The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
Also at Ars Technica and STAT News.
Related: Probiotics Come with Bold Health Claims, but the Science is Shaky
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Supplement Maker on FDA Blacklist After Deadly Bacteria Found in Water System
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Homeopathic "Healing Bracelet" Poisons Baby With High Levels of Lead
FDA: Love is Not an Ingredient
FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Biohackers Disregard FDA Warning on DIY Gene Therapy
Related Stories
The "good bacteria," or probiotics, that fill the pomegranate drink are everywhere these days, in pills and powders marketed as super supplements. Probiotics are said to improve digestive and immune health. They're touted as potential treatments for conditions ranging from inflammatory bowel disease to eczema to tooth decay. Some marketing campaigns even hint that they can prevent the flu.
Scientific evidence, however, does not necessarily support those claims.
Studies in rodents and small groups of humans point to possible health benefits of consuming probiotics. But there have been only a few large human trials — in large part because Food and Drug Administration rules have dissuaded food companies and federally funded researchers from conducting the types of studies that could confirm, or refute, the proposed benefits of consuming "good" microbes.
http://www.statnews.com/2016/01/21/probiotics-shaky-science/
President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.
Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.
The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.
Arthur T Knackerbracket has found the following story:
The Food and Drug Administration advised consumers and healthcare providers Friday to avoid all liquid products made by PharmaTech LLC of Davie, Florida after finding dangerous Burkholderia cepacia bacteria in the water system used to manufacture its products. Those products include liquid drugs and dietary supplements labeled under Rugby Laboratories, Major Pharmaceuticals, and Leader Brands.
An outbreak of B. cepacia infections affecting at least 60 people in eight states led the FDA and Centers for Disease Control and Prevention to PharmaTech. Late last year, the agencies tracked the source to more than 10 lots of PharmaTech's oral liquid docusate sodium, a stool softener. But suspicion of contamination crept to the company's other products, and this month PharmaTech issued a voluntary nationwide recall of its other liquid products, such as its liquid vitamin D drops and liquid multivitamins that are marketed for infants and children.
"B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems," FDA Commissioner Scott Gottlieb said in a statement. "These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online—making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products."
-- submitted from IRC
The U.S. Food and Drug Administration has given its approval for Phase 3 trials to treat participants with PTSD using MDMA ("ecstacy"):
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.
The first Phase 3 trial (MAPP1), "A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder," will begin enrolling subjects in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall.
[...] The Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
In MAPS' completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.
Also at ScienceAlert, the Washington Post, and Science Magazine:
Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.
Ars Technica is reporting on a story where the CDC report that a Homeopathic “healing bracelet” caused lead poisoning in a infant girl
[...] during a routine health screening. Healthcare workers found that the baby was anemic and had a blood lead level of 41 micrograms per deciliter (μg/dL). While no level of lead is known to be safe, the CDC recommends health interventions when a child’s blood lead level reaches 5 μg/dL.
[...] The authorities subsequently homed in on the bracelet, a homemade “homeopathic magnetic hematite healing bracelet.” The baby’s parents said they bought it from an artisan at a local fair and gave it to the baby to wear and mouth to ease teething pain. Small spacer beads on the bracelet (shown) tested positive for lead at a level of 17,000 parts-per-million. The Consumer Product Commission in 2010 set the allowable limit of lead in products intended for children at 100 parts-per-million.
The authors of the report—Drs. Patricia Garcia and Jennifer Haile, lead treatment specialists at Connecticut Children’s Medical Center—noted that the bracelet had no warnings or branding. They added that they couldn’t get the fair’s vendor information and were unable to track down the bracelet’s maker.
Also at Live Science
The U.S. Food and Drug Administration on Tuesday released a warning letter to Nashoba Brook Bakery, reprimanding the West Concord, Massachusetts-based baker and wholesaler about the ingredients it lists in its granola.
One, in particular.
"Your Nashoba Granola label lists ingredient 'Love,'" the agency wrote in the Sept. 22 letter. "'Love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."
Nashoba Chief Executive Officer John Gates said the FDA's take on love as an ingredient "just felt so George Orwell."
Ars Technica additionally reports that was not all that the FDA found:
During a recent bakery inspection, FDA agents discovered: dirt and filth caked onto ceiling vents and sprinklers directly above ready-to-eat foods; parts of the floor and ceiling that were missing for some reason; equipment, including bowls and cooling racks, that wasn't cleaned or maintained; and counters, shelves, and food production surfaces that were coated with an unknown residue.
Insects also proved worrisome. At one point, an FDA inspector noticed a one-inch-long, unidentified crawling insect directly underneath a batch of pastries. Last, the FDA reported that employees weren't following proper hygiene practices. One baker repeatedly dipped a blue bracelet into raw dough while mixing it.
For your reading pleasure, here is the warning letter.
The U.S. Food and Drug Administration is warning four companies that sell products containing cannabidiol (CBD) to stop making unsubstantiated health claims, such as "combats tumor and cancer cells":
The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer's and other serious diseases.
The companies in question are Greenroads Health, Natural Alchemist, That's Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC.
Also at Bloomberg, The Cannabist, The Hill, NBC, and Newsweek.
Related: U.S. Federal Cannabis Prohibition Remains Intact
"Hollyweed" and More Cannabis Stories
According to Gallup, American Support for Cannabis Legalization is at an All-Time High
Study Finds That More Frequent Use of Cannabis is Associated With Having More Sex
The FDA has issued a public health advisory warning of deaths related to kratom (Mitragyna speciosa) and warning against using it to treat opioid withdrawal symptoms. The DEA attempted to temporarily regulate kratom as a schedule I drug in 2016, but stopped short of doing so after a public backlash. From FDA Commissioner Scott Gottlieb's statement on the advisory:
It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.
There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
"Cease & Desist" has not worked:
Despite a warning from the federal government about do-it-yourself gene therapy, two companies say they'll continue offering DNA-altering materials to the public.
The companies, The Odin and Ascendance Biomedical, both recently posted videos online of people self-administering DNA molecules their labs had produced.
Following wide distribution of the videos, the U.S. Food and Drug Administration last week issued a harshly worded statement cautioning consumers against DIY gene-therapy kits and calling their sale illegal. "The sale of these products is against the law. FDA is concerned about the safety risks involved," the agency said.
Does the Executive Branch want the market to decide, or not?
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @05:01PM (14 children)
Accurate and thorough labeling is a good thing. People should be able to know what it is they are buying.
(Score: 4, Insightful) by DannyB on Wednesday December 20 2017, @05:11PM (12 children)
The labeling should make purchasers aware that the product does not work and may actually be harmful. Or is the leading cause of lung cancer.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @06:14PM (1 child)
I'm sort of stuck on the fact that heomeopathic anything are actually classified as "drugs".
What if I diluted a placebo?
(Score: 1, Insightful) by Anonymous Coward on Wednesday December 20 2017, @07:32PM
If you dilute a placebo, then you'd have a perfectly servicable homeopathic remedy for whatever arbitrary problem you want to market it for.
Homeopathic solutions are diluted to the point where there's at most one molecule of the active ingredient and usually none at all.
(Score: 1) by fustakrakich on Wednesday December 20 2017, @06:23PM (9 children)
Too much negativity in this world, we have to put those things in a positive light...
La politica e i criminali sono la stessa cosa..
(Score: 5, Insightful) by DannyB on Wednesday December 20 2017, @06:33PM (7 children)
I know you omitted sarcasm tags. But that is the fallacy.
We should not be concerned with whether information is negative or positive, but rather whether it is true or is false.
I would rather have the truth, even if it is 'negative'.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @09:51PM (1 child)
The positive truth? You can't handle the truth in it's positive form, nobody can.
As an example of the partial truth in the positive form [wikipedia.org]:
- this solution is fat free
- this solution contains no added hormones, preservatives or colours
- this solution is more than 99.99% natural
- nobody divorced their partner because of this solution
- you don't need to wear a condom to use this solution. But it won't prevent you in wearing one
- there's nothing in the Constitution of the USA to interdict this solution
Etc.
(Score: 2) by DannyB on Wednesday December 20 2017, @10:07PM
The truth in its positive form, as you say is not the entire truth. Which is another name for an alternate fact. From the father of alternate facts.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 1) by fustakrakich on Thursday December 21 2017, @11:44PM (4 children)
I would rather have the truth
That would make you unique. Most people wouldn't. And if you don't believe me, just look the the voting records over the last millennium or so...
La politica e i criminali sono la stessa cosa..
(Score: 2) by DannyB on Friday December 22 2017, @02:49PM (3 children)
Not unique. Just a minority. There are others who would rather have the truth even if it is not what they want to hear.
Bad news does not get better with time.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 1) by fustakrakich on Friday December 22 2017, @06:23PM (2 children)
Not unique. Just a minority.
Please, permit me some license for minor embellishment.. but, it is not too harsh to say that people who continue to vote for the political status quo have no taste for the truth.
La politica e i criminali sono la stessa cosa..
(Score: 2) by DannyB on Friday December 22 2017, @06:51PM (1 child)
I am unclear what you are trying to say.
I would rather have the truth, however unpleasant, to the best extent that I am able to discern and understand what is true.
As for voting for status quo. That can refer to so many things. One candidate may make some changes. The other candidate may make some different changes. But neither of them are going to change the things that really matter -- because they are in the pockets of the rich and powerful.
A change that no candidate will ever make, for example, is working for the common people and not the rich and powerful people. It's not that rich and powerful should be treated unfairly. But they can shoulder a much greater tax burden and still have more money than they will ever spend before they die, and vastly more than most people. So I would hardly call it unfair.
But wandering out of the weeds, I would rather know an unpleasant truth that climate is going to change in some very bad ways, than have someone tell me a pleasant lie that everything is going to be just great!
Or maybe I am simply too dense to understand what you are getting at.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 1) by fustakrakich on Friday December 22 2017, @08:04PM
Or maybe I am simply too dense to understand what you are getting at.
No, you're just taking it personally. I don't know why, but shit happens, I guess.
La politica e i criminali sono la stessa cosa..
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @06:55PM
This drug will positively kill you.
(Score: 2) by wonkey_monkey on Wednesday December 20 2017, @11:00PM
Active ingredients: fuck all.
There, done.
systemd is Roko's Basilisk
(Score: 3, Insightful) by DannyB on Wednesday December 20 2017, @05:02PM (10 children)
I thought Republicans were against any kind of regulation?
The same kind of arguments for regulating homeopathetic products would apply to regulating polluters of our air and water. Or regulating those causing climate change. Or regulating abuses of internet access by ISPs.
Is some regulation is more equal than other forms of regulation? If there is some insight I am missing, I would be happy to be informed.
None of this is about taxes.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 5, Funny) by Anonymous Coward on Wednesday December 20 2017, @05:06PM
Well, if you dilute the regulation, say, 1to 100, it becomes even more effective, because of the "memory" of regulation. Republican regulation. Just wait 'til this Congress applies the same thinking to Social Security!
(Score: 2) by The Mighty Buzzard on Wednesday December 20 2017, @07:21PM (7 children)
Well, I should certainly hope so. I expect you're looking for ISPs to be regulated but you disapprove of the Fairness Doctrine, for instance. Regulation should always be as limited as is possible; best if it can be absent entirely but this is not always practical.
My rights don't end where your fear begins.
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @09:49PM
Projecting much? Typical bird brain.
(Score: 2) by DannyB on Wednesday December 20 2017, @09:54PM
I agree Regulation should be as limited as possible. But not absent when it is necessary. Any necessary regulation should be strong enough to accomplish its purpose, and be for the public good.
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 2) by DannyB on Wednesday December 20 2017, @10:04PM (4 children)
I do want ISPs to be regulated. There shouldn't be "fast lanes" paid for by destinations. Fast Lanes should be something that the ISP sells to their own customers. But the necessity of offering suggests that the ISP isn't doing its job of building out its infrastructure to support its customer base.
ISPs should be dumb pipes. Period. Where my packets go to or come from is none of the ISP's business. The amount of incoming or outgoing bandwidth that I use should cost ME money, not the other end of the connection, to the disadvantage of everyone else. Netflix already pays handsomely for its bandwidth. The ISP should not discriminate based on where my packets go, nor what they contain. Only to the extent that it is necessary to manage their network fairly for all users.
Basically, ISPs brought on the need for regulation by their own doing. They shouldn't cry about it now. Even with the net neutrality repeal, I suspect in time that things are going to swing back the other way. And hard.
I have mixed feeling about the Fairness Doctrine. On one hand, not all views are equally valid.
A public controversy about whether the sun rises in the east vs the sun rises in the west should not give equal weight to both views. Especially if the controversy is created by trolls for commercial interest to the detriment of everyone else.
After seeing what FoxNews started as, and how CNN and others later became equally as bad, I'm not sure I can trust any of them to be good actors in presenting or even recognizing what is fair.
On the other hand, simple controversial views should be covered equally. Issues like taxes. Social Security. Military Spending. Gun Control. Abortions. These are highly charged issues, and worthy of public debate. But are we even capable of having a debate any longer?
People who think Republicans wouldn't dare destroy Social Security or Medicare should ask women about Roe v Wade.
(Score: 4, Insightful) by The Mighty Buzzard on Wednesday December 20 2017, @10:46PM (3 children)
Outstanding. That's an important step on the path to wisdom. Try for forgetting the notion of "fair" in regards to journalism next. Your "fair" is always going to be someone else's "tyrannical". Just accept that all media sources are biased and seek a variety of ideological sources that often commit good journalism. The ones you disagree with will likely even expand your thinking more than the ones you agree with. If nothing else, they'll leave you with a better thought out position.
Yes but with a huge caveat. There are extremely powerful forces who have vested interests in us not engaging in civil debate. It allows them to frame any issue any way they want and count on large, predictable amounts of unthinking support and opposition.
My rights don't end where your fear begins.
(Score: 2) by Azuma Hazuki on Thursday December 21 2017, @06:32AM
You're so close. Soooooo close. Keep following this line of thought.
I am "that girl" your mother warned you about...
(Score: 0) by Anonymous Coward on Monday December 25 2017, @03:55AM (1 child)
Wait, there are media source that often commit good journalism? Are you sure these sources actually exist?
(Score: 2) by The Mighty Buzzard on Monday December 25 2017, @11:53AM
For a certain value of often, yes.
My rights don't end where your fear begins.
(Score: 2) by VLM on Wednesday December 20 2017, @11:46PM
Its a classic neocon vs alt right argument. Also there's usually a distinction between criminal fraud and being really good at making business deals, standards of corporate contract law like having a meeting of the minds, also there's some subtle distinction between monopolies (ISPs?) and commodities (distilled water masquerading as medicine). So beyond a fox news level of argument of "regulation = bad" its nuanced.
As a gross simplification if you take classical republicanism and add a little common sense social stuff you end up with "nationalist socialism" which is actually a pretty good idea although it seems to have a bit of a historical reputation issue.
Of course if you want it simplified into convenient straw dog format, then it does in fact simplify down to "regulation is badthink", sure, although thats inapplicable in any real form.
(Score: -1, Offtopic) by Anonymous Coward on Wednesday December 20 2017, @05:23PM (3 children)
Homeopathic remedies getting held to clinical standards.
Oh, and look, the Washington Post got it all wrong:
https://www.washingtonpost.com/news/to-your-health/wp/2017/12/18/debate-erupts-within-hhs-about-words-to-avoid-such-as-vulnerable-diversity-and-entitlement/ [washingtonpost.com]
TL;DR: so-called "forbidden" words aren't. It's about trying to get money from congresscritters and how not to piss them off.
(Score: 2) by takyon on Wednesday December 20 2017, @05:26PM (1 child)
http://archive.is/kFiIp [archive.is]
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 0, Troll) by Sulla on Wednesday December 20 2017, @05:40PM
Thats a really interesting read and to me makes a lot of sense. If you are trying to convince someone to fund you it is going to get you a lot further if you provide the details of the science instead of saying it is "science based" or to provide the facts instead of saying "fact based". Science-based/fact-based are appeals to authority where you should assume it is good because someone in-the-know says it is instead of providing the background information.
If you want to sell a liberal program to a republican you don't call it the 'entitlement for aborting fetuses due to mother safety risk' you call it 'emergency procedures to terminate pregnancy to preserve mothers life'.
All marketing bullshit, but effective. Hell you could sell ice to democratic Eskimos if you said it was fair-trade organic pro-impeachment ice packaged by a woman owned company.
Ceterum censeo Sinae esse delendam
(Score: 1, Interesting) by Anonymous Coward on Wednesday December 20 2017, @06:18PM
Uh hey
did you not notice that *all* of the department of Stuff are adhering to the conservative agenda in order to keep their funding and protect against the chopping block?
Ignorance may be bliss--but with significantly smaller tax revenue forcasts, ignorance won't pay for anything. They have to be smart about it.
News is news, and someone at a number of news corporations decided to try to make a big deal out of it.
The REAL NEWS is that the SAME IDEAS can be phrased in a way that people will accept, when previously using DIFFERENT WORDS they rejected due to deep seated bias!
that's the issue. The framing of the terms is relevant only to keep the process operational. Every governmental department has to cater to those in charge, even if it means altering their vocabulary to say the same things in a different way. ANd it's not 1984 newspeak -- they are not censoring or eliminating terms -- they're using marketing and advertising to sell their needs to the ones that pay them.
You won't sell your services to someone who says they'd fire you for doing it, but you might if you tell them you actually are doing something else...
I mean, think about it -- they don't read the bills they vote into laws, they don't understand any of this stuff. tell them what they want to hear and you can stay in business.
(Score: 4, Funny) by The Mighty Buzzard on Wednesday December 20 2017, @07:22PM
What a bunch of homeophobes.
My rights don't end where your fear begins.
(Score: 2) by istartedi on Wednesday December 20 2017, @07:22PM (3 children)
The dietary supplement industry lobbying [theatlantic.com] must have passed its expiration date. I distinctly remember this going down during the early days of the Clinton administration. At the time I was much more conservative and living among more left-leaning people in a college town. I expressed my suspicion that a politically well-connected figure with ties to the industry had made some impact. I can't remember the name of that figure; but I remember the reaction I got. There was the sort of "hippie" connection into the Democratic party at the time that actually wanted de-regulation of this market. The Trump administration is the antithesis of that. The early 90s FDA wanted to regulate supplements like food or drugs. Ironically, Trump is following the spirit of the agency mission on this one, and perhaps even the science.
Appended to the end of comments you post. Max: 120 chars.
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @07:30PM
Orin Hatch was, and still is, the well-heeled champion of the "dietary supplement" industry. He's very vigorously defended them for decades. Coincidentally, his family is in the dietary supplement business.
(Score: 2) by frojack on Wednesday December 20 2017, @09:14PM
Not to mention following those who voted for him.
Conservatives have ALWAYS known this was voodoo medicine, but they were blocked by big money crossing hands into the Clinton machine coffers for decades. None of this crap is paid for by Medicare/Medicaid (afik) and its time to start treating it as the snake oil it is.
Can Chrioquacks be far behind? They are better organized, and probably actually help some people.
But they will still sublux (or whatever they call it these days) your back to fix a bruised foot, and shoot xrays at anything that moves.
Even confined to their historical alleged area of "expertise" they cause adverse effects in 30% to 61% of all patients. [nih.gov]. Some are life threatening. [washingtonpost.com]
No, you are mistaken. I've always had this sig.
(Score: 0) by Anonymous Coward on Thursday December 21 2017, @12:38AM
The legislation you're talking about was created by Orrin Hatch, the conservative Republican from Utah. Utah is home to a lot of homeopathic "cures" and Hatch is personally invested in them. It actually completely removed many of the FDA regulations on homeopathic "medicines".
(Score: 3, Insightful) by requerdanos on Wednesday December 20 2017, @07:48PM (5 children)
A "drug" is a particular substance, or combination of substances, that has some effect on the body.
A "homeopathic" composition is woo-woo [inscientioveritas.org] that has meticulously had anything that might possibly (but probably not) have had any effect carefully removed by means of dilution [rationalwiki.org] to oblivion.
It's like saying "the wet sun" or "the blinding brightness of the dark." Might sound real impressive until you think about it: One or the other. Can't be both. Either something is homeopathic, or it's not and therefore possibly a drug.
People who believe that "homeopathic" "drugs" exist are to be pitied, but not encouraged. People who encourage others in this belief are to be actively discouraged.
Since any such products "have not been shown to offer clinical benefits" and never will be, it can only be a good thing that they are now required to put up or shut up.
(Score: 0) by Anonymous Coward on Wednesday December 20 2017, @09:56PM (2 children)
Thanks for that, I never bothered to look into it and just assumed homeopathy and herbal medicines were basically the same thing.
(Score: 2) by MichaelDavidCrawford on Thursday December 21 2017, @01:35AM
.. that might actually kill you. You're lucky if you only get sick.
At least with homeopathic "drugs" they have the benefit of not poisoning you.
Yes I Have No Bananas. [gofundme.com]
(Score: 0) by Anonymous Coward on Monday December 25 2017, @04:03AM
Some things that are labelled homeopathic, actually aren't. So don't assume that just because something is called homeopathic, that it follows homeopathic principles and is essentially harmless (aside from any potential harm caused by it being used as an alternative to actually effective treatments).
(Score: 2) by takyon on Wednesday December 20 2017, @11:09PM (1 child)
Take it up with the FDA, I used their words.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by requerdanos on Thursday December 21 2017, @01:31AM
I frequently use these comment areas as a forum for addressing the subjects (or authors) of T-various-FAs. This is no exception; it was their words I quoted, and to their words I spoke. No offense to any editors intended.
(Score: 0) by Anonymous Coward on Thursday December 21 2017, @12:52AM (2 children)
From the opioid saga, the FDA has little credibility as interested in protecting patients over drug profits.
From the cost of new drugs versus their benefit over generics, same answer.
So what to do?
Do our job, fix the problem? No, of course not, that might be career affecting.
Instead, let's make a distraction so it will look like we are doing something useful.
Merry Christmas from the FDA.
If you happen to be a drug company, we definitely have your six.
It is interesting that Trump actually has direct experience in drug addiction, and the FDA runs merrily along.
(Score: 2) by MichaelDavidCrawford on Thursday December 21 2017, @01:33AM (1 child)
I was once prescribed Latuda as an antidepressant. It set the American taxpayer back thousands of dollars per month.
But it did nothing for me.
Back in the day I took the SSRI Paxil but it only "benefited" me in one way: I had infinite lasting power, because Paxil made me Anorgasmic.
My witch doctor replaced the Paxil with imipramine. My monthly supply was only $15.
I asked to switch from Latuda to amitryptiline. It has been generic for decades. I don't know the price because its low, low price is covered by Obamacare but I _can_ tell you that I'm doing really well these days.
In February I went to an emergency room because I had become suicidal. I knew that my depression was delusional but just knowing that I'm delusional doesn't make the delusion go away.
That's when I got set up with Latuda.
Decades of experience teaches me that if I'm not suicidal I can claim to be feeling pretty damn good.
Yes I Have No Bananas. [gofundme.com]
(Score: 3, Informative) by Azuma Hazuki on Thursday December 21 2017, @06:35AM
Be careful with imipramine and its ilk; those are tricyclics and have some nasty effects, I'm told. In particular they can cause serotonin syndrome, which is no fun at all.
I am "that girl" your mother warned you about...
(Score: 2) by MichaelDavidCrawford on Thursday December 21 2017, @01:25AM
Stuff like wormwood capsules. Real wormwood has shown that it's effective for depression but not all of the "wormwood" supplements actually contain wormwood.
Yes I Have No Bananas. [gofundme.com]
(Score: 2) by Subsentient on Thursday December 21 2017, @02:19AM
"It is no measure of health to be well adjusted to a profoundly sick society." -Jiddu Krishnamurti
(Score: 2) by Lester on Thursday December 21 2017, @02:36PM
FDA to More Strictly Regulate water and other excipients with no trace active ingredient