In the wake of the investigation by the US Senate Finance Committee into Emory University psychiatry professor Charles Nemeroff, the National Institutes of Health is now imposing new conditions before agreeing to award grants to the university, according to an October 10 memo sent to faculty.

An NIH regulation requires researchers to report to their universities any “significant financial interests” they hold in research financed by the agency - defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities are required to tell the NIH whether they were able to manage or eliminate the conflicts in order to avoid bias in the research findings.

The committee is investigating Nemeroff’s alleged failure to fully disclose payments from Glaxo while simultaneously conducting research into Glaxo drugs, and Emory’s failure to take any action even after conducting an internal inquiry (back story).

And so last week, David Wynes, Emory’s vp for research administration, wrote that the NIH won’t send any fund unless full disclosure is now made by all professors. You can click to see the actual memo or read it right here…

From: All Emory University Faculty [All-Faculty@emory.edu]
On Behalf Of Johnson, Julie [JRAE@emory.edu]
Sent: Friday, October 10, 2008 3:10 PM
To: All-Faculty@emory.edu
Subject: FCOI Letter to Research Community

Sent on behalf of David Wynes, Vice President of Research Administration. The test of the letter is included below in the event you are unable to open the pdf format.

October 10, 2008

Members of the Emory Research Community:

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In a ruling that reflects ongoing tension between federal and states rights in product liability cases, the court agreed to hear Merck’s argument that FDA approval of its notorious painkiller should preclude such lawsuits in New Jersey courts.

The certification is an outgrowth of an appeal Merck filed after a split decision by the state’s appeals court last spring, which tossed $9 million in punitive damages and ruled there was no violation of New Jersey’s Consumer Fraud Act, but upheld $4.5 million in compensatory damages, plus interest. At the time, the appeals court ruled there was no preemption of the state’s Product Liability Act.

In its appeal, Merck had argued the McDarby case warranted reversal, because Superior Court Judge Carol Higbee shouldn’t have let jurors second-guess the FDA’s approval of a label that didn’t warn of heart attack risks (back story). Now, the issue will be revisited, although a hearing date was not set. Meanwhile, the US Supreme Court will examine preemption on November 3 (read here).

Merck, however, failed to convince the court about a few significant points needed to overturn the compensatory damages - that John McDarby’s doctor would not have prescribed Vioxx if he had received a warning about cardiovascular risks, a reference to what’s known as a heeding presumption; that under state law, FDA approval and labeling language was an adequate warning; and that other medical risk factors contributed to the heart attack suffered by the retired insurance agent. Here is the NJ Supreme Court certification.

As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees - a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us.

How Pfizer may actually peddle units that focus on heart disease, gastrointestinal illnesses and obesity, for instance, remains to be seen, but presumably other drugmakers may be approached about a purchase or venture. The effort could include offering both intellectual property and staff, sources say. This leaves the fate of some facilities at R&D headquarters in Groton, Connecticut, up in the air.

As a sign that more job cuts are coming, sources say Pfizer recently extended its severance package program, which was due to expire on September 30, until December 31, because the drugmaker couldn’t defend treating the new round of layoffs differently from previous rounds. A Pfizer spokesman tells us “various pre-announced initiatives across the entire company…will continue into 2009.”

Meanwhile, Pfizer brass continue to explore possible acquisitions as they refocus the company. Whether this would include revisiting a bid for Biogen remains unclear, although one source suggests the possibility has been discussed. You may recall, Pfizer eyed Biogen last year, but the notion was squelched over disagreements about integrating the biotech into the Pfizer fold, among other things.

A Pfizer spokesman declined to comment on what he termed “speculation,” other than to say “we’ll continue to realign the company to better serve our customers.”

Regulatory setbacks. Expiring patents. Huge layoffs. What’s an R&D chief to do? Glaxo’s Moncef Slaoui tells Nature that he hopes to turn the corner next year…

Nature: What have been the most significant changes at Glaxo recently?
Slaoui: I would say the biggest change in the past five years is an acute and profound realization of the major challenges in front of us. And the willingness to grab them by the horns and deal with them, rather than pretend that we will spend a bit more money and try a little harder and find this big blockbuster that’s going to save the situation.

Nature: What are those major challenges?
Slaoui: On the one hand, science has become extraordinarily powerful from a technological standpoint. It is generating huge amounts of information and data, but it’s harder to integrate that information into a meaningful biological or clinical conclusion. So, much more money goes to generating information, but that information doesn’t tell us remarkably more.

On the other hand, there are a number of medical needs that are not fully addressed, but are partially addressed. That puts the bar higher for any newer medicine to come in and have a meaningful clinical impact. Also, regulators have moved the pendulum around the safety-benefit equation of medicine a little bit too far to the safety side in some instances. They’re putting the hurdle higher.

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Labor officials in Nova Scotia want to know to why a 46-year-old quality-control technician died 18 hours after inhaling D-Malic acid at a Sepracor plant in Windsor, where a stop-work order has been issued to the laboratory, the Canadian Broadcasting Corporation reports. Three other workers at the Sepracor plant were also exposed to the compound, but did not suffer any reactions.

“The lab has been closed to performing this procedure with this material until further notice,” a Labor Department spokeswoman told the CBC. “The company has also been ordered to provide the department with their health and safety procedures, and the company is going to be carrying out an incident investigation of their own, to be completed by October 24.”

Investigators are examining protective equipment in the area where the technician was exposed to the compound, which is used in the analysis of drug ingredients. “It’s something dangerous enough that it is normally used within a fume hood. But in this particular case, as part of a larger investigation, we are looking into whether or not a fume hood was operating properly at the time,” she said.

“Sepracor has been informed that the employee had been home for several hours after leaving work in apparently good condition on October 7,” the drugmaker said in a statement. “Sepracor is unaware of any link between the employee’s work duties and the condition he reported in hospital, and is co-operating with all concerned authorities, including the Department of Labor.”

Welcome to the working week. Hope your weekend was pleasant. We accomplished sundry errands and spent time with the Pharmalittles, among other things. Now, though, the usual routine beckons. And so here are a few items to get you started while we research still more. Have a good day, everyone…

Merck Shingles Vaccines Remains In Short Supply (The Wichita Eagle)

King Extends Tender Offer For Alpharma (press release)

More Consumers Getting Health Info On The Internet (PharmaTimes)

Hello, everyone. We apologize for leaving so abruptly this afternoon, but a personal matter required that we be elsewhere. And for once, it was impossible to use the laptop. Nonetheless, we are now catching up and thought it would be worth noting a few developments. Coincidentally, they all involve a legal ruling. In any event, we hope your weekend goes well. Splendid time to pick a few apples, yes?

Alabama settled Medicaid drug pricing lawsuits against Bristol-Myers Squibb and four other companies, according to Jere Beasley, a lawyer representing the state. Bristol-Myers is one of more than 70 companies the state has sued for allegedly overcharging the state’s Medicaid program, and Beasley says undisclosed settlements were reached with four other companies that were not named. A trial had been set to begin October 27. State juries have ruled in favor of the state in cases against Glaxo, Novartis and AstraZeneca.

The US Court of Appeals upheld a preliminary injunction barring Roche from launching its Mircera anemia drug, which would compete against Amgen’s Epogen and Aranesp meds. Last year, a jury found that Roche violated Amgen patents. A Roche spokeswoman says the drugmaker will “continue to pursue opportunities to appeal this matter and that Roche believes strongly there should be treatment options for patients with chronic kidney disease and as well as choice for healthcare providers.”

A Pennsylvania state court jury ruled that Wyeth was not responsible for the death of a woman who had taken its Pondimin diet pill and developed PPH, or primary pulmonary hypertension. The drugmaker withdrew the fen-phen diet pills in 1997 after links to PPH and heart-valve disease surfaced, and eventually took $21.1 billion in charges to cover litigation costs.

Would you be surprised if the answer is AstraZeneca’s Nexium? The web site for the heartburn med, known as purplepill.com, generated the most site traffic in this year’s second quarter, with more than 1 million unique visitors, a 55 percent increase from a year earlier. Runners-up include sites for Takeda’s Actos diabetes drug and the Sanofi-Aventis Ambien CR sleeping pill.

“AstraZeneca has aggressively marketed Nexium this year, running approximately twice as much online display advertising in Q2 as either of its major competitors, Prevacid and Aciphex,” John Mangano, senior director of comScore, says in a statement. “This additional marketing muscle appears to have helped generate strong site visitation.”

For the past several months, the US Senate Finance Committee has been investigating undisclosed conflicts of interest involving academic researchers who receive NIH grants and pharma funding. At issue is whether universities are fulfilling their requirements to adequately monitor these disclosures in an effort to maintain scientific integrity and objectivity (back story here, here, here, here and here. Nature Medicine spoke with Chuck Grassley, the ranking Republican on the committee, about the probe. This is an excerpt…

Nature Medicine:What are you hoping to accomplish?
Grassley: NIH gives $24 billion worth of grants…The law requires the universities to have their researchers report outside income. We found out the law wasn’t being followed. The universities were not doing their job of gathering the information. We started looking into it and got inconsistent information between the researchers and what the university had. We found out that NIH was not really enforcing current law. It’s a matter of making sure the law is followed and making sure that we make all this information transparent. Let the sun shine in…

Nature Medicine: Do you feel, then, that that is reflective of a widespread, systemic problem or some isolated pockets of less-than-perfect behavior?
Grassley: It is systemic. But it’s systemic not as a planned thing. Because of the lack of oversight, it just happens. I don’t think a university is out to see what they can get away with. They just aren’t doing their job.

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In an era where ceo compensation is hotly debated, one sport is keeping tabs on the overpaid, but not overworked. So proxy advisor Glass Lewis has come up with a list of the most eggregious examples that it calls ‘Pay Dirt,’ which focuses on “the best examples of boards and compensation committees that have failed in their fiduciary duty to link pay with performance.”

The 42-page report slices and dices ceo pay and performance several ways, but we noticed that King Pharmaceuticals ceo Brian Markison shows up on the firm’s ranking of the S&P 500 Overpaid 25, a dubious distinction. To be specific, Brian ranked No. 23 with about $30.3 million in total compensation, while King stock fell about 36 percent and earnings per share growth plummeted nearly 37 percent.

On average, the stocks on this list fell almost 33 percent during their 2007 fiscal years, compared to an average gain of almost 43 percent for Underpaid 25 stocks. Average return on equity was a dismal negative 24 percent, compared to a 35 percent return on equity for S&P 500 companies in the Underpaid 25. All the S&P companies on the Overpaid 25 received a pay-for-performance grade of F.

Over on the Russell 3000 Index, the boards at several smaller pharma companies seem to have difficulty calculating pay for performance - Theravance, Nektar Therapeutics, Arena Pharmaceuticals, Ligand Pharmaceuticals, Neurocrine Biosciences and Idenix Pharmaceuticals.

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