2 Paths of Bayer Drug in 80's: Riskier One Steered Overseas
New York Times
By continuing to sell the old version of the life-saving medicine, the records show, Cutter officials were trying to avoid being stuck with large stores of a product that was proving increasingly unmarketable in the United States and Europe.
Yet even after it began selling the new product, the company kept making the old medicine for several months more. A telex from Cutter to a distributor suggests one reason behind that decision, too: the company had several fixed-price contracts and believed that the old product would be cheaper to produce.
Nearly two decades later, the precise human toll of these marketing decisions is difficult, if not impossible, to document. Many patient records are now unavailable, and because an AIDS test was not developed until later in the epidemic, it is difficult to pinpoint when foreign hemophiliacs were infected with H.I.V. -- before Cutter began selling its safer medicine or afterward.
But in Hong Kong and Taiwan alone, more than 100 hemophiliacs got H.I.V. after using Cutter's old medicine, according to records and interviews. Many have since died. Cutter also continued to sell the older product after February 1984 in Malaysia, Singapore, Indonesia, Japan and Argentina, records show. The Cutter documents, which were produced in connection with lawsuits filed by American hemophiliacs, went largely unnoticed until The Times began asking about them.
2. GSK Sold Ineffective, Addictive Anti-Depressant (Paroxetine aka Seroxat aka Paxil) to Children
GSK Knew Seroxat Wasn't 'Effective' On Children
BBC News, 2/3/04
The secret document, relating to two clinical trials held in the 1990s, reveals that drug trials had shown little or no effect on helping depression in minors.
The company was also advised to avoid publishing the full data because it would be "commercially unacceptable" and would "undermine the profile" of the drug.
The confidential paper, sent anonymously to BBC's Panorama programme, reveals that the company were advised to publish only the positive aspects of one study and that there were no plans to publish a second - more negative - study.
The document claims that in one trial the drug was no more effective in reducing depression in minors than a placebo pill. In a second study, the placebo drug [i.e. the sugar pill] seems to be more effective in combating feelings of depression in teenagers.
It was concluded "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated."
The company was also worried that such a statement would "undermine the profile of paroxetine (Seroxat's medical name).
GlaxoSmithKline (GSK) Staff Told Not To Publicize Ineffectiveness If Its Drug
British Medical Journal, 2/21/04
CMAJ (the journal of the Canadian Medical Association) has published details of an internal document from the drug company GlaxoSmithKline that advised its staff to withhold the findings of a clinical trial in 1998 showing that the antidepressant paroxetine had no benefit in treating adolescents.
The association has publicised the document on its website in an early release of its Analysis column (www.cmaj.ca).
Last year, the drug, which is marketed as Paxil in North America and Seroxat in the United Kingdom, was banned for paediatric use in several countries because of a perceived increased risk of suicide.
The UK Medicines and Healthcare Products Regulatory Agency advised doctors last June that they should not prescribe the drug to patients under the age of 18.
3. The Bernie Madoff Ponzi Scheme
The Talented Mr. Madoff
The New York Times
So who was the real Bernie Madoff? And what could have driven him to choreograph a $50 billion Ponzi scheme, to which he is said to have confessed?
An easy answer is that Mr. Madoff was a charlatan of epic proportions, a greedy manipulator so hungry to accumulate wealth that he did not care whom he hurt to get what he wanted.
But some analysts say that a more complex and layered observation of his actions involves linking the world of white-collar finance to the world of serial criminals.
They wonder whether good old Bernie Madoff might have stolen simply for the fun of it, exploiting every relationship in his life for decades while studiously manipulating financial regulators.
“Some of the characteristics you see in psychopaths are lying, manipulation, the ability to deceive, feelings of grandiosity and callousness toward their victims,” says Gregg O. McCrary, a former special agent with the F.B.I. who spent years constructing criminal behavioral profiles.
Madoff Whistleblower Blasts SEC
CNN Money
NEW YORK (CNN) -- A whistleblower who repeatedly warned the Securities and Exchange Commission that Bernard Madoff was perpetrating a massive investment fraud testified Wednesday that the regulatory agency that oversees financial markets is inept, "financially illiterate" and far too cozy with the financial titans it is supposed to be regulating.
"The SEC is also captive to the industry it regulates and it is afraid of bringing big cases against the largest most powerful firms," said Harry Markopolos, an independent financial fraud investigator. "Cleary the SEC was afraid of Mr. Madoff."
Markopolos began contacting the SEC at the beginning of the decade to warn that Madoff was a fraud. He sent detailed memos, listing dozens of red flags, laying out a road map of instructions for SEC investigators to follow, even listing contacts and phone numbers of Wall Street experts whom he said would confirm his findings. But, Markopolos' whistle-blowing effort got nowhere.
Madoff Sentenced to 150 Years on June 29th 2009
• Given the nature of Madoff's previous house arrest, the fact that he knew he would be caught and that he is an unrivaled con artist with friends he did not betray his stay in prison is likely to be a comfortable one. Stay tuned for a news story on his having an HDTV, a leather couch and expensive liquors in his "cell".
4. Corporate Accounting Scandals 2000-2002
The Corporate Scandal Sheet
Forbes, 8/26/02
NEW YORK - With the avalanche of corporate accounting scandals that have rocked the markets recently, it's getting hard to keep track of them all--but our Corporate Scandal Sheet does the job. Here we'll follow accounting imbroglios only--avoiding insider-trading allegations like those plaguing ImClone, since chronicling every corporate transgression would be impractical--and our timeline starts with the Enron debacle.
5. Pfizer Experiments on Critically Ill Nigerian Children Without Parental Consent, Fires Whistlebower and Settles for $75 Million.
November 13th 2008
Pfizer's Nigerian Nightmare
Forbes Magazine
What really happened at a remote sub-Saharan hospital in Kano, Nigeria may never be known. But interviews with Pfizer employees, parents of some of the victims, Food & Drug Administration officials, court filings and other legal documents provide an unsettling look at the pitfalls of doing hurried drug trials in Third World countries.
That's happening more often these days. Under pressure to reduce research costs and win fast-track approvals, drug companies do 43% of their clinical trials abroad, up from 14% ten years ago. The Tufts Center for the Study of Drug Development says that number will rise to 65% within three years.
Pfizer had hired Juan Walterspiel, a pediatric infectious disease specialist at Yale Medical School, in 1994 for Trovan's pediatric clinical development. Pfizer says it doesn't know why Dr. Walterspiel wasn't selected to go to Nigeria. But Dr. Walterspiel, who declined to speak with FORBES, would later write to chief executive Steere that the Nigerian study was "in violation of ethical rules for the conduct of medical experiments in humans."
But parents of the dead children in the Trovan group claim they were never shown--or were read--a consent form and weren't told about Trovan's risks or that a proved treatment from Doctors Without Borders was just steps away.
Pfizer says it had bilingual nurses on-site who obtained oral consent from all the parents. The company also says it has all the patient charts with "yes" and "oral" boxes checked as to whether and how their consent was obtained. But Pfizer declined to show these consent forms to a reporter.
However the lawsuits turn out, no more patients will be exposed to Trovan. Having initially applied to use it for pediatric meningitis, Pfizer withdrew that use from its application after the FDA audit found dozens of discrepancies in Pfizer's records. The company says it intended to renew its application following a global pediatric trial already under way.
But it never had the chance. After approving Trovan for 14 other uses in 1997, the FDA advised Pfizer to pull the drug--two years and more than 2.5 million prescriptions later--citing "safety concerns." The problem: deaths from Trovan-linked liver injuries.
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