Noteworthy News Articles on Mental Health Topics, March 25- , 2008
More on the Alaska Suit Against Lilly Alex Berenson, New York Times- 3/27/2008 The prospect of a pending Supreme Court case that could sweep away many lawsuits against drug companies loomed over Alaska’s decision to settle the state’s suit against Eli Lilly over the schizophrenia drug Zyprexa, lawyers for Lilly and the state said Wednesday. Alaska had sued to recoup medical bills it said were generated by Medicaid patients who developed diabetes while taking Zyprexa. But on Wednesday it agreed to settle for $15 million — a fraction of the hundreds of millions of dollars in damages that Ed Sniffen, Alaska’s senior assistant attorney general, had said the state was seeking when the trial opened three weeks ago. On Wednesday, though, Mr. Sniffen said he was satisfied with the deal, in which Lilly did not admit wrongdoing. “It’s a good settlement,” Mr. Sniffen said. “Probably not a great settlement, but I think it’s a good settlement.” Good, at least, in light of that looming Supreme Court case. Mr. Sniffen noted that in October 2008, the Supreme Court is expected to hear Wyeth v. Levine, in which the drug maker Wyeth argues that federal laws bar, or “pre-empt,” most state court lawsuits filed by patients who say they were injured by drugs they have taken. Based on last month’s 8-to-1 Supreme Court ruling in favor of pre-emption in a similar case about medical devices, the court is assumed to be leaning in favor of the drug industry in the Wyeth case. And so plaintiffs’ lawyers and state attorneys general are worried that they could have many of their pending claims dismissed when the court decides Wyeth. Even cases that have already reached trial could be vulnerable, since drug makers almost always appeal jury verdicts against them, extending cases for months, if not years. “We had this issue with the Supreme Court deciding pre-emption this fall that could have completely unwound any victory we might have had,” Mr. Sniffen said. Nina Gussack, a lawyer for Pepper Hamilton, which represented Lilly, agreed that pre-emption concerns had played a major role in the settlement. “The state took a very strong and hard look at their case, and recognized that even if they were successful, they had a substantial chance of losing their case on pre-emption grounds,” Ms. Gussack said. Given the fact that Alaska has fewer than 700,000 residents, and only 6,300 Medicaid patients taking Zyprexa, the $15 million payment is larger than it first seems. But the private lawyers Alaska hired to represent it at the trial said Wednesday that they were unhappy that the state had agreed to settle. They said they believed that the jury had understood the medical evidence and the Lilly marketing documents presented to it and was ready to rule in their favor. “The settlement was done exclusively by the attorney general without our input,” said Tommy Fibich, a lawyer from Houston who was one of the outside attorneys hired by Alaska. “As a lawyer, I feel we really have not been treated well.” Still, Mr. Fibich said he understood the state’s concerns about pre-emption. He added that he was worried that without the threat of lawsuits in state courts, drug makers would be even more aggressive about hiding risks and promoting drugs for unapproved uses. Internal Lilly documents presented at the trial indicated that company executives had played down Zyprexa’s health risks to doctors and had encouraged its use for off-label conditions like Alzheimer’s disease. “If you think these guys speed now, wait and see what happens when they get pre-emption,” Mr. Fibich said. The impact of the Alaska settlement on Lilly’s other legal problems over Zyprexa is not yet clear. Nine other states have sued Lilly with claims similar to those made by Alaska. Another 33 have not yet sued but are investigating the company in a joint action and seeking a single settlement of their claims. At the same time, federal prosecutors in Pennsylvania are investigating Lilly’s marketing of Zyprexa and whether the company hid Zyprexa’s dangers from doctors and the Food and Drug Administration. If the company does seek a broad settlement to resolve all the state and federal investigations at once, the $15 million payment to Alaska — considered per patient— could represent a benchmark for broader talks. If it does, Lilly might need to pay billions of dollars to resolve the bigger cases, since more than 10 million people in the United States have used Zyprexa. Lilly and the prosecutors in Philadelphia have already discussed a settlement of the federal investigations that would require Lilly to pay $1 billion to $2 billion, according to people who have been briefed on the talks. At this point, though, none of the remaining lawsuits are likely to reach courtrooms before the Supreme Court decides the Wyeth pre-emption case — and potentially knocks out many of the remaining state lawsuits. At the same time, Lilly will argue that the Alaska settlement should not represent a benchmark for future cases, said George Lehner, a partner at Pepper Hamilton. Mr. Lehner said Wednesday that Alaska consumer protection laws were unusually favorable to plaintiffs, so other states’ claims would be worth less per person than Alaska’s. Alaska and Lilly discussed a settlement before the trial began, and mediation efforts resumed last week, according to the statement announcing the settlement. Schizophrenia Linked to Rare, Often Unique Genetic Glitches Rick Weiss, Washington Post- 3/28/2008 Patients with schizophrenia are three to four times as likely as healthy people to harbor large mutations in genes that control brain development, and many of those glitches are unique to each patient, researchers reported yesterday. The findings are forcing scientists to rethink the reigning model of how genes and environment conspire to cause the debilitating disease, which affects about 1 percent of the population worldwide. In part, scientists said, the new view is daunting because it suggests that many people with schizophrenia have their own particular genetic underpinnings. At the same time, the study shows that new screening techniques can find and differentiate among those various mutations. In the long run that could help doctors choose the best medications for individual schizophrenics and speed the development of drugs tailored to certain patients' needs. "If the genetics tells us that schizophrenia is really 10 different disorders, then let's have 10 treatments that optimize the outcomes for everyone and not just use the same drugs for everybody," said Thomas Insel, director of the National Institute of Mental Health, which helped fund and conduct the study. The work also offers evidence that autism shares some genetic roots with schizophrenia. "Take away schizophrenia's hallucinations and delusions," said Jon McClellan, a child psychiatrist at the University of Washington and a leader of the study, published in yesterday's online issue of the journal Science, "and the symptoms that remain, the lack of social interest and withdrawal, are what we call autism. There is clearly an intersection of the brain systems involved." "It's not that we're now going to be able to solve schizophrenia tomorrow," said Samuel Barondes, director of the center for neurobiology and psychiatry at the University of California at San Francisco, who was not involved in the work. "But it does present a new way of figuring this puzzle out." Schizophrenia is a disease of disordered thinking and behavior. Patients have trouble organizing their thoughts or communicating sensibly, and many have auditory or visual hallucinations. The disease, which typically emerges in early adulthood, used to be blamed on "bad mothering" but has since come to be recognized as having genetic roots. Yet environmental factors also contribute. Pregnant women who experience famine are at increased risk of giving birth to children who will get schizophrenia. Childhood infections may also add to the risk. Further muddying the picture, most schizophrenics have no family history of the disease. That suggests that, to the extent the disease is genetic, the mutations often arise spontaneously either at conception or during fetal development, perhaps after having inherited a general propensity to get such mutations. Those and other details led scientists to conclude that the mutations contributing to schizophrenia are probably common in the population but have little impact individually, and that only when several occur together is a critical mass of neurological trouble achieved. The model emerging from the new study is quite different. It says most cases of schizophrenia may be caused by rare genetic glitches that are individually potent. The turnaround is the result of sophisticated gene scans conducted on 233 schizophrenics, including 83 who got the disease in childhood, a more serious condition. The scans looked for rare stretches of DNA where more than 100,000 "letters" of genetic code were either missing or mistakenly present in duplicate. About 15 percent of schizophrenics, and 20 percent of those affected in childhood, had such glitches, compared with 5 percent of healthy individuals who were also studied. Yet the glitches, including one previously associated with autism, were different in each person. Unlike previous scans based on older technology, which could at best find general genomic "neighborhoods" where mutations associated with schizophrenia are present, the new scans pinpointed the individual genes affected. "It's fabulous to be able to find these mutations directly rather than indirectly," said Mary-Claire King, a geneticist at the University of Washington who was on the team. "You just go for the jugular." The genes implicated are diverse, but many are known to play crucial roles in how the brain gets wired early in life. Normally that process starts with a huge overproduction of neurons, followed by a controlled winnowing that leaves only those that have made proper connections. "Changes in these genes could bias the way circuits get sculpted out and could perhaps lead to a brain in which signals that would normally get filtered out don't get filtered out," which could interfere with thinking and prompt hallucinations, Insel said. The delayed onset of the disease can be explained by the fact that some genes and brain connections do not take on central roles until young adulthood, said Jonathan Sebat of Cold Spring Harbor Laboratory, one of the study leaders. "Genes have timing," Sebat said. "They follow developmental programs for where and when they're going to be active." Colleges Watching Troubled Students Closely Jeffrey McMurray, Associated Press- 3/28 LEXINGTON, KY. - On the agenda: A student who got into a shouting match with a faculty member. Another who harassed a female classmate. Someone found sleeping in a The Murky Politics of Mind-Body Sarah Kershaw, New York Times- 3/30/2008 From Plato and Aristotle to Descartes, the great thinkers have for millennia argued over what is known in philosophy as the “mind-body problem,” the relationship between spirit and flesh. Dualism tends to win the day: The mind and the body, while linked, are separate. They exist independently, perhaps mingling but not merging. The debate lives on these days in less abstract form in the United States: How much of a difference should it make to health care — and health insurance — if a condition is physical or mental? Decades of culture change and recent scientific studies have blurred the line between these types of disorders. Now a critical moment has been reached in a 15-year debate in statehouses and in Congress over whether treatment for problems like depression, addiction and schizophrenia should get the same coverage by insurance companies as, say, diabetes, heart disease and cancer. This month, the House passed a bill that would require insurance companies to provide mental health insurance parity. It was the first time it has approved a proposal so substantial. The bill would ban insurance companies from setting lower limits on treatment for mental health problems than on treatment for physical problems, including doctor visits and hospital stays. It would also disallow higher co-payments. The insurance industry is up in arms, as are others who envision sharply higher premiums and a free-for-all over claims for coverage of things like jet lag and caffeine addiction. Parity raises all sorts of tricky questions. Is an ailment a legitimate disease if you can’t test for it? A culture tells the doctor the patient has strep throat. But if a patient says, ‘‘Doctor, I feel hopeless,’’ is that enough to justify a diagnosis of depression and health benefits to pay for treatment? How many therapy sessions are enough? If mental illness never ends, which is typically the case, how do you set a standard for coverage equal to that for physical ailments, many of which do end? The United States has a long history of separating the treatment of mental and physical illnesses, dating back to the days when the severely mentally ill were put in poorhouses, jails and, later, public asylums. That ended after the deinstitutionalization movement of the 1960s, but mental health experts and advocates say that the delivery of services is still far from equal, because emotional illness is still not considered to be on a par with medical illness. Countries like Canada and the United Kingdom, with national health care systems that don’t limit access to any services, have long ago moved toward merging these two branches of health care, and the Scandinavian countries are known for treating mental illnesses as medical diseases, according to researchers who have studied the various systems. In the United States over the last five years, research studies examining the link between physical brain abnormalities and disorders like severe depression and schizophrenia have begun to make a strong case that the disorders are not scary tales of minds gone mad but manifestations of actual, and often fatal, problems in brain circuitry. These disorders affect behavior and mood, and they look different from Parkinson’s disease or multiple sclerosis in brain imaging. Still, a growing number of studies — and many more are under way — are making the biological connection, redefining the concept of mental illness as brain illness. “Insurance companies balk at this, but there are striking similarities between mental and physical diseases,” said George Graham, the A.C. Reid professor of philosophy at Wake Forest University. “There is suffering, there is a lacking of skills, a quality of life tragically reduced, the need for help. You have to develop a conception of mental health that focuses on the similarities, respects the differences but does not allow the differences to produce radically disparate and inequitable forms of treatment.” While squarely in the minority, some still question the legitimacy of calling any mental ailment a disease. A louder chorus argues that addiction is a behavioral and social problem, even a choice, but not a disease, as many mental health professionals and the founders and millions of followers of Alcoholics Anonymous maintain. Critics of parity say that anything that would not turn up in an autopsy, as in depression or agoraphobia, cannot be equated with physical illness, either in the pages of a medical text or on an insurance claim. These critics also say that because the mental abnormality research is so new, it should still be considered theory rather than an established basis for equal payment and treatment. “Schizophrenia and depression refer to behavior, not to cellular abnormalities,” said Jeffrey A. Schaler, a psychologist and an assistant professor of justice, law and society at American University in Washington. “So what constitutes medicine? Is it what anybody says is medicine? Is it acupuncture? Is it homeopathy?” Nevertheless, as federal parity legislation has wobbled along over the years, 42 states have adopted their own versions of parity, offering a patchwork of standards for insurance companies on coverage for addiction and mental illnesses. A federal law would extend insurance parity to tens of millions more Americans who are not covered under the laws and set one broad standard for the nation. As the states have experimented with parity, however, many providers have complained that insurance companies have often found it easy to deny benefits by ruling that claims are not “medically necessary,” a potentially tough standard when it comes to ailments of the mind. Meanwhile, attitudes about mental illnesses and addiction have changed significantly in the decades since advocates for the mentally ill — and for parity — first tried to include broad coverage of mental illnesses in the nation’s insurance plans. Pop culture has normalized and even glamorized rehab and even suicide attempts, chipping away slowly at social stigmas and lending strength to the idea that the sufferer of a mental illness or addiction may be a victim, rather than a perpetrator. Still, a cancer patient generally remains a far more sympathetic figure than a cocaine addict or a schizophrenic. But scientific advances may go a long way to help the parity cause. The biological and neurological connection lends strength to the notion that mental illnesses are as real and as urgent as physical illnesses and that there may, at long last, even be a cure in this lifetime, or the next. And if you can cure something, you can treat it and there is a finite quality to that treatment — and its cost. So you may, if you are an insurance company, be a lot more willing to pay for it. “The more research that is done, the more the science convinces us that there is simply no reason to separate mental disorders from any other medical disorder,” said Thomas R. Insel, director of the National Institute of Mental Health, which has conducted a series of studies on the connection between depression and brain circuitry and on Thursday released an important study showing a connection between genetics and the ability to predict the risk for schizophrenia. Last fall, the Senate passed its own parity bill with substantial differences from the House bill, which had been co-sponsored by Representative Patrick J. Kennedy, Democrat of Rhode Island. Mr. Kennedy has admitted to struggling with addiction and depression. Supporters and opponents both expect the negotiations over how to reconcile the two bills to be protracted; President Bush, who has voiced support for the more limited coverage called for in the Senate bill, has said he would not support the House version, which estimates a cost to the government of $3.8 billion over the next decade through coverage from federally funded insurance. The bill also includes ways to offset the cost. The precise impact of the House bill on private health insurance premiums was difficult to calculate, insurance industry experts said, but they said that increases to group plans would be likely, with some of the costs passed on to employees. Neither bill applies to employers with 50 or fewer employees or to the individual insurance market. Despite such warnings that premiums might increase, however, it is unclear by how much. Such extensive parity requirements have never been tested on a federal level, and one question is how many people might take advantage of new benefits even if they were available. The uncertainty is plain when experts try to estimate the effect. The Congressional Budget Office estimated that the Senate bill, with its minimalist approach, would increase health-plan costs by four-tenths of one percent. However, a report released last month by the Council for Affordable Health Insurance, an insurance industry group, estimated that state-based parity formulas were likely to increase rates by about 5 to 10 percent, on average. And a 2006 study in The New England Journal of Medicine, examining the costs associated with a parity program put into place by President Bill Clinton for all federal employees, found that it actually didn’t increase the use or the cost of mental health services. And that plan, it said, was similar to the one proposed in the more generous House bill. The House bill would require insurance companies that offer mental health benefits to cover treatment for the hundreds of diagnoses included in the Diagnostic and Statistical Manual of Mental Disorders, from paranoid schizophrenia to stuttering to insomnia to chronic melancholy, or dysthymia. The Bush administration and other opponents say the list of disorders is far too broad. That leads from parity to another, parallel morass in the fields of psychiatry and pharmacology. Both fields are accused of over-diagnosis and of seizing on fashionable diagnoses — bipolar disorder or post-traumatic stress disorder, for example — for financial gain or through highly subjective assessments. “It’s the phone-book approach of possible conditions,” said Karen Ignagni, president of America’s Health Insurance Plans, an industry group representing insurance companies that cover 200 million Americans. “And this comes at a time when advocates have made a very persuasive case about the importance of covering behavioral health.” But in the halls of Congress, at least, the mind-body problem is far from resolved, particularly when it is uncertain who the next president will be. |