What’s Wrong With That Big NYT Piece on Gardasil?

August 20, 2008

The NY Times today published 4,100 words on Merck’s Gardasil under the rubric “The Evidence Gap.” the Times touts the story this way: “this series will explore medical treatments used despite scant proof they work and will consider steps toward medicine based on evidence.”

Scant proof that Gardasil works? Oh boy! This is the big one. The Times is finally bringing down the hammer on one of the most controversial drug launches ever, just like I predicted … right?

Er, no.

The piece has a number of problems that will leave drug industry folk scratching their heads as to why it was published. Doubtless the folks at Drug Wonks are already banging furiously at their keyboards in outrage at the Times’ anti-pharma bias.

More seriously, it’s long, boring, and filled with old news and non-news. So that you don’t have to read it yourself, here’s a users’ guide:

First, despite the bug-line, there’s no evidence in the article that the drug doesn’t work. Merck has never marketed Gardasil as a vaccine for all HPV, just some of the major strains.

Second, the Times’ math as explained in the story doesn’t add up. (Regular readers will be familiar with the fact that the Times is not great at explaining its numbers.) The drug costs $400-$1000 for a complete treatment, but the Times then says “Health economists estimate that depending on how they are used, the two cervical cancer vaccines will cost society $30,000 to $70,000, or higher, for each year of life they save in developed countries — a cost commonly seen in treating people already suffering from deadly cancers.” There is no explanation of how these economists got from $400 to $70,000, which would be nice, because on its own the claim makes no sense. Readers are asked to speculate that perhaps because patients who have Gardasil will be less likely to die of cervical cancer they will live longer and use more healthcare resources for different chronic diseases? Who knows. I’m just guessing.

Third, the story claims that “experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them.” Then it admits a few grafs later that Gardasil and Cervarix between them have been through eleven and a half years of trials. Gardasil alone has been through 16 million doses. From all that, there are only 9,749 adverse event reports at the FDA and 20 deaths. Even of the fatalities, there’s “no indication that the deaths or serious side effects were caused by the shot,” the Times reports.

The most inflammatory part of the story goes like this:

Phillip and Barbara Tetlock, both professors at the University of California at Berkeley, are asking whether Gardasil shots that their daughter, Jenny, received last year contributed to her illness, an extremely rare form of progressive paralysis that has left her bed bound and needing assistance to breathe at age 14.

The Tetlocks, who are not pursuing legal action, are appealing to the C.D.C. and Merck for more data and searching for other girls with similar conditions through their blog (www.jenjensfamily.blogspot.com). “Her parents are scientists – they know better than to assume Gardasil caused her disease,” said Terry Murray, a close friend speaking for the family. “But you have to explore the possibility.”

[Dr. Diane Harper, a professor of medicine at Dartmouth Medical School ] said she believed the vaccine was generally safe. She vaccinated her own children. But with Gardasil’s use having grown so fast, she added, … “The Tetlocks are right to ask these questions.”

Well, sure, but by the evidence presented by the Tetlocks, their friends, their blog and the Times itself, there’s zero connection whatsoever to Gardasil other than the fact that this poor girl got sick around the time she had the injections.

Most of the rest of the story is about two years old — there’s a complete rehash, for instance, of Merck’s clumsy and cynical lobbying campaign in Texas and Virginia, which was widely reported in both local and national media at the time.

Did the Times get anything right? Credit where it’s due: It was certainly worth reporting this conflict of interest:

Gregory A. Poland, a vaccine expert at the Mayo Clinic, was a nonvoting member on the C.D.C. panel that recommended Gardasil in 2006 and has publicly defended the panel’s decision. Records show he received at least $27,420 in expenses and consulting fees from Merck from 1999 to 2007. Both the C.D.C. and Dr. Michael Camilleri, chairman of the Mayo Clinic Conflict of Interest Review Board, speaking on Dr. Poland’s behalf, said the payments complied with institutional requirements.

But beyond that, I am mystified as to why this deserved such massive airtime this late in the day.

Advertisements

7 Responses to “What’s Wrong With That Big NYT Piece on Gardasil?”

  1. John Mack Says:

    Regarding the math and getting from $400 to $70,000 per extra year of life.

    I believe this is a population calculation where they take $400 per person ($1,000 per person if booster shots are required) inoculated and multiply that by millions of people in the general population who are eligible to be inoculated and then dividing by extra years of life that results (which depends on the efficacy of the drug and the actual expected incidence of the disease in the population In developed countries, the incidence is LOW.)

    I don’t have all the numbers, but the article says that Canada will spend $300 million on a cervical cancer vaccine program. In the year 2002, it is estimated that there was approximately 1,400 new cases and 410 deaths due to the disease (it has been decreasing over the years). Not all those deaths would have been prevented by inoculation with Gardasil, but say that half would be saved. The cost is $300/205 or about $1,500,000 to save those 200 or so lives. Of course, we’d have to factor in the number of extra years of life, say 50, for each survivor. I get about $30,000 per year of life.

    Assuming that the US has 2X the population of Canada and would have to spend 2X as much on its inoculation program, then y9ou’d get close to the $70,000 per year of life estimate in the NY Times article.

    QED.

  2. John Mack Says:

    Sorry, that’s $300,000,000/205 to get $1,463,414, which divided by 50 gives you $29,268.

  3. John Mack Says:

    Sorry again. How to get from $30,000 in Canada to $70,000 in the US — my logic may be wrong but I believe my rough calculations put me in the right ballpark — its only a matter of a factor of 2, which may be eliminated if Canada does NOT include booster shots in its program, but the calculation for the US DOES.

  4. Chris P Says:

    Take a look at the NNT (Number Needed to Treat) on how to get the calculation of $30,000. If the NNT measured in reducing 1 cervical cancer death is 75 and the product costs $400, then 75 * $400 = $30,000.

    http://en.wikipedia.org/wiki/Number_needed_to_treat


  5. The style of writing is quite familiar to me. Have you written guest posts for other bloggers?

  6. jenstalk Says:

    if only 10% of adverse affects are ever reported to VARES – then given the total number of vaccines administered – it has been suggested given the large number of girls now coming forward in blogs and internet talk forums that there could be up to 1.5 million now suffering server adverse affects

    remember there has never ever been an admittance by ‘official’s of any link to death or adverse affects of any vaccine not even thalminide when it first came out – and now 60 years later there has been an apology !!!!

    It boggles my mind why so many support this so uncritically and attack those who through first hand experience link it directly to their ill health – where is open mindedness, true investigative reporting

    if boys started dropping like flies after having this would you all take more notice – there is a growing body of evidence that the girls that are dropping like flies are very high achievers and very athletic suggesting a higher than normal Testosterone level – so lets see how its going to affect boys we already know that there are more autistic boys then girls —-

    your all like the christians of old – ready to demonize anything you don’t want to look at – there is a huge tragedy happening here and little need for such a vac in the first place – if you bothered to do our home work rather than be the drug pushers lackey’s

  7. CarTe Says:

    You have shown a complete ignorance of elemental statistics and health policy. You sound more like an activist with a hidden agenda


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: