That’s better than the Surgeon General’s recommendation.
{{ Winfrey is now helping WeightWatchers bring its members on board with a new philosophy that maintains that it is OK to seek prescriptive help for weight loss. Earlier this year WeightWatchers agreed to pay $106 million to acquire a telehealth company called Sequence that prescribes the drugs. Success is critical: WeightWatchers stock has only recently begun to reverse a steep yearslong decline.
Shares in WeightWatchers rose 7.4% to $7.37 on Wednesday. Shares of
Novo Nordisk, the maker of Ozempic and Wegovy, and Eli Lilly, which produces Mounjaro, also climbed. }}
If there are major side effects, it depends how many people get them. And if the side effects are same/similar for the group or a wide variety of major side effects that could be a threat to patients’ lives. That is why we hear that LONG LIST of “potential side effects” AND “don’t use if” statements in the TV commercials. They are trying to cover their legal butts.
No, it’s a requirement. I’m sure it’s entirely possible to lie/obscure inconvenient data in the early stages of drug development…but major side effects are hard to hide once they’re happening to any degree once theyve been approved.
Well, that depends on what you mean by “higher doses”, surely…per recommended/approved dose in the studied population demographics? (using it correctly) Or following the notion of “a little’s good, so a LOT will be better”. Ozempic and similar medications aren’t the only medications to be used incorrectly, I’m sure.
I read very clearly last night in my travels that reporting severe side effects is voluntary. It was not a blogger trying to be sensational or stir things up. There are no laws imposed on the drug makers to report.
The higher doses are compared to treating diabetes. The issue endocrinologists treating type 2 diabetes longer term with these drugs have a good idea of the severe side effects. That is why these doctors are okay with using Ozempic for weight management. But the higher doses multiply the severe side effects. The doctors will not for the next few years have any picture develop regarding the numbers of severe side effects in the US. They may in the EU.
Just like the EU is putting responsible laws in place regarding internet privacy the EU will regulate pharma. Plus negotiate prices.
The US won’t. Or will be a Jonny come lately at best.
I do not have that link. It sailed by my last night. I have no clue where it is.
The drug companies pull their own literature on the side effect stats. That is a well known practice in the US. The doctors and public fly in the dark.
File this under “Welcome to America”. You are correct the drug companies must report.
Reporting serious side effects is voluntary by doctors and patients, but drug companies are required to notify the F.D.A. any time they become aware of an adverse event caused by a drug they manufacture.Feb 2, 2015
But…that does not mean the companies are reporting…
Snippet
The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.
The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.
The difference is noteworthy because drug makers’ reports account for close to 97 percent of all adverse events that are collected by the system. The report analyzed more than 847,000 case reports received for the 12-month period that ended in March of 2014.
For the individuals that these medications are being prescribed for, the disease states that they’re being prescribed for are appreciably more of a health risk, in both the short and long term than the risk the medication appears to pose… when taken per prescription.
Just like any other worthwhile medication, it would be obviously more risky to take it when it’s not needed.
I feel the same about metformin. For me, that is, without metabolic syndrome or signs of insulin resistance.
The more immediate reports a few months ago cited a tripling of 5 severe side effects. Google is a who$e good luck finding that press release. If you do let me know.
As I have said right now we do not know.
BTW what you are saying makes a lot of sense but 94% of all drugs from phase 1 through being on the market for five years are pulled due to either lack of efficacy or side effects…usually the latter. At the end of the day what you said does not make sense at all for new drugs. Upping the dosage of a drug is a higher risk.
Well, you can usually rely on press releases to over hype whatever the press release is about…whether it’s a news item about side effects, the positive results of a study or the benefits of a brand new drug. I don’t bother with them beyond pointing out the misleading nature of them (which, I guess applies to this one you can’t find)
As for your figures on phase1 to 5 years post introduction to market, I have no reason to disbelieve that…but, taken at face value, it’s again misleading. Of the 94% that gets withdrawn, I’d guesstimate close to 94% of that figure represents the number that don’t even make it beyond phase 1…with more falling by the wayside even before they receive FDA approval. One reason that novel drugs are expensive to produce.
And, of course, increased dosage has a greater potential for producing side effects…that’s the case with any medication new.or old. Ozempic, metformin…aspirin, tylenol. A sensible person would be advised not to do that.
I think I documented this here a few months ago. I think the 94% does not include all the other drug candidates.
But it is fuzzy now.
Yep the press have everyone on board. We are all sick about popping another pill. But we are off to the races.
Yeah Google buries everything that is not commercial. If it matters.
100% on your last comment.
I do not know where my BIL stands now. I do not think he is informed. He has backed off his earlier this is a safe drug. Now the jury is out. I know better so he is able to speak. He can do clinical work but he really is running one of the more important labs. In fact he is overseeing a lot of important labs run by others plus the clinical side of his department. Plus he has to see everyone employed or related to the hospital who has diabetic concerns. He is good but science on the clinical side is playing some odds.
I am not touching these odds for now. Probably never.