen gathered to work through the nuances of banning ED drugs from reimbursement under Medicare, they'd still back the ban. But the decision would be grounded in lack of faith in prescribing behavior, not disregard for a debilitating condition.

For pharma companies large and small, one of the most pressing challenges of the next few years will be to understand compliance at a much deeper level, to obtain the tools to make it possible.

Part of the value of a drug comes from the supply chain that protects its integrity. There's a similar supply chain that preserves the value of drug information. And it needs help.

A new TV doctor show features the most loathsome pharmaceutical executive in recent memory. But in another important way, the show is serving pharma's best interests.

In a bright airy office above fifth avenue in New York, Lynn O'Connor Vos is talking about topics dear to her heart: trust-and how pharma can regain it-the need to put physicians back in the center of pharmaceutical marketing, and reinvention, a theme in her own life and the core to her approach to business.

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.

Journalists try to tell both sides of a story. That's fine when there are two groups in conflict. But how do you tell the story right when the real conflict is between the two halves of one ambivalent opinion.

Reeve had done something that many of us who communicate about health issues try in vain to accomplish.