The following books and published op-eds were written by Paul A. Offit, MD and other VEC scientists.
Polio Revisited – book review by Dr. Paul Offit
The Lancet, May 25, 2013
In Michael Moore's "Sicko," pharmaceutical companies are taken to the movies. It isn't the first time. In "The Constant Gardener," a pharmaceutical company that also makes pesticides makes an antibiotic that is highly effective against multi-drug resistant tuberculosis. When the antibiotic is found to have a fatal side effect, the company buries victims in a mass grave outside of town and kills others who know of the problem. In "The Fugitive" a pharmaceutical company hires a one-armed man to kill Richard Kimble when he finds out that their drug, nearing FDA approval, causes fatal liver damage. Neither the screenwriters nor the public considered these two scenarios to be implausible.
In "Sicko," pharmaceutical companies don't fare much better. Moore shows how citizens in Cuba pay pennies for medicines that cost hundreds of dollars in the United States; and how companies make drugs like Ambien to “dope up” citizens who now realize that the American dream is only a myth. He shows buildings bearing the logos of Pfizer, Merck, and Eli Lilly: faceless, monolithic, and impenetrable. Moore never interviews anyone from these companies. “They already have their story out there,” he said. “It's called the nightly news.”
Moore's choice not to talk to anyone from pharmaceutical companies was a loss for his viewers. For example, during the past century the lifespan of Americans increased by 30 years; almost all of that increase was due to one class of medical products: vaccines. Children today receive 14 different vaccines by the time they are 2 years old. Although most people don't know it, 9 of those 14 vaccines — which save about 8 million lives a year — were made by one man. And that man, Maurice Hilleman, worked for a pharmaceutical company. If he hadn't, if he'd stayed in academia, he would never have been able to convert his dedication and brilliance into the products that save our lives. When Moore talked about better health, it would have been nice to have seen Hilleman's image on the screen.
There is another image that Moore could have included. In 2006, a vaccine to prevent rotavirus was licensed by the Food and Drug Administration. Rotavirus, a disease of young children that causes vomiting, high fever, diarrhea, and dehydration, kills 2,000 children in the developing world every day and causes a great deal of suffering in the developed world. Penny Heaton was the pharmaceutical company executive who headed the program. At the end of a pre-licensure study that took four years to complete, included 70,000 children, and cost about $350 million, Heaton called together 200 people at her company. (As a co-inventor of the vaccine, I was present at this meeting.) She started with a series of slides. “This is what the world looks like now,” she said, pointing to a map that contained hundreds of small black dots concentrated in Asia, Africa, and Latin America. “Each of these dots represents 1,000 deaths a year from rotavirus.” Then Heaton showed a map without any black dots. “Now,” she said, pointing to the clean map, “we have the technology in hand to eliminate deaths from this disease.” Then she wept. She stood in front of 200 people with her head down and her shoulders shaking. This isn't an image that anyone has of a pharmaceutical company. The rotavirus vaccine is now available in Mali, Ghana, Vietnam, Bangladesh and Nicaragua.
Moore could have framed the real problems with pharmaceutical companies by asking the right questions. How can we eliminate marketing practices that unduly influence clinicians by providing unethical incentives? Does direct-to-consumer advertising mislead the public by creating the notion of magic medicines without side effects? Do we benefit from companies developing yet another hair loss or potency product while diseases with a much smaller market go ignored? Can the federal government become the sole purchaser of drugs without eliminating the profit that drives companies to make them? And does society benefit from the tax that is included in the price of every drug because of massive litigation? But Moore yielded to the Zeitgeist, vilifying companies and their lobbyists — an easy, populist act that failed to educate his viewers.
"Knocked Up" is a movie about taking risks. Ben Stone meets Alison Scott at a bar; they get drunk, sleep together, and Alison gets pregnant. In a somewhat surprising twist, Alison decides not to end her pregnancy; young and unmarried, she risks bringing a baby into her life. Now she must decide whether she wants to risk marrying Ben, a well-meaning, good-hearted man with a frat-house mentality. And Ben must decide whether he wants to risk marrying Alison, knowing that he will be forced to grow up.
The movie also centers on Alison's sister, Debbie, a women who is skeptical of Ben as a husband and is herself consumed by daily risks: specifically, neighborhoods with sex offenders and vaccines with mercury. Debbie reflects today's risk-averse culture. But like most of us, she's really not risk averse. Because we don't know where the real risks lie, we're actually risk takers.
For example, for the past four years we have been besieged by the notion that a bird flu pandemic is just around the corner. Stories in the media appear almost weekly about our lack of preparedness, about who would be immunized first, and about preliminary studies of a bird flu vaccine. Books like John Barry's "The Great Influenza" underline just how devastating flu pandemics can be. But bird flu hasn't caused a pandemic. And although two or three influenza pandemics will occur in this century, many more Americans will be killed by epidemic influenza — about 35,000 to 40,000 every year — than pandemic influenza. Despite these grim statistics, elderly adults, those most likely to die of flu, are fairly casual about getting their yearly flu shot.
In March 2003, when the United States invaded Iraq, the Department of Defense feared a biological counterattack with smallpox. So they inoculated soldiers with the smallpox vaccine; 40,000 healthcare workers were also immunized. Since December 2002 about 1.2 million people have been immunized with a vaccine to prevent a disease that was eliminated from the face of the earth in 1979. And unlike the prevention of many infectious diseases, smallpox vaccine works even when it is given 48 hours after exposure to someone with smallpox, a disease whose symptoms aren't subtle. We could have distributed the vaccine, made sure that systems were in place to give it quickly and efficiently, and waited. But we didn't. As a consequence, about 140 people were harmed when the vaccine virus caused inflammation of their heart muscle. Getting smallpox vaccine was riskier than waiting to get it.
As for Debbie's fear of mercury in vaccines, the only vaccine that might include a mercury-containing preservative is the influenza vaccine, now recommended for all children between 6 months and 5 years of age. The quantity of mercury in that vaccine, about 12 micrograms of ethylmercury, is dwarfed by the amount of mercury that one typically encounters in the environment. Further, several studies have clearly demonstrated that vaccines containing mercury as a preservative don't cause neurological problems, including autism. (Since mercury as a preservative was removed from vaccines given to young infants in 2001, the incidence of autism has actually increased.) Influenza virus, on the other hand, causes the hospitalization of more than 100,000 children every year and the deaths of about a hundred; most of these children were previously healthy. Debbie's choice to avoid mercury in vaccines wasn't a risk-free choice; it was just a choice to take a greater risk.
The media doesn't do a very good job of educating us about risk. We're scared of anthrax, botulism, tsunamis, and serial killers when we should be scared of French fries (Strokes and heart attacks are the most common causes of death). We're scared of pandemic flu when we should be scared of epidemic flu. And we're relatively unconcerned about the greatest threat from vaccines — driving to get them. About 150 Americans children die every year in motor vehicle accidents.
Parents of autistic children are about to have their day in court. On June 11, in an unprecedented action before a federal claims court, lawyers for 4,800 autistic children will argue that vaccines caused autism. If successful, these claims could exhaust the pool of money currently set aside to compensate children who have been hurt by vaccines. Further, lawyers will then be encouraged to take their claims that vaccines caused autism to civil court, where awards could be enormous. “We need to figure out how we're going to compensate these families; how we're going to take care of these children; how we're going to remove the burden from states, because right now they're footing the bill for everything,” said David Kirby, author of the book "Evidence of Harm." “I don't want to see the drug companies go out of business. I don't think anyone wants that. [But] we are looking at trillions and trillions of dollars of care for these people.” Massive litigation against vaccines threatens one of the greatest achievements of modern medicine.
During the twentieth century, the lifespan of Americans increased by 30 years. Some of the increase was caused by advances such as antibiotics, purified drinking water, sanitation, safer workplaces, better nutrition, safer foods, seatbelts, and a decline in smoking. But no single medical advance had a greater impact on human health than vaccines. Before vaccines, Americans could expect that every year measles would infect four million children and kill 3,000; diphtheria would kill 15,000 people, mostly teenagers; rubella (German measles) would cause 20,000 babies to be born blind, deaf, or mentally retarded; pertussis would kill 8,000 children, most of whom were less than one year old; and polio would permanently paralyze 15,000 children and kill 1,000. Because of vaccines all of these diseases have been completely or virtually eliminated from the United States. Smallpox — a disease estimated to have killed 500 million people — was eradicated by vaccines. And we're not finished; vaccines stand as our only chance to prevent pandemic influenza, AIDS, and bioterror.
Although dire predictions about the fate of vaccines may seem overly dramatic, vaccines were the first medical product almost completely eliminated by lawsuits.
In the mid-1970s a British researcher named John Wilson published a paper claiming that the whooping cough (pertussis) vaccine caused permanent brain damage. Wilson reported the stories of 22 children who suffered epilepsy or mental retardation following vaccination. The British media hailed Wilson's report as fact and the percentage of children immunized dropped from 80 to 30. As a consequence, 300,000 children were hospitalized and 70 killed by pertussis.
Fears of pertussis vaccine spread to the United States. In front of jurors persuaded more by emotional appeals than by science, lawyers successfully claimed that the pertussis vaccine caused Sudden Infant Death Syndrome (later found to be associated with sleep position), Reye's Syndrome (later found to be associated with aspirin), unexplained coma, paralysis, mental retardation, and epilepsy. Seven companies stopped making the vaccine; within a few years only one, Lederle Laboratories, remained. Lederle was punished for its persistence. In 1986 a jury awarded $1.13 million to parents claiming that Lederle's pertussis vaccine had paralyzed their son — an award that was more than half of the annual sales of the vaccine. Vaccine makers were poised to leave the business. Ironically, subsequent studies of hundreds of thousands of children showed that the risk of permanent brain damage was the same in children who had or hadn't received the vaccine.
To save vaccines, the federal government stepped in, creating in 1986 the National Childhood Vaccine Injury Act. Designed to put an end to unfounded lawsuits, the Act included the Vaccine Injury Compensation Program. Now, if parents wanted to sue for damages caused by vaccines, they would first have to go through a federal claims court. Vaccine court established a list of compensable injuries and lessened frivolous litigation. Children actually hurt by vaccines, such as those paralyzed by the oral polio vaccine or those with severe allergic reactions to egg proteins in the influenza vaccine, were compensated quickly, generously and fairly. On the other hand, people whose claims were disproven by epidemiological evidence, such as those claiming that the Haemophilus influenzae type B vaccine caused diabetes or that the hepatitis B vaccine caused multiple sclerosis, weren't compensated. The bleeding stopped. Unfortunately, the legacy of the pertussis litigation remains.
Many pharmaceutical companies that abandoned vaccines never came back. At the beginning of the 1980s, eighteen companies made vaccines; by the end, only four were left. The infrastructure to make vaccines became tenuous and vaccine shortages became commonplace. For example, in 1998, the tetanus vaccine was in such short supply that its use was restricted to emergency rooms. Beginning in 2000, a pneumococcal vaccine for children, designed to prevent a common cause of pneumonia, bloodstream infections, and meningitis, was available only intermittently; parents could only hope that their children weren't among the thousands permanently harmed or killed every year by pneumococcus. Between 2003 and 2004 an influenza epidemic created a demand that dramatically exceeded supply; more than 150 children died that year from influenza. Since 1996 severe shortages have occurred for 10 of the 16 vaccines routinely given to children and adolescents. All of these shortages resulted in a delay in getting vaccines and some children never got the vaccines that they missed.
Now, vaccine makers are again threatened. Lawyers will argue that either the measles-mumps-rubella (MMR) vaccine or a mercury-containing preservative (thimerosal) in vaccines or the combination of the two caused autism. This theory has been advanced on television shows such as 60 Minutes, in popular magazines such as Time and Newsweek, and on national radio programs such as Imus in the Morning. Most prominently, the mercury-caused-autism theory has been advanced by a parents advocacy group called Safe Minds — a group now at the center of the litigation.
Certainly there is plenty of evidence to refute the notion that vaccines cause autism. Fourteen epidemiological studies have shown that the risk of autism is the same in children who received or didn't receive the MMR vaccine and five have shown that thimerosal-containing vaccines also don't cause autism. Further, although large quantities of mercury are clearly toxic to the brain, autism isn't a consequence of mercury poisoning; large, single-source mercury exposures in Minamata Bay and Iraq caused seizures, mental retardation, and speech delay, but not autism.
Finally, vaccine makers removed thimerosal from vaccines routinely given to young infants about six years ago; if thimerosal was a cause, the incidence of autism should have declined. Instead, the numbers continue to increase. All of this evidence should have caused a quick dismissal of these cases. But it didn't and now the court, overwhelmed by massive litigation, has turned into a circus.
Autism can be a heart-breaking disorder, often draining parents emotionally and financially. Although many promising genetic, epidemiological, and biological studies have been published during the past few years, autism remains a disorder without a known cause or cure. This has been enormously frustrating for parents. It would be nice if there were someone or something to blame. We could blame the government and use the federal vaccine compensation program to pay for care. Or we could blame vaccine makers, and get them to pay in civil court. But if vaccine makers — faced with large awards for a problem that wasn't their fault — make the same decisions that they did in the early 1980s, all American children will suffer, including those with autism. Then, we'll have only ourselves to blame.
On the morning of August 23, 2005, Marwa Nadama brought her 5-year-old autistic son, Abubakar, to the Advanced Integrative Medicine Center in Portersville, Pennsylvania for treatment. There she met Dr. Roy Eugene Kerry, a board-certified physician and surgeon. Dr. Kerry was certain that he could help cure Abubakar's autism by removing mercury from his body.
Ms. Nadama had heard that thimerosal, a mercury-containing preservative in some vaccines, caused autism. Indeed, parent testimonials found throughout the Internet claim that thimerosal causes autism. Although thimerosal had been taken out of most vaccines by 2001, Ms. Nadama believed that its toxic effects hadn't been taken out of her son's body.
For years Ms. Nadama struggled to help her son, but to no avail: Abubakar remained distant and uncommunicative and was unable to return her affection.
Dr. Kerry represented a ray of hope. He believed he could rid Abubakar's body of the cause of his autism by using chelation therapy, a technique used to remove heavy metals such as lead, arsenic and mercury from the body by introducing chemicals that will attach to (or chelate) metals in the bloodstream or body tissues and then enhance their excretion from the body.
At about 10:00 am, under the direction of Dr. Kerry, Abubakar's arm was cleaned with alcohol, and EDTA (ethylene diamine tetraacetic acid), a chelate, was directly injected into the boy's bloodstream. At 10:50 am, Abubakar Nadama was dead of a heart attack.
Epidemiologic studies performed on three continents by four separate research groups have shown that mercury in vaccines doesn't cause autism. The findings are clear, consistent, and reproducible. Futhermore, the signs and symptoms of mercury poisoning are different from those of autism.
So, if mercury in vaccines doesn't cause autism, why did more than 10,000 autistic children in the United States this year receive medication to rid them of mercury?
The notion that vaccines might cause autism contains all of the elements of a great story: greedy pharmaceutical companies, government cover-up, uncaring doctors, and parents fighting against all odds for their children. But the facts don't support the story.
On the one hand, every major medical organization including the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics and the Institute of Medicine state that mercury doesn't cause autism. On the other, a few marginal scientists and clinicians — in the absence of any solid, reproducible data — say that it does. The media gave equal time to both sides, but downplayed the fact that one side had no evidence for their arguments. This makes for great stories, but, unfortunately, perpetuates the dissemination of myths.
Although scientific studies have shown that vaccines do not cause autism, scientists have done little to explain these studies to the public. On July 19, 2005, Dr. Julie Gerberding, the director of the CDC, called a press conference to explain the science that refutes the notion that vaccines cause autism. Gerberding is an excellent communicator, and her message was clear and compelling. But that was one conference on one day; a tiny bell ringing against the constant, deafening drumbeat of weekly stories in the media that suggested otherwise.
Parents of autistic children desperately want to find something — anything — that works to help their children. So they're susceptible to fad therapies. Several years ago it was said to be the measles-mumps-rubella (MMR) vaccine that caused autism. Before that, secretin, a small protein secreted by the intestine, was proposed as a cure; many parents traveled hundreds of miles and spent thousands of dollars for secretin injections. Parents felt just as strongly about secretin and MMR at one time as they do today about mercury.
The Dr. Kerry phenomenon isn't new. During the polio epidemic in New York City in 1916, Dr. George Retan ignored warnings from his colleagues and drained large quantities of spinal fluid from the backs of polio victims and infused a salt solution into their veins to "cure" polio. The procedure killed many people. But in 1916, as today with autism, no one knew what caused polio or how to treat it. And George Retan offered hope.
If we are to effectively prevent the next tragedy, we must communicate the science of vaccines to the general public with equal fervor to those who firmly believe that mercury in vaccines causes autism. We must show that we are not just doctors and researchers standing behind a one-way mirror of science, but that we are also parents who don't want to see another child sacrificed at the alter of bad information. Otherwise, the death of Abubakar Nadama won't be the end of this.
In response to the growing threat of bird flu in Southeast Asia, President Bush released his "National Strategy for Pandemic Influenza" on November 2, 2005.
One component of the plan surprised and angered some lawmakers: "The Administration is seeking to remove one of the greatest obstacles to domestic vaccine production - the growing burden of litigation...Congress must pass liability protection for the makers of life-saving vaccines."
Many suspected the President was simply offering a gift to pharmaceutical companies, thanking them for supporting his campaign. They worried that the President's plan would enable companies to cut corners and make even larger profits, free from the supervision of the courts if their vaccines caused harm. "We don't need to throw out important consumer protections to address problems in our vaccine supply," said a spokesperson for Henry Reid (D, Nevada).
But was Bush merely rewarding his friends? Or did vaccine makers really need protection from litigation? The answer can be found in the history of vaccine litigation.
During the past 100 years, pharmaceutical companies have made vaccines against pertussis (whooping cough), polio, measles, rubella (German measles), and Haemophilus influenzae type B (Hib), among others. As a consequence, the number of children in the United States killed by pertussis decreased from 8,000 each year to less than 20; the number paralyzed by polio from 15,000 to 0; the number killed by measles from 3,000 to 0; the number with severe birth defects caused by rubella from 20,000 to 0; and the number with meningitis and bloodstream infections caused by Hib from 25,000 to less than 50.
Vaccine makers have been the single most powerful force in determining how long we live; during the twentieth century, the lifespan of Americans increased by 30 years-mostly because of vaccines. But the landscape of vaccines is also littered with tragedy.
In the late 1800s, starting with Louis Pasteur, scientists made rabies vaccines using cells from nervous tissue (such as animal brains and spinal cords); the vaccine prevented a uniformly fatal infection. But the rabies vaccine also caused seizures, paralysis, and coma in as many as 1 of every 230 people that used it.
In 1942, the military injected hundreds of thousands of American servicemen with a yellow fever vaccine. To stabilize the vaccine virus, scientists added human serum. Unfortunately, some of the serum came from people unknowingly infected with a hepatitis virus. As a consequence, 330,000 soldiers were infected, 50,000 developed severe hepatitis, and 62 died.
In 1955, five companies stepped forward to make Jonas Salk's new formaldehyde-inactivated polio vaccine. One company - Cutter Laboratories of Berkeley, California - made it badly. Because of Cutter's failure to completely inactivate the virus in their vaccine, 120,000 children were inadvertently injected with live, dangerous poliovirus; 40,000 developed mild polio, 200 were permanently paralyzed, and 10 were killed. It was one of the worst biological disasters in American history.
Given all of these problems, what role did personal-injury lawyers play in pushing vaccine makers to make better, safer products? The answer is - none. That's because the tragedies caused by vaccines weren't the result of foul play, cost cutting, deceit, misrepresentation, or dark figures lurking in the shadows. Every problem was caused by the inevitable, painful, but requisite process of knowledge gained with time that is required for advances in science and medicine.
Scientists eventually found a way to grow rabies virus in safer cells. The Cutter tragedy - later found to be caused by a problem filtering the virus and shared by all five companies making polio vaccines-was quickly identified and corrected. And, when researchers later discovered hepatitis B virus-the virus that had in retrospect contaminated the yellow fever vaccine - they made a vaccine to prevent it.
Like it or not, we learn as we go. And no amount of suing is ever going to change that. In addition to contributing nothing to making vaccines safer, personal-injury lawyers have made vaccines more expensive and less available. That's because most lawsuits have been directed at problems that were not, in fact, caused by vaccines. For example, in the late 1970s and early 1980s, personal-injury lawyers sued vaccine makers claiming that the pertussis vaccine caused Sudden Infant Death Syndrome (SIDS), paralysis, mental retardation, epilepsy, and unexplained coma.
Despite a series of epidemiologic studies showing these claims to be groundless, many lawsuits were successful. As a consequence, the price of the pertussis vaccine increased from $0.17 per dose to $11.00, the number of companies making vaccines decreased from 26 to 4, and the number of U.S.-based companies making influenza vaccine decreased from 6 to 0.
And they're still at it. Today, personal-injury lawyers are claiming that thimerosal, a mercury-containing preservative in vaccines, caused autism - despite abundant scientific evidence to the contrary.
So, how can we protect pharmaceutical companies from frivolous litigation and still compensate people for those rare times when they really are harmed by vaccines? The answer lies in the government's response to the pertussis-vaccine litigation, when vaccines became the first medical product almost eliminated by lawsuits.
To save vaccines, Congress passed the National Childhood Vaccine Injury Act in 1986; an act which included the Vaccine Injury Compensation Program. Now, when people claim to be harmed by vaccines, they take their case to "vaccine court" where scientists, epidemiologists, and clinicians review data and decide whether the claim is valid. The system brings reason and fairness to decisions about vaccine safety.
"Vaccine court" could also protect against the unlikely possibility of harm caused by a pandemic-influenza vaccine. Because, if companies are left exposed to the vagaries of juries (as is likely with the current thimerosal litigation), vaccine makers won't make a pandemic-influenza vaccine. And young Americans will be able to experience first-hand just what an influenza pandemic looks like - something that all of the lawsuits in the world won't be able to stop.
Reviewed by: Paul A. Offit, MD
Date: April 2013
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