Later On

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Archive for the ‘Medical’ Category

Illinois Sues Controversial Drug Maker Over Deceptive Marketing Practices

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Jessica Huseman reports in ProPublica:

Illinois’ attorney general has filed suit against Insys Therapeutics, accusing the controversial pharmaceutical company of using deceptive marketing practices — including paying an indicted doctor thousands of dollars for “sham” speaking events — to sell its signature pain medication.

It’s not unusual for drug makers to pay doctors who have histories of misconduct for consulting or speaking about their products. A recent ProPublica analysis found that more than 2,300 doctors with records of discipline in five states had received payments from drug and medical device companies since 2013.

Insys was one of more than 400 companies that made payments to such doctors, but its activities have received far more attention than those of its peers.

According to investigations in several states, Insys’ business model relied on funneling substantial payments to the doctors who most frequently prescribed its drugs, even if they had troubling disciplinary records or even criminal histories. These payments were mostly for services related to Subsys, a fentanyl-based medication approved by the FDA to treat patients suffering from cancer pain resistant to other types of opioid drugs.

Insys’ activities have been the subject of 2014 and 2015 reports by CNBC and The New York Times. In June 2015, a nurse in Connecticut pleaded guilty to receiving kickbacks in connection to speaking payments she received from Insys while she was the top prescriber of Subsys to Medicaid patients in the state. In February of this year, a sales representative in Alabama pleaded guilty to fraud charges and in April, a district manager and a sales representative pleaded not guilty in New York, all in relation to kickbacks to doctors involved in speaking programs.

The most recent civil suit, filed Thursday by Illinois Attorney General Lisa Madigan in Cook County Circuit Court, seeks to impose financial penalties and bar the company from selling its products in the state. Madigan contends Insys routinely marketed the drug for off-label uses, including treatment for chronic migraines. Rather than forging relationships with doctors who treated cancer patients, “Insys instead directed its promotion and marketing in Illinois to high-volume opioid prescribers who are not oncologists or pain specialists who treat cancer,” the lawsuit says. An Insys spokesperson did not return a call for comment.

The company’s highest volume prescriber was Dr. Paul Madison, who prescribed 58 percent of Subsys prescriptions in the state despite treating “few, if any, cancer patients.” Madison was indicted in December 2012 on federal false claims charges for billing insurers for non-existent procedures. Insys sales representatives were aware of this indictment, and were also aware of Madison’s troubling prescribing habits, the lawsuit alleges.

The lawsuit says that . . .

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Written by LeisureGuy

29 August 2016 at 1:40 pm

Public health initiative: The Best and Worst College Campuses for Sexual Health, Ranked

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The public health aspect is that the worst colleges in terms of sexual health will be highly motivated to improve their standing.

Written by LeisureGuy

28 August 2016 at 4:36 pm

A doctor’s take on marijuana

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Nathaniel Morris, MD, blogs at the Scientific American:

On August 11th, the Drug Enforcement Administration announced its decision to keep marijuana classified as a Schedule I drug. The federal government has historically referred to this category as the “most dangerous” group of substances, including drugs like heroin and bath salts.

As a resident physician specializing in mental health, I can’t make much sense of this.

Every day, I talk to patients about substance abuse. Whether evaluating patients in clinic, in the emergency department, or on inpatient units, my colleagues and I screen patients for substance use. It’s a vital component of any clinical interview, particularly in mental health care, and helps us understand patients’ habits and their risks for medical complications.

During my medical training, I’ve learned which substances to worry about, and which ones matter less.

Alcohol is usually the first substance I ask about. Many people have seen drinking go wrong, be it a friend making a bad decision or a family member struggling with alcoholism. But clinicians see the worst of this on the front lines.

Intoxicated patients stream into emergency departments after crashing their cars, inhaling their own vomit, or falling into a coma. According to the National Institutes of Health, alcohol-related conditions contributed to more than 1.2 million emergency department visits in 2010. The Centers for Disease Control reports excess alcohol consumption causes roughly 88,000 deaths in the US each year.

And alcohol can be just as frightening when patients stop drinking. Heavy drinkers who don’t consume as much as they usually do can go into alcohol withdrawal, ranging from mild tremors to terrifying seizures and death. I’ve spent much of my residency training so far learning how to treat and recognize complications from alcohol withdrawal.

It’s not only alcohol that clinicians worry about. Cocaine can cause heart attacks, kidney failure, and complications during pregnancy like placental abruption. Methamphetamine can trigger an assortment of responses, from hyperthermia to violent agitation to cardiogenic shock. Opioids like morphine can plunge patients into respiratory failure and kill them. Intravenous drug use puts patients at risk for hepatitis, endocarditis, or even brain abscesses.

But, for most health care providers, marijuana is an afterthought.

We don’t see cannabis overdoses. We don’t order scans for cannabis-related brain abscesses. We don’t treat cannabis-induced heart attacks. In medicine, marijuana use is often seen on par with tobacco or caffeine consumption—something we counsel patients about stopping or limiting, but nothing urgent to treat or immediately life-threatening.

The federal government’s scheduling of marijuana bears little relationship to actual patient care. The notion that marijuana is more dangerous or prone to abuse than alcohol (not scheduled), cocaine (Schedule II), methamphetamine (Schedule II), or prescription opioids (Schedules II, III, and IV) doesn’t reflect what we see in clinical medicine. . .

Continue reading.

Written by LeisureGuy

28 August 2016 at 10:55 am

Obamacare’s Faltering for One Simple Reason: Profit

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Jon Schwarz reports at The Intercept:

There have been dozens if not hundreds of news articles about Aetna leaving the Affordable Health Care Act’s online marketplaces in eleven states, and whether this signals serious problems for Obamacare down the road.

But none of them have truly explained that what’s happening with Aetna is the consequence of a flaw built into Obamacare from the start: It permits insurance companies to make a profit on the basic healthcare package Americans are now legally required to purchase.

This makes Obamacare fundamentally different from essentially all systems of universal healthcare on earth. (There is one tiny exception, the Netherlands, but of the four insurance companies that cover 90 percent of Dutch citizens, just one is for profit.)

Why does this matter? The answer is complicated but extremely important if Obamacare is going to avoid collapsing.

Insurance companies like Aetna complain that fewer young people than anticipated are buying insurance on the exchanges. The Obama administration was aiming at over 38 percent of the exchange pool being between 18 and 35 years old, but right now that number is just 28 percent. That means insurers have to pay more in health costs for customers who are older and sicker than anticipated, making those insurers more likely to abandon the exchanges. So a big swath of the U.S. now has just one insurance company offering Obamacare plans, and one county in Arizona has none.

The failure of young people to sign up in expected numbers is connected to the weakness of the Obamacare mandate. The amount that people who don’t buy health insurance must pay in penalties started off very low, and while it’s increased, it’s still usually significantly less than the cost of even the cheapest plan on exchanges.

By contrast, in other countries with private health insurance, the government response is ferocious if you don’t buy the basic package. Switzerland will seize your wages to pay for the necessary insurance. If you get sick in Japan without buying insurance you have to come up with all your back premiums before your insurer will pay your medical bills.

It is, of course, technically feasible to set up something similar in the U.S. But it will never be politically feasible. That’s because there would, rightfully, be an intense political backlash if the government started garnishing our paychecks and sending the money to Aetna, whose CEO made $28 millionlast year.

In Healing America, probably the best book ever written about how different countries provide universal healthcare, T.R. Reid explains that . . .

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Written by LeisureGuy

27 August 2016 at 2:06 pm

Doctors who sexually abuse patients go to therapy and then return to practice

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No protection, no oversight, no accountability. Ariel Hart reports in the Atlanta Journal-Constitution:

After medical regulators said he fondled patients, exposed himself and traded drugs for sex, Dr. David Pavlakovic easily could have lost his license. Law enforcement thought his acts were criminal.

Instead of losing his job, Pavlakovic was placed in therapy. He was allowed to return to practice. And he didn’t even have to tell his patients.

The way Alabama handled Pavlakovic’s case reflects a growing trend across the nation: Medical regulators are viewing sexual misconduct by doctors as the symptom of an impairment rather than cause for punishment. Doctors who abuse, regulators and therapists say, can be evaluated and managed — sometimes with as little as a three-day course on appropriate doctor-patient “boundaries,” other times with inpatient mental health treatment that may include yoga and massage.

Society has become intolerant of most sex offenders, placing some on lifelong public registries and banishing others from their professions or volunteer activities. But medical regulators have embraced the idea of rehabilitation for physicians accused of sexual misconduct, a national investigation by The Atlanta Journal-Constitution found.

Increasingly, it is left to private therapists, rather than police investigators, to unearth the extent of a doctor’s transgressions. There is little pretense of the check and balance of public scrutiny. Instead, some in the medical profession have discouraged public input, concerned it could trigger outrage that disrupts important work.

Even doctors with egregious violations are allowed to redeem themselves through education and treatment centers, which have quietly proliferated over the past two decades.

After boundary training and treatment, California reinstated a doctor who’d had a string of young women take off their underwear as he watched and then had them move their legs or butt cheeks so he could see or touch their anus and genitals. His victims included a high-school-aged girl in for a head cold.

Montana restored the license of a physician who served time in federal prison on a child pornography charge. The doctor exemplified the transformation that can result from treatment, the president of Montana’s medical board said this spring at a convention of medical regulators in San Diego.

“This was a very negative thing for the public,” Nathan Thomas said, acknowledging public criticism of the board’s decision.

However, he said the board worked with a program that pushed for the doctor’s rehabilitation., “I feel that this is a great example of the advocacy of our program,” Thomas said. . .

Continue reading. And read the whole thing: it’s very troubling.

Written by LeisureGuy

27 August 2016 at 12:26 pm

Cannabinoids remove plaque-forming Alzheimer’s proteins from brain cells

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Very interesting finding reported by the Salk Institute:

Salk Institute scientists have found preliminary evidence that tetrahydrocannabinol (THC) and other compounds found in marijuana can promote the cellular removal of amyloid beta, a toxic protein associated with Alzheimer’s disease.

While these exploratory studies were conducted in neurons grown in the laboratory, they may offer insight into the role of inflammation in Alzheimer’s disease and could provide clues to developing novel therapeutics for the disorder.

“Although other studies have offered evidence that cannabinoids might be neuroprotective against the symptoms of Alzheimer’s, we believe our study is the first to demonstrate that cannabinoids affect both inflammation and amyloid beta accumulation in nerve cells,” says Salk Professor David Schubert, the senior author of the paper.

Alzheimer’s disease is a progressive brain disorder that leads to memory loss and can seriously impair a person’s ability to carry out daily tasks. It affects more than five million Americans according to the National Institutes of Health, and is a leading cause of death. It is also the most common cause of dementia and its incidence is expected to triple during the next 50 years.

It has long been known that amyloid beta accumulates within the nerve cells of the aging brain well before the appearance of Alzheimer’s disease symptoms and plaques. Amyloid beta is a major component of the plaque deposits that are a hallmark of the disease. But the precise role of amyloid beta and the plaques it forms in the disease process remains unclear.

In a manuscript published in June 2016’s Aging and Mechanisms of Disease, the Salk team studied nerve cells altered to produce high levels of amyloid beta to mimic aspects of Alzheimer’s disease.

The researchers found that high levels of amyloid beta were associated with cellular inflammation and higher rates of neuron death. They demonstrated that exposing the cells to THC reduced amyloid beta protein levels and eliminated the inflammatory response from the nerve cells caused by the protein, thereby allowing the nerve cells to survive. . .

Continue reading.

This means, were the DEA and the Obama Administration rational, that marijuana would no longer be a Schedule I drug, since Schedule I drugs, which are drugs that satisfy three conditions:

  1. The drug or other substance has a high potential for abuse.
  2. The drug or other substance has no currently accepted medical use in treatment in the United States.
  3. There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Since marijuana does not satisfy any of these (marijuana’s potential for abuse is much less that that for alcohol, which is not a Schedule I drug), marijuana is being used to treat pain and PTSD (and the use of addictive opioids for pain relief is significantly lower in states in which medical marijuana is legal), and the use of marijuana is much safer than, for example, the use of alcohol. The CDC reports: “There are more than 2,200 alcohol poisoning deaths in the U.S. each year – an average of 6 alcohol poisoning deaths every day.” Alcohol is not a Schedule I drug, but it does meet all the criteria. Marijuana is a Schedule I drug, but it meets none of the criteria.

This seems extremely stupid to me.

Written by LeisureGuy

27 August 2016 at 11:04 am

How Veterans Are Losing the War at Home: Making America Pain-Free for Plutocrats and Big Pharma, But Not Vets

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Ann Jones writes at TomDispatch.com:

A friend of mine, a Vietnam vet, told me about a veteran of the Iraq War who, when some civilian said, “Thank you for your service,” replied: “I didn’t serve, I was used.” That got me thinking about the many ways today’s veterans are used, conned, and exploited by big gamers right here at home.

Near the end of his invaluable book cataloguing the long, slow disaster ofAmerica’s War for the Greater Middle East, historian Andrew Bacevich writes:

Some individuals and institutions actually benefit from an armed conflict that drags on and on. Those benefits are immediate and tangible. They come in the form of profits, jobs, and campaign contributions.  For the military-industrial complex and its beneficiaries, perpetual war is not necessarily bad news.

Bacevich is certainly right about war profiteers, but I believe we haven’t yet fully wrapped our minds around what that truly means. This is what we have yet to take in: today, the U.S. is the most unequal country in the developed world, and the wealth of the plutocrats on top is now so great that, when they invest it in politics, it’s likely that no elected government can stop them or the lucrative wars and “free markets” they exploit.

Among the prime movers in our corporatized politics are undoubtedly the two billionaire Koch brothers, Charles and David, and their cozy network of secret donors.  It’s hard to grasp how rich they really are: they rank fifth (David) and sixth (Charles) on Business Insider’s list of the 50 richest people in the world, but if you pool their wealth they become by far the single richest “individual” on the planet. And they have pals. For decades now they’ve hosted top-secret gatherings of their richest collaborators that sometimes also feature dignitaries like Clarence Thomas or the late Antonin Scalia, two of the Supreme Court Justices who gave them the Citizens United decision,suffocating American democracy in plutocratic dollars.  That select donor group had reportedly planned to spend at least $889 million on this year’s elections and related political projects, but recent reports note a scaling back and redirection of resources.

While the contest between Trump and Clinton fills the media, the big money is evidently going to be aimed at selected states and municipalities to aid right-wing governors, Senate candidates, congressional representatives, and in some cities, ominously enough, school board candidates. The Koch brothers need not openly support the embarrassing Trump, for they’ve already proved that, by controlling Congress, they can significantly control the president, as they have already done in the Obama era.

Yet for all their influence, the Koch name means nothing, pollsters report, to more than half of the U.S. population. In fact, the brothers Koch largely stayed under the radar until recent years when their roles as polluters, campaigners against the environment, and funders of a new politics came into view. Thanks to Robert Greenwald’s film Koch Brothers Exposed and Jane Mayer’s book Dark Money: The Hidden History of the Billionaires Behind the Rise of the Radical Right, we now know a lot more about them, but not enough.

They’ve always been ready to profit off America’s wars. Despite their extreme neo-libertarian goal of demonizing and demolishing government, they reportedly didn’t hesitate to pocket about $170 million as contractors for George W. Bush’s wars.  They sold fuel (oil is their principal business) to the Defense Department, and after they bought Georgia Pacific, maker of paper products, they supplied that military essential: toilet paper.

But that was small potatoes compared to what happened when soldiers came home from the wars and fell victim to the profiteering of corporate America. Dig in to the scams exploiting veterans, and once again you’ll run into the Koch brothers.

Pain Relief: With Thanks from Big Pharma

It’s no secret that the VA wasn’t ready for the endless, explosive post-9/11 wars.  Its hospitals were already full of old vets from earlier wars when suddenly there arrived young men and women with wounds, both physical and mental, the doctors had never seen before.  The VA enlarged its hospitals, recruited new staff, and tried to catch up, but it’s been running behind ever since.

It’s no wonder veterans’ organizations keep after it (as well they should), demanding more funding and better service. But they have to be careful what they focus on. If they leave it at that and overlook what’s really going on — often in plain sight, however disguised in patriotic verbiage — they can wind up being marched down a road they didn’t choose that leads to a place they don’t want to be.

Even before the post-9/11 vets came home, a phalanx of drug-making corporations led by Purdue Pharma had already gone to work on the VA.  These Big Pharma corporations (many of which buy equipment from Koch Membrane Systems) had developed new pain medications — opioid narcoticslike OxyContin (Purdue), Vicodin, Percocet, Opana (Endo Pharmaceuticals), Duragesic, and Nucynta (Janssen, a subsidiary of Johnson & Johnson) — and they spotted a prospective marketplace.  Early in 2001, Purdue developed a plan to spend hundreds of thousands of dollars targeting the VA.  By the end of that year, this country was at war, and Big Pharma was looking at a gold mine.

They recruited doctors, set them up in private “Pain Foundations,” and paid them handsomely to give lectures and interviews, write studies and textbooks, teach classes in medical schools, and testify before Congress on the importance of providing our veterans with powerful painkillers.  In 2002, the Food and Drug Administration considered restricting the use of opioids, fearing they might be addictive. They were talked out of it by experts like Dr. Rollin Gallagher of the American Academy of Pain Medicine and board member of the American Pain Foundation, both largely funded by the drug companies. He spoke against restricting OxyContin.

By 2008, congressional legislation had been written — the Veterans’ Mental Health and Other Care Improvement Act — directing the VA to develop a plan to evaluate all patients for pain. When the VA objected to Congress dictating its medical procedures, Big Pharma launched a “Freedom from Pain” media blitz, enlisting veterans’ organizations to campaign for the bill and get it passed.

Those painkillers were also dispatched to the war zones where our troops were physically breaking down under the weight of the equipment they carried. By 2010, a third of the Army’s soldiers were on prescription medications — and nearly half of them, 76,500, were on prescription opioids — which proved to be highly addictive, despite the assurance of experts like Rollin Gallagher. In 2007, for instance, “The American Veterans and Service Members Survival Guide,” distributed by the American Pain Foundation and edited by Gallagher, offered this assurance: “[W]hen used for medical purposes and under the guidance of a skilled health-care provider, the risk of addiction from opioid pain medication is very low.”

By that time, here at home, soldiers and vets were dying at astonishing rates from accidental or deliberate overdoses. . .

Continue reading.

Written by LeisureGuy

26 August 2016 at 10:05 am

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