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g00s3_caLL_x2

Medicine in America will never do this, at least not for the foreseeable future.

They moved from 'cures' decades ago.

Plus add a big heaping spoonful of the FDA and the red-tape that must be jumped through.

Anytime someone ingests something, someone, somewhere, will die from it.

When you work in pharma, you learn that there are teams of lawyers and budgets just to deal with the inevitable deaths.

Just getting to human trials during the experimentation phase takes years.

I'd say look more toward real-working natural cures and improving our lifestyles and environments would be more realistic in the short term.

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“According to industry watchdogs, reducing clinical trial costs will not help curb list prices because those prices are not determined by investment costs; they’re determined by what the makers think the market can bear, which helps explain why profit margins are so high.”

https://www.nytimes.com/2018/06/08/opinion/drug-approval-cut...

isn't that a bit circular? If investment costs (lets include capital, time, and risk)were low, wouldn't there be a influx of motivated innovators to create a greater selection of new drugs, which would either drive down price of equivalent drugs (or produce better drugs with are more efficacious/less toxic)? If investment costs/risk aren't limiting abundant new drugs, what is?

The FDA.

IIRC approval time takes about 10 years minimum. Then you have 20 years to cash that cow out before the patent runs out.

So the FDA should be more lax on requirements for approval? Should they reduce the Preclicnal PharmTox requirements? How long should a cancer trial take if it has 500 brain cancer patents to enroll and it measures improvements in survival that takes over a year? Should Pharma just one study or should they do a coulple of serially run clinical studies to understand the toxicities and how the drug works best? I'd love for development timelines to be quicker, but I need a Gantt chart to better understand where the time savings would come from without compromising the safety and data supporting efficacy. Help me understand.

Also. Most substantial patents are filed way before the approval of the drug. Rarely if ever has a drug had, for example, a composition of matter patent for 20 years after approval-- even with the extensions for regulatory delay that the USPTO allows. Not to say that Pharma don't extensively engage in product life-cycle management, sometimes very questionably extending exclusivity of products, and that is something that should be addressed.

Isn't FDA a factor in delay rather than throughput?

> If investment costs/risk aren't limiting abundant new drugs, what is?

If we had lots of new drugs available for testing in the first place, they would still require the 6y minimum of trials, then a few years for approval. So FDA doesn't really sound like a good reason to single out.

Often the most expensive drugs you hear about are lifesaving drugs. Imagine you could charge whatever you wanted for a lifesaving something that only you are allowed to sell. Is it really that common for a competitor to come up a unique (patentable) invention to treat the exact same niche disease? It should be no surprise that drugs are expensive.

The article also says: “Another thing federal officials can do is to use independent cost-benefit analysis to set a drug’s list price. The United States is the only developed country in the world that doesn’t do this”

I’m not saying pharmaceutical companies should not be able to profit off of their drugs. I think we should decide on some reasonable limits.

Also, what are you going to do to loosen regulation? Get rid of several years of clinical trials and let consumers decide for themselves whether a drug works? There’s too much of an incentive for drug companies to misinform consumers for that to work.

I’m also not trying to say the FDA is perfect. There are probably things they could do to speed up the process. I think the FDA is not the root of the problem though.

The Gilead Hepatitis C case study mentioned elsewhere in this thread deserves consideration. They made a ton of money for a few years and that is now drying up, since competition came in and the prevalent patient population has shrunk as the drug is a cure. Down the road there will be large savings to the healthcare system, as the costs of a patient leading up to, through and after a liver transplant is insanely large, and the frequency of those will dramatically be reduced because of the HepC drugs. Sharing the cost savings to the overall healthcare system with the innovator drug company incentivizes drug companies to effectivley address expensive diseases. The timing of the economic benefits (reduced advanced liver disesase) and costs (HepC drug price) uncoupled to the casual viewer so Gilead looks to be just a money-grubbing corporation.

I’m also uneasy about federal officials appointing a panel that has final say on drug prices. It’s a hypothetical, and details would matter. Done wrong it could crash industry investment. To those that claim that there will always be investment- How much of your IRA/401K is in small/mid-cap biotech? -there are huge risks and expenses getting drugs to market, and looking at the profitable companies assumes huge survivorship bias on the companies that "made it". Look at the state of antibiotics drug development (this terrifies me), or look at the availably of a standard, approved bladder cancer drug (Bacillus Calmette-Guerin or BCG) or a handful of other drugs (please internet search for BCG / chemotherapy shortage). These real-time problems illustrate the fragility of the economics of development and manufacture of drugs. Its not just a turn-the-crank widget. Should drug companies be spending on superbowls ads, no. Should Skrelli reprice proven drugs by 500x, Nope. Anything like Valeant or Purdue pharma, just nope. Should a pharma CEO be making $50MM /year, probably not. There are many problems to fix, but hitting the industry with a wrecking ball in order to set drug prices is short sighted will have consequences. Transparency on pricing is a good step. Get the PBMs, the Payors, and Pharma all to disclose where the money is flowing and what the true costs are. That will allow for some informed discussion. I’m not a pharma shill. They need to be held accountable, but accusations such as ditching cancer or Alzheimer disease cures isn’t valid or constructive. It doesn’t even make sense. Thank you for the thought provoking comments. Hope my rant is coherent and useful to you.

That's obviously false. See sofosbuvir for a recent counter example.

Such a good example! It only costs ~$84,000 to take a full coarse of sofosbuvir in the United States......................................................................... ... .....

Counterpoint: Sovaldi was basically a miracle drug for a widespread, expensive disease and even priced at $84K, that represented huge savings for the US healthcare system.

At the time it came out, the destiny for a Hep C patient was a $1M liver transplant. And that's not even including all of the other costs and misery Hep C patients incur as their liver fails. Now those people are treated quickly, saving tons of money and time, as well as improving their lives.

Also, because of the high price, it inspired competition and innovation. Within a couple years of Sovaldi and Harvoni, several other improved and cheaper drugs appeared on the market. The cost dropped to a quarter of the price of Harvoni and with half of the treatment cycle and better cure rates (Mavyret).

"improving our lifestyles and environments would be more realistic in the short term"

Unfortunately not realistic but it would be very desirable. For some reason it's accepted that people live very unhealthy lives and have big medical expenses but it's not accepted to change things like exercise and eating habits which would be very cheap and simple.

From the aspect of what would happen first, this would be more realistic than getting more companies on board for curing and preventing vs maintaining.

Having a regional or even global movement for healthier lifestyles would be easier done than convincing shareholders to make less money. Sad, but true.

GO find one of the children that has been helped by the new Cystic Fibrosis drugs (or their parents) and have a chat about this.

I'm not saying I agree with this, I'm saying this is how pharama business works. I've worked for some of the biggest players globally, and I can tell you they are not in the business for cures.

I'm also familiar with the industry. At what level are the cure being limited? Are Pharma scientists not looking for curative potentially approaches? or maybe ditching promising candidates precinically? are Pharma ClinDev folks designing studies for cures to intentionally fail maintaining demain for their chronic drugs? Did GIlead miss the opportunity to break cure they spent all that cash on? the I'm having a hard time understanding the specifics of how this strategy is executed. There is MUCH wrong with the pharma industry.The noise of conspiracy theories can dilute legitimate criticisms that could lead to corrective pressures.

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