Example of a Pharma-Political complex gone wrong

[WaveSculptor]

So how does everyone feel about Merck's lobbying push for its HPV vaccine Gardasil to become mandatory for all girls attending public schools? I think it's a thinly veiled attempt to subsidize their antitrust litigations... Although Cervical Cancer is a significant health issue, 80% of its victims are claimed in developing countries rather than industrialized nations, and sadly I doubt Merck has any interest in helping those people. In addition, the prevalence of HPV types associated with Cervical Cancer is relative low (3.4%), and let's not forget that contracting it is contingent upon promiscuity and the failure to protect oneself. Given the facts: that Cervical Cancer kills less than a percentage of the population, and that a girl's chances of contracting it from HPV are actually quite low and that she would have to be having unprotected sex to do so, I don't think it's prudent to mandate a vaccine whose safety has not been evaluated outside of 5 years, nor has its effectiveness in continuing to prevent the disease (they suggest periodic booster shots).

Oh yeah, and by the way it's the most expensive vaccine ever offered at roughly $360 a person for a series of 3 injections. That'll pay for a few of the heart attacks and sudden strokes that Vioxx users experienced... and amazingly the thing they learned from it was not to research the risks & benefits of their products more thoroughly before pushing them onto the market, but instead to get crafty and shift the burden to the state in case something does go wrong. Just one concern is that the aluminum used in the vaccine to elicit a more vigorous immune response may accumulate in the brain and contribute to alzheimer's or allergic reactions. You also don't have to dig very deep to see whose pockets the politicians pushing for this are in (see TX gov. Rick Perry and former Chief of Staff Mike Toomey, now a Merck lobbyist).

Well there you have it, I can certainly speculate further but I'll wait to see what people's thoughts are on this.

Here is a link to a thoughtful article about it:

http://jama.ama-assn.org/cgi/content/full/297/17/1921

[rubyraks]

Re: Example of a Pharma-Political complex gone wrong

just one example in a long list of corrupt relationships between gov't and pharmies

[toasty]

Re: Example of a Pharma-Political complex gone wrong

Well, you'd be hard-pressed to find someone with less sympathy for the pharmaceutical industry than me. Obviously, Merck's motivation for pushing making this vaccination mandatory is financially based and has very little to do with altruism. I'm not going to be the one to tell them they can't push for it, though, because that's the way our economy works. Whether or government ought to mandate it is another question, entirely, though, and I'll agree that that's a bit troubling.

For me, the bigger part of this story are the over-protective yahoos that are unwilling to vaccinate their children against what it essentially a sexually transmitted disease because it suggests they are approving of them having sex. Guess what? When I was a kid, I was vaccinated against a host of different things, and didn't ask or care why because my parents assured me it was for the best. Some opponents suggest that the conversation has to go like this:

"We're giving you this shot so that if you have sex, you're protected against certain types of cancer."

How about this:

"We're giving you this shot to protect you against certain types of cancer."

You're getting the shot either way. There's no reason for it to become a sex talk or have anything to do with sex at all. It is totally irrelevant to the discussion.

Imagine that a parent declines this vaccine and their daughter (gasp) has sex anyway and contracts this virus that is linked to cervical cancer. Or to take it a step further, suppose the daughter follows her parents wishes but is raped? Wouldn't you, as a parent, like to know that there is that extra layer of protection? If there was an AIDS vaccine available, I would think it would be pretty irresponsible for a parent to decline it for their child and rely upon their abstinence instead.

Point taken re the fact that this won't protect against all, or even most, forms of cervical cancer, but I'd still want my daughter to get vaccinated just the same.

[88Mariner]

Re: Example of a Pharma-Political complex gone wrong

i'm with toasty on this. personally, the bigger story is the latter bit. frightening stuff. if i remember correctly, this started in Texas. gofuckingfigure..

[WaveSculptor]

Re: Example of a Pharma-Political complex gone wrong

It's of paramount importance that we have the best healthcare options for ourselves and our families. My concern however, is that this opens up a quarter billion dollar anual revenue pipeline to bail Merck out of the hot water it got into by doing the same thing with Vioxx only a few years earlier (financing their own studies to gain preliminary approval and then forcing it onto the market before the risks become apparent). You are absolutely right that the economy works this way... my question is: shouldn't we routinely re-evaluate these practices? The energy industry creates an Enron, the accounting industry creates an Andersen, the communications industry creates MCI, infrastructure demand and the perpetual war cycle give rise to Halliburton/KBR, and now pharmaceutical giants are manipulating the political process for private gains... Aggressive and selfish practices run rampant in the domestic & international business communities and it pains me to see the standard of success being defined in this way. I sincerely hope Gardasil turns out to be a great innovation with no drawbacks, but as that remains unclear I urge caution until the mechanics of this juggernaut become plainly visible. I mean we're talking about a lot of money here, over 350 dollars a person... is everyone ok with that kind of cash flowing to Merck from families all over the country? Does everybody know what type of political agendas and candidates Merck channels that money towards? I guarantee we will see a continual increase in these aggressive practices, not just from Merck but from any company that hopes to compete in a similar market, for when we allow the economy to operate in this way, then we also effectively chastise honorable businesses for their 'failure to adapt' to this nascent, highly artificial terrain.

[Localizer]

Re: Example of a Pharma-Political complex gone wrong

heh, here you go - from last week.

Medical Journal Questions
Efficacy of HPV Vaccine

By JOHN CARREYROU and KEITH WINSTEIN
May 10, 2007; Page D3

An editorial published in the New England Journal of Medicine raises questions about the overall effectiveness of Merck & Co.'s cervical-cancer vaccine, Gardasil, and advises policymakers, doctors and parents to adopt "a cautious approach" toward vaccination.
The editorial accompanied a study published in the medical journal analyzing results of a clinical trial of the vaccine, which targets two types of the human papillomavirus thought to cause most cervical cancers and two other types that cause genital warts.
The Merck-funded study, involving 12,167 women, found the vaccine was 98% effective at preventing precancerous lesions of the cervix related to the two cancer-causing types, known as HPV 16 and 18, among a subgroup of women previously uninfected with the virus.
But its efficacy against precancerous lesions related to HPV 16 and 18 fell to 44% among the broader group of women, which included women previously infected with HPV. And the efficacy figure dropped to 17% when all precancerous lesions were taken into account in that broader group. The women were followed for three years following vaccination.
Merck has touted Gardasil as a breakthrough vaccine that may help eradicate cervical cancer, noting that HPV 16 and 18 are thought to cause 70% of cervical cancer cases. But the 17% efficacy figure suggests that the vaccine will have less impact than advertised in the general female population.
In a page-one article in The Wall Street Journal last month, some scientists raised doubts about whether the vaccine will really reduce cervical-cancer rates in the U.S. and suggested the billions of dollars likely to be spent on Gardasil in coming years might be better used to expand Pap screening among low-income women.
Merck aggressively lobbied state legislatures to make vaccination a school requirement for 11- and 12-year-old girls before pulling the campaign in February. Sixteen states are considering making such requirements law, and two states, Texas and Virginia, have already acted to do so.
However, Texas has since pulled back. Texas Gov. Rick Perry said Tuesday he wouldn't veto a bill passed by the legislature blocking state officials from following his earlier executive order mandating vaccination of girls entering the sixth grade. Mr. Perry's order had come under heavy criticism because he received campaign contributions from Merck and one of Merck's lobbyists in Texas was the governor's former chief of staff.
In their NEJM editorial, George F. Sawaya and Karen Smith-McCune, members of the department of obstetrics and gynecology at the University of California, San Francisco, wrote that "a cautious approach" toward vaccination "may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time."
The authors called the vaccine's overall efficacy against precancerous lesions of the cervix "modest" and theorized that one reason for this limited efficacy might be that other cancer-causing HPV types fill "the biological niche left behind after the elimination of HPV types 16 and 18." HPV has more than 100 different types, roughly 17 of which are thought to cause cancer.
Eliav Barr, who heads Merck's HPV vaccine program, has said this phenomenon, known as replacement, is unlikely based on other analyses the company has conducted.
Dr. Barr has also defended Gardasil as a "lifesaving" vaccine whose widespread adoption will result in "a substantial decline in the rate of cervical cancer."
Write to John Carreyrou at john.carreyrou@wsj.com

2nd article

JAMA Editor: Don’t Mandate Cancer Vaccine

Posted by Jacob Goldstein
In the latest salvo in a national debate, the editor of JAMA opposes requiring girls to get vaccinated against the virus that causes cervical cancer.
Routine use of a new vaccine, sold by Merck under the brand-name Gardasil, “undoubtedly is beneficial to the public’s health, as it is likely to reduce the incidence of cervical cancers,” Catherine DeAngelis (pictured, left) writes in an editorial in this week’s JAMA. “However, the rush to make HPV vaccination mandatory in school-aged girls presents ethical concerns and is likely to be counterproductive.”
The editorial, co-written with a health-law expert, comes as many states consider making the vaccine, which was approved last year and costs over $300, mandatory for school girls.
DeAngelis, a pediatrician, points out an essential difference between Gardasil and other mandated vaccines. The cervical cancer virus, called HPV, can only be transmitted sexually, while diseases prevented by other vaccines are transmitted through the air. She notes that Gardasil has not been tested in young girls, and says the duration of the immunity it confers is unclear. And in an interview with the Health Blog this afternoon, she criticized Merck for lobbying legislatures to make the vaccine mandatory.
“I am very pro-vaccinations and immunizations when they’re good because they save a lot of lives, and they save a lot of sickness. But you do not make it mandatory for children by approaching politicians to make laws,” she said. “The American Academy of Pediatrics recommended it; they never said to make it mandatory. It’s for the parents to decide, not a politician.”

[WaveSculptor]

Re: Example of a Pharma-Political complex gone wrong

The authors called the vaccine's overall efficacy against precancerous lesions of the cervix "modest" and theorized that one reason for this limited efficacy might be that other cancer-causing HPV types fill "the biological niche left behind after the elimination of HPV types 16 and 18." HPV has more than 100 different types, roughly 17 of which are thought to cause cancer.
Eliav Barr, who heads Merck's HPV vaccine program, has said this phenomenon, known as replacement, is unlikely based on other analyses the company has conducted.

'unlikely based on other analyses the company has conducted'...
sounds like a pretty astute theory to me, isn't this the way we observe the biological world to function? How'd they construct their study to suggest otherwise I wonder.

[superdave]

Re: Example of a Pharma-Political complex gone wrong

If the vaccination really works and could prevent girls from getting cervical cancer, then I think they should. I know that I would want my daughter to get the vaccination.

[WaveSculptor]

Re: Example of a Pharma-Political complex gone wrong

If the vaccination really works and could prevent girls from getting cervical cancer, then I think they should. I know that I would want my daughter to get the vaccination.

My friend also made the point that if it's going to succeed in eliminating the disease, it has to be mandatory, but again that's going to cost a half billion American dollars a year...much of which no doubt is funneled right back into the political machinery, and to me that represents a hazardous conglomeration of economic and political force. Par for the course maybe, but the vaccine doesn't protect against all strains of HPV, and of over a hundred strains only a few (3.4%) could later lead to cancer... To me that doesn't justify forcing millions of families to shell out over 300 bucks per daughter to a company with strong political influences that don't represent the views or interests of those families.

Unfortunately it's not as if this vaccine would eliminate cervical cancer, as 80% of cases occur in developing nations who are already well familiar with the operating practices of the pharmaceutical industry. I can't help rolling my eyes at the so-called 'Profit vs. Service' dilemma faced by pharmaceutical multinationals, whose profits are among the most lucrative of any industry. There's no uncertainty where any of them stand on that issue.

All things considered, I want the best for all of our children. That includes healthcare, education and safety, but I'm always concerned when I see an aggressive move like this, with a company going over the heads of parents to make healthcare decisions for their kids. I don't want them to be medical test subjects against their will, and it would be a travesty if our government were contaminated enough to facilitate it.

[88Mariner]

Re: Example of a Pharma-Political complex gone wrong

i think they should pump more money into preventing prostate cancer.

[Localizer]

Re: Example of a Pharma-Political complex gone wrong

If the vaccination really works and could prevent girls from getting cervical cancer, then I think they should. I know that I would want my daughter to get the vaccination.

Understandable, but that's not the point. The point is that this has little effect on the general population. Gardasil, according to the NEJM, is only able to protect a tiny fraction of the population. With this said, big pharma has done mass campaigning with celerity to promote this nonpareil wonder vaccine. What use is purchasing this immunization if it can't even protect greater than half of the general population?

Like wave said, I'm sure we all want the best for our needs, but we occasionally have to step back and look at the figures presented before us before we suggest that all young girls should have this vaccination. This is a great promotional method by big pharma to sucker the population into thinking that this is a miracle vaccination. The days of altruists like Jonas Salk are gone. $$$ is what it's all about and they'll do what they can to get every last bit of it from you.