NEW YORK – While skimming tens of millions of dollars from U.N. levies imposed on airline travelers, the Clinton Foundation's Clinton Health Aids Initiative worked closely with a pharmaceutical company in India to distribute "drastically substandard" generic antiretroviral drugs to Third World countries that had no chance of helping HIV/AIDs patients, according to a Wall Street analyst.
As WND reported Wednesday, over the past six weeks, Charles Ortel shared with WND, prior to publication, the results of his six-month, in-depth investigation into what he characterizes as an elaborate scheme devised by the Clintons to enrich themselves. WND reported Thursday the Clintons appear to have personally profited from an airline-ticket levy program run by the U.N. group UNITAID that used the Clintons' international prestige to “leverage” manufacturers of prescription quality drugs and health-care products and sell them to developing countries at a discount price.
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Ira Magaziner, the chief executive officer and vice chairman of the Clinton Health Aids Initiative, known as CHAI, approached the Indian company, Ranbaxy, in 2002 to negotiate a deal. It allowed CHAI to assume a controlling position to administer the airline-ticket levy program through UNITAID, a program of the U.N.'s World Health Organization in Geneva.
CHAI proposed to Ranbaxy that "they could put the developing countries together to form a sort of 'buying club' that could "ramp up economies of scale and lower cost," according to Professors Ethan B. Kapstein of Arizona State University and Joshua W. Busby of the University of Texas at Austin in their Cambridge University Press 2013 book "AIDS Drugs for All."
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A Kaiser Health News "Morning Briefing" dated Nov. 21, 2003, reported former President Bill Clinton "visited Indian generic drug Ranbaxy Laboratories' pharmaceutical plant in Gurgaon, India, to show support for Indian companies that have agreed to manufacture low-cost generic antiretroviral drugs for nationwide HIV/AIDS treatment plans in four African and more than 12 Caribbean countries."
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Clinton hooks up with UNITAID and WHO
According to the UNITAID website, CHAI, established by President Bill Clinton in 2002, approached UNITAID, created in 2006, "to reach groups in developing countries that were neglected by HIV drug markets," resolving to combine forces in 2008.
The UNITAID-CHAI joint venture's goal was to combine UNITAID's innovative financing that relied on levies charged on airline tickets in participating countries with CHAI's entrepreneurial approach to getting international pharmaceutical companies to produce antiretroviral, or ARV, drugs throughout the developed world at prices discounted because of the massive scale of the market.
"The deal positioned the Clinton Foundation to have access to hundreds of millions of dollars from what amounted to a tax imposed on millions of average airline passengers," explained Ortel.
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"The Clinton Foundation financial reporting strongly suggests the Clintons were able to skim off for their personal use tens of millions of dollars from the funds WHO sent to CHAI from UNITAID levies," Ortel said.
"The scam was perfected," he concluded, "when a key player in developing the CHAI 'discount generic drug' strategy touted as revolutionary by Bill and Hillary Clinton, namely Ranbaxy in India, achieved their 'economy of scale' by selling drugs the company knew were so drastically substandard that the Ranbaxy ARV products had no chance of curing any HIV/AIDS patients taking the drugs in the third world countries to which the Clinton Foundation delivered them.
"It seems in hindsight a textbook case of reckless and wanton neglect," Ortel stressed.
'It's just blacks dying'
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Ranbaxy on May 13, 2013, pleaded guilty to seven federal criminal counts of selling adulterated drugs with an intent to defraud.
The company failed to report that its drugs didn't meet specifications and made intentionally false statements to the government.
Ranbaxy agreed to pay $500 million in fines, forfeitures and penalties, the most ever levied against a generic-drug company.
A Fortune magazine article in May 2013 by investigative reporter Katherine Eban titled "Dirty Medicine" detailed the Ranbaxy pharmaceutical scandal.
The article captured the moral bankruptcy of Ranbaxy through a conference call Dr. Kathy Spreen, Ranbaxy's executive director of clinical medicine, had with a dozen company executives in which a participating Ranbaxy executives dismissed concern that the company was producing defective drugs.
"Who cares? It's just blacks dying," the executive said, according to Fortune.
Fortune further reported a decision by Ranbaxy to withdraw all seven of its ARVs tested by Vimta Labs from WHO prequalification, as announced by the WHO Nov. 9, 2004, was dishonest.
Ranbaxy executives plotted to blame the problem on fraudulent tests run by one rogue contractor without disclosing further problems that may have made it more difficult, if not impossible, to re-establish WHO approval of Ranbaxy ARV drugs tested by labs other than Vimta.
Less than a year later, on Aug. 16, 2005, Ranbaxy managed to get the World Health Organization to reinstate the seven ARV drugs to the WHO prequalification list. The company did it simply by convincing the WHO that Ranbaxy management had solved the problem by replacing Vimta Labs with "globally recognized contract research organizations" assigned to conduct independent tests of the ARV drugs Ranbaxy had produced in its "WHO-approved plants."
The Fortune magazine exposé, however, made clear Ranbaxy never stopped the subterfuge until forced to do so by the Department of Justice settlement in 2013.
Fortune reported Ranbaxy "manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data," including forging standard operating procedures to hide from health inspectors the truth that Ranbaxy never stopped substituting "cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bioequivalence tests to produce better results."
The Fortune article further exposed "systematic fraud in Ranbaxy's worldwide regulatory filings" designed to hide that the majority of products filed in Brazil, Mexico, the Middle East, Russia, Romania, Burma, Thailand, Vietnam, Malaysia and African nations "have data submitted that did not exist or data from products and from other countries."
Fortune noted Ranbaxy "not only invented data but also fraudulently mixed and matched data, taking the best results from manufacturing in one market and presenting it to regulators elsewhere as data unique to drugs in their markets."
For its HIV drugs, Fortune concluded Ranbaxy "had used ingredients that failed purity tests and blended them with good ingredients until the resulting mix met requirements," such that "a mélange cold degrade or become toxic far more quickly than drugs made from the high-quality materials required."
"The Ranbaxy tragedy," Ortel pointed out, "was that even after the Clintons had reason to suspect Ranbaxy was producing defective ARV drugs for HIV/AIDS patients in Third World countries.
"Yet, CHAI continued to allow Ranbaxy to sell Ranbaxy ARV drugs into the stream of pharmaceuticals that flowed to desperately poor suffers, as if there were no problem."
Clintons endorse Ranbaxy
A UNITAID press release May 17, 2011, announced that since 2008, the CHAI partnership with UNITAID had "achieved price reductions that will generate global savings of at least $600 million over the next three years, making HIV treatment more widely available."
"With more than nine million people worldwide in need of HIV/AIDS treatment, we must see rapid action to increase people's access to treatment," Clinton said in the UNITAID press release.
"Over 70 countries and 70% of the HIV-infected population have access to the prices my Foundation negotiated; so these new price reductions, which have been agreed to by a wide range of suppliers, will provide millions of people with increased access to better, cheaper and more convenient first and second-line drug regimens," Clinton continued. "We have helped almost four million people gain access to life-saving medicine, and I'm proud that we can now reach millions more."
What Clinton neglected to mention was that since the formation of the CHAI partnership with UNITAID in 2008 through the date of the 2011 press release, Ranbaxy ARV drugs were on the list of CHAI-provided HIV/AIDS drugs available for distribution in Third World countries.
Fortune made clear the Ranbaxy scam of producing adulterated ARV drugs was known to Ranbaxy executives as early as 2004. It was made public in a U.S. Justice Department court filing in 2008 but not stopped until January 2012, when the Justice Department placed Ranbaxy under a sweeping consent degree the Justice Department described as "ground breaking in its international reach."
The UNITAID May 15, 2013, statement mentioned in the last paragraph that Ranbaxy was among the CHAI/UNITAID "key suppliers of ARVs."
A CHAI-produced "Antiretroviral (ARV) Price List" dated May 2011 that includes Ranbaxy on the list of approved drugs boasted: "The Clinton Health Access Initiative (CHAI) supports national governments to expand high-quality care and treatment to people living with HIV/AIDS. CHAI offers reduced prices for antiretrovirals (ARVs) to members of its Procurement Consortium."
Yet, in a visit to Mumbai April 11, 2013, Bill Clinton praised Ranbaxy for its role in assisting his Clinton Foundation in leading efforts to treat AIDS patients by agreeing 10 years earlier to cut the price of its ARV drugs sold in developing nations.
"I told myself that never again will I come to India without saying a thank you," drawing applause from 600-plus people who included "some of India Inc.'s leading CEOs, businessmen, and strategists," the Economic Times reported.
Despite Ranbaxy being in the process of finalizing the $500 million settlement with the Department of Justice, Clinton was as enthusiastic during his 2013 to India as he was 10 years earlier, when on Nov. 21, 2003, he was there to announce the Ranbaxy deal.
In 2003, Clinton used a Ranbaxy R&D facility in New Delhi to hold a press conference with Prime Minister Atai Bihari Vajpayee and several representatives of the Indian government to announce the Clinton Foundation had just reached an agreement with Ranbaxy to sell to HIV/AIDS patients in the developing world.
In the speech, Clinton bragged the Clinton Foundation in conjunction with Ranbaxy aimed to make low-cost ARV drugs in the countries of South Africa, Rwanda, Mozambique, Tanzania, Haiti, the Bahamas, the Dominican Republic and the Eastern Caribbean States with the goal of making ARVs available to "some 2 million people around the world in the next four to five years."