Posted on 06/20/2002 1:37:20 PM PDT by goody2shooz
Heard around 12:25 pm on Fox News Alert: the CDC, in a panel of twelve "experts", have announced that no widespread vaccinations of Americans will be conducted.
Right now, the major vaccine manufacturers are having trouble even delivering the routine childhood vaccines. We've had a national shortage of whooping cough, tetanus, chickenpox, measles, mumps, rubella, and pneumococcal immunications. These shortages are peculiar and deserve investigation from the AG's office.
Meanwhile, we're all still sitting ducks for anthrax and smallpox because a bunch of pencil-necked bureaucrats feel that THEY should be setting medical policy for all citizens...instead of permitting ADULTS to make a decision for themselves!
Someone from the administration needs to tell the ACIP, AAP, AAFP, and CDC (if you know the acronyms, you should be doing something about this scam) that the free market can actually take responsibility.
The major reason for the problems in vaccine production stem from liability issues. So many people are suing the vaccine companies that there are now only 4 (really only 3) vaccine companies in the entire nation!
Actually, the Soviet India 1 strain was not successfully engineered to have an equal mortality rate against non-vaccinees as against vaccinees. It can infect and sicken people who were vaccinated, but usually ones who were vaccinated more than 10 years earlier, or who had weakened immune systems.
If Saddam or al Qaeda hit us with smallpox, the strain they use may be similar to the Soviet strain.
Its highly likely that it will be identical to the Soviet strain. The Soviets produced 20 tons of this stuff and goodness knows whether or not it was all destroyed. Any impoverished Russian scientist could have pocketed a vial and flogged it to the Iraqis or the Iranians.
Hmmmm.... I must have misinterpreted that article. I'll back and read it again tomorrow. Maybe it's not talking about the India 1 strain or something. Right now I'm getting offline. THanks.
My understanding was that the anthrax vaccine was being manufactured by a small facility in Michigan. However, I am not exactly familiar with the specifics of where the plants are located.
Frankly, I've been attempting to locate the vaccine production facilities for every vaccine in the US market in order to understand the ownership and political interests involved. However, I have been entirely unsuccessful. Although I am a physician and purchase tens of thousands of dollars worth of vaccines per year, the pharmaceutical industry is tight lipped regarding where the components of US vaccines originate.
We physicians are left with a "trust me" relationship!
Reagan's philosophy of trust but verify is crucial. However, the companies have not permitted verification of manufacturing issues by any other than FDA alone.
Wyeth pharmaceuticals, a division of American Home Products, was manufacturing the tetanus immunization. They withdrew from the market with only 10 business days warning to the entire nation. This left our entire nation with only one supplier, Aventis-Pasteur. Vaccines appear to require one year lead time to manufacture. So, Wyeth's sudden departure left our national health in a bad position.
Merck makes the Measles-Mumps-Rubella and the chicken pox vaccine. Both were in short supply in the early part of the year. However, Merck had the corporate citizenship to send letters to all physicians. The letter discussed the fact that the company was addressing issues identified by FDA. They were tightening security on the manufacturing facility and tightened controls on the processing of the live virus vaccine. Merck expects their operation to be up to full speed soon.
On the other end, Wyeth's 10-Q at Yahoo.Com appears to admit "manufacturing" issues. They can not project when shortages of the pneumococcal vaccine will end. It sounds as if the conjugate vaccine called Prevnar will be in short supply for the next year!
I want my family vaccinated!! I CANNOT understand this decision by the CDC.
The only hope is if the President and DHS secretary are strong enough to realize what's happening. They need to pass tort and liability reform laws. The days of the "Larry Parker, JD got me 2.1 million dollars" should be ended now!
The tort liability issues are primarily responsible for the inability of free market forces to bring the vaccines to market. If people want to get the vaccine, you can't. That is a total travesty!
FeatureSalon.com
October 15, 2001 Monday
The anthrax vaccine scandal
By Laura Rozen
Why did the Pentagon allow BioPort Corp. to remain the sole U.S. supplier of a crucial weapon against bioterror, despite years of failure to deliver the vaccine?
With each new confirmed anthrax infection raising fears of a wider bioterror attack in the U.S., pressure is mounting on the Defense Department and the Food and Drug Administration (FDA) to give the green light to Michigan-based BioPort Corporation, the nation's lone anthrax-vaccine manufacturer, to ship new lots of the vaccine to the Pentagon.
Anthrax vaccine shipments from BioPort have been suspended by the FDA since 1998 because of questions about the facility's quality control, forcing the Pentagon to dramatically reduce its program to vaccinate all 2.4 million U.S. soldiers and reservists against anthrax. Now the lack of the vaccine threatens to become a scandal, as the U.S. is sending thousands of soldiers overseas and calling up reserves, and as the public is clamoring for access to protection from the deadly bacterium.
After three years of getting bailed out by the Defense Department, BioPort could be poised to make a fortune -- as its CEO Fuad El-Hibri did working with the British seller of anthrax vaccine, Porton International, during the Gulf War a decade ago. But only if the FDA approves the company's renovated plant, as expected, sometime in the next week. The decision could open the door for BioPort to market the drug to a worried public, as new anthrax scares are reported daily. The story of the troubled U.S. anthrax-vaccine program is a tangled saga of science, politics, private-sector deal-making and national security. There have been persistent questions about the vaccine's safety and effectiveness. Critics say Defense Department studies have never proven the vaccine works against the more dangerous inhaled form of anthrax, only against cutaneous, or skin anthrax. Some military personnel have complained of mysterious illnesses after taking the vaccine, and at least 400 have been disciplined for refusing the mandatory inoculation. But the Pentagon insists the vaccine is both effective and safe. Even now, some researchers say the vaccine is seriously outdated, as BioPort gears up to ship more.
Then there are questions about BioPort's role as the nation's only anthrax-vaccine maker. How did Fuad El-Hibri, 43, a German-born entrepreneur and former director of British vaccine-maker Porton Products, come to have so much control over the West's supply of anthrax vaccine? Why didn't the Pentagon turn to a larger, more established drug maker for the crucial anti-biowarfare weapon? And how could it let BioPort remain the sole maker of the vaccine after it failed repeatedly to gain FDA approval for its renovated facility?
"It speaks to DoD culture more than anything else," says a congressional staff aide who asked not to be named. "The Pentagon just does not have a corporate culture. Once they decided to go with this program (BioPort), they stuck with it, even though oversight indicated they had built their biodefense program on a foundation of sand, and they had an unreliable producer. The DoD is simply incapable of admitting a mistake. They genetically just can't back out."
The Pentagon and BioPort deny they made a mistake, of course, and they believe their problems will be solved, perhaps next week. Government sources close to the process say as early as Monday, the FDA will approve BioPort's renovated facility, and enable it to resume shipments of the vaccine it has been stockpiling since 1999.
A government official who asked not to be named says while BioPort is "70 percent on the way there" in terms of improvements in quality control demanded by the FDA, political pressure due to the terrorism scare is playing more of a role than quality control in expediting FDA approval. But BioPort officials say FDA approval for their renovated facility is long overdue.
"We have heard the process will be speeded up, and it has taken an incredibly long time," said Jay Coupe, a longtime aide to Adm. William Crowe, who with Fuad El-Hibri serves as one of BioPort's owners, and who served as chairman of the Joints Chiefs of Staff during the Reagan administration. (Fuad's father, Ibrahim El-Hibri, also well-connected to the defense establishment, is a third partner in the venture.) "While BioPort certainly supports the FDA, and doesn't want any special consideration and wants a safe and effective vaccine, the approval process has gone on for a very long time for most vaccine manufacturers. This is one of the reasons people are getting out of the vaccine business."
"We have been manufacturing vaccine," BioPort spokeswoman Kim Brennan Root said. "As we submit final documentation for approval from the FDA, we have been manufacturing vaccine and contributing it to the stockpile so when approval comes we can be in a position to release the vaccine."
But critics of BioPort say that repeated FDA inspections have shown the company has failed to prove it can produce the same dose of vaccine twice.
"The most fundamental problem has to do with the quality of the process of vaccine manufacture," a congressional aide, who asked not to be named, told Salon. "They cannot show they can produce the same vaccine of the same potency and consistency twice in a row. The quality of the process is not validated. That means they don't have the data to show that, within this process, within this heat range, this process produces this vaccine. They are trying to retrofit a modern inspection and validation process on an old system."
"BioPort has tried to say it didn't know how much it would cost to bring the company to 2001 FDA standards," another congressional staffer told Salon. "But that is kind of a hard pill to swallow. They consistently showed deviations from good manufacturing practices. Some of the FDA complaints are substantive. There were contaminants in the lot. There were some deficiencies in packaging. There were problems with paperwork and record keeping. There was an inability to show consistency from one lot to the next."
"They have come a long way," he added, "at significant taxpayer support." Even if BioPort gets FDA approval to resume vaccine sales, anthrax vaccine will be available only to the military, not to the general public. That is, unless BioPort can step up production, and get the Defense Department to agree to sales to federal health agencies. If the current anthrax scare in New York and Florida grows, some members of the public are certain to pressure their political leaders for access to the vaccine.
"I will tell you right now, I wish I had access to the vaccine myself, I can tell you," says Dr. Zsolt Harsyani, a former business partner of Fuad and Ibrahim El-Hibri who is president of the Washington office of Porton International.
BioPort's Kim Brennan Root would not disclose how much vaccine the company had stockpiled while awaiting FDA approval for their renovated facility since renovation was completed in 1999. But a congressional aide who has researched the matter estimates that approximately 5 million doses are stockpiled. Vaccination requires six doses over 18 months, and a yearly booster shot.
In testimony to congressional committees, BioPort CEO Fuad El-Hibri has indicated BioPort's viability depends on being able to sell anthrax vaccine to a much larger market than to just the Defense Department, which he said is getting "rock-bottom prices."
"It has become clear to us that the prices paid by the Department of Defense for anthrax vaccine are significantly below BioPort's costs for producing anthrax vaccine," El-Hibri told the House Government Reform Committee in June 1999, a year after he purchased the Defense Department's former anthrax vaccine supplier. "Traditionally vaccine manufacturers have been able to offer lower prices to the government by recovering a substantial portion of their costs through commercial sales. Because of the current unavailability of product, the commercial sales market has not materialized as anticipated. Without a second market, the government cannot expect the rock-bottom pricing it enjoys with some of the other vaccines it purchases."
"As a commercial entity," el-Hibri added, "BioPort cannot continue to subsidize the DoD."
Critics of BioPort are outraged at El-Hibri's contention that BioPort has subsidized the Defense Department. Chief among them is U.S. Rep. Walter Jones, R-N.C., who sits on the House Armed Services Committee. Jones estimates that the Pentagon has paid BioPort almost $150 million since BioPort purchased the state-owned Michigan Biologics Products Institute (MBPI) in 1998, giving it the exclusive U.S. license to make anthrax vaccine -- with no new shipped vaccine to show for the money.
"My whole concern has been that this company cannot meet FDA requirements to produce the product," Jones told Salon Thursday. "So how long does the government continue to put taxpayers' money into a company that cannot produce the product?"
"Since former Secretary of Defense Bill Cohen raised the concern about the possibility of anthrax being used on the military or civilians," Jones added, "the Clinton administration made the decision to go with BioPort."
As his comment suggests, partisan politics may at least initially have played a part in Jones' troubles with BioPort, and its co-founder, Adm. Crowe. Alone among top military brass, particularly those who served Republican administrations, Adm. Crowe endorsed the election of "draft-dodger" Bill Clinton, who was widely despised by the Republican-leaning military establishment. Clinton rewarded Crowe for his endorsement, Jones suggests, with a plumb ambassadorship to England from 1994 to 1997.
And England in the years during and after the Gulf War is key to understanding the close links between the half dozen people who have come to dominate the sale of vaccines against deadly bioweapons in the U.S. and the U.K. Only two countries, the U.S. and Britain, make anthrax vaccine, and El-Hibri has been involved in both, first at Porton International in Britain during the Gulf War, and now with BioPort in the U.S., as the world faces a new terrorism scare. Sources say El-Hibri remained involved with Porton International up until the firm partnered with defense contractor DynCorps in 1997 to get a new Defense Department contract to make a second generation of vaccines against bioweapons. The new company is named DynPort Vaccine Company, and its license to make second generation vaccines to protect against small pox, anthrax and other bioweapons was publicly announced Thursday, although the contract appears to date from 1997. It was in Britain that Ambassador Crowe resumed his acquaintance with an old family friend, Ibrahim El-Hibri, a wealthy Venezuelan citizen of Sunni Lebanese descent, and his son Fuad. Ibrahim El Hibri had made a fortune in the telecom business with Phillips Company, working in the Gulf states.
Crowe and Ibrahim el-Hibri were first introduced decades ago by a U.S. Naval Academy classmate of the admiral who, like Ibrahim El-Hibri, lived in Venezuela. They had stayed in close contact during the 1970s when Adm. Crowe was posted to head the U.S. Central Command in Qatar, in the Middle East, where Ibrahim El-Hibri was active in his businesses. And in England during his ambassadorship, they met again.
The mania for privatization in Margaret Thatcher's England made it a great place for entrepreneurs like El-Hibri. In the 1980s, an El-Hibri acquaintance named Zsolt Harsyani, an American Ph.D. in genetics who had spearheaded an early report on biotechnology for the U.S. Office of Technology Assessment, became involved in what would become in its time the largest private biotechnology firm in the world, Porton International. Porton got the rights to sell vaccines and other products developed by the U.K.-government run laboratory, the Centre for Applied Microbiology and Research (CAMR), on commercial markets. CAMR had done the early research into products like botulinum toxin, or botox, a bacterium that can be injected to stop spasms (as well as prevent wrinkles, its most popular use in the U.S., at least until now) and anthrax vaccine.
The marketing relationship between Porton and CAMR ended in the 1990s, Dr. Harsyani said, and CAMR now markets its own products.
"At the time of Mrs. Thatcher, there was a philosophy in the U.K. supporting taking public works to the private sector," Harsyani told Salon. The spirit of public-private partnership that existed in Thatcher's England in the 1980s then moved to the States, Harsyani explained. "A lot of U.S. government and military research was not commercialized because there was no mechanism for it. One of the things that has changed in the United States in the last 20 years is that intellectual property that came out could in fact be owned by the institution where the researchers worked. The U.S. has now taken steps towards that kind of privatization."
In 1989-1990, with Persian Gulf tensions heating up and the U.S. and Britain preparing to lead a war against Saddam Hussein's invasion of Kuwait, El-Hibri became a principal silent investor in Porton, while his Yale and Stanford-educated son Fuad was installed as director of a Porton subsidiary, Porton Products. Their Middle East connections were put to use, as Porton sold tens of millions of dollars worth of anthrax vaccine to Saudi Arabia and other countries -- deals all approved by the British Ministry of Defense.
(A U.S. government investigator says Porton sold vaccine to Saudi Arabia at the insanely high price of $300-$500 per dose -- some 30 to 50 times what the U.S. Defense Department agreed to pay BioPort per dose.)
The Gulf War was a boon to businesses like Porton, as well as its officers, the el Hibris and Dr. Harsyani. Increasingly, they started to look for similar business opportunities in the U.S., particularly in areas that revolved around biodefense. They gravitated to opportunities where the government-run defense industry meets the private sector.
After the Gulf War, with concerns mounting in the U.S. about reports of Iraq's production of anthrax, Adm. Crowe was posted as ambassador to England. There, he resumed his friendship with the El-Hibris. About the same time, the El-Hibri family was hearing that the U.S.'s lone anthrax vaccine manufacturer, the state-owned Michigan Biologics Products Institute (MBPI), was financially troubled and looking for a buyer.
In 1970, the Michigan lab had received the only U.S. license to make anthrax vaccine, but its facility was antiquated. By the late 1980s, according to Judith Miller's "Germs," Michigan's Biologic Products Institute was making small batches of the vaccine -- 15,000 to 17,000 doses -- every four years, and selling them mostly commercially, to people in the animal hides business who came into contact with anthrax. But in 1988, the U.S. Army went to the lab and signed a contract to buy 300,000 doses in five years. The order was ambitious. By the time Gulf War troops assembled in early 1991, there was only enough vaccine to protect 150,000 of the half million troops assembled there, and none for civilians or allies, though the Saudis were able to buy some from the U.K.'s Porton International.
After the war, as worry increased over Iraq's biowarfare capacity, some in the Pentagon proposed that the military build its own vaccine factory, but officials thought it best left to the private sector. By 1996, however, concerns were mounting that the Michigan facility, already inadequate to the challenge of producing enough vaccine for the entire military, was having new problems. After several years of troubling inspections, the FDA threatened to close the lab in 1997, citing problems with sterility and equipment maintenance as well as scientific procedure. The only other facility producing a vaccine, Britain's CAMR, which at one time had a marketing relationship with Porton, now terminated, was using a different anthrax strain, and wasn't licensed for U.S. use anyway.
The el-Hibris and Crowe came up with the idea for BioPort, which they thought could do in the U.S. what Porton had done in Britain: bring private-sector methods (and profits) to a public research lab. As Fuad el-Hibri testified to Congress in 1999, "When BioPort was originally conceived, we believed that Admiral Crowe's background would be important in ensuring that we did everything correctly in establishing a company that would best serve DoD's needs."
El-Hibri and Crowe also partnered with two former managers of the state-owned facility, Robert Myers, who serves as BioPort's COO, and Rob van Ravenswaay -- a deal former Michigan state Sen. Linng Brewer, a Lansing Democrat, has long charged was ethically suspect, because Myers and Ravenswaay as employees of MBPI "knew the identities of at least two bidders (El-Hibri and Crowe) and the substance of their bids, information not made available to the general public. It appears they used information not available to others to enhance their financial position relative to the other bidders, a clear violation." The BioPort partners have long denied the charges.
In June 1998, BioPort's $24 million bid for MBPI -- $17 million upfront and the rest in loans to be paid over five years -- beat out competitors, including a $16.6 million bid endorsed by the Defense Department by Gruppo Marcucci, that involved no debt. Some expressed concern about selling the sensitive national security facility to a foreign company. (Brewer says the Marcucci bid lost out because it had failed to partner with managers of the Institute, but he has been unable to bring his ethical violations against Myers and Ravenswaay to court.)
A former Porton employee who asked not to be named says the company was looking to make a fortune on the Pentagon contract. "When El-Hibri bought the Michigan plant, he thought they would make a killing. The lab was already knocking out this product. The vaccine was already FDA approved. It's an essential business but no one wanted to talk about bioweapons back then, even though they knew Iraq and other countries had anthrax."
But it didn't turn out to be so easy. Despite El-Hibri's experience marketing anthrax vaccine at Porton, Crowe's strong ties with the defense establishment, and growing interest from the Pentagon in protecting troops from anthrax, BioPort's problems quickly mounted after it acquired the MBPI facility.
Troubles seemed unlikely, because in May 1998, shortly before BioPort's bid for MBPI was finalized, Defense Secretary William Cohen announced plans to require all 2.4 million U.S. soldiers and reservists to be inoculated against anthrax, which looked like a windfall for the new venture.
In testimony to Congress, Adm. Crowe has adamantly denied that he had any insider knowledge that led to his purchase of the anthrax vaccine facility. "It has on occasion been rumored that the decision to inoculate all service personnel was made to benefit BioPort Corporation and indirectly me, presumably because of my past associations with the military and the administration," Crowe told the House Committee on Government Reform in October 1999. "If this charge were not so ridiculous, it would be offensive. It outrageously exaggerates my influence. Let me be completely clear. I never, repeat never, solicited any official of this administration to install or promote a mandatory inoculation program."
Despite the Pentagon's decision to require anthrax vaccination for all troops, which clearly could have been lucrative for the new firm, BioPort was struggling. Only three months after their acquisition of MBPI, El-Hibri and Crowe were prevented from shipping any new vaccine, by a scathing FDA inspection that found over 40 items wrong with the plant, the vaccine, its consistency, the firm's accounting, and other problems. Indeed, by September 1999, BioPort was already appealing to the DoD for relief from a contract requesting BioPort's delivery of some 8 million doses of anthrax vaccine. It simply could not deliver, and certainly not at that price.
A Defense Department audit from July 12, 2000, shows that shortly after BioPort bought MBPI, the DoD awarded it a $29.4 million contract to supply 8.7 million doses of anthrax vaccine at the price of $4.36 a dose. But a year later, unable to ship product, BioPort requested and the DoD granted $24.1 million in relief to BioPort, reduced the number of doses demanded from 7.9 million to 4.6 million, and agreed to raise the price per dose from $4.36 to $10.36.
Even after a full-scale yearlong renovation of its manufacturing facilities, and significant efforts to meet FDA requirements to get its new facility reapproved, BioPort continues to wait for FDA approval to ship doses of the vaccine it has been manufacturing all this time. Problems have been found not simply with BioPort's process, but with the doses of the anthrax vaccine already produced. FDA tests found a lack of consistency in dosage and other problems with the finished product.
The delay has prevented the Pentagon from vaccinating all but the troops it is currently sending abroad, and has forced some soldiers to actually suspend vaccination mid-process.
"Now we're in a situation with the terrorist attack that we still have this company that has still not met FDA approval," Rep. Walter Jones says, "and we're spending almost $3 million per month on this company that is still months away from having FDA approval."
So why did the DoD stick with BioPort all these years of their failing to get final FDA approval -- until now, when the U.S. faces a real anthrax crisis?
"I blame everybody," says a congressional staffer well versed in the BioPort controversy. "The buyer -- the Pentagon -- kept BioPort alive. The DoD should have pulled the plug on this outfit a long time ago."
To be fair to the Pentagon and BioPort, however, it's not as if major pharmaceutical companies have been clamoring for the contract. A reliable anthrax vaccine has proven hard to make, and questions about its safety have likely scared off other manufacturers (although the Defense Department agreed to protect BioPort against lawsuits by military personnel.) Even now, just as BioPort seems set to perhaps overcome its long regulatory and financial difficulties, many in the industry and government are coming to consensus that the anthrax vaccine BioPort produces is outdated.
Increasingly, the government is also supporting research into a second generation of vaccines that can protect against multiple bacteria -- perhaps all in one shot. The government has also turned to the well-connected defense contractor, DynCorps, known for its involvement in the drug war in Colombia, and sending retired U.S. cops to Bosnia and Kosovo to serve as U.N. police, to subcontract vaccine research. (DynCorps was implicated in the accidental killing of an American Baptist missionary and her infant daughter by the Peruvian military earlier this year.) In 1997, DynCorps partnered with the El-Hibris' old company Porton International, to form DynPort Vaccine Company (DVC), just in time to beat out four other bids for a $322 million, 10-year contract.
Under the award, "DVC acts as a prime system contractor for the management of the existing stockpile of biological defense vaccines (except anthrax vaccine) and the advanced development, testing, production, FDA licensure, and storage of up to 18 new biological defense vaccines, including new vaccines against anthrax, small pox, plague, botulism and tularemia," according to Pentagon spokesman Jim Turner.
Why did the Pentagon turn to the unknown DynPort over more established companies? Some in the industry say not a whole lot of pharmaceutical companies want to get into bioweapons vaccine research, because the capital costs to build a dedicated lab safe from airborne toxins are so high, and the market -- at least until now -- has been so small, primarily just the Pentagon.
"No one else wants these contracts," insists Ron Rader, who leads an industry research firm called BioPharm.com. "Spore-forming microorganisms, because of FDA regulations, require totally separate facilities. Botulinim toxin, anthrax -- the facilities have to be dedicated. No one wants to have a dedicated, one-product facility. The trend now is to have multiple suites, and/or large manufacturing facilities. That way, you can switch from product to product every few months. No one wants to deal with spore-forming organisms.
"Also back then, anthrax vaccine was just not an attractive product. It's associated with biological warfare -- and that's not a positive thing. It's not the kind of thing you want to put in your brochure. Mainstream pharmaceutical companies had no interest. And you're also talking about being absolutely dependent on one customer. Very few companies are willing to take that risk. Any day, the Defense Department could just walk away." But P.W. Singer, a scholar at the Brookings Institution who has studied private military companies such as DynCorps and Military Professional Resources Inc., says the Pentagon seems to be treating bioweapons vaccines as just another weapons system they want to outsource to a trusted private-sector insider.
"The Pentagon is in search of two things: efficiency, and expediency," Singer said. "They either think they can get a better product in terms of quality or price or rapidity, or for expedient reasons. DynCorps provides a disconnection, when they would rather not have the government involved in some activity."
"My concern," he added, "is that the company in Michigan BioPort is actually a government lab that was privatized. It strikes me that for something so important for societal security, that you don't want to leave it in private hands. There are just some things that are too important."
And indeed, for BioPort CEO Fuad El-Hibri, BioPort is not an exclusive priority. El-Hibri, who became a U.S. citizen around the time of the BioPort purchase of MBPI, does not work out of the Michigan company, but out of the Rockville, Md., offices of his company East West Resources Management. His secretary there, Sheila Glick, says BioPort is one of 15 different companies El-Hibri runs, including some mobile phone operators in El Salvador, Venezuela and Jamaica. El-Hibri did not respond to numerous requests by Salon for an interview, and his secretary later referred questions to back to BioPort.
Dr. Zsolt Harsyani, president of Porton International, which has now been bought by the French pharmaceutical company Ipsen, and who is now involved in the DynPort vaccine contract with the Defense Department, said there is nothing sinister about the way the El-Hibris have approached the business of anthrax vaccine -- as a business opportunity.
"Mr. Ibrahim El-Hibri is a wonderful gentleman," Harsyani said Friday. "He started a charity for orphans." A scan of the Internet shows Mr. El-Hibri on the board of a Beirut-based Sunni charity, Dar Al Aytam Al Islamyah, that provides relief to orphans and widows, and espouses "commitment to the humanitarian principles of Islam such as justice, tolerance, and abhorrence of confessionalism or sectarianism."
Harsyani said he had not spoken with Ibrahim El-Hibri in over a year, but that the two parted on good terms. The El-Hibris divested from Porton International about three years ago, about the time when DynPort got the Pentagon contract to begin work on a second generation of bioweapon vaccines.
The former Porton employee, who asked not to be named, says the El-Hibris should be viewed as defense contractors, and their relationship with the Pentagon is not unique. "You have to realize: BioPort and now DynPort, these are arms dealers. They are part absolutely of the military industrial complex. This is their business. They are selling to a captive audience: the Defense Department. That's all-American. All these defense contracts -- they are boondoggles -- and that's the American way, to make as much money as possible. There's not that much unique about BioPort."
Although Bioport appears to be an issue, the interesting point is that FDA appears to be identifying "manufacturing" issues. FDA does not appear to be releasing publicly the nature of these observations at the various vaccine factories.
Perhaps we should suggest that FDA release their evaluations of the vaccine production lines. Why is it that there are these deficiencies? Is FDA over regulating? Or, is the vaccine company deficient?
I too had read about the smallpox outbreak near the Aral Sea in 1971, and how the hurried vaccinations saved lives. Very encouraging.
And that would work in the normal course of events - an accidental release for example. But a terrorist driven attack will come in as many outbreaks as possible simultaneously - Americans will be the targets of these attacks.
I would like to ask the 12 member CDC panel how many of them are NOT vaccinated for smallpox. What we need to press for is free vaccine available for all Americans who want it. "Free" to avoid the racist or whatever other ist charges (with all the cr@p the govt wastes money on to draw the line on this issue is suicidal) and voluntary to let Darwin settle this.
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
The Weekly Standard
October 29, 2001
Vol. 7, No. 7; Pg. 29
All About Anthrax; Everything you didn't want to know
BY DAVID TELL
(snip)
And guarding public health against prospective anthrax releases isn't easy, either. It, too, has never really been tested on human subjects, but a vaccine against anthrax does exist. Trouble is, the sole source of that (understocked and controversial) vaccine in the United States is a company called BioPort in Lansing, Michigan, which is currently operating under a license suspended by the FDA as punishment for a history of laboratory contamination, inadequate documentation and staff training, and low manufacturing standards.BioPort's best known owner/investor is retired Admiral William Crowe. But day-to-day responsibility for the company, for what it's worth, falls to a German immigrant of Lebanese ancestry named Fuad El-Hibri. Fuad El-Hibri's father, an international businessman named Ibrahim El-Hibri, is prominently associated with an Islamic charity headquartered in Beirut.
(snip)
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
Townsend Letter for Doctors and Patients
January 1, 2002
Pg. 16Anthrax Vaccine; Shorts
Klotter, Jule
The Lansing, Michigan, laboratory that manufactures anthrax vaccine for the U.S. has been unable to pass FDA inspection since 1997. According to a Wall Street Journal article, an October 2000, FDA report cited multiple faults, resulting in the conclusion that "a section of the plant where vials are filled with the anthrax vaccine and other products 'does not assure sterility.'"The state of Michigan had put the laboratory up for sale in the mid-1990s. It was finally bought in September 1998, for $ 24.8 million by BioPort, a company formed by Fuad El-Hibri, a former German national of Lebanese extraction, now a US citizen. Mr. El-Hibri had directed a British company that made bio-defense vaccines for anthrax and botulinum.
Less than two weeks after the sale closed, the Pentagon signed a contract for $ 45 million that made BioPort its only source of anthrax vaccine. Shortly thereafter, BioPort closed its laboratory "for a major overhaul."
In August 1999, the US government gave BioPort an additional $ 24.1 million in 'extraordinary contractual relief,' and the Defense Department agreed to pay BioPort 2-5 times more per dose, for fewer doses than agreed upon in the original contract.
Although he denies trying to influence the Defense Department, retired Admiral and former US ambassador to Britain, William J. Crowe Jr., has supported Mr. El-Hibri from the beginning. The former chairman of the joint chiefs of staff was given 12-13% of the company in exchange for a "token amount" and BioPort's use of his name.
(snip)
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
The New York Times
November 12, 2001
Section B; Page 7
A NATION CHALLENGED: THE SUPPLIES;
The Only U.S. Laboratory for the Anthrax Vaccine Says Production Will Be Delayed
By KEITH BRADSHER
LANSING, Mich., Nov. 9
The only laboratory in the country that makes anthrax vaccine will not be ready for a crucial federal inspection until mid-December, later than federal officials had hoped.
The lab, owned by BioPort, a private 220-employee company here, was partly dismantled for a thorough cleaning just as the anthrax attacks began in early October. Company officials say they finished cleaning on Thursday and will need several more weeks to work up to production. The delay is the latest in a series of problems that have prevented the military from using the anthrax vaccine produced here since December 1997.American officials are anxious enough about vaccine supplies that they have asked foreign governments for samples of their vaccines to test for possible use in the United States. A bipartisan panel on terrorism, created by Congress in 1999, recommended on Nov. 1 that a government-owned vaccine laboratory be created to produce vaccines for anthrax, smallpox and other bioterrorism threats.
"We can't expect a private contractor to gear up and fill these contracts," said Gov. James S. Gilmore of Virginia, a Republican who is the panel's chairman.
But officials at BioPort say that they are close to resolving their production problems at last and making millions of doses available to the military.
Robert G. Kramer Sr., BioPort's president, [No more mention of el-Hibri. Gee, I wonder why?] said that the comprehensive cleaning of the laboratory was carefully planned so that equipment could be reassembled at any time and put back into production within 10 days. But the military never asked the company to do so, he said.
"We are taking all the prudent and precautionary steps to be ready for a very rigorous inspection by the F.D.A. while being sure that we can be back in production quickly if need be," Mr. Kramer said. "It's a balancing act." He added that the country should have a second anthrax vaccine factory, possibly run by another company, as a precaution.
The company and the Food and Drug Administration have argued for years over quality-control problems at the Lansing laboratory. The F.D.A. has in particular criticized the sterility of the lab's process for decanting the vaccine into 10-dose vials. The company has given up trying to use its own equipment for this task, and now plans to ship the vaccine in bulk to another company, Hollister-Stier Laboratories, in Spokane, Wash., which will decant it into the vials and ship it back to Lansing.
Decanting vaccine into vials was a problem for the Lansing laboratory even before its sale to BioPort, said George Burgoyne, a BioPort critic who was the laboratory's chief of vaccine production until the state of Michigan sold it to BioPort in September 1998.
Mr. Burgoyne said the laboratory had two people sterilize vials and carry them into the room that contained the filling machine. "No matter how you dress people, organisms come off them all the time," Mr. Burgoyne said.
Many drug companies, including Hollister-Stier, automated this task entirely in the 1980's and early 1990's, and the F.D.A. responded by setting more stringent standards for sterility in the vial-filling process. The state of Michigan began renovating the lab in February 1998, and BioPort completed the task in April of the following year. But the renovation did not include automating the filling process, and the laboratory failed an F.D.A. inspection in October 2000.
The inspection report describes numerous problems, especially in the filling area. Inspectors noted that insufficiently clean air was entering the area, and that employees were touching nonsterile surfaces on their way in.
BioPort has also had problems with its labeling. At the F.D.A.'s urging, the company replaced the labels on an unspecified number of anthrax vials in September 2000, after it printed inaccurate expiration dates on them. Hollister-Stier is talking with BioPort to take over the labeling, too.
The lab will work up to full production over the next several weeks in preparation for another inspection, Mr. Kramer said. If it passes the inspection this time, BioPort will ask the F.D.A. to approve the use of 600,000 vaccines already decanted by Hollister-Stier in late summer, he said. Earlier vaccines, decanted here, would be administered only under the F.D.A.'s program for new drugs, which requires close medical supervision.
BioPort and the F.D.A. have been leery of moving too quickly to resume anthrax vaccine production because the vaccine itself has long been controversial. Several hundred military personnel have refused to take it after reports that it might be linked to a wide range of illnesses, including "Gulf War sickness," a combination of symptoms sometimes seen in veterans of that conflict.
Dr. Meryl Nass, a physician who advises soldiers who oppose the vaccines, said that fixing manufacturing problems was a good idea, but that the way the vaccine is produced -- by filtering toxins from anthrax bacteria -- inherently produces excessive variations in the vaccine's potency and purity.
The Defense Department, the F.D.A. and BioPort all say the vaccine, which was developed in the early 1960's, is safe. The Army is working with the drug industry to develop a new vaccine, but still has years of work ahead, a person involved in the work said.
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
American Health Line
January 15, 2002, Tuesday
SECTION: BIOTERRORISM
BIOPORT: FDA APPROVES RENOVATED ANTHRAX VACCINE FACTORY
Lansing, Mich.-based BioPort Corp., the country's only maker of the anthrax vaccine, has received FDA approval for its newly renovated factory, but the company still has many "hurdles" to clear before it can resume distribution of the vaccine, the Wall Street Journal reports. According to the Journal, the FDA on Dec. 27 sent a letter to the company saying that before distribution could begin, BioPort must finish work on two quality control tests (Wall Street Journal, 1/15).The company was forced to close its plant in 1998 after FDA inspectors found quality control and sterility problems (American Health Line, 10/29/01). In addition, the sterility of the laboratory's process for decanting the anthrax vaccine into 10-dose vials is still an issue.
BioPort has "given up" trying to use its own equipment for the process and now plans to send the vaccine "in bulk" to Hollister-Stier Laboratories in Spokane, Wash., which will decant and then ship the vials back to Michigan (American Health Line, 11/12/01). FDA inspectors have cited six "production-related changes" that must be made at the Spokane facility before it can receive approval (AP/CBS News.com, 1/14).
Not for commercial use. Solely to be used for the educational purposes of research and open discussion.
American Health Line
February 1, 2002, Friday
SECTION: BIOTERRORISM
ANTHRAX: FDA ALLOWS BIOPORT TO DISTRIBUTE VACCINE
In an "important step in the government's efforts to prepare for anthrax attacks," the FDA yesterday cleared BioPort Corp., the nation's sole maker of the anthrax vaccine, to resume shipping and production of the shots, ending a four-year delay caused by safety violations at the company's factory, the Los Angeles Times reports (Ornstein, Los Angeles Times, 2/1).The agency said that BioPort, based in Lansing, Mich., had met "all federal [safety] requirements" and can now make the vaccine for the Department of Defense, which will allow the agency to resume its mass inoculations of American military personnel (AP/New York Times, 2/1). The FDA clearance will allow BioPort to ship 209,000 doses of the vaccine immediately and make more as necessary (Gillis, Washington Post, 2/1).
HHS Secretary Tommy Thompson said that BioPort will produce two million doses this year and three million to eight million next year. The Defense Department vaccine program has been on hold since 1998, as the FDA has found repeated safety violations at the factory BioPort purchased from the state of Michigan that year, including contamination of doses, inadequate record-keeping, sterility problems and unapproved procedures (AP/New York Times, 2/1).
Getting the company back on line took on more urgency within the FDA following last fall's anthrax incidents, which caused five deaths. Mark Elengold, deputy director of the FDA's Center for Biologics Evaluation and Research, said the agency did not compromise safety standards in its assessment of BioPort, but said, "Did we have people working on it longer and harder? Yes" (Los Angeles Times, 2/1).
THE DEFENSE DECISION
While yesterday's action allows the Defense Department to resume its vaccination program, it is not clear if, or to what extent, it will do so, given the controversial nature of the program. So far about 500,000 armed forces members have been inoculated, a process that requires six shots over 18 months and an annual booster shot (AP/New York Times. But citing possible health risks, many military personnel have refused to receive the vaccine. "Hundreds" have been dismissed from the military after refusing the vaccine, and at least 100 have been court-martialed after refusing (Washington Post, 2/1).The Pentagon said yesterday that it will continue to vaccinate only special mission units while it reviews the approval, with a decision about the larger vaccination program to be made in the near future. The Los Angeles Times reports that the consensus among most scientists is that the vaccine is safe and produces only minor side effects. In its approval, the FDA did require BioPort to place some additional warnings on the vaccine, including one about possible risks of birth defects for pregnant women (Los Angeles Times, 2/1).
According to an attorney who has represented soldiers court-martialed for refusing to take the vaccine, the recent anthrax incidents may sway more soldiers toward wanting to obtain the vaccine. "It's hard to say whether you'll see the same type of opposition in the ranks, because of the change in circumstances," the attorney said.
CIVILIAN USE?
All of the anthrax vaccine BioPort has made so far is owned by the Defense Department, and the company currently has no plans to supply the vaccine for "broad civilian use" (Washington Post, 2/1). And while the federal government does not recommend vaccination for the general public, Thompson said that the resumption in production is important if a bioterrorist attack on the civilian population makes the vaccine necessary for members of the public."This product is a critical component in our arsenal," he said (AP/New York Times, 2/1). In December, the CDC offered the vaccine to 10,000 people deemed at high risk of anthrax exposure resulting from tainted letters mailed last fall along the East Coast, but only 190 have chosen to take it so far (Los Angeles Times, 2/1). BioPort also plans to discuss with federal health officials whether the vaccine should be given to emergency responders who would be first on the scene at a bioterrorist attack (Washington Post, 2/1).
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.