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Focus shifts to Merck's Gardasil as new adverse events uncovered
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25/05/2007
www.pharmatimes.com
With all eyes firmly on GlaxoSmithKline's Avandia (rosiglitazone) all week in the wake of a New England Journal of Medicine data meta-analysis showing a massive increase in the risk of cardiovascular events associated with the diabetes drug, it was the turn yesterday of Merck & Co after a conservative watchdog group issued new reports of serious adverse events linked to its cervical cancer vaccine Gardasil.
Judicial Watch, a US public interest group set up to investigate government corruption, released documents obtained from the Food and Drug Administration under the Freedom of Information Act spotlighting 1,637 reports of adverse reactions to Gardasil since its approval in June last year.
More seriously, three deaths were also associated with the vaccine, according to the FDA documents, after the girls experienced heart problems and/or blood clotting - in one case as little as three hours after being immunized - and there were 371 serious reactions ranging from paralysis and seizures, to spontaneous abortions and foetal abnormalities amongst pregnant women who'd been given the human papillomavirus vaccine.
A "catalogue of horrors"
Reading like a "catalogue of horrors," Judicial watch President Tom Fitton added: "Any state of 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." No one was available for comment from Merck at time of going to press. However, an article in the Wall Street Journal cites FDA and company spokespeople as saying the adverse events were "probably unrelated" to the vaccine.
However, a recent NEJM report also raised doubts about Gardasil's long-term effectiveness and the value of across-the-board vaccination for young women. In an editorial in the NEJM, Drs George Sawaya and Karen Smith-McCune of the University of California, San Francisco, said that while Gardasil appears to be safe and effective, "a cautious approach may be warranted" because of questions that still remain about the drug's long-term effectiveness and potential for adverse effects that could emerge over time. "Until we have the data, I view the situation as an ongoing experimental trial. The ultimate safety of the vaccine is unknown and it's going to be decades before we know anything,'' wrote the doctors.
The US giant's share price only stuttered on the New York Stock Exchange yesterday, but investors will no doubt be sitting up and paying attention to this latest issue to beset Merck. The firm only relatively recently left a nadir following the global withdrawal of its one-time best selling agent Vioxx (rofecoxib) for arthritis, which was found to double the risk of heart attack when given for more than 18 months, reporting first quarter growth of 12% driven by its asthma agent Singulair (montelukast), as well as newer agents Januvia (sitagliptin) for diabetes and Gardasil. The latter reeled in $367 million in the first three months.
Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine
http://judicialwatch.org
Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to Gardasil
(Washington, DC) -- 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 below.
(A recent study, published in the New England Journal of Medicine, also questioned the general effectiveness of Gardasil.)
2 Wall St JNL Reports
May 24, 2007, 8:08 am
Watchdog Airs Adverse-Event Reports on Cancer Vaccine
Posted by Jacob Goldstein
A conservative watchdog group has released FDA reports of health problems in women who received Gardasil, Merck's cervical cancer vaccine. But health officials at the FDA and CDC "dismissed the adverse events as probably unrelated to the vaccine," John Carreyrou writes in this morning's WSJ.
Some two to three million women and girls have received the vaccine since it was approved by the FDA last June. Judicial Watch, a nonprofit group that opposes laws that would make the vaccine mandatory, obtained the adverse-event reports from FDA under the Freedom of Information Act .
The reports included 18 pregnancy complications, 16 of which were miscarriages. Merck's executive director of medical affairs noted that miscarriages are very common during the early stages of pregnancy, and that the vaccine likely played no role. There was also one case of an abnormal fetus, and a possible case of "fetal defect," the WSJ reports.
The vaccine isn't recommended for pregnant women, because it hasn't been expressly studied in that group. But John Iskander, who runs the CDC's immunization safety office, told WSJ that because the vaccine doesn't use a live virus, it "should not cause any infections that would affect fetuses."
Three deaths have been reported to the FDA in women who received the vaccine. Two women died of blood clots. They were both taking birth control medication, which raises the risk of clots. A 12-year-old girl who suffered from heart disease and died of a heart inflammation associated with the flu had also received the vaccine. Officials at the FDA and the Centers for Disease Control and Prevention said the deaths were probably unrelated to Gardasil.
Public health officials have welcomed the vaccine, but Merck faced criticism after lobbying heavily to make the vaccinations mandatory in many states.
FDA Data on Gardasil May Fuel Controversy
Conservative Group Publicizes
Statistics on Adverse Events
Reported on Merck Vaccine
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.
Gardasil -- designed to protect women against cervical cancer -- is approved for use in girls and women age 9 to 26.
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."
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