Tuesday, January 29, 2008

Did Rost Just Pull a Mike Huckabee?

Yesterday, I received an email from Peter Rost entitled "Schering-Plough tries to silence upcoming BrandweekNRX article," in which he summarized correspondence between him and some lawyer at Schering-Plough regarding an expose he said he was writing for BrandweekNRx/BrandWeek. I believe the documents in that correspondence were also posted on NRx for a short time yesterday, but I can no longer find that post.

Over the weekend, Rost wrote a letter to Ken Banta, a strategic adviser to Schering-Plough CEO Fred Hassan, asking him to confirm or deny a couple of statements in an "upcoming story we are writing for BrandWeekNRx/BrandWeek." The first three statements made some damaging revelations about Fred Hassan's wife and her shady-sounding real estate deals involving Schering-Plough properties. Here's Rost's email to Schering-Plough regarding that story (click image to enlarge and read):

[Sorry, that image is no longer available!!! You'll have to take my word for it -- also, see Rost's comment to this post.]

The problem is that Rost hasn't written that story. He has, however, written an excellent story focusing on Hassan and what a terrible job he's doing (see "Did Fred Hassan use smoke-and-mirrors to 'turn around' both Pharmacia and Schering-Plough?").

"This is the story Schering-Plough tried to stop," Rost claimed in email I received this morning. But there is no mention of Mrs. Hassan in the story.

I think this may be the first case of a "Mike Huckabee" style withdrawal of a negative attack piece in Pharma BlogosphereTM history!

P.S. Peter, I think you're doing a great job! Keep up the good work.

Thursday, January 24, 2008

PhRMA Intern vs. Botox Redux

Pharmalot recently reported that Public Citizen Demands A Black Box For Botox.

A Public Citizen analysis of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, there were 658 reported cases of people suffering adverse effects from injections of botulinum toxin. Of these, 180 were associated with aspiration (fluid in the lungs), dysphagia and/or pneumonia; 87 required hospitalization. There were 16 deaths, including four in children younger than 18 years old.
Botox DTC ads have bothered me for a long time because they are "reminder ads" that do NOT have to mention such side effects. Here's a post I made to Pharma Marketing Blog over a year ago!

On her lunch break, while innocently reading the latest issue of Woman's Day magazine, Emily Jameson, mild-mannered summer intern at PhRMA -- America's pharmaceutical trade association -- is startled by an ad she sees...

Emily believes that Principle #10 of PhRMA's Guiding Principles for Direct To Consumer Advertising for Prescription Medicines calls for the elimination of so-called "Reminder Ads," which are usually 30-second TV commercials that mention a drug's name without stating the health conditions for which the medicine is approved and without listing the major risks associated with the drug. These ads are perfectly legal from a regulatory point of view.
You might have seen reminder ads on TV for Lunesta (see, for example, "Sepracor Sneaks In Lunesta Reminder Ad").
Here's the BOTOX ad Emily saw in Woman's Day magazine:

According to the BOTOX Web site, BOTOX Cosmetic is indicated for the "temporary improvement in the appearance of moderate to severe glabellar lines [ie, wrinkles between the brows] associated with corrugator and/or procerus muscle activity in adult patients." Neither lady in the ad exhibits any hint of glabellar lines, which I suppose is the point -- they've already been "hit up" with their BOTOX injections and are enjoying their brief "time" between injections!

But you already know what BOTOX is for!
Very few people have escaped the PR and buzz about BOTOX, which has become part of the culture of many countries (in some countries, however, people are much less concerned about wrinkles between the brows). Again, this is the power of public relations as a marketing tool (see, "Marketing Disguised as PR", for more on this).
Viagra is another drug that has benefited greatly by PR and buzz. However, you won't see any Viagra reminder ads -- at least not in the US. Here are some examples of what are purported to be Viagra reminder ads in other countries.
Once again (see the first installment of "The Adventures of PhRMA Intern"), Emily is quick to respond:

Ducking into PhRMA's Office of Responsibility, mild-mannered Emily Jameson -- lowly summer intern -- transforms into PhRMA Intern!

BOTOX is produced and marketed by Allergan, a biotechnology company that likes to call itself a pharmaceutical company. BOTOX Cosmetic accounts for perhaps 40% of Allergan's total sales.

Just a few minutes after leaping from the small window in the Office of Accountability,
PhRMA Intern lands at Allergan headquarters in Irvine, California and confronts Allergan's Executive Committee (and Corporate Counsel)...

PhRMA Intern offers the BOTOX print ad that she ripped out of Woman's Day magazine as proof of non-compliance. She doesn't mention all the similar BOTOX TV ads she has seen. Since PhRMA Intern didn't mention the TV ads, and because PhRMA's DTC Guideline #10 only applies to TV ads and NOT to print or Internet ads, Allergan's Corporate Counsel can truthfully claim that Allergan needs "no stinking guidelines."

"Drats," exclaims PhRMA Intern, "foiled again by a wily corporate counsel!"

Back at PhRMA headquarters,
PhRMA Intern -- now disguised as mild-mannered Emily Jameson -- learns the REAL reason why Allergan can run BOTOX reminder ads with impunity!

Not only are PhRMA's Guiding Principles voluntary, they apply only to PhRMA's member companies and only to those who have agreed to comply with them. [If you are trying to search PhRMA's Web site for the signatories, don't bother. There is no such list available.]

Allergan, like other biotech and specialty pharmaceutical companies, is a member of another trade association headed up by a former politico:
BIO, the Biotechnology Industry Organization.

Considering that biotechnology companies like Allergan are beginning to market their products directly to consumers much like the rest of the pharmaceutical industry (see "
Biotech DTC: Business Not As Usual"), it behooves BIO and its member companies to at least do what PhRMA has done: draw up a set of principles for DTC advertising that its members can use.

PhRMA Intern says: "Considering that many biotech drugs (eg, injectables) have very serious side effects -- BOTOX Cosmetic's side effects include 'serious heart problems and serious allergic reactions' -- BIO should certainly insist that its members NOT run reminder ads on TV, in print, or on the Internet!"

What's Your Political Compass?

Jack Friday at PharmaGossip and Aubrey Blumsohn at the Scientific Misconduct Blog both challenged me and other pharma bloggers to take the "Political Compass" survey and compare my results with theirs. Well here it is (click to enlarge).

Take the test yourself and see how to analyze it here.

On the left-right scale (economics), I am about as Marxist as Jack Friday, whereas Aubrey is a centrist. On the vertical social scale, however, Jack is the most authoritarian and Aubrey the most libertarian of us three. I'm somewhere between the two.

Jack and I share the same quadrant as Gandhi, Nelson Mandela, and The Dalai Lama. I would not have put the latter in that square -- Mr. Lama seems much more authoritarian to me. After all, don't millions of people pray at his feet? In my case, only my dog is at my feet.

Sunday, January 20, 2008

Who are These Wolves and LRRH Supposed to Be?

Give up? See "Different Views of Pharma and its Critics"

Here's a hint taken from a scene shortly following the above encounter:

Thanks to Eka's Portal for the image source.

Wednesday, January 16, 2008

'Round the Sphere: Rope-a-Dope-a-Pharma

Round 1: Lipitor's Jarvik is outed
Round 2: Vytorin Trial Ends In Failure - Patients Left Out in Cold
Round 3: Congress Investigates Vytorin Ads
Round 4: Congress To Probe Vytorin Insider Stock Sales
Round 5: Study Says Patients, Doctors Get Distorted View of Antidepressants
Round 6: FDA Won't be Previewing TV DTC Ads!
Round 7: Taking Statins no Better Than Betting the Lottery!

Announcer: "Big Pharma is reeling! Is this the final round? There are deep cuts over both Big Pharma's eyes (R&D and Marketing)! How much more pummeling can it take? Is this fight over?"

Tuesday, January 15, 2008

If It Wasn't for Dr. Nissen, I Wouldn't Have an Informed Opinion at All!

Do you take Zetia like me? Now that there's all this news about how the ENHANCE trial failed (see "The Controversial Vytorin Trial Ends In Failure"), I'm not sure what to do!

The only expert opinion I've heard is from Dr. Steven Nissen (see below), head of cardiology at the Cleveland Clinic in Ohio, who has called for a "moratorium" on the use of Vytorin and Zetia. "In the absence of any evidence of a clinical benefit," said Dr. Nissen, "these drugs should now be used as a last resort."

MY cardiologist hasn't called me or emailed me and the Zetia Web site is mum on the whole subject!

I think this lack of attention to patients like me from our own physicians and from the drug companies whose products I depend upon is SHAMEFUL! or worse!

Please read more about why I feel this way in today's post to Pharma Marketing Blog ("Should I Stop Taking Zetia?").

Friday, January 11, 2008

'Round the Sphere: Christiane Truelove and the Jarvik Fop Flap

Some day I'll meet up with Chris Truelove -- she works just down the road from me! For now, however, I'll just have to be content with reading "Pharma Blogs: Week in Review," the weekly e-newsletter Chris writes (subscribe here). This week's edition is a gem, and not only because she mentions me at least 3 times! She managed to cite every one of the posts I made this week to Pharma Marketing Blog! Thanks, Chris.

I don't think Chris will mind if I excerpt some of her comments here.

Chris cited several blogger comments about Jarvik, the "doctor" celebrity Lipitor spokesperson. She notes that uber-liberal Peter Rost at Brandweek's NRx and Ayn Rand groupie Peter Pitts over at Drug Wonks make strange bedfellows agreeing with one another on the Jarvik issue:

What I am very surprised at is that Mr. Pitts and Dr. Peter Rost at BrandWeekNRx actually agree that picking on Dr. Jarvik for not being a licensed physician is wrong. Dr. Rost came to Dr. Jarvik’s defense. "Quite frankly, I'm shaking my head a bit," Dr. Rost says. "It is one thing to go after celebrities who know nothing about medicine and another to go after a guy who happens to have contributed more to medicine than most practicing docs."
Obviously, there's "medicine" and then there's the "practice of medicine," which is a point Bob Ehrlich and I (two other strange bedfellows) focused and agreed on. Chris writes:
John Mack at the Pharmaceutical Marketing Blog had thought Dr. Jarvik was a practicing physician when the ads first aired. Now that Dr. Jarvik has been outed, Mr. Mack says, “I am not belittling the contribution Jarvik has made to medicine, but it does appear to me that the Lipitor ads are misleading consumers into believing that Jarvik is a doctor similar to the doctors they are used to seeing in real life -- one that treats patients and has experience with cholesterol medications. Why else would we believe him as an endorser of Lipitor?”

At DTC Perspectives’ blog, DTC in Perspective, Bob Ehrlich admitted that he was surprised to hear that Dr. Jarvik was not a licensed physician. “I assumed he was a leading cardiologist,” he says. “Of course that was my assumption, not something Lipitor ever said in their ads. Jarvik is what he says he is. He is a scientist who invented the artificial heart. Like many researchers who have a medical degree, they do not practice. I am sure; however, Jarvik knows a thing or two about the heart.” Although “Pfizer is not guilty of anything in a literal sense,” Mr. Ehrlich suggests that Pfizer put a clarifying statement on the commercial that states that Dr. Jarvik does not practice medicine.
Yes, Pfizer is not guilty of anything except a lack of transparency.

Speaking of using celebrities in DTC ads, Jarvik actually was MADE a celebrity in the public's eye BY the Lipitor ads. I mean, do you think Joe Sixpack ever heard of Jarvik BEFORE the ads aired? I don't think so. On the other hand, the Boniva commercials do not even have to mention Sally Field's name; everyone knows her! In other words, Pfizer CREATED the image of Jarvik as a world-renowned DOCTOR in the public's eye -- they even fooled an expert like Ehrlich into believing Jarvik was a practicing cardiologist who knows something about treating high cholesterol.

BTW, even a layperson like Paul Winchell, the renowned ventriloquist, can invent an artificial heart, which he did BEFORE Jarvik did. In fact, the Winchell family claims that Jarvik STOLE Winchell's idea after forcing him to donate his patent to the University of Utah. Here's a comment I received to my October, 2006, post "Lipitor's Jarvik: Fop or Flop?" that first "outed" Jarvik as possibly a closet gay guy (not that there's anything wrong with that):
I am offended by Dr. Robert Jarvik's claim to be the inventor of the artificial heart. It appears he's stretching the facts, perhaps due to what you alleged might be vanity. As a young medical student in the 1970s, he joined the research team on artificial organs at the University of Utah under Dr. Kolff. Dr. Kolff had convinced the inventor of a battery-powered artificial heart to donate his patent to the University. That man was Mr. Paul Winchell. Mr. Winchell invented the artificial heart in the 1950s and filed for a patent in 1961. Dr. Kolff requested he donate his research and the patent ten years later in 1971. Winchell was a pre-med student at Columbia at the time of his invention, but later dropped out. If you recognize his name, he earned his money for medical school through entertainment--as the famous Paul Winchell, with sidekicks Jerry Mahoney and Knucklehead Smiff. I believe this is why Dr. Jarvik does not acknowledge Winchell as the original inventor. Jarvik used air compression in his version of the artificial heart, and did indeed create the first one for use in humans. Winchell didn't agree with the air compression design and kept trying to get the University researchers to consider batteries for power, so patients would not be tied to a compressor (about the size of a briefcase with tubes to the body). Kolff and Jarvik distanced themselves from Winchell, and as far as I can determine, have never credited Winchell for 1) inventing the first artificial heart, or 2) dontating his patent to the medical community for the benefit of the world. You can read Winchell's side of the story at his site, www.paulwinchell.com. One last note--it's interesting that Dr. Jarvik is now going public on a national scale only after Winchell died in 2005. Spread the truth. ~Kimn Gollnick
BTW, I should note that the Lipitor ads are very careful to say that Jarvik invented the "Jarvik artificial heart" as opposed to any other type of "artificial heart." I bet the Pfizer lawyers were all over the ad agency on that point just to be sure that "Pfizer is not guilty of anything in a literal sense!"

Thursday, January 10, 2008

CMPI, aka DrugWonks, is a "breeding ground for industry moles"

According to Evelyn Pringle, investigative journalist writing for Counterpunch, the Center for Medicine in the Public Interest (CMPI), which brings us DrugWonks, is virtually run by ex-FDA staffers appointed by the Bush Administration. Here's what she has to say:

On its web site, the Center describes itself as "a non-partisan, non-profit educational charity," and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.

The Manning firm apparently fills two important roles. It's a breeding ground for industry moles preparing to enter "public service" and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.

In his CMPI bio, Mr Pitts describes his duties as the FDA's Associate Commissioner from 2002 to 2004 as serving as the agency's "Chief Messaging Officer."

On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: "I know Doug Arbesfeld and he is a guy devoted to advancing the public health."

According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.

"He is also a guy," Mr Pitts says, "who took a pretty significant pay cut to put in some time in public service."

Some would no doubt argue that it's difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.

Mr Pitts' sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg's bio also says he used to be Director of the Manhattan Institute's Center for Medical Progress and Chairman of its 21st Century FDA Task Force.

In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration's FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the "Godfather of Preemption," sits on this "charity's" Advisory Board.

Troy,s bio points out that he "played a principal role in FDA,s generally successful assertion of preemption in selected product liability cases."

This "assertion of preemption" says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product's serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.

Now that he's switched back to private practice, Mr Troy's CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with "particular focus" on what else - clients regulated by the FDA.

The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.

That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called "Patient-Centric and Prospective Medicine," CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, "former Medicare administrator and FDA commissioner, will chair the group."

So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration's FDA can find it right in the middle of cyberspace on the CMPI web site.
Also see "Drug Wonks Are PR Wonks".

Monday, January 7, 2008

Big Pharma, "Real" People, Wonkers?

Ed Silverman over at Pharmalot is trying to draw out the anonymous creators of a Website called BigPharmaRealPeople and challenged the principal--one Scott McTavish (aka John Galt)--to a blogging duel:

"One other thing, Scott. Since you chose not to answer any of our messages directly, we are still curious to know more about your background and those of your ’staff.’ We would also like to know what, if any, sponsorship or backing you may have. If you really do enjoy an open debate about all the facts, more disclosure would be helpful - unless your site is merely an example of astroturfing dressed up as a social networking experiment." (See "Big Pharma, Real People, Bitter Web Site").

I can't imagine that this site gets any pharma sponsorship money. If it did, it could afford to be sure that its web site was compatible with every browser out there, especially FireFox. It's not.

When I access the site using FireFox 5.0 for Windows, it's a mess!

I first heard of BigPharmaRealPeople from the Pharma Fraud blog (see "Big Pharma: Real (Phony) People"), which believed it was a spoof site. Frankly, I don't think there's much about it to get worked up about.

However, I find it amusing that perhaps the site took an idea I had and ran with it. Namely, the idea that the stories of "real" people working at pharmaceutical companies are not getting out. I suggested, for example, that the J&J people over at JNJ BTW should let their rank and file people tell their stories on that blog (see, for example, "Advice to All Pharma PR Bloggers Out There").

Could it be that a rogue person within J&J read my blog and decided to do what I suggested? Could be (I think Pharma Fraud believes it could be). Except BigPharmaRealPeople takes it a step further and potty mouths critics of the pharmaceutical industry, choosing to focus on "negative attack ads" rather than positive personal stories, which makes it sound more like someone from Cafe Pharma is behind this.

BigPharmaRealPeople is NOTHING like the open and frank style of JNJ BTW, but is very SIMILAR to attack dog style of Drug Wonks, who are also big Ayn Rand fans. It wouldn't surprise me, therefore, it those people were behind BigPharmaRealPeople!

Thursday, January 3, 2008

Riddarhuseter Rost Re-establishes Roost at Brandweek's NRx

After languishing for over a month without any word from Peter Rost, BrandweekNRx is "Baack"... sort of (hat tip to Pharmalot for that).

This bit of news is now circulating through the Pharma BlogosphereTM (see, for example, here and here).

Let's dig a little deeper and learn some more.

Here, for example, is a comment from Todd Wasserman, BrandWeek’s editor, which was reported in Pharmalot:

"We let him go in December because of lack of advertising, but are bringing him back in January even (though) we don't have ads to support him - yet. Peter is great at generating traffic and we like being able to take part in the pharma blogging discussions, so we wanted to bring him back on a month-to-month basis."
Of course, I have always wondered about the QUALITY of Brandweek's eclectic Rost-generated traffic viz-a-viz how attractive it would be to advertisers. See, for example, "What's Brandweek's NRx Strategy?" in which I said:
"If Brandweek's strategy was to get a quick jump in readership no matter who those readers are, then it has succeeded! It may more like a tactic than a strategy, however. I still remember Rost saying that his assignment may be temporary. Perhaps Brandweek intends to sell NRx and the pumped up readership can only help."
Peter J. Pitts -- pundit over at Drug Wonks blog -- had this to say in a comment to the WSJ Health Blog post:
"No revenue but a lot of traffic? What does this say about the state of the blogosphere? (I think it says that Rupert will not come calling any time soon.) It must be Rost-based accounting."
Recall that Pitts' colleague over at DrugWonks -- Robert Goldberg -- previously wished Rost luck when he first signed on at BrandweekNRX:
"I don't get all the consternation about Peter Rost becoming a journalist as opposed to a blogger. Let the guy make a steady living. At least, unlike others in the media, he makes his viewpoint known, never gets ruffled and is not afraid to fire back when challenged. I don't agree with him but I will look forward to reading him in his new perch. Good luck to the 'other' Peter."
Let's wish him luck again, and every month that Brandweek decides to "bring him back."

Of course, Rost has since donned at least one 'other' persona -- anti-pharma litigation witness for hire -- to help him "make a steady living."

Speaking of these "other" Rosts and making a living, here's a comment to the Pharmalot post from "Dan":
"A bit of trivia: Think I read on Corey Nahman blog some time ago that Dr. Rost is a multi- millionare and is a decendent of nobility. This suprised me, considering his disposition and stance on the issues facing the peasants."
I knew that Rost made a lot of dough as a Pfizer VP (about $700K per year in salary, not including bonuses), which, if he was frugal and invested in various assets, could give Rost a multi-million dollar "net worth," but I did not realize he could be descended from nobility!

Now I know why he returns to Sweden so often -- to visit his noble family at the Riddarhuset to get some cash and to be invited to speak before its Parliament!