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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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mcrost.jpgIt’s not quite yet official, and we were sworn to secrecy until this morning, but the rumor is now confirmed – John Mack, one of the grandfathers of pharma bloggers, and Peter Rost, designated bad-boy whistleblower and pharma blogger, have decided to turn their verbal swords into plowshares, unite egos, and become a single blogger. In a Freudian slip, the news of these 2 Egos becoming one Superego was allowed to leak before the new official ID was established.

Now blogging under the name J.P. MacRost, the two have become 1 expansive psyche of blogging bluster, threatening to overwhelm the entire pharma blogosphere with their combined fulminations, self-promotions, and appeals to readership numbers.

In fact, they are about to announce their new combined site, The Pharma Egosphere, where the new MacRost will continue to seek world domination through blogging bloviation.

egosphere.jpg

“It was a natural fit,” stated the former Peter Rost, once a pharmaceutical executive and now a full-time self-promoter. “John had nothing to offer, and I’m the best, so it made sense for him to join forces with me. In this case, the whole may not be equal to the sum of its parts, but he is certainly getting the better end of the deal. Plus, I have hair.”

Mack seemed to concur. “When you get beneath all the bluster and blather, you realize that, at bottom, Peter’s a pretty sparse fellow. Certainly all the fame I’ve given him will be better served if I latch onto the coattails I’ve created and try to find some substance to add to the formula. I mean, how much talent does it take to blow a whistle? My nephew did that when he was two years old!”

Rost, in particular, noted the synergies inherent in the merger. “After releasing ‘Killer Drug’, my new novel now sinking to the bottom of the charts faster than a breached submarine staffed with a crew of ballast, it was clear that the pipeline was pretty barren. The new J.P. MacRost will at least have John’s marketing newsletter, so that I’ll have a vehicle to keep my – excuse me, our – name in front of people on a regular basis.”

Both parties denied that the recent mud-slinging going on between their former blogging identities was merely a tactic to drive up readership numbers in order to make the merger appear more attractive. “Nothing could be further from the truth,” declared Rost. “Except your ridiculous novel,” chimed in Mack, who seemed to have a limited appreciation for the flight of literary fancy recently published by his new alter ego. “What a futile exercise in pseudo-thriller writing. What’d you do, give a bucket of money to some anonymous med ed writer to create it, in between his duties of making off-label slides for your former employer?”

Other members of the former Pharma Blogosphere (now made nearly invisible by the supernova-like expansion of the Pharma Egosphere) were not so sanguine about the blockbuster merger announcement. “I think there may be some issues with hot air monopolization, perhaps even requiring the purchase of CO2 ‘offsets’,” complained John Thursday, an anonymous blogger in some obscure country outside of J.P. MacRost’s area of residency. “In order for this to go through, they may have to shed some overlapping areas of content, like posting bogus survey results, or slapping up pictures of Sweden on slow news days.”

“I’ll miss the way they continually roast each other,” declared Pharma Grills, known to skewer overly inflated bloggers himself from time to time. “Perhaps the Jekyll-Jekyll dual personality dissociative disorder that is inevitable in this type of merger will lead to bitter disagreements within the same post, which could be fairly amusing, as long as we don’t get any more theme songs about novels and the like. I do hope he – they – whatever – continue to post stuff about Switzerland, or wherever they’re from.”

PharmaFlawed, another one of those anonymous-type bloggers, even went so far as to question whether Swedish spinmeister Peter Rost ever existed. “I kinda figured he was a persona made up by that Mack fellow years ago – you know, a sort-of executive avatar. You know how some corporations set up shell companies? I mean, how hard is it to find some old-time Swedish ABBA fan to pose for a few pictures anyway. I think I even stumbled into a Rost look-alike in Second Life and he answered to the name of of ‘Mack.’ All I can say is, it’s real suspicious-like.”

blue-woman-sm.jpgThe scoop came from an anonymous blogging insider, June Dough, who e-mailed a juicy tip about the impending merger to Impactiviti and left some discarded blog posts hidden under a dumpster in Short Hills. June painted herself blue to disguise her real identity. (Impactiviti suspects that the “blue woman” may be a double agent, however – the Mack-Rost spin machine has been hyping this mysterious upcoming announcement for 2 days, trying to get maximum exposure for the leaked news…I’m feeling used!)

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20070713110344.jpgSo now we find out the details on how the Big Hormone Scare of 2002 was seriously overblown. Some voices were raised, at that time, about the flawed methodology used to draw those early conclusions from the Women’s Health Initiative, but they were effectively drowned out by the panicky stampede of newspaper ink jumping on the story of how something everybody thought was good for women – the use of hormones later in life – was suddenly bad.

We’re seeing a repeat of this process with the bash-Avandia bandwagon in the present day. It may indeed turn out that there are serious problems with Avandia – but then again, there are still open questions. None of that seems to give pause to the rush to judgment – particularly if it gives a chance to gain headlines, and bash Big Pharma.

Personally, I thought that the hammering of Tysabri a few years back, and its temporary withdrawal from the market, was a major mistake. But it was great fear-mongering and sold papers, so the knee-jerk crowd carried the day.

All this is to say that we need to cultivate some skepticism about this process. Taking slices of data and turning them into major crises may be great for journalists, but it’s not good for medicine. There are plenty of skeptics who have their guns perpetually aimed at this industry – people who figure that Michael Moore must ride a white horse, and that the only evil agenda is to be found within corporate boardrooms – but that is naive. We need to reject Kool-Aid drinking in either direction, and press for solid presentation of facts and honest analysis of data. Everyone – CEOs, doctors, bloggers, journalists, film-makers, regulators, authors, politicians – has an agenda. Maybe the most difficult discipline of all is keeping a cool head and waiting for the truth to sift out.

[Speaking of being skeptical, take a read of this article from a pro-pharma blog, DrugWonks. The premise is that sampling is good, because it gives access to newer medicines, and it quotes from a "study" purporting to show that there are longer life spans in states where there is better access to newer medicines. Here is the article referenced. I'm having a very difficult time swallowing the idea that this study has truly addressed all the relevant variables, and managed to pinpoint with such precision that better access to more-recently approved medications explains the life-span differential between states. Something about this whole premise does not pass the smell test.]

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Time was, corporate misdeeds could be pretty effectively covered up. Sure, some scandals would leak out and make headlines, but information could often be contained, insiders constrained, or ignorance feigned.

transparent2.jpgNo more. We’re in a time of new transparency.

It’s getting very difficult to keep the lid on wrongdoing, and I, for one, think that is a good thing. What has changed? In a word, electronic communications.

Damning information is leaking out all over nowadays. In our industry, there has been a significant uptick in corporate e-mails, Powerpoint slides, documents, and other documentation of wrongdoing flowing out and becoming public. Much of this has occurred through the emerging pharma blogger community (most notably, Peter Rost over at Question Authority; but now others, such as Ed Silverman at Pharmalot, are being given such info).

Of course, a lot of “after the fact” electronic information gets exposed during trials, as archived e-mails and other documents are unearthed. But now, we no longer have to wait for the discovery process of trials. We’ve seen information leaked, exposure occur, investigations begun, and people fired within weeks – because blogs suddenly make it possible to publicize information almost immediately. Including pictures and videos (far more ubiquitous nowadays).

This has its dangers, of course. Most bloggers are not trained journalists. Sometimes due diligence has not occurred. Rushes to judgment can occur. But when clear electronic evidence is brought to light…well, a refusal to take action suddenly becomes less of an option.

This forced transparency can have a salutary effect. Ethical behavior may be forced on those who otherwise would blur the lines. If you have nothing to hide, you have nothing to fear. But if you’re playing games, the likelihood now is far greater that you’ll pay the price. Very publicly.

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