Celltex Under Fire by the FDA

A week ago the FDA released its 483 inspection report relating to Celltex Therapeutics Corporation’s practices banking and facilitating the administration of adult stem cells for therapeutic purposes.  News sources (here and here) and the Center for Genetics and Society published portions of its startling findings.  Celltex processes, multiplies, distributes, and facilitates the injections of mesenchymal cells derived from adipose tissue using technology licensed from RNL Bio based out of Seoul, South Korea.  Prominent physician Carl Elliot, MD, PhD and bioethicist Leigh Turner, PhD have both expressed public concern about Celltex’s seemingly flagrant circumvention of FDA regulatory standards, licensing partnership with a controversial corporation, and conflict of interest in the oversight of its operations.

Since its opening in December 2011, Celltex is the largest stem cell bank in the US and facilitates the process and supplies the product for individuals seeking to receive stem cell injections, charging a hefty fee ranging from an estimated $20,000-$30,000 for its services.  It has garnered significant publicity arising in part from Texas Governor Rick Perry’s support, his personal use of stem cell injections for a back injury, and Perry’s push for state legislation to create a state adult stem cell banking initiative and revise Texas Medical Board regulations relating to physicians’ ability to administer non-FDA approved stem cell “treatments” to their patients.

Back in February, Turner compiled a letter of listed concerns relating to Celltex’s practices, requesting that the FDA investigate the company’s practices.  Turner and other media sources have pointed out the following, along with other issues:

Celltex has not offered substantial data or clinical trials to show the stem cells it offers are safe and efficacious.   In January 2012 the FDA issued a Consumer Health Information guide cautioning consumers to make sure that any stem cell treatment they consider has been approved by the FDA or is subject to a current protocol submitted to the FDA to ensure that the stem cells are safe, effective, and have undergone adequate and well controlled clinical trials.  Furthermore, the FDA must oversee the manufacturing process to assure the products’ safety, purity, and potency.

If individuals are receiving experimental injections, Celltex and the physician should thoroughly explain that the procedure is experimental medical research rather proven clinical medicine and the risks associated with the procedure.  Both the FDA and physician commentators have noted that patients seeking to have cells injected face safety risks arising from the procedure, even if they are the patient’s own stem cells and the corporation follows good manufacturing practices.  Jamshid Lofti, MD, a neurologist who has administered injections to more than 20 patients has admitted the need for controlled trials, but has problematically downplayed such risks, asserting that “the worst that can happen is it won’t work.”  Not according to the FDA and numerous other physicians, who list potential risks to include tumors, cancer, and even death.  Such risks are at the forefront of investigation (see here and here) into partner company RNL Bio’s practices in South Korea, where former patients and their families have come forth with allegations of cancer and death linked to receipt of RNL Bio’s stem cells. 

Celltex contends that it merely processes and expands individuals own stem cells, only minimally manipulates the cells, and is currently coordinating prospective clinical studies.  According to Nature, Celltex coordinates with physicians and pays physicians $500 per injection, and each patient receives at least three injections.  Celltex argues that the process of culturing and preparing the stem cells does not constitute the manufacture of a biological drug, so the process stands outside the scope of FDA regulations normally required for biological drugs.  A Colorado court is currently examining this issue arising from the practices of another company Regenerative Sciences, who proffered a similar argument to avoid applicability of FDA requirements. 

However, Rita Chappelle, a spokesperson for the FDA’s Center for Biological Evaluation and Research asserts that any “expanded” cells cannot be considered minimally manipulated.  Importantly, the FDA’s 483 inspection form classifies Celltex as a biological drug manufacturer in the business of manufacturing mesenchymal  stem cells rather than minimally manipulating stem cells.  Independently of how Celltex classifies its processes, the 483 report made news headlines based on the number of alarming deficiencies in the processing and manufacturing procedures.  It found Celltex failed to validate processes to prevent contamination; to distinguish between components being quarantined or approved; to routinely calibrate and check the equipment; to review quality processing systems; and could not guarantee the sterility, uniformity or integrity of the cells.  Celltex’s press release in response is here.

Had there been any uncertainty about the scope of FDA regulation, the Consumer Health Information guide back in January clarified that the manufacture of stem cells must undergo FDA review.  Yet Celltex continued its operations charging clients tens of thousands of dollars for unproven and unregulated “treatments,” evaded FDA’s clarification, and exposed consumers to additional risks based on its manufacturing deficiencies detailed in the 483 inspection.  More problematically, associated figures such as Gov. Perry and physicians who administer the injections provide the imprimatur of  Celltex’s practices- creatively flouting regulatory requirements, downplaying risks of the procedure, and reaping hefty profits.  Even in the name of therapeutic progress and statewide economic growth, it is time for the FDA to set an example that such disregard for its jurisdiction and review process will not be tolerated. 

--Katherine Drabiak-Syed

California Department of Public Health Orders Changes to Berkeley's Genetic Test Program

Last week Berkeley altered its Bring Your Genes to Cal Program to stop the genetic test results from being disseminated back to participating students in response to an order from the California Department of Public Health (CDPH). Berkeley will still hold discussions and lectures based on the aggregate information as previously planned. [See our posting on the Bring Your Genes to Cal Program here.]

On August 11, Berkeley and CDPH met to discuss the program’s compliance with the California Business and Professions Code which requires that a physician order clinical laboratory tests. In a statement to CDPH, Berkeley asserted its program should fall under an exemption for labs performing tests as research where the results are not reported to patients as part of a medical or health assessment. Berkeley maintained that these statutory requirements were not applicable to its program because Bring Your Genes to Cal constituted an “educational experiment,” students are not “patients,” and the three specific gene variants tested are not disease related.


Despite these claims, the program would have returned genetic test results back to each student, which should be defined as part of a health assessment because the program directed students to use these results to inform their dietary and nutritional choices as well as make personal health decisions. According to Dean Schissel’s message to students in the informed consent video, these genetic test results would then allow them to take measures to improve their health such as eating more or less of a particular food, or avoiding alcohol if their test results showed an ethanol “allergy.” Schlissel’s assertion stretched the meaning of California’s exemption in denying that this “experiment” constitutes clinical laboratory tests or that this information is medically significant. Arguments over statuory construction closely parallel the current federal regulatory loopholes relating to DTC genetic tests.

As genomeweb observed, the semantic debate between Berkeley and CDPH is strikingly similar to the volleys between CDPH and DTC genetic test companies that occurred back in 2008. In June of 2008, CDPH had responded to consumer complaints and sent out thirteen cease and desist letters to DTC genetic testing companies, asserting that their policies did not comply with licensure requirements set forth in California law. Two of the targeted companies, 23andMe and Navigenics, asserted they offer an “informational service” providing personal genetic information and not “medical testing services,” so they did not need to obtain a license. CDPH agreed and granted licenses to Navigenics and 23andMe in August 2008.

Now, with Congress and the FDA scrutinizing the federal regulatory requirements, CDPH seems to be responding to the current political shift of opinion and the uncertainties related to providing genetic test results without a physician intermediary and oversight of the test's accuracy and validity. Or perhaps CDPH agreed with concerns in the defeated California Assembly Bill 70. This bill would have urged state schools within the California State University and University of California system from requesting students’ DNA for the purpose of genetic testing.

Defeated AB 70 also raised specific privacy concerns stemming from a university collecting students’ DNA samples for genetic testing and retaining students’ coded genetic information. Although Berkeley's program will incinerate students’ DNA samples following testing, it plans to keep students’ genetic information for further study. Data attack in GWAS studies exemplifies the principle that our understanding of data security relating to genetic information is uncertain, and we have continually underestimated the potential for security breaches. Dean Schlissel’s unwavering promises of absolute privacy seems naively optimistic given what we know in this area.

It seems this “teaching study” has given Berkeley and its freshmen more than they could have anticipated. In addition to the campus lectures about genetics and personalized medicine, students have already learned the ethical and legal complexities associated with emerging technology- the varied parties who have a say, the definition debates, and the unpredictability of the resolution.

--Katherine Drabiak-Syed

DTC Tests Face Scrutiny at FDA, by GAO, and Congress

Last week produced a flurry of activity at the FDA and before Congress relating to regulation of field of DTC genetic tests. Here is a summary:

At the FDA:

The FDA sent out additional letters to fourteen more DTC companies, stating that the companies’ respective tests constitute in vitro diagnostic devices subject to FDA regulation. These letters mirror the original letters sent out in June to 23andMe, Navigenics, deCODE Genetics, Knome and Illumina, which we discussed here and here.

On July 19-20, the FDA convened its Public Meeting on the Oversight of Laboratory Developed Tests to discuss the history and current regulatory status of LDTs and status of DTC genetic tests. The meeting was divided into four sessions to address:

• patient and clinical considerations;
• clinical laboratory challenges;
• concerns, benefits, and risks of DTC testing; and
• education and outreach so laboratories can comply with regulations and physicians are enabled use the genetic information provided in these tests

GAO Report:

On July 22, the Government Accountability Office released its report Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices and offered it as testimony during the hearing before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce in the House of Representatives.

The GAO posed as consumers and sent DNA samples from five people to four selected companies. It also examined a sample if fifteen companies’ advertising and marketing practices.
This report revealed numerous appalling flaws related to selected DTC test’s accuracy, company follow up with consumers, and consumer privacy protections. The report found the following five problems:

(1) each donor’s factual profile received disease risk predictions that varied across all four companies, indicating that identical DNA can yield contradictory results depending solely on the company it was sent to for analysis;

(2) these risk predictions often conflicted with the donors’ factual illnesses and family medical histories;

(3) none of the companies could provide the donors who submitted fictitious African American and Asian profiles with complete test results for their ethnicity but did not explicitly disclose this limitation prior to purchase;

(4) one company provided donors with reports that showed conflicting predictions for the same DNA and profile, but did not explain how to interpret these different results; and

(5) follow-up consultations offered by three of the companies provided only general information and not the expert advice the companies promised to provide.

Varied risk prediction from each company grossly undermines each company’s claim of superiority and accuracy, weakening the reliability of the test results. For example, a male “consumer,” age 48, received three different results about his risk for hypertension. One company claimed he had a below average risk of developing hypertension, a second company stated his risk was average, and a third company noted his risk was above average. Accordingly, if a real consumer would integrate this information to make lifestyles changes as advocate by one of the companies, he may be incentivized toward undesirable health behaviors based on a mistaken belief of lower risk.

A widely circulated YouTube video documented some companies’ dangerous blurring of risk and diagnosis during follow up with company representatives. Here is one example:

Fictitious consumer: “So if I’m high risk, does that mean I’ll definitely get breast cancer?”

Company representative: “You…you’d be in the high risk of, you know, pretty much getting it.”

The GAO classified this exchange as “horrifying” and “disconcerting.” It leads me to wonder how many real consumers received similar devastating and incorrect information when they attempted to follow up their own test results? How many went to their physicians with these results and remained unconvinced when the physicians attempted to reassure them? In the near future, these companies should brace themselves for the legal backlash that is sure to follow from consumers who experienced such troubling exchanges and may vent their anxiety and frustration in the form of legal complaints alleging negligence and emotional damages.

Before Congress

During the hearing on the Hill, Rep. Griffith echoed this cautious sentiment, suggesting when confronted with alarming genetic risk information, consumers are likely to panic first and ask questions later. The Genomics Law Report provides a summary of the hearing here.

Despite GAO’s conclusion that DTC companies provide results that are “ambiguous and misleading,” Rep. Burgess and Rep. Waxman voiced their disfavor of overly intrusive regulation and advocated for a system that would still allow consumers to access their personal genetic information.

However, the GAO report illustrates precisely why the model for these tests will continue to encounter problems without the guidance of a physician as gatekeeper and interpreter. In another exchange recorded on the YouTube video, a company representative tells one “consumer” he can eventually stop taking his prescription medicine for high cholesterol if he purchases and uses the company’s pricey vitamin supplements. Advice connecting risk to behavior and medication changes should require a visit to a healthcare provider, not a phone call to a faceless company representative with uncertain credentials.

Even if a company’s test is accurate and it ceases to disseminate misleading advice about the power of its supplements, consumers still want (and need) additional information and advice from healthcare professionals to interpret and act on the test results they receive.

-Katherine Drabiak-Syed

Berkeley Scheduled to Move Forward with Freshmen DNA Testing

Yesterday, Berkeley’s student newspaper The Daily Californian published on op-ed questioning Berkeley’s decision to move forward with its experiment designed collect DNA from consenting incoming freshman. The “Bring Your Genes to Cal” experiment originally made headlines over a month ago, when the New York Times and other major newspapers described the program and the corresponding polarized responses. In a few weeks, Berkeley is scheduled to send out information packets, informed consent forms, and buccal swab kits to the incoming freshman class to test for genetic variation related to their ability to process lactose, metabolize alcohol, and examine their levels of folic acid.

Mark Schlissel, MD, PhD, Professor of Immunology and Dean of Biological Sciences at Berkeley views the program as a lesson of how genetics and personalized medicine will impact students’ lives in the future. “We wanted to give students a sense of what’s coming, through genes that can provide them with useful information. I think it’s one of the best things we’ve done in years,” said Schlissel to the New York Times. Schlissel described how the campus will hold seminars and forums in the fall to discuss the significance of personal genetic information.

Despite Schlissel’s enthusiasm, the program is not without criticism. Jesse Reynolds, a policy analyst at the Center for Genetics and Society, acknowledged that educating incoming students on new genetic technologies can indeed constitute an important teachable experience, but raised several cautionary notes. First, Reynolds questioned whether students will freely consent to the test or whether they will feel subtle social pressure to submit a DNA sample. Second, and importantly, Reynolds asserted that by suggesting freshmen’s participation in this experiment, Berkeley is legitimizing or promoting the direct-to-consumer genetic testing industry.

As recent Berkeley alumnae Jillian Theil pointed out in her op-ed on Monday, the scientific validity of these tests when they are offered by direct-to-consumer (DTC) companies is still unknown. Earlier this month, the FDA stepped forward to assert that tests offered by companies such as 23andme and Navigenics are in fact invitro devices and fall under FDA review. But until the FDA and the companies offering DTC genetic tests work through the regulatory process, the current DTC genetic tests’ analytical and clinical validity remains uncertain.

Problematically, students will not fully learn about the complexities of federal regulation, genetic information, and how to contextually interpret it until after they receive their results during the fall discussion sessions on campus. Contrary to Schlissel’s categorization of these variants as innocuous information, bioethicist George Annas argued that a college student’s genetic variant relating to alcohol metabolism is far from harmless. “What if someone tests negative, and they don’t have the marker, so they think that means they can drink more? Like all genetic information, it’s potentially harmful,” asserted Annas in the New York Times.

Theil’s title hit the mark: proceed with caution, indeed. Students should know that similar tests offered in the marketplace are in the middle of potentially sweeping regulatory changes. Even if Berkeley’s tests are accurate, as Annas noted, students should interpret their genetic information carefully (should they choose to participate) and forgo basing any lifestyle decisions on their results.

--Katherine Drabiak-Syed

Direct-To-Consumer Baby Gender Mentor Test in a Three Year Stalemate

In 2005, news headlines excitedly shared the latest development in direct-to-consumer testing: the Baby Gender Mentor early prenatal gender detection test. Acu-Gen Biolab, Inc., a company based in Lowell, Massachusetts, claimed that as early as five weeks, pregnant women could use a simple finger-prick test to obtain a blood sample and send it to Acu-Gen who would use “established qPCR technology analysis” to determine their baby’s sex. Originally claiming their $275 test was “infallible” and 99.9% accurate with a 200% money back guarantee, many expectant women relying on Acu-Gen’s claims eagerly purchased the test.

Months later, numerous accusations surfaced relating to the accuracy of the test, Acu-Gen’s failure to honor the warranty policy, and more disturbingly, allegations that C.N. Wang, PhD, President of Acu-Gen, advised several women that the results of their gender detection test conflicted with their ultrasound results because their baby had chromosomal abnormalities or a fetal “defect.” As a result of this alleged medical advice, many women sought further testing and procedures to determine whether their baby did indeed have a chromosomal abnormality. In addition to enduring the tremendous anxiety caused by Wang’s statements, these women underwent additional procedures such as extra ultrasounds, amniocentesis, and chromosomal testing, accumulating costly and unnecessary expenses.

Why is this seemingly dated piece of news still an issue? Because it has yet to be resolved. Although thepregnancystore.com, a prior vendor of the test no longer carries the product, The Baby Gender Mentor website still sells the potentially dangerously misleading early prenatal gender detection test.

In early 2006, New Jersey law firm Gainey & McKenna filed a class action law suit, Blumer, et. al. v. Acu-Gen Biolabs, Inc., et. al. on behalf of over 100 women who purchased the Baby Gender Mentor test, claiming among other things, that Wang and Acu-Gen’s deceptive advertising, misrepresentation of the test’s accuracy, and illusory guarantee induced them to purchase an inaccurate test and caused them corresponding harm, amounting to eight counts of legal violations.

In the complaint, Blumer et. al. requested:

(1) profit disgorgement and restitution, which would recognize Acu-Gen’s unfair business practices and require them to pay Blumer and the women back, thus honoring their money back guarantee;

(2) compensatory damages, to compensate women for any other undue expenses such as the hundreds or thousands of dollars spent on additional medical testing to clarify whether their baby suffered from a chromosomal abnormality;

(3) punitive damages, to penalize the defendant’s wrongdoing and serve as a deterrent to similar companies; and

(4) injunctive relief to prevent Acu-Gen and Wang from further marketing, selling, and profiting from the test.

Acu-Gen maintains their product works, and Wang has referred to the allegations as “totally bogus.”

Although Gainey & McKenna negotiated on behalf of Blumer and arrived at a settlement agreement with Acu-Gen and Wang, according to Barry Gainey, lead counsel for the plaintiffs, both defendants reneged on their settlement agreement. The District Court of Massachusetts denied Blumer’s motion to enforce the settlement, leaving these women and all other similarly situated individuals at square one- susceptible to cutting edge and supposedly infallible technological advancements that leave them aggrieved without effective or timely recourse.

Barry Gainey confirmed that the case is still active and plaintiffs filed a motion to amend the complaint. To clarify this timetable: over three years have passed since filing serious accusations of legal violations, yet there has still not been a hearing on the case’s merits or enforceable settlement. This progression illustrates the inefficiency of the judicial system to address gaps in federal regulation and the potentially grave impact of direct-to-consumer tests.

Like many other direct-to -consumer tests available online, gender prediction tests have been treated as outside the scope of federal regulation. Despite the FDA’s mandate to regulate medical devices used in the diagnosis of disease or other conditions (such as pregnancy), the FDA has thus far declined to regulate the “home-brew” variety to direct-to-consumer tests where a laboratory such as Acu-Gen uses its own reagents and protocols. Thus, the FDA does not regulate the clinical or analytical validity of these tests. The FTC has similarly followed suit in declining to regulate the industry, despite its authority to prohibit false or misleading advertising.

Private remedy through the judicial system is ineffective in addressing the regulatory shortcomings in direct-to-consumer tests. Over three years later, and the women wronged by the Baby Gender Mentor test have yet to receive their day in court. Meanwhile, Acu-Gen continues to market, sell, and profit from a test that at best, is of uncertain validity, and more troubling, may reflect the allegations in the Blumer complaint. How many more aggrieved individuals and how many more years must the public wait until the FDA and the FTC step in?

-Katherine Drabiak-Syed

Translational Medicine, Cancer and Biobanks: Predictive Health Ethics Events at IU

On December 1-2, 2008 the Indiana Health Industry Forum will present From Basics to Bench to Bedside: Emerging Trends and New Developments in Cancer Discovery, Diagnosis and Treatment. The purpose of this summit, the third in a series, is to examine the state of life sciences research in Indiana with a diverse range of individuals and institutions interested in cancer research, diagnosis and treatment. Of particular interest to those keen on predictive health is a panel discussion on December 2nd at 1:00 PM entitled “Tailored Therapeutics and Implications for Regulatory Endpoints.” Panelists include Jerome Yates, MD, MPH, National Vice President for Research at the American Cancer Society, Eric Meslin, PhD, Director of the Indiana University Center for Bioethics (IUCB), Lawrence Lesko, PhD, FCP, Director of the Office of Clinical Pharmacology at the FDA’s Center for Drug Evaluation and Research, and Silvana Borges, MD, Medical Officer for the Genomics Group of the same.
   
On December 4, 2008 the Indiana Clinical and Translational Sciences Institute and IU Simon Cancer Center are hosting a symposium entitled Biorepositories: Scientific, Technical and Ethical Considerations at the Cancer Research Institute on the Indiana University – Purdue University Indianapolis campus. IUCB Faculty Investigator Jennifer Girod, JD, PhD, RN, will be giving a talk on “Ethical and Legal Considerations in Biobanking.” Other presentations will address issues specific to the storage of biospecimens, the extraction and processing of RNA and DNA, tissue procurement, the impact of storage conditions on DNA, and the benefits of biorepositories to research.

On December 8- 9, 2008 the Indiana University School of Medicine will be holding an event that addresses the FDA in the 21st Century: Issues and Their Impact on Medical Technology. This event, which will focus on the future role of the FDA in a changing market, is part of the medical school’s Medical Technology Leadership Forum [Flyer - PDF]. IUCB Director Eric Meslin, PhD, will be moderating a morning session on December 9th specific to ethics and conflicts of interest with Ora Pescovitz, MD, President and CEO of Riley Hospital for Children and Elazar Edelman, MD, PhD, Director of the Harvard-MIT Biomedical Engineering Center. – Amy Lewis Gilbert

The Best Predictive Health Ethics Blogs - May 2008

It was a busy month for predictive health news: the president signed GINA, Francis Collins announced his eminent retirement, bloggers reported from important conferences at Case Western and Cold Spring Harbor, and Google announced the debut of Google Health. These events, and others, are reflected in this month's edition of the best blogs on the ethical issues of predictive health.

Are you diseased? Pre-diseased? Potentially diseased? Greg Dahlmann, blog.bioethics.net. 6 May 2008.
In this insightful post, Dahlmann examines how predictive health is changing our concept of disease. When, exactly, does increased risk = illness? Dahlmann writes:

So we're moving from the concept of disease as a state of impaired function to it representing particular sets of probabilities. In the past you were sick when you had a heart attack. Today, you're sick -- or pre-sick, perhaps -- when you have high cholesterol. What about when it's possible to identify constellations of genes that significantly increase your chances of having high cholesterol, or a heart attack. Would that be considered a disease?

Also see Dahlmann's follow up post on "previvors": Blood Matters. Greg Dahlmann, blog.bioethics.net. 11 May 2008.

NHGRI Director Francis Collins to Step Down on August 1. Hsien-Hsien Lei, Eye on DNA. 28 May 2008.
Lei shares the news the Francis Collins will retire from his post this summer and that Alan E. Guttmacher will become acting director. Lei also some thoughts on Collins' book The Language of God.

In All Fairness. Fred Trotter, Fred Trotter: My life and thoughts, often about FOSS in medicine. 23 May 2008.
Following the news coverage on the release of Google Health, Fred Trotter weighs in on the privacy questions. Trotter argues that Google is not a health care provider and is, therefore, not covered by HIPAA. He writes:

Both Google Health and HealthVault are designed to make the process of dissemination of your health information to people you want them to be disseminated to easier. Are they doing that in a secure, privacy respecting way? Excellent question; fodder for further posts. Should they be covered by the same laws that cover your healthcare providers? No.

Workman's Compensation, Stereotypes and GATTACA. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 10 May 2008.
Murphy addresses a few of the potential social consequences of predictive medicine, by examining the following scenario:

Young person goes to 23andME/Navigenics/ETC (They just may add this immediately)....gets predictive testing indicating that he is at a 300 fold increased risk of herniating a disc in his back. Avoids manual labor (plays video games all day) never herniates the disc. Did we do society a service?

23andMe, deCODEme and Navigenics at Cold Spring Harbor. Daniel MacArthur, Genetic Future. 9 May 2008.
MacArthur reports, first hand, from the "Biology of Genomes" meeting at Cold Spring Harbor. In addition to the big players in the consumer genomics movement, the speakers at the event included some ethics and policy experts, like Kathy Hudson from Johns Hopkins. Hudson, MacArthur notes, "responded to the problem of patients being given data of very limited predictive value with a very sensible solution: 'In the absence of demonstrable harm, the default should be to provide the information.'"

Genetic testing ethics - consent forms becoming incomprehensible. Elaine Warburton, Genetics and Health. 7 May 2008.
Warburton covers the Translating ELSI, Ethical Legal Social Implications of Human Genetics Research conference at Case Western University in Cleveland. In this entry she reports on Laura Beskow's comments regarding informed consent and the attitudes and concerns of research participants. Also see Warburton's related coverage of pediatric research ethics discussions at the conference in her post: Genetic Ethics - testing and storing our kids’ DNA. Genetics and Health. 7 May 2008.

The FDA ditches the Declaration of Helsinki. Stuart Rennie, Global Bioethics Blog. 6 May 2008.
Stuart Rennie of Global Bioethics Blog examines the implications of the FDA's decision to abandon the Declaration of Helsinki. While Rennie focuses on the potential impact of this decision on US research overseas, and not specifically on predictive health research, this decision may have far reaching consequences on clinical trials of any sort. Rennie concludes with the following verdict: "the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad".

GINA Series: Irrational Bureaucratic Risk Abhorrence [Page 1]. Andrew Yates, Think Gene. 24 May 2008.
This is the first post of a (thus far) four part series on GINA. Each post begins with the introduction:

Recently, President Bush signed GINA, the Genetic Information Nondiscrimination Act, into law. GINA makes it illegal for employers or health insurers to discriminate based on genetics. Virtually the entire genetics community has lauds this legislation, yet few have written why it's wrong that employers and services review objective facts to make decisions. … “It’s not fair…” but why?

The Puzzling Consensus in Favor of the Genetic Information Nondiscrimination Act. Eric Posner, The University of Chicago Law School Faculty Blog. 6 May 2008.
In what may be the most influential post covered in this edition of the best predictive health ethics blogs, Chicago Law professor Eric Posner examines the GINA and asks some compelling questions:

Should the insurance company be permitted to offer the cheap insurance policy only to people who obtain a doctor's certification that a genetic test shows that they belong to the low-risk group? If you think that insurers should be able to discriminate on the basis of visible markers and on the basis of simple doctors' tests for the presence of dangerous diseases, then you should think they should be able to discriminate on the basis of genetic tests. There is no morally relevant distinction between looking at a person's blood for the evidence of infection and looking at his DNA for evidence of susceptibility to a disease. ... The only explanation for the enthusiasm for GINA is that there is an inchoate feeling among people that there is something wrong with the way the insurance market operates.

Medical Genetics Is Not Eugenics. Gabriella Coleman ("biella"), What Sorts of People. 16 May 2008.
Coleman responds to Ruth Cowan’s article in The Chronicle of Higher Education, “Medical Genetics Is Not Eugenics”. Although Cowan sees little value in thinking about the similarities of modern medical genetics and the mid-century eugenics movement, Coleman cautions:

Even if, as [Cowan] rightly states that genetic testing is oriented primarily toward easing human suffering, genetic testing is still entangled with fraught ethical questions about what types of life we value, what is acceptable human life, and what is not—the very sorts of questions central to eugenics.