Women taking Paxil at the same time as tamoxifen to stop breast cancer from recurring are more likely to die from the disease, according to a study in BMJ. The cancer med is prescribed for five years at a time to thousands of breast cancer survivors, many of whom also suffer from depression. But other antidepressants did not have the same effect.

The study looked at 2,430 women aged 66 and over who were being treated between 1993 and 2005. All were taking tamoxifen and one of five antidepressants, and over the next 2.4 years, 374 died from breast cancer. The data, as The Daily Mail notes, showed those taking Paxil were far more likely to die from breast cancer and slightly more likely to die from any other cause, compared with women not on the drug.

The results also found that if patients took GlaxoSmithKline’s Paxil for 25 per cent of the time they were on tamoxifen, they were 24 per cent more likely to die from breast cancer. When the antidepressant was taken for 50 per cent of the time, there was a 54 per cent increase in the chance of death, and when taken for 75 per cent of the time, patients were 91 per cent more likely to die.

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To do so, the agency will use a new screening system to expedite importation of real meds and help inspectors focus their efforts on “high risk” products. Currently, customs officials examine a sliver of the 20 million shipments that reach US ports each year and that most inspections occur randomly.

The new web-based system is called Predict (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting), and assigns a risk rating to drugs and other goods based on contents, supplier and point of origin. High risk imports are flagged for inspection, The Pink Sheet notes. You can watch a video here to see how things should work.

“Up to 40 per cent of the drugs (US citizens) take are imported” and “up to 80 per cent of the active pharmaceutical ingredients in those drugs come from foreign sources,” FDA commish Margaret Hamburg said in a speech at the Center for Strategic and International Studies. “Clearly, our nation’s traditional approach – relying on FDA inspections to catch problems at the border or in foreign facilities – needs a significant overhaul.”

The answer is Joe Jimenez. When he was first named to run the Novartis pharmaceutical business in 2007, Jimenez liked to talk about key account management, which is how a packaged-goods company views its relationship with a retailer. That wasn’t terribly surprising, given that he had spent eight years at Heinz, where he oversaw the introduction of green ketchup for kids, among other things.

Somehow, the analogy still stands, in so far as speed is of the essence. Recently promoted to succeed Dan Vasella as the drugmaker’s ceo, Jimenez is still reaching back to his consumer products days for lessons on running Novartis. With consumer packaged goods, “decisions have to be made quickly because the market moves quickly,” he tells Bloomberg News. But drugmakers have long development lead times, which “tends to slow decision-making in areas where it doesn’t need to.”

Hmmm… Just shake and pour?

Hat tip to PharmaGossip

The National Institute for Health and Clinical Excellent declined to recommend two expensive cancer drugs from Novartis and another from Bristol-Myers Squibb from being used within the state-run health service, Reuters writes.

NICE rebuffed Afinitor as a second-line treatment for kidney cancer, adding there was limited data about how long it could extend life. And the agency declined to recommend Tasigna and Bristol’s Sprycel for chronic myeloid leukaemia in patients who are intolerant to Gleevec - an older drug from Novartis - because effectiveness evidence was “very poor” and their cost was “extremely high”.

“It would be heartening to hear that the pharmaceutical company manufacturers are prepared to share some of the very high cost of the drugs with the NHS (National Health Service),” NICE director Peter Littlejohns says in a statement. NICE has struck several previous deals with companies to reduce the cost of medicines before recommending them for use in the NHS.

Hello, everyone. Nice to see you again. Another busy day awaits, yes? Many of you are dashing about the BIO gathering in New York. Meanwhile, there are forecasts of still more snow in some parts of our readership area. Business cards in one hand. A shovel in the other. Meanwhile, we are about to wake the short people for another day at the schoolhouse. So while we brace for our various activities, here are a few items to see you through. All best…

Amgen’s D-mab Helps Fractures In Prostate Cancer Patient (Bloomberg)

Lilly’s CEO Got $20.9M In ‘09 Compensation (Indianapolis Star)

FDA Clears Wider Use Of Crestor (Reuters)

Most Glaxo Job Cuts To Come From The UK (The Harlow Herald)

Pfizer Gives Trovan Documents To Nigerian Authorities (ThisDay)

Merck Sorono’s Lawyer In The UK (The Lawyer)

Mississippi To Get $18M From Zyprexa Lawsuit (Associated Press)

A New Jersey appeals court decided last week that a trial court should reconsider whether an expert should be allowed to testify in a lawsuit alleging the Accutane acne drug causes depression. And the move, which comes as part of long-standing litigation over the issue, may cause some controversy.

The New Jersey trial court, where hundreds of lawsuits allege Accutane is tied to depression, had ruled that Emory University professor Doug Bremner should not be allowed to offer expert testimony due to what was considered a flawed study. His study was funded by Accutane plaintiffs and lawyers, and published in a peer-reviewed article in the American Journal of Psychiatry in 2005. Accutane, by the way, was withdrawn last year, although generics are still available.

Using positron emission tomography scans, Bremner found metabolic changes in the brains of acne patients treated with Accutane that were not present in those given antibiotics. The area affected was the frontal lobe which is associated with depression, The New Jersey Law Journal writes. Based in part on the study, Bremner provided a report concluding Accutane can cause depression and suicide. Roche, which sold the drug, challenged the report and a subsequent hearing found missing data, inaccurate data and that Bremner failed to follow methodology he claimed to have used. A trial judge decided his study was central to his opinion and dismissed the case.

Now, though, the appeals court decided the study comprised only a portion of Bremner’s opinion and he may yet testify, although the study itself won’t be introduced (see here). Meanwhile, the Drug & Device Law blog calls the decision “amazing,” and labeled the study “junk science” and “litigation-inspired trash,” likening it to the scandal over Andrew Wakefield and his autism research in The Lancet (see here). In turn, Bremner writes on his own blog that the study was largely funded by a parent not directly connected with the litigation (although the parent’s son committed suicide while on Accutane) and attempts to explain problems with the reported data which, he notes led to a single-line correction, not a retraction.

The links offered in our post, notably the ruling, provide some context, so please take a look. And then tell us what you think…

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Much of the long-running controversy over the Provenge prostate-cancer vaccine, which could be approved by the FDA on May 1, has centered on the viability of the data or a 2007 FDA advisory panel recommendation for approval that was overturned by FDA higher-ups amid dizzying conflict of interest charges (some background here, here and here, here).

The messy episode has prompted patient protests, unusual stock trades, a lawsuit accusing the FDA of illegally withholding info and countercharges from the FDA that conspiracy theorists are wasting the agency’s time. Much of the sparring, though, has centered on patients and the drug-approval process, but another subplot appears to be emerging - the U.S. Securities and Exchange Commission may be probing some of the rollercoaster trading in Dendreon shares during some of the more volatile moments of the past couple of years.

A September report by the SEC’s Office of Inspector General notes a probe was opened into complaints from an investor “alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug. The investor also has alleged that the SEC failed to investigate a recent bear raid on the stock of the company that developed the drug, causing a severe plunge in the stock price. The OIG has reviewed several hundred pages of documents, including numerous e-mails and attachments provided by the complainant.” The OIG concludes by saying it expects to issue findings in its next reporting period, which would be April (see page 106).

There was, indeed, some volatility. As noted in BusinessWeek, Dendreon shares fell 70 percent in just a few minutes one day last April - the same day that Dendreon was expected to announce Provenge test results, which proved favorable. Interestingly, there was a mysterious message left on a Yahoo Finance message board about a forthcoming bear raid. This chart shows the curious and pronounced drop in the stock price. And according to a source who is familiar with the Dendreon saga and market manipulation, the SEC has been looking at trading in the vaccine maker. Of course, to some, this may be yet another sideshow in the larger debate over whether and how Provenge wins approval. But it may also epitomize the passion and frenzy surrounding the product and its prospects.

Russian Prime Minister Vladimir Putin sacked a senior health official for public criticizing a draft law introducing state regulation of pharmaceutical pricing, according to RIANovosti. The bill, which was passed by the Federal Assembly, has been criticized as running counter to free-market principles and likely to nurture black-market production.

Nikolai Yurgel, who headed the Federal Service for Supervision of Healthсare and Social Development, violated civil service law by expressing “his disagreement with the position of the health ministry and the government (and) siding with experts who have not studied the bill in detail or have openly lobbied against it,” the government said.

The bill includes a ban on sales of meds that are on the list of lifesaving and essential products approved by the government on December 30, 2009, if their prices have not been officially registered. The 5,000-plus meds account for about 35 percent of drug sales in Russia; most are generics, and around 30 percent are produced by non-Russian firms, PharmaTimes notes. The government said the bill sets tougher quality requirements, introduces state regulation of prices, and ensures equal conditions for foreign and domestic pharmacies on the Russian market.

Hello, everyone. Nice to see you again. Hope your weekend was pleasant and rewarding. Now, though, the routine returns and, of course, that means those deadlines and meetings. So to help you along, we have uncovered a few nuggets of interest. And of course, we also encourage to grab a cup of something stimulating. We are about to do so. Meanwhile, have a good day…

Andrew Witty Discusses His Job And Goals (The Telegraph)

Sanofi To Decide On Reviving Merck Venture (Dow Jones)

CVS Caremark Posts Higher Quarterly Profit (Reuters)

Coffee is courtesy of chichcacha flickr creative commons

To cover the cost of a settlement and other lawsuits related to Medicaid reimbursement, the world’s largest generic drugmaker is setting aside $315 million, although Teva hasn’t disclosed how much it will actually pay (here is the statement) and other lawsuits remain unresolved.

In any event, the lawsuits, which allege Teva inflated the prices of drugs in order to get bigger Medicaid reimbursements, involved the federal government as well as the states of Florida, Texas, and California. The lawsuit was brought by Ven-A-Care of the Florida Keys, which in recent years has filed several suits against drugmakers, including Schering-Plough, Mylan Labs, Abbott Labs and Sanofi-Aventis. About 15 states are involved altogether.