Controversy over cervical cancer vaccine

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(This article was #26 in Discover Magazine’s top 100 stories of 2007.)

This past year, several countries and at least 24 states in the United States introduced laws to mandate vaccination against cervical cancer for preteen girls. Although the vaccine was initially hailed as a breakthrough, urgent proposals to make it mandatory quickly triggered a backlash. “In the long term,” says Susan Wood, a former director of the FDA Office of Women’s Health, “the rush to get this mandated immediately has done more harm to the issue.”

The FDA approved Merck’s Gardasil vaccine in 2006, after clinical trials showed that it protects against four strains of human papillomavirus (HPV), which together cause about 70 percent of cervical cancers and 90 percent of genital warts. HPV is the most common sexually transmitted virus among Americans (and cervical cancer is the second most common cancer in women worldwide). Because the vaccine doesn’t reverse existing exposure, the CDC recommends it be administered before the age of sexual activity—specifically to girls ages 11 to 12. As for women who already have HPV, two separate studies published in May in the New England Journal of Medicine reported that the vaccine’s effectiveness in preventing cervical lesions dropped to 20 percent or less.

Some conservative groups oppose targeting preteens, arguing that because the virus is sexually transmitted, the vaccine will encourage promiscuity. Meanwhile, bioethicists who are skeptical about compulsory vaccination laws note that all other mandated vaccines protect against diseases easily transmitted in schools. “In my opinion, there’s not a compelling ethical reason [to mandate],” says Richard Zimmerman, professor of family medicine at the University of Pittsburgh. “The ethics is the opposite: to strongly recommend, but not to mandate.”

New vaccine blocks bird flu

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(This article was #12 in Discover Magazine’s top 100 stories of 2007.)

Although avian flu made few headlines in 2007, the virus continued to claim lives in Asia, particularly in Indonesia. The good news is that this year the FDA approved the first bird flu vaccine and announced plans to stockpile it for emergency use during a crisis.

The H5N1 strain of bird flu first appeared in Hong Kong in 1997 and since then has infected more than 330 people, killing more than 200. In 2007, the virus—which normally infects birds and occasionally jumps from birds to humans—affected seven countries, prompting experts to warn that it could gain the ability to jump from person to person and trigger a pandemic.

In April, the FDA approved a two-shot vaccine made by Sanofi Pasteur. In a clinical trial, this vaccine protected 45 percent of the adults who received the highest dose against infection from H5N1. The government said its goal was to stockpile enough doses of the Sanofi vaccine to protect 20 million people as a stopgap measure until a more potent vaccine is available.

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Unreasonable doubt

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(This Opinion column ran on Nature’s website June 15, 2007. You can see the original post here.)

A ‘vaccine court’ case on autism could have disastrous consequences if people confuse its verdict with scientific consensus.

Why are there so many more cases of autism now than there were 30 years ago? It’s a question the best scientific minds have been unable to answer. But I’m afraid a US court now looking at that question may settle it on the basis of emotion rather than science.

The parents of thousands of autistic children think that the routine measles-mumps-rubella (MMR) vaccine and the mercury-based vaccine preservative called thimerosal damaged their healthy children’s brains and made them autistic — and they’re now suing the US government for damages. On Monday, three ‘special masters’ of the US Court of Federal Claims began hearing testimony in the first of nearly 5,000 such cases, some of which have been pending for years.

I sympathize with these parents and can understand their need to find a reason for their children’s suffering. But I trust in science, and I can’t ignore the fact that so many peer-reviewed studies — and every scientific panel entrusted with evaluating those studies — has come to the same conclusion: neither the MMR vaccine nor thimerosal is associated with autism.

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Don’t rush your vaccines

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(This Opinion column ran in Nature’s news site on May 17, 2007. You can read the original post here.)

The ethical debate about a vaccine for a sexually transmitted disease has been premature, says Apoorva Mandavilli; we don’t even know how well it works.

Here’s a good lesson: before you start pushing for a controversial vaccine to be made compulsory, best wait for the research — and I mean all the research — to come up with results.

For more than a year, we’ve been hearing that there is a vaccine that is 100% safe and effective in protecting young girls and women from the deadly viruses that cause cervical cancer.

Merck’s Gardasil, a vaccine against human papilloma virus (HPV), has been hailed as perhaps the biggest boon for women since the contraceptive pill. Across the world, including many American states, politicians and activists have proposed laws to make Gardasil mandatory for girls in their early teens or younger. Australia has already started a national programme of free vaccines for young girls.

All that sounds a bit premature — and rightly so. As we find out more about this vaccine, including new studies in last week’s New England Journal of Medicine¹^,², it’s clear we simply don’t know enough about it to be giving it to young girls en masse.

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FDA approves vaccine for cervical cancer

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(This article was #27 in Discover Magazine’s top 100 stories of 2006.)

The cervical cancer vaccine—the second vaccine after the hepatitis B vaccine to target a sexually transmitted disease—debuted this year. In June the Food and Drug Administration approved the vaccine, distributed under the brand name Gardasil, for girls and women ages 9 to 26. The European Union and Australia have also approved the vaccine, and a similar product to be manufactured by GlaxoSmithKline is in the works.

The vaccines work by inducing antibodies to the human papillomavirus, or HPV, which can cause genital warts and cervical cancer. In large clinical trials, the vaccines were more than 99 percent effective in preventing HPV infection. Like most vaccines, however, they are most effective among people who have not yet been exposed to the virus. An American government advisory panel therefore recommended that Gardasil be given routinely to 11- and 12-year-old girls—and in some cases to girls as young as 9.

Every year cervical cancer kills more than 230,000 women worldwide, about 80 percent of them in developing countries. In the United States, the disease claims the lives of roughly 4,000 women each year. Based on a mathematical model, GlaxoSmithKline claims that immunizing every 12-year-old girl with the vaccine would reduce U.S. cases and deaths from cervical cancer by 70 percent. But some conservative groups have opposed the vaccine, saying it might promote sexual activity.

Poor countries also face a more practical obstacle. The full course of the vaccine—three shots over a six-month period—costs about $360. “The biggest issue will be price,” says John Schiller, a senior investigator at the National Cancer Institute, who did some of the early work that led to the vaccine’s development. “It’s the most expensive vaccine we have.”

Business: Reinventing an industry

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(I reported this article when I was in India in 2006. Typically, I did not manage to get an interview with Kiran Mazumdar-Shaw till my uncle pulled some strings. Nature has less power in India than nepotism. Also, I’m proud of the fact that, along with an article I wrote about a famous Indian advocacy group, I managed to get photos of two Bollywood stars into Nature. You can download a pdf of this article.)

Two years after a radical change that brought India’s patent laws into line with international trading rules, the country’s drug makers are taking a new direction.

Star turn: Actor Shah Rukh Khan (left) helps Biocon’s Kiran Mazumdar-Shaw launch BIOMAb-EGFR.

Kiran Mazumdar-Shaw is India’s uncrowned queen of biotechnology. She started her company, Biocon, in a garage in 1978 with just Rs10,000 (US$225) in working capital and has built it into the country’s largest biotech company, with 1,800 employees and revenues last year of $180 million.

Said to be the richest woman in India, Mazumdar-Shaw was in the spotlight last September when her Bangalore-based company launched the first new drug to be developed, tested and taken through approval by an Indian company. The drug, BIOMAb-EGFR, is a monoclonal antibody for treating head and neck cancers.

This could be the harbinger of a brighter and more innovative future for India’s drug industry, which until recently relied on sup- plying cheap ‘generic’ copies of drugs — many of which were still under patent elsewhere.

That all changed in January 2005, when India brought itself into compliance with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) — international rules that forbid the copying of patented drugs.

The transition has gone smoothly. “Companies are playing by the rules,” says Frederick Abbott, a professor of international law at Florida State University who knows the Indian drug industry well.

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