And so we turn our attention to other matters, such as raking leaves and spending time with our short people. We may even read a book. And you? Whatever your passion, we hope you enjoy the time. Meanwhile, here are a few items to help you stay abreast, even as other activities beckon…

Amgen’s Aranesp Data Disappoints (TheStreet.com)

Fosamax Users Seek Class-Action Lawsuit Status (Yahoo/AP)

King Pharma Options Up On Takeover Speculation (Yahoo/Reuters)

DEA Move May Not Hurt Cardinal Health (Yahoo/AP)

UK’s NHS Calls For Redirecting Cancer Med Expenditures (BBC)

For the past few months, a vociferous non-profit group known as Care To Live has waged a lawsuit against the FDA for failing to approve Dendreon’s prostate-cancer vaccine, Provenge, after an agency advisory panel last spring issued a recommendation. The FDA move came after two dissenting panel members wrote the agency to go slow, prompting outcries from cancer patients and Dendreon investors, who later accused one panel member of undisclosed financial conflicts of interest. You can read about the details in the lawsuit, which by the way was largely dismissed.

One aspect of this melodrama has been an effort by the non-profit to learn more about the behind-the-scenes dealings that prompted the panel members to write their letters. The non-profit alleges the panel members were encouraged by Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs, as part of a Byzantine power play, and that the letters were subsequently leaked to The Cancer Letter, an influential industry newsletter, as part of an effort to gain broader support for delaying Provenge approval.

Now, in a development that threatens to distract the Provenge advocates from their cause, The Cancer Letter is seeking sanctions against the lawyer for Care To Live who, over the past few months, has aggressively sought to compel the newsletter editor and publisher - a husband-and-wife team who work out of their Washington, DC, home - to disclose their sources. The lawyer, Kerry Donahue, contends that any effort to impede Provenge approval amounts to a death sentence against thousands of men with prostate cancer. The newsletter couple, however, claim journalistic privilege and argue Donahue failed to follow federal rules for subpoeanas. They also cite e-mails from Donahue that their lawyer described as threatening, according to court documents.

Read more »

The chairman of the House Oversight and Government Reform committee is concerned that a new FDA draft guidance about distributing journal articles will open the door to promote “potentially dangerous uses” of drugs and devices without prior FDA review and approval. The forthcoming guidance, which you can see here, represents FDA thinking on the publication and dissemination of studies on unapproved new uses of approved drugs and devices.

The topic gained attention several years ago as a commercial free speech issue, and in the guidance, the FDA writes that “the public health may be advanced by healthcare professional’s receipt of medical journal articles and medical or scientific reference publications on unapproved or new uses of approved or cleared medical products that are truthful and not misleading…If a manufacturer follows the recommendations found in…the guidance and there is no unlawful promotion of the product, the FDA does not intend to use the distribution of medical and scientific information as evidence of an intent by the manufacturer that the product be used for an unapproved use.”

But Waxman is concerned the agency is opening what he calls an “ill-advised guidance” and a big loophole for drug and device makers. The plan would allow companies to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he writes in a letter to FDA commish Andy von Eschenbach. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices, and puts the public at risk for ineffective and dangerous uses of drugs.”

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The big announcement will be made next Wednesday, when the drugmaker holds a briefing for Wall Street analysts and fund managers, who will hear how Bristol ceo Jim Cornelius hopes to generate some growth. Meanwhile, though, attention is focused on layoffs, although exact numbers and the like won’t be disclosed until the day of the meeting.

The cutbacks will include manufacturing plants and a variety of office-bound locales. Already, though, the drugmaker has announced its intent to close a plant in Puerto Rico, which employs about 400 people. And word is starting to go out among employees who work at Bristol headquarters on Park Avenue in New York, where such departments as legal, finance and compliance are expected to be trimmed.

“Senior management has previously stated that they’ve got a $25 billion infrastructure, but a $15 billion revenue organization,” Lehman Brothers analyst Tony Butler tells Bloomberg News. “These things are companywide. There are no sacred cows.”

By the way, if you would like to listen to the details next week, you can register here.

We apologize for the long break. We had a task involving one of the short people and then a trip to the friendly dentist, who declared that our fangs are as sharp as ever (please see the photo). Now, though, we have returned and your service disruption is officially over. In our absence, much has happened and so let us now try to catch up together…

FDA Needs More Money And Staff (Bloomberg News)

Wyeth Promotes Joe Mahady to Pharma President (Yahoo/Reuters)

Genentech Seeks Approval To Sell Avastin For Breast Cancer (Bloomberg News)

Novartis Completes Its Latest Share Buyback (Yahoo/Reuters)

Sanofi-Aventis Restructures Japan Joint Venture (Yahoo/AP)

Caraco Gets FDA OK For Generic Lexapro (Yahoo/Reuters)

Massachusetts Biotech Council Begins Lobbying Campaign (Boston Herald)

Garnier, as you know, will be retiring from Glaxo shortly and already he has found ways to keep busy. The unflappable man has agreed to join a newly formed advisory board of Dubai International Capital, the Middle East emirate’s $13b sovereign wealth fund, The Independent reports. His role will apparently involve seeking out investments abroad and provide key contacts. Hmm. Do you think he would recommend anything in the pharma sector? Which, if any, of his rivals do you think he’d like to see bought out? Or maybe he’d say none are terribly attractive?

The fund is the investment vehicle most often used by the Dubai government for foreign acquisitions, which have become a priority as it tries to diversify away from its dependence on oil revenues and establish itself as the financial center of the Middle East, the paper writes. In the past two months, the emirate has bought stakes in the London Stock Exchange, the US hedge fund giant Och-Ziff, the southern European private equity giant Marfin, and earlier this week, Japan’s Sony.

JP will be one of three outside members on the new supervisory board of DIC’s Global Strategic Equities Fund (GSEF), a $2b fund established this year. The goal of the fund is “to become a leading shareholder in pre-eminent global large capitalisation stocks, whilst aiming to create value through long-term exposure to a concentrated portfolio of undervalued companies,” the paper writes.

Also joining the board are Helmut Panke, BMW’s former ceo, and Nobuyuki Idei, chairman of Sony’s advisory board. Politicians have called for greater regulation of sovereign wealth funds. The addition of Mr Garnier and the other high-profile corporate execs could somehow help to ease regulator concerns, the paper speculates.

JP has led Glaxo since 2000. While at the helm he has faced down several controversies, including a shareholder revolt over his multi-million-dollar pay package, the paper reminds us. And he is recently unveiled a restructuring program ( see story below ) that will see thousand of jobs cut. He steps down in May.

Hat tip to PharmaGossip

That’s the charge contained in a lawsuit filed against the health care giant. Johnson & Johnson allegedly misled docs and the FDA for years by altering and withholding medical data about the patch, according to a motion filed in federal court in Toledo, Ohio, Bloomberg News reports.

J&J faces lawsuits by 2,400 women who claim the patch releases high levels of estrogen that cause strokes, heart attacks, and blood clots in the legs and lungs. Internal documents and pre-trial interviews with J&J scientists show the company learned the risk in 1999 and misled the FDA when seeking approval in 2001 to market the device, Bloomberg writes in citing the filings.

The company “withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels” of estrogen than oral contraceptives. “Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing.”

Five million women have used Ortho Evra since it went on the market in 2002. The filing offers the first detailed look at evidence previously deemed confidential by the judge and may indicate why J&J settled dozens of cases without allowing any to go to trial, Bloomberg notes. J&J won’t release financial terms of any of the settlements. The FDA warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with use of the pill.

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A scientist that the University of Washington found guilty of research misconduct now works for the big drugmaker, according to The Scientist blog. In an e-mail to the site, a Schering-Plough spokesman confirms that Scott Brodie, a former AIDS esearcher at the University of Washington, “is a current employee and that we recently became aware of the University of Washington investigation.”

The university’s investigation into Brodie’s work found 15 instances of scientific misconduct involving altered images and fabricated data, and the school banned him from working there. Brodie sued the school and The Seattle Times to prevent them from disclosing the investigation’s report, but lost the case, the blog notes. The faked data was contained in published and unpublished journal articles, and grant proposals concerning HIV research.

The investigators recommended that Brodie be banned from future employment at the university. All his research is now “viewed with suspicion” and subject to independent verification, according to a UW Investigation Committee Report that was cited by The Seattle Times. “Accepted scientific practices do not allow a scientist to falsely label an image as suits his or her fancy simply because such work is conducted in the scientist’s lab; to do so is instead a gross deviation of accepted scientific practices,” the investigators wrote.

While searching in the Thomson ISI database for publications Brodie produced while at UW, The Scientist noticed that a ‘Scott Brodie’ had published papers on interleukins in the last two years, the blog writes. It’s not clear, though, whether Schering-Plough was already aware of Brodie’s past at the time The Scientist questioned the drugmaker. The Schering-Plough spokesman wrote in his e-mail, “As this is a personnel matter, we cannot comment further.”

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This is hardly surprising, given the overwhelming desire to take advantage of lower costs in such places as China, for example. During an investor presentation in Hong Kong last night, Pfizer officials say they want to outsource as much as 30 percent of its manufacturing, mostly to Asia, according to Dow Jones.

Pfizer currently outsources about 15 percent of its manufacturing, but wants to double that figure, as part of its ongoing cost cutting measures, although no timetable was given, or specific Asian countries named. Given the problems with corruption and toxic goods coming out of China, drugmakers are generally loathe to publicly embrace the country as a place to make their meds. AstraZeneca, for example, embarassed itself this fall by trying to deny such plans.

Earlier this year, Pfizer announced plans to shutter manufacturing sites in Brooklyn, N.Y. and Omaha, Neb., and sell a third manufacturing site in Feucht, Germany. These cuts, along with the closure of several research sites, were part of a company-wide plan to cut its worldwide workforce by 10 percent, or 10,000 jobs, and save $2 billion, Dow Jones reminds us.

The drugmaker indicated last month that a “global” program that would shrink most areas of its business. Yesterday, a TV station in Research Triangle Park, North Carolina, where about 5,000 people work, primarily in research and manufacturing, reported an undisclosed number of layoffs has begun. And sources say a couple of hundred jobs in US headquarters in Philadelphia may be trimmed next week. We previously reported about 1,000 sales jobs would be eliminated shortly, although roughly half are supposedly already vacant.

“You can expect to hear from time to time that employees have been notified of job reductions as that program gets implemented in different parts of the business,” a Glaxo spokeswoman wrote us. “We are not confirming numbers or areas of the business where reductions are taking place. As is our practice, we are working to move people to different jobs in the company where skills are transferrable, and also to not fill vacant positions instead of losing people. Keep in mind that job reductions are only one element to the program; we are also investing in growth areas of the business as well.”

The TV station reported that about 100 people are likely to be laid off in North Carolina, where the asthma drug Advair is manufactured. Earlier this week, an FDA panel recommending more specific warnings for Advair and its Serevent drugs over potential health risks to children, although Glaxo disagreed with the decision. Already, Glaxo announced plans to shutter a manufacturing plant in Puerto Rico where Avandia is made and that employs 900 people.

Avandia is a big reason, of course, for the retrenchment. The diabetes pill, a $2.8 billion seller, has slumped severely ever since a study last May in The New England Journal of Medicine indicated the drug poses a 43 percent increased risk of heart attacks, prompting an FDA review that led to a Black Box warning.