The Week in Review

1. Sex bias in control of cancer pain. Women get less meds, more pain. Sounds like a Raw Deal.

2. AAAS comments on human subject protection training.

3. Gardasil requirement for immigrants stirs backlash.

4. Paxil suit settled by Glaxo for $40M.

5. Inspire Pharmaceuticals reaches deal with SEC in investigation related to clinical trial of experimental dry-eye treatment.

6. Chinese parents file tainted milk lawsuit.

7. Personalized medicine: new predictive tool can help determine treatment for breast cancer patients (identifies those most at risk of relapse, potentially avoiding chemo).

8. Doctors urge the FDA to ban OTC cough and cold medicines for children until they are found safe and effective. Not safe and effective? Perhaps we should resort to that cherry-flavored placebo elixir reported on in these very pages a few weeks back, eh?

9. Impact of expanded newborn screening in the US.

10. "Friendly" bacteria protect against Type 1 diabetes. Ah, friendly, protective bacteria. Such a nice change from those drug-resistant ne'er-do-wells.

11. Secrets revealed! Penicillin bug genome unraveled.

12. Scientists find gene pathway that triggers the spread of melanoma.

13. Researchers find yet another new source of multipotent stem cells—in the walls of blood vessels.

14. How best to schedule downtime for ERMs (Electronic Medical Record Systems) . *Is* there any good time for the records to be unavailable?

15. No more excuses! Health clubs gear programs for those with ailments.

16. Faster genetic test for flu virus approved in the US.

17. Genentech warns about PML (progressive multifocal leukoencephalopathy—a rare brain infection) death in a patient taking Raptiva for psoriasis.

18. European drug makers urge regulators to impose price controls. I know, this sounds counterintuitive, but you'll see, it's not (seriously).

19. NIH announces funding for new epigenomics initiative.

20. FDA grants 510(k) clearance to I-Flow for topical wound dressing that controls oxygen and moisture. I'd like to see this thing. How does it manage all that? I'm thinking of robo-bandage here.

AND in the category of "Weird News":

21. Tainted candy from China found in US: White Rabbit Creamy Candy. Yes, that's the actual name of the candy. Is it me, or does it sound oddly sinister? Or perhaps I read "Alice in Wonderland" one too many times as a kid. Darn, now I have Jefferson Airplane's song "Go Ask Alice" stuck in my head.

22. If bioterrorists strike, letter carriers might deliver antibiotics. Neither rain, nor snow, nor anthrax spore . . . Wait a minute, weren't these the guys who were targeted with the anthrax in the first place?

23. Experts call for warning labels on energy drinks. Apparently, these things are so chock full o' caffeine that they deliver quite a blast, and people aren't really aware of just how much caffeine they're loading up with. Gives me the shakes just thinking about it.

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

More evidence for a mandate?: FDA approves Gardasil For Prevention Of Vulvar, Vaginal Cancers

We and other blogger friends have blogged about Gardasil before here and there -- and in a quick and dirty drive-by post, we thought we'd update you on the latest developments:

The AP press reports that federal health officials approved expanding the use of Gardasil, the cervical cancer vaccine, to prevent cancers of the vagina and vulva:

"The Food and Drug Administration first approved Gardasil in 2006 for the prevention of cervical cancer in girls and women ages 9 to 26. The vaccine works by protecting against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers. The HPV virus, transmitted by sexual contact, causes genital warts that sometimes develop into cancer.

'There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same virus for which it also helps protect against cervical cancer' said Dr. Jesse Goodman, director of the FDA center that oversees vaccines."

Full Story can be accessed here.

Adding to our collection of posts about Gardasil and the HPV vaccine is the news that HPV is one of two viral links to lung cancer. Two new studies suggest that viruses - specifically, HPV and measles - can significantly boost a smoker's already serious risk of developing non-small cell lung cancer. Almost 90% of the over 200,000 cases of lung cancer that will be diagnosed in the United States this year are typed non-small cell lung cancer, and it tends to be a highly malignant version of cancer to end up with.

Both findings were presented Friday by separate research teams attending the European Lung Cancer Conference in Geneva.

"In terms of HPV, our finding is pretty controversial," said study author Dr. Arash Rezazadeh, a fellow of medical oncology and hematology at the University of Louisville in Kentucky. "And this is just the beginning of the road. There is much more work to be done. But it's important to know that being infected with this virus does appear to increase lung cancer risk."

As for the role of measles, the second study's lead author, Dr. Samuel Ariad, from the department of oncology at Soroka Medical Center in Beer Sheva, Israel, said that infection -- perhaps even asymptomatic infection -- seems to be associated with half of the lung cancer cases he tracked.

So,... can we mandate HPV vaccinations for all, now?

(Yes, I admit it would be good to see more studies done on this, in larger numbers, and with smokers as well as ill non-smokers. But I watched someone die from non-small cell lung cancer last year, and it's not something I'd wish on anyone - if we can stop even a small handful of those cases, along with all the other types of cancer HPV has been indicated in causing, isn't it worth the unlikely chance that the vaccine itself would encourage promiscuity?)
-Kelly Hills

Embracing the HPV Vaccine -- Warts and All?

We've posted before here and here about the HPV vaccine and debated whether or not it should be 'mandated' for girls; today in the NY Times an article in the Fashion and Style section (??) asks whether or not the parents would encourage their boys to get the vaccine. Currently, Gardasil is only FDA approved for girls and is marketed as preventing cervical cancer; but boys could benefit too, because the vaccine also protects against genital warts. Currently the vaccine is already approved for boys in Australia, Mexico and countries in the European Union; Merck will seek FDA approval for boys later this year. The question is, will the parents of young boys and girls in the USA buy it? Full article accessible here.

Gardasil, Assumptions, and Men

I was speaking with someone this morning about the Gardasil vaccine, and she made a very interesting point. Everything around the vaccine is very heteronormative. There's an assumption that everyone is going to be straight! So vaccinate the women, protect them.

But what about the gay men? Anal cancer is caused by the same strains of HPV that cause cervical cancer, yet we don't see people flocking out to advocate vaccinating boys. Because there is an inherent undercurrent that the boys don't need it, they don't develop HPV-related cancers, only [straight] girls get that.

If we are going to act on the presumption that children will become sexually active when they're older, regardless of the morals their parents try to institute, shouldn't we also avoid the presumption of heterosexuality and vaccinate both genders equally, to confer to both protection?

While the vaccine is currently limited by the FDA to women, why are we not discussing the broader implications and potentials of vaccinating everyone?

Washington State to Offer Free Gardasil Jab

Washington state Gov. Christine Gregoire's budget includes buying bulk quantities of Gardasil and offering it for free. Doctors will still be able to charge for the jab as a service performed, but they won't be able to charge for the vaccination (fluid) itself.

Gregoire thought that it was premature to make the vaccination mandatory, which doesn't rule out that she will make it so in the future. The cost to the state is a bit unknown, since its being lumped under the reported budget for the next two years along with a rotavirus vaccine; the two together will cost about $26 million for 2.5 years.

Texas Governor Orders STD Vaccine For All Girls

From MSNBC:

Bypassing the Legislature altogether, Republican Gov. Rick Perry issued an order Friday making Texas the first state to require that schoolgirls get vaccinated against the sexually transmitted virus that causes cervical cancer.

Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21.

Beginning in September 2008, girls entering the sixth grade — meaning, generally, girls ages 11 and 12 — will have to receive Gardasil, Merck & Co.’s new vaccine against strains of the human papillomavirus, or HPV.

And for those of you wondering how Gov. Perry has the authority to issue such an order:

By employing an executive order, Perry sidestepped opposition in the Legislature from conservatives and parents’ rights groups...

The order is effective until Perry or a successor changes it, and the Legislature has no authority to repeal it, said Perry spokeswoman Krista Moody. Moody said the Texas Constitution permits the governor, as head of the executive branch, to order other members of the executive branch to adopt rules like this one.

It'll be interesting to see how this plays out in the media, with the public, and I'm sure, eventually a courtroom. Bravo to Gov. Perry for taking the lead on this issue.

See previous WBP posts here.

Virginia considers requiring girls to get HPV vaccine

A bill has been introduced in Virginia that would require girls to receive their first vaccination against HPV prior to their entry into middle school, or have parents apply for an exemption after reading the literature on and being educated about the vaccine. The bill would add HPV to the list of immunizations needed for school attendance, and make the state one of the first to require the vaccine.

On the face of this, it sounds good - but digging a bit further in to it, a few questions are raised. While I initially wanted to cheer to see that a Republican was sponsoring the bill, it turned to dismay and, well, suspicion as I read the following:

Hamilton said pharmaceutical company representatives approached him about submitting the bill, probably because he chairs the House Committee on Health, Welfare and Institutions. Drug companies have been among the largest contributors to Hamilton's election campaigns.

So the companies that have financed most of his campaigns now want him to make a vaccine, which is not covered by all insurance companies (and runs around $350), mandatory for all girls?

Hmm. Strikes me as a bit ethically questionable.

Of course, one thing that many people are saying is ethically questionable is vaccinating girls against a sexually transmitted disease, something that doesn't raise any questions for me. Why? Here are a couple of reasons:

• 1) At the age people are talking about (9-13), most kids aren't being given specific and detailed information about what the shots they're receiving do - it's just part of the evils of going to the doctor. It's not like anyone is sitting down saying "alright, now you won't get measles, mumps, or cervical cancer so you can be sexually promiscuous now!"


• 2) Hepatitis B is a required immunization, and is sexually transmitted (among other ways)


• 3) We're talking something that kills. There are 10,000 new cervical cancer cases diagnosed every year, and something like 3500 women die every year. Given that we know most people do not abstain from sex until marriage (and we know this has been true for a long time), safety really seems like it should trump anything else. Or put another way: do you want to be the parent whose daughter tells you she has cervical cancer, knowing you could have prevented it through three simple shots?

I know parents hope that their children will adhere to their morals, and I support teaching your children your values and beliefs. But I also think there's the necessity to be realistic; if you can prevent disease via a combination of teaching morals and actual protection, why would you choose otherwise?

I remain skeptical of Hamilton's motivations for proposing this bill, but I suppose that sometimes, the ends do justify the means.