NEW JERSEY SUED FOR CONSTITUTIONAL VIOLATIONS IN DENYING IMMIGRANT PARENTS ACCESS TO STATE-FUNDED MEDICAID

Class Action Seeks Relief for 12,000 Lawful Permanent Residents Affected by Immigration-Based Medicaid Cuts

NEWARK, NJ - Seton Hall Law School’s Center for Social Justice and Gibbons, P.C., filed a class action complaint today in New Jersey, alleging that the State’s Department of Human Services (”Agency”) is violating permanent residents’ equal protection rights under the United States and New Jersey Constitutions by denying them State-funded Medicaid because of their alienage and immigration status. The Plaintiffs, many of whom work at low-wage jobs, are lawful-permanent-resident parents in New Jersey, who because of their low-income were deemed eligible to receive and, until recently, did receive State-funded Medicaid known as New Jersey FamilyCare (”NJFC”). Citing the State’s financial crisis, however, in April and July of this year, the Agency terminated Plaintiffs’ Medicaid coverage, stating that Plaintiffs were no longer eligible for NJFC because they have not been lawful permanent residents for at least five years.

The complaint describes the harm experienced by the nearly 12,000 low-income, lawful permanent residents affected by those cuts: without NJFC assistance, Plaintiffs can no longer afford regular checkups, preventive care, and treatment for serious illness. One of the named plaintiffs, a single mother with two small children, had surgery to remove a kidney in 2007. She is now unable to afford monitoring of her kidney problems or medical care in the event of future illness. Two other plaintiffs-working parents from Haiti and Ecuador-required emergency medical care last month, but after being terminated from State-funded Medicaid, were unable to pay for such treatment. Several of the Plaintiffs have family histories of heart disease, high cholesterol and diabetes and worry that without regular check-ups and preventive care, they will be unable to prevent irreversible damage to their health.

The complaint alleges that by singling out this group of immigrants for termination of their healthcare coverage, the Agency is discriminating against plaintiffs on the basis of their alienage and immigration status in violation of the equal protection guarantees of the Federal and State Constitutions.

“Not only is it unconstitutional to distinguish between New Jersey residents on the basis of their alienage and immigration status when dispensing critical health care assistance-it is counterproductive,” said attorney Jenny-Brooke Condon, an Associate Professor at Seton Hall’s Center for Social Justice. “Many of the 12,000 lawful permanent residents affected by these State-Medicaid cuts are hard-working residents of the State, who pay taxes and support their families by working inlow-wage jobs. Ensuring that the working poor receive essential, preventive healthcare and treatment for illness keeps New Jersey residents healthy, which, in turn, keeps them working.”

Many of the Class Representatives named in the lawsuit expressed outrage at being singled out for healthcare cuts on the basis of their immigration status. “I work hard, pay taxes, and play by the rules; I am a lawful resident of this State,” said Class Representative Nadia Chery, a native of Haiti who works as a home healthcare aide. “So when the government said it was cutting my benefits because of my immigration status, it was as if I had done something wrong because I am an immigrant. I felt that I was being discriminated against.”

Class Representative Manual Guaman, a native of Ecuador who works as a cook to support his wife and three small children, described the anguish he felt when he suffered a severe allergic reaction in July after losing his NJFC assistance. “I didn’t know what to do. Should I get treatment at a hospital, knowing I will not be able to afford the bill, or should I take my chances that I will get better?” said Guaman. “I decided to go to the hospital, thinking that if I became sicker I might not be able to keep working and support my family. Being healthy for my family is my first priority.” But Guaman added that not being able to pay the hospital bill he received after his July emergency room visit has discouraged him from seeking follow-up care and additional medical assistance.

In addition to asserting equal protection claims, the complaint alleges that in denying Class Members NJFC assistance, the Agency has also violated a New Jersey statute governing the State Medicaid program. That statute provides that both citizens and lawful permanent residents are eligible for State-funded Medicaid. The complaint filed today amends a complaint filed by Plaintiffs on June 29, 2010, and newly challenges the Agency’s July 6, 2010 regulation, which the Agency published only after it had already terminated most Class Members’ NJFC assistance. Plaintiffs seek a declaration from the court that the agency’s actions and regulation violate the Federal and State Constitutions and the NJFC statute, and also seek injunctive relief restoring Class Members’ NJFC assistance.

A copy of the complaint can be found at http://law.shu.edu/ProgramsCenters/PublicIntGovServ/CSJ/upload/Guaman_Amended_Complaint.pdf

Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching with a strong focus on clinical education. The Center for Social Justice, a core of Seton Hall Law School’s Catholic mission, provides clinical education and volunteeropportunities to students and engages in various forms of advocacy, scholarship and direct legal services in an effort to secure equality, civil rights and legal protection for individuals and communities in need. Seton Hall Law School is located in Newark. For more information visit, http://law.shu.edu/.

The law firm Gibbons P.C. sponsors the John J. Gibbons Fellowship in Public Interest & Constitutional Law under the guidance of John J. Gibbons, former Chief Judge of the United States Court of Appeals, Third Circuit, and Lawrence S. Lustberg, Director of the Gibbons Fellowship Program. The Gibbons Fellowship, supported by the broader resources of the firm as a whole, undertakes public interest and constitutional law projects and litigation. Working with a broad cross-section of public interest groups, the Fellowship Program has become widely known in New Jersey and nationally as a voice for the poor and underrepresented. The Fellowship has been and remains involved in the most significant and controversial issues that confront the Federal and State courts today. For more information visit http://www.gibbonslaw.com/about/index.php?view_page=3

Fourth Annual Student Health Law Conference To Be Held at Seton Hall Law on October 22nd

The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path on Friday, October 22, 2010, in Newark, New Jersey.

This conference, which is attended by law students from law schools throughout the country, seeks to expose law students to the myriad career paths for attorneys in health and life sciences. The conference provides an introductory session on health law, panels on a variety of employment opportunities in health law, and a networking reception with the conference speakers. Career paths that will be represented include academia, compliance, private firms, government agencies, nonprofit organizations, drug and device companies, health insurers, and hospitals. Speakers for this year’s conference have been chosen for their health law expertise and background.

The format of the conference is a series of panels focused around a particular kind of health law career. Each panel is approximately one hour long and comprised of two to four panelists. Students will have the opportunity to explore nontraditional employment opportunities across the health law spectrum, receive support and guidance from professionals familiar with the experience needed for various careers as well as recruitment and hiring processes, and network with health law attorneys.

Interested in learning more about career paths for attorneys in health and  life sciences?  Click here for information on attending the conference.

Contesting Depression

Social disagreement about the medicalization of experience is intensifying. Psychiatrist Allen Frances complains that the draft DSM is too quick to pathologize grief:

A startling suggestion is buried in the fine print describing proposed changes for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders — perhaps better known as the D.S.M. 5, the book that will set the new boundary between mental disorder and normality. If this suggestion is adopted, many people who experience completely normal grief could be mislabeled as having a psychiatric problem.

Suppose your spouse or child died two weeks ago and now you feel sad, take less interest and pleasure in things, have little appetite or energy, can’t sleep well and don’t feel like going to work. In the proposal for the D.S.M. 5, your condition would be diagnosed as a major depressive disorder. . . .[This change] would give mentally healthy people the ominous-sounding diagnosis of a major depressive disorder, which in turn could make it harder for them to get a job or health insurance. . . .

Grieving is an unavoidable part of life — the necessary price we all pay for having the ability to love other people. Our lives consist of a series of attachments and inevitable losses, and evolution has given us the emotional tools to handle both.

Moving from the end of life to the beginning, another commentary mentions worries that quiet and listless preschoolers may be pigeonholed as depressed:

Today a number of child psychiatrists and developmental psychologists say depression can surface in children as young as 2 or 3. . . . [But c]lassifying preschool depression as a medical disorder carries a risk of disease-mongering. “Given the influence of Big Pharma, we have to be sure that every time a child’s ice cream falls off the cone and he cries, we don’t label him depressed,” cautions Rahil Briggs, an infant-toddler psychologist at Children’s Hospital at Montefiore in New York.

Though research does not support the use of antidepressants in children this young, medication of preschoolers, often off label, is on the rise. One child psychologist told me about a conference he attended where he met frustrated drug-industry representatives. “They want to give these kids medicines, but we can’t figure out the diagnoses.” As Daniel Klein warns, “Right now the problem may be underdiagnosis, but these things can flip completely.”

Both stories foreshadow larger struggles over the meaning of “health” in risk societies where there is less margin for error or “underperformance” at work or school. Virtually any wealthy New Yorker with small children has a story about the crucial “pre-school interviewing process,” where elite schools can use an hour-long interaction with a child to decide whether or not to accept him or her as a student. On the other end of the income scale, high unemployment means that at-will employees who can’t keep up an adequate reserve of chipper and helpful “can-do” spirit are always at risk of being sacrificed in favor of some member of the reserve corps of unemployed. Business can’t survive if it’s culture is “too nice.” And hiring may end up being driven by whether an “analysis by an organizational psychologist can tell the hirer whether an applicant will have a problem with the manager or team.”

Larger social currents are feeding anxieties about these trends. Some corporate mottos appear to be “get healthy, or else:”

“We have this notion that you can gorge on hot dogs, be in a pie-eating contest, and drink every day, and society will take care of you,” says Harvard Business School Professor Michael E. Porter, who co-authored Redefining Health Care. “We can’t afford to let individuals drive up costs because they’re not willing to address their health problems.”

Hence the wellness fixation at companies as varied as IBM, Microsoft, Harrah’s Entertainment, and Scotts. Employees who voluntarily sign up for such programs often receive discounts on health-care premiums, free weight-loss and smoking-cessation programs, gratis gym memberships, counseling for emotional problems, and prizes like vacations or points that can be redeemed for gift cards.

M. Todd Henderson assures us that “corporate nannies are superior to their state analogs in some cases,” in part because “corporate policies are subjected to more instantaneous feedback from labor markets, which reduces overreaching.” As unemployment climbs and benefits end, that “feedback from labor markets” gets weaker and weaker: employees take whatever job they can find.

What’s the end result of these trends? I can’t predict, but I think Gary Shteyngart’s recent satirical novel provides one template for the workplace of the future. His protagonist, Lenny Abramov, finds that his employer has placed “five gigantic Solari schedule boards” in the office. The boards:

[D]isplayed the names of . . . employees, along with the results of our latest physicals . . . our fasting insulin and triglycerides, and, most important, our ‘mood + stress indicators,’ which were always supposed to read ‘positive/playful/ready to contribute,’ but which, with enough input from competitive co-workers, could be changed to ‘one moody betch today” or ‘not a team playa this month.’ On this particular day . . . one unfortunate Aiden M. was lowered from ‘overcoming the loss of loved one’ to ‘letting personal life interfere with job.’ (57-58)

Ultimately, moods become health problems when they seriously interfere with activities of daily living, including family, work, spirituality, and play. What Shteyngart reminds us is that the demands of work are quite flexible, and always-evolving. Without a robust societal sense of the proper claims of grief and other emotions, economic imperatives are likely to shrink them inexorably. Unlike the film Gattaca, where extant social structures somehow persist in the wake of massive changes in enhancement technology, Shteyngart’s novel describes a world where relatively small changes in self-concept, media use, and aspiration in an elite can fundamentally destabilize societal expectations.

Given the current balance of power between labor and employers, the disciplinary impact of new technology is likely to rise. As Hannah Pitkin puts it, if we are not careful, the very tools invented to reduce suffering may end up increasing it, by making authorities less tolerant of human need:

We have developed astonishing techniques of communication, persuasion, indoctrination, organization. . . . Yet these extraordinary capacities somehow have not made people happy or free or even powerful. . . . We do not direct these, our alleged powers; if anything, they direct us and determine the conditions of our lives, developing with a momentum of their own in ways we cannot foresee and that are often obviously harmful to human life and civilization

The contestation of pre-school and post-death depression concerns fundamental questions about what it means to be human. Circumstances need to be better engineered to accommodate the normal range of human experience. Otherwise a Procrustean drift will result in humans better engineered to to accommodate their circumstances. As Jaron Lanier has written, “When people are told that a computer is intelligent, they become prone to changing themselves in order to make the computer appear to work better, instead of demanding that the computer be changed to become more useful” (36). Perhaps employers without “grief leave” policies should be changed more quickly than employees in search of non-medical solace.

Renewed Efforts to Reduce Industry Funding of CMEs

Last week’s Journal of the American Medical Association (JAMA) reported on the challenges that certain medical schools and medical centers across the country are facing as they decrease or eliminate industry funding of their continuing medical education (CME) programs.  These institutions have shown concern over the potential conflicts of interest when pharmaceutical and medical device companies fund educational programs which could bias future prescribers/customers toward their targeted products.  The adoption of industry-free CMEs could help filter out any potential marketing messages, and leave behind a balanced and evidence-based perspective.  After all, as the New York Times has reported, there are over 700 accredited CME providers in the United States and CME spending hovers around $2.5 billion per year, nearly half of which is paid by pharmaceutical and medical device companies.

Last year, three medical schools declined industry support for their CMEs: the University of Missouri-Kansas City School of Medicine, Nova Southeastern University College of Osteopathic Medicine, and Touro University Nevada College of Osteopathic Medicine.  This past June, the University of Michigan Medical School (UMMS) announced an actual policy change, effective January 1, 2011, whereby the school will no longer accept industry funds, which presently comprise almost 45% of its total CME funding.  UMMS believes contributions from various departments will help offset this sizable loss, as will higher CME registration fees and “less glamorous venues.”  UMMS is the first medical school to introduce such a policy and does so noting “we should take pride in our position as a national leader on this issue.”

This is all well and good, but in light of the enormous industry contributions, the $64,000 question really becomes: “Is Industry-free CME a Sustainable Model?“  And that’s exactly what speakers and attendees asked at the June 25, 2010, PharmedOut Conference entitled “Prescription for Conflict: Should Industry Fund Continuing Medical Education.” The conference was held at Georgetown University (PharmedOut is a Georgetown University Medical Center project funded by the Attorney General Consumer and Prescriber Education grant program.  Its team of physicians and academics lecture on the physician-pharma relationship, and provide access to online and industry-free CMEs).  Dr. Robert Wittes, Physician-in-Chief at Sloan-Kettering’s Memorial Hospital for Cancer and Allied Disease (”Memorial Hospital”), told his colleagues during the Conference that:

[t]here is life in CME after you do something like this.  But you have to be willing to prioritize the activity, such as putting institutional funds toward the balance [previously covered by commercial funds] and/or charge registration fees for CME activities that involve outside physicians.

Memorial Hospital stopped accepting industry money for its CMEs in 2007.  Dr. Wittes acknowledged that “[w]e don’t have these things in hotels in mid-Manhattan anymore; we have them on our own premises.”  Yet he cautioned against any institution from completely severing ties with the industry because there are positive interactions which can result in improved products and commercial science.

For further reading, check out Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy’s whitepaper on “Drug and Device Promotion: Charting a Course for Policy Reform.”  The Center makes several recommendations for overhauling the CME funding mechanism.  It also points out that accountants, lawyers, and other professions pay for their continuing education programs.   Be sure to check out Michael Ricciardelli’s post on industry funding of CMEs for nurse practitioners and Kate Greenwood’s post on ACCME Standards for Commercial Support too.

Good News for Health Care Reform Implementation

HCR implementation is steaming ahead. Jonathan Cohn lays out some of the key issues in a recent article in The American Prospect. A restrictive definition of “grandfathered plans” (which are not subject to the Affordable Care Act (ACA)) was an early victory for consumer advocates. Coverage appeal rules will soon be hotly contested during the rulemaking process:

Even if insurers are required to take all comers at relatively nondiscriminatory prices — “relatively” since age can be a rough proxy for medical condition — they’ll still have financial incentives to restrict care. This isn’t entirely a bad thing: Given the evidence of rampant overtreatment in American medicine, insurers should exercise some check on the use of technology, drugs, and other resources, for the sake of the patients as well as the insurers’ bottom line. But because insurers sometimes deny even necessary care, just to increase profit margins, the law seeks to limit the insurers’ authority — most obviously, by opening up treatment denials to outside appeal.

The idea sounds simple enough: Allow patients convinced they’ve been wrongly denied care to make their case to independent experts with authority to overrule the insurer. But who are the experts? How quickly must they rule? And what’s to stop insurers from ignoring the recommendations? The Obama administration has to write regulations answering all of those questions. A viable, working model exists: The National Association of State Insurance Commissioners has a framework, similar to what’s already in place in several states. HHS will consult those guidelines in devising a new scheme. The model is not perfect, but with sufficiently strong regulations it could give consumers significant new leverage.

Cohn also notes some important appointments at HHS. Having examined her work in the past, I was encouraged by the appointment of Karen Pollitz to “set up an Internet portal to provide basic information about different insurance policies.”

Nevertheless, Tim Jost warns that there are many possible obstacles ahead:
Read more

New Interim Federal External Review Process for Health Insurance Appeals Announced

As reported earlier in New Rules for Insurance Appeals, the departments of Health and Human Services, Treasury, and Labor issued interim final rules on July 23, allowing patient appeals of health insurance coverage.  On August 23, the U.S. Department of Labor, Employee Benefits Security Administration (EBSA) issued Technical Release 2010-01, regarding “Interim Procedures for Federal External Review Relating to Internal Claims and Appeals and External Review” under PPACA.

Looking back at the interim final rules, as they relate to the interim procedures (from New Rules for Insurance Appeals):

Under the rules, new health plans beginning on or after Sept. 23, 2010, must have an internal appeals process for beneficiaries to challenge “adverse benefits decisions” — a “denial, reduction, or termination of, or a failure to provide or make a payment (in whole or in part) for a benefit.”

If the internal appeal is denied, patients may choose to have the claim reviewed by an independent reviewer.  According to Appealing Health Plan Decisions, States are encouraged to adopt the National Association of Insurance Commissioners (NAIC) standards in “their external appeals laws to adopt these standards before July 1, 2011.”  If State laws don’t meet these standards, consumers in those States will be protected by comparable Federal external appeals standards.

The EBSA release “sets forth an interim enforcement safe harbor for non-grandfathered self-insured group health plans not subject to a State external review process, and therefore subject to the Federal external review process.”  The Federal process will apply to plan years beginning on or after Sept. 23, 2010 and will continue until the interim period is over.

The issuer of the “non-grandfathered self-insured group health plans” (hereinafter, “health plans”) is primarily responsible for compliance with the interim final regulations.  During the interim enforcement safe harbor, the Internal Revenue Service (IRS) will not take enforcement action against health plans that comply with either of the two interim methods provided by the EBSA.

1.      Compliance with State external review processes

Health plans may voluntary comply with the provisions of their State’s external review processes.  However, the State must first choose to expand access to their external review processes to health plans that are not subject to relevant State laws.

2.      Compliance with the procedures set forth in the technical release

A health plan may also adopt the external review procedure outlined in Technical Release 2010-01.  The release sets forth procedures based on the Unified Health Carrier External Review Model Act promulgated by the National Association of Insurance Commissioners (NAIC Model Act).  The EBSA procedure requires that an external review may be standard or expedited.

A. Standard Review

Health plans must allow a claimant’s request for external review if filed within four months of the adverse benefit determination.  A preliminary review must be completed by the health plan within five days of the claimant’s request and must determine whether:

a.       The claimant was covered under the plan at the time the service was requested or provided

b.      The adverse benefit determination was related to a failure to meet eligibility requirements

c.       The internal appeals process has been exhausted or is not required

d.      All information and forms required for the external review have been provided

Within one business day of completion, the health plan must provide written notice to the claimant of the health plan’s determination.  If the claimant is not eligible for external review, the health plan must provide the reason for ineligibility.  If the request is incomplete, the health plan must notify the claimant that further information or materials are required and provide the claimant with an opportunity to complete the request.  Health plans must allow the claimant until the end of the four-month filing period or forty-eight hours from the receipt of the notification, whichever is later, to perfect the request.

The health plan must contract with at least three independent review organizations (IRO) to conduct external reviews.  The IROs must be “accredited by URAC or by a similar nationally-recognized accrediting organization.”  An independent, unbiased method for claim assignments, such as rotation or random selection, must be used.  The IRO may not have a financial stake in the outcome of its decision.

The following must be provided in the contract between a health plan and an IRO:

a.       The IRO will utilize legal experts as appropriate.

b.      The IRO will provide the claimant with timely written notification including a statement of the request’s eligibility and acceptance for external review and a statement that claimant may submit additional information for consideration within ten business days of the receipt of notification.

c.       The IRO may choose to consider additional information received ten business days after the receipt of notification.

d.      The IRO must submit all additional information received by the claimant to the health plan within one business day.  The health plan may reconsider its adverse determination and terminate the external review if it decides to reverse its prior determination and provide coverage or payment.

e.       The health plan must provide all documents and information related to the adverse determination within five days; otherwise, the IRO may terminate the external review and reverse the adverse decision.

f.       The IRO will review the claim de novo based on all information and documents timely received.

g.      Within 45 days of the assignment, the IRO will provide written notice of its decision to the health plan and claimant. The decision notice will contain a description of the disputed claim, the date of assignment, and reference to the evidence relied upon and reasoning for its decision.  The notice must provide a statement that the decision is binding to the extent that other remedies may be available under the law and that judicial review is available to the claimant.

h.      The IRO will maintain all records related to a claim for six years and make them available for examination upon request by the claimant, health plan, or government oversight agency.

B. Expedited Review

A group health plan must allow a claimant to request an expedited review when a claimant receives:

(a) An adverse benefit determination if the adverse benefit determination involves a medical condition of the claimant for which the timeframe for completion of an expedited internal appeal under the interim final regulations would seriously jeopardize the life or health of the claimant or would jeopardize the claimant’s ability to regain maximum function and the claimant has filed a request for an expedited internal appeal;

or

(b) A final internal adverse benefit determination, if the claimant has a medical condition where the timeframe for completion of a standard external review would seriously jeopardize the life or health of the claimant or would jeopardize the claimant’s ability to regain maximum function, or if the final internal adverse benefit determination concerns an admission, availability of care, continued stay, or health care item or service for which the claimant received emergency services, but has not been discharged from a facility

The main difference between the expedited and standard review is the timeframe (unsurprisingly).  During an expedited review, the health plan must perform the preliminary review immediately and send notice of its determination immediately.  Upon assignment to the IRO, the health plan must transmit all documents and information related to the claim by any expeditious method.  The IRO must provide notice of the final external review decision as quickly as possible, but no later than 72 hours after assignment of the claim.

Center for Health & Pharmaceutical Law & Policy Submits Comments on Conflicts of Interest in Research to the National Institutes of Health

On August 19, 2010, on behalf of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Seton Hall Law Professors Kathleen Boozang and Carl Coleman, along with Research Fellow Kate Greenwood, submitted comments on the National Institutes of Health’s proposed revisions to its regulations governing conflicts of interest in federally-funded research.  While the Center’s November 2009 White Paper Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight endorsed limits on conflicts of interest beyond those that the NIH has proposed, the revised regulations are a step in the right direction and in its comments the Center commends the NIH for its decisive action on this issue.


Briefly, the Center:

• Supports the NIH’s proposal that that researchers disclose to their institutions any significant financial interest that “reasonably appears to be related to the Investigator’s institutional responsibilities,” with “institutional responsibilities” defined to include “activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.” This comports with the Center’s recommendation in the White Paper that investigators not be charged with determining for themselves whether one or more of their financial interests could be affected by a specific research project.

• Supports the NIH’s decision to significantly lower the monetary threshold at which a researcher’s financial interest becomes “significant” to $5,000, but argues that a lower threshold would be better. Collection of data about all of a researcher’s relationships with industry, even those that fall below the proposed $5,000 threshold, would facilitate better conflict of interest assessment and management and make possible research into the effects of conflicts on research integrity and human subject welfare.

• Supports the NIH’s decision not to exclude income from non-profit entities for lectures and similar engagements from the definition of significant financial interest and its conclusion that any equity interest in a non-publicly traded entity is significant, as are any and all intellectual property rights, but encourages the agency to revisit its decision to shield from disclosure (1) equity interests held by investigators in commercial or for-profit institutions and (2) royalties and other remuneration other than salary paid to an investigator by an institution that appoints or employs him or her.

• Notes that the draft revised regulations do not address the White Paper’s criticisms that the conflict of interest regulations place no “substantive limits on the kinds of conflicts that may exist” and fail to put forth “a required minimum response for conflicts that pose the greatest risks to participants and the integrity of the research” and encourages the NIH to consider again the benefits of setting forth required minimum responses to those conflicts that are the most problematic.

• Supports the NIH’s decision to require that grantees provide “sufficient information to enable the [agency] to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution’s management plan.”

• Supports the requirement in the draft revised regulations that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to PHS-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web.

• Supports the draft revised regulations’ requirement that investigators complete training on “the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations” before the commencement of research and then at least once every two years. As recommended in the Center’s White Paper, it would be beneficial for the training to include as well a discussion of the nature of conflicts of interest and their potential for harm.

• Recommends that the agency adopt its own suggestion that institutions be required to “maintain up-to-date, written, enforced policies” on institutional conflicts of interest, as they are for investigator conflicts, and that these policies be made publicly available via the world wide web. The nudge this requirement would provide is necessary because institutions have been slow to develop and adopt policies on institutional conflicts.

• Recommends that the section of the regulations devoted to remedies be revised to include a non-exclusive list of potential enforcement actions such as temporary withholding of cash payments pending correction of the deficiency, suspension or termination of the contract or grant in whole or in part, monetary assessments and penalties, and suspension or debarment from eligibility for future contracts or grants.

The Center’s comments in their entirety are available here.

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy. The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices.

Florida Attorney General McCollum Falls Victim to Collective Mandate, Loses Bid for GOP Nomination for Governor

Attorney General Bill McCollum, noted of late for spearheading the state suits against the Individual Mandate in health reform, has lost his bid for the Republican Party nomination for governor of Florida. Political newcomer Rick Scott, a self styled “conservative outsider” and former hospital corporation CEO, poured over $30 million of his own money into the race and won the nomination.  According to Fox News/AP, Mr. Scott, who has never run for any office before, “was active last year opposing the health care legislation in Washington.”

With 93 percent of precincts reporting, Scott led McCollum 47 percent to 43 percent.

Fox/AP also reports that the result is the culmination “of months of personal attacks, name-calling and negative TV ads….”

And that

McCollum, who racked up endorsements from big Republican names, hit Scott hard for past Medicare fraud allegations. Scott was the CEO of HCA/Columbia Hospitals when it settled the biggest Medicare fraud case in history — Scott, who was forced out as CEO by his board amid the government investigation in 1997, has said repeatedly that he didn’t know about any criminal activity and was never charged.

Tip of the Hat to JanetHasty via good ol’ twitter.

Finding an Understanding Between Doctors and Patients

A general perception has been that doctors choose their profession over their patients. The perception takes shape as medical professionals sometimes choose to protect their profession over the chance to improve the quality of medical care– whether doctors refusing to report a colleague’s mistake or perhaps even hindering the efforts of a doctor rating system.

So when medical mistakes occur and possible lawsuits are on the horizon, it’s no shock that medical professionals sometimes fail to own up to their mistakes–implementing instead a code of silence about the case to avoid or limit liability.  In a critical time when patients or family members are looking for answers, doctors can be unavailable to provide it for them. It would also not be a shock if, after any such information could be helpful to the patient, doctors did so under the advice of counsel.

However, a study has been recently reported by the NY Times which suggests that perhaps silence may not be the most prudent approach.  According the NY Times,

Since 2001, the University of Michigan Health System has handled patient injuries by initiating discussions with patients and families, conducting internal investigations and offering apologies with offers of compensation should those investigations reveal medical errors. To examine the repercussions of such an open disclosure with compensation policy, researchers analyzed the number of claims and lawsuits filed against the hospital system between 1995 and 2007, comparing data from before and after the policy took effect.

Contrary to fears that such transparency might worsen litigation, the researchers found that there were actually fewer lawsuits and claims after the hospital began its disclosure with compensation program. Moreover, the hospital system’s liability costs for lawsuits, patient compensation and legal fees dropped, and claims in general were resolved faster than ever before.

While it may seem counter-intuitive to admit fault from a litigation standpoint, these efforts at transparency and an acknowledgment have actually decreased the number of lawsuits.  Richard C. Boothman, who devised and carried out the disclosure program, says, “[w]hen you break that paradigm of litigation and give patients the chance to understand the human element of the other side — of the doctor and what they are struggling with — you find that people are far more forgiving and understanding than has been typically assumed.”

It’s an interesting proposition,  disclosure and accountability as both a means to litigation loss reduction and changing negative perceptions of the profession. In revealing the doctor’s ordeal– in disclosing the fault, one may move forward towards greater understanding between patients and doctors.

It’s also worth noting that additional disclosure methods are being studied.  The Wall Street Journal reports a study about a project, known as OpenNotes, where doctors share their notes with their patients electronically.  While doctors do complain that the OpenNotes may be burdensome, there are those who think it it may be worth the additional burden because it shows– perhaps whether or not the handwriting is decipherable–that doctors are willing to take the extra time to attempt to keep them informed.

But of course, it would better if patients actually understood their doctors. But this would be in stark contrast to a recent study we wrote about here on HRW last week. The study showed a woeful lack of communication (and a wide gap in perception) between hospital staff physicians and “their” patients:

• Only 18% of patients knew their main doctor by name.
• Sixty-seven per cent of doctors believed their patients knew them by name.
• Fifty-seven per cent of patients knew their diagnosis.
• Seventy-seven per cent of doctors believed their patients knew their diagnosis.
• Fifty-eight per cent of patients thought that physicians always explained things in a comprehensible way.
• Twenty-one per cent of doctors stated they always provided explanations of some kind.
• Sixty-six per cent of patients reported receiving a new medication in the hospital, 90% noted never being told of any adverse effects of these medications.
• Ninety-eight per cent of doctors stated that they at least sometimes discussed their patients’ fears and anxieties.
• Fifty-four per cent of patients said their doctors never did this.

PPACA and the Growing Shortage of Pediatric Subspecialists

Over the course of this year, a spate of articles and op eds have highlighted a growing shortage of pediatric subspecialists.  Earlier his month, Amy Mansue, CEO of Children’s Specialized Hospital here in New Jersey, addressed the problem in a very interesting post on the National Association of Children’s Hospitals’ With All Our Might blog.  Ms. Mansue describes a recent visit to Capitol Hill during which she discussed the implementation of the Patient Protection and Affordable Care Act, explaining to the staffers that:

[t]he differences between strategies to address the needs of the newly insured children versus strategies to address the needs of adults couldn’t be more different.  Start with the basic fact that there is a critical shortage of specialists in pediatrics, where the biggest issue facing adults is how to access primary care. There can be a utilization of physician extenders in the short run until more primary care physicians are trained; there is no similar ‘quick fix’ in pediatrics.

Pediatric neurologists and developmental-behavioral pediatricians are in especially short supply.  A survey of children’s hospitals conducted by the National Association of Children’s Hospitals and Related Institutions in December 2009 revealed average wait times of 9 weeks for an appointment with a pediatric neurologist and 13 weeks for an appointment with a developmental-behavioral pediatrician.  An earlier study published in Pediatrics found that, in addition to enduring long waits, parents and children also travel long distances to see these specialists–on average 73 miles to see a subspecialist in neurodevelopmental disabilities and 44 miles to see a developmental pediatrician.

This is concerning for a host of reasons, including the importance of early, appropriate intervention to the future success of children with developmental delays.  As I discussed previously here and here, the “right” medical diagnosis can be key to accessing needed services, as can a thorough written evaluation and a doctor willing to advocate on a child’s behalf.  This is true whether a family is fighting for publicly-provided disability benefits or special education services or to get a private insurance plan to pay for medically necessary therapies.

What explains the subspecialist shortage?  As Ms. Mansue puts it, “it is all about math.  There is no incentive to go through an additional decade of training to get paid less than what a pediatric nurse practitioner is now demanding in my home state of New Jersey.”  Congress has tried to change the equation.  PPACA provides for loan forgiveness of up to $35,000 per year for up to three years for pediatric subspecialists who “work for a provider serving in a [Health Professional Shortage Area] or medically underserved area, or among a medically underserved population that has a shortage of the specified pediatric specialty and a sufficient pediatric population, as determined by [HHS], to support the specified pediatric specialty.”  But funding for this measure has not yet been appropriated.  The federal government has also attacked the problem through its Children’s Hospitals Graduate Medical Education Payment Program, which provides funding for specialty training for pediatricians.  According to a recent New York Times op ed, however, this program’s funding is also uncertain, suggesting that an end to the shortage of pediatric subspecialists may not be in sight.

Missouri Votes Against Individual Mandate, May Impact Standing Argument in Federal Court

Recently, Missouri voters overwhelmingly approved a ballot initiative which, according to the AMA’s amednews.com, “ask[ed] voters in part if they want to ‘deny the [federal] government authority to penalize citizens for refusing to purchase private health insurance or infringe upon the right to offer or accept direct payment for lawful health care services.’”

More than 71% of voters approved the initiative which seeks to negate the individual mandate, 29% voted against.

As recent events in California regarding Proposition 8 have shown, a referendum deemed unconstitutional  is without force of law.

In the AMA’s article, it is noted that

Few legal experts consider the state proposals more than symbolic, as federal law generally trumps state law. But lawsuits filed or joined by officials in 21 states challenging the federal government’s authority to require health insurance have the potential to overturn the federal law.

Generalities aside, as is best in this regard, it strikes me that the Missouri initiative may have more than just symbolic value. Importantly, in the recent federal court decision regarding Virginia’s suit against the individual mandate, the judge in that case found standing for the state of Virginia–an exceedingly important, though procedural, ruling. It is exceedingly important because without standing the case could simply not go forward. The judge in the case found standing for Virginia’s 10th Amendment claim largely based upon a law passed subsequent by the state of Virginia. Regarding that matter I wrote:

In deciding the standing issue, Judge Hudson, according to Professor Jack Balkin, made much of the “Virginia Health Care Freedom Act– which asserts that no Virgina citizen may be forced to purchase health care insurance; that this law conflicts with the federal Affordable Care Act, and therefore Virginia has standing to challenge the act under the 10th amendment.”

Virginia’s Act was passed subsequent to the federal law in question; other states challenging the individual mandate do not, at present, have such a law to rely on. As Professor Balkin points out, however, the Virginia Act being deemed sufficient to buttress standing in a States’ rights Tenth Amendment claim is interesting– to say the least. It begs the question.

In more than just symbolic terms, Missouri may have just answered that question–at least in terms of 10^th Amendment standing–if, of course, its federal district court sees the matter in the same way as did Judge Hudson. Certainly not guaranteed– the Missouri Federal Court is not bound by the Federal Court of Virginia– but nonetheless, Missourian’s just laid claim to an argument that has won elsewhere.

Trouble Brewing for Pharmaceutical Companies

Bribery and recalls.  Federal agencies are turning up the heat on pharmaceutical companies.  Were you surprised by the eight recalls of Johnson & Johnson products this year?  Maybe you shouldn’t be.  As HealthReformWatch.com reported in We May Need More Than a Spoonful of Sugar to Help Our Medicine Go Down, drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008.  Bowman Cox, managing editor of the Gold Sheet (which first broke the story) told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year.

Why So Many Recalls?

Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue.

1.   Drug repackaging

Advantage Dose, a now-defunct Shreveport, LA based drug repackager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and relabel drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009.

2.   The generic rush

Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality.  “The first applicant typically gets the lion’s share of the business for the new drug… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug.”  One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009.

3.   Manufacturing lapses

Some experts say the biggest culprits include the quality of raw materials and contamination. Approximately one month ago, HealthReformWatch.com reported in Pharmaceutical Outsourcing: Trading Quality for Lower Costs? that India’s largest pharmaceutical manufacturer had been cited several times in recent years for manufacturing violations.  Additional recalls include vaccines produced by Shantha Biotechnics for Sanofi-Aventis and injectible drugs made by Claris Lifesciences for Pfizer.  The FDA stated its intent on May 5, 2010 to “propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…”

4.   Increased FDA scrutiny of manufacturing facilities

Which came first, the chicken or the egg?  Increased FDA oversight may or may not have led to the increased number of recalls; however, the recalls will probably lead to increased FDA regulatory power.

As Jennifer Jascoll reported, Senator Michael F. Bennet (D-CO) proposed the Drug Safety and Accountability Act of 2010 on August 3, 2010.  According to Bennet’s press release, “[t]he bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.” Currently, the FDA is empowered to issue warnings and recommend that a manufacturer issue a recall.

Two prior bills would also increase FDA powers to mandate a recall:

• The Protect Consumers Act of 2009 (sponsored by Rep. Betty Sutton, D-OH) would require the Secretary of HHS implement a recall if it is determined to be necessary.
• H.R. 6740 (sponsored by Rep. Edolphus Towns, D-NY) would provide the Secretary of HHS with the ability to mandate a recall “if the Secretary has reason to believe that the use or consumption of, or exposure to, a drug (or an ingredient or component used in any such drug) may cause serious adverse health consequences or death to humans or animals.”

According to CNN Money, the FDA has not identified any alarming pattern.  FDA spokeswoman Elaine Gansz Bobo stated, “[s]ince every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year… At this time, however, we have not identified any trends.”  Despite the FDA’s lack of concern, other federal agencies are interested in the practices of pharmaceutical companies.

Further Federal Investigations

According to the N.Y.Times, federal prosecutors and securities regulators are investigating pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act (FCPA).   The FCPA is an anti-bribery law which bars companies from offering foreign government officials items of value for profit.  For instance, Pfizer disclosed in April “that it paid $35m over six months to 4,500 doctors in private practice for education and the development and marketing of new drugs.”  Although this practice is legal in the U.S., such payments are illegal in many foreign countries where physicians are employed by the government.

On November 17, 2009, Assistant Attorney General Lanny A. Breuer stated that the Department of Justice intended to focus its attention on the pharmaceutical industry:

In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCPA unit and our terrific health care fraud unit will be working together to investigate FCPA violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area.

“Corrupt practices” under the FCPA are not limited to cash in envelopes.  Inappropriate payments for lavish hospitality, consulting, licensing agreements, and even charitable donations may raise red flags for government investigators.

Could bribery be contributing to decreased quality and the sudden rise in recalls?  According to the Financial Times, the DoJ is focusing its efforts elsewhere:

[T]he DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 percent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

It appears that the DoJ’s scrutiny of clinical trials is not without merit.  The N.Y.Times reports that “[l]ast month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events.”  The clinical trials for Avandia included many foreign trial sites, which were submitted in support of the drugs’ application to enter and remain on the U.S. market.  GlaxoSmithKline, the trial’s sponsor, has not been accused of fraud.

According to recent regulatory filings, the following companies are under investigation for possible violations of the FCPA:

• Merck is cooperating with a federal investigation of company activities in multiple foreign nations.
• Medtronic is cooperating with investigations of company activities in Greece, Poland, Germany, Turkey, Italy, and Malaysia.
• Eli Lilly is cooperating with the investigations of subsidiaries in several countries, including Poland.
• Federal investigators are looking into improper payments related to the sale of Zimmer products abroad.
• Johnson & Johnson voluntary disclosed the possibility that company subsidiaries abroad had made improper payments to government officials in two countries relating to the sale of medical devices.
• Pfizer and Bristol-Myers Squibb have also disclosed that they are subject to federal investigations. AstraZeneca, GlaxoSmithKline, and Baxter SciClone have also received inquiries from federal enforcement agencies.

Secretary of State Hillary Clinton on the Global Health Initiative

This C-SPAN report is worth considering: “Secretary of State Hillary Clinton spoke at Johns Hopkins University’s School of Advanced International Studies on the Obama Administration’s Global Health Initiative. She discussed the six-year, $63 billion investment that focuses on improving the health of women, children and newborns throughout the world.”

You can see the video (or the transcript) by clicking on the picture.

We May Need More Than A Spoonful Of Sugar To Help Our Medicine Go Down

Today CNNMoney reports that drug recalls quadrupled from 426 in 2008 to a record 1,742 in 2009.  The recalls have been attributed to “manufacturing lapses” in raw material quality, labeling and packaging, and contamination.  Generic and over-the-counter drugs have been affected the most.  CNNMoney notes that the race to put generic products on the market and the pressure to cut costs have caused drug companies to

sometimes fail to spend enough time learning how best to make the drug….  And since generic and over the counter drugs aren’t as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.

One such cost-cutting measure involves outsourcing production to foreign manufacturing sites and this measure seems to have received the most attention.  (Check out fellow blogger Jae W. Joo’s post on outsourcing.)

Earlier this month, Senator Michael Bennet (D-Colorado) introduced the Drug and Safety Accountability Act of 2010 which seeks to ensure the safety and efficacy of drugs sold in America, regardless of their manufacturing location.  The bill would require, among other things, that:

• manufacturers have quality management plans which the FDA can inspect;
• manufacturers maintain supply chain documentation;
• the Secretary of Health and Human Services track facilities manufacturing drugs or active ingredients for the American market; and
• the FDA be given more power to ensure drug safety, including the authority to enact mandatory recalls for batches of drugs that pose risks and to assess civil penalties for violations of the Federal Food, Drug, and Cosmetic Act.

Click here for more details about the bill and here for Sen. Bennet’s own promotion of it.  Sen. Bennet has lamented how:

[f]or too long, the FDA has lacked the proper authority to adequately safeguard our drug supply.  Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made.

A father of three, Sen. Bennet has said that the recent McNeil recall of over-the-counter children’s medicine spurred him into action.

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson has issued a statement in response to the bill, saying that:

[t]he lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop.  Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.

In addition, drug manufacturing for the U.S. market — regardless of where it occurs — is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA).  These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

The U.S. regulatory system for prescription drugs is the toughest and safest in the world….

Okay.  But other people here don’t think so.  (Click here to read a good opinion by Dr. Lynn Parry, Chair of the Colorado Prescription Project, on why this bill should pass.)

According to a recent Pew Prescription Project poll, less than 10% of Americans feel confident about medications manufactured in India and China.  89% of Americans support Congressional action to introduce new drug safety measures.  How many of those people realize that approximately 80% of the materials used to make or package drugs sold in America comes from foreign sources?  I didn’t, but then, is such high a percentage really that surprising?

Reading through the CNNMoney report, I was reminded a little of a scene from a seventh season episode of Friends:

Phoebe: It’s amazing! My headache is completely gone! What are those pills called?
Monica: Hexadrin.
Phoebe: Oh, I love you, Hexadrin!  Oh look!  It comes with a story!
Monica: No, Phoebe, those are, like, the side effects and stuff.
Phoebe: Say what?
Monica: You know, the possible side effects.
Phoebe: Oh my God!  Dizziness, nervousness, drowsiness, facial swelling, nausea, headache…  Headache! Vomiting, stomach bleeding, liver damage!  Now, okay, I don’t recall any of this coming up when you gave me these little death capsules! Oh, I’m sorry, extra-strength death capsules!

Admittedly, the scene concerns how potential side effects can be worse than the problem being treated (and that’s a whole other blog post).  Yet it’s also a reminder of how we can forget about the other potential hazards of these potent drugs, delivered in easy-to-swallow capsules/tablets/liquids, if there are quality control or other manufacturing issues.  It’s as easy to forget as it is to pop them, well, like candy.

Would You Like Statins With That?

As we wrote on this blog the other day about research which raised questions about the efficacy of statins for those who have not yet experienced a heart attack– an off label prescription–the WSJ pointed to a new paper in the American Journal of Cardiology from authors at  Imperial College, London, U.K., which suggests that  statins should be made available free of charge to consumers along with the purchase of fast food. The press release from Imperial College can be found here.

Low level doses of statins may be purchased over the counter in England.

In a prior post, I  wrote about meeting with a cardiologist who suggested I commence taking statins because of my various cardio risk factors. A point, however uncomfortable at the time, made ultimately moot by the favorable results of my stress test, echocardiogram and calcium scoring. I had, prior to my surprisingly clean bill of cardiac health, relented mentally to the prospect of what would become a life long prescription. Of statins, I wrote:

“If one has risk factors, it is prophylactic and is prescribed to reduce the risk of heart attack, stroke and other heart diseases. It is doubtful whether once I start taking this drug I will ever stop. There is no foreseeable time (while alive) that I will wish to stop reducing the risk of heart attack or stroke. And that I suppose is the essence of the onset of age– piling up prescriptions. A daily regimen that will follow one to the grave–only the dosages or the brand names changing as each day welcomes a regimen of pills. In short, this prescription feels like the onset of dependence. The forward guard, if you will. A harbinger of a pharmaceutical future.”

One might say I didn’t take the news well. But crucial to my decision to relent were the words of my cardiologist and another heart doctor. I wrote:

Seeing my, shall we say, chagrin, the cardiologist told me that, like over 50% of the cardiologists he knows, he takes a statin. “We’ve seen the data.” Another recently told me  “Yeah, I take it. They should put it in the water.”

And now, apparently, in burgers.

But, we wrote of some  important (and conflicting) recent findings regarding statins here at HRW last week:

A LA Times article has recently highlighted the problems of off label prescriptions.  In the article, it has come to light that the off label use of statins, one of the world’s most prescribed medication, may not have the efficacy that many doctors had previously thought.  The LA Times reports,

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose - called “secondary prevention” - the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.

Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins - called “primary prevention” - has driven the growth in the market for statins over the last decade.

Statins certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease but it’s not so clear they work that way in people who are healthy. In spite of that uncertainty, statins’ use for primary prevention has sky rocketed.

One wonders how so many physicians came to believe that statins could also reduce the risk first time heart attacks.  Dr. John Abramson, from Harvard Medical School, attributes statins’ off label growth to a “conspiracy of false hope.”  He states, “[t]he public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

So, with all these interests pushing for statins’ off label use, it should not be a great surprise that extensive research has not been performed regarding statins’ primary preventive effects- and conflicting results have emerged.  The LA Times reports,

In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack. A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”

So??? Statins anyone?

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