Author: Jonathan D. Rockoff

The FDA posted documents today saying the effectiveness of Forest Laboratories’ experimental lung drug Daxas was “quite modest” while expressing concern about side effects seen in clinical trials.

In particular, the FDA staff cited three suicides and two suicide attempts among patients using the drug who were studied. Here’s the Dow Jones article.

Despite the low efficacy and pscyhiatric side effects, many analysts think the drug has a good chance to win approval. A committee of outside experts is scheduled to meet Wednesday and review roflumilast, as Daxas is known. The panel will give its thoughts to the FDA, which will make the final decision.

The once-daily pill aims to chronic obstructive pulmonary disease, a nasty condition — often caused by smoking — that makes breathing difficult. There’s no cure available for the ailment, a big plus for the potential treatment aimed at a largely unmet need like COPD, analysts say.

It also helps Daxas’ cause, analysts point out, that Forest Labs took a number of steps to minimize the risks. The company recently narrowed the indication it was requesting to the treatment of flare-ups, rather than more frequent use to treat symptoms. It also said it would warn about the psychiatric side effects in the drug’s label. And it agreed to closely monitor patients taking Daxas for signs of trouble.

Approval would be a big victory for Forest Labs, which licensed the compound last August. Yearly sales could reach as much as $2 billion, says Jefferies & Co. analyst Corey Davis.

It’s not every season that a long-shot team like the Butler University Bulldogs makes it to the championship round of the NCAA basketball tournament. And it’s certainly not every year that the coach of a Final Four team used to sell prescription drugs.

Between college and the start of his coaching career, Brad Stevens, the 31-year-old coach of the Bulldogs, did a short stint as a marketing associate at Eli Lilly working from Lilly’s HQ in Indianapolis. He left the drug maker in 2000 to join the staff at Butler, also in town.

Stevens is now in his third year as the Bulldogs’ coach, and is leading the team into the championship weekend that starts tomorrow in — as luck would have it — Indianapolis. That’s generated huge home-town support for Butler, including a big turnout at a Bulldog practice session held today at Lucas Oil Stadium (see picture).

The team’s surprising success also has stirred up supporters at nearby Lilly. Spokesman Ed Sagebiel tells the blog that the company has raised Butler University flags around the headquarters’ main entrance. At night, the company has been bathing its 12-story corporate tower in lights that are Butler blue.

No word if the company’s animal-health division is providing any assistance to Butler Blue II, the university’s bulldog mascot.

Bonus trivia: One of Stevens’ predecessors at Butler, coach Tony Hinkle, came up with the idea of coloring basketballs orange — to make them easier for players to see, the university proudly proclaims in advertising.

Photo: Ed Sagebiel

AstraZeneca has reached across the Atlantic to poach a well-regarded neuroscientist from Pfizer to lead its drug discovery, research and early development efforts, according to people familiar with the hire.

Menelas Pangalos was chief scientific officer in charge of neuroscience research at Pfizer, but only for a few months. He had just come from Wyeth, as part of its takeover by Pfizer last year.

AstraZeneca confirmed the move and said Pangalos would become executive vice president of innovative medicines as of May 1.

In championing Wyeth’s acquisition, Pfizer executives had liked to mention that Pangalos would come along with the deal. Pfizer CEO Jeff Kindler called him “world class” in a conference call with investors and analysts last month. R&D executive Martin Mackay referred to him in a call last October as an “outstanding talent.” Neuroscience research is a priority for Pfizer.

Pfizer has named Anabella Villalobos to fill Pangalos’ post on an interim basis, and has begun looking for a permanent successor, a company spokeswoman said.

Pangalos, a U.K. citizen, will succeed Jan Lundberg, who left AstraZeneca to head R&D at Eli Lilly.

Photo: Associated Press

The FDA says it added its strongest warning today to the label of the widely used bloodthinner Plavix, Bristol-Myers’ best-selling drug, to help physicians treat patients correctly. But the warning could make doctors’ job more difficult.

Docs prescribe Plavix to reduce the risk of heart attacks, strokes and other serious heart problems. The drug prevents dangerous blood clots that can cause those conditions. As a growing number of studies has demonstrated, however, Plavix doesn’t work well in certain patients – those with a genetic variation that makes it difficult for them to metabolize the drug.

The FDA says between 2% and 14% of Plavix users don’t respond well to the drug and might benefit from alternative treatment. Hence the new so-called black-box warning.

Genetic testing could identify the poor responders. But most doctors aren’t well equipped to do genetic testing. They don’t have quick access to the tests. Even if they did, they might not have time in the cases of many patients to wait for results to come back.

What’s more, the FDA has approved only one genetic test, Roche’s AmpliChip, to look for the variation, but not specifically for determining treatment with Plavix. Many laboratories offer other tests, whose quality the FDA says doctors will have to assess before using. Doctors should make sure the tests are at least 98% accurate, FDA officials told reporters.

Christopher Cannon, a Harvard Medical School associate professor and editor-in-chief of Cardiosource, tells the WSJ’s Ron Winslow that heart-doctor associations will need to develop protocols for testing and treatment. The alternatives include increasing the dose of Plavix or switching to bloodthinner Prasugrel from Lilly and Daiichi Sankyo, but Cannon says neither has been tested for that purpose.

“Thus a real conundrum” for patients and their physicians, Cannon said. “I expect mass confusion in response to this FDA warning,” he added.

Plavix, which is also marketed by Sanofi Aventis, is the second-best selling drug world-wide with $8.6 billion in sales in 2008, according to IMS Health.

Health Blog readers aren’t the only folks who realize the influence of the Internet. So do drug marketers. They have taken notice of the Web’s impact on people’s preferences and are adjusting pharmaceutical advertising accordingly, today’s Wall Street Journal reports.

Hence the small but growing number of advertisements for prescription medicines that feature the stories of real patients — like the one pictured at the right, for Pfizer’s Chantix — rather than using celebrity endorsers or gauzy voice-overs to pitch their products.

Pfizer, the world’s biggest pharmaceutical company, began running patient testimonials with ads for cholesterol fighter Lipitor, after spots featuring artificial heart inventor Robert Jarvik were attacked. (The controversy led to congressional investigations and guidelines.)

Pfizer is now using patient stories to sell smoking-cessation therapy Chantix. “The role of the peer is important because it really provides a positive example,” said Jim Sage, a Pfizer marketing official.

Market research has shown pharmaceutical ad folks the power of peer influence, drug marketers say. The sick are relying more and more on the experiences and recommendations of fellow patients, rather than heeding the endorsements of celebrities or pitches of companies.

It’s both a sign and a symptom of the fact that discussions of drugs are flourishing on online message boards, chat rooms and social-networking sites. And even the Health Blog.

Photo: Pfizer

Last we heard of Fablyn, an experimental bone drug for the treatment of postmenopausal women, U.S. regulators were holding off on approval after FDA staff and outside reviewers raised concerns and Pfizer, the pill’s maker, was shopping it around to other companies.

Today’s New England Journal of Medicine reports that the drug met the goals of a key study. Fablyn prevented certain fractures in postmenopausal women and reduced the risk of breast cancer, said the study, sponsored by Pfizer. However, the drug didn’t show a statistically significant benefit preventing debilitating hip fractures. Also, it increased the risk of blood clots by two times.

The Phase 3 study looked at 8,556 women between the ages 59 and 80 over five years. Its mixed results aren’t likely to clarify Fablyn’s future. Here’s a Reuters account of the findings.

The study’s lead author, Steven Cummings of the California Pacific Medical Center Research Institute, said the results show Fablyn’s effectiveness as a second-line treatment for certain postmenopausal women. The drug would be a candidate, he said, for those women coping with osteoporosis who are at high risk of breast cancer but not for spine fractures, which other osteoporosis therapies treat more effectively.

But Carolyn Becker, an osteoporosis specialist at Harvard Medical School who treats the patients at Brigham and Women’s Hospital, said Fablyn doesn’t provide any benefits greater than the variety of currently approved treatments. (Among the alternatives is a drug in the same class as Fablyn that Eli Lilly sells as Evista.)

“The question is, Is there enough of a difference to choose this drug over a drug that’s been out on the market over 10 years and has a lot of safety data with it,” she said. “There’s no compelling reason for me to switch unless the cost is much less, which is unlikely.”

A Pfizer spokeswoman says the company continues to seek a suitor for Fablyn, and the company hasn’t yet responded to the FDA’s request for more information about the drug.

Fablyn is approved in the European Union for treatment of osteoporosis in postmenopausal women at increased risk of fracture. Here’s more on various experimental bone drugs.

Image: iStockphoto

Diabetes doctors are facing a new round of questions from worried patients after findings of a Senate investigation that renewed concerns about the safety of Avandia. What should the patients do?

Dr. Richard Bergenstal, executive director of the International Diabetes Center in Minneapolis, tells the Health Blog that the most important thing is that patients stay on whatever medicines they are taking until talking things through with their doctors. Skipping or dropping treatment altogether could worsen their diabetes. Better they first review their options with their endocrinologist.

“There are a lot of medications, and we can discuss the options. The last thing we want is someone to be stressed,” said Dr. Bergenstal, who is also president of medicine and science at the American Diabetes Association.

Physicians typically prescribe drugs like Avandia to patients whose diabetes isn’t well controlled by improvements to diet and exercise and by the medicine called metformin that is often prescribed first.

Diabetics and their doctors have been here before. Concerns that people taking Avandia have a higher chance of suffering a heart attack than patients taking other diabetes pills surfaced in 2007. Since then, doctors have taken many patients off of Avandia. Last year, the American Diabetes Association recommended that physicians use other drugs.

Yet many patients continue to take Avandia, which is made by GlaxoSmithKline. Dr. Zachary Bloomgarden, editor of the Journal of Diabetes and a clinical professor at Mount Sinai School of Medicine in New York, says he kept diabetics on Avandia if they weren’t at risk of heart problems and the drug was working well to control high blood sugar levels.

Dr. Bloomgarden, who has been paid by GlaxoSmithKline and its competitors to speak and consult, says he won’t put new patients on Avandia, giving the controversy surrounding it, but he has advised patients doing well on the drug to stay on it.

So does the FDA. There’s no new medical or scientific information in the recent medical-journal articles about Avandia, Dr. Bloomgarden emphasizes.

You can read the Senate report here.

Photo: Bloomberg News

Johnson & Johnson figures that compensation for many of its its 115,000 employees is out of kilter with the health-care industry and it’s starting to to do something about it.

Under a plan called the Global Compensation Framework, J&J has established 3,000 job classifications and 20 pay grades across the company, the WSJ reports this morning. The big health-care company also has come up with higher performance bonus targets for 27% of its employees and lower ones for 38%. Yearly stock bonuses will also be adjusted, the company says.

Put it all together and an unspecified number of employees will be getting overall cuts in compensation, the WSJ says. But others will see increases and in fact, the cost savings from the overhaul will be “minimal,” according to the company.

“This program is about creating a global compensation program that is consistent and equitable for our employees across the company,” a J&J spokeswoman told the WSJ. The spokeswoman says one goal is to make it easier for employees to transfer from one unit to another among J&J’s many businesses.

But J&J, like other health-care outfits, is also under profit pressures. You’ll remember that J&J last month reported its fourth-quarter earnings fell 19% on restructuring charges and the company posted its first full-year sales decline in 76 years.

Elsewhere in the industry, Bristol-Myers Squibb said this month it is freezing salaries this year for employees where it can. That move won’t affect bonuses, the company said.

Photo: Associated Press

With an apparent eye on Pfizer’s experience early this month, Merck officials made one thing abundantly clear during the morning’s earnings report: “Nothing in our guidance has changed,” CFO Peter Kellogg said on a conference call with analysts.

The emphasis was undoubtedly a reaction to Pfizer’s Feb. 3 earnings report when it lowered its 2012 guidance. Pfizer officials dismissed the import of the change at the time, saying it merely reflected some divestitures. Still, the news pushed down Pfizer shares 2.3%, and weighed on the Dow Jones Industrial Average for the day.

Merck made no such adjustments to its long-term guidance while reporting its first results since taking over Schering-Plough in November. Merck said it aimed for a yearly growth rate for earnings per share between 2009 and 2013 in the high single digits, excluding items. The drug maker didn’t provide a specific 2010 outlook, saying it would do so in April.

As careful as the company was to reaffirm its previous expectations for the long term, its statements lacked detail. Officials said that would come later. “Obviously we need to grow the business, and we’re looking forward to putting together a strategy to do that,” CEO Richard Clark said.

In the meantime, there was little way to compare the combined company’s performance during the fourth quarter with what it would have been a year earlier had the merger been in effect. Still, analysts praised Merck’s latest results and noted the growth of key products. (See Dow Jones Newswires’ report here.)

Photo: Associated Press