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]
Why does this not surprise me….we are fighting against the medical/industrial complex. If you want a change, read the text of I-1600. It gets to the core of the issue. Will it make it to the ballot? Very uncertain. But something has to change in this country if we want to lower costs and bring about a positive change to patients and providers.
What a difference a border makes, when it comes to the cost of cancer care. Common chemotherapy for advanced colorectal cancer costs twice as much in Washington state as it does a short walk across the Canadian border into British Columbia, researchers report.
This is an odd story, but points out the dangers of supporting your enemy. And let’s be clear, when it comes to making healthcare better in this country, the Republicans are the enemy of that goal. They have fought for every opportunity to make things better in favor of religious fundamentalist goals that deny healthcare to women and other low income populations, and they have shown no interest in improving anything but the bottom line of their donors. The SEIU 1199, in supporting a Republican over a Democrat simply because the R was at one time a nurse, is absurd, since this former nurse is working against their interests.
It’s time we stop treating addiction like a character flaw and treat it for what it is, a medical condition. A good read by the NY Times.
And more on the anti-vaccination myths. Worth subscribing to Dr. Barrett’s blog.
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There is no clear evidence that debunking anti-vaccination myths has a significant effect on anti-vaccination attitudes. To explore why this is so, Australian researchers surveyed people in 24 countries ionn six continents. Based on responses from 5,323 participants, the researchers found that anti-vaccination attitudes scores were associated with:
- conspiratorial thinking
- reactance (the tendency to have low tolerance for impingements on one’s freedom)
- disgust toward blood and needles
- individualistic and hierarchical as opposed to egalitarian and communitarian worldview
These relationships were not strong among respondents in Asian and South American countries, but in Australia, Canada, Germany, New Zealand, U.K., and the U.S.A., beliefs about conspiracies were found to account for 17% to 27% of the variation in anti-vaccination attitude. Gender and education level were not significantly related to anti-vaccination attitude, but conservative political ideology and younger age were each found to be weakly related. [Hornsey MJ and others. The psychological roots of anti-vaccination attitudes: A 24-nation investigation. Health Psychology 37:307-315, 2018]
Interesting retraction on a study that was jumped on by the anti-vaccine crowd.
The open-access journal Scientific Reports has retracted a 2016 article that claimed to provide scientific support for anecdotal reports alleging that the human papilloma virus vaccine Gardasil had side effects such headaches, fatigue, and poor concentration. The article also claimed that Gardasil administered to mice damages regions of the brain to induce adverse reactions. Soon after it was published, the Respectful Insolence blog blasted its design and the evidence presented. [Orac. Torturing more mice in the name of anti-vaccine pseudoscience. Respectful Insolence Blog, November 18, 2016] The retraction announcement stated:
The Publisher is retracting this Article because the experimental approach does not support the objectives of the study. The study was designed to elucidate the maximum implication of human papilloma virus (HPV) vaccine (Gardasil) in the central nervous system. However, the co-administration of pertussis toxin with high-levels of HPV vaccine is not an appropriate approach to determine neurological damage from HPV vaccine alone. The Authors do not agree with the retraction.
Although critics welcome the retraction, some have chastised the journal for taking so long to do it. [Normile D. Journal retracts paper claiming neurological damage from HPV vaccine. Science, May 11, 2018] And, despite the retraction, the full text of the retracted article is still on the journal’s Web site.
HPV vaccination can prevent most of 30,000 annual cases of cancer in the U.S. caused by some types of HPV. It can prevent cancers of the cervix, vulva, vagina, penis, or anus as well as oropharyngeal cancer. HPV is transmitted through intimate skin-to-skin contact, oral sex, and most commonly through vaginal or anal sex. HPV infection can resolve on its own, but can also develop for many years before symptoms first appear. The Centers for Disease Control and Prevention currently recommends HPV vaccination for girls and boy at ages 11 or 12 years, but it can begin as early as age 9. For dosage schedules, see HPV vaccines: Vaccinating your preteen or teen. CDC, updated Aug. 24, 2017.
Consumer Health Digest