The FDA Should Approve Drugs Based on Evidence, Not Emotions

The FDA Should Approve Drugs Based on Evidence, Not Emotions

http://www.slate.com/articles/health_and_science/medical_examiner/2016/12/the_21st_century_cares_act_could_be_dangerous_for_everyone.html

On Dec. 7, the New York Times ran an inspiring, dangerous story about Celine Ryan, a 50-year-old whose advanced colon cancer was successfully treated with experimental immunotherapy. Inspiring, because researchers repeatedly rejected Ryan’s requests to participate in a clinical trial, but her heroic refusal to accept their verdict led to her eventual admission—and remission. Dangerous, because although the article emphasizes that success in one patient proves very little, Ryan’s story served as powerful anecdotal reinforcement of a widespread and mistaken view that groundbreaking cures are stuck in trial stages, and that patients need to take it upon themselves to fight bureaucratic gatekeepers for access. This type of narrative undermines the necessity of the Food and Drug Administration, whose scientific standards are crucial to keeping medical costs down, preventing health crises, and ensuring objective evaluations of new drugs.

The consequences of buying into this mistaken picture are illustrated perfectly by the recently approved 21st Century Cures Act, an enormous piece of health care legislation that includes everything from increased funding for the National Institutes of Health to programs that will fight opioid addiction. Packaged with these uncontroversial goodies, however, is a provision that asks the FDA to relax evidentiary standards for drug approval by granting weight to “real-world evidence” and “patient-experience data.” Supporters argue that the provision will allow patients quicker access to cures. If passed, it could also incentivize competitive development of new drugs by lowering their cost to market—the current gold-standard for evidence of efficacy is randomized placebo-controlled trials, which are time-consuming and expensive. Health policy experts, on the other hand, are rightfully nervous about the unintended results of laxer standards: A market flooded with potentially unsafe drugs that are no more effective than placebo.

From the perspective of a cancer sufferer who has just read Ryan’s story—gutsy individual triumphs over hidebound bureaucracy—it’s hard to take calls for caution seriously. How many others have suffered and died, the logic goes, because they didn’t stand up to the system? Patient advocacy groups—often funded by industryroutinely take this position, criticizing the FDA for excessive conservatism that forecloses on Americans’ right to decide what constitutes a promising treatment and whether or not to take it. (As one Wall Street Journal op-ed put it in 2002: “FDA to Patients: Drop Dead.”) The push for less stringent FDA standards makes willing but unlikely bedfellows of pharmaceutical companies and everyday people, united against the perceived inefficiency of callous government elites who prefer exercising power to saving lives.

But this picture of the FDA couldn’t be further from the truth. In reality, regulations are in place to protect everyday people against the interests of pharmaceutical companies and our own impatience for new medicine. Left unregulated, the market for medicine can generate catastrophic results. Just ask Louise Medus, one of thousands of severely deformed “thalidomide babies” born in the late 1950s and early ’60s. (Medus, who is British, was born with limb deformities.) Thalidomide, developed to treat morning sickness, was made available in 49 countries for two years—despite early evidence that the drug might cause rare birth defects including phocomelia, the underdevelopment or absence of limbs. “I can’t imagine what my dad thought or felt when a grim-faced doctor led him to a delivery room an hour after my birth,” Medus told the Guardian. “All I know is that he almost fainted with shock when I was fully revealed and blurted out: ‘Surely you’re not going to allow a child in this state to live.’ ”

Unlike many other countries, the United States managed to avoid the thalidomide crisis, thanks to a heroic FDA regulator named Frances Oldham Kelsey. Despite intense pressure from the drug’s manufacturer, Oldham demanded further testing, pointing to inconclusive results about thalidomide’s efficacy in humans and initial evidence that the drug caused nervous system side effects. Six applications for approval were denied, and the subsequent birth of countless deformed babies like Medus vindicated the wisdom of Kelsey’s tenacity. For her efforts, she received the President’s Award for Distinguished Federal Civilian Service from John F. Kennedy in 1962. That same year Congress unanimously passed the landmark Kefauver Harris Amendment, which raised the evidentiary bar for new drug approval.

“It’s well-known scandals and crises like thalidomide that led to the FDA having the power it has today,” says Rachel Sachs, a law professor at Washington University who specializes in health law, innovation, and patient access. “Perhaps the existence of the FDA is a slight barrier to innovation. But in my view, it’s far more important to prevent unsafe, ineffective drugs from coming to market.”

Even if eroded standards don’t lead to a devastating public health crisis, it’s almost certain that they’ll lead to a massive increase in costly drugs that don’t actually work. As Sachs pointed out to me, ineffective drugs are already a problem. Under enormous pressure from patient advocacy groups and biotech companies, the FDA recently approved Exondys 51, a drug for a rare disease called Duchene’s muscular dystrophy, despite only limited evidence of efficacy and the sky-high cost of $300,000 per year. The manufacturer of Addyi, aka “pink Viagra,” secured approval for a drug that many experts believe to be not only ineffective but also dangerous. And a recent report suggests that more than a dozen cancer drugs with prices of more than $100,000 per year remain on the market without good evidence they work, approved on the basis of shoddy evidence. If anything, we should be strengthening the FDA’s regulatory oversight. Instead, we are weakening it at our own peril.

The reduced evidence standard proposed by the 21st Century Cares Act is a bad solution aimed at the wrong problem. Evidence is not collected or paid for by the FDA. (It’s paid for by the drug companies.) Reducing the standards simply means that the FDA will not have the necessary evidence it needs to ensure efficacy. “FDA approval is not what shows that a drug works; clinical data do that,” Derek Rowe, an expert on pharmaceutical development, wrote in response to the 21st Century Cures Act. “You can instruct everyone to collect less data, but then you will approve—and ask people and their insurance companies to pay for—more things that don’t actually work.”

So are we destined for rocketing insurance costs and another thalidomide? It’s still hard to gauge the potential consequences of the provision. According to Patti Zettler, a professor at Georgia State who served as associate chief counsel for the FDA, the provision’s vague wording gives the FDA a significant amount of interpretive authority. “There’s room for them to minimize the impact of the law and construe it narrowly,” she told me. Staff members of the FDA seem inclined to that approach, and recently offered a conservative interpretation of the new evidentiary standards in the New England Journal of Medicine.

Unfortunately, President-elect Trump seems to be on the bad side of the law.* His selection for head of the FDA might embrace the act, and open it to a free-for-all. Silicon Valley venture capitalist Jim O’Neill, rumored to be one of Trump’s picks for FDA commissioner, made an extreme case against FDA regulation of drug efficacy in a 2014 speech. “Let’s prove efficacy after they’ve been legalized,” he suggested, an absurd statement that reflects O’Neill’s frightening lack of scientific or medical qualifications. (For one thing, safety and efficacy are not separable factors in drug approval; side effects that are acceptable in effective cancer medication, say, would be unacceptable in headache medicine.) Trump is also rumored to be considering venture capitalist Scott Gottlieb, who, as a former deputy commissioner at the FDA, would be a more traditional choice.

Even without an FDA head who is abjectly anti-evidence, the bill’s passage paired with increased leniency toward pharmaceutical companies could be devastating. Imagine if a drug were developed with a focus on addressing a condition with a specific end point, for example, the ability to concentrate. Without randomized controlled trials, the data on these drugs is virtually guaranteed to be infected by bias, especially if it comes from the company that developed them. Autism would be an ideal condition, since autism research is plagued by difficulties distinguishing real treatment effects from placebo—exactly the kind of problem that high-quality trials are designed to address.

Next, pharma companies could sponsor patient advocacy groups’ campaigns for approval, using testimony from mothers whose children participated in experimental, low-quality trials with miraculous results. Trump tweets something about how the FDA needs to get its act in gear so autistic children don’t suffer. So, they do, and a potentially unsafe, ineffective, and highly profitable medication is approved. Rinse and repeat.

This will be the model for medication approval driven by outrage and desperation, rather than evidence and reason. It is tragic that some people end up waiting for effective treatment, and it is inspiring when patients like Ryan take matters into their own hands and end up beating the odds. I cannot imagine anything more painful than watching a loved one suffer or die, only to find out that speedier approval might have saved them. But allowing such stories to inform our medical decisions is not kind; it is potentially dangerous. This is precisely the kind of mistake that randomized controlled trials are meant to guard against in medicine. Let’s not make the same mistake with public policy.

Botticelli underwent a court-ordered treatment program for alcohol abuse

Obama’s drug policy chief pushes for a compassionate solution to the opioid crisis

fusion.net/story/375351/michael-botticelli-jorge-ramos-obama-drug-policy/

Michael Botticelli doesn’t want to be known as the Obama administration’s “drug czar.”

That’s because Botticelli, the head of National Drug Control Policy at the White House, thinks that moniker calls back to the failed drug policies of other administrations, which he said haven’t focused enough time and energy on fighting addiction as a public health issue.

In a new interview on AMERICA with Jorge Ramos, Botticelli said he’s spent his tenure championing a more humane and compassionate approach to battling to ongoing heroin epidemic in the United States.

 “The disease of addiction…is not people’s moral failing or a sign of character weakness, this is a deep-rooted disease that we can’t arrest and incarcerate our way out of,” Botticelli told Ramos.

It’s an issue that hits close to home for the White House official. Botticelli is the first person to serve as drug policy chief who’s lived through substance abuse recovery. After causing a car accident in 1988 while driving under the influence, Botticelli underwent a court-ordered treatment program for alcohol abuse. Now, he’s been sober for 27 years.

Although the rate of overdoses related to opioid abuse are on the rise, Botticelli said the administration is already seeing evidence that its policies are taking hold, saying they’ve seen reductions in doctors prescribing the powerful painkillers that can lead to heroin use. He’s also confident that the 21st Century Cures Act, the major healthcare legislation that passed with bipartisan congressional support this month, will only continue that momentum.

President Obama is slated to sign the bill, which contains provisions to fight opioid abuse, on Tuesday.

 Asked about what role legalization could play in stemming the demand for illegal drugs crossing the Mexican border into the United States, Botticelli said one major miscalculation in the drug war was a focus only on cracking down only on the drug supply, rather than also addressing the demand for drugs at home.

“I don’t believe that legalization is really going to solve our drug use and its consequences in the United States,” he said. “One just has to look at the prescription drug issue we have here in the United States. These are not drugs that came across the border. These are drugs that came from our own medical community.”

So as the sun sets on the Obama administration, how does Botticelli want to be remembered for his drug policy work?

“I’ve been called the recovery czar. I think it shows drug policy can have a much more humane response,” he said. “We have to have a comprehensive response, and that’s been what this administration has tried to put forward.”

OMG! : kratom, the state’s poison control center has received 24 calls so far this year, in comparison with five in 2015.

MIAMI, FL - MAY 10: In this photo illustration, capsules of the drug Kratom are seen on May 10, 2016 in Miami, Florida. The herbal supplement is a psychoactive drug derived from the leaves of the kratom plant and it's been reported that people are using the supplement to get high and some states are banning the supplement. (Photo by Joe Raedle/Getty Images)Herbal drug kratom faces uncertain legal future, despite public outpouring

http://www.pbs.org/newshour/updates/whats-next-kratom/

Kratom, a leafy-green herbal supplement used by an estimated 3 to 5 million Americans, has inspired tens of thousands of responses in a public comment period over its possible controlled substance designation by the Drug Enforcement Agency.

The substance is derived from a Southeast Asian plant that belongs to the same family as coffee. It’s ground down into an earthy-green powder and then put inside capsules or mixed into a liquid and sipped like tea. Depending on how much is ingested, it can act as a stimulant or a painkiller.

READ MORE: If DEA blocks kratom, promising research on opioid alternative may suffer

Kratom has been used for hundreds of years in places like Thailand, but only within the last few years has it became popular in the U.S. It is widely available online and in convenience stores.

It grabbed the attention of the DEA when calls to poison control centers increased ten-fold from 2010 to 2015. Most callers complained about effects such as increased heart rate, agitation, drowsiness, nausea, and hypertension. One death was reported in a person who was also on an antidepressant and a mood stabilizer. So far, in 2016, the American Association of Poison Control Centers has received around 480 calls about kratom. (For context, critics cite that the center has received more than 10,000 calls just this year for laundry detergent pods.)

In Illinois, where earlier this year the federal government confiscated hundreds of thousands of dollars of kratom, the state’s poison control center has received 24 calls so far this year, in comparison with five in 2015. For perspective, there have been 1,772 calls for prescription opioids in 2016 so far.

Michael Wahl, the medical director of the Illinois Poison Center said most of the calls came from hospital emergency centers where users experienced more serious effects like hallucinations, seizures, and withdrawal from the plant.

In August, in response to the uptick in calls to poison control centers, the DEA announced emergency scheduling of the legal drug, which would have temporarily made kratom a Schedule I substance like heroin, banning the substance and bypassing the normal process.

However, pushback from the public and members of Congress resulted in an unprecedented reversal. The DEA withdrew the immediate scheduling, and opened a public comment period that ended Dec. 1.

The DEA received some 23,210 comments online, an abnormally high amount, according to DEA spokesperson Melvin Patterson. He said all comments will be taken into consideration in the search to find out which benefits, if any, kratom provides. Personal stories offered by commenters could help the DEA make a decision despite a lack of research on and knowledge of the drug’s effects.

Dr. Richard Clark of U.C. San Diego’s toxicology department says our lack of knowledge is exactly why we should be cautious. “The most educated way to approaching it is, if we don’t know much, we ought to be careful, and maybe banning it is the right way to go so it doesn’t hit the streets full force,” Clark said.

Clark is concerned about how the herb affects our brain, and in particular how it interacts with our brain’s opioid receptors. “We know that most drugs that affect those receptors can build up tolerance and dependence, and there are a couple cases that I’ve seen that suggest that people can get dependent and addicted on kratom.”

Andrew Turner, a Maryland resident who became active in efforts to keep kratom legal, will be personally affected by the DEA’s decision. He spent more than nine years in the U.S. military, serving in Iraq, Jordan, and South Korea. His experience landed him a long list of ailments like severe PTSD, cluster headaches and degenerative disc disease.

“All these things work against me, and it makes life hard to deal with,”Turner said.

He received painkillers and other pharmaceuticals from the Department of Veterans Affairs, but found that the prescription drugs did not help him, and the side effects were damaging.

After finding kratom about two years ago he hasn’t taken anything else for his pain, aside from the occasional Tylenol.

“Kratom doesn’t fix the symptoms but it gives me an overall sense of well-being,” Turner said. “The ticks go away, my speech is much more eased. It’d be awesome if it were a magical cure; it isn’t, but it helps.”

Along with the comments, the DEA will receive analysis from the FDA, which will assess the drug based on eight factors. Patterson says the decision will be largely dependent on this analysis.

An advocacy group called the American Kratom Association conducted a study using the same eight-factor analysis, headed by a researcher previously with the National Institute on Drug Abuse (NIDA). It concluded that there was “insufficient evidence for the U.S. Drug Enforcement Administration (DEA) to ban or otherwise restrict the coffee-like herb kratom under the Controlled Substances Act.”

Once the DEA receives the FDA assessment and goes through the public comments, there are a couple of possible outcomes: it could return to emergency scheduling putting kratom into Schedule I immediately; the DEA could go through routine scheduling opening up another public comment period; or scheduling could not be pursued at all.

Turner, the military veteran, knows kratom has to go through the DEA’s process and welcomes regulation, but he doesn’t believe it’s being given a fair assessment.

“It’s going to need some sort of regulation. Healthy oversight helps the market and helps the consumer and I think that’s what everyone is hoping for,” said Turner. “But we don’t get the feeling that the DEA is even trying to make it safe, because if they ban it they are going to create a black market.”

For now, kratom is legal, but considered a drug of concern. Online shops and brick and mortar stores selling kratom are doing so legally.

A petition with more than 145,000 signatures reached the threshold to warrant comment from the White House. The Obama administration has no deadline to comment and has not yet weighed in, although they are expected to give remarks.

 

 

Treatment reserved for addicts…. treatment for chronic pain — not so much !

$20.4 million invested into 45 Pennsylvania drug treatment centers, six in Midstate

abc27.com/2016/12/12/20-4-million-invested-into-45-pennsylvania-drug-treatment-centers-six-in-midstate/?

HARRISBURG, Pa. (WHTM) – The stress of the holiday season can be hard for many and even more challenging for those struggling with opioid addiction. Governor Tom Wolf recently made an investment in drug treatment in hopes of tackling those holiday blues.

Wolf spent $15 million in state dollars and $5.4 million in federal dollars for the Centers of Excellence to battle the drug epidemic taking 10 lives a day in Pennsylvania.

Josh, left, and Todd, second from left, died of heroin overdoses.
Josh, left, and Todd, second from left, died of heroin overdoses.

“I was raised the oldest of three boys in Cambria County, Pennsylvania,” Jason Snyder said.

Snyder describes his family as blue collar, working class, and typical until tragedy entered their lives.

“Addiction became front and center in our lives,” Snyder said. “In 2005, my brother Todd at age 28 died of a heroin overdose.”

Todd’s girlfriend called Snyder, who found his brother dead in the kitchen.

“I had to make the phone call and told my mother Todd had overdosed,” Snyder said. “That set off a chain reaction of wailing.”

Todd left behind his five-year-old daughter Trinity.

Jason Snyder and his nephew Paighton.
Jason Snyder and his nephew Paighton.

 

“When it happened again a little more than two and a half years later, we were devastated,” Snyder said.

This time, Snyder’s mother called him to tell him the tragic news. His brother Josh also died of a heroin overdose and never had the chance to meet his son Paighton, who was born two months after he died.

“I was left as the last man standing so to speak, the last living child of my parents, which made it all the more difficult for me in 2011 to tell them that I was entering inpatient drug treatment for an addiction to prescription pain medication,” Snyder explained.

Stigma is one of the obstacles that stopped Snyder from getting treatment.

“I had been doing drugs and alcohol for 20 years,” he said.

He was introduced to prescription pain killers and eventually bought them on the streets.

Snyder has been clean for five years and now helps others who were once in his shoes. He works at the Department of Human Services, which runs the Centers of Excellence.

“We’re going to treat the whole person,” Snyder said. We’re not just going to treat the individual’s addiction, but we’re also going to treat any underlying mental health or physical health issues that may be driving that person’s addiction.”

Those receiving help at the Centers will received medication-assisted treatment, as well as employment opportunities and training.

The Snyder brothers on the beach.
The Snyder brothers on the beach.

 

“The state has to respond, and we have to do a better job of providing quality care and ensure that people stay in treatment longer if we are to begin to reverse what has been over the last several years a steadily increasing death toll,” Snyder said.

Snyder said only 48 percent of people with an opioid addiction in 2014 got treatment, and of that percentage, only 33 percent remained engaged in treatment for more than 30 days. He hopes the Centers of Excellence can change that.

“This is Governor Wolf’s really signature response to addressing the opioid epidemic,” Snyder said.

Six of the 45 Centers of Excellence are in the Midstate. You can see the full list of locations by clicking here. Patients can pay through insurance or Medicaid.

“Addiction affects anyone. It’s urban, it’s suburban, it’s families like mine, it’s comes from broken families, good families, wealthy families. It knows no boundaries,” Snyder said.

3,383 people died from drug overdoses in Pennsylvania in 2015. That’s up from more than 2,500 in 2014, according to the Pennsylvania Department of Drug and Alcohol Programs.

The Governor recently launched a toll-free hotline for people battling a heroin or prescription drug addiction. You can call 1-800-662-HELP 24 hours a day, seven days a week. The hotline is staffed by trained professional and is available in both English and Spanish.

Alleged Drug Overcharging Scheme Spawns 10 Lawsuits

Alleged Drug Overcharging Scheme Spawns 10 Lawsuits

https://www.bna.com/alleged-drug-overcharging-n73014448384/

Dec. 9 — Accusations of a prescription drug overcharging scheme involving some of the country’s largest pharmacy benefit managers and health insurers have spawned 10 proposed class actions in the past two months.

Taken together, the lawsuits claim that PBMs OptumRx and Humana Pharmacy Solutions Inc. worked with health insurers to overcharge patients for prescription drugs. The most recent complaints were filed on Dec. 7 and Dec. 8 against Cigna and UnitedHealth, respectively. According to the lawsuits, when a given prescription drug costs less than a patient’s copayment amount, insurers including United Healthcare, Cigna and Humana “claw back” the difference through an improper scheme kept hidden from patients ( Davis v. OptumRx, Inc. , C.D. Cal., No. 8:16-cv-02165, complaint filed 12/7/16 ; Mastra v. UnitedHealth Grp., Inc. , D. Minn., No. 0:16-cv-04119, complaint filed 12/8/16 ).

Since Oct. 4, at least 10 lawsuits have been filed challenging this alleged scheme. The recent complaint against UnitedHealth claims that “tens of thousands” of people have been affected, while the Cigna lawsuit places the number in the “hundreds of thousands.”

Bloomberg Law®, an integrated legal research and business intelligence solution, combines trusted news and analysis with cutting-edge technology to provide legal professionals tools to be proactive advisors.

 

Many of the lawsuits cite an investigation into health insurance clawbacks that New Orleans television station Fox 8 began airing in May. The investigation found that some insured patients may be paying more for prescription drugs than they would if they lacked insurance altogether.

The Dec. 7 lawsuit against Cigna and OptumRx was filed by Whatley Kallas LLP, Steel Wright Gray & Hutchinson PLLC and Mauriello Law Firm. This legal team also filed a lawsuit against OptumRX and UnitedHealth on Nov. 23.

The Dec. 8 suit against UnitedHealth was filed by Gustafson Gluek.

A representative for Cigna declined to comment on the lawsuit against it. UnitedHealth representatives didn’t immediately respond to requests for comment.

To contact the reporter on this story: Jacklyn Wille in Washington at jwille@bna.com

To contact the editor responsible for this story: Jo-el J. Meyer at jmeyer@bna.com

OHIO: makes Gabapentin a controlled substance indirectly ?

Effective Dec 1, Pharmacies, Prescribers, and Wholesalers Must Report Gabapentin to Ohio Automated Rx Reporting System

http://www.natlawreview.com/article/effective-dec-1-pharmacies-prescribers-and-wholesalers-must-report-gabapentin-to

Beginning December 1, 2016, the State of Ohio Board of Pharmacy requires pharmacies, prescribers, and wholesalers to report the dispensing, personal furnishing, and wholesale sale of all products containing gabapentin (brand names: Neurontin, Gralise, Horizant) to the Ohio Automated Rx Reporting System (OARRS). Gabapentin has not been reclassified as a controlled substance, but it is being added to the Board’s list of drugs reportable to OARRS following increased reports of misuse, abuse, and concomitant abuse of gabapentin nationwide.1

No new requirement to review an OARRS report prior to dispensing gabapentin

Unlike the rules requiring pharmacists and prescribers to request and review an OARRS report prior to dispensing, prescribing, or personally furnishing controlled substances, there is no requirement to request and review an OARRS report prior to dispensing, prescribing, or personally furnishing gabapentin. Pharmacists and prescribers are expected to use professional judgment to determine the need to request an OARRS report prior to dispensing, prescribing or personally furnishing gabapentin.

Changes to prior exemptions to reporting

Pharmacies or prescribers that were previously exempt from OARRS reporting requirements because they did not dispense or personally furnish controlled substances do not need to reapply for a reporting exemption if they do not dispense or personally furnish gabapentin. However, pharmacies and prescribers that were previously exempt from OARRS reporting requirements, but do dispense or personally furnish gabapentin, must begin reporting such dispensing or personal furnishing to OARRS effective December 1, 2016.

More information on reporting to OARRS can be found in the Ohio PMP Handbook, available under the Pharmacies & Prescribers section on the OARRS website.

VA hospital left deceased veteran in shower room for 9 hours, report finds

Bay Pines VA hospital in Bay Pines, Florida. (Fox 13 Tampa)VA hospital left deceased veteran in shower room for 9 hours, report finds

An internal report blames staffers at a Veterans Affairs hospital in Florida for leaving the body of a deceased veteran to decompose in a shower for nine hours and then trying to cover it up.

The 24-page report concluded that hospice staffers at the Bay Pines VA hospital failed to provide appropriate post-mortem care to the veteran’s body, Fox 13 Tampa reports.

The report found hospice staff put the veteran’s body in a hallway and left it there for an unspecified time, the station reported. Staff then put the veteran’s body in the shower room and did not “check on the status of the decedent…for over nine hours.”

The report also found that a staff member then “falsely documented” the incident, Fox 13 reported.

The investigative report said that leaving the body unattended for so long increased the chance of decomposition.

“The report details a total failure on the part of the Department of Veterans Affairs and an urgent need for greater accountability,” Rep. Gus Bilirakis, R-Fla., told the station. “Unsurprisingly, not a single VA employee has been fired following this incident, despite a clear lack of concern and respect for the veteran. The men and women who sacrificed on behalf of our nation deserve better.”

The unnamed veteran died in February after spending time in hospice care.

The hospital’s Administrative Investigation Board ordered retraining for staff.

Hospital spokesman Jason Dangel told the Tampa Bay Times hospital officials view what happened as unacceptable.

Survey find insurance companies switch meds up to 70% of the time

http://www.ghlf.org/GHLF_Access%20To%20Care%20Survey_Louis_Tharp_11-29-10.pdf

Are insurance practicing medicine without a license?… Switching a patient’s medications mostly based on a cost decision. What other conclusion can one come to ?

ACLU sues because … resident who said the image of the lighted cross has caused him “irreparable harm.”.. GIVE ME A BREAK !

christmas

Bah! Humbug! ACLU sues over Christmas tree cross

http://www.foxnews.com/us/2016/12/11/bah-humbug-aclu-sues-over-christmas-tree-cross.html

For as far back as anyone can remember, there’s always been a cross atop the Christmas tree on the square in Knightstown, Indiana. 

But that could change if the Grinches at the American Civil Liberties Union of Indiana have their way. 

The ACLU filed a federal lawsuit against the town on behalf of Joseph Tomkins,  a resident who said the image of the lighted cross has caused him “irreparable harm.

“The cross is the best known symbol of Christianity and Knightstown’s prominent display of this symbol represents an establishment of religion in violation of the First Amendment to the United States Constitution,” the lawsuit states.

The lawsuit demands the immediate removal of the cross, monetary damages and a declaration that the cross display violates the First Amendment, the Indianapolis Star reports.

Mr. Tompkins alleges he is “forced to come into direct and unwelcome contact” with the cross as he drives through town. 

It’s unclear whether the town will hire an attorney and fight this modern-day Ebenezer Scrooge, but many in this small town are ready to wage a yuletide legal battle.

“There’s a church on every corner here,” resident and relative Mark Tompkins told Fox 59.

For more on this story, visit ToddStarnes.com.

What good are laws against human rights violations… if no one will enforce them ?

Government Accountability  for Torture and Ill-Treatment  in Health Settings

AN OPEN SOCIETY FOUNDATIONS BRIEFING PAPER THE ABSOLUTE prohibition under human rights law of all forms of torture and cruel, inhuman, and degrading treatment (“torture and ill-treatment”) does not apply only to prisons, pretrial detention centers, and other places where torture and ill-treatment are commonly thought to occur. It also applies to places such as schools, hospitals, orphanages, and social care institutions—places where coercion,  power dynamics, and practices occurring outside the purview of law or justice systems can contribute to the infliction of unjustified and severe pain and suffering on marginalized people.
This briefing paper focuses on torture and ill-treatment in health settings, including hospitals, clinics, hospices, people’s homes, or anywhere health care is delivered. It does not seek to stigmatize health providers as “torturers,” but rather to focus on government accountability for placing health providers and patients in unacceptable situations whereby torture and ill-treatment is neither documented, prevented, punished, nor redressed.
The United Nations Human Rights Committee has explicitly recognized that the legal prohibition against torture and ill-treatment protects “in particular . . . patients in . . . medical institutions.”1 Yet, national, regional, and international mechanisms to promote accountability for and to prevent torture are rarely applied to health settings. Human rights bodies responsible for monitoring compliance with anti-torture provisions should systematically examine
1 UN Human Rights Committee, Torture on Cruel, Inhuman, or Degrading Treatment or Punishment (Art 5): 03/10/92. CCPR General Comment. No. 20. Forty-fourth session, 1992.
health settings in their reports and make actionable recommendations to governments on how to stop this abuse.
The Legal Definition of Torture and Ill-Treatment
The legal definition of torture and ill-treatment is broad enough to encompass a range of abuses occurring in health settings. Under international law, any infliction of severe pain and suffering by a state actor or with state instigation, consent, or acquiescence can, depending on the circumstances, constitute either torture or ill-treatment.2
Whether an act qualifies as “torture,” “cruel and inhuman treatment or punishment,” or “degrading treatment or punishment” depends on several factors, including the severity of pain or suffering inflicted, the type of pain and suffering inflicted (i.e. physical or mental), whether the pain and suffering was inflicted intentionally and for an improper purpose, and whether the pain and suffering is incidental to lawful sanctions. Generally speaking, cruel and inhuman treatment or punishment can be intentional or unintentional and with or without a specific purpose, while torture is always intentional and with a specific purpose.3
2 Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, G.A. res. 39/46, [annex, 39 U.N. GAOR Supp. (No. 51) at 197, U.N. Doc. A/39/51 (1984)], June 26, 1987, art. 1, 16 3 Manfred Nowak & Elizabeth McArthur, The United Nations Convention against Torture: A Commentary, p. 558. Article 1 of the Convention against Torture provides a non-exhaustive list of improper purposes that would support a finding of torture: “obtaining from him or a third person information or a confession, punishing him for an act he or a third person has committed or is suspected of having committed, or intimidating or coercing him or a third person, or for any reason based on discrimination of any kind.”
2      GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS
Examples of Torture and  Ill-Treatment in Health Settings
Torture and ill-treatment in health settings commonly occur among socially marginalized populations. People who are perceived as “deviant” by authorities, who pose a “nuisance” to health providers, who lack the power to complain or assert their rights, or who are associated with stigmatized or criminalized behaviors may be especially at risk. The following are documented examples of torture and ill-treatment against specific populations.
People needing pain relief, whether as part of palliative care or for chronic disease, injury, surgery, or labor may experience ill-treatment if their pain is severe enough and avoidable. Denial of pain relief is a pervasive problem among all of the populations discussed later in this briefing note: people with disabilities, women seeking reproductive health care, people living with HIV, people with tuberculosis, people who use drugs, sex workers, lesbian, gay, bisexual, transgender, and intersex (LGBTI) persons, and Roma. Denial of pain relief is also disturbingly common among children.
According to the World Health Organization, approximately 80 percent of the world’s population—or tens of millions of people each year—have either no or insufficient access to treatment for moderate to severe pain, leading to profound physical, psychological, and social consequences.4 In interviews with Human Rights Watch, people who had experienced severe pain in India “expressed the exact same sentiment as torture survivors: all they wanted was for the pain to stop. Unable to sign a confession to make that happen, several people [said] that they had wanted to commit suicide to end the pain, prayed to be taken away, or told doctors or relatives that they wanted to die.”5 A 28-year-old former drug user from Kyrgyzstan reported in 2006 that he had been given orthopedic surgery without anesthesia because doctors feared it would fuel his addiction. “They tied me down,” he said. “One doctor held me down, pushed me to the table, and the second doctor gave the operation. I was screaming, awake, feeling all the
4 World Health Organization, Briefing Note: “Access to Controlled Medications Programme,” (September 2008), cited in Human Rights Watch, “Please, do not make us suffer any more…”: Access to Pain Treatment as a Human Right (March 2009), p. 11. 5 Human Rights Watch, “Please, do not make us suffer any more,” pp. 6–7.
pain, screaming and screaming as they hammered the nails into my bones.”6
The reasons for denial of pain relief are many, including: ineffective supply and distribution systems for morphine; the absence of pain management policies or guidelines for practitioners; excessively strict drug control regulations that unnecessarily impede access to  morphine or establish excessive penalties for mishandling it; failure to ensure that health care workers receive instruction on pain management and palliative care as part of their training; and insufficient efforts to ensure morphine is available.7 Having considered these reasons, the former United Nations Special Rapporteur on Torture, Manfred Nowak, concluded that the “[f]ailure of governments to take reasonable measures to ensure accessibility of pain treatment, which leaves millions of people to suffer needlessly from severe and often prolonged pain, raises questions whether they have adequately discharged this obligation [to protect people under their jurisdiction from inhuman and degrading treatment],” and furthermore, that “the de facto denial of access to pain relief, if it causes severe pain and suffering, constitutes cruel, inhuman, or degrading treatment or punishment.”8 In a joint statement with the UN Special Rapporteur on the Right to Health, he additionally confirmed, “The failure to ensure access to controlled medications for pain and suffering threatens fundamental rights to health and to protection against cruel, inhuman and degrading treatment.”9
People with disabilities are especially vulnerable to torture and ill-treatment in health settings, though this is not the only context where they suffer such abuse. The situation is especially dire for the thousands who
6 Public Association Aman Plus, Observance of the Rights of People Who Use Drugs to Obtain Health Care in the Kyrgyz Republic, Open Society Institute and Soros Foundation Kyrgyzstan (December 2008). 7 Human Rights Watch, “Please, do not make us suffer any more,” p. 2. 8 UN Human Rights Council, Report of the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Manfred Nowak, A/HRC/10/44, January 14, 2009, para. 72, http://daccessdds. un.org/doc/UNDOC/GEN/G09/103/12/PDF/G0910312.pdf?OpenElement (retrieved August 4, 2009). 9 Letter from Manfred Nowak and Anand Grover, Special Rapporteur on the Right to the Highest Attainable Standard of Health, to Her Excellency Ms. Selma Ashipala-Musavyi, Chairperson of the 52nd Session of the Commission on Narcotic Drugs, December 10, 2008, p. 4, http://www.hrw. org/sites/default/files/related_material/12.10.2008%20Letter%20to%20 CND%20fromSpecial%20Rapporteurs.pdf (retrieved November 6, 2009).
GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS      3
are forced to live for decades, and often for life, in longstay closed institutions. Restrictions on legal capacity affecting the right to refuse treatment, mental health laws that override refusal to consent to treatment, laws that suspend the right to liberty, and stigmatization against people with disabilities in health care systems are of particular concern. In 2008, Manfred Nowak concluded, “The requirement of intent in article 1 of the Convention against Torture can be effectively implied where a person has been discriminated against on the basis of disability. This is particularly relevant in the context of medical treatment of persons with disabilities, where serious violations and discrimination against persons with disabilities may be masked as ‘good intentions’ on the part of health professionals.”10 Nowak went on to say that “forced and non-consensual administration of psychiatric drugs, and in particular of neuroleptics, for the treatment of a mental condition needs to be closely scrutinized. Depending on the circumstances of the case, the suffering inflicted and the effects upon the individual’s health may constitute a form of torture or ill-treatment.”11
In a recent report on Serbia, Mental Disability Rights International alleged torture and ill-treatment against children and adults in institutions marked by “unhygienic conditions and filth.” Bedridden patients are forced “to urinate and defecate in metal buckets which are kept under their beds,” locked away in “tiny isolation rooms” as punishment, subjected to lack of heat during the winter, and forced to sleep in bedrooms contaminated by mice and rats. Medical neglect had led to emaciated and dehydrated children lying in cribs, children with untreated hydrocephalus (an abnormal buildup of cerebral spinal fluid that causes swelling in the brain and skull and frequent death), and people with open cuts and sores, eye infections, and missing or rotten teeth.12 Also documented
10 Report of the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Manfred Nowak, A/63/175, July 28, 2008, para. 49. 11 Ibid, para. 63. A leading case in the area of torture and ill-treatment against persons with disabilities is the 2006 case of Ximenez-Lopes v. Brazil, in which the Inter-American Court of Human Rights found that Brazil had violated its obligations to protect a patient with a severe psychiatric disorder against inhumane treatment and the violation of his right to life. Among other abuses, the patient was physically assaulted as part of his “treatment” and subsequently died while interned in a mental health facility. Ximenes Lopes v. Brazil, 2006 Inter-Am. Ct. H.R. (ser. C) No. 149. 12 Mental Disability Rights International, Torment not Treatment: Serbia’s Segregation and Abuse of Children and Adults with Disabilities (November 2007).
were dehumanizing practices such as shaving residents’ heads, denying them access to their personal clothes and effects, and imposing “work therapy” whereby residents are forced to do chores in exchange for rewards such as coffee. Similarly, in a psychiatric hospital in Kyrgyzstan, the NGO Mental Health and Society found that patients were forced to bake bread in the name of “labor therapy.” Though the patients are unpaid for this work, the hospital charges the government market prices for the product.13 Another major problem is the widespread and extensive use of physical restraints—sometimes throughout a patient’s lifetime— without any standards controlling their usage or any justification for using them.
The use of cage beds in mental health facilities is a stilldocumented practice that violates the right to be free from torture and ill-treatment. In a 2003 report, the Mental Disability Advocacy Center (MDAC) documented the routine use of cage beds in Hungary, the Czech Republic, Slovakia, and Slovenia.14 MDAC found that cage beds were routinely being used as a substitute for adequate staffing or as a form of punishment against people with severe intellectual disabilities, elderly people with dementia, and psychiatric patients. People were placed in cage beds for “hours, days, weeks, or sometimes months or years.” A former user of psychiatric services said of the use of cage beds, “You feel like you would rather kill yourself than be in there for several days.” Another reported having been rendered unconscious by an involuntary injection administered just after giving birth and then placed in a cage bed. When she woke up, she was not permitted to use the bathroom and “had to do it in the cage bed like an animal.”
Women seeking reproductive health care frequently encounter “low-quality, often negligent and abusive care and treatment” that sometimes rises to the level of torture or ill-treatment.15 In a 2011 briefing paper, the Center for Reproductive Rights (CRR) identified several violations of
13 B. Makenbaeva, Budget of Mental Healthcare: Do the Public Money Flows Meet the Needs of People with Mental Health Problems? (Mental Health and Society and Open Society Institute, 2009). 14 Mental Disability Advocacy Center, Cage Beds: Inhuman and Degrading Treatment or Punishment in Four EU Accession Countries (2003). MDAC gives the following definition of “cage bed”: “A bed with a cage placed on top of it to enclose a person within the confines of the bed. Often, a distinction is made between cage beds, constructed of metal bars, and net beds, constructed of metal frames and netting. Since the material with which it is constructed is of secondary importance, MDAC refers to both as cage beds.” 15 Ibid.
4      GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS
women’s reproductive rights, including verbal and physical abuse by health providers, extended delays in care leading to physical and emotional suffering, and involuntary detention in inhumane conditions for failure to pay medical bills. According to Human Rights Watch, medical staff at hospitals in Burundi have denied post-natal care, such as treating a baby’s respiratory problems or removing the stitches from a caesarean delivery, to women who are locked up for failure to pay their medical bills.16
Forced and coerced sterilizations are also examples of torture and ill-treatment. Such practices have been documented against women living with HIV, Roma women, and women with mental disabilities, among other vulnerable and marginalized groups. According to CRR, “Experts recognize that the permanent deprivation of one’s reproductive capacity without informed consent generally results in psychological trauma, including depression and grief.” This issue has recently been litigated in countries as diverse as Chile, Namibia, and Slovakia. Both the UN Human Rights Committee and the Committee against Torture have addressed forced and coerced sterilization as a violation of the right to be free from torture and illtreatment.17 At the other extreme, women may be denied abortion or post-abortion care for the discriminatory and improper purpose of discouraging them from, or punishing them for, terminating their pregnancies, which can result in severe and long-lasting pain and suffering. The Committee against Torture has also considered denial of both abortion and post-abortion care in the context of the right to be free from torture and ill-treatment.18
People living with HIV in many countries report being mistreated by health providers or denied treatment in a manner that is cruel, inhuman, or degrading. In Vietnam, people living with HIV recently reported being ignored by health professionals, marked as HIV-positive on their clothes, segregated from other patients, and denied services such as lymph node incisions, in-patient admission, and cleaning.19 Forced or compulsory HIV testing is also a
16 Human Rights Watch, A High Price to Pay: Detention of Poor Patients in Hospitals (September 2006), p. 35. 17 Center for Reproductive Rights, Reproductive Rights Violations, pp. 20-21 18 Ibid., pp. 22-24 19 Khuat Thi Hai Oanh, “Access to Tuberculosis Services among People Living with HIV in Vietnam,” presentation at the World Lung Conference, 2007 (on file with the Open Society Foundations).
common abuse that may constitute degrading treatment if it is “done on a discriminatory basis without respecting consent and necessity requirements…especially in a detention setting.”20 Unauthorized disclosure of HIV status to sexual partners, family members, employers, and other health workers is a frequent abuse of people living with HIV that may lead to physical violence, especially against women.21
Ill-treatment of people living with HIV in health settings is compounded by the association of HIV with criminalized behavior such as illicit drug use, homosexuality, and sex work. In Ukraine, injecting drug users living with HIV have been “denied emergency medical treatment, including by ambulances who refused to pick them up,” “kicked out of hospitals,” and “provided inadequate treatment by doctors who refused even to touch them.”22 In Jamaica, where HIV is stereotyped as a “gay disease,” medical professionals have avoided touching the skin of people living with HIV with medical equipment, with one nurse saying she was “concerned about contracting the virus from patients who…‘really hopelessly wanted you to get HIV too.’”23 In Namibia, despite a policy of providing HIV prevention and treatment services free of charge to those who cannot afford them, sex workers who meet eligibility requirements are often discriminated against and denied these services.24
People with tuberculosis, a contagious and sometimes drug-resistant disease, have been unnecessarily detained for “treatment” in institutions where conditions can amount to ill-treatment. Detaining patients with tuberculosis is a form of administrative detention that is intended to prevent the further spread of disease; thus authorities must demonstrate that the detention is a necessary last-resort, and the detention itself should “respect human dignity, be culturally sensitive,
20 Report of the pecial Rapporteur on Torture and Other Forms of Cruel, Inhuman, or Degrading Treatment or Punishment to the Human Rights Council, A/HRC/10/44 (January 14, 2009), para. 65. 21 Suzanne Maman, et al, “The Intersections of HIV and Violence: Directions for Future Research and Interventions,” Social Science and Medicine 50, pp. 459, 474. 22 Human Rights Watch, Rhetoric and Risk: Human Rights Abuses Impeding Ukraine’s Fight against HIV/AIDS, p. 44. 23 Human Rights Watch, Hated to Death, p. 39. 24 Jayne Arnott and Anna-Louise Crago, Rights Not Rescue: A Report on Female, Male, and Trans Sex Workers’ Human Rights in Botswana, Namibia, and South Africa (2009), pg. 44, 46.
GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS      5
and be periodically reviewed by courts.”25 In practice, this is often not the case, and persons with TB are detained even when they are capable of adhering to infection control regimens and to treatment. In March 2008, The New York Times described the Jose Pearson Tuberculosis Hospital, a detention center for people with drug-resistant tuberculosis in South Africa, as “a prison for the sick,” with razor wire to prevent patients from escaping, overcrowding, poor ventilation fueling the further spread of tuberculosis, and a single social worker for more than 300 detainees.26 One detained patient told The New York Times, “I’ve seen people die and die and die. The only discharge you get from this place is to the mortuary.” Poor conditions in TB treatment facilities can lead to the development of additional drug resistance and transmission to health care workers, resulting in patients that are more difficult and costly to treat.27 Treatment in the community has been shown to be a more effective and less rights-violating alternative to detention of people with tuberculosis, who in any case have an absolute right to freedom from ill-treatment in confinement, and to due process to challenge their confinement.28
People who use drugs are a highly stigmatized and criminalized population whose experience of health care is often one of humiliation, punishment, and cruelty. In Ukraine, Human Rights Watch documented cases of drug users being kicked out of hospitals, provided treatment in an inadequate or abusive manner, and denied emergency care.29 For example, one man said he had been denied a hospital room and told by a doctor, “Why do you come here and make more problems for us? You are guilty yourself for this.” Another person was denied treatment for tuberculosis once the clinic workers found out she was a drug user: “I was
25 Andrea Boggio, et al, “Limitations on Human Rights: Are They Justifiable to Reduce the Burden of TB in the Era of MDR- and XDR-TB?,” Health and Human Rights: An International Journal, vol. 10, no.2 (2008). See also, United Nations, Economic and Social Council and U.N. Sub-Commission on Prevention of Discrimination and Protection of Minorities, Siracusa Principles on the Limitation and Derogation of Provisions in the International Covenant on Civil and Political Rights, Annex, UN Doc E/CN.4/1984/4 (1984). 26 Celia W. Dugger, “TB Patients Chafe Under Lockdown in South Africa,” The New York Times, March 25, 2008. 27 See, e.g. J. Jarand et al, “Extensively Drug-resistant Tuberculosis (XDR-TB) among Health Care Workers in South Africa,” Trop Med Int Health 15(10) 1179-84; S. Naidoo, “TB in Health Care Workers in KwaZulu-Natal, South Africa,” Int J Tuberc Lung Dis 10(6), 676-82. 28 Joseph J. Amon, Françoise Girard and Salmaan Keshavjee, “Limitations on Human Rights in the Context of Drug-Resistant Tuberculosis: A reply to Boggio et al.,” Health and Human Rights: An International Journal 11/1 (2009), Perspectives, http://hhrjournal.org/blog/wp-content/uploads/2009/10/amon.pdf. 29 Human Rights Watch, Rhetoric and Risk, p. 48.
staying at a tuberculosis clinic. My tuberculosis should have been [treated]. As soon as they found out that I was an addict, I was refused.”30 A report by the Eurasian Harm Reduction Network documented similar cases of ill-treatment, including the testimony of an outreach worker who brought a woman to a clinic for a leg abscess related to drug injection, only to be asked by the doctor, “Why do you mess with her, she’s a drug addict!”31 Limited coordination and integration of services in Ukraine and throughout Eastern Europe and Central Asia often forces patients to choose between TB, HIV, and drug treatment.32
A particular form of ill-treatment and possibly torture of drug users is the denial of opiate substitution treatment, including as a way of eliciting criminal confessions through inducing painful withdrawal symptoms.33 The denial of methadone treatment in custodial settings has been deemed by both Manfred Nowak34 and the European Court of Human Rights35 to be a violation of the right to be free from torture and ill-treatment in certain circumstances. Similar reasoning ought to apply to the non-custodial context, particularly in instances where governments, such as the Russian Federation, impose a complete ban on substitution treatment.36
In many Asian countries, including Cambodia, China, Laos, Malaysia, Thailand, and Vietnam, thousands of children and adults who use drugs are administratively detained without due process in compulsory centers that purport to provide addiction treatment but in fact inflict abuse amounting to torture and ill-treatment. Practices documented in these centers include long hours of forced labor under extremely harsh conditions, partial lobotomy of drug users by inserting heated needles into their brain for up to a week,
30 Eurasian Harm Reduction Network, Sex Work, HIV/AIDS, and Human Rights in Central and Eastern Europe and Central Asia (2006). 31 Aman Plus, Observance of the Rights of Injecting Drug Users. 32 See M. Curtis, Building Integrated Care Services for Injection Drug Users in Ukraine (World Health Organization, 2010); World Health Organization, United Nations Office on Drugs and Crime and Joint United Nations Programme on HIV/AIDS, Policy Guidelines for Collaborative TB and HIV Services for Injecting and Other Drug Users (Evidence for Action Technical Paper, 2008). 33 According to Manfred Nowak, “[I]f withdrawal symptoms are used for any of the purposes cited in [the] definition of torture enshrined in Article 1 of the Convention against Torture, this might amount to torture.” A/HRC/10/44, para. 57. 34 A/HRC/10/44, para. 71. 35 McGlinchey and Others v. United Kingdom, Application No. 50390/99 (2003). 36 Human Rights Watch, Lessons Not Learned: Human Rights Abuses and HIV/ AIDS in the Russian Federation.
6      GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS
imprisonment in thorn-tree cages, handcuffing of drug users to beds while they undergo withdrawal, suspension by the arms and legs for hours and beatings on the feet, and sexual abuse of inmates by guards.37 Medical care is routinely denied. A doctor in one drug detention center in Guangxi Province, China, told Human Rights Watch, “The purpose of the detox center is really just disciplinary, it’s not to give people medical care.” 38
Sex workers, like people who use drugs, face ill-treatment in health settings stemming from their criminalized status. A report on sex workers in Botswana, Namibia, and South Africa documented negative and obstructive attitudes on the part of medical workers, including denial of necessary health care services to sex workers. 39 One sex worker said, “I’m afraid to go to the clinic” because of harassment from nurses and doctors. A male sex worker seeking HIV treatment in Namibia said, “The nurse called a few other nurses and they were laughing at me.” Another was chased out of a hospital after a doctor screamed, “You are a prostitute!” to her in front of other staff and patients. A sex worker in Kyrgyzstan said that when she went to the hospital with appendicitis, the nurse “became rude with me” after learning she worked in a sauna, “saying that girls like me should be killed or put in jail.”40 She was discharged from the hospital before her stitches were removed.
Breaches of privacy and confidentiality are a further indignity experienced by sex workers in health settings. In Macedonia in 2008, police rounded up more than thirty people in an area known for sex work and subjected them to forced testing for HIV, hepatitis B, and hepatitis C. Following the arrests, the Ministry of the Interior released a press announcement disclosing personal information about the detainees, and media outlets published photos and videos of them. The NGO Healthy Options Project Skopje (HOPS) is supporting several of the sex workers in litigation against
37 Open Society Foundations, Human Rights Abuses in the Name of Drug Treatment: Reports from the Field (2010). 38 Human Rights Watch, An Unbreakable Cycle: Drug Dependency Treatment, Mandatory Confinement, and HIV/AIDS in China’s Guangxi Province (December 2008), p. 28. 39 Open Society Foundations, Rights Not Rescue: Female, Male, and Trans Sex Workers’ Human Rights in Botswana, Namibia, and South Africa (2008) 40 Public Association Musaada, Observance of the Rights of Sex Workers to Obtain Health Care: Monitoring of Human Rights in Medical Institutions in Osh City in the Kyrgyz Republic, Open Society Institute and Soros Foundation Kyrgyzstan (December 2008).
the Ministry and the health clinic for breach of privacy and inhuman and degrading punishment.41 In Austria, where registered sex workers are required to undergo weekly medical check-ups and take regular blood tests for sexually transmitted diseases, the Committee against Torture recently noted “reports of alleged lack of privacy and humiliating circumstances amounting to degrading treatment during medical examinations.”42
Lesbian, gay, bisexual, transgender, and intersex (LGBTI) persons have reported abuses in health settings that amount to cruel and degrading treatment. In Kyrgyzstan, doctors have refused to treat LGBTI persons and accompanied this refusal with cruel and degrading comments such as: homosexuality is “absurd,” “condemned by Islam,” or “abnormal,” or that LGBTI people are “not our patients.”43 Health providers in Jamaica have “refused to treat men whom they knew or perceived to be gay and made abusive comments to them, at times instigating abusive comments by others.”44 In one case, “a health worker told a gay man with gonorrhea that he was ‘nasty’ and asked why he had sex with other men.” Some health providers still treat homosexuality as a mental disorder, a form of discrimination that may also amount to cruel, inhuman, or degrading treatment, and subject them to “conversion therapy” with severe psychological consequences.45
Transgender people routinely face degrading treatment in health settings stemming from discrimination and prejudice on the basis of gender identity or presentation. In the United States, a 2010 report of the National Gay and Lesbian Task Force and the National Center for Transgender Equality documented cases of transgender people being refused care outright because they were transgender or gender non-conforming, postponing their own care due to fear of disrespect by medical providers,
41 Sex Workers Rights Advocacy Network (SWAN), In Focus: Macedonia Alert: Police Raids, Detention, Involuntary STI-Tests (November 2008), available at http://swannet.org/en/node/1219 42 Center for Reproductive Rights, Reproductive Rights Violations as Torture and Cruel, Inhuman, or Degrading Treatment or Punishment: A Critical Human Rights Analysis (April 2011), p. 19. 43 Open Society Foundations, Access to Health Care for LGBT People in Kyrgyzstan (July 2007), p. 20. 44 Human Rights Watch, Hated to Death: Homophobia, Violence, and Jamaica’s HIV/AIDS Epidemic (November 2004), p. 38. 45 See, e.g., D.C. Haldeman, “Therapeutic Antidotes: Helping Gay and Bisexual Men Recover from Conversion Therapies,” Journal of Gay & Lesbian Mental Health, vol. 5, no. 3 (2001), pp. 117-130.
GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS      7
harassment in medical settings, and other abuses.46 One survey respondent reported problems finding a doctor who would treat or “even look at you like a human being.” A survey from Europe similarly found that transgender people avoided routine medical care because they anticipated prejudicial treatment.47 Transgender people additionally face a particular form of ill-treatment in health settings stemming from arbitrary requirements that they undergo psychiatric evaluation, genital surgery, or even sterilization in order to officially change their gender. Such requirements are inherently a form of coerced medical treatment that may violate the right to be free from torture and ill-treatment.
Children born with intersex conditions or atypical sex organs (also called disorders of sex development) routinely face abuse amounting to ill-treatment in health settings.48 These include a variety of forced, unnecessary, and irreversible medical procedures such as sterilization, hormone therapy, and genital-normalizing surgeries such as clitoral “reduction,”49 considered genital mutilation by some intersex people.50 These procedures are rarely medically necessary, but are performed for social reasons and can cause scarring, loss of sexual sensation, pain, incontinence, and lifelong depression.51 They are typically performed without any legal restriction or oversight in an attempt to impose a biological gender of either male or female.52 Parents are frequently pressured to consent to
46 J.M. Grant et al, National Transgender Discrimination Survey Report on Health and Health Care (National Center for Transgender Equality and National Gay and Lesbian Task Force, 2010). 47 S. Whittle et al, Transgender EuroStudy: Legal Survey and Focus on the Transgender Experience of Health Care (International Lesbian and Gay Association – Europe and Transgender Europe, April 2008), p. 10. 48 See generally, Intersex Society of North America, www.isna.org; see also, Order Changing Guardianship (Identification of Minor Suppressed), Sentencia SU-337/99 (Corte Constitucional, May 12, 1999) (Colom.); In re Guardianship XX, Sentencia T-551/99 (Corte Constitucional, Aug., 2, 1999) (Colom.); Sentencia No. T-477/95 (Corte Constitucional, 1995) (Colom.), http://www.isna.org/node/516 (retrieved April 20, 2011). 49 P.A. Lee, C. Houk, C., S.F. Ahmed et al, “Consensus Statement on Management of Intersex Disorders,” Archives of Disease in Childhood 91 (2006), pp. 554-63. 50 Dan Christian Ghattas, “Human Rights and ‘I’: Knowing Intersex Demands,” Powerpoint presentation, Organisation Intersex International – Germany and TransInterQueer e.V., on file with Open Society Foundations. 51 Marcus De María Arana, A Human Rights Investigation into the Medical “Normalization” of Intersex People (San Francisco Human Rights Commission, 2005). 52 Hazel Glenn Beh and Milton Diamond, “An Emerging Ethical and Medical Dilemma: Should Physicians Perform Sex Assignment Surgery on Infants with Ambiguous Genitalia?” Michigan Journal of Gender and Law, vol. 7(1) (2000), pp. 1-63.
these procedures for their children without adequate information about the long-term risk to sexual function and mental health.53 Intersex children are also often exposed to humiliating and unnecessary exams,54 or are used as teaching tools or in unethical medical experiments.55 In 2008, a German intersex woman, Christine Völling, successfully sued her surgeon for damages for removing her ovaries and uterus without her informed consent.56
Roma in Central and Eastern Europe face what the European Roma Rights Center (ERRC) has called “a consistent pattern of discriminatory treatment” by medical professionals.57 Such discrimination may rise to the level of cruel, inhuman, or degrading treatment, as when health workers insult Roma patients and their families. In one case documented by the ERRC, a woman whose son had died after being released from the hospital, reportedly in good condition, said that in response to her demands to see her son’s medical file a doctor said of her son’s death, “It’s not a big thing—one Gypsy less.” Denial of medical care to Roma has taken the form of failure of ambulances to respond to requests for assistance coming from Roma neighborhoods, outright refusals by medical professionals to provide services to Roma, and demands for payment for services that ought to be provided at no cost. In one case, a 20-year-old Roma woman gave birth to a stillborn after an ambulance took 90 minutes to arrive at her home in a Roma settlement; one dispatcher mockingly told the woman’s husband “to put his wife into a wheel-barrow and wheel her to the medical center.” In another case, a woman was inappropriately charged for medical treatment for a spontaneous miscarriage, apparently because doctors assume that Roma women induce their own abortions to avoid paying the cost of surgical abortions.
53 A. Tamar-Mattis, “Exceptions to the Rule: Curing the Law’s Failure to Protect Intersex Infants,” Berkeley Journal of Gender, Law & Justice, vol. 21 (2006), pp. 59-110 54 Advocates for Informed Choice, Know Your Rights (2010), http://aiclegal.org/ publications/ (retrieved April 20, 2011). 55 A. Dreger and E.K. Feder, “Bad Vibrations,” Hastings Center Bioethics Forum, June 16, 2010, online: http://www.thehastingscenter.org/ Bioethicsforum/Post.aspx?id=4730&blogid=140 (retrieved April 20, 2011); C. Elton, “A Prenatal Treatment Raises Questions of Medical Ethics,” Time, June 18, 2010; S. Begley, “The Anti-Lesbian Drug,” Newsweek, July 2, 2010. 56 Organisation Intersex International, “Congratulations to Christiane Völling,” press release (February 6, 2008), http://www.intersexions.org/t886-pressrelease-congratulations-to-christiane-volling (retrieved April 20, 2011). 57 European Roma Rights Center, Ambulance Not on the Way: The Disgrace of Health Care for Roma in Europe (September 2006), p. 39.
8      GOVERNMENT ACCOUNTABILITY FOR TORTURE AND ILL-TREATMENT IN HEALTH SETTINGS
A particularly humiliating practice is the segregation of Roma patients into rooms called “gypsy rooms” or the “Chinese quarter.” According to the ERRC, these Roma wards are of inferior quality “in material and sanitary conditions and services.” It has also been reported that Roma women accompanying their sick children are made to clean the ward.
Conclusion: The Need for Monitoring and Accountability
The preceding examples of torture and ill-treatment in health settings likely represent a small fraction of this global problem. In order to better understand and confront this problem, a necessary first step is for human rights organizations and official mechanisms to systematically include health settings among the places they document and advocate against torture and ill-treatment. Courts and tribunals which are confronted with cases of severe abuse in health settings should likewise consider whether these abuses rise to the level of torture and ill-treatment. While some have already done so, this has mostly been in the case of abuses occurring in prisons and pretrial detention centers, not traditional health settings.
An important way to prevent torture and ill-treatment is to monitor the human rights of people in the settings where such practices are likely to take place. The Optional Protocol to the UN Convention against Torture (OPCAT) obliges States Parties to establish independent “national preventive mechanisms” to carry out preventive visits to places of detention. For the reasons set out in this paper, health settings may well be considered places of detention where people are subject to torture and ill-treatment. For anyone with disabilities, States have further obligations to “ensure that all facilities and programmes designed to serve persons with disabilities are effectively monitored by independent authorities,”58 and that the implementation of human rights is monitored,59 with the participation of
58  UN Convention on the Rights of Persons with Disabilities, Article 16(3). 59 Ibid, Article 33(2).
civil society, particularly people with disabilities and their representative organizations.60
The legal implications of a finding that abuse in health settings amounts to torture or ill-treatment are significant. With respect to addressing acts of cruel, inhuman, or degrading treatment or punishment, the Convention against Torture requires governments to provide education and information to public officials (including medical personnel), require a prompt and impartial investigation of allegations, and require an appropriate complaint mechanism.61 With respect to torture, governments are additionally obliged to prosecute offenses and ensure a civil legal remedy for compensation of victims, among other things.
Real accountability for torture and ill-treatment in health settings, however, means identifying the laws, policies,  and practices that lead to abuse, rather than simply singling out individual health providers as “torturers.” Health providers may abuse the rights of patients because they  are ordered to by authorities, because regulations restrict the type of care they can provide, or for other reasons beyond their control. These situations are sometimes referred to as dual loyalty, defined as “simultaneous obligations, express or implied, to a patient and a third party, often the state.”62 As part of their obligation to prevent torture and ill-treatment in health care, governments should take concrete steps to protect health providers from dual loyalty conflicts.
Torture and ill-treatment are antithetical to every notion  of health care and human dignity. Health settings should be places where human rights are realized and fulfilled,  not debased and violated. To stop the scourge of torture and ill-treatment in health care, health providers and antitorture advocates must come together to listen to the stories of victims, understand the problem and its roots, and propose solutions.
60 Ibid, Article 33(3). 61 Convention against Torture, Article 16(1). 62 International Dual Loyalty Working Group, Dual Loyalty & Human Rights In Health Professional Practice; Proposed Guidelines & Institutional Mechanisms (2002), p. 11.
http://updates.pain-topics.org/2011/07/stop-torture-in-health-care-treat-pain.html