Ethics: September 2010 Archives
A politically influential Florida chiropractor wants Mark and David Geier, proponents of the debunked link between the vaccine preservative thimerosal and autism and hawkers of chelation and Lupron, to have access to the state's confidential vaccine records. The Miami Herald has the infuriating story, and Kathleen Seidel at the neurodiversity blog provides substantial background. Among other things, Seidel reminds us of one very important and relevant fact: When the Geiers mined the CDC's Vaccine Safety Datalink for their dubious research in 2003 and 2004, they were accused of breaching patient confidentiality, and their work was temporarily halted as a result.
Now, she sells...
Yesterday afternoon, the 3-judge panel of the US Court of Appeals for the DC Circuit granted a long-term stay that allows NIH funding of hESC research to continue. The next legal hurdle: The appeals court will decide whether to overturn (not just stay) Judge Royce Lamberth's August 23 injunction against federally funded work on hESC. In yesterday's 1-page order, the court wrote that this appeal will be expedited and that the "parties will be notified by separate order of the briefing schedule and oral argument date."
hESC = human embryonic stem cell.
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
The Great Beyond Blog provides transcript excerpts of yesterday's proceedings between the lawyers and appellate court judges, who focused on the issues of irreparable harm, the definition of research, and whether the text of the Dickey-Wicker amendment is plain or ambiguous. Judge Brett Kavanaugh, a 1990 Yale Law grad, sparred with the plaintiff's Hungar, a 1987 Yale Law grad.* "The problem is that the text is not as plain as one might like, in either direction," declared Kavanaugh, who clearly disagreed with Hungar's "plain text" stance.
About 40-50 spectators were present, according to the GBB, which hesitates to guess at the timing of a decision.
* Brinkmann also graduated from Yale Law: class of '85.
Images, in descending order, are of DoJ attorney Beth Brinkmann, plaintiff attorney Thomas Hungar, and Judge Brett Kavanaugh.
In the ongoing litigation concerning the use of federal funds to support research with hESCs (for reverse chronological background, start here), the plaintiffs (Dr. Sherley et al) raise an interesting fact in their September 14th opposition to the government's emergency motion to stay Judge Lamberth's ruling (which precluded federal funding of hESC research).
In 2001, the Senate attempted to alter the Dickey-Wicker Amendment by inserting the following permissive language, "...Federal dollars are permitted, at the discretion of the President, solely for the purpose of stem cell research, on embryos that have been created in excess of clinical need and will be discarded, and donated with the written consent of the progenitors."
According to Sherley et al, this language is evidence that Congress recognized that federal support of hESC work did not agree with the "plain terms" of the Dickey-Wicker Amendment. Although one could argue, conversely, that such language was added precisely to clarify the terribly ambiguous terms of the Dickey-Wicker Amendment. Nevertheless, the added language was "deleted in Senate floor action," and the 2001 version of the Dickey-Wicker Amendment was repassed in 2002 (and yearly thereafter).
Another interesting tidbit: Although plaintiffs Sherley and Deisher, who work only with adult stem cells, argue that they are at risk of irreparable harm* if/when NIH funds are made available to scientists who perform hESC research, Dr. Sherley himself received $425,500 in NIH grant money under the 2009 guidelines for performing hESC research. But Sherley et al counter that this objection is "a complete non sequitur" and add, "Dr. Sherley's receipt of particular NIH dollars does nothing to vindicate his right to seek additional federal funding free from competition from illegal grant applications."
Brief, oral arguments from both sides are scheduled for Monday, September 27th, before Judges Judith Rogers, Thomas Griffith, and Brett Kavanaugh in the US Court of Appeals for the District of Columbia Circuit.
The latest, revealing court documents from the plaintiffs and defendants (Sebelius et al) are courtesy of yesterday's post at The Great Beyond blog.
hESC = human embryonic stem cell.
* On the basis of the competitor-standing doctrine.
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
Facilities at Iowa's Wright County Egg, the apparent origin of the recent egg-borne salmonella outbreak, tested positive for the disease-causing bacteria, Salmonella enteritidis, at least as far back as 2 years ago. The revelation is made in a letter sent Tuesday by Congressmen Henry Waxman and Bart Stupak, chairmen of the House Investigations and Oversight Subcommittee, to Austin "Jack" DeCoster, CEO of Wright County Egg. Waxman and Stupak cite 28 sample reports, obtained by unclear means,* that reveal at least 73 instances in which Salmonella serogroup D was detected on chickens, egg belts, or "pit rows" in DeCoster's hen houses. The most recent sample report, dated July 26, 2010, revealed that DeCoster's poultry tested positive for serogroup D and ultimately S. enteritidis.**
The publicized testing records, which are incomplete and heavily redacted, show more than 400 instances in which environmental swabs (ie, "sponges") at DeCoster's egg farms were contaminated with various serogroups of Salmonella—B, CI, C2, D, "untypeable," and polyvalent. Isolates revealing serogroups D, untypeable, and polyvalent, detected on samples by the Veterinary Diagnostic Laboratory at Iowa State University (which were presumably taken as a part of routine surveillance testing performed by the company), were then forwarded for species identification to the NVSL, or the National Veterinary Services Laboratory. However, only about half, or 10, of these NVSL results are included in the publicized testing records. Of the available NVSL reports, 8 (80%) revealed S. enteritidis. (The NVSL is a part of the USDA—a fact that raises questions about the government lab's responsibility for further scrutinizing facilities that repeatedly test positive for infectious pathogens.)
The Subcommittee's information gathering, which is ongoing, is in anticipation of the DeCoster's voluntary appearance before Congressional members on Tuesday, September 21 (Hearing on Salmonella Outbreak and Egg Recall, beginning at 12 noon EDT). "Habitual violator" DeCoster, up until now, has been almost Howard Hughes-like in his ability to avoid direct media scrutiny and public accountability for the recent outbreak, the eyebrow-raising conditions at his egg farms, and several past infractions.
Whether DeCoster's S. entertidis isolates are related to the recent salmonella outbreak is currently unknown (or at least unpublicized). DNA characteristics of DeCoster's bacterial samples, including recent samples detected by the FDA, would have to be compared with those of bacteria cultured from infected individuals. The CDC reports that this egg-borne salmonella outbreak is distinct in that DeCosters' eggs are infected internally—meaning through the infection of his chickens' ovaries.
* Waxman's and Stupak's letter indicates that DeCoster provided, on request, documents to the Subcommittee on September 11, but that these did not contain the "potentially positive Salmonella Enteritidis test reults." The congressmen want to know why these reports weren't provided by DeCoster.
** Serogroup D includes the bacterial species S. enteritidis.
Nah. Just messin' with ya.
But medical residents are extremely reluctant to take off work because of illness. While this is a time-honored fact known to anyone and everyone who's spent time in the field of healthcare, MGH resident Anupam Jena nevertheless felt compelled to conduct a survey on the subject—ostensibly to determine exactly what percentage of residents have worked while sick during the course of a year (specifically 2008-2009). The answer, which is printed in a letter to JAMA: 58%.
That's a lowball figure, IMO. When I was a resident [cue younger generation to roll eyes far, far back into head], working 80-plus-hour weeks at HUP and taking every third night call for 2 years [might as well milk it], an intern or resident would never have dreamed of calling in sick unless he or she were already in the hospital—as a patient. Taking the day, and especially the night, off because you weren't feeling well would be like asking to be excused from the Battle of the Bulge because of trench foot. The resentment engendered in your already spent colleagues, who would have to make up for your absence, was simply not worth it, if you had a speck of pride, integrity, martyrdom...whatever.
Image of Saint Sebastian by Guido Reni from Wikipedia.
Orthopedic surgeons don't seem to be particularly forthcoming when revealing their financial ties to industry. Last year, Okike et al showed that about 30% of orthopods presenting at the annual meeting of the American Academy of Orthopedic Surgeons (AAOS) failed to disclose payments—some in excess of $1 million—from medical-device makers.
Now another analysis, by Chimonas et al in the Archives of Internal Medicine, indicates that the disclosure rate is worse among ridiculously compensated orthopods who write journal articles. Among 32 published surgeons who received $1 million or more from device companies,* only 44 (46%) of their 95 articles disclosed a financial relationship. And only 7 articles, all published in The Journal of Bone and Joint Surgery, printed any information about the amount of money received; however, in this case, the disclosure merely revealed that payments were "in excess of $10,000." The investigators, from Columbia University, found that authors were also inconsistent in their disclosure, but that disclosure was significantly more likely if authorship position was prominent—meaning a first, second, or anchor position.
Chimonas et al used the same information as Okike, the OIG-mandated disclosure of physician payments from 5 orthopedic-device companies* in 2007, to assess whether the highest-paid docs are fessing up when disclosure is requested. The authors ultimately assessed the disclosure behavior of 32 physicians who received $1 million or more by cross checking data from the online payment information and 95 printed articles (clinical studies, reviews, meta-analyses, and device evaluations).
OIG = Office of the Inspector General.
** Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer.
Strother Martin in Cool Hand Luke.
Yesterday the US Court of Appeals of DC granted an emergency motion of stay against Judge Royce Lamberth's August 23 order, which banned research on human embryonic stem cells (hESCs). Wrote the appeals court,
The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the [DoJ's] emergency motion for stay and should not be construed in any way as a ruling on the merits of that motion.
The appeals court ordered the appellees (Sherley et al) to file a response to the emergency motion by September 14 and allowed the appellants (Sebelius et al) to file a reply on September 20.
On the basis of the news, NIH officials signaled a tentative OK to restart intramural hESC work and to fast-track pending extramural grants for hESC research.
Background on this story can be found here, here, and here; but in the interest of sheer thoroughness, I recommend coverage of this story by The Great Beyond:
Appeals court temporarily lifts stem cell injunction - September 09, 2010
NIH tells researchers to recommence stem cell work - September 09, 2010
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
Yesterday federal judge Royce Lamberth, the judge who ruled that government funding of research on human embryonic stem cells (hESCs) violates federal law, denied the Obama administration's motion for a stay of his order. "Defendants are incorrect," he wrote in his latest decision, "about much of their 'parade of horribles' that will supposedly result from this Court's preliminary injunction." (For background on this story, go here and here.)
Lamberth continued:
In this Court's view, a stay would flout the will of Congress, as this Court understands what Congress had enacted in the Dickey-Wicker Amendment. Congress remains perfectly free to amend or revise the statute. This Court is not free to do so.
Congress has mandated that the public interest is served by preventing taxpayer funding of research that entails the destruction of human embryos.
Lamberth's ruling also confirmed that "projects previously awarded and funded are not affected by this Court's order," an opinion conceded by the plaintiffs.
However, there appear to be at least 2 sources of confusion regarding Lamberth's ruling, both raised by the plaintiffs:
- Whether the order exempts intramural (ie, on-site) NIH projects.
- Whether the order prevents the NIH from reviewing research applications or maintaining the hESC Registry.
Lamberth advises that motions to clarify these issues "can be expeditiously briefed and decided."
The judge also reveals that plaintiffs will likely file a motion of summary judgment by the end of this week (September 10). Recourse for the Obama administration consists of an appeal and, of course, asking Congress to revise the law.
N.B.—The Nature blog ("The Great Beyond") is all over this ongoing story and provides easy access to relevant court documents.
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
The reason to care about medical ghostwriting is that it may be used to convey drug-industry messages through credited academic authors. In other words, there is an attempt by industry to influence a physician-reader's prescribing practices under the guise of academic objectiveness (although nobody, to my knowledge, has demonstrated this outcome).
But I would argue that the issue of medical ghostwriting is irrelevant when pharma-employed scientists are among the credited authors of articles (which are usually reports of pharma-supported studies). In these cases, the potential for commercial influence in the published material is already obvious, regardless of who actually wrote the article.
Nevertheless, the possibility that there are situations in which medical ghostwriting is immaterial is evidently lost on some (nor will it get in the way of a mission to root out ghostwriting, no matter how immaterial). Case in point:
In a 2-part effort to impugn the marketing of the antidiabetes drug Avandia (rosiglitazone), the Senate Committee on Finance sent a letter to FDA Commissioner Margaret Hamburg on July 12, alleging that manufacturer GSK 1) failed to publish negative studies of the drug "in a timely manner" and 2) hired ghostwriters to pen medical articles that were favorable to Avandia. The former charge, the more serious of the two, has received considerable press attention—most notably in a recent NYT article by Gardiner Harris. However, the ghostwriting charge has not, by any means, been ignored.
In a confusing post at the generally anti-pharma (and often sensationalist, IMO) blog Pharmalot, Ed Silverman asked his readers last Thursday, "Did the American Heart Association's Circulation journal publish a ghostwritten article about Avandia?" Silverman's answer, yes, lies in an exchange of letters among the Senate Committee, the FDA Commissioner, and the AHA. But a closer examination of the letters and the published literature reveals a more nuanced answer than what Silverman concluded (and what his blog readers are likely to be receptive to). A closer examination also reveals how deftly and stubbornly the Committee maintained its ghostwriting allegations against the AHA while failing to acknowledge 1) its confusing and/or mistaken evidence and 2) when medical ghostwriting is an important issue.
In its July 12 letter, the Finance Committee provided 2 attachments to substantiate allegations of Avandia-related ghostwriting by GSK. The first attachment, H (pp 58-109 of 158), contained an e-mail from the Avandia Publication Strategy Manager, who presented a draft manuscript to his GSK colleagues. The manuscript, which reviewed 5 modifiable risk factors for cardiovascular disease, was to be credited to University of Texas cardiologist Steven M. Haffner, MD, and "targeted" to the American Journal of Cardiology, an independent peer-reviewed medical journal that is published by Elsevier. The journal is not affiliated with the AHA.
The text of the redacted and "VERY poorly written"* manuscript mentioned rosiglitazone exactly twice (at the end of the article), both times in conjunction with its chief competitor, pioglitazone (Actos). A notable, suggested edit was to use "Avandia references" in the construction of a table detailing the effects of thiazolidinediones on cardiovascular risks.
The Committee's follow-up attachment I (pp 110-158) contained Haffner's "reworked" and highly condensed manuscript, entitled, "Modifying cardiovascular risk in the type 2 diabetes patient." The title page of the review now indicated the authorship of Haffner and nurse Holly B. Cassells, PhD, who is on faculty at the University of the Incarnate Word [?!]. The title page also acknowledged that the paper was "[s]upported by an unrestricted, educational grant from GlaxoSmithKline" (thereby acknowledging the potential for commercial influence in the manuscript). The heavily redacted text in the attachment mentioned rosiglitazone 4 times (by my count) and highlighted a study of the cardiovascular effects of combined therapy with atorvastatin (Lipitor; Pfizer) and rosiglitazone (Cohen et al, 2001). A GSK e-mail suggested that the review article should now be targeted to another non-AHA journal, Clinical Cardiology (published by Wiley).
In its attachment I to Hamburg, the Committee chased the Haffner review paper with another Haffner-authored article, which was evidently accepted into the journal Circulation, a bona-fide AHA journal. This article, "Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus," described the results of an actual study; in other words, it was not a review article (and it was clearly not the review manuscript previously cited by the Committee in its attachments). The article, published in 2002, had 6 credited authors, 3 of whom (including Martin I. Freed, MD) were acknowledged employees of GSK, and the study's GSK funding was made clear.
On August 23, the AHA responded to the Committee's charges by sending a letter to Hamburg. Donna K. Arnett, PhD, the chair of the AHA's Scientific Publishing Committee, attempted to clarify the distinction between the 2 articles cited by the Committee in its attachments. Arnett noted correctly that the review article was never published in Circulation and was targeted to at least 2 non-AHA journals.** Arnett concluded,
Since Circulation has never published a review article by Haffner and Cassel[sic] entitled, "Modifying Cardiovascular Risk in the Type 2 Diabetes Patient," as claimed in the letter to you, the letter and its appendices are misleading. We have requested that [the Committee] provide a correction for the record.
But not to let details get in the way of a mission, Ranking Member of the Committee, Senator Chuck Grassley, responded to Hamburg with yet another letter, dated September 1. Grassley disingenuously wrote (or one of his staffers disingenuously ghostwrote),
At the time, it was unclear if the emails about ghostwriting concerned the article that appeared in Circulation, or if they were discussing a separate manuscript.
To which I say: Rubbish. The featured, originally ghostwritten review article by Haffner (and then Haffner and Cassells) was the clear subject of the GSK e-mails.
Then Grassley (or his staffer) added, while completely ignoring the cited review article,
Regardless, my staff has consulted with GSK, and the company confirmed that the manuscript which appeared in Circulation was written for GSK by a medical education company.
To which I say, more or less, to the Committee (and Pharmalot): So what? Given that 3 of the 6 authors of the Circulation article were acknowledged GSK employees and that the study was transparently funded by GSK, the potential for commercial influence is obvious to any physician-reader, regardless of who actually wrote the article.
Now as far as the originally ghostwritten review article is concerned, which Senator Grassley (or his ghostwriting staffer) failed to address in the September 1 rebuttal letter, a quick search of the literature reveals that Cassells and Haffner (credited in that order) finally published, “The metabolic syndrome: risk factors and management,” in the Journal of Cardiovascular Nursing in 2006. This journal is not an AHA journal. Because access to the article requires a subscription, I am (at this time) unable to assess the objectiveness of the article, how closely the article adheres to the attachment I text, or whether commercial support is acknowledged.
* As it was described by GSK's Julia Eastgate, Head of Diabetes Communications, Europe, in her e-mail.
** Silverman called Arnett's letter "sharply worded"; on the contrary, I find Arnett's wording moderate in tone and matter-of-fact.
In a 3-part criminal and civil agreement with the Department of Justice, Allergan, the maker of Botox, has dropped its free-speech suit against the FDA—which had the potential to be a pivotal case on the rights of commercial free speech. In addition, the company has pleaded guilty to a single misdemeanor "misbranding" charge, stemming from the off-label promotion of Botox during 2000-2005, and will pay $375 million. Last Allergan will fork over another $225 million to resolve civil claims made by the DOJ under the False Claims Act (concerning qui tam or whistleblower complaints). The plea agreement was announced yesterday in a company press release and also by the DOJ.
According to the government, Allergan, during the described time period, "exploited" an approved indication for cervical dystonia (obtained in 2000) to expand the off-label use of Botox for headache. Company reps were also instructed to call on doctors who typically treat off-label conditions (like pediatric spasticity), and Allergan held workshops to inform healthcare providers on how to be reimbused for injecting Botox off label.
The civil settlement resolved 3 qui tam lawsuits, with whistleblowers Dr. Amy Lang (a former Allergan consultant), Charles Rushin (a former Botox sales rep), Cher Beilfuss (a former Regional Healthcare Policy Manager for Allergan), Kathleen O'Conner-Masse (a former Payor Reimbursement Account Manager for Allergan), and Edward Hallivis (a former I-don't-know-what). They will split $37.8 million.
The current, FDA-approved indications for Botox (not Botox Cosmetic) in adults are the following:
- Cervical dystonia
- Primary axillary hyperhidrosis
- Blepharospasm and strabismus
- Upper limb spasticity (approval obtained March 2010)
In an effort to better understand the legal issues surrounding the use of human embryonic stem cells (hESCs) for research, the following timeline is provided. It is is mostly informed by Judge Royce C. Lamberth's August 23rd decision, which blindsided many researchers who work with hESCs; however, it is also supplemented (and confirmed) by other linked sources.
1960s: Researchers discover, isolate, and begin to work with human stem cells, which are derived directly from bone marrow, peripheral blood, or discarded tissues, like the umbilical cord and placenta. These cells are multipotent, meaning that they can differentiate into a limited number of cell types. Their most notable therapeutic use during the next decades is the reconstitution of bone marrow during bone marrow transplantation.
1996: Congress passes and President Bill Clinton signs the Balanced Budget Downpayment Act, which contains the Dickey-Wicker Amendment. The amendment, or really rider, prohibits the use of federal funds to support research "in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero." Since 1996, Congress includes the Dickey-Wicker Amendment in every iteration of its appropriations bill for the DHHS.
November 1998: James Thomson, VMD, PhD, of the University of Wisconsin, and colleagues report their process of creating stem cells from human embryos. The hESCs are pluripotent, meaning that they can differentiate into any of the 200 or so cell types found in the human body. They can also be maintained indefinitely. The potential of hESC-based research surpasses that of work on traditional stem cells, because the latter are only multipotent, not pluripotent. Creation of the hESCs, however, requires destruction of a human embryo (or really its potential to develop into a human being), which produces a moral/ethical dilemma.
July 7, 1999: The Clinton administration circumvents the Dickey-Wicker Amendment by arguing that hESCs are not embryos as defined by the statute and that research on existing hESC lines should not be prohibited, because it does not destroy embryos. Congress subsequently fails to alter the Dickey-Wicker Amendment.
August 9, 2001: President George W. Bush publicly addresses the use of federal funds to conduct research on hESCs. Informed by his conservative beliefs, he reports to the nation,
As a result of private research, more than 60 genetically diverse stem cell lines already exist. They were created from embryos that have already been destroyed, and they have the ability to regenerate themselves indefinitely, creating ongoing opportunities for research. I have concluded that we should allow federal funds to be used for research on these existing stem cell lines, where the life and death decision has already been made.
June 20, 2007: President Bush issues Executive Order 13435, which expands on his statement from August 2001. The order stipulates,
The Secretary of Health and Human Services (Secretary) shall conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus [emphasis added].
And
...[T]he destruction of nascent life for research violates the principle that no life should be used as a mere means for achieving the medical benefit of another...human embryos and fetuses, as living members of the human species, are not raw materials to be exploited or commodities to be bought and sold...
December 2007: Thomson et al report their success in genetically reprogramming some specialized adult human cells to assume a stem cell-like state. Through the use of viral vectors, these induced pluripotent stem cells (iPSCs) are forced to express genes that confer the defining properties of ESCs. The NIH later warns, however, that, although iPSCs meet the defining criteria for pluripotent stem cells, it is not known if iPSCs and ESCs differ in clinically significant ways. Moreover, in animal studies, the virus that is used to introduce stem cell factors sometimes causes cancers. According to the NIH, researchers are investigating nonviral delivery methods. If iPSCs become, for all practical purposes, equivalent to ESCs, their use cannot be objected to on the basis of the destruction of human embryos.
March 9, 2009: President Barak Obama issues Executive Order 13505 (Removing Barriers to Responsible Scientific Research Involving Human Stem Cells), which states that the DHHS Secretary (Kathleen Sebelius), through the NIH Director (Francis Collins, MD, PhD), "may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law." The executive order pertains to extramural NIH-funded stem cell research. The executive order revokes the President Bush's statement of August 9, 2001 and his follow-up Executive Order 13435 of June 20, 2007.
April 23, 2009: In response to Executive Order 13505, the NIH publishes draft guidelines, "National Institutes of Health Guidelines for Human Stem Cell Research," which allow for the funding of research with hESCs "that were derived from human embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose." The NIH receives approximately 49,000 comments on the draft guidelines.
July 7, 2009: The NIH publishes its final guidelines for scientific work on hESCs, with a number of stipulated conditions for their use. The guidelines also acknowledge,
Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted this provision as not applicable to research using hESCs, because hESCs are not embryos as defined by Section 509. This long-standing interpretation has been left unchanged by Congress, which has annually reenacted the Dickey Amendment with full knowledge that HHS has been funding hESC research since 2001. These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo’s destruction, for which federal funding is permitted.
August 19, 2009: Plaintiffs James L. Sherley, MD, PhD, Theresa Deisher, PhD, Nightlight Christian Adoptions (“Nightlight”), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association (“CMA”) file suit in the US District Court for the District of Columbia against Kathleen Sebelius et al. The plaintiffs seek declaratory and injunctive relief to prevent the NIH's Guidelines for Human Stem Cell Research from taking effect. Specifically plaintiffs argue that the NIH guidelines violate the Dickey-Wicker Amendment.
October 27, 2009: Judge Lamberth dismisses the plaintiffs' suit, finding that the plaintiffs lack standing. Lamberth also denies the plaintiffs' motion for a preliminary injunction as moot. The plaintiffs appeal.
June 25, 2010: The Court of Appeals reverses, concluding that Drs. Sherley and Deisher, who work with adult stem cells, had standing under the competitor-standing doctrine. Because the other plaintiffs did not contest the Court’s prior finding, the Court of Appeals treats "their lack of standing as conceded." The Court of Appeals then remands the matter back to the US District Court for the District of Columbia to consider the plaintiffs’ motion for a preliminary injunction.
August 23, 2010: Judge Lamberth rules "that the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of hardships, and public interest considerations each weigh in favor of a preliminary injunction." Lamberth agrees that federal funding of hESC research increases competition for limited NIH funds, thereby causing an "actual, imminent injury" to Drs. Sherley and Deisher. "Accordingly, plaintiffs would suffer irreparable injury in the absence of the injunction," Lamberth writes. Moreover, Lambert concludes that the imminent injury to Drs. Sherley and Deisher outweighs any potential harm to individuals who may otherwise benefit from hESC research. He concludes, "It is not certain whether ESC research will result in new and successful treatments for diseases such as Alzheimer’s and Parkinson’s disease." Lamberth did not agree with the defendants that the Dickey-Wicker Amendment is ambiguous (thus allowing for the distinction between the creation of hESC lines—which necessarily destroy an embryo's potential to develop into a human being—and subsequent research on extant hESC lines). On the contrary, he ruled that adherence to the amendment is in the public interest.
Here, the will of Congress, as expressed in the Dickey-Wicker Amendment, is to prohibit federal funding of research in which human embryos are destroyed. Accordingly, it is in the public interest to enjoin defendants from implementing the Guidelines because the Guidelines allow federal funding of ESC research, which involves the destruction of embryos.
August 31, 2010: The Justice Department files an emergency motion, asking Judge Lamberth to temporarily stay his ruling, while the government appeals.
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
