Who’s REALLY To Blame For The Vaccine Shortage
This is long, but very good reading.
by William Tucker
JOHN KERRY wasted no time jumping on President George Bush about the unexpected shortage in flu vaccines this year. Why wasn’t Bush paying attention? He should have done things differently. And of course Kerry had a “plan” to solve the whole mess.
If Kerry thinks he can solve the flu vaccine problem, he need look no further than his own running mate, trial lawyer John Edwards. Vaccines are the one area of medicine where trial lawyers are almost completely responsible for the problem. No one can plausibly point a finger at insurance companies, drug companies, or doctors. Lawyers have won the vaccine game so completely that nobody wants to play.
Two weeks ago, British regulators suspended the license of Chiron Corp., the world’s second-leading flu vaccine supplier, for three months. Officials cited manufacturing problems at the factory in Liverpool, England, where Chiron makes its leading product, Fluvirin. Chiron was scheduled to supply 46 million of the 100 million doses to be administered in the United States this year. The other 54 million will come from Aventis Pasteur, a French company with headquarters in Strasbourg.
So why is it that 100 percent of our flu vaccines are now made by two companies in Europe? The answer is simple. Trial lawyers drove the American manufacturers out of the business.
In 1967 there were 26 companies making vaccines in the United States. Today there are only four that make any type of vaccine and none making flu vaccine. Wyeth was the last to fall, dropping flu shots
after 2002. For recently emerging illnesses such as Lyme disease, there is no commercial vaccine, even though one has been approved by the Food and Drug Administration.
All this is the result of a legal concept called “liability without fault” that emerged from the hothouse atmosphere of the law schools in the 1960s and became the law of the land. Under the old “negligence” regime, you had to prove a product manufacturer had done something wrong in order to hold it liable for damages. Under liability without fault, on the other hand, the manufacturer can be held responsible for harm from its products, whether blameworthy or not. Add to that the jackpot awards that come from pain-and-suffering and punitive damages, and you have a legal climate that no manufacturer wants to risk.
In theory, prices might have been jacked up enough to make vaccine production profitable even with the lawsuit risk, but federal intervention made vaccines a low-margin business. Before 1993, manufacturers sold vaccines to doctors, doctors prescribed them to patients, and there was some markup. Then Congress adopted the Vaccine for Children Act, which made the government a monopsony buyer. The feds now purchase over half of all vaccines at a low fixed price and distribute them to doctors. This has essentially finished off the private market.
As recently as 1980, 18 American companies made eight different vaccines for various childhood diseases. Today, four companies–GlaxoSmithKline, Aventis, Merck, and Wyeth–make 12 vaccines. Of the 12, seven are made by only one company and only one is made by more than two. “There are constant shortages,” says Dr. Paul Offit, head of the Vaccine Education Center at Children’s Hospital of Philadelphia. “With only one supplier for so many vaccines, the whole system is fragile. When even the smallest thing goes wrong, children miss their vaccinations.”
The intersection between mass vaccinations and the tort system was bound to be messy. When you vaccinate enough people, someone, somewhere, is going to have a bad reaction. You could give a glass of milk to 100 million people and a few would inevitably get violently sick from it. With vaccines, there will be allergic reactions and a tiny but predictable percentage of people will suffer some kind of permanent damage or even die. Because of liability without fault and the generosity of the tort system, the result is huge damage awards.
The first instance of this came in 1955 with polio vaccinations. Cutter Laboratories, the California company that now distributes Cutter’s Insect Repellent, made an early batch of vaccines, some of which had live viruses in them. Almost all the children in Idaho were administered the vaccine and several dozen contracted polio. In 1957, the parents of Anne Gottsdanker, an 8-year-old girl whose legs had become paralyzed, sued Cutter, with famed personal injury lawyer Melvin Belli representing them.
The jury found Cutter’s actions were not negligent–the orders had been rushed, standards had not been clear, and safety precautions were still rudimentary at the time. But, using the new doctrine of liability without fault, the jury held Cutter accountable anyway and awarded $147,300. “That decision made Ralph Nader possible,” Belli later claimed.
“It was a turning point,” says Dr. Offit, whose book The Cutter Incident will be published next year. “Because of the Cutter decision, vaccines became one of the first medical products to
be eliminated by lawsuits.”
That this would be the outcome wasn’t immediately clear. Soon after the trial, the Yale Law Journal published an article arguing that insurance against adverse reactions was the solution. The public wouldn’t buy policies because it would be too complicated and expensive, but vaccine makers could. Insurance would cover the cost of bad outcomes and the manufacturers would pass these costs on to their customers. Those few who were harmed by a vaccine would be covered by those who benefited. Everything would work out. Unfortunately, this thesis failed to anticipate how high damage awards would go.
WHEN AN UNUSUAL EPIDEMIC occurred at Fort Dix, N.J., in 1976, for example, the federal government decided to vaccinate the whole country against the new “swine flu.” To the astonishment of Congress, the insurance companies refused to participate. Senator Ted Kennedy charged “cupidity” and “lack of social obligation.” The Congressional Budget Office predicted that with 45 million Americans inoculated, there would be 4,500 injury claims and 90 damage awards, totaling $2 million. Congress decided to provide the insurance.
As Peter Huber recounts in his book Liability, the CBO’s first estimate proved uncannily accurate. A total of 4,169 damage claims were filed. However, not 90 but more than 700 suits were successful and the total bill to Congress came to over $100 million, 50 times what the CBO had predicted. The insurance companies knew their business well.
Adding to the problem are the predictable panics about vaccines that spread among parents and are abetted by trial lawyers. In 1974, a British researcher published a paper claiming that the vaccine for pertussis (whooping cough) had caused seizures in 36 children, leading to 22 cases of epilepsy or mental retardation. Subsequent studies proved the claim to be false, but in the meantime Japan canceled inoculations, resulting in 113 preventable whooping cough deaths. In the United States, 800 pertussis vaccine lawsuits asking $21 million in damages were filed over the next decade. The cost of a vaccination went from 21 cents to $11.
Every American drug company dropped pertussis vaccine except Lederle Laboratories. In 1980, Lederle lost a liability suit for the paralysis of a three-month-old infant–even though there was almost no evidence implicating the vaccine. Lederle’s damages were $1.1 million, more than half its gross revenues from sale of the vaccine for that entire year.
In recent years, the most prevalent anti-vaccine rumor has held that Thimerosal, a mercury-containing preservative used in vaccines from the 1930s until just recently, is behind an “epidemic of autism.” Once again, scientific studies have disproved the allegation, but hundreds of parents are filing suit, and trial lawyers continue to troll for clients.
Congress tried to stave off liability problems with the National Childhood Vaccine Injury Act in 1986. The program functions almost as an ideal “medical court,” with panels of scientists, virologists, and statisticians reviewing each complaint and rewarding those that seem legitimate. Unfortunately, the program allows plaintiffs to opt out of the system. Trial lawyers continually bypass it and elect to go to trial–particularly for cases where the review looks unpromising. With Thimerosal, lawyers have argued that the law does not apply because mercury was an additive, not the actual vaccine. The result is jackpot awards and very little protection for the vaccine companies. In 1998, the FDA approved a vaccine for Lyme disease, which strikes 15,000 people a year. GlaxoSmithKline manufactured it for three years but quit when rumors began circulating that the vaccine caused arthritis.
All this has made the flu an epidemic waiting to happen. Each year flu viruses circle the globe, moving into Asia in the spring and summer and back to North America in the winter. Surface proteins change along the way so that the previous year’s vaccine doesn’t work against the following year’s variation.
Each year in February, the Centers for Disease Control meets with the vaccine-makers–all two of them–and decides which strain of the virus to anticipate for next year. Then they both make the same vaccine. Last year the committee bet on the Panama strain, but a rogue “Fujian” strain suddenly emerged as a surprise invader. A mini-epidemic resulted and 93 children died, only two of them properly vaccinated.
With several companies competing in the field, as was once the case, somebody would have been more likely to produce a dark horse vaccine. If that rogue strain emerged, the dissenting company would hit the jackpot, and there would be ample supplies of an effective vaccine, at least for those most at risk. In the “planned economy” of the CDC, however, there is no back-up for an unexpected turn of events. This year there isn’t even a front line.
Are trial lawyers ready to accept responsibility for their starring role in creating this health hazard? Don’t hold your breath. “This is just the typical garbage and propaganda from the drug manufacturers,” says Carlton Carl, spokesman for the Association of Trial Lawyers of America. “There’s absolutely no disincentive for making vaccines. American companies don’t do it for the same reason they’re sending jobs overseas–because it increases their profits.”
Whether doctors are quitting the profession because of an out-of-control tort system, whether malpractice premiums are the cause of health care increases–such hardy perennials of the litigation debate are still a subject of lively controversy. But with vaccines there is no argument. Trial lawyers have all but ruined the market. Yet they are still unwilling to take responsibility.
William Tucker is a fellow at the Discovery Institute. His book on trial lawyers, Civil Lynchings, will be published next year.
Serbian National Says: October 18th, 2004 at 10:13 pm
Lawyers disgust me. Not the ones that fight for a cause, or work for the state, getting paid nothing to prosecute serious criminal offenders, but the people that go into the law so they can either take advantage of other people who are lost, confused and easily lead into paying the lawyer money for an easy job or the ones who go into it to prosecute, needlessly, companies that try and do their job to the best of their ability and have a few incidents. It’s stories like these that get my blood running hot. John Edwards made his money prosecuting doctors, for Christ’s sake!
Here’s a nice little article I found on the net about Edward’s performance at the VP Debate.
It was the defining moment of the vice-presidential debate: CEO Dick Cheney took the upstart junior exec John Edwards to the woodshed. “You’ve missed 33 out of 36 meetings of the Judiciary Committee, almost 70 percent of the meetings of the Intelligence Committee,” Cheney said, “You’ve missed a lot of key votes on tax policy, on energy, on Medicare reform. … You’ve got one of the worst attendance records in the United States Senate.” And now you think you deserve my job, you could almost hear Cheney thinking.
John Edwards needed to reassure Americans that he was capable of stepping into the presidency if necessary. Edwards failed, utterly. Will it make a difference in the ultimate outcome of the election? Probably not, but it should. Dan Quayle’s callow performance in the 1992 vice-presidential debates, while not a decisive factor in the race, is estimated to have cost the Republicans a couple of percentage points on Election Day. In an election as tight as the 2004 contest, voters ought to hold Edwards accountable for his inexperience and indifference to his sworn duty as a United States senator.
Why should voters trust a man who has so disregarded his obligations as an elected official? Edwards — a multimillionaire — continues to draw his $158,100 salary in the Senate, but has been AWOL from the Senate for most of the last two years. His even richer running mate, Sen. John Kerry, too, has neglected his duties, missing 72 percent of the 119 recorded votes in 2003 alone. Both men apparently believe they have the right to live off the taxpayers, while competing for a promotion to the top jobs in government. When faced with a similar decision in 1996, Bob Dole did the honorable thing: He resigned both as majority leader of the Senate and as senator from Kansas.
Edwards tried to forestall an attack on his shallow record by saying, “a long resume does not equal good judgment.” But neither Edwards nor Kerry has shown much judgment by holding on to no-show jobs. Whether you’re talking about an assembly line worker or the chairman of the board, attendance records like Senators Edwards’ and Kerry’s would get anyone else fired.
Their willingness to ignore their official duties — which both men have taken a solemn oath to uphold — is a major character flaw. It cuts to the heart of whether or not these men can be trusted to do what they promise. For months, Kerry and Edwards have hammered President Bush on what they claim is a credibility gap. They have accused him of lying, deceiving and misleading the public. Edwards did it again last night. “You are not being straight with the American people,” he said in reference to the situation in Iraq.
But Edwards did no better than Kerry in explaining what the Democrats would do differently. “We need a president who will speed up the training of Iraqis, get more staff in for doing that. We need to speed up the reconstruction so the Iraqis see some tangible benefit. We need a new president who has the credibility, which John Kerry has, to bring others into this effort.”
But Edwards’ answer begged the question. The Bush policy is to train the Iraqis as quickly as possible. They’ve succeeded in getting other nations to pitch in on this effort, including NATO. And even John Kerry admitted yesterday that he won’t have much luck in bringing French or German troops to Iraq. “Does that mean allies are going to trade their young for our young in body bags? I know they are not,” Kerry said at a campaign stop in Iowa.
Whatever John Kerry or John Edwards are saying, their actions have belied their rhetoric. Given his absence from his Senate duties, it’s hard to know where John Edwards stands on important defense issues besides voting against the money to protect our troops in Iraq. But Kerry’s record is long — almost 20 years in the Senate alone. As Cheney pointed out, “A little tough talk in the midst of a campaign or as part of a presidential debate cannot obscure a record of 30 years of being on the wrong side of defense issues.” Based on their records, neither John Kerry nor John Edwards deserves a job promotion.
DS Says: October 19th, 2004 at 3:39 am
Yes, it’s disgusting how quick they are to blame Bush and company.
bonniem Says: October 21st, 2004 at 3:39 pm
Yep, don’t you know some of Bush’s cabinet flew over to Europe, when into that factory and contaminated the vaccine.?! Blame it on Bush!!!
JD Says: October 21st, 2004 at 3:54 pm
Bush took another pitch he could have hit out of the park on this one. All he would have had to say was this is what you get when the government fixes prices. Shortages and poor quality. Soviet style health care. Just like Canada.
Liz Says: October 21st, 2004 at 8:53 pm
I got a forwarded e-mail saying that there was one lawsuit that really caused the downfall of Chiron, the flu vaccine producer. It was a frivolous lawsuit in which the “victim” (the guy that filed suit) was represented by John Edwards. Is this true?? I really want to know before I pass this info on.
Liz Says: October 21st, 2004 at 8:56 pm
BTW: if you know that edwards did in fact represent in the lawsuit against Chiron, please e-mail me at lizzielefevre@yahoo.com
bonniem Says: October 21st, 2004 at 10:44 pm
I read that the lawsuits in the U.S. drove the companies that used to make the vaccine there out of business. But it did not put the blame on any one attorney.
zack Says: October 22nd, 2004 at 2:56 pm
That would be great ammunition….but, no, it was not Edwards. http://www.snopes.com (type in John Edwards).
Evan Says: October 22nd, 2004 at 4:41 pm
HHS WEBSITE: A Report of the National Vaccine Advisory Committee said: “The Vaccine Injury Compensation Program (VICP) enacted in the late 1980s has been of immense value in stabilizing the vaccine market. Prior to its enactment, litigation led to national shortages, withdrawal of manufacturers from the marketplace, and instability of supply of essential childhood vaccines. The VICP was designed to compensate individuals who suffered a serious adverse event as a result of administration of a covered vaccine in a manner that was rapid, simple, generous and appropriate. The VICP has assisted in stimulating the availability of new vaccines since its inception in 1988. Despite the success of the program, criticism of the VICP could lead to significant legislative changes, including a more relaxed burden of proof standard for determining eligibility for compensation. Today, litigation again threatens stability of the vaccine program in the form of class action law suits, exemplified by those that have been filed involving vaccines that contain thimerosal. The VICP is currently understaffed to meet the new increased numbers of claims. While current vaccine shortages do not appear to be liability related, the VICP should be maintained and strengthened as supported by scientific evidence, including continuing expansion of VICP to include additional vaccines as they are recommended for routine administration to children. The VICP coverage of vaccines should recognize that “vaccine” includes the active ingredient as well as preservatives, additives and other excipients. Strengthening the VICP would benefit manufacturers, providers and consumers and further safeguard the nation’s vaccine supply.” [http://www.hhs.gov/nvpo/bulletins/nvac-vsr.htm#liability]
Serbian National Says: October 22nd, 2004 at 6:42 pm
It was lawyers like Edwards, which is exactly what he said. Lawyers who profit off of doctors who make a few honest mistakes which may or may not result in serious consequences. But to blame the doctors for other people’s mistakes, or the inaccuracy of their information, or the volitility and unproven nature of their profession. Doctors try their honest best to save people’s lives - does it make sense to persecute them when they make a mistake (or not even, but we’ll err on the side of the lawyers) that they couldn’t have prevented?
zack Says: October 22nd, 2004 at 6:51 pm
My problem is that trial lawyers make their case by saying that their client needs this…20 million or whatever he’s asking for. Well Mr. Lawyer, if they need that 20 million, why are you taking half of it?
steve Says: October 26th, 2004 at 6:15 am
First off JD is giving the public way too much credit to think they are going to understand his logical but not simple arguments. Think of ways to dumb it down to make it palatable, even though your right of course.
No Liz John Edwards is not the man responsible for the vaccine stuff, the article never said he was. Edwards was busy suing doctors for giving babys Cerebral Palsy even though, og course, that medically impossible. Tell it to the boderline retarded jury.
Finally dont you love how Kerry siad in the debates “…of course medical tort reform is importnat, but its only 1% of the health care cost.” Wow does anybody think its really just 1% when you consider its economic raminifications? Of course the silly hting is that Kerry is saying, de facto, he doesnt plan on doing squat about medical liability or tort reform because its a nominal cost. Thats what you get as he is in bed with the ABA and the trail lawyers. I wish he just didnt lie about saying its “important” and then pretty much say he isnt going to do anything about it in the same sentence.
Serbian National Says: October 26th, 2004 at 2:22 pm
“the goal here . . . is a stable Iraq, not whether or not that’s a full democracy”
Sen. Kerry prefers the stability of a tyranny over the momentary unstability and freedom of a democracy in a sorely freedom-starved part of the world.
I have heard very little of what Sen. Kerry actually plans to DO, and with his record in the Senate I don’t know how people can trust him! If you don’t have trust in your President, what do you have in him? As President Bush said yesterday, “You may not agree with what I may do, but at least you know what I’m going to do when I do it.”
JD Says: October 26th, 2004 at 3:46 pm
Steve: To dumb an argument down you usually make it so long nobody reads it. Pithy one issue arguments will have to suffice. Especially with the short attention span of liberals.
USMC1 Says: October 27th, 2004 at 11:56 pm
quit whining about the flu vaccine , christ , I havent ever had a flu vaccine and probably never will , if all the whiners and deadbeats (you know ) welfare reciprients and SSI assholes didnt hog all the vaccines the people that really need it , the senior citizens and infants would have it , but we have to give it to the welfare and SSI rejects and inmates and other less than desirable creatons in our society 9thanks to the democrats) , End welfare today and SSI take em all out back and execute ‘em , then the people who work to provide for there families will have what they need!
Suzanne Katz Says: November 5th, 2004 at 3:26 am
For those who must have the flu vaccine, there is enough, for the rest of us, just get into the habit of washing your hands, and stop complaing.
There are more important things going on, and if you get the flu please stay at home.
Steve Says: December 2nd, 2004 at 11:58 pm
Plane and simply, Bush did not plan well enough to meet the demands of the flu shots for his own people. He is the presdient, Right? Who else HAS to take care of it. Who controls the funding for the flu shot. You say its too quick to blame. Its the same attitude Bush had/has with the flu shot, not enough talk when there needs to be.
Steve Says: December 3rd, 2004 at 12:01 am
By the way, Suzanne, i guess u have enough “pull” in this country to get the flu shot because it sounds like you had it. If i cant get the flu shot and i come down with it, i’ma be standing on your front proch waiting to talk to you about the horrible effects it has on a human body. But you wouldn’t care, u got ur shot and have more important things to worry about than if everyone gets the shot or just u.
Suzanne Katz Says: December 3rd, 2004 at 12:53 am
Sorry, no I do not have any pull in this country, and no, can not get the flu shot, first time in five years, Hey if you get an amonina, (bad spelling) that will help you, not as good as the flu shot, but a must
If I had that kind of pulll, I would make sure you got one, and even if your under age 60 and not at death risk, then if you wanted to take one away from those who are, then there are ways to get one, and Yes, I could if I had wanted to get one at the VA that is where I get my medical, but I decided it is best for those at risk to have what supply we have, I will just keep my hands washed, and take care of myself, stay away from those who are sick, and if I get the flu, well so be it!
And if you want to come and stand on my porch and talk to me, hey it is cold here, so come on into my office and sit down and we will have a chat. As I care deeply about the things that have horrible effects on humans, I feel deeply about the drugs being given to children, I feel deeply about the drug companies who experiment with these mind chemicals, I feel more than deeply I feel down right angery, so do not think for one second I do not feel, trust me, I feel why more than you could ever think, I just do not wave banners, but I worry about the future generation the children who are on anti depressants, today, what are those drugs doing to those forming minds, and what are we doing to our children? Let alone to the Men of this country, with the 6 hour love pill? Good Grief, lets get real, a pill is not the answer for our problems, (on that six hour thing, boy do I have a lot to say about that terrible deed being done to the men of this country) \
Now, where did you get the idea I could get the flu shot, where did you get the idea I do not care, where in the world did you get anything you wrote, either I wrote something and was half asleep or you do not understand english.
Suzanne
send me an email and lets get this shit straight, because if anyone cares I do, and you don;t even know where to start caring!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Gina Says: January 21st, 2005 at 9:17 pm
Though Avetis Pasteur is headquartered in France, the United States recieves our flu vaccine from their PA manufaturing location. In addition, drug companies find it more profitable to create yet another choloesterol medication than to create a vaccine for malaria. Afterall the people who get malaria are poor, so where would they make a profit?
Cathy B Says: April 4th, 2007 at 5:19 pm
Drug companies should be frightened about producing vaccines. There is not enough testing, pre or post vaccination, to determine effectiveness. There is no medical protocol when you or your child have an immunization reaction. Then, when you file a VICP claim, the Department of Justice has unlimited resources to fight the claim. They bog it down for years and years, and many of us have had to file bankruptcy in the meantime. Call me a liberal, but let it be one of your children who become disabled for life. Everyone is one disaster away from becoming an advocate.
Vaccines are incubated in chick and money tissue. Then, additives and “stabilizers” are added, some of which are neurotoxins.
Children are now mandated to have over 20 vaccinations, and as a result, the number of VICP claims continues to climb.
The National Vaccine Advisory Committee is filled with people who have conflicts of interest, including the vaccine makers. Dept. of Justice has too much power and money to fight VICP claims.
On the one hand, the government sets up this no fault litigation. Then it funds DOJ with approximately $6 million a year to fight the claims. Cases take 8-12 years to settle, and then usually for a small amount of the actual damages.
VICP desperately needs oversight by an unbiased group.
Don’t feel sorry for the vaccine makers. They are making huge profits on this. Doctors and lawyers are as well.
dr.biamonte Says: October 25th, 2007 at 8:21 pm
I am a registered republican and a physcian. This statement below is false. I don’t agree with John Kerry or Edwards on anything except that Thimerosal is the cause of Autism. I have seen this with my own eyes.
“In recent years, the most prevalent anti-vaccine rumor has held that Thimerosal, a mercury-containing preservative used in vaccines from the 1930s until just recently, is behind an “epidemic of autism.” Once again, scientific studies have disproved the allegation, but hundreds of parents are filing suit, and trial lawyers continue to troll for clients.