Friday, September 28, 2007
Check it out on BrandweekNRX.
Is Pfizer’s Pharmacia & Upjohn the Unnamed Growth Hormone Drug Pusher?
21 Corporate Crime Reporter 38, September 28, 2007
Earlier this week, the Justice Department entered into a deferred prosecution agreement with Specialty Distribution Services, Inc., a unit of Express Scripts.
In the agreement, the company admitted that it “knowingly distributed human growth hormone to certain well-known athletes and entertainers, including a well-known athlete in Massachusetts, knowing that their intended use was athletic performance enhancement.”
The company agreed to pay a $10 million fine and cooperate with the government over three years.
But what was the drug?
And who was the supplier?
The government is mum on this.
The deferred prosecution agreement leads with this:
“Whereas, in October 2000, SDS, a wholly owned subsidiary of Express Scripts, Inc., was awarded a contract, by a pharmaceutical company, to distribute that pharmaceutical company's human growth hormone product.”
Peter Rost, a former vice president at Pfizer’s Pharmacia & Upjohn, says he knows who the “pharmaceutical company” is.
How does Rost know?
“I was the VP of the whole department at the time,” Rost says. “The person who managed this program worked for me.”
The question now is – why won’t the Justice Department name Pharmacia as the company involved?
Why the big secret?
Covington & Burling partner Ethan Posner, Pharmacia’s attorney, did not return calls seeking comment.
Neither did Ropes & Gray Partner Brien O’Connor, who represents Express Scripts.
Earlier this year, Pfizer’s Pharmacia & Upjohn Company Inc. unit pled guilty to offering a kickback in connection with the sale of its human growth hormone product.
A second Pfizer unit, Pharmacia & Upjohn Company LLC, entered into a deferred prosecution agreement for illegally promoting its human growth hormone drug Genotropin for such off-label uses as anti-aging, cosmetic use and athletic enhancement.
The companies will pay a total of $34.7 million in fines and penalties.
As a result of the plea agreement and the deferred prosecution agreement, Pfizer Inc. was granted a non-prosecution agreement.
In the past several years, human growth hormone has gained popularity with athletes and entertainers as a performance enhancement or “fountain of youth” drug.
Distribution by anyone, including a pharmacy such as SDS, or a physician, is illegal for these purposes under the federal law.
“This summer it seemed that not a week went by without a news report of some athlete receiving or using human growth hormone. It is important for the public to recognize that the use of human growth hormone for athletic or anti-aging purposes is not merely the dirty and increasingly poorly kept secret of the sports and entertainment industries,” said U.S. Attorney Michael Sullivan. “The distribution for these types of uses is illegal according to a specific federal statute. The public should also realize that human growth hormone has not been shown to be safe and effective for athletic, cosmetic or anti-aging uses, and it must not be promoted or distributed for such uses.”
Thursday, September 27, 2007
Must-view video here.
When the young man said he's done nothing wrong, the police officer goes crazy:
"You wanna try me? You wanna try me tonight? You think you have a bad night? I will ruin your fuckin night? You wanna try me? Do you wanna try me young boy? Do you wanna try me tonight young boy? YOU WANNA GO TO JAIL for some fuckin reason I come up with? You wanna see who knows the law better? Me or you? My experience compared to your young ass! Ha!? Ever be smart mouth with a cop again or I'll show you what a cop does. You wanna scare me? Try to talk back. Try to talk back again and I'll say you resisted arrest or something. You wanna come up with something, I'll come up with nine things!
The young man is Brett Darrow, and he says, "I truly thought if I didn't suck up, I would be beaten and maybe killed. The officer's name is Sgt. James Kuehnlein. Please excuse the clicking in the video."
After the video became an Internet sensation, the cop was fired for not having turned on his own video.
But that's not the end of things . . . now the cop's friends in the police force have started stalking the young man's house. Read more here:
Wednesday, September 26, 2007
Understand the Consequences
Going up against the evil corporations or the Big Bad Fed can have serious repercussions -- whistleblowers have been ostracized, fired, threatened, jailed, and worse.
Still, from Deep Throat to Big Tobacco, whistleblowers have a distinguished legacy of helping the public good. Stephen M. Kohn, President of the National Whistleblower Center in Washington DC says "The majority of all civil fraud recoveries in the U.S. are based on whistleblower disclosures," which means it could be up to you to point out wrongdoings.
In the end, most whistleblowers do end up exposed out of necessity, whether for legal testimony or simply due to accidental exposure. Most get fired, but many whistleblowers have also sued their former employers and won their cases. Legal protection for whistleblowers varies from country to country, and Wired can't provide you with legal advice, but you should understand that the choice to blow the whistle is ultimately fraught with risk.
Here are some tips that might help you remain anonymous -- and possibly evade detection long enough to get the word out.
One tool explicitly designed with whistleblowers in mind is Tor (surf to https://tor.eff.org/). Tor is a free networking software program and allows you to use the internet anonymously. Need to log in to that GMail account you used to contact the press, but you're stuck at work? Tor can help cover your tracks.
When you log into to Tor you join a network of machines scattered around the world that pass internet traffic randomly amongst themselves before it emerges at its destination. The process is somewhat like a ball bouncing around inside a sealed box. Every now and then a ball comes out of the box, but it's impossible to tell who put it in the box to begin with.
The process is called "onion routing," and it was first developed at the Naval Research Laboratory. Tor uses a layered encryption protocol, which is where the onionskin analogy comes from. Tor is designed to defeat one specific type of digital eavesdropping known as traffic analysis, a form of network surveillance that tracks who is talking to whom over a public network.
Without Tor, a malicious employer can easily detect any outgoing traffic announcing your whistleblowing intentions.
Tor alone isn't enough to hide you from the snoops. To use our earlier example, if you login to Gmail via Tor and send your whistleblowing message, the company might not be able to trace where it can from, but they can read it the minute it leaves Tor.
In other words, anonymity is not the same as security.
It's important to recognize that Tor does not encrypt traffic once it emerges from the Tor network. Thus, there's the possibility your data is going to be exposed unless you've bothered to encrypt it.
To learn more about encrypting your e-mail, see the Wired How To Wiki entry: Keep Your E-mail Private, Secret and Secure.
But if you're collecting whistleblowing data you'll likely want to encrypt more than just your e-mail.
Lock Down Your Files
Protect those contact lists and secret documents with some hefty crypto if you don't want to get caught.
Encrypting a file in Windows XP is easy as long as your hard drive is formatted as NTFS. The FAT32 filesystems doesn't natively support encryption, but if you're running NTFS, the process is simple. Just select the files or folder in Windows Explorer, right click and choose "Properties." In the "Attributes" section at the bottom, click "Advanced" and check the "encrypt contents to secure data" box. Click OK twice.
There are a couple of caveats here. First, the encryption is useless if someone else knows your login password (which is often assigned by the IT department). Second, if you encrypt a folder, anyone can still read the file names. They just can't open the files. So, changing the names to something obfuscated is a good start.
A better option is to use GPG4win, an open source encryption program for Windows. It encrypts files with a private key, always the strongest type of file encryption. Again, if anyone else has access to your account, the security provided is ruined because they will have access to your GPG key.
If you find yourself in a situation where you can't control access to your computer, you might consider investing in an encrypted USB thumb drive, though there could be some record of accessing it on your computer that leaves you vulnerable.
Tuesday, September 25, 2007
Those caught are not happy.
So now they have a web site to whine that they are getting tickets like regular mortals, on those unusual occasions when their buddies don't look the other way.
Here it is. And the write ups are complete with names of "offending officers" who issued tickets.
Friday, September 21, 2007
Thursday, September 20, 2007
Wednesday, September 19, 2007
FOX News has the following take and this is what the New York Times writes.
In a Chinese village children are forced to cross a raging torrent on a steel cable to get to school. Nearly 500 children, from the Maji village, cross the the Nujiang River each day. The children fasten themselves to the cable with a metal carabiner and a rope and slide across the 200 yard wide canyon. The villagers say that usually four-year-old children are taken by their parents, and begin to go by themselves from the age of five.
Tuesday, September 18, 2007
Monday, September 17, 2007
Sunday, September 16, 2007
Saturday, September 15, 2007
Friday, September 14, 2007
By the way you should check out who Bob is and what he reads.
Of course, I realize that Pfizer's lawyers and lobbyists in Sweden and the U.S. will want to hear what I have to tell the Swedes about the marketing of drugs . . . so for those lawyers, go here to download the program to the left, for October 24.
Three of the Swedish political opposition parties are paying for my travel . . . kind of cool.
I'm also having a fourth sponsor, I'll be doing a speech in Göteborg, Sweden on October 18, as part of "Entreprenörsdagen" which translates into "The Entrepreneur's Day."
You may wonder why they asked me to come, and, sure I've started some businesses, some of whom still exist (like the book publisher Affärslitteratur AB, which I sold before moving to the U.S.), but that's not the reason they invited me.
The theme happens to be "Med ett rent samvete" or "With a clean conscience." And I guess they thought I have something to say about that.
But the fun doesn't end there:
The Swedish translation of my book "Killer Drug," called "Wolfpack" in Sweden, or "Vargflocken" in Swedish will also be officially launched with some major press activity and a launch party.
When that's done, we may just come back and do a more formal launch in the U.S.
Of course, those of you reading this blog already know the book exists, but no word has been spread outside the blog world, so far.
Thursday, September 13, 2007
Wednesday, September 12, 2007
He was arrested a few blocks away.
This is his mug shot.
Don't believe this story?
Check out the Associated Press and the Smoking Gun.
Ropes & Gray, yet another Pfizer law firm caught changing Wikipedia.
Covington & Burling, a Pfizer law firm, caught cleaning up its reputation on Wikipedia.
Tuesday, September 11, 2007
The woman, whose name was not released, was temporarily banned by the Environmental Court in Vaxjo from smoking close to her neighbor's hedge, The Local reported Tuesday. The ban was put in place until a conflict between the woman and her neighbor -- a lawyer who claims an aversion to cigarette smoke -- can be resolved.
However, the court must now wait on the outcome of the appeal before proceeding. The woman claims the partial outdoor smoking ban has no legal basis.
The woman's neighbor claims he has to wear an oxygen mask to walk from his home to his car because of his sensitivity to the smoke.
"He walks around with the mask on regardless of whether I'm smoking or not. It used to annoy me but now I don't care any more," the woman said
As for me, I know what the lawyer is complaining about. I used to have a neighbor who smoked his cigar, when he returned home, in his backyard every day. He just moved. And yeah, I didn't enjoy smelling his cigar instead of roses.
Monday, September 10, 2007
Look who's talking now
By Dominic Tyer, Deputy Editor of Pharmafocus
The internet loves a good scandal. From compromising celebrity videos to the latest political whisperings, whatever your interest in life, the chances are its seamier side will be covered somewhere on the web.
This is just as true for pharma, where industry gossip, rumour and horror stories send many people online and these days their first stop is usually a weblog or blog. Once little more than online diaries, blogs have come to represent a key development in the next generation of internet applications known as Web 2.0.
Central to Web 2.0 is the idea of user participation; that is, users generating content, on websites like Wikipedia, Flickr and YouTube, and other users commenting on it, and the interaction that follows.
One industry-focused blog is the aptly named PharmaGossip, run from an unknown location in the UK by Insider.
"I saw the opportunity to shine a light on Big Pharma and some of their practices. The key challenge in blogging is to get readers!" Insider told Pharmafocus via email. "This is my way of getting Big Pharma to 'shape up' and stop doing the shoddy stuff." By this, he means data manipulation, ghostwriting, key opinion leader influencing, ever-greening and off-label marketing - all of which he says he sees in his day-to-day job.
His identity has been a closely guarded secret since the blog began in September 2005. The site now attracts between 900 and 1,000 visitors each day, half of whom are Big Pharma employees. Depending on commitments, stories and inspiration, Insider spends between one and four hours a day on the site.
When pressed for his pharma credentials, Pharmafocus was told: "I am an insider. You'll just have to trust me. I stand or fall by my posts. I don't speak to anyone. Sorry!"
When it comes to tip-offs on stories that mainstream media doesn't see, blogs are ideally placed to benefit from the convenience and anonymity of the internet. The most recent of these concerned the exit of a senior Novartis statistician in the US.>
Novartis Global Director of Oncology Statistical Reporting and Standards Reporting, David Olagunju, was allegedly fired for blowing the whistle on illegal and unethical activities at the company concerning the testing and reporting of clinical trial results for the cancer drug Tasigna. The story was first broken by former Pfizer marketing vice president Pfizer Dr Peter Rost, who wrote about Olagunju on his Question Authority blog, and he has been covering it ever since.
One of the prime movers in the pharma blog scene, Rost's writing has recently encompassed confidential training tapes, leaked marketing emails, as well as the Novartis story.
A recent post even details his personal experiences of applying for the position of German country manager at Novartis and the deadend he met after revealing his whistle-blowing past at Pfizer. This past is well documented in his book The Whistleblower: Confessions Of A Healthcare Hitman.
One of the interesting things about Rost's Olagunju/Novartis story is that although the story's various twists and turns are now freely available for all to read on the internet, the mainstream media have virtually ignored it. With this being the blogosphere, the story has been picked up by a number of other bloggers, linking to each other and commenting on it and the way the company has reacted to the story.
This highlights the challenge companies face in the blogosphere. There is no control over the message and the message can be read and added to by anyone. This presents a tricky issue for pharma when it comes to corporate PR and there are no easy answers.
Washington DC-based Mark Senak takes a different approach to blogs like PharmaGossip with his own eyeonfda.com. The blog focuses on regulatory affairs and product communication, but with a resolutely professional aim and outlook.
A senior vice president with Fleishman Hillard, Mark wanted to set up a weblog to distinguish himself in the professional world and he succeeded in getting the buy-in of his PR employers after they agreed some guidelines.
"I never write about an issue that a client is directly involved in, where they have skin in the game," he explained. "I don't want to be perceived as a troublemaker. I want to give objective information when and where I can."
He spends on average 15-30 minutes per day updating his blog and tries to post every day. In doing so, he has developed a loyal following of more than 800 subscribers, not counting the additional more casual readers.
"A blog becomes very much like 'talk radio'. You pick and decide the tone for what you're going to do and you can either be a shock jock and go out there and do some name-calling, or you can be a totally different type of programme."
The blogosphere recently saw two unlikely additions to the ranks of professional blogs. There are many examples of corporate blogs outside pharma, but at the beginning of June, they were joined by GlaxoSmithKline and Johnson & Johnson, launching pharma's first official blogs within days of each other. with low-cut, viral marketing strategies designed to appeal directly to the blogosphere.
GSKs product-specific blog, alliConnect, was the first to appear online on 1 June, and was soon followed by JnJs corporate JnJBTW (Johnson & Johnson By The Way) blog.
alliConnect is a US, consumer-focused blog for OTC weight loss treatment Alli (orlistat). The goal of this blog is to have a two-way conversation about weight loss issues, Steve Burton, vice president of weight control for GSKs consumer healthcare division writes on the blog. "We are going to challenge many people's notions about weight loss. And, we want you to challenge us in return."
Steve is just one of a team of GSK employees authorised to contribute to the blog. Alli's marketing director, brand manager and lawyer, plus a corporate blogging consultant, all join him in working on the site either by posting or working behind the scenes. Readers can post comments to the site, but only after GSKs team reviews them first.
One of the site's drivers is the company's desire to broadcast an official voice on Alli and a particular treatment effect it has. Basically, if someone takes the drug and then eats too much fatty food, they will urgently need to visit the toilet. The blog has been quite open about this, even suggesting some people think it keeps them honest in their diet.
The JnJ site covers a wider range of topics and has a single lead author taken from within the company's media relations team, which may give it the edge when it comes to developing a unique voice.
Mark Senak commented: "I was very pleased to see two international companies stepping up and dipping their toes in the water here. There's such a spectrum out there in terms of companies and where they are in terms of their relationship with new media. You go from those who are very sophisticated and now issue their press releases on RSS feeds, and you've got other companies where the people involved in communications don't even know what an RSS feed is."
He said GSK and JnJ will both face the challenge of posting regularly as well as the issue of how companies in such a highly regulated industry can inject the element of spontaneity integral to blogs. Nevertheless, Senak thinks the blogs are intriguing developments for pharma.
UK blogging guidelines
In the UK, the first consideration for any company looking to blog is the ABPI Code of Practice. Already, a small number of companies have approached the Prescription Medicines Code of Practice Authority about blogs; not because they want to start one, but because they want to know if they would be held responsible for the views expressed on a company-sponsored blog and the answer from the authority is 'yes'.
As with any sponsored material, blogs would have to clearly show they are sponsored and the company involved must ensure all information original postings and their responses comply with the code.
PMCPA communications manager Niamh MacMahon explains: "Pharma companies are not prohibited from setting up blogs - our advice is simply that as the purpose of blogs is to give contributors the opportunity to freely and spontaneously express personal views on a subject, it is virtually impossible for a company to retain any control over content and ensure compliance with the code, so they are probably best avoided."
A company could disregard this advice and set up a blog on a disease area, such as a breast cancer blog, but it would be the company's responsibility to make sure that such a blog didn't promote prescription-only medicines to the public.
So, in theory, GSKs approach - postings by authorised contributors with legal backup and the rigorous screening of public comments - if applied to a disease area, rather than a product, would be possible, but it would require close monitoring and would be a clear case for investigating the sources.
But for the time being, it remains easier for pharma's insiders to dominate the conversation.
The best blogs for pharma:
By Insider from Somewhere, GB.
"Looking beyond the spin of Big Pharma PR, but encouraging gossip."
An often irreverent take on Big Pharma happenings. Pictures of heart-shaped coughing ashtrays share space with linked excerpts from mainstream media stories on senior appointments, product warnings and lawsuits. There is, of course, also gossip.
NHS Blog Doctor
By Dr John Crippen, an NHS doctor
"A candid look at healthcare"
A straight-talking doctor blogging about pharma company relations, his local PCT and NHS reform. Most receive fairly short shrift. Less healthcare-related matters are also covered, such as the best way to humanely cook a lobster. Also does a handy roundup of other NHS blogs.
Question Authority with Dr Peter Rost
By former Pfizer marketing vice president Pfizer Dr Peter Rost.
"If you have no humor or if you are a boring person, you are not supposed to read this blog."
Something of a celebrity after his battles with Pfizer, Dr Rost last year published his pharma expos The Whistleblower: Confessions Of A Healthcare Hitman. Rost's blog most recently broke a story about a whistle-blower at Novartis. The site has also featured confidential training tapes and leaked marketing emails.
By Ed Silverman, a journalist on The Star-Ledger of New Jersey
"News, comment and conversation."
A well-written blog that positions itself as a home for news and debate about pharma, Pharmalot recently teamed up with Question Authority to pile the pressure on Novartis. Silverman combines edited mainstream content with his own commentary, adding original research and a dash humour.
By Mark Senak, senior vice president with PR agency Fleishman-Hillard
"Rx for pharma industry communications and planning."
A professional blog, EyeonFDA provides regulatory and industry commentary. It has a wide collection of online resources, and links to audio files of Senak's interviews with ex-FDA personnel and others. Removed from the original, anything goes idea of blogging, Senak's blog has links to his employer's website, and its clients are off-limits for his writing.
By a team of GSK employees led by vice president of weight control Steve Burton
"A place to talk about weight loss with the creators of Alli."
Pharma's first product-specific blog, it covers GlaxoSmithKlines OTC weight loss treatment Alli. It candidly addresses the products side-effects, addresses criticism that the product is a lifestyle drug, and explains how best to use the product. As a US-based, consumer-focused blog, it doesn't lead the way for UK marketers, but it's a fascinating first start for pharma.
By Marc Monseau, from JnJs media relations department
"A three-dimensional view of Johnson & Johnson."
Conceived as a way for JnJ to talk about itself, it covers a range of topics from the company's pipeline to biosimilars to the doctor-patient relationship. Recent comment also took in JnJ's global review of its media planning and buying activities. Like GSK's blog, it can't lose its corporate voice, but nevertheless, both provide interesting test cases for pharma.
Hat tip PharmaGossip, who found this story.
Saturday, September 08, 2007
I mean, I haven't gotten any new whistleblower stories in a while. And Ed Silverman is digging up new, cool stuff every day, and I just don't feel like reading the NEJM as much as he does. Or find out the latest details about Merck.
And, isn't just doing pharma blogging a bit boring?
I think PharmaGossip has understood that. As soon as Jack gets bored, he throws in something that is simply entertaining.
I mean, I can write about pharma stuff on BrandweekNRX. In fact, I have to. Well, maybe not have to, because when the pharma news is simply too boring I do throw in a nekkid president Putin. And try to make the connection with the pharma world by mentioning Viagra.
At least I already know what I'm going to post on BrandweekNRX on Monday. A post supportive of the drug industry. The world's best drug ad. No kidding.
Thursday, September 06, 2007
Internet Drug News
News Now Pharmaceutical Feed
And I also find CafePharma's Pharmagather real helpful
Which ones are your favorite places? Let us know in the comment section!
If you've read Killer Drug, you now what this is.
Not sure what will happen this week, but if you are starting to feel pangs of abstinence symptoms, you may want to try John Mack's recently posted blog summary 'Round the Sphere: New Media Tricks, Old Media Mystery, News Media Morons.
Wednesday, September 05, 2007
Clin Psych writes in Rost Busts Pfizer and Journalists:
But that has not stopped the so-called health media from running with the story from the Lipitor saves, generics kill angle (see several sources on Rost's site). Here's more fuel for the fire:
"The bottom line on this particular study is that the data tell us such switching may not be without consequences," said Michael Berelowitz, senior vice
president of Pfizer's global medical division, in a phone interview."
With all due respect, Mr. Berelowitz, it would appear that you are either ignorant on this point or you are lying. An analogy in the mental health field would be if patients who tried Effexor and then switched to a generic tricyclic antidepressant (say, imipramine) were found to have worse depression outcomes than patients who stayed on Effexor. Duh! Again, maybe people who dropped Effexor are treatment-resistant and/or had more severe depression -- medications don't work as well for them. So it would be a pretty stupid comparison to say that those who switched antidepressants were acting dangerously by switching medications, wouldn't it?
But Healthcare Renewal brings some perspective:
"But isn't it odd that the investigators didn't compare the results of people who switched from Lipitor to simvastatin to people who switched from say, simvastatin to Lipitor, or from Lipitor to a third drug? One wonders whether their failure to consider alternative explanations of their data had something to do with the economic interests of their employer?It's also too bad that the media coverage of this study did not initially consider that there may be interpretations of its results other than those provided by its commercially sponsored study investigators."
Humble question: How come "simple bloggers" can put things in perspective and regular journalists can't?
“The clowns at Pfizer clearly have no way of keeping confidential data safe,” commented Dr. Peter Rost, a former Pfizer vice president who has become a prominent blogger at his Question Authority Web site, peterrost.blogspot.com.
The Day also reported that the CT state attorney general said, “We are alerting criminal authorities, specifically the U.S. Attorney's Office, as to the possibilities of criminal wrongdoing.”
Tuesday, September 04, 2007
We have written extensively about the first two ones, but this is starting to get old. The clowns at Pfizer clearly have no way of keeping confidential data safe.
Judd Rousseau, chief operations officer of Identify Theft 911, an Arizona-based identity management company said, "While the number of data thefts is clearly on the rise, seeing a company struck three times in such a short period is rare."
One breach can happen to anyone," he said. "By the third breach you are starting to show a pattern. It wouldn't shock me if you start seeing litigation in connection to this."
We don't disagree with this assessment. Can't wait to see this in court. Uh, it happened once. Uh it happened twice. Uh, it happened three times.
Hat tip Pharmalot.
Monday, September 03, 2007
Sure, it takes two to tango . . . but it turns out that part of this is myth, and part is not.
Check out the Scandinavian countries on this chart and compare them with the latin, self-described, "lovers."
Click on chart to view.