What is the difference in cheap and expensive oral contraceptives?

[JoelUpchurch]

@mnemosyne

I am definitely not an expert on this at all, but I’m not sure it’s quite that simple. If a drug is found, once it’s on the market (or information/studies are deliberately delayed) to have a use to treat another disease entirely without making changes to the formulation at all, it is possible to obtain a patent extension for that purpose, but I’m not sure of the details. This is something that happened with Wellbutrin and Zyban - the initial drug approvals for use as treatment for depression gave a certain amount of patent protection with an extension granted when it was launched as a smoking cessation aid (or vice versa, I’m going by memory here!)

Your wrong, but it is easy to understand, since GlaxoSmithKline was very active in filling lawsuits to keep generic competitors off the market. Back in October they settled a class action lawsuit for $49 million for these actions.

http://www.prescriptionaccess.org/lawsuitssettlements/past_lawsuits?id=0027
http://www.post-gazette.com/pg/11304/1185740-499.stm

Off label usages do not extend the original patent. The only extension that is allowed is because of the FDA approval delay, which can take several years.

Most drugs aren’t approved for use on the market based on their performance in comparison to another drug, they are approved based on their ability to treat the medical condition in question as compared to no treatment or a placebo. There are comparison studies out there - and manufacturers, particularly brand name ones - are interested in the results for marketing purposes, but they aren’t reflective of the process to get a drug on the market in the first place. (Does that make sense?)

Anecdote != data. Some people will experience side effects that others don’t, some will experience positive effects, some will experience worse effects. Human biochemistry is actually rather variable - diet, disease, genetics, random factors come into play when seeking to understand how the body reacts to a drug. When side effects and efficacy of a drug is studied in clinical trials, the data is collected over a statistically significant population, not just in single individuals. So while I avoid taking Midol, for example, because it makes me weirdly woozy, it’s fantastic for many people and my reaction to it doesn’t actually mean there is anything wrong with it and that it ought to be avoided.

As with all science, it comes down to good experiments and a good statistical understanding of the data obtained. There is an enormous amount of data that is examined before drugs even get close to approval. Generally speaking, I trust the process.

You obviously don’t understand what a double blind clinical trial means.

http://en.wikipedia.org/wiki/Blind_experiment#Double-blind_trials

This is usually done to separate the actual differences in the chemical behavior of the drugs being tested from the psychological reactions of the patients.

[mnemosyne]

I do understand double-blind clinical trials.

I may have misunderstood your original post and we are talking about different things- I thought you were looking for studies that compared BirthControlPill A to BirthControlPill B to see if one was better than the other… those aren’t as common as studies that compare a BirthControlPill to placebo, although an existing drug might be compared to in the study as well if the one in question is a novel competitor.

Much of the work is paid for by the drug companies, though, and it’s true that a lot of the results are not made public, though they are made available to the FDA (unless the data is being hidden, of course).

As for Wellbutrin/Zyban I admit to not being sure of the details, but the situation I’m thinking of predates the case of Wellbutrin SR. I thought that bupropion was under patent as an antidepressant (immediate release) then got a patent extension as a cessation aid, thereby delaying generics of immediate release antidepressant generics. As I said, I might be completely wrong on that - it’s been a long time since I’ve even looked into it, I probably misremember the details and I don’t really care that much

It seems to me than Enbrelis going through a similar process - I thought as a new indicated use gets approved, a small patent extension is granted, thereby pushing back entry into market by a generic competitor?

Perhaps someone more well-versed in patent law can really address this topic. I was just a chemist!

[asterion]

@mnemosyne

Good example - it’s a rather interesting case given as colchicine has been around forever.

I haven’t really worked in pharmaceuticals since 2007 - I got the crazy idea in my mind to become a mechanical engineer instead of chemist - so I’m really not up to date on what’s going on in the industry right now, though I am following the major news somewhat.

Safer choice anyway. I’ll be a bit surprised if I still have a job in five years. Though I think I’m a bit safer in process than I would be in discovery.

The big news, besides the layoffs, tends to be the FDA cracking down on everything and a lot of things failing in late phases. But you probably know that already.