The Vaccination Debate
BETTY ANN BOWSER: By now, the U.S. military expected its two-year-old program to vaccinate all service members against anthrax would be up and running smoothly.
Anthrax is a deadly bacteria that looks like this under a microscope. When put into weapons like these Iraqi artillery shells and fired into the air, it can cause massive numbers of deaths.
SPOKESPERSON: A little poke. There we go.
BETTY ANN BOWSER: Since the program started in 1998, 400,000 active duty and reserve personnel have taken at least one of the six shots the Pentagon says is necessary for protection from anthrax inhalation. Plans call for 2.5 million people to be inoculated.
SPOKESPERSON: No allergies? You don't have a problems?
Behind schedule, more complaints
BETTY ANN BOWSER: But now the mandatory shot program is behind schedule, and a growing number of people have complained to the Congress that the vaccine has made them sick.
SOLDIER: Swelling on my hands and feet, dizziness, memory loss, sleep disorders, one blackout, night sweats, chest pains...
BETTY ANN BOWSER: That same committee heard similar testimony from other personnel. Congressman Christopher Shays chairs the subcommittee and says the program should be stopped.
REP. CHRISTOPHER SHAYS, (R) Connecticut: The bottom line to our recommendation to the full committee as it relates to anthrax is that this program be suspended as a mandatory force- wide program until we develop a better vaccine. Do you solemnly swear...
BETTY ANN BOWSER: After hearing from 46 witnesses, including top brass from the Pentagon, and 20 hours of testimony, the House National Security Subcommittee issued a scathing report that questioned the safety of the vaccine. It also said the Pentagon has been blind to the increasing number of adverse shot reactions.
SPOKESPERSON: The Department of Defense is very confident in the anthrax program that we have undertaken.
BETTY ANN BOWSER: The Defense Department immediately responded that only 620 service members have had adverse reactions, most of them extremely minor. But in a survey recently taken by a member of the ninth airlift squadron at Dover Air Force Base in Delaware, 58% of those who filled out the questionnaire said they got sick after taking the vaccine. Captain Michele Piel was one of those who took part in the survey. She's a C-5 transport plane pilot and Air Force academy graduate who says she was forced to leave the service after she developed auto-immune thyroditis, an illness she blames on the shots.
CAPT. MICHELE PIEL, U.S. Air Force: I had vertigo, headaches, nausea, and weakness in my muscles. And it was something that I never experienced before, so I really didn't know what was happening to me, but I knew that I was in trouble.
BETTY ANN BOWSER: Twelve weeks later, she says she was still in trouble, and getting nowhere with her military doctors. CAPT.
MICHELE PIEL: They started saying things like, that I was a malinger, that I just didn't want to fly anymore. I was told that maybe I was depressed. And probably the most insulting thing was when they told me that maybe I just wanted to have babies.
No long term adverse effects?
BETTY ANN BOWSER: The top medical officer at Dover would not comment on Piel's charges, but says all military personnel get good medical treatment on his base. Lieutenant Colonel Tom Luna also says there's no problem with the anthrax vaccine.
LT. COLONEL TOM LUNA, U.S. Air Force: We have seen no long-term adverse effects with this vaccine whatsoever.
BETTY ANN BOWSER: With anybody?
LT. COLONEL TOM LUNA: With anyone, that's right. As physicians I can tell you-- as medical professionals-- we haven't seen anything unusual in the spectrum of illnesses that we see, either from before the vaccine till now.
BETTY ANN BOWSER: And Dr. Luna says adverse reactions from the anthrax shot have not been significant.
LT. COLONEL TOM LUNA: We've got local reactions for about 30% of the people who may have some type of local reaction to it, meaning a sore arm, tenderness, maybe a little bit of swelling. And then very, very infrequently we do have some systemic reactions lasting about 24, 48 hours, a flu-like type of symptom, but much less than we see for a lot of other types of vaccines.
BETTY ANN BOWSER: Congressman Shays' committee took issue with the military's claim that there have been few adverse reactions. It also said it had a problem with the safety record of the only company licensed to make the vaccine, Bioport of Lansing, Michigan. In 1997, the federal Food and Drug Administration threatened to close Bioport down after finding repeated violations in the manufacturing process. And last November, the plant flunked another FDA quality- control inspection. Then in December, the Pentagon postponed the next phase of the vaccine program, in which an additional one million military personnel were to receive the shots.
SUE BAILEY, Assistant Secretary of Defense Health Affairs: We will not begin phase two and phase three until the FDA completes its certification and Secretary Cohen is confident that Bioport meets the highest possible standards.
BETTY ANN BOWSER: Congressman Shays says the Pentagon is seriously behind in meeting its own vaccine schedule, and he says he has no faith in the vaccine or the program.
REP. CHRISTOPHER SHAYS: I have a gigantic problem with one provider of this vaccine, because basically we're stuck with them. The protocol of this vaccine says six shots in 18 months. They are not living up to the protocol. If they're not living up to the protocol, they should not be doing it.
BETTY ANN BOWSER: How serious do you think the shortages are of this vaccine?
REP. CHRISTOPHER SHAYS: Well, I think they're quite serious.
BETTY ANN BOWSER: Bioport defended itself in this video it sent the NewsHour.
NANCY SUMMERTON: (video) I would characterize the facility as definitely state-of- the-industry, which means that the quality of the facility, the critical utilities that feed the process-- water for injection, purified clean steam, clean compressed air, and the equipment that is used in the process are equivalent to those companies in the industry that are manufacturing under good manufacturing design requirements.
Quality control
BETTY ANN BOWSER: Major General Randy West was appointed by the Secretary of Defense to deal with the anthrax controversy. He says he thinks Bioport will soon be up to speed.
MAJ. GENERAL RANDY WEST, USMC, Anthrax Adviser, Defense Department: I do believe that Bioport will eventually be certified to produce the vaccine. At their last inspection, they were down to 29 or 30 discrepancies. Since that inspection, a lot of those have been corrected, and several more have been agreed upon with FDA in terms of how to proceed to make those discrepancies go away.
BETTY ANN BOWSER: But Major Sonnie Bates, another C-5 pilot at Dover with 13 years in the Air Force, is not so convinced.
MAJOR SONNIE BATES, U.S. Air Force: When you have a lack of quality control, which it's been proven that this manufacturing plant has had, then you think of it as a minefield. There's little... There's doses of vials out there that may have mixtures that are inconsistent with the way they should be.
BETTY ANN BOWSER: That's one of the reasons Bates refused the vaccine. Officially, the Pentagon says about 351 people have refused to take the shots. All have either been court-martialed or disciplined. Bates is the highest-ranking officer so far threatened with a court-martial. But in a deal worked out between his attorney and the Air Force, Bates was allowed to resign, but will lose all his benefits, including a $36,000-a-year pension. The Pentagon says it doesn't keep figures on refusals in the reserves and Air National Guard, or on the number of people quitting over the anthrax policy. But all over the country, National Guard and Air Reserves units are losing pilots because of the shots. Many of them are commercial airline pilots who fear an adverse reaction could ground them from their civilian jobs. At Dover, Lieutenant Colonel Jay Lacklen says he's lost more than half of his pilots because of the anthrax policy.
BETTY ANN BOWSER: How seriously has this affected readiness?
LT. COL. JAY LACKLEN, U.S. Air Force: (Reserve) I don't really want to say catastrophically, but it's almost at that point. When the balloon goes up or the North Koreans go South, they're going to come to me and say "okay, give me your 58 pilots." And I said, "I'm not going to have 58 pilots. I going to have 33, 34, 35, maybe 40 in a couple of months." I'm just not going to have them.
MAJ. GENERAL RANDY WEST: We're concerned about it. We want to keep it to an absolute minimum, but...
BETTY ANN BOWSER: Is it a problem? Is anthrax having an impact on readiness?
MAJ. GENERAL RANDY WEST: I mean, I think to say that it's not having any impact would be an irresponsible response. It's not having an impact that keeps us from meeting our mission every day, but it's making it more challenging.
BETTY ANN BOWSER: In order to convince personnel they need the shots...
SPOKESMAN: We have a safe and effective vaccine.
BETTY ANN BOWSER: ...The Pentagon has intensified its massive education program, and is distributing 12,000 copies of this new videotape to forces around the world.
MAJ. GENERAL RANDY WEST: We've never really faced anything exactly like this before. We've never had an organized group of people for a lot of different reasons that were opposing something like the Secretary's decision. We hope that we're beginning to turn the corner in that. There have been 406,000 service men and women that are taking the shots since the Secretary instituted the program. That's over 1.5 million decisions to take it. There've only been 351 refusals.
BETTY ANN BOWSER: Congressman Shays says because there is so much controversy and so much uncertainty about the vaccine, the mandatory shot program is doomed.
REP. CHRISTOPHER SHAYS: I don't want to add to the problem, and I don't want to make it worse, but I think that this program is imploding. I don't think we can get the supply necessary to do the vaccines required. I don't think we can live up to the protocol and stay on target with the six within the 18 months. So I think it's going to fall, frankly, by its own weight.
MAJ. GENERAL RANDY WEST: We believe that we're right. And we believe-- I'm naive enough to believe-- that right prevails in the long run. Aerosolized anthrax is invisible. You can't see it, you can't smell it, you can't taste it. It's very difficult to build a detector with the sensitivity to quickly let you know that it's been delivered against you. So normally you don't know it until the symptoms start, and then it's too late.
SPOKESPERSON: Do you have any allergies, anything?
SOLDIER: Nope.
SPOKESPERSON: Do you have asthma?
SOLDIER: Nope.
SPOKESPERSON: Okay, you ready?
BETTY ANN BOWSER: In spite of congressional criticism and growing resistance in the ranks, the Pentagon says it has no plans to shut down the vaccine program.
Anthrax is a deadly bacteria that looks like this under a microscope. When put into weapons like these Iraqi artillery shells and fired into the air, it can cause massive numbers of deaths.
SPOKESPERSON: A little poke. There we go.
BETTY ANN BOWSER: Since the program started in 1998, 400,000 active duty and reserve personnel have taken at least one of the six shots the Pentagon says is necessary for protection from anthrax inhalation. Plans call for 2.5 million people to be inoculated.
SPOKESPERSON: No allergies? You don't have a problems?
Behind schedule, more complaints
BETTY ANN BOWSER: But now the mandatory shot program is behind schedule, and a growing number of people have complained to the Congress that the vaccine has made them sick.
SOLDIER: Swelling on my hands and feet, dizziness, memory loss, sleep disorders, one blackout, night sweats, chest pains...
BETTY ANN BOWSER: That same committee heard similar testimony from other personnel. Congressman Christopher Shays chairs the subcommittee and says the program should be stopped.
REP. CHRISTOPHER SHAYS, (R) Connecticut: The bottom line to our recommendation to the full committee as it relates to anthrax is that this program be suspended as a mandatory force- wide program until we develop a better vaccine. Do you solemnly swear...
BETTY ANN BOWSER: After hearing from 46 witnesses, including top brass from the Pentagon, and 20 hours of testimony, the House National Security Subcommittee issued a scathing report that questioned the safety of the vaccine. It also said the Pentagon has been blind to the increasing number of adverse shot reactions.
SPOKESPERSON: The Department of Defense is very confident in the anthrax program that we have undertaken.
BETTY ANN BOWSER: The Defense Department immediately responded that only 620 service members have had adverse reactions, most of them extremely minor. But in a survey recently taken by a member of the ninth airlift squadron at Dover Air Force Base in Delaware, 58% of those who filled out the questionnaire said they got sick after taking the vaccine. Captain Michele Piel was one of those who took part in the survey. She's a C-5 transport plane pilot and Air Force academy graduate who says she was forced to leave the service after she developed auto-immune thyroditis, an illness she blames on the shots.
CAPT. MICHELE PIEL, U.S. Air Force: I had vertigo, headaches, nausea, and weakness in my muscles. And it was something that I never experienced before, so I really didn't know what was happening to me, but I knew that I was in trouble.
BETTY ANN BOWSER: Twelve weeks later, she says she was still in trouble, and getting nowhere with her military doctors. CAPT.
MICHELE PIEL: They started saying things like, that I was a malinger, that I just didn't want to fly anymore. I was told that maybe I was depressed. And probably the most insulting thing was when they told me that maybe I just wanted to have babies.
No long term adverse effects?
BETTY ANN BOWSER: The top medical officer at Dover would not comment on Piel's charges, but says all military personnel get good medical treatment on his base. Lieutenant Colonel Tom Luna also says there's no problem with the anthrax vaccine.
LT. COLONEL TOM LUNA, U.S. Air Force: We have seen no long-term adverse effects with this vaccine whatsoever.
BETTY ANN BOWSER: With anybody?
LT. COLONEL TOM LUNA: With anyone, that's right. As physicians I can tell you-- as medical professionals-- we haven't seen anything unusual in the spectrum of illnesses that we see, either from before the vaccine till now.
BETTY ANN BOWSER: And Dr. Luna says adverse reactions from the anthrax shot have not been significant.
LT. COLONEL TOM LUNA: We've got local reactions for about 30% of the people who may have some type of local reaction to it, meaning a sore arm, tenderness, maybe a little bit of swelling. And then very, very infrequently we do have some systemic reactions lasting about 24, 48 hours, a flu-like type of symptom, but much less than we see for a lot of other types of vaccines.
BETTY ANN BOWSER: Congressman Shays' committee took issue with the military's claim that there have been few adverse reactions. It also said it had a problem with the safety record of the only company licensed to make the vaccine, Bioport of Lansing, Michigan. In 1997, the federal Food and Drug Administration threatened to close Bioport down after finding repeated violations in the manufacturing process. And last November, the plant flunked another FDA quality- control inspection. Then in December, the Pentagon postponed the next phase of the vaccine program, in which an additional one million military personnel were to receive the shots.
SUE BAILEY, Assistant Secretary of Defense Health Affairs: We will not begin phase two and phase three until the FDA completes its certification and Secretary Cohen is confident that Bioport meets the highest possible standards.
BETTY ANN BOWSER: Congressman Shays says the Pentagon is seriously behind in meeting its own vaccine schedule, and he says he has no faith in the vaccine or the program.
REP. CHRISTOPHER SHAYS: I have a gigantic problem with one provider of this vaccine, because basically we're stuck with them. The protocol of this vaccine says six shots in 18 months. They are not living up to the protocol. If they're not living up to the protocol, they should not be doing it.
BETTY ANN BOWSER: How serious do you think the shortages are of this vaccine?
REP. CHRISTOPHER SHAYS: Well, I think they're quite serious.
BETTY ANN BOWSER: Bioport defended itself in this video it sent the NewsHour.
NANCY SUMMERTON: (video) I would characterize the facility as definitely state-of- the-industry, which means that the quality of the facility, the critical utilities that feed the process-- water for injection, purified clean steam, clean compressed air, and the equipment that is used in the process are equivalent to those companies in the industry that are manufacturing under good manufacturing design requirements.
Quality control
BETTY ANN BOWSER: Major General Randy West was appointed by the Secretary of Defense to deal with the anthrax controversy. He says he thinks Bioport will soon be up to speed.
MAJ. GENERAL RANDY WEST, USMC, Anthrax Adviser, Defense Department: I do believe that Bioport will eventually be certified to produce the vaccine. At their last inspection, they were down to 29 or 30 discrepancies. Since that inspection, a lot of those have been corrected, and several more have been agreed upon with FDA in terms of how to proceed to make those discrepancies go away.
BETTY ANN BOWSER: But Major Sonnie Bates, another C-5 pilot at Dover with 13 years in the Air Force, is not so convinced.
MAJOR SONNIE BATES, U.S. Air Force: When you have a lack of quality control, which it's been proven that this manufacturing plant has had, then you think of it as a minefield. There's little... There's doses of vials out there that may have mixtures that are inconsistent with the way they should be.
BETTY ANN BOWSER: That's one of the reasons Bates refused the vaccine. Officially, the Pentagon says about 351 people have refused to take the shots. All have either been court-martialed or disciplined. Bates is the highest-ranking officer so far threatened with a court-martial. But in a deal worked out between his attorney and the Air Force, Bates was allowed to resign, but will lose all his benefits, including a $36,000-a-year pension. The Pentagon says it doesn't keep figures on refusals in the reserves and Air National Guard, or on the number of people quitting over the anthrax policy. But all over the country, National Guard and Air Reserves units are losing pilots because of the shots. Many of them are commercial airline pilots who fear an adverse reaction could ground them from their civilian jobs. At Dover, Lieutenant Colonel Jay Lacklen says he's lost more than half of his pilots because of the anthrax policy.
BETTY ANN BOWSER: How seriously has this affected readiness?
LT. COL. JAY LACKLEN, U.S. Air Force: (Reserve) I don't really want to say catastrophically, but it's almost at that point. When the balloon goes up or the North Koreans go South, they're going to come to me and say "okay, give me your 58 pilots." And I said, "I'm not going to have 58 pilots. I going to have 33, 34, 35, maybe 40 in a couple of months." I'm just not going to have them.
MAJ. GENERAL RANDY WEST: We're concerned about it. We want to keep it to an absolute minimum, but...
BETTY ANN BOWSER: Is it a problem? Is anthrax having an impact on readiness?
MAJ. GENERAL RANDY WEST: I mean, I think to say that it's not having any impact would be an irresponsible response. It's not having an impact that keeps us from meeting our mission every day, but it's making it more challenging.
BETTY ANN BOWSER: In order to convince personnel they need the shots...
SPOKESMAN: We have a safe and effective vaccine.
BETTY ANN BOWSER: ...The Pentagon has intensified its massive education program, and is distributing 12,000 copies of this new videotape to forces around the world.
MAJ. GENERAL RANDY WEST: We've never really faced anything exactly like this before. We've never had an organized group of people for a lot of different reasons that were opposing something like the Secretary's decision. We hope that we're beginning to turn the corner in that. There have been 406,000 service men and women that are taking the shots since the Secretary instituted the program. That's over 1.5 million decisions to take it. There've only been 351 refusals.
BETTY ANN BOWSER: Congressman Shays says because there is so much controversy and so much uncertainty about the vaccine, the mandatory shot program is doomed.
REP. CHRISTOPHER SHAYS: I don't want to add to the problem, and I don't want to make it worse, but I think that this program is imploding. I don't think we can get the supply necessary to do the vaccines required. I don't think we can live up to the protocol and stay on target with the six within the 18 months. So I think it's going to fall, frankly, by its own weight.
MAJ. GENERAL RANDY WEST: We believe that we're right. And we believe-- I'm naive enough to believe-- that right prevails in the long run. Aerosolized anthrax is invisible. You can't see it, you can't smell it, you can't taste it. It's very difficult to build a detector with the sensitivity to quickly let you know that it's been delivered against you. So normally you don't know it until the symptoms start, and then it's too late.
SPOKESPERSON: Do you have any allergies, anything?
SOLDIER: Nope.
SPOKESPERSON: Do you have asthma?
SOLDIER: Nope.
SPOKESPERSON: Okay, you ready?
BETTY ANN BOWSER: In spite of congressional criticism and growing resistance in the ranks, the Pentagon says it has no plans to shut down the vaccine program.
