Posts Tagged ‘FDA’

« Older Entries
Newer Entries »

Paxil and Prozac Linked to Risk of Heart Birth Defects

Monday, June 27th, 2011

AboutLawSuits.com – June 27, 2011

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.

The researchers also found that women who took any SSRI antidepressant during pregnancy were more than twice as likely to give birth to a child with a neural tube defect; 22 out of every 10,000 newborns, as compared to 9 out of every 10,000 newborns born to women who did not take any SSRI during pregnancy.

SSRIs are a relatively new class of antidepressants, which help reduce symptoms of depression by preventing certain nerve cells in the brain from re-absorbing the chemical serotonin. These drugs are commonly used by millions of Americans with depression.

Although the drugs have been found to cause fewer side effects than older anti-depressants, research has shown that users of the drugs could also face an increased risk of suicides, and use during pregnancy has been linked to a risk of birth defects, especially among users of Paxil.

Prozac (fluoxetine) is marketed by Eli Lilly and is approved for the treatment of depression, obsessive-compulsive disorder (OCD) and other psychiatric problems. In 2007 there were more than 22 million Prozac prescriptions in the United States.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

The company reportedly agreed to settle hundreds of Paxil heart birth defect lawsuits last year. The Paxil lawsuits were filed by parents who say that the use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) and other birth defects. The lawsuits claimed that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claimed that the company purposefully hid test results that would have revealed the side effects of Paxil and misled doctors.

http://www.aboutlawsuits.com/paxil-prozac-birth-defect-study-19139/

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , ,
Posted in News | 1 Comment »

At annual convention, psychiatrists collaborate on mental disease mongering to boost profits

Wednesday, June 8th, 2011

Natural News – June 8, 2011

by Monica G. Young

While sipping drinks from coconut shells, psychiatrists from around the world recently met in Honolulu to discuss more ways to capitalize on human behavior and promote drug dependency. The occasion was the annual meeting of the American Psychiatric Association (APA), held in a Hawaiian convention center lined with mental disorder displays and pharmaceutical booths.

“Hot” topics (potential markets for social control and drug pushing) included:

1) Mental health issues during a woman’s reproductive cycle, such as “treating” pregnant women for bipolar – a disorder said to cause unusual shifts in mood and energy levels. In speaking to Medscape News, an APA committee co-chair, Dr. Don Hilty, called this “a really nice-growing area.”

Yet most every woman experiences mood and energy shifts during pregnancy. Despite this, it is not uncommon for pregnant women to be diagnosed as bipolar and prescribed antipsychotics, some of the most powerful drugs on the market. Even the FDA website alerts doctors to “be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy.” The site warns of abnormal muscle movements and withdrawal symptoms, and the FDA’s adverse effects reporting program (Medwatch) includes cerebral hemorrhage, heart malformations and death as documented reactions in newborns. Similarly, studies show birth defects and other serious risks for infants whose mothers took antidepressants while pregnant.

2) Childhood disorders were a particularly popular issue at the convention. But they didn’t stop there – prenatal and newborn genetic screening for mental illness has taken on new emphasis in the psychiatric world. “It’s also trying to understand how genetics predict what medications can be used,” stated APA’s Dr. Hilty.

Having already labeled millions of kids “abnormal” and drenched their brains in toxic substances – a multi-billion dollar business – apparently they aren’t satisfied. They aim to brand children as mental patients and destine them for drug-dependency before they’re even born.

The conference even touched upon electroconvulsive shock therapy (ECT) for children – sending electric volts through their heads. That will teach ‘em to shut up and sit still! It will also cause permanent brain damage.

3) ADHD is usually promoted as a childhood disorder but a team of psychiatrists proposed a new definition to make it easier to diagnose (and drug) older teens and adults. They claim people who tend to miss work deadlines and interrupt others deserve this label.

This would surely lead to millions more on daily meds. Who doesn’t know co-workers who miss deadlines or even friends who interrupt you? Not emphasized however is that, per a study published in The Clinical Neuropsychologist, one in four adults seeking an ADHD diagnosis fake it to obtain stimulant drugs.

4) Capitalizing on America’s service men and women was another hot one: diagnosing and drugging the military for post-traumatic distress disorder, depression and anxiety.

Did they mention that 18 U.S. veterans commit suicide daily, largely due to psychiatric drugs? Not likely. As reported by Neev M. Arnell in NaturalNews, “the increasingly high number of deaths among both veterans and active duty soldiers-including suicides, accidental overdose, and lethal drug interactions-have now been linked to the exponential increase in the prescribing of drugs for post traumatic stress disorder, depression and other psychological illnesses.” (http://www.naturalnews.com/032598_v…)

5) Anticipating the “silver tsunami” as the Baby Boomer generation moves into the over-65 bracket, psychiatrists stressed the need for more psychiatric services for the elderly.

Not stressed, if mentioned at all, is the rampant over-use of psychiatric drugs in nursing homes. Elderly patients’ reactions to physical ailments are often squelched with mind-altering drugs. And a recently released government audit shows nearly one in seven elderly nursing home residents are given antipsychotics – nearly all of them dementia patients for whom the drugs can be lethal. Many lawsuits and settlements have revealed that drug companies have falsely promoted these drugs to doctors and nursing homes for years.

6) While not on the “hot” list, another issue that bit was bedbugs. A New York psychiatrist and his colleagues presented a detailed study showing bedbugs can trigger anxiety.

What a remarkable – and potentially profitable – discovery! Gee, with the rise in bedbug infestation in New York City, maybe Bedbug Anxiety should be included in the next edition of the DSM (psychiatry’s diagnostic and billing bible).

Father of psychiatry – the bloodletter

The American Psychiatric Association calls itself “the voice and conscience of modern psychiatry.”

Adorning the convention hall was the APA logo which enshrines Dr. Benjamin Rush (1746-1813) as the father of psychiatry. A very influential doctor, teacher and statesman of his time, Rush propagated his theory that Blacks suffered from an inherited disease called “Negritude.” The only evidence of a cure, he said, was the skin turning white. He warned, “whites should not intermarry with them, for this would tend to infect posterity with the ‘disorder.’” Whites, seeking not to be “infected,” used this fabled disease to justify segregation.

Rush was also a chief proponent of bloodletting as a cure-all for mental and physical illnesses. Widespread in America in those days, he made lots of money at it. One of Rush’s students applied his teachings to a patient who complained of a sore throat: nine pints of blood were removed from the man’s body in twenty-four hours and he died. That patient was George Washington, the first President of the United States.

Sources for this article include:
http://www.medscape.com/viewarticle…

http://www.medscape.com/viewarticle…

http://healthland.time.com/2011/05/…

http://healthland.time.com/2011/04/…

http://www.nytimes.com/2011/05/10/h…

http://www.jstor.org/pss/985399

http://www.websters-online-dictiona…

http://www.cchr.org/cchr-reports/cr…

About the author:
Monica G. Young is a human rights investigator and educational writer with a purpose to expose the truth about the pharmaceutical and psychiatric industries and safeguard human liberty. She encourages non-drug alternative approaches based on healthy lifestyles and human decency. She supports the Citizens Commission on Human Rights and like-minded groups.

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , , , , , , , , , , ,
Posted in News | 1 Comment »

FDA Issues Draft Guidance For Investigator Conflicts

Thursday, June 2nd, 2011

Pharmalot
By Ed Silverman
May 24th, 2011

Image thanks to tyger lyllie on flickr

In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years.

“During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.”

The guidance would require any drugmaker to submit financial disclosures for all investigators who work on studies that would be used by the FDA to assess effectivenesss or any study in which a single investigator makes a significant contribution to demonstrate safety. However, this would not include Phase 1 tolerance studies or pharmacokinetic studies, most clinical pharmacology studies, large open safety studies conducted at multiple sites, treatment protocols and expanded access protocols.

What has to be disclosed? Compensation given an investigator by any sponsor of a covered clinical study in which the value could be affected by the outcome. A proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright or licensing deal. Any equity interest in any sponsor of the study, such as ownership interest, options or other financial interest whose value cannot be readily determined through reference to public prices. This requirement applies to interests held during the time the investigator is working on the study and for one year afterwards.

What else? Any equity interest in any sponsor of the study if the sponsor is a publicly held company and the interest exceeds $50,000 in value. This requirement also applies to financial interests held during the time of the study and for one year after completion. And yes, this includes financial info for a spouse and any dependent children. And yes, the same financial disclosure obligations are required whether studies are conducted at foreign or domestic sites.

Then there’s something called SPOOS, or significant payments of other sorts, which the FDA defines as payments with a cumulative value of $25,000 or more made by any sponsor of a covered study to the investigator or the investigator’s institution, during the time the clinical investigator is carrying out the study and for one year afterwards. This payment would be made beyond the costs of conducting the study (such as a grant to the investigator or to the institution to fund the investigator’s ongoing research or compensation in the form of equipment), or to provide other reimbursements, such as retainers for ongoing consulting work or honoraria.

You can read the entire guidance here.

Read article here:  http://www.pharmalot.com/2011/05/fda-issues-draft-guidance-for-investigator-conflicts/

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , ,
Posted in News | No Comments »

Cause for alarm: Antipsychotic drugs for nursing home patients

Tuesday, May 31st, 2011

CNN
By Daniel R. Levinson, Special to CNN
May 31, 2011

Daniel Levinson, inspector general for the OIG in the Department of Health and Human Services.

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a “black box warning” on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.

Another view: In defense of antipsychotics for dementia

The study began a few years ago, when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs are known as “atypical” or “second generation” antipsychotics. They replaced the antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia — and, incidentially, are far costlier.

The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.

Another finding: A little more than half the antipsychotic drug claims for which Medicare paid should not have been covered. Why? The claimed drugs were not used for medically accepted reasons or there were no records the drugs were actually provided.

To be clear: Most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, and also to patients for whom the boxed warning applies. Ideally, however, doctors who prescribe in such ways first determine that the benefits outweigh the risks.

Yet it remains a concern that so many elderly nursing home residents with dementia are prescribed antipsychotics. And, unfortunately, examples abound of companies’ improper promotion of these drugs.

Government investigations of Bristol-Myers Squibb, AstraZeneca and Pfizer found that they improperly promoted their antipsychotic drugs for unapproved uses.

Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation’s largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

And Eli Lilly pleaded guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors who treat elderly nursing home patients.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

How do we solve this problem? There’s plenty to do.

Family members of nursing home residents must learn about their loved ones’ medications, the reasons for their use, proper dosages and possible side effects.

Nursing homes and pharmacies that serve the elderly must keep the best interests of the patient in mind when dispensing pharmaceuticals and not base the decision on the improper influence of drug companies.

Doctors, too, should rely on their best medical judgments and engage in an especially careful analysis when prescribing drugs for off-label use.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

And drug companies should follow the laws, and refrain from promoting drugs for unapproved uses — or paying kickbacks to influence doctors and institutions. About 46 million people are enrolled in Medicare. That will only grow as the huge baby boomer population retires. We cannot afford to leave unaddressed the urgent problem of antipsychotic drug use among elderly nursing home residents.

The opinions in this commentary are solely those of Daniel Levinson.

Read article here:  http://www.cnn.com/2011/OPINION/05/31/levinson.nursing.home.drugs/

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , ,
Posted in News | No Comments »

Creating juvenile zombies, Florida-style

Sunday, May 29th, 2011

The Miami Herald – May 28, 2011

By Fred Grimm

They’re children of the new Florida ethic. Zombie kids warehoused on the cheap in the state’s juvenile lock-ups. Kept quiet, manageable and addled senseless by great dollops of anti-psychotic drugs.

A relatively small percentage of young inmates pumped full of pills actually suffer from the serious psychiatric disorders that the FDA allows to be treated by these powerful drugs. But adult doses of anti-psychotic drugs have a tranquilizing effect on teenage prisoners. Prescribing anti-psychotics for so many rowdy kids may be a reckless medical practice, but in an era of budget cuts and staffing shortages, it makes for smart economics.

Florida fairly inundates juvenile offenders with this stuff.

The Palm Beach Post reported last week that the Florida Department of Juvenile Justice has been buying twice as many doses of the powerful anti-psychotic Seroquel as it does ibuprofen. As if the state anticipated more outbreaks of schizophrenia than headaches or minor muscle pain.

The Post found that Florida purchased 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs during a two-year period for the boys and girls who occupy the 2,300 beds in state-run residential facilities. (Most of the state’s juvenile offenders are held in jails operated by for-profit contractors. Records revealing the quantity of medications that private companies pour down their prisoners’ gullets were not available.)

Such drugs, meant for adults, are known to send children into suicidal despair, along with risking heart problems, weight gain, diabetes and facial tics. Yet, the DJJ and its contract psychiatrists push them willynilly onto their young wards.

It’s not as if state officials have been unaware of the risks facing children prescribed “off label” uses (unapproved by the FDA) of these pharmaceuticals. Even as the state doled out Seroquel like candy to kids in DJJ jails, the Florida Attorney General’s office was entering into a lawsuit with 36 other states against drug manufacturer AstraZeneca for promoting dangerous, off-label uses of Seroquel for treating both the young and the elderly. (AstraZeneca agreed to settle the lawsuit in March for $68.5 million and to stop marketing the drug for unauthorized uses.)

It was as if the schizophrenics most in need of Seroquel were roaming the halls of government, not the juvenile jails.

“This is the face of all these budget cuts; what happens when you eliminate social workers and prison guards,” said Broward Public Defender Howard Finkelstein. He suspects that DJJ has compensated for the staff shortages at state lockups by pumping “the most powerful drugs known to man into children who have not been diagnosed for psychiatric problems.”

Finkelstein says he assigned two of his staff attorneys last week to visit juvenile lock-ups and investigate what he calls the “zombification” of young offenders who had been represented by his office.

Florida Attorney General Pam Bondi opened her own investigation last week. Bondi’s staff attorneys are interested in the Post’s report that psychiatrists prescribing off-label uses of such astounding quantities of the profitable anti-psychotics for DJJ prisoners (at taxpayer expense) had been greased by drug manufacturers with some $250,000 in gifts and speaking fees.

The DJJ drug scandal seems all the more maddening considering that it follows a similar uproar just two years ago after the suicide of a seven-year-old Margate foster child. Young Gabriel Myers had been given adult dosages of three anti-psychotics before he hung himself.

The Gabriel Myers Task Force, made up of child advocates, state officials, political leaders and judges from across the state, spent a year investigating whether the Florida Department of Children and Families had administered dangerous drugs as “chemical restraints” for troublesome foster children.

Foster kids, as it turned out, weren’t the only victims of the on-the-cheap ethic. But don’t think of children reduced to zombies. Think of all the money we save on prison guards.

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , , , , , , ,
Posted in News | No Comments »

How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

Friday, May 27th, 2011

BNET
By Jim Edwards
May 27, 2011

In 2008, the FDA declared that powerful antipsychotics such as AstraZeneca (AZN)’s Seroquel were being over-prescribed and started a monitoring initiative to curb their use. It hasn’t worked, judging by an analysis of the FDA’s adverse event database by the Institute for Safe Medication Practices.

Seroquel is only approved for schizophrenia, mania and bipolar disorders. It’s a powerful drug that has serious side effects if taken for a long time: It’s associated with weight gain and diabetes, among other problems.

Yet the ISMP found that 47 percent of all adverse events linked to Seroquel since 2004 occurred when the drug was being used for unapproved or “off-label” purposes, such as depression. 21 percent of adverse events are linked to off-label use of Seroquel in depression — a condition for which there are plenty of other available drugs — and 26 percent of events occur with other off-label uses:

The ISMP said:

the adverse event data show quetiapine [Seroquel] has become a general purpose psychiatric drug with most reported injuries occurring outside its core indication for treatment of the most severe mental disorders, schizophrenia and psychosis.

In the off label category more than half the cases were for sleep disorders and insomnia. The next largest group was anxiety, and the remainder was divided among many other medical uses including autism, panic attack, headache, restlessness, nervousness, dementia and agitation.

The report is yet another in a series of publications from a variety of sources that suggest some psychiatric doctors are abusing their patients with Seroquel. In addition to the FDA’s 2008 declaration, consider:

Injuries from Seroquel’s side effects can be severe and permanent. In addition to diabetes they include suicidal/self-injurious behavior, and neurological movement disorders such as tardive dyskinesia, dystonia and parkinsonism.

AstraZeneca’s role in promoting Seroquel for off-label uses is well documented. The company has paid $1.5 billion in legal costs and settlements for its mismarketing of the drug ($520 million to the Department of Justice; another $743 million in legal costs in unresolved cases through March 2011; and $198 million in civil settlements.)

So doctors have no excuse. The FDA — which has almost no jurisdiction over physicians — and the courts have performed their roles. It’s time for the medical profession to take responsibility for the damage it is causing and cut down on its dispensing of Seroquel.

Read article here:  http://www.bnet.com/blog/drug-business/how-seroquel-a-risky-antipsychotic-became-a-8220general-purpose-8221-mental-health-drug/8545

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , , , ,
Posted in News | 1 Comment »

The business of ADHD

Wednesday, May 25th, 2011

SFGate.com City Brights Blog
By Winston Chung, Child Psychiatrist
May 24, 2011

Psychiatrists convened in sunny Honolulu for the 164th Annual Meeting of the American Psychiatric Association (APA) last week, discussing, among other things, moving forward with plans to make the diagnostic criteria for ADHD less stringent: proposed changes include reducing the number of required symptoms from 6 to 4, for adults and teens, and increasing the age-of-onset criteria from 7 to 12.

Russell Barkley, Ph.D., and Joseph Biederman, M.D., have written about abandoning or generously broadening age-of-onset criteria, arguing that the current, precise age-of-onset criteria poses “unwarranted practical problems for the study of older adolescents and adults.” These two men are considered ADHD experts and contributed to the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ADHD, which serve as guidelines by which most child psychiatrists practice.

According to a story from the New York Times, Joseph Biederman did not tell university officials about more than a million dollars received from drugmakers from 2000 to 2007, and he promised Johnson & Johnson research results that would benefit the drug company. On the list of AACAP Conflicts of Interests for Practice Parameters not listed in the Practice Parameters, Russell Barkley receives or has received research support, acted as a consultant and/or served on a speaker’s bureau for Eli Lilly and Company and Shire Pharmaceuticals Group.

Shire Pharmaceuticals Group has a substantial focus on ADHD meds, and they have been pulling out all the stops to try and turn a profit in the face of competition from generic drugs.

Earlier this month, Reuter’s Health described how drugmakers, including Shire, have raised prices to make up for lack of new products and loss of patent protection.

“Prices were just shoved up every year to make more money and meet earnings, to be blunt,” Shire (SHP.L) Chief Executive Angus Russell said.

Shire’s CEO also indicated that the FDA is supporting their plan to study the use of their ADHD drug, Vyvanse, for use in depression and schizophrenia, hoping for billions of dollars in extra sales through expansion of potential indications. Amphetamines for schizophrenia? Hmmmm…..

Jim Edwards of BNET wrote about Shire increasing the price of one of their own ADHD drugs, Adderall XR, to encourage users to switch to their branded, cheaper and newer ADHD drug, Vyvanse, leading to increased sales.

Shire somehow sold more ADHD drugs during a recent, national shortage of ADHD medications – their sales of Adderall XR increased 21 percent in the first quarter of 2011 – a time when many of the patients in San Francisco’s public mental health system were unable to receive their regular ADHD medications.

BNET posted excerpts of separate lawsuits filed by Impax and Teva, manufacturers of generic forms of Adderall XR. They claim that Shire did not honor their contracts and hoarded product for themselves during this recent shortage. In the Wall Street Journal, the associate director of FDA’s drug shortages program reported that this national ADHD drug shortage mostly affected generic forms of ADHD meds. Coincidence?

Other ways of getting around stagnant drug development and generic competition include taking an old drug or active ingredient, and changing the delivery system or duration of action and presenting it as a new, patent-protected product. Here are a few examples that have been associated with Shire:

- Vyvanse: Also known as lisdexamfetamine, Vyvanse is a prodrug of dextroamphetamine. Dextroamphetamine has been used since 1937 to treat hyperactivity in children, so it is hardly new. Vyvanse was marketed as having lower abuse potential – specifically, preventing abuse from snorting, since the prodrug requires digestion to release the active form. In my clinical experience, most abuse of stimulants is due to people taking it without a prescription or shaping their symptoms to get a prescription, and a prodrug likely does little to curb college students from seeking stimulants to study for exams.

- Daytrana: The transdermal methylphenidate (methylphenidate is the active ingredient in Ritalin) patch is worn on the skin and was developed as a way of bypassing the digestive tract, and my experience prescribing this drug was met with equivocal reports from patients and families. I guess there is a reason I can’t remember anyone saying it worked – Shire gave up on the ADHD patch after 9 product recalls and a federal probe.

- Intuniv: An extended release form of guanfacine, Intuniv is touted as a new, non-stimulant treatment for ADHD. But child psychiatrists have been using guanfacine in ADHD for years, and this ‘extended-release’ form has a half-life of about 18 hours, while generic guanfacine has a half-life of about 17 hours – not a robust difference, in my opinion.

I liken these approaches to gimmicks utilized in the mass-produced, beer market: color changing labels to let you know if your beer is cold, wide-mouth beer cans, or vortex bottles. Do any of these ‘innovations’ really change the fact that you’re drinking cheap beer?

As the DSM-V looms closer to becoming a reality, I can’t help but think of words from the man who chaired the committee for the DSM-IV. Allen Frances, M.D., wrote in the in the LA Times:

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be conservative and careful but inadvertently contributed to three false ‘epidemics’ – attention deficit disorder, autism and childhood bipolar disorder. Clearly, our net was cast too wide and captured many ‘patients’ who might have been far better off never entering the mental health system.

The DSM-IV was and the DSM-V will be published by the APA. The same APA that, in 2010, rejected internal recommendations – led by an APA past-president – to regulate or curtail individual psychiatrists’ relationships with the pharmaceutical industry.

Loosening the diagnostic criteria for ADHD, as proposed, will no doubt lead to more people being diagnosed and, inevitably, taking more ADHD drugs. I like to think that the APA and their doctors pushing for the changes are motivated by helping patients and not drug company profits.

After all, if anyone can identify and address unconscious conflicts or psychologically-defended, aggressive drives, it’s a psychiatrist, right?

Read article here:  http://www.sfgate.com/cgi-bin/blogs/wchung/detail?entry_id=89494

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , , , , , , , , , , , ,
Posted in News | No Comments »

Unregulated prescription of antipsychotic drugs in elder care facilities on the rise

Monday, May 16th, 2011

Santa Cruz Sentinel -  May 15, 2011

A recent study by the Office of the Inspector General of the United States indicates that residents of some nursing homes may be regularly given atypical antipsychotic drugs as a means of chemical restraint, sometimes to the detriment of their health, including death.

The report, published May 9, states: “For the period January 1 through June 30, 2007, we determined using medical record review that 51 percent of Medicare claims for atypical antipsychotic drugs were erroneous.”

A member of Congress requested the office evaluate the extent to which nursing home residents receive atypical antipsychotic drugs and the associated cost to Medicare. The member expressed concern with these drugs were being prescribed for off-label conditions — i.e. conditions other than schizophrenia and/or bipolar disorder — and/or in the presence of a condition specified in the Food and Drug Administration’s boxed warning.

“We determined that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with the condition specified in the FDA boxed warning,” the Office of the Inspector General found.

The California Advocates for Nursing Home Reform has been concerned about this issue for some time. For more information, visit www.canhr.org/help.html

http://www.santacruzsentinel.com/ci_18067580

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , ,
Posted in News | No Comments »

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

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , ,
Posted in News | No Comments »

Wellbutrin – To Promote or Not Promote… That is the Question

Friday, May 6th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 6, 2011

Did they or didn’t they?

Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing.

Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.

Millar was head of GSK’s marketing for Wellbutrin and remained insistent that GSK’s promotion of its product was as an antidepressant that carried low risk of weight gain and sexual dysfunction.

GSK have claimed that they worked with doctors to stop the promotion of Wellbutrin for off label use.

In 2002, writes Law 360′s Christopher Norton, “GSK became aware that the company’s two top promotional-speaker doctors were using slides in their presentations including information for off-label uses of the drug, but swiftly took steps to bring the pair into compliance with all regulations.”

Those top two doctors were named as Psychiatrist James Hudziak and physician James Pradko, they were both the most highly paid doctors in GSK’s Wellbutrin promotional stable.

It was Millar who, alongside others at GSK, worked with doctors that GSK, claimed, paid to promote the drug in an effort to ensure the physicians removed any mention of off-label uses from their presentations, especially in the wake of new regulations that began to roll out around 2002, he told the jury, writes Christopher Norton for Law360.

It is alleged that Lauren Stevens lied to the FDA when they sought information from GSK about whether or not they promoted Wellbutrin for weight loss. It’s also alleged that Stevens knew GSK had sponsored programs that promoted Wellbutrin as a weight loss drug. Stevens is also alleged to have known that GSK had paid many doctors to promote Wellbutrin to other doctors which included “off-label” use.

Millar claims that he was sent to monitor Psychiatrist James Hudziak after concerns were raised about his potential use of off-label slides, slides he used at presentations. Millar was apparently able to make Hudziak change the presentation and got him to start using a “company approved” slide kit.

Stevens has claimed that she concealed slides from the FDA showing that GSK was promoting Wellbutrin for illegal unapproved use, she has also claimed that she was advised by a company lawyer to do so.

So, we have GSK saying they did everything in their power to stop doctors promoting the illegal, unapproved use of Wellbutrin… yet we have Stevens, as part of her defence, claiming she concealed slides that showed GSK was promoting Wellbutrin for illegal unapproved use. Not only that – she was told to do so by one of GSK’s lawyers!

The mind boggles at how this company operate.

It seems that Stevens, the former Glaxo associate general counsel, is now turning against the very same people she used to work for. You go girl.

The case against Stevens continues.

Her re-indictment can be viewed HERE

Read article here:  http://fiddaman.blogspot.com/2011/05/wellbutrin-to-promote-or-not.html

« Return to news items

RSS News Feed

Share

Tags: , , , , , , , , , , , ,
Posted in News | No Comments »

« Older Entries
Newer Entries »