Controversy

Hassan gets $30M pay package

Thu, 24 Apr 2008 06:59:54 -0400

Fred Hassan (photo) may have his hands full these days, defending Vytorin and Zetia while cutting jobs and costs. But at least his pockets are full, too. The Schering-Plough CEO chalked up more than $30 million in 2007 compensation, according to the company's proxy. (The Associated Press totes up $24.7 million, because it leaves out pension benefits.)

The details: Salary came to $1.67 million, up from $1.65 million in 2006. He got no bonus, but did rake in $18.4 million in stock and options, more than double the amount he brought in last year. His $608,000 in perks included $146,680 for personal security.

One interesting note in the proxy: If the stock performance as of March 31, 2008 had been used to calculate compensation (rather than December 31, 2007) then Hassan's "five-year transformational incentive" would have paid out exactly nothing. The Vytorin controversy thus puts a big chunk of Hassan and his fellow Schering-Plough bigwigs' pay at risk, the proxy states. Duly noted.

- find Schering's proxy at the SEC
- check out Pharmalot's calculations
- see the Associated Press numbers
- get the specifics on Hassan's at-risk pay at the Shearlings Plowed blog

FDA wants to lengthen stent testing

Thu, 27 Mar 2008 07:59:55 -0400

Looking for hard evidence that the FDA is tightening approval standards? Here it is. The agency today proposed tougher clinical trial guidelines for drug-coated stents. Rather than letting new versions of the artery-decloggers onto the market after nine months of study, the new rules would require data collected two years after the procedure. Then, after the stent is approved, companies would continue monitoring the product for complications, preferably for five years.

The new guidelines closely follow standards the agency used to assess new stents from Medtronic and Abbott Laboratories. The more stringent analysis of those products came after studies raised concerns about blood clotting in the stents long after they were implanted. For about a year, warring research muddied the safety waters around coated stents, but consensus has settled around a "perhaps" for clots years after the procedure and a "probably not" for increased deaths or blood clots overall. The FDA's new rules seek to minimize the "years later" risk, and according to analysts, aren't a big surprise. They "conform to the way the industry has already been thinking about product design," one told the Wall Street Journal. We'll see how the companies themselves respond.

- see the WSJ story
- check out the article in the Chicago Tribune

Related Articles:
Tough times for stent market. Report
Decline in drug-coated stent use at cardiac centers. Report
Insurers may cut stent payouts. Report
Little common ground in stent controversy. Report

Congress: Were Enhance results secret?

Tue, 12 Feb 2008 06:59:57 -0500

Finally, someone asked the question we've been wanting to ask ourselves: Even if the Enhance study data remained blinded, could Merck or Schering-Plough have divined its overall sway? Sen. Charles Grassley, who's been shooting out letters to the two companies at the rate of at least two a week, made the query in another round of correspondence yesterday.

The question of who knew what exactly when has been central to the whole Vytorin controversy. As the world waited for the Enhance results, did Merck and Schering execs know Vytorin didn't slow the progression of heart disease any better than simvastatin alone? Did Schering execs know anything, for instance, when they sold millions worth of stock last May? Did the companies know anything while they were pushing Vytorin via a big-time TV ad blitz?

Grassley's counterparts in the House also posted new letters this week, asking about some posts on a website for drug reps, Café Pharma. One post last March said, "have a buddy at [Schering-Plough Research Institute]. He says that the study is a bust." Who else, Congress wants to know, might this "buddy" have told?

- find links to the House letters at Energy and Commerce's website
- read the Grassley piece at the Wall Street Journal Health Blog
- check out the Café Pharma item

Related Articles:
FDA to review Enhance study. Report
Congress promises Vytorin hearings. Report
Merck, Schering's Vytorin fails trial. Report

Stent sales stabilize as rival enters

Mon, 04 Feb 2008 06:59:57 -0500

In the stent world today, it's good news, good news, and bad news. First, the bad news: Last year's fourth quarter was the worst in several years for drug-coated stents. In December, only 62 percent of stent procedures used a coated device; that's compared with 80 percent as recently as mid-2006. You'll recall that sales of these stents dropped precipitously after some studies showed they might increase the risk of blood clotting; since then, additional studies have shown that the drug-eluting stents are actually safer for some patients, though they're not recommended for others.

Next, some good news: It looks as if the market has bottomed out, so there's nowhere to go but up for coated stents. At least that's the Wall Street Journal's estimation of the figures; as a percentage of stent procedures, the coated versions accounted for 68 percent in July, 66 percent in August, and 62 percent for each month until year's end.

Meanwhile, Medtronic got some good news from the FDA. The device maker got the nod to sell its new Endeavor drug-coated stent; in this case, the tiny mesh tube is coated in zotarolimus, a clog-prevention drug developed specifically for use on a stent. That may not be such great news for stent-makers Boston Scientific and Johnson & Johnson, which have suffered as sales declined. But perhaps they'll be comforted by the fact that Medtronic will soon have to join them in competing with a new rival; FDA is expected to give the go-ahead to another coated stent, the Xience V, sold jointly by Abbott Laboratories and Boston Scientific.

- see the FDA's release about the stent approval
- here's the release from Medtronic
- check out the article from the Wall Street Journal
- read the report on Endeavor's approval

Related Articles:
Study: Bypass better than stents. Report
Docs reconsider drug-coated stents. Report
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report

J&J CEO talks tech

Mon, 14 Jan 2008 06:59:57 -0500

What do you obsess about when you're CEO of Johnson & Johnson? Well, it's not Band-Aids. In an interview with the Financial Times, Bill Weldon (photo) admits to a fascination with technology. Perhaps that's one reason he's so determined to get new ideas from his so-called "Office of Strategy and Growth" set up in November. Could J&J soon partner up with the likes of, say, Google? "Who knows who it's going to be?" Weldon says.

The interview glances off controversy--Weldon briefly defends his decision to let Boston Scientific outbid J&J for device-maker Guidant, and all he says about suing the American Red Cross for trademark violation is that it was "the last thing we wanted to" do. It only mentions J&J's restructuring --and 4,000 layoffs-- in passing. But it gives Weldon plenty of space to talk over J&J's virtues, as he sees them, such as its approach to innovation and its decentralized management structure. Though the latter, he says, causes at least some people to wonder just how he spends his time in exchange for that his most recent annual paycheck of $28 million. "My son says I just sit around and drink coffee and go to meetings," he says.

- read the rest of the interview in the Financial Times

Related Article:
J&J weathers fallout from Red Cross suit. Report

Amgen in new talks over ESA safety

Fri, 07 Dec 2007 06:59:55 -0500

Amgen is sitting down with regulators for a little frank talk about the safety warnings on Aranesp and Epogen, its two cash cows in the anemia market that were worth $6.6 billion in revenue last year. The biotech giant also says that the Oncologic Drugs Advisory Committee plans to meet and review the ESA drugs in the first quarter of next year. Revenue from the ESA category has been falling steadily as federal and private payers enforce limits on their use. That trend has forced Amgen to restructure and pay more attention to pipeline development projects.

- here's the AFX report on Amgen

Related Articles:
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report
Amgen, J&J win a round in anemia controversy. Report
Amgen discusses the future with analysts. Report
New rules limit use of anemia drugs. Report

Docs reconsider drug-coated stents

Mon, 12 Nov 2007 06:59:54 -0500

Well, maybe drug-coated stents aren't so bad after all. Some doctors are now saying that the medical community overreacted to data on the clotting risks of the eluting stents. New data, plus a closer analysis of the old, is leading cardiologists to consider returning to the drug-coated stents for some patients.

But even if the clotting risks aren't as bad as originally thought, some doctors and researchers still say that only the sickest patients should get stents at all. Diet and drugs--including statins and beta blockers--should come first for most, they say. For high-risk patients, on the other hand, stents work. And drug-coated stents don't appear to be less safe than the bare ones. They are, however, less costly--which may continue to drive sales away.

- read the New York Times report

Related Articles:
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Decline in drug-coated stent use at cardiac centers. Report

Study: Coated stents aren't cost-effective

Fri, 02 Nov 2007 07:59:54 -0400

If drug-eluting stents were on the shelves at Costco, most value-conscious customers wouldn't buy. A new Swiss study has found that the coated stents aren't cost-effective for most patients--and wouldn't be even if prices were cut substantially. In fact, it would be "almost impossible" for the more expensive stents to become cost-effective in low-risk patients. That doesn't hold out much hope to manufacturers Johnson & Johnson and Boston Scientific.

But here's one positive to comfort stent makers. They're a good value for a subset of high-risk patients, concluded the study, published in this week's The Lancet. In these patients, who had small-vessel or bypass-graft stenting, the drug-coated versions were cost-effective. In some cases, the coated stents saved money that would have been spent treating complications.

-read The Lancet's release about the study

Related Articles:
Little common ground in stent controversy. Report
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Medical device makers to fund stent safety study. Report
Decline in drug-coated stent use at cardiac centers. Report

Teva inks deal to sell generic Avandia

Fri, 28 Sep 2007 06:59:56 -0400

Remember when, as a kid, you really, really wanted something for your birthday--but then it didn't seem so great once you got it? We wonder if that's the way Teva Pharmaceuticals feels now it's clinched a deal to begin selling generic forms of Avandia and two Avandia combo drugs in 2012. In its typical aggressive fashion, Israel-based generics maker had copied Avandia and prepared to sell its version, but GSK sued, claiming infringement of the patent on the drug's active ingredient (expiring in 2012) and a related patent (expiring in 2015).

Of course, this was all before the big brouhaha over Avandia's potential for causing heart problems, including heart attack and death. The controversy reached its height over the summer and led to an FDA warning that the drug boosts the risk of heart failure. Terms of the settlement deal weren't disclosed, but we bet Teva paid less than it would have twelve months ago--and more than it might have before the new studies showing Avandia might not be as hard on the heart as previously thought.

- check out Teva's release
- read the report from RTT News

Related Articles:
FDA adds to drumbeat of bad news for Avandia. Report
Expert committee says Avandia should stay. Report
Docs shunning Avandia in wake of safety study. Report

Shire recalls some Daytrana shipments

Tue, 04 Sep 2007 06:59:54 -0400

Mom, I can't get my ADHD patch on! Shire is recalling some lots of Daytrana, its attention deficit hyperactivity disorder patch--not because of safety issues, but because patients are having a hard time removing the release liner so they can administer the drug. The withdrawal is expected to cost the British drug maker some $10 million.

- see this release
- here's the report from MarketWatch

Related Articles:
FDA approves Daytrana ADHD patch. Report
FDA signals a quick approval for Shire's ADHD drug. Report
CDC estimates reignite ADHD controversy. Report

After controversy, Plan B sales strong

Thu, 23 Aug 2007 06:59:55 -0400

Like Madonna, the Plan B has faced its share of controversy. Like Hilary Clinton, it's attracted more than its share of political sniping. Like both, it's risen undeterred. Since Plan B was approved for over-the-counter administration last August, sales of the pill have skyrocketed to $80 million for 2007, double the 2006 figure and eight times greater than 2004's. Its manufacturer, Barr Pharmaceuticals, says it's pleased.

Perhaps Barr fears that crowing too loudly about the pill's sales growth will only intensify critics' attempts to overturn the ruling that legalized OTC sales to customers at least 18 years old. A coalition of conservative groups have filed suit against the FDA to do just that. But advocacy groups are just as active, and they want everyone to be able to buy Plan B, regardless of age.

- read the report from The Washington Post

Related Articles:
Barr takes cautious approach in marketing Plan B. Report
FDA clears Plan B, ending FDA confirmation fight. Report
FDA clears way for Plan B to go OTC. Report