State demands child take cancer-causing drugs

Goes to court insisting that boy endure dangerous course of medication

By Bob Urich

In what is being seen as a preview of a fully implemented Obamacare, government officials in Michigan are demanding that a 9-year-old child follow standard procedure and take a dangerous course of cancer medications that can cause additional cancer – even though the boy has had three scans indicating an absence of the disease.

The case is being fought on behalf of Ken and Erin Stieler and their son Jacob by attorneys with the Home School Legal Defense Association.

The organization concerns itself with home school rights, responsibilities and restrictions but also intercedes in cases that could have a significant impact on child and parental rights.

The HSLDA’s chairman, Michael P. Farris, confirmed today that the Michigan Department of Human Services has filed suit to force the parents to administer the chemicals to their son even though he’s been clean of cancer on scans over the past year. In addition, lower courts twice have ruled against the demands of state agency officials.

Now the state agency has filed an appeal with the Michigan Court of Appeals demanding Jacob be given the chemicals, including ifosfamide, etoposide and doxorubicin, even though the U.S. Food and Drug Administration states that for ifosfamide and etoposide, the “safety and effectiveness in pediatric patients have not been established.”

The warning for doxorubicin is stronger, stating, “Pediatric patients are at increased risk for developing delayed cardiotoxicity.”

Farris told WND that the facts of the case are important, because Jacob underwent treatment for cancer and has been clean on the last three scans over the last year.

Further, the treatment demanded by the state, which insisted that prosecutors bring a medical neglect case against the parents, is not guaranteed to help and not even guaranteed to be safe.

On the HSLDA website, Farris wrote, “If they succeed they will force Jacob to resume chemotherapy despite the fact that the drugs in question are not FDA approved (either for children in general or for this particular cancer). Moreover, these drugs do not promise anything close to a guaranteed cure. And, the FDA requires the drug manufacturers to disclose that these drugs cause new cancers to form, heart disease in children, failure to sexually mature, and many other serious side effects in some cases.”

Farris told WND that there is concern about the outcome of the case, as the state’s argument is that the drugs are demanded in the “national standard of care” for the condition.

That’s the same type of concern that has been raised by many organizations and individuals about Obamacare, which is to face arguments before the U.S. Supreme Court later this month.

Farris told WND that parents have the right to make such medical decisions, not the state.

David Ackerly, director of marketing for the Michigan Department of Human Services, took a message from WND requesting comment on the case but did not respond.

Farris said it would be different if there was a clear and present medical danger, the treatment was proven and the family still refused.

He said the parents have asked for an individual evaluation of their son’s case, only to be reminded about the “standard” that the state intends to follow, which is described as dangerous.

“If we are put in a position where national standards are established, whether by practice or the government, it comes out the same,” he said.

It was in December when a trial judge dismissed a medical neglect case against the family. Now, at issue is “the ability of parents to make medical decisions contrary to the views of doctors.”

“This case may well shape parental rights principles for the long haul. We believe that parents, not doctors, should make tough decisions like this,” Farris said.

The HSLDA earlier reported how Jacob was diagnosed with Ewing Sarcoma, a dangerous bone cancer, and he had surgery to remove a tumor and then chemotherapy to follow up.

“The treatment was incredibly difficult, and Jacob’s mom, Erin, told me that when she looked her son in the eyes, she knew in her heart that he simply could not survive many more rounds of these drugs,” Farris reported.

They tapped into a prayer network and were joined by hundreds to pray for their son’s recovery.

“After all of these rounds of chemotherapy were completed, there was a PET scan done to check on the status of the cancer. There was no evidence of cancer detected in Jacob’s body. Jacob’s family and friends rejoiced in his healing – praising God for this wonderful outcome,” Farris said.

But he said the doctors demanded to continue chemotherapy and radiation, citing their “standard of care.”

Jacob’s parents “begged the doctors to make an individual diagnosis, rather than simply following unbending standards. But the doctors were steadfast. All children with this cancer needed multiple rounds of these drugs – regardless of PET scan results, the doctors contended,” HSLDA reported.

The parents refused, and the doctors contacted Child Protective Services to ask that the parents be charged.

When the local CPS agency and prosecuting attorney refused, the doctors called the state to pressure the agency to file charges.

Farris said key to the case, which was decided in favor of the family before being appealed, is the treating physician.

“‘Have all of these drugs been approved by the FDA as safe and effective for children?’ I asked Jacob’s treating oncologist,” he said. “‘Yes,’ she replied, they have been FDA-approved for children.”

However, according to the official package inserts mandated by the government to describe the drugs contained and their complications, she was “flat wrong,” Farris said.

“In fact, as it turned out, the treating doctor had never even seen, much less read, these official FDA-required package inserts,” he reported.

A warning accompanying another drug demanded by the doctors, vincristine, was typical of those in the case, he said.

That warning said, “Patients who received chemotherapy with vinchristine sulfate in combination with anticancer drugs known to be carcinogenic have developed second malignancies.”

“This is not an easy case. It is not a case where a child has a current illness and the treatment is tested and proven to be safe and effective – those cases are easily resolved. The best evidence is that Jacob no longer has objective evidence of cancer. And not a single drug that the doctors want to give Jacob is FDA-approved for children for his kind of cancer,” Farris said.

He said it is a judgment call, a balancing of risks, and the issue is who makes that decision.

“The doctor told me during the deposition that she thinks that she should make the call – for every child in this situation. And she would give the same answer every time, rather than making an individual judgment,” Farris wrote. “I can’t imagine a more clear case of the need for parental rights.”

He said the project is being supported by the organization’s Homeschool Freedom Fund.

Source http://www.wnd.com/2012/03/state-demands-child-take-cancer-causing-drugs/

Off-Label Use Of Risky Antipsychotic Drugs Raises Concerns

By Sandra G. Boodman

Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia.

"It's a total outrage," said Fugh-Berman, a physician who is an associate professor of pharmacology at Georgetown University. "These kids needed some basic sleep [advice], like reducing their intake of caffeine and alcohol, not a highly sedating drug."

Those Georgetown students exemplify a trend that alarms medical experts, policymakers and patient advocates: the skyrocketing increase in the off-label use of an expensive class of drugs called atypical antipsychotics. Until the past decade these 11 drugs, most approved in the 1990s, had been reserved for the approximately 3 percent of Americans with the most disabling mental illnesses, chiefly schizophrenia and bipolar disorder; more recently a few have been approved to treat severe depression.

But these days atypical antipsychotics -- the most popular are Seroquel, Zyprexa and Abilify -- are being prescribed by psychiatrists and primary-care doctors to treat a panoply of conditions for which they have not been approved, including anxiety, attention-deficit disorder, sleep difficulties, behavioral problems in toddlers and dementia. These new drugs account for more than 90 percent of the market and have eclipsed an older generation of antipsychotics. Two recent reports found that children and adolescents in foster care, some less than a year old, are taking more psychotropic drugs than other children, including those with the severest forms of mental illness.

In 2010 antipsychotic drugs racked up more than $16 billion in sales, according to IMS Health, a firm that tracks drug trends for the health-care industry. For the past three years they have ranked near or at the top of the best-selling classes of drugs, outstripping antidepressants and sometimes cholesterol medicines. A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million. And a recent report by pharmacy benefits manager Medco estimated that the prevalence of the drugs' use among adults ballooned more than 169 percent between 2001 and 2010.

Critics say the popularity of atypical antipsychotics reflects a combination of hype that the expensive medicines, which can cost $500 per month, are safer than the earlier generation of drugs; hope that they will work for a variety of ailments when other treatments have not; and aggressive marketing by drug companies to doctors and patients.

"Antipsychotics are overused, overpriced and oversold," said Allen Frances, former chair of psychiatry at Duke University School of Medicine, who headed the task force that wrote the DSM-IV, psychiatry's diagnostic bible. While judicious off-label use may be appropriate for those who have not responded to other treatments for, say, severe obsessive-compulsive disorder, Frances said the drugs, which are designed to calm patients and to moderate the hallucinations and delusions of psychosis, are being used "promiscuously, recklessly," often to control behavior and with little regard for their serious side effects. These include major, rapid weight gain -- 40 pounds is not uncommon -- Type 2 diabetes, breast development in boys, irreversible facial tics and, among the elderly, an increased risk of death.

The Latest Fad?

Doctors are allowed to prescribe drugs for unapproved uses, but companies are forbidden to promote them for such purposes. In the past few years major drugmakers have paid more than $2 billion to settle lawsuits brought by states and the federal government alleging illegal marketing; some cases are still being litigated, as are thousands of claims by patients. In 2009 Eli Lilly and Co. paid the federal government a record $1.4 billion to settle charges that it illegally marketed Zyprexa through, among other things, a "5 at 5 campaign" that urged nursing homes to administer 5 milligrams of the drug at 5 p.m. to induce sleep.

Wayne Blackmon, a psychiatrist and lawyer who teaches at George Washington University Law School, said he commonly sees patients taking more than one antipsychotic, which raises the risk of side effects. Blackmon regards them as the "drugs du jour," too often prescribed for "problems of living. Somehow doctors have gotten it into their heads that this is an acceptable use." Physicians, he said, have a financial incentive to prescribe drugs, widely regarded as a much quicker fix than a time-intensive
evaluation and nondrug treatments such as behavior therapy, which might not be covered by insurance.

In a series in the New York Review of Books last year, Marcia Angell, former editor in chief of the New England Journal of Medicine, argued that the apparent "raging epidemic of mental illness" partly reflects diagnosis creep: the expansion of the elastic boundaries that define mental illnesses to include more people, which enlarges the market for psychiatric drugs.

"You can't push a drug if people don't think they have a disease," said Fugh-Berman, who directs PharmedOut, a Georgetown program that educates doctors about drug marketing and promotion. "How do you normalize the use of antipsychotics? By using key opinion leaders to emphasize their use and through CMEs (continuing medical education) and ghost-written articles in medical journals," which, she said "affect the whole information stream."

James H. Scully Jr., medical director of the American Psychiatric Association, sees the situation differently. He agrees that misuse of the drugs is a problem and says that off-label prescribing should be based on some evidence of effectiveness. But Scully suggests that a key factor driving use of the drugs, in addition to "intense marketing and some effectiveness," is the growing number of non-psychiatrists prescribing them. Many lack the expertise and experience necessary to properly diagnose and treat mental health problems, he said.

Among psychiatrists, use of antipsychotics is rooted in a desire to heal, according to Scully. "All of the meds we use have their limits. If you're trying to help somebody, you think, 'What else might I be able to do for them?' "

Since 2005, antipsychotics have carried a black-box warning, the strongest possible, cautioning against their use in elderly patients with dementia, because the drugs increase the risk of death. In 2008 the Food and Drug Administration reiterated its earlier warning, noting that "antipsychotics are not indicated for the treatment of dementia-related psychosis." But experts say such use remains widespread.

In one Northern California nursing home in 2006 and 2007, 22 residents, many suffering from dementia, were given antipsychotics for the convenience of the staff or because the residents refused to go to the dining room. In some cases the drugs were forcibly injected, state officials said. Three residents died.

A 2011 report by the inspector general of the Department of Health and Human Services found that in a six-month period in 2007, 14 percent of nursing home residents were given antipsychotics. In one case a patient with an undetected urinary-tract infection was given the drugs to control agitation.

"The primary reason is that there's not enough staff," said Toby S. Edelman, senior policy attorney for the Center for Medicare Advocacy, a Washington-based nonprofit group, who recently testified about the problem before the Senate Special Committee on Aging. "If you can't tie people up, you give 'em a drug" she said, referring to restrictions on the use of physical restraints in nursing homes.

Drugs At 18 Months

Nursing home residents aren't the only ones gobbling antipsychotics.

Mark E. Helm, a Little Rock pediatrician who was a medical director of Arkansas's Medicaid evidence-based prescription drug program from 2004 to 2010, said he had seen 18-month-olds being given potent antipsychotic drugs for bipolar disorder, an illness he said rarely develops before adolescence. Antipsychotics, which he characterized as the fastest-growing and most expensive class of drugs covered by the state's Medicaid program, were typically prescribed to children to control disruptive
behavior, which often stemmed from their impoverished, chaotic or dysfunctional families, Helm said. "Sedation is the key reason these meds get used," he observed.

More than any other factor, experts agree, the explosive growth in the diagnosis of pediatric bipolar disorder has fueled antipsychotic use among children. Between 1994 and 2003, reported diagnoses increased 40-fold, from about 20,000 to approximately 800,000, according to Columbia University researchers.

That diagnosis, popularized by several prominent child psychiatrists in Boston who claimed that extreme irritability, inattention and mood swings were actually pediatric bipolar disorder that can occur before age 2, has undergone a reevaluation in recent years. The reasons include the highly publicized death of a 4-year-old girl in Massachusetts, who along with her two young siblings had been taking a cocktail of powerful drugs for several years to treat bipolar disorder; the revelation of more than $1 million in unreported drug company payments to the leading proponent of the diagnosis; and growing doubts about its validity.

Helm said that antipsychotics, which he believes have become more socially acceptable, serve another purpose: as a gateway to mental health services. "To get a child qualified for SSI disability, it is helpful to have a child on a medicine," he said, referring to the federal program that assists families of children who are disabled by illness.

Ask Your Doctor

Psychiatrist David J. Muzina, a national practice leader at pharmacy benefits manager Medco, said he believes direct-to-consumer advertising has helped fuel rising use of the drugs. As former director of the mood disorders center at the Cleveland Clinic, he encountered patients who asked for antipsychotics by name, citing a TV commercial or print ad.

Some states are attempting to rein in their use and cut escalating costs. Texas has announced it will not allow a child younger than 3 to receive antipsychotics without authorization from the state. Arkansas now requires parents to give informed consent before a child receives an anti-psychotic drug. The federal Centers for Medicare and Medicaid Services announced it is summoning state officials to a meeting this summer to address the use of antipsychotics in foster care. And Sens. Herb Kohl (D-Wis.) and Charles E. Grassley (R-Iowa) introduced legislation that would require doctors who prescribe antipsychotics off-label to nursing home patients to complete forms certifying that they are appropriate.

Medco is asking doctors to document that they have performed diabetes tests in patients taking the drugs. "Our intention here is to get doctors to reexamine prescriptions," Muzina said.

"In the short term, I don't see a change in this trend unless external forces intervene."

Source http://www.kaiserhealthnews.org/Stories/2012/March/13/off-label-use-of-risky-antipsychotic-drugs.aspx

Woman sues DYFS after her adopted child was allegedly sexually, physically abused under institution's watch - New Jersey

By Megan DeMarco/Statehouse Bureau

TRENTON — While under the care of the state’s child protection agency, a Monmouth county baby was burned, beaten, and sexually abused, then ignored as doctor after doctor recommended therapy for anxiety and post-traumatic stress disorder, a lawyer for her adopted mother says.

Three different caseworkers at the state’s Division of Youth and Family Services could have stopped the abuse several times, attorney David Mazie contends, but none did.

Now the girl is 13, and her adopted mother is suing the state Division of Youth and Family Services and three caseworkers for damages in a trial that kicked off Monday with impassioned opening arguments in Trenton.

Child advocates say it is rare for civil cases against DYFS to reach a full trial, where the actions of caseworkers in charge of protecting children can be put on full display.

The case also comes amid an ongoing overhaul of the child welfare system that was in its early stage when the allegations were first raised.

Some child welfare advocates say the case indicates problems that exist in DYFS to this day, but others say reports of a federal monitor appointed in 2003 show the child protection system is improving. The state has spent more than $1 billion on the reforms.

"To the extent that there is any good news in all this it is only that this case is part of the legacy of DYFS’ failed past," said Richard Wexler, executive director of the National Coalition for Child Protection Reform. He added the federal monitor’s reports show, "this is a much better agency now than it was before, and such tragedies are a lot less likely."

Richard Gelles, a dean at the University of Pennsylvania who provided expert testimony for the woman suing DYFS, said the case exposes "a severe systemic dysfunction" that still exists, noting that some of those who handled the girl’s case continued to work for the division. One of the three caseworkers named in the case worked for the Department of Children and Families as of Sept. 30, according to public payroll records.

During opening arguments, Mazie outlined alleged negligence by DYFS from 2000 to 2005, when the girl, identified as S.A., was placed with the woman who would adopt her.

"They failed in this case, they failed miserably. They turned a blind eye on this child," Mazie said. "This is going to be with her for the rest of her life."

As a 2-year-old, she was given to her biological father in 2000, without proper vetting, Mazie said. While in his care and under DYFS supervision, the toddler suffered sexual and physical abuse.

She was brought to the emergency room twice, and a neighbor reported she had burns on her body and a belt mark on her chest, the attorney said. She was removed when the father’s girlfriend reported she was bound, beaten and hanging from a hook in the wall, he added.

Mazie said after she was removed from the home, doctors recommended therapy for post traumatic stress disorder. It took DYFS two years to provide it, and escalated the girl’s anxiety by allowing visits with her father, he said.

He added that a caseworker was supposed to visit with the girl once a month, but there were several months when no one appeared at the home, or checked on her in foster care.

Elliott Abrutyn, a lawyer hired by the state to represent DYFS, said children under the state’s care also have a legal guardian independent of DYFS, and often the caseworkers were following court orders.

"What happened to (her) of course is tragic," he said, telling the jury that it was "paramount" to understand DYFS caseworkers "were always absolutely looking out for the best interest of the child."

Abrutyn said doctors who treated the baby when she was brought into the emergency room could have reported suspected abuse to DYFS, and did not.

"Whatever our clients did, they did in good faith," he said.

Lauren Kidd, a spokeswoman for DYFS, said the division does not comment on pending litigation.

The adopted mother, identified only as L.A., is seeking monetary damages to assist in the care of her daughter. The case is expected to last two to three weeks.

Source http://www.nj.com/news/index.ssf/2011/12/woman_sues_dyfs_after_her_adop.html

Doctor at Austin State Hospital accused of child sex abuse - Texas

By Andrea Ball and Eric Dexheimer

The state Department of Family and Protective Services has accused a longtime staff child psychiatrist for the Austin State Hospital of sexually abusing at least one child in his care, and investigators from an independent oversight agency have opened a wider inquiry into accusations from at least eight possible victims dating back a decade.

The state agency alerted hospital officials three weeks ago that it had confirmed that Dr. Charles Fischer had been involved in two separate instances of sexual abuse, said Patrick Crimmins, a spokesman for the agency. The agency terms an incident "confirmed" if its investigation shows the allegation is supported by a preponderance of the evidence.

Carrie Williams, a spokeswoman for the Department of State Health Services, which runs the Austin hospital, said Fischer, 59, was fired effective Monday.

The state hospital is a residential facility for people with mental illness. The child and adolescent unit where Fischer worked houses youths up to the age of 18. The Adult Protective Services division of the Department of Family and Protective Services is required by law to investigate allegations of abuse and neglect in state hospitals.

Crimmins said police have been notified of the agency's findings; however, an Austin police spokeswoman said Fischer has not been charged with any crimes.

Contacted at his West Lake Hills home, Fischer declined to comment. "You'll have to ask the hospital about that," he said.

The Texas Medical Board, which licenses physicians, shows Fischer has an unblemished disciplinary record. Details of the case against Fischer were still unclear late Wednesday. Williams did not say when the two confirmed incidents occurred, how they were confirmed, if the youth was a boy or a girl, or whether he or she was still a hospital resident.

But, she said, Fischer, who earned $185,000 a year from the state, had been accused of sexually abusing patients in the past.

"There were previous allegations against Dr. Fischer over the years," she said. "Each was reported and investigated outside the agency, but the allegations were never confirmed."

Crimmins said the Department of Family and Protective Services investigated each of the abuse allegations as they became known.

"We have received several reports alleging sexual abuse by Dr. Charles Fischer dating back several years. In each instance in which sexual abuse by Dr. Fischer was alleged, law enforcement was notified at the time of the initial report, and again when a finding was made," he wrote in an email response to questions.

"Each case was investigated thoroughly, but none were confirmed until October, when two separate allegations of sexual abuse against Dr. Fischer were confirmed, and the Department of State Health Services was notified."

A spokeswoman for the state Health and Human Services Commission said the agency's internal investigative arm was looking into the abuse allegations. Stephanie Goodman declined to say whether the Office of Inspector General was investigating the incidents of alleged abuse or the agency's response to them.

And on Wednesday, Disability Rights Texas — a nonprofit organization officially designated by the federal government to protect the rights of the state's disabled — said it had launched an inquiry into cases involving eight potential victims in incidents involving Fischer dating back to 2001. Because of its federal affiliation, the organization has access to records at state hospitals and can bring lawsuits against the state on behalf of people with disabilities.

Beth Mitchell, an attorney for the organization, said she did not yet know if the eight cases it had been notified of included the two abuse incidents confirmed by the Department of Family and Protective Services.

"We are all heartbroken over these allegations," Williams said. "These kids come to us to heal, and the situation is very sad and extremely troubling for everyone involved."

State records show Fischer received his medical license in 1978 from the University of Texas Health Science Center in San Antonio. He completed a residency in general psychiatry and further specialized training in child psychiatry, the records show.

http://www.statesman.com/news/local/doctor-at-austin-state-hospital-accused-of-child-1974447.html