An ERISA Defense Conference with Nine “Renowned Federal Judges”

On Health Reform Watch we’ve written quite a bit about transparency, accountability and gifts as it regards Pharma and Physicians. I saw this today on Illness and Insurance Hell, a rather wide ranging and interesting blog devoted to procuring assistance to a spouse with multiple sclerosis. The author takes a macro view, however, and this wound up in her web: A conference held, it seems, yearly now, in October:

“ERISA LITIGATION: Expert defense strategies for leading outside counsel and in-house counsel on litigating today’s key issues involving benefit plans and fiduciaries”

For those of you who don’t know, ERISA stands for the Employee Retirement Income Security Act of 1974. (Pub.L. 93-406, 88 Stat. 829, enacted September 2, 1974. Erisa is a

federal statute that establishes minimum standards for pension plans in private industry and provides for extensive rules on the federal income tax effects of transactions associated with employee benefit plans. ERISA was enacted to protect the interests of employee benefit plan participants and their beneficiaries by requiring the disclosure to them of financial and other information concerning the plan; by establishing standards of conduct for plan fiduciaries; and by providing for appropriate remedies and access to the federal courts.

There can be major implications for worker benefits, including  health care benefits, in cases brought against employers under ERISA. It is a complex area of law, to say the least. And it is entirely understandable that those charged with the oversight of such plans, should want to meet to discuss how best to discharge their complex duties; how best to comport themselves in a manner in accord and compliance with law; how best, as is their duty if they are attorneys, to zealously represent their clients.

The conference provides a veritable smorgasbord of effective strategies and interesting panels presented by what seems  to be a truly stellar faculty of practitioners:

Senior in-house counsel, top outside defense litigators and renowned

jurists will provide you with winning strategies and practical information on:

• Preventing improper parties from being named as defendants and identifying available remedies

under §502(a)

• Using the claims review process to set up, control and strengthen the defense
• Effective strategies to strengthen the administrative record and memorialize the decision-making

process

• Addressing evidence outside the administrative record, standards of review, conflicts of interest

& discovery once a suit is filed

• The newest theories of liability in 401(k) fee cases and what to do when your plan discovers it has

paid unknown fees

• Defending against stock drop suits and other defined contribution plan claims
• Tibble v. Edison: the trial, theories of the defense, selection of experts, and other practical insights
• ERISA fiduciary litigation: The newest plaintiffs’ liability theories, substantive defenses and trends

in defense pleadings and motions

• How to structure your fiduciary’s role to minimize risk
• Underwriting of fiduciary liability insurance and strategic ideas for litigating and settling cases

when a fiduciary (and their insurance plan) is involved

• Judicial communication: Explaining plan documents and ERISA nuances to the court
• New areas of liability as a result of healthcare reform
• ERISA preemption - the procedural and substantive aspects of the defense
• Defending against age-based and other “recessionary economy” ERISA claims: Cash balance plans,

early retirement, reductions in force, multi-employer plan funding and beyond

If you’re a law geek (I am), a legal practitioner in this area of the law, a representative of an insurer, or a member of a corporation bound by these laws, this conference looks absolutely fascinating (click here, for an overview, download pdf for the full view). And I have no doubt that attendance will be rewarded with a great deal of newly acquired knowledge and an important grasp of methodology. But the faculty also includes nine “renowned federal judges,” who “will help you convey ERISA complexities to a court.”

Having had the benefit of a legal education, I have some idea of the complexity of the matter at hand ( a quick look here will give you some idea as well)  and can fully understand how judges would want to educate practitioners defending claims so as to better execute and expedite the process.  A case, court system or retirement plan riddled with ignorance is in no one’s best interest. And a knowledge of the law enables compliance with the law.

But I would suggest, humbly, that it just doesn’t look good.  It is, after all, a conference designed to “defend against” ERISA claims. I would be at least somewhat surprised if these federal judges were speaking at a conference for impoverished workers who were deprived of their retirement benefits. If am wrong, I am gladly so. And one could make the case that the many federal judges who teach as adjuncts at law schools across the United States are doing just that–taking time out of an arduous schedule to teach law, compliance and process to what will be both defense and prosecution– because we all benefit from an effective legal system. But this conference seems a bit more–or less– than that; at least in the eyes of smart non-lawyers like the author of Illness and Insurance Hell. To her it just looks like “the fix is in.” Like Big Money is courting the Law and those inviolable robes, the buttresses of justice, have shown a slip. I have a great deal more faith in the Law than that. I capitalize the word without apology. And I have no doubt that this is just a matter of appearances–and that appearances can be misleading. But despite my efforts here, I really don’t think she, who has struggled in the legal system against an insurer to get medical help for her very sick husband, and people like her, will believe me. Or the judges. And that’s a problem.

Developments In Domestic and Global HIV/AIDS Strategies

The White House recently released its HIV/AIDS strategy to reduce the number of new infections in the United States by 25% over the next five years.  During a press conference, President Obama observed that “[t]he question is not whether we know what to do, but whether we will do it.  Whether we will fulfill those obligations… to prevent a tragedy.”  Those obligations primarily concern reducing the number of new infections through HIV prevention programs, increasing access to and quality of care for those living with HIV, and decreasing HIV-related health disparities.  Right now there are 56,000 new infections in the United States every year.  Approximately 1.1 million Americans are living with HIV, but 1 in 5 don’t know it.

Advocates have criticized both the administration and Congress for failing to adequately fund HIV/AIDS efforts at home and abroad.  A recent AIDS Healthcare Foundation (AHF) “Who’s Better on AIDS?” advocacy advertisement unfavorably compared President Obama’s track record to that of President Bush.  (In 2003, the Bush administration implemented the President’s Emergency Plan for AIDS Relief (PEPFAR), a multibillion dollar initiative which has proved successful in lowering the AIDS death rate in Africa, though not the rate of HIV infection).   Michael Weinstein, President of AHF, told CNN that:

“when you see what this administration has done on AIDS, you have to give them very low grades.”

Obama has “consistently underfunded AIDS” programs, Weinstein said.  The president “did not mention the word AIDS for the first five months of his administration.  This national AIDS strategy has been worked on for 15 months, [and] I think it could have been done in 15 minutes.  There’s nothing new in it.”

Weinstein [also] criticized the administration’s intention to redirect money to those groups at greatest risk of contracting HIV/AIDS.  “It’s not good to pit one group against another and it’s unnecessary,” he said.  “The bottom line is that we should be seeking to get all sexually active people to get an HIV test.”

Some recent Canadian research also suggests another bottom line: treating people with HIV reduces the number of new infections.  And there the treatment is free.

The Center for Disease Control (CDC) recently presented its findings that heterosexuals living below the poverty line ($10,000 or less) in American cities were twice as likely to be infected with HIV as their higher-income neighbors.  The statistics translate to 1 in 42 people (the national average is 1 in 222 people).  Most studies focus on sexual orientation, race, and/or intravenous drug use.  None of those factors were included here though.  Kevin Fenton, a CDC HIV/AIDS expert, said that “HIV clearly strikes the economically disadvantaged in a devastating way.”  Researchers found that the risk of spreading HIV came from a lack of access to medical care and unawareness of infection.  Dr. Carlos del Rio, Chair of Global Health at Emory University’s Rollins School of Public Health, frames the issue differently as “[y]ou can talk about ‘Can we decrease the HIV burden in the United States?’  I would say, ‘What can we do to decrease poverty in the United States?’”

The 18th International AIDS Conference took place last week in Vienna, Austria.  Policymakers, researchers, advocates, and persons living with HIV met to draw attention to the epidemic and assess the global response to it.  According to the Associated Press, Julio Montaner, President of the International AIDS Society and Chairman of the Conference, opened the event by pointing to how:

the G-8 group of rich nations has failed to deliver on a commitment to guarantee so-called universal access and warned this could have dire consequences.

“This is a very serious deficit,” Montaner said.  “Let’s rejoice in the fact that today we have treatments that work … what we need is the political will to go the extra mile to deliver universal access.”

With the global economic crisis in full swing, AIDS activists are concerned about developed countries reducing their foreign aid, including funding for AIDS assistance.

In its annual report released last week, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the Kaiser Family Foundation found that global AIDS spending has “flattened.”  Although public and private sources contributed $15.9 billion in 2009, the amount was $7.7 billion short of the estimated $23.6 billion needed to combat AIDS in low and middle-income countries.  Contributing governments included the U.S. (58%), United Kingdom (10.2%), Germany (5.2%), the Netherlands (5%), France (4.4%), and Denmark (2.5%).  The report noted that “without U.S. funding, international AIDS assistance from donor governments would have significantly declined between 2008 and 2009.”

Possible Repeal of Massachusetts Ban: A Gift to Prescribers, Patients or Industry?

Next month marks the second anniversary of the enactment of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, a law requiring pharmaceutical and medical device manufacturing companies to designate a compliance officer and implement a compliance program reflecting the commonwealth’s regulations on meals, CME sponsorship, use of non-patient identified prescriber data, gifts and other payments, etc.  The law, which went into effect on July 1, 2009, builds upon the Pharmaceutical Research and Manufacturers of America’s revised Code  on Interactions with Healthcare Professionals (”PhRMA Code“) and the Advanced Medical Technology Association’s revised Code of Ethics on Interactions with Healthcare Professionals (”AdvaMed Code“), two voluntary codes intended to eliminate any influence — perceived or otherwise — of the industry over healthcare professionals with respect to gifts, entertainment, recreation, educational programs, professional meetings, scholarships, and the like.

The Massachusetts law is more restrictive, however, than its PhRMA and AdvaMed counterparts.  It prohibits companies from sponsoring continuing medical education programs that do not meet Accreditation Council for Continuing Medical Education guidelines.  The PhRMA and AdvaMed Codes do not.  It prohibits any company employee from providing meals outside of a hospital or office setting.  The PhRMA Code only restricts sales representatives and their immediate supervisors to a hospital or office setting.  The AdvaMed Code does not impose any restrictions on the location of meals.

Furthermore, starting on July 1, 2010, the law requires companies to annually certify their compliance with commonwealth regulations and, among other things, to disclose any gifts or payments valued over $50 and given to anyone who can prescribe, purchase, or dispense drugs or devices.  Effectively, it’s a ban on all gifts to prescribers (and in so doing goes a step further than the PhRMA and AdvaMed Codes which make an exception for educational gifts).  Companies must also submit $2,000, payable to the commonwealth’s Department of Public Health, with each annual disclosure report.  Violations can result in penalties up to $5,000 per occurrence.  The first round of disclosures were due 16 days ago and covered activities for the July 1, 2009 to December 31, 2009 period.  Next year companies will be expected to report on their activities for the January 1, 2010 to December 31, 2010 period.  Or will they?

The Massachusetts House recently passed an economic development bill that repeals the disclosure requirement/gift ban (the bill also establishes a sales tax holiday and consolidates commonwealth economic agencies).  The Senate version of the bill does not include the repeal.  It’s a wait-and-see as to how the two chambers will work out the final bill through their conference committee.

Opponents of the gift ban claim it has adversely affected pharmaceutical clinical research as well as the restaurant and convention industries.  Almost two years ago, PhRMA Senior Vice President Ken Johnson expressed his disappointment over the law, saying:

[it is] very likely damaging for medical partnerships, clinical research and patients in Massachusetts….

Public disclosure of a pharmaceutical company’s arrangements with principal investigators of its clinical trials also could reveal sensitive, proprietary business information to a company’s competitors.  This could erode the independent decision-making of companies trying to bring science from research facilities to patient care setting….

The disclosure requirements subjects all of the physicians, academic institutions and hospitals involved in such trials to publicity in a form that may be difficult to understand and likely will generate unwanted and unnecessary public scrutiny.  This could make Massachusetts an unattractive place for academic scientists to live and work — and for pharmaceutical research companies to do business.  Such a policy clearly is not in the best interest of public health — and it flies in the face of the ongoing efforts to further cultivate the life sciences industry within Massachusetts.

Indeed, the Wall Street Journal and Boston Herald report that some medical groups either have threatened to take their annual meetings elsewhere or have actually done so in protest of the law.

Supporters of the law say otherwise.  Health Care For All, a Massachusetts-based advocacy organization, views banning gifts as a step in the right direction.  According to the organization:

[t]he pharmaceutical industry gives gifts to promote their drugs and make a higher profit.  Under the guise of promoting welfare for all, the industry maximizes their own revenue….

Experts living within the guidelines of the gift ban find that it is not interfering with their work or professional relationships according to Dr. David Coleman, Boston University School of Medicine.

‘The Massachusetts Gift Ban legislation is an important step in the process of reducing both biases in therapeutic decision-making and healthcare costs.  The Ban has not adversely impacted the important relationships of our physician-faculty with the pharmaceutical and device industries….’

Health Care For All also maintains there is no connection between the decrease in restaurant revenues and the law as:

[t]he Massachusetts Prescription Reform Coalition has researched the decrease in restaurant profits, and found sales are down across the country — including in states without a gift ban.   According to the trade paper, Restaurants & Institutions, sales at the nation’s top 100 independent restaurants were down 10% in 2009….

Massachusetts Senators, who recognize the value of the gift ban legislation, also see that these lost profits mirror similar recession-caused losses in the restaurant industry across the country.

Georgia Maheras, Private Market Policy Manager at the Massachusetts Prescription Reform Coalition, considers the current House bill to be a “significant step backward” in the fight to curb medical costs.

Massachusetts is not alone in attempting to reform pharmaceutical and medical device marketing practices.  Neighboring Vermont has a similar, and in fact more stringent, law which even allows the Attorney General’s office to track free samples given to physicians (though a reporter for the Times Argus, a Vermont newspaper, worries how a repeal in Massachusetts might have a ripple effect).  California, the District of Columbia, Maine, Minnesota, Nevada, and West Virginia also have some form of a marketing code.  The federal government’s Patient Protection & Affordable Care Act includes the Physician Payment Sunshine Provision (”Provision”) requiring disclosure of payments made to physicians and teaching hospitals by manufacturers of products covered under Medicaid, Medicare, and SCHIP (click here to read a summary).

So who has it right?  It would seem as though PhRMA and AdvaMed opened the door for state and federal government to codify modified versions of these industry codes.  From a compliance perspective, it must be quite inefficient — and headache inducing — to wade through state marketing disclosure laws that lack uniformity.  Starting January 1, 2012, the Provision will preempt state disclosure laws except for where the state requires additional information.  Maybe this will help, maybe it will add to the headache, or maybe this particular episode will no longer matter.   For now, though, from a patient perspective, a repeal of the Massachusetts disclosure requirement/gift ban, or that of any other state, would feel more like a gift to the industry and prescribers than a service to the “best interest of public health.”

The Center for Health & Pharmacy Law & Policy here at Seton Hall Law has issued two white papers addressing these issues: Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” in which the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research; and Drug and Device Promotion: Charting a Course for Policy Reform,” in which the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry– including the recommendation “that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians.”

The Center has also recommended “the adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, ‘the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.’”

Obviously, the adoption of additional federal standards in this regard will lessen the ability of industry to pit one state against another and make compliance easier. The Physician Payment Sunshine Provision is a step in that direction, the Massachusetts development bill is a step back.

Direct to Consumer Genetic Testing — The Need for Early Filtering of Genetic Information

[Ed. Note: We are pleased to welcome Professor Gaia Bernstein to Health Reform Watch. Articles about her recent scholarship, "Over-parenting," may be found at the ABA Journal and The New York Times Magazine.]

Genetic testing for adult onset diseases used to be mainly a medical service. In most cases a person who had a certain genetic disease that was prevalent in her family would go to test to see if she carries the genetic mutation. For example, a woman who had several cases of breast cancer in her family would test for the breast cancer genetic mutation BRCA1/BRCA2 to see if she carries the mutation and has a high probability of getting the disease. But, the proliferation of direct to consumer genetic testing changes the nature of the service to a consumer service. Companies like 23andme and Pathway Genomics (who was planning to start selling its kits in Walgreens) offer consumers the option to buy packages of tests (ranging from 25 to over a 100 conditions). Consumers often buy the tests to satisfy their curiosity or they may even receive them as a gift. People purchasing the testing packages usually do not consult a medical professional when deciding to undergo the tests and receive the results alone by accessing a website.

Yesterday I spoke before the FDA, which is considering regulating direct to consumer genetic testing. My presentation was based on a symposium piece I am working on. I argued for the need for a medical professional to guide people throughout the process and advise them not just on the interpretation of the results but also earlier in the process to determine what genetic information they actually want to have.

Interpreting the results of genetic tests is not easy. Unlike other over the counter tests, like a pregnancy test, which gives a clear positive or negative result, genetic tests are about probabilities. Even a person who tests positive for a certain mutation may still not get sick depending on other non-genetic factors. People have a hard time understanding the results of genetic tests and for that reason there have been many calls to require the guidance of a medical professional for the delivery of the results.

But I believe focusing on the interpretation of the results is only half the issue. It is important to have professional guidance also at the outset to determine what tests to undergo. A medical professional should guide individuals and tailor the panel of tests to the individual who desires to test. Why is that? Well, first of all, some people, if they get a chance to give it some thought, may not want to know all their genetic information. For example, a person may prefer not to know that he is likely to get Alzheimer’s at a young age. Secondly, not all genetic information is made equal. Some genetic tests do not convey that much useful information. For example, a positive result in some tests may only demonstrate a slightly higher likelihood of getting the disease than the probability in the general population. Eliminating such tests at the outset will facilitate the interpretation of the results. It would be possible to focus on the truly important positive results at the end of the process.

To achieve all this it is important for the law to require the guidance of a medical professional who is not a representative of the genetic testing company. A medical professional working for the genetic testing company may have good knowledge of the tests, but could have an interest in having the consumer purchase as many tests as possible. This could place him in a conflict of interest with the consumer who could be best off by purchasing a more limited panel of tests tailored specifically for him.

Cross-Posted at PrawfsBlawg

Sunlight is a Weak Disinfectant

One of the most robust “memes” in contemporary law is the power of disclosure. In health law, disclosure comes up again and again: patients need to give “informed” consent, insurers are supposed to explain their policies clearly, and conflicts of interest, when not proscribed, should at the very least be exposed. But there are growing challenges to the disclosure meme, both within health law and without.

George Lowenstein and Peter Ubel note some problems with disclosure approaches in this article on the weaknesses of behavioral economics generally:

It seems that every week a new book or major newspaper article appears showing that irrational decision-making helped cause the housing bubble or the rise in health care costs. Such insights draw on behavioral economics, an increasingly popular field that incorporates elements from psychology to explain why people make seemingly irrational decisions, at least according to traditional economic theory and its emphasis on rational choice. . . . But the field has its limits. As policymakers use it to devise programs, it’s becoming clear that behavioral economics is being asked to solve problems it wasn’t meant to address.

[T]ake conflicts of interest in medicine. Despite volumes of research showing that pharmaceutical industry gifts distort decisions by doctors, the medical establishment has not mustered the will to bar such thinly disguised bribes, and the health care reform act fails to outlaw them. Instead, much like food labeling, the act includes “sunshine” provisions that will simply make information about these gifts available to the public. We have shifted the burden from industry, which has the power to change the way it does business, to the relatively uninformed and powerless consumer.

The same pattern can be seen in health care reform itself. The act promises to achieve the admirable goal of insuring most Americans, yet it fails to address the more fundamental problem of health care costs. . . . [T]he act tries to lower costs by promoting incentive programs that reward healthy behaviors. . . . [But s]tudies show that preventive medicine, even when it works, rarely saves money.

At its worst, disclosure can become merely pro forma; as Kafka (via Trudo Lemmens) puts it, “Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.” Omri Ben-Shahar has argued that disclosure is one of many aspects of consumer protection law with little real impact on individual welfare. As Amelia Flood reports,

Ben-Shahar, who spent last summer studying all the mandated disclosure statutes in Illinois, Michigan and California, argues that consumer protection advocates have gotten it wrong when it comes to mandating information access for consumers. He says consumers get lost in a sea of technical language, unread disclaimers and long-shot lawsuits. . . . According to Ben-Shahar, disclosures are of more use to consumer ratings groups like Zagat and Consumer’s Digest than they are to most consumers.

So perhaps there is some hope here: third-party aggregators and raters might use disclosures as part of an overall effort to rate various hospitals or doctors. The question then becomes–who shall pay (and rate) the raters? One irony here is that doctor rating sites have themselves been accused of being insufficiently transparent about the ways in which they evaluate physicians. New York Attorney General Cuomo even pursued the matter. His office eventually settled with insurers who ran rating sites. They pledged to “fully disclose to consumers and physicians all aspects of their ranking system.”

What’s the lesson here? First, that consumers are, by and large, too busy to process piecemeal disclosures by professionals like physicians and other health care providers. Second, third party raters can fill some of this information gap by aggregating information. Third, this process of aggregation and rating itself will likely need to be closely supervised by a good-faith regulator, lest it fail to take into account the full range of interests (and quality of information) proper for the task.

Intersecting Issues: Immigration Reform and Health Care Reform

The LA Times reported this past week that the pending health care reform would negatively affect rather than improve the health of California’s citizens.  Why would this be the case?  Nearly thirty percent of the state’s population consists of immigrants.  In L.A. County itself, there are more uninsured residents than any other U.S. county; as the L.A. Times calculates, the majority of that uninsured population are likely immigrants:

It’s a safe bet that the majority of those people are immigrants, because health officials say that 40% of all the patients treated at county hospitals are undocumented. In recognition of that fact and of the hospitals’ legal and ethical responsibilities to treat the uninsured ill and injured — regardless of their immigration status — Washington currently subsidizes their care at facilities, like L.A. County’s, with “disproportionate” numbers of such patients.

The House bill for health care reform would reduce the funding for such subsidies modestly, while the Senate bill would significantly decrease payments towards the subsidies.  Whatever the outcome of the compromise bill, L.A. County will be left worse off.

As we know, neither the House nor the Senate bill would cover undocumented immigrants, or allow them to receive subsidies or tax credits for purchasing insurance.  However, even if the country will not be paying for the health coverage of such immigrants, it will be and already is paying for the high costs of having immigrants treated in emergency rooms, since many hospitals, such as those mentioned in the L.A. Times piece above, treat patients regardless of their immigration status.  Hospitals that provide emergency services and participate in Medicare are required to treat all who come to them for emergency services by the Emergency Medical Treatment and Active Labor Act; some of the costs for the emergency care are covered through Medicaid, while others result in expenditures that the hospitals incur as debt.  The effects of the debt can result in higher hospital fees for other patients.  But greater hospital charge rates for the uninsured are a matter of contention, and tend to obscure the actual value of services rendered and unpaid for. Having said that, it is not unimaginable to think that provisions in the health care bills may actually drive up medical expenses for some segments of the population–and that such increased expenses will have significant adverse affect upon the whole.

Again, the House bill does a better job than the Senate version does at addressing the issue of immigrant health, as the House would allow for undocumented immigrants to participate in the health insurance exchange by permitting them to purchase insurance policies. While the House bill would require immigrants to pay for the policies entirely, the Senate bill does not allow for immigrants to participate whatsoever.  It is worth considering that the immigrant community consists largely of young, healthy individuals; the impact upon the risk pool of their inclusion is no small thing.

Some health care advocates believe that resolution lies in immigration reform, so that immigrants can become citizens of the United States.  An LA Times story about a UCLA study released this last week is also worth considering:

The report said that legalization, along with a program that allows for future immigration based on the labor market, would create jobs, increase wages and generate more tax revenue. Comprehensive immigration reform would add an estimated $1.5 trillion to the U.S. gross domestic product over 10 years, according to the report.

Though many Americans seem to feel that immigrants are taking jobs away from unemployed American citizens, CNN writer Ruben Navarrette, Jr. points out that much of the labor immigrants participate in is in areas of work that Americans themselves have shunned.

Behind the politics of both health and immigration reforms lies the compelling stories of immigrants who have labored in our county and who are in desperate need of health care.  While data and numbers can show the cost-benefits of allowing immigrants to participate in health care, the issue of treating ill humans seems an ethical one– not something to be justified by statistics alone.  But at the heart of this is the simple question, is healthcare a  human right? Or is it a luxury–a “treat,” if you will,  to be dispensed according to the rules of carrots and sticks? and not just a luxury.

Drug Study Fails to Mention Risk of Death to Test Subjects

[Ed. Note: Today's Post is by Maansi K. Raswant, a Seton Hall Law student pursuing the Health Law concentration. She is a research assistant to the Center for Health & Pharmaceutical Law & Policy and an intern at the NYC Health and Hospitals Corporation.]

As reported recently in the Boston Globe, a federal probe found that heart attack survivors enrolled in a clinical trial conducted in over 120 sites nationally had not been adequately informed of the safety risks of the study, including the risk of death.

The process under study, chelation, involves “periodic infusions of a drug– in this case, disodium EDTA.” The infusions are being tested in conjunction with the ingestion of high doses of  vitamins and minerals. However, according to the federal probe, “in 2008 FDA removed disodium EDTA from the FDA’s approved list and withdrew of approval of new drug applications for disodium EDTA.” Test subjects were not informed that disdodium EDTA “is no longer FDA approved for any use and has been removed from the market because of safety concerns.”

Funded by the National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine, the study has over 1,500 subjects. Though researchers suspended enrollment last August due to the investigation, federal officials allowed the study to continue pending further findings of the probe, a decision that has been highly criticized.

In addition to the deficiencies regarding the  informed consent of study participants, the Boston Globe reported that the investigation found that several co-investigators involved in the study had been disciplined for “substandard practices” or had been involved in insurance fraud. Three were convicted felons. Federal officials explained that they found the substandard practices and convictions of the principal investigators “concerning” but not a reason to “automatically preclude an investigator from participating in research.”

The U.S. Office of Human Research Protections detailed the findings of the investigation and required corrective actions in a letter to the three medical institutions heading the study. In response to the investigation’s findings, the study modified the consent form to recognize death as a “rare complication of the EDTA [chelation] infusions.” The Office of Human Research Protections has also requested further modification of the form to disclose that disodium EDTA had been removed from the market.

Despite the change in consent form, questions remain about the acceptability of the risks posed by the study. As the Globe reports, critics of the study, including the head of bioethics at the University of Pennsylvania, Arthur Caplan, have charged that the risks posed by the study are unethical. The complaint against the study filed with the Office of Human Research Protections noted that since “the mid-1970’s court documents and newspapers have reported at least 30 deaths associated with intravenous EDTA.”

The probe is the lastest in a string of major investigations of clinical trials, including the continuing investigation into payments by device maker Medtronic to Dr. Timothy Kulko (who is accused of falsifying author names and  study results), and the Synthes indictment for allegations that its subsidiary, Norian, conspired to conduct unauthorized clinical trials that placed subjects at risk of death without properly informing them of the risks. In the Synthes/Norian matter, three patients are believed to have died as a result of the use of the companies’ bone cement products.

Dr. Collins and the Pope

President Obama’s nomination of Dr. Francis Collins as the new head of the NIH should be unsurprising, given his extraordinary accomplishments in leading the sequencing of the human genome, and fighting for its general accessibility to facilitate research.  Nonetheless, according to the New York Times some apparently object to his appointment due to his public religiosity — these critics demean the merits of his appointment by referring to it as a bone for the religious right.  To the contrary, it should be affirming that the leader of the nation’s research agenda should so publicly value ethical decision-making, especially in a time when we possess the power to accomplish so much that is both extraordinary and potentially destructive of our intrinsic nature as humans.   Whether a public intellectual’s ethical grounding is in religion or a secular philosophy should not become the basis of opposing his leadership; rather, we should celebrate the leader with a firm ethical grounding.

More specifically, religious perspective still has much to contribute to public debate, even when we disagree with that perspective.   Pope Benedict XVI’s June 29, 2009 encyclical, Caritas in Veritate, advocates the Church’s social doctrine, which the Pope presents as being interdisciplinary:

It allows faith, theology, metaphysics and science to come together in a collaborative effort in the service of humanity. It is here above all that the Church’s social doctrine displays its dimension of wisdom. Paul VI had seen clearly that among the causes of underdevelopment there is a lack of wisdom and reflection, a lack of thinking capable of formulating a guiding synthesis, for which “a clear vision of all economic, social, cultural and spiritual aspects” is required. The excessive segmentation of knowledge, the rejection of metaphysics by the human sciences, the difficulties encountered by dialogue between science and theology are damaging not only to the development of knowledge, but also to the development of peoples, because these things make it harder to see the integral good of man in its various dimensions.

Erasmus, Hans Holbein the Younger, 1523

While the Church may not always advance solutions that precisely befit our culture and time, the over-arching philosophy is one that but might provide a useful template for emulation in our own society.  This is particularly relevant as we contemplate whether to create a health care system that would provide universal access to health care in the United States.

Again, the guideposts demarked in Caritas in Veritate speak to the choices that confront us in this perennial public policy debate.  While embracing the value of the market, the Pope suggests that economic activity cannot solve all social problems, thereby requiring that it act in concert with the political community, whose focus should be on achieving the common good.  Driven by commitment to charity and justice, the Pope suggests that “Solidarity is first and foremost a sense of responsibility on the part of everyone with regard to everyone, and it cannot therefore be merely delegated to the State.”  And so I suggest that religiously-grounded social teaching remains relevant to our contemporary debates. We must pursue a system in which each of us has access to health care, which necessarily requires that, in solidarity for our fellow being, those of greater fortune accept the responsibility for those who do not, giving the gift of an opportunity for the basic good of health.