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Author Topic: The Politics of Health Care  (Read 278885 times)
Power User
Posts: 4995

« Reply #1450 on: January 21, 2016, 11:14:01 AM »

I don't know.  I kind off resent these fabulously rich companies asking for tax paid government handouts to research drugs that are needed but as profitable.

I don't believe they cannot fund research in the area of superbugs.  I just do not buy it but feel like we are being played again.
Power User
Posts: 4995

« Reply #1451 on: January 29, 2016, 08:28:48 AM »

American College Of Physcians

If they had their way they would ban all guns so they have toned it down some recently.  I agree their is a connection between mental health and guns but I wish ACP would stay in the bounds of that link rather than agreeing with Da Bamster about "closing loopholes".  As usual the medical organizations have sold us down the politically correct toilet.   That is my opinion on this board before that also gets flushed down the toilet.  From the ACP in my email box helping cheer my day:

*****Advocacy and policy news for internists

Presidential Action on Firearms Meets With Approval From ACP

Steps to address health consequences of gun violence are in sync with College policies, officials note

President Obama's executive order aimed at lowering the toll of gun violence in the United States has elicited positive reactions from the American College of Physicians.

"The president's actions are consistent with ACP advocacy and policy positions in support of improved background checks, more resources for the FBI to conduct those checks and expanded research at the CDC and other centers into firearm violence," said Dr. Wayne J. Riley, president of ACP.

But, Dr. Riley said, more work still needs to be done.

"Although the president's actions are clearly helpful, it is important that Congress pass commonsense legislation to curb firearm violence, given its epidemic proportions," he said. "Legislation alone cannot totally stop firearm deaths and violence, but we know it has the real prospect of markedly decreasing such events."

Noting that gun violence has resulted in more than 100,000 deaths in the United States in the past decade, President Obama announced on Jan. 4 a series of executive actions regarding firearms:

The federal government is clarifying who qualifies as a gun seller and thus must get a license and conduct background checks. It's also clarifying who must undergo a background check when buying a weapon.
The FBI is overhauling its system for doing background checks, with an eye toward creating a 24/7 program. More than 230 examiners and other staff members will be hired.
The president will seek budget funding for 200 new agents and investigators for the Bureau of Alcohol, Tobacco and Firearms who would be devoted to firearms issues.
The president will seek $500 million in new funding to improve access to mental health care and to improve background checks on people who should be prohibited from owning weapons because of mental health issues.
Federal agencies will conduct or sponsor research into gun safety technology.
"We're very supportive," said Bob Doherty, ACP's senior vice president for governmental affairs and public policy. "Our support is based on ACP's policies dating back to the 1990s, which focus on the need to address the consequences of firearm violence from a health standpoint."

ACP has emphasized the importance of closing loopholes in the system that allow some people to buy guns despite potentially dangerous mental health issues -- a stance in line with the president's actions, Doherty said.

However, ACP has cautioned that improvements in restrictions on firearm ownership should not cast a wide net. The law shouldn't further stigmatize the mentally ill by labeling people as dangerous if they are not a danger to themselves or others, Doherty said.

"The vast majority of people with mental illness are not at risk of committing gun violence," he said. "In fact, they're more likely to be victims of gun violence."

In addition, "we support more research into making guns safer so they're less likely to be set off by a toddler or child in a house," Doherty said. "We want more progress toward safety precautions, like guns that can't be fired except by the owner."

The problem, he noted, is that commonsense firearm regulations have not gotten congressional support. But Doherty said he's hopeful that Congress will work in a bipartisan way to increase funding for mental health care, as the president has proposed.

What about critics who say the new executive order is an abuse of power?

"Actually, what it does is better enforce current law," Doherty said. "This doesn't go around current law. Instead, it enforces current law."

Going forward, ACP plans to continue its advocacy toward smart restrictions on firearms.

"We still need legislation from Congress, and we need to see the states step up and make improvements in their policies, including legislation to close loopholes," Doherty said. "This is not the end of the story."*****
Power User
Posts: 35910

« Reply #1452 on: January 29, 2016, 11:54:56 PM »

Not much word on why herein , , ,


Drug Shortages Forcing
Hard Decisions on
Rationing Treatments

Such shortages are the new normal in American medicine. But the
rationing that results has been largely hidden from patients and the public.

By SHERI FINKJAN. 29, 2016

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CLEVELAND — In the operating room at the Cleveland Clinic, Dr. Brian Fitzsimons has long relied on a decades-old drug to prevent hemorrhages in patients undergoing open-heart surgery. The drug, aminocaproic acid, is widely used, cheap and safe. “It never hurt,” he said. “It only helps.”
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Then manufacturing issues caused a national shortage. “We essentially did military-style triage,” said Dr. Fitzsimons, an anesthesiologist, restricting the limited supply to patients at the highest risk of bleeding complications. Those who do not get the once-standard treatment at the clinic, the nation’s largest cardiac center, are not told. “The patient is asleep,” he said. “The family never knows about it.”
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In recent years, shortages of all sorts of drugs — anesthetics, painkillers, antibiotics, cancer treatments — have become the new normal in American medicine. The American Society of Health-System Pharmacists currently lists inadequate supplies of more than 150 drugs and therapeutics, for reasons ranging from manufacturing problems to federal safety crackdowns to drugmakers abandoning low-profit products. But while such shortages have periodically drawn attention, the rationing that results from them has been largely hidden from patients and the public.
When a shortage developed for a decades-old drug to prevent hemorrhages in patients undergoing open-heart surgery, “We essentially did military-style triage,” said Dr. Brian Fitzsimons, an anesthesiologist at the Cleveland Clinic, restricting the limited supply to patients at the highest risk of bleeding complications. Credit T.J. Kirkpatrick for The New York Times

At medical institutions across the country, choices about who gets drugs have often been made in ad hoc ways that have resulted in contradictory conclusions, murky ethical reasoning and medically questionable practices, according to interviews with dozens of doctors, hospital officials and government regulators.

Some institutions have formal committees that include ethicists and patient representatives; in other places, individual physicians, pharmacists and even drug company executives decide which patients receive a needed drug — and which do not.

An international group of pediatric cancer specialists was so troubled about the profession’s unsystematic approach to distributing scarce medicine that it developed rationing guidelines that are being released Friday in The Journal of the National Cancer Institute.

“It was painful,” said Dr. Yoram Unguru, an oncologist at the Children’s Hospital at Sinai in Baltimore and a faculty member at the Berman Institute of Bioethics at Johns Hopkins University. “We kept coming back to wow, we’ve got that tragic choice: two kids in front of you, you only have enough for one. How do you choose?”
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“Two kids in front of you,
you only have enough for
one. How do you choose?”
Dr. Yoram Unguru

At the Cleveland Clinic, which has been unusually proactive in dealing with shortages and allowed a reporter access to personnel making decisions about them, one scarce leukemia drug, daunorubicin, was saved for patients in clinical trials, to avoid making the results invalid by substituting another drug. But when a different drug, methotrexate, was in short supply, pediatricians stopped giving it to all patients who required high doses, including those in research trials. “We didn’t want to say just because you’re on a clinical trial you get an advantage,” Dr. Rabi Hanna said.

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Patients’ weight can be taken into account. Obese patients, who researchers found needed up to three times the amount of an antibiotic before surgery than average-size patients, were given only the standard dose at the Cleveland hospital until a shortage subsided.

Some institutions prioritize based on age; others do not. Marc Earl, a Cleveland Clinic pharmacist, said children were not favored over adults during chemotherapy shortages. But at other hospitals, they have been, because of their potentially longer life span or because they sometimes require smaller doses of a drug.

“We do play the pediatric card for sure,” said Alix Dabb, a pharmacy specialist in pediatric oncology at Johns Hopkins Hospital. Dr. Kenneth Cohen, director of pediatric neuro-oncology there, and his colleagues were close to being forced into making “very, very hard decisions,” he said. “The discussions became, ‘Why are two kids more important than one adult?’”

Ning-Tsu Kuo, a pharmacist at the Cleveland hospital’s home infusion pharmacy, said children came first during shortages of nutritional products such as intravenous vitamins and fats for patients who cannot absorb food. The logic was that adults have more reserve. But after one man pleaded not to have his dose cut, Dr. Kuo agreed. When reprimanded by colleagues, she recalled saying: “Patients are not equally the same. You need to look case by case.”
‘Downright Scary’

Such decisions have real consequences. For some shortages, doctors can soon see the effects of rationing, such as increased pain or nausea when drugs typically used to control symptoms are withheld, or patients who have to undergo invasive surgery to control cancer when anti-tumor medications are delayed.

Studies have associated alternative treatments during drug shortages with higher rates of medication errors, side effects, disease progression and deaths. For example, children with Hodgkin’s lymphoma who received a substitute to the preferred drug had a higher rate of relapse, researchers found, and adults with a genetic disorder called Fabry disease had decreased kidney function when their medication was cut by two-thirds. One alternative guideline adopted during a shortage of intravenous nitroglycerin “was downright scary from a clinical perspective,” according to Dr. Nicole Lurie, a senior federal health official.
Continue reading the main story

“Patients are not equally
the same. You need
to look case by case.”
Ning-Tsu Kuo

Physicians say that many of the changes they are compelled to make appear to do no harm. But, they acknowledge, typically no one is tracking outcomes in patients who get a drug and others who get a substitute or delayed treatment.

Doctors and hospitals often do not tell patients about shortages and the resulting rationing because they do not want them to worry, especially when alternative drugs are available, or because they feel it would stir up too much anger.

Dr. Ivan Hsia, an anesthesiologist in Ontario, Canada, said many physicians in his field adopt what he called “the paternalistic model — like I’ll inform them when I think it’s unsafe enough to inform them.”

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When he and his colleagues surveyed hundreds of patients at the Mayo Clinics in Arizona and Florida and others in Canada about their preferences, the results surprised him. Most wanted to know about a drug shortage that might affect their care during elective surgery, even if there was only a minor difference in potential side effects, and many said they would delay surgery.

When the study was published last year in the journal Anesthesia and Analgesia, an accompanying editorial urged health professionals to disclose shortages and their implications. “Patients want to know and they should know,” the editorial said. “There is no ethical ambiguity.”

Continue reading the main story
Beverly Smith, a Cleveland Clinic patient who has Crohn’s disease, said she had no idea that an important ingredient had been removed from the daily intravenous nutritional treatments she depends on until she developed side effects from the deficiency. “Why didn’t anybody tell me?” she asked. Credit Andrea Bruce for The New York Times

Dr. Eric Kodish, a children’s cancer doctor who heads the Cleveland Clinic’s center for ethics, humanities and spiritual care, said patients should be told. “It’s their bodies and their lives that are on the line.”

Indeed, Beverly Smith, a Cleveland patient who has Crohn’s disease, said she had no idea that an important ingredient had been removed from the daily intravenous nutritional treatments she depends on until she developed side effects from the deficiency. “Why didn’t anybody tell me?” she asked.
Who Gets Preference?

In a basement storeroom filled with plastic crates and cardboard boxes, Chris Snyder, a Cleveland Clinic pharmacist and the point man for drug shortages, spends part of each workday poring over the hospital’s drug orders.

He tracks a list of shortages that included more than 75 drugs the first week of January. Dr. Snyder moves stocks among the hospital’s campuses, identifies alternatives, and — in the most dire situations — helps devise and enforce restrictions on which drugs can be ordered for which types of patients.
Top, Chris Snyder, a pharmacist at the Cleveland Clinic, tracks a list of shortages that included more than 75 drugs the first week of January. Bottom, pharmacy technicians in a compounding clean room that is used to prepare drugs for use within the clinic. Credit T.J. Kirkpatrick for The New York Times

Many drugs are made by only one manufacturer, so production or safety problems at a single plant can have big effects. For another company to begin making the products and getting them approved by regulators requires the right combination of manufacturing capabilities and economic incentives.

The chances of getting a drug also depend in part on where a patient happens to live, how adept the local hospital is at finding — and hoarding — scarce drugs, or a patient’s access to a major medical center.

The Cleveland Clinic, for example, has an advanced compounding room where workers swaddled in disposable gowns, bouffant caps and blue gloves mix up remedies from raw ingredients. During a shortage of papaverine, a drug used for surgery on blood vessels, the clinic produced its own version. When other hospitals began asking about it, Dr. Snyder said he had to tell them, “It’s a franchised recipe we can’t give out.”

At Cleveland, decisions about conserving, substituting and allocating scarce drugs typically are made by small groups of doctors and pharmacists; Dr. Kodish’s ethics committee is not involved. But such decisions are not always made by doctors or hospitals. One company, Janssen, chose to ration its ovarian cancer and multiple myeloma drug Doxil on a first-come-first-served basis during a prolonged shortage.
Continue reading the main story

“We’ve been forced into
what we think is a
highly unethical corner.”
Dr. Peter Adamson

Continue reading the main story

Another company, Jazz Pharmaceuticals, recently consulted a small group of oncologists to recommend how to allocate its cancer drug, Erwinase, if it ever became necessary. “Who deserves the drug more than anyone else?” said Dr. Wendy Stock, a leukemia specialist at the University of Chicago Medicine, who participated in the discussion. “We gave them some guidelines on that. ”
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Recent Comments
Grossness54 15 minutes ago

This is exactly what to expect when profits are considered more important than people's lives. And to think we actually hanged people who...
Science Teacher 15 minutes ago

This isn't the sole fault of the Republicans although many will try to pin all the blame on them - put a lot of the fault in Obamacare -...
Jeff Byrne 15 minutes ago

Any supply chain expert (and there are loads of them in the pharm industry) could tell you that these shortages are a direct result of...

    See All Comments Write a comment

In a survey of cancer doctors conducted in 2012 and 2013, 83 percent of respondents who regularly prescribed cancer drugs reported having been unable to provide the preferred chemotherapy agent at least once during the previous six months. More than a third of them said they had to delay treatment “and make difficult choices about which patients to exclude,” according to a letter published in The New England Journal of Medicine.

The threat of future shortages in children’s treatments is serious enough that Dr. Peter Adamson, who leads the Children’s Oncology Group, the largest international group of children’s cancer researchers, assigned his organization to set priorities. “We’ve been forced into what we think is a highly unethical corner,” he said in an interview.

The effort, led by Dr. Unguru, the Baltimore oncologist, recommended that the drugs be rationed based on the ability to save lives or years of life, including curability of a child’s cancer and the importance of the drug in improving the chances. It also recommended that children participating in clinical research should not get priority over those who are not, because of concerns about coercing families into trials. The group also advised that allocation decisions be public.
Dr. Yoram Unguru, an oncologist at the Children’s Hospital at Sinai in Baltimore, said that developing rationing guidelines for scarce medicines “was painful.” Credit Matt Roth for The New York Times

A recent shortage of a therapy for bladder cancer, BCG, demonstrates how the lack of national guidance can lead to very different decisions. One Cleveland Clinic urologist, Dr. Andrew Stephenson, said he came up with BCG rationing guidelines that were used with dozens of patients after being shared with colleagues. “We tried to reserve the BCG for those patients who needed it the most,” he said.

Merck, the manufacturer, said it filled requests from a waiting list in the order received, and left rationing decisions to doctors. Some cancer centers reduced the length of BCG treatment from three years to one, because the benefit may be smaller after the first year. Others restricted BCG to patients whose tumors were mostly likely to spread or recur. And still others decided to reduce the typical dose so that each vial could be used for three patients instead of one, which some experts say raises questions about efficacy. Some outpatient clinics just ran out.

In interviews and comments on a support website, Inspire, patients seemed confused about why they were or were not getting BCG. “I found out people were getting it in different parts of the country,” said Don Keating, whose bladder cancer was diagnosed in 2014. He was told by his doctor in Boston that he needed BCG, but that it was not available.
Continue reading the main story

“I believe if I had gotten it
when it was first prescribed,
I wouldn’t have had to go
through those operations.”
Don Keating, a cancer patient

Mr. Keating had to wait about six months before obtaining the drug, during which time his cancer recurred. “I believe if I had gotten it when it was first prescribed, I wouldn’t have had to go through those operations,” he said.

Continue reading the main story

Continue reading the main story

Many urologists said they saw similar recurrences possibly due to the shortage, and that some patients underwent high-risk bladder removal surgery that probably would have been avoided if BCG had been fully available.

Dr. Kamal Pohar, a urologist at Ohio State University’s cancer hospital, said he remembered driving home, wondering if he was making the right calls for his patients. “I can still feel the stress,” he said. “I’ve never been faced with this.” Supplies of BCG are again adequate, Merck and doctors report.

The vagaries in distribution and inconsistencies in rationing have led to calls for change. Doctors and others have suggested the creation of a clearinghouse of scarce drugs and voluntary sharing to promote equitable access for patients. Others argue that there should be a registry of patients given nonstandard treatments so the results can be tracked.

Dr. Lurie, the federal health official in charge of emergency preparedness and response, said that the government was working to encourage hospitals to conserve and substitute drugs to avoid a crisis and trying to fill gaps in manufacturing. Steps taken by the Food and Drug Administration have also helped reduce the number of shortages, she said.

Still, she argued that tools developed for disaster response, including ethical and procedural guidelines, should be applied. “Different places around the country are each doing their best to patch together their own guidelines,” she said, adding, “if they’re doing anything at all.”
Power User
Posts: 4995

« Reply #1453 on: February 11, 2016, 08:46:42 AM »

Mark Levin has pointed out  for years that the ban on DDT was junk science and proven false yet the left trumpets this as some sort of progess:
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