In next week’s issue of Forbes, Matthew Herper, the magazine’s medical editor, penned the article, The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine, an insightful analysis of why Gardasil, the vaccine for human papillomavirus (HPV), has not become as important to vaccination strategies as measles or whooping cough. All vaccines keep you alive, even if the disease does not appear to be scary. There’s a belief, especially amongst the anti-vaccination crowd, that measles is just a few spots, and there are few risks to being infected. The risk of severe complications is small, but significant.
On the other hand, the HPV vaccine does one thing and does it well–it prevents an HPV infection. Human papillomavirus, a sexually transmitted disease, causes 70% of cervical cancers, 80% of anal cancers, 60% of vaginal cancers, and 40% of vulvar cancers. It also prevents the majority of HPV caused oral cancers. In other words, these diseases are in a different league of danger. And they can be prevented.
In the article, Herper tells the story of a successful CEO:
Neal Fowler, 50, the chief executive officer of a tiny biotech called Liquidia, was assuming a position common to road-warrior entrepreneurs: leaning his elbows on the seat-back tray in an airplane so he could gaze at the screen of his laptop. That’s when he felt the lump in his neck.
Fowler, a pharmacist, figured his lymph node was swollen by a recent cold, but the oncologist seated next to him—his chairman of the board—thought they’d better keep an eye on it.
The chairman was right. Over the next week the lymph node got bigger and harder. It was not sore to the touch, as happens during a cold. Fowler went to the doctor, then a specialist who knew exactly what he was seeing: a new form of throat cancer that ear, nose and throat specialists across the U.S. now say dominates their practices. Some 8,000 of these tonsil tumors turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer. Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing.
His prognosis was good—80% of those with this new tumor survive. His status as a drug industry veteran and chief executive of a biotechnology company didn’t hurt, either. He went from diagnosis to having the primary tumor removed from his tonsil in just a day. His first team of doctors wanted to do a second surgery, opening up his neck, but by polling other experts he found a different team and a different option: chemotherapy and radiation.
But it gnaws at Fowler, who thinks about vaccines all day long—Liquidia’s vaccine work made it the only startup to receive an equity investment from the Bill & Melinda Gates Foundation—that one that might prevent other boys, including his teenagers, from ever developing this cancer isn’t being used. Gardasil, one of two HPV vaccines, is already approved in boys to prevent anal and penile cancers, but because these diseases are rare, only 1% actually get it. And tests that might well prove that this Merck product can prevent the new throat cancer strain would take at least 20 years, until the boys sampled actually became sexually active and then contracted the disease.
“We’ve got this two- or three-decade window where more and more of these patients like myself are going to emerge,” says Fowler. “To me the [vaccine] risk is minimal, and I’d say, why not do that?”
Outstanding question. Why aren’t young men and women getting this vaccination? The answer is probably complex. Young adults still think they’re immortal, so they don’t worry what’s going to happen 20 years from now (or why would tanning parlors exist). But the answer probably much more complex than pop psychology.
A big part of the answer is politics. Drug safety, vaccines, antibiotics and reproductive medicine—all have become proxies for the culture war, often tripping up public health in the process. Big Pharma hasn’t helped, with deep p.r. wounds that have made it anathema to both political parties. Nor has the FDA, which has shifted the goalposts on approving new antibiotics enough to scare away many innovators just as resistant bacteria have become a big health problem. Both parties undermined the FDA further by overruling it on how the Plan B emergency contraceptive should be used, weakening the agency’s authority. Now a coalition on the right is pushing to remove all testing of whether some medicines are effective, while many on the left still think the FDA remains too cozy with the drug industry.
Proxies for the culture war? That was just one of the most difficult things to read. Once again, politics places itself into science and medicine, unconcerned with the fact that there is not a scientific controversy about HPV vaccines (like evolution and global warming), but just a cultural-political one. Sadly, in this case, both the left and right are supporting anti-science ideals, making unfounded statements that make no sense.
Nothing underscores that point more than what has happened to Gardasil, a vaccine with an exceptional safety record and effectiveness rate that nonetheless reaches a fraction of those who need it, endangering hundreds of thousands of lives in both the developed and developing world. Besides the paltry numbers for boys, only 30% of eligible girls get Gardasil or a rival product, Cervarix, made by GlaxoSmithKline.
For many on the right the issue is promiscuity. Because HPV is usually transmitted through sex, it is viewed as a permission slip for lasciviousness.
For many on the left the issue is the big, bad drug companies. Merck lost credibility through its aggressive tactics marketing Vioxx, an arthritis pill that turned out to cause heart attacks. But now that taint hinders the prospects for all their products, notably Gardasil.
Why is the right wing so obsessed with sexuality? Maybe they think that any young woman who gets the vaccine is a slut? Maybe they think their daughter is pure as the driven snow? Since premarital sex is so prevalent, even in fundamentalist homes, the risk remains of HPV infection is very high. And even if their daughter is perfect, who knows if her future boyfriend, or even husband, has that same virtue. And change daughter to son, and the same questions should be asked.
And the hatred of Big Pharma by the left is annoying on so many levels. This writer is, by every standard, a left winger. Big Pharma does far more good for the world than any other industry. Pharmaceutical companies can list the number of lives saved. Vaccines have prevented massive epidemics of diseases. They have produced devices and drugs that have helped many people live productive and thrilling lives after cardiovascular diseases, cancer, arthritis, and more than can be listed here. Yes, some companies have erred, whether through incompetence, bad luck or unethical behavior. The FDA has prosecuted many of them.
In the 1990’s, a large cardiovascular device company manufactured a angioplasty device that had a tip break off. And a piece of metal in a coronary artery is never good. That company failed to report the failures to the FDA. Well, executives were arrested (and eventually sent to prison), the FDA took control of the company (approving or disapproving almost everything going on there), and pretty much destroyed the reputation of the company for two decades. In fact, even today, a lot of people in the medical industry refuse to work for them.
But even if any of these things were true, it is amazingly delusional to keep young adults from getting a vaccine that substantially reduces the risk of some awful cancers.
And both sides increasingly embrace the narrative that vaccines, one of the great success stories of modern innovation, are somehow unsafe. In many ways they’re just channeling their voters: A Thomson Reuters/NPR Health Poll last year found one in four Americans believes there are safety problems with vaccines, which experts say are among the safest medical products ever created.
It’s clear that the anti-vaccination lunacy has had more of an effect than many believe, even though vaccination rates have mostly stayed high (around 90%), because no one wants their little baby to contract these diseases. But it’s clear that there’s something more about Gardasil, that exacerbates the fear of vaccines. That socio-political soccer ball is worse than we thought.
But 2011 was still a very bad year for Gardasil. In September, as the Republican presidential candidates jostled for position, Representative Michele Bachmann attacked Texas Governor Rick Perry for being the first major politician to mandate Gardasil use. Rather than simply point out his ties to Merck or question his authority to do it, Bachmann asserted that Gardasil was dangerous and, on TV the next day, claimed she’d met a mother whose daughter had become “mentally retarded” because of the vaccine.
Otis Brawley, chief medical officer of the American Cancer Society, calls the episode “disastrous.” “It’s an insult that people are not looking at the evidence,” says Brawley. “It’s a tragedy that we could prevent people from dying from cervical and head and neck cancer but our society just can’t bring itself to have an open, rational, scientific discussion about the facts.” Bachmann did not return multiple requests for comment.
It’s a sad predicament for a drug with such a distinguished and promising history. Gardasil sprang from the 1976 discovery that cervical cancer tumors were caused by the human papilloma virus. Harald zur Hausen, a German scientist, won the 2008 Nobel Prize in Physiology & Medicine for this discovery. The Nobel Prize committee noted that HPV might play a role in 5% of human cancers and at least half of people get HPV at some point in their lives.
First, we would have to ask why anyone would listen to the babbling of Michele Bachmann, rather than a Nobel Prize winner. Or the science which shows minor risks (and incredible benefits). Or frankly anything about medicine, but then again, Ms. Bachmann has kind of disappeared from view. Second…oh there is no second, Bachmann is just not a source for anything scientific.
Still, Merck has left itself a tempting target for opponents. Websites brandish graphics that say “Gardasil! From the people who brought you Vioxx.” Others show photos of girls whose disease or death they say is linked to the vaccine.
Yet the data indicate Gardasil is actually an exceptional drug, extremely safe and extremely effective. In clinical trials of 30,000 people, potential side effects ranging from fever to death occurred at the same rate whether patients were given a saline solution placebo or Gardasil. Deaths occurred in only 0.1% of people in either group. Since the vaccine was approved, it has been given to at least 10 million people, mostly teenage girls. The FDA and the CDC have received reports of 71 deaths of people who got the vaccine and, on examining them, found no pattern.
They looked specifically at the terrible neurological disease called Guillain-Barré Syndrome, because it’s known that a swine flu shot given in the 1970s caused it. The rate of GBS reported for Gardasil was half what it was for other vaccines, meaning that Gardasil probably wasn’t causing any elevated risk of the disease.
Safe and effective. And even if the 71 deaths have any relationship to Gardasil (let’s not forget Post hoc ergo propter hoc and other logical fallacies), that risk is tiny.
Gardasil should be at the center of disease control in the US and throughout the world, yet for the lamest of reasons, it is not. Can this be overcome? Not in the current environment where Big Pharma is hated, that vaccines are supposedly harmful, or that Gardasil increases promiscuity. Sometimes, you just want to give up.
But we won’t.
Please read the whole article by Matthew Herper. It’s worth your time.