Why are products approved before they are proven safe? What do you think could be done to ensure a food product is safe before it is approved?

Why do you think products need to be tested before going on the open market? Think that through once. Would you be willing to buy a product, not knowing anything about it's effectiveness, value, contradictions, possible side effects and adverse reactions? Would you be willing to go into any grocery store and buy whatever was on the shelf or in the dairy case or meat counter, not knowing if those products met a standard of excellence?

Think about that. Then you can answer your own question.

Thanks but that's not what I asked though. What I'm asking is why are products realised on the market before they are proven to be safe. Only after the fact when something happens to someone then they recall the product...

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Originally Posted by Sanjay Persad

Why are products approved before they are proven safe?

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Hello Sanjay:

Approved by who?? There's nobody watching. We don't have a government agency who's responsibility it is to inspect every product on the market, and, we couldn't afford the products if we did.

excon

Products are tested before they are approved. It is the testing that needs looking after and who is doing the testing and WHERE the products are coming from. Would you trust a product made in China, for example, after hearing about some of the products coming from there? Is every country testing? I do not know. It is the standard of quality that should be addressed. Also the buyer needs to beware - caveat emptor - and know what they are buying.

As for drug companies, more extensive testing should be done, even though the drug companies say they test for years before a drug is approved. But they miss the mark at times too. Look at the fen-phen drug - it was not known to cause the heart complications.

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Originally Posted by shygrneyzs

Products are tested before they are approved. It is the testing that needs looking after and who is doing the testing and WHERE the products are coming from. Would you trust a product made in China, for example, after hearing about some of the products coming from there? Is every country testing? I do not know. It is the standard of quality that should be addressed. Also the buyer needs to beware - caveat emptor - and know what they are buying.

As for drug companies, more extensive testing should be done, even though the drug companies say they test for years before a drug is approved. But they miss the mark at times too. Look at the fen-phen drug - it was not known to cause the heart complications.

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This is my line of work (devices, not drugs), so I have some insight into the process. I'm going to use devices as examples, because pharma has different quirks which I am not qualified to talk about. But first, "fen-phen" was never tested, because it is not a drug. It's two drugs that physicians prescribed in combination off-label. Because they were never intended by their manufacturers to be used together, they were never tested together, and the only way that you will find out the adverse effects in that case is by seeing what happens in real people.

Which gets to point one: FDA has the legal authority to regulate cosmetics, drugs, medical devices, and some authority over foods. A company that wants to bring something brand new onto the market has to show that it's safe and effective for its intended use. But the FDA has no authority to regulate the practice of medicine. So the pharma companies showed that Phentermine ("phen") and fenfluramine ("fen") were safe for their intended uses, and then no one has the power to keep doctors from doing what they want with them after they are on the market. ("Off-label" uses are a real headache, because the approval process is a nightmare to go through, and so a lot of things get approved for X when everyone knows that they are really going to be used for Y.)

Point two: Clinical trials are expensive, and time-consuming. If you have a complex medical device with electronics and computer circuitry, you can be looking at a product life-cycle in the 18 month range as new improvements in microchips, etc. allow you to bring out a new generation product. Your approval process can range from 90 days to about two years or more (depends on a lot of variables). Throw in a clinical trial that is probably going to be at least 6 months, and possibly longer than 5 years (depending on study end-points and enrollment rates), and you quickly find out that the device that gets approved is now about 3 generations behind what you actually want to bring to market. Which means that you will generally do bench testing to show that the new improved version does the same thing as the one in the clinical trial, rather than repeat the trial. Which is true most of the time, but it is possible that you get glitches that don't show up until you are in the market.

Point three: Clinical trials are designed to show that the device is safe and effective for its intended use. They are not designed to find all the potential problems with the device. And you obviously do not start doing testing in humans unless you are already pretty sure the device is safe and effective. So you set your sample sizes and study lengths to get the amount of data you need to support those points, and to allow you to detect any serious problems. You do not power them to find the things that happen once in 5 million people. And you generally don't do studies with "vulnerable" populations (kids, pregnant women, the extremely elderly) because of ethical and legal issues, even if the product is going to be used in those populations.

Point four: If a treatment seems to be working in a clinical trial, and there are no other alternatives available, patient interest groups will push to get the product on market faster. Think AIDS drugs. So those may very well go on the market before their full risk/benefit ratio is understood.

At the end of the day, it's a balancing act. Push for more proof that products are safe before approval, and the people who would benefit from those products will not be able to use them during that time. And that means that some people will die while companies do studies that may show that there were no safety risks. Allow product on the market with less data, and you get adverse events showing up in the public that might have been caught with more testing.

And the other issue to keep in mind: nothing is 100% safe. The question that FDA and the medical industry asks is: "Do the benefits outweigh the risks?" If they do, the product is approved. That doesn't mean that it won't still kill/injure some people, even if used appropriately. Some drugs, for example, are very potent, and minor variations in metabolism can lead to an overdose in one person when the same course of treatment wouldn't in 99% of the population.