Posts Tagged ‘Abilify’

Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly

Thursday, May 26th, 2011

TIME
By Maia Szalavitz
May 26, 2011

Maryland Correctional Institution, Jessup, Maryland - Marvin Joseph/The Washington Post/Getty Images

Pharmaceutical companies have recently paid out the largest legal settlements in U.S. history — including the largest criminal fines ever imposed on corporations — for illegally marketing antipsychotic drugs. The payouts totaled more than $5 billion. But the worst costs of the drugs are being borne by the most vulnerable patients: children and teens in psychiatric hospitals, foster care and juvenile prisons, as well as elderly people in nursing homes. They are medicated for conditions for which the drugs haven’t been proven safe or effective — in some cases, with death known as a known possible outcome.

The benefit for drug companies is cold profit. Antipsychotics bring in some $14 billion a year. So-called “atypical” or “second-generation” antipsychotics like Geodon, Zyprexa, Seroquel, Abilify and Risperdal rake in more money than any other class of medication on the market and, dollar for dollar, they are the biggest selling drugs in America. Although these medications are primarily approved to treat schizophrenia and bipolar disorder, which combined affect 3% of the population, in 2010 there were 56 million prescriptions filled for atypical antipsychotics.

In a presentation this week at an American Psychiatric Association meeting, Dr. John Goethe, director of the Burlingame Center for Psychiatric Research in Connecticut, reported that over the last 10 years, more than half of all children aged 5 to 12 in psychiatric hospitals were prescribed antipsychotics — and 95% of these prescriptions were for second-generation antipsychotics. Many of these children didn’t have a condition for which the drugs have been shown to be helpful: 44% of youngsters with post-traumatic stress disorder (PTSD) and 45% of children with attention deficit hyperactivity disorder (ADHD) were treated with them.

Pharmacologically, the ADHD prescriptions make no sense: FDA-approved drugs for the condition raise levels of the neurotransmitter dopamine, while antipsychotics do they opposite, lowering them.

Geothe also noted another study that showed that the number of office visits by children and teens that included antipsychotic drug prescriptions rose 600% from 1993 to 2002. “The obvious second-generation bias is very apparent in these data, as is the irrational use of antipsychotics for indications such as PTSD and ADHD for which there is no controlled evidence whatsoever that these are safe or effective treatments,” says Dr. Bruce Perry, senior fellow at the ChildTrauma Academy in Houston. (Full disclosure: Dr. Perry is my co-author on two books.)

The situation may be similar in state-run juvenile detention systems. Late last week, an exposé by the Palm Beach Post revealed that antipsychotics were among the top drugs purchased by the Florida Department of Juvenile Justice (DJJ), and were largely used in kids for reasons that were not approved by the government — for instance, sleeplessness or anxiety. The Post reported:

In 2007, for example, DJJ bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children.

That’s enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day.

Among the psychiatrists hired by the state to evaluated incarcerated kids, about a third received drug company money, the Post reported. Those 17 psychiatrists wrote 54% of the prescriptions for antipsychotics; the 35 doctors who did not take such payments wrote the rest. In other words, one-third of doctors — all of whom were paid by drug companies — wrote more than half of all antipsychotic prescriptions for the state’s locked-down youth.

The statistics on children in foster care are equally alarming. Youth in foster care are not only three times as likely to be medicated as comparable low-income youth on Medicaid, but more than half are treated with antipsychotics. It is not likely that all or even most of these children have a condition for which antipsychotics have been approved by the government to treat.

Among the problems with unnecessary use of antipsychotic medications is that they can cause serious, sometimes irreversible, damage. Atypical antipsychotics are associated with weight gain and may double users’ risk of Type 2 diabetes. Recent research also suggests that they may shrink the brain and there is little data on how they affect brain development during the teen years, when the brain grows more than at any other time but infancy. Indeed, youth are more vulnerable than any other group to the drugs’ worst side effects (excluding death).

“The majority of antipsychotic medication use in children and adolescents has not been limited to the few age groups or conditions for which there is credible evidence of efficacy and safety,” says Perry. “There is no reason to expect irrational prescribers to change their bad habits.”

He adds that many experts would argue that if doctors began prescribing antipsychotics “responsibly and cautiously” — that is, being mindful of the lack of efficacy data and the evidence of harm — the rate of prescriptions in children would drop by 90%.

Meanwhile, rates of prescriptions for patients at the other end of the lifespan are also out of control. In nursing homes, 14% of residents have been given at least one prescription for a second-generation antipsychotic, according to a government investigation. A full 88% of these prescriptions are given to people with dementia, despite the fact that these drugs may double the risk of death in these patients (there is a black box warning on the drug to this effect). The investigation estimated that $116 million Medicare dollars have been spent filling antipsychotic prescriptions that never should have been written.

So why are these drugs so widely prescribed? Aggressive drug company marketing is only one part of the story. A key reason they are overused in institutional settings is that they are sedating, making patients easier to manage. Secondly, unlike other sedative drugs, they are not associated with misuse (with the possible exception of Seroquel, which has fans among some addicts). In fact, most people resist taking antipsychotics, which is why overmedication is much more common in settings where people are locked-in and compliance can be forced.

The second point — that these drugs are not considered addictive — by itself probably accounts for a big part of why drug companies have been able to get away with so much misleading marketing and the resultant overprescribing. Although prescribing of traditional sedatives like benzodiazepines (Valium, Xanax), which are vulnerable to misuse, is limited by their status as controlled substances, few people enjoy misusing antipsychotics (side effects like weight gain, pleasurelessness, movement disorders and low energy and motivation are not generally sought by recreational drug users), so they can be prescribed for unapproved uses like behavior control and sleep-inducement in children and the elderly.

In other words, addiction is basically seen as a worse side effect than death. The fact that the most vulnerable youth and elderly often cannot advocate for themselves has made it easier to sweep the problem under the rug.

Fortunately, there is at least one bright spot in this depressing picture. The main patent on Risperdal expired in 2007, and those for Zyprexa and Seroquel expire this year. Geodon’s patent expires next year, while Abilify’s comes up in 2015. When most drugs go off-patent, drug companies’ marketing pressure — and profits — will subside, perhaps keeping children and the elderly safer from inappropriate medication.

Read article here:  http://healthland.time.com/2011/05/26/why-children-and-the-elderly-are-so-drugged-up-on-antipsychotics/

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Antipsychotic Drugs Deadly for Elderly Patients, Prescribed Anyway

Thursday, May 12th, 2011

ThirdAge.com

by Alex Heig

Antipsychotic drugs prescribed to as many as one in seven patients with dementia at nursing homes increase the risk of death and are not approved for such uses, a government audit has found.

Drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are “potentially lethal” to many of the patients getting them and in many cases, completely unnecessary and unneeded.

The Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics can be attributed to drugmakers’ habit of paying kickbacks to nursing homes to increase prescriptions for the medicines.

Medicare officials said that diagnosis information is for the most part omitted from prescriptions so officials are unable to tell whether the prescription is appropriate.

The Food and Drug Administration has warned doctors of the risk of using antipsychotic drugs in elderly dementia patients, but doctors have continued the practice because of a relative lack of other options.

Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” said Dr. Daniel J. Carlat, editor-in-chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

The results of the government audit showed that during the first six months of 2007, 304,983 elderly patients in nursing homes (out of 2.1 million total) had at least one Medicare claim for an antipsychotic medicine.

Meanwhile, 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia, for whom the drugs can be lethal.

Federal regulations prohibit any drug paid for by the government from being used for non-approved reasons. Auditors found that 51 percent of claims for antipsychotic medication violated this rule.

Additionally, the government bans drugs used in excessive duration or dose level, even for patients that qualify. Auditors found that 22 percent of claims failed to live up to this requirement.

http://www.thirdage.com/news/antipsychotic-drugs-deadly-for-elderly-patients-prescribed-anyway_05-10-2011?page=1

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Antipsychotic Drugs Called Hazardous for the Elderly

Monday, May 9th, 2011

The New York Times
By Gardiner Harris
May 9, 2011

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, a government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the audit found, costing the program $116 million for those six months.

“Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions,” Daniel R. Levinson, inspector general of the Department of Health and Human Services, wrote in announcing the audit results.

Mr. Levinson noted that such drugs — which include Risperdal, Zyprexa, Seroquel, Abilify and Geodon — are “potentially lethal” to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses “putting profits before safety.”

The audit is an unusual assessment by the government of whether doctors are treating Medicare patients appropriately in nursing homes. Mr. Levinson suggested that the government should collect information on the diagnoses given Medicare patients so that the government can assess whether the drugs prescribed to them are appropriate.

While common in the private sector, such basic oversight is unheard of in the Medicare program and would almost certainly be opposed by doctors’ groups and many in Congress who view government intrusions into the doctor-patient relationship as inappropriate. In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

Medicare officials said that diagnosis information is not generally included with prescriptions so the government cannot assess in real time whether prescription payments are appropriate.

While the Food and Drug Administration has warned doctors that using antipsychotic drugs in elderly patients with dementia increases their risks of death, doctors continue the practice because they have few other good choices, said Dr. Daniel J. Carlat, editor in chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

“Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” Dr. Carlat said.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

The auditors found that 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia — for whom the drugs can be lethal.

“These results are alarming,” said Senator Charles E. Grassley, Republican of Iowa, who asked for the audit. “Medicare officials need to pay attention.”

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

Government rules also ban drugs that are used in excessive doses or duration, even if patients are found to have a condition for which the drug is appropriate. Auditors found that 22 percent, or 317,971 of 1.4 million claims, for antipsychotic medicines failed this standard.

Read article here:  http://www.nytimes.com/2011/05/10/health/policy/10drug.html?_r=2

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How Big Pharma’s Deceptive Advertising Helps Addict Patients, Screw Over Doctors and Jack Up Insurance Rates

Monday, April 18th, 2011

AlterNet – April 18, 2011

by Martha Rosenberg

All you knew about prescription drugs were creepy ads in a JAMA at the doctor’s office with a lot of fine print. Even if you knew the name of a drug, you’d never ask your doctor for it because that would be self-diagnosing and cheeky for a patient.

Flash forward to the late 1990s when direct-to-consumer (DTC) drug advertising, drug Web sites and online drug sales came on board, and self-diagnosing and demanding pills has become medicine-as-usual for the doctor/patient encounter.

The DTC/Web perfect storm didn’t just sell drugs like Claritin, Prozac and the Purple Pill, it sold the diseases to go with them like seasonal allergies, GERD and depression. It sold risk of diseases like heart events for which you’d take a statin like Lipitor, osteoporosis for which you’d take a bone drug like Boniva and asthma attacks for which you’d use a second asthma drug like Advair. Of course, by the very definition of prevention, you didn’t know if the drugs were working but you weren’t paying out of pocket anyway so what the hay…

Thanks to DTC advertising, people started taking seizure drugs like Topamax and Lyrica for everyday pain or headaches and antipsychotics– hello? — for everyday blues or mood problems. They started taking monoclonal antibodies made from genetically engineered hamster cells like Humira that invite cancer, superinfections and TB when they didn’t have to. And FDA mandated risk disclosures — brain bleeds, sudden death, difficulty breathing, stomach bleeding, liver failure, kidney failure, muscle breakdown, fainting, hallucinations — perversely increased drug sales either because people like the identity in having a disease, chemically experimenting on themselves and/or taking a dare or because ad frequency itself sells regardless of the message.

Soon anxiety graduated to depression which graduated to bipolar disorder. Children got schizophrenia and depression like adults and adults got ADHD like kids. And it didn’t stop there. If the depression you or your kid had didn’t go away — maybe because it wasn’t depression in the first place but a thing called “life” — you needed to add a drug like Abilify or Seroquel on to the original drug(s) because your depression was “treatment resistant.”

Of course if people were paying for the drugs out of their pocket and you told them to add a drug that costs almost $500 a month because the first one isn’t working, they would say the only thing “treatment resistant” is your sales pitch — go find another sucker. But if third party payers get stuck with the bill, no one seems to mind pharma’s double-(and triple)-its-money plan — or even notice it.

In fact psychiatric drug cocktails of eight, ten and twelve drugs are now common medical practice for “treatment resistant” depression and PTSD (often paid by government entitlement health plans) even though the drugs have never been tested when taken together. Unless you count the patients taking them now!

Pharma also adds an urgency pitch to the sell in case you think you can wait to take you or your child’s treatment resistant drug cocktail until symptoms worsen. Depression is now a “progressive” disease say pharma-paid doctors after being known for decades as a self-limiting disease. (The one good thing you could say about depression; it would go away.)

And don’t think kids will outgrow mood problems either, says pharma. That erratic behavior is no doubt early mental illness that will become Worse if you’d don’t treat it in the bud. Even mothers of one-year-olds with the sniffles are told serious asthma is just around the corner if they don’t treat their toddler now.

Pharma is also having a field day with sleep because everyone is in the demographic. In fact comedian Chris Rock riffs about hearing a DTC ad that asks, “Do you fall asleep at night and wake up in the morning?” and recognizing himself. “Yeah, I got THAT,” he says.”

Not falling asleep soon enough of course is the disease of insomnia which can have “strains” like “middle-of-the-night” and “terminal” insomnia. But it also sets you up for — what’s the pharma euphemism — wakefulness problems the next day. And once you’re using a wakefulness aid like Adderall or Nuvigil, what do you bet you’ll have sleep problems?

Because of pharma-paid doctors, PR firms and industry subsidized medical journals and Web sites like WebMD, pharma is able to create new diseases (osteopenia, the “risk” of osteoporosis), perimenopause and Low T), “humanize” others by giving them nicknames (ED, RA, RLS, Hep C) and elevate others to public health problems like HPV/venereal warts. (It doesn’t hurt that Julie Gerberding, MD, former CDC head resurfaced as head of Merck vaccines after she left the government.)

But a more insidious sell are pharma subsidized “patient groups” that lobby FDA and state agencies about expensive drugs, often psychiatric. While these “patients” — often flown by pharma to testify at FDA hearings — pretend they can’t get needed drugs like terminal cancer patients, the issue is seldom availability but money: either they want a new use covered by insurers or don’t want an older, cheaper drug substituted.

The same patients appear on Web site testimonials and phony grassroots PSAs (public service messages) about the epidemic of depression or childhood mental illness. How can you tell they’re not real patients but pharma plants? The Web sites and PSAs look exactly like direct-to-consumer ads.

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California claims drug giant bribed docs to prescribe

Wednesday, March 23rd, 2011

Ventura County Star, March 22, 2011

Associated Press

photo by Boaz Yiftach

LOS ANGELES – California has joined a whistleblower lawsuit that claims Bristol-Myers Squibb Co. bribed doctors to prescribe its drugs, costing insurers perhaps millions of dollars in the largest alleged health care fraud case ever handled by the state, Insurance Commissioner Dave Jones announced Friday.

The suit claims company salespeople plied physicians with speaking fees, expensive meals, gifts and trips to induce or reward them for prescribing large amounts of its drugs, which were billed to private insurers.

For example, the company invited doctors to attend Los Angeles Lakers games at Staples Center and spent thousands of dollars on luxury suites, the suit claimed.

“Golf outings, basketball camps, samba lessons, you name it,” Jones said at a news conference.

The lawsuit said the aim was to boost prescription levels for legally approved and so-called “off-label” uses of drugs ranging from the antipsychotic Abilify to the blood thinner Plavix.

The company is accused of setting up a speakers bureau that doled out thinly veiled kickbacks in the form of cash payments to influential or high-prescribing doctors for speaking about its products.

One doctor received a $2,500 honorarium even though he never actually spoke, Jones said.

The company denied any wrongdoing.

“Bristol-Myers Squibb believes this lawsuit has no merit and the company will defend itself vigorously,” said Laura Hortas, a company spokeswoman.

California joined a 2007 lawsuit filed by one current and two former employees of the pharmaceutical giant. If they win, the whistleblowers and the state would share damages.

The amended complaint was filed by state insurance department lawyers two weeks ago in Los Angeles Superior Court.

It’s not the first time New York-based Bristol-Myers Squibb has been accused of kickbacks by its own workers.

In 2007, the company agreed to pay $515 million to settle federal lawsuits brought by whistleblowers in Massachusetts and Florida.

The current lawsuit says the company tracked prescription figures, and low-prescribing doctors were threatened with loss of perks.

A sales plan entitled “Rounding Up the Docs!” instructed salespeople at dinner events to get physicians to commit to prescribing for specific types of patients and to monitor the number of new prescriptions by doctors. the suit states.

The company is believed to have made at least 15,000 kickbacks from 1999 to 2005, and investigators suspect that the practice is continuing, Jones said.

The cost of the alleged practice was unclear, but Jones noted the size of the previous federal settlement.

No doctors have been sued or charged with a crime because the insurance department is focusing on the company in its civil action.

The suit seeks unspecified damages that include a $10,000 fine for each prescription obtained through fraud and repayment of any profit the company made from the alleged scheme.

The investigation was continuing.

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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New JerseyDrinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

OklahomaKaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Federal Judge & DOJ back lawsuit accusing Johnson & Johnson of illegal kickback scheme to push antipsychotic drugs on elderly

Tuesday, March 1st, 2011

AboutLawsuits.com

March 1, 2011

A federal judge has refused to toss out a whistleblower lawsuit backed by the Department of Justice (DOJ), which accuses Johnson & Johnson of involvement in an illegal kickback scheme to push their antipsychotic drugs on elderly nursing home residents that did not need them.

Johnson & Johnson sought to have claims brought by the DOJ, a number of whistleblowers and states dismissed, saying that what the plaintiffs are calling illegal kickbacks were completely legal rebates. However, U.S. District Judge Richard Stearns found that plaintiffs had sufficient evidence to go forward with the complaint.

Judge Stearns did remove several plaintiffs from the case, including the states of Nevada, Texas and Illinois, but allowed Kentucky, Indiana and Virginia to stay part of the lawsuit. Whistleblower David Kammerer was also removed from the lawsuit.

The DOJ filed a civil False Claims Act compliant against J&J on January 15, 2010, saying that the company paid millions to Omnicare, Inc. as kickbacks for selling Risperdal to nursing home patients.

In 2009, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.

According to the DOJ complaint against Johnson & Johnson, the drug maker paid $50 million to Omnicare between 1999 and 2004 to get it to prescribe Risperdal to elderly patients with dementia, and then hid those kickbacks as payments for services that Omnicare never actually provided. Omnicare then enacted intervention programs such as the “Risperdal Initiative” to persuade physicians to prescribe the drug to elderly dementia patients.

Omnicare, the largest pharmaceutical supplier for nursing homes in the U.S., has pharmacists on staff who review patients’ records and then makes recommendations to the patients’ physicians. Those recommendations are followed about 80% of the time, the DOJ said.

The claims were originally made by Omnicare pharmacist Bernard Lisitza in 2003, and the DOJ chose to intervene on Lisitza’s behalf.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen, which is a subsidiary of Johnson & Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is commonly used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.

Risperdal is not approved for treatment of dementia, and patient advocates have been pushing nursing homes to reduce the use of the drug among elderly due to the health risk and a lack of actual health benefits. According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.

http://www.aboutlawsuits.com/risperdal-omnicare-lawsuit-proceeds-16571/

To see more international drug regulatory warnings and studies on Risperdal and other antipsychotic drugs, visit CCHR’s Psychiatric Drug Side Effects Database here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

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Nation of Pill Poppers: 19 Potentially Dangerous Drugs Pushed By Big Pharma

Tuesday, December 7th, 2010
AlterNet — December 6, 2010
by Martha Rosenberg
Here are some of the dicey drugs many Americans are hooked on,
thanks to greedy pharmaceutical companies.

Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers — choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it.

But if patients want the drugs, doctors and pharma executives want them to have the drugs and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem?

Yes, when you consider the cost of private and government insurance and the health of patients who take potentially dangerous drugs like these.

Seroquel, Zyprexa, Geodon, atypical antipsychotics

Even though the antipsychotic Seroquel surpasses 71 drugs on the FDA’s January quarterly report with 1766 adverse events, even though it’s linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year.

Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses — and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)

Foisted disproportionately on the young, poor and disadvantaged, atypicals cause such weight gain and metabolic derangement — 16 percent of Zyprexa patients gain 66 pounds and some gain over 100 — manufacturer Lilly Eli Lilly agreed to pay the state of Alaska $15 million in 2008 for the Medicaid costs of Zyprexa patients who developed diabetes.

Atypicals carry warnings of death in demented patients but are widely used in nursing homes. And even though Risperdal maker Johnson & Johnson, Geodon maker Pfizer, Abilify maker Bristol-Myers Squibb, Lilly and AstraZeneca have all entered into government settlements that acknowledge fraudulent or wrongful atypical marketing, FDA rewarded atypical makers by approving Zyprexa and Seroquel for children last year. And approved a new atypical antipsychotic, Latuda, in October. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

When it comes to the epidemic of 5.3 million US children between 3 and 17 diagnosed with ADHD, suspicions of pharma pushing the disorder are exceeded only by pharma’s admissions thereof.

During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola credited the “very dynamic ADHD market” to Shire’s globalization efforts and “investments we have made in new uses for our existing products.”

Those uses, a.k.a. diagnoses, for Shire products like stimulants Adderall, Vyvanse and Intuniv include adult ADHD, cognitive impairment, depression and excessive daytime sleepiness.

Still, Cola says despite the 10 percent ADHD “new starts” that are helping Shire “grow the market,” and the “co-administration market” of add-on prescription drug$, the ADHD franchise suffers from patients who drop out when they quit seeing their pediatrician. “We don’t see those patients show up again until their mid-to-late 20s,” laments Cola.

ADHD drugs, in addition to “robbing kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors,” as Anatomy of an Epidemic author Robert Whitaker puts it, can also be deadly.

A 2009 article in the American Journal of Psychiatry called Sudden Death and Use of Stimulant Medications in Youths found 1.8 percent of youthful stimulant users died sudden deaths from cardiac dysrhythmia or unexplained causes versus 0.4 percent who were not on stimulants. Though it helped fund the study, the FDA said the results proved no “real risk” and kids should keep taking their meds.

Meanwhile, says Robert Whitaker, kids on ADHD meds “are told they are going to be on these drugs for life. And next thing they know, they’re on two or three or four drugs,” a phenomenon also known as the co-administration market.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate pharma profits in the last decade than direct-to-consumer advertising and Viagra put together, no pun intended: over 60 million prescriptions were filled in the US in 2007 with many patients reporting their depression lifted.

But some critics say for mild depression, SSRIs don’t work at all and are no better than placebo.

And others say they can add aggression, bizarre behavior, self-harm and suicidal thoughts to depression. In fact, there are 4,200 published reports of SSRI-related violence, aggression, bizarre behavior, self-harm and suicide since the drugs were introduced in 1988 including the well known gun massacres at Columbine (1999), Red Lake (2005), NIU and likely, Virginia Tech (2007).

SSRIs have non-behavioral perks both sides agree on: life-threatening serotonin syndrome when taken with migraine drugs, gastrointestinal bleeding when taken with aspirin, Aleve or Advil and the bone condition, osteoporosis.

Paxil can reduce or abolish the effect of tamoxifen in breast cancer patients and increase deaths says British Medical Journal. It’s linked to a two-fold increased risk of cardiac birth defects in infants according to its own manufacturer, GSK.

And sex? SSRIs are so linked to dysfunction even the pharma-identified web site WebMD admits many will experience impotence, delayed ejaculation or no orgasm. But there is a solution (besides going off SSRIs) says WebMD: Add another antidepressant that’s not an SSRI, like Wellbutrin!

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. But the problem with giving a psychoactive drug for pain is that you’re giving a psychoactive drug for pain. “After three months of taking Savella [another SNRI], I started self-destructing and cutting myself,” writes a 40 year old woman on askapatient.com. “I don’t know why or anything, but it does similar to Prozac where it makes you think and do weird things.”

And Cymbalta, approved this fall for chronic back pain and osteoarthritis?

Cymbalta was the drug healthy 19-year-old volunteer Traci Johnson was testing when she hung herself in an Eli Lilly dorm in 2005. It was the drug Carol Anne Gotbaum killed herself on at Phoenix’s Sky Harbor airport in 2007.

SNRI’s are also harder to quit than SSRIs, especially Effexor. 25-year-old Chicagoan David F. told AlterNet he stood at the top of an 8-story parking lot contemplating jumping every day for weeks after quitting. It’s also the drug Andrea Yates was on when she drowned her five children in 2001.

But not all SNRI side effects are behavioral. The FDA would not approve Pristiq, a newer version of Effexor, when Wyeth/Pfizer tried to market it for vasomotor symptoms, because it caused heart attacks, coronary artery obstruction and hypertension in clinical trials. That’s similar to another SNRI, the diet pill Meridia, which was just withdrawn from the market for causing heart problems. Pristiq is still available.

Read the rest of the article here: http://www.alternet.org/story/149078/nation_of_pill_poppers_19_dangerous_drugs_shamelessly_pushed_by_big_pharma?page=entire

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South Carolina Doctors Under Fraud Investigation After Writing Thousands of Antipsychotic & Painkiller Prescriptions

Monday, November 22nd, 2010
The State, November 22, 2010
By Renee Dudley

CHARLESTON — An influential U.S. senator is checking up on South Carolina doctors who have billed millions of dollars in prescriptions to the financially struggling, taxpayer-funded Medicaid program.

U.S. Sen. Charles Grassley, an Iowa Republican, requested data from each state this year listing which doctors write the most prescriptions for eight common drugs covered by Medicaid, the federal health program for the poor. The reports were intended to “ensure that taxpayer dollars are appropriately spent,” Grassley wrote in a letter to state officials.

The Palmetto State’s report, released to The (Charleston) Post and Courier, identifies a handful of doctors who have written thousands of prescriptions for painkillers and anti-psychotics over the past two years. While many of the claims are legitimate, state Department of Health and Human Services officials confirmed this week that some doctors on the list are under investigation for fraud.

  • The report detailed the top prescribers of the following drugs:

    Abilify

    Geodon

    Oxycontin

    Risperdal

    Roxicodone

    Seroquel

    Xanax

    Zyprexa

Kathleen Snider, the state agency’s compliance chief, declined to say which doctors are under review because their cases are open. State health departments are responsible for monitoring Medicaid prescription rates and billing irregularities.

Among the doctors getting the most reimbursements were a Columbia psychiatrist who wrote about 3,900 prescriptions for the drugs in question in 2008 and 2009. The doctor billed about $1.3 million to Medicaid, according to a Post and Courier review of the data.

A family doctor in Summerville billed about $635,000 for writing nearly 2,400 prescriptions for antipsychotics and painkillers during that time.

A psychiatrist with an Augusta address wrote more than 1,300 prescriptions, billing nearly $720,000 over the two years.

A Sumter family doctor billed more than $500,000 for writing about 860 prescriptions.

Grassley, a member of the Senate Finance Committee, which oversees Medicare and Medicaid, requested the state reports after discovering a Florida provider wrote 96,685 prescriptions for mental health drugs in a 21-month period.

Although the report shows no Palmetto State doctors approached that figure, Grassley took South Carolina’s data into consideration when he wrote to U.S. Secretary of Health and Human Services Kathleen Sebelius last month. His letter detailed states’ findings and encouraged the federal department to “step up efforts to monitor providers that are outliers” in both the Medicaid and Medicare systems.

A spokeswoman for Grassley said Friday Sebelius has not yet responded.

The states’ data does not indicate illegal activity, but shows that “there are very often providers that prescribe certain drugs at significantly higher rates than their peers,” Grassley wrote in his letter.

He continued, “This may be because a particular physician has a specific expertise or patient population, but it might also suggest overutilization or even health care fraud.”

Grassley also noted that the top prescriber for a particular drug often writes several times more prescriptions than the 10th highest prescriber. This was the case for several of South Carolina’s lists.

For example, a Greenville area neurologist wrote 100 prescriptions for Oxycontin in 2009 — 10 times more prescriptions that the No. 10 prescriber on the list.

The No. 1 prescriber of Xanax, a Greenville psychiatrist, wrote 1,073 prescriptions in 2009, while the number 10 prescriber wrote 63, according to the data.

Snider, of the S.C. Department of Health and Human Services, said over the past several years, the state has enacted data-mining surveillance systems to target Medicaid doctors who over-prescribe drugs.

While prescription drug abuse strains the system, Snider said other examples of fraud — billing for duplicate tests, extra hours or phantom patients — cause even more wasteful payouts because they can be harder to detect.

Read more: http://www.thestate.com/2010/11/22/1572561/medicaid-questions-raised-about.html#ixzz162671Yli

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In Indiana, Psychiatrists Once Again Top the List of Top Drug Prescribers Under Medicaid/Medicare

Monday, November 15th, 2010

IndyStar.com

by John Russell

Indiana doctors who write thousands of prescriptions a year for drugs covered by publicly funded Medicaid and Medicare programs are coming under federal scrutiny.

U.S. Sen. Charles Grassley of Iowa has launched an investigation into doctors here and around the country who are top prescribers for drugs billed to the federal program, citing concerns that expensive medications are being overprescribed. Several states, including Indiana, have already responded with lists of top prescribers.

Grassley said that some physicians are writing tens of thousands of prescriptions for costly drugs. He cited a doctor in Florida who wrote 96,685 prescriptions for mental health drugs in a 21-month period.

No Indiana doctor came close to that amount, according to a list sent to Grassley’s office by the Indiana Family & Social Services Administration. The agency compiled a list of top prescribers overall in 2008 and top prescribers for certain psychiatric medications in 2008 and 2009, including Zyprexa, Geodon, Risperdal and Abilify.

According to the list, the top overall prescriber in Indiana is Dr. Daniel Kinsey, a psychiatrist in Goshen. He wrote 2,894 prescriptions in 2008, which resulted in $791,289 in medication charges to the state.

The next highest was Dr. Melinda Weekly, a psychiatrist in Bloomington, who wrote 2,456 prescriptions in 2008, resulting in charges to Indiana of $1.16 million.

Other states have also compiled lists. In Texas, one doctor authorized 13,596 prescriptions for anxiety drug Xanax in 2008, and increased it to 14,170, according to a letter Grassley recently sent to the U.S. Department of Health and Human Services.

In Connecticut, one doctor ranked consistently as the top prescription writer across a full range of pharmaceuticals, Grassley said, writing 5,945 prescriptions in 2008 and 7,459 in 2009 for seven medications.

“I want to be clear that none of the information provided suggests any illegal or wrongful behavior,” Grassley wrote. “It merely demonstrates that across pharmaceutical brands and categories, as well as across states, there are very often providers that prescribe certain drugs at significantly higher rates than their peers.”

He continued: “This may be because a particular physician has a specific expertise or patient population, but it might also suggest overutilization or even health care fraud.”

Grassley, who is a top member of the Senate Finance Committee, urged federal authorities to look into the matter.

“The trend is found again and again across the states, suggesting that top prescribers stand out not only against other providers in their state, but against the very top prescribers in those states,” he said.

http://www.indystar.com/article/20101115/NEWS09/101115017/Inquiry-eyes-Ind-doctors-who-write-prescriptions?odyssey=tab|topnews|text|IndyStar.com|optionb|t

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