From Cyberlaw

Contents 1 May 4, 2006 2 May 1, 2006 3 April 25, 2006 4 April 24, 2006 4.1 Today's Articles 4.2 Bioethicist Oral Argument 5 April 23, 2006 6 April 18, 2006 7 April 17, 2006 8 April 13, 2006 9 April 12, 2006 10 April 3, 2006 10.1 Sex-Selective Abortions 10.2 General Post-Class Thought 11 March 30, 2006 12 March 21, 2006 13 March 20, 2006 13.1 Post-class thought 13.2 Articles 14 March 19, 2006 15 March 17, 2006 16 March 16, 2006 17 March 14, 2006 18 March 13, 2006 19 March 12, 2006 20 March 7, 2006 21 Feb. 28, 2006 22 Feb. 27, 2006 23 Feb. 22, 2006 24 Feb. 21, 2006 25 Feb. 20, 2006

May 4, 2006

Catching up on articles...

From Tuesday's NYT: Vatican rethinking condom ban for married couples when one person has AIDS. Related Kristof op-ed about Plan B and the abortion rate.

From Wednesday's NYT: Supreme Court Memo on the Roberts court as it nears the end of its first year. Horrifying story on an execution in Ohio, when the inmate raised his head during the procedure to say, "It's not working."

From today's NYT: Doctors are angry that drug companies can get data on their prescribing habits.

Will now post class notes! Belee 09:18, 4 May 2006 (EDT)

May 1, 2006

Krugman op-ed today on health insurance made me think back to our HMO day. Belee 17:12, 1 May 2006 (EDT)

April 25, 2006

Following up on yday's post on the FDA, a Tierney Op-Ed ran today titled Potheads and Sudafed.

Really cool ScienceTimes article on how chromatin may determine cell fate w/ little tags on those spools winding the DNA here. Belee 10:16, 25 April 2006 (EDT)

April 24, 2006

Today's Articles

Front of National section in today's NYT: article on politicization of stem cells. Also shows confluence of religion and the right.

Also, article on FDA drug approval.

On a more lighthearted note, Snuppy's 1! Sidenote: according to my dad, Dr. Hwang gave Snuppy his name (as opposed to Snoopy) bc of his tie to Seoul National University (SNU), which is where my dad went, too. Belee 14:08, 24 April 2006 (EDT)

Bioethicist Oral Argument

My notes for today, which I had to turn over :) (note: parts of this verbatim from bioethicists' brief)

Ethics do not stand alone

Difference between personal morals and political/institutional policy

Brief on behalf of 55 leading bioethicists, involved bc of effect on health care and bioethical practices/teachings in hospitals and schools; also Autonomy, Inc., a disability rights advocacy org

Four central values in medicine that come from ethical, religious, and legal traditions:

• Beneficence: proper goal of medicine is to promote patient’s well-being

• Integrity of health care professionals: right to remain true to own conscientious moral and religious beliefs

• Justice: equitable basis for health care, with ethical limits on liberty to demand, rather than forgo, scarce medical resources

• Personal autonomy: patient’s right to determine his or her own medical care

o If a patient lacks decision making capacity, an appropriate surrogate should make decisions on patient’s behalf

o Present case involves surrogate decision making in case when there is no advance directive but the patient has otherwise made known her prefs and values – i.e. substituted judgment

Personal autonomy is at intersection of bioethics and the law

• Right to make choices pertaining to one’s health, including right to refuse treatment

o Florida Constitution

o DPC of 14th A

• When patient is incompetent, decision must be made by surrogate or proxy

Florida law has set out order of pref for proxies:

• Previously appointed guardian for person w/ developmental disability

• Spouse

• Adult child

• Parent

• Adult sibling

• Adult relative

• Close friend

• Licensed clinical social worker

Proxy must be able to make health care decision he reasonably believes the patient would have made for herself under the circumstances

• Under Florida law, proxy may present a health care decision to a court for judicial resolution – MS did this for TS

o Stranger surrogate held to same standard as family or friend surrogates

• Unfortunate that court must be surrogate but totally inappropriate for governor to make such a decision by executive fiat – Terri’s Law is unconstitutional

o No legal framework for determining wishes of patient

o No pretence of even attempting to determine wishes, since Gov. Bush ordered reinsertion of tube w/in hours of getting his purported authority to do so

o Focus is on politics and public opinion, not TS

o Trumps the bioethical and legal hierarchy of preferred proxies

o No requirement in bill that Governor Bush make health care decision that he reasonably believes TS would have made, no standards for determining her wishes

o Constitutional separation of powers puts case-specific decision-making in hands of judges, who are guided by rules of evidence and procedure

This case is narrow: only ab proxy exercise of right to personal autonomy

• Does not implicate “futile care theory” bc case is ab TS’s choice, not her physician’s

• Not ab rights of elderly or disabled – not ab deprivation of wanted treatment but implementing fundamental right to decline life-prolonging measures they would abhor

• Not ab protection of patients from self-interested surrogates: proxy decision-maker is the trial court, not MS

• Not ab Catholic church’s policies: Pope’s speech ab ppl in PVS having right to basic health care did not change Catholic Health Association of U.S. policies ab PVS patient, including allowing w/drawal of feeding tubes

The Supreme Court (O’Connor’s concurring op in Cruzan) has said that the liberty guaranteed by the DPC must protect an individual’s deeply personal decision to reject medical treatment, including artificial delivery of food and water. The same is true of Florida’s constitution. The courts have determined TS’s personal decision on clear and convincing evidence, and the Governor’s attempt to trump that decision infringes her constitutional rights and should be overturned. Belee 22:24, 24 April 2006 (EDT)

April 23, 2006

Does anyone know when the final paper is due? Belee 14:39, 23 April 2006 (EDT)

April 18, 2006

Related back to our first class ab drs being present in interrogations, NYT article today on a federal judge in NC who decided that drs don't have to be present during executions so long as a machine monitoring the prisoners' brain waves is used to make sure they are unconscious and unable to feel pain. Now who thinks that the ppl administering the lethal injections are going to know how to work these machines? Or care?

Front of the business section had an article on the creation of a "service science" curriculum. V interesting to me, in part bc of the nationalistic undercurrent running through the article ab how Americans are losing good jobs to India and China.

Also, ScienceTimes article on women and heart disease. My favorite paragraph:

Puzzling differences have emerged between men and women with heart disease, making it plain that past studies, mostly done on men, do not always apply to women. Researchers have come to realize that to improve diagnosis and treatment for women, they must sort out the differences.

Sex bias in research should be shocking, but it's really not -- I've had conversations w/ friends ab how common it is. Belee 20:03, 18 April 2006 (EDT)

April 17, 2006

just posted the class notes. also wanted to make note here that i thought the class today was really interesting bc i don't often get exposed to the hmo side of the argument when discussing health care w/ fam and friends. the class notes include some of my personal thoughts -- i'd be interested to see if ppl add to the notes their own bc i think a lot of us have v strong opinions ab the current hmo system. any wiki love out there? Belee 00:59, 18 April 2006 (EDT)

April 13, 2006

See Julie's journal for an extremely interesting NYT article on diagnostic testing.

Internationally, an appeals court in London said that a health service must pay for a woman's breast cancer drugs when the woman could not afford to pay for it. I also just saw this article from last Saturday ab disastrous clinical trials that were held in Britain. Belee 22:35, 13 April 2006 (EDT)

April 12, 2006

Article in the NYT today about DNA testing to determine ancestry. Ppl are using these tests to get %s that they then use in college admissions, financial aid, and employment papers among other things. Concerning affirmative action, I find this a little odd -- AA, which I strongly support, is in place to help those disadvantaged by historical discrimination and to ensure diversity at all levels of society in the future. If you need a test to tell you that, for example, you're 2% Asian, how can you say with a straight face that you should get the benefit of AA? One college applicant in the article marked Asian after such a test result came back for her older sister -- and these tests have margins of error!

Here's the link to the testing company, DNAPrint. Belee 18:15, 12 April 2006 (EDT)

April 3, 2006

Sex-Selective Abortions

I'll post class notes in a bit, but I just have to say this first:

I am shocked that the majority of the class appeared to be fine w/ sex selective abortions. I know I'm probably just repeating what Prof. Sandel said today, but sex selective abortions stem from the belief that women are inferior to men. I know that other cultures have different beliefs, and I do not think that there should be a push for a uniform culture across the globe. I'm the child of immigrants; I think different cultures are a huge strength to the world, including when they clash, not just when they align. But I do think that this practice, this belief that girl babies are preferable to boy babies is just wrong. I don't have a justification for my belief. I know that and acknowledge it -- for who gives anyone the right to determine that their value system is the "right one"? I also know that some parents probably abort girls because they think that it's better for the child. But that's just feeding into a system of discrimination that I find morally repugnant. It's hard for me to say anything more definitely, and my thoughts are complicated by the fact that I'm ardently pro-choice. And finally, it was hard not to think ab my Gender Violence seminar today and how systems in place perpetuate male domination over women.

• Brenda- I share in your shock that so many people are fine with sex selective abortions, since, to me, they are also a morally repugnant practice. However, even being pro-choice, I fear that this is one arena where what we might feel morally and ethically cannot translate practically into what the law should be. If we are going to let women decide ultimately whether or not to have abortions, how could we possibly qualify the validity of the choices they make? I fear that if we disallowed sex-selective abortions by law, women in countries that favor boys over girls would either resort to infanticide (whether or not it is illegal) or would abort their children claiming some other "legitimate" reason of their choice. Perhaps many people in class recognized this practical impossibility, this distinction between morality and enforceable, executable law, in their approval of sex-selective abortions. Julie Baher 09:51, 4 April 2006 (EDT)

• Hi Julie, and thanks for the post. I agree that in terms of practicality, a law against sex selective abortions (which I do think exists in India) would be ignored by a lot of ppl. I think that having a law in place, however, is important at least for symbolic effect; otherwise, a cultural presumption that boys are better than girls will be perpetuated. I'm actually a little surprised at myself for believing this, in part bc so much of my frustration w/ the left (as a lefty) is that it fails to address practical considerations a lot of the time. But w/o a specific denunciation of the practice of sex selective abortions by a supposedly higher authority, how is anything going to change? Belee 02:32, 5 April 2006 (EDT)

• As one of the people in class that spoke out to defend the legality of sex-based abortion I thought it might be helpful to say a few words about why…

First, I think Julie did a good job pointing out a number of the practical difficulties that underlie the criminalization of sex-based abortions, particularly the difficulty in bringing into concordance with a generally pro-choice view of abortion.

But there's a larger element to this problem: that of gender inequality. While I understand that sex-based abortions are symptomatic of an underlying problem - the stigmatization and diminished importance of females in certain segments of Indian culture and society - I don't think that criminalizing the practice sends the correct message.

What is the message actually conveyed by India's sex-based abortion prohibition, a law which is clearly not respected by many and is largely unenforceable? Rather than acknowledging that gender inequality is a cultural and societal problem that needs to be seriously and immediately addressed, the abortion law pays lip service to gender equality without any real hope of affecting it. As Albert Einstein said, albeit in a different context (the 18th amendment), "nothing is more destructive of respect for the government and the law of the land than passing laws which cannot be enforced."

Instead of half-heartedly pursuing gender equality by trampling on reproductive freedoms, a process that is almost certain to disadvantage women more so than men, I think, perhaps, a different solution is in order. I’m not familiar enough with Indian society and gender relations to speak specifically on this point, and I know that weakens my argument to a degree, but I think that there are other ways to address gender inequality and skewed sex ratios.

Perhaps I’m being naïve, or idealistic, but it strikes me that we should be able to have gender equality and reproductive freedom, without having to sacrifice one for the other. At the very least, I’d hope we could do more to explore that possibility before resorting to criminalization… DVorhaus 16:59, 8 April 2006 (EDT)

• I agree, that's the goal -- gender equality + reproductive freedom (although we may differ on how to define "reproductive freedom"). I'm curious, what do you think is a possible "different solution" if it does not include clear condemnation of sex selective abortions?

Sidenote: This discussion has helped me solidify what I want to write my 3L paper on, so I am grateful for these debates we're having. I've been inspired, which has been infrequent for me in law school. I've also noticed a whole glut of media coverage on reproductive technology this semester while looking for things to post to this wiki and find it fascinating. And so, I plan on looking at reproductive technology and the bioethics surrounding it next year. I'm hoping to incorporate scientific opinions (researchers, doctors, profs, etc.) with feminism and the media. More to come... Belee 14:47, 10 April 2006 (EDT)

General Post-Class Thought

Even though I'm upset ab class today, I think that it was by far my favorite one this semester. I had Sandel in college for Justice, which was a huge class that filled Sanders theater. He would lecture for a bit then take his mic and run into the audience to take comments. V Geraldo style. As interesting as that class was (he actually got me to read Kant), he was even better today in a small group setting. So I'd like to say thanks to him and the rest of the class for a v involving discussion. Belee 21:03, 3 April 2006 (EDT)

March 30, 2006

Back from Mexicooooo! Awesome break. Hope all had as good a time on theirs :)

Siiiigh trying to get down to business...have been thinking ab paper topics for a good while now, and after reading a bunch of articles, talking to friends, my bro, and a faculty member or two, and staring into space, I think I've got one that I find interesting. Deals w/ how the cts can fill the gap where religion and science divide, i.e. where advances in biotech and their implications supposedly clash w/ religious beliefs. I'm thinking ab Schiavo/end of life decisions, ID/teaching, and abortion and wrongful births/beginning of life decisions. Somehow condensed into 20 thrilling pages...any thoughts welcome. Otherwise, let's see how it goes... Belee 23:46, 30 March 2006 (EST)

March 21, 2006

See frontpage of biotech wiki for latest NYT article on Guidant. Also, ScienceTimes article on genetic diseases that Bedouins suffer from bc of intermarrying. The researchers hone in on mutant genes and then tell the families if they are carriers as well as working towards drug therapies. Belee 22:24, 21 March 2006 (EST)

March 20, 2006

Post-class thought

Did it bother anyone else today that Brown came up w/ different answers to the same question when he switched hats? I know that ppl are motivated by different things, esp when working for a company and thus looking out for the company's best interests rather than, oh, I dunno, the greater good, but isn't there some sort of impulse to do what's right? Or if said impulse doesn't exist, shouldn't we be doing something to bring it into being? Esp when you have enormous resources at your disposal and huge ramifications for things like public health? It just seemed strange to me that when Brown put on the "meta-physical patent hat," he refered to what the "right thing" to do would be -- and that was different from what he would tell Millenium to do. Who or what is the check on this?

It's like what I was attempting to say below ab the polio article in today's NYT. The "hurt" I said I feel knowing that polio still exists in poor countries when developed nations have managed to eradicate it completely stems from feeling like there's a gap there -- a moral gap -- that should never have been allowed to open up in the first place. Polio shouldn't still exist. Someone -- and granted, I'm dodging an issue by not saying who that someone is -- should have made sure that every child got the necessary rounds of polio vaccine simply because that vaccine exists. Profit margins should be irrelevant. Belee 23:36, 20 March 2006 (EST)

Articles

Two articles: The first in a series of articles on diseases that have been eradicated from developed countries but persist in some poor countries. This one deals w/ polio. It hurts me to think ab ppl still suffering from polio when knowing that the disease has been abolished completely in the U.S. Makes me think that I should be doing more to help. Hope I keep thinking that way and actually do something.

Also, from the front of the business section, the Metabolite/LabCorp case, which the USSC will hear tmw. More to come from class, I'm sure. Belee 16:07, 20 March 2006 (EST)

March 19, 2006

V interesting NYT Mag piece on sperm donors and single mothers here. Seems to me that this relates to the article in today's paper ab fathers' adoptive rights and the discussion below ab egg donors...reproduction, science, gender roles...it all fits together somehow in my head, am working on verbalizing it...

Good news on the environmental front from the D.C. Circuit. Related editorial found here.

And just wanted to highlight the Crichton op-ed that our guest lecturer posted on the front page of the wiki. Happy reading! Belee 15:42, 19 March 2006 (EST)

March 17, 2006

Maybe I just didn't notice before Dr. Lorell's talk, but it seems to me like there's been a lot of device/drug safety news these days in the NYT: malfunctioning laparoscopes and Alzheimer's drug risk stories today.

Also an op-ed warning ab the limits of relying on DNA technology. Belee 11:51, 17 March 2006 (EST)

March 16, 2006

Just a few articles...

NYT on W's FDA chief appt and its relationship to OTC sales of Plan B.

NYT on S. Korea's govt-sponsored plan for wireless (mentioned in my March 7 post) and a related editorial on "stealing" wireless.

And as a heads up: there's an excellent article on the politicization of science in the March 13 New Yorker. Belee 10:20, 16 March 2006 (EST)

March 14, 2006

Tiny post: NYT article on Ambien's adverse side effect of sleep-related eating disorder. Also some lang in the article ab the effect of consumer ads. Belee 13:13, 14 March 2006 (EST)

March 13, 2006

Just wanted to throw out this out there -- the elephants in the room that Dr. Lorell brought up at the end of class reminded me of the "why do numbers matter" debate that I first encountered in depth in my Justice class taught by Michael Sandel (who I believe is guest lecturing later this semester) in undergrad. The hypo was something like, if there was a broken train car (or something like it) hurtling towards a group of 100 ppl who would die and you were able to flip a switch that would divert the car to an alternative track where only 5 ppl would die, would you flip the switch? Is the answer the same if that group of 5 was your family?

It's the familiar philosophical problem: we all think life is precious, but we also are able to make decisions based on sheer numbers of ppl who live and die. Utilitarianism makes sense -- up to a point. It seems to break down when you know who's affected.

For a more thorough treatment in relation to drugs/devices, take a look at Dan's recent entry. Belee 21:41, 13 March 2006 (EST)

March 12, 2006

From a NYT front page story on a price increase for an old cancer drug:

The increase has stunned doctors, who say it starkly illustrates two trends in the pharmaceutical industry: the soaring price of cancer medicines and the tendency for those prices to have little relation to the cost of developing or making the drugs.

. . . .

And once a company sets a price, government agencies, private insurers and patients have little choice but to pay it. The Food & Drug Administration does not regulate prices, and Medicare is banned from considering price in deciding whether to cover treatments.

So, from this article, I gather that there is no central oversight for drug prices. Is this correct? And if so, why is it okay to leave everything to the market when it's can be a matter of life and death?

In other news, an AP article (via NYT) ab a stem cell initiative in MO. Interesting article from the public editor ab the conservative beat at the NYT. Also from Week in Review, an evaluation of the USSC decision on military recruiting at law schools. And finally, a thought-provoking NYT magazine article on wrongful birth lawsuits, made possibly only by improved genetic testing during pregnancies. Belee 23:12, 12 March 2006 (EST)

March 7, 2006

Class notes will now be posted under, shockingly, "Class Notes" on the front page...

In the news (this is from a few days of NYT, got behind on posting bc of the APALSA conf):

Front page story ab how humans are likely still evolving found here. I think it's probably true that humans are still evolving -- we're definitely not perfect yet...I thought the race discussion in the article was also v interesting.

Depressing news ab abortion in SD. More depressing news ab how the Bush administration has affected science-related policy (specifically abortion and the environment) towards the end of this article.

• Follow-up: editorial on the mssg that SD is sending. Belee 23:18, 12 March 2006 (EST)

Really disturbing op-ed ab the tissue black market. Reminds me of a Robin Cook book.

This article on stealing wireless made me laugh -- I'm all for wireless for everyone. Maybe not stealing, but perhaps govt sponsored? Compare the U.S. w/ S. Korea, where everyone's wireless. Also see the Wireless Philadelphia page linked to at left.

Cute story ab chimps.

And, I couldn't resist, preview on cnnsi.com ab the SI story on Bonds. Who didn't know the man was using roids and HGH?? He was a skinny guy when he first came up, and now he's the size of a house; if you just look at the man's head, it's grown like a billion sizes! Belee 21:55, 7 March 2006 (EST)

Feb. 28, 2006

Article in today's NYT ab the fertility business. Reminded me of the controversy we had while I was at the College working on the Crimson ab running the ads for Ivy League egg doners...

Sidenote: can't believe it's the last day of Feb already

• Can you say a little more about your involvement with the Crimson and these types of ads back in college? What kind of controversy did you witness both as an editor of a university publication and personally as a member of a rapidly-changing society? I find this topic fascinating! Julie Baher 15:14, 1 March 2006 (EST)

• From what I can remember, the Crimson and other Ivy League student-run papers decided to run the ads bc they were such a good source of revenue; I also think the ads run in Harvard Magazine. I don't think the ads specifically asked for Ivy League women to be donors, but more like good SAT scores and certain physical characteristics, like height. For me, it's a hard subject to wrap my head around -- I think that ads like those get us closer to "designer babies" and other eugenics-like choices that non-science ppl screech ab, but I also can't imagine what it's like to want a baby, have to rely on an egg donor to have one, and then face the temptation to pick "the best" egg. Part of the problem is the inherent difficulty in obtaining eggs from donors as opposed to going to a sperm bank as ppl have for years, reading the bios of the donors, and picking based off them. Maybe at the root of all this brouhaha over egg donors is latent sexism. Granted, there is a huge difference, and not just in terms of difficulty of obtaining donations, between going to a sperm bank and offering tens of thousands of dollars for eggs. The NYT interview I linked to above ended this way:

Q. What was the most unexpected thing you learned working on your book?

A. Everyone I spoke to who had gone through these difficult processes — high-tech reproduction, surrogacy, international adoption, donated eggs or sperm — came out with a child that they were convinced was the only child that they were ever destined to have.

No matter how they acquired that child and regardless of whether they had a genetic relationship to it, they saw it as theirs.

To me, it shows that there's something in humans that connects us to our children and it goes even deeper than genetics alone.

The last sentence is nice to think ab, although I think it's a thinly veiled effort to make us comfortable ab choices like these that go to the v root of our humanity. But maybe I'm just a cynic... - BEL

Feb. 27, 2006

Notes from today...

Wiki

• Add to the wiki!
• Panel on March 7 (interactive)

- Ames Courtroom

- Register 5:30-6:15; Program 6:15-8:00 – w/ remarks from Summers (for the official Harvard take on his resignation, see here)

- Nesson wants our class to participate

Chakrabarty (1980):

• Odd that case wasn’t hotly litigated – as in, no disagreement on allowing patenting of organisms
• Argument was whether statute should be interpreted that way or if it should be strictly interpreted and have Congress say that you could patent organisms
• Arguments against patenting living thing:

- Someone can take organism and prevent others from having it and not contribute it to the public domain (implicates profit motive)

- Human chimeras, patenting human DNA (some bkgd matl on the Papua New Guinea DNA patent I found online), Harvard mouse

- Asserting ownership over living things – where to draw the line

- Nesson: seems too fanciful to get morally outraged ab everything

- Tragedy of the commons leads to bargaining for use of patented organisms will be prohibitive

- But that’s true w/ patents generally, our sys now has lots of ppl who have patents, ready to sue for infringement if no license

• Do these arguments seem substantial?

- We always think we can draw a line

Bayh-Dole Act and Derek Bok (prez of Harvard in early 80s when B-D passed)

• Statute that allows non-profit orgs including universities to hold patents in knowledge created by federal money
• To promote small business firms, collaboration between for-profit and non-profit institutions (including universities), to promote release of inventions for public good
• If you’re Bok, what do you think?

- You can make money off everything, but universities are supposed to be “non-profit”

- What will this do to the faculty?

- What is purpose of research? Scientific norm of searching for truth, not getting patents

- Might slow disclosure of results to ensure patentability – do provisional patents help ameliorate this problem? Pressure from both PTO and financing

- Need to get best and brightest – do academics need incentive of profits?

- Possible shift in focus of academia (e.g. third world research goes by the wayside for profitable drugs/first world problems)

- NIH already only gives money to public interest problems like AIDS and cancer

- His piece indicates that he sees it as a net positive (incentives to get research out in commercial sphere) – didn’t address much ab faculty and how most tech transfer is not valuable

Imagine you’re the TTO for Harvard, and a researcher comes in w/ drug that reduces pancreatic cancer growth; researcher is eager to publish, patent, etc. What are you concerns?

• Figuring out scope of invention, its patentability

- If something there, need to figure out what’s already known and by whom, prior art, etc

• Splitting pie between university and researcher – i.e. TTO isn’t necessarily on researcher’s side; work for hire, so Harvard doesn’t have to give researcher anything

- Ex ante incentive necessary? Renegotiation when discovery is valuable?

- Harvard gives 35% of first $200,000 to PI and after that PI gets everything; PI decides whether to share w/ his team

• Choice of company for licensing, type of license

- Researcher and TTO want to obtain patent but also want to make arrangements in its development that leads to revenues for university, so that means dealing w/ biotech companies

- Step 1: confidentiality agreement

- Concerns w/ Biotech:

- Funding

- Speed

- Academic freedom (e.g. publication)

• Effect of patent on research on other researchers, including other Harvard faculty

- Negotiation of intra-university use

Hypo:

• Retain control – it’s TTO/university’s asset
• Retain freedom to publish and continued experiments for Dr. Onc – it’s like when profs publish w/ journals and have to retain rights to distribute article to students
• Milestone obligations

- Tox/confirmatory studies – v expensive, Biotech would be more efficient

- IND (investigatory new drug study)

- Do we worry ab an exit strategy?

• Reimbursement – patent filings and prosecutions are v expensive, esp if it works out and you file around the world
• License fees and milestones and payments – upfront costs + security ~ downpayment on a house; checkpoint payments bc profits are so delayed, keep level to keep incentives steady

- Feels like poker game, would love to make a killing (comes w/ royalties)

- Milestone payments are like the pot, but you’re partners w/ Biotech so don’t want it too high – reaffirms relationship, value of research has gone up if you reach the milestone

- Depends on a lot of diff factors

• Sublicenses – want to approve of purpose? Is it just money?

- We want a trusting relationship w/ control

- We want control over who we are tied to

• Liability insurance/indemnification – can we even get this? Would be nice but not likely
• Termination – ability to take over if they’re not doing the job
• Unrestricted research funding – also unlikely to get

Feb. 22, 2006

Quick post, just two NYT articles that I saw today, one on Gitmo and the other on executions. Made me think ab the discussion we had the first class ab drs' oath to "first do no harm" and how sometimes maybe they should participate in awful things to ensure they're done in the least harmful way.

Feb. 21, 2006

At the gym this morn, watching CNN, had a thought ab the feds' wiretapping after seeing the story ab the New Yorker article on the topic: The writer noted how the Bush administration went out and sought different opinions when one lawyer advised it that the program was legally unsound. This practice reminded me of what we talked about in class yday, ab how corps go out and seek scientific opinions to get them to the conclusions they want. But then I thought, well, in law school, what we seems to be learning is the ability to argue both sides of an issue. And it's not like you can necessarily say that seeing both sides of an argument means that you are morally vacant, even when the issue is something like the civil liberties of Americans, because it's likely that you will personally believe one side is right (or at least more right than the other) but we've developed the ability to argue both.

So then, what's the difference with bioethics? We have already seen how bioethics is political, how ppl have strong opinions on both sides, how difficult it would be to compose a central governing body and then decide what it would dictate as standards and norms... I think ppl feel that bc bioethical issues are so huge, often going to the root of humanity, there should be one right answer that ppl can agree on, but I also feel that way ab protecting my ability to have a phone convo w/o fear of the feds listening in... I guess it's all just part of breaking down the notion that there is one law/justice or one ethic that controls. Which makes me nervous ab who gets to determine the one that does control...

Also -- some articles in today's NYT: a Kenyan lake chockful of goodies, stem cells and cancer, evolution/religion, and science for the masses. The last two articles are particularly interesting to me bc I wrote an article ab the Dover intelligent design case for my journal (CR-CL), and part of my conclusion was that science needs to break out of the ivory tower and into the public discourse to avoid being stifled by religion, esp when Establishment Clause violations may occur. And, thanks to my Cyberlaw class last Spring w/ John Zittrain, I see collaborative efforts like the wiki as part of that discourse continuum...

• I agree that science needs to be more willing to step out from the ivory tower and into the muddied waters of public discourse, especially when the stakes are as high as they were in Dover. But I have my own questions about the efficacy of something like the Times' most recent article on the intelligent design-evolution/religion-science "controversy." I've posted a few thoughts about that over on my own journal. DVorhaus 12:44, 22 February 2006 (EST)

Feb. 20, 2006

Professor Nesson asked me to post class notes and add in some links when I felt like it...so here goes...

Professor Krimsky's presentation (to supplement the PPT presentation, not to replace it):

• Corrupted Science
• Funding Effect: does source of funding affect outcome of research?
• COI rules based on

1. Stewardship: doesn’t fit very nicely w/ science

2. Transparency: imp bc we want to know if scientists are biased

3. Consequentialism: if COI has an effect on the science – open question

4. Scientific Integrity: is it imp that scientists appear objective/neutral

• Corporate connection to science

- Corps see science just as an input into production – i.e. if corps can control science, they will (e.g. tobacco); corps have discredited science that hurts them, have suppressed unfavorable results

- Nesson: sophistication of companies who anticipate litigation in process of research to avoid having to turn over results during discovery

- Krimsky: funded science also exists, ready to use in anticipated litigation

- Corps have influence speakers at conferences, set up fronts, bought science to support own conclusions

• Historical bkgd: Bayh-Dole Act of 1980 gives universities title to IP developed w/ taxpayer money – led to commercialization of research

- Public investment goes directly to private interest

- Was supposed to create incentives, lead to tech transfer

- Chakrabarty case: w/o this case, biotech industry wouldn’t be lucrative

- Right now, focus is on patenting genes

• Conflict also w/ govt science:

- Bush administration has politicized science (e.g. global warming - see NYT article)

- Ethics/Science advisory committees – waiving of COI rules, soft ties with industry

- See this in all areas of science, e.g. dietary guidelines, DSM IV, EPA/climate change/conservation

- These are seen as political issues, not scientific ones – okay to suppress info as long as politically correct

• Suppression of research

- Able to sue for damages bc they sign restrictive agreements w/ universities

- Universities are willing to sign bc they want the funding

• Does the source of funding affect outcome of research?

- Meta-study in JAMA said industry sponsored research tends to draw pro-industry conclusions

- There are exceptions to the rule – although scientists who publish unfavorable research likely never get funding again

- Generic/name brand studies never come out w/ generic as better (note: the only thing the same between the two is the active ingredient, they are not identical)

- Wouldn’t we expect only to see the favorable science bc industry has already done so much internal research?

- Tipping factor: once a company decides to push something, takes a lot to convince them to stop

- How does funding effect occur if experiments are done properly? This question wasn’t asked until quite recently (c. 1986)

- Gary: question ab source of bias

- Krimsky: internalization of industry desires leads to tweaking of conclusions (he argues this is conscious bc they know funding is dependent on certain outcomes)

- Why doesn’t peer review process catch the tweaking? Krimsky: peer review is not that great, best comes at trial

- Peer review is mainly methodology

- Ghostwriting (this reminded me the Korean cloning article controversy)

- So what should be do ab this?

- Some ppl think the answer is just transparency

- Krimsky: need separation between ppl who make the drugs and ppl who do the studies

- Suggests national institute of drug testing, which would select who does the testing; trying to create firewall of no relationship between testers and the drug company, data owned and shared by feds

- Would this institute be even more susceptible to capture by industry?

- What is to stop this agency from being politicized?

- How would this be funded? Krimsky: fees

- Necessary in addition to tort system? No safe harbor from liability once they pass the tests

- Science shouldn’t end after marketing – points to Japan’s system requiring reporting of adverse drug effects

- Trying to deal w/ both biased results and withholding of results

- Difficult bc hard to get negative results published

Affirms our first two classes:

• George Annas: politics
• Teo Dagi: drive to make money
• Nesson: we understand how powerful the drive to make money is and the myriad ways to affect the environment surrounding what drugs to prescribe/use

- Examples of outrage are there (and tort lawyers live off them)

- But still not satisfactory soln out there

Problems w/ Krimsky’s proposal:

• Pulling of drugs not necessarily bc of bias but bc of harmful results

- Krimsky: investigations now ab whether those harmful results were suppressed

- Comment that FDA has high threshold, Viscusi says more likely to hold back drugs than let them go to market (this reminded me about my torts class, taught by Hanson, and the debate he had w/ Viscusi)

- Krimsky: is our medical system prepared to give drug to ppl most likely to be helped by it, says it’s “moral balancing” to say that it’s okay to release drug that helps 9 but kills 1 out of 10

- Who is the appropriate arbiter? Wouldn’t person making decisions ab taking the drug want to know the studies were made by disinterested ppl?

• No need to eliminate the relationship completely?

- Asterisk to disclose financial interest in article

- Should human subjects be told?

- Harvard prohibits scientist w/ financial interest to be PI in clinical trial

- Multi-vested better than complete divestment?

- There is value in these relationships

- More disclosure/transparency

- Central disclosure of all clinical trials – not just the positive results