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Cassandra Books - Monthly Newsletter (May 2001)
- By Kathleen Deoul
The Anthrax Vaccine: Making Our Soldiers Guinea Pigs Part One
Arlington cemetery is a solemn place. Row upon row of white markers stand in silent testimony to the sacrifice that has kept America free. From the desperate winter at Valley Forge to the burning heat of the Kuwaiti desert, citizen-soldiers have placed themselves in harm’s way to defend our nation. They did so willingly, in full knowledge that they might have to pay the ultimate price. Despite this knowledge, they chose to subordinate their own safety and well being to the greater good. Their country called and they answered. Today, our brave young men and women are again being called to service and are again answering that call. As in times past, they do so in full understanding of the risks they face – at least on the battlefield. There is, however, another risk America’s citizen-soldiers may face. But it is not a risk posed by some fanatical enemy or foreign power. It is a risk that comes from the end of a needle – ironically a needle that is supposed to provide protection from a battlefield threat. It is the risk posed by the anthrax vaccine. Over the next few months, as many as 400,000 American military personnel may be initiating the six shot anthrax immunization regimen. Department of Defense officials insist that the so-called Anthrax Vaccine Immunization Program or AVIP is a necessary precaution to protect our troops from the threat of an attack with the deadly virus. More important, they have consistently claimed that it is safe. But is it? Many members of the armed forces don’t think so. In fact over 440 of them have faced judicial action rather than take the vaccine. They may be right. Even as the Department of Defense insists the vaccine is safe, evidence is mounting to challenge that conclusion – evidence from their own studies. One study of soldiers at Ft. Bragg, N.C. found that 44 percent of those vaccinated suffered an adverse reaction. Another study conducted at a U.S. facility in Korea found that between 72 percent and 74 percent of women who received the vaccine suffered an adverse event and that between 42 percent and 44 percent of men who were vaccinated had such a reaction. These figures are a far cry from the 5 percent to 35 percent rate that DOD claims. Of course, the statistics don’t really tell you what the reactions entail. Major Roman Savioe, an Air Force pilot with over 25 years service who ultimately resigned her commission rather than be vaccinated described what members of her squadron experienced. “ Some people were saying it was the most painful vaccine they’d ever had, and their arms were sore for three weeks at a time with big lumps in them. Some people were losing strength in their arms. The ones that got me were the dizziness, tingling that didn’t go away. And just fatigue. And as a pilot, if you’re dizzy or experience any kind of vertigo for an unexplained reason, that’s the end of your career. It’s over.” What is perhaps worse, is the military’s failure to acknowledge the problem. One well-documented case is that of Air Force pilot Michelle Peal. After being vaccinated, Captain Peal was flying back from Honduras when her right ear began to fill with fluid. She described the experience as being like “someone turned on a faucet.” When she landed at Pope Air Force Base in North Carolina, she was immediately grounded by the flight surgeon that initially diagnosed her as having a head cold and middle ear infection. Within days, the fluid build-up in her ears began to cause dizziness. When the problem persisted, the military’s reaction was to accuse her of malingering – faking it. It was only with the intervention of her commanding officer that she received proper medical care. Even then, however, she was never returned to flight status. Her career was over. Major Savoie knows of many other cases. Moreover, almost half of her squadron – 32 pilots in all – resigned rather than allow themselves to be vaccinated. Despite these facts, Dr. Sue Bailey told Congress “The vaccine has very few side effects, and they are mild and they are temporary.” So what is the real story? Is the Anthrax Vaccination Implementation Program a vital step in protecting our troops against a threat, or is it something else? DOD claims the former, but a review of thousands of pages of congressional testimony and documents as well as first-hand interviews of military personnel forced to take the anthrax vaccine paints a very different picture. It is picture of an out of control program tainted from the outset by corruption, cronyism and arrogance. It is a picture of a program that has put profit and public relations ahead of the well being of our men and women in uniform. Most disturbingly, it is a picture of a program that may pose a greater threat to military readiness than any foreign aggressor. A QUESTIONABLE SOURCEThe truth is that there have been questions about the Anthrax Vaccination Implementation Program, or AVIP from the start. One of the most important of the controversies surrounding the AVIP has centered on the vaccine’s manufacturer, BioPort Corporation and its predecessor the Michigan Biologic Products Institute or MBPI. Established in 1907 by the State of Michigan, MBPI was one of a number of state-owned vaccine laboratories established in the 1920s. Early in its history, MBPI produced vaccines such as the diphtheria-pertussis-tetanus shot given to school age children. In 1965, the Department of Defense and the Centers for Disease Control awarded MBPI a contract to initiate development of an anthrax vaccine. MBPI received a license from the FDA to produce the vaccine in 1970. Since anthrax had been virtually eliminated in the United States, only about 68,000 doses of MBPI’s anthrax vaccine were administered over the next two decades – an average of about 1,300 per year. It was a marginal product used primarily by veterinarians and tannery workers. The Iraqi invasion of Kuwait would radically alter its status. As the U.S.-led coalition deployed to the Persian Gulf in 1990, military commanders were gravely concerned over the possibility that Saddam Hussein would attack with biological weapons. Since he was believed to hold substantial stockpiles of anthrax spores, protecting our troops against this deadly disease was a high priority, and MBPI was the only vaccine manufacturer that had a licensed anthrax vaccine at that time. Even though it had not been approved for protection against inhalation anthrax, a decision was made to vaccinate all U.S. troops, and some 600,000 doses were administered – despite the fact that the vaccine had never been tested for inhalation anthrax. In the months following the Gulf War’s conclusion, tens of thousands of soldiers who had fought there began complaining of a variety of symptoms – all essentially autoimmune dysfunctions. Their malady would eventually be given a name – Gulf War Syndrome. There was a problem, however, no specific cause could be identified. One prevailing theory was that troops had been exposed to low levels of biological and chemical weapons when Hussein’s stockpiles were destroyed. Eventually, another potential cause was suspected: the anthrax vaccine troops were given to protect them against this very threat. Still, confirmation of the Iraqi stockpiles of biological weapons was seen as a warning bell. Our troops would have to be protected against this threat in the future. THE DEFAULT CHOICEWith the newfound concern over biological weapons in general and anthrax in particular, DOD officials renewed their interest in a vaccine to protect the troops. Although the MBPI product had been used in the Gulf War, it was widely viewed as a stopgap within the military command structure – something that was used by default because there were no other options. There were several reasons why many military leaders held this view. First, as noted, was the fact that existing vaccine had not been specifically designed to combat inhalation anthrax – the primary threat in a wartime environment. A second concern was how effective the existing vaccine would be against a bio-engineered “weaponized” version of the anthrax spore such as troops would likely encounter. A third concern was the fact that the existing vaccine was over twenty years old and used antiquated manufacturing processes. Finally, there were concerns regarding the manufacturer itself. MBPI had fallen on hard times. A lack of investment had allowed the facility to fall into such a sad state of repair that it failed a number of FDA inspections. By the late 1990s it was estimated that at least $15 million would have to be invested by the State to bring it into compliance. Otherwise, the FDA indicated they would shut it down. As a result, a decision was made to sell the facility to a private company. It was at this point that things got interesting. The two MBPI employees who were assigned the task of facilitating the sale formed a partnership, Michigan Biologic Products, Inc., or MBP Inc., to purchase the Institute. They had good reason to be interested in a buy-out. They had insider knowledge of a pending lucrative contract from the Department of Defense to produce anthrax vaccine for military use. This, mind you was in addition to other products such as the DPT vaccine and Rabies vaccine that Institute already was selling. Astoundingly, the State permitted them to bid on the purchase despite what many would see as a conflict of interest. Even more curious was the facility’s valuation. An outside accounting firm was brought in and, with the assistance of the two employees valued the Institute at a mere $10.5 million. The figure was so low that Michigan State Representative Lingg Brewer filed a lawsuit to block the sale from going through. Although his suit would not be successful, his complaint apparently was, because the ultimate sales price was $25 million! Initially, it didn’t seem to matter that the two employees had bid on the purchase because the winning bidder was a company called BioPort that was formed for the specific purpose of purchasing the Institute. But like all things associated with the anthrax vaccine, there was more to the story than was being told. AN INSIDER DEAL?To say that BioPort was the product of a murky financial web is an understatement. Understanding its shadowy beginnings, however, is an important part of understanding the entire anthrax controversy. BioPort was established by a company called Intervac for the express purpose of purchasing the Michigan Biologics Products Institute. One of the principal owners of Intervac was none other than Admiral William Crowe, former Chairman of the Joint Chiefs of Staff, and Clinton appointee as Ambassador to Great Britain. According to his own spokesman, Crowe, who owns 22.5 percent of Intervac made no financial investment in the company. Some 30 percent of Intervac stock is held by Nancy El-Hibri who ABC News described as a “mother and homemaker in Suburban Maryland.” It is the balance of the ownership, however, that is of real interest. It is held by a company called I&F Holdings which is owned by El-Hibri’s father-in-law Ibrahim El-Hibri and Mrs. El-Hibri’s husband, Fuad El-Hibri. The senior El-Hibri is a Lebanese citizen, and Fuad El-Hibri held German citizenship at the time of the sale. He has since become a naturalized American. Previously, Fuad El-Hibri worked in the mergers and acquisitions department of Citibank in Jeddah, Saudi Arabia where he acted as a financial advisor to a number of wealthy Saudis. When the Saudis indicated that they were interested in obtaining vaccines against biological agents – particularly anthrax and botulinum Type A – he decided to fill that need. The El-Hibris (Fuad and his father) set up I & F Holdings to purchase Porton Products Ltd., a British company that marketed various vaccines against biologic agents. They immediately began selling large quantities of anthrax vaccine and botulinum Type A vaccine to the Saudis. With the acquisition of the Institute, I & F Holdings had an effective worldwide monopoly on the anthrax vaccine. Defense experts suggest that the Pentagon would never have approved the purchase of a facility that was the sole producer of a product deemed vital to national security to a company controlled by a foreign national, so Crowe’s ownership position was critical to the sale. His share in the venture, combined with that of Mrs. El-Hibiri, who is also is a U.S. citizen meant that over 50 percent of BioPort was owned by American nationals. The fact that Mrs. El-Hibri’s husband was a foreign national with strong ties to the Middle East apparently didn’t occur to the DOD screeners. Citizenship wasn’t all that Crowe brought to the table. Just one month after the sale was completed the Pentagon granted BioPort a $29 million contract to produce, bottle and store anthrax vaccine. But that wasn’t all. The Pentagon also agreed to provide the $15 million for renovations the FDA wanted made to the plant. Moreover, experts familiar with the Pentagon’s plans concerning the vaccine estimated that over time the contract could be worth as much as $300 million. It all the earmarks of a sweetheart deal – and then another shoe dropped. Representative Brewer, still not satisfied with the purchase price filed suit to block the sale. In the course of his suit it was revealed that there was another group of investors involved in the sale: the two state employees who had been overseeing the bidding process! They wound up with a 32 percent stake in the new venture, but that’s not all. The details of the sale were remarkable. To begin with, the State itself provided much of the funding for the purchase through low-interest loans. Not only that, but a substantial portion of the purchase was to be paid for “in-kind” by providing various vaccines and other biologic products. In the end, BioPort only had to come up with $3.25 million in cash for their $25 million purchase! Over the next few years, however, the federal government’s largesse made the State seem like a piker. According to testimony by the Government Accounting Office, once DOD got involved, the BioPort gravy train really got rolling. First, on August 4, 1999 the Department provided what they called “extraordinary contractual relief.” And what was this relief? To begin with, the value of the contract was raised by $24.1 million by raising the price of each dose to $10.64. Originally it had been $2.26! Then DOD gave BioPort an interest-free advance payment of $18.7 million. DOD also allowed BioPort to hold back a portion of its vaccine stockpiles for sale to civilian customers. Finally, DOD reduced the quantity of vaccine BioPort was required to deliver from 7.9 million doses to 4.6 million. This, however, was just the beginning. In February of 2000, DOD increased the value of BioPort’s contract by an additional $13 million. It also agreed to return $7.4 million of the advance $18.7 million payment the company had repaid to the Department and to extend the repayment terms of the advance. A Government Accounting Office Audit of BioPort’s funding, however, discovered over $2 million in inappropriate spending, including some $1.28 million in bonuses for company executives, $900,000 in spending for office furniture and a $10,000 per month sweetheart consulting contract to a former employee. Overall, between 1999 and 2001, DOD would pump over $75 million in BioPort even though it still had not obtained full FDA approval! But what has all this money bought? Potentially nothing but trouble, because nagging doubts about the vaccine’s safety remain. In part two of our special series on the anthrax vaccine, we will discuss the real facts about the vaccine'’ safety. Be sure to visit next month to get more of the story. |