Federal “right to try” law enacted – Consumer Health Digest

This is not going to help anyone. In fact, it very likely will hurt people who are dying.  While the idea behind this seems to the uninformed to be an interesting idea, the possibility of dying people taking drugs that may cause greater suffering to them is very real. The Trump Administration attempt to undermine the  FDA is clearly underway. The beneficiaries of this are large drug companies. 

President Donald Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, which had been opposed by a coalition of more than 100 non-governmental organizations. The law permits terminally ill patients who have exhausted approved treatment options and who are unable to participate in a clinical trial of an investigational new drug to receive the drug after it has passed only the first of three phases of testing required for marketing approval. Phase 1 testing requires only 20 to 80 healthy volunteers to determine a drug’s most frequent side effects and how it is metabolized or excreted. While it can reveal unacceptable toxicity, Phase 1 does not establish effectiveness. Most drugs that move past Phase I testing do not get approved for marketing because they are found to be unsafe and/or ineffective.

The Food and Drug Administration (FDA) already has “compassionate use” programs with safeguards that enable people with serious and life-threatening diseases to receive investigational medical devices, drugs, and biologics outside of clinical trials. The agency sometimes requires dosing and safety improvements but grants 99% of requests it receives and enables treatment to begin within 30 days (or five working days after emergency requests). The new law removes FDA’s consultative role in ensuring safety and fails to ensure informed consent requirements. It also “limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.”

Senator Ron Johnson, who sponsored the legislation, said recently that its goal was to “diminish the FDA’s power over people’s lives, not increase it.” It was based on a model bill drafted by the Goldwater Institute, a libertarian think tank that opposes the FDA’s regulatory power. The Koch brothers-associated, right-wing groups Freedom Partners and Americans for Prosperity lobbied for the legislation. Similar legislation has already been enacted in 38 states. David Gorski, M.D., Ph.D. recently wrote:

Right-to-try is only a little about helping patients. It’s far more about dismantling the FDA and giving drug and device manufacturers more freedom to market drugs and devices with much less testing. [Gorski D. The very worst version of the sham known as “right-to-try” is poised to become law. Science-Based Medicine, May 21, 2018]

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Daily on Healthcare: Here are the healthcare items that made it into the spending bill – Washington Examiner

The recent federal spending bill coverage.

Here are the healthcare items that made it into the spending bill. The spending bill Congress released Wednesday night funds or changes several healthcare programs. In all, the Department of Health and Human Services will see a $10 billion boost. Here are some details about how the spending deal will affect healthcare programs:

https://www.washingtonexaminer.com/daily-on-healthcare-here-are-the-healthcare-items-that-made-it-into-the-spending-bill

340B is a well-intentioned drug discount program gone awry -Stat Magazine

There have been questions raised here in Jefferson County about the issues that are covered in this article. A good example is the following statement:

A study in the journal Health Services Research examined the impact of the 340B program on the cost of cancer care. It found that hospital participation in the program is associated with a shift of patients’ care from more affordable physician offices to more expensive hospital outpatient care centers, contributing to market-wide increases in per-patient spending.

https://www.statnews.com/2018/03/22/340b-drug-discount-program-gone-awry/

Bad bedside manner: Bank loans signed in the hospital leave patients vulnerable – Seattle Times/Kaiser Health News

Just when we think the American healthcare system can’t get any worse, hospitals and banks figure out a way to take us further into debt. Just what a person who is brought into the ER wants to see, a banker show up. It’s like a sick joke.

Here’s a very telling stat from this article: In 2016, the federal government estimates, consumers spent $352.5 billion out-of-pocket on health care.

We *think* we have it good. We could have paid for universal healthcare with that amount.  You are essentially being taxed on that money, but it accrues to the sickest of us and the bulk of that money is spent in the last 6 months of life. To put it in perspective the US spent $584 B on defense, $588B on Medicare and $368B on Medicaid.

https://www.seattletimes.com/nation-world/bad-bedside-manner-bank-loans-signed-in-the-hospital-leave-patients-vulnerable/

The Gathering Threat to Abortion Rights – NY Times

Here we go again.

Mr. McConnell is set to hold a procedural vote this week on a bill that would ban abortion at 20 weeks of pregnancy. The so-called Pain-Capable Unborn Child Protection Act, sponsored by Senator Lindsey Graham, a South Carolina Republican, is part of a long-term legislative effort by the anti-abortion movement to gut Roe v. Wade and severely curtail abortion access nationwide.

Where a divided Washington can find common ground: Health care

Our own Jefferson Healthcare is a rural designated hospital.

The Critical Access Hospital lifeline was established in 1997 in reaction to a flurry of rural hospital closures, mostly in Midwest and southeastern states. Some of those closures and consolidations in areas of dwindling populations were healthy, but it threw a scare into small hospitals all over the country.

http://crosscut.com/2018/01/where-a-divided-washington-can-find-common-ground-health-care/