Big Pharma Whistle-Blower--Dr. Peter Rost

Our buddies at the Alliance for Human Reseach Protection are touting a great, new book by Dr. Peter Rost -- Whistleblower: Confessions of a HealthCare Hitman.

Wow, this is some good stuff. Dr. Rost was a high-level Pharma executive with Wyeth, who, at some point, developed a conscience, and starting singing like a canary. For you youngsters, he's the Frank Serpico of the Pharma Industry! Here's a nice summation of misdeeds, misconduct, misappropriations and malfeasance by our high-tech drug pushers:

In 1997: After pulling Pondimin and Redux off the market because of heart valve damage, Wyeth was forced to set aside $21.1 billion to settle "fen-phen" liability cases.

In 2000: Wyeth signed an FDA Consent Decree and paid $30 million

In 2001: "TAP-Astra Zeneca Pay Over a Billion Dollar in Fines"--re: criminal marketing of Lupron.

In 2002: Pfizer paid $49 million to settle state and federal Medicaid fraud charges involving Lipitor.

In 2002: Schering-Plough signed a FDA consent decree and paid a $500 million fine--the biggest in FDA history.

In 2003: Bayer pled guilty to violating the federal Prescription Drug Marketing Act, paying $257 million including a criminal fine for its marketing of Cipro.

In 2003: GlaxoSmithKline shareholders questioned GSK CEO, Jean-Pierre Garnier, about his pay package to which he responded: "I am not Mother Teresa." [Heh! No, Frenchy you ain't!]GlaxoSmithKline also ran afoul of the IRS--it is facing a demand for $7.8 billion in backdated taxes and interest. [$7.8 Billion!!!!!! -- That's a whole lotta shekels!!!!]

In 2003: GSK signed a corporate integrity agreement and paid $88 million in a civil fine for overcharging Medicaid for the antidepressant, Paxil and nasal-allergy spray, Flonase

In 2004: Schering-Plough paid $345 million to resolve criminal and civil liabilities for illegal marketing of Calritin.

In 2004: Pfizer admitted criminal marketing of Neurontin, agreeing to pay $420 million.

In 2004: Merck withdrew its lethal painkiller, Vioxx. Estimates are that it would cost the company $50 billion. [$50 Billion?!!? Man-o-Manischewitz -- these numbers are making me dizzy. Can I get some Paxil?]

In 2004: The IRS served Merck with a "preliminary notice of deficiency" that could lead to $2.04 billion.

In 2004: New York State Attorney General slapped GSK with fraudulent marketing of Paxil--the company settled and posted its previously concealed pediatric clinical trial data. [Oops, ixnay on the axilpay.]

In 2004: Bristol-Myers Squibb was ordered by the Securities and Exchange Commission to pay $150 million to settle charges of inflating its revenue by $1.5 billion in 2000 and 2001. A separate criminal investigation by the U.S. Attorney General's Office in NJ resulted in the indictment of two executives for securities fraud--the company agreed to pay $300 million to shareholders.

In 2005: Serono Laboratories (Switzerland) agreed to pay $704 million to resolve criminal and civil charges in connection with the marketing of Serostim, an AIDS drug. [What a surprise!]The company also pled guilty to marketing conspiracy. [Conspiracy theorists rejoice!]

In 2005: Eli Lilly pled guilty and paid $36 million for its illegal marketing of Evista for off-label uses.

In 2005: the Justice Department announced that GSK had paid "over $150 million to resolve allegations of violations to the False Claims Act through fraudulent drug pricing and marketing.

[Stunned silence in the court room....jury members avoid eye contact with the slick, high-priced, attorneys for the Defendant Pharmaceutical companies....one juror asks the judge if he can have a calculator:)]

Comments

[Pharma Bawd]

Hey, you missed one Hank.

Schering-Plough, $435 million, one count of conspiracy, just last week I believe.

http://www.boston.com/business/healthcare/articles/2006/08/30/drug_firm_hit_with_3d_big_penalty_in_five_years/

for off label marketing and other offenses.

Personally, I think the new VP deserves yet another fine for this blatantly bad science metaphor:

"The heart of the program is to really embed business integrity and compliance into our DNA," said Saunders."

[McKiernan]

You Bet Your Life.

Ha ha, that's funny.

So if we say the secret word will the duck come down and award $ 100
or a New DeSoto ?

[George]

Hank's got HTML enabled in The Comments now too!

And PB agreed with something he posted?

What's going on?

Once I was watching You Bet Your Life with my first wife, and the duck came down (which it did with a lot higher frequency than HIV is horizontally transmitted. Although come to think on it, we was going at it pretty hot and heavy in those days of wine and roses and who knows what we passed between us).

Anywhere (as I like to say to my grand children), the duck came down and Groucho gave the woman who said "ironing board" a brand new, Monopoly money $100. The woman looked at it, and Groucho and said something like, "Wait a minute here, I want REAL money!" George (Feneyman) and George me, explained to the little woman simultaneously almost (Lise) that it was against the law at that time to show actual money on the television, and that she would get her "real" hundred after the show.

[Michael]

Hey Hank, Judging from all of the funds going to pay fines and lawsuits, at least now we know why most drugs sold in the US are so overpriced and expensive. Ultimately it is the public that uses any of the drugs, including any of the helpful, beneficial drugs, that pays for this ever increasing fiasco!

[Lise]

And would you know, after all these years I'm still waiting for the REAL money from the old doter.

Mr G, the show in question was "Bet Your life" not "Here's Your Life". Get it?

[HankBarnes]

Big Asbestos=> Big Oil=> Big Tobacco=> Big Pharma.

The trajectory's the same for all these industries -- down the tubes!

Sell short, sez I!

HankB

[Andrew Maniotis]

Andy "the lawyer" Maniotis here:

Former CDC Head, Donald Francis’s company is supported through the military, by taxpayer money to make a vaccine for anthrax following the divestment following his unfortunate announcement of the failure of AIDSVAX). For example, The "Biodefense and Pandemic and Vaccine and Drug Development Act of 2005” was passed in order to alleviate the industrial-medical establishment from impediments such as claims for vaccine or drug damage. As a new directive, the bill amends the Public Health Service Act to enhance biodefense and pandemic preparedness activities, and for other purposes (http://thomas.loc.gov/ Search Bill Title or Number - S.1880). The bill releases makers and health providers from the following impediments:

page 30

"A manufacturer, distributor, or administrator of a security countermeasure, or a qualifed pandemic and epidemic product, described subsection [b,1,A] or a health care provider shall be immune from suit or liability caused by or arising out of: the design, development, clinical testing and investigation,manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure, or a qualified pandemic and epidemic product
[....]"

"[I]n general, no cause of action shall exist against a person [company] described in subsection a for claims for loss of property, personal injury, or death arising out , reasonably relating to, or resulting from: the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use ...in defense against, or in response to, or recovery from an actual or potential public health emergency.."

What is being described here is a total freedom at last to use untested vaccines, pharma products, drugs, or "security countermeasures" carte blanche, because of this Burr-Frist-Bush-Eli Lilly-Big pharma bill. And there is nothing AIDS denialists can do about it because it is in the interests of National Security!

Why did VAXGEN, Donald Francis’s company that conducted the failed US and Thailand AIDSVAX trial, receive money to salvage their company from investor withdrawal in order to produce “an anthrax vaccine" in the aftermath of 9/11?

And why didn’t the Bush administration bust Bayer’s patent rights in the face of the 9/11 Tom Brokaw and Senator Daschl, US postal service "crisis" (because this can be accomplished), and allow other companies who had stockpiled cipro to deliver it to the populations in the US who might need it?

From Businessweek:

“Despite extensive domestic support for suspending Bayer's patent on Cipro, the response of Bush administration was outrageous. Tommy Thompson considered it "illegal" to suspend Bayer's patent on Cipro. Instead he entered into negotiations with Bayer with the intention of lowering the price of Cipro. Facing an unprecedented public embarrassment, Bayer agreed to lower the price of Cipro for government purchase from $1.77 to $0.95.”

“Dubbed as "historic victory" in the US official circles, it would be absurd to view this agreement as a major accomplishment of the Bush administration. Rather, it was a major victory for Bayer which remains the sole supplier of the drug in the US until December 2003. Further, the agreement with Bayer only covers government purchases of Cipro from the company while the drug will be sold at hospitals and drug stores at the regular retail price. Even at a discounted price, Bayer is still making profits from huge orders placed by the health authorities. Meanwhile, perturbed over this lopsided agreement with Bayer, consumer activists in several states have filed a lawsuit asking the court to scrap the agreement that gives monopoly rights to Bayer.”

“Canada announced on October 18th that it would suspend Bayer's patent on Cipro and allow generic drug manufacturers to sell the drug in the country. The Canadian authorities also approached a domestic generic drug maker, Apotex, to produce one million pills since Bayer was unable to meet the demand for Cipro. Apotex agreed to sell its generic version at $0.95 per pill to the health authorities, which was significantly lower than $1.59 charged by Bayer.”

“This move by the Canadian health authorities sent shock waves in the entire pharmaceutical industry. The drug industry was taken aback by the sudden change in the Canadian stance because the country had consistently supported the US position on the intellectual property rights in the past. Bayer, in collusion with several lobby organizations, used all kinds of pressure tactics -- including threatening to sue the Canadian government -- to reverse this move. Within hours, Canadian officials reversed their stand and announced that they would honor Bayer's patent on Cipro and would buy the drug only from the company. This sordid episode demonstrates the power of the drug companies and their lobby organizations to stifle competition from low cost generic drug manufacturers.”

The US Administration: Hand in Glove with the Drug Giants

“The Bush administration did not suspend the patent of Bayer largely because it was more concerned with the wider implications of such an action, particularly on the ongoing negotiations at the WTO. Realizing that scrapping Bayer's patent would set a precedent that could give legitimacy to the growing demands of the poor and developing world for more flexibility on patent issues, the US sent a clear message to the world that patents are more important than public health. Such a calculated move was not only meant to serve the corporate interests of drug manufacturers, but also to convey the message to the developing nations that the US administration would continue its discriminatory policy on the issue of patents.”

“In international economic negotiations, the US administration has been one of the strongest allies of the global drug industry. Washington played a key role in initiating the Uruguay round of GATT negotiations where several TRIPs agreements on pharmaceuticals were pushed forward. The US has challenged various countries at the WTO tribunal and has even threatened trade sanctions against several countries including Thailand, India, South Africa and Brazil for breaching TRIPs. In the last couple of years, Washington has advocated even more stringent measures for protecting patents under the so-called 'TRIPs-Plus' mechanism.”

Cheers!

Andy

[Peter]

Great mention of the book!

Here you can find THE WHISTLEBLOWER MOVIE, sample pages and a lot more:

http://the-whistleblower-by-peter-rost.blogspot.com/

[HankBarnes]

Dr. Rost,

Welcome! We are rooting for you, Sir. Sue those bastards into oblivion:)

Hank

[Mouth of the Yellow River]

Ni Hao! Kannichi Wa!

More insiders are needed to “sing” (protest) louder (like Harvard Cell Biologist Steve Elledge) against the mounting mega-billion squander of valuable basic research resources aimed at mindless sequencing of cancer genomes known as the Human Cancer Genome Project, or filling what will be the endless (and mostly useless relative to its cost) Cancer Genome Atlas. (Search Google, Cancer Genome Atlas for recent news).

As expected the number of mutations in predicted coding genes is mind boggling (nearly 200) for a single cancer sample with almost no overlap between types of cancers (breast v. colon) according to the most recent paper in Science sequencing most genes from a couple of cancer samples (CANCER: First Pass at Cancer Genome Reveals Complex Landscape, Science 8 September 2006: 1370, DOI: 10.1126/science.313.5792.1370).

Not one of the hundreds of alterations have been demonstrated as cause of the cancer at any moment in time and space. Mostly likely most are random consequence and correlative to the individual cancer. Although this first study should be heralded as a cautionary one to re-evaluate and slow down the juggernaut, as expected it is being touted to justify squandering the predicted billions to sequence diverse cancer genomes ad infinitum that are expected to be endlessly different with no unifying cause and effect. These resources as those that will be squandered on AIDS research by Gates and Buffet money is sorely needed for more functional and rational individual investigator-initiated novel hypothesis testing.

As thinkers like Peter Duesberg, Harvey Bialy and others have predicted, cancer is a continuously evolving organism comprised of continuously evolving single cells within it in respect to single genomic mutations because of increasing genetic instability that occurred early in its origin due to massive genomic shuffling (aneuploidy). We are now on the way to sequencing every individual type of cancer sample from every individual, at every time in its progression and evolution long after it is detectable for sampling, and from every cell within the mind-boggling heterogeneous sample defined as a single cancer sample. And with that information a new target emerges for design of a drug for intervention with consequences of every one of the hundreds of the downstream alterations.

At least HIV is a single potentially false target to squander billions on for drug intervention with AIDS. Where the Cancer Genome Atlas is headed gives us orders of magnitude greater potentially correlative, not causal targets, underlying cancer without being any further towards a unifying understanding and rational approach to prevent cancer at its origins or combat the symptoms of it in a general way.

MOTYR

[HankBarnes]

Welcome Mouth!

Well done, you are one insightful dude (or dudette).

Following the "success" of the human genome project, I recall Venter (or someone else) suggesting an immediate embarking on a further mindless boondogle (the human cancer genome project, to which you allude), whereupon Dr. Duesberg quipped:

"Why don't they start with the diploid ones?"

Ba-de-bing

HB

[Daniel Haszard]

Eli Lilly is a big drug company that puts profits over patients.

They covered up findings that their Zyprexa has a TEN times greater risk of causing type 2 diabetes

Daniel Haszard Eli Lilly zyprexa drug caused my diabetes http://www.zyprexa-victims.com