Yep. I agree with Jim.After Department of Justice loss against Serono execs, chance of anyone going to jail has gone way down.
More here.
Showing posts with label genotropin. Show all posts
Showing posts with label genotropin. Show all posts
Monday, May 07, 2007
Brandweek: "[A]ny execs involved with the Genotropin fiasco have got to be feeling a lot more confident right now."
Yep. I agree with Jim.After Department of Justice loss against Serono execs, chance of anyone going to jail has gone way down.
More here.
Wednesday, April 11, 2007
$400 Million Pfizer Settlement for Bextra/Celebrex Kickbacks to ExpressScripts?
Most of you know about the $35 Genotropin settlement between the Department of Justice and Pfizer. About $20 million of that settlement relates to kickbacks to a pharmacy benefit manager, to improve formulary position.
What you don't know is what will happen next, and who that pharmacy benefit manager is, or COMPANY Q as it is called in the non-prosecution agreement.
Of course, I'll tell you the name of COMPANY Q: It is ExpressScripts.
And here's what happened, according to the deal between DOJ and Pfizer: Genotropin overpaid ExpressScripts to improve formulary position. See Pfizer's settlement agreement below.
And what will happen to ExpressScripts, you may now wonder? One major competitor, Caremark, already agreed to pay $137.5M to settle kickback charges.
So of course it is logical if ExpressScripts is next, after all, ExpressScripts has repeatedly disclosed to the Securities and Exchange Commission that they are under investigation by the DOJ for this type of issue.
But the story doesn't end there.
Genotropin didn't simply pay that extra money, a couple of million dollars every year, out of the Genotropin budget. No, for some interesting reason, the money came from the Bextra/Celebrex budget.
I still don't know quite what went on here, but it sure looks to me like Bextra/Celebrex got something out of the deal. Like improved formulary placement . . . sooooooooooo is it just me or is a Department of Justice settlement related to both Pfizer's Bextra/Celebrex and ExpressScripts next?
And here is where things get really interesting. Genotropin sales in the US have been around $200 million. Bextra/Celebrex sales at its peak were over $4 billion and are now around $2 billion. So 10 to 20 times as much money.
Does that mean Pfizer will end up ponying up 20 times what they paid for the Genotropin kickback charges, or around $400 million? And will ExpressScripts pay maybe $50 to $100 million?
And why have they not settled yet?
Here's a complication: With Genotropin Pfizer could easily just blame Pharmacia. Even though they allegedly continued some of the inappropriate selling to anti-aging docs long after they bought Pharmacia, DOJ let them off the hook on that one. But with Bextra/Celebrex Pfizer was part of the marketing from the beginning, as a 50% co-promotion partner with Pharmacia. No place to hide. So I would guess Pfizer is right now negotiating with DOJ about how they can avoid being named. And who knows. DOJ wants a big settlement. Don't we all? So maybe Pfizer can buy themselves out of this one too . . . kind of like, OK, OK we'll pony up $400 million, on the condition that DOJ agrees to put out this nice press release we have written blaming Pharmacia, and if we can get this nice non-prosecution agreement in which DOJ agrees it was Pharmacia management who were the bad boys and girls.
When that deed is done, you'll see the settlement in the news.
What is Pfizer's comment on this?
It is right there, in their most recent annual report: "We have been considering various ways to resolve these matters":
"Since 2003, we have received requests for information and documents from the Department of Justice concerning the marketing of Genotropin as well as certain managed care payments. In 2005, the Department of Justice informed us that it is investigating Pharmacia’s former contractual relationship with a healthcare intermediary. We are in discussions with the Department of Justice seeking to resolve the Genotropin and healthcare intermediary matters.
Since 2003, we have received requests for information and documents concerning the marketing and safety of Bextra and Celebrex from the Department of Justice and a group of state attorneys general. We have been considering various ways to resolve these matters."
What you don't know is what will happen next, and who that pharmacy benefit manager is, or COMPANY Q as it is called in the non-prosecution agreement.
Of course, I'll tell you the name of COMPANY Q: It is ExpressScripts.
And here's what happened, according to the deal between DOJ and Pfizer: Genotropin overpaid ExpressScripts to improve formulary position. See Pfizer's settlement agreement below.
And what will happen to ExpressScripts, you may now wonder? One major competitor, Caremark, already agreed to pay $137.5M to settle kickback charges.
So of course it is logical if ExpressScripts is next, after all, ExpressScripts has repeatedly disclosed to the Securities and Exchange Commission that they are under investigation by the DOJ for this type of issue.
But the story doesn't end there.
Genotropin didn't simply pay that extra money, a couple of million dollars every year, out of the Genotropin budget. No, for some interesting reason, the money came from the Bextra/Celebrex budget.
I still don't know quite what went on here, but it sure looks to me like Bextra/Celebrex got something out of the deal. Like improved formulary placement . . . sooooooooooo is it just me or is a Department of Justice settlement related to both Pfizer's Bextra/Celebrex and ExpressScripts next?
And here is where things get really interesting. Genotropin sales in the US have been around $200 million. Bextra/Celebrex sales at its peak were over $4 billion and are now around $2 billion. So 10 to 20 times as much money.
Does that mean Pfizer will end up ponying up 20 times what they paid for the Genotropin kickback charges, or around $400 million? And will ExpressScripts pay maybe $50 to $100 million?
And why have they not settled yet?
Here's a complication: With Genotropin Pfizer could easily just blame Pharmacia. Even though they allegedly continued some of the inappropriate selling to anti-aging docs long after they bought Pharmacia, DOJ let them off the hook on that one. But with Bextra/Celebrex Pfizer was part of the marketing from the beginning, as a 50% co-promotion partner with Pharmacia. No place to hide. So I would guess Pfizer is right now negotiating with DOJ about how they can avoid being named. And who knows. DOJ wants a big settlement. Don't we all? So maybe Pfizer can buy themselves out of this one too . . . kind of like, OK, OK we'll pony up $400 million, on the condition that DOJ agrees to put out this nice press release we have written blaming Pharmacia, and if we can get this nice non-prosecution agreement in which DOJ agrees it was Pharmacia management who were the bad boys and girls.
When that deed is done, you'll see the settlement in the news.
What is Pfizer's comment on this?
It is right there, in their most recent annual report: "We have been considering various ways to resolve these matters":
"Since 2003, we have received requests for information and documents from the Department of Justice concerning the marketing of Genotropin as well as certain managed care payments. In 2005, the Department of Justice informed us that it is investigating Pharmacia’s former contractual relationship with a healthcare intermediary. We are in discussions with the Department of Justice seeking to resolve the Genotropin and healthcare intermediary matters.
Since 2003, we have received requests for information and documents concerning the marketing and safety of Bextra and Celebrex from the Department of Justice and a group of state attorneys general. We have been considering various ways to resolve these matters."
Wednesday, April 04, 2007
"Pfizer Inc: the Dots Unconnected"
Check out HealthCare Renewal's thorough analysis of Pfizer's criminal slap-on-the-fingers-settlement for illegal marketing of Genotropin.
Pfizer's $35 million fine: Equivalent to a speeding ticket.
How much money is the $35 million criminal fine Pfizer was forced to pay this week for illegal marketing of Genotropin??Last year Pfizer's profit was $11 billion.
But that profit doesn't include all the additional profit Pfizer is hiding in off-shore tax havens.
The New York Times in 2005 described a new tax break for corporations, part of the American Jobs Creation Act, signed into law by President Bush, which allowed companies a one-year window to return foreign profits to the United States at a 5.25 percent tax rate, compared with the standard 35 percent rate. The New York Times went on to state "Pfizer . . . will repatriate at least $28 billion under the act."
Obviously, the $11 billion profit is just a fraction of Pfizer's real profit, but let's use that number anyway.
$11 billion translates into nearly $35 million in profit EVERY DAY.
So the $35 million criminal fine was equivalent to one day's profit.
Let's put that in perspective: If you make $50,000 a year, that means you earn $137 every day. That is equivalent to a regular speeding ticket.
Did a speeding ticket ever stop you from speeding again?
Tuesday, April 03, 2007
Links to Pfizer's Genotropin settlement agreements with DOJ
Pfizer's guilty plea.
Deferred prosecution agreement.
Non-prosecution agreement. (Contains the other two, so this is the only one you have to read.)
Deferred prosecution agreement.
Non-prosecution agreement. (Contains the other two, so this is the only one you have to read.)
Monday, April 02, 2007
"Pfizer Settles Off-Label Marketing Probe"
Brandweek article:
Pfizer Settles Off-Label Marketing Probe
April 02, 2007
By Jim Edwards
NEW YORK -- Pfizer will pay $34.7 million to end an investigation by the Department of Justice into the off-label marketing of its human-growth hormone brand, Genotropin, and allegations that a unit of the company made kickbacks to “an outside vendor” in order to increase its sales, the company said today.
Pfizer admitted in its statement that a company it acquired, Pharmacia, “improperly promoted Genotropin between January 2000 and March 2003 for anti-aging purposes, improved athletic performance, and enhanced appearance.”
The company also said it will plead guilty to a single count “of offering to an outside vendor remuneration in the form of an award of a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of Pharmacia medicines.”
In the plea agreement, the vendor is not named. However, the agreement describes how Pharmacia awarded a contract to a pharmacy benefit manager in return for that company recommending that its customers purchase other Pharmacia products. The vendor got the contract, despite a competing bid that was “$12 million less expensive” than the vendors’ bid.
The settlement requires Pfizer execs to cooperate with any ongoing grand jury probes, the settlement states.
The settlement’s description of the kickback scheme matches a series of allegations reported by Brandweek last year. (Bad Medicine, March 20, 2006).
Two Pharmacia executives, ex-marketing vp Peter Rost and former senior director of U.S. marketing Carl Worrell, told Brandweek that Express Scripts managed the Genotropin patient assistance program even though other companies had offered to handle the business for much less money.
Rost said that when he tried to move the contract to the cheaper vendor he was told that it was balanced out by an advantageous relationship Pharmacia had with Express regarding its much bigger drug, the painkiller Celebrex. "There was some setup in accounting so the Celebrex team reimbursed us $2 million," Rost said at the time.
Both Pfizer and Express have repeatedly disclosed to the Securities and Exchange Commission that they were under investigation by the DOJ for this type of issue. Express declined comment at press time.
Pfizer distanced itself from the probe in today’s release. “Pfizer’s marketing and promotion practices are not involved in the settlement,” said Pfizer svp-general counsel Allen Waxman in a statement.
The settlement ends the DOJ’s interest in Pfizer, but it does not end Pfizer’s legal entanglements with Genotropin—Pfizer remains a defendant in two legal cases related to the fiasco. In both cases, Rost sued Pfizer alleging he was wrongly fired for complaining to Pfizer prior to its acquisition of Pharmacia that the company was engaged in off-label marketing. His federal whistleblower complaint is currently being heard by an appeals court in Massachusetts; his wrongful termination suit is pending before New York State Supreme Court in Manhattan.
“The relationships between pharmaceutical companies and the pharmacy benefit managers who have so much influence over the drug choice of millions of Americans must be free of the taint of kickbacks or other illegal payments,” said U.S. Attorney Michael Sullivan in a statement. “It is my hope that the conduct exposed by this investigation will bring greater transparency and integrity to the dealings between pharmaceutical companies and pharmacy benefit managers.”
Pfizer Settles Off-Label Marketing Probe
April 02, 2007
By Jim Edwards
NEW YORK -- Pfizer will pay $34.7 million to end an investigation by the Department of Justice into the off-label marketing of its human-growth hormone brand, Genotropin, and allegations that a unit of the company made kickbacks to “an outside vendor” in order to increase its sales, the company said today.
Pfizer admitted in its statement that a company it acquired, Pharmacia, “improperly promoted Genotropin between January 2000 and March 2003 for anti-aging purposes, improved athletic performance, and enhanced appearance.”
The company also said it will plead guilty to a single count “of offering to an outside vendor remuneration in the form of an award of a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of Pharmacia medicines.”
In the plea agreement, the vendor is not named. However, the agreement describes how Pharmacia awarded a contract to a pharmacy benefit manager in return for that company recommending that its customers purchase other Pharmacia products. The vendor got the contract, despite a competing bid that was “$12 million less expensive” than the vendors’ bid.
The settlement requires Pfizer execs to cooperate with any ongoing grand jury probes, the settlement states.
The settlement’s description of the kickback scheme matches a series of allegations reported by Brandweek last year. (Bad Medicine, March 20, 2006).
Two Pharmacia executives, ex-marketing vp Peter Rost and former senior director of U.S. marketing Carl Worrell, told Brandweek that Express Scripts managed the Genotropin patient assistance program even though other companies had offered to handle the business for much less money.
Rost said that when he tried to move the contract to the cheaper vendor he was told that it was balanced out by an advantageous relationship Pharmacia had with Express regarding its much bigger drug, the painkiller Celebrex. "There was some setup in accounting so the Celebrex team reimbursed us $2 million," Rost said at the time.
Both Pfizer and Express have repeatedly disclosed to the Securities and Exchange Commission that they were under investigation by the DOJ for this type of issue. Express declined comment at press time.
Pfizer distanced itself from the probe in today’s release. “Pfizer’s marketing and promotion practices are not involved in the settlement,” said Pfizer svp-general counsel Allen Waxman in a statement.
The settlement ends the DOJ’s interest in Pfizer, but it does not end Pfizer’s legal entanglements with Genotropin—Pfizer remains a defendant in two legal cases related to the fiasco. In both cases, Rost sued Pfizer alleging he was wrongly fired for complaining to Pfizer prior to its acquisition of Pharmacia that the company was engaged in off-label marketing. His federal whistleblower complaint is currently being heard by an appeals court in Massachusetts; his wrongful termination suit is pending before New York State Supreme Court in Manhattan.
“The relationships between pharmaceutical companies and the pharmacy benefit managers who have so much influence over the drug choice of millions of Americans must be free of the taint of kickbacks or other illegal payments,” said U.S. Attorney Michael Sullivan in a statement. “It is my hope that the conduct exposed by this investigation will bring greater transparency and integrity to the dealings between pharmaceutical companies and pharmacy benefit managers.”
Genotropin settlement spin.
I note that the Department of Justice allegedly gives Pfizer gets credit for acting “responsibly” and not a word was wasted on the guy who forced Pfizer’s to report . . . last year a judge ruled that Rost, not Pfizer, was the first to disclose the off-label sales; that Rost’s claims were based upon his own knowledge of Genotropin sales and not Pfizer’s disclosures to the government; and that Rost, not Pfizer, was the original source of the disclosures.
"The relationships between pharmaceutical companies and the pharmacy benefit managers who have so much influence over the drug choice of millions of Americans must be free of the taint of kickbacks or other illegal payments," U.S. Attorney Michael J. Sullivan said in a prepared statement.
Sullivan noted that New York-based Pfizer, which acquired Pharmacia in April 2003, acted responsibly when it disclosed Pharmacia's unlawful promotion of human growth hormone to various federal government agencies in May of that year.Pfizer said both settlements cover activities that occurred at the Pharmacia subsidiaries, based in Bridgewater, N.J., before it was acquired by Pfizer.
"As the Department of Justice has acknowledged, Pfizer voluntarily and fully self-disclosed the off-label promotion of Genotropin by a Pharmacia subsidiary before Pharmacia was acquired by Pfizer," Pfizer General Counsel Allen Waxman said in a prepared statement.”
Part of AP story.
"The relationships between pharmaceutical companies and the pharmacy benefit managers who have so much influence over the drug choice of millions of Americans must be free of the taint of kickbacks or other illegal payments," U.S. Attorney Michael J. Sullivan said in a prepared statement.
Sullivan noted that New York-based Pfizer, which acquired Pharmacia in April 2003, acted responsibly when it disclosed Pharmacia's unlawful promotion of human growth hormone to various federal government agencies in May of that year.Pfizer said both settlements cover activities that occurred at the Pharmacia subsidiaries, based in Bridgewater, N.J., before it was acquired by Pfizer.
"As the Department of Justice has acknowledged, Pfizer voluntarily and fully self-disclosed the off-label promotion of Genotropin by a Pharmacia subsidiary before Pharmacia was acquired by Pfizer," Pfizer General Counsel Allen Waxman said in a prepared statement.”
Part of AP story.
No, I'm not getting any money from the $35 million Pfizer/DOJ settlement
For everyone asking me about my comments on the Pfizer/DOJ settlement:1. I'm delighted that my false claims suit resulted in a $35 million criminal Genotropin settlement between Pfizer and DoJ.
2. I'm also very happy that I made $35 million for American tax payers.
3. Considering my contribution to the treasury, do I still have to pay taxes? Oh, forget about that, I have to have an income to worry about such things . . .
And what is Pfizer's position?
Uhm, well, after I spent months twisting their arm, they "self-reported."
"As the Department of Justice has acknowledged, Pfizer voluntarily and fully self-disclosed the off-label promotion of Genotropin by a Pharmacia subsidiary before Pharmacia was acquired by Pfizer," Pfizer General Counsel Allen Waxman said in a prepared statement.
Thank you Allen, for making sure you didn't mention my role with a single word! I guess you don't want to encourage more whistleblowers . . .
Pfizer pays $35 million Genotropin settlement
I HAVE FINALLY BEEN PROVEN RIGHT ABOUT ILLEGAL MARKETING OF GENOTROPIN AND “PHARMACIA & UPJOHN, INC, WILL BE DISQUALIFIED FROM PARTICIPATION IN GOVERNMENT HEALTHCARE PROGRAMS.”
For the full, painful story about what it took to force Pfizer to go to the DOJ, click HERE.”
The following resolves the criminal charges resulting from my false claims suit—not the civil complaint:
April 02, 2007 01:38 PM Eastern Daylight Time
Pharmacia Subsidiaries Reach $34.7 Million Settlement with DOJ;
Resolve Allegations of Improper Activities Prior to Acquisition by Pfizer
Pfizer Discovered and Promptly Reported Subsidiary’s Off-Label Marketing of Genotropin to Justice Department, Other Agencies
NEW YORK--(BUSINESS WIRE)--Pfizer announced today that two subsidiaries of Pharmacia have reached separate settlements with the United States Department of Justice to address charges stemming from the off-label marketing of Genotropin — a human growth hormone medicine — and the inappropriate use of a vendor contract to increase the sales of other Pharmacia medicines. Both settlements cover activities that occurred at Pharmacia before that company was acquired by Pfizer in 2003. The subsidiaries have agreed to pay fines totaling $34.7 million.
One subsidiary — Pharmacia & Upjohn Company Inc. — will plead guilty to a single count of offering to an outside vendor remuneration in the form of an award of a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of Pharmacia medicines. The contract was awarded in 2000. The subsidiary, which has no operational role in Pfizer today, was assessed a fine of $19.7 million and will be disqualified from participation in government healthcare programs. The disqualification will have no impact on current or future Pfizer medicines approved for use in the United States and will not affect the continued marketing of Genotropin.
A second Pharmacia subsidiary — Pharmacia & Upjohn Company LLC — has entered into a Deferred Prosecution Agreement with the Department of Justice (DOJ) that includes a fine of $15 million to address the improper promotion of Genotropin, which Pfizer discovered and self-reported to the Department of Justice, the FDA and the Office of the Inspector General within the first month following completion of the Pharmacia acquisition. Under the agreement, no criminal charges will be filed against Pharmacia in return for compliance with the terms of the agreement.
“As the Department of Justice has acknowledged, Pfizer voluntarily and fully self-disclosed the off-label promotion of Genotropin by a Pharmacia subsidiary before Pharmacia was acquired by Pfizer,” said Allen Waxman, senior vice president and general counsel. “Pfizer’s marketing and promotion practices are not involved in the settlement. The company has internal controls to guard against these types of practices.”
As detailed in the settlement agreement, the subsidiary improperly promoted Genotropin between January, 2000 and March, 2003 for anti-aging purposes, improved athletic performance, and enhanced appearance. The settlement does not allege that patients suffered any adverse health effects from those off-label uses. Genotropin is FDA-approved for the treatment of children with hormone-related growth failure, pediatric patients with Prader-Willi Syndrome, and adults with growth hormone deficiency.
The two settlements resolve the Department of Justice investigation of these matters.
Source.
----------------------------------------------------------------------------------
Just a reminder, from Pharmaceutical Executive:
You've very publicly taken on Pfizer. How has that affected the way you've been portrayed in the media?
Pfizer used about 20 lawyers and PR people to prepare for my termination. Then they terminated me when I was out of the country and couldn't respond very well to the press. Pfizer also said a number of things to the press that were completely untrue, and they did it in a very sophisticated manner.
The company put their charges into their own legal filing, which is a protected form of speech. That way, it was hard for me to claim libel. The legal filing contained information that was intended to make me look like I was trying to blackmail Pfizer and that I was a parasite on the case [meaning that the original source of the information about off-label promotion came from somewhere else]. The PR person of Pfizer even said to The New York Times that, since I was the VP, I was blowing the whistle on my own conduct.
It is Marketing 101. Number one, blame the whistleblower. Number two, make him look like a criminal and an idiot. That's how it works—it's just sad to see it played out.
For the full, painful story about what it took to force Pfizer to go to the DOJ, click HERE.”
The following resolves the criminal charges resulting from my false claims suit—not the civil complaint:
April 02, 2007 01:38 PM Eastern Daylight Time
Pharmacia Subsidiaries Reach $34.7 Million Settlement with DOJ;
Resolve Allegations of Improper Activities Prior to Acquisition by Pfizer
Pfizer Discovered and Promptly Reported Subsidiary’s Off-Label Marketing of Genotropin to Justice Department, Other Agencies
NEW YORK--(BUSINESS WIRE)--Pfizer announced today that two subsidiaries of Pharmacia have reached separate settlements with the United States Department of Justice to address charges stemming from the off-label marketing of Genotropin — a human growth hormone medicine — and the inappropriate use of a vendor contract to increase the sales of other Pharmacia medicines. Both settlements cover activities that occurred at Pharmacia before that company was acquired by Pfizer in 2003. The subsidiaries have agreed to pay fines totaling $34.7 million.
One subsidiary — Pharmacia & Upjohn Company Inc. — will plead guilty to a single count of offering to an outside vendor remuneration in the form of an award of a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of Pharmacia medicines. The contract was awarded in 2000. The subsidiary, which has no operational role in Pfizer today, was assessed a fine of $19.7 million and will be disqualified from participation in government healthcare programs. The disqualification will have no impact on current or future Pfizer medicines approved for use in the United States and will not affect the continued marketing of Genotropin.
A second Pharmacia subsidiary — Pharmacia & Upjohn Company LLC — has entered into a Deferred Prosecution Agreement with the Department of Justice (DOJ) that includes a fine of $15 million to address the improper promotion of Genotropin, which Pfizer discovered and self-reported to the Department of Justice, the FDA and the Office of the Inspector General within the first month following completion of the Pharmacia acquisition. Under the agreement, no criminal charges will be filed against Pharmacia in return for compliance with the terms of the agreement.
“As the Department of Justice has acknowledged, Pfizer voluntarily and fully self-disclosed the off-label promotion of Genotropin by a Pharmacia subsidiary before Pharmacia was acquired by Pfizer,” said Allen Waxman, senior vice president and general counsel. “Pfizer’s marketing and promotion practices are not involved in the settlement. The company has internal controls to guard against these types of practices.”
As detailed in the settlement agreement, the subsidiary improperly promoted Genotropin between January, 2000 and March, 2003 for anti-aging purposes, improved athletic performance, and enhanced appearance. The settlement does not allege that patients suffered any adverse health effects from those off-label uses. Genotropin is FDA-approved for the treatment of children with hormone-related growth failure, pediatric patients with Prader-Willi Syndrome, and adults with growth hormone deficiency.
The two settlements resolve the Department of Justice investigation of these matters.
Source.
----------------------------------------------------------------------------------
Just a reminder, from Pharmaceutical Executive:
You've very publicly taken on Pfizer. How has that affected the way you've been portrayed in the media?
Pfizer used about 20 lawyers and PR people to prepare for my termination. Then they terminated me when I was out of the country and couldn't respond very well to the press. Pfizer also said a number of things to the press that were completely untrue, and they did it in a very sophisticated manner.
The company put their charges into their own legal filing, which is a protected form of speech. That way, it was hard for me to claim libel. The legal filing contained information that was intended to make me look like I was trying to blackmail Pfizer and that I was a parasite on the case [meaning that the original source of the information about off-label promotion came from somewhere else]. The PR person of Pfizer even said to The New York Times that, since I was the VP, I was blowing the whistle on my own conduct.
It is Marketing 101. Number one, blame the whistleblower. Number two, make him look like a criminal and an idiot. That's how it works—it's just sad to see it played out.
Monday, March 26, 2007
Pharmalot/NJ Star Ledger: "Anna Nicole Smith And...Peter Rost?"
By Ed Silverman
March 26, 2007
Anna Nicole Smith And...Peter Rost?
An unllikely pair, but there's speculation a connection exists.
March 26, 2007
Anna Nicole Smith And...Peter Rost?
An unllikely pair, but there's speculation a connection exists.
First, let's take Peter Rost. He's the notorious former Pfizer exec who filed a whistleblower lawsuit against the drugmaker, alleging unlawful, off-label promotion of Genotropin, a human growth hormone treatment that he was responsible for marketing.
Now, poor Anna. The medical examiner's report, which was released today, indicates several prescription drugs, including human growth hormone, were ingested. Although the cause of death was overdose from methadone and antidepressants, her case may highlight HGH abuse.
As Rost notes on his own blog, HGH is prescribed for dwarfism and other growth deficiences, not the weight issues that plagued Anna Nicole. As Jim Edwards at BrandWeekNRX points out, this sordid publicity may work in Rost's favor. A federal appeals court is about to decide whether to let his lawsuit, which was denied last year a federal court judge, to proceed.
Hmm. Let's see. A corporate whistleblower. A drugmaker charged with nefarious behavior. A federal prosecutor. And an over-the-top dead celebrity and Playboy Playmate who looked like Marilyn Monroe. Sounds like a movie. Rost has said he wants to make a movie. Here's the script. Any guesses on who will play Hank McKinnell?
Peter Rost's blog;
Associated Press story about accidental overdose;
Medical examiner's report;
Hat tip to Jim Edwards at BrandWeek.
Posted by Ed Silverman
Brandweek: "Could Anna Nicole Smith's Death Boost Peter Rost's Case Against Pfizer?"
BrandweekNRX
By Jim Edwards
Could Anna Nicole Smith's Death Boost Peter Rost's Case Against Pfizer?
I can't believe I am typing these words, but ... Given that the coroner today said that human growth hormone was found in Anna Nicole Smith's body, could that assist former Pfizer vp Peter Rost in his jihad against Pfizer?
For those of you late to class: Rost sued Pfizer when the company failed to respond to his complaints that Genotropin, the brand Pfizer acquired in the Pharmacia merger, was being marketed off-label to healthy people for vanity purposes.
A Massachussetts judge kicked Rost's whistleblower suit out of court, and the feds officially declined to show an active interest. But Rost recently appealed the judge's decision on the grounds that in order to show he has a case he would have to file confidential patient data in court—which, in a classic Catch 22, is against the law.
The feds perked up again when they saw Rost's appeal, and asked for time to file their own brief. Rost suspects that the DOJ suspects that if the ruling stands it will knock out any other pharma whistleblower case that relies on patient data. The feds likely don't want that because it would make it virtually impossible to bring a whistleblower case without violating patient data privacy.
Anyway, to bring this full circle—given that Smith was using HGH, that almost certainly means she was abusing it, says Rost (it's indicated for dwarfism and various GH deficiencies, not weight problems).
And given that her death has now highlighted the prevalence of HGH abuse (check it out on Google here), could this be the extra fact that tips the appeals court to overturn the decision and allow Rost's suit to proceed?
You can't make this stuff up. Perhaps this is the ending Rost needs for his alleged movie?
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