The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Freedom of Information Act, some of which the group maintains were deleted or destroyed (see here).

Of course, their effort may be overtaken by events - Dendreon, which makes Provenge and earlier this year released positive study results - today disclosed that the FDA assigned a PDUFA date of May 1, 2010, to respond to its request to market the vaccine (see here). The other issue, though, is how the FDA handles alleged conflicts. The Provenge episode was a pox on former FDA commish Andy von Eschenbach, whose staff turned a tin ear to the problem. Whether Margaret Hamburg, the new commish, chooses to be more responsive to such concerns remains to be seen.

The case of Loretta Esposito, a 63-year-old Clearwater resident who died of breast cancer in 2006, is the only Prempro case in a Florida court, which means it may be subject it to the state’s Sunshine in Litigation law, according to The St. Petersburg Times, which adds that this prohibits the court from keeping papers secret if they concern a public hazard.

Citing this statute, Esposito’s lawyers have refused to agree to the confidentiality order Wyeth has required other plaintiffs’ attorneys to sign before giving them access to an estimated 16 million discovery documents, the paper writes. A hearing is scheduled for Monday.

In a motion opposing the hearing, Wyeth lawyers wrote, “Even assuming that Prempro is a ‘public hazard,’ there is no information in the underlying documents that would provide a woman taking Prempro today information about the risks of Prempro that is not already known.” But after listening to a similar argument from a Wyeth attorney last month, Pinellas-Pasco Circuit Judge Anthony Rondolino asked: “How can you be saying this is secret if you’re saying the public knows about it?”

XOMA hired James Neal as vp business development;
Trubion Pharmaceuticals named Steven Gillis as acting president;
Depomed promoted William Callahan to vp;
Watson Pharmaceuticals hired Robert Stewart as senior vp global operations;
Almac hired Helen McKeever as preclinical program manager;
Alticure Research appointed C. Kannan Janakiraman as ceo and president;
The European Generic Medicines Association elected Didier Barret as its president.

Ladder thx to Flickr Creative Commons Robert CB

Roche’s Actemra Succeeds In Arthritis Study (Reuters)

Health Canada Warns About Pet Drugs And Diabetes (Canadian Press)

NICE Calls Bayer’s Nexavar Too Expensive (The Wall Street Journal)

Ranbaxy Recalls Acne Drug From The US (The Business Standard)

Glaxo, Merck Developing Drugs For Kala Azar (DNAIndia)

Interpol Seizes 167,000 Countefeit Pills (PharmaTimes)

Former McKesson Exec Convicted Of Securities Fraud (KTVU.com)

So why not bring Fido with you? After all, what’s another beast at the dinner table when there’s so much turkey to be had? And not to worry that your pooch may suffer from motion sickness during the car ride. Pfizer has it all figured out for you. How so? Pfizer has a salve called Cerenia, which the drugmaker markets to cure….motion sickness in dogs. What a surprise.

But caution is advised. In the prescribing information for Cerenia, Pfizer disclosed that in US studies, one adverse reaction was, of all things, vomiting not associated with motion sickness. Doggies in the placebo group didn’t throw up once. But those given Cerenia, well, there was a 5.3 percent throw-up rate. And in European studies, Cerenia caused more than twice as much vomiting - for whatever reason - as a placebo, 9 percent versus 4 percent.

In other words, Fido may vomit no matter what, even if given the drug. But there’s another unknown - what if your dog throws up after you’ve arrived at Grandma’s house? As Oliver Hardy would say: That’s another fine mess. So bring the barf bag, just in case.

There had been speculation, though, surrounding the bespectacled scientist. When Lilly announced its grand reorganization, Paul’s name failed to appear in either related announcement (see here and here). The backdrop to such scuttlebutt were a couple of recently failed Phase III drugs, which only served to underscore a meager late-stage pipeline and the magnificently steep patent cliff that lies ahead. For the record, Lilly says Paul had planned to retire early next year.

In any event, Paul will receive an extra 10 years of service credit for his pension benefit and become fully eligible, which won’t be reduced by an early retirement decision. How much all that is worth is not clear. However, Paul was eligible to receive that extra credit only if he remained employed past age 60, or was involuntarily terminated before he turns 60. Again, Paul is 59. Last year, Paul’s salary was $1 million and his total compensation was $6.25 million, according to the proxy statement (see page 33).

Hat tip to IndyStar

Bernard Prigent, Pfizer Canada’s medical director, was appointed last month to the CIHR’s governing council (see here). Last month, CIHR president Alain Beaudet said that he hopes to create closer ties with industry to ensure involvemetn and investment, but the move has stirred concerns since the organization is responsible for allocating research funding across the country, the paper writes.

“There’s no place in our scientific organizations like CIHR for a drug company official,” NDP MP Judy Wasylycia-Leis, tells The Tyee. “It’s shocking that this government appointed the vice president of the biggest brand name drug company in the world, to the board of the CIHR which is supposed to be a body of independents and scientific endeavors free from any ties to industry at all.”

This is actually the second flap this week in Canada involving Pfizer in some way. The same person who led a controversial review that provided controversial advice on British Columbia’s pharmaceutical policies has a new position advising the drugmaker, The Tyee notes.

Don Avison was recently appointed as the Canadian representative on Pfizer Global’s International Advisory Board, according to The Tyee. Two years ago, the BC government appointed Avison as the chair of a pharmaceutical task force that advised the health ministry (back story).

The panel’s report, released last year, suggested cutting the amount paid for generics and getting rid of the University of British Columbia’s Therapeutics Initiative, a group of researchers who provide independent evidence-based advice about prescription drugs.

“Is this international advisory position payback for what he delivered in the task force report? Because that’s what it looks like,” health policy researcher Alan Cassels tells The Tyee. Avison didn’t respond to the paper’s request for comment.

But British Columbia Health Minister Kevin Falcon isn’t perturbed. “If someone’s speculating that as a result of the task force he’s now taken a position that he’s going to receive a personal benefit out of as a result of work he did, I don’t think that would be fair based on my assessment of Don and his many years of public service,” he tells The Tyee. “He did a good job, very good job in fact, as chair of the pharmaceutical task force. The fact he’s now been asked to sit on an international advisory board, I don’t have any discomfort with that.”

Last July, you may recall, European Union competition commissioner Neelie Kroes issued a report saying that delays in bringing generic drugs to the market had cost consumers and healthcare providers billions. And last month, the European Commission raided several drugmakers on suspicion they had violated rules against restrictive business practices and abuse of a dominant position.

“We will ask companies to give a copy of patent settlements between July 2008 to December 2009,” Dominik Schnichels, who heads the commission’s pharma taskforce, told an industry conference. “We will not take the view per se that patent settlements are probably illegal but we would look closely at the justification the company gives for the settlement. We will look at the merits of the case.”

The paper writes that a report showing that 90 percent of universities relied solely on researchers to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research (here is the report).

Moreover, half of universities don’t ask faculty members to disclose the amount of money or stock made from drug and device makers, and so the report concludes the potential for extensive conflicts with their government-financed research is often known only to the researchers themselves, the Times writes.

The Times reminds us that researchers are required to report to their universities any outside income that may conflict with government-financed research, and a lot of that comes from the NIH. Federal rules also require universities to manage conflicts. Sally Rockey, the NIH acting deputy director for extramural research, tells the paper that the agency announced in May it was considering changes to its conflicts of interest rules and the report recommendations would be considered.

The issue has received considerable attention due to a series of ongoing investigations by Chuck Grassley, an Iowa Republican on the Senate Finance Committee.

Photo thanks to Jerome Kassirer, author of ‘On The Take’

The case concerns Trisenox, a leukemia drug developed by Cell Therapeutics, which claims it marketed the med off-label on the advice of a consultant, formerly known as Documedics Acquisition and now called Lash Group, the AP writes. As a result, docs billed Medicare for unapproved uses. After a former employee filed a whistleblower lawsuit, Cell Therapeutics agreed to settle $10.5 million without admitting liability.

Cell Therapeutics believes the mistake was not its fault and sued Lash Group, hoping to recover the $10.5 million plus $12.3 million in attorneys fees and damages, including loss of reputation, the AP continues. There’s the twist. As the AP notes, historically, courts have not allowed defendants in whistleblower suits to try to recover fines or settlements by suing others.

But the appeals court noted the biotech never admitted liability. So was wrongdoing committed? The court sent the case back to US District Court in Seattle. “For the first time here, the 9th Circuit has now swept away the rationale for all of that law,” Dan Dunne, who represented the biotech, tells the AP. “That’s a very important development. With hundreds of billions of dollars of stimulus money being sprinkled across the country, you can expect qui tam lawsuits to be a growth industry.”

It’s not clear if Lash Group will appeal, the AP writes, adding that Cell Therapeutics sold Trisenox to Cephalon in 2005.