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Posts Tagged ‘Boehringer Ingelheim’

One of this week’s major news items in the world of pharma is the less-than-enthusiastic response of an FDA panel to Boehringer-Ingelheim’s experimental “sexual desire for women” pill, flibanserin.

I believe the quest for a “female Viagra” (an inaccurate parallel, by the way) is fundamentally misguided. Here’s why:

There’s a big difference between sexual function and sexual desire. Viagra does something that a pill can, in fact, do – impacts a physiological process. Erectile dysfunction is, in some cases, a medical problem that can be addressed with a medical solution.

But sex is not purely physical. And sexual desire is not some abstraction or isolated function that can be fixed by some sort of medical booster.

Yes, our bodies age and the physiological aspects of libido may be impacted. I’m not denying that. But can any pill really deal with the many elements that make up sexual desire, including:

– a loving relationship

– a climate of trust and freedom

– confidence and a sense of self-esteem

– personal attractiveness (and attracted-to-ness) on multiple levels

– hormonal fluctuations/levels

– physical function that allows fulfilling intercourse

And, in fact, are we even addressing the right question anyway with these proposed treatments? Should our focus be on creating/boosting a physiological desire for sex, or on making better relationships? Physiological aspects are a component of sexual desire…but are we going to keep medicalizing some things that are, to a large extent, simply part of a normal aging process?

I realize that there’s no money to be made by drug companies on the latter, but frankly, I’m forced to conclude that the whole exercise is a futile pursuit of profit at the expense of a healthier focus on the better relationships that will lead to better sex.

A pill is not a substitute for the genuine work of nurturing one’s mate so that a steady desire to please and be one with each other is a natural outgrowth. Viagra can make some things grow that forgot how. But I seriously doubt that any female Viagra will grow something as multi-faceted as sexual desire. Let’s go about curing real diseases.

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TODAY’S NEWS

Sometimes I can’t help but voice a bit of skepticism, especially when it comes to sexual disorder treatments. So, count me as less than convinced about this experimental treatment from Boehringer-IngelheimData from pivotal Phase III clinical trials demonstrate that a higher proportion of pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD) receiving flibanserin 100mg reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebomore (the single-question Patient Benefit Evaluation appears to me to be really…ummm…meaningful).

Lung cancer preventer for former smokers? Interesting – A drug approved to treat a range of conditions may also work to prevent lung cancer in people who have given up smoking, U.S. researchers reported on Tuesdaymore

AstraZeneca replaces Nexium sales force with telemarketers. And it works.

J&J‘s recall of OTC products. This is becoming a huge black eye, for a company that managed to keep quite a good reputation over the years. It will be an interesting case study of reputation management and quality improvement, esp. for a company that has been a leader in social media usage in this sector.

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Red Meat – maybe this picture isn’t so simple after all. Intuitively, this result is actually not too surprising. AND – Are you in a Museum?

JUST FOR FUN

I only rarely get to see hailstorms. That’s what makes this video particularly awesome. Must be seen to be believed!

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Novartis to cut a bunch more (sales) jobs; does another management shuffle – As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, although half of the jobs are said to vacant, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010…more

But, at least Novartis is making some profitIn good times and in bad times, people will get sick. That reality has helped Swiss drug maker Novartis post strong earnings for the third quarter on Monday, in spite of the banking crisis and global economic slowdown. Yet even as the pharmaceutical sector sticks to the pattern of being insulated from greater financial troubles, growth at Novartis will not be as robust as last year…more

Is specialty pharma the place to be? – Here are some interesting numbers to chew on…

B-I has some interesting stuff in the pipeline – Boehringer Ingelheim announced that patients and physicians may have several innovative Type 2 Diabetes treatment alternatives available in the coming years. At its Second International Research & Development Press Conference, Boehringer Ingelheim unveiled a pipeline of unique oral anti-diabetic compounds in phase II and III, establishing the company in the Type 2 Diabetes arena…more

Genentech sales soaring – It seems Genentech made the right choice in turning down a takeover bid from its majority holder, the Swiss pharmaceuticals company Roche Holding: its sales are soaring and investors apparently don’t mind that its latest earnings missed Wall Street’s estimates, possibly because of costs associated with defending itself against the bid…more

New study: Vioxx does cause heart risks – An analysis of an infamous Vioxx study found the notorious painkiller does, indeed, double the risk of heart attacks and strokes, although the likelihood of a serious cardiovascular event lessened one year after people no longer took the pill…more

Pfizer’s desperate times/desparate measures – As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees – a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us…more

Effient: wait ’til Feb – Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And the agency’s Drug Safety and Risk Management Advisory Committee may also be convened…more

Fred Baron to receive Tysabri after all (this human/medical interest story is a bit involved, but brings up important issues about experimental/compassionate use).

High-dose Zevalin with stem-cell infusion leads to strong survival results for NHL.

Abbott’s experimental bioabsorable stent looking very interesting – Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries…more

FDA becomes FDelAy – Takeda drug, others stalled at agency. Who needs those stinkin’ deadlines?? But, next-generation Astelin (from Meda) does get an approval.

Wisconsin Medical Society bans pharma gifts – The doctors’ group, which boasts 12,000 members, has joined a growing number of academic medical centers, professional societies and legislators that have decided gifts from the pharmaceutical industry are questionable, if not unacceptable forms of influence…more

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J&J announces leadership transition – Johnson & Johnson appointed Sheri McCoy, leader of its surgical care group, on Thursday worldwide chairman of its pharmaceuticals group, effective Jan. 1. McCoy will replace Christine Poon, whose departure from J&J was announced last month. Poon, who has also served as J&J’s board vice chairman, plans to step down in March…more

Teva and AZ in a tiff about Crestor patents.

FDA to Takeda on Alogliptin review: Sorry, understaffed! – Takeda Pharmaceutical Co, Japan’s biggest drugmaker, said on Friday that U.S. health authorities have not been able to complete a review of a key diabetes drug candidate on schedule due to lack of resources…more

AZ‘s PurplePill website continues to generate impressive traffic numbers.

1 in 4 teenage girls have received Gardasil – Whether this means Merck’s HPV vaccine is making great inroads is unclear, but Gardasil does appear to be on its way to becoming accepted, according to the first federal government study of vaccination rates for the controversial shot…more

Rituxan OK’d for cancer treatmentRheumatoid arthritis drug Rituxan helps to fight cancer, but now its makers can actually share that with the world…more

Watson gets approval for Rapaflo for BPH – Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved RAPAFLO(TM) (silodosin), the company’s new alpha blocker for the treatment of the signs and symptoms of BPH…more

Neurontin: the gaffe that keeps on taking – Pfizer Inc  tried to suppress medical studies that did not support the use of its epilepsy drug Neurontin, internal Pfizer documents submitted in a U.S. lawsuit against the company showed…more

St. John’s Wort for depressiondoes he or doesn’t he?

Drug samples under attack!

Eli Lilly buying up ImClone.

Dendreon’s Provenge has some tantalizing data, but still must wait – Amid the stock sell-off, a bright spot appears and, of all things, it turns out to be Dendreon, the controversial and much-maligned little company that continues to press ahead with its Provenge prostate cancer vaccine…more

Another university looks at banning pharma gifts – A university medical school task force recommends prohibiting faculty, medical residents and students from receiving gifts from drug and device makers, according to an unreleased report obtained by The Minnesota Daily, the university’s newspaper. Docs would also be required to disclose all relationships with a drugmaker before writing a prescription and create a website to report conflicts…more

King and Alpharma start talking – Are you surprised? After the usual posturing and harsh language, the two drugmakers have agreed to a confidentiality agreement, according to a filing with the US Securities and Exchange Commission…more

Who should get Avastin? Genetic tests may tellGenetic tests could in future show who will respond best to Genentech and Roche’s blockbuster cancer drug Avastin — a positive development for patients but not necessarily for sales…more

Spiriva: more not-so-great mixed results – Spiriva, marketed by Pfizer and Boehringer Ingelheim, offered no advantage over an inhaled placebo for moderate-to-very-severe chronic obstructive pulmonary disease, or COPD, researchers reported on Sunday…more On the other hand, Novartis has a promising new COPD candidate doing well in mid-stage trials.

Peter Rost whistleblower suit against Pfizer gains new traction.

Good results for Remicade in combo treatment – Crohn’s disease patients taking Johnson & Johnson’s (JNJ.N: Quote, Profile, Research, Stock Buzz) Remicade either alone or with azathioprine experienced steroid-free remission in significantly greater numbers than those taking azathioprine alone, according to results of a clinical trial…more

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