re: Drug companies protected by FDA and patent law raise prices in unison again

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you made a new product---not a new compound

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Came up with new use for existing material.

Try again.

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We can immediately allow uses of known compounds regardless of the intent of the use. In other words no bureaucrat has to approve the use of a compound that has known hazards for any use a doctor decide. If all we want the FDA to do is to warn of hazards why should be care if Doctor Joe thinks a compound created for high blood pressure might be helpful for balding

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Clarification that you are probably aware of: Patents don't prevent prescribers from prescribing for whatever reason they think the drug will work. It's mostly about marketing and cost. Drugs can only be marketed for what they were proven to do and have empirical evidence to support. I can't say I disagree with that notion. The cost of obtaining that data is immense. And things that seem like they would make sense in this off-label world don't necessarily hold up when the data come out later.

Two examples: 1) there are two drugs that do as you say- lower blood pressure but also make you grow hair. One gets FDA approval and hikes the price. The other one isn't marketed as doing the same thing, but with a good understanding of pharmacology and reading original trials/case reports of adverse affects, a lot of prescribers will write the similar, cheaper agent. The group that fronted the money to show it worked deserves 1) to be compensated for the trials and 2) to make a little bit of profit to bolster their next studies 3) to be the only group allowed to market for such a purpose until someone else proves they're at least not as bad. Nothing in that prevents us from writing the similar agent, but...
Example 2) similar agents aren't always similar. Pravastatin's makers said, "we want to be the station used when patients have heart attacks" (more or less). They design the TIMI trial and put themselves at a 40mg dose head to head against Atorvastatin 80mg (Lipitor). The results? The Lipitor patients died less. Pravastatin makers fronted money that hurt them by making the other drug look better. But what didn't they look at?
They didn't use Crestor (Rosuvastatin) at all. It has LDL-lowering effects that are even more potent than Lipitor. Should it be used instead? Is it better? They also didn't use other less-potent drugs like Lovastatin. Is being worse at saving lives in acute MI a property of low-potency statin or inherent to Pravachol? We don't know (based off that trial). But what we now know is that if Pravastatin tries to market an "MI dose" of Pravastatin, we shouldn't use it. And they haven't tried to do so.


That was a bit technical, but it is to make a point: most of the data out there is plot points with a heck of a lot of extrapolation. I understand awarding the creators of those points exclusive rights to point out that their data is what we are using, so if they make up a new name and dose for their drug to capitalize a little bit, it's kind of a good thing. I do think when we look at numbers, it gets to absurd numbers very fast. But I also know that almost every company has special programs to get patients what they need regardless of their ability to pay. There is absolutely some amount of corruption and high-profit motive exhibited by these companies, but I think the end result is far more alternative ways of payment or treatment than the proverbial "people dying in the street of something that could have been treated 20 years ago."


ETA: I have no financial disclosures and receive no money from drug companies.


ETA 2: sildenafil (Viagra) at 100mg is expensive. At 20mg (Revatio) it is not (at some pharmacies). The 100mg dose causes erections. The 20mg dose is for pulmonary hypertension (life threatening without it). Sometimes, I (and most of my practice) will prescribe 3-5 pills of the low-cost one before sexual activity. It's not illegal. It's just off-label and the company can't recommend that we do it.