Bad Science

Critics Say Vaccine "Study" Harms Public Health

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Public Health Feature – March 2011

Tex Med. 2011;107(3):27-32.

By Crystal Conde
Associate Editor

Parents used to ensure their children's vaccinations without question. That changed, however, in 1998 when The Lancet published a case report by English physician Andrew Wakefield, MD, that linked the measles, mumps, and rubella (MMR) vaccine to a new syndrome of autism and bowel disease. The report set off frenzied media coverage and forever altered the dialogue physicians have with parents about immunizations. Some critics say it led to thousands of unnecessary illnesses.

Dr. Wakefield and the report faced considerable scrutiny after publication of The Lancet article. In 2004, 10 of the study's coauthors withdrew their support for its interpretations over concerns that Dr. Wakefield had a financial conflict. Then last year, England's General Medical Council revoked his license to practice medicine after its Fitness to Practice Panel concluded he was guilty of serious professional misconduct regarding dishonesty over the study's admission criteria and its funding. The Lancet ultimately retracted the report.

Now, the British Medical Journal (BMJ) alleges that Dr. Wakefield falsified data in his report, committing an "elaborate fraud."

In a Jan. 5 BMJ investigative report, "How the Case Against the MMR Vaccine Was Fixed," journalist Brian Deer reveals that Dr. Wakefield, who now lives in Austin, received about $674,000 from attorneys who planned to sue vaccine manufacturers. It was not the first time Dr. Wakefield's motives came into question.

An accompanying editorial in BMJ said Mr. Deer "found that not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration, and that in no single case could the medical records be fully reconciled with the descriptions, diagnoses, or histories published in the journal."

Adding to the controversy, BMJ reported on Jan. 11 that Dr. Wakefield stood to profit "off the back of the vaccine scare, diagnosing a purported – and still unsubstantiated – 'new syndrome.'" Dr. Wakefield called the syndrome "autistic enterocolitis" and estimated in materials for prospective investors that a test for the disorder could bring in up to $43 million in revenue, the journal reported.

BMJ also said the product's initial market would include "litigation-driven testing" of U.S. and British patients. On top of that, one of Dr. Wakefield's business partners was the father of a child studied in the 1998 report.

Dr. Wakefield didn't respond to a Texas Medicine request for comment but has defended his report in multiple news media interviews.

Mr. Deer told CNN that Dr. Wakefield should face criminal charges for allegedly falsifying data in his report.

Ari Brown, MD, an Austin pediatrician and member of TMA's Be Wise — ImmunizeSM Advisory Panel, has no doubt Dr. Wakefield's report and the subsequent news media firestorm influenced parents' comfort level with vaccinations.

"Parents developed a global fear of vaccines. Parents were asking to separate the MMR vaccine instead of giving the combination vaccine," she said.

Jason Terk, MD, a member of TMA's Council on Science and Public Health and the Be Wise — Immunize Advisory Panel, says Dr. Wakefield generated a flood of vaccine safety questions and concerns from parents that has lasted for more than a decade.

"In my practice, suddenly the mission of providing lifesaving vaccines was made much more difficult because of the risks implied in this now-discredited and retracted report," he said. "Parents' confidence in the safety of vaccines was seriously eroded, and many chose unwisely to withhold them from their children. Many more raised questions about vaccine safety that I needed to answer before we could proceed with providing vaccines, which required much more time during the encounters."

TMA member Adolfo Valadez, MD, MPH, assistant commissioner for Prevention and Preparedness Services at the Texas Department of State Health Services (DSHS), says that in general, vaccination rates in Texas and the United States have fluctuated slightly over the years but remain high. Education about vaccination effectiveness and safety has helped. "An increase in the amount of time providers spend with their patients has led to parents who are more engaged in their children's health care," he said.

Dr. Valadez says DSHS cannot speculate how Dr. Wakefield's report affected vaccination rates in Texas. He does, however, acknowledge it may have influenced some parents' decisions on vaccinations for their children. Currently, he says, only about 0.4 percent of children in Texas schools have a conscientious objection on file, and the vast majority of parents feel vaccinations are safe.

Scot R. Morris, MD, a Brownwood pediatrician and member of TMA's Committee on Child and Adolescent Health, says the BMJ allegation that Dr. Wakefield's study was fraudulent will help calm the fears of those linking rising rates of autism to vaccines.

"I predict we will see a modest increase in vaccination coverage rates in Texas. Some groups, however, will be slow to change their beliefs on this matter. A criminal conviction for fraud would help even more," Dr. Morris said.

At press time, Dr. Wakefield wasn't under criminal investigation.

The Report's Impact

Dr. Wakefield's report in The Lancet has had a far-reaching effect on public health, Dr. Terk says. In 2008, the United States experienced an outbreak of measles. Dr. Terk says the suffering caused by the measles outbreak was "preventable and occurred because of fear created by this public fraud."

From January to July 2008, the Centers for Disease Control and Prevention (CDC) received reports of 131 measles cases, compared with an average of 63 cases per year from 2000 to 2007. According to DSHS, none of the reported cases were in Texas.

At the time, CDC reported 76 percent of the measles cases were in people younger than 20 years. In addition, 91 percent of the reported measles cases were in people who had not been vaccinated or whose vaccination status was unknown. Of the 131 cases, CDC reported that 89 percent came from other countries, particularly in Europe, where several outbreaks occurred.

MMR immunization rates dropped in Britain following the Wakefield report, falling to 80 percent in 2004. According to BMJ, MMR vaccination rates are below 95 percent in the United Kingdom today. The World Health Organization (WHO) recommends a 95-percent vaccination level to ensure herd immunity.

England and Wales declared measles endemic as the number of confirmed cases soared to 1,370 in 2008.

And in a frightening turn of events, polio emerged in countries where the disease hadn't been present before. Last year, there was an outbreak of poliovirus imported from India in the Republic of Tajikistan. CDC reported the outbreak represents the first importation of polio into the WHO European Region since being certified polio-free in 2002.

As of October, the Tajikistan Ministry of Health reported 706 cases of acute flaccid paralysis. Of those, 458 were laboratory-confirmed as polio. Twenty-six patients died.

Of the confirmed polio cases, 298 were in children younger than 5 years. The number of paralysis cases per week fell substantially after four immunization campaigns were conducted in the region in May and June.

In addition, Turkmenistan, Russia, and Kazakhstan had confirmed 18 polio cases as of October.

Dr. Morris believes fewer vaccinations led to the recent outbreaks of measles and polio. He says if vaccination rates lag, Texas and the rest of the United States could see a substantial reemergence of vaccine-preventable diseases.

"There are consequences to what we as professionals do and say," Dr. Terk said. "Dr. Wakefield committed a public fraud, according to the investigation by BMJ. This fraudulent scientific work has resulted in thousands of children not getting lifesaving and life-preserving vaccines because trust in their safety was undermined wrongly."

Out of the controversy spurred by Dr. Wakefield's report blossomed an opportunity for the scientific community to answer a critical question: Are vaccines safe? At great monetary and human cost, Dr. Terk says, the answer to this question, after 13 epidemiologic studies and a review by the Institutes of Medicine (IOM), is a resounding yes.

"We can feel good that when such a fundamental question was raised, science was able to answer the call to respond to this question. It will take time and all of our [physicians'] patience to continue to articulate the truth and debunk the fraud that persists on the Internet and in the books of vaccine controversy profiteers," Dr. Terk said.

Report Triggered Vaccine Scare

Dr. Brown says parental concern over vaccine safety peaked in 2008, at the time actress and author Jenny McCarthy was on tour for her book, Louder Than Words: A Mother's Journey in Healing Autism. That same year, government health officials determined that the family of Hannah Poling, a 9-year-old Georgia girl, whose regression in development associated with her underlying medical disorder occurred after she had a fever with her vaccinations, should be compensated by the federal vaccine injury compensation program,.

Since 2008, however, Dr. Brown says dialogue with patients about vaccines has improved. She attributes the shift in parental attitudes to research findings that report no connection between vaccines and autism and proactive messages about vaccine safety from health organizations and the medical community.

She adds that England's General Medical Council decision to strip Dr. Wakefield of his license to practice medicine and The Lancet's retraction of his case report last year also helped allay parents' fears.

The initial fear from parents regarding vaccine safety has transformed into a quest for answers and information, Dr. Terk says. Unfortunately, some parents who are simply trying to perform due diligence on their questions about vaccine safety can't discern the quality of the information they are viewing.

"Now much of the dialogue with parents is about deconstructing vaccine myths that live on in cyberspace," Dr. Terk said.

When Dr. Terk counsels families about vaccine safety, he says he treats them with respect and keeps in mind that most parents are trying to make a good decision for their children. He adds that a small but vocal minority of parents with vaccine safety concerns aren't open to thoughtful dialogue because they distrust the "medical establishment."

"Many parents are confused by the controversy they have heard and simply need their questions answered in a respectful way. That is why it is important that the physician providing this counseling be up to date on the history of the controversies surrounding vaccine safety, as well as the best evidence validating their safety," he said.

In response to vaccine safety concerns, some parents have chosen an alternative vaccine schedule that allows them to delay or space out the administration of immunizations for their children. Dr. Terk says some physicians created these alternative vaccine schedules to leverage the vaccine safety concerns of the past decade for their financial benefit.

The schedules pander to parents who distrust vaccines and continue to question vaccine safety despite the now-overwhelming evidence that vaccines are safe and absolutely necessary according to the CDC-recommended schedule studied and developed by the Advisory Committee on Immunization Practices (ACIP), he says.

"I explain to parents that an alternate or delayed schedule results in delaying protection for their children when they are most vulnerable. I make clear that I cannot participate in a medical plan that enhances the risk to my patients and I therefore will not support a choice to follow a delayed vaccine schedule unless the medical status of the patient requires it," Dr. Terk said.

Dr. Morris says about 95 percent of his patients' parents remain committed to getting their children vaccinated, often after much discussion. He says some elect to wait until their children are older or forego vaccination until school entrance.

"If you add this number to the children who don't get vaccinated due to lapses in coverage or other unintentional barriers, the problem grows into an eminent threat to the health of our children," Dr. Morris said.

According to Dr. Valadez, DSHS follows ACIP's guidelines.

"Physicians should continue educating patients about vaccines and vaccine safety and talking about the importance of vaccinating children on schedule. They should also impress the fact that vaccine intervals are based on science and are timed to ensure optimal protection for children from vaccine-preventable diseases," Dr. Valadez said.

Ethical Questions

The BMJ investigative report alleges Dr. Wakefield altered data to achieve the results published in his report. Dr. Brown says this lapse in ethics harms public health and may change the way physicians look at peer-reviewed articles published in medical journals.

"Physicians have assumed they can trust that a study has been done ethically and that the data hasn't been altered to game the results. Now, medical professionals are going to need to examine reports more critically to ensure that astounding findings are accurate," Dr. Brown said.

She also contends one case report should never alter medical practice.

"You need more than one study that shows the same results before any medical professional changes what's presumed to be true. Families shouldn't base medical decisions on the results of one study either," Dr. Brown said.

Dr. Morris agrees and says Dr. Wakefield "hijacked the scientific method."

"Observation should lead to small studies, which, if validated, lead to larger studies. If these observations are validated in larger studies, funding for studies continues," he said. "This is predicated on the honest reporting of data. Fears of a link between autism and vaccines have resulted in a great deal of attention to this subject. These fears are not based on science, only fraud and fear."

The BMJ editorial on Dr. Wakefield's article linking MMR vaccine to autism says Dr. Wakefield declined to replicate the findings in his 1998 paper or to say he was mistaken. The journal also reports no one has been able to duplicate Dr. Wakefield's original findings.

No Link

The BMJ editorial also charges that unbalanced media reporting, along with an ineffective response from government and medical professionals contributed to harming the public's health.

In August, Jeffrey L. Levin, MD, MSPH, chair of TMA's Council on Science and Public Health, sent a letter on behalf of TMA to Fox 7 News in Austin after the television station aired a story on parents choosing not to vaccinate their children.

The story cited Dr. Wakefield's retracted report in The Lancet. Dr. Levin recognizes the uncertainty about autism spectrum disorders and that the disorders can be devastating to families who want answers and solutions.

In his letter, he acknowledged the need for research into autism spectrum disorders but said, "There is no need to continue linking the discussion to vaccines. Doing so can have serious public health consequences." He referred to multiple analyses by public health and independent institutions such as the IOM that could not identify a link between autism and vaccines.

In 2000, IOM – at the request of CDC and the National Institutes of Health – conducted an independent, thorough review of completed and ongoing studies, published medical and scientific reports, and expert statements to determine whether a link existed between autism and the MMR vaccine. IOM found the evidence examined didn't support a connection between autism and the MMR vaccine.

The same year, the American Academy of Pediatrics (AAP) convened a conference on the MMR vaccine and autism. An expert panel reviewed relevant information introduced by parents, scientists, and medical professionals. Like IOM, AAP couldn't find any evidence to maintain the theory that the MMR vaccine caused autism or related disorders.

TMA supports research and surveillance of autism and other developmental disabilities.  

Be Wise ― Immunize is a service mark of the Texas Medical Association.

Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail.

Accompanying Commentary: What Hath Andy Wakefield Wrought? By Steve Levine


Education Resources to Spread the Truth About Vaccines

Physicians can send patients and the news media an accurate, evidence-based message about vaccine safety if they are informed about the current credible scientific evidence surrounding the risks and benefits of vaccines, says Jeffrey L. Levin, MD, MSPH, chair of TMA's Council on Science and Public Health.

He recommends physicians consult the vaccine safety webpage of the Centers for Disease Control and Prevention for up-to-date information and resources, as well as the website of the Advisory Committee on Immunization Practices for the latest immunization recommendations and schedules.

In addition, the Be Wise — ImmunizeSM physician toolkits for children and adolescents help physicians implement vaccination best practices in the office. The toolkits inform physicians and staff members on how to use ImmTrac, the Texas immunization registry; join the Texas Vaccines for Children program; and talk to parents about conscientious objection.

One of the Be Wise — Immunize program's main goals is to communicate that vaccines are safe and effective. To aid physicians, the website features a fact-and-fiction handout, available in English and Spanish, regarding childhood vaccines. Physicians can request copies of this handout from TMA and share it with patients as an educational tool.

To request the handout, contact Tammy Wishard, TMA outreach coordinator, by telephone at (800) 880-1300, ext. 1470, or (512) 370-1470, or by e-mail.

Be Wise — Immunize, a joint initiative of TMA and the TMA Alliance, receives funding through a grant from the TMA Foundation with major support from H-E-B. The program began in 2004.

Jason Terk, MD, member of TMA's Council on Science and Public Health and the Be Wise — Immunize Advisory Panel, has some advice on how physicians can educate parents about vaccines. He says the medical community needs to be just as good at telling its story about the critical need to provide the recommended schedule of vaccines as are people like actress Jenny McCarthy who have manipulated people's fears to persuade parents to avoid or to delay immunizations for their children.

"Yes, we need to refer to the science, but we need to remember that people are persuaded by anecdotes and personal experiences much more than the statistics from epidemiologic studies," Dr. Terk said.

To access resources that can help physicians reinforce the importance of vaccination as a public health intervention, Dr. Terk suggests The Center for Vaccine Awareness and Research at Texas Children's Hospital. The center's website features publications and posters available for purchase that tell the story of people whose lives have been affected by vaccine-preventable diseases and can assist physicians in helping parents understand the importance of vaccines.

The Texas Department of State Health Services (DSHS) also is active in educating Texas physicians and patients about vaccine safety and effectiveness through the Texas Vaccines for Children program.

Information about vaccine education and safety is available on the DSHS website. DSHS offers an online educational module for vaccine safety along with links to CDC resources. In addition, the department works closely with the Texas Pediatric Society and TMA to educate medical professionals.

"We [DSHS] hope all children are vaccinated against vaccine-preventable diseases. Public health and provider associations, like TMA, must remain steadfast and aggressive in educating the providers and the public about vaccines and vaccine safety," TMA member Adolfo Valadez, MD, MPH, assistant commissioner for Prevention and Preparedness Services at DSHS, said. "We must also be proactive with providers, parents, schools, and day care centers to continue to promote the importance of vaccines and vaccine safety. Most importantly, we must ensure that kids are vaccinated on time, every time."


DSHS Data: Vaccines Work

The Texas Department of State Health Services (DSHS) has data on incidence rates of vaccine-preventable disease in Texas from 1998 to 2009 that show hepatitis A, acute hepatitis B, meningococcal disease, and varicella rates have decreased over time. The incidence of varicella dropped from 104.2 per 100,000 in 1998 to 17.9 per 100,000 in 2009.

Unfortunately, Texas' rates of pneumococcal disease and pertussis have increased. The incidence of pertussis grew from 1.5 per 100,000 in 1998 to 13.5 per 100,000 in 2009. When DSHS began recording rates of pneumococcal disease in 2003, the figure was 1.2 per 100,000. By 2009, pneumococcal disease had grown to a rate of 7.9 per 100,000.

The National Immunization Survey estimated vaccination coverage with one or more measles-mumps-rubella (MMR) vaccines among children aged 19–35 months in 2009 at about 90 percent for the United States and about 88 percent in Texas. Texas requires children to receive two MMR vaccinations to start school.

The survey indicates that in 2008, about 78 percent of children aged 19 to 35 months received the recommended 4-3-1-3-3-1 vaccine series – four diphtheria, tetanus, and pertussis (DTaP); three polio; one MMR; three hepatitis B; three Haemophilus influenzae type b (Hib); and one varicella – in Texas and nationwide.

DSHS data indicate no incidence of measles, tetanus, Hib, or rubella in Texas in 2009.

Adolfo Valadez, MD, MPH, assistant commissioner for Prevention and Preparedness Services at DSHS, says vaccines have reduced disease in Texas. For example, Texas has not had a case of rubella since 2004, and the last case of congenital rubella syndrome was in 1998.

"However, there are still challenges like pertussis, where we see cases increasing in certain parts of our state," he said.

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