Finished the chores? The kids aren’t underfoot? Not sure what to do next? Kickback with these in the meantime…..

Unused medications are showing up in Oregon’s rivers and streams, and the state has created a task force to deal with the problem. The Mail-Tribune of Medford, Or., takes us there.

Sanofi-Aventis has finished construction of a $150 million building in northeastern Pennsylvania that would double its production of vaccine for seasonal or pandemic flu. The highly computerized plant now awaiting final government approval will not pump out vaccine until late next year. The Philadelphia Inquirer gives us a tour.

There are only two FDA approved meds for long-term weight control, and they had relatively modest sales of $1.2 billion globally last year because of side effects and only moderate sustained weight loss. With such an urgent need, why can’t drugmakers find a safe and effective weight-loss pill at a time when they are discovering revolutionary new treatments for cancer? The Star-Ledger of New Jersey explores.

An FDA advisory committee will meet soon to decide whether Avandai can remain on the market, thanks to a recent and controversial analysis by Steve Nissen. The uproar is the latest example of why Nissen, 58, whose day job is chairman of cardiovascular medicine at the Cleveland Clinic, has emerged as a Naderesque figure and the nation’s unofficial arbiter of drug safety. The New York Times does a profile.

For the curious, a Nissen profile appeared last year in The Star-Ledger of New Jersey, which owns Pharmalot. You can read that one here….

A MATTER OF PERCEPTION
By ED SILVERMAN
STAR-LEDGER STAFF

To the pharmaceutical industry, he is increasingly troublesome, scuttling potential blockbuster medicines by raising red flags about safety.

To some patient advocates, he’s an ally, who has shown more backbone than the Food and Drug Administration when it comes to monitoring prescription drugs.

Others accuse him of having it both ways, crusading on safety while accepting money from drugmakers to run their clinical trials.

Meet Steve Nissen, the nation’s most controversial heart doctor.

Nissen, who is chief of cardiovascular medicine at the renowned Cleveland Clinic and the new president of the American College of Cardiology, says he would rather be known for helping patients and setting standards for the nation’s 28,000 heart doctors.

“Honestly, the safety thing is not how I want to be known,” the studiously upbeat Nissen said recently, as he drove back to his office after taping a public-radio show about drug safety. “I understand how people may think that. But being an industry critic is not who I am.

“The most exciting thing I do is bring medicines to patients.”

Still, he has thrust himself into the national debate over drug safety, warning anyone who will listen — colleagues, regulators, consumers — about the risks posed by certain drugs.

“He’s extremely credible and reasonable,” said Peter Gross, who heads the internal medicine department at Hackensack University Medical Center and is chair of the FDA’s drug-safety panel, which until recently included Nissen. “You have to respect his opinion.”

Nissen’s first big moment in the spotlight came in 2001, when he co-authored a paper in the Journal of the American Medical Association questioning the safety of two widely used painkillers, Merck’s Vioxx and Pfizer’s Celebrex. This was three years before Vioxx was withdrawn from the market over links to heart attacks and strokes.

During the past 18 months, Nissen has been on an especially strong roll.

Last year, he voiced concern that Natrecor, a Johnson & Johnson heart drug used in hospitals and clinics, was marketed inappropriately and lacked sufficient safety studies. Though he sat on an FDA panel that endorsed the drug, his criticism focused national attention on the issue.

He has also helped squelch drugs before they landed in pharmacies. In 2004, he convinced other members of an FDA panel not to endorse Exanta, an AstraZeneca blood thinner. FDA panels include doctors and scientists who advise the agency on whether to approve new medicines for the market.

Last fall, he co-authored a withering critique of Pargluva, a Bristol-Myers Squibb diabetes pill up for FDA approval. The drug is on hold.

Just a few weeks ago, Nissen sparked a debate that stunned doctors and parents nationwide. As a member of an FDA drug-safety panel reviewing several popular attention-deficit disorder pills, he raised questions about heart risks. This prompted the panel to recommend a severe warning, although the FDA hasn’t issued one.

“He’s becoming radicalized,” said Arthur Levin, director of the non-profit Center for Medical Consumers and another member of the FDA drug-safety panel. “And he’s getting tougher, which is a good sign. Having somebody of his stature in cardiology taking a strong stand on risks is very important. He can’t be dismissed.”

Nissen is no ordinary gadfly. Rather than throw darts at drugmakers and regulators from outside the drug-approval process, Nissen says he’s trying to change attitudes and behavior from within. As a result, he’s more than happy to sit on FDA panels, and he regularly consults for drugmakers, including those whose medicines he slams.

Companies have increasingly turned to Nissen because of his pioneering work with intravascular ultrasound, an imaging technology used to study heart medicines. By overseeing a large network of hospitals that participate in clinical trials, he wields clout with an industry that relies on testing.

His client list reads like a who’s who of the industry: AstraZeneca, Abbott Laboratories, Bayer, Wyeth, Novartis, Pfizer, Hoffmann-La Roche, Sanofi-Aventis, Eli Lilly, GlaxoSmithKline, Merck and Schering-Plough, among others. Major drugmakers declined to comment on Nissen.

These entanglements can also be a lightning rod for criticism.

Recently, Nissen, 57, led a study that found AstraZeneca’s Crestor cholesterol drug reversed the build-up of plaque in arteries. This was the first time any of the so-called statin pills, a group that includes Pfizer’s Lipitor, was shown to do so. The results received national attention, and Nissen sang the medicine’s praises. “The results were shockingly positive,” he told Reuters at a cardiology conference in Atlanta where the results were released.

But not everyone was impressed. The study used the highest Crestor dosage, which has been linked to severe muscle and kidney damage. The hoopla over the results prompted Sidney Wolfe, a drug-industry critic at Public Citizen, the consumer-advocacy group, to charge Nissen with promoting the interests of the drugmaker, not patients.

“This appears to be good news, but it really only helps AstraZeneca,” Wolfe said. “If this study causes people to use the higher and more dangerous dose, that would be a disservice. “Remember that he takes money from all kinds of companies.”

Said Merrill Goozner of the Center for Science in the Public Interest: “Nissen isn’t out there to be a safety advocate. To a certain extent, it’s a sideline to him. He’s beginning to see the safety issue more clearly now than before, but I have real problems with his aggressive use of statins.”

Nissen said there is no conflict. For the past three years, he has asked drugmakers to send his consulting and speaking fees directly to the American College of Cardiology, which disburses it to charities, a point confirmed by the college. He doesn’t take a tax deduction, either, he said.

“The minute you go work for a company, you have to put on a commercial hat. And that doesn’t appeal to me,” said Nissen, a balding and bespectacled man who relaxes by bicycling or spending quiet time with his wife, a photographer. “I have a better job — I get to work with all of them. I try to effect change my own way.”

To hear Nissen tell it, he loves to change things. An Ohio native, he grew up in Fullerton, Calif., where his father was a gynecologist. But at first he rejected his father’s push to pursue medicine. Instead, he got caught up in the 1960s anti-war protests while attending the University of Michigan in Ann Arbor, where he spent eight years majoring in “social activism.”

“Those were times when we saw that people in power didn’t always do the right thing,” said Henry Grix, a lawyer in Bloomfield Hills, Mich., who co-edited the university newspaper with Nissen. “All of us on the paper were people who felt it was prudent to question authority. Steve was constantly somebody who had those feelings. It doesn’t surprise me he’d question statements others make.”

Some drugmakers have learned this the hard way. AstraZeneca, for instance, was funding Nissen’s Crestor study at the same time he dashed their hopes to see the Exanta blood thinner approved. A company executive acknowledged frustration over the episode, but said AstraZeneca held its corporate tongue because the high-profile doctor was needed to complete the study.

“We didn’t need Steve to know (Exanta) was going to be a challenge,” said Adele Gulfo, vice president of cardiovascular research at AstraZeneca, which withdrew Exanta in Europe over the same concerns voiced by Nissen nearly two years earlier. “But he gave us a hard time and, ultimately, did what he thought was right. I don’t think he’s immovable on a topic, but you just can’t pay him to be a spokesperson.”

Nissen’s stubborn streak is, in part, what ultimately led him to medical school. After hanging around Ann Arbor for so long, he decided to use some of the lessons learned from student protests and enter a profession that gave him the opportunity to do what he likes to call “meaningful work.”

The Cleveland Clinic, a sprawling health-care institution that encompasses 37 buildings and employs 20,000 people, is often cited as one of the nation’s leading heart hospitals. It regularly tops the rankings compiled by U.S. News & World Report magazine.

Finding Nissen in this city-within-a-city isn’t easy. Located just a few minutes east of Cleveland’s gritty downtown, the clinic is a maze where an army of doctors and nurses parade through connecting corridors as they shuttle between labs and offices. The complex is so big that it can take more than five minutes to walk from the main entrance to Nissen’s office.

“I have all these unpacked boxes stacked up because I just moved into this space two weeks ago,” he said during a break between meetings last month. “But it’ll be home soon.”

In February, Nissen was named interim chair of the hospital’s famed cardiovascular department after his predecessor, Eric Topol, resigned amid controversy. The pair gained prominence when they published the 2001 JAMA article raising concerns about Vioxx and Celebrex. But a few months ago, Topol provided videotaped testimony for a Vioxx product-liability trial in which he lambasted Merck’s management. Shortly afterward, he left the clinic.

Overseeing a budget north of $100 million, Nissen spent a recent afternoon juggling a variety of tasks — holding a conference call with some pharmaceutical executives about a drug under development; taking another call with a biotechnology company to rework terms of a licensing deal; meeting with a job candidate; and a quick stop at the department lab to chat with a few of the 800 employees he supervises.

Keenly aware of how he’s perceived by the outside world, Nissen wants to leverage his role at the Cleveland Clinic to perfect what he calls an academic research organization, an entity that runs clinical trials for drugmakers while retaining the right to publicize data. This contrasts with contract research companies that do the industry’s bidding and never share data.

By promoting this concept, Nissen hopes to build the Cleveland Clinic into an even more influential medical-research powerhouse that transforms the way drugmakers do business. As Nissen sees it, drugmakers have left themselves little choice but to acquiesce to demands to do a better job of monitoring safety.

“We’re on the verge of a breakthrough with the industry to make them understand that it’s not in their interest to hold everything so close to the chest,” he said. “It may sound self-serving, but we can provide a level of confidence and integrity that will allow the public to regain confidence.”

Steve Nissen
Job: Interim chairman, Cardiovascular Medicine Department
Claim to fame: Drug safety czar
Age: 58
Education: B.S., M.D., University of Michigan
Unofficial college major: Anti-war activist
Family: Married, no children
Hobby: Cycling
Quote: “I don’t do anything. I’m boring.”

Cleveland Clinic
What it is: World-renowned hospital system based in Cleveland
Founded: 1921
Staff: 1,300 physicians in 120 specialties; 20,000 employees total
Beds: Nearly 3,000
Best known for: Cardiology, urology, gastrointestinal
Accolades: No. 4 in U.S. News & World Report’s ranking of top U.S. hospitals