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Medicine United States

Another Online Pharmacy Bypasses the FDA To Offer Cut-Rate Weight Loss Drugs 124

Posted by msmash from the how-about-that dept.
An anonymous reader shares a report: Hims & Hers Health, one of the online pharmacies that got its start prescribing dick pills, is now offering knockoff versions of GLP-1 weight loss drugs. Hims & Hers says it will offer drugs that mimic Ozempic and Wegovy, the active ingredient of which is semaglutide. The copycat versions are made by compounding pharmacies. The formulations aren't the same as the FDA-approved versions of the drug and haven't been directly evaluated by the FDA, either. But they're cheaper than the real thing: $199 a month, compared to the branded version, which can cost more than $1,000 a month without insurance.

Compounding pharmacies can make knockoff versions of branded drugs when they are in shortage, as the GLP-1 drugs -- prescribed for diabetes and weight loss -- currently are. The FDA has already received reports of adverse events for compounded versions of semaglutide. Hims & Hers says it "conducted extensive research for over a year" into finding a supplier, but does not name the one it chose to partner with. "Over the last year, we have grown in our conviction -- based on our medical experts' evaluation and the strength of our infrastructure -- that if done properly, compounded GLP-1s are safe and effective," the company said in its statement.
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Another Online Pharmacy Bypasses the FDA To Offer Cut-Rate Weight Loss Drugs More

Another Online Pharmacy Bypasses the FDA To Offer Cut-Rate Weight Loss Drugs

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  • Might be worth it (Score:4, Interesting)

    by MBGMorden ( 803437 ) on Monday May 20, 2024 @12:34PM (#64485555)

    I know several people who have gotten prescriptions for the semaglutide weight loss drugs who won't buy it because insurance (even most good insurances) won't cover it and out of pocket its just too expensive.

    $199 per month is still expensive but it takes it from unattainable for most down to just a rather expensive prescription. In general though we need both a) the drug to get cheaper and b) insurances to start covering it. Weight loss at the level that this is usually prescribed isn't merely cosmetic - its a true health issue.

  • what is the canada price for real one?

  • I haven't dug into what the real results of semaglutide are but if this is a real measurable reduction in obesity with an acceptable prevalence of side effects and with obesity being the growing problem that it is then just buy the patent and make it cheap for everyone to take.

    For important drugs with wide implications I think the public should reserve the right to say "this is too important to have under a single provider at a premium price" so just pay them for their dev costs and little more on the top f

    • The barbell deadlift results in a measurable reduction in obesity plus other beneficial effects and isn't subject to patents.

      • Re:Buy the patent (Score:5, Interesting)

        by jacks smirking reven ( 909048 ) on Monday May 20, 2024 @12:50PM (#64485613)

        See that's exactly what I am talking about.

        You are 100% correct and every doctor and health professional will tell people just the same but it is almost 100% useless as a policy prescription. Does the government buy everyone a gym membership? How do you make them go? How do you make sure they have proper technique? It take's a lifetime to become obese and stay that way, we need multi-pronged solutions for sure and advocacy is a big part of it but it can't just stop there.

        The doctor can't even force someone to exercise despite telling them to do it every single time they see them but if they don't and say their blood pressure keeps rising he can keep saying that but at some point he's just gonna have to write the script because the patients health is getting worse.

        So yes, it makes us feel good to say "just exercise there fatty fat fat" it doesn't really get us closer to having an effect on obesity *as a society*. This is that line between what we say to each other as individuals ("hey get started exercising, i'll help you get started and you probably won't have to take any drugs" is what we would tell someone we know) versus what we say and do as a society.

        • So yes, it makes us feel good to say "just exercise there fatty fat fat" it doesn't really get us closer to having an effect on obesity *as a society*.

          The problem is many people love to judge others - I imagine it makes them feel better about their own perceived personal shortcomings somehow. They really have no interest in solving the problem or helping anyone - they just like to dismissively shit on other people.

          • So yes, it makes us feel good to say "just exercise there fatty fat fat" it doesn't really get us closer to having an effect on obesity *as a society*.

            The problem is many people love to judge others - I imagine it makes them feel better about their own perceived personal shortcomings somehow. They really have no interest in solving the problem or helping anyone - they just like to dismissively shit on other people.

            Exactly.

            Sarcasm truth alert - I mean if we are obese, it has to be a personality defect, people too mentally weak and lacking impulse control that the better people have. A true strain on society, when the superior healthy and thin people have to pay the medical bills for those who shouldn't be covered at all because the fatties are 100 percent responsible for all their health problems. Sarcasm off

            It's a whole lot more complex than simple lack of willpower, and there is a direct link between endocrine

        • How do you make sure they have proper technique?

          And that's the hardest part because most "coaches" or "trainers" are more like glorified personal cheerleaders whose primary skill is setting the pins in machines.

          • Exactly so I am not exactly keen to subsidize that industry. I would totally support more advocacy for exercise, I'm glad the Presidential Fitness Test is back on for kids

            But if you've been obese since your teenage years chances are you need medical intervention so take the pills if it helps and we should encourage that. We American's already love drugs way too much, what's one more?

            • If you've been obese since you've been a teenager, you've likely suffered quite a bit of stigma. And you're not a natural athlete. Chances are you've never even been taught a proper squat and deadlift. We find people who were obese their whole lives, learn to squat and deadlift and sixty years old, and go on to win championships. Chances are you need a coach who is interested in your health and not a coach who is looking for people who are already beautiful in order to use that to advertise their busine

      • >"The barbell deadlift results in a measurable reduction in obesity plus other beneficial effects and isn't subject to patents."

        Eater fewer calories is a lot easier and cheaper. I am not anti-exercise, but there is absolutely no need to exercise in order to lose weight.

        • Eating fewer calories results in the loss of muscle and bone density and then you will slip and fall, break your hip, and spend the rest of your life sitting on an ECV where it's nearly impossible not to end up extremely overweight. Plus it's a huge hit to your quality of life. It's not easier to restrict calories all day even when you're hungry and it affects your job than it is to spend an hour with a barbell three times a week. Lifting weights for health takes three hours a week. Starving yourself ta

          • I do agree that it is *better* to lose weight by raising metabolism. Or a blend of caloric reduction and exercise. I was just saying it isn't a requirement. But if you still over-eat, even if the ideal point is raised through a higher metabolism, there will still be fat weight gain. Think Sumu wrestlers- lots of muscle, but also overweight with too much fat as well (of course, that is their goal).

            • I do agree that it is *better* to lose weight by raising metabolism. Or a blend of caloric reduction and exercise. I was just saying it isn't a requirement. But if you still over-eat, even if the ideal point is raised through a higher metabolism, there will still be fat weight gain. Think Sumu wrestlers- lots of muscle, but also overweight with too much fat as well (of course, that is their goal).

              This is exactly my point. For Sumo wrestlers to be that size, they are eating more food than most people could consume if they tried. Many people who first want to get strong are encouraged to eat diets of like 3k-4kCal/day and they complain that its "so hard" to eat that much.

    • Very very few people would take the risk of investing in costly research and development activity if the government could just swoop in and steal the fruits of it. Ironically it's the government that's made R&D so expensive.

      • so just pay them for their dev costs and little more on the top for their trouble

        I said as such but let me re-iterate: I would not expect a pharma company to just do all the work of developing a drug and not be compensated for it or end up in the red, so they can submit their R+D expenditure and what their expected revenue would be and we can even throw them some of that. They did the work, they should get paid. That does not mean they are entitles to the maximum amount of profit for the maximum amount of time.

        I said the exact same about the CV19 vaccines, that they should have been be

        • Re: (Score:2)

          by hawk ( 1151 )

          >so just pay them for their dev costs and little more on the top for their trouble

          but that's the catch.

          In very round numbers, it's a billion dollars to get a drug to the point of late clinical trials.

          I'm not sure of the exact number, but call it 1 in 3 that makes it to actual approval. (again, we're being very round, here).

          Total sales of that one drug needs to cover the costs of its siblings, as well.

          And production cost of that drug may well be a small fraction of what it cost to develop it.

          Just to pull

          • Total sales of that one drug needs to cover the costs of its siblings, as well.

            Sure but we can always work around that with some form of tax break or helping cover costs for other things they are developing, especially if those are also important. Also if the drug worked and was so important that this rule would come into affect chances are the government also is going to be purchasing a large amount of it (Medicaid is pretty much the #1 drug buyer in the country) so we could also give them that contract exclusively and let everyone else deal with generics.

            Like the #1 killer is still

      • Re: (Score:2)

        by ufgrat ( 6245202 )

        Wow. It's unusual to encounter this level of naivete. The fact that you think the high drug prices in the United States have anything to do with R&D is adorable.

        Look up the history of the "epi pen" and why Mylan raised the price by FIVE HUNDRED PERCENT in 2016, when the original product was developed and brought to market 33 years earlier.

        Merck's cancer drug Keytruda costs $100,000 more in the U.S. than it does in France, according to a committee analysis. Bristol Myers Squibb's blood thinner Eliquis costs almost 10 times more in the U.S. than in Germany. Johnson & Johnson's arthritis drug Stelara costs five times more in the U.S. than it does in Japan.

        If you have EVER had as much as a single episode of atrial fibrillation (the most common heart arrhythmia in the world), then there is a very good chance that your d

        • The epi-pen is a point in my favor lol .. did you even READ what I wrote .. read my last sentence 10 times slowly. The epi-pen price is entirely due to government. It's 33 year old tech right? You should be able to make one with a 3D printer or something really cheap .. right? So try doing it and get back to me from prison.

          • Re: (Score:2)

            by ufgrat ( 6245202 )

            Actually, CVS and a few others made a clean-room implementation of the epipen.

            If you had been a bit more direct, and said that the patent laws need to be reformed, I'd have agreed with you.

    • Re: (Score:2)

      by olddoc ( 152678 )
      Yes, GLP-1 drugs are the real deal. They really result in lots of weight loss. They also have been shown to help prevent heart problems in diabetic patients. But the profits are so extreme that NovoNordisk wouldn't sell the patent for $50 billion. However, the patent expires in 2026 and hopefully there are no sleazy tricks to extend it and prevent generic competition.

      • That's good to hear and I see them getting advertised a bunch now and I've read positive results, I just haven't kept up with any long term studies. I also figured there are newer formulations on the way as well.

        If they really work then then that's exactly my point, even if it cost $50B to buy it from them if it reduced obesity a measurable amount it'd probably be a "profitable" investment in medical savings alone. So take your $50B check Novo and try to put on a smile about it.

        This could turn into an ins

    • I haven't dug into what the real results of semaglutide are but if this is a real measurable reduction in obesity with an acceptable prevalence of side effects and with obesity being the growing problem that it is then just buy the patent and make it cheap for everyone to take.

      For important drugs with wide implications I think the public should reserve the right to say "this is too important to have under a single provider at a premium price" so just pay them for their dev costs and little more on the top for their trouble (and they are still welcome to sell it) but then allow it to go generic for easier access. Even if we got a 10% reduction in the rate of obesity that would pay for itself in the long run.

      And we are Americans so we talk a big game about personal responsibility and yes, everyone should eat right and exercise and blah blah blah but people ain't doing that and asking millions of people to change ingrained lifelong behaviors is a recipe for failure at a policy level so the American thing to do is use pills and money to get us out of a jam.

      What is your metric of acceptable side effects? Thyroid cancer? The claim is that Ozempic causes thyroid cancer in rats, but not in humans. Okay, they tell people who have relatives that had thyroid cancer not to take it. Pancreatitis is a possibility, and the list is a pretty long on of the more common side effects https://www.drugs.com/sfx/ozem... [drugs.com]

      And perhaps it is time to remind people again that despite the popular narrative, there are actually people other than Americans who are obese. In the EU, a m

      • What is your metric of acceptable side effects?

        I mean that's up to the FDA and the actual doctors. We do have criteria for the percentage and severity of side effects and what the cost/benefit should look like. Is thyroid cancer 1:100k? 1:1m? 1:100m? If the risk of pancreatitis is non-specific enough and common enough then no, I would not implement this. I might put out a prize call or ease the process for a safer formulation. That said if you are obese you are already at high risk for several conditions so we have to weight the side effects again

        • Well I only spoke to America because we end up fronting so much of the cost for these products even though the world gets to take advantage. I haven't looked up how those health systems are working with GLP-1 drugs but I imagine if they are effective they will make them available in their systems but my point is those people will probably pay way way way less than Americans will.

          Also if GLP-1 really is so successful then at that point it could make the WHO vital medicine list eventually.

          Now the next question. If the metric of health is being at the proper weight, what if a person doesn't want to take the drugs. Perhaps they should be punished? There was a professor at an Eastern University who claims that as little a 5 pounds overweight makers for health problems.

          I can imagine some believing that we should embark on a large scale shaming program like they do for cigarette smoking. Why not?

          And then there is myself. According to the charts, I am morbidly obese. Yet it is overwhelmingly m

          • Now the next question. If the metric of health is being at the proper weight, what if a person doesn't want to take the drugs. Perhaps they should be punished? There was a professor at an Eastern University who claims that as little a 5 pounds overweight makers for health problems.

            Nope but If it works and made accessible I think the majority will use it, nobody want's to be obese really, its culturally ingrained in us today. I think that's a "cross that bridge when we get there". It will take decades for the numbers to trend downwards so continued downward trend is the target, edge cases are when they are edges.

            I can imagine some believing that we should embark on a large scale shaming program like they do for cigarette smoking. Why not?

            We do, as much as the "healthy at any size" group tries to do generally a good thing fact is you are effectively shamed indirectly all the time and directly pretty often. I

            • Trying to extend that all on the old age side of life might not be as great as people think, as we turn into chemical people, taking drugs that might just kill us.

              I mean sure but that's also why there's some Nobel's just waiting for someone to come up with an effective Alzeimer's treatment. I think we're actually getting pretty good at people living excellent lives well into their old day's and to me that's a worthy goal, we can wax poetic for sure but time only moves on direction so we don't really have an option. I for one welcome our cyber-pharmo-kinetic future, to me it's a modern luxury to have to think about the fact we might have too much access to things that are literal miracles just a couple centuries prior, everything on that WHO list is a triumph of mankind in my opinion.

              We have more people living older before they die, but we haven't actually extended lifespan, only the average age at death.There are no 200 year old people, and I doubt there will be. Lots of things like bones are not designed to live those sort of spans. We wear them out. Shoulders, knees, hips, titanium people.

              Even so, have you spent much time around Nursing homes? A lotta people there that cry all day long. But fear not, their doctors prescribe them more pills to keep them crying longer.

              Anyhow, if yo

    • > so just pay them for their dev costs and little more on the top for their trouble

      Last I heard about 10 $3B dev cost drugs fail for every one that succeeds.

      So your solution would rapidly bankrupt Pharma companies. Maybe that's for the best, but we're close to curing most cancers.

      • That can also be addressed, we can ease the trial process in a number of different ways since that is a shared burden (OWS did a lot of good things there).

        This isn't something I would apply to even a minority of pharma products, the criteria would be pretty strict but it should be on the table for something that would have immediate positive effects on a large portion of society.

        Another option is a voluntary prize system "if you develop this drug, you get this money". The US already does something similar w

  • Once you understand that you quit carbs, eat fatty meat, drink water (ideally spring water), and most of the time the pounds come off. They lied about red meat and animal fat being bad for us. But you can't keep the Sickcare Industrial Complex at 20% of GDP if people eat correctly.

    Bonus points for finding local farms raising livestock on pasture and patronizing them. Their animals are healthier and they're building soil without herbicides, pesticides and synthetic fertilizer. Best way to put Monsanto etc ou

    • Giving up carbs is hard over a long duration. I have tried it and it inevitably leads to weight off to weight on cycles. You end up feeling crappy and losing muscle mass. I think it is too extreme. For most people, I think they can make incredible long term strides by just giving up the worst, most unnatural, and most addictive carb: refined sugar.

      I think that for most people, that diet change alone along with light exercise, if done strictly and for a long period of time (lifestyle change), will get them f

      • >"Giving up carbs is hard over a long duration [...] .I think they can make incredible long term strides by just giving up the worst, most unnatural, and most addictive carb: refined sugar."

        You don't need to get rid of ANY food or food type to lose weight. It might not be the most healthy or effective way to lose weight, but one can eat nothing but pizza and soda and lose weight. Ultimately, it is primarily about the caloric intake. Almost all cases of weight gain are simply eating more calories than

      • I recently (about 1 month ago) gave up all extra sugar, keeping my intake to below the USRDA, which is about 50 grams of sugar. It's been a real bitch to kick the sugar habit, but I've done it. Lost 2 pants sizes and 20 pounds just form that change alone.

  • That difference in price tells you one important thing: big pharma could make the real thing for that price, and ALL the rest is profit. And Him and Hers Health is guaranteed to be marking it up 100% from what they pay.

    Nationalize big pharma. I mean it.

    • Re: (Score:2)

      by mysidia ( 191772 )

      The government is a Huge part of the problem when it comes to pharmaceuticals, Because the FDA by design makes the Approval process Time consuming and extremely expensive before they can even create a sellable product.

      The Average timeframe to get a drug approved before they can start selling it is 12 Years, for example.

      That is 12 years after the company researched and developed a drug that can be Life-saving medication.

      And the risk of this process is so extremely high of being denied approval and gettin

      • Re: (Score:2)

        by whitroth ( 9367 )

        100% WRONG. You don't know what you're talking about.

        You don't *want* them doing serious scientific testing? Really? Look up thalidomide.
        And then there's the money they spend on drugs that do no better than an existing one... but whose patent is running out. Think I''m making that up, India refused a patent to a drug from big pharma for *exactly* that reason a few years ago.

        On top of which, 60%? 80% of all basic research in the US on new drugs is FUNDED BY THE NIH (your tax dollars at work)(ObDisclosure: I

    • This is like expecting to stream any movie for 40 cents because that's how much the bandwidth costs.

  • Sure, why not (Score:3)

    by smooth wombat ( 796938 ) on Monday May 20, 2024 @02:25PM (#64485917) Journal
    Both Ozempic and Wegovy are linked to severe stomach issues [nbcnews.com] along with thyroid tumors, pancreatitis, changes in vision, hypoglycemia, gallbladder issues, kidney failure and cancer issues, along with hospitalization [cbsnews.com]. Why not have someone make knockoffs wth little to no oversight? What's the worst that could happen?
  • Ozempic and Wegovy are under patent protection in the USA. NovoNordisk does not supply semaglutide for compounding and I don't understand how any pharmacy can legally acquire semaglutide in the USA. A compounding pharmacy could make cherry flavored chewable ibuprofen gummies at 325mg per dose because they can obtain pure ibuprofen. They shouldn't be able to package any form of semaglutide. The only thing I could think of that is somewhat safe and legit would be breaking apart 4x2.4mg dose pens into 9 one mg

    • Re: (Score:2)

      by Thud457 ( 234763 )
      I take it you're unfamiliar with "The Stuff" [wikipedia.org]?

    • Right - article makes no sense.

      Maybe it's smuggled in from China but that's not what compounding means.

    • China and its probably full of god knows what other toxins

    • >"I don't understand how any pharmacy can legally acquire semaglutide in the USA. A compounding pharmacy could make cherry flavored [...]"

      Thank you.

      That is what I was going to post. I suspect this has nothing to do with "compounding" and sounds more like just illegally copying a patented medication, then illegally selling it.

  • As soon as you stop taking these drugs, you immediately start gaining weight again. So as a permanent weight loss strategy, you will be on the drug for life. Thus the Total Cost of Ownership is ((Life Expectancy - Current Age) * monthly drug cost * 12). Example: a 40-year old who expects to live to 82 and pays full US non-insured rate of $1,000/month = ((82-40)*1,000*12) = $504,000. For comparison, the median home price in the US in 2023 was $412,000.

    No thanks.

    • >"As soon as you stop taking these drugs, you immediately start gaining weight again."

      If you continue to eat more calories than your body needs, yes. That will always be the case after any weight loss regimen.

      >"Example: a 40-year old who expects to live to 82 and pays full US non-insured rate of $1,000/month = ((82-40)*1,000*12) = $504,000."

      I think the generic will be out in a few years at a small fraction of the current cost. Of course, the alternative, eating less, not only averts all that cost, i

  • Buying knockoff pills with a very short track-record of human usage from a sketchy online 'pharmacy'...

    Sure, why not.

    Pro-Tip: Make sure you use a credit card so you can do a chargeback when these knockoff 'meds' make your kidneys stop working or cause your spleen to explode.

  • Statement from their racist CEO:

    Moral courage > College degree
    If you’re currently protesting against the genocide of the Palestinian people & for your university’s divestment from Israel, keep going. It’s working.
    There are plenty of companies & CEOs eager to hire you, regardless of university discipline.

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