What We've Been Reading This Past Week

~ Stem-cell ‘tourists’ travel to where they have access to controversial stem-
cell therapies/ treatments.

~ Every baby born a decade from now will have its genetic code mapped at
birth predicts head of genomics company. Just because we can, does that
mean we should?

~ More docs tell pharma reps to keep out. Does this mean no more free post-
its?

~ Comprehensive reform bill that would have banned pharma gifts to docs voted
down in Colorado.

~ Experts say consumers should have more facts in drug ads so they can make informed decisions.

~ Glaxo to cut prices on drugs sold in poor countries. They will also invest
profits in building clinics in those countries.

~ The U.S. drug industry has shifted most of its clinical trials to overseas
sites raises serious ethical concerns.

~ U.S. court: No link between vaccines and autism.

~ Pfizer owes damages for bilking Wisconsin Medicaid.

~ EU governments have no right to conceal the location of field trials of genetically modified (GM) crops.

~ Men may be their own worst enemy when it comes to their health.

~ Women on the other hand …: Coffee drinking lowers women’s stroke risk. Ooooh, imagine a Starbucks ‘pharmacy’ on every corner …

~ BUT, too much soda can kill a girl’s kidneys.

~ Deadly bacteria defy drugs, alarming doctors. Is this an argument for or against anti-bacterial soap? You decide!

~ Llama’s have unique antibodies that one day might be used to treat immune system diseases in humans.

~ Scientists have unraveled the genetic code of the common cold. Spectacular!

~ Decoy molecules drive cancer cells to suicide.

~Altered virus effectively delivers new gene to replace faulty one that causes CF and completely rids the lung of disease. I wonder if these researchers have seen I Am Legend?

~ Researchers have discovered that the good bacteria found in dairy products might also be an effective vehicle for an oral vaccine that can provide immunity to anthrax exposure.

~ A new study indicates that a pneumonia vaccine can significantly cut the risk of heart disease.

~ Oh, Baby: A prenatal link to Alzheimer's?

~ Doctors have identified two genetic mutations that control the growth and
development of malignant gliomas; maybe good news for brain tumor patients.

~ Cotton candy as a substrate to re-grow vascular tissue.

~ Biotechnology's potential barely exploited.

~ Stimulus package includes funds for comparison of the effectiveness of
medical treatments.

~ President Obama to lift ban on embryonic stem cell research soon.

~ Scientists and doctors try to qualm public fears about vaccines and autism.

~ Scientists preparing to storm Capitol Hill on March 25 (a.k.a. the million
scientist march?). Registration ends Feb. 23.

~ No European stem cell patent for spinal cord repair.

~ Retired nurse invents cough, sneeze cover. Maybe she can convince the
airlines to make these standard issue …

~ FDA approves new and improved treatment for gout (the first in 40 ~years!).

~ But agency second guessing another …Savient gout drug faces approval delay.

~ FDA orders Bayer to correct earlier claims in Yaz birth control ad.

~ FDA deliberately backed off of "Good Laboratory Practice" requirements for
medical device makers.

~FDA wants one strain changed for next flu vaccine.

~ Orphaned baby chimpanzees cared for by humans in a loving, attentive manner have been found to be more cognitively advanced than some human infants. But, then, is this really that weird? They do share over 99% of our DNA.

~ Parody: FDA Approves Depressant Drug For The Annoyingly Cheerful.

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is partially 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.]

U.S. Court of Claims Denies Claim of Vaccine/Autism Link

A specially convened vaccine court, part of the process required to seek compensation under the Vaccine Injury Compensation Program, has ruled against parents saying that the MMR vaccine caused autism in their children. The court specifically said that there was absolutely no compelling scientific proof of the claim, and that the "petitioners' theories of causation were speculative and unpersuasive."

This was one of three test cases going before the court, and the court has yet to rule on the claim that thimerosal alone is the culprit. However, the language the court used in this case is very telling: "The petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction."
-Kelly Hills

The Dignity of a Person

The Catholic Church released their Dignitatis Personae on Friday, which is an update of the 1987 Donum Vitae. Dignitatis Personae is the most up-to-date view of the Catholic Church on assisted reproductive technologies, and it spells out clearly what and why the Vatican approves (or in this case, largely disapproves) of most modern reproductive options.

It's been 21 years since Donum Vitae, and technology has made incredible leaps forward: IVF, intracytoplasmic sperm injection, all kinds of surrogate motherhood, PGD, etc. And most of these leaps are condemned by the Church.

It's my own personal opinion that it's necessary for everyone involved in bioethics to understand the Catholic position, regardless of your personal or professional inclinations. The Church has a powerful lobbying group, especially in states in the northeast of the United States, and this document has the ability to affect many people simply because it does clear up a lot of the grey areas that existed in Catholic doctrine.

Reading the Dignitatis Personae is an exercise in patience and self-control; it's hard to resist the urge to go wake someone up to have someone to discuss such wince-inducing logic as this: This ethical principle, [ed- that life begins at conceptions] which reason is capable of recognizing as true and in conformity with the natural moral law, should be the basis for all legislation in this area. I can tell you with full certainty that such 'reasoning' (a term I use loosely) would fail a philosophy 101 test. But if you can get through the document, you'll learn that the fresh-off-the-newstands update to Catholicism forbids any reproductive act that does not result in fertilization and implantation happening as a result of the sexual act between a married couple. Or put more simply: if the technology assists in intra-uterine conception, YAY! If conception occurs outside the uterus, BOO!

For better or for worse, the Catholic position is at least internally consistent - and for this I certainly give credit where it's due. There's very little cherry-picking of preferences; life begins at conception, all conceived embryos deserve full moral status of a human, etc. But aside from theological and philosophical differences, two things in the Dignitatis Personae stand out to me as worthy of further discussion and debate.

The first is the idea that

"The origin of human life has its authentic context in marriage and in the family, where it is generated through an act which expresses the reciprocal love between a man and a woman. Procreation which is truly responsible vis-à-vis the child to be born “must be the fruit of marriage”.

Put plainly, and as I said above, children must be conceived through sexual intercourse. Their conception at fertilization in the woman's body is when they become ensouled. What then, does this mean, theologically, for the multitudes of people now being born outside of this very narrow definition of procreation? It's not an answer I have, it's not an answer that is clear in the Dignitatis Personae, and it's definitely not an answer that anyone my local Catholic Conference has been able to answer. So it is a lingering question, and one that should be answered.

The second, and much larger issue, is the chapter on "The use of human “biological material” of illicit origin". This chapter discusses the obligation of researchers to refuse to use materials of illicit origin - that is, human cell lines obtained from stem cells, aborted fetuses, etc. Many, if not most, news outlets are reporting this to mean that the Vatican has said that Catholics may not use vaccines which are grown on human cell lines created from the lung tissues of aborted fetuses (the Meruvax rubella vaccine, at the very least).

Reading the chapter, though, instead of relying on news reports, gives a slightly different interpretation. While the document is clearly against researchers using any biological material of so-called illicit (theologically) origin, and suggests that ethical researchers will refuse to use these mediums, it draws a different line for the general public. The document allows that

Grave reasons may be morally proportionate to justify the use of such “biological material. Thus, for example, danger to the health of children could permit parents to use a vaccine which was developed using cell lines of illicit origin, while keeping in mind that everyone has the duty to make known their disagreement and to ask that their healthcare system make other types of vaccines available.

Unfortunately, this again raises more questions than it solves. If there is such a thing as a single grave reason that may be morally proportionate to justify the use of illicit biological material - vaccinating your child from a deadly disease - then why are there not other grave reasons? Isn't this suddenly a large degree of "wiggle room" that will allow individuals an out, who can say that this document is not intended for the lay Catholic but the scientist Catholic, the researcher who spends their life in this and thus needs to consider ethics and morality at a different level than the average person (or at least average Catholic)?

As I said, more questions. But in all fairness, I can't say more questions than answers, since the document clearly gives answers that people have been wondering about for the last 21 years.

Give it a read this morning over your coffee, tea, breakfast, and see what you think the impact of this document will be.
-Kelly Hills

Parents Want Alternatives

by Leane Scoz

Autism is a developmental disorder defined by impairment in social interaction and communication, and the presence of repetitive or unusual behavior and interests. The Center for Disease Control and Prevention (CDC) reports that 1 in 150 children under the age of 8 have an autism spectrum disorder (ASD). With a cure yet to be found, parents of autistic children are seeking alternative treatments over the limited conventional treatments currently available.

Chelation is one alternative therapy gaining rapid popularity among the autistic population. The unproven treatment, which removes heavy metals from the body, is believed to help children with autism by removing levels of mercury from the body. According to a recent CBS News article, the theory behind the treatment stems from the believe that mercury in vaccines triggers autism.

Since this theory has never been scientifically proven and mercury (thimerosal) has been discontinued in childhood vaccines since 2001, scientists believe the proposed government study to test chelation treatment on autistic children is unethical and dangerous. Many parents of autistic children disagree and are even resorting to using chelation without results from a study to prove whether it is beneficial or not. In fact, CBS News reports the proposed study is on hold due to safety concerns after an animal study linked the treatment to lasting brain problems in rats.

The concerns are certainly not without merit since a 5-year-old autistic boy died after undergoing chelation therapy in 2005 and hundreds of lawsuits are currently underway because of the effects of chelation therapy. However, parents of autistic children are not deterred. An estimated 3,000 autistic children in the United States participate in chelation treatment at any given time. Some children are under the care of a physician during treatment and others under the care of their parents since chelation therapy can be done with a variety of over-the-counter dietary supplements.

Parents of autistic children simply want answers. They want their children to live a normal life, free of a developmental disorder. If regulated medicine can not provide them with the answers they are seeking, they have not choice but to resort to alternative treatments, such as chelation. But, at what cost? Is it really worth putting your child's health and well-being in danger in the hopes of possibly finding an answer? It is an ethical question autistic parents will struggle with until a cure for autism is discovered.

Neurodiversity blogger subpoenaed in "vaccine-autism link" lawsuit

Kathleen Seidel, of Neurodiversity Blog, has been subpoenaed by the plaintiffs' lawyer in a lawsuit claiming that vaccines caused autism. It appears that this subpoena may be retributive action from the lawyer for the plaintiffs, whom Seidel criticized a few weeks ago.

She has since filed a motion to quash the subpoena because she is uninvolved in the Sykes v. Bayer case other than as an independent blogger who has discussed issues related to neurobiology and autism.

This action has many potential impacts for the medical and legal arenas, and opens up the possibility of harassment and undue barriers for bloggers if they can be required to produce the amount of paperwork required in a subpoena at the drop of a hat by a bitter lawyer who perpetuates fraud.

More from:

* Pure Pedantry

* Pharyngula

Autism Vaccine Settlement

The parents of nine-year old Hannah Poling, daughter of a Georgia couple, speak out about the government's admission of responsibility for their daughter's vaccine-linked autism, and have agreed to pay an as yet undisclosed settlement amount to compensate the Poling's for their family's pain and suffering as a result. The CDC is calling the case an anomaly, not an outcome to be experienced by the majority of children receiving vaccines. What should be a reasonable settlement for these types of cases? What are the ethical issues facing parents fearing an autism-link to vaccines in the decision to vaccinate or not?

See the entire CNN article here.

Politics, science, and autism: part 547

Despite substantial evidence to the contrary, some people believe that vaccines (specifically, trace amounts of mercury in vaccines) cause autism. Apparently John McCain is one of those people. He was quoted this week as saying that the incidence of autism is rising (true, according to the CDC's most recent report), and that "there’s strong evidence that indicates that it’s got to do with a preservative in vaccines."

It just ain't so. That's according to--at least--the Institute of Medicine (report here); researchers at the California Department of Public Health (abstract); and the Centers for Disease Control (ongoing research). And a study reported last month in Pediatrics concluded that babies excrete thimerosal (the mercury-containing preservative in vaccines) more quickly than previously thought.

The NYT suggests that the Senator's claim is designed to garner support from the numerous parents' groups that believe in the thimerosal-autism connection. To further confuse the issue, the Department of Health and Human Services recently agreed to settle a case that alleges that administration of standard childhood immunizations caused illness in a child with a pre-existing mitochondrial abnormality. You can learn more in this New Scientist article.

This isn't to pick on Senator McCain--we're nonpartisan on the blog--but it did make me think about how and why politicians choose sides on controversial issues in science. In that sense, the autism controversy isn't much different from climate change or evolution. If the meta-issue here (politics and science) is of interest to you, check out Sciencedebate 2008--a call for the presidential candidates to share their views on the environment, health and medicine, and science and technology policy.

Fiction or...?

As I'm sure most of the regular blog readers have realized, I'm a fan of pop culture. I'm endlessly fascinated with the media and how it spreads knowledge - or misinformation.

The new ABC show Eli Stone, which I have quite been looking forward to - the premiere has George Michael as prophet singing Faith - is by the same producer who's given us Brothers & Sisters and Dirty Sexy Money. So I was thinking "how in the world could this go wrong, it'll be fabulous!"

Well, apparently the world likes to make a point sometimes. The American Academy of Pediatrics wants the first show either pulled or substantially re-edited, because the opening scene involves a woman suing a pharmaceutical company over the supposed autism/vaccine link, saying that it's the reason her child is autistic. The link we know doesn't exist. Where the lead researcher involved was charged with misconduct in an effort to put the link/controversy to rest. The lawyers settle, after the woman makes your typical heartwarming by a wronged mother speech.

Given the description, you would think that the pharma companies would be going after ABC, but instead it's the pediatricians. They're worried that the heavy promotion ABC has been giving Eli Stone (a new show in a sea of repeats due to the writer's strike), and the likelihood of high viewership, will result in frightening more parents away from vaccinating.

The sad thing is, it's clear from the entire set-up that the scenario is supposed to make us dislike Eli, the main character, so that at his redemption we feel something for him. But it would have been completely possible to make him an utter bastard of a lawyer - and not propagate medical misinformation in the process.

ABC's response, to run a website for the CDC at the end of the show, isn't going to alleviate fears - it's not even going to address them. It's the difference between using scare tactics to get a message across versus a mass mailed flyer. And ultimately, they're counting on popular misconception and fear to tell their story for them, which is plain lazy writing.

But don't take my word for it, make your own decision. You can see for yourself. The first seven minutes of the show are available at ABC. Just select Eli Stone from the left side menu, and then select the sneak peak episode.
-Kelly

Should Children be Vaccinated against Addiction?

blog.bioethics.net points to an article in Time on the new "cocaine vaccine" and asks whether it should be given preemptively to children.

Basically, the "cocaine vaccine" works by stimulating the body to produce antibodies that bind to cocaine molecules, preventing them from binding to the receptors in the brain that, when activated, produce the "high" from the drug. As a result, the "high" is negated or greatly reduced, which removes the incentive to continue to use the drug.

While I see the potential for this treatment to help addicts overcome cocaine addiction, the talk of giving this preemptively to children worries me. Beyond the issues of informed consent mentioned, I have concerns about using any treatments that could affect brain receptors in children unless it is medically indicated. Psychoactive drugs affect us because our brains have receptors that respond to particular drug molecules; these receptors probably have some other function in normal life. Stimulating the body to produce antibodies that bind to drug molecules to inhibit them from binding to our receptors could have adverse impacts on the natural auto-stimulation and regulation from our bodies. In children whose brains are still developing (and will go into overdrive during puberty), we cannot safely anticipate what the long-term effects on neurotransmitters and brain activity could be.

Because the vaccine has been show to be effective on adults, and because there is usually sufficient time to respond to cocaine addiction, I do not feel that vaccinating children in this case is justified.

And because I still am bitter about the controversy over the HPV vaccine: aren't moralists worried that giving the cocaine vaccine to children will tell them it's okay to start doing drugs?

YouTube, Public Health, and anti-vaccination campaigners

At it's best YouTube, is a wonderful resource for amusement, education, disseminating information. At its worst, it is like a virus, providing information that is downright false, misleading and just plain bad -- makes me wish there was some form of trash collection on the web. The latest example of the latter are "documentary-type videos capturing the views of parents of autistic children who blame particular vaccines or thimerosal, a mercury-based preservative formerly used in vaccine manufacture, for the autism."

That's one way to undermine evidence-based medicine.

An article written by Helen Branswell, a medical reporter for The Canadian Press, chides public health researchers for not being tech-savvy enough and suggests that they need to get up to speed and try some new strategies, like YouTube for getting their message.

Sounds like a fun grant project to me -- anybody game?

A disparity of priorities

Bioethics Blog brings up the possibility of a future "obesity vaccine."

I can't help but feel a burning cynicism as I predict the warm acceptance of such a technology: how generous funding from McDonald's will spur its rapid development, how subsidies by the government in light of this "urgent health crisis" will make the vaccine affordable to every low-income child whose parents lack the money to eat anything but fast food, how "vaccine-mobiles" will trek across cities to share the largesse of freedom from flab. "A Modern Miracle!" reads the headlines as nutritionists are shunted back off to the far reaches of food science, their cautions and advice now out of vogue as people celebrate their newfound immunity to prudence.

Meanwhile, a single mother will scrape together her meager finances to give her daughter a chance at a life free of cervical cancer, but $360 is a long way to go, and her pastor says it will promote a sinful life.

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.