Archive for May 6th, 2008

US Attorneys Probe Schering-Plough Over Vytorin

fred-hassan-3How many and from which offices? The filing with the Securities and Exchange Commission doesn’t specify. We asked a Schering-Plough spokeswoman for clarity, but until we receive a reply, we are left to wonder whether this involves a securities matter, healthcare reimbursement or, perhaps, both.

To an extent, this is not surprising. As Schering-Plough notes in the filing, “Schering-Plough, the joint venture and/or its joint venture partner, Merck, have received a number of governmental inquiries and have been the subject of a number of investigations” concerning Vytorin. And most, but not, all of this has already been widely reported.

“These include several letters from Congress, including the House Committee on Energy and Commerce, the House Subcommittee on Oversight and Investigations, and the ranking minority member of the Senate Finance Committee, collectively seeking a combination of witness interviews, documents and information on a variety of issues” related since 2006 to the controversial Enhance trial, Vytorin promotion and advertising, and stock sales by execs, specifically, Schering-Plough’s Carrie Cox.

Who else is asking for info? The probes “also include several subpoenas from state officials, including State Attorneys General, and requests for information from US Attorneys seeking similar information and documents.” What we don’t understand is why Merck didn’t mention US Attorneys in its own quarterly filing made this week, unless the focus is on Schering-Plough exclusively at this point.

You may recall that, last month, Merck disclosed it expects equity income from the venture to fall by $700 million this year due to the hoopla over Vytorin. Unlike Merck, Schering-Plough has been unwilling to provide any numbers, probably because Schering-Plough is more vulnerable than Merck to a big drop in revenue.

That emerged on April 23 and, by the way, the next day, US Attorney Bob Kirsch of the Newark, New Jersey, office visited the Shearlings Got Plowed site after it ran a blow-by-blow of a Wall Street teleconference in which Hassan denied any such forecasts existed. Look here to see how Kirsch spent his sleuthing time.

Another Axe Falls: Medtronic To Cut 1,100 Jobs

medtronic-defibrillatorWe mostly write about drugmakers throwing people overboard, but today it is a devicemaker. The move comes after a protracted slowdown in sales of implanted cardiac defibrillators, which have been shrinking ever since Medtronic and its rivals recalled product three years ago. And last year, Medtronic halted sales of the thin wires that connect the heart to defibrillators after links to five deaths.

Medtronic, in fact, already began cutting back last year, a step that included trimming 900 jobs, The Minneapolis Star-Tribune reports. The latest job losses will hit R&D and manufacturing. For example, the company intends to move cardiac rhythm operations currently in the Netherlands to Minneapolis, the paper writes.

NPR: On The Air, But Not In The Open

fred-goodwinThe latest saga of an undisclosed connection between experts and pharma comes to us courtesy of Slate. This is how a new piece begins: “A few weeks ago, devoted listeners of National Public Radio were treated to an episode of the award-winning radio series The Infinite Mind called “Prozac Nation: Revisited.”

The segment featured four experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown, Slate writes. The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, was hosted by Fred Goodwin, a former director of the National Institute of Mental Health.

But Slate writes that he never revealed to listeners that all four experts, including himself, have financial ties to drugmakers that sell antidepressants. Also unmentioned: “unrestricted” grants the show has received from drugmakers, including Lilly, which sells Prozac and Cymbalta. The mag goes on to write that it remains unclear how much funding was provided or when the show last received any funding, since neither Goodwin nor the show’s producers responded to repeated requests for interviews. We have left our own message for Bob Lichtenstein, whose company produces the show.

What are the connections? Goodwin is on the board of directors of Center for Medicine in the Public Interest, an industry-funded group that receives a majority of its funding from drugmakers. CMPI prez Peter Pitts was one of Goodwin’s three guests for “Prozac Nation.” Slate asked him to identify the companies that fund his group, but he told the mag, “I don’t want to go into that.”

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Canadian Patent Rule Would Delay Generics

canadaA new set of patent rules proposed by the federal government would delay generic versions of Lipitor, Viagra and several other blockbuster drugs by as much as two years, The National Post reports. And generic drugmakers, not surprisingly, are warning the effort will cost consumers and taxpayers tens of millions of dollars annually.

The government says the regulations would simply restore fairness and stability to the brand-name industry after two court rulings put unexpected new curbs on the practice of “evergreening,” which involves filing new patents on a drug in an attempt to stave off generic competition. Generic drugmakers say the move is an unjustified sop to the brand-name industry, the paper writes.

“It completely surprised us. We had no inkling it was coming,” Jim Keon, president of the Canadian Generic Pharmaceutical Association, tells the Post. “The provincial drug plans (which pay for many medications) are really going to feel this in a big way.”

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US Kids Use Antipsychotics More Than In The UK

teens-and-pillsAmerican children take antipsychotics at about six times the rate of children in the UK, according to a comparison based on a study published in Pediatrics.

But does this mean kids in the US are being overtreated? Or are Uk children undertreated? Experts say that’s almost beside the point, because use is rising on both sides of the Atlantic, Reuters reports. And with little long-term safety data, the drugs may be overprescribed for children in both countries, research suggests.

In the study, there were 595 antipsychotic scrips for kids in 1992, or a rate of fewer than four children per 10,000 using the drugs. By 2005, 2,917 scrips were written, or a rate of seven children per 10,000 - a near-doubling, Fariz Rani, a researcher at the University of London’s pharmacy school and the lead author, tells Reuters.

By contrast, an earlier US study found that nearly 45 American children out of 10,000 used the drugs in 2001 versus more than 23 per 10,000 in 1996. There are big differences that could help explain the vastly higher US rate. A recent report in The Lancet suggested the UK’s universal health care system limits prescribing practices there, and noted that direct-to-consumer ads are more common in the US.

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China: Baxter Is Obstructing Heparin Probe

probeThis is the international version of the blame game. Last month, Chinese officials voiced doubt that a contaminant identified in Heparin caused 81 deaths and severe allergic reactions in hundreds of Americans, and suggested the problem could have occurred in the US. Now, they insist the Chinese-made blood thinner wasn’t to blame and accused Baxter International of obstructing an investigation.

“Apart from the US and Germany, more than 10 other countries using heparin products containing the ‘heparin-like substance’ have not reported adverse reactions,” China’s Food and Drug Administration said in a statement, Reuters writes. The agency adds that reactions also occurred in some Heparin batches that didn’t contain the substance, hypersulfated chondroitin sulfate.

But Jin Shaohong, of China’s National Institute for the Control of Pharmaceutical and Biological Products, didn’t address the issue of how the chemical made its way into the Heparin batches during his news conference today. Baxter, you may recall, has recalled batches of the drug heparin that were found to be tainted with the substance.

China’s regulator, meanwhile, says Baxter isn’t cooperating with Chinese authorities. “Baxter failed to provide necessary cooperation in the process of the investigation, which is not conducive to further identifying the reasons for the adverse reactions to heparin,” China’s FDA said. Baxter denied the charge.

Baxter had also destroyed some samples of the drug and production records that China considered key to investigating the cause of the problems, Jin said. “I was very surprised,” he said. “This is extremely regrettable.”

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How To Bank $41 Million: Delay The Vioxx Deal

money-in-handLast November, Merck reached a $4.85 billion settlement to cover most Vioxx lawsuits in the US. As with any such deal, of course, there are stipulations, including one that calls for Merck to deposit $4.1 billion in an escrow fund by a certain date. In this case, the money was to have been deposited by April 16, based on a clause citing to two items - an enrollment date and a walk-away right.

Here’s how it works: the settlement agreement gave Merck until February 29 to convince 85 percent of the eligible claimants to participate in the deal. However, the drugmaker can exercise its right to walk away from the settlement anytime up to 45 days after that deadline, which would have been April 15. Merck actually exceeded the 85 percent threshold, but has twice rolled back the final enrollment date, citing the need to give people more time to fill out paperwork and to verify claims.

The second and latest postponement moves the enrollment deadline to June 30, and this means the date by which Merck must now deposit the $4.1 billion into escrow is August 18. Why? Merck doesn’t have to deposit $4.1 billion into an escrow fund until two business days after the expiration of its walk away right, which is now Aug. 14, or 45 days after June 30. That’s also four months later than April 15.

Is four months a big delay? Well, $4.1 billion earning 3 percent interest compounded monthly amounts to nearly $41.2 million, according to Greg McBride, senior financial analyst at Bankrate.com. In other words, as a consequence of the delays, Merck gets to hold on to the interest that would have accrued to the settlement fund during those four months. Here’s a timeline.

Of course, Merck was within its rights to do so and a Merck spokesman denies this was the reason for the postponements. He writes us to say this: “The possibility of extensions like this were contemplated by both plaintiffs’ counsel and Merck in the agreement that was signed in November 2007, and the public announcement of the agreement was explicit that August 2008 was the earliest time that payments to claimants could begin.

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FDA Won’t Test All Drugs For Psychiatric Problems

john-jenkinsDespite recent reports that may have suggested the agency is eyeing suicidality studies for drugs across the board, one FDA official says that just isn’t happening.

“That’s simply not true,” John Jenkins, who heads the FDA’s Office of New Drugs, tells The In Vivo Blog. “It’s being done in a targeted manner, wherever it seems to be appropriate based on what we’ve seen from other products in the class, the pharmacology of the drug itself, or other studies of that same drug.”

Although the agency is investigating Merck’s Singulair, for instance, not every new asthma or allergy drug will be similarly scrutinized. The FDA is “still evaluating (Singulair) case reports that are coming in from spontaneous reporting,” Jenkins says. “We’re not systematically asking every sponsor of an anti-asthmatic drug or an allergic rhinitis drug to include suicidality as part of their targeted assessments.”

“We have to be careful not to over-generalize this and suggest that every trial has to have a specific rating scale for suicidality,” he tells In Vivo. “You could start taking that to its logical extreme and have every trial have a rating scale for every possible adverse reaction, even though there may not be a reason prospectively to specifically be concerned in that setting.”

Pharmalot… Pharmalittle… Good Morning

sunrise-4The sun is shining on the nation’s medicine chest this morning. And so as we reach for our first cup of stimulation, please join us in catching up on events. We hope your days goes well - meetings, deadlines and assorted pressures aside…

Pfizer Drops NicOx Glaucoma Drug (Yahoo/Reuters)

Long-Term Ibuprofen Use Cuts Alzheimer’s Risk (Reuters)

Glaxo Creates New Venture Fund (The In Vivo Report)

Lilly Discovery Could Help Control ‘Hunger Hormone’ (Indianapolis Star)

Teva Profit Weighed Down By CoGenesys Charge (Globes)

Roche Moves 300 US Jobs To Germany (Associated Press)

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