Rost's FDA push makes PharmaTimes

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
PharmaTimes

Whistleblowers payday!

Come clean, help clean up the industry and make money.

Peter Rost can advise.

AstraZeneca - the Zubillaga saga contd.: Listen with Rost

Oh dear!

The UK's Indy covers the Zubillaga Saga

A doctor's is a 'big bucket of money, grab a handful', said fired Astra sales chief

By Karen Attwood
The Independent

Published: 21 April 2007

The pharmaceutical giant AstraZeneca is at the centre of a storm in the US after firing one of its sales directors for comments he made likening doctors' offices to "a big bucket of money".

Documents have surfaced on industry insider websites allegedly describing illegal drug marketing practices and AstraZeneca has since launched an investigation into the activities of several employees.

Mike Zubillaga, who was regional sales director for AstraZeneca's Mid-Atlantic Business Center in Wayne, Pennsylvania, was quoted in a internal newsletter saying: "I see it like this: there is a big bucket of money sitting in every office. Every time you go, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money."

Unfortunately for Mr Zubillaga, who was intending to motivate his sales staff to sell more cancer drugs, an industry blogger got hold of the newsletter from a whistleblower and published the comments, sparking an online debate about the ethics of drug companies.

Concern was raised after another comment from Mr Zubillaga in the same newsletter appeared to highlight a more serious issue. He allegedly appeared to be suggesting sales staff should counter-promote drugs, which is selling by comparing another company's drug, a practice prohibited in the US.

AstraZeneca sacked Mr Zubillaga just hours after his comments surfaced on the web two weeks ago and said "the direction he gave the team violated the core purpose of the company".
The company said it was investigating claims about sales practices and compliance issues raised by various blogs. One group calling its self the AstraZeneca Group of Seven has been set up for employees "to submit comments anonymously".

"The company takes claims of misconduct very seriously and investigates these in a timely and effective manner," AstraZeneca said. Some investigations had been initiated and concluded while others were ongoing, the company said. "Responding to complaints is a fundamental element of our compliance programme and is consistent with the ethical values that underpin our business."

Some commentators have suggested that Mr Zubillaga was simply telling the truth, although others have taken offence. Peter Rost, a former marketing executive at Pfizer, who first posted the newsletter on his "whistleblower" blog two weeks ago, wrote: "AstraZeneca lacked the internal controls to make sure the truth didn't get out, and now they are trying to show they are holier than thou, by firing the guy who said what everyone knows to be true ... Instead of a reprimand, AstraZeneca created a sacrificial lamb to cover the corporate rear end."

Congressman Stark, meet Mike Zubillaga

Ed at Pharmalot makes the introductions.

Pfizer try to stop Rost's "Whistleblower" book in court

Dr. Peter Rost, author of “The Whistleblower—Confessions of a Healthcare Hitman,” today revealed that Pfizer has asked the US District Court, NY, to advise on relief and for sanctions against Dr. Rost for writing “The Whistleblower,” per recently released court records, case no. 05-CV-10384.

In a separate legal communiqué, Pfizer’s lawyer writes, “Be advised that we are in the process of evaluating the extent to which this book likewise violates the Protective Order.” Pfizer has also requested “Confidential” designation of virtually all documents used to write “The Whistleblower.”

“Pfizer’s attempt to stop ‘The Whistleblower’ and deny the public the right to view associated documents may not be surprising considering the explosive content and Pfizer’s infamous history as the only drug company forced by the government to sign not just one, but two separate Corporate Integrity Agreements,” said Dr. Rost.

The New York Post wrote the following review, “A drug company executive is about to blow the lid off the pharmaceutical industry . . . revealing everything from sex in the corner office to private investigators spying on employees, company phone surveillance, FBI investigations and financial shenanigans resulting in million-dollar payouts.”

And L Magazine stated, “In this Enron-esque exposé of the healthcare industry, an . . . executive reveals everything you should already be assuming about most multinational corporations. You know, greed, spying, million-dollar payouts, and sex in the corner office.”

Medical Marketing & Media, a drug industry publication, concluded that “The Whistleblower” is “a scathing account of the allegedly 'insidious' practices of the industry that once paid [Dr. Rost’s] salary and of the US healthcare system. The media is sure to lap it up.”

Soft Skull Press sold the entire first printing during the first day of sale, September 10, 2006.

For more information on “The Whistleblower,” sample pages, news, reviews, and the “Whistleblower Video,” go to: http://the-whistleblower-by-peter-rost.blogspot.com/

Dr. Peter Rost daily blog: http://peterrost.blogspot.com/

Insider's review of the book can be found here.