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Drug Goes from $13.50 a Tablet to $750, Overnight

nytimes.com

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Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#441

Post by crusso »

Daishiman wrote: post #436
crusso wrote: post #393

Earlier quoted context omitted.

The FDA was the big lever that Skreli was attempting to use to skew the market in his favor. If the FDA weren't so powerful, flawed, and easily corruptible, the strategy would make no sense.

So on a weaker FDA it would be exactly the same, except that now your guarantees about the safety and efficacy of the drug are reduced. How is that better?

How about a weaker FDA that simply advised people on the safety and efficacy of drugs rather than forcing everyone to follow their rules? That would technically be a weaker FDA, but enable more freedom for patients and their doctors to pursue treatments that they found efficacious.

How about a weaker FDA that allowed the import of drugs from other countries? That would create international scale competition for the US drug purchasing market.

There are lots of ways that we could get creative in solving these problems if there weren't a monolithic government agency in the way of our personal freedoms.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#442

Post by dhimes »

dlss wrote: post #374
dhimes wrote: post #111

Earlier quoted context omitted.

Then what does it include?

Reinvested profits?

The biotechs with which I am familiar are the early-stage research arm of the development chain. Kind of like acqui-hire startups for google. They live off of investments from vc and/or license deals for final product. My impression was vc was the bulk.

But my view might be myoptic, so I was double-checking.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#443

Post by anthony_d »

cowsandmilk wrote: post #407
anthony_d wrote: post #242

Earlier quoted context omitted.

I don't think your view of the situation is any less biased. The problem is that there is very little incentive to ever reject a drug. Shorting is the only case I can think of and even that assumes the drug in question is important enough to actually move share price. Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best:…

> Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best Uh... no. Just from that page, it states the FDA ensures "that drugs and devices are safe and effective for their intended uses". If safety was the only concern: 1) Why does the FDA approve indications? 2) Why has there been prosecution (possibly violating the first a…

From the entire page you found the one case where the word "effective" is used and it's used after the word "safe".

Here's what the page says about new drug applications:

The IND application must contain information in three broad areas: * Animal Pharmacology and Toxicology Studies - It must be reasonably safe. * Manufacturing Information - The company can make consistent batches of the drug. * Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.

The 3 requirements around the new drug application are all safety based. Later on they look at efficacy, but it's later in the process. Efficacy doesn't mean it has to be very effective just somewhat. Read the references for your Wiki page, the FDA is concerned with removing harmful drugs.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#444

Post by Daishiman »

crusso wrote: post #441
Daishiman wrote: post #436

Earlier quoted context omitted.

So on a weaker FDA it would be exactly the same, except that now your guarantees about the safety and efficacy of the drug are reduced. How is that better?

How about a weaker FDA that simply advised people on the safety and efficacy of drugs rather than forcing everyone to follow their rules? That would technically be a weaker FDA, but enable more freedom for patients and their doctors to pursue treatments that they found efficacious. How about a weaker FDA that allowed the import of drugs from other countries? That would create international scale competition for the U…

Because when people are fucking dying they tend to try whatever options they have left even if they're not guaranteed to work 100%. So now the market every disease for anyone in a precarious position will be saturated by shitty chemicals tested with far less rigor.

Seriously, it's like you're just ignoring what happens in every country that currently does have weaker systems and who look up to the strong regulatory practices of the US and Europe for exactly that reason.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#445

Post by FireBeyond »

cowsandmilk wrote: post #414
FireBeyond wrote: post #388

Earlier quoted context omitted.

Given the multiple issues Martin has faced over the years, I think it's fair to say that 'impartiality' is the least of his motivations. "If an analyst looks at the data and sees issues" - what are they? A stockbroker, or pharmaceutical scientist? How many are both? It would only make financial sense to push for the drug not to be approved -if- you had a position that made a gain from that, but let's not pretend like…

I don't care about Shkreli, I care about whether the practice is ethical. There are plenty of pharma analysts who have used the same techniques who have medical degrees, have worked on clinical trial design at pharma companies, etc. They often aren't the names you see when pharma complains about people shorting their stocks because pharma only wants to point at the head of the hedge fund who has no life sciences expe…

And if pharma analysts who have medical degrees want to analyze filings from these companies, great.

But the specific example is talking about Martin Shkreli doing this - a man whose formal education is a Bachelor of Business from CUNY.

And ethics have roots in motivations. Shkreli couldn't give two hoots whether the drugs had efficacy or not. He wanted them to fail approval only because of his position in the companies.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#446

Post by wllchng »

In an interview with Vox, Bernie Sanders covers how powerful the pharmaceutical industry are, how they are a source of high medical costs in US, and how prices should be regulated. He makes an interesting point on how while many of his colleagues push for free trade (e.g. lettuce and tomatoes from Mexico), we cannot import name brand drugs from around the world. https://youtu.be/S5vOKKMipSA?t=3m20s

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#447

Post by refurb »

dhimes wrote: post #442
dlss wrote: post #374

Earlier quoted context omitted.

Reinvested profits?

The biotechs with which I am familiar are the early-stage research arm of the development chain. Kind of like acqui-hire startups for google. They live off of investments from vc and/or license deals for final product. My impression was vc was the bulk. But my view might be myoptic, so I was double-checking.

You are correct. Biotech start-ups live off of VC funding and maybe some NIH funding if they are lucky. Most of them never bring a product to market, instead they are acquired by a big pharma/biotech who has the capital to bring the molecule through FDA approval.

The last number I saw was $6B invested in 2014.[1]

[1]https://www.pwc.com/us/en/technology/assets/pwc-life-science...

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#448

Post by bduerst »

codexon wrote: post #408
ken47 wrote: post #404

Earlier quoted context omitted.

If you do some research into this particular medicine, you will see that there are clear, non-free market roadblocks to producing a generic version.

I looked into it and I don't find any. It is not patented, and no law forces you to only use the brand Daraprim. If someone created a generic replacement, it would be on the fast track to be approved like every other generic. The synthesis method is even listed publicly. https://pubchem.ncbi.nlm.nih.gov/compound/4993#section=Use-a... The only roadblock to a generic version was because no one wanted to compete with $1…

You keep saying generic. Daraprim is a generic, which has a government instituted monopoly, making it not a subject to free market.

Others could go through the process to be Medicare approved, but that doesn't change that it's not subject to a free market.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#449

Post by codexon »

bduerst wrote: post #448
codexon wrote: post #408

Earlier quoted context omitted.

I looked into it and I don't find any. It is not patented, and no law forces you to only use the brand Daraprim. If someone created a generic replacement, it would be on the fast track to be approved like every other generic. The synthesis method is even listed publicly. https://pubchem.ncbi.nlm.nih.gov/compound/4993#section=Use-a... The only roadblock to a generic version was because no one wanted to compete with $1…

You keep saying generic. Daraprim is a generic, which has a government instituted monopoly, making it not a subject to free market. Others could go through the process to be Medicare approved, but that doesn't change that it's not subject to a free market.

I don't think you or ken47 have more than a layman's understanding of the subject.

Daraprim is a brand name. Pyrimethamine is the active ingredient.

When you create a generic, it must be checked that it is roughly equivalent to the approved version. Meaning there are no impurities and you digest the drug about the same rate which is determined mostly by the inactive ingredients. This process is relatively fast, often taking 1 year or less compared to the decades it takes to approve a new drug. And if you are going to be saving medicare millions of dollars, you can bet it is going to be put at the top of their todo list and will probably be tested within days.

To say that this is a government monopoly because you can't sell your drug from day 0 without any testing is quite a stretch.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#450

Post by bduerst »

codexon wrote: post #449
bduerst wrote: post #448

Earlier quoted context omitted.

You keep saying generic. Daraprim is a generic, which has a government instituted monopoly, making it not a subject to free market. Others could go through the process to be Medicare approved, but that doesn't change that it's not subject to a free market.

I don't think you or ken47 have more than a layman's understanding of the subject. Daraprim is a brand name. Pyrimethamine is the active ingredient. When you create a generic, it must be checked that it is roughly equivalent to the approved version. Meaning there are no impurities and you digest the drug about the same rate which is determined mostly by the inactive ingredients. This process is relatively fast, often…

Right - Exactly. Pharma drugs are granted monopolistic power by the government. Or even duopolistic power. That's exactly what ken47 and I are saying.

To say that a market, which is regulated with government-granted monopolistic or duopolistic power, is a free market is quite a stretch.

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