There…they did it again—launched a “blockbuster” medical innovation…rolled it out…told everyone to get it…and later discovered that there may be unintended consequences. Oops!
This time, it’s Gardasil, the blockbuster vaccine for human papillomavirus (HPV), approved by the FDA in 2006 and sped to market due to its “incredible” results in protecting against several types of HPV-related cancers. While top experts in the field still tout the vaccine’s success at protecting against HPV, which has been found to cause cancers of the cervix, vagina, vulva, anus and throat and genital warts in women…and cancers of the penis, anus, throat and genital warts in men, it now seems to be associated with a significant reduction in fertility for women who have received the vaccine.
According to the CDC’s annual National Health and Nutrition Examination Survey, a review of the records of 25-to-29-year-old women residing in the US between 2007 and 2014 showed that women who received the vaccine were between 33% and 42% less likely to conceive than women who had not. Specifically, “approximately 60% of women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived. For married women, 75% who did not receive the shot were found to conceive, while only 50% who received the vaccine had ever been pregnant.”
Those are some pretty powerful numbers with some frightening implications for the future health and lives of these young women and their families.
Normally, I would think that lifestyle factors would influence the outcome of associative conclusions such as these. For example, one would think that eating more leafy green vegetables would lower the incidence of disease because people who eat more leafy green vegetables generally don’t get sick as often as people who eat less. That is an association, not a direct cause—there could be many other physical or lifestyle factors that strengthen the immune systems of people who eat more salads and thus lower their vulnerability to disease. But in the case of the HPV vaccine, preteens and teens are given the vaccine because their parents think it is the right thing to do—not because the preteens and teens are thinking about their chances of becoming pregnant or having children later in life.
The bottom line on this? While the researchers concluded that “further study is warranted,” I once again conclude that it is very risky to jump on the bandwagon of any newly launched drug, vaccine, medical device or innovation until it has been thoroughly used and tracked across many people for many years. The only exception to my rule: If it is a life-or-death situation, and there are no other options.
While manufacturers tout their quantitative controlled study statistics, the fact is that there are simply too many variations of age, gender, weight, interactions with other medications and more for drugs to be fully tested under all “conditions.” And unless drugs, devices, vaccines and surgical procedures are tested over extended periods, researchers and manufacturers simply don’t know the long-term effects until well after a product has been launched and potential damage may have already been done.
Mind you, the after-the-fact discovery of the HPV vaccine’s dangers are not an isolated Incident. This is a common occurrence. We all are painfully aware of the results of pregnant women taking Thalidomide in the 1950s and 1960s. The drug was originally marketed very successfully as a tranquilizer and sleeping pill but was soon prescribed off-label as a “miracle cure” for morning sickness—until babies were born with deformities.
JAMA reported last year that approximately one-third of all new drugs approved between 2001 and 2010 were either withdrawn or received “black box” warnings regarding side effects or other safety risks. On average, it took approximately four years for the risks to be identified, though the report also talked about the flaws in the approval system in which drug and device-related problems are reported to the FDA only on a voluntary basis.
One of the most famous examples of this enormous flaw in the system was the “blockbuster” painkiller Vioxx, introduced in 1999 and advertised as being significantly better than commonly used NSAID painkillers because it had fewer gastrointestinal side effects. But Vioxx was taken off the market in 2004 after it was discovered that the drug increased the risk for cardiovascular events among users and that its manufacturer, Merck, had suppressed that data in the FDA approval filings.
After-the-fact discoveries are not unique to medications or vaccines. Johnson & Johnson reached a settlement of about $1 billion this past spring for its Pinnacle artificial hip. It was supposed to be the “Cadillac” of hip replacements when it was introduced. But several years after the device was surgically implanted, the Pinnacle started to “shed” metal shards into the body, causing pain, swelling and metallosis, which can cause bone and tissue death. Patients with the hip were now confronted with the cost and risk of yet another surgical procedure to receive a replacement hip.
We like to think of medicine as a trusted science—but it is not. There are too many unique elements that prevent testing from being done in the most controlled and scientific way. The manufacturers try…but it’s cost prohibitive to do the testing right, and the desire for profits encourages companies to cut corners during the testing process. In the end, it’s the patients who suffer.
If you doctor recommends any drug, treatment—any anything—ask him/her the following questions…
- How long has this been available?
- How much data is there on its long-term efficacy and safety? How much data is there for “patients like me”?
- What experience do you personally have in using this on your patients?
- Are there alternatives that have more long-term data on efficacy and safety?
- Is there a noninvasive and/or nonpharmaceutical option that would be safer?
We Americans love being first on line to get the shiny new toys. That’s great for new cars and the latest fashion trends. When it comes to health discoveries, step aside and let yourself be at the end of the line.