Study Participant Receives NIAID/GSK Candidate Ebola Vaccine (Photo by NIAID)
By Maggie Fox
Just 12 hours after he got an experimental Ebola vaccine, and just two days after he stuck himself with a needle while caring for Ebola patients in September, Dr. Lewis Rubinson started getting sick.
By then, Rubinson was aboard a jet, being evacuated from Sierra Leone to the United States. He wasn't sure if he was infected with Ebola or if the vaccine was causing a reaction. He was en route to strict isolation at the National Institutes of Health outside Washington D.C.
Months later, it's fairly clear the vaccine caused the reaction. He has no trace of Ebola infection. What's not entirely clear is whether the vaccine stopped the virus from taking hold, or whether he was never infected in the first place.
"My gut leads me to believe he was never exposed. You can never prove it," Thomas Geisbert, an Ebola vaccine expert at the University of Texas Medical Branch, Galveston, told NBC News.
[...]
Rubinson had two choices: an experimental drug made by Canadian company Tekmira, or an experimental Ebola vaccine that had not, at that time, ever been tested in humans. Rubinson chose the vaccine.
He was put aboard a specially equipped jet for the long flight to Maryland and vaccinated.
"The patient developed malaise, nausea and fever 12 hours after the vaccination while on the transport jet," Dr. Mark Mulligan of Emory University and colleagues wrote in a study published in the Journal of the American Medical Association Thursday.
They could have been symptoms of Ebola, or from the vaccine, which is made using a "live" virus called vesicular stomatitis virus (VSV) genetically engineered to carry a small, non-infectious piece of Ebola virus. By design, the vaccine causes a mild infection that activates the immune system and helps it recognize Ebola.
By Ronald David Jackson
The following "Mercury in Medicine" report was added to the Congressional Record on May 20, 2003. The report was prepared by the staff of the Subcommittee on Human Rights and Wellness, Committee on Government Reform. The report is the result of a three-year investigation initiated in the Committee on Government Reform. The key findings of the investigation are highlighted with black outlines and in some cases with black and yellow outlines. Some of the key findings include:
1) No one knows for sure if vaccines are safe or unsafe because while there are studies comparing health outcomes in those who did and did not get the vaccine (epidemiological studies) - the vaccines themselves (and more importantly, the various ingredients in the vaccines) have never been thoroughly tested for safety in humans. Specifically: "The FDA [Food and Drug Administration] has never required manufacturers to conduct adequate safety testing on thimerosal and ethylmercury compounds."
2) As the rate of autism has grown at epidemic proportions during the last two decades, the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold.
3) The Institute of Medicine (an American non-profit, non-governmental organization founded in 1970) determined that a relationship between autism, attention deficit hyperactive disorder, and speech or language delay, and the increased use of thimerosal in vaccines is plausible and deserves more scrutiny (even though there was not enough evidence to support or reject this hypothesis).
4) In 1998, the FDA finalized a rule requiring that ethylmercury be removed from over-the-counter products like topical ointments and skin creams (suggesting that ethylmercury—used as a preservative in many vaccines—could be hazardous to health) . Yet it took the FDA 18 years to get around to doing this, even though an advisory committee determined that ethylmercury was unsalfe in these products in 1980.
5) The FDA and the CDC [Center for Disease Control] failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type B vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled.
6) The amount of ethylmercury to which children were exposed through vaccines exceeded the safety thresholds established by the Federal government for a closely related substance methylmercury, "experts agree that the methylmercury guidelines are a good substitute."
7) Federal health officials have conceded that the amount of thimerosal in vaccines exceeded the EPA threshold of 0.1 micrograms per kilogram of bodyweight. "In fact, the amount of mercury in one dose of DTaP or Hepatitis B vaccines (25 micrograms each) exceeded this threshold many times over.
8) The FDA has: a) Failed to require the pharmaceutical industry to conduct extensive safety studies on thimerosal or ethylmercury. b) Failed to require the pharmaceutical industry to conduct adequate testing to determine how thimerosal is metabolized. c) Failed to require the pharmaceutical industry to determine the maximum safe exposure level to thimerosal.
9) Over the course of two decades the FDA slowly removed ethylmercury from many medicinal products - WHY?
10) In June of 2000, the CDC's Advisory Committe on Immunization Practice met in Atlanta. One of the key factors that weighed against a recommendation for a preference for thimerosal-free vaccines was the financial health of the vaccine industry. A recommendation for thimerosal-free vaccine had "the potential for financial losses of existing inventories", "could harm one or more manufacturers and may then decreased the number of suppliers", and "could entail financial losses for all existing stocks of vaccines that contain thimerosal."
It appears that protecting the industry's profits took precedent over protecting children from mercury damage.
Global Research Editor’s note: We bring to the attention of our readers this incisive and carefully documented 2005 article by Robert F. Kennedy Jr. published by Rolling Stone, first posted on Global Research in July 2009. The article sheds light on the collusion between Big Pharma and the US government and the dangers associated with vaccines produced by major pharmaceutical companies. In 2009 this article was of particular relevance to the debate on the H1N1 swine flu virus and plans by the WHO, The Obama Administration and Big Pharma to develop a swine flu vaccine.
By Robert F. Kennedy Jr; Rollingstone.com 20 July 2005
In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session — only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly “embargoed.” There would be no making photocopies of documents, no taking papers with them when they left.
The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency’s massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines — thimerosal — appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. “I was actually stunned by what I saw,” Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants — in one case, within hours of birth — the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.
Robert F. Kennedy, Jr.: The number of public figures with his level of integrity is quickly
dwindling to zero. (Photography by Mark Sutton)
Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. “You can play with this all you want,” Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results “are statistically significant.” Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting’s first day, was even more alarmed. “My gut feeling?” he said. “Forgive this personal comment — I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on.”
Unapproved, But Used In Surgery:Firm sold 18,000 knee-replacement tools before the government called a halt.
By Marshall Allen and Olga Pierce ProPublica This story was co-published with the New York Times.
Carla Muss-Jacobs didn't give much thought to the tools her surgeon would use to replace her knee. Like most patients, she just wanted to feel better and trusted that any devices in the operating room would be safe.
In her case, the surgeon sliced open her leg and positioned special cutting guides, like carpentry jigs, over her thigh and shin bones to line up his bone saw precisely. The device, called the OtisKnee, was supposed to speed the surgery and the recovery.
Muss-Jacobs' recovery was not speedy. In terrible pain after the operation, she eventually underwent a second knee replacement.
As it turned out, the OtisMed Corporation, the maker of the OtisKnee, did not seek clearance from the Food and Drug Administration for its OtisKnee guides before it started selling them. When the company did apply for FDA review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective.
In December, OtisMed and its former chief executive pleaded guilty in Federal District Court in Newark to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 of its OtisKnee devices from 2006 to 2009 without FDA approval.
No one can say with certainty if the OtisKnee device caused Muss-Jacobs' problems, but in announcing an $80 million settlement of criminal and civil charges against OtisMed, United States Attorney Paul J. Fishman said patients "should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved."
An examination of the OtisKnee case shows how easily that trust can be violated in the rapidly evolving world of medical devices, a thriving $110 billion-a-year industry. If not for a whistle-blower, the public might never have learned about the widespread use of a potentially dangerous device that sidestepped regulation.
About 700,000 knee replacements are performed every year, making it the most common elective surgery in the country. An aging population is increasing demand, creating opportunity for companies that make orthopedic devices and the accessories used to implant them.
OtisMed was an Alameda, Calif., start-up that saw an opening in that growing market. The company's guides worked with knee replacement components made by other medical device makers. The idea was to use magnetic resonance imaging and three-dimensional software to create guides at an OtisMed facility that were then shipped to the hospitals. The guides directed the angle of the surgeon's cuts so the artificial knee would be properly aligned. In theory, the method helped surgeons tailor bone cuts to a patient's anatomy.
Experts say the cutting blocks were a good idea, and similar devices are made by other companies. But the FDA trusts manufacturers to properly classify their devices, effectively giving them say over whether safety studies are required before they are sold. That can allow some products that should receive closer scrutiny to slip by.
Dr. Steven B. Haas, chief of knee service at the Hospital for Special Surgery in Manhattan, said OtisMed pioneered the use of disposable, patient-specific surgical instruments. The problem was that research hadn't demonstrated that the OtisMed alignment method was effective.
"OtisMed got it half right," Dr. Haas said.
Feeling Like a Guinea Pig
In 2008, Muss-Jacobs, a real estate agent in Beaverton, Ore., had a terrible pain in her left knee. Years earlier, she had a knee operation, but things were getting worse, so she went to see Dr. Ronald Teed, an orthopedic surgeon.
Teed told her many doctors were using the OtisKnee device for custom knee replacements, with faster recoveries and reports of less pain, she said.
Teed performed the surgery in May 2008 at Tuality Community Hospital in nearby Hillsboro. Muss-Jacobs, now 56, said she awoke with so much pain she couldn't stop crying. She knew immediately that something was wrong. Hospital records she provided document her persistent complaints about pain.
Muss-Jacobs said she had to hobble around with a walker and for several months was unable to show any homes to real estate clients. Six months later, she went to another surgeon, Dr. Ira Weintraub, in Portland, who said the new knee had failed and was misaligned. Dr. Weintraub performed a complex revision surgery, and Muss-Jacobs said she could walk the next day, though she still had a long, painful recovery. Teed said pain after a knee replacement could last up to a year and that Dr. Weintraub's revision surgery wasn't necessary. Dr. Weintraub and Tuality Community Hospital declined to comment.
Muss-Jacobs lived alone. Because she was unable to work, her bills mounted and, in 2009, she declared bankruptcy. When she couldn't persuade a lawyer that a malpractice case was worthwhile, she sued Teed on her own, but the case was dismissed. (In an interview, Teed said Muss-Jacobs had refused to comply with her rehabilitation plan. "She didn't do what she was told," Teed said, "and she ends up with a bad outcome.")
While Muss-Jacobs was preparing her lawsuit, she learned that there were complaints about the OtisKnee. She found news reports and OtisMed promotional materials and read medical device bulletin boards online. She discovered that some surgeons questioned whether the device was safe and that it had not been approved by the FDA.
The revelation made her feel like she'd been a "guinea pig," she said.
Promoting the OtisKnee
Like other medical device makers, OtisMed marketed directly to providers. And it had a powerful message for them: The OtisKnee would simplify surgery and bring in extra revenue from additional MRI scans, according to Justice Department case filings.
The company made its pitch to doctors over dinner and during cocktail parties at meetings of the American Academy of Orthopedic Surgeons. The OtisKnee was supposed to preserve more of a patient's bone and ligaments, improving fit and longevity. But none of the promotional claims had been evaluated by the FDA, the Justice Department said.
The company's public relations efforts worked. According to a case study in PR Week, the number of surgeons adopting the OtisKnee doubled each month in 2007.
Among the converts was Teed.
He endorsed the OtisKnee to a gathering of potential patients in an informational video obtained by Muss-Jacobs. The surgery is a "piece of cake," Teed tells the audience. "It doesn't take me a lot of effort."
Teed explained that operating room efficiency is crucial to reducing the risk of infections and other complications. He said he had been able to do as many as 12 knee replacements a day by bouncing among two or three operating rooms. Then OtisMed approached him and said that with the OtisKnee, he could work even faster.
"And of course, you can catch my attention with that," Teed says in the video. "It's like, 'Well, that sounds good to me, let's sit down and talk.'"
Eventually, though, Teed said, he found problems. He said he had taken part in an OtisMed study and was one of the first surgeons to discover that the procedures were not always working as hoped. "Some did. Some didn't," he said. "They weren't perfect."
During some surgeries, he could see that alignments weren't right. In a few cases he had to revert to the standard knee replacement method and redo the operation on the spot, he said.
He said he had visited the company's headquarters and "they seemed like they couldn't figure it out." Later, Teed said, he heard that OtisMed had changed the materials used to make the cutting guides, which might have led to them warping when they were sterilized before surgery.
The FDA should have been sterilizing "the crud" out of those things to test them, Teed said.
Faulty cutting guides were not a problem in Muss-Jacobs' case, Teed maintained. Nonetheless, he said he had learned a valuable lesson from the OtisKnee: "Don't jump on the bandwagon too early."
A Regulatory Bypass
The FDA regulates medical devices by classes, and each is treated differently.
Class III devices, like pacemakers, require extensive testing because they are implanted or sustain or support life and could put patients at serious risk.
Class II devices, like powered wheelchairs or pregnancy tests, are approved if companies assure that they are similar to other devices on the market.
Class I devices — bandages, dental floss, forceps and the like — must be registered but don't require premarket review because they present a low risk. They can be sold without any other FDA involvement.
The FDA gives companies some freedom in classifying their devices. And in the case of the OtisKnee, OtisMed officials told doctors and hospitals that its cutting guides were a Class I device and didn't need FDA approval or clearance, the Justice Department said.
According to the agency's legal filings, OtisMed worked closely with Stryker, a $9 billion medical device company based in Kalamazoo, Mich., to market the OtisKnee. Stryker made knee replacement components that worked with the OtisKnee. Stryker became interested in buying OtisMed, according to the Justice Department case, and requested that the start-up apply for FDA clearance to market the OtisKnee, which it did in October 2008.
Nearly a year later, in September 2009, Stryker was prepared to acquire OtisMed for $100 million when the FDA notified OtisMed that it had not demonstrated that the guides were safe. The notice said that the OtisKnee was a Class III device and that OtisMed's submission was missing data about how patients had fared, raising concerns about failure rates. The notice expressly warned against distributing the devices, according to the Justice Department.
The OtisMed board voted unanimously to halt shipments, the Justice Department said in court filings. But Charlie Chi, who was then the company's chief executive, directed employees to ship a batch of guides that had been held up since the FDA denial. OtisMed sent out 218 of the devices to surgeons, the Justice Department filings state.
Stryker executives were unaware of the shipment, the filings say. Stryker's acquisition of OtisMed went through in November 2009.
On Oct. 2, 2009, Richard Adrian, who worked in sales for Stryker, filed a whistle-blower case, accusing OtisMed of selling unapproved devices. Mr. Adrian received about $7 million as part of the resolution of the case. Mr. Adrian's lawyer said he declined to comment.
In settling the case, OtisMed paid $80 million in criminal and civil fines. Mr. Chi is to be sentenced on March 18 and faces up to three years in prison and $300,000 in fines. Stryker was not charged with wrongdoing and agreed to audit its other devices to ensure they had proper FDA approvals.
Representatives from OtisMed, including Mr. Chi, declined to comment for this article. Stryker said in a statement that the criminal conduct occurred before it acquired OtisMed and without its previous knowledge, and that the company "is committed to conducting its affairs ethically and lawfully."
Malfunction Reports
OtisMed sold $27 million worth of its cutting guides before the FDA rejected them. Problems began showing up as early as November 2007, according to a ProPublica review of injuries and side effects reported to the FDA.
There were 11 reports that month alone and 58 overall by the end of 2009, most classified as malfunctions: "Femoral guide does not fit, rocks freely." "Too much anterior slope in the tibia cut." "Femur and tibia guides would not seat correctly. Both slid around freely."
There were warning signs in the medical community, too. A January 2008 study in The Journal of Arthroplasty examined four cases: "The potential for malalignment with this system places implants at high risk of early failure," the study said.
No one knows how many patients might have been harmed by the device. Lawyers for the Justice Department said finding a number wasn't part of the agency's case.
Stacie Bilek, who directs premarket compliance at the FDA's Center for Devices and Radiological Health, would not discuss the OtisKnee case because it had been the subject of a criminal investigation. But there are so many Class I medical devices on the market that the agency generally does not check to see if they are properly classified, she said.
"It's based on voluntary compliance," Ms. Bilek said, noting that the FDA will sometimes investigate complaints. "We presume companies know the rules and regulations."
An FDA spokesman said the agency learned in late 2007 that the OtisKnee was being sold without proper clearance. An investigation was opened, then dropped after OtisMed sought approval in 2008.
Diana Zuckerman, president of the National Center for Health Research, an FDA watchdog group, said the agency wasn't doing enough to keep patients safe.
The FDA's "surveillance system is so flawed and so weak and so subjective and so inadequate," Ms. Zuckerman said, "that there are no automatic red flags going up when something happens."
As for Muss-Jacobs, December's settlement was bittersweet. While she is happy that OtisMed paid a price, she was disappointed that no medical provider was taken to account in her case.
"What happens to all the patients who had this device used on them?" Muss-Jacobs asked. "We're so marginalized. It's like we're not even in the equation in all of this."
__________
Related stories: Read more patient safety coverage by Marshall Allen and Olga Pierce.
ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for their newsletter.
On September 23, 2014, an Italian court in Milan awarded compensation to a boy for vaccine-induced autism. (See the Italian document here.) A childhood vaccine against six childhood diseases caused the boy’s permanent autism and brain damage. While
the Italian press has devoted considerable attention to this decision
and its public health implications, the U.S. press has been silent.
By Mary Holland
On September 23, 2014, an Italian court in Milan awarded compensation to a boy for vaccine-induced autism. (See the Italian document here.) A childhood vaccine against six childhood diseases caused the boy’s permanent autism and brain damage.
While the Italian press has devoted considerable attention to this decision and its public health implications, the U.S. press has been silent.
Italy’s National Vaccine Injury Compensation Program
Like the U.S., Italy has a national vaccine injury compensation program to give some financial support to those people who are injured by compulsory and recommended vaccinations. The Italian infant plaintiff received three doses of GlaxoSmithKline’s Infanrix Hexa, a hexavalent vaccine administered in the first year of life. These doses occurred from March to October 2006. The vaccine is to protect children from polio, diphtheria, tetanus, hepatitis B, pertussis and Haemophilus influenza type B. In addition to these antigens, however, the vaccine then contained thimerosal, the mercury-containing preservative, aluminum, an adjuvant, as well as other toxic ingredients. The child regressed into autism shortly after receiving the three doses.
When the parents presented their claim for compensation first to the Ministry of Health, as they were required to do, the Ministry rejected it. Therefore, the family sued the Ministry in a court of general jurisdiction, an option which does not exist in the same form in the U.S.
Court Decision: Mercury and Aluminum in Vaccine Caused Autism
Based on expert medical testimony, the court concluded that the child more likely than not suffered autism and brain damage because of the neurotoxic mercury, aluminum and his particular susceptibility from a genetic mutation. The Court also noted that Infanrix Hexa contained thimerosal, now banned in Italy because of its neurotoxicity, “in concentrations greatly exceeding the maximum recommended levels for infants weighing only a few kilograms.”
Presiding Judge Nicola Di Leo considered another piece of damning evidence: a 1271-page confidential GlaxoSmithKline report (now available on the Internet). This industry document provided ample evidence of adverse events from the vaccine, including five known cases of autism resulting from the vaccine’s administration during its clinical trials (see table at page 626, excerpt below).
Italian Government, Not Vaccine Maker, Pays for Vaccine Damages
As in many other developed countries, government, not industry, compensates families in the event of vaccine injury. Thus GSK’s apparent lack of concern for the vaccine’s adverse effects is notable and perhaps not surprising.
In the final assessment, the report states that:
“[t]he benefit/risk profile of Infanrix hexa continues to be favourable,” despite GSK’s acknowledgement that the vaccine causes side effects including “anaemia haemolytic autoimmune,thrombocytopenia, thrombocytopenic purpura, autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, haemolytic anemia, cyanosis, injection site nodule, abcess and injection site abscess, Kawasaki’s disease, important neurological events (including encephalitis and encephalopathy), Henoch-Schonlein purpura, petechiae, purpura, haematochezia, allergic reactions (including anaphylactic and anaphylactoid reactions),” and death (see page 9).
The Milan decision is sober, informed and well-reasoned. The Ministry of Health has stated that it has appealed the Court’s decision, but that appeal will likely take several years, and its outcome is uncertain.
Rimini: 2012 – Italian Court Rules MMR Vaccine Caused Autism
Two years earlier, on May 23, 2012, Judge Lucio Ardigo of an Italian court in Rimini presided over a similar judgment, finding that a different vaccine, the Measles-Mumps-Rubella vaccine (MMR), had caused a child’s autism. As in the Milan case, the Ministry of Health’s compensation program had denied compensation to the family, yet after a presentation of medical evidence, a court granted compensation. There, too, the Italian press covered the story; the U.S. press did not.
In that case, a 15-month old boy received his MMR vaccine on March 26, 2004. He then immediately developed bowel and eating problems and received an autism diagnosis with cognitive delay within a year. The court found that the boy had “been damaged by irreversible complications due to vaccination (with trivalent MMR).” The decision flew in the face of the conventional mainstream medical wisdom that an MMR-autism link has been “debunked.”
Italian Court Decisions Break New Ground in Debate Over Vaccines and Autism
Both these Italian court decisions break new ground in the roiling debate over vaccines and autism. These courts, like all courts, are intended to function as impartial, unbiased decision makers.
The courts’ decisions are striking because they not only find a vaccine-autism causal link, but they also overrule the decisions of Italy’s Ministry of Health. And taken together, the court decisions found that both the MMR and a hexavalent thimerosal- and aluminum-containing vaccine can trigger autism.
Italian Court Rulings Contradict Special U.S. Vaccine Court
These court decisions flatly contradict the decisions from the so-called U.S. vaccine court, the Court of Federal Claim’s Vaccine Injury Compensation Program. There, from 2007 to 2010, in the Omnibus Autism Proceeding, three decision makers, called Special Masters, found that vaccines did not cause autism in any of the six test cases, and one Special Master even went so far as to compare the theory of vaccine-induced autism to Lewis Carroll’s Alice in Wonderland.
The Italian court decisions contrast starkly with these U.S. cases based on similar claims.
"Perfectly healthy" 10-year-old Florida girl gets flu shot, is paralyzed with rare brain infection and can no longer speak
Marysue Grivna.
By Jason Molinet A flu shot meant to protect a Florida girl instead was the likely culprit that left the 10-year-old bedridden and mostly unable to speak.
The family of Marysue Grivna said everything changed after she got the influenza vaccine on Nov. 22, 2013. Three days later, Marysue’s parents called 911 after she didn’t immediately wake and could not speak.
Her parents blame acute disseminated encephalomyelitis, or ADEM, an immune-mediated disease of the brain that can be brought on following a viral infection. It’s a debilitating illness that strikes approximately 8 people per 1,000,000, WTSP reported.
