An Autism Diagnosis: Key to Unlocking Needed Services?

Michael Poreda’s excellent post yesterday called attention to what looks to be a fascinating panel discussion — “Serving Urban Students With Autism: Newark, New Jersey” — to be held here at Seton Hall Law on April 5th.  Michael interviewed Leslie Long and Michele Adubato — Adubato will be speaking on the panel — of Newark’s North Ward Center which plans a 2011 launch of a new initiative to better serve individuals living with autism in Newark.

In his post, Michael writes that he “wanted to know if students with autism in Newark were getting the same services as students elsewhere in the New Jersey, and if not, whether law or policy played a role in the disparity.”  He goes on to highlight a number of areas of potential disparity between Newark and New Jersey’s suburbs and towns, all disturbing.

I was particularly troubled by Michael’s report that the Newark schools’ wait-and-see approach to diagnosing children with autism leads to children from birth to age three being denied (or simply not accessing) early intervention services.  There is nothing wrong in theory with waiting and seeing with regard to diagnosing an infant or toddler with autism.  I believe the choice to wait-and-see is one that parents should be free to make in consultation with their baby or child’s healthcare providers.  That choice is in no way free if advocating for and/or accepting an autism diagnosis is the key to accessing needed services.  (My previous post on the pressure parents can face to accept the diagnosis is here.)

In my opinion, early intervention services should never be linked to a diagnosis; they should always be based on the demonstrated needs of the individual child.  A key takeway from the dispute over the inclusion of Asperger’s Disease in the DSM-V is that while diagnoses of mental disorders can no doubt be useful in certain contexts, they are also mutable and political, describing and potentially shaping a complicated reality.  They seem a shaky basis for divvying up scarce educational resources amongst very young children.

In New Jersey children do not, legally, need to be diagnosed with autism — or any other   -ism — to access early intervention services.  A child with an autism diagnosis is presumptively eligible for early intervention services, but that same child could also qualify without the diagnosis, based only on his or her individual developmental delays.  After a child turns 3 and is no longer eligible for early intervention, a diagnosis is still not (supposed) to be the key to services.  In New Jersey, a child between the ages of 3 and 5 with developmental delays can qualify for special education as a “preschooler with a disability.”  N.J.A.C. 6A:14-3.5(c)(10).  I wonder whether the use of these avenues to accessing services is more common in the New Jersey suburbs than in Newark– and whether this is yet another disparity.

Rising Maternal Death Rate: A Sentinel Event

California Watch, a project of the Center for Investigative Reporting, reported earlier this month that the rate of maternal deaths directly related to pregnancy and birth nearly tripled in California between 1996 and 2006– from 5.6 maternal deaths per 100,000 live births to 16.9 per 100,000.  Even after accounting for improved information gathering, the rate has more than doubled and “[c]hanges in the population — obese mothers, older mothers and fertility treatments — cannot completely account for the rise … said Dr. Elliott Main, the principal investigator for the task force” that prepared the report.  While the reason or reasons for the rise in deaths are not yet understood, Dr. Main notes that the rate of Cesarean sections increased by 50 percent over the 1996-2006 time period.

Sadly, California is unlikely to be unique in this regard.  Maternal death rates have probably increased in other states and in the country as a whole as well.  On January 26th, the Joint Commission issued a Sentinel Event Alert to hospitals, notifying them that “current trends and evidence suggest that maternal mortality rates may be increasing in the U.S.”  The Commission acknowledged that that incidence of maternal death remains low — at an estimated 13.3 deaths per 100,000 live births — and that a possible reason for the increases seen is better identification of women who die during or shortly after pregnancy.  Still, the Commission quoted the CDC’s Dr. William M. Callaghan as follows: “[T]here clearly has been no decrease in maternal mortality in recent years, and we are not moving toward the U.S. government’s Healthy People 2010 target of no more than 3.3 maternal deaths per 100,000 live births[].”  Moreover, “[m]aternal deaths are the tip of the iceberg for they are a signal that there are likely bigger problems beneath — some of which are preventable,” says Dr. Callaghan. “It is important to consider the women who get very, very sick and do not die, because for every woman who dies, there are 50 who are very ill, suffering significant complications of pregnancy, labor and delivery.”

Not all maternal deaths are preventable, of course.  To reduce the rate of those that are, the Joint Commission suggests a number of actions for hospitals and physicians to take, including participating in state-level maternal mortality reviews and developing protocols (and holding drills to train staff on the protocols) for responding to conditions such as hemorrhage and pre-eclampsia.  More concretely, the Commission quotes Dr. Steven L. Clark of the Hospital Corporation of America who argues that the “only cause of maternal death amenable to nationwide systematic prevention efforts is pulmonary embolism [a blood clot in the lung].”  Disappointingly, while nearly all adult patients undergoing major surgery receive prophylactic measures for the prevention of venous thromboembolism (VTE) — even patients with no risk factors for the condition — pregnant women undergoing Cesarean delivery traditionally do not, despite the fact that they are at increased risk.   In light of the Commission’s Sentinel Event Alert, it seems to me that hospitals would be well-advised to adopt VTE prophylactic measures for all pregnant women undergoing Cesarean sections at once.  Is there a downside I am missing?

Allergan v. FDA: Where Does Disseminating Safety Information End and Promotion Begin?

In the Fall of 2009, the drugmaker Allergan made waves when it sued the FDA alleging that the ban on off-label promotion was chilling its “First Amendment right to share truthful medical information with physicians about how to safely use Botox off-label [to treat muscle spasticity] to achieve a benefit while minimizing risk of serious adverse events.”  Allergan was back in the news last week when the LA Times reported that trial was set to begin in a case brought against Allergan by the mother of Kristen Spears, a seven-year-old girl with cerebral palsy who died after being injected with Botox to treat muscle spasticity in her legs.

Allergan manufactures two FDA-approved botulinum toxin products, Botox Cosmetic, the well-known anti-wrinkle treatment, and Botox, which is approved to treat, among other conditions, cervical dystonia, “a movement disorder that causes [the muscles of the neck and shoulders] to contract and spasm involuntarily.”  Botox is also frequently used “off-label” for conditions it is not approved to treat, including muscle spasticity.  Per the NIH,  locally-injected Botox “has become a standard treatment for overactive muscles in children with spastic movement disorders such as cerebral palsy.”  The FDA agrees.  An agency physician describes Botox as a “commonly used” and “very effective” treatment for spasticity, which he characterizes as a “significant disability[y.]“  Per the LA Times, Botox can “sometimes help young patients walk without surgery.”

While the NIH’s website states that the undesirable side effects of Botox are “mild and short-lived,” the FDA’s informs physicians that “a Boxed Warning has been added to the prescribing information to highlight that botulinum toxin may spread from the area of injection to produce symptoms consistent with botulism,” “that swallowing and breathing difficulties can be life-threatening and there have been reports of deaths related to the effects of spread of botulinum toxin,” and “that children treated for spasticity are at greatest risk for these symptoms[.]”

In addition to requiring the addition of the black box warning to the Botox label, the FDA has ordered Allergan and other manufacturers of botulinum toxin products to adopt a Risk Evaluation and Mitigation Strategy (REMS) which includes “a Medication Guide [for patients] and Communication Plan, including a Dear Health Care Provider letter, and a timetable for submission of assessments.”

In its complaint against the FDA, Allergan alleges that while “the boxed warning and REMS materials identify the risk of potential distant spread of toxin effect, … they do not give physicians using Botox for spasticity specific guidance about how to further minimize that risk while still obtaining an acceptable therapeutic effect.”  Allergan wants to provide physicians with specific information about treating spasticity including “proper dosing, patient selection, and injection technique.”  Allergan argues, with good reason I believe, that if it were to, say, develop a slide deck about dosing, patient selection, and injection technique in treating spasticity and present it to physicians it would be exposing itself to criminal liability for promoting an off-label use.  In its brief in opposition, the FDA disagrees — sort of — arguing that disseminating safety information about unapproved uses is “not necessarily” promotion and that Allergan has “ample room” “to disseminate truthful, non-promotional information about dangers associated with unapproved uses of Botox.”  (I will have more to say about the parties’ legal arguments in a subsequent post.)

In an interesting twist, the LA Times reports that Kristen Spears’ pediatrician and his nurse practitioner wife testified in depositions that they “learned to use Botox on children with cerebral palsy at Allergan-sponsored seminars in 2000 and 2001″ and that “Allergan’s sales agents discussed the use of Botox for juvenile cerebral palsy patients … repeatedly, visiting the practice about 50 times over several years.”  They also claimed that they were told by sales representatives that other doctors were using “in range of 10 to 15 units” of Botox per kilogram to treat their pediatric patients.  Dr. Mitchell Brin, Allergan’s Chief Scientific Officer for Botox, testified that fifteen units per kilogram, which is the dose given Kristen Spears, is nearly twice the maximum dose that the company considers safe for children.  He also testified that, because of the ban on off-label promotion, Allergan did not disseminate its maximum dosage information to physicians.  If it is true that Allergan’s sales force was providing doctors with dosing information gleaned from anecdotal reports from other doctors they called on while the experts in the company’s medical department kept their dosing knowledge to themselves, it is an example of an all-too-common disconnect between the field and headquarters that in this case may have had tragic consequences.

Medical Marijuana Act Signed Into Law: Some Chronically Ill New Jerseyans Rejoice While Others Continue to Wait

As expected, on January 18, 2010, Governor Jon Corzine signed the New Jersey Compassionate Use Medical Marijuana Act into law, making New Jersey the 14^th state to legalize marijuana for medical use.  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy endorsed the Act in a position paper distributed to key lawmakers in June 2009.

The Act’s backers celebrated its passage with “hugs and tears,” while its opponents expressed continued concerns, including that the for-profit “alternative treatment centers” that the Act will allow to grow and distribute marijuana will have negative effects on the neighborhoods where they are established.  An interesting abcnews.com article by Susan Donaldson James highlights a third constituency: New Jerseyans with chronic illnesses that are responsive to treatment with marijuana but who are not considered to have debilitating medical conditions under the Act.

The article profiles Jack O’Brien of Laurel Lake, New Jersey who was born without fingers and toes and suffers from “crushing neuropathic pain.”  He wakes up to shooting pain in his arms and legs and can only walk short distances on his deformed feet.  According to O’Brien, smoking marijuana is “like having a valve on the forearm, turning it and having the coolness of relief through my extremities. … I try to walk on these feet and I can go four or five blocks, with my wife. With marijuana, I can go forever.”  State Assemblyman Reed Gusciora, who was a prime sponsor of the Act, explained that while he had empathy for O’Brien and others in his position, the legislature “had to do a measured approach,” citing fears that New Jersey could become another California, where medical marijuana “seemed to be spiraling out of control.”   Assemblyman Gusciora promised that in two years the legislature would “revisit the issue and add ailments.”

Addendum:

While Jack O’Brien’s case provides only anecdotal evidence of marijuana’s efficacy against neuropathic pain, as the Center noted in its position paper, “in the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated that smoked marijuana is effective against neuropathic pain, including for patients who have tried the available conventional treatments and are still in pain.”   The existence of this evidence is remarkable because, as recent articles in the New York Times and Wall Street Journal explain, researchers must surmount formidable hurdles to study marijuana’s potential medical uses.

For those who are curious, under the compromise version of the Act which was signed into law January 18^th, “debilitating medical condition” is defined to include the following:

• Seizure disorder, including epilepsy, if resistant to conventional medical therapy;
• Intractable skeletal muscular spasticity, if resistant to conventional medical therapy;
• Glaucoma, if resistant to conventional medical therapy;
• HIV or the treatment of HIV, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• AIDS or the treatment of AIDS, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• Cancer or the treatment of cancer, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• Amyotrophic lateral sclerosis;
• Multiple sclerosis;
• Terminal cancer;
• Muscular dystrophy;
• Inflammatory bowel disease, including Crohn’s disease; and
• Terminal illness, if the physician has determined a prognosis of less than 12 months of life.

New Jersey Legislature Passes Medical Marijuana Bill

Yesterday, the last day of its 2008-2009 legislative session, the New Jersey legislature voted to legalize the use of medical marijuana by New Jersey residents suffering from debilitating medical conditions.

The version of the New Jersey Compassionate Use Medical Marijuana Act passed yesterday represents a compromise between the version that the state Senate passed in February of 2009, which Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy endorsed in a position paper distributed to key lawmakers, and the Assembly version, which included a number of amendments intended to bolster the Act’s already strict safeguards against abuse and diversion.  (The differences between the Assembly and Senate versions are outlined here; a summary of the changes made in the final legislation is posted here on the Legislature’s website.)   Governor Corzine is expected to sign the Act into law before he leaves office next week.

Among other changes, the final legislation:

• revises the definition of “debilitating medical condition” to specify that severe or chronic pain, severe nausea or vomiting, and cachexia or wasting syndrome qualify a patient to use medical marijuana if they are symptoms of cancer, HIV/AIDS, “or the treatment thereof.” The new definition also adds inflammatory bowel disease, including Crohn’s disease, muscular dystrophy, and terminal illnesses expected to cause death in 12 months or less to the list of debilitating conditions;

• deletes the Assembly provision that allowed patients to designate an individual to transport marijuana to them in an emergency, and reverts to the Senate language allowing patients to designate a primary caregiver to assist them with their use of medical marijuana on an ongoing basis; and

• preserves the Assembly version’s requirement that patients obtain their marijuana from “medical marijuana alternative treatment centers,” i.e., that they not be allowed to grow their own, but increases the amount of marijuana that patients can be dispensed in a 30-day period from one ounce to two ounces.

Interestingly, the final legislation also requires that the system the Division of Consumer Affairs in the Department of Law and Public Safety establishes to monitor the dispensation of marijuana for medical use must “serve the same purpose as, and be cross-referenced with” the Division’s system for monitoring the dispensation of certain prescription drugs with the potential for abuse.  This is further evidence that marijuana is slowly but surely, as Fordham Law Professor Kimani Paul-Emile writes, “migrating from the criminal regulatory regime into the public health regulatory regime.”

Developments in the Law Governing Physician-Owned Ambulatory Surgery Centers in New Jersey

Over the past year, one or the other of my sons has had minor surgery in no less than three of New Jersey’s many ambulatory surgery centers (”ASCs”).  So, I noted with interest the Appellate Division’s recent decision in Garcia v. Health Net in which it affirmed a lower court holding that physicians who make referrals to ASCs in which they have an ownership interest violate the Codey Law, New Jersey’s version of the Stark Law.  The Appellate Division also affirmed the lower court’s decision that, despite the illegal referrals, the physician-owners in the case committed no fraud.  They (along with other physicians-owners across the state) acted in reliance on the New Jersey Board of Medical Examiners’ conclusion that the Codey Law’s exception to the self-referral ban for services provided at the referring physician’s medical office applied to ASCs.

In response to the lower court’s holding and heavy lobbying from physicians, the New Jersey State Legislature enacted revisions to the Codey Law which were signed into law in March 2009.  Physicians are now expressly permitted to refer patients to ASCs in which they have a financial interest if they meet a list of conditions, including that: (1) for patients they refer, they personally perform the surgery; (2) they be paid in proportion to their ownership interests, not the number of patients they refer; (3) they and their physician partners make all healthcare decisions, leaving non-physician partners without a say; and (4) they inform their patients in writing of their ownership interest at the time they make the referral.

On the other hand, the Legislature acted to all but put a stop to the establishment of new physician-owned ASCs, with the exception of those which are jointly owned by a general hospital.  Development of hospital– and medical school–owned centers may proceed apace.  Fox Rothschild’s Elizabeth Litten notes  that this “resonates more of long-forgotten certificate of need and health planning policy than it does of the original law’s concern with physician profit motives and overutilization.”  Clearly, the Legislature hopes that the new limits will be good for general hospitals’ financial health.  Professor Frank Pasquale has written here and elsewhere about the concern that ASCs and other niche facilities harm general hospitals by “cherry-picking” lucrative patients and “lemon dropping” those that are more costly.

What about patients?  Should we care whether ASCs are physician-owned or not?  Unsurprisingly, the American Medical Association believes that “physician ownership interests in health facilities, products or equipment can benefit patient care.” Peer-reviewed research suggests that physician-ownership makes no difference in health outcomes, however.  And, as Dean Kathleen Boozang states here, there is evidence that “physicians who hold an equity interest in an entity that provides ancillary health care services, such as a clinical laboratory or MRI, more frequently order those services for their patients, referring them, unsurprisingly, to the entity they own,” although there is no evidence that “this higher use equated to over-utilization.”  I would suggest, admittedly based on a small (and potentially unrepresentative) sample, that, if nothing else, physician-owned surgery centers have better amenities than those that are hospital-owned.  Some of these amenities could easily be done without (orchids in the lobby, souvenir teddy bear); others (popsicles and DVDs in the recovery room) are potentially more significant.

New Jersey Medical Marijuana Legislation Update: Poised to Pass?

Supporters are hopeful that before Governor-Elect Chris Christie takes office next month, the New Jersey legislature will pass — and current Governor Jon Corzine will sign — medical marijuana legislation.  In February 2009, the “New Jersey Compassionate Use Medical Marijuana Act,” which would allow patients suffering from “debilitating medical conditions” to treat their symptoms with marijuana without fear of state criminal reprisals, passed the state Senate.

In June 2009, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy issued a position paper calling on the full legislature to pass the Act, arguing that it would “allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.”  Soon thereafter, the Act cleared the Assembly Health, Human Services and Senior Citizens Committee, albeit with a number of amendments, including several bolstering the Act’s already strict safeguards against abuse and diversion.  (For a detailed summary of the differences between the Senate and Assembly versions of the Act, see below.)

According to an article in the New Jersey Law Journal, a legislative aide “says they are trying to get the [Act] posted for a floor vote on Dec. 7, Jan. 7 or Jan. 11, the remaining voting sessions in the current term.  The Assembly is expected to pass it.”  Due to the amendments added by the Assembly Committee, the Senate would need to pass the Act again before it would reach the Governor’s desk.  Even if the Act is not passed during the current lame-duck session, however, there is hope for its passage in sessions to come. Governor-Elect Christie has indicated that, with sufficient restrictions in place, “he would be supportive of such legislation.”

Summary of Differences between Assembly and Senate Versions

Change to definition of “bona fide physician-patient relationship.”

The Senate’s version of the Act (S119) requires that patients who wish to use medical marijuana obtain a “written certification” from a physician with whom they have a “bona fide physician-patient relationship.”  Such a relationship is said to exist whenever a physician has completed a full assessment, including a physical examination, of a patient.  The Assembly’s version (A804) includes a significantly narrower definition, providing that only the physician with “ongoing primary responsibility” for treating a patient’s “debilitating medical condition” can approve that patient to use marijuana.  Such a physician must be “board-certified, if available” in the specialty appropriate for caring for the condition which qualifies the patient to use marijuana.

Changes to list of eligible “debilitating medical conditions.”

• Whereas S119 would have granted eligibility for marijuana to patients suffering from “severe and persistent muscle spasms, including, but not limited to, those characteristic of multiple sclerosis or Crohn’s disease,” A804 limits eligibility to those with “intractable skeletal muscular spasticity,” which would, it would seem, include some patients with multiple sclerosis, but exclude those with Crohn’s disease.
• Whereas S119 made all patients with cachexia or wasting syndrome, severe nausea, or severe or chronic pain eligible, under A804 patients with those conditions are only eligible if their symptoms are the result of AIDS or cancer. Concomitantly, neither AIDS nor non-terminal cancer render a patient eligible unless they cause cachexia or wasting syndrome, severe nausea, or severe or chronic pain.
• A804 adds to the list of those eligible for marijuana, patients suffering from amyotrophic lateral sclerosis and multiple sclerosis. Patients with cancer that is “terminal” and glaucoma that is “resistant to conventional therapy” are also eligible; under S119 all cancer and glaucoma patients were eligible.
• Notably, both versions include a provision allowing for additional medical conditions to be added by regulation.

Changes to rules governing “medical marijuana alternative treatment centers.”

Under A804, eligible patients will no longer be permitted to grow marijuana.  The statute’s protection will only apply to patients who obtain marijuana from New Jersey Department of Health and Senior Services-approved “medical marijuana alternative treatment centers.”  A804 adds as a requirement of approval that such centers be operated on a nonprofit basis.  They do not have to be recognized as such by the IRS but they do need to comply with all state nonprofit laws.  Perhaps in an effort to mitigate hardship that might arise as a result of these, more restrictive, provisions, A804 exhorts DHSS to “seek to ensure the availability of alternative treatment centers throughout the State, including, to the maximum extent practicable, at least two each in the northern, central, and southern regions of the State.”

Other potentially-significant changes.

• Unlike S119, A804 does not protect patients and others from arrest or prosecution; its protection is limited to waiver of applicable “civil or administrative penalties.”
• A804 also eliminates protection for caregivers who assist patients with medical marijuana use. Instead, it provides that “[t]he commissioner shall adopt regulations to: (1) provide for the use by a registered qualifying patient of a designated individual in an emergency situation to transport marijuana to the patient who is otherwise unable to obtain marijuana from an alternative treatment center[.]“

The FDA Steps In: Regulating Prescription Drug Promotion on the Internet

The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet.  Earlier this year, the FDA expressed the view that the message was what was important, not the medium, meaning that companies should simply apply the rules governing prescription drug advertising in print media to the internet.  On April 2, 2009 the agency issued Notice of Violation letters to 14 companies who sponsored links on internet search engines advertising their products; the links gave the name of the drug and, in some cases, its indicated use, without including the required “fair balance,” i.e., safety information such as contraindications and potential side effects.  In reliance on the so-called “one-click rule” — which had never actually been adopted by the FDA — the companies had put the required safety information one click away on a separate page.

In recent months, the FDA has indicated that it is open to providing internet-specific marketing guidance.  Yesterday and today (November 13^th) the agency is holding a hearing on “Promotion of FDA–Regulated Medical Products Using the Internet and Social Media Tools.”  Representatives from advertising agencies, consumer groups, health-related websites, pharmaceutical companies, and search engines are scheduled to testify.

In written testimony released before the hearing, PhRMA, the pharmaceutical industry’s trade group, proposed that the FDA approve a standard universal warning: PhRMA suggests “All drugs have risks.  Click here for more information from the manufacturer.” — for use “in places throughout the Web where there is not enough room for complete disclosure of all warnings, indications, and contraindications (e.g., search results and microblog posts.)”  Such a warning would, PhRMA argues, allow companies to take advantage of sponsored links, make full use of Twitter, etcetera, while also providing easy access to safety information.  PhRMA even suggests that the warning incorporate the FDA’s logo, arguing that this could mitigate against “the dangers posed by illegal Internet drug sellers.”

It will be interesting to see whether and how the proposals of the other groups represented at the hearing differ from PhRMA’s, and, of course, whether the FDA in the end decides that its “fair balance” requirements should be modified for the web.  Among the other interesting issues FDA may address is companies’ responsibility for web content they do not control.  Google’s introduction of Sidewiki, which allows anyone visiting a pharmaceutical company’s website to leave a comment, has brought this issue to the fore, raising, for example, the prospect of doctors discussing a product’s off-label uses on the manufacturer’s site.

Anyone who wishes to comment on these or other internet-specific promotion issues may do so through February 28, 2010.

Short Shrift for Stillbirth in Health Reform?

Short Shrift for Stillbirth?[1]

The health reform bill that cleared the Senate Finance Committee earlier this month — S. 1796 — incorporates at least two pieces of pending legislation relating to maternal and infant health.  Section 1631 of the bill, authorizing Medicaid coverage for services provided at freestanding birth centers, adopts the text of S. 1423, while Section 1802, authorizing grants to fund services to new mothers struggling with postpartum depression or psychosis, is derived from the Melanie Blocker Stokes MOTHERS Act, which the House passed in March.  Not making the cut was legislation currently pending in the House — H.R. 521 and H.R. 3212 — and Senate — S. 1445 — aimed at reducing the number of stillbirths and sudden unexpected infant and child deaths.

According to the Centers for Disease Control, there are about 25,000 stillbirths — defined by the CDC as the death of a fetus after 20 weeks of gestation or, if the gestational age is unknown, weighing 350 grams or more — in the United States each year.  About 1 in every 160 deliveries in this country ends in a stillbirth.  (Per the CDC, these numbers may be low estimates, because they are based on information contained in death certificates, which studies have shown underestimate the true incidence of stillbirth.)   All too frequently in these cases, no cause of death can be determined.  As Alan Goldenbach put it in a moving essay in the Washington Post: “[T]he most common result after a stillbirth is a doctor telling grieving parents, ‘I don’t have an answer for you.’”

Better data is a necessary first step to finding answers.  As the American Congress of Obstetricians & Gynecologists explains, inconsistencies in the evaluation and classification of stillbirths across jurisdictions frustrate data collection efforts.  The United States has the lowest stillbirth autopsy rate among developed countries, and other important elements of a thorough post mortem evaluation, including analysis of the placenta and umbilical cord and genetic testing, may be left undone.  In addition, recordkeeping is inadequate.  Death certificates are often filled out — incompletely — before any investigation into the cause of death is done.  All of these factors hinder research.

First introduced in June 2008 by then-Senator Barack Obama, and now sponsored by Senator Frank Lautenberg (D-NJ) and Representative Frank Pallone, Jr. (D-NJ), the Stillbirth and SUID Prevention, Education, and Awareness Act of 2009 (H.R. 3212 and S. 1445; H.R. 521 is similar) would, among other things, (1) establish “a task force to develop a national research plan to determine the causes of, and how to prevent, stillbirth” and (2) require the CDC to develop guidelines for increasing the performance of thorough postmortem stillbirth evaluations and to continue its efforts to develop and disseminate a standard protocol for stillbirth data collection and surveillance.  The Act would also expand pilot programs in metropolitan Atlanta and Iowa which supplement the current passive information-gathering system — which relies on death certificates — with an active system in which trained staff make regular visits to clinics and hospitals to gather data.  A study published in 2007 in Public Health Reports demonstrated that Atlanta’s active surveillance system captured more stillbirths than were reflected in death certificates and gathered better data about each one. Expanding the Atlanta and Iowa programs to additional jurisdictions and taking the other steps provided for by the Act would put us on the road to answers to the countless painful questions posed by each unexplained stillbirth.

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[1] Credit for the idea and background research for this post goes to Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy.  On November 10, 2008, Cathy’s first and only grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation.

ACCME: Showing Some Teeth?

This week, the New York Times reported on efforts by the Accreditation Council for Continuing Medical Education (ACCME) to step up its enforcement of its Standards for Commercial Support.  Drug and device companies spent over a billion dollars on accredited continuing medical education (CME) courses in 2008; ACCME’s Standards for Commercial Support are meant to ensure that industry funding does not translate into commercially-biased content.  ACCME’s new focus on enforcement comes in the wake of a Senate Committee on Aging hearing over the summer at which Dr. Steven Nissen of the Cleveland Clinic testified that ACCME should be abolished because it is a toothless watchdog, “uninterested or incapable” of enforcing its Standards.  And that was not the first time ACCME’s oversight of CME has attracted congressional attention.  A 2007 Senate Finance Committee investigation uncovered numerous cases in which drug and device companies violated ACCME’s Standards and expressed concern about ACCME’s years-long delays in imposing penalties for compliance failures.

While noting that medical education is largely self-regulated, Dr. Murray Kopelow, ACCME’s head, told the New York Times that, relative to years past, ACCME was active in 2008 and 2009, investigating twelve complaints and finding five courses to be commercially biased.  In addition, the organization will soon post to its website a list of CME courses and providers found to be biased.  ACCME will also consider a proposal that providers whose courses are found to be commercially biased be required to alert the doctors who attended and provide them with corrective materials.

While these efforts are salutary, an effective enforcement program would require a significant commitment of time and resources (in 2008, there were just under 50,000 accredited CME activities), which ACCME may not have.  Well-known critic of industry-funded CME Daniel Carlat (author of “Dr. Drug Rep,” a fascinating piece about his experience giving paid promotional talks for a drug company) had this  to say about the prospects for effective enforcement:

…if the Atypical Antipsychotic program is bad enough to be pulled for commercial [bias], my conservative estimate is that at least half, probably more, of all industry funded psychiatry CME will also need the retraction treatment. The problem is, who on earth has the time to police these things? Certainly not ACCME. Dr. Carroll and I try to keep on top of the worst of the worst, but we have other things to do in order to make a living. The best and simplest solution would be to end industry funding of medical education altogether.

Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy has recommended just that — that industry funding be ended altogether, on the grounds that drug and device industry funding too often leads to bias and that such bias is incompatible with CME’s educational aims.  Dr. Nissen makes the additional argument that ending bias in CME would reduce inappropriate prescribing of branded prescription drugs, which would in turn yield significant cost savings.  As Dr. Nissen told the Senate Committee on Aging, “That’s one of the ways we can pay for healthcare reform.”

Autism, Autistic-Like, and Health Insurance Reform

In his post Implementing Reform: Children with Special Health Care Needs, Professor John Jacobi notes that providing “health insurance” to children with special health care needs (”CSHCN”) does not ensure that their needs will be met.  Many private health insurance plans do not cover services such as occupational, physical, or speech therapy for CSHCN.  Private plans frequently limit coverage for such therapies to otherwise healthy children who need therapy to facilitate their recovery from an illness or injury.

Through their power to regulate insurance, states can require private plans to extend coverage for needed therapies to CSHCN.  For example, in legislation passed earlier this year, New Jersey became one of an estimated 15 states to specifically require insurers to provide treatment for individuals with autism.  Children with autism have benefited from a wave of recent legislation — 8 states enacted laws related to autism and insurance coverage in 2009 alone.  Children with other special needs have been largely left behind.  Many go without services; others may be shoehorned into an inappropriate autism diagnosis.  A recent documentary, Autistic-Like, tells the story of parents pressured to accept an autism diagnosis in order to access state-funded services for their son.  While New Jersey’s autism mandate is admirably broad, requiring private insurers to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability,” other states’ mandates are strictly limited to children on the autism spectrum.

Insurance mandates are attractive to legislators because they are off budget.  They are not, however, without cost.  The Council for Affordable Health Insurance, an insurance industry association, estimates that “an autism mandate increases the cost of health insurance by about 1 percent.”  Mandates like New Jersey’s, which extends beyond autism, could lead to even greater cost increases.  Piecemeal reform that privileges some special needs over others has costs of its own, however, not the least of which are borne by children living with labels that do not fit.

Under the Radar: Health Care Reform & Drug Advertising & Marketing

At the Food and Drug Law Institute’s 21^st Annual Advertising & Promotion Conference John Kamp of the pro-industry Coalition for Healthcare Communication discussed four proposals addressing drug advertising and marketing issues that may be incorporated into the final health care reform bill but have not been widely debated.  Mr. Kamp’s presentation is available here.  

Off the Table (For Now)

Of most concern to industry is an oft-floated proposal to eliminate the tax deduction for drug advertising.  (See, for example, bills sponsored by Representative Jerrold Nadler (D-NY) and Representative Daniel Lipinski (D-IL) here and here.)  Most recently, on September 11, 2009 Senator Bill Nelson (D-FL), a member of the Senate Finance Committee, announced his plan to put forth an amendment to the Baucus Bill that would eliminate the “tax break drugmakers get for TV advertising.”

Direct-to-consumer advertising is a prime target because, as the New York Times put it, for many “the ads are a daily reminder of a health care system run amok,” which “prompt people to diagnose themselves with chronic quality-of-life problems like insomnia or restless leg syndrome; lead people to pressure their doctors for prescriptions for expensive brand-name drugs to treat these conditions; and steer people away from cheaper generic pills.”   There is also concern that DTC ads do not present an accurate picture of drug risks and benefits and that they drive uptake of new drugs before their safety is fully known.

Another obvious driver is the need to pay for health care reform.  Senator Nelson echoed a claim made earlier this year by Congressman Charles Rangel (D-NY) that eliminating the tax break for TV ads would free up $37 billion over the next ten years.  Industry representatives contest the $37 billion figure, arguing that drug companies spend far too little on direct-to-consumer advertising to achieve that level of additional tax revenue.  They contend that Congress would have to eliminate the tax deduction for physician advertising and other marketing expenditures to garner $37 billion.

Less than a week after he announced it, Senator Nelson backed off his plan, perhaps under pressure from other members of Congress who come from districts with a strong media presence and have spoken out against eliminating the deduction.  According to Mr. Kamp, however: “Somebody else will raise this again before it’s over, you bet … Baucus says the reforms will cost $850 billion, the Congressional budget office $750 billion. Three-quarters of a trillion dollars is a lot of real money in Washington. The $37 billion will continue to be in the buffet of options as they try and figure out healthcare.”  

Still on the Table

Three proposals related to drug and device promotion are still on the table, with varying chances for inclusion in the final health care reform bill.

First, health care reform bills in both the House and the Senate contain transparency provisions akin to those in the Physicians Payments Sunshine Act of 2009 introduced in January by Senator Chuck Grassley (R-IA).  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy recommended that disclosure of drug and device company payments to doctors be federally mandated in its January 2009 white paper.  As the Sunshine Act has widespread support, including from industry, transparency provisions are likely to be included in the final bill.

Second, Section 138 of the health care reform bill reported out of the House Education and Labor Committee   bans the commercial use of “prescription information containing patient identifiable and prescriber identifiable data,” essentially adopting as federal law New Hampshire’s ban on prescription data mining which survived a First Amendment challenge in the First Circuit.  If passed, Section 138 would end drug reps’ current practice of tailoring their sales messages to each doctor’s prescribing history, which many believe creates undue pressure on doctors to prescribe newer more expensive medications.

Third, a bill sponsored by Senator Jack Reed (D-RI) would authorize the FDA to evaluate whether use of a “drug facts box” format for presenting a drug’s benefits and risks would improve healthcare decision making and, if so, to promulgate regulations requiring that drug facts boxes be added to drug labels.  Senator Reed’s bill also empowers the FDA to set standards for comparative clinical effectiveness information included in drug labeling and advertising.

It is difficult to predict whether the data mining ban or Senator Reed’s bill will be included in the final health care reform bill.  Mr. Kamp calls Senator Reed’s bill’s chances a “toss up;” regarding the data mining ban, he has “no idea.”

Medical Science Liaisons: Walking the Line between Scientific Exchange and Promotion

[Ed. note: As noted in the post above, we are very pleased to welcome Kate Greenwood, J.D., to the blog today.]

As the Wall Street Journal recently reported, at a time when the ranks of pharmaceutical sales representatives are thinning, the number of medical science liaisons (MSLs) is (or was until very recently) growing.  MSLs are doctors, pharmacists, or scientists employed by drug companies to disseminate scientific information about the companies’ drugs — including information about off-label uses of those drugs — usually to physicians who are key opinion leaders.  MSLs are, at most companies, part of the medical affairs or research and development departments and, unlike sales reps, they are not typically evaluated or compensated based on increases in market share or prescription volume in their regions.  Still, as suggested by this PharmExec article on permissible metrics for measuring the value to companies of both MSLs and the thought leaders they court, it is not always clear how the work MSLs do differs from that of a sales rep.

FDA regulations ban companies from “represent[ing] in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation” but explicitly allow companies to engage in “the full exchange of scientific information.”  Sales reps cannot take advantage of the scientific exchange safe harbor to discuss off-label uses with physicians, but MSLs can, as long as they do so in response to a physician’s unsolicited request.  Jeff Patrick, who holds a doctorate in pharmacy and is Director of Medical Scientists at the biopharmaceutical company Dyax, explained to the Wall Street Journal that, unlike a sales rep, he could respond to a question like “Were there pediatrics in your trial?” even if the drug being evaluated was not approved for pediatric use.

Because MSLs are out in the field engaging doctors in free-ranging and difficult to police discussions, they present evident compliance challenges for companies attempting to follow the rules regarding off-label promotion.  On the other hand, their scientific expertise and established relationships with thought leaders may also present compliance opportunities.  For example, earlier this year, the FDA approved the use of MSLs in the Risk Evaluation and Mitigation Strategy (REMS) for UCB’s Cimzia, a drug used to treat Crohn’s disease and rheumatoid arthritis which carries with it a risk of serious infection.  The Cimzia REMS requires as part of its communication plan that the company’s MSLs make a presentation about the drug’s risks to all of the nation’s approximately 500 gastroenterology key opinion leaders.