Medicine needs to embrace open source
zdnet.com
zdnet.com
The impression the original article gave was that the company ignored compelling evidence because they couldn't make any money off of it. But the "compelling evidence" actually comes across more like the sort of thing you'd find here: https://www.tylervigen.com/spurious-correlations . As Derek Lowe puts it, "One of the biggest objections to the idea inside the company was that this finding was unlikely to be real because Enbrel doesn’t really penetrate into the brain."
A final coda: the actual data may not have been public, but the potential correlative results were published in 2010: https://www.ncbi.nlm.nih.gov/pubmed/20478733/. So much for being buried?
I'd hate to see old, frail people getting Etanercept (an immunomodulator) to prevent Alzhemier's based on very questionable evidence when all they really get are the costs (increased risk of serious infections leading to death-- an FDA black box warning).
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This particular case may well be a beat-up, but there's undeniably a regular habit within pharma to not publish neutral or negative results, and we don't know how useful those data may be simply because we don't have access to them.
AFAIK no country has laws requiring this, so it's not a regulatory / enforcement problem - it's a legislative one.
Call me a sceptic but I don't believe that for a minute.
Instead I'm sure they acted on some other ulterior motive.
Read the link to Derek's Loew's analysis in Science for deeper analysis: it's posted elsewhere on this discussion.
"I understand that AD affects many families who would very much like to have an intervention for the disease, and are anxious to see this trial clinical proceed. Nevertheless, I do not feel that this trial is warranted based on the existing data. Additional studies are needed to understand the mechanistic connection between HSV-1 infection and AD, and specifically to clarify whether infectious virus, or viral proteins are involved."
Sounds like it's not yet in the realm of proven effectiveness.
Without seeing the results of the test it would be impossible to know.
But hypothetically the reason could be as simple as them not wanting to provide any kind of help to their competitors, no matter how small.
Their explanation that they did not release the data because it could lead to other scientists heading down another dead end path of research is just stupid.
The field of science is full of such dead ends and is exactly the scientific process that has got us to where we are now.
I would say it is more likely Pzifer did not release the data to help ensure their competitors would head down that same dead end should they try.
For example, if they created drug X with the research cost of $10M. When sales/crowdfunding reaches:
- $1M: drug margin is reduced by 10% - $5M: drug margin is reduced by 50% - $10M: drug is sold at cost & recipe is now open-sourced
These clear goals will be big incentive for people and organizations to donate. A successful fundrasising could drive new medicine cost way down or open-source it.
But of course, the system can still be exploited by inflating cost numbers, etc.
And is downloadable under a CC license: https://www.drugbank.ca/releases/latest
The US National Library of Medicine provides an API to query drug interactions based on DrugBank: https://rxnav.nlm.nih.gov/InteractionAPIs.html#
I want the industry to come together and make an open source drug database so that it can become the world standard. This way a lot of legacy businesses will no longer have a reason to exist and charge exorbitant licensing fees.
It seems like your frustration is mostly with the Surescripts monopoly on electronic prescribing. You say that they dictate an approved commercial vendor. This is a very different problem, and would have very different solutions, than the problem We don't have any open source drug interaction database, which is where this thread started.
The open source solutions aren't good because validating and fixing this data is very time consuming (read: expensive) and carried legal liability (read: expensive). Open source tends to not be good at requiring many people to do tedious things (see: most open source documentation). Companies could pay people to do it but then you've recreated a commercial vendor except competitors who don't pay get a benefit. Companies tend to open source things which are not direct competitive advantages for others in the same industry while this would be exactly that.
How it can help in medicine is by saving people's lives or improving their quality of life, it can't line people's pockets - indeed that goal is contrary to the aforementioned benefits.
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.
https://www.nytimes.com/2018/06/08/opinion/drug-approval-cut...
IIRC approval time takes about 10 years minimum. Then you have 20 years to cash that cow out before the patent runs out.
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.
> 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.
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.
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.
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).
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.
Having a regional or even global movement for healthier lifestyles would be easier done than convincing shareholders to make less money. Sad, but true.