Saturday, January 5, 2013

Funding Existing Drugs

This is a blog posting which I wrote several years ago.  I think in 2009. I lost track of it, and it never got posted.  But I recently came across it while cleaning old entries.  I think it is still valuable today, so I'm posting it.  Also, it makes a nice pairing with my last blog posting on Vitamin D.

Discussion about the argument that "Treatment X can't get funded because it uses an old / cheap / generic / unpatented drug so there is no profit in it!"

One complaint that is sometimes heard about the funding of cures for type-1 diabetes, is that some treatments can not get funded because they are generic drugs, so no one will fund development. Most recently, this argument is often used by fans of BCG and LDN to explain why they have so much trouble getting funded: it's because they are generic drugs, according to this line of reasoning.

This argument has never made sense to me, and below I've included two counter arguments and one example: an argument based on data from drug trials, one based on common sense, and the example of aspirin.

Clinical Research on Old, Generic, or Cheap Drugs

Since I track only clinical trials, I thought I would take a look at how this argument ("generics / existing drugs / old drugs can't get funded") compared to the actual clinical trials that I track. It turns out that this argument simply doesn't match with reality. Several generic treatments are being funded right now, by several different organizations.

There are a total of 27 treatments that are in clinical (human) trials to cure type-1 diabetes (remember, this was in 2009). Several of these treatments involve more than one drug.  Out of the those 26 treatments, 7 use only "old drugs" or drugs that are unpatented. They are:

  • Thymoglobulin (also known as ATG) by Gitelman
  • Umbilical Cord Blood Infusion by Haller at University of Florida
  • Brod at University of Texas-Health Science Center
  • Atorvastatin (Lipitor) by Willi at Children's Hospital of Philadelphia (Generics available 2011)
  • ATG and autotransplant by Burt at University of Sao Paulo
  • GCSF by Haller at University of Florida
  • GCSF and autotransplant by Esmatjes at Hospital Clinic of Barcelon
That means that 27% of drugs currently in clincial trials are exactly the kind of old or unpatented drugs that these guys say can not get funded. It is the ultimate proof that they can get funded: they are being funded!

BCG Specifically

When Dr. Fastuman's supporters claim that she can't get funded because she is using a generic that no one will profit from, an even more specific data set is available. The drug that Dr. Faustman is currently testing is BCG. So an obvious question to ask is this: have any clinical trials of BCG been funded in the time period from about 2002-2008 (which is when she was looking for funding). If her trial could not get funded because BCG is a profitless generic, then certainly no other clinical trial of BCG could get funded, either.

But, when I look at the US Government web site (www.clinicaltrails.gov) which tracks human trials there are 15 BCG trials in progress (ie. records updated) between 2002 and 2008. I limited my count to trials that were testing BCG's effects, so I excluded trials that were comparing a newer treatment to BCG, and I also excluded all trials that used BCG and another treatment (even if that other treatment were old / cheap / generic, etc.)  Even with all those exclusions, there were 15 different clinical trials using BCG.

Think about that: at the same time Dr. Faustman's supporters are claiming that her BCG research could not get funded because it was not a patentable/big profit drug, 15 other researchers were getting funded to study that exact same drug! Obviously, the supporters are wrong about this reason why Dr. Faustman had so much trouble getting funded.

Low Dose Naltrexone (LDN)

The story was similar for LDN: there were currently five separate LDN studies recruiting patients at the same time a type-1 diabetes study had not been funded. So obviously, the economics are such that LDN research can get funding, even though it is an old drug which is no longer covered by patients. Indeed, just recently, it did get funded, even though it is still an old / cheap / unpatented drug.

The Common Sense Argument

Every drug that you can buy today, is made by some company that is making a profit off that drug. And if they sold more of it, they would make more profit. So every drug made today has a company (or many companies) behind it.  Companies that want to make more of it. It doesn't matter if it is an old drug or a new one or if it is covered by a patient or not. Sure the exact dollars are different, but the basic profit motive doesn't change. Older drugs might be lower profit, but they are also cheaper to use in experiments, and much cheaper to get approved.  Usually they are already approved for marketing!

Right now there are at least three large drug companies that make a profit by selling BCG.  And, they want to sell more.  At least one of them (SSI) does not sell any diabetes treatment equipment or supplies, so they would be particularly interested in funding Dr. Faustman's work, if it had any chance of working.

Furthermore, this whole argument is based on the idea that the only groups that fund research are profit-motivated companies. But we all know that is not true. Sure companies fund a lot of research, but so do private non-profits (not just JDRF, but DRI, ADA, JLN, etc.). Plus there are government agencies. In the US there are at least four that commonly fund diabetes cure research, and that's not counting countries all over the world which also fund diabetes research. And to push that idea even a little bit farther: many non-profits or government agencies actually prefer to fund research on unpatented drugs. It is easier to justify, and can help more people more cheaply than a patented drug. So those guys will be biased in favor of an unpatented drug, not against them.

Aspirin

As a very quick example, consider aspirin to prevent heart attack. In the 1970s, aspirin was the ultimate in old, generic, unpatentable drugs.  It has been first discovered over 100 years before, and the "modern" form was over 70 years old even then!  Yet when early research suggested a completely new use for aspirin, preventing heart attacks, there was no difficulty in running several very large studies.  Some of these studies involved thousands of people, and more than enough were done to get aspirin approved by the FDA for a new use.  Surely if research into new uses for low-profit, old, unprotected drugs could not be funded, then the research into aspirin as a heart attack preventative in the 1970s and 1980s would never have happened.

For all these reasons, whenever I hear someone say "it's a generic drug, so it can't get funded" I always think to myself "no, the reason it can't get funded, because the people who might fund it don't think it will work".

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My blog contains a more complete non-conflict of interest statement. 
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/

7 comments:

Bennet said...

Well spoken, Thanks.

T said...

Just wanted to let you know that I love your blog. I really like your balanced approach to interpreting research related issues. Keep up the good work!

Scott S said...

Like you, I find the argument without much merit. The reality is that not only can researchers get NIH funding for those (which pays for much of the discovery research anyway), and increasingly, we're seeing payors (insurance companies) as well as pharmacy benefits managers help pay for research on generic meds because they're cheaper and compliance is often much higher with such meds. In the end, the excuse sounds nice but doesn't really hold as much credibility as one might suspect.

Łukasz Moliński said...

Regarding dr. Faustman - I'm following her research since I was diagnosed. At first BCG was described to have a potential to cure, reverse fully established diabetes. Last publications shows us that they have changed paradigm from a cure to a treatment (supporting existing treatments) for diabetes. Which I think proves that even she has changed her beliefs.

christopher boulware said...

people are dieing slowly from this disease everyday of there lifes absolute ridicoulous why they cant just go ahead and start doing this vaccine right away going to laugh when those big pharma get this disease there selfs

nevet said...

Sorry, but without an in-depth qualitative (vs your simplistic quantitative) comparison of other on-going trials using BCG, I don't believe you've supported your conclusions at all!

Dr Faustman's research is aimed at finding a CURE for IDDM which, if realized, poses an obvious and self-evident threat to the survival of a multi-billion dollar industry which derives its profits from TREATING diabetes...99% gone if a cure is ever found, generic or not.

Do any of your other trials you cited pose a similar threat to big pharma? I doubt it.

Unknown said...

The GABA study at the University of Alabama Birmingham has been canceled. I communicated with Penny Jester, and she said that the study lost funding.