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Archive for the ‘Scandal’ Category

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TODAY’S NEWS

Big approval news for Gilead Sciences Gilead Sciences Inc., the world’s largest maker of HIV treatments, won U.S. approval of an inhaled antibiotic for lung infections in cystic fibrosis patients. The Food and Drug Administration cleared sales of the medicine, given the brand name Cayston, the company said today in a statement. Outside advisers to the FDA backed the product’s safety and effectiveness in a 15-2 vote on Dec. 10more

What is the future of “personalized medicine”? Probably, it’ll look a lot like this (encouraging story from NY Times). Plus, in a cooperative effort, Eli Lilly, Merck and Pfizer have formed an independent, not-for-profit company Asian Cancer Research Group (ACRG) to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asiamore

Of course, in this industry, there is often a mix of good news and bad – and “bad” usually means bad behavior by people who love dollars above sense: lack of openness at AZ?; secret tapes and GSK (plus, a “fixer” who spiked research?); research fraud by rogue doc; kickbacks and J&J; risk of depression assessment and Eli Lilly (are you alive? then you’re at risk!!!). Reminds me of some prior posts on the Gold-in Rule

Novartis looking to expand even more at East Hanover campus. Including themed food venues!

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I’m feeling much safer now. FDA finally comes out against “ear candling“! Next up, perhaps – a prohibition of USB-to-nasal-passage uploads??

JUST FOR FUN

Delightful (and BIG) pictures from Vancouver Olympics. Love the colors in the very first one. From Boston.com’s very nice The Big Picture section.

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TODAY’S NEWS

FDA panel to Forest on new use for heart drug: thumbs down - Federal health advisers on Monday unanimously rejected a new use of Forest Laboratories’ hypertension drug for patients at risk of heart failure. The Food and Drug Administration’s outside panel of heart specialists voted 8-0 against approving Bystolic to prevent death or hospitalization caused by heart failure, according to an agency spokeswoman….more

Withdrawal rates, Oxycontin, and selective publication of details. Sigh, Purdue.

Vivus’ new erectile dysfunction drug: fast results – Vivus Inc. on Monday reported positive test results for its erectile dysfunctional drug candidate avanafil, saying most men who took the drug were able to have sex within 15 minutesmore

Vertex lost less than $650 million in 2009. Well, that’s a relief!

The Medicines Company cutting 10% of workforce. Ouch.

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$3M CME grant with NO strings attached? Wow (Pfizer-Stanford)!

JUST FOR FUN

Obnoxious guitar design. Really. Obnoxious.

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What do you think?Those Dreaded Capabilities Presentations: can we make the whole process better? My ideas – what are yours (add in the comments)

TODAY’S NEWS

Pharma and paid search – Adios, after FDA warning letters. Paid search ads by pharmaceutical companies dropped a whopping 84% between March 26 of this year and the end of June.

Novartis expands anti-infective armamentarium – Novartis AG bought global rights to an experimental antibiotic from privately held Paratek Pharmaceuticals, adding a pill that may treat life-threatening infections caused by bacteria resistant to available medicines. The drug candidate, known as PTK 0796, may be taken in pill form, meaning patients can continue treatment after being discharged from the hospital, Basel, Switzerland-based Novartis saidmore

On Selling: The Changing Pharmaceutical Sales Landscape (from PharmaExec). Plus, Key Account Management (a rationale for change). And, Physicians less Receptive to Drop-in Sales Visits.

AstraZenca, Seroquel, lawsuits, and “weight-neutral.” Ouch.

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Implanted defibrillator saves a man’s life – by stopping a bullet. I love the final quote.

JUST FOR FUN

Million-to-one apple is half red, half green. Pretty cool picture!

Coming up this month:

Oct. 26-27 – Kru Research’s e-Patient Connections conference, Philadelphia, PA. I’ll be speaking and live-blogging. Here’s a discount code to save $500 off your registration: SW500

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TODAY’S NEWS

Novartis’ new MS drug (FTY 720) looking good in Phase III trials. New results just released.

Vertextakeover target? For a company looking to expand into Hepatitis C, Vertex is a prime candidate.

Boston Scientific and J&J making peace with the lawyer-enriching stent suits.

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Careful of those press releases, pharma execs. They could land you in jail! Of course, mishandling data can get you publicly fired. And, from bNet Pharma, the 10 weirdest drug stories of the month.

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TODAY’S NEWS

Sepracor to be purchased by Japanese company, according to report – By purchasing Sepracor, which sells drugs to treat central nervous system and respiratory disorders, Dainippon would be able to open a sales channel in the U.S. for its new schizophrenia drug currently in phase-3 clinical studiesmore

Pfizer fined $2.3 Billion (not a typo!) – Officials from the Justice Department and the Department of Health and Human Services said the world’s largest drug company promoted four drugs for use on certain ailments or at dosages that were not approved by the Food and Drug Administrationmore Plus, Jim Edwards adds 10 amazing facts about the settlement.
On the Pfizer fraud (note that the nonsense occurred at Pharmacia, before Pfizer acquired them), here’s the “money quote” from one of the internal whistleblowers, which perfectly underscores my recent blog post on the Gold-in Rule:
“In the Army, I was expected to protect people at all costs,” said the whistleblower, John Kopchinski, a West Point graduate and Gulf War veteran. “At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn’t do that.” (hat tip: PharmaGossip)

Forest Labs on the hot seat for questionable promotional practices – those 88 pages make clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors’ pockets and food into their mouthsmore And, more commentary here on Daniel Carlat’s blog.

Novartis reports results on Diovan and reduced cardiovascular events – Novartis presented data at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, which demonstrated that the addition of the angiotensin receptor blocker (ARB) Diovan (valsartan) to a non-ARB-based treatment regimen for high blood pressure provided a significant 45% relative reduction in cardiovascular eventsmore

Promising (though very early) results for a new Genentech cancer drug – In a small study, the drug, known as GDC-0449, shrank tumors in 18 of 33 patients, or 55%, with an advanced form of a skin cancer called basal cell carcinoma. In addition, the drug had a dramatic, though temporary, effect on a 26-year-old patient who had undergone multiple surgeries, chemotherapy and radiation in an unsuccessful battle against a brain cancer called medulloblastoma….more

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Ask the Ten Questions. As a consultant, here’s what I ask to try to help bring shape to your training/marketing initiative.

JUST FOR FUN

We don’t see them too often at this latitude. But here are 30 great aurora borealis shots. One day, I want to see one of these “live”!

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Prasugrel - the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.

Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.

Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)

Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis  has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.

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The article starts out this way:

    I look at the pharmaceutical industry from a public-relations perspective and I see this: A business that has lost its heart and its soul.

Kevin is an editor and blogger over at O’Dwyer, a P.R. news firm. He goes on to describe the downward spiral of the reputation of “Big Pharma,” and the many events that have led up to this current state. Lots of factors have contributed to the battering of the reputation of the pharmaceutical industry, and many of them are self-inflicted wounds.

Spin control won’t restore heart and soul. At the risk of seeming overly simplistic or moralistic, let me suggest three very concrete perspectives that, if embraced and practiced, will make any company sturdy and respectable:

    1. There will be many choices to make between maximized short-term profits, and doing what you know is right. Err on the side of choosing the latter.
    2. Assume that everything you say and do will be exposed someday (this used to be called the fear of God. Now it seems to be the fear of blogs!)
    3. Admit when you’ve screwed up.

Nothing brilliant or original here. Just good old-fashioned honesty and the Golden Rule, applied to business. But that’s where you get reputational capital – not from fawning Wall Street analysts, or spinmeistering P.R. professionals. As long as companies (& individuals) choose short-term gain varnished over with cover-up du jour, the public floggings will continue.

Hat tip on P.R. article: PharmaGossip blog

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