the truth about drugs

how much do we get told about drugs?? just as much as the drug companies want us to know! i was told by a neurologist that the drug companies do 3 months trials on drugs to see how effective they are in that time and what acute side effects they produce in that time. if they were trialed for longer they would be showing up more side effects and wouldnt beable to be marketed. down the years my father had to try out many new drugs on the market for mig. how many others feel theyre just testing out new drugs or know what the longterm effects are of their drugs??

Dawn,

Maybe your neurologist is misinformed. That's just not accurate. Maybe SOME trials are only three months long, but there are four phases of trials, and every drug has to pass the first three before applying for FDA approval. It takes literally years for a drug to go through clinical trials. This article might be helpful, The Basics of Clinical Trials.

Teri

im taking about rials on pts not at the mouse trial stage. i dont know about whether your drugs companys are different in the states?

Trials on patients take years too, even when it's just a new delivery system for an old drug. Levadex, the inhaled DHE, has been in trials for about two years now.

Teri

dawn.binks wrote:im taking about rials on pts not at the mouse trial stage. i dont know about whether your drugs companys are different in the states?

Having spent several years working for a pharmaceutical company I can verify Teri is correct.

I've participated in trials, and I know they lasted longer than 3 months.

What does this mean....there is a difference between trials i the US and UK?
We usually seem to be more cautious....

Dawn, do you think he got it wrong?

I don't know anything about how the drug trials work. However, I personally think we are over prescribed medications horrendously.

Here's the typical development cycle of a drug in the USA:

Discovery and pre-clinical Testing - 6.5 years
this includes animal testing. At the end of this period the company will file an Investigation New Drug Application (IND) with the FDA to explain how the drug works, why it may be useful in treating a disease and what are the known side effects

Phase 1 Trial - 1.5 years
This is done on a small group of healthy volunteers to test the basic safety of a drug. If it looks OK it goes to

Phase 2 Trials - 2 years
Safety and Efficacy testing. They try the drug on a larger group of people with the targeted diseases or disorders and again monitor for safety/side effects but also
how well the drug works. Dosing levels are investigated. Typically a double-blind protocol is used. If the drug looks effective compared to placebo and the safety still looks OK it goes to

Phase 3 Testing - 3.5 years
This is the large, expensive trial with a large population. Normally randomized, double-blind with a placebo. This looks for adverse effects in a large population as well as efficacy.

After all this, the FDA reviews the results and may allow the company to market the drug. It typically takes about a year once they get approval to market the drug and start getting it to physicians.

So the idea they only test a drug on people for a few months is absolutely wrong.


Even so, what we lack is a system to reliably capture side effects once a drug is released for prescription. In spite of all the testing, effects on tiny subpopulations could be different. Subtle problems are not likely to be caught at this stage. Only significant effects, like maybe a drug that causes serious side effects or death in a subpopulation. So this is an area that really needs working on. I'd love it if there was a uniform reporting system that doctors and patients could use to report drug side effects. Of course these reports by themselves would be meaningless, as many things other than the drug could be causing these apparent side effects, but if anything unusual popped up, or the reported side effects were significantly unlikely to be random, the FDA could do a careful study.


In any case, one of the reasons I like using THC (one of the active ingredients in cannabis/marijuana) as a preventative is that this drug has been investigated for almost 40 years by the DEA, via research grants, to find harm from marijuana to justify prohibition. Unfortunately, they funded a lot of unscientific studies. But when you look at the subset that were performed scientifically, you find there is very little chance it causes any long-term harmful effects. I don't think any other FDA approved pahrmaceutical has been put though this intensive a review. Makes me feel safe in using it.

Thank you so much for that time table. It was very enlightening and far more detail than I knew.

Teri

Marcia Angell is no light-weight. She's a physician and spent more than two decades as editor in chief of the New England Journal of Medicine.

This is a quote (her words) taken from Wikipedia:

"Many drugs that are assumed to be effective are probably little better than placebos, but there is no way to know because negative results are hidden.... Because favorable results were published and unfavorable results buried ... the public and the medical profession believed these drugs were potent.... Clinical trials are also biased through designs for research that are chosen to yield favorable results for sponsors. For example, the sponsor's drug may be compared with another drug administered at a dose so low that the sponsor's drug looks more powerful. Or a drug that is likely to be used by older people will be tested in young people, so that side effects are less likely to emerge. A common form of bias stems from the standard practice of comparing a new drug with a placebo, when the relevant question is how it compares with an existing drug. In short, it is often possible to make clinical trials come out pretty much any way you want, which is why it's so important that investigators be truly disinterested in the outcome of their work.... It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.[36]"

Perhaps phase 3 testing takes more than 3 years but that does not mean that individuals take the drugs for three years. Many trials are done, which takes time, but individuals on whom the drugs are tested often take these drugs for a far shorter time.

I have to say that, as someone who knows some doctors who do clinical trials, I find such broad generalization pretty pathetic. It's easy to criticize clinical trials and pharma companies. Funny that none of the people who do the criticizing can come up with a better system.

The docs I know who conduct the Migraine trials would NOT continue to do them if the trials were biased or weighted. That's flat-out insulting, and I don't care who said it or where it was published.

Teri

Sounds like it was written by some one p.o.ed at their statistician.

I work for a medical school and particularly in the department that houses the statisticians. While I might not understand entirely what they do, what I do know is that studies are designed such that they will see a result. Now that result might not be what the researcher was looking for but it's a result none the less.

I get complaints from researchers regarding my staff because they performed the statistics they way that they should but they didn't get the result that the researcher wanted. Most researchers when receiving unexpected results, go hmm that's interesting and why did that happen. Not the b*&^%ing that it wasn't what it was supposed to be. This is science people...if we knew what was going to happen before running a study, there would be no need to do them.

Stepping off my soapbox for today.

There have been some drug studies that were distorted, but they are a very small subset. Dishonesty can happen anywhere. The FDA tries to maintain a system that is as objective as possible. Doesn't mean it is perfect. No human venture is. But overall, I trust the results.

Regarding some approved drugs being little better than placebo - there IS some truth to that. I was looking at a metastudy of the neuropathic pain reduction acheived by the neuroleptics like Lyrica. The study found a very statistical significant reduction in pain compared to placebo of the three drugs reviewed.

BUT - on the 11-point pain scale the difference compared to placebo was only about 0.9 to 1.4 points on the pain scale. Because of the large numbers in the trials, this was very statistically significant.

But clinically, is a 1 point drop in pain levels worth any significant side effects from the drugs? I can get better than a 1-point lowering of my pain just by listening to some music or petting my dog.

I think a lot of medicines are likely this - they have statistically significant effects, but clinically they are questionable.

Also, I noticed in these studies that the pain reduction saturated at a fairly low dose, with no improvement after the dose was raised above a certain level. But reading what many post here, your doctors keep raising the dosage trying to get better pain reduction when this is very unlikely. For instance, 25 mg 3x a day of Lyrica was barely better than placebo. But at 100 mg it was significant. But 200 mg is not distinguishable from 100 mg. So there would be no point in going past 100 mg and in fact I suspect it saturated at a lower dose.