For those who may have been far removed or simply out of touch in the past few weeks, let’s recount recent events. Although Gardasil has periodically generated headlines since its approval five years ago, the vaccine became a hot campaign issue thanks to Texas governor and Republican presidential candidate Rick Perry, who accepted from Merck donations in the years leading up to his controversial 2007 decision to sign an executive order requiring school-age girls to receive Gardasil shots.
This was actually an old story. At the time he signed this order, which was later overturned by the Texas legislature, it was reported that his former chief of staff was a Merck lobbyist. And the drugmaker had conducted a surreptitious marketing campaign to enlist female legislators — especially those who belonged to a group called Women in Government — to push for mandatory vaccination in schools. But the issue arose anew during Republican presidential debates, resurrecting Gardasil’s controversies and making turbulence for Gov. Perry’s candidacy.
The first issue is ongoing concern among social conservatives and some parents that inoculating teenage girls with an HPV vaccine may suggest they have a green light to engage in pre-marital sex. Gardasil was approved to combat four strains of HPV in girls as young as nine years old up to women who are 26. Health officials have endorsed the vaccine because HPV can lead to cervical cancer. The second issue is the extent to which side effect reports reflect genuine safety issues that need to be further explored.
Enter Rep. Michele Bachmann (R-MI). At a time when the U.S. economy is struggling just to tread water and corrosive political gridlock has generated tremendous ill will toward Capitol Hill, the Minnesota congresswoman and Republican candidate tried to smear Gov. Perry by saying that he failed to disclose the depth of his ties to Merck. Gov. Perry only acknowledged receiving $5,000 in donations, but had actually accepted $28,500 and, since early 2006, Merck had given
another $377,500 to the Republican Governors Association, an organization he periodically headed and which was one of his large campaign backers.
Although his effort to enforce a mandate may have generated credibility with social conservatives, Gov. Perry quickly disavowed the move upon entering the Republican primary this summer. He then mistakenly appeared to play dumb when asked about Merck donations. This allowed Rep. Bachmann to portray him as someone who did not really care about conservative values, but was really more interested in accepting corporate donations. Such are the twists and turns of a campaign trail.
For a brief moment, though, it then seemed that the latest Gardasil flap might have faded from view. But it was, indeed, a very brief moment. A day later, Rep. Bachmann then cited or fabricated an anecdote in which a woman, who Rep. Bachmann says she did not know, approached her after a campaign debate to complain that Gardasil caused her daughter to develop brain damage. She repeated this during a televised debate, not bothering to investigate the claim and leaping straight to the conclusion that Gardasil is a dangerous product.
At the same time, social conservatives were railing about Merck and Gardasil in California, where a bill was proposed this past summer to remove parental consent for vaccinating children 12 and older against sexually transmitted diseases. State law already allowed children 12 and older to consent to treatment for sexually transmitted diseases without parental involvement, but the bill expands that right to immunizations, such as HPV vaccines.
Merck was, once again, lurking in the background of this story. Reports showed that many members of the California senate and assembly who voted to approve the legislation also received money last year from Merck. This group included assemblywoman Toni Atkins, who introduced the bill but earlier this past summer denied to me that she ever received money from the drugmaker (although she did acknowledge accepting money from GlaxoSmithKline, which sells the rival Cervarix vaccine).
All this behind-the-scenes activity that was suddenly laid bare served as a reminder that Merck provided educational grants before and after the Gardasil approval to various medical associations, including the American College of Obstetricians and Gynecology, which endorsed the California bill. However, as a 2009 paper in the Journal of the American Medical Association made clear, the material did not fully address the complex issues surrounding Gardasil or provide a balanced recommendation of risks and benefits. Meanwhile, these groups created educational programs and speaker bureaus to promote the vaccine.
And so in the course of less than a month, Gardasil skeletons old and new have been on full display and the Merck vaccine has become more controversial than ever. Even worse for Merck execs, the same issues that have plagued the drugmaker these past few years now show signs of stubbornly remaining front and center indefinitely. This comes at a time when Merck is struggling to revive Gardasil sales. Twice, Merck has failed to persuade the FDA to approve the vaccine in women ages 27 to 45, a huge market. Public health officials, meanwhile, recently reported that teenage vaccination rates for the HPV vaccine trail the other two vaccines recommended for teens and pre-teens.
Not surprisingly, Merck execs were beside themselves during this latest episode. Feeling helpless to stop the deluge of media reports and Internet chatter, the drugmaker released a brief statement that simply reaffirmed the safety and effectiveness of its vaccine. To some extent, Merck’s cause was helped by the reckless way Bachmann went about discussing Gardasil. Her remarks, in fact, prompted a pair of bioethicists to offer a $10,000 bounty for any legitimate examples in which someone was rendered cognitively impaired by the vaccine. To date, the bioethicists — Arthur Caplan of the University of Pennsylvania and Steve Miles of the University of Minnesota — say no one has come forward.
However, this combustible chain of events has also renewed debate over whether Gardasil is really the sort of salve that both the drugmaker and public health officials have made it out to be. For instance, Diane Harper, who is one of the original Gardasil researchers and works as a professor at the University of Missouri-Kansas City School of Medicine, where she specializes in community and family medicine, obstetrics and gynecology, has repeatedly pointed out that long-term effectiveness is unknown, raising questions about whether booster shots are needed. She has also noted that other HPV strains may become more daunting over time, lessening the effects of the vaccine, and pointed out that vaccination is not likely to become more effective at reducing cervical cancer rates than that old standby, pap smears.
The upshot is that Merck will struggle to transform its vaccine into the blockbuster product first envisioned several years ago. Instead of hearing the sound of ringing registers and grateful praise, Merck execs instead can be expected to hear debate over Gardasil safety and effectiveness to continue on some level indefinitely, especially given lingering suspicions among a segment of the public about the veracity of vaccines in general. And while Merck has wrapped itself in the cloak of public health by making cervical cancer prevention a cornerstone of its Gardasil marketing effort, the drug maker has failed to make the vaccine available on an affordable basis to countries where HPV and cervical cancer rates are higher than in the U.S., undermining its potential for generating considerable goodwill.
Of course, Merck has every right to attempt to influence public opinion and support legislation that furthers its goals. And no drugmaker can be expected to control how wildcard politicians portray its products, regardless of the size of the campaign donations that it doles out or the educational programs that it funds. But the recent flap is the sad legacy of an older, misguided marketing policy gone awry. After all, not every state mandates other vaccines for diseases that
can be caught sitting next to another person. If the Merck execs really want to defuse controversy, they should refrain from pushing legislation that can upset parents and agree to fund a long-term efficacy study. Until then, they will need inoculation against not only bad publicity, but bone-headed ideas. And so far, no Merck scientist has come up with such a vaccine.
Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor’s Business Daily. Ed blogs about the drug industry at Pharmalot, at www.pharmalot.com. He can be reached at email@example.com.