The American Pain Foundation

ProPublica's Charles Ornstein & Tracy Weber report, "As the U.S. Senate Finance Committee launched an investigation Tuesday into makers of narcotic painkillers and groups that champion them, a leading pain advocacy organization said it was dissolving 'due to irreparable economic circumstances.'" The American Pain Foundation, which ceased operations today, was the focus of a December investigation by ProPublica in the Washington Post that detailed its close ties to drugmakers.

The U.S. Senate Finance Committee launched the investigation due to "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers." In letters sent by Senators Max Baucus and Charles Grassley, they note the growing body of evidence that suggests that drug companies "may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs' safety and effectiveness."

"The group received 90 percent of its $5 million in funding in 2010 from the drug and medical-device industry," note the reporters, "and its guides for patients, journalists and policymakers had played down the risks associated with opioid painkillers while exaggerating the benefits from the drugs."

Ornstein & Weber add, "The senators are targeting a who’s who of the pain industry, seeking extensive records and correspondence documenting the links, financial and otherwise, between them and the makers of the top-prescribed narcotic painkillers. Letters went to three pharmaceutical companies, Purdue Pharma, Endo Pharmaceuticals, and Johnson & Johnson, as well as five groups that support pain patients, physicians or research: the American Pain Foundation; American Academy of Pain Medicine; American Pain Society; Wisconsin Pain and Policy Study Group; and the Center for Practical Bioethics."

Billion dollar Fine for Risperdal

The L.A. Times reported the $1.1 billion fine imposed by a federal judge in Arkansas litigation against Johnson & Johnson after a jury found that the companies downplayed and covered up risks associated with taking the antipsychotic drug Risperdal.  Circuit Judge Tim Fox determined that Johnson & Johnson and subsidiary Janssen Pharmaceuticals Inc. committed nearly 240,000 violations of the state's Medicaid fraud law — or one for each Risperdal prescription issued to state Medicaid patients over a 31/2-year period.  Each violation carried a $5,000 fine, the state's mandatory minimum amount, bringing the total to more than $1.1 billion. Fox issued an additional $11 million fine for more than 4,500 violations under the state's deceptive practices act, but he rejected the state's request to levy fines in excess of the $5,000 minimum for the Medicaid violations.

Arkansas was one of several states to sue over Risperdal. A South Caroline judge upheld a $327-million civil penalty against J&J and Janssen in December 2011.  Meanwhile, Texas reached a $158-million settlement with the companies in January in which they didn't admit fault.

 

Generic Drugs

The NY Times had an article explaining how dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a ridiculous Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.   The Supreme Court’s ruling, which was split 5 to 4 on ideological lines, has its roots in the Hatch-Waxman Act, the 1984 law that led to generic drugs. That law allowed companies to skip the approval process required if they could prove that the generic drug was equivalent to its brand-name counterpart.  It also required generic manufacturers to use the same labels — the lengthy list of a drug’s uses, dosages and risks — used by the brand names.

If a problem develops, the brand-name companies are responsible for changing the label, and the generic companies must follow their lead. As a result, the court’s majority ruled, generic companies cannot be held responsible for failing to alert patients to problems with their drug. The dissent, which was written by Justice Sonia Sotomayor, argued that generic companies nevertheless have a responsibility to report problems to the F.D.A. and should be held liable for failing to warn patients.

The article refers to two cases:
Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it.  Her case was quietly thrown out of court.  That result stands in contrast to the case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.   How is that fair or just?

Almost 80 percent of prescriptions in the United States are filled by a generic, and most states allow pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June, including some who dismissed dozens of cases consolidated under one judge.

Mr. Waxman argued in a brief opposing the generic companies in the Supreme Court case last year that Congress had never intended for generic companies to be freed of all responsibility. “Congress did not intend for consumers’ rights to be categorically eliminated simply because they purchased a generic rather than a brand-name drug,” he wrote.

Obamacare Lowers Drug Costs

USA Today reported that "almost 4 million seniors saved about $2.16 billion through discounts for their prescription medications in 2011", according to the Department of Health and Human Services.  "The 2010 health care law required a 50% discount on prescription drugs in the so-called doughnut hole, or the gap between traditional and catastrophic coverage in the Medicare drug benefit, also known as Part D. In 2012, the coverage gap is $2,930. The Affordable Care Act eliminates the doughnut hole by 2020." 

In 2010, Medicare sent $250 rebate checks — totaling $846 million — to nearly 3.8 million seniors to try to counterbalance the gap. In the first two months of 2012, about 100,000 people have received $92.7 million in discounts — about $904 per person

Government costs for prescription medications through Medicare should decrease after seniors saved more than $2 billion in 2011 through discounts offered by the program. When Medicare recipients are able to take their medications, they are hospitalized less often for heart attacks, low blood sugar and asthma attacks thus reducing long term health care costs.

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Chemical Restraints and Informed Consent

Carole Herman wrote an interesting article on the overmedication of nursing home residents.  Ms. Herman formed the Foundation Aiding The Elderly (FATE) in 1982 after her aunt was overmedicated by her family physician and subsequently fell, broke her hip and ended up in a nursing home for rehabilitation.  She argues that the overmedication of her aunt was a  "chemical restraints".  "The adverse side effects Haldol caused her to stop talking and swallowing; made her unable to do rehab; and ultimately made her bed-ridden, which caused her to develop a bed sore that eventually killed her."  

"Over the years, I have worked very hard getting the word out about this national disgrace. Our most vulnerable citizens in long-term care facilities do not have a voice and FATE has been able to fill that void by speaking loud and clear for them and their families about abuses in long-term care facilities and, in particular, the overmedication of the patients in those places."

The federal government set regulations that antipsychotic medications in nursing homes may not be administered unless agreed to by the patient or the patient's decision maker in the event that patient was incompetent. It is called "informed consent" and the informed consent can only be obtained by the physician. It must be documented that the consent was in fact obtained by the physician.

"FATE began a letter-writing campaign a couple of months ago targeting the CEO's of the major television networks, publishing companies and newspapers and magazines, asking that they consider not advertising antipsychotic medications because of the horrific adverse side effects of these drugs -- especially in the elderly. So far, not one response!"

"I realize that we are fighting two of the biggest industries in the country -- nursing homes and pharmaceutical companies. Not only are these industries huge advertisers, they are also big campaign donors. However, it is time that the problems with prescribed medications and nursing home abuses are brought to the forefront so that the public knows what to watch out for."

"With the baby boomers now turning 66, these problems are only going to get worse. It is not a mystery any longer that nursing home patients die each year from poor care, neglect and adverse side effects of antipsychotics drugs. And yet, the beat continues and the drugs are still being prescribed, and usually without consent. The pharmaceutical companies are taking our minds away from us and it's being allowed because the industry has tons of money to make sure that they are marketed to the public for consumption and the physicians continue to prescribe them."

Herman argues that "there is an epidemic of the use of mind altering drugs that needs to be addressed, as well as the lack of oversight by the government regulators to insure that all of us citizens who may end up in a nursing home someday get the proper care and treatment that we all deserve and that we all are paying for."

 

Off-label Abuse of Antipsychotics

Kaiser Health News blog in collaboration with The Washington Post had a great article on the use and abuse of atypical antipsychotics.  The skyrocketing increase in the off-label use alarms medical experts, policymakers and patient advocates.  "Until the past decade these 11 drugs, most approved in the 1990s, had been reserved for the approximately 3 percent of Americans with the most disabling mental illnesses, chiefly schizophrenia and bipolar disorder; more recently a few have been approved to treat severe depression."

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

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

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

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

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

A 2011 report by the inspector general of the Department of Health and Human Services found that in a six-month period in 2007, 14 percent of nursing home residents were given antipsychotics. "The primary reason is that there's not enough staff," said Toby S. Edelman, senior policy attorney for the Center for Medicare Advocacy, a Washington-based nonprofit group, who recently testified about the problem before the Senate Special Committee on Aging. "If you can't tie people up, you give 'em a drug" she said, referring to restrictions on the use of physical restraints in nursing homes.

 

 

AARP Report on Drug Prices

The L.A. Times reported that the price of drugs widely used by elderly Americans grew by almost double the rate of inflation from 2005 to 2009, according to a new study by the AARP.

The average retail price over the five-year period for the 469 drugs most often used by AARP members grew by 25.6%, compared to the 13.3% rise in inflation over the same period, according to the report.

The report also says that 406 of the 469 most commonly used drugs are used to treat chronic conditions and that the average cost of taking such medicines for chronic conditions was $1,152 higher in 2009 than it was five years earlier.

 

A Monopoly on Health Care

USA Today recently had a disturbing article about the Medicare fraud involving the nation's largest drugmakers.    The multinational companies have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade.  They only remain in business because they hold a monopoly on life saving medications.  Government investigators can exclude these companies from providing medications to Medicaid and Medicare beneficiaries as punishment for prior fraud, but that would leave beneficiaries without drugs patented through a particular company.

Pfizer alone has paid almost $3 billion in fines since 2002 and entered into three corporate integrity agreements with the Department of Health and Human Services aimed at preventing future fraud. Pfizer's 2009 settlement was for improperly promoting the use of drugs for purposes other than those for which they were approved by the government.

Merck paid $1.6 billion in fines since 2008, Medicare and Justice Department records show, to resolve claims it was not paying proper rebates to the government.  Merck's 2008 settlement involved claims the company paid illegal kickbacks to health care providers in exchange for prescribing its drugs.

Pharmaceutical companies altogether spent more than $200 million lobbying Congress in 2011, including $12 million spent by Pfizer. At least 12 pharmaceutical and medical device companies are lobbying specifically against a House bill, HR 675, that complements Grassley's.

 

 

Medical Uses of Abused Drugs

Christine works for Medicalbillingandcoding.org.  She wrote us about a recent article published with infographics, “Medical Uses of Abused Drugs”.

 

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Study Links Haldol and Mortality

Nurse.com published an article on a recent study by the Harvard Medical School showing that nursing home residents ages 65 and older who take certain antipsychotic medications for dementia are at an increased risk of death. The record study involved 75,445 older nursing home residents from 45 states between 2001 and 2005. All nursing home residents studied were 65 and older. The researchers examined mortality risks during a six-month span.

The Food and Drug Administration warned in 2005 that atypical antipsychotic drugs are associated with an increased risk of mortality in elderly patients with dementia. This warning was expanded to include conventional antipsychotics in 2008.  The study assessed mortality risks associated with individual antipsychotic drugs including aripiprazole, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone.

The effect of haloperidol (Haldol) was strongest during the first 40 days of treatment, which did not change after a dose adjustment. Almost half of deaths (49%) were recorded as due to circulatory disorders, 10% to brain disorders and 15% to respiratory disorders.

 

Poliakoff & Associates, P.A., is one of South Carolina’s most respected and distinguished law firms. The Poliakoff firm began nearly 60 years ago by three attorney brothers: Matthew, J. Manning, and Bernard. With a history of believing the justice system...More...