Several years ago, Emory University psychiatry and radiology professor Doug Bremner was immersed in a long-running controversy over Accutane and links to suicide. His research vexed the drugmaker, Roche, and he wound up as an expert witness in litigation. The experience and subsequent scandals about undisclosed side effects prompted him to write a book, “Before You Take That Pill: Why The Drug Industry May Be Bad For Your Health.” In his view, consumers need more info than they generally receive and so Bremner, who has also consulted for Glaxo, Novartis and Wyeth, details the risks, benefits and other background data on some 300 meds. This is an excerpt from a recent conversation…

Pharmalot: What made you write this book?
Bremner: It came out of my work with Accutane, after reading the material and how the side effects were dealt with internally - Accutane caused depression, but it was rewritten by the marketing team over concerns that it would effect sales. But in general, I was interested in the risks and benefits of drugs as they’re presented by the drug companies. It’s the job of drug companies to sell drugs, and they’re doing a good job of that. But I wanted to provide an alternative viewpoint.

Pharmalot: So the assumption is there’s a need for more info to counter-balance what companies disseminate?
Bremner: Consumers don’t have the time or means to obtain and read medical journals and primary literature. This is a way they can learn for themselves about risks and benefits. They should have some info to take with them when they talk to their doctor. Wouldn’t you want more information about statins if you were told to take a drug to treat high cholesterol? The marketers have done a good job of promoting drugs, but some are overpromoted. Through marketing and advertising, the potential risks may not be highlighted as much.

Pharmalot: But it’s not as if people don’t get useful info from their doctors, right?
Bremner: Most physicians are getting presented literature by a sales rep about a favorable clinical trial. But most physicians also don’t have the time to read all the clinical trials about a drug. I’m not saying the information is misrepresented. But the marketing affects how physicians write prescriptions. I think people should educate themselves. There’s no reason they shouldn’t know about the drugs they’re taking.

Read more »

A House investigator charged that the FDA’s Office of Chief Counsel has undermined a congressional drug safety investigation, InsideHealthPolicy* reports.

Energy and Commerce Committee investigator David Nelson told a bipartisan committee the probe was stymied because the FDA office denied investigators access to documents and personnel, the web site wrote. Committee investigators interviewed operational and field staff at FDA - who were involved in heparin inspections and scientific analyses - but not agency lawyers involved in policy decisions, according to InsideHealthPolicy.

“We’ve not gotten interviews with the counselors that make many of these decisions or at least have veto authority over those decisions,” Nelson told the committee.

Read more »

After a 31-year pharma career, including the past eight at Wyeth, Ruffolo, 58, plans to leave later this year and he’ll be replaced by Mikael Dohlsten, 49, an exec vp at Boehringer Ingelheim. The move comes after a stretch of disappointments for the drugmaker which, like most of its rivals, is struggling to develop drugs more quickly and win FDA approval.

Recently, Wyeth received the FDA’s blessing to market the Pristiq antidepressant and the Relistor bowel drug. Until these approvals, however, the drugmaker ran into a series of setbacks that so infuriated outgoing chairman Bob Essner that he publicly chastised the FDA for being too cautious. Pristiq, for instance, has yet to win approval as a treatment for menopausal hot flashes.

In response, Wyeth has been laying off thousands of employees. Back in the lab, Ruffolo initiated programs to drastically step up the pace of discovery work to identify promising drugs in hopes of generating a growing number of compounds that would proceed quicker along the development path.

“Bob Ruffolo has been the driving force of our R&D progress, establishing Wyeth as one of the research leaders in the pharmaceutical industry. His legacy will be our pipeline, recognized as one of the industry’s most innovative,” says Bernard Poussot, Wyeth’s ceo, in a statement. Poussot, by the way, was promoted to ceo just a few months ago.

Read more »

New Jersey may be the nation’s medicine chest, but that’s nothing compared with being the pharmacy of the world. But where is that pharmacy located? Right now, many would argue it’s the US. But the European Commission and members of the European Federation of Pharmaceutical Industries and Associations today are releasing details of plan to end Europe’s declining international role in medical research, Reuters reports.

To be called the Innovative Medicines Initiative, the effort will offers grants to academic institutes and small companies to research ways of beating bottlenecks in the drug development process. Teams of commercial and not-for-profit researchers will be able to seek support on condition that their findings are publicly shared in an effort to stimulate faster and safer drug development, The Financial Times writes.

“This is a chance for us to really get back on the right foot,” Arthur Higgins, president of the EFPIA and head of Bayer Healthcare of Germany. “We’re sending a signal to the US, Japan, China and India that Europe is taking its bioscience sector really seriously.”

Read more »

Andrew Witty may not be ceo yet - that doesn’t happen until May 22 - but he’s already announcing senior management changes. The biggest move involves creating what he calls an emerging markets division to encompass activities in places such as Russia, China, India, Brazil and the Middle East. The unit that will be headed by Abbas Hussain, who spent 20 years at Lilly (pictured to the left).

At the same time, Witty is shuffling other divisions - the North America division now includes the US, Canada and Puerto Rico, and will be run by Chris Viehbacher, who heads the US pharma unit. A new Asia/Pacific region is being created to include Japan and Australia, and will be headed by Marc Dunoyer, who has headed the Japanese division. And Bob Ingram is no longer listed as a vice chairman. (Here’s the old line-up).

However, there is an opening for senior vp and general counsel. So if you know anyone…

No sales reps need apply. But the agency hopes to fill more than 600 new positions and more than 700 others that have gone begging. Such as? FDA officials say they want biologists, chemists, medical officers, epidemiologists and statisticians as part of a “multi-year hiring initiative.”

“It takes a large pool of talented people for the FDA to protect and promote the public health,” John Dyer, the FDA’s deputy commish for operations and chief operating officer, says in a statement. “Each month there is a delay in bringing critical staff on board impairs the agency’s ability to fulfill this mission.”

The effort is a result of legislation and initiatives, such as the FDA Amendments Act of 2007 and the Import Safety Plan, which are designed to improve reviews and oversight, a national sore point following numerous scandals over such products as Vioxx and Heparin.

And so the FDA is holding job fairs across the country - even in Germany. Here’s the schedule. Moreover, the agency says it has a new fast-track program - qualified candidates could be on the job in as little as three weeks. No word, though, on whether this includes the commissioner’s job, even though FDA commish Andy von Eschenbach still won’t say how much money the agency needs to do its work.

The healthcare giant yesterday notified employees it will consolidate the sales and marketing operations of two subsidiaries, Ortho Biotech and Centocor, leading to roughly 400 job cuts nationwide, The Star-Ledger of New Jersey reports.

The move is a response to the declining sales of its Procrit anemia med, a spokesman tells the paper. Procrit scrips fell sharply last year after the FDA issued new safety warnings, which were also placed on anemia meds sold by Amgen. More recently, an FDA panel recommended that current use should be restricted over concerns the drugs can increase the risk of tumor growth and death.

“It is important that we take these significant and difficult steps in our business to free up resources that can be redeployed to opportunities that will make the greatest difference to patients and to our own future success as a business,” Kristine Peterson, J&J’s company group chair for biotech, immunology and oncology, wrote in an e-mail to workers.

Ortho Biotech’s sales and marketing operations had been based in Bridgewater, New Jersey, but will shift to Centocor’s headquarters in Horsham, Pennsylavania, and will be led by Kim Taylor, who is currently president of commercial operations for Ortho Biotech. Centocor’s sales and marketing chief, Neal Fowler, stepped down from his post last month. Researchers for Ortho Biotech will remain at the unit’s home office in Bridgewater. The consolidation is expected to be completed by year’s end.

In their quest to boost Zetia scrips, Schering-Plough and Merck are truly scrambling. First, there was the ‘49 Plan,’ which was a seven-week-long effort to wine and dine docs in hopes they would write more scrips for the cholesterol pill.

Now, the drugmakers have gotten really inventive - they’re slapping Zetia stickers on anything that docs and their office staffs can throw down their throats. Of course, offering chocolates is a clever move - a recent University of Illinois study found that eating chocolate bars reduced cholesterol. Although the study was funded, in part, by Mars, which makes chocolate. But that’s a familiar tactic, isn’t it?

Hat tip to Question Authority

A fight has erupted in Congress over the question of whether companies should be allowed to keep patents they obtained by misrepresentation or cheating, The New York Times reports. And the issue has emerged as a contentious point in legislation to overhaul patent laws.

In several cases, the courts have voided patents after finding that companies intentionally misled the Patent and Trademark Office. Federal judges can void patents after finding a company engaged in “inequitable conduct,” a reference to misrepresentation or info that was concealed with an intent to deceive the patent office. In such cases, judges can declare the patents unenforceable.

“This is like imposing the death penalty for relatively minor acts of misconduct,” Bob Armitage, Lilly’s senior vp and general counsel, tells the paper. As his remark indicates, brand-name drugmakers are urging Congress to eliminate the penalty, or to curtail it as proposed under a bill passed by the House.

But Debra Barrett, a Teva Pharmaceuticals vp, tells the Times that the changes sought by brand-name drugmakers “would make it easier for them to cheat and get away with it, easier for them to defend their patents and more difficult for us to get generic products onto the market in a timely way.”

Read more »

Lurking in a federal court in New Jersey is a lawsuit brought by a generic company that could change some assumptions about Schering-Plough and its cherished status as a big drugmaker with few near-term patent problems.

At issue is the Clarinex allergy med, which was a $799 million seller last year and is increasingly important as Vytorin sales decline. The drug has patent protection until 2020, according to Schering-Plough. But in its patent challenge, Orchid Pharmaceuticals charges that Clarinex doesn’t have anywhere near the patent protection Schering-Plough claims.

The fight centers on Schering-Plough’s assertion that the formulation for its Clarinex RediTabs is covered by existing patents and that those patents were filed properly. Orchid argues otherwise, but has been prevented from selling a generic by an automatic 30-month waiting period that was triggered by Schering-Plough’s patent infringement lawsuit, which was filed in September 2006.

Not surprisingly, Orchid is seeking an order that forces Schering-Plough to delete its patent listing. Meanwhile, the Indian generic drugmaker indicates in an April 15 court filing that it’s ready to start selling a generic Clarinex. “In short, the 30-month stay is the only remaining barrier to the availability of generic desloratadine orally disintegrating tablets to the public.”

Orchid and its attorneys at Latham & Watkins maintain the 30-month stay ends in March 2009, which would allow the FDA to approve its version at that time. A Schering-Plough spokesman disagrees but won’t say when the stay ends, suggesting some legal maneuvering lies just ahead. The real issue, though, is if the court orders the patent to be delisted even sooner, maybe anytime over the next few weeks or months.

Could this be the making of an at-risk launch? You know, that’s when a generic drugmaker goes ahead and sells its copycat version even as litigation with the brand-name drugmaker continues. Orchid hasn’t tipped its hand, but unless Schering-Plough can prove its filings exists and are legit, perhaps its top line will be in for another hit.

Hat tip to Shearlings Got Plowed