Tuesday, December 1, 2015

Prison or Hospital

 The is the last season of Getting On, an HBO series that is funny, distressing and utterly fascinating about the hospice side of care.  If you have not seen it you must as it brings humor to the little dignity that is faced when one is now in the stages of final care.

 Below are three articles that discuss gerontology, the practice of caring for the elderly. From force feeding to over treatment and expensive drugs that do nothing to aid the individual nor enrich their quality of life that remains on the receiving end but do so for those on the giving side, it becomes a Pas de deux - a duet only less as tranquil and beautiful.

And it is not limited to age but it seems targeted largely regarding gender and of course financial opportunity. The abuse by the medical industrial complex is like the criminal justice one - they take prisoners and release them in less than productive states when they arrived. The parallels cannot be overlooked as they treat those with less that human parameters, id numbers, odd "uniforms", poor nutrition, abusive and neglectful care givers and of course demeaning and demanding little from family and support networks. 

Prison or hospital? It is my new drinking game.

Force-Feeding: Cruel at Guantánamo, but O.K. for Our Parents

The New York Times 
NOV. 24, 2015

THE practice of forced feeding has been highlighted by its use on hunger strikers in Guantánamo Bay and, more recently, in Israel, where a vigorous debate about the ethics of such a practice is taking place. But you don’t have to be in prison to have a feeding tube jammed up your nose. Millions of elderly Americans are fed through tubes despite a lack of substantial evidence pointing to any clinical benefit.

Tube feeding was developed to provide nutrition for patients — increasingly patients with dementia — who are unable to eat on their own. Most of them, especially as they approach the terminal end of the disease, develop difficulties in swallowing and frequently aspirate food or other stomach contents into their lungs, developing pneumonia.

Study after study, however, has shown that tube feeding doesn’t provide any benefit compared with feeding these patients by hand, which is more labor-intensive but much better for the patients. It doesn’t improve survival, reduce infections, reduce the incidence of aspiration pneumonia or improve patients’ nutritional status over those who are hand fed or even over patients not fed at all.

If anything, feeding tubes can be harmful. One study showed that patients with feeding tubes had a higher incidence of pressure ulcers in their backs from being immobilized and lying in bed. Feeding tubes also have frequent complications of their own like being dislodged or being clogged. (Feeding tubes are a necessary evil in some cases, such as after surgery or after a serious accident.)

Tube feeding typically starts with the placement of a silicone tube, about 20 inches in length, that goes up the nostril into the back of the throat, ending in either the stomach or the small intestine. Tubes are usually placed without any anesthesia or sedation, and a viscous nutritional formula is then pumped down the tube.

The closest I ever came to experiencing what it might feel like was last winter when I came down with the sniffles and went to the clinic for a nasopharyngeal swab to rule out the flu. The swab inserted in my nose was perhaps a tenth the size of the smallest feeding tube, and I felt as if it were tearing all the way into my brain stem. My eyes watered uncontrollably, my hands gripped the chair and every muscle in my body was taut. No wonder an inmate in Guantánamo described forced feeding by saying he “never experienced such pain before.”

Much of the pressure to place feeding tubes comes from the patients’ families, but physicians are equally to blame. Doctors are known to be an overly optimistic bunch, and a survey revealed that almost two-thirds of them erroneously believed feeding tubes would improve survival in their patients. In fact, given that tube feeding has now been shown to be harmful in patients with dementia, it should not even be offered to this population.

Every weekday, get thought-provoking commentary from Op-Ed columnists, The Times editorial board and contributing writers from around the world.

The overuse of feeding tubes is also an example of how financial incentives drive some deplorable practices in medicine. Research by Susan Mitchell, a professor of geriatrics at Harvard Medical School, has shown that patients in for-profit nursing homes are much more likely to have feeding tubes. Nursing homes charge higher rates for patients with feeding tubes, and they require much less involvement of nursing staff compared with careful hand feeding, a practice recommended for patients with dementia. “If you get paid less, but require more staffing, it’s hard to make the case for hand feeding,” Dr. Mitchell said.

Like any other problem in medicine, cutting this epidemic to size will require cooperation from all the interested parties. Financial incentives that may be driving overuse need to be discarded. Patients who are expected to live at least a few days should be fed by hand, but families must accept that in some cases, the inability to eat is itself often a sign that the disease has progressed to its final stage. For those patients who can’t be hand fed and who don’t want to be fed, inserting a tube only compounds their agony.

Not long ago, I walked to the bedside of a glassy-eyed patient looking at the ceiling. Suffering from dementia, he had a tube in his chest, draining excess fluid that had collected in his lungs because of pneumonia, and now the family had requested a feeding tube, hoping to prevent food from going down the wrong pipe.

My intern lathered the tube with lubricant, and started to swivel it up his nose. The man, who had endured much without uttering even a whimper, started to shake, and went on to say the first pair of words he had spoken in months: “Kill me.” What started as a faint, shivering whisper, was repeated until he was screaming “killmekillmekillmekillme!” as loudly as his lungs would allow.

Meanwhile while Pfizer claims their merger is good for America? It is? Then why is Congress concerned? Not that that means anything or they would actually do something as proposed by the op ed page of the Times

Personal Health
A Prescription for Sticker Shock Caused by Drug Costs
By Jane E. Brody
The New York Times
November 23, 201

There are millions of people out there, like me, who are frustrated with the maddening obstacles to obtaining prescribed medications with your insurance.

My doctor calls the system byzantine, a rip-off in which the government, including Medicare, is not permitted to negotiate costs with drug companies, instead allowing them to charge whatever they think the market will bear.

“Escalating drug prices have alarmed physicians and the American public and led to calls for government price controls,” Peter J. Neumann and Joshua T. Cohen of Tufts University Medical Center wrote last week in The New England Journal of Medicine.

Most manufacturers maintain that drug prices should be be based on research, development and production costs, but Dr. Neumann and Dr. Cohen suggested that these costs should reflect the value the drugs provide, including such factors as health benefits and cost-effectiveness.

The rising cost of prescription drugs is especially worrisome given the recent escalation in their use in the United States.

Elizabeth D. Kantor, an epidemiologist at Memorial Sloan Kettering Cancer Center, and colleagues recently reported in JAMA that from 1999 to 2012, the number of American adults using prescription drugs rose to 59 percent from 51 percent, and those who took five or more medications increased to 15 percent from 8.2 percent. The increases, which occurred in 11 classes of drugs, persisted even when the rising age of the population was considered.

The researchers arrived at their numbers by analyzing seven cycles of the National Health and Nutrition Survey, each involving personal interviews with thousands of adults. Americans today are using more drugs than ever to lower cholesterol, blood pressure and blood sugar, treat depression and pain, control acid reflux and breathing problems, and relax muscles.

Among other concerns, the findings “raise the question of how much the rise in obesity is affecting increased drug use,” Dr. Kantor said in an interview. “As obesity continues to rise and people develop the consequences, it remains to be seen how effective drugs are in treating them.”

Using medications to treat what is primarily a consequence of unhealthy living habits means rising drug costs that neither the government nor the public can control.

Unfortunately, it is likely to take an act of Congress to change the current system, so we’re all stuck with it for some time to come, perhaps indefinitely. Within the system, however, it pays to know how to get what you need at the lowest cost and with the fewest hassles.

Every drug insurer has its own annually issued “formulary” — a booklet listing the drugs it will cover during the year and the required co-pay. Some policies also have large deductibles that force consumers to shell out hundreds of dollars starting in January for needed medications.

It is not unusual for consumers to need a new drug that doesn’t happen to be in their insurance company’s formulary, though the insurer must cover it until the end of the year, when policy holders may be able to switch to a different insurer. (People who obtain medical and drug insurance through an employer-funded health plan are most likely stuck with those plans.) Furthermore, companies change their formularies each year, adding drugs or, more likely, deleting ones previously covered.

I get my drug insurance through Medicare Part D. But since signing up in 2006, when the program began, I have had many hassles with the company that was suggested to me by the Medicare adviser I consulted on the phone. Among other issues (like the company denying coverage because it erroneously insisted I had other drug insurance), the most expensive of the four medications I use — the only one not available generically — is not included in that company’s formulary.

The company suggested two alternatives that my doctor and I knew were medically inadvisable. So he had to file an appeal every year to have the drug covered (albeit at a high co-pay), and when that was denied, he had to file a second appeal. What an aggravation and a waste of medical office time.

During the current enrollment period, from Oct. 15 to Dec. 7, I decided to switch to another insurer. Since everyone with a computer is supposed to be able to do this, I gave it a try.

I am most happy to report that, despite the problems many consumers initially had signing up for insurance under the Affordable Care Act, the government did a great job with the website for Medicare Part D. Expecting the task to take hours, I enrolled with a new company in about 15 minutes. Here is the link: https://www.medicare.gov/find-a-plan/questions/home.aspx.

You start by entering your ZIP code and answering two questions about your Medicare coverage. (Be sure to have your subscriber number handy.) Type in the name of each prescription drug you take, up to 25, as well as the dosage, quantity and frequency, and whether you get it from a pharmacy or by mail order.

If you choose a pharmacy, you are given a list of those near your home (the distances vary depending on your ZIP code). You are then asked to select the desired type of Medicare and drug plan. For example, I selected “drug plan with original Medicare.”

You can then refine your search according to such options as “limit to the monthly premium” (up to $290), “limit to annual deductible” (up to $360) and the company’s rating (I chose one with four stars out of five, the highest among the companies that fit my criteria).

The next screen estimated my annual drug and health care costs. Nineteen Part D plans were found in my ZIP code, listed from least to most expensive. For each company, the website showed my estimated annual drug costs if purchased retail or by mail order (cheaper by mail); the monthly premium, which in my case is deducted from my Social Security benefit; the annual deductible, if any; the drug co-pay amount; whether all my drugs are in the company’s formulary; and the company’s star rating.

By the way, if you can get your prescriptions written for a 90-day supply, the cost is less than for a 30-day supply refilled twice.

And then we have this news that the tests we take we are not the ones who are failing. And this might also explain the sudden rise in Ovarian cancer.

F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs

The New York Times
NOV. 23, 2015

WASHINGTON — Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.

Life-threatening diseases go undetected in some cases. In others, patients are treated for conditions they do not have.

“Patients have been demonstrably harmed or may have been harmed by tests that did not meet F.D.A. requirements,” federal investigators concluded in a report to Congress last week.

The findings come at a time when the use of laboratory-developed tests is booming, the Obama administration is seeking new regulatory powers and even Republicans in Congress are working on legislation to set stricter standards. The new standards, whether set by Congress or by the administration, would be the most significant change in the regulation of laboratories since 1988, lawyers say.

Elizabeth Holmes, the founder and chief executive of Theranos, has become a Silicon Valley celebrity. But recently questions have been raised about how well the company’s testing technology works.

In 20 case studies — half involving tests used to diagnose and treat cancer, others focused on heart disease, autism and Lyme disease — the F.D.A. laid out a compendium of serious problems.

One blood test to help detect ovarian cancer was never shown to be effective, the report said, but was used anyway. False-positive tests may have led to “unnecessary surgery to remove healthy ovaries.”

Pregnant women have considered or had abortions because other tests inaccurately indicated abnormalities in the fetus.

Several tests now on the market detect a genetic variant that was once thought to increase the risk of heart disease, a link that has not been confirmed. Yet more than 150,000 people have been given these tests, the report said, and “many were likely over- or undertreated with statins,” cholesterol-lowering drugs, at a cost estimated at more than $2.4 billion.

“The problems are more prevalent than people want to recognize,” said Dr. Jeffrey E. Shuren, the director of the Center for Devices and Radiological Health at the F.D.A. “Doctors and patients rely on these tests to make well-informed health care decisions. If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result.”

Dr. Shuren said officials did not know how many people might have been harmed, because information on “adverse events” associated with laboratory-developed tests is not systematically collected or reported — a gap that many in Congress and the administration want to close.

Inaccurate test results pose a significant threat to President Obama’s plan to develop treatments tailored to the genetic characteristics of individuals. Many of the new “personalized medicines” are used with a diagnostic test that identifies patients who are most likely to benefit, or to suffer serious side effects. If the tests are unreliable, the treatments could be ineffective.

The maker of one of the tests cited by the F.D.A., Genomic Health of Redwood City, Calif., rejected the criticism. Victoria Steiner, a spokeswoman for the company, said that “a wealth of evidence has supported use of our test to help guide chemotherapy treatment decisions in more than 500,000 breast cancer patients to date.”

Diagnostic tests are now regulated differently depending on where they were developed and manufactured. Products that will be sold to multiple labs — “commercial test kits” — are typically subject to review by the F.D.A. before they go on the market. Manufacturers are supposed to inform the government if they learn that their products may have contributed to a death or a serious injury, and they may have to notify the government if they recall defective products.

But for tests manufactured and used within a single laboratory, the agency has not actively enforced regulatory requirements, even though doctors around the country may submit samples to that lab for testing.

The Obama administration is moving to assert its enforcement authority over such laboratory-developed tests, saying they have become more complex, more widely used and more similar to commercial tests that the government has regulated for nearly 40 years.

Democrats and consumer groups have generally supported the efforts to regulate or legislate.

“Patients and their physicians should be able to trust the results of their tests, regardless of how or where a test is developed or performed,” said Representative Frank Pallone Jr. of New Jersey, the senior Democrat on the House Energy and Commerce Committee. “It does not make sense to regulate tests differently based on who develops them.”

Republicans are divided between those who are willing to consider a larger federal role and others who are skeptical.

“This is a tough area for conservative Republicans who think that government is too big and costs too much,” said Representative John Shimkus, Republican of Illinois. He indicated that he was willing to consider legislation because “the volume and complexity of these tests have grown exponentially,” and federal standards may be needed to ensure that the tests do what they are supposed to do.

But Representative Michael C. Burgess, Republican of Texas and a physician, expressed concern that the proposals “could stifle medical innovation and open the door to federal regulation of the practice of medicine.”

Jeffrey N. Gibbs, a Washington lawyer who represents medical device companies and laboratories, said he had seen a shift in the past six months: People once adamantly opposed to the regulation of laboratory-developed tests are now open to the idea.

“It is more likely that the F.D.A. will have a role in regulating laboratory-developed tests as a result of either congressional action or a guidance document issued by the agency,” Mr. Gibbs said.

The American Clinical Laboratory Association, a trade group, contends that “the F.D.A. lacks the statutory authority to regulate laboratory-developed tests.”

But Jayson S. Slotnik, a consultant to drug and device companies, said: “There will be more regulation, and it need not stunt innovation. The right regulation would separate good from bad tests and encourage use of the better ones.”

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