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Archive for November, 2007

From BusinessWeek101 Best Web Freebies. Interesting collection of web sites where you can get free stuff. From this page, I found Silver Jewelry Club, where you can order some nice-looking jewelry for free (only pay shipping) – we’ll see what my wife thinks at Christmas!

Wakerupper - put in the time, and this site will give your cell phone a wake-up call (free).

A couple interesting healthcare-related items, seen at a conference a couple weeks back:

- SearchMedica – a very cool targeted search engine for healthcare professionals, for finding great medical content. Recently reviewed here as well.

- Simple and cool little tool for patient persistence – check out this brilliant device (Dose-Alert).

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rep.jpgFrom PharmaVoice – free download of an article from a number of thought leaders on needed changes in the field sales model for pharma.

RepReview2007 – you can get this free article forwarded to you. Much of it is a keen grasp of the obvious, but for those needing to make a case for specific training initiatives (esp. Advanced Sales Training), there is some good data here.

From Jane Chin‘s blog, a quick summary of the quintessential competencies for a pharma sales professional.

Earlier this week, I published a blog post about this long and fascinating article describing the experience of one physician who (for a time) became a speaker for Wyeth (you’ll need 10 full minutes to read the entire article, and it’s worth it). Since then, Dan Carlat has decided to do some counter-detailing – you can read more here and also his summary of various reactions here.

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Glaxo buying Reliant - GlaxoSmithKline Plc has agreed to buy privately held heart drug specialist Reliant Pharmaceuticals for $1.65 billion in cash, in a move to boost its flagging drug sales in the United States…more

J&J says good-bye to $440 mil – Johnson & Johnson said on Thursday its fourth-quarter results would include a special after-tax, noncash charge of $440 million from a write-down related to a decline in sales of acute heart failure drug Natrecor…more

Fountain of youth? – Scientists at Sirtris Pharmaceuticals Inc. say they have created a drug that mimics the ingredient in red wine linked to longevity and the cell structures that power endurance athletes like cycling champion Lance Armstrong. The new molecule is 1,000 times more potent than the wine derivative, resveratrol, and could lead to solutions for diseases of aging, including cancer and diabetes, according to authors of a study in today’s issue of the journal Nature…more

Abbott‘s Xience stent showing good side effect profile and efficacy…gets FDA panel green light – Abbott Laboratories Inc  won a U.S. advisory panel’s support on Thursday for an experimental drug-coated stent for heart patients. A committee of advisers to the Food and Drug Administration voted 9-1 to recommend approval of the device, called Xience. The FDA usually follows panel recommendations…more

On the Oncology front…

Novartis gets EU approval for Tasigna – Novartis AG (NVS) Wednesday said that Tasigna, a potential follow-up to Gleevec, the Swiss drugmaker’s second best-selling drug, won European Union approval for the treatment of a certain form of leukemia. Novartis, based in Basel, said Tasigna is a new targeted cancer drug for patients with a form of the life-threatening blood cancer chronic myeloid leukemia, who are resistant or intolerant to treatment with Gleevec. Novartis expects Tasigna to eventually replace Gleevec and plans to test its efficacy and safety in patients who haven’t yet been treated with Gleevec…more

Celgene‘s Revlimid combined with dexamethasone effective for multiple myeloma – A combination drug regimen that includes a derivative of thalidomide extended survival, as well as the time it took for the disease to reappear, in patients with multiple myeloma…more

Freeze tumors, reduce pain – Freezing tumors may help relieve the extreme pain of cancer that has spread to the bone, which is often untouched by narcotics or radiation, U.S. researchers said on Tuesday. This freezing process, called cryoablation, is often used to destroy kidney, prostate and other tumors, but researchers at the Mayo Clinic in Rochester, Minnesota, found it eased cancer pain in 80 percent of patients in a small study, and the effect lasted for up to six months…more

It’s not drugs, but it’s fascinating – Vivek Rangnekar, a University of Kentucky College of Medicine professor of radiation medicine and a team of researchers say they have found a tumor-suppressor gene called “Par-4″ in the prostate. The researchers discovered that the Par-4 gene kills cancer cells, even highly aggressive types, but not normal cells, according to a study published in the journal Cancer Research and funded by grants from the National Institutes of Health. Rangnekar’s study found that mice born with this gene do not develop tumors. They grow normally, have no defects and actually live a few months longer than the control animals…more

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A long and interesting article from NY Times magazine, about the process a doctor went through as a “recruit” to be a paid spokesperson for a drug company.

Excerpt:

    How many doctors speak for drug companies? We don’t know for sure, but one recent study indicates that at least 25 percent of all doctors in the United States receive drug money for lecturing to physicians or for helping to market drugs in other ways. This meant that I was about to join some 200,000 American physicians who are being paid by companies to promote their drugs. I felt quite flattered to have been recruited, and I assumed that the rep had picked me because of some special personal or professional quality…Regardless of how I preferred to think of myself (an educator, a psychiatrist, a consultant), I was now classified as one facet of a lunch helping to pitch a drug, a convincing sidekick to help the sales rep. Eventually, with an internal wince, I began to introduce myself as “Dr. Carlat, here for the Wyeth lunch.”

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From the WSJ today

Drug That Lengthens Eyelashes Sets Off Flutter

By RHONDA L. RUNDLE
November 19, 2007; Page B1

In the latest blurring of the line between cosmetics and drugs, new products that promise to make eyelashes look longer are causing a stir among physicians and regulators because they contain ingredients that are the same or similar to those in prescription drugs for an eye disease.

Doctors and patients alike have noticed that eyelash growth is a side effect of a glaucoma drug called Lumigan, sold by California drug maker Allergan Inc. That phenomenon has set off a race among cosmetics companies to create new eyelash treatments that contain either bimatoprost — the active ingredient in Lumigan — or other so-called prostaglandins found in glaucoma drugs.

[Eyelash]
Before and after using Lumigan daily for 10 weeks

The eyelash products look like mascara tubes and have a brush or tip for applying the product along the base of the lashes, and typically sell for $140 to $160 in spas and doctors’ offices. At the same time, some doctors are writing Lumigan prescriptions for their cosmetic patients, a practice allowed because a drug may be prescribed for any use once it is approved by the U.S. Food and Drug Administration for one use.

But the companies pushing into this arena are already facing two big fights: one with each other, the other with the FDA.

Allergan itself, which sells the antiwrinkle drug Botox and is making a major push into aesthetic medicine, is believed to be testing Lumigan for lash enhancement. That strategy would echo Allergan’s development of Botox for cosmetic use many years after it was launched to treat eyelid spasms and other neuromuscular problems. Earlier this month, Allergan filed a patent-infringement suit against several eyelash companies that it says use a prostaglandin in their products.

Meanwhile, the new cosmetic products are already causing regulatory concern. On Friday, federal agents sent by the FDA went to a San Jose, Calif., warehouse and seized thousands of tubes of Age Intervention Eyelash, which the FDA called an “unapproved and misbranded drug.” The agency said it hadn’t received any reports of patient injuries, but warned the product might be potentially harmful because it contains bimatoprost, the Lumigan ingredient.

Jan Marini, founder and chief executive of Jan Marini Skin Research, which introduced Age Intervention Eyelash in 2005, said it was discontinued a year ago after the FDA raised questions about it and state officials embargoed the inventory that was seized at the San Jose warehouse. This February, the company relaunched the product with a slightly different name, Age Intervention Eyelash Conditioner, and a similar active ingredient that isn’t in any prescription medication. Ms. Marini says the company isn’t aware of any safety complaints related to either the original or the new formulation.

The scramble to develop and sell eyelash products derived from the glaucoma drug shows how the line between a cosmetic and a drug isn’t always clear. Cosmetic products can use ingredients that are also used in prescription medications.

However, if a company promotes its product to change the structure or function of the body — rather than just its appearance — then it is classified as a drug and must prove its safety and efficacy in human tests. The FDA’s Web site says that a product may be considered a drug if its ingredients have a well-known therapeutic use. FDA officials have so far declined to say how its rules apply to cosmetic eyelash products that contain ingredients found in glaucoma drugs.

FDA spokesman Brad Swezey declined to say if the agency is generally investigating cosmetic eyelash products or claims. However, in its press release Friday about the seizing of the original Jan Marini product, the agency said that Age Intervention Eyelash, if used together with a prescription glaucoma drug, could increase the risk of optic-nerve damage. Used on its own, the product “may cause other adverse effects,” including swelling of the retina and inflammation in the eye “which may lead to decreased vision.” Neither the agency nor the company has received any report of adverse effects, according to Mr. Swezey and Ms. Marini.

Other companies in the eyelash business are also trying to understand the regulatory landscape. Michael Brinkenhoff, an ophthalmologist who founded Henderson, Nev.-based Athena Cosmetics Corp., the seller of a product called RevitaLash, said recently that he has talked with FDA officials and believes he is complying with government regulations. He declined to reveal the ingredients used in RevitaLash, but he says they are “of a concentration that is reduced from anything that would be in any kind of a medication,” and “I have been scrupulously careful not to make any claims outside the realm of beautification.”

Jeffrey O’Donnell, chief executive officer of PhotoMedex Inc. of Montgomeryville, Pa., said the active ingredient in the company’s MD Lash Factor is a “derivative” of a molecule used in glaucoma medications. The product was launched in September and “sales have doubled in the last month,” he said earlier this month. “Ours isn’t considered a drug and our claims are cosmetic,” he said, adding that the FDA hasn’t raised issues about the product or its marketing.

Even as the cosmetics firms search for regulatory answers, Allergan is moving to defend its turf. An Allergan spokeswoman, Caroline Van Hove, declined to discuss its drug development plans. But she added: “We’ve got intellectual property in this particular area.”

On Nov. 7, Allergan filed a patent-infringement suit in federal court in Santa Ana, Calif., against seven eyelash-product companies. Among the defendants are Jan Marini Skin Research, Athena Cosmetics and PhotoMedex. Ms. Marini called the suit “baseless” and pledged that the company would vigorously defend itself. Athena’s Dr. Brinkenhoff and PhotoMedex’s Mr. O’Donnell declined to comment on the suit.

Allergan isn’t alone in trying to learn more about Lumigan’s effect on eyelashes. Physicians at the University of California at San Francisco, who say their research isn’t funded by a pharmaceutical company, are testing Lumigan and another glaucoma drug in patients who have lost their eyelashes because of alopecia areata, an autoimmune disease that causes hair loss.

Other researchers are developing tools to measure growth of the tiny hairs. “There are scales to look at wrinkles, but no one has developed an eyelash scale,” said Leslie Baumann, director of cosmetic dermatology at the University of Miami’s Miller School of Medicine. Dr. Baumann says many more eyelash-growth products are headed to market. They are probably safe, she says, but could permanently darken the color of the iris if allowed to drip into the eye.

Lorrie Klein, a cosmetic dermatologist in Laguna Niguel, Calif., says she started prescribing Lumigan after noticing “beautiful, long lashes” on a patient using Lumigan for glaucoma. Now, Dr. Klein promotes Lumigan on her Web site as “easy to use at home with only a once daily application” for “one to three months to achieve the desired length, and then once weekly for maintenance.” She advises patients to use a disposable brush to apply the drug.

Dr. Klein says she feels comfortable prescribing Lumigan because it comes from Allergan, which sells other dermatological drugs and products. Some of her patients, she says, work for Allergan and have told her the company has recruited subjects for a clinical trial of Lumigan for cosmetic use. Dr. Klein notes that Lumigan’s safety has been validated by FDA tests. “It’s scary to me as a physician that some cosmetic companies are slipping in a prescription drug,” she said.

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Looks, on the surface, like a good match of products and market presence – Celgene buys Pharmion. And, in other important oncology news, Nexavar (from Bayer) gets expedited approval for liver cancer.

Also, Schering cleared to take over Organon – by divesting bird vaccines to Wyeth.

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Where did THIS come from?

A mid-November surprise, before many of the leaves have come down.

nov-snow.jpg

Sure is beautiful, if ultimately ephemeral – probably won’t last through the day.

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As is becoming a more common event, this week’s news posting is being composed from an airport hotel room. My NJ ASTD colleagues are networking at the Annual Technology Training Showcase in Bridgewater; I’m in Chicago watching UConn stomp Gardner-Webb in basketball – oh, well.

It’s been another noisy week in pharma, mainly with the blacker black box for Avandia (see links below).

With GSK‘s Avandia woes deepening, Takeda is about to launch an advertising blitz for Actos. Meanwhile, GSK experiments with new selling models (including fewer sales reps, of course…)

Why restrict rough product news to one Top 5 company? Sanofi‘s Acomplia gets another cloud perched over it.

Reorganization is in the air, at least in New Brunswick. Changes at J&J.

Good news Bad news for Roche. Good news – anemia drug approved by FDA! Bad news – can’t sell it…

I’m sorry. Really. Here’s a $135 million apology.

Samples for sale! Go directly to…

Forteo goes one up on Fosamax.

Door locked in Pittsburgh. Another Med. Ctr. restricts drug reps.

Not necessarily news, but a nice resource I just came across. Selling Power’s Pharmaceutical Newsletter (free registration).

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How role play is being used effectively in another industry (real estate) for sales training.

Truly buying in to this perspective should shape/re-shape the entire approach to initial sales training, as is the case with at least one of my clients. You may wish to consider how to strategically push more of the didactic learning into Home Study, so that initial in-house training can focus more on practical application.

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Very interesting article in today’s USA Today newspaper, about the use of transplanted islet cells to re-awaken pancreatic function for producing insulin.

If this works out, it could certainly revolutionize some aspects of diabetes treatment in the future.

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