2008 in 40 seconds . . .

One year in 40 seconds from Eirik Solheim on Vimeo.

Wishing you a season . . .‏

. . . filled with warm moments . . . and cherished memories





Happy Holidays and all good wishes for the New Year

Peter

White Christmas

FiercePharma: Survey says: Nissen or Rost for FDA Commish

Survey says: Nissen or Rost for FDA Commish

Created Dec 19 2008 - 12:17pm

Steven Nissen (photo [1]) may be on Big Pharma's short list for the least desirable candidate [2] for FDA Commissioner, but many apparently think its critics like him who should be at the top of the list. That's according to a survey conducted by Pharma Marketing News. Nearly 500 respondents weighed in with their picks for who should be nominated as FDA Commissioner. The survey asked for opinions for 10 potentials usually mentioned in the media. Peter Rost took first place, Steven Nissen came in at second, with Susan Wood in third. Janet Woodcock and Robert Califf tied for fourth place.

Survey respondents included pharma industry execs and staff, agents and vendors to the industry, healthcare professionals, government staff and readers from the general public. Interestingly, although Rost was favored overall, Nissen was favored among US respondents. But broken down by industry, the results showed that Pharma in particular favored FDA insiders Woodcock and David Kessler, while healthcare professionals supported Nissen and the general public preferred Rost.

Pharma Marketing on FDA Commish online vote: "And the winner is . . . 1. Peter Rost"

Thursday, December 18, 2008

Pharma Industry Out of Touch with Their Customers When It Comes to Who They Favor for FDA Commissioner

FDA critics like Steve Nissen and Peter Rost are the candidates of choice in the Pharma Marketing News survey that asked respondents to vote on who they think should be nominated as the next FDA Commissioner.

The survey included representatives from various stakeholders, including executives and staffers working within the pharmaceutical industry, agents and vendors to the industry, healthcare professionals, members of the general public, and staffers within government health agencies.

It is particularly interesting that former FDA Commissioner David Kessler is almost as popular as Janet Woodcock among pharmaceutical industry respondents.

Perhaps it is not surprising that the drug industry favors these “insiders” and not “change agent” outsiders like Nissen, Rost, or Susan Wood, who are favored by pharma's customers: the general public and healthcare professionals.

It’s just another indication that the industry may not be ready for changes that their customers want to see.

You can get the complete results of the survey here: http://tinyurl.com/43o6o2

In this document John Mack also writes:

"And the winner is . . . 1. Peter Rost"

Among the general public (N=99), Rost is the favorite with 32% of that group’s vote.

Respondents affiliated with the drug industry (Pharma + Agency; N=146) preferred Woodcock and Kessler who received 56% and 54%, respectively, of that group’s vote.

Nissen is the favorite among academics plus HCPs (N=143) with 44.9% of that group’s vote.

Finally, among the government group (N=51), Kessler, Nissen, and Wood are favorites with 18.9%, 16.9%, and 12.9%, respectively, of that group’s vote.

Tonight: Debate Peter Rost vs. Richard Bergström, CEO PhRMA Sweden

I guess Billy Tauzin, CEO PhRMA USA wouldn't quite be up to that. Or am I wrong?

Economic Models explained with Cows - 2008 update

You may think you've heard this one before, but it has been updated with very important new lessons . . .


SOCIALISM

You have 2 cows.

You give one to your neighbour.

COMMUNISM

You have 2 cows.

The State takes both and gives you some milk.

FASCISM

You have 2 cows.

The State takes both and sells you some milk.

NAZISM

You have 2 cows.

The State takes both and shoots you.

BUREAUCRATISM

You have 2 cows.

The State takes both, shoots one, milks the other, and then throws the milk away...

TRADITIONAL CAPITALISM

You have two cows.

You sell one and buy a bull.

Your herd multiplies, and the economy grows.

You sell them and retire on the income.

SURREALISM

You have two giraffes.

The government requires you to take harmonica lessons

AN AMERICAN CORPORATION

You have two cows.

You sell one, and force the other to produce the milk of four cows.

Later, you hire a consultant to analyse why the cow has dropped dead.

ENRON VENTURE CAPITALISM

You have two cows.

You sell three of them to your publicly listed company, using letters of credit opened by

your brother-in-law at the bank, then execute a debt/equity swap with an associated

general offer so that you get all four cows back, with a tax exemption for five cows.

The milk rights of the six cows are transferred via an intermediary to a Cayman Island

Company secretly owned by the majority shareholder who sells the rights to all seven

cows back to your listed company. The annual report says the company owns eight cows,

with an option on one more. You sell one cow to buy a new president of the United States,

leaving you with nine cows. No balance sheet provided with the release. The public then

buys your bull.

A FRENCH CORPORATION

You have two cows.

You go on strike, organise a riot, and block the roads, because you want three cows.

A JAPANESE CORPORATION

You have two cows.

You redesign them so they are one-tenth the size of an ordinary cow and produce twenty

times the milk. You then create a clever cow cartoon image called 'Cowkimon' and market it worldwide.

A GERMAN CORPORATION

You have two cows.

You re-engineer them so they live for 100 years, eat once a month, and milk themselves.

AN ITALIAN CORPORATION

You have two cows, but you don't know where they are.

You decide to have lunch.

A RUSSIAN CORPORATION

You have two cows.

You count them and learn you have five cows.

You count them again and learn you have 42 cows.

You count them again and learn you have 2 cows.

You stop counting cows and open another bottle of vodka.

A SWISS CORPORATION

You have 5000 cows. None of them belong to you.

You charge the owners for storing them.

A CHINESE CORPORATION

You have two cows.

You have 300 people milking them.

You claim that you have full employment, and high bovine productivity.

You arrest the newsman who reported the real situation.

AN INDIAN CORPORATION

You have two cows.

You worship them.

A BRITISH CORPORATION

You have two cows.

Both are mad.

AN IRAQI CORPORATION

Everyone thinks you have lots of cows.

You tell them that you have none.

No-one believes you, so they bomb the **** out of you and invade your country.

You still have no cows, but at least now you are part of Democracy....

AN AUSTRALIAN CORPORATION

You have two cows.

Business seems pretty good.

You close the office and go for a few beers to celebrate.

A NEW ZEALAND CORPORATION

You have two cows.

The one on the left looks very attractive.

InVivo on FDA Commish race: "Rost is probably the one commissioner candidate that scares the bejesus out of pharma"

The Long Campaign for FDA Commissioner (Part 3)

We’ve given you some of our thoughts on the candidates for FDA commissioner in the new Administration in several recent posts (here and here). Today, though, we tackle a bigger question: Why would anyone possibly want this job?

For a position that may well be the most thankless job in health care, an awful lot of people seem to be lining up to be the next commissioner of FDA.

With all the problems at FDA right now—a deeply underfunded agency with a nearly impossible mandate to protect the nation’s food and drug supply—it’s a wonder anyone would want to lead the agency. Add the prospect of contentious Senate confirmation hearings, a low public opinion of FDA, and a constant threat of whistleblowers, and you don’t exactly have your dream job.

But that hasn’t prevented people from wanting to be the next FDA commissioner. While much of the campaigning is taking place behind closed doors, some candidates are choosing to be a bit more vocal. Those individuals tend to fall into two categories; the Peter Rost Category of Candidates and the Steve Nissen/David Kessler Category of Candidates.

On one extreme end of the campaigning spectrum, there’s former Pharmacia marketing executive Peter Rost. As the Pfizer whistleblower over off-label promotion of the human growth hormone Genotropin, Rost is probably the one commissioner candidate that scares the bejesus out of pharma (or at least Pfizer) more than Nissen. Or he would if he had any chance of actually landing the job.

Not only is Rost openly campaigning, he is, in his words, “running” for FDA commissioner as though it’s an open Senate seat. Rost’s personal blog is now dedicated to his campaign run, and he has successfully solicited letters of endorsement from Sen. Sherrod Brown (D-Ohio) and Rep. JoAnn Emerson (R-Mo.).

On the other end of the spectrum, we’ll cite David Kessler. Kessler isn’t sending out press releases expressing his interest in the commissioner post, but he is indicating he’d be open to the job through public appearances. As we reported in an earlier blog post, when asked for his ideal profile for an FDA commissioner, Kessler essentially described himself.

The same goes for Nissen. While Nissen may be the last thing that anyone in industry wants in an FDA commissioner, he is laying out an agenda that sounds quite reasonable: more money for FDA, an end to the missed user fee deadlines, and restoring integrity to the agency. Indeed, we laid out in an earlier post why we think FDA commissioner Nissen wouldn't be the worst thing that ever happen to industry.

But even Nissen recognizes the challenges facing the next commissioner, and has publicly questioned whether anyone would want the job. Here’s what he said at FDC-Windhover’s FDA/CMS Summit last week:

“The problem is in the current environment, getting anybody confirmed looks like it could be really tough. You know what the last bunch of commissioners have gone through. You have to be a masochist to want to do that, and there aren’t a lot of people who would want to do that.”

Of course, in saying someone would have to be a masochist to want the job, Nissen didn’t mention whether he was a masochist. Knowing what we know about Nissen, we'd have to say yes.

image via run100miles.com. nothing particularly masochistic about that, eh?

President Bush attacked with shoes in Iraq

The Pink Martini, China Forbes and Thomas Lauderdale story . . . if you're curious.

From the Guardian:

"We see ourselves as musical ambassadors," says China Forbes. "We're trying to portray a side of America that people don't see. Maybe a bit more intellectual and a little bit more broad, speaking in different languages and travelling the world ... George Bush's America might be isolated and not interested in the outside world, but there are vast numbers of Americans who are not like that."For those in danger of losing hope in America, here is a band who would seem to embody all those liberal ideals that have guided the work of campaigning songwriters from Woody Guthrie to Steve Earle. And yet Pink Martini are most certainly not protest singers, folk singers or progressive country-rockers. Quite the opposite. On one level, at least, they are a retro lounge band, specialising in tuneful, gently quirky easy listening and committed to "putting romance back into music".On stage, the glamorous Forbes is surrounded by men in suits playing grand piano, double-bass, brass and percussion. She starts with unashamedly romantic ballads and breathy, Latin-edged big-band numbers, then veers off to sing in Japanese, Croatian, French, Turkish or Portuguese. "It's certainly not world music," she says. "If pressed, I'd say we are old-fashioned pop in the Frank Sinatra sense, with orchestration. But then there's the whole Latin thing, and all the different languages."This may be easy listening but it's also very clever. In their non-confrontational, gently charming way, Pink Martini are promoting their view of an alternative America, either by displaying their delight in other languages and travel, through Thomas Lauderdale's explanation that "this song was written with some drag-queen friends", or (far more directly) by his regular onstage apologies for the re-election of George Bush. In the process, they have become unexpected celebrities, packing out the Festival Hall in London, playing in Beirut or Taiwan, and becoming cult heroes across Europe, where they have sold 600,000 albums. Not bad going for a band with no major American record label behind them, and who operate from Portland, Oregon.Their unlikely story started at Harvard. Forbes was studying visual arts with the aim of becoming a painter, and met up with Lauderdale, a history and literature student who played piano in the Boston clubs. They both came from multi-racial backgrounds. Forbes had "a black mum and a white French-Scottish dad", while Lauderdale was "adopted, and a mystery Asian - he might be half-Chinese or something, but doesn't want to know". The duo discovered they had a shared interest in opera. Lauderdale was a classically trained pianist, and at Harvard he would take out Puccini and Verdi arias from the library "and we went into the common room at night, where he would play the grand piano and I would sing in the dark. Nobody was listening but we had this cute bond that was our secret little thing."After college, the two parted. Forbes had taught herself to sing not just by practising opera but "by listening to Donna Summer, my first teacher, then Stevie Nicks and Joan Armatrading". She spent two years as an off-Broadway actress, then became a professional musician. "So I started writing songs and playing guitar in a Sheryl Crow style, and had a band and put out a solo album."Lauderdale settled in Portland and decided he either wanted to become a concert pianist or run for mayor, and began organising political fund-raisers. There was one big problem. He hated the music that was played at such events, and so decided to form his own band.Finding suitable personnel was more difficult, and he began ringing his old Harvard friend China Forbes, begging her to join. "He called me desperately, asking if I could come to Portland, and I didn't even know where it was. But he was very persuasive." For three years, Forbes commuted between New York and Portland "when he really needed me", and then she too moved to this city "hidden away from America", and committed herself full-time to the band "though I had never imagined Pink Martini as a style I would do".The band's unlikely sound evolved from a fusion of Forbes's work as a singer-songwriter and Lauderdale's musical obsessions. They write the lyrics and music between them. "I love writing melodies but he'll put in much more interesting chord structures, and tempers my autobiographical leanings, which is about relationships and heartbreak, and helps me to be more sweepingly romantic."As for the Latin influence, this came from Lauderdale's love of old films and Spanish director Pedro Almodovar. "The sexiness of Latin music really appealled to Thomas, and he wanted to apply his classical background to a melange of Latin and then jazz." Slowly, the band developed a cult following. In Portland, they played fundraisers, from cleaning the Oregon river to playing for various politicians, including Forbes's "distant cousin" John Kerry.Then they began to travel. Forbes had appeared in a film, "playing a straight part in a drag-queen musical", and a song from her earlier singer-songwriter career was used on the soundtrack. She was asked to sing it at a party at the Cannes film festival, but decided instead to take Lauderdale with her to play some Pink Martini songs. The following year, they took the full Martini band to Cannes "on our own dime, to see what happens" and ended up playing at celebrity parties and then saw their albums released across Europe. In France, the quirky chanson Sympathique (Je Ne Veux Pas Travailler) became a best- seller. "Everyone there knows it," says Forbes. "It's crazy. We recorded it like an old radio song and I was told I sound like Josephine Baker because the accent is different, better than most Americans, but not quite French." So why have they become so popular in Europe? "Maybe because we aren't a typical American band. They can claim us as their own, then they find we are American, and it's a nice surprise. And we're very anti-Bush, so maybe they like that ..."Back in the US, they have begun to expand. They started as a five-piece, now it's up to 10 or 12, depending on the string players: "Thomas always wants the music to be bigger." An experimental collaboration with the Oregon Symphony Orchestra led to more orchestral bookings, right across the US. Along with all of that, Forbes has now revived her solo career, as a sideline, and is recording a solo album.She has had a bizarre and brilliant career, but acts as if it wasn't really happening. At the Festival Hall earlier this month, she came off stage and walked out into the hall to chat to friends. "It's weird," she says. "I don't spend hours thinking how we come across. I just sort of do my part and be myself."· Pink Martini's single Lilly is out on April 25 on Wrasse Records.

Pink Martini: If you've never heard of them you've missed out on life.

Una Notte a Napoli



Hang on Little Tomato



Lilly



Amado Mio

VOTE VOTE VOTE: John Mack opens online poll for FDA Commissioner for one more day!

After having closed the poll, John Mack decided to open it again . . . here's your chance!

He writes:

"OK. One more day for Rost Blog readers to vote for their choice (do not use the inactive link in the post, use this link: As Peter mentioned according to the results of an ongoing survey of consumers, healthcare professionals, government agency staffers, and drug industry executives, Steve Nissen AND Peter Rost are neck-and-neck in first place.

I invite everyone to take the survey and vote for your choice here: http://tinyurl.com/5dqx25

THE SURVEY ENDS TONIGHT AT MIDNIGHT, EASTERN US TIME!

Your response is anonymous unless you provide contact information for attribution. You can also write in your own choice.Results of this survey will be published in the next issue of Pharma Marketing News.

Tell the drug industry who should be the next FDA Commish.

Vote for your choice here: http://tinyurl.com/5dqx25

And here are the result right now.

Steve Nissen loyals suddenly swamp FDA Commissioner online vote . . .

Over the last day the number of people voting have jumped from 300 to 400 . . . and the recent votes are coming in for Steve Nissen from the Cleveland Clinic which means that he now has the same number of votes as yours truly.

So go to Pharma Marketing and vote for your favorite candidate!

Here you can view latest survey results for who should be the new FDA Commissioner. Right now Nissen is head to head with Rost.

Colbert vets the Obama vetter, Cliff Sloan from Slate

Cliff Sloan was the publisher of Slate magazine and is now the vetter for the Obama administration. Colbert asks "who vets the vetters?" and if Mr. Sloan would take responsibility for the following articles . . . Mr. Sloan says he's proud to stand behind everything in Slate . . . saying Slate covers a wide variety of subjects:

A Sex Toy a Day Keeps the Doctor Away.

My Other Vagina.

Is Maureen Dowd necessary?

And some journalists (hello Jim Edwards!) have asked if my stories are too racy to become FDA Commish!

Don't think so. They're almost conservative compared to the stories Mr. Sloan stands proudly behind!

Here is part 2 of the interview with Cliff Sloan:

The Colbert ReportMon - Thurs 11:30pm / 10:30c

Stephen's Vetting Process - Cliff Sloan Pt. 2

Colbert at Christmas
Colbert Christmas DVD

Green Screen
Bill O'Reilly Interview

Revenge against tow trucks.

BBC: The compressed air car.

The Detroit Bailout.

The Bush Legacy

Should a doctor in the UK be warned a year earlier for a dangerous drug than a doctor in the US?

Of course not. But that is exactly what happens today, and vice versa, because of provincialism at regulatory authorities in both US and Europe.

The FDA should work together with the European regulatory authority, EMEA, and could inform US doctors when a major warning goes out in Europe, if the FDA is not yet ready to issue the same warning, and let them know what the FDA's schedule is. At a minimum this would keep US doctors informed. And it doesn't cost more than printing the letter.

It is time for change at the FDA and to start protecting the American public.

Another academic as FDA Commissioner won't create change. Doing the same thing and expecting a different result is the definition of insanity.

Placebo Alarm: Rost: FDA und EMEA sollten verstärkt zusammenarbeiten

[Use Google Translate if you don't speak German]

Rost: FDA und EMEA sollten verstärkt zusammenarbeiten

Strappato von Stationäre Aufnahme ist ein kleiner journalistischer Scoop gelungen: Er interviewte Peter Rost, der derzeit als Kandidat für die US-Gesundheitsbehörde FDA gehandelt wird.

Der Ex-Pharmaindustriemanager, hatte über Praktiken in der Branche ausgepackt und über seine Erfahrungen ein Buch mit dem bezeichnenden Titel "The Whistleblower" veröffentlicht - und er ist Blogger.

Eine der Kernaussagen in dem Kurzinterview strappatos: FDA und die europäische Arzneimittelbehörde EMEA sollten enger zusammenarbeiten. "Der gegenwärtige Provenzialismus ist naiv", sagt Rost. Häufig bekämen Ärzte auf einem Kontinent eine Warnung zu einem Arzneimittel ein Jahr vor den Ärzten auf dem anderen. Er sehe keinen Grund, warum ein Arzt in Deutschland oder Großbritannien ein Jahr früher vor gefährlichen Nebenwirkungen gewarnt werden sollten als ein Arzt in den USA.

Das ganze Interview exklusiv bei Stationäre Aufnahme.

"FDA und EMEA sollten verstärkt zusammenarbeiten" - Interview mit Peter Rost

[Use Google Translate if you don't speak German]

From

"FDA und EMEA sollten verstärkt zusammenarbeiten" - Interview mit Peter Rost

Wenn es um den Posten des neuen Chefs der FDA (US-Behörde für Arzneimittelaufsicht) geht, wird immer wieder auch Peter Rost als möglicher Kandidat genannt. Seine Bewerbung wird unter anderem von einem Senator und einem Abgeordneten des Repräsentantenhauses unterstützt.

Eine Berufung des ehemaligen Pharmaindustriemanagers würde eine Zäsur bei der Leitung der Mammutbehörde bedeuten, deren Commissioner, so die Bezeichung des Amts, bisher aus der Gesundheitsverwaltung und Wissenschaft kamen. Rost war Vize-Präsident für Marketing bei Pharmacia. Als Whistleblower zeigte er das illegale Marketing des Wachstumhormons Genotropin und Unregelmässigkeiten in der Bilanzierung bei Pharmacia an. Bei der Übernahme von Pharmacia hat Pfizer den unbequemen Manager kalt gestellt. Rost hat, trotz Pfizers Grossaufgebots an Anwälten, die meisten Klagen gegen seinen früheren Arbeitgeber gewonnen. Die Erlebnisse und Erfahrungen schrieb er in einem Sachbuch und einen Thriller nieder. Der Pharmakritiker ist heute als Autor, Redner, Gutachter, Experte tätig. Als Blogger hat er in den letzten 2 Jahren weiter unethische und illegale Praktiken der Pharmaindustrie angeprangert und aufgedeckt.

Grund für mich, Peter Rost einige Fragen zu seiner Bewerbung und der Rolle der FDA aus seiner Sicht zu stellen. In dem Interview verweist er darauf, dass die FDA eine starke Führung braucht, mit Erfahrung in der Leitung grosser Organisationen. Bei der anstehenden Gesundheitsreform sieht er die Hauptaufgabe der FDA darin, das Vertrauen der Bürger in die Sicherheit von Arzneimitteln wiederzugewinnen. Die Zusammenarbeit mit der europäischen Zulassungsbehörde EMEA könnte nach Meinung von Peter Rost dazu beitragen. Den derzeitigen Provinzialismus hält er für naiv. Er könne sich als Frühwarnsystem vorstellen, dass wenigstens die Aufsichtsbehörden die Ärzte und Fachkreise darüber informieren, dass die jeweils andere Behörde Entscheidungen gefällt hat. In Hinblick auf die US-Gesundheitsreform hält Peter Rost es für nicht unwahrscheinlich, dass der Staat in den USA mit dem Programm Medicare zukünftig einen höheren Anteil der Arzneimittelausgaben übernimmt. Er sieht gleichwohl das Problem des möglichst effizienten Einsatzes der begrenzten Mittel. Daher müssten pharmakoökonomische Bewertungen Teil des Systems werden.



Die bisherigen Commissioner der FDA kamen aus der Politik, Verwaltung oder Wissenschaft. Welche zusätzlichen neuen Impulse sollte ein Commissioner mit Erfahrungen in der Pharmaindustrie bei der Bewältigung der zukünftigen Aufgaben der FDA geben?

Peter Rost: This is a key change and also a key challenge. I think there's a reason it is mostly business people running scientific corporations such as big pharma, the skill sets are different than those needed as a scientist in a lab or clinical setting. For the same reason I think the FDA would benefit from someone with former P&L responsibility who has focused on managing large organizations effectively and not just science. The FDA has a ton of great scientists, what they need now is great leadership. That's what I would expect to contribute. The fact that I also have an M.D. is simply a bonus.

Welche relevante Rolle könnte die FDA bei Reform des US-Gesundheitswesens spielen?

Peter Rost: The FDA is there to ensure safe and effective drugs and food supply. Trust has broken down and the FDA is no longer regarded as well as it used to be. Clearly the FDA appears to have been slow with warning the public for various dangerous drugs and perhaps food products. It needs to be easier to take a drug off the market than getting it approved for marketing. I would take a top down look at resources and work with the agency to restore its credibility and to ensure a better balance between efforts to approve new drugs and protecting the public against dangerous ones.

Die FDA und die EMEA bewerteten in der Vergangenheit Sicherheit und Nebenwirkungen von Medikamenten zum Teil unterschiedlich. Könnte es Bedarf für eine verstärkte Zusammenarbeit geben?

Peter Rost: I agree. The current provincialism is naive. We frequently see doctors on one continent receiving a warning letter a year before doctors on another continent. I see no reason why a doctor in Germany or the UK should be warned a year earlier about a dangerous side effect, than a doc in the US, yet that is exactly what happens today and the companies involved are unfortunately not helping. I could envision either agency at least notifying its healthcare professionals that a decision has been made by the other agency and informing them that they are still studying this, so an early warning system. That way we cut through the bureaucracy.

Zur Begrenzung der steigenden Arzneimittelausgaben setzen in Europa die veranwortlichen Politiker ihre Hoffnung auf auf pharmakoökonomische Bewertungen und HTA (health technology assessments). Könnte das auch für die USA eine Lösung sein?

Peter Rost: Most definitely. It surely wouldn't be popular, drug companies today fear UK's NICE system, and would do what they can to work against this, but at the end of the day, we're dealing with limited resources that need to be spent in a manner that produces the greatest public good. It is not unlikely that Medicare in the US will be given a larger role in paying for drugs in the future, and to do this effectively pharmaeoeconomic evaluations would have to be part of the system.

--
Here are the questions for the english-speaking audience:
Q1: The previous commissioners had been come from policy, administration or science. Which additional fresh stimulus should be giving a commissioner with experiences in the pharmaceutical industry the FDA to cope with the future tasks?
Q2: Which considerable part could the FDA play in the reform of the US health care system?
Q3: In the past the FDA and the EMEA have assessed safety and side effects of drugs partly differently. Might there the need for greater collaboration?
Q4: For restriction of rising expenditures for drugs responsible politicians in Europe place their hopes in phamacoeconomic evaluations and HTA. Could it be a solution also in the USA?

[Ausland]

PharmaGossip: Rost's FDA push makes PharmaTimes

Story . . . Rost's FDA push makes PharmaTimes

Pharma Times: Current FDA leaders “have lined their pockets,” Obama told

Pharma Times
08 December 2008

A leading US politician has told President-elect Barack Obama that “a complete change” is needed in the leadership of the Food and Drug Administration (FDA), as the agency’s current senior staff are “too close with the industries they regulate, creating a question of whom they are working for.”

“I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA,” writes Bart Stupak, the Democratic Representative for Michigan, in a letter to Mr Obama released last Friday. While he names no agency officials in his letter, Rep Stupak’s plea to the incoming president is being widely seen as an attempt to counter support for Dr Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research (CDER), to be the next Commissioner, or to take the post on an interim basis, when Dr Andrew von Eschenbach steps down.

Commissioner von Eschenbach, who has held the post since September 2005, has made no announcement about his future plans, but his resignation is expected shortly.

Rep Stupak has been a member of the House Energy and Commerce Committee for 12 years, during which time he has been involved in “numerous” investigations of the FDA, he tells Mr Obama. Also, for the past two years has chaired the panel’s oversight and investigations subcommittee, which has primary oversight of the FDA, and: “since February 2007, I have held 16 hearings into the inadequacies of the FDA to protect Americans from unsafe food, drugs and medical devices. The subcommittee’s investigations revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses. The agency has abandoned its core mission of protecting Americans from contaminated food, unsafe drugs and medical devices,” he writes.

“A new Commissioner or Interim Commissioner must bring the agency back to the forefront of science, integrity and transparency,” Rep Stupak urges the incoming president.

CDER director Dr Woodcock is widely reported to be the industry’s choice to lead the Administration. This fact alone could be enough to wreck her chances of landing the post, and her 22 years at the agency also means that she is not regarded as a likely force for reform.

Pfizer whistleblower says: “I want to be FDA Commissioner
Meantime, a new name in the frame for FDA Commissioner is Peter Rost, the controversial former Pfizer vice president who is currently involved in long-running whistleblower litigation against his former employer. He has made public his interest in the agency top job and is being supported by Democrat Sherrod Brown, the junior Senator from Ohio, with whom he has campaigned for imports of cheaper prescription drugs from Canada, and by Missouri Democrat Representative Jo Ann Emerson. Rep Stupak is also reported to be backing Mr Rost.

By Lynne Taylor

Pharma Manufacturing: Two Congressmen Endorse Peter Rost for FDA Commissioner

Pharma Manufacturing
Mon, 12/08/2008

I thought the whole "Rost for FDA Chief" that surfaced after John Mack's recent poll was a joke, but then read that Dr. Rost, who emerged as the favorite candidate in that poll, has received the backing of at least two members of Congress.

Wouldn't it be interesting to see an FDA headed by an industry gadfly? Dr. Rost, as an M.D., is qualified for the title. However, he has spent most of his career in marketing, so he's been distanced from the science, which is changing rapidly and becoming quite complex, especially in areas such as followon biologics and pharmacovigilance....(but how many recent FDA chiefs have been on top of all the science. In theory, Chief Rost could delegate all that, preferably to someone like Janet Woodcock).

But if Peter Rost as FDA chief seems a bit of a stretch, I could easily see him appointed by the Agency as special advisor on pharma marketing practices, a sort of pharma marketing ethics czar. (If he gave up seeking remuneration from his lawsuit.)

As he's said all along, Rost doesn't hate the industry....although one wonders how objective he'd be in decisions involving Pfizer.

Whatever comes of this latest news, Dr. Rost has become the "Madonna" of whistleblowers, changing his image and strategy, staying in the public eye and keeping people interested in what he has to say.

Pasted below, an article by Lee Howard, published in Friday's edition of The Day.
-AMS

If Pfizer Inc. were to describe its worst nightmare, it might very well be seeing former company whistleblower Peter Rost become commissioner of the U.S. Food and Drug Administration.

So guess who is actively seeking the FDA's top post?

Rost, a former Pfizer vice president who turned whistleblower after he alleged that a subsidiary of the company started promoting off-label uses of various drugs, not only is in the running for FDA commissioner, but he has at least two congressmen in his corner.

This week, the Web site Pharmalot reported that U.S. Sen. Sherrod Brown, D-Ohio, would be sending a letter of recommendation for Rost as well as several other candidates for the post. Rost also has picked up support from U.S. Rep. Bart Stupak, D-Mich., chairman of the Oversight and Investigations subcommittee of the House Energy and Commerce Committee, who has been involved in many investigations of the FDA.

"I encourage you to seek meaningful reform of the FDA, which begins with a complete change in the FDA's leadership," Stupak wrote in a letter to president-elect Obama endorsing Rost's candidacy.

Rost said he is looking for a shakeup of the FDA, including a reorienting of the agency's priorities from serving the drug industry to helping American citizens.

"That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling (is) revised in a more timely manner," Rost said in an interview this week with eDrugSearch. com, which endorsed his candidacy.

Some of Rost's most controversial stances include his views on reimportation of drugs from Canada, which he approves, and his opposition to direct-to-consumer advertising.

"DTC advertising is not part of a 'free market' - it is part of manipulation of consumers who don't know better and doctors who give the patient whatever they ask for," Rost said.

Pfizer fired Rost in 2005 after it became known that the marketing executive's allegations about off-label promotion of drugs had led to a criminal investigation against the company.

Rost went on to write a bestseller about his experiences, titled "The Whistleblower: Confessions of a Healthcare Hitman," which detailed payouts to doctors, marketing drugs to children and various illegal and unethical activities he said he witnessed.

My position on federal preemption of state law as it relates to the FDA.

Federal preemption generally refers to the effect that federal law has on a conflicting or inconsistent state law. For instance, express preemption exists if a federal statute explicitly states that it preempts state law.

When it comes to the abuse of federal “preemption” to eviscerate state laws providing stronger public health and safety protections, replacing them with federal laws that favor corporate special interests, I'm strongly against this.

The FDA and other state agencies are never all knowing, with a full set of facts, and can't and shouldn't play God. Any legal process may bring forward facts that were unknown by a federal agency, and hence, an FDA decision should not preempt i.e. a lawsuit in state court.

I think that federal preemption of many state-court lawsuits related to FDA-approved products shields drug and device companies inappropriately when they market unsafe or mislabeled products.

Today the FDA and the industries it regulates are too closely tied together for the agency to be counted on to protect the public health adequately. This is the reason the public trust in the FDA needs to be restored.

For more on my positions on issues related to the FDA, please see my interviews with eDrugSearch and BNet.

The Day: "Pfizer whistleblower in running for top FDA post"

And . . . if you haven't voted yet in the online poll, go to Pharma Marketing and vote for your favorite candidate! Here you can view latest survey results for who should be the new FDA Commissioner.


Pfizer whistleblower in running for top FDA post
Former Pfizer VP Rost finds support for job

By Lee Howard
Published on 12/6/2008
The Day, CT

If Pfizer Inc. were to describe its worst nightmare, it might very well be seeing former company whistleblower Peter Rost become commissioner of the U.S. Food and Drug Administration.

So guess who is actively seeking the FDA's top post?

Rost, a former Pfizer vice president who turned whistleblower after he alleged that a subsidiary of the company started promoting off-label uses of various drugs, not only is in the running for FDA commissioner, but he has at least two congressmen in his corner.

This week, the Web site Pharmalot reported that U.S. Sen. Sherrod Brown, D-Ohio, would be sending a letter of recommendation for Rost as well as several other candidates for the post. Rost also has picked up support from U.S. Rep. Bart Stupak, D-Mich., chairman of the Oversight and Investigations subcommittee of the House Energy and Commerce Committee, who has been involved in many investigations of the FDA.

”I encourage you to seek meaningful reform of the FDA, which begins with a complete change in the FDA's leadership,” Stupak wrote in a letter to president-elect Obama endorsing Rost's candidacy.

Rost said he is looking for a shakeup of the FDA, including a reorienting of the agency's priorities from serving the drug industry to helping American citizens.

”That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling (is) revised in a more timely manner,” Rost said in an interview this week with eDrugSearch. com, which endorsed his candidacy.

Some of Rost's most controversial stances include his views on reimportation of drugs from Canada, which he approves, and his opposition to direct-to-consumer advertising.

”DTC advertising is not part of a 'free market' - it is part of manipulation of consumers who don't know better and doctors who give the patient whatever they ask for,” Rost said.

Pfizer fired Rost in 2005 after it became known that the marketing executive's allegations about off-label promotion of drugs had led to a criminal investigation against the company.

Rost went on to write a bestseller about his experiences, titled “The Whistleblower: Confessions of a Healthcare Hitman,” which detailed payouts to doctors, marketing drugs to children and various illegal and unethical activities he said he witnessed.


l.howard@theday.com

Here's why hiring another gullible academic as FDA Commish is insanity.

The debate about who should become the next FDA Commissioner continues.

For those who want to know my qualifications may I humbly suggest a review of my CV over at http://drugexpertwitness.com/.

I think my past performance speaks for itself.

It is time to get a business executive who truly understands the drug business, that the FDA is supposed to regulate, to run the FDA.

After all, yet another academic is no match for Big Pharma. If this concept worked, the FDA's reputation wouldn't be in tatters right now and Chairman Stupak wouldn't have written to President-Elect Obama that "The agency has abandoned its core mission of protecting Americans from contaminated food, unsafe drugs, and medical devices."

Insanity: Doing the same thing and expecting different results.

And the winner in Pharma Marketing's online poll for FDA Commissioner is . . .

Here you can view latest survey results.

I'm honored and greatful for the result, thank you everyone who voted!

Dr. Peter Rost came in number one with 22.6% of the vote.

He was followed by Dr. Steve Nissen who took second place with 14.4% and Dr. Susan Wood with 13.5%.

Bloomberg News reports that friends of the pharmaceutical industry--in particular, PhRMA, the trade lobbying group--have put in a bid for Dr. Janet Woodcock; she came in fourth with 11.6% of the vote.

It should be noted that out of those who voted, 79% said they were neutral, somewhat supportive or very supportive of the drug industry.

U.S. Congressman Bart Stupak asks President-Elect Obama "not to appoint any current senior FDA employee as Commissioner"

Click on image to read.

Do you want to support Peter Rost for FDA Commissioner?

If so, I now have the email addresses to some of the key people on President-Elect Obama's transition team, so you can contact them directly.

But I can't just post them here, since that wouldn't be polite.

So just write me a line, (click for my email) and tell me who you are, and why you support Peter Rost for FDA Commissioner.

And I'll send you the email addresses for the transition team.

There are enough people out there who may not want me to get the job, so I do need your support.

BNet: Q&A: Peter Rost on His Quixotic Bid to Become Obama’s FDA Chief

Story and Q&A over at BNet.

Pharma Blogosphere: Rost for FDA Commish Gains Support from Senator, Congresswoman, and Blogger

Full story over at the PharmaBlogoSphere.

BioJobBlog: Peter Rost for New FDA Commish?

Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator Sherrod Brown, an Ohio Democrat, is nominating several candidates for the post and one of them is Peter Rost, MD!

For those of you who may not know Dr. Rost, he is a former Pfizer marketing executive who blew the whistle on some alleged marketing and sales violations at the drug maker. His court case is working its way up the judicial ladder and Dr. Rost apparently has the upper hand so far.

Pfizer fired Dr. Rost “for cause” after a raucous, public skirmish that went on for almost 2 years. After he left Pfizer, he wrote a book, worked for the Huffington Post and started his own blog, which currently has a post about his candidacy for the FDA Commissioner job.

I first met Peter when he was still at Pfizer and I was organizing a meeting on drug reimportation (he is an ardent supporter). He agreed to talk at the meeting but unfortunately the conference was canceled for one reason or another. I have no doubt that he has the medical credentials and business acumen to handle the job. The one thing that worries me is his penchant for self promotion—something that is not a desirable trait in an FDA Commissioner.

Time will tell. Personally, I would like to see Dr David Kessler come back and run the agency—another whistleblower (at UCSF) who ran the agency from 1990-1997 and did an outstanding job. The way things are going at FDA these days maybe being a whistleblower ought to be one of the requirement for the job!

Until next time…

Good Luck and Good Job Hunting

From BioJobBlog

Senator Recommends Peter Rost As FDA Commish

Ed Silverman over at Pharmalot has the story.

Pharma Marketing on the battle to become FDA Commish

The story is called: Byrd Loves Rost and Scores!

And . . . just for the record, Pharma Marketing endorses Susan Wood for FDA Commissioner.

U.S. Senator Sherrod Brown and U.S. Representative Jo Ann Emerson support Dr. Rost for FDA Commissioner.

Maybe the Jig Is Up"

Health Beat
by Niko Karvounis

Yesterday Reuters reported that, in comments at a Financial Times conference in London, a top executive at Roche Pharmaceuticals condemned direct-to-consumer advertising as a disaster. “Direct-to-consumer promotion [of drugs] was the single worst decision for the industry," said William Burns, Roche’s head of pharmaceuticals, to conference attendees. "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility,” he continued.

Burns’ despondency is understandable: if ever there was a time that the prescription drug industry needed credibility, it’s now. For the first time in recent memory, drug companies are facing the prospects of an end to their free ride of unregulated profiteering. There are already rumblings that both the Obama Administration and the Democratic Congress want to stack up a series of clean legislative victories by going for “low-hanging fruit”—bipartisan, popular initiatives that will pass easily—and there are few juicier targets than Big Pharma. 


A few days ago, The Chicago Tribune reported that President Obama will likely push for “cheaper copies of expensive drugs derived from biotechnology,” will let Medicare “negotiate drug prices directly with drug companies,” and will try to make “it legal for pharmaceuticals to be imported into the U.S.” In other words, Obama wants to make drugs cheaper for patients, and thus impact drug companies’ bottom line. According to David Dranove, professor of health industry management for Northwestern University's Kellogg School of Management, these changes have been “hanging there [in Congress] for some time and will be easy sells and easy to get through."

For its part, the industry knows that it’s got a big, fat target on its back. During the presidential election, drug companies were torn over which candidate to support, mostly because they couldn’t decide who hated them less. Even John McCain boasted—not untruthfully—that he repeatedly “took on the drug industry” over the course of his career.

The comparable distastefulness of both candidates led to a development that hasn’t happened in almost twenty years: the prescription drug industry gave to the Democratic and the Republican presidential candidate in almost equal amounts (usually pharma goes for the GOP). “Both [Obama and McCain] blame big drug companies for high prices and reduced innovation,” sighed one industry insider. “In either case, we should expect more price negotiation and re-importation [of drugs].” Translation: the honeymoon is over.

Indeed, momentum for meaningful changes to how—and how much—our system pays for prescription drugs seems to be building. Today The New York Times published an article about how the British model of institutionalized comparative-effectiveness research is inspiring reformers and policymakers around the globe. Meanwhile, here in the states, there’s already a comparative-effectiveness bill in Congress—and it even has the support of the Pharmaceutical Research Association.

This is compelling stuff: by definition, comparative-effectiveness research compares the effectiveness of different treatments, which means someone’s product is going to come out the loser. The fact that the pharmaceutical industry is supporting comparative-effectiveness research, even at this early stage, strongly suggests that industry knows that our health care status quo is unsustainable.

Another sign that Congress is likely to tilt the status quo against drug companies is the recent election of Rep. Henry Waxman (D-Calif.) to chair the House's Energy and Commerce Committee, which has oversight of the Food and Drug Administration (FDA). Waxman is famous (or infamous) for being an energetic watchdog, and has a long history of taking on the prescription drug industry, specifically direct-to-consumer (DTC) advertising: in the past, Waxman has proposed a mandatory FDA approval of all DTC ads before airing and a two- to three-year moratorium on ads for new drugs.

Like Waxman, Obama has DTC advertising in his sights, although the president-elect has been somewhat vague in defining his intended actions. Possibilities include Waxman’s proposals, generally more restrictive advertising standards, or limiting DTC advertising’s tax deductibility as a business expense. (Given all these possibilities, one gets the sense that Burns’ open criticism of DTC ads could be of the “if you can’t beat ‘em, join ‘em” variety).

The final piece of Big Pharma’s nightmare is an FDA with teeth—something that looks to become a reality under Obama. The folks supposedly under consideration for FDA commissioner read like a list of the drug industry’s greatest nemeses. Amongst the contenders is Dr. Steven Nissen, a Cleveland Clinic cardiologist who first made the link between Vioxx and an increased risk of heart attacks and strokes (much to the dismay of the drug’s manufacturer, Merck). Nissen also blew the whistle on Pargluva, a diabetes drug produced by Bristol-Meyers Squibb that increased risks of cardiovascular death, and publicly insisted that Vyotrin, a blockbuster cholesterol drug, only be used “as a last resort.”

Dr. Joshua Sharfstein, another possible FDA commissioner, is also bad news for drug companies. Sharfstein has served as a health policy advisor to Rep. Waxman and led the campaign to ban over-the-counter cold medicine for children under two. His efforts eventually forced the industry to “voluntarily” pull from the shelves all medicine that it claimed was safe for young kids. Also in the running is Peter Rost, a former Pfizer executive who’s become a vocal proponent of drug re-importation and increased price competition amongst prescription drugs—and who has been publicly lauded by Obama chief of staff Rahm Emanuel. 


One way or another, it looks like the prescription drug industry is in for a bumpy ride—or, to quote a (perhaps overly-dramatic) AdAge blog post: “Obama [is] already turning into a nightmare for Big Pharma.”

Let’s hope that this is the case. As we’ve noted oh-so-often here on Health Beat, the industry’s practices are consistently alarming, ranging from distortions of clinical data to a deluge of DTC advertisements that work hard to convince relatively healthy patients that they’re sick. All this scamming costs a whole lot of money: our per capita expenditure on pharmaceuticals is 92 percent higher than the average for OECD countries, and DTC advertising increased by 330 percent from 1996 to 2006, topping out at a whopping $4.2 billion that year. But patients get very little bang for the buck—and it’s time that this equation was changed. The new political establishment looks willing to explore the possibilities for doing just that.


Also relevant is the recession, which will inevitably change the political calculus of prescription drugs in the U.S. Like everyone else, drug companies will have to tighten their belts, which means that they’ll have to be more selective in their PR campaigns and legislative battles. Politicians will also come under increased pressure to take a more populist stance on the prescription drug issue. After all, backing up Big Pharma during the heady 1990s was one thing; but over the next few years, supporting drug company interests will increasingly mean keeping drug prices too high for struggling Americans to afford their medications. That’s not a choice that any politician wants to make.

The prescription drug industry will have to make some hard choices under an Obama Administration. The industry’s best hope is to recognize that its business practices are unsustainable and must be revised as our nation’s problems grow more severe, just as Burns did when he declared that the “marginally-different-and-market-it-like-hell model [of prescription drugs] is over” at the FT conference.

Let’s hope he’s right.

If you want Peter Rost as the next FDA Commissioner, this is what you can do.

The selection of a new FDA Commissioner takes a lot of consideration. It is likely that various Members of Congress who may have an interest in the outcome suggest candidates that they think may be suitable.

So key is to be one of the names they propose.

And that's where you can make a difference.

There is a web site that makes it very easy to write to the staff of any Congressman or Senator and it is called Outsource Congress.

Simply go there, leave "State" blank and select "House and Senate," then put in the name of the individual you want to contact to say that Peter Rost should be the next FDA Commissioner.

Trust me, it works, if enough people write in, and the system is automatic so your email will open by itself when you click on "Staff." In the "to" line you can for instance put in your own email address, that way you get all the staff bcc:d on your communication.

And, you can select Barack Obama, as well as new White House chief of staff Rahm Emanuel, Senator Byron Dorgan, Senator Bernie Sanders, Representative James Langevin, Representative Marion Berry, Representative Rosa DeLauro, Representative Jo Ann Emerson and Representative Dan Burton.

All of them as well as Senators and Representatives from your own state may be willing to listen . . .

So what are you waiting for?

Go to Outsource Congress and make your voice heard!

Q&A with Dr. Peter Rost, eDrugSearch.com’s choice for FDA commissioner

Q&A with Dr. Peter Rost, eDrugSearch.com’s choice for FDA commissioner

December 3rd, 2008

eDrugSearch.com offers news and advocacy for online prescription drug consumers. Subscribe to our blog's RSS feed.

It should come as no surprise to readers of this blog that we are delighted about the prospect of a new FDA commissioner in 2009 — one who we hope will put the interests of the people above those of large pharmaceutical companies.

We have also been pleasantly surprised to see the groundswell of public support for Pfizer whistleblower Dr. Peter Rost for the FDA’s top job. A clear industry outsider like Dr. Rost might seem a longshot to ultimately win the job — but then again, Obama was a longshot to win the presidency. And there are these three hopeful signs:

1. Dr. Rost is blowing away the competition in the voting at John Mack’s influential Pharma Marketing Blog.

2. President-elect Obama’s chief of staff is a big fan of Dr. Rost.

3. Dr. Rost himself has jumped on the bandwagon, renaming his blog “Peter Rost for FDA Commissioner”!

Today, eDrugSearch.com officially endorses Peter Rost for FDA commissioner. We think he would bring the changes the agency so desperately needs.

On the occasion of our endorsement, Dr. Rost agreed to answer a few questions about how he would handle the commissioner’s job. He has some insightful comments on topics ranging from Canadian drugs to DTC advertising. Enjoy —

eDrugSearch.com: In the 1970s, the FDA had one of the highest public approval ratings among government agencies. Today, the agency’s reputation is a mess. What went wrong?

Dr. Rost: Same reason Wall Street’s reputation used to be great and is now a mess; they screwed up. The FDA is there to protect the public health, both by approving life-saving drugs and taking dangerous drugs off the market. They got too focused on approval and lost out on protecting the public against dangerous drugs (i.e. Vioxx); as a result we’ve had a number of scandals when the FDA has been perceived as being way behind the eightball.

eDrugSearch.com: What are the first three actions you would take as FDA commissioner, and why?

Dr. Rost: It is really impossible to answer without first having had a chance to evaluate the agency from the inside. In general terms, however, I’d like to reorient the FDA to focus on its primary customers . . . American citizens, instead of primarily serving the drug industry. That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling revised in a more timely manner. Both these objectives should be equally important.

I would also want to ensure that hundreds of unapproved drugs that are sold illegally as prescription drugs would be taken off the market, and that reimportation of drugs would become legal and regulated and appropriate safety measures taken to protect the public.

Finally, I’d want to bring the kind of internal and external accountability that normally exist within private corporations to a government agency and work for limitation of direct-to-consumer advertising, which is counter productive to efficient healthcare.

eDrugSearch.com: Are there concrete steps the FDA commissioner can take — directly or indirectly — to help reduce the cost of prescription drugs for American consumers? If so, what are these steps and how would they impact drug prices?

Dr. Rost: Support legalized and regulated reimportation of drugs, which would increase price pressure.

eDrugSearch.com: What is your view of the Wyeth v. Levine case? How do you believe the Supreme Court should rule and why?

Dr. Rost: My view is that no government agency, including the FDA, should be considered the equivalent of “God.” An FDA decision or lack of decision shouldn’t preempt a legal challenge and an FDA decision or lack of decision shouldn’t be used as a legal shield. The FDA doesn’t know everything, doesn’t have all information, only what it receives from drug companies and doctors . . . quite frankly, a decision in favor of preemption would be a disaster for American consumers.

eDrugSearch.com: What should the FDA do about direct-to-consumer drug advertising? Is there a role for consumer advertising of prescription medications — and if so, what should that role be?

Dr. Rost: I used to be in favor of DTC and a “free market” but a free market requires informed consumers. Most of them don’t have medical degrees; hence, most of them are not qualified to judge and make decisions based on DTC advertising and, hence, DTC advertising is not part of a “free market” — it is part of manipulation of consumers who don’t know better and doctors who give the patient whatever they ask for. DTC advertising is not in the best interest of evidence-based healthcare or the American consumer.

eDrugSearch.com: Are there ways the FDA can leverage Health 2.0 and other technologies to do its job better?

Dr. Rost: Yes. We are still in the Stone Age when it comes to optimizing use of eHealth, sharing information and medical collaboration and education. Too big a topic to get into detail.

eDrugSearch.com: What would you do as FDA commissioner regarding Canadian drug reimportation?

Dr. Rost: I’m in favor of regulated and legalized reimportation with access to these drugs through regular brick and mortar pharmacies. Today we have a very dangerous system, the Wild West. We need to protect consumers from illegal and misbranded drugs sold by Internet pharmacies. The only way to do it is to legalize and regulate this trade.

eDrugSearch.com: President-elect Obama has been a vocal advocate of Canadian drug reimportation. Apparently in response, Big Pharma and its proxies have been waging a renewed battle against reimportation in the media. Specifically, opponents of reimportation make the case that the FDA lacks the necessary staff and other resources to effectively regulate drugs coming in from Canada. What do you think of this argument?

Dr. Rost: That’s BS, like most of what Big Pharma has been saying in respect to reimportation. In Europe this has been done for 20 years with no major staffing issues.

eDrugSearch.com: Opponents of drug reimportation also claim that drugs coming into the United States from Canada do not meet the same standards as the drugs dispensed to Canadian residents. What do you think of this argument? Can we trust the Canadian government’s licensing procedures to protect the safety of U.S. consumers? What should be the FDA’s role in this issue?

Dr. Rost: Untrue. We can trust both Canada and Europe, since they use drugs from the same manufacturers and have stringent approval procedures. In fact, drugs from these countries may be safer than U.S. drugs, since we have a completely fragmented, state-based system regulating drug trade and wholesalers with lots of entry points for counterfeit drugs. The FDA’s role should be the same as for any other drug, ensuring safety of the drug supply.

eDrugSearch.com: eDrugSearch.com is delighted to endorse you for FDA commissioner! Any final thoughts for our readers?

Dr. Rost: Well, if Obama really is looking for CHANGE what better way to do this than to appoint a candidate who has already shaken up the drug industry?

In the end, we need an FDA accountable to the public, ensuring not only availability of life-saving drugs but also better protecting us against dangerous drugs.

We’ve had enough of tainted advisory boards and people who scratch each others backs, I think I could bring in some fresh air and sunlight.

The FDA is never going to be perfect, but we can all agree that this is one government agency which could do a lot better. The American public deserves better and so do all the great FDA staffers. I don’t think FDA employees are the problem, I think the issue we’ve had is a lack of leadership at the top and we need to bring in someone who has the guts to do what it takes and the vision to know that nothing is ever impossible.

Tags: FDA · Pharma bloggers · Rost Watch

Meet the Person Likely to be the Next FDA Commissioner

From Pharma Marketing:

Meet the Person Likely to be the Next FDA Commissioner

To date, nearly 250 people have responded to my Who Should Obama Nominate for FDA Commissioner? survey. The results so far show Rost, Wood, Nissen, Woodcock, and Califf as the top 5 contenders.

Eighty-six percent (86%) of respondents are from the US and the charts below focus on choices made by these respondents. These are preliminary results -- I intend to keep the survey going until someone is nominated. If you haven't yet voted, I hope you will take a couple of minutes to do it now and include what you think should be at the TOP of the new commissioner's agenda.

Peter Rost -- who has made a reputation as whistle blower, muckraker, and Pfizer nemesis -- holds the lead among all US respondents, 31% and 28% of whom are very and somewhat supportive of the pharma industry, respectively. Most of Rost's US voters are among those who claim to be very or somewhat unsupportive of the industry (see chart below).

"[Peter Rost] knows how Big Pharma operates, isn't owned by them and probably wouldn't be bought, either. He is also two cents short of a dollar, which helps." -- Anonymous respondent

Among industry supportive US voters, Susan Wood is the person of choice, but Steve Nissen, M.D., who has often criticized clinical trial data, is the #2 choice among US voters who support the drug industry.

"[Susan Wood is] a true believer in the promise of change. Return the FDA to science based leadership." -- Anonymous

"[Steve Nissen] is a doctor, he's not scared to stand up to pharma, he's intelligent, and the new commish should clean house of the 'insiders' who have gotten too cozy to big pharma." -- Robert Lands, Engineer, Union Pacific Railroad. Robert says he "somewhat supportive" of the pharma industry.

The level of industry support of voters for the top 5 contenders is illustrated in the chart below. Industry support is rated on a scale of -2 (very unsupportive) to +2 (very supportive) with neutral=0.


Some comments about other contenders include:

"[Robert Califf has an] excellent background and credentials...does not come from pharma." -- Vince DeChellis, Principal, NHHS Healthcare Consulting

"I think [Dora Hughes] will offer a balance between business and science that will ring true." -- Norma-Jeanne Hennis, President, MedPharm Communications

"[David Kessler is] Someone who is familiar with industry and how it works but who will call the executives on the carpet when they knowingly are pushing medicines for dollars not patient quality of life." -- Juanita Hawkins, President, Juanita Hawkins Consulting LLC

"[FDA] needs [Janet Woodcock who has a] ... deep history and knowledge of FDA." -- Anonymous

Who's your choice? Vote here.

Latest result in online poll for new FDA Commissioner

Here are most recent results in the poll for new FDA Commissioner. If you haven't voted go here.

So, this is the deal: If I became the new FDA Commissioner I would want to reorient the FDA to focus on its primary customers . . . American citizens, instead of primarily serving the drug industry. That means the agency would focus not only on fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling revised in a more timely manner. Both these objectives should be equally important.

I would also want to ensure that hundreds of unapproved drugs that are sold illegally as prescription drugs would be taken off the market, and that reimportation of drugs would become legal and regulated and appropriate safety measures taken to protect the public.

Finally, I'd want to bring the kind of internal and external accountability that normally exist within private corporations to a government agency and work for limitation of direct to consumer advertising, which is counter productive to efficient healthcare.

Läkemedelsvärlden the official Swedish Pharmacy Magazine speculates about Rost for FDA Commissioner . . .

Google Translate may help with this . . . they've noted the results in the poll for new FDA Commissioner. If you haven't voted go here.

And . . . since Ms. Stenberg wonders what my "position on the FDA is", you can check that out on the Facebook campaign site and also join the cause on Facebook!


Ingrid Stenberg, redaktionschef Läkemedelsvärlden.

I den amerikanska bloggvärlden vinner Peter Rost valet.

Om man är road av vad som rör sig i den amerikanska läkemedelsindustrins hjärna så är ett gäng bloggar en bra början, Pharma Marketing blog och Eye on FDA för att nämna två.
På den förstnämnda pågår just nu en omröstning om vem läsarna skulle vilja se som näste chef för amerikanska läkemedelsverket, FDA. Diskussionerna pågår för fullt efter presidentvalet om vem som kommer att få ta över efter Eschenbach, för en mer utförlig genomgång av de diskussionerna, läs här.

Namnen är många, men för en svensk läsare är det kanske av intresse att veta att just nu leder den svenske före detta Pfizer-vd:n Peter Rost omröstningen på Pharma Marketing blog. Enligt vad man kan läsa på bloggarna blev Rost själv lite förvånad först, men sen har han döpt om sin egen blogg till ”Peter Rost for FDA commissioner”.

Det finns en önskan från flera håll att få en industrikritisk ledare till FDA, vilket väl talar för Peter Rost. På Rosts egen blogg ligger mest en massa glada tillrop om varför andra tycker att han ska bli chef för FDA, vad han själv tycker i frågan är lite oklart.

Men den som undrar kan ju fråga honom den 18 december. Då ska han debattera något (programmet förklarar inte vad) med Lif:s vd Richard Bergström på ett event i Uppsala arrangerat av Sveriges Farmacevtförbund.

Själv kan jag inte låta bli att fundera över, vad skulle svenskarna bli mest stolta över? En svensk stjärnkock i Vita Huset? Eller en svensk whistleblower på FDA

My latest columns for the Swedish business site Realtid

To read in English or another language use Google Translate.

Suicide: Om självmord (2008-11-28)
Save your toe nails: ”Dr Rosts okända superkur räddar dina tår” (2008-11-24)
Crime Medicine: En annan sida av Crime Medicine (2008-11-10)
Another drug company bites the dust: Ännu ett läkemedelsbolag åker dit (2008-10-28)
Barack Obama--the right cure for the US: Barack Obama rätta medicinen för USA (2008-10-13)
Halt: Tvärstopp (2008-09-30)
Viagra isn't the future of Pfizer: Viagra är inte Pfizers framtid (2008-09-29)
Are vaccines dangerous?: Vaccinering – kan det vara farligt? (2008-09-15)
Prescription for excercise: Motion på recept (2008-09-01)

Smooth by Santana

Here's why the FDA needs Peter Rost . . .

Ailing FDA May Need a Major Overhaul, Officials and Groups Say
By Rob Stein, Washington Post

The Obama administration will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food and a flood of questionable imports from China and other countries.

Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply, and food.

But morale within the FDA, along with its credibility outside, has plummeted as the agency has been stretched to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension.

"FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates."

Alarm about the agency began to spike after a series of highly publicized incidents, including the discovery that the painkiller Vioxx caused heart attacks. That has been followed by other safety issues, including questions about the widely used diabetes medication Avandia and several psychiatric drugs.

"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.

At the same time, there has been increasing alarm about the agency's ability to protect the food supply -- concerns highlighted by recent major outbreaks of E. coli infection in spinach and salmonella in spinach and peppers. That has prompted calls to split the agency in two -- with one dedicated to drugs and the other to food.

"Food safety tends to get short shrift," said Christopher Waldrop of the Consumer Federation of America. "The drug side tends to get much more attention than the food side. Food is equally important and needs to get the attention it deserves."

Both the food and drug parts of the FDA's responsibilities have been hobbled by its inability to adequately monitor goods pouring into the United States from around the world, including food, drugs and raw materials, many say. Such concerns were highlighted by contaminated toothpaste from China; tainted pet food that killed hundreds of dogs and cats; and the fouled blood thinner heparin, which took the lives of at least 81 Americans and caused hundreds of serious illnesses.

"The agency is still stuck at the border," said Carl R. Nielsen, who was in charge of the FDA's import operations for the last six of his 28 years at the agency. "There has to be radical reorganization -- no doubt about that."

Although the FDA has started opening offices overseas to try to better police safety standards at the source, experts say much more needs to be done. For starters, the agency needs to sharply boost inspections abroad, develop strict new regulatory standards, and update and integrate its computer systems, which are woefully antiquated and disjointed, Nielsen and others said.

"It's still largely a paper-driven agency," Nielsen said. "The agency has great information pigeonholed all over the place, but it cannot be applied in real time, which is what you need today."

The FDA has also been one of the many federal agencies where Bush administration critics say ideology has trumped science, citing the long delay in approving the over-the-counter sale of the emergency contraceptive Plan B.

"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

Questions have also been raised about the agency's handling of suspected toxins such as bisphenol A in baby bottles and other products. And internal dissension has erupted publicly from the usually hermetically sealed agency. Last week, the House Energy and Commerce Committee released a letter from FDA scientists complaining about "serious misconduct" by top managers who oversee medical devices.

The turmoil comes as the FDA is facing a host of new demands, including the next wave of drugs and other products resulting from breakthroughs in genetics, nanotechnology and bioengineered foods, among others. And Congress may give the FDA the power to regulate tobacco for the first time.

"This would be a totally new regulatory responsibility that the FDA doesn't have expertise in," said Mark B. McClellan, who led the agency in President George W. Bush's first term.

While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.

"There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources," McClellan said. "The most important thing is overall effective leadership that leads in a way that establishes public trust."

Many hope the new administration will quickly name a new FDA commissioner -- a post that has frequently been left in the hands of acting commissioners for long periods. An acting commissioner ran the agency for more than half of the past eight years.

"The FDA can't be left to drift," said Hubbard, the former official. "There's a lack of leadership when a caretaker is in charge, and the FDA can't afford that."