And so for the first time since Pharmalot began earlier this year, we are taking an official vacation break. What does this mean? The usual flow of news, views and chattiness will be suspended until after Labor Day. Generally, this is a slow time of year, and we all need a respite now and then. You understand.

However, we will be checking e-mail, of course, and prepare items of interest for our return. Have something interesting for us to see? Send it along. On that note, we look forward to seeing you again and resuming our correspondence. Until then, we leave you with these. Catch a wave, everyone….

Europe Places New Restrictions On Novartis’ Prexige (PharmaTimes)

Roche’s Avastin Approved For NSCLC In European Union (PharmaTimes)

Merck Lawyer Objects To Petition For New Vioxx Trial (The Madison-St.Clair Record)

ImClones Finance VP Is Resigning (Yahoo/Reuters)

Viagra Boosts Lovey-Dovey Hormone, A Study Says (Yahoo/Reuters)

Conflicts of interest are all the rage these days. And for good reason. Understanding the factors influencing decisions - which finding may be emphasized, which paper gets published, which medication is endorsed - is increasingly of concern. So a handful of researchers, with NIH backing, measured financial ties on display at two meetings of the American Society of Clinical Oncology.

They perused 3,529 abstracts and 25,416 authors in 2004 and 3,556 abstracts and 26,181 authors in 2005. Their findings, which were published in the Journal of Clinical Oncology: In 2004 and 2005, 23 percent of abstracts had one or more authors with a personal financial interest. More than 75 percent of all personal financial interests were valued at less than $10,000.

On one hand, 23 percent may be seen as high or, perhaps, unsurprising. And some may argue that financial interests less than $10,000 isn’t very much. Then again, perceptions can differ. As an accompanying editorial notes, “the absolute amount of monetary involvement should be compared with overall income or wealth. Psychology research shows that a $100,000 reward to a millionaire may have less utilitarian value than $100 to a person with no income.”

Unfortunately, the ASCO conflict of interest policy states that “disclosure of the conflicting or potentially conflicting interest will itself suffice to protect the integrity of the subject activity.” In other words, a potential conflict can be resolved by the mere fact that disclosure took place, but without regard to the value of the financial stake involved. That isn’t good enough.

For more results, please keep reading…

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Nearly six years after the breast-cancer treatment was first subsidized by the Australian government for late-stage sufferers, an analysis of all Australian women who have taken the Roche drug has found an urgent need to review guidelines. Despite a compelling body of evidence that Herceptin can increase the risk of cardiac failure, a University of New South Wales study has found that only 3 percent of those prescribed th med had their heart checked before and during treatment.

“We were all extremely surprised with the results,” Robyn Ward, a University of NSW professor, tells The Age. “We just couldn’t believe that people weren’t monitoring the safety of what was still a very, very new drug.”

The study, which reviewed 1,469 women who received the med between 2001 and 2005 and was published in the Journal of Clinical Oncology, found that some clinicians had ignored the warning labels altogether. Thirty-three women received the drug in combination with a type of chemotherapy known to heighten the risk of heart failure.

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Between meetings? Getting a sandwich? Need a fresh perspective before diving into the next report? Here are a few items to help you along….

GPC Biotech Slashes Staff, Slows Research (NJBiz.com)

Heat Shrink Labeling Used To Thwart Counterfeiting (in-PharmaTechnologist.com)

MedImmune Licenses Genetic Technology To Novartis (MarketWatch.com)

FDA Considers Outsourcing 300 Jobs (Forbes/AP)

A new study of 650 patients who were prescribed a cholesterol med found that 87 percent who experienced an adverse symptom, such as memory or nerve pain, or memory loss, spoke to their doc about a possible connection. Most of the time, patients initiated discussion of a possible link between the drug and the side effects. And the docs were very likely to dismiss a connection even when literature existed to support the contention.

“A number of patients stated their physician attributed their problems to age or imagination, dismissed the importance of their symptoms or stated that a connection of symptoms to statins was not possible,” wrote the researchers in the latest issue of Drug Safety. “Assuming that physicians would not likely report adverse drug reactions in these instances, these patient-submitted ADR reports suggest that targeting patients may boost the yield of ADR reporting systems.” (Look here for the study).

In other words, docs need to pay more attention to what their patients are saying (yes, we know time is at a premium, but there is an obligation here; no need to discuss time spent at free CME dinners). And if more patients were encouraged to report their side effects to, say, the FDA’s Medwatch program, perhaps safety data would be more informative and timely.

Have Glaxo and Novartis stumbled yet again? That’s the question raised in a look at Protein Sciences, a much smaller company using a DNA technology to develop flu vaccines that may prove faster than the methods being used by its much bigger rivals, Bloomberg News reports.

Losing the flu-shot race may be the latest in a series of setbacks for both drugmakers, which are building plants that are part of a $1 billion US initiative to produce millions of inoculations within six months of an outbreak of a deadly flu. But Protein Sciences, with just 40 employees, is close to winning approval for a method that would cut the time at least in half.

Novartis is investing $600 million to build a cell-based flu-shot plant in North Carolina, and has won a $221 million US government grant for clinical trials. And Glaxo, which is getting $275 million in US funding, is building a Pennsvlvania factory in a facility acquired from Wyeth for an undisclosed sum. Both are growing influenza virus in animal cells as an advance over the decades-old technique of making flu shots using chicken eggs.

But cell culture “is an amazingly stupid investment to make for the future,” argues Manon Cox, Protein Sciences’ chief operating officers. “It’s as if we’re still living 100 years ago and recombinant DNA was never developed.”

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Which ones? Pfizer, Lilly and AstraZeneca. And the State Tax Inspectorate maintains all three may be costing Lithuania’s treasury 29 million Euros, or more than $39 million annually. The controversy stems from an audit, since 2005, that concluded the drugmakers’ Lithuanian branches, which are supposedly limited to marketing, were in fact engaged in trading activities, and therefore should be taxed on products sold.

“Activity of some undertakings in Lithuania is not limited to marketing functions alone, i.e. the collected data shows that in fact, trading activity is also in place,” Darius Alinskas, the STI’s Deputy Head, tells The Baltic Times. “During the tax audit, evaded taxes shall be estimated and sanctions anticipated in tax laws shall be applied, i.e. surcharges for late payment and respective fines.”

While the STI is not allowed to comment on which specific companies it says were involved, the marketing branches of Eli Lilly, Pfizer and AstraZeneca have come forward to say they’ll fight the STI’s demands that they pay. “We don’t sell medicines,” sniffs Saulius Sabunas, general director for AstraZeneca’s Lithuanian branch, “we sell ideas.”

“We know we can defend our case. They (tax authorities) have the wrong address. We are good corporate citizens and will continue this way,” says Pfizer’s Luxembourg General Manager Raimundas Voihska….

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With more than 13,800 lawsuits stacked up, NJ Superior Court Judge Carol Higbee has to do something. So, once again, she’s proposing four simultaneous trials writes The Star-Ledger of New Jersey (which owns Pharmalot). She attempted the same feat last year, but a host of scheduling issues - and Merck’s objections - nixed the idea.

The goal, of course, is to ease the logjam. With so many lawsuits, it’s entirely possible that many of the Vioxx plaintiffs will never see their day in court, or collect if they do win, because Merck is appealing every outcome that doesn’t go its way. For this reason, Wall Street believes Merck’s Vioxx liability is $5 billion, not the $25 billion or more that many once estimated.

Under Higbee’s plan, which has been discussed in conference meetings with lawyers involved in the cases, three other judges would be assigned to preside over the additional trials. All four trials are scheduled to begin Jan. 22 at the Atlantic City courthouse. During the past two years, Higbee has presided over just four trials. Another 14,000 suits are in federal court.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. Here are some of the latest moves…

Cardinal Health named Vivek Jain exec vp of strategy and corporate development;
XTENT adds Mike Eagle, former Lilly manufacturing vp to its board;
Quintiles Transnational named Mike Troullis as cfo;
BioVex appointed Thaddeus Pullano vp of quality assurance;
Mediware Info Systems hired Noel Strong as chief tech officer and R&D vp;
AEterna Zentaris appointed Paul Blake sr vp and chief medical officer;
SpectraScience appointed Michel Vaudry as director of international sales;
Ketchum adds Ann Moravick as executive vp and director, global healthcare and brand advocacy.

Hat tip to Pharmaceutical Executive

The new continues to trickle in, from all directions. Here are a few we managed to grab. Please enjoy….

Celgene Elects Ernest Mario, Former Glaxo CEO, To Its Board (press release)

Astellas Bets On New Prograf Drugs To Thwart Generics (Bloomberg News)

Exelixis To Speed Review Of Cancer Compound (Yahoo/Reuters)

Sanofi, Regeneron Start Phase III Cancer Trials (Yahoo/Reuters)