US politics and Merck's bad public image are keeping a breakthrough vaccine from saving hundreds of thousands of lives around the world and endangering the cures of the future
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 US now say dominates their practices. Some 8,000 of these tonsil tumours turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer.
His prognosis was good—80 percent of those with this new tumour 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 tumour 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 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 percent 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? 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 PR 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.
“If you look at both sides of the political spectrum I’m amazed and appalled by the lack of knowledge that’s being put forward as knowledge,” says Robert Ruffolo, former head of research at Wyeth. “They’re not scientists, they’re not physicians, and many politicians will say almost anything during election season.”
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 percent 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. 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.
The company seems to agree. “Merck suspended our lobbying five years ago because our involvement became a distraction, and we believed the focus should be on the battle against cervical cancer,” a spokeswoman says. 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 percent 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.
(This story appears in the 11 May, 2012 issue of Forbes India. To visit our Archives, click here.)