Medical News
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McKesson Paying $350 Million to Settle Drug-Price Litigation
McKesson, the big drug distributor, said this morning it has entered a legal settlement over a pretty arcane drug-pricing issue that has had a real effect on drug spending.
At issue: “average wholesale price,” or “ain’t what’s paid,” as some wags put it. While AWP is an important pricing benchmark, nobody who does big-time drug purchasing pays that amount. Even so, pharmacists often get reimbursed for medicines they dispense at a set percentage below a drug’s AWP. So if a drug’s AWP goes up, so would the amount paid by an insurer, PBM or patient.
So what does this all have to do with McKesson? As this front-page WSJ story explained a couple of years back, First DataBank, a unit of Hearst, plays an important role in determining AWP by publishing price lists. At the time, that company settled its own legal battles over revisions to its list of AWPs that inflated drug prices.
Curtain Falls on ImClone Drama, as Lilly Completes Tender
Martha Stewart leaves Manhattan Federal Court in March 2004, after guilty verdicts in her ImClone stock fraud trial.
For those absorbed by the twists and turns of ImClone Systems — from the insider trading of Sam Waksal, to the obstruction-of-justice of Martha Stewart, to the maneuvering of Carl Icahn — it may be time to switch the channel to another biotech soap opera.
The sale of the up-and-down-and-up-again company to Eli Lilly received overwhelming support from ImClone’s shareholders, who tendered 95.5% of ImClone’s outstanding shares at the $70 per share price as the clock struck midnight Thursday. (In this market, at that price, we wonder who’s holding the other 4.5%?)
Lilly, which reported the completion of its $6.5 billion offer this morning, said it expects to formally seal the deal “on or about” Monday.
Although Lilly will get a blockbuster cancer drug, a state-of-the art biologics manufacturing plant and cancer drug pipeline from ImClone, the hard part for Lilly may just be starting.
The company must now integrate a biotech whose biggest product, the blockbuster Erbitux, is shared with Bristol-Myers Squibb and Merck KGaA. Bristol’s Jim Cornelius had his own designs on ImClone before losing out. And Bristol may challenge Lilly’s rights to an Erbitux successor.
Given the rich price paid by Lilly, the company will have to hope that ImClone’s pipeline of new products, including that follow-on to Erbitux, is as promising as touted. Now we’ll turn our attention to Roche’s takeover offer for Genentech.
Layoffs, Financial Woes Stress Out Workers and Their Counselors
You know times are tough when the crisis counselors are feeling overwhelmed.
Getty ImagesIt’s not easy being a telephone counselor these days.
People are turning to short-term counseling services offered by their employers in numbers not seen since 9/11. This week Aetna said its unit serving the employee-assistance programs for corporate clients logged a 60% increase in the number of calls from members in the third quarter of 2008 compared with the same period last year.
“EAPs are like a canary in a coal mine,” Dennis Derr, director of EAP services at Aetna. Demand is up sharpest from callers seeking help with their finances.
It’s not just people using EAPs who are feeling rattled by the financial crisis. “Everyone is impacted, including counselors,” says Marina London, a spokeswoman for the Employee Assistance Professionals Association, or EAPA., “They’re feeling stressed out.”
With no end in sight for the nation’s economic woes, it can be hard for counselors to know how to pace themselves when working with so many clients, she says.
And like other Americans, the counselors are concerned about layoffs. Membership at EAPAs Hudson Valley Chapter, near New York, has jumped 20% in the past few months as industry professionals seek to freshen their skills and sniff around for job opportunities, London tells us. “I personally know people who worked for Lehman Brothers’ in-house EAP program who lost their jobs,” when the firm collapsed, she adds.
Wyeth Names Kamarck to Run Factories
When Wyeth named Michael Kamarck as its new head of manufacturing this week, we asked, “Who is that guy?”
Wyeth indulged us. And we found out Kamarck, 57, was trained as a biochemist, and that he’s been looking after biotech manufacturing for the company since joining in 2001 from Bayer.
His goals in the new job, he told us in a telephone chat, are to increase efficiency across the board for the maker of small-molecule drugs, vaccines and biologics. “What’s most important to us right now is shortening the time to development and getting these products into the clinic and the market more quickly,” he said.
Wyeth has had its share of manufacturing problems in the past. Besides a run of FDA trouble, Wyeth failed to meet demand at times for its widely used pneumococcal vaccine Prevnar and the anti-inflammatory biologic Enbrel, co-marketed with Amgen.
Kamarck acknowledged that the demand for these products wasn’t “adequately anticipated” early on. But Wyeth has beefed up infrastructure and improved manufacturing processes. The company opened a state-of-the-art factory in Ireland last year and has even patented some innovations to its manufacturing chain. And the company has been making a stockpile of a new, more complex version of Prevnar in anticipation of FDA approval in 2010.
UPMC, Once Transplant King, Takes Risks to Regain Crown
The University of Pittsburgh Medical Center, a pioneer in transplant medicine, was performing about 600 liver transplants a year in the mid-1980s. But how the mighty can fall. As other U.S. hospitals, including some whose transplant docs trained at UPMC, jumped into the lucrative surgical service, the health system’s volume fell to 132 liver transplants in 2001.
Enter Amadeo Marcos, a colorful surgeon who promised to double the number of liver transplants in his first after joining non-profit UPMC. An article on the front page of this morning’s WSJ explains that while he did accomplish that goal, his methods for doing so raised questions over medical judgment and safety.
Older donors: One way to cope with a shortage of organs is to use “expanded criteria donors” — deceased people who had been older or sicker than preferred liver donors. After Marcos joined UPMC, the average age of its deceased liver donors rose to from 41 to 47, nine years above the national average.
Higher-risk recipients: Liver patients are ranked by how advanced their disease is. Most experts now believe the risks of a transplant generally outweigh the benefits for patients with so-called MELD scores of 14 or lower. (Lower scores mean healthier patients.)
Grassley Knocks Radio Host Goodwin for Drug-Industry Conflicts
Sen. Chuck Grassley is squawking about another eyebrow-raising conflict-of-interest in psychiatry. This tale of drug-industry influence comes with another twist: It involves National Public Radio.
Perhaps you’ve listened to The Infinite Mind, the popular public-radio program hosted by psychiatrist Frederick Goodwin (pictured). On the award-winning program, Goodwin has talked about some big topics in the field that have also mattered commercially to drug makers, including one program in which he said “there is no credible evidence linking antidepressants to violence or suicide,” as quoted in the New York Times story on Goodwin this morning.
Well, it turns out Goodwin raked in at least $1.3 million from 2000 to 2007 giving marketing lectures for drug makers, the NYT reports. That includes some $20,000 from GlaxoSmithKline, the maker of antidepressant Paxil, the same week he hosted that show on antidepressants.
Harvard Med Students Might Want to Look Up Charles Grassley
Harvard Medical School on a quieter day.
Medical students, unite! It’s time to fight for your right to know your profs’ drug-industry ties!
That’s what’s happening over at Harvard, where some 40 students rallied recently on the steps of Harvard Medical School’s Gordon Hall. Along with some folks from Tufts and Boston University, they were waving signs and pushing for tighter conflict-of-interest policies vis-a-vis Harvard docs and pharmaceutical companies, as the Harvard Crimson reports. Doctors’ drug-industry conflicts sure are the topic of the day, what with Sen. Charles Grassley’s latest salvo about a radio host who’s a psychiatrist.
As the Crimson tells it, students have been trying for six years to get the administration to tighten its conflicts policies, both in the classroom and at the affiliated hospitals where the students train. One idea they’re pushing is to require faculty and students, while talking about drugs in the classroom, to disclose any ties to the makers of those drugs.
Harvard’s dean for faculty and research integrity, Gretchen Brodnicki, told the Crimson the administration is taking the students’ concerns seriously. But she noted some practical issues, especially when it comes to the hospitals, which Harvard does not own or operate. The school can’t “force” affiliated hospitals to change their existing policies to line up with what the medical school requires internally, she said. She added, though, that the hospitals’ policies “go well beyond where we stop.”
Hat Tip: PharmaGossip
Health Tip: Signs That a Child May Be Autistic (HealthDay)
Iressa as Good as Chemotherapy for Lung Cancer (HealthDay)
Children of Centenarians May Follow in Parents' Footsteps
Weight-Alzheimer link different for men and women (Reuters)
Saturated fat tied to small intestine cancers (Reuters)
With Boxed Warning, Oral Eltrombopag Okayed by FDA for Chronic ITP
With Robotics, Perception Trumps Reality
-WesMusings of a cardiologist and cardiac electrophysiologist.
Tort Conform
At least the American Heart Association is pleased, stating:"... We commend Senators Baker, Daschle, Dole and Mitchell for their commitment to develop and promote policies aimed at providing all Americans access to high-quality, affordable health care."And it looks like the trial lawyers will be happy, too.
*Sigh*
So much for tort reform any time soon.
-WesMusings of a cardiologist and cardiac electrophysiologist.