Gardasil-Talk.com

Archive for August, 2008

An article in today’s New York Times gives some interesting details on Gardasil’s approval, and Merck’s marketing of the vaccine, as well as critics’ objections to both. Just some quick highlights:

• The Food & Drug Administration (FDA) expedited Gardasil’s approval application, and gave it the ok in just six months. It was recommended by the Centers for Disease Control (CDC) for girls ages 11-12 just weeks later. Dr. Diane Harper, a researcher who worked on Gardasil clinical trials, and who has been mentioned on this blog before, says that was too fast. She said that most vaccines take three years to get such a CDC recommendation, and then 5 to 10 more for universal acceptance. “In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”
• In clinical trials, there were indications that immunity from Gardasil might start to wear off after just five years. That means that a girl who had the vaccine at age 11 might not have any protection when she reaches college.
• In Western countries, like the U.S., cervical cancer is already preventable via regular Pap tests, but Merck’ Gardasil marketing has created a panic about the disease. And because Gardasil doesn’t work against all forms of HPV, regular Pap tests are still needed.
• In addition to its “one less” commercial, Merck has paid hundreds of doctors to lecture and give talks on Gardasil. The Times says some doctors are getting paid $4500 per lecture.
• Merck has also been lobbying politicians, state officials and others to convince them to pass legislation to fight a global killer - which pretty much translates into making Gardasil mandatory for young girls.
• Merck’s efforts are working. According to The New York Times, Gardasil has now been made available to the poorest girls in the country, up to age 18, at a potential cost to the U.S. government of more than $1 billion. Proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall.

Australia’s Therapeutic Goods Administration (TGA) is investigating three cases of pancreatitis that might be linked to Gardasil. According to the TGA, 3.7 million doses of Gardasil, have already been distributed in Australia and to date there have been about 1,013 reported adverse reactions. These have included soreness, swelling, redness or other reaction at the injection site, headaches, dizziness, nausea and vomiting.

However, some of the side effect reports have been for serious ailments. Among the most serious are three cases of pancreatitis. Pancreatitis occurs when pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. This causes a sudden, debilitating attack of severe upper abdominal pain. Complications include respiratory, kidney or heart failure, all of which can be fatal.

One of the Australian pancreatitis cases was recently discussed in an article in the Medical Journal Of Australia. According to that article, a 26-year-old woman was admitted to the hospital four days after receiving her first dose of Gardasil. She was hospitalized for 10 days with fever, rash, severe pain and vomiting and was diagnosed with pancreatitis.

The doctors treating her could not find a cause for the pancreatitis, and wrote in the article that the Gardasil vaccine could not “be excluded as a potential cause”. They also wrote that pancreatitis should “be considered in cases of abdominal pain following HPV vaccination.”

Merck has been pushing Gardasil by claiming it could prevent 70 percent of all cervical cancers. But according to two experts - one of whom actually worked on developing Gardasil - there is no way to know right now how effective Gardasil is going to be in the long run.

“If we vaccinate every single 12-year-old, it should reduce by half the number of cervical cancers in the next 35 years,” Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, said in an article published in the Sun-Sentinal. “With Pap screening, we’ve reduced it by nearly 75%.”

People who have been following the Gardasil controversy might recognize Dr. Harper’s name. Not only was she a lead researcher on Gardasil clinical trials, but a few months ago, she actually criticized Merck’s efforts to convince states to make Gardasil a mandatory vaccine for young girls.

Another expert, Dr. Karen Smith-McCune, an obstetrician and gynecologist at the UC San Francisco School of Medicine, said in the same Sun-Sentinal article that tests of Gardasil before the FDA approved it didn’t run long enough to prove its effectiveness conclusively - especially since it can take a decade for someone exposed to HPV to develop the cancer.

“Even though it guards against two HPV strains, the other HPV types need to be taken into account,” Dr. Smith-McCune said. “It will take a long time before we know the true efficacy of the vaccine.”

The Food & Drug Administration (FDA) has told Merck that it has resolved safety issues at the Pennsylvania vaccine plant were Gardasil is made.

In April, The Philadelphia Inquirer reported that an FDA inspection of the Merck vaccine plant had uncovered 45 areas of concern, including contaminated packaging of children’s vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots. An FDA spokesperson told The Philadelphia Inquirer that the agency sent the letter, dated April 28, because it did not believe the company was moving fast enough to correct past problems.

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The warning letter said the company had failed to ensure that equipment for manufacturing and processing was “calibrated, inspected or checked according to a written program designed to assure proper performance.” The letter also said that in the course of making vaccines, “failures are not fully investigated and documented”.

The FDA specifically cited unwanted fibers that were showing up on vial stoppers for such vaccines as MMR, or measles, mumps and rubella. These stoppers are placed in special bags for sterilization. The FDA said the company was using “lesser quality” bags that were breaking down slightly and producing the fibers. The FDA cited Merck for only discarding vaccines where the fibers were found. The company should have assessed all potentially affected products, the FDA said.

“On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility,” Merck CEO Dick Clark said in a recent press release. “As a result, any filed sBLAs which were held up due to the inspection can now move through the agency’s normal review and approval process.”

Merck is currently trying to expand the labeling for Gardasil. The company also said it will be responding to another FDA letter denying approval of Gardasil for women ages 27-45.