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Averting Mental Health and Fiscal Crises: Crisis Intervention Teams and Access to Meaningful Treatment for Mental Illness

Posted Aug 26 2014 12:00am
Tara Ragone

Cross-Posted at Bill of Health

Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for increased training of law enforcement in crisis intervention as well as the need for improved access to treatment for people with mental illness.

The first is a video of the fatal police shooting of Kajieme Powell in St. Louis, Missouri earlier this month.  Mr. Powell was twenty-five years old and suspected of shoplifting junk food from a convenience store.  The first eighty seconds of the video show Mr. Powell pacing and muttering on the sidewalk with four pedestrians passing by without incident before the police arrive.  The police then exited their vehicles with their guns drawn, shouted at Mr. Powell to drop his weapon, and fired about twelve shots fewer than twenty seconds after they arrived on the scene.

The second is an NPR story that included an audio recording of law enforcement officials in San Antonio, Texas responding to a 911 call about a twenty-four year old group home resident named Mason, who was off of his medications, had set his blanket on fire, and was a danger to himself and others.  When they arrived at the scene, the officers acknowledged that they did not use the “tough guy command voice” that they typically would in responding to a 911 call reporting suspected criminal activity.  Instead, in plain clothes and without their weapons drawn, they spoke calmly with Mason, reassuring him that they wanted to get him help.  They astutely noticed signs suggesting that Mason was experiencing tactile, auditory, and visual hallucinations, and with patience and skilled questioning, got him to acknowledge the hallucinations and seek psychiatric treatment.

The San Antonio officers were members of a six-person mental health squad that the city created to confront severe prison overcrowding.  As NPR correspondent Jenny Gold reported , the city and county have saved $5 million and eliminated prison overcrowding over the past five years by diverting people with mental illness out of prisons and overcrowded emergency rooms and into appropriate mental health treatment.  Officers must take forty hours of crisis intervention team (“CIT”) training to help them learn how to handle mental health crises.

By juxtaposing the St. Louis and San Antonio incidents, I am not suggesting that they necessarily can be fairly compared.  The facts that were available to the officers in each situation may have justified different law enforcement responses.   The San Antonio officers were warned in advance that Mason may have been experiencing increased symptoms of mental illness and, when they arrived, Mason was sitting by himself without any suspected weapon.  In contrast, the St. Louis 911 call reportedly did not raise any concerns that Mr. Powell was suffering from a mental illness.  In addition, the police claim that Mr. Powell was brandishing a knife as he approached the officers, and a knife reportedly was recovered at the scene.  Michael Woody , a CIT expert and former police trainer in Akron, Ohio, has opined that the St. Louis scene was not stable enough for the CIT protocol to be appropriate.  (But query whether other tactics short of lethal force could have controlled the situation and spared Mr. Powell’s life.)

The starkly different outcomes in these cases shine a spotlight on the potential for CIT training to arm officers with effective tools to help de-escalate mental health crises in appropriate cases.  In a December 2012 article in the Community Mental Health Journal, Kelli E. Canada, Beth Angell, and Amy C. Watson summarized some of the preliminary findings of CIT effectiveness, including:

  • “improved officer preparedness and improved disposition of mental health calls”
  • “improved attitudes, increased knowledge and patience, and an increase in support of local treatment programs”
  • “the potential to reduce stigma and alter beliefs about mental illness”
  • “increases in the number of identified mental health calls[,] . . . transports to treatment by CIT officers[,] . . ., and voluntary transports”
  • “increasing access to mental health services through linking individuals with community providers”
An analysis of interviews these researchers conducted of CIT and non-CIT trained officers in Chicago “uncovered three specific areas that CIT trained officers demonstrated specialized procedures in comparison to non-CIT trained officers: assessment, response tactics, and disposition.”

Here in New Jersey, Camden was the first city to use CIT training back in 2008, and eleven New Jersey counties currently have CIT programs.  A Union County officer reported that the training caused him to think twice before curtly shuffling a homeless man along.  Instead by talking with the man, the officer learned that he was suicidal and convinced him to seek treatment for his previously undiagnosed schizophrenia.  New Jersey should continue to expand CIT programs in law enforcement agencies throughout the state.

But, as the St. Louis incident reminds us, CIT training alone is not enough.  (Indeed, reportedly one of the officers involved in the shooting of Mr. Powell was CIT-trained.)  New Jersey also needs to invest in treatment services for patients with mental illness, both to help them avoid a crisis and to have appropriate and available treatment options when they reach a crisis.  Officers need places to bring or refer individuals in need of mental health treatment.  Yet patients often report difficulty trying to access appropriate mental health services in New Jersey as in other states.  We need to be sure there are adequate networks of providers to meet the needs of people with mental illness.

Given current fiscal realities, it is unclear how New Jersey will fund efforts to improve mental health access.  Gold reports that jails, hospitals, courts, police, and the mental health department in San Antonio banded together to build the Restoration Center , which offers an array of mental and physical health services, including “a 48-hour inpatient psychiatric unit; outpatient services for psychiatric and primary care; centers for drug or alcohol detox; a 90-day recovery program for substance abuse; plus housing for people with mental illnesses, and even job training.”

New Jersey agencies similarly should explore ways to coordinate.  Given the cost savings San Antonio has realized, perhaps New Jersey should revisit the role for social impact financing to improve mental health network adequacy.

1. This past week the ubiquitous ALS ice bucket challenge came to Seton Hall Law, with Professor Mark Alexander (video ) and Dean Patrick Hobbs (video ) taking part. For those interested in how the money raised will be spent, I recommend this post by Carey Goldberg at CommonHealth. Goldberg spoke with “Dr. Lucie Bruijn, chief scientist of the ALS Association that is reaping the ice-bucket windfall” who “describe[d] a field that is forging ahead in multiple directions.” To give just one example,  the Association might direct some of the money towards a clinical trial of “a compound that has been approved for people who have changing emotions in ALS laughing and crying that’s exaggerated” to see if it might also, as anecdotal evidence suggests, improve swallowing. On a sobering note, Dr. Bruijn notes that “trials can be anywhere up from $25 million plus, just for perspective. So these are not small investments.”

2. This interview , by Geoff Colvin at Fortune, of Kathy Giusti, a former pharmaceutical executive who founded the Multiple Myeloma Research Foundation (MMRF), touches on similar themes. There are currently six drugs approved to treat multiple myeloma, “and the MMRF played a role in advancing all of them, with more in the pipeline. Life expectancy for many patients has doubled.” Giusti credits her foundation’s success to her decision to focus on funding research (to the exclusion of advocacy or public policy or healthcare), and, in particular, to focus on fixing a cancer research system that Giusti describes as “broken.”

3. This week also brought news of a recent development in Depomed’s struggle to protect its drug Gralise, a once-a-day version of gabapentin, from generic challengers.  As Arlene Weintraub reports at FiercePharma, “Judge Joel Pisano of the U.S. District Court in New Jersey ruled that Actavis’s filing for FDA approval of generic Gralise infringes all seven of Depomed’s patents on the product. With this ruling, Depomed’s market exclusivity will be protected until 2024.” Depomed continues to litigate on another front, however. As Weintraub explains: “Simultaneously, Depomed has been in a war with the FDA, which approved Gralise under its Orphan Drug program but did not grant the company the 7 years of market exclusivity that normally goes along with orphan designation. Depomed sued the FDA in September 2012 seeking that exclusivity and is still awaiting a decision from a federal district court judge, according to the company’s latest quarterly filing.

4. Also at FiercePharma, and also by Arlene Weintraub, this article about the Drug Enforcement Administration’s re-classification of “combination drugs containing hydrocodone . . . as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.” As Weintraub explains: “Vicodin and similar products used to be grouped in the less restrictive Schedule III, but recent DEA research showed that the drugs can be as addictive as pure opioids and “may lead to severe psychological or physical dependence,” a statement from the agency says. “Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential.”

5. Finally, at The Hill, Peter Schroeder reports that the Inspector General for Tax Administration has found a number of problems with the Internal Revenue Service’s implementation of the Affordable Care Act’s device tax. Among other things, “IRS agents were still having a hard time determining exactly which medical device manufacturers were subject to the tax” and “both the returns filed and revenue raised have come in well short of expectations.”

1. The high-priced Hepatitis C drug Sovaldi continued to make headlines this past week. At Forbes, Yevginiy Feldman noted that “the UK’s National Institute for Health and Care Excellence (NICE) just approved the drug as being cost-effective, and recommended it for subgroups of patients.” Feldman suggests that, “given that a system with very tight price controls, and what can be described as a true single-payer system, decided to cover Sovaldi for some subgroup of patients, perhaps the mud-slinging against [Sovaldi's manufacturer] Gilead is a bit unwarranted. The evidence appears to be shifting in Sovaldi’s favor.

2. At Kaiser Health News, Jim Burress reported on the barriers that stand in the way of more widespread use of the anti-viral medication Truvada by individuals at risk of, but who do not have, HIV or AIDS. Burress quotes researcher Dr. Melanie Thompson who “says no doctor would refuse to prescribe cholesterol-lowering statins to patients because they’re overweight.  Somehow, the conversation around PrEP is different. ‘So I think it’s a very interesting moralistic attitude that soon will be outdated.  But I do think that this is a barrier for some patients,’ Thompson says. ‘They feel stigmatized. And honestly, health care providers need to step up their game and do better than that.‘”

3. AP Health Writer Matthew Perrone wrote about former AIDS activist Gregg Gonsalves, who “still travels to Washington, but with a different agenda: to defend the FDA.”  Perrone reports that “[s]ince May, three states – Colorado, Louisiana and Missouri – have passed laws designed to allow terminally ill patients to receive experimental drugs that have not been cleared by the FDA. Arizona will vote on its own so-called ‘right to try’ initiative in November and lawmakers in Florida, Oklahoma and Utah are set to introduce similar bills. All of these efforts are driven by lobbyists from the Goldwater Institute, a libertarian think tank. … In closing his talk on Capitol Hill earlier this summer, Gonsalves warned Senate staffers that a political shift to the right in coming elections could ‘change the game’ for drug safety and effectiveness. ‘We will have a different FDA than we have had for the last 30 years.’”

4. Charles Ornstein of Pro Publica broke the news that “[n]ext month, when the federal government releases data about payments to physicians from pharmaceutical and medical device makers, one-third of the records will be withheld because of data inconsistencies, an official told ProPublica. The issue is the latest hurdle for the federal government as it seeks to launch the already-delayed Open Payments database mandated under the Physician Payment Sunshine Act, a provision of the 2010 Affordable Care Act.” The data inconsistencies were uncovered after a physician in Kentucky named David E. Mann complained that some of the payments attributed to him were actually made to a David E. Mann in Florida. Even before he discovered the inconsistencies, Dr. Mann was frustrated. On August 1st, he Tweeted the following: “Just completed the application to view my #sunshine act data on CMS website. Applying for a visa to North Korea would be simpler.“

5. Finally, at the Drug and Device Law blog, Jim Beck opines , with his usual entertaining irascibility, about the Alabama Supreme Court’s “re-decision” in . In , the Court held, as it did the first time around in , that a plaintiff who was injured by a generic drug could bring suit against the manufacturer of the drug’s branded equivalent, to the extent that the plaintiff’s physician prescribed the generic drug in reliance on misrepresentations made by the branded manufacturer. Beck’s “[b]ottom line”: “Alabama has more home-grown plaintiff lawyers than pharmaceutical companies – and after , it most assuredly always will.” (A video of (among other things) me giving my (contrary) take on and innovator liability generally is here .)

coleman_carl_lg2 The Ebola outbreak , which has claimed nearly 1,000 lives since its emergence in West Africa in December 2013, has brought renewed attention to policies surrounding the “compassionate use” of unapproved medications – i.e., the provision of unapproved medications to individuals outside the context of clinical trials.   The issue rose to the forefront early last week when it was reported that two American aid workers in Liberia were treated with an “ experimental drug that has never before been tested for safety in humans.”  Both workers appeared to respond well to the drug, known as ZMapp .  The drug was also provided to a Spanish priest , who died shortly thereafter; it was unclear whether he took the drug before he died.  Following some controversy over the fact that the first three recipients of the drug were all foreign aid workers, on Tuesday it was reported that the drug’s manufacturer had sent its remaining stocks of the drug to Liberia for the treatment of two African doctors.

The FDA recognizes three broad categories of compassionate use, which are grouped under the general label of “expanded access.”  These include expanded access for individual patients, including for emergency use; expanded access for intermediate-size patient populations; and expanded access for large patient populations under a treatment IND or treatment protocol.  All of these categories are limited to patients who have serious or immediately life-threatening diseases or conditions for which no comparable or satisfactory alternative treatment exists.  The FDA must determine that the potential benefits of the unapproved drug outweigh the potential risks, and that the risks “are not unreasonable in the context of the disease or condition to be treated.”  In addition, the FDA must determine that allowing expanded access “will not interfere with the initiation, conduct or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.”

The FDA typically grants most requests for expanded access.  When requests are denied, they most frequently involve emergency requests to use drugs that are not already undergoing clinical trials – precisely the situation facing ZMapp.  On the one hand, it is understandable that the FDA would be cautious in allowing expanded access when no safety information exists and when there is no time to perform an exhaustive assessment.   On the other hand, patients who are expected to die in a short time because they have no treatment alternatives may reasonably decide that they are willing to assume a high level of risk.  Moreover, if clinical trials have not even been initiated, allowing expanded access cannot possibly interfere with the trials’ completion.  While there is some possibility that systematically allowing expanded access in emergency situations would interfere with the initiation of trials, the manufacturer would have its own incentives to initiate trials once the expected demand for the drug is sufficiently high.

For now, all of these questions are moot, as existing supplies of ZMapp have reportedly been exhausted.   When more supplies become available, further requests for expanded access are certain to arise.  However, granting access to the drug through compassionate use programs is not a long-term solution.  As an ethics panel convened by the World Health Organization concluded on Tuesday, the ideal way to introduce new Ebola medications is “in the best possible clinical trials under the circumstances in order to definitely prove their safety and efficacy or provide evidence to stop their utilization.”

Clinical trials of Ebola treatment will of course raise difficult questions in their own right.  Unlike with expanded access, where everyone obtains the medication they have expressly requested, in a clinical trial some participants may be assigned to control groups that receive different medications or even placebos.  Because no effective treatment for Ebola currently exists, placebo-controlled trials of new Ebola treatments would appear to be consistent with the ethical principles in the Declaration of Helsinki .  Yet, particularly after American and Spanish foreign aid workers received the first doses of the experimental medications through compassionate use programs, asking African patients to enroll in placebo-controlled trials would surely be controversial.  As the WHO panel delicately put it, the goal should be to devise “ethical ways to gather data while striving to provide optimal care under the prevailing circumstances.”   The challenge will be to figure out effective strategies for carrying this out.

paradiseLGjpg_1 The pharmaceutical industry has long-been criticized for use of anticompetitive tactics.  Brand pharmaceutical companies have been publicly accused of several high-profile activities to increase profits and stifle competition.  These include: shifting demand to a modified form of an existing brand drug (often called “ product hopping ”), using authorized generics to retain market share, frivolously filing citizens petitions to delay generic market entry, and using reverse payment settlements to keep generics of the market during their 180 day exclusivity period (otherwise known as pay-for-delay settlements ).  A persistent opponent in these tactics, the Federal Trade Commission (FTC), routinely invokes antitrust and unfair competition law to frame legal challenges.  In fact, the 2012 Supreme Court case FTC v. Actavis examined pay-for-delay settlements entered into between new drug application (NDA) patent holders and generic applicants, holding that they were not per se illegal but subject to a rule of reason test.

Many are now pointing to brand pharmaceutical manufacturers use of Risk Evaluation and Mitigation Strategies (REMS) as the latest anticompetitive tactic.  The Food and Drug Administration Amendments Act of 2007 (FDAAA) introduced REMS to enhance the FDA’s post-approval authority over drugs.  FDAAA contains new statutory provisions that allow the FDA to require further studies for safety and efficacy, along with increased authority for FDA to review these commitments on a continuing basis.  The FDA can require a REMS as either a condition of approval or, in the case of already approved products, as a subsequent additional condition for continued marketing.  A REMS may require a medication guide for patients, prescription physician information, communications to health care providers and pharmacies, limitations on labeling, promotion, and prescribing in order to assure safe use by patients, and a plan for implementation.  Violations trigger civil money penalties and subject manufacturers to litigation under misbranding provisions within the Food, Drug and Cosmetic Act.  To date, the FDA has implemented 70 REMS , half of which include elements to assure safe use (ETASU) that often take the form of distribution restrictions, training and recordkeeping requirements for prescribers and pharmacists, and prescribing limitations.

As noted here , a recent study announced last month estimates that $5.4 billion per year has been lost in prescription drug savings due to distribution restrictions imposed by brand drug manufacturers.  Brand manufacturers subject to a REMS for an NDA drug product claim that they cannot make samples of that drug available to the generic applicant because they would be in violation of distribution restrictions placed on the products by the FDA in the REMS.  However, in order to obtain approval through the generic drug approval process, a generic applicant must show bioequivalence to the NDA product through pharmacokinetic and pharmacodynamic measures.  The medical community is already targeting this practice as problematic, noting that it is a direct threat to the effective use of a drug-safety tool in order to increase profits and keep generic products off the market. In an April 2014 New England Journal of Medicine article , excerpted here , the authors urge that “the use of REMS requirements to block the market entry of generic drugs could well lead to higher health care costs and adverse patient outcomes.”

The REMS tactic is playing out in court in New Jersey.  Mylan Pharmaceuticals filed a complaint earlier this year against Celgene Corporation , claiming violations of federal antitrust law.  Mylan alleges that Celgene refuses to distribute the products Thalomid and Revlimid for bioequivalence testing for products in development by Mylan.  Because of their teratogenic nature, the FDA has invoked ETASU REMS for both Thalomid and Revlimid consisting of various extensive requirements to prevent embryo-fetal exposure, among other things: see here and here .  One aspect of the ETASU is strong oversight and requirements for distribution only through authorized dispensing pharmacies.  Celgene’s position is that the distribution restrictions prohibit the transfer of drug samples to Mylan for any purpose, including bioequivalence studies.

The FTC has taken a strong interest in the case, and filed an amicus brief on June 17, 2014 .  In the brief, the FTC argues that Celgene is potentially engaging in exclusionary conduct in violation of the Sherman Act by “refusing to sell to rivals.”  The FTC notes that Celgene may be in violation of both Section 1 and  2 of the Sherman Act by not only refusing to directly provide samples to Mylan, but also implementing restrictions that prevent Mylan from purchasing samples though customary distribution channels.  Celgene has moved to dismiss.

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