Tuesday, June 13, 2017

Killing Medicine, Killing Us

Ballooning medical bureaucracy does both.

Since the 1970s, the number of physicians entering the workforce has remained relatively constant. The number of administrators (who are handsomely paid) has risen almost 3,000%. This is not helping patients.

Doctors and their private practices are increasingly being eaten up by hospitals. In fact, the number of physicians employed by hospitals grew by more than a third between 2000 and 2010. There are a number of factors behind this shift, but, like most shifts in the healthcare industry, it all comes down to money, not care.

Medicare pays hospitals and hospital owned practices more for the same service than private practices, as much as 70% more. Employing doctors also allows hospitals to more easily funnel patients into their other facilities and services. Having doctors on staff also puts hospitals in a better position to negotiate with insurers.

As employees of hospitals, doctors and the medical decisions they make increasingly work at the whim of hospital administrators, whose primary aim is often not patient care but profitability. Estimates say that 80% of healthcare costs derive from decisions that doctors make, such as what medicines to prescribe and what procedures to recommend. There is a strong financial incentive for government, hospitals, and insurance companies to restrict the ability of physicians to make independent decisions.

One method being used by administrators to seize control from doctors is making healthcare incomprehensible to physicians through arcane coding and billing systems and complex information technology. Studies estimate that doctors spend just 12% of their day with patients; the rest is spent processing forms, dealing with electronic medical records, and other administrative duties. The unstated goal, according to an article by Dr. Richard Gunderman, is to train physicians to understand that fealty to the hospital is the center of their professional life, not the doctor-patient relationship.

All of this makes life for doctors working at hospitals tedious, frustrating, and grim. Recent surveys show eight out of ten doctors are “somewhat pessimistic or very pessimistic about the future of medicine.” Doctors today are more likely than any other professional group to commit suicide. Doctors, after years of expensive and extensive education and training, now describe themselves as “technicians on an assembly line” and “worker bees in the factory of the administrative overlords.” Independent judgement is further reduced by the threat of lawsuit, which also leads to many unnecessary tests and referrals to specialists.

Is it possible to reform this dysfunctional system? Yes, it is. All that is needed is to legalize patient driven medicine, as recommended in the next article in this week’s Pulse.



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Make Healthcare A­ffordable Again

Why we need both Obamacare and a new consumer-led system.

The following appeared as an ad in the back page of Roll Call on June 6, 2017.

Obamacare has doubled premiums and doubled deductibles while restricting doctor choice. It has failed.

Even so, it isn’t necessary to repeal it totally. If Congress would just end the Obamacare monopoly and allow a consumer-led healthcare system to grow up alongside it, that is all that is needed to drive costs down.

Here is one example of today’s crazy costs. A teenager went to an emergency room for food poisoning. The bill was $8,000. The insurance company knocked it down to $4,000. But what about the uninsured? They would have been told to pay the full $8,000 and even face bankruptcy if unable to do so.

How can we get medical costs down? You hear that medicine is so expensive because of technology. Nonsense. Technology in most industries reduces costs.

Basic economics tells us that in order for prices to fall we must get supply of products and services up faster than demand. That automatically reduces prices. The only way to get supply up (and improve products and services as well) is to create a system in which all suppliers are allowed to compete with one another for the dollar of the consumer.

Who are the suppliers being shut out of today’s market or severely restricted by law? In the medical ­ field, they include millions of nurses, who are rarely allowed to use their full training, chiropractors, four-year-trained naturopathic doctors, and other quali­fied practitioners. It also includes generic drug companies, supplement companies that could make generic drugs and other treatments, compounding pharmacies, and food producers. Science tells us conclusively that food is a powerful medicine. But walnut and cherry growers have been threatened with jail for speaking of the proven health benefi­ts of eating these foods, because it’s illegal to make these types of claims, unless made by a drug company about a commercially available drug. Restrictions even apply to describing exercise as medicine.

To make this expanded supply network flourish, the consumer must be in charge—not the insurance companies or the American Medical Association or other agents or allies of government, all of whom will only seek to make market-restrictive deals with regulators. Only a consumer-controlled market with free flowing information and real competition can give us better services at lower and lower prices. We have seen this in computers and automobiles and so many other ­ fields. How much do you think food or computers or autos would cost if run like healthcare?

So what exactly is wrong with the way healthcare is run today and why has it led to such high costs? The answer is again quite simple. Government, in its effort to protect people, has actually created a monopoly system in which big drug companies are protected from competition by patents and multi-billion FDA approvals. Meanwhile, hospitals and doctors are protected from competition by price control rules and unnecessary licensing restrictions.

The Medicare system ­ fixes the practitioner prices (these are monopoly prices favoring hospitals in particular). Economists on both left and right agree that price controls never work. They back­fire by discouraging investment and thus limiting supply. Government subsidies for consumers are a band aid that cannot possibly keep up with the spiraling monopoly prices. Government subsidies for big insurance companies are even worse. More medical crony capitalism we do not need.

Government should not try to define what healthcare is or what an insurance policy is. Leave that to the consumer. Let them decide on the kind of coverage they want and how much they will pay. But meanwhile, don’t force everyone to accept a consumer-led market. Let anyone who wishes stay on Obamacare or in the Medicaid medical ghetto.

It is quite enough to open up the Obamacare system to competition from a consumer-led system. Then let consumers (and voters) decide for themselves which they prefer. This way all the transition problems associated with repealing Obamacare disappear. Nobody will lose coverage. On the contrary, millions more will likely gain coverage. The idea that 23 million consumers would lose coverage if given more choices and options was always completely bogus. But if both systems are available, the argument collapses.

Let’s also be honest. The House bill does not repeal Obamacare. My state must ask the federal government for a waiver from the Obamacare mandates. Many states will not do this, so their residents will not be allowed to take advantage of consumer-led healthcare. If the waiver is granted by the federal government, it only lasts for ten years. A new president could refuse to grant any more waivers and the Obamacare monopoly would be right back. In the interim, medical providers won’t have the certainty they need to create more healthcare supply.

Are you worried that a new consumer-driven system cannot be created through Senate reconciliation? Don’t be. Just add modest fees payable by consumers or providers to participate in or to offer the new system. Consumers and providers will gladly pay for the privilege of being exempted from the Obamacare monopoly and their payments will add up. Before long, when the new system is bringing prices down sharply, the fees can be dropped out of the billions of savings for the federal government. Meanwhile the voters will hear that the fees were in effect imposed by senators supporting an Obamacare monopoly.

 



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Now Serving: Mutated Food

What does gene editing do to food? What does it do to us? Research shows we should be very wary.

New gene editing methods like CRISPR-Cas9, have been touted as the gentler, softer application of biotech to agriculture. Where earlier genetic engineering put spider genes into a tomato, for example, technology like CRISPR is used to go into an organism’s DNA to cut and slice here and there to permanently modify that organism’s DNA. Plants that are produced through gene editing also avoid most of the federal rules put in place to regulate GMO crops, including labeling them as “GMO.” The USDA has already decided it will not regulate CRISPR-edited mushrooms.

A new study suggests that this approach needs to be reconsidered. The researchers found that gene editing can introduce hundreds of unintended mutations into the genome.

The US government needs to wake up and realize that gene editing is not as safe, reliable, or consistent as industry is touting it, and Americans have the right to know if their food was created using this technology. Once again, however, cronyism seems to outweigh the science.

 

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Now Serving: Mutated Food

What does gene editing do to food? What does it do to us? Research shows we should be very wary.

New gene editing methods like CRISPR-Cas9, have been touted as the gentler, softer application of biotech to agriculture. Where earlier genetic engineering put spider genes into a tomato, for example, technology like CRISPR is used to go into an organism’s DNA to cut and slice here and there to permanently modify that organism’s DNA. Plants that are produced through gene editing also avoid most of the federal rules put in place to regulate GMO crops, including labeling them as “GMO.” The USDA has already decided it will not regulate CRISPR-edited mushrooms.

A new study suggests that this approach needs to be reconsidered. The researchers found that gene editing can introduce hundreds of unintended mutations into the genome.

The US government needs to wake up and realize that gene editing is not as safe, reliable, or consistent as industry is touting it, and Americans have the right to know if their food was created using this technology. Once again, however, cronyism seems to outweigh the science.

 



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Thursday, June 8, 2017

Fighting Back: ANH, Allies Leading the Charge for Natural Medicine

The FDA has been waging an all-out war against natural medicine. In response, we are uniting with allies to articulate the truth. Will the FDA listen to science, or Big Pharma?

We’ve been keeping readers up to date on the FDA’s salvo of new regulations and rules for the compounding industry, which makes customized, natural medicines to accommodate the needs of sensitive populations.

Recently, our friends at the Integrative Medicine Consortium (ICM) sent official comments to the FDA laying out folly in the FDA’s approach to writing these new rules. Their comments echo many of the same points made in ANH’s own comments to the FDA.

The main thrust of the comment concerns the criteria proposed by the FDA to judge whether substances can be allowed on the Bulk Drug Ingredients list. Remember that a substance can only be compounded by a traditional pharmacy if it 1) has a USP monograph, 2) is a component of an approved drug, or 3) appears on the pre-approved Bulk Drug Ingredients list.

As we’ve reported before, the Pharmacy Compounding Advisory Committee (PCAC) has recommended that the FDA reject many, many natural substances from the list, including curcumin, aloe vera, boswelia, and others.

Consider this example, taken from IMC’s comments:

Based on the FDA’s “criteria,” the dietary supplement MSM (Methylsulphonylmethane) is pending rejection for arthritis management in large measure because of four cases of bleeding, while the Agency believes that the availability of a COX-2 inhibitor, a drug carrying a black box warning for risk of heart attack and stroke, is not only acceptable but such a clear choice that physicians should be denied MSM as a treatment option in favor of the COX-2 inhibitor.

IMC also points out that the stated criteria by which the FDA said it would make its decisions—physical characteristics, safety, efficacy, and historical use—are not applied in practice. Instead, more subjective judgments are made. The comment charges that actual FDA practice has been to:

  • presume that if an ingredient is nominated for a specific indication for which an approved drug exists the nominated ingredient will be denied for even minimal safety risks.
  • impose a standard that an ingredient can be rejected in part from a concern that its use could unnecessarily delay treatment with a commercially approved drug.
  • allow unproven concerns for safety or effectiveness to override a history of safe use of an ingredient.
  • impose a substantial burden of evidence while failing to include all available evidence of effectiveness.
  • impose a standard that an ingredient can be rejected in part upon the finding that a condition the ingredient is proposed to treat is “serious.”

Many more excellent points are made in the comment.

It is time for the FDA to wake up to scientific realities and hear ANH and IMC’s concerns. There are signals that the tide is turning. We reported recently that language was included in a federal spending bill to reign in some of the FDA’s rules. Additionally, sixty-five members of Congress signed a letter to FDA Commissioner Scott Gottlieb urging him to reconsider “office use” restrictions for traditional pharmacies.

The absurdity of the FDA position was well articulated by IMC, as it has been by us. With members of Congress being alerted to the grave concern with this out-of-control agency, how much longer until it changes course and ceases to do the bidding of Big Pharma?



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Fighting Back: ANH, Allies Leading the Charge for Natural Medicine

The FDA has been waging an all-out war against natural medicine. In response, we are uniting with allies to articulate the truth. Will the FDA listen to science, or Big Pharma?

We’ve been keeping readers up to date on the FDA’s salvo of new regulations and rules for the compounding industry, which makes customized, natural medicines to accommodate the needs of sensitive populations.

Recently, our friends at the Integrative Medicine Consortium (ICM) sent official comments to the FDA laying out folly in the FDA’s approach to writing these new rules. Their comments echo many of the same points made in ANH’s own comments to the FDA.

The main thrust of the comment concerns the criteria proposed by the FDA to judge whether substances can be allowed on the Bulk Drug Ingredients list. Remember that a substance can only be compounded by a traditional pharmacy if it 1) has a USP monograph, 2) is a component of an approved drug, or 3) appears on the pre-approved Bulk Drug Ingredients list.

As we’ve reported before, the Pharmacy Compounding Advisory Committee (PCAC) has recommended that the FDA reject many, many natural substances from the list, including curcumin, aloe vera, boswelia, and others.

Consider this example, taken from IMC’s comments:

Based on the FDA’s “criteria,” the dietary supplement MSM (Methylsulphonylmethane) is pending rejection for arthritis management in large measure because of four cases of bleeding, while the Agency believes that the availability of a COX-2 inhibitor, a drug carrying a black box warning for risk of heart attack and stroke, is not only acceptable but such a clear choice that physicians should be denied MSM as a treatment option in favor of the COX-2 inhibitor.

IMC also points out that the stated criteria by which the FDA said it would make its decisions—physical characteristics, safety, efficacy, and historical use—are not applied in practice. Instead, more subjective judgments are made. The comment charges that actual FDA practice has been to:

  • presume that if an ingredient is nominated for a specific indication for which an approved drug exists the nominated ingredient will be denied for even minimal safety risks.
  • impose a standard that an ingredient can be rejected in part from a concern that its use could unnecessarily delay treatment with a commercially approved drug.
  • allow unproven concerns for safety or effectiveness to override a history of safe use of an ingredient.
  • impose a substantial burden of evidence while failing to include all available evidence of effectiveness.
  • impose a standard that an ingredient can be rejected in part upon the finding that a condition the ingredient is proposed to treat is “serious.”

Many more excellent points are made in the comment.

It is time for the FDA to wake up to scientific realities and hear ANH and IMC’s concerns. There are signals that the tide is turning. We reported recently that language was included in a federal spending bill to reign in some of the FDA’s rules. Additionally, sixty-five members of Congress signed a letter to FDA Commissioner Scott Gottlieb urging him to reconsider “office use” restrictions for traditional pharmacies.

The absurdity of the FDA position was well articulated by IMC, as it has been by us. With members of Congress being alerted to the grave concern with this out-of-control agency, how much longer until it changes course and ceases to do the bidding of Big Pharma?

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Wipeout: FPA Approved Drugs Kill More People than Live in Seattle

Since 2005, the FDA has approved the death instrument of 786,000 people. That’s more than the population of Seattle, DC, or 4 entire states! Action Alert!

Researchers at the Yale School of Medicine found that nearly one third of drugs approved between 2001 and 2010 had major safety issues after being made available to patients. This isn’t just the discovery of innocuous new side effects; 71 of 222 drugs approved during that time were either withdrawn from the market, required to carry a black box warning (the strictest warning a prescription drug can carry), or had a safety announcement issued about new risks from the drug. This means, your odds would be far better playing Russian roulette than putting an FDA approved drug into your body.

Part of the problem, according to the researchers, is that many important drug trials used for approval involve fewer than 1,000 patients and last six months or less. Others add that patients used in clinical trials are often cherry-picked to produce the best results for the drug.

This is yet another piece of damning evidence showing that our drug approval process is broken and responsible for death and hardship for millions of Americans. Worse, the drugs that won’t kill or sicken you probably won’t give you any benefit at all.

At the center of this broken drug approval system is the systemic corruption that the FDA’s own scientists have lamented, where sound science and safety concerns are ignored in order to rush blockbuster drugs to market. This crony feeding-frenzy has devoured roughly 3x more lives than were lost in Hiroshima and Nagasaki, yet is drawing little attention from lawmakers. The full figures are detailed on our FDA Death Meter page.

The facts are clear. Nevertheless, our politicians talk of speeding up drug approvals and increasing the fees Big Pharma pays to the FDA—putting the agency deeper into industry’s pocket!

The death toll and complications from FDA approved drugs is a sharp contrast from the record of supplements. One report from the Government Accountability Office found that there were an average of 1,575 adverse event reports (AERs) related to supplements per year between 2008 and 2011. When you factor in that about half of Americans (157 million people) take supplements every day, this means that only one-hundredth of one percent of all supplement users ever experience any problems at all.

Despite the safety of dietary supplements, there is a pending proposal from the FDA that threatens to eliminate thousands of products from store shelves. Send a message to Congress and the FDA urging them to fix this guidance and turn their attention to the drug industry—the real danger to the American people.

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