Merck's Gardasil Has Higher Rates of Fainting, Clots
The Wall Street Journal - Health
AUGUST 18, 2009, 4:15 P.M. ET
By PETER LOFTUS
“Recipients of Merck & Co.'s Gardasil cervical-cancer vaccine had higher rates of fainting and blood clots than those receiving other vaccines, but it doesn't appear to raise the risk of certain severe adverse events, according to a new safety analysis.
A separate article accompanying the safety study, published Tuesday in the Journal of the American Medical Association, criticized Merck's marketing of Gardasil, including the company's funding of education campaigns by professional medical associations, which the authors said didn't provide a balanced view of the vaccine.
The two articles add to questions about the safety, effectiveness and marketing of Gardasil, which have dogged the vaccine since its 2006 introduction.
Doctors have questioned how effectively the vaccine prevents cervical cancer, given that its regulatory approval was for protecting against two strains of human papilloma virus, or HPV, that can cause cancer, but not all cancer-causing strains. Also, the vaccine was tested in only a few hundred 11- and 12-year-old girls, which some doctors said was too small a number to declare it safe for that age group. Critics assailed Merck's efforts to get states to require HPV vaccination, a push Merck backed away from in 2007.
Gardasil sales have stalled over the past year after brisk growth initially. U.S. Gardasil sales for the first six months of 2009 declined 34% to $363 million. Merck has had a particularly tough time persuading women ages 18 to 26 to get the shot--which costs nearly $400 for the full three-dose regimen.
The shot is designed to prevent infection by some types of HPV, a sexually transmitted virus that can cause cervical cancer, rarer forms of cancer and genital warts. Merck is seeking regulatory approval to market its use in males.
The U.S. health authorities who led the safety review say the vaccine is safe, despite the higher rates of fainting and blood clots they identified. The vaccine's benefits and potential to prevent cervical cancer outweigh the risks, said Barbara Slade, the study's lead author and a medical officer in the immunization safety office of the U.S. Centers for Disease Control and Prevention.
But others urge greater caution among doctors and patients in deciding on Gardasil vaccination. Cervical cancer takes decades to develop, and there are established methods for detecting and treating it, said Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association. Ms. Haug, who wrote an accompanying editorial in this week's JAMA, called Merck's marketing for Gardasil "pushy" and "disturbing."
Researchers at the CDC and U.S. Food and Drug Administration analyzed more than 12,400 reports of adverse events following Gardasil vaccination that were filed between June 2006 through December. During this time, more than 23 million doses of Gardasil were distributed in the U.S.
About 6% of the reported events resulted in hospitalization, permanent disability or death, Dr. Slade said. This was a smaller percentage than other vaccines, and the 32 deaths weren't higher than would be expected among the vaccine's target population--females ages nine to 26. Plus, nothing suggested that Gardasil caused the deaths, Dr. Slade said.
Of nearly 1,900 reports of fainting, 200 resulted in falls that caused head injuries including fractures and dental injuries. Anxiety and pain from the shot may be causing the fainting spells, Dr. Slade said. The study's authors recommended health-care professionals keep recipients in the office for about 15 minutes after vaccination to mitigate fainting.
Blood clots were less common, occurring 56 times, according to the study. They included four deaths due to pulmonary embolisms. But the authors say the clot data should be viewed with caution because 90% of those with clots had other risk factors, such as being smokers or using oral contraceptives.
Rick Haupt, program lead for HPV vaccines at Merck's research arm, said the study supports Merck's view that Gardasil has "high efficacy" and a "favorable safety profile."
In the marketing critique, researchers from Columbia University wrote that Merck's strategy maximized the threat of cervical cancer to adolescents, minimized the sexual transmission of HPV, and "practically ignored" the sub-populations most at risk, including African Americans in the South, Latinos along the Texas-Mexico border and whites in Appalachia.
Merck, of Whitehouse Station, N.J., funded professional medical associations to help spread the word about Gardasil, including groups of gynecologists and doctors working at colleges. These groups developed lecture programs and other educational materials that, according to the Columbia researchers, "did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits."
Spokespeople for the groups say their educational campaigns were developed with no oversight from Merck, and that the information used was consistent with recommendations by health authorities.
Merck said it provided about $750,000 to the three groups highlighted in the JAMA article to help improve understanding of HPV. Also, Mr. Haupt said, Merck's marketing focused on cervical cancer because two HPV types targeted by the vaccine are believed to cause about 70% of all cervical-cancer cases, and health authorities believe routine vaccination of adolescent girls will prevent many cases.”
Personal comment: There is no evidence in this research to suggest that Gardasil is more dangerous or less effective than the initial studies suggested. I think the most criticism is coming from religious conservative individuals or groups who are uncomfortable with anything that might protect women from the danger caused by some forms of HPV. Are there effective alternatives? In some cases there are, but not from genital warts if a partner is shedding cells. Do many women still die each year from cervical cancer? Yes, because they aren’t getting routine PAPs that will pick it up in time. Gardasil has a place as an effective vaccine for young women. As I’ve posted before all the students at St Lucy’s get the Gardasil vaccine as do all my female casino performers and escorts.