When Merck and Co. introduced Gardisil, the media acknowledged that there were some concerns about the safety, effectiveness and cost of the vaccine, but the concern quickly died, and the media for the most part allowed itself to be sucked up into the excitement that finally there was a vaccine that could prevent cancer. After I wrote a piece addressing the issues mentioned above as well as Merck’s lobbying and marketing blitz (”Making the HPV Vaccine Mandatory is Bad Medicine“) along with several blog posts here (see below for links), I took a great deal of flak, much of it from feminist friends who wondered how I could possibly bad-mouth this pharmaceutical wonder that might save so many lives.
The answer quite bluntly had to do with looking beyond the very well-funded Merck hype and examining the facts. But beyond myself and a few others, the media did not make much effort to investigate whether the hype was justified or appropriate.
Last week however, The New York Times ran several articles by Elizabeth Rosenthal (here and here) that finally address the points that I had raised. Rosenthal writes that, according to the New England Journal of Medicine,
“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease.”
Those are rather serious issues considering that 16 million doses of the drug have already been distributed in this country alone, at a cost of $360 and upwards for a series of 3 shots, putting a serious crimp on the pocketbooks of parents and public health agencies and billions of dollars into the Merck coffers. And as Rosenthal points out, while cervical cancer is a major killer in developing countries,
“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.
Given that there are still serious unknowns about the effectiveness and safety of the vaccine , it is important to examine the sudden concern about HPV and cervical cancer.
““Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.
“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”
In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance.”
And as anyone who watches television, reads teen and women’s magazines or has been in a pediatrician or gynecologists office lately knows, the Merck marketing campaign was indeed quite impressive. The campaign has included such tactics as getting hundreds of doctors as unofficial spokesmen (paying them $4500 for each talk given about Gardisil), letting girls sign up to get text messages reminding them to get their next dose of the vaccine (as long as they let Merck use the information they provide for marketing purposes) and funding ‘awareness’ conferences, sometimes not so transparently. Merck also has provided substantive funding to legislative groups such as “Women In Government”, a group that suddenly appeared from nowhere to champion the vaccine (see this earlier post detailing the funding trail for this seemingly impartial group.)
There are also serious questions about the use of health dollars on this very expensive vaccine,
“(W)ith their high price, the vaccines are straining national and state health budgets as well as family pocketbooks. These were the first vaccines approved for universal use in any age group that clearly cost the health system money rather than saved it, in contrast to less expensive shots, against measles and tetanus, for example, that pay for themselves by preventing costly diseases.”
“Looked at another way, countries that pay for the vaccines will have less money available for other health needs. “This kind of money could be better used to solve so many other problems in women’s health,” said Dr. (Abby) Lippman at McGill (University). “Some of our provinces are running out of money to provide primary care. I’m not against vaccines, but in Canada and the U.S., women are not dying in the streets of cervical cancer.””
Another concern is that since it is not yet known for how many years the vaccine provides protection, the vaccine could actually cause more deaths by, “giving girls false security that they are protected for life and no longer need to be screened.”
One wonders (but only for about one second) what would have happened if Merck had marketed the drug for use on boys who obviously are 50% of the reason that HPV is so contagious. The answer is it would have been a non-starter not only because boys don’t get cervical cancer but also because it is so much easier to portray Merck as the great protector who has created a drug to “save” young ,vulnerable girls. And, like breast cancer, it is a disease that is closely entwined with sexuality–much more likely to capture the public imagination than lung cancer and heart disease that kill far more women.
What are we to take away from this? Perhaps the most major thing is that we need to have an inquiry as to why the FDA (and their counterparts in countries such as Britain and Canada) are so susceptible to big pharma induced panic over a disease that, with proper health care is highly treatable rather than asking the obvious, hard questions about the need, safety and effectiveness of the product as part of advancing public health. In this country we have let pharma advertising run amok, allowing profit to drive our healthcare system. The result is we have lousy, expensive healthcare and Gardisil is a blatant example of the results of that policy. Finally, it is simply not acceptable to make this kind of gamble with the health of an entire generation of adolescent girls.
Note–we have covered the HPV vaccine issue several times in the past, see here, here, and here. You can run a search using “HPV” as a search term on our blog for a complete list of posts addressing this topic.
H/T to Our Bodies Our Blog for where I first learned about the NYT articles that are the subject of this blog.
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