Gardasil studies stopped due to sucess

March 2, 2007

I just found out about this – rest assured I’ll post more about it when details surface:

LONDON, Feb 27 (Reuters) – Clinical trials of Gardasil, the recently launched cervical cancer vaccine marketed by Merck & Co Inc and Sanofi-Aventis SA, are to be halted because of the success of the product.

Sanofi Pasteur MSD, a joint venture of the two companies, said on Tuesday the independent Data and Safety Monitoring Board for two trials had recommended they be terminated on ethical grounds, so that young women on placebo could receive Gardasil.

Gardasil was approved last year as the first vaccine to prevent human papillomavirus (HPV), which causes cervical cancer. GlaxoSmithKline Plc has a rival product called Cervarix in development.

People without scientific or epidemiological training may be confused about this result. For the uninitiated here are some explanations.

People are somewhat familiar with clinical trials, in which the drug is given randomly to one group and a placebo to the other. It is unethical to not give a patient a treatment that we know that works, so in the case of clinical trials we give one group the experimental drug and the other group the established standard treatment – again, it is unethical to not treat patients.

Specifically, these are parallel track phase III studies, one previously completed in females, the other ongoing in older females and in adolescent males, which had not been completed at the time of original licensure.

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HPV: maybe it is women’s fault (Cartoon of the Day)

February 20, 2007

Bad news

(From Nick Anderson, Houston’s Chronicle’s excellent editorial cartoonist)

Ah, so what is it gonna be, conservative idiots? As a future doc, this picture sums up my feelings quite nicely.

Given all the brouhaha over HPV and Texas Governor Rick Perry’s order to implement a mandatory vaccination program for all school-age girls in Texas, I found an interesting nugget that has been largely ignored:

First lady’s influence?

Also, a spokesman indicated that first lady Anita Perry’s strong support for the vaccine may have played a role in the governor’s decision. A former nurse and the daughter of a doctor, Anita Perry works for an organization dealing with sexual assaults.

“I know they have discussed it, and it’s something they both feel very strongly about,” said Press Secretary Robert Black.

But some who oppose the bill have suggested that a political contribution from the vaccine-maker influenced his decision.

So his wife, a former health professional, may have had a bit to do with it. Do I buy that? Sure, why not – but lots of first ladies are involved in humanitarian and educational endeavors as well. If politicians actually listened to their wives a little, things would be a lot better in ALL countries.


Hell Just Froze Over – Mandatory HPV Vaccination in Texas?

February 3, 2007

Did hell just froze over because of Texas?

Yes my friends, apparently hell just froze over:

HOUSTON, Feb. 2 — Texas on Friday became the first state to require all 11- and 12-year-old girls entering the sixth grade to be vaccinated against a sexually transmitted virus that causes cervical cancer.

Averting a potentially divisive debate in the Legislature, Gov. Rick Perry, a Republican, signed an executive order mandating shots of the Merck vaccine Gardasil as protection against the human papillomavirus, or HPV, starting in September 2008.

Mr. Perry’s action, praised by health advocates, caught many by surprise in a largely conservative state where sexual politics is often a battleground.

“I had no idea; I was absolutely caught off guard,” said Representative Jessica Farrar, Democrat of Houston, who sponsored a bill to require the vaccinations starting this September. “Normally, the governor does not take things like this upon himself, although I’m glad he did.”

If you live in Texas and see some snow falling, it is not due to global warming, it is because Gov. Rick Perry – a stalwart conservative republican who is against abortion and stem-cell research – finally recognized that doing the right thing is not such a hard thing to do:

“Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs,” said Mr. Perry, who was re-elected to his second full term last November.

And it is official as well:

It is Republican Gov. Rick Perry who issued an executive order directing the state’s Health Human Services Commission (HHSC) to get ready to administer the HPV vaccine in girls at noted ages before they enter sixth grade.

The order, effective September 2008, also directs HHSC and the Department of State Health Services (DSHS) to “make the vaccine immediately available to eligible young females through the Texas Vaccines for Children program for young women ages 9 to 18, and through Medicaid for women ages 19 to 21,” says the statement of the governor’s office on its website.

See? It wasn’t that hard. Good for you, Gov. Perry. So every parent must vaccinate their school-aged girls with Gardasil, right? Wrong:

Under the order, girls and women from 9 to 21 eligible for public assistance could get free shots immediately. The governor’s office said parents could opt out of the school program “for reasons of conscience, including religious beliefs.”

Ahh, I see. So at least he didn’t completely screw over his conservative friends. I wonder what is the point of having a mandatory vaccination program if parents can opt out because of religious beliefs, but I digress. Time and education will eventually replace misinformation and stereotypes.

But I wonder, did Gov. Perry did this out of the goodness of his conservative heart, or because the scientific evidence finally convinced the guy? If by “scientific evidence” you mean “my former Chief-of-Staff, who is now a lobbyist for Merck, told me this would mean truckloads of money for them and for me”, then yes, he was convinced:

Is Perry’s order politically motivated? No one knows. But, USA Today has reported today that Perry has several ties to Merck, the maker of the HPV vaccine, and Women in Government, a not-for-profit organization comprised of state woman regulators, which some watchdog has claimed is too cozy with Merck.

Media has reported that Women in Government is quite active in promoting the Merck’s vaccine, which analysts say is positioned to make Merck more than billion dollars a year. According to USA Today, Mike Toomey, Perry’s former chief of staff, serves as one of the drug company’s three lobbyists in Texas. Perry’s current chief of staff’s mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a head of Women in Government.

“Perry also received $6,000 from Merck’s political action committee during his re-election campaign,” USA Today says.

Ah, now everything seems to make sense. A conservative politician from Texas is opposed to everything this vaccine stands for, and knows he can lose his conservative base over this, but he can make up those votes from the other side, and make a ton of money for his friends at Merck in the process.

Now let me play Devil’s Advocate for a moment. Is there a conflict of interest here? Very likely. But are Gov. Perry’s actions regarding mandatory HPV vaccination wrong? Well, no. Merck does make the damn vaccine, and a generic will not become available in a long time. This vaccine represents a huge leap forward for women’s health. At around $400 for 3 shots over an 8-month period, it is expensive, and most health plans will NOT cover it. But while preventing cervical cancer is morally and medically correct, it is not exactly sound fiscal policy:

Mr. Perry says it makes sense to use the vaccine to prevent cervical cancer which would otherwise cause a large burden on medical expenditure. But does this mandatory inoculation of the HPV vaccine really save medical costs?

On average, a 5-year treatment for a case of cervical caner would cost $11,000, early studies show. For a 5-year span, about 5800 new cases of the disease are expected to be diagnosed in Texas, which means the medical cost for five years is 63.8 millions or 12.8 million a year.

In Texas, there are about 6.31 millions people now under age 18, meaning the number of girls who are required to receive the HPV vaccine each year is about 0.35 million. The total number of girls to receive the vaccine is 1.76 million, meaning that Merck can rake in 630 million dollars in five years or 126 million dollars in the vaccine sales in Texas alone with Mr. Perry’s order.

The cost for the first year would be double the price tag as girls both at age 11 and 12 will receive the vaccine. The calculation is based on the price of the vaccine at $360 per girl.

It seems that this state mandatory vaccination can save about 700 women’s lives a year in Texas at a cost of 126 million dollars a year spent on the preventive vaccine. These 700 women would otherwise need 7.7 million dollars for treatment of their cervical cancer.

Perry’s order can save some women’s lives, but it does not save money.

I am not saying that vaccinating women with Gardasil is not worth it – it is. It does make sense from a public health point of view, because cervical cancer it is the second most common cancer in women after breast cancer. Gardasil, the HPV vaccine, will definitely be most valuable in the developing world, where most women don’t have access to a yearly PAP smear. But the big fight, the one that will set the precedents for other countries to follow, is taking place in the United States and Texas, of all places, just landed a knockout blow.