Americans may soon be able to get cholesterol-lowering medications and other widely used prescription drugs without seeing a doctor, a first step in what could amount to sweeping changes to how patients access treatments for chronic conditions.
The Food and Drug Administration in a draft guideline on Tuesday outlined how such a status, which the agency said could help lower health-care costs, would work. Patients could answer questions on a mobile-phone app to help determine whether they should be able to access a medication without a prescription.
"Our hope is that the steps we're taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription," FDA Commissioner Scott Gottlieb said in a statement.
Order your drugs from a smartphone app.
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Scott Gottlieb walks through the revolving door to the Pfizer board
The revolving door turns again. After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world's largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines.
And in doing so, Gottlieb is also picking up where he left before joining the agency, since he had been on the board of several smaller pharmaceutical companies and was also a partner at a venture capital firm that invests in life sciences companies.
"This is classic and it's not surprising," said Sidney Wolfe, a founder of Public Citizen Health Research Group and a long-time FDA watchdog, who had expressed concern about Gottlieb's ties to industry before joining the agency. "Philosophically, he's returning to the ecosystem where he's most comfortable. And he'll get paid very well for it, too."
Also at Financial Times.
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(Score: 0, Insightful) by Anonymous Coward on Thursday July 19 2018, @09:20AM (5 children)
"Mommy, mommy! There's a monster in my closet!"
"Oh, shush. There's no such thing as monsters. Let me prove it to you."
Following the exchange with her son, the mother got up off of the boy's bed and walked over to the closet. The woman then opened the accordion-style closet door about halfway, and stopped. Just as she was about to turn around and smile at her son, a hand reached out of the closet, grabbed her throat, and quickly pulled her in. After this, the closet door slammed shut.
Then came the screaming. Oh, did she scream. The mother screamed so loud that it pierced one's eardrums. This was accompanied by loud bangs and slams, moans of pleasure, and flesh slapping against flesh. The closet door was shaking so violently that it seemed as if it would fall right off. And the boy just stared blankly at the door. Even though he should have run away, he was paralyzed by terror and despair, and so he simply stared. Suddenly, a loud thud was heard, and everything went silent. Total silence.
However, that silence was short-lived; the closet door soon opened partway, and someone's upper body leaned out from within. It... was a man. It was an obese man with beady little black eyes and a smile on his face. Oh, what a smile. Oh, what a horrifying smile it was. As the man exited the closet and crept towards the bed, the little boy simply stared at the nightmarish figure before him. Yes, there was no chance of escape, anyway...
"Night-night!" said the man, as he gently tucked them into bed. To him, seeing them sleep so soundly together was truly heartwarming. The man left the house with a genuine smile on his face, never to return.
Several months later, a mother and her son would be found lying on a bed together. They lived together, they slept together, and now they rotted together.
(Score: 2) by Subsentient on Thursday July 19 2018, @06:39PM (4 children)
Whoever keeps writing these is probably a serial killer or belongs to a demented cult.
"It is no measure of health to be well adjusted to a profoundly sick society." -Jiddu Krishnamurti
(Score: 2) by Azuma Hazuki on Thursday July 19 2018, @07:23PM (3 children)
And there is zero effort, NONE, by the staff of this place to get rid of them (the stories or the poster) as far as I can tell. THAT'S what really disturbs me...
I am "that girl" your mother warned you about...
(Score: 2) by Subsentient on Thursday July 19 2018, @11:53PM
I mean, it's a very unpleasant read, but I'm alright with it I guess. I don't like permabans. Still wish he'd at least make them funny.
"It is no measure of health to be well adjusted to a profoundly sick society." -Jiddu Krishnamurti
(Score: 2) by Phoenix666 on Friday July 20 2018, @03:11AM (1 child)
I don't think that's true. I checked in on the IRC channel a while back and they were in the middle of a conversation about how they keep banning him and he keeps coming back.
Washington DC delenda est.
(Score: 2) by Azuma Hazuki on Friday July 20 2018, @03:28AM
We've already seen it's possible to lameness-filter posts. What they need to do is implement a multi-level Bayesian filter and train it on this guy's unique vocabulary and sentence structure. I'm sure that's difficult, but also sure it can be done.
I am "that girl" your mother warned you about...
(Score: 5, Insightful) by Anonymous Coward on Thursday July 19 2018, @09:34AM (1 child)
Usually this is done to when insurance companies want to get expensive drugs officially 'over the counter', which means that insurance companies then no longer need to cover them under their 'prescription drug plans', the patient now has to pay out of pocket.
I.e. this is cost shifting to the consumer.
Which lobbyists are pushing for this proposal? Follow the money..
(Score: 2) by ElizabethGreene on Thursday July 19 2018, @01:04PM
This is exactly what I was going to say. Insurance companies pushed acid reducers like Zantac and Nexium OTC because now they don't have to pay for them. The price has come down since, thanks generics, but when they first went out it was crazy expensive.
(Score: 1, Funny) by Arik on Thursday July 19 2018, @10:25AM
Next week, I might try to teach you morons to speak English.
Probably not though. You bore me.
If laughter is the best medicine, who are the best doctors?
(Score: 2) by driverless on Thursday July 19 2018, @11:41AM (1 child)
Way too risky unless it uses really good encryption. I usually text my dealer a comment on game plays from the last few days, and he knows how to translate that into the appropriate amount and type of weed.
(Score: 0) by Anonymous Coward on Friday July 20 2018, @07:19PM
weed is for pussies. heroin and cocaine are the kewl kidd drugs.
(Score: 3, Interesting) by AndyTheAbsurd on Thursday July 19 2018, @11:52AM (19 children)
Can we just go back to being able to get codeine and pseudoephedrine OTC like people that actually give a damn about getting effective drugs? Phenylephrine is fucking useless and codeine is more effective than all the current OTC painkillers.
Please note my username before responding. You may have been trolled.
(Score: 3, Informative) by bzipitidoo on Thursday July 19 2018, @12:08PM (14 children)
I ran into that pseudoephedrine vs phenylephrine. You can get them both OTC, but for the former they make you jump through a few extra hoops. Don't need a prescription, but they keep it inside the pharmacy out of immediate reach so they can have you sign an acknowledgment before they sell it to you. And they won't sell you more than 20 pills or so per day. All that is the War on Drugs, because it's supposed to be easy to turn into meth. The latter is in the store aisles.
And then in our case the pseudoephedrine turned out not to help much either. Helped a little at first, but the underlying problem was not allergies. And it is more of a strain on the heart. You're right about the phenylephrine-- didn't do anything.
(Score: 2) by fadrian on Thursday July 19 2018, @12:35PM (12 children)
You can't get pseudoephedrine in all states without a prescription. At least, here in Oregon, you need one.
Yes, it's a pain in the ass. No, it doesn't make the place a totalitarian hellhole.
That is all.
(Score: 3, Interesting) by bzipitidoo on Thursday July 19 2018, @12:57PM (5 children)
My experience was with Texas.
One thing about Oregon that stands out in my memory is full service gas, only. Only other place I encountered that one was Manitoba. They won't let you pump gas yourself, and as I learned, that's bad. If you ask them to fill it up, the attendants will overfill your tank and some will slosh out-- gasoline is kinda hard on the paint job, you know. And some even deliberately pump a little onto the ground, to "make it come out even". It was pathetic to see those teenage attendants liking that law because it gave them jobs.
(Score: 2) by Runaway1956 on Thursday July 19 2018, @02:29PM (2 children)
So - uhhh - let me cross examine you just a little bit. In Texas, I can get pseudephedrine, in limited quantities, without a prescription, today? If so, I simply didn't know it. I only live 25 miles from New Boston, Tx. Here in Arkansas, I was flat out told that I couldn't get it without a script, quite a number of years ago. So, I didn't even try to get any, unless the doctor filled out his paperwork.
If so, I'll be making a quick trip to either New Boston, or Texarkana, soon, just to get a bottle. I don't care that it's limited quantities - I don't plan on misusing the stuff. I certainly have no interest in meth!!
(Score: 0) by Anonymous Coward on Thursday July 19 2018, @05:10PM (1 child)
You can. It's a behind the counter drug, so you have to go to the pharmacy counter, you'll need an ID, and they limit the amount you can buy per month (they do track it). Pain in the butt, but better than nothing.
(Score: 2) by bzipitidoo on Thursday July 19 2018, @10:24PM
Correct. They will ask to see your driver's license so they can flag it in case you try to go to another store and buy more on the same day. Might want to call first, check if an AR license is acceptable before driving over.
I don't recall the limit either, think 20 pills per person per day. Bring several adults with IDs with you, and they will let you have 20 pills per person, all at once.
(Score: 2) by RS3 on Thursday July 19 2018, @04:51PM (1 child)
New Jersey is the same: not allowed to pump your own gasoline.
(Score: 0) by Anonymous Coward on Friday July 20 2018, @02:33PM
Why? That sounds.. stupid..
(Score: 4, Interesting) by Phoenix666 on Thursday July 19 2018, @01:58PM (4 children)
It's why I stock up on drugs I know are useful, like anti-biotics, whenever I travel to a 3rd World Country, exactly because they don't make you jump through doctor and insurance hoops. You got the cash, they got the meds.
We talk about FLOSS all the time in our community, and folks have started talking about Open Harware, Open Cars, and that sort of thing, so I'd add that it would be great to start talking about Open Medication. Yes, I'm aware of potential pitfalls, but I'm also keenly aware of what a racket Drug companies have going.
For me, it's a question of freedom. Every single time we let ourselves depend on a corporation or government to do something, they turn right around and abuse it. If we give ourselves the means to walk away then it levels the playing field.
Washington DC delenda est.
(Score: 1, Interesting) by Anonymous Coward on Thursday July 19 2018, @02:05PM
Fuck the pitfalls. Give me a chemputer that prints antibiotics, LSD, cocaine, heroin, or whatever. The DEA never had a high ground to lose.
(Score: 4, Insightful) by DeathMonkey on Thursday July 19 2018, @04:53PM (2 children)
My personal philosophy is that all drugs should be legal for individuals to purchase. This includes all prescription drugs.
The implementation would be a phased approach where we slowly introduce new drugs in reverse-order of harm. E.g. crack would probably go last.
(Score: 2) by HiThere on Thursday July 19 2018, @05:37PM (1 child)
I'm not sure I agree about this for anti-biotics, but where the only damage is done to the person taking the drugs I'm fine with it. But I think that the laws allowing the advertising of drugs are far too loose. And I include alcohol on that list. (Not, however, coffee or tea. Despite the humor those are neither excessively dangerous nor addictive, and only slightly habituating.)
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 2) by DeathMonkey on Thursday July 19 2018, @05:45PM
I'm not sure I agree about this for anti-biotics, but where the only damage is done to the person taking the drugs I'm fine with it.
Hmm...hadn't really thought about antibiotics in that frame...
There is a compelling, direct, harm to the public there.
However, it's not taking the drugs that's the problem. It's not-taking the drugs that's the problem.
Id' rather see failing to complete the course of antibiotics be illegal than starting an unapproved course in the first place . Although....I have no idea how you'd implement something like that.
(Score: 0) by Anonymous Coward on Friday July 20 2018, @01:48AM
Though you may be singing a different tune when the government comes for you, because you bought over your allocated amount before the 31 day window was over.
(Score: 0) by Anonymous Coward on Thursday July 19 2018, @02:51PM
Yeah, that is because the chemical makeup of the two is identical, but they are mirror images of each other. The thing is, that getting the one to switch to the other is harder than just making it from other sources, but that doesn't stop them from making your life harder because someone thinks it seems too similar.
(Score: 0) by Anonymous Coward on Thursday July 19 2018, @02:22PM (2 children)
This is Australia son. In order to save a few hundred people from killing themselves using codeine you must have a script. If a doctor will write you one. If you are willing to store your medical data in the government myhealth record system so they can sell the info to companies. Suck it up princess. Take 2 asprin and slap yourself in the face in the morning.
(Score: 2) by Runaway1956 on Thursday July 19 2018, @02:32PM (1 child)
Wow, that sounded awesome. Almost as awesome as https://www.youtube.com/watch?v=eZeYVIWz99I [youtube.com]
(Score: 0) by Anonymous Coward on Friday July 20 2018, @04:10AM
Our pollies are awesome
they just want to protect us
really
(Score: 3, Informative) by Taibhsear on Thursday July 19 2018, @03:48PM
Assuming you aren't one of the 10% or so of people (like myself) who are effectively immune to codeine. I believe 4-5% of people metabolize it better than normal too. So if you are in that group and don't realize it, taking it over the counter could really fuck you up. Whereas if you're in the former group you're just pissing away your money.
"The conversion of codeine to morphine is effected by CYP2D6. Well-characterized genetic polymorphisms in CYP2D6 lead to the inability to convert codeine to morphine, thus making codeine ineffective as an analgesic for approximately 10% of the white population. Other polymorphisms can lead to enhanced metabolism and thus to increased sensitivity to the effects of codeine. Variation in metabolic efficiency is evident among ethnic groups. For example, Chinese individuals produce less morphine from codeine than whites and are less sensitive to the effects of morphine." -Gregory R. Polston, Mark S. Wallace, in Kelley and Firestein's Textbook of Rheumatology (Tenth Edition), 2017
(Score: 0) by Anonymous Coward on Thursday July 19 2018, @12:23PM (4 children)
I can use an app to get over the counter LSD?
Wait, it's just for discount Lipitor and the opioid pen. Fuck you, Scott.
(Score: 1, Troll) by DannyB on Thursday July 19 2018, @01:59PM (2 children)
How about a convenient "High" Schooler's multi pack with:
* e-cigarettes
* opoid inhaler attachment accessory
* LSD extended release controlled dose arm patch
* an 87 sided dice you can roll to decide which gender you are today
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 0) by Anonymous Coward on Thursday July 19 2018, @02:03PM
Shitlord talk. How dare you imply there are so few genders.
However I will take the patch in LSD and DMT flavors.
(Score: 0) by Anonymous Coward on Thursday July 19 2018, @06:58PM
Am I the only person who remembers that the phenomenon of gendered toy preferences in the crib (before any socialization could have possibly happened) was proof that the gender wage gap was not a problem at all and only the result of voluntary preference and emergent behavior between the genders?
(Score: 5, Interesting) by Phoenix666 on Thursday July 19 2018, @02:04PM
Back in my Madison Avenue days Pfizer was one of my clients. At the time we were working on a campaign for them for a drug that combined Lipitor with some other drug commonly prescribed along with Lipitor. The reason was Lipitor was on the verge of losing its exclusivity and generics were waiting to jump into the market; if they re-mixed Lipitor with another drug they could presumably prolong their lock on the market. Lipitor constitutes a huge share of Pfizer's revenue, 60% I think it was then, so they were eager to not have generics eat into that.
So this I read as trying to go the other way, to make up in volume by selling OTC what they lost selling at a premium. It's a play on their name recognition.
Washington DC delenda est.