Activists see link between over-prescribing of opioid painkillers and increase in overdoses

 

Tammy and Tim Smick, center, join families of victims of drug abuse, physician overprescribing, and medical malpractice at a California Medical Association convention last year in Anaheim. Barbara Davidson Los Angeles Times

Alex Smick’s agonizing, fateful slide toward death by prescription drugs began with a simple act of kindness: He tried to save a little dog from a big dog.

It was a sunny day in Southern California in 2010, and Alex was riding his skateboard, the family dog loping by his side. A tiny, yapping challenger charged at them, and Alex made a quick turn of his skateboard to block off the little David to his dog’s Goliath. Too quick, it turned out.

He hit the pavement hard. He severely injured his back, ending up with five bulging disks – though he would not learn this for months. The family’s health insurance company denied requests for diagnostic imaging of his spine. Instead, three different doctors over the next two years would put him on a regimen of opioid prescription painkillers that escalated in potency – from Vicodin to oxycodone to morphine. He was 18.

At 20, Alex had not yet been seen by a spinal cord injury specialist. There was no plan for treatment. But he was fed up with the drugs and checked into an Orange County hospital in 2012 to detoxify. There, a fourth doctor put him on a lethal combination of 11 drugs, including more opioids. Alex stopped breathing. Cause of death? Poly-acute drug intoxication.

It’s a wrenching story that his mother, Tammy Smick, a Downey schoolteacher, tells time and again. A parent-advocate fighting for more responsible use of prescription painkillers, Smick has joined a growing number of parents nationwide who’ve lost their children to the same scourge: over-prescribing of dangerously powerful and addictive opioid pain medications.

“Alex wasn’t a drug-seeking kid,” his mother said. “He was my big, beautiful, athletic, kind, handsome son. Alex thought going to the hospital was the safest, smartest way to get off the drugs. But they loaded him up with so many meds, they just put him to sleep. I didn’t know enough about excessive prescribing. I was naive.”

No longer. Smick retraced the steps of Alex’s care. She hit the website Epocrates, educating herself on the drugs Alex was given, including the risk of interaction with other medication. She hired a private pathologist. She sought sanctions against the hospital, doctor and nurses. She speaks out about medical negligence, and how it’s the third-leading preventable cause of death.

In rallies on Capitol Mall in Washington and across the nation, in testimony before legislators, in community meetings and online, parent-activists are trying to make their voices heard. They are armed with statistics such as this shocker from the Centers for Disease Control and Prevention: In 2012, health care providers wrote 259 million prescriptions for painkillers, enough for every adult in the United States to have a bottle of pills.

Their message is spurring action on several fronts. States tallying the highest numbers of prescription drug overdoses are cracking down on the most prolific prescription drug providers – and those who obtain drugs for illegal sale. Elected officials from the U.S. Congress on down are taking notice of a federal research finding that 50 percent of deaths by drug overdose involved prescription drugs; and that 75 percent of those deaths involved legal opioid painkillers.

Law enforcement agencies are deploying narcotics agents to curb street sales of opioids. States are reining in so-called “pill mills,” or pain management clinics that prescribe large quantities of the painkillers. Attorneys general of 29 states signed a letter to the U.S. Federal Drug Administration recommending that the FDA reverse its 2013 approval of a new, highly potent narcotic called Zohydro that can by given at doses as much as 10 times higher than what’s typically prescribed.

A coalition of addiction specialists, doctors and parent-activists called Fed Up! recently demanded the removal of FDA commissioner Margaret Hamburg, noting that it’s been under her watch that the overdoses have escalated to roughly 15,000 a year nationwide.

Some citizen-petitioners are even demanding that the FDA take opioid narcotics off the legal market altogether, stirring up a hornet’s nest of objections from pain management doctors who, for decades now, have argued they have an obligation to ease their patients’ suffering.

FDA chief Hamburg stands with them: “We must meet the very real medical needs of the estimated 100 million Americans living with severe chronic pain or coping with pain at the end of life.”

On Monday, the federal Drug Enforcement Agency tightened restrictions on a class of opioid analgesics called hydrocodone combination products, moving them into a more restrictive controlled substances category called Schedule II, from Schedule III. This means that drugs such as Vicodin or Norco are now classified as having the greatest potential for harm, abuse and dependency.

But it is oxycodone, used in OxyContin – already a Schedule II drug – that the DEA has identified as the most-abused medicine in America. Hydrocodones rank second.

Dr. Timothy Albertson is the UC Davis Medical Center’s chairman of internal medicine for pharmacology, toxicology, anesthesiology and emergency departments. He also serves as the medical director of the Sacramento division of the California Poison Control System.

He applauded the DEA’s action, which no longer allows automatic refills, or faxing or phoning of prescriptions to pharmacies.

“The use of high-dose, chronic opioid treatment creates the environment for drug diversion and drug misadventure for the patients,” Albertson said. “We continue to see the numbers of prescription opioid overdoses increasing in our emergency departments.”

California has set up an electronic database for pharmacists and doctors to check if a new patient has already obtained controlled-substance medications and is simply seeking more drugs, or “doctor-shopping.”

On Sept. 29, the Medical Board of California made a formal recommendation that all California pain-medication prescribers use the database, known as CURES.

Even drug companies have responded to the crisis – in their own way. Purdue Pharma, which manufactures the blockbuster drug OxyContin, came up with a way to add an opioid receptor blocker to a new high-dose oxycodone painkiller, called Targiniq ER.

If the pill is crushed for injection or snorting, the opioid blocker naloxone prevents the enhanced effect abusers seek. But when swallowed, naloxone has no effect.

CDC Director Dr. Thomas Frieden has issued a call for reform of prescribing practices. For anything other than cancer pain or end-of-life suffering, the risks of prescribing opioids outweigh the benefits, he said.

He draws a direct line between over-prescribing and the decadelong pattern of steady increases of drug overdose deaths – now officially the No. 1 cause of accidental deaths nationwide, surpassing fatal car accidents.

“Prescription drug overdose is epidemic in the United States,” Frieden said.

California has already heeded Friedan’s call for a “good Samaritan” law that allows people to dial 911 to report an overdose without getting themselves in trouble.

Recently, the state took a significant step toward helping families or people close to opioid users. Gov. Jerry Brown signed into law a provision allowing people to buy the antidote to opioid overdoses without a prescription to have on hand in case of emergency. When injected or used as a nasal spray, naloxone reverses an opiod overdose. It’s been used in ambulances and emergency rooms for decades.

California is one of the lowest-prescribing states. Still, public health officials are worried about prescription painkillers leading users to heroin, a cheaper option than the pricey oxycodone.

State tallies of death-by-poisoning show California saw a 60 percent increase in drug deaths from 2000 to 2012, largely driven by the opioid overdoses.

Opioids are chemically similar to opium, derived from the seeds of poppies grown largely in Afghanistan. For centuries, opium has been used as a mind-altering substance in certain cultures. Modern versions include the prescription drugs, heroin, morphine, methadone and codeine.

Prescription painkillers work by binding to receptors in the brain to decrease its perception of pain and introduce a feeling of euphoric well-being. In the process of sedation, the user’s breathing slows and, in cases of overuse, stops altogether.

In Sacramento County, about 2,500 residents were hospitalized for opioid overdoses from 2006 and 2012. Of the state’s 15 largest counties, none had a higher rate of the hospitalizations, according to data from the Office of Statewide Health Planning and Development.

David Sheff is the author of “Clean,” an exhaustive look at addiction as a disease, and “Beautiful Boy,” a best-seller that laid bare his family’s chaotic and emotionally painful home life during his son Nic’s years of addiction.

In an interview, Sheff, who lives in the Bay Area, said not enough is being accomplished to fight addiction disease.

“We are way behind where we should be,” he said. “With more funding, we’d have a renaissance in terms of scientific understanding of addiction and how to treat it. We could be so much further.”

That’s a goal that Alex Smick’s mother pushes for as she repeats her story over and over to different audiences.

The night Alex died, he was left unmonitored for seven hours, even though the nurses’ station was right around the corner from his room, Tammy Smick said. By the time a nurse did check on him, Alex’s body was in full rigor mortis.

“All we want to do is bring about change,” Smick said. “This is about the small percentage of negligent and over-prescribing doctors. Change is not moving quickly enough and many people have died.”

Phillip Reese contributed to this story. Call The Bee’s Cynthia H. Craft, (916) 321-1270.

Medical errors kill hundreds of thousands each year in the US

November 18, 2013 | Ramon Galindo | RT News

Staggering new numbers are shedding light on a critical problem in the American healthcare system.

A recent report by the Journal of Patient Safety indicates that between 200,000 and 440,000 people are killed each year in the United States from preventable medical errors. These patients aren’t dying from the condition that forced them to go to the hospital in the first place. They’re dying from unintended mishaps.

Eric Andrist is overcome with emotion as he remembers the death of his sister Cali. Andrist cared for his mentally disabled sister day and night, and recalls that once he took her to the emergency room at Providence St Joseph’s in Burbank, California for a stomachache. Days later she was dead.

“My sister was writhing in pain for so long. It just haunts me. The last moments my sister, are just engrained in my head,” Andrist said.

A binder full of medical records shows a long list of possible mistakes healthcare professionals made when treating Cali.

Deadly medical errors can happen at even the most highly rated hospitals. New research shows that up to 440,000 people die every year in America from preventable medical mistakes. That would make it the third leading cause of death in the US, following heart disease and cancer.

“The incidence of people dying of errors in hospitals is abysmal in this country. It’s really a crisis level problem,” said Leah Binder, the president and CEO of Leapfrog Group, a non-profit watchdog group which rates hospital safety in the US.

In 1999, the Institute of Medicine reported that up to 98,000 people a year die because of mistakes in hospitals. In 2013, a study in the Journal of Patient Safety said that number may now be between 210,000 and 440,000 patients: more than the population of Miami, Florida.

Not all medical errors kill, but they can still cause a lifetime of pain.

“When I left the operating room, I had a fever, I was nauseous, I was having chills, and I was told that was probably due to the anesthesia,” said Alicia Cole, a medical error survivor.

Cole, who used to work as an actress and model, went to the hospital for a routine myomectomy to remove two uterine fibroids. She expected to be out in a few days. Instead, she contracted Necrotizing Fasciitis, also known as flesh-eating bacteria.

“You can see this is all eaten out here, and cut out. Here it is going down my thigh,” Cole said as she showed photos of the infection overtaking her body’s midsection.

Years later Cole is still in physical therapy.

Her claim of hospital injury is not isolated.

Shelly Skalicky was diagnosed with Spina Bifida as a child. In 2008, she went into the hospital for elective surgery to relieve some of her symptoms.

Skalicky and her husband Danny Long used to enjoy an active outdoor lifestyle. However, after her trip to the hospital, Skalicky came out a quadriplegic and now requires round the clock care.

Home videos show Long helping his wife to do the simplest tasks.

“We have never been allowed to talk to any doctors. We’re not allowed to talk to the patients’ safety department. We’re not allowed to talk to the ethics department. We’re not allowed to talk to anybody except hospital lawyers,” said Long.

Because some states have caps on malpractice claims, many lawyers refuse to take on cases of medical error.

Despite their frustration with the healthcare system, their love has strengthened during the struggle.

“I rely on her as much as she relies on me. If most guys were honest they would have to admit that too. She is my rock,” said Long.

Many healthcare professionals want to reduce accidents but transparency remains a major barrier.

“It’s long since been time that we have a national conversation about these deaths in hospitals,” said Binder.

A requirement in the Affordable Care Act encourages Medicare providers to report medical errors, but it stops short of requiring all health care providers from participating.

“The best hospitals find ways to create safety nets around the mistakes they expect people to make,” said Binder. “They double-count their sponges, they barcode their sponges, to double check they are not leaving sponges inside a patient. There is barcoding for medication administration now too,” Binder added.

And while technology might help, simple, inexpensive things like good hygiene can prevent infection.

In Alicia Cole’s case, the State Health Department found her hospital had broken several patient safety laws.

“Ask your doctor what the infection rate is for the procedure you’re going to have,” said Cole

“Document everything. Take a little notebook with you and write down every drug they give you. Make sure you have your cell phone with your little camera so you can take pictures of things,” said Andrist.

“It’s not right that in a country as wealthy as the US and with the resources that we have, there’s no reasons patients should have to go through that,” Cole added.

It’s time to fix California’s outdated medical malpractice law

The Medical Injury Compensation Reform Act of 1975 has destroyed the ability of large segments of California patients to file malpractice lawsuits.

Eric Andrist, 50, is photographed in his home in the Valley Village area of Los Angeles on July 8, 2013. Eric is the brother of Cali Andrist who passed away on March 9, 2012 at Providence Saint Joseph Medical Center in Burbank. Her cause of death was strangulation of the small bowel and sepsis conducted through a private autopsy requested by Eric. The hospital listed she died from cardiac arrest, small bowel obstruction and chronic atrial fibrillation. Eric is suiing the hospital for medical negligence for his sisters death. (Photo by Gary Friedman/Los Angeles Times via Getty Images)

It’s a very rare thing for a legislator to admit that a law he sponsored hasn’t worked out as expected. It’s even rarer for him to label it “oppressive” and call for its revision.

But that’s the case with former California Assemblyman Barry Keene and one of his legislative offspring. The law is the Medical Injury Compensation Reform Act of 1975, or MICRA, which tried to address a malpractice insurance “crisis” — rising premiums threatened to drive doctors out of California or into retirement — by imposing draconian restrictions on patient lawsuits.

Has MICRA worked? By some measures, yes.

The law has destroyed the ability of large segments of California patients to file malpractice lawsuits. It’s not uncommon for those who sue their doctors and win to see their damage awards slashed by hundreds of thousands of dollars. So the goal of its original supporters, which was to make malpractice cases harder to bring and cheaper to defend, has been gloriously realized.

But as Keene acknowledges, MICRA is grossly outdated. The good news is that there’s a move on to bring it into the 21st century, which Keene supports. The consumer group Consumer Watchdog is drafting a ballot initiative it hopes to place before the voters at the November 2014 election.

The group says it will hold off if the Legislature reforms MICRA this summer. Given the grip that the insurance industry and the medical lobby have on the Legislature, the chances of that are slim. So brace yourself for an initiative campaign likely to break spending records next year.

MICRA imposes a cap of $250,000 on all damages in malpractice cases except for the victim’s medical bills and economic losses, typically lost earnings. Everything else, such as “pain and suffering,” mental anguish and loss in quality of life, is subject to the cap.

That cap was set in 1975. Because it was not indexed to inflation, in 1975 dollars it’s worth less than $58,000 today. To put it another way, if it had been inflation-indexed in 1975, the cap now would be $1.1 million. Raising the cap to at least to that level and permanently indexing it to inflation is the goal of the proposed initiative.

Keene, now 74 and long retired from the Legislature, is tormented by the failure to protect the $250,000 cap from inflation.

As he explained to me in an email, he proposed an inflation-indexed cap in an amendment to his original bill, assuming it would pass routinely. Instead the trial lawyers lobby, which adamantly opposed MICRA, came out against the inflation index in order to make the bill as noxious as possible to guarantee its rejection.

They misplayed their hand. To their shock, MICRA passed the Legislature without the inflation provision, got signed by then-Gov. Jerry Brown and then was upheld by the state Supreme Court.

There’s no mystery about who really gets whacked by MICRA. A 2004 study by Rand Corp. found that juries tended to award proportionately more pain and suffering judgments to women than men, who typically can show higher earning losses. As a result, women’s damage awards were typically cut more than a third to meet the MICRA limit, while men’s awards were cut only 25%. Damage awards to injured plaintiffs less than 1 year old were slashed in 71% of the cases Rand studied.

Consider the case of Cali Andrist, 59, who died after treatment at Providence St. Joseph Hospital in Burbank last year. Cali had been developmentally disabled all her life, with a mental age of 4, according to Eric Andrist, her brother and long-term caregiver. Andrist alleges that she died in part because the hospital failed to diagnose that the abdominal pain that brought her to the emergency room came from a bowel obstruction.

Cali was the perfect MICRA victim: She had no earnings and obviously no future medical expenses. Determined to bring a lawsuit, Eric Andrist was turned down by more than 15 lawyers who viewed the case as one with a recovery topped out at $250,000, and possibly less.

“There’s no way they could make enough money to take the case on,” Andrist told me last week. “MICRA made Cali’s life valueless.”

Eventually Christopher B. Dolan, a San Francisco personal injury lawyer, agreed to take on the case practically pro bono. Andrist’s lawsuit was filed in Los Angeles County Superior Court on May 30. The hospital declined to comment.

There’s plenty of evidence that the only real beneficiaries of MICRA are insurers. Doctors would like to think that the insurers pass MICRA savings on to them, but they’re dreaming. Last year, Insurance Commissioner Dave Jones ordered rollbacks of $52 million in “excessive” malpractice premiums.

Over the last 22 years, California malpractice insurers have paid out in claims an average of only 36 cents of every premium dollar they’ve collected, according to Insurance Department statistics. For comparison’s sake, for all property and casualty insurance lines the figure is 62 cents; for passenger auto insurers alone it’s more than 60 cents.

MICRA’s backers, chiefly the medical and insurance industries, paint the law as a bulwark against frivolous lawsuits filed by unscrupulous lawyers. Don’t buy it. According to a 2006 study of 1,452 claims published in the New England Journal of Medicine, the facts don’t support this picture of malpractice litigation.

The researchers found that the most frequent injustice in malpractice cases involved not undeserving patients collecting payments, but the opposite, deserving patients getting nothing.

Nevertheless, the MICRA lobby keeps parroting the myth. And it doesn’t stop there. A central claim of Californians Allied for Patient Protection, or CAPP, the medical and insurance industries’ cynically named pro-MICRA lobby, is that merely doubling the cap to $500,000 would drive up California healthcare costs by $9.5 billion a year.

This is the kind of eye-opening number that begs for scrutiny. It’s based on a 2002 study by researchers at Stanford and the Hoover Institution that calculated the cost of “defensive medicine” — extra tests and procedures performed only to stave off malpractice claims — at 3.04% of total spending. So CAPP simply multiplied total healthcare spending in the state, which was $296 billion in 2010, by 3.04%. It threw in some putative increases in Medi-Cal and premium costs and presto! You get $9.5 billion.

The problem is that the Stanford study dealt only with the treatment of elderly heart patients on Medicare, a very narrow category. The idea that their figures are applicable to healthcare in general has been widely questioned, including by the Congressional Budget Office. The CBO, in fact, has estimated the cost of defensive medicine at 0.3% of total spending, or one-tenth CAPP’s figure.

But that’s just a taste of the bogus statistics we’ll be inundated with in an initiative campaign.

Malpractice litigation has indeed failed to serve patients and their doctors. The cost of a lawsuit, which includes extensive expert witness fees, has become exorbitant for both sides, and the typical case takes five years to resolve.

The remedy is to make the process more efficient, perhaps by steering such cases to a specialized arbitration court. Simply padlocking the courthouse to whole categories of plaintiffs doesn’t meet the fairness test. But MICRA shoulders all other options to the back burner. It’s time to bring this 37-year-old law into the 21st century, and fix the malpractice system so that it actually works.

Michael Hiltzik’s column appears Sundays and Wednesdays. Reach him at [email protected], read past columns at latimes.com/hiltzik, check out facebook.com/hiltzik and follow @hiltzikm on Twitter.

July 09, 2013|Michael Hiltzik | Los Angeles Times

MICRA appeal update

NOVEMBER 28, 2014

MICRA constitutionality might be early test of the “new” Supreme Court

The Supreme Court on Tuesday granted review in Hughes v. Pham.  A group who supported review is touting the court’s action as a decision to “review the constitutionality of [what the group characterizes as] the state’s arbitrary 39-year-old damages cap of $250,000 in medical malpractice cases.”  That’s wrong . . . at least for now.

The constitutionality of Civil Code section 3333.2 — the limit on noneconomic damages in healthcare professional negligence cases enacted as part of the 1975 Medical Injury Compensation Reform Act (MICRA) — is not currently before the court in Hughes, but it could be before spring.  If that happens, it will be a harbinger of change at the Supreme Court due to the court’s three newest justices, all appointed by Governor Brown.

The Hughes petition for review raises the constitutional issue, but, in granting review in Hughes, the court clearly did not agree to decide that issue.  In fact, the court did not agree to decide any issue in Hughes at all.  Hughes is a grant-and-hold case; action on the matter is deferred pending disposition of Rashidi v. Moser, S214430, and the eventual “action” on a grant-and-hold case is usually not a written opinion.  Moreover, the court will not decide the constitutional issue in Rashidi, either.  Indeed, the court is expressly avoiding that issue there:  the Court of Appeal upheld the constitutionality of the cap in a published opinion and the Rashidi plaintiff’s petition for review raised the constitutional issue, but the court specifically limited the case to an issue about how the damage cap is applied, thereby presuming the statute’s constitutionality.

But, just because Hughes‘s status as a grant-and-hold case means the court normally would not issue an opinion in the matter does not mean that the status won’t change.  The court can, and occasionally does, un-hold a case and order briefing, hold oral argument, and issue an opinion.  If that happens in Hughes, the court could decide the constitutionality of the MICRA damage cap in that case.  And it might happen.  Some history tells why.

Actually, the Supreme Court already decided the constitutionality of the MICRA cap.  It upheld the law almost 30 years ago in Fein v. Permanente Medical Group (1985) 38 Cal.3d 137.  Within the last ten years, however, plaintiffs lawyers have renewed their attack on the cap in court with somewhat different constitutional arguments.  So far, they’ve been unsuccessful.  For example (and a disclosure), Horvitz & Levy filed an amici curiae brief supporting the cap five years ago in a case raising the same constitutional issues as in Hughes.  In that case, the Court of Appeal upheld the MICRA cap’s constitutionality in an unpublished opinion and the Supreme Court denied review.  (The plaintiffs’ bar has also failed to raise the amount of the cap legislatively, most recently winning only 33 percent of the vote for a ballot initiative.)

Three years ago, however, when the Court of Appeal again rejected constitutional attacks on the MICRA cap, in Stinnett v. Tam (2011) 198 Cal.App.4th 1412, the Supreme Court again denied review, but Justices Kathryn Werdegar and Goodwin Liu voted to hear the case.

In Stinnett, the court was two votes short of review.  Within the next two months, there will be two new justices on the court — Mariano-Florentino Cuéllar and Leondra Kruger — who could join with Justices Werdegar and Liu in voting to decide the constitutional issue.  And the first opportunity to do so would be un-holding Hughes.  That could happen after a decision in Rashidi,  which was argued in October, or even before then.

A change in court personnel can profoundly affect the outcome of cases.  The court’s MICRA jurisprudence itself is a prime example.  When the Supreme Court first reviewed the constitutionality of MICRA, examining a part of that statutory scheme other than the damages cap, the court initially struck down the law in a 4-3 decision.  (American Bank and Trust Co. v. Community Hospital (1983) 190 Cal.Rptr. 371.)  There were three pro tem justices on the case; two voted with the majority and one with the dissenters.  Soon after the decision, Governor Brown (in his first stint as governor) appointed Joseph Grodin to the court, replacing one of the pro tems who had been in the majority.  Justice Grodin voted with the three dissenters to rehear the case and he and those three formed a new majority to uphold MICRA.  (American Bank & Trust Co. v. Community Hospital (1984) 36 Cal.3d 359.)

Legal observers have been discussing how Governor Brown (in his second two terms as governor) could reshape the Supreme Court.  An early indication of that impact will come when his three appointees this time around — Liu, Cuéllar, and Kruger — vote whether to treat Hughes as a typical grant-and-hold or to use that case as the vehicle to reevaluate the constitutionality of MICRA’s damage cap.

LINK

DECEMBER 12, 2014

MICRA opinion filing Monday

On Monday morning, the Supreme Court will file its opinion in Rashidi v. Moser, which was argued on the October calendar.  In Rashidi, the court will answer this question:  If a jury awards the plaintiff in a medical malpractice action non-economic damages against a healthcare provider defendant, does Civil Code section 3333.2 entitle that defendant to a setoff based on the amount of a pretrial settlement entered into by another healthcare provider that is attributable to non-economic losses or does the statutory rule that liability for non-economic damages is several only (not joint and several) bar such a setoff?

Rashidi is perhaps more notable for what is not being decided than what is.  The statute the court will interpret is the part of the 1975 Medical Injury Compensation Reform Act (MICRA) that limits to $250,000 the recoverable amount of noneconomic damages in healthcare professional negligence cases.  The plaintiffs’ bar doesn’t want the statute interpreted; it wants the statute struck down as unconstitutional, and the plaintiff asked the court to do that in Rashidi.  But the court specifically limited the issue (See below) it would decide to the narrower statutory construction question.

The opinion can be viewed Monday starting at 10:00 a.m.

LINK

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