Julie Baher
From Cyberlaw
Contents |
April 18
Duke case
Duke lacrosse players indicted today, despite lack of evidence from DNA testing...can't help feeling overwhelmed by the controversy surrounding this case and the elements of mob mentality involved on both sides.
April 17
Third-Party Payment Systems in the Legal Field?
Sometimes the overlap of law school classes strikes me as something more than accidental. Just a few hours ago, we discussed HMO's and health insurance plans with our guest lecturers. A few moments before that discussion began, my legal professions class was wrapping up a discussion about the possibility of "legal insurance" plans and the lack thereof in the United States. Coincidence?
We talked in legal professions about "judicare," a government-sponsored program in some European countries that sets up public funds to help poor and moderate income individuals needing legal services, enabling them to pay for private lawyers who agree to handle their cases at rates set by the state. This type of a program essentially sets up Medicare/Medicaid-like, government-funded programs to ensure "universal" access to legal services. We had been looking at already-existing group legal services and government legal aid with a very critical eye and subsequently dismissed the idea of judicare as impractical for the United States. Perhaps this has something to do with dissatisfaction with the current state of Medicare/Medicaid, but maybe it is also telling of peoples' intrinsically biased perceptions of the differences between access to the healthcare system and access to the legal system. Perhaps, also, as we only began to broach today in relation to the healthcare field, we are particularly concerned in the field of law with conflicts of interest that may (and likely would) stem from third-party payment systems, and with the resultant possibility of diminished quality of services. But why is it that we are more readily dismissive of unmet legal needs and people being closed off from the larger- than- life ideal of "justice" than we are of unmet medical needs? And would something like judicare actually be superior to the (much criticized) kinds of government legal aid and group legal plans currently available to the lower-income sector of our country?
April 13
Interesting NY Times Article
Sorry, I know this is usually Brenda's job, but I couldn't resist posting this article...
A Crystal Ball Submerged in a Test Tube By ANDREW POLLACK Published: April 13, 2006
When her hairdresser asked her last fall whether she would continue wearing her hair long, Elizabeth Sloan broke down crying. Unbeknown to the hairstylist, Ms. Sloan had recently had a breast tumor removed and was expecting to begin chemotherapy, which would probably mean losing her hair.
But later that day, Ms. Sloan received the results of a new $3,500 genetic test, which indicated that her cancer probably would not come back even if she skipped chemotherapy.
"It was a huge relief," said Ms. Sloan, 40, a mother of two young boys who lives in Manhattan. "I did not want to napalm-bomb my body with chemicals."
The test taken by Ms. Sloan, known as Oncotype DX and offered by a company called Genomic Health, is part of a new wave of sophisticated genetic or protein tests that are starting to remake the diagnostics business, both for the technology they use and the way they are developed and sold.
Traditionally regarded as a low-profit, poor cousin of prescription drugs, diagnostic tests are emerging as high-profit products in their own right. Test developers are "trying to do what pharmaceutical companies have done with their drugs," said Jondavid Klipp, managing editor of Laboratory Industry Report, a newsletter.
Unlike the conventional $10 cholesterol or blood sugar test, the new tests are expensive, often patent-protected and are marketed directly to doctors or in some cases patients instead of to medical laboratories. The effectiveness of some tests is being assessed using clinical trials, as Genomic Health has done with its Oncotype DX.
The company's test could receive new attention as a result of a major medical journal study, published yesterday, which found that women with a certain kind of breast tumor might not benefit from chemotherapy. Genomic Health's test could potentially be used for further screening by such women and their doctors.
But the trend toward such high-priced tests, many of them not yet covered by insurance, is raising concerns in some quarters that diagnostics could become a new contributor to rising health care costs — while increasing the gap between people who can afford good health care and those who cannot.
In any case, the new generation of tests represents some of the first fruit of the long-anticipated genome revolution and could help pave the way to personalized medicine, in which treatments would be tailored for each therapy, potentially making them more effective and less costly. Such tests are either now available or being developed for purposes like detecting cancer early, monitoring heart transplants and choosing which drugs might work best to treat cancer, AIDS or heart disease.
Within its industry of genetic testing — a business now estimated at $5 billion and growing by 25 percent annually — Genomic Health is being seen as a model.
"They are raising the tide for everyone else," Jorge Leon, the president of Leomics Associates, a diagnostics consulting firm, and the acting chief science officer at Orion Genomics, which is developing tests to detect cancer. He said Genomic Health had done a "fantastic" job of validating its test using clinical trials and then of "packaging it in a Starbucks package at a high price."
Kleiner Perkins Caufield & Byers, the prominent Silicon Valley venture capital firm that provided early financing for Genomic Health before it went public last year, is now backing four other companies with the same business model, said Brook Byers, a partner. But some experts are concerned that Genomic Health and companies with similar business models perform all the testing in their own laboratories, rather than selling or licensing the tests to a variety of hospital and commercial labs. That makes it difficult to measure a laboratory's reliability by comparing it with others, and it lowers the pressure to improve the test.
"I don't think having a sole provider of a medical service, a test, is in the best interest of public health," said Dr. Debra Leonard, a professor of pathology and laboratory medicine at Weill Medical College of Cornell University. "It can't be validated by other people. And there's no making the test better. And there's no competition on pricing."
The Food and Drug Administration has also become concerned that such tests are not properly regulated. Tests done by a single laboratory are currently classified as laboratory services and do not usually need F.D.A. approval, unlike test kits that are sold to hospitals and doctors. But the F.D.A. has sent letters to some providers of these tests saying that tests used to diagnose disease may legally be considered medical devices and require agency approval.
One such test, to detect ovarian cancer, is still not on the market two years after its developer, Correlogic Systems, received such a letter from the F.D.A. Genomic Health got a letter in January, raising at least the prospect that its test may have to come off the market while it undergoes F.D.A. review.
Randy Scott, co-founder and chief executive of Genomic Health, said the company was in discussions with the F.D.A., but he would not comment further.
Many testing laboratories say that requiring F.D.A. approval at the outset would make it uneconomical to develop many tests, which have smaller sales than drugs. Genomic Health, for example, performed only about 7,000 tests in 2005, the second year the test was offered. And it is still losing money.
"I'm not sure we could exist at all if we were required up front to have F.D.A. approval," said Mr. Scott. He said that, industrywide, there were hundreds of genetic tests, only a handful of them approved by the F.D.A.
Mr. Scott also said that the price of the Oncotype test might not be much of a barrier. "We didn't see much price sensitivity once you get above $1,000," he said.
He and others in the industry argue that diagnostics account for only a few percent of overall health care spending but have a potentially great impact. Mr. Scott said the Oncotype test could save money over all by allowing many women to skip chemotherapy, which can cost $20,000 or more.
In deciding to finance Genomic Health and similar companies, Mr. Byers, the venture capitalist, said, "we went and looked at decisions that would lead to expensive treatments and for which there is little information."
Another company Mr. Byers is backing, XDx, offers a $3,000 blood test that analyzes whether a transplanted heart is being rejected. Such a test may be able to substitute for the heart biopsies now used to test for rejection, which themselves cost several thousand dollars and are invasive.
Genomic Health, which is based in Redwood City, Calif., is not the first company to offer a high-priced genetic test as a laboratory service. Myriad Genetics of Salt Lake City has been offering a patent-protected test for the risk of developing breast cancer since the late 1990's. It charges $3,000 for the most thorough version.
At an investor conference in January, Peter Meldrum, Myriad's chief executive, extolled the "pharmaceutical-like" profit margins on the breast test and three other cancer risk tests. Myriad's testing sales reached $71 million in the fiscal year ended June, 2005, up 75 percent from the previous year.
Monogram Biosciences, based in South San Francisco, Calif., offers tests costing up to $1,460 that help doctors tell which drugs would be best to use for a particular patient infected by the AIDS virus. It had $48 million in revenue last year.
Not all such tests succeed. Exact Sciences has experienced slow sales of a $500 DNA test, performed on a stool sample, that screens for colon cancer. Eric Book, chief medical officer of Blue Shield of California, said Blue Shield decided not to pay for the test, in part because it appeared little better than a $5 test that looks for blood in the stool. Exact Sciences maintains its test is better, although it is working to improve it.
Genomic Health, though, expects about 70 percent growth in sales of its Oncotype DX tests this year, to 12,000. The stock closed yesterday at $9.92, down from the $12 initial public offering price.
Oncotype DX is only for women whose tumors' growth is fueled by estrogen and has not spread to lymph nodes. That accounts for about half of the 230,000 cases of breast cancer diagnosed in the United States each year, according to Genomic Health.
Previous clinical trials have shown that after the tumor is surgically removed, 85 percent of such women, even without chemotherapy, will not have a recurrence within 10 years if they take tamoxifen, a hormone therapy. But because there has been no good way to determine who among the estrogen-sensitive cancer patients might benefit from chemotherapy, many women have taken the treatments anyway, exposing themselves to needless toxicity. Genomic Health is promoting the Oncotype DX test as the way for those women to better gauge their prospects.
In January, the company won approval for reimbursement for its test for most Medicare patients. But many insurers still do not reimburse for the test. Last year, a committee that evaluates technology for Blue Cross Blue Shield said Genomic Health had not adequately demonstrated a medical benefit.
Ms. Sloan, of Manhattan, is still working on getting reimbursement from Oxford Health Plans.
Mary Sullivan, who is 47 and lives in Lido Beach, N.Y., had the test early in 2005. She said she was still trying to obtain reimbursement from her insurer, UnitedHealthcare, which in a letter to her termed the test "unproven."
Ms. Sullivan said it took more than two months to get her test results back from Genomic Health, instead of the two weeks advertised, because additional samples of her tumor were needed. By then, she said, she and her doctors had already decided to skip chemotherapy. The test later classified her as low risk for recurrence.
Ms. Sullivan said she and her husband had wanted all the information possible to deal with a life-or-death situation. "We were going to go through with it whether the insurance company would pay for it or not," she said.
Other companies are hoping for similar patient demand. In February, Aureon Laboratories, a start-up in Yonkers that has attracted investment from Pfizer as well as Becton, Dickinson & Company, began offering a $2,000 test that combines protein analysis, pathology and other measurements and uses a computer algorithm in an effort to predict recurrence of prostate cancer.
Asked about the price, Rob Shovlin, Aureon's executive vice president for sales and marketing, replied, "It's less than the Genomic Health price of $3,500."
He added, "Patients have given us feedback that they'd be willing to pay more than that to have this information."
- wasn't this article so interesting?? and pls, anyone should post articles! :) Belee 22:15, 13 April 2006 (EDT)
April 3
The Line Between Medical and Non-Medical Intervention?
I don't think it is possible to differentiate between medical and non-medical uses of genetic enhancements or interventions as Professor Sandel urges us to do in drawing some sort of line between what is morally permissible and not and between what the legal system should allow and disallow. Many ethicists argue that the line should be drawn such that therapeutic uses of genetic technologies are permissible, whereas non-therapeutic, or enhancement, uses are impermissible. The standard for determining which uses practically fit into either category is quite often that of "medical need." However, "medical need" seems very arbitrary to me. For example, it may not be medically necessary for me to pursue a genetic technology aimed at strengthening my arm (so I’d call such an effort an enhancement), but perhaps for a pitcher, who is likely to overuse and injure his/her arm during the course of his/her career, such a technology would prevent severe injury (so the pitcher would call such an effort therapeutic). So enhancement and therapy become two sides of the same coin, very much dependent on the qualities of the person intending to utilize them.
Moreover, subjective perceptions about what it actually means to be a disease will influence whether a person feels that the genetic intervention in question is "medically necessary" or not. Professor Sandel used the example of the two deaf lesbian women who successfully stacked their odds of having a deaf child by choosing a sperm donor that they knew has had 5 generations of deafness in his family. While many, like Professor Sandel, would object to this practice because it involves parents "playing God," designing their children, or attempting to control that which should remain uncontrollable, others would vehemently object that the parents should be condemned for choosing a "disability" for their child and, thus, acting opposed to the child's best interests. I, personally, agree with the parents of the deaf child who believe that deafness is not a disability but rather a cultural difference. I don't see deaf people as disadvantaged, but rather as enriched by virtue of their deafness and the close-knit community that has developed amongst them. But, again, the line is quite blurry and there are plenty of people out there who would argue that deafness is in fact a disability. Thus, it is not for us to say what medical or non-medical uses are, and it is not for us to define what a disease might be. As Dan said in class today, we are better off avoiding gray areas like this, because we shouldn't be drawing a line at all in the first place.
What Professor Sandel did not tell us about the story of the deaf parents (since we were running out of time), is that the parents of this deaf child have chosen to "shun" chochlear implant devices or hearing aids for their two children, at least one of whom actually has some residual hearing (the second child being born after a sperm donation by the same donor) that would allow the children to pick up speech patterns. Instead, their children will be taught sign language and given a choice later on about whether they want to wear hearing aids or not. The parents' reasoning had to do with wanting to share the aspects of their deaf community- a sense of belonging and connectedness- with their children and with a sense of pride in the lifestyle that they live. Being that I don't view deafness as a disability, it is puzzling to me why this decision left me feeling somewhat angered with the parents. I guess it has something to do with choice- had the parents given their children access to the hearing aids and cochlear devices early on, they could have belonged to both the hearing community and the deaf community, but since they were deprived of these aids, they may never learn to speak. While the parents may desire only to be a part of the deaf community, it is not fair that the children are unable to make this choice for themselves. Although, I guess there are plenty of choices that young children are never able to make for themselves without objection (such as where to grow up, what religion to initially be raised, etc.), so the situation remains kind of confusing for me. For anyone who thought during class that what these parents did was perfectly acceptable, does this addendum to the story change your mind at all?
March 14
The Weather
What's up with the wacky weather patterns today? I woke up umbrella-less hoping not to get poured on on my way to class, and now it's a beautiful spring-like day. Very strange. I'm remembering April, pre-1L year, visiting Harvard in the snow, and am wondering what made this winter so mild and the hurricane season so harsh...is it our fault?
- What's this 'our' business? I blame this guy, personally. Oh, and if anyone is interested, here's an article from the Globe on New England's mild winter. This January was the 6th warmest on record. It was also the warmest winter ever in Canada. You know something is up if Canada, winter, and warm are being used in the same sentence... DVorhaus 15:11, 14 March 2006 (EST)
Devices v. Drugs
I'm still thinking about what Bruce said yesterday in class about how if manufacturers of devices comply with all of the specific processes for pre-market approval and corrective action, in theory they will have a defense against product liability, but the same does NOT hold true for manufacturers of drugs. What is so fundamentally different about devices and drugs that would lead to such differing schemes of liability? Is it that we trust makers of manufactured devices more than we trust those involved with pharmaceutical compounds? I just don't see the motivation for treating the two regimes so differently, especially when, as was brought up in our discussion yesterday, there can be hybrid cases that are both drugs AND devices (e.g., the example of the drug-elluding stent). What happens to the availability of product liability then? Finally, what will become of potential products liability plaintiffs in device cases who no longer have valid claims against the manufacturers? From a corrective justice standpoint, this seems fundamentally unfair.
March 7
Lingering Questions
I am left wondering about strategy after last class and after our Harvard-Biotech negotiation. Why is it that we were all exposed, as a class, to the wishes and interests of Harvard and the Tech Transfer Office before being broken up into negotiating teams, and yet only the Biotech team was privy to Biotech's interests and intentions? Is this asymmetry of information closer to how it would be in the real world, or did we simply do it this way for administrative ease? Would Biotech companies ordinarily be so well-informed about the interests of the Universities with whom they wish to enter into licensing agreements, or would it instead be the Universities that have access to a larger store of information? And finally, for those on the Biotech side (I represented Harvard), did you feel that your greater access to information about Harvard's interests gave you more or less leverage during our negotiations, or was it simply irrelevant?
- As a representative of the Biotech side, knowing Harvard's numbers had the following impact on me. 1) Ex ante, I was more willing to cooperate. By knowing what the other side wanted, I was inclined to share specific information about my position and try to work things out. The "ZOPA" was apparent. 2) I think the asymmetry made the Harvard side less comfortable with us - it seemed like they thought we knew something they didn't. Some members of the Harvard side were standoffish. Accordingly, at the end of the day, the asymmetry may have caused more harm than good. How did the asymmetry make Harvard feel? -JHarlow
Feb. 24
"Believability of Industry-Sponsored Research"
For anyone who previously had faith in the effects of reporting industry-sponsored research results in peer-reviewed journals...
"Many continuing medical education events at local and international levels and peer-reviewed journals would not be possible without the generous support from industry partners. Although published statistics are lacking, industry partners finance the majority of medical and nutrition research." Heyland, D. In Search of the Magic Nutraceutical: Problems with Current Approaches, Journal of Nutrition. 2001;131:2591S-2595S.
Going along with the theme of trust from my previous post, does this mean we should be wary of trusting even the results of clinical trials published in respected journals if these very journals are supported and funded by the same industry that we so emphatically have been taught to distrust due to inherent bias and conflict of interest?
Feb. 20
Jesse Gelsinger
Jesse Gelsinger....The name is still ringing in my ears. This is not the first time I've thought about him in an academic setting. He first surfaced in my Genetic Engineering class back in college; he came back later in an upper level molecular biology class, followed by Food and Drug law here at the law school, Bioethics seminar, and now Biotechnology class. And each time I read more about his case I am more disturbed. We spoke today about how one of the problems with the Jesse Gelsinger clinical trial was that the conflicts of interest were not disclosed to him; both that the principle investigator was being paid by the biotech company and that the University of Pennsylvania owned stock in the company that was sponsoring the research. In addition to the conflicts of interest, those administering the clinical trial negligently failed to inform the Gelsingers that the gene therapy technique had previously been performed on monkeys who had very adverse reactions to it. But I think what bothers me the most is that Jesse became involved in the clinical trial for reasons that had nothing to do with benefiting himself or his own genetic condition. He stood to gain no personal health benefits from his involvement in the procedure; he simply wanted to help others in the future. And this young man, with all of his goodwill, was unfortunate enough to be matched with a corporate system, with researchers, with doctors, with a University that cared ONLY about their own interests. This leads me to question how it has come to be that the worthiest of goals (e.g., healing the sick) have managed to end up in the hands of the solely profit-minded. We learn in basic Corporations classes that a corporation is obligated, above all else, to serve the interests of its shareholders by maximizing shareholder wealth. But isn't there something wrong with a system that allows these same corporations to control the fate of life-threatening human experiments? If we can't trust the researchers and biotech companies and Universities that are responsible for generating the ideas that will potentially save our lives, who CAN we trust?
Feb. 18
Bioethics & Biotech in the Supreme Court
Hey all. I attended the panel discussion on Bioethics and Biotech in the Supreme Court this past Thursday night, and I have to say it was without a doubt one of the most interesting events I have been to during my three years at HLS. I first wrote out a summary of what the speakers had said (sort of a Cliff's notes version for those who were unable to attend), but then I remembered that the panel was going to be webcasted, thus obviating the need for my incomplete account of what went on. Instead, I'd like to explore a couple of the issues discussed that I found most interesting.
First, Professor Dan Brock introduced a topic I had never really heard much about- neuroethics. One can envision, as Professor Brock discussed, lie-detector type technologies utilizing electro-mechanical/chemical/organic techniques to enable us to get closer to one another's subjective states of mind. But, as Professor Charles Fried later discussed, would this be a violation of the 5th Amendment? Would it be illegal even if not used in a testimonial context? Is it a violation of the right to privacy? Even if there is no legal hook for prohibiting such a technology, it seems to me that there are still moral/ethical objections to be raised by invasions into the previously exclusive realm of the inner workings of one's mind. And, it just plain weirds me out that anyone could feasibly have access to thoughts that I might not even realize that I'm having.
Another topic I found quite interesting was Professor John Robertson's discussion of the slippery slope concerns with allowing cloning for therapeutic purposes (assuming such technology has been made safe and effective). Because therapeutic and reproductive cloning technologies originate from the same starting point, allowing therapeutic cloning could lead to the practice of reproductive cloning somewhere along the line (even if reproductive cloning is explicitly banned). I grappled with this issue extensively last semester in Professor Sandel's Bioethics seminar and found myself coming to the unpopular conclusion that there would be no way to allow therapeutic cloning and ban human reproductive cloning (which I believe is absolutely necessary). I thus believed that both forms of cloning should be banned entirely. Professor Robertson posed the question of whether we should really deny patients in the present access to potentially life-saving therapies just because of concerns that reproductive cloning (which is currently nowhere near being safe or feasible) might occur in some unspecified amount of time in the future. And, I admit, this makes me question my absolutist position from last semester, especially when I ponder whether restrictions on therapeutic cloning technologies would actually violate a patient's Constitutional right to life under the 5th and 14th Amendments (as discussed by Professor Robertson). So what are we to do? Is the integrity of life tomorrow to take precedent over patient's lives today? Or are we to allow the medical profession today to do everything in its power to heal the patients who are currently suffering while accepting that this might mean we have no real power to stop the "manufacturing" of human clones somewhere, sometime in the not so distant future?
- I think the slippery slope issue that both you and Professor Robertson raise is a very interesting one. I've commented on it in more detail in my most recent journal entry. Having never done a Wiki journal before I'm not entirely certain what the best way is to comment/respond to other people's writings... DVorhaus 14:28, 20 February 2006 (EST)
