Posts Tagged ‘black box’

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


Share

Prescription Pill-Popping By Far a Leading Killer as Florida’s Drug Deaths Spike 20%

Thursday, July 1st, 2010

FlaglerLive.Com
July 1, 2010

Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined. Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today by the Florida Medical Examiners Commission.

That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state.

The number of people killed by prescription drugs is a significant 20 percent increase over last year’s 6,200 deaths attributed to overdoses. Much of the increase is due to a spike in oxycodone addiction. The increase in prescription-drug addiction continues a trend that began in Florida 10 years ago, when prescription drugs overtook illegal drugs as leading causes of drug-related deaths.

Alcohol is also included in the examiners’ analysis, and it leads the way of all drug-related deaths, with 4,046.

The annual report is a stark look at the effects of legalized drug addiction and over-prescription of drugs, both of which affect a far larger segment of the population than recreational or illegal narcotics.

For the first time in 2009, the commission tracked deaths by region. In Flagler County’s district, which includes St. Johns and Putnam counties, 22 deaths were attributed to oxycodone (the fourth lowest number in the state’s 23 districts), with 13 of those deaths directly attributed to the drug, and nine cited as being present among other drugs that contributed to death.

Hydrocodone claimed 16 lives in the district. Cocaine contributed to 19 deaths in the Flagler district, though only four cases were directly attributed to the drug. In 15 cases, cocaine was present in the body in conjunction with other drugs that proved lethal. Overall in Florida, cocaine-related deaths (including the majority of cases where cocaine wasn’t directly the factor but was present in the body at the time of death), have fallen from a peak of 2,179 in 2007 to 1,462 in 2009. (Again, cocaine was the direct result of death in 529 cases out of those).

Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)

Anti-psychotic drugs carry a variety of black label warnings of increased mortality in elderly patients (including a death rate almost twice as high for people taking Risperdal, for example). Those drugs, prescribed and often overprescribed in nursing homes and assisted living facilities, include Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa.

“Certainly, the actual number of prescription drug deaths is higher than the annual report states,” Kramer said. “It is unknown just how much higher because the Medical Examiners Commission does not track these classes of drugs.”

Two years ago Kramer got his concern heard by the commission following an email exchange with a commissioner in which he argued that antidepressants and anti-psychotic drugs’ contributions to mortality should be part of the annual report. He was rebuffed. One examiner vsaid he had not seen “more than the occasional death caused by these types of drugs,” according to the minutes of the Aug. 13, 2008 meeting of the commission.

Read entire article:  http://flaglerlive.com/7256/florida-prescription-drugs-deaths-oxycontin-oxycodone

« Return to news items


Share

National Alliance on Mental Illness (NAMI) – A Pharma front group

Thursday, October 22nd, 2009

The Citizens Commission on Human Rights (CCHR) states it is no wonder that the National Alliance on Mental Illness (NAMI), a group that claims to be an advocacy organization for people with “mental illness,” opposed the black box warnings on antidepressants causing suicide for under 18 year olds in 2004, and black box warnings on ADHD drugs causing heart attack, stroke and sudden death in children in 2006, when you look at their biggest source of funding: Pharma.

Today’s New York Times article, “Drug Makers Are Advocacy Group’s Biggest Donors” states “A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators. The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry. Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private. But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.”

Read NY Times article here: http://www.nytimes.com/2009/10/22/health/22nami.html?_r=2

More on NAMI:

    • NAMI’s pharmaceutical funding was first exposed in the November 1999  Mother Jones article  “An influential mental health nonprofit finds its grassroots funded by Pharmaceutical millions,”  Internal documents obtained by Mother Jones found 18 drug firms gave NAMI a total of $11.72 million between 1996 and mid-1999. These include Janssen ($2.08 million), Novartis ($1.87 million), Pfizer ($1.3 million), Abbott Laboratories ($1.24 million), Wyeth-Ayerst Pharmaceuticals ($658,000), and Bristol-Myers Squibb ($613,505).  And that NAMI’s leading donor was Eli Lilly and Company, maker of Prozac, which gave $2.87 million during that period. In 1999 alone, Lilly will have delivered $1.1 million in quarterly installments, with the lion’s share going to help fund NAMI’s ‘Campaign to End Discrimination’ against the mentally ill.”

    • In a 2000 Insight Magazine article, NAMI spokesperson Bob Carolla stated, “Mental illness is a biologically based brain disorder” and deferred to the U.S. Surgeon General’s 1999 Report on Mental Health as evidence of this. Yet the author of the article, Kelly Patricia O’Meara reviewed the entire report looking for this evidence, and found, “The Surgeon General’s report does not provide a single piece of scientific data supporting mental illness as a brain disorder or disease.”

    Factually, the Surgeon General’s report admitted there is no medical proof to substantiate NAMI’s claims. The report states, “The diagnoses of mental disorders is often believed to be more difficult than diagnoses of somatic or general medical disorders since there is no definitive lesion, laboratory test or abnormality in brain tissue that can identify the illness.”

    Psychiatrist Loren Mosher, former Chief of Schizophrenic Research Studies National Institute of Mental Health (NIMH) stated, “The National Alliance for the Mentally Ill (NAMI) gets the pharmaceutical money and then says they spend it on their ‘antistigma’ campaign. They say that mental illness is a ‘brain disease.’ And it works well for the people who suffer from this to use their drugs. This is why NAMI is pushing for forced medication. It is an amazing selling job on the part of NAMI.”

    • December 18, 2003, The New York Times reported that NAMI bused scores of protestors to a hearing in Frankfort, Kentucky, took out full page ads in Kentucky newspapers, and sent angry faxes to state officials, all protesting a state panel proposal to exclude the antipsychotic drug Zyprexa from Medicaid’s list of preferred medications. According to the article, “What the advocacy groups did not say at the time was that the buses, ads and faxes were all paid for” by the manufacturer of the antipsychotic drug Zyprexa, Eli Lilly.

    In 2004, NAMI opposed the FDA issuing “black box” warnings on antidepressants about their increased risk of suicidal thoughts and behaviors in under 18-year-olds.

    In 2006, despite overwhelming evidence of serious adverse cardiac events and sudden deaths caused by ADHD drugs, NAMI took the position that the “black box” warning on ADHD drugs was “premature.”

If NAMI was truly a patient’s rights advocacy group as they purport to be, the question must be asked why they opposed legislation that forwards patients rights.

Take for example the Child Medication Safety Act, a bill that passed the House of Representatives 425-1 in 2003. The bill stated that as a condition of receiving federal funds, states develop policies and procedures that prohibit schools from requiring a child to take psychiatric drugs as a condition of attending school. NAMI reported in their Policy Alerts section of their Beginnings newsletter that summer that they were “not opposed to the intent of the bill.” However, in the same article they stated “given the bill’s stern enforcement provisions—threatening the loss of federal education funds—it’s enactment would inevitably have a chilling effect on schools across the country.” They went on to encourage people contact their Senators to “express concern” about the bill.

Despite NAMI’s efforts, the bill, hailed as a protection for parents rights, was passed in December 2004 as the Prohibition on Mandatory Medication Amendment, a bill CCHR and many other concerned groups had been strongly in support of, after numerous parents came forth stating they had been forced to have their children take psychiatric drugs as a condition of attending school, and even had been charged with medical neglect for failing to comply.

« Return to news items


Share