Hvorfor må man bruke Freedom of Information Act for å få frem disse tallene? Er de hemmelige? Det er bra at tallene kommer frem nå, før departementets høring.
Se http://www.fritthelsevalg.org/htmlsite/aktuelt.asp?parent=1&flag=1&ban=1&id=437 om høringen.
Dagbladet
Dagbladet publiserte disse nye tallene (etter tips fra FHV) den 30 mai: http://www.dagbladet.no/dinside/2007/05/30/502077.html
Folkehelseinstituttet
Folkehelseinstituttet skrev på sitt nettsted den 22 mai, under tittelen "Misvisende inntrykk av HPV-vaksinen":
Kilde: http://www.fhi.no/eway/default.aspx?pid=233&trg=MainLeft_5669&MainLeft_5669=5544:64976::0:5667:1:::0:0
"Ingen alvorlige bivirkninger registrert
Det er ikke registrert alvorlige bivirkninger av HPV-vaksinen så langt. En del mindre alvorlige lokale reaksjoner på injeksjonsstedet er registrert. Dette er basert på data fra kliniske utprøvninger, samt to millioner doser utsendt etter at vaksinen ble tilgjengelig i 2006, de fleste i USA."
Fritt Helsevalg skrev for sikkerhets skyld en e-post til Folkehelseinstituttet 30 mai om saken:
ref: artikkelen "Misvisende inntrykk av HPV-vaksinen" http://www.fhi.no/eway/default.aspx?pid=233&trg=MainLeft_5669&MainLeft_5669=5544:64976::0:5667:1:::0:0 , datert og oppdatert 22 mai.
Her står å lese:
"Ingen alvorlige bivirkninger registrert. Det er ikke registrert alvorlige bivirkninger av HPV-vaksinen så langt. En del mindre alvorlige lokale reaksjoner på injeksjonsstedet er registrert. Dette er basert på data fra kliniske utprøvninger, samt to millioner doser utsendt etter at vaksinen ble tilgjengelig i 2006, de fleste i USA."
Vi ber om at dette blir korrigert snarest i lys av de ferske tall som Judicial Watch har fått gjennom FOI fra FDA:
se: http://www.fritthelsevalg.org/htmlsite/aktuelt.asp?parent=1&flag=1&ban=1&id=439
og http://www.dagbladet.no/dinside/2007/05/30/502077.html
Direkte link til Judicial Watch: http://judicialwatch.org/6299.shtml
Vi anmoder også om en forklaring på hvorfor (som Juducial Watch forteller) denne informasjonen ikke er generelt tilgjengelig og må uthentes med brekkstang (Freedom of Information Act).
FDA er ikke til å stole på, det er et velkjent faktum. Vi ber om at Folkehelseinstituttet (alt. Legemiddelverket) sender en klage til FDA, og kopierer oss på denne, samt kopierer oss på svaret. Og vi ber om beskjed når artikkelen deres er korrigert på nettstedet.
Vennlig hilsen
Jan Klyve
Nestleder i Fritt Helsevalg
UPDATE 8 Juni: Folkehelseinstituttets artikkel står idag fremdeles uendret, tross den nye informasjonen fra VAERS. Folkehelseinstituttet har svart på Fritt helsevalg henvendelse (e-post gjengitt ovenfor). Og svaret er:
Takk for kommentarer knyttet til det som står på vår nettside om HPV-vaksinen.
Når et stort antall personer blir vaksinert, vil det alltid dukke opp uønskede hendelser i tiden etter vaksineringen. Noen hendelser kan være forårsaket av vaksinen. I andre situasjoner foreligger det bare et tilfeldig sammenfall i tid, hendelsen ville ha kommet uavhengig av om personen ble vaksinert eller ikke. Det er viktig at slike hendelser blir registrert og kan gi signal om mulige sammenhenger som må følges opp videre.
Det er imidlertid en forutsetning at meldingene blir analysert og vurdert nærmere før det trekkes konklusjoner. Denne vurderingen tilligger legemiddelmyndighetene. Folkehelseinstituttet har ikke funnet noe grunnlag for å stille spørsmål ved det arbeidet legemiddelmyndighetene gjør i så måte. Det gjelder så vel FDA som det europeiske EMEA og det norske Legemiddelverket. Som offentlig institusjon kommer vi fortsatt til å forholde oss til offisiell informasjon fra disse kildene.
Vennlig hilsen
Gunhild Wøien
Kommunikasjonsdirektør
Nasjonalt folkehelseinstitutt
Pb. 4404 Nydalen
0403 OSLO
Tlf. 23408113 / 91762570
Tolkning: Folkehelseinstituttet ønsker ikke at det norske folk skal vite dette. De må først gå gjennom rapportene og bli kvitt mest mulig av dataene før de vil publisere sitt vurderte og reduserte tall. M.a.o. mange av de innmeldte bivirkningene "ekisisterer" ikke for Folkehelsa, eller de ansees som "rent tilfeldige sammentreff". Tildels har de nok rett i dette, men å la det stå uendret på nettstedet at "alvorlige bivirkninger er ikke registrert", er en soleklar løgn og en direkte forbrytelse mot folks rett til å vite.
Det er verdt å merke seg at bivirkningsrapporteringssystemet VAERS er frivillig, og at det er alment anerkjent at det fanger mellom 5% og 10% av bivirkningene. Det blir således store mørketall. Om 10% er innmeldt, tyder det på at det kan være 16370 bivirkninger totalt, fra de om lag 2000.000 vaksinene som er distribuert.
Og hermed over til selve saken, slik Alliance for Human Research Protection (AHRP) refererer den. Første del av artikkelen er oversatt til Norsk av Børge Eliassen, leder i Fritt Helsevalg. Les teksten videre på engelsk, etter markeringen der oversettelsen til norsk slutter.
En Oppdatering om Gardasilvaksinen
(oversatt fra nedenstående engelske artikkel):
Judicial Watch, en offentlig interessegruppe som etterforsker og forfølger korrupsjon hos myndighetene, fikk tak i FDA’s rapporter på kraftige reaksjoner via Freedom of Information Act.
Organisasjonen ga en pressemelding som sa:
”FDAs rapporter på kraftige reaksjoner fra HPV-vaksinen ser ut som en skrekkatalog. Enhver stat eller lokal styresmakt nå okkupert av Mercks lobbyistkampanjer for å få denne HPV-vaksinen gjennom til unge piker, bør ta en titt på disse reaksjonsrapportene.”
FDAs VAERS database viser at 1637 kraftige reaksjonsrapporter ble mottatt siden den ble godkjent for markedsføring i juni 2006. Av disse var 371 alvorlige reaksjoner, inkludert tre dødsfall knyttet til Mercks vaksine. En kvinnelig pasient ”døde av en blodpropp tre timer etter å ha fått Gardasilvaksinen.” To andre rapporterer om jenter på 12 og 19 som døde pga hjerteproblemer og/eller blodpropp.
Andre alvorlige reaksjonsrapporter inkluderte lammelse, Bells lammelse, Guillan-Barre syndrom, og anfall. Og av 42 kvinner som ble vaksinert med Gardasil mens de var gravide, opplevde 18 komplikasjoner, fra abortering til fosterabnormaliteter, ifølge FDAs data. En av de 18 kvinnene ble diagnostisert med et abnormalt foster, og en prøve utført på en annen kvinne i løpet av hennes graviditet viste en økt risiko på fosterskader.
The Wall Street Journal rapporterer at medfødte (congenitale) abnormaliteter var et emne til bekymring under FDAs vurdering av vaksinen sist år. ”I dets kliniske prøver rapporterte Merck fem tilfeller av fødselskader blant kvinner som fikk vaksinen innen 30 dager etter unnfangelsen.” Merck sier: ”at de konkluderte at de ikke viste noe mønster, og det var usannsynlig at de var forbundet med vaksinen.” Men Merck er neppe en troverdig kilde for risikovurdering: Selskapet er ansvarlig for tusenvis av unngåelige dødsfall fra dets smertestillende medisin, Vioxx, hvis dødelige risiko ble totalt benektet mens dødstallene steg mellom 1999 og 2004.
(Kommentar: Vioxx drepte ca 60 000 mennesker, og var skyld i minst 40 000 flere hjerteattakk. Minst 400 nordmenn døde, ifølge Statens legemiddelverk.)
Godkjennelsen og uortodoks markedsføring av Mercks vaksine er et godt eksempel på hvor kraftig kommersielle interesser har avsporet medisin fra dets oppdrag. I hver medisinske skandale som involverer en FDA-godkjent medisin eller vaksine utøvde de allmektige aksjeholderne i farmasøytiske selskaper en uproporsjonal påvirkning for å fremme nye medisiner og vaksiner selv før deres sikkerhet og effektivitet var fullt ut evaluert – ofte med katastrofale resultater.
Karen Collier og Jane Metlikovec fra Australias Herald Sun peker ut: ”Penge/profitt-motivet skal virkelig ikke bli forbigått når man ser på rasjonalet bak dette stormløp for å vaksinere de unge. Minimalt er mer forskning påkrevd før det grønne lyset blir gitt for å inkorporere nok en serie av vaksiner, med spørsmål fortsatt som blir spurt om alle skuddene barn mottar akkurat nå! Knytningene blant så mange av universitetene, organisasjonene, forskerne og legene opp mot farmasiselskapene, bør, selv om de ikke skal bli sett på som en direkte beskyldning av noen eller noen gruppers motiver, likevel vekke ettertanke.
Mercks kontroversielle markedsføring av denne vaksinen inkluderer å kanalisere penger gjennom en falsk støttegruppe av kvinnelige lovgivere med navnet Women in Government, som drev lobbyvirksomhet mot sine respektive staters lovmakere for å få en lov som gjorde vaksinasjon obligatorisk. Selv om selskapet stoppet dets lobbykampanje i slutten av februar etter kritikk, vurderer 16 stater obligatorisk vaksinasjonsforslag. En stat, Virginia, har vedtatt et slikt lovforslag.
Mercks markedsføringsstrategi, både før og etter godkjennelse, har posisjonert massebruk av denne vaksinen av pre-tenåringer som et moralitetsspill for å unngå å snakke om den defekte vitenskapen de brukte for å få vaksinen godkjent.” Og media sluker fisken, og beskriver de som utfordrer hastverket med å eksponere unge piker for vaksinens farlige virkninger som ”konservative”….
Men, som Barbara Leo Fisher, president i National Vaccine Information Center påpeker: "Dette dreier seg ikke bare om tenåringer og sex, det dreier seg også om hvorvidt Gardasil er dokumentert trygg og effektiv for småjenter".
…. og så over til den engelske versjonen. Den oversatte delen er gjengitt i kursiv.
Gardasil Vaccine: So far 3 deaths and 1,637 Adverse Reaction Reports to FDA
Kilde: http://ahrp.blogspot.com/2007/05/gardasil-vaccine-so-far-3-deaths-and.html
Alliance for Human Research Protection (AHRP)
Gardasil vaccine update:
Judicial Watch, a public interest group that investigates and prosecutes government corruption, obtained FDA’s adverse event reaction reports under the Freedom of Information Act. [Link below] It issued a press release noting:
“The FDA adverse event reports on the HPV vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
FDA’s VAERS data base shows that 1,637 adverse event reaction reports were received since it was approved for marketing, June, 2006. Of these, 371 were serious reactions, including three deaths linked to Merck''s vaccine. A female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.
Other serious AER reports included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. And of 42 women who were vaccinated with Gardasil while pregnant, 18 experienced complications, ranging from miscarriages to fetal abnormalities, according to new FDA data. One of the 18 women was diagnosed with an abnormal fetus, and a test conducted on another woman during her pregnancy showed an increased risk of fetal defect.
The Wall Street Journal reports (below) that congenital anomalies was an issue of concern during the FDA''s review of the vaccine last year. “In its clinical trials, Merck reported five cases of birth defects among women who received the vaccine within 30 days of conception.” Merck says, “it determined that they didn''t fit any pattern and were unlikely to be connected to the vaccine.” But Merck is hardly a credible source for risk assessment: this company is responsible for thousands of preventable deaths from its painkiller, Vioxx whose lethal hazards the company vehemently denied as the body count mounted between 1996 and 20004.
The approval and unorthodox marketing of Merck''s vaccine is a vivid example of how powerful commercial interests have derailed medicine from its mission. In each medical scandal involving an FDA approved drug or vaccine the all-powerful pharmaceutical-medical stakeholders wielded undue influence to promote new drugs and vaccines even before their safety and efficacy was fully evaluated—often with catastrophic results.
Karen Collier and Jane Metlikovec of Australia''s Herald Sun point out: "The money/profit motive truly shouldn''t be discounted when looking for the rationale behind this stampede to vaccinate the young. Minimally, more research is needed before the green light is given to incorporate yet another series of vaccines, with questions still being raised about all the shots children receive at present! The ties among so many of the universities, organizations, researchers and physicians with the pharmaceutical companies, obviously, ties that should not be viewed as an outright indictment of anyone or any groups'' motives but, nonetheless, do give one pause!" [Link]
Merck''s controversial marketing of this vaccine included funneling money through a phony advocacy group of female legislators, Women in Government, who lobbied their state legislators for a law mandating vaccination. Though the company halted its lobbying campaign in late February amid criticism, some 16 states are considering mandatory-vaccination bills. One state, Virginia, has passed such a bill into law.
"Merck''s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed." And the media swallowed the red herring, describing those challenging the rush to expose young girls to the vaccine''s hazardous effects are "conservatives." But, as Barbara Leo Fisher, President, National Vaccine Information Center points out: "This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls." .
(over til engelsk):
Indeed, we are independent skeptics whose argument is buttressed by the lack of scientific evidence to support the vaccine''s safety, efficacy, or medical need to justify the risks. Indeed, an analysis in the New England of Medicine (May 10) found that the efficacy of Gardasil among women previously infected with the virus is lower than expected. An accompanying editorial recommended caution in view of the absence of adequate safety data and the fact that the vaccine’s efficacy was “modest.”
Below are several news reports from Olympia, Washington; Reno, Nevada; and Victoria, Australia--all attesting to the fact that the Gardasil vaccine controversy continues to gather storm. [Link]
In an article published in the Denver Post (March 22, 2007), Sigrid Fry-Revere, the director of bioethics studies at the Cato Institute provides the following sobering assessment: Gardasil is not all it''s cracked up to be--and, besides, there is NO epidemic of cervical cancer from HPV infections.
"A recent study in the Journal of the American Medical Association finds that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent - much lower than the 50 percent figure cited on Merck''s website. More importantly, the rates for HPV 16 and 18 - the two types responsible for 70 percent of all cervical cancers - are astronomically lower: only 1.5 percent and 0.8 percent, respectively. And even among those cases, last month''s American Cancer Association guidelines report that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75 percent of infections in adults and 90 percent of those in adolescents disappear on their own.
It''s worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for the disease is over 90 percent.
In short, even without the vaccine, when early detection methods are used, the number of girls who actually are at risk of dying of cervical cancer from HPV is extremely low. Most of the time, the body takes care of the virus without any help whatsoever. Under these circumstances, are we really prepared to spend untold millions administering this vaccine? In truth, the vaccine may very well cause more harm than good."
The most comprehensive documented coverage of the Gardasil issues is in a front page report by John Carreyrou of The Wall Street Journal (April 16, 2006): [Link below]
Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to Gardasil
WASHINGTON, May 23 /PRNewswire--- Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil.
Three deaths were related to the vaccine. One physician''s assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.
As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions. Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities.
Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.
"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors," stated Judicial Watch President Tom Fitton. "Any state or local government now beset by Merck''s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug."
Judicial Watch filed its request on May 9, 2007, and received the adverse event reports from the FDA on May 15, 2007. Judicial Watch has posted the adverse event reports on their Internet site at: [Link]
~~~~~~~~~~~~~~~~
Nevada Appeal News Service
Family claims cervical-cancer vaccine caused paralysis Health Department disputes that determination
by Jo Rafferty May 17, 2007
Fourteen-year-old Jessica Vega went into the emergency room at Renown Regional Medical Center in Reno on Thursday night when she couldn''t move her legs and her arms felt weak. "Her legs are paralyzed, her arms are affected. She is very weak in her arms," said Tondra Vees a family friend. "She has to use a walker. Even with that, she can''t get to the bathroom. She can''t stand up at all."
Vees said the girl has been determined by her doctor to have Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The girl, whose mother Rhonda Vega is a full-time teacher''s aide at Carson Valley Middle School, received her first booster shot of the cervical cancer
prevention vaccine Gardasil on May 2. "According to her neurologist, that''s what caused this," said Vees, Nevada State Health Officer Dr. Bradford Lee said the Web sites the Nevada State Health Department checks don''t list the girl''s symptoms as a side-effect. "We are aware of a report of an alleged side-effect," said Lee. "Based on the CDC''s site and the manufacturer''s site, this is not a side-effect of the vaccine."
Vees said the girl has been determined by her doctor to have Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. Vees said the girl was being moved to a rehabilitation center on Tuesday. "Thankfully, since Thursday, it doesn''t appear to be ending up in her respiratory system, although she''s getting weaker," Vees said. "They were going to let her go home, but now she''s not. I think they expect her to be in (rehabilitation) for a month or so."
Vees cites a Feb. 21 report on the National Vaccine Information Center Web site, nvic.org, in which NVIC president Barbara Loe Fisher states, "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a TDAP (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre syndrome."
Vees cites that according to nvic.org, the vaccine''s manufacturer, Merck & Co., studied Gardasil in fewer than 1,200 girls younger than age 16 in "pre-licensure trials." According to Vees, the girl had not received any other vaccines at the same time, and prior to Thursday was "healthy as a horse."
Public information officer Martha Framsted and Lee, both of the Nevada State Health Department, said Monday they check for vaccine information only from government-approved Web sites. "We always try to go to the Web sites that have been scientifically proven," said Framsted. "I don''t believe (the National Vaccine Information Center) is one of our federal partners."
The agencies the health department does check with before approving a vaccine are the Center for Disease Control and Prevention ([Link] the manufacturer''s Web site (in this case gardasil.com and merckvaccines.com) and with the Advisory Committee on Immunization Practices, the only entity in the federal government which can make recommendations regarding routine administration of vaccines, according to the CDC.
The Web site gardasil.com states that the only side effects are "pain, swelling, itching and redness at the injection site, fever, nausea and dizziness."
CATO Institute Questions Remain on Gardasil
by Sigrid Fry-Revere March 22, 2007
There''s nothing wrong with drug makers publicizing their products and their benefits, but the lure of lucrative government contracts can prompt them to play fast and loose. In lobbying state lawmakers to make its latest vaccine mandatory, Merck has greatly exaggerated both the threat of a disease, and the ability of a drug to prevent it.
The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for 70 percent of cervical cancer cases. The U.S. Food and Drug Administration approved Gardasil last year for use against HPV in females aged 9 to 26. Texas, New Mexico and Virginia have all recently mandated HPV vaccination, and Colorado might be next.
Sen. Suzanne Williams, D-Aurora, is pushing Senate Bill 80, which would require that girls be given the HPV vaccine before they turn 12 or they would not be permitted to attend school. With a price tag of $360 for a series of three shots, mandatory vaccination would be quite a boon for Merck. If all 11- and 12-year-old Colorado girls were vaccinated, the company could reap almost $150 million.
Gardasil is not all it''s cracked up to be. A recent study in the Journal of the American Medical Association finds that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent -much lower than the 50 percent figure cited on Merck''s website. More importantly, the rates for HPV 16 and 18 - the two types responsible for 70 percent of all cervical cancers - are astronomically lower: only 1.5 percent and 0.8 percent, respectively. And even among those cases, last month''s American Cancer Association guidelines report that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75 percent of infections in adults and 90 percent of those in adolescents disappear on their own.
It''s worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for the disease is over 90 percent.
In short, even without the vaccine, when early detection methods are used, the number of girls who actually are at risk of dying of cervical cancer from HPV is extremely low. Most of the time, the body takes care of the virus without any help whatsoever.
Under these circumstances, are we really prepared to spend untold millions administering this vaccine? In truth, the vaccine may very well cause more harm than good.
What if the vaccine lulls young women into a false sense of security? Gardasil only protects against the viruses responsible for 70 percent of cervical cancers, and women may not realize the necessity of regular Pap tests even when they''ve been vaccinated. As a result, many pre-cancerous conditions may go undetected before it is too late.
Merck''s drug trials followed women who received Gardasil for an average of less than three years, so we know little of how long the immunity lasts or the long-term risks that may be associated with it. Children vaccinated in middle school could potentially lose their immunity by the time they were seniors in high school.
And what if some horrible unexpected side-effect were to materialize later? The possibility isn''t as far fetched as you might think. In 1976, swine flu caused only one documented death in the U.S., but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré Syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.
Mandatory Gardasil vaccinations certainly brighten Merck''s future, but it''s not so clear that they''re in the best interest of the public. In all but the most clear cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it''s simply not sensible policy to experiment on such a large portion of our population all at once.
Mandating HPV vaccinations would bring Merck huge profits, all right, but they might well come at the expense of ordinary Coloradans - or at least at the expense of Colorado''s little girls.
Sigrid Fry-Revere is the director of bioethics studies at the Cato Institute. This article appeared in the Denver Post on March 22, 2007.
FDA Data on Gardasil May Fuel Controversy Conservative Group Publicizes Statistics on Adverse Events Reported on Merck Vaccine
Wall Street Journal
By JOHN CARREYROU May 24, 2007; Page D1
In a move likely to fuel the debate over Merck & Co.''s Gardasil cervical-cancer vaccine for young women, a conservative watchdog group disseminated new reports of serious adverse events linked to the vaccine. The reports included problems in pregnant women who had received Gardasil. Health officials and Merck dismissed the adverse events as probably unrelated to the vaccine, which targets the human papillomavirus strains linked to most cervical cancers. Adverse events with drugs and vaccines are routinely reported to the Food and Drug Administration by doctors. But they don''t necessarily indicate that the medication or vaccine caused the event, which might be related to a person''s underlying health or other factors.
Eighteen women who received the vaccine while pregnant experienced complications, ranging from miscarriages to fetal abnormalities, according to new FDA data. The data were obtained by Judicial Watch, a group based in Washington, through a Freedom of Information Act request. Some states are debating whether to make the vaccine mandatory for schoolgirls. Judicial Watch opposes such school requirements.
The new data also show that three female patients who received the vaccine died. However, Merck, the FDA and the Centers for Disease Control and Prevention, which helps the FDA monitor vaccine adverse events, said the deaths were unlikely to have been caused by Gardasil. Two of the women were taking birth-control pills and died from blood clots, a known risk of contraceptive medication, according to the CDC. The third, a 12-year-old girl, suffered from heart disease and died from a heart inflammation brought on by the flu, the CDC said.
So far, there have been 1,637 reports of adverse reactions, not an unusually high number given that two million to three million women may have received the vaccine. Most of the adverse events involve minor side effects such as pain at the site of injection, itching and dizziness. Merck has distributed more than five million doses of Gardasil in the U.S. since its introduction in June 2006. The vaccine is administered in three shots over a period of six months.
Karen Riley, a spokeswoman for the FDA, said the agency was closely monitoring the adverse events associated with Gardasil, including the pregnancy complications, but "we haven''t seen anything at this point that would suggest we''d make any changes in the product." Gardasil became the subject of much controversy after Merck lobbied states to make it a school requirement for pre-teen girls. Though the company halted its lobbying campaign in late February amid criticism, some 16 states are considering mandatory-vaccination bills. One state, Virginia, has passed such a bill into law.
Those opposed to school mandates range from religious conservatives, who say the vaccine conflicts with their abstinence message, to parents who worry that it is too new and untested to administer to 11- and 12-year-old girls. Some scientists have also raised doubts about the vaccine''s efficacy against cervical cancer and suggested that the billions of dollars likely to be spent on it in coming years might be better used to expand Pap screening among low-income women.
Of the 1,637 adverse-event reports, 136 have been deemed serious by the FDA, ranging from seizures to Guillain-Barre Syndrome, a rare life-threatening disorder in which the immune system attacks nerves and induces paralysis. Of the 18 pregnancy complications, 16 have involved miscarriages. Gardasil isn''t recommended for pregnant women, but at least some of the women in the adverse-events reports said they were unaware that they were pregnant when they received the vaccine.
Richard Haupt, Merck''s executive director of medical affairs, said the miscarriages likely had nothing to do with Gardasil, noting that miscarriages are very common during the first trimester of a pregnancy. However, one of the 18 women was diagnosed with an abnormal fetus, and a test conducted on another woman during her pregnancy showed an increased risk of fetal defect. There is no report on the outcome.
Congenital anomalies were one issue of concern during the FDA''s review of the vaccine last year. In its clinical trials, Merck reported five cases of birth defects among women who received the vaccine within 30 days of conception. Upon looking at the cases more closely, Merck says, it determined that they didn''t fit any pattern and were unlikely to be connected to the vaccine.
Dr. Haupt says that Gardasil''s label states that it is "not recommended for use in pregnant women" merely because the vaccine hasn''t been "systematically studied" in a large population of pregnant women, not because of any concern about birth defects.
Among the postmarketing commitments Merck made upon receiving FDA approval for Gardasil, the company committed to compiling a registry of pregnant women who have received the vaccine, to monitor any effect the vaccine might have on pregnancies. The registry has more than 300 pregnant women exposed to the vaccine, and Merck says that the registry has received no reports of congenital anomalies.
John Iskander, acting director of the Immunization Safety Office at the CDC, says Gardasil isn''t a live vaccine, so it shouldn''t cause any infections that would affect fetuses. He also notes that 3% of all live births involve a birth defect of some sort, and some cases would be expected to occur naturally among pregnant women vaccinated with Gardasil.
"None of the information I''m aware of or have seen suggests that there''s any pattern here linking birth outcomes to the vaccine," says Dr. Iskander. But, he added: "The bottom-line message to pregnant women is that, if they''ve received the vaccine, to make sure they''re enrolled in the registry and make sure they keep up with their routine prenatal care."
ends.
The National Vaccine Information Center, a parent lead organization, states as its purpose “....to prevent vaccine injuries and deaths through public education. NVIC provides assistance to parents whose children have suffered vaccine reactions; promotes scientific research to investigate vaccine safety and effectiveness as well as to identify factors which place individuals at high risk for suffering vaccine reactions; advocates the institution of oversight mechanisms and informed consent protections within the mass vaccination system to make it safer.”
Get the facts about HPV and GARDASIL vaccine to make an informed decision, provided the following facts: 1. HPV infection is naturally cleared by more than 90% of sexually active women and men but, rarely, HPV infection can become chronic. 2. Among high risk factors for chronic HPV infection are smoking: co-infection with herpes, chlamydia, or HIV; long term birth control use; multiple births. 3. Women chronically infected with HPV, who don''t get pre-cancerous cervical lesions promptly identified and treated, can get cervical cancer and die. 4. After pap screening became routine in the 1950''s, cervical cancer cases in the U.S. dropped 74%. 5. Less than 1% of all diagnosed cancer cases and cancer deaths in the U.S. every year involve cervical cancer. 6. Merck''s GARDASIL vaccine was studied for several years in less than 1200 girls under age 16 and a few hundred girls age 11 or younger. 7. GARDASIL contains only 2 of 15 HPV types associated with cervical cancer and it is unknown if it will prevent cervical cancer long term or if it will increase the risk for those actively infected with HPV types in the vaccine. 8. Reported GARDASIL reactions include sudden collapse, seizures, facial paralysis, Guillian Barre Syndrome, arthritis and other serious health problems. 9. It is unknown if GARDASIL will cause infertility, cancer or damage genes. 10. There is no pre-licensure data proving it is safe to give GARDASIL with most of the other vaccines for children.
Linker:
Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine http://www.judicialwatch.org/printer_6299.shtml
Derfra kan du linke direkte til The Vaccine Adverse Event Reporting System (VAERS) Reports as of May 11, 2007
Herald Sun, Storm over cervical cancer jab
http://www.news.com.au/heraldsun/story/0,21985,21778801-24331,00.html
Health care industry today, videre linker til relevante artikler
http://health.einnews.com/news/cervical-cancer-vaccine
Wall Street Journal (The most comprehensive documented coverage of the Gardasil issues is in a front page report by John Carreyrou of The Wall Street Journal (April 16, 2006):
http://online.wsj.com/article_print/SB117668541991270825.html
Nevada Appeal, Family claims cervical-cancer vaccine caused paralysis
http://www.nevadaappeal.com/article/2007105170090
CATO institute, Questions Remain on Gardasil
http://www.cato.org/pub_display.php?pub_id=8147
Wall Street Journal, FDA Data on Gardasil May Fuel Controversy
http://online.wsj.com/article/SB117997026351112898.html
Vaccine Adverse Event Reporting System
http://vaers.hhs.gov/
How do I find out if a vaccine adverse event has been reported to VAERS? top
You can request information about adverse events reported to VAERS by faxing requests to (301) 443-1726, or by sending requests to:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
(301) 827-6500
CDC
http://www.cdc.gov/
Vaccine Safety Data link project (VSD):
http://www.cdc.gov/od/science/iso/research_activties/vsdp.htm
Folkehelseinstituttet, all info on HPV-vaksinen: http://www.fhi.no/eway/default.aspx?pid=233&trg=MainArea_5661&MainArea_5661=5530:0: