Why Big Pharma distrust is fueling the anti-vaxxer movement and playing a role in the measles outbreak
Outbreaks across the U.S. have forced officials to declare emergencies. Why are we starting to see the rise of these outbreaks? It dates back to the anti-vax movement. USA TODAY
Bernadette Pajer doesn't trust the pharmaceutical industry. And she doesn't trust vaccines.
The founder of a Washington state advocacy group says her dual distrust shouldn't come as any surprise. She notes drugmakers have a "pretty poor record overall" on safety and transparency. Not to mention the opioid crisis, though Pajer often does.
Pajer is not alone. As distrust of the pharmaceutical industry grows, so has the anti-vaccination movement. That is a critical issue as the number of measles cases in the USA surges.
Vaccine supporters – which include federal, state and local officials, the public health community and most doctors – say it wasn't drugmakers' idea to require protection from largely eradicated deadly diseases. It's the government's doing.
It's also the government that shields drugmakers from liability when vaccines are found to cause injury. To vaccine skeptics, including drug safety advocate Kim Witczak, this suggests they may be hiding or at least getting away with something.
When voters were surveyed in January about their feelings toward industries that benefit from the North American Free Trade Agreement, nearly half had an unfavorable opinion of pharmaceutical companies, up from about a third in 2008, according to the advocacy group Public Citizen and the research firm Citizen Research.
"The pharmaceutical companies in particular push the negative reactions off the chart, with nearly half giving the most intense negative response," says a summary by pollster Stanley Greenberg. “Just mentioning the pharmaceutical companies as benefiting is like throwing a bomb in every quarter of the electorate."
The anti-vaccine movement has both gained and lost ground after the recent measles outbreaks in the USA. The Centers for Disease Control and Prevention said Monday that 704 measles cases in 22 states have been confirmed since Jan. 1. The numbers surpass the record of 667 set in 2014, the previous highest total since the disease was declared eliminated in 2000.
Pajer has stepped up her advocacy even as the government fights back by prohibiting unvaccinated children in public places in New York City, site of one of the outbreaks. The mystery writer and former grocery store clerk says no one ensures the science is valid. She describes herself as pro-"scientific integrity in vaccine policy" and not "anti-vaccine."
Pajer's advocacy group says drugmaker Merck can't be trusted with its measles, mumps and rubella vaccine, also known as MMR, in large part because it is fighting a federal whistleblower lawsuit in court that alleges the company overstated the effectiveness of the mumps vaccine. She questions the long-term effectiveness of Merck's measles vaccine and says the risk of the rubella portion causing arthritis has not been publicized.
A statement from Merck says it is "prepared to disprove the false allegations at trial, if necessary." It cites CDC estimates that two doses of the MMR vaccine have an average effectiveness of 88% for mumps. The CDC says there's been a 99% drop in the annual number of U.S. cases of mumps since the vaccine was introduced in 1967.
Pajer says she didn't know anything about vaccine risks until her son, now 16, developed severe allergic reactions called anaphylaxis to the food ingredients in vaccines as a child.
Despite her son's reaction, his then-pediatrician didn't want to stop vaccinating and suggested Pajer's son have the rest of his shots "in the hospital in case he goes into shock," she says. Pajer declined, and her son has a lifetime medical exemption from vaccines.
Is your doctor lying to you?
Paul Offit, an author and infectious disease physician at Children's Hospital of Philadelphia, has fought the anti-vaccine movement for about 20 years.
It's easier to understand a parent – or a celebrity, such as vaccine opponent Jenny McCarthy – who says children are injured or develop autism because of vaccines than it is to understand the science of why 26 shots are needed in the first few years of life to prevent 14 diseases few have ever seen, Offit says.
For these fears to be well-founded, a massive coverup of data would be required, he says.
"In order to believe vaccines are hurting you means your doctor is lying to you," Offit says. To believe that, "on some level you have to be a conspiracy theorist" who believes the industry is "directing the government and the health care industry to lie about vaccines."
For baby boomers and older Americans, polio, smallpox and chicken pox could be deadly and crippling. But those diseases have been eradicated for so long, younger generations may have no knowledge or memory of them. Autism is a more common concern among today's parents.
"Vaccines are largely a victim of their own success," Offit says. "If you don't fear the disease, you're more likely to fear the vaccine."
'A healthy dose of skepticism'
Witczak sees close parallels between doctors' near unanimous push for vaccines and the enthusiasm for antidepressants.
In August 2003, Witczak's husband died by suicide, five weeks after his doctor prescribed him the antidepressant Zoloft to treat his sleep problems. Timothy Witczak never suffered from depression or expressed suicidal thoughts until he began taking the drug, she says.
Kim Witczak recalls her typically gregarious husband in the fetal position on the floor, saying, "Help me, help me. It's like my head is outside my body looking in."
Witczak sued drugmaker Pfizer for failing to warn the medical community and consumers about the risks of suicidal thinking and death associated with Zoloft. The case was settled, and she became a drug safety advocate.
The advertising and marketing communication consultant is a vocal industry critic and consumer representative on the Food and Drug Administration advisory panel that evaluates psychopharmacologic drugs – those that can affect mood, thinking and behavior.
At the time of Timothy Witczak's death, the Zoloft label noted "possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs."
"Suicidal ideation" was included in a long list of possible psychiatric side effects and described as rare. In a statement, Pfizer says the label "has included the risk of suicide since the product was approved in December 1991," adding that all drugs have risks and benefits.
In 2005, "black box" warnings, which relate to the most serious risks, were added to antidepressants, including Zoloft, disclosing the link to suicide and suicidal thinking. It was too late to help Witczak's family.
Witczak questions the "sheer numbers of vaccines" and points to a recent British Medical Journal study questioning the reported effectiveness of the HPV vaccine.
"There's something bigger happening, and you have to have a healthy dose of skepticism," she says. The government "shouldn’t be attacking the patients out there. I would question, 'Do we need all of them?' "
The drug industry's trade group, Pharmaceutical Research and Manufacturers Association, says we do, calling vaccines "one of the greatest achievements of biomedical science and public health."
"And biopharmaceutical companies remain committed to making more diseases history," PhRMA says in a statement. "Today, there are 264 vaccines in development by biopharmaceutical companies to both prevent and treat diseases."
Taking claims to court
One of the biggest factors underlying some vaccine critics' skepticism is the fact that the federal government shields pharmaceutical companies from considerable liability with the National Vaccine Injury Compensation Program. Anyone who petitions that a vaccine caused an injury or illness must file a claim first with the program.
Narayan Nair, director of the division of injury compensation at the Department of Health and Human Services, says the agency is not aware of anyone continuing on to sue a drug company after losing their federal claim.
The Justice Department represents HHS in the proceedings, and special masters in the U.S. Court of Federal Claims decide the cases.
The program wasn't started to protect drug companies, Nair says. It was meant to protect consumers who need a reliable supply of vaccines. Vaccines are such an "important pillar" of the health care system that Congress decided in the 1980s "the federal government needed to step up and play a role," he says.
The National Childhood Vaccine Injury Act of 1986 followed a rush of lawsuits over DPT vaccines that convinced many drugmakers it "wasn’t profitable to make vaccines, and very few were interested," Nair says.
Since 1988, 20,428 petitions have been filed with the compensation programs. Of these, 17,718 cases were heard – 6,430 were found eligible for compensation, and 11,288 were dismissed. No autism claims have been compensated.
The government's total bill: about $4 billion.
The program is generous – almost to a fault, Offit says. In about 70% of cases that the program agrees to pay, the compensation is part of a negotiated settlement and "HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury," the agency says.
No 'memory' of measles
Claire Foster has good friends who work in vaccine development where she lives in Auckland, New Zealand.
"This work is undertaken in an academic environment, and they are by no means getting rich from Big Pharma," she says. "These are highly educated people motivated purely by the prevention of disease and suffering."
A strong believer in vaccines, Foster gets frustrated by what she calls ill-informed fear-mongering online. She posted "The 'I've done my homework' Pop Quiz" to tweak the anti-vaccine crowd. The multiple-choice questions included one asking readers to identify a cell type by its photo and another that asked which antibody chain is the first to respond to an antigen.
Those who got questions wrong were told their definition of research is different from that of the scientists who develop vaccines.
Indeed it is, Offit says.
"When Jenny McCarthy gets on TV and says, 'I'll take the measles every time,' that tells you something important," he says. "It shows me that not only have we eliminated measles, but we've eliminated the memory of measles."