This study suggests calcium supplements are dangerous. They can raise your risk of heart attacks. There are probably better ways to reduce osteoporosis.
Conventional clinical trials overstate the value of drugs, says this paper. One reason is that they compare drug to placebo. In clinical practice, the choice is never drug or placebo; it is drug or other treatment (usually a different drug). “We need to put an end to this kind of gaming of the system” — a system in which standards of evidence grossly favor drug companies at the expense of everyone else.
Doctors use patient’s need for help to remove bad reviews. “The doctors simply make their patients sign a contract handing over the copyright of any review they might publish online afterwards. So, if the patients post any bad review, the company is able to send a DMCA notice demanding that the content be removed immediately.”
I’m sure it’s true that clinical studies overstate drug effectiveness, but the conclusion that the FDA ought to be *more* restrictive in approving drugs “for wider use” doesn’t follow. Maybe the government should be more restrictive in deciding what to reimburse, but banning the use of a drug entirely is a truly terrible way to accomplish cost savings. If we allow more drugs to get approved, (a) there will be some competition between vendors that could drive down prices or improve quality, (b) people for whom the most popular drug doesn’t work well will have other options.
The idea that nothing should be allowed on the market unless the FDA is well and truly satisfied that it’s an unambiguous improvement over what was available before is one of the many reasons drugs are so expensive.
(Imagine if anyone who wanted to sell a new breakfast cereal had to prove it wasn’t just reasonably safe and nutritious but also was *better* than existing cereals that it resembled, as judged by a panel of cereal experts reviewing years of test results. How many cereals would you expect to find on shelves and how good a value would they be to consumers?)
I don’t say improvement should be required for approval. I do think that large comparative studies — experiments that compare the proposed drug to the best existing drugs for the same problem — should be required for approval. And the results of those comparative experiments should be widely-publicized and easy to find — in the packaging, for example.
The ‘rapid responses’ to the calcium heart attack/stroke risk meta-analysis leave me hesitant to update much. For example, https://www.bmj.com/content/342/bmj.d2040.abstract/reply#bmj_el_259724 points out that (most of) the studied individuals weren’t randomly assigned to supplement vs. placebo groups – they chose their own supplementation regime.
It doesn’t look like a high quality piece of evidence after 2 minutes’ evaluation.
If there are good alternatives that leak *NO* mercury (as opposed to “totally healthy small amounts”) then of course those should be used for new fillings.
Quackwatch has zero credibility with me. The amalgam filling essay you link to is typical. He simply leaves out the best evidence of harm. There is a reason mercury fillings are banned in several countries but Quackwatch says nothing about that. Using one of those mercury-vapor measurement devices, I found I had surprisingly high levels of mercury vapor in my mouth — without chewing on anything beforehand. This is one reason I decided to have an amalgam filling taken out. At exactly the same time as the extraction happened, my arithmetic scores (how fast I could do simple arithmetic) started to improve after being stable for months. There were no other obvious changes in my life at the time. There’s evidence of harm for you.
“They chose their own supplementation regime.” You have misunderstood the experiment. Subjects were allowed to supplement in addition to the experimental assignment. The data were then analyzed taking the self-chosen level of supplementation into account.
I’m sure it’s true that clinical studies overstate drug effectiveness, but the conclusion that the FDA ought to be *more* restrictive in approving drugs “for wider use” doesn’t follow. Maybe the government should be more restrictive in deciding what to reimburse, but banning the use of a drug entirely is a truly terrible way to accomplish cost savings. If we allow more drugs to get approved, (a) there will be some competition between vendors that could drive down prices or improve quality, (b) people for whom the most popular drug doesn’t work well will have other options.
The idea that nothing should be allowed on the market unless the FDA is well and truly satisfied that it’s an unambiguous improvement over what was available before is one of the many reasons drugs are so expensive.
(Imagine if anyone who wanted to sell a new breakfast cereal had to prove it wasn’t just reasonably safe and nutritious but also was *better* than existing cereals that it resembled, as judged by a panel of cereal experts reviewing years of test results. How many cereals would you expect to find on shelves and how good a value would they be to consumers?)
Prof. Roberts,
you may find this familiar:
https://wholehealthsource.blogspot.com/2011/04/food-reward-dominant-factor-in-obesity.html
I don’t say improvement should be required for approval. I do think that large comparative studies — experiments that compare the proposed drug to the best existing drugs for the same problem — should be required for approval. And the results of those comparative experiments should be widely-publicized and easy to find — in the packaging, for example.
The ‘rapid responses’ to the calcium heart attack/stroke risk meta-analysis leave me hesitant to update much. For example, https://www.bmj.com/content/342/bmj.d2040.abstract/reply#bmj_el_259724 points out that (most of) the studied individuals weren’t randomly assigned to supplement vs. placebo groups – they chose their own supplementation regime.
It doesn’t look like a high quality piece of evidence after 2 minutes’ evaluation.
Re: mercury amalgam, what’s the evidence of harm? This mainstream (status quo is fine) view is pretty good at tarring the anti-amalgam movement by its association with some quacks – https://www.quackwatch.com/01QuackeryRelatedTopics/mercury.html
If there are good alternatives that leak *NO* mercury (as opposed to “totally healthy small amounts”) then of course those should be used for new fillings.
Quackwatch has zero credibility with me. The amalgam filling essay you link to is typical. He simply leaves out the best evidence of harm. There is a reason mercury fillings are banned in several countries but Quackwatch says nothing about that. Using one of those mercury-vapor measurement devices, I found I had surprisingly high levels of mercury vapor in my mouth — without chewing on anything beforehand. This is one reason I decided to have an amalgam filling taken out. At exactly the same time as the extraction happened, my arithmetic scores (how fast I could do simple arithmetic) started to improve after being stable for months. There were no other obvious changes in my life at the time. There’s evidence of harm for you.
“They chose their own supplementation regime.” You have misunderstood the experiment. Subjects were allowed to supplement in addition to the experimental assignment. The data were then analyzed taking the self-chosen level of supplementation into account.