Drug makers and the FDA hid from the public Risperdal side effects

PHILADELPHIA (CN) – Regulators failed to act on signs that the popular antipsychotic Risperdal causes teenage boys to grow breasts, a federal complaint from the law firm Sheller PC alleges.

Sheller notes in the Jan. 29 action that it represents hundreds of children suing Johnson & Johnson and its subsidiary Janssen in Pennsylvania over serious side effects attributed to the use of Risperdal, or its generic versions, as well as the newer schizophrenia treatment Invega.

Claiming that the drugs can cause adolescent males to grow abnormal breasts, a condition known as gynecomastia, and other adverse effects on sexual maturation, the law firm says it petitioned the Food and Drug Administration in 2012 to remove the pediatric approval of Risperdal or apply a black-box warning about on the drugs.

Sheller notes that, during the course of its representation of consumers suing the makers of Risperdal, it acquired certain confidential documents that establish the drug’s danger.

It allegedly cannot produce these documents to the FDA, however, “because they are subject to confidentiality and protective orders in those cases.”

Sheller said its citizen petition to the FDA implored the agency to obtain those confidential documents directly from Johnson & Johnson and Janssen, or to have the drugmakers release Sheller from the confidentiality orders. Continue reading “Drug makers and the FDA hid from the public Risperdal side effects”

Antipsychotic Drugmakers Target Marketing Dollars at D.C. Medicaid Psychiatrists, Study Indicates: Prescribing Antipsychotics to non psychotic Children

ScienceDaily (Sep. 26, 2012) — The D.C. Department of Health (DOH) has released a study by George Washington University School of Public Health & Health Services (SPHHS) indicating the high levels of marketing by antipsychotic drug manufacturers to Medicaid psychiatrists in the District of Columbia.

Antipsychotics are one of the top-selling drug classes; In 2010, top antipsychotic manufacturers spent more than $25 million on marketing in Washington DC. Among 26 psychiatrists receiving at least $1000 from top antipsychotic manufacturers in 2010, 7 (27%) were Medicaid providers. Medicaid psychiatrists, however, received a disproportionate, share of industry largesse, receiving two-thirds (66%) of gifts and payments. In 2008 (the most recent data available),antipsychotic use by Medicaid recipients was especially high in the nation’s capitol, with approximately 1 in 10 recipients receiving a prescription — a rate five times higher than the total national population.

A large proportion of Medicaid recipients are children under the age of 18. Antipsychotics can cause sedation, weight gain, diabetes, and other adverse effects. Previous studies have shown a high rate of inappropriate off-label use (for conditions the FDA has not approved). Some adverse events may be more likely to occur in children and young adults.

Lead researcher Susan Wood, PhD, Associate Professor at SPHHS, said, “Pharmaceutical marketing affects which drugs are prescribed. Prescribing decisions can have a profound effect on both state coffers and population health.”

“Antipsychotics are clearly being used in patients who are not psychotic,” said Adriane Fugh-Berman, MD, collaborator on the report and Associate Professor of Pharmacology and Physiology at Georgetown University Medical Center.

The report is in fulfillment of AccessRx, the District of Columbia’s 2006 law requiring public disclosure of pharmaceutical marketing expenditures spent on all health care providers by every pharmaceutical company that markets in the District. The DOH’s Health Regulation and Licensing Administration commissioned the study by SPHHS on the 2010 data. The amounts paid by antipsychotic manufacturers to DC Medicaid and non-Medicaid psychiatrists are included in the report, along with the effects of the new public records on prescribing and marketing trends.

Access to the report is available on DOH’s web site, http://doh.dc.gov/node/158762


23rd Health Research Report 23 JAN 2008 – Reconstructed

Health Technology Research Synopsis

23rd Issue Date 22 JAN 2008

Compiled By Ralph Turchiano

Editors Top Five:

1.      Lipoic acid could reduce atherosclerosis, weight gain
2.      Probiotics affect metabolism, says new study
3.      Value of drugs for pre-osteoporosis exaggerated
4.      Selective reporting of antidepressant trials exaggerates drug effectiveness
5.      4 health behaviors can add 14 extra years of life

In this issue:

1.      More sun exposure may be good for some people
2.      Muscles are affected by cigarette smoking
3.      4 health behaviors can add 14 extra years of life
4.      New statistical technique shows more informative picture of survival
5.      Evidence for Dopamine Toxicity in Neurodegeneration
6.      UCLA study finds brain response differences in the way women with IBS anticipate and react to pain
7.      High degree of resistance to antibiotics in Arctic birds
8.      Stem cells make bone marrow cancer resistant to treatment
9.      Editorialist: Scientific Journals Must Provide a Forum for New Discoveries Based on Clinical Observation
10.  Vitamin D2 supplements may help prevent falls among high-risk older women
11.  Diets high in lutein, zeaxanthin and vitamin E associated with decreased risk of cataracts
12.  Selective restraints and reduced medication could reduce nursing home falls says 4-year study
13.  Aggression as rewarding as sex, food and drugs
14.  Lipoic acid could reduce atherosclerosis, weight gain
15.  Celecoxib can adversely affect heart rhythm
16.  Combined HRT increases risk of lobular breast cancer fourfold after just 3 years of use
17.  Probiotics affect metabolism, says new study
18.  Popular osteoporosis drugs triple risk of bone necrosis
19.  Cholesterol-lowering drugs may not prevent Alzheimer’s disease
20.  Selective reporting of antidepressant trials exaggerates drug effectiveness
21.  Indian medicinal plant Acanthus ilicifolius may combat liver cancer
22.  How does Fu-Zheng-Jie-Du-Decoction act on PTEN expression in hepatocellular carcinoma?
23.  Weight gain induced by antipsychotic drugs can be avoided
24.  Toxoplasma Infection Increases Risk of Schizophrenia, Study Suggests
25.  Newly discovered virus linked to deadly skin cancer
26.  Value of drugs for pre-osteoporosis exaggerated
27.  Saline nasal wash helps improve children’s cold symptoms

More Children Being Prescribed – Quote “Lobotomizing” Antipsychotics Than Adults Now.

More Kids Taking Antipsychotics for ADHD: Study

HealthDayBy By Steven Reinberg HealthDay Reporter | HealthDay – 2 hrs 17 mins ago

TUESDAY, Aug. 7 (HealthDay News) — Use of powerful antipsychotic  medications such as Abilify and  Risperdal to control youngsters with  attention-deficit/hyperactivity disorder (ADHD) and other behavior  problems has skyrocketed in recent years, a new study finds.

Antipsychotics are approved to treat bipolar disorder, schizophrenia,  other serious mental problems and irritability related to autism. But they  don’t have U.S. Food and Drug Administration approval for ADHD or other  childhood behavior problems, and their use for this purpose is considered  “off label.”

“Only a small proportion of antipsychotic treatment of children (6  percent) and adolescents (13 percent) is for FDA-approved clinical  indications,” said lead researcher Dr. Mark Olfson, a professor of  clinical psychiatry at Columbia University Medical Center in New York  City.

“These national trends focus attention on the substantial  and growing  extent to which children diagnosed with ADHD and other disruptive  behavioral disorders are being treated with antipsychotic medications,”  said Olfson.

The researchers found that doctor visits between 1993-1998 and  2005-2009 that involved a prescription of antipsychotic medication for  children jumped sevenfold — from 0.24 to 1.83 per 100 people. For teens,  14 to 20 years old, the rate rose from 0.78 to 3.76 per 100 people, and  for adults, it just about doubled, from 3.25 to 6.18 per 100 people.

Many of the prescriptions for children were ordered by doctors who are  not psychiatrists, the researchers found.

Although these drugs can deliver rapid improvement in children with  severe conduct problems and aggressive behaviors, it is not clear whether  they are helpful for the larger group of children with ADHD, he said. Nor  has their long-term effect on children’s developing brains been studied.

Olfson said most children and adolescents treated with antipsychotics  are not receiving psychotherapy. “This suggests that more needs to be done  to increase access and availability of psychosocial interventions,” he  said.

“Parent management training and cognitive problem-solving skills  training are examples of effective but underused treatments for young  people with disruptive behavioral problems,” he said.

The study, published in the Aug. 6 online edition of the Archives of  General Psychiatry, used data from the National Ambulatory Medical  Care Surveys from 1993 to 2009. More than 484,000 people were included in  total.

The researchers found prescriptions for antipsychotics increased for  children and adults. But doctors prescribed more antipsychotics to  children and adolescents (68 percent and 72 percent, respectively) than to  adults (50 percent).

For children 13 and younger, the most prescribed drug was risperidone  (Risperdal). Other drugs included aripiprazole (Abilify), quetiapine  (Seroquel) and olanzapine (Zyprexa). Of these drugs, Abilify was most  commonly prescribed to adolescents, aged 14 to 20, the study found.

All of these antipsychotics, developed since the 1990s, are considered  “atypical” or second-generation  antipsychotics.

For elderly patients, the FDA recently issued a Public Health Advisory  about  atypical antipsychotic medications after determining that death  rates are higher for elderly people with dementia when taking atypical  antipsychotics.

Dr. Peter Breggin, a psychiatrist from Ithaca, N.Y.,  and an outspoken  critic of widespread antipsychotic use in children, said these drugs  damage developing brains.

“We have a national catastrophe,” said Breggin. “This is a situation  where we have ruined the brains of millions of children.”

In controlling behavior, antipsychotics act on the frontal lobes of the  brain — the same area of the brain targeted by a lobotomy, Breggin  said.

“These are lobotomizing drugs,” he added. “Of course, they will reduce  all behavior, including irritability,” he said.

Olfson’s team found that most children treated with antipsychotic  medications are diagnosed with ADHD, oppositional behavior and unspecified  disruptive behavioral disorders.

Between 2005 and 2009, controlling “disruptive behavior” accounted for  63 percent of the reason antipsychotics were given to children and almost  34 percent for adolescents, the researchers found.

In contrast, bipolar disorder and depression were the most common  reasons these drugs were prescribed to adults during that time period.

Simon Rego, director of psychology training at Montefiore Medical  Center/Albert Einstein College of Medicine in New York City, said these  drugs have serious side effects, including weight gain, diabetes and heart  problems.

“But, perhaps even more important is the finding that a substantial  majority of the child antipsychotic visits were for young people diagnosed  with disruptive behavior disorders, for which there are currently no  FDA-approved antipsychotic medications,” he said.

Given the uncertain effects that antipsychotic medications have on  cognitive (brain), social and physical development in children and  adolescents, it may be necessary to reevaluate clinical practice patterns,  Rego said.

Efforts to educate physicians about the safety and effectiveness of  antipsychotic medications are also needed, he said.

More information

For more information on antipsychotics, visit the U.S. National Institute of Mental Health

How antipsychotic medications cause metabolic side effects such as obesity and diabetes

LA JOLLA, Calif. — In 2008, roughly 14.3 million Americans were taking antipsychotics—typically prescribed for bipolar disorder, schizophrenia, or a number of other behavioral disorders—making them among the most prescribed drugs in the U.S. Almost all of these medications are known to cause the metabolic side effects of obesity and diabetes, leaving patients with a difficult choice between improving their mental health and damaging their physical health. In a paper published January 31 in the journal Molecular Psychiatry, researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham) reveal how antipsychotic drugs interfere with normal metabolism by activating a protein called SMAD3, an important part of the transforming growth factor beta (TGFbeta) pathway.

The TGFbeta pathway is a cellular mechanism that regulates many biological processes, including cell growth, inflammation, and insulin signaling. In this study, all antipsychotics that cause metabolic side effects activated SMAD3, while antipsychotics free from these side effects did not. What’s more, SMAD3 activation by antipsychotics was completely independent from their neurological effects, raising the possibility that antipsychotics could be designed that retain beneficial therapeutic effects in the brain, but lack the negative metabolic side effects.

“We now believe that many antipsychotics cause obesity and diabetes because they trigger the TGFbeta pathway. Of all the drugs we tested, the only two that didn’t activate the pathway were the ones that are known not to cause metabolic side effects,” said Fred Levine, M.D., Ph.D., director of the Sanford Children’s Health Research Center at Sanford-Burnham and senior author of the study.

In a previous study aimed at developing new insights into diabetes, Dr. Levine and his team used Sanford-Burnham’s high-throughput screening capabilities to search a collection of known drugs for those that alter the body’s ability to generate insulin, the pancreatic hormone that helps regulate glucose. That’s when they first noticed that many antipsychotics alter the activity of the insulin gene. In this current study, the researchers set out to connect the dots between antipsychotics and insulin. In doing so, experiments in laboratory cell-lines showed that antipsychotics known to cause metabolic side effects also activated the TGFbeta pathway—a mechanism that controls many cellular functions, including the production of insulin—while the drugs without these side effects did not.

Wondering whether their initial laboratory observations were relevant to the human experience, the researchers reanalyzed previously published gene expression patterns in brain tissue from schizophrenic patients treated with antipsychotics. What they found supported their earlier findings—TGFbeta signaling was activated only in those patients receiving antipsychotic treatment. Looking further, they found that the extent to which each antipsychotic drug activated the TGFbeta pathway in human brains correlated very closely with the extent to which those same drugs activated SMAD3 and affected the insulin promoter in their cell culture experiments.

The TGFbeta pathway also plays an important role in metabolic disease in people who don’t take antipsychotic medications. “It’s known that people who have elevated TGFbeta levels are more prone to diabetes. So having a dysregulated TGFbeta pathway—whether caused by antipsychotics or through some other mechanism—is clearly a very bad thing,” said Dr. Levine. “The fact that antipsychotics activate this pathway should be a big concern to pharmaceutical companies. We hope this new information will lead to the development of improved drugs.”


This study was funded by a gift from Mr. T. Denny Sanford to the Sanford Children’s Health Research Center at Sanford-Burnham. Co-authors include Thomas Cohen, Sanford-Burnham and University of California, San Diego; S. Sundaresh, NextBio; and Fred Levine, Sanford-Burnham.

About Sanford-Burnham Medical Research Institute

Sanford-Burnham Medical Research Institute is dedicated to discovering the fundamental molecular causes of disease and devising the innovative therapies of tomorrow. The Institute consistently ranks among the top five organizations worldwide for its scientific impact in the fields of biology and biochemistry (defined by citations per publication) and currently ranks third in the nation in NIH funding among all laboratory-based research institutes. Sanford-Burnham is a highly innovative organization, currently ranking second nationally among all organizations in capital efficiency of generating patents, defined by the number of patents issued per grant dollars awarded, according to government statistics.

Sanford-Burnham utilizes a unique, collaborative approach to medical research and has established major research programs in cancer, neurodegeneration, diabetes, and infectious, inflammatory, and childhood diseases. The Institute is especially known for its world-class capabilities in stem cell research and drug discovery technologies. Sanford-Burnham is a U.S.-based, non-profit public benefit corporation, with operations in San Diego (La Jolla), Santa Barbara, and Orlando (Lake Nona). For more information, please visit our website (http://www.sanfordburnham.org) or blog (http://beaker.sanfordburnham.org). You can also receive updates by following us on Facebook and Twitter.