Draft Stem Cell Guidelines Threaten Research

Death Metal suggests we peruse a piece up at Wired on how the Obama administration's draft guidelines for stem cell research could invalidate hundreds of cell lines. "Under the Obama administration's proposed rules for funding embryonic stem cell research, hundreds of existing cell lines could be ineligible, even those that qualified under President Bush. The guidelines were written by the National Institutes of Health and are currently in draft form and expected to be finalized in July. But in their current state, they restrict funding to stem cell lines produced according to new rules that are only now being established. Few existing cell lines will meet those requirements. 'The so-called Presidential lines aren't suitable for actual medical application,' said Patrick Taylor, deputy counsel at Children's Hospital Boston, who criticized the NIH guidelines in a paper published Thursday in Cell Stem Cell. 'But we're talking about many, many more lines. The new lines were created with extensive ethical oversight. They're at stake here.'"

Comments

And...

[Spazztastic]

And this is why I was so cynical about the election. It's the same old business as usual.

Re:And...

[Shakrai]

It's the same old business as usual.

That's not true. The people in charge now are less interested in telling us who we can sleep with and more interested in telling us what kinds of foods we can eat. Yeah, the Government is still trying to micromanage our lives like an obsessed baby sitter, but hey, it's still change you can believe in ;)

Re:And...

[Chris Burke]

Well of course no matter who you elected it was by and large going to be business as usual (yes, Ron Paulians, even if that long shot had occured).

But what I'm not seeing is how this is actually the same. I RTFA (gasp) and it seems the issue is that the new rules include informed consent requirements for egg donors that the old lines, despite being collected under informed consent standards of their own, don't meet the letter of the new rules, which are applied retroactively. The new rules were drafted by the NIH, who said that they estimated the new rules would make 700 old lines available for research that weren't before. A number of researchers are saying that they don't think that's the case and many of the old lines would not meet the new standard despite being collected ethically.

So which seems more likely:
- NIH really intended to make all those old lines available, but botched the legalese, which can be fixed by loosening the retroactive requirements while keeping the new requirements for new lines or various other changes.
- NIH was lying and is trying to quash stem cell research "just like Bush, business as usual" by disqualifying these old lines, while simultaneously allowing arbitrarily many new lines to be created using standards that are qualitatively if not technically nearly identical to the old ones.

The second just doesn't make much sense to me. Why bother lying when the practical effect would be obvious and nobody can really do anything about it anyway, why even display the draft rules rather than just put them into effect, why allow new stem cell collection under standards nearly identical to the old if the goal is to quash it entirely? Why's Obama trying to quash stem cell research anyway? Pressure from the religious right? I don't get it.

Re:And...

[Shakrai]

I know this will hard for you US'ians to accept but it's a proper role for Government to regulate what you can eat when your obesity rates are driving up the cost of medicine.

Bzzt, no, it's not a "proper role" for Government to protect me from myself. If my insurance carrier wants to penalize me for a being a fatass then all the power to them. It's none of Washington's business.

This was pretty much already the case

[Gat0r30y]

The so-called Presidential lines aren't suitable for actual medical application

They were, and still are, suitable for research. Many of these lines have been contaminated in ways which pretty much already precluded any actual medical application.

its called

[nimbius]

a draft...meaning its up for review and revision...

there can also be, get this, several of them created until they get it right.

Re:its called

[flitty]

The base of the problem:

The NIH requires consent forms that clearly mention human embryonic stem cell research, forbid donating eggs for the benefit of a specific person, and contain various other stipulations that were generally mentioned during older consent processes, but not rigorously codified. These rules could have a massive impact on existing and proposed research.

So, the previous consent forms conflict with the new consent forms, rendering most cell lines unusable. Sounds like the DRAFT needs to add a grandfather clause. This isn't that big of a deal other than it's sloppy standards writing. Good on Wired for bringing it up so that it can be fixed.

At Least These Concerns Were Based On Ethics

[darkmeridian]

At issue here are the NIH's proposed guidelines regarding a woman's consent to stem cell research when her donated eggs and embryos are used to create a cell line. The NIH wants to stiffen them to make sure that a woman has to specifically agree to let her eggs be used for stem cell research. I can understand that because I sure as hell wouldn't want cell lines made from my genetic material without my consent.

The problem is that these standards, if applied retroactively, would invalidate many of the currently-available stem cell lines. Scientists are more than happy to apply these new standards going forward, but obviously want current stem cell lines to be grandfathered in. I hope that the NIH clarifies the guidelines to allow already-existing stem cell lines to be used. After all, these are the draft standards, not the final ones.

I am happy that the NIH concerns do not seem to be motivated by a political agenda. Informed consent is the keystone of all medical treatment and medical research. This is a welcome change compared to the Bush Administration, which made scientific decisions based on religious and political grounds. Snow flake babies? Really? Come on.

Re:At Least These Concerns Were Based On Ethics

[Chris Burke]

For the same reason I think the genetic material in the condom I threw away is "mine", and would be upset if someone used it to procreate without my consent!

Go ahead and make a property rights argument about how I don't legally get to say what is done with my stuff that lands in the landfill. Who cares. This is about ethics, and I for one am glad that the medical research profession takes ethics into consideration.