Intellectual Property and Superbugs

Thomas Lord

Sun Aug 19 09:46:48 -0700 2007

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This doesn't sound much like a patent problem: it sounds like a financing problem.

Per tfa, the therapies in question here are well understood and have been in use for a long time, albeit abroad.   They became popular in the first half of the 20th century.

So:

Either no new discovery is needed or only very highly directed discovery is needed.

It should be a lot cheaper than with most therapies to establish safety and efficacy.

Given that this is old tech, they don't seem to be hard to manufacture.

Big pharma doesn't want this because they are set up to pour almost a billion into discovery and testing before turning over the first sale.   That shouldn't stop others, though:  these could be brought to market with much less up front investment, albeit, sure, with less profit per sale.   If Krispy Kreme or Starbuck's can grow selling products that, essentially, anyone could make -- others should be able to do the same with widely needed, unpatented meds.

-t

Intellectual Property and Superbugs

Rob

Sun Aug 19 14:06:41 -0700 2007

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Very interesting information...thanks for a new information thread to pursue...antibiotic resistant bacteria should be a concern of anyone who reads history...
It is true that a company can make money without a patent.  The margins are lower since an economic monopoly is not granted, which is probably outside the limits of a typical drug company's business plan.  That just means an opportunity for a new, hungry company willing to take risks.
The information on the prevalence of bacteriophages in natural waters interested me.  In the old days, curative properties were often ascribed to immersion in various local waters.  These Victorian era accounts of "taking the waters" have today been largely dismissed as ignorant superstition.  I wonder if the healing properties could have been real?

Intellectual Property and Superbugs

Thomas Lord

Sun Aug 19 14:21:24 -0700 2007

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Careful though -- it's not all free market pricing theory from economics 101.

Dominating drug product costs are the up-front, sunk, speculative costs on getting regulatory approval.    Getting over the FDA hurdle is one of the large expenses that big pharma enjoys as a barrier to entry and that it tries to recoup with patent protection.

I'm skeptical that the regulatory costs are so high that a non-patent medicine can't make it but that is a claim big pharma makes and, so far, the facts on the ground don't much disagree with that claim.

That's why I want to know if this isn't a finance problem:  something that biotech venture funds might want to give some attention to rather than just taking the word of big pharma execs.    Some entrepreneurialism might yield the business model for "new commodity medicines" just as we've found open source business models.

-t

Intellectual Property and Superbugs

Uncle Entity

Sun Aug 19 15:29:54 -0700 2007

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That's why I want to know if this isn't a finance problem...

Big time finance problem. Big Pharma hasn't done their own research for quite a while now. No one is going to put in for a grant to study something that they can't patent and make a few 100 million on selling to the drug companies when there are so many other potentially patentable ideas out there.

I would speculate its all about free market pricing theory, after you publish your studies in a peer reviewed journal you have just lost all control over how your work is used without a government granted monopoly. Anyone with the desire can take your work and jump through all the FDA hoops to get a treatment to market and not have to pay you a single dime...even the journals don't share the profits with their authors.

Scientists and universities aren't going to let 'their' work go to market without taking a cut of the profits. Doesn't matter 'public' money paid for the research for the common good, they want their share.

I'm skeptical that the regulatory costs are so high that a non-patent medicine can't make it but that is a claim big pharma makes and, so far, the facts on the ground don't much disagree with that claim.

You should be skeptical. This barrier to entry is created by Big Pharma and the fact they basically own the FDA through all the various laws they got passed over the years. Much too lazy to go looking for links to support that claim but information's out there. Very important to control the playing field if you want to maintain one of the highest profit margins of any industry.

What's it take to get a new medicine to market, a few clinical trials and send the results to the bureaucrats to bless with the royal stamp? There are some who believe the FDA may actually be acting against the welfare of the American people for whatever reason.

Some entrepreneurialism might yield the business model for "new commodity medicines" just as we've found open source business models.

Look at the battles that have taken place over open source so far. BSD would own the server space if they hadn't been held back by ATT(?) and Linux is getting beat on by proxies to the Evil Empire today.

Now picture an industry that has a true, complete and legal monopoly and imagine if their business model was threatened. They've managed to make it illegal to go to Canada or Mexico to buy the exact same drug sold in the US, you really think they're going to let some upstart show the voters that it is possible to get drugs to market in an economical fashion?

Somewhat of an aside...The new drugs they get patented based on the older drugs don't have to show that they are in any way better. It is speculated that most of them are actually worse than the patent expired drugs they replaced. This is one of the main reasons they spend so much time and money marketing to the Doctors and the public. A better generic doesn't help them even a little so they push the latest reformulation through all the various tricks they have developed over the years.

Intellectual Property and Superbugs

Uncle Entity

Sun Aug 19 16:33:48 -0700 2007

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It is true that a company can make money without a patent. The margins are lower since an economic monopoly is not granted, which is probably outside the limits of a typical drug company's business plan.

It would appear the company in Georgia has a world wide monopoly on this sort of treatment. If they were to find a partner company in the US to get this through the FDA approval they would probably do quite good since there seems to be close to zero risk associated with this treatment for patients. Unless I'm mistaken anti-biotics also kill the helpful bacteria in the digestive tract which this wouldn't do.

Not to get into the complications of the FDA approval process but to me something taken from nature with 70+ years of active use and no real complications that can't be attributed to misdiagnoses should just be able to be sold without government approval, kind of like aspirin or dirt.

Intellectual Property and Superbugs

pyro9

Sun Aug 19 18:02:51 -0700 2007

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While not patentable, at the same time there is a fairly sizable existing body of practical clinical data as well as well developed methods of maintaining cultures and determining the correct phage for a particular infection.

While that doesn't mean instant FDA approval (for both good and bad reasons) it's not as if they're starting from scratch. I suspect that in the west, countries with socialized medicine will end up well ahead of the U.S.  since cost effective treatments mean a lot more than profits there.

Intellectual Property and Superbugs

Bill Riedel

Sat Sep 01 17:25:00 -0700 2007

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Dear Technocrat: It should be noted that Big Pharma has largely withdrawn from antibiotic research. The only problem for not using phage therapy is regulatory. Perhaps the references in the following paper I give to people who are interested in phage therapy should help people make up their own mind:

Choosing to let patients with superbug infections die rather than phage them!!!!
 
It is my humble opinion that the antibiotic-resistance superbug crisis is the mother of all regulatory-scientific-environmental misadventures; however, the absurdity of the superbug crisis consists of the fact that it can be demonstrated that we had technology, namely bacteriophage therapy, long before we created the antibiotic-resistance superbug crisis through massive abuse of antibiotics and other antimicrobials. Additionally many politicians, bureaucrats, scientists and members of the public health community are or should be well informed about phage therapy which can cure many superbug infections. In spite of a voluminous literature attesting to the scientific validity, safety and medical effectiveness of phage therapy (see http://www.phage.org and find phage therapy references), there are still phage therapy deniers who would resist the careful deployment of these weapons of mass-destruction for specific pathogens in the war with superbugs (It would appear that public health systems are AWOL from the war with superbugs).

What is Phage Therapy? Prior to the discovery and widespread use of antibiotics, bacterial infections were treated worldwide by the administration of bacteriophages. Bacteriophages or phages are highly specific viruses that invade bacterial cells and, in the case of lytic phages, disrupt bacterial metabolism and cause the bacterium to die. Interestingly it was the French-Canadian microbiologist, Felix d'Herelle, while working at the Institute Pasteur in Paris in 1917 who is credited with discovering and promoting phage therapy. While the use of phage therapy was discontinued in the West soon after the discovery of antibiotics they continued to be utilized in Eastern Europe and today many infections untreatable with antibiotics can be treated in clinics in Georgia (Europe) and Poland. Once one accepts the fact that it requires microscopes to see the world of bacteria and bacteriophages, phage therapy may be compared to any biological control methodology and can conceptually be described as: What a cat is to a mouse the right bacteriophage is to a specific bacterium or superbug. Phage therapy has been going on in nature as a balancing force in the evolution of microbes for a long time. Medical phage therapy is simply the intervention by humans to ensure that the balance is in favour of bacteriophages over susceptible bacterial pathogens! While there is considerable expertise on phage therapy in Canada at the research level, as can be substantiated by googling phage therapy ("pages from Canada" only), medical phage therapy is not currently approved or practised in Canada; however, according to a letter signed by the former federal health minister phage therapy can be made available legally to Canadian patients under the Special Access Program of our Food & Drugs Act! Additionally, there are moral and ethical reasons for making phage therapy available since Canada appears to be a member of  The World Medical Association which states: "In the treatment of a patient, where proven prophylactic, diagnostic and

therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life." ( see below for quote source ).

A discussion of phage therapy is currently very timely, not only because too many patients are dying of superbug infections; but also because of the recent release of the Canadian film: Killer Cure: The Amazing Adventures of Bacteriophage and the June 2006 release of the book by Thomas Haeusler entitled, Viruses vs. Superbugs, a solution to the antibiotics crisis? ( see http://www.bacteriophagetherapy.info ) - both are available at Ottawa libraries. Additionally, the record of an excellent questions-and-answers session with Dr. Roger Johnson of the Public Health Agency of Canada can be found at http://meristem.com/topstories/ts06_08.html .

Further, the phage therapy file has dramatically changed during the last few months because the US Food and Drug Administration (FDA) has amended the US food additive regulations to provide for the safe use of a bacteriophage preparation on ready-to-eat meat and poultry products as an antimicrobial agent against Listeria monocytogenes (see http://www.fda.gov/OHRMS/DOCKETS/98fr/02f-0316-nfr0001.pdf ). This excellent submission evaluation changes the scientific validity of phage therapy from Eastern European science, which, sadly, too many of us Westerners dismiss with hubris and bias as not credible, to approved and supported by the all-knowing and all-seeing FDA at least for ready-to-eat meats. An enlightening FDA questions-and-answers document can be found at http://www.cfsan.fda.gov/~dms/opabacqa.html . 

Superbugs are everybody’s business because superbugs make everybody their business and every North American should study the above references because sooner or later everybody will be faced with an infection or know a relative or friend who will be suffering or dying with one. Withholding such treatment from patients when antibiotics are failing ought to be a crime; however, those who have the money, knowledge and time to travel when faced with an infection where antibiotics are failing may be able to get phage therapy treatment in Georgia ( http://www.phagetherapycenter.com ) or Poland - http://www.aite.wroclaw.pl/phages/phages.html . A record of a trip to Georgia to get phage therapy treatment by UK citizens can be seen at http://www.relax-well.co.uk/news.html .

What is even more surprising and frustrating is that an American company, Phage International Inc., ( http://www.phageinternational.com ) would probably be willing and able to set up a phage therapy clinic in any country if the right regulatory climate existed. A recent article describing how foreigners from many countries are treated at their Phage Therapy Center in Tbilisi, Georgia can be found at http://www.phagetherapycenter.com/doc/sjbizjournal.pdf .

Since January 1, 2000 as many 87,000 Canadians may have died of superbug bacterial infections and there is not even a memorial for them, although some people are starting to wear blue ribbons in memory of superbug victims. Would it not be nice if the Canadian governments, public health officials and media got together and funded the Felix d'Herelle Center for Phage Therapy to provide the phage therapy treatment option for patients when antibiotics fail and we have nothing left to offer them?

P.S.: WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI PARAGRAPH 32:

"In the treatment of a patient, where proven prophylactic, diagnostic and
therapeutic methods do not exist or have been ineffective, the physician,
with informed consent from the patient, must be free to use unproven or new
prophylactic, diagnostic and therapeutic measures, if in the physician's
judgement it offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, these measures should be made the
object of research, designed to evaluate their safety and efficacy. In all
cases, new information should be recorded and, where appropriate, published.
The other relevant guidelines of this Declaration should be followed."

FROM: The World Medical Association:

http://www.wma.net/e/policy/b3.htm - and

http://www.aite.wroclaw.pl/phages/phages.html

Intellectual Property and Superbugs

pyro9

Sat Sep 01 18:04:44 -0700 2007

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This part bears repeating:

"In the treatment of a patient, where proven prophylactic, diagnostic and
therapeutic methods do not exist or have been ineffective, the physician,
with informed consent from the patient, must be free to use unproven or new
prophylactic, diagnostic and therapeutic measures, if in the physician's
judgement it offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, these measures should be made the
object of research, designed to evaluate their safety and efficacy. In all
cases, new information should be recorded and, where appropriate, published.
The other relevant guidelines of this Declaration should be followed."

I simply cannot understand the sort of reasoning that would deny a dying person the right to try an experimental treatment even if it could be fatal, particularly when the quality of their remaining life will be poor anyway. Further, as long as they're trying a "hail mary" cure, it should be well documented in the event that it can advance medical knowledge.

I have no doubt such approaches might hasten a few inevitable deaths, but they will have known it might. Further, terminal cancer patients in particular sometimes want their death hastened anyway. Since euthanasia is illegal, it happens by prescribing a dose of morphine adequate to control their pain, which just happens to usually be fatal.

Given all of that, what sort of idiot would prefer that state of affairs to letting them try "one more thing" before they go? It might just save some lives. It's even more likely to provide knowledge that eventually saves many more lives.

Intellectual Property and Superbugs

Bill Riedel

Mon Sep 03 16:50:05 -0700 2007

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In the case of phage therapy what is even harder to understand is that we have observations in writings of  at least 3 religions, Hinduism, Islam and Judeo-Christian, that can be explained on the basis of phage therapy:

Hinduism - see Let's start a Hindu crusade - Why Ganga water is sacred for Hindus - http://anandkumar1978.blogspot.com

Islam - google "Hadith of the fly" or try http://www.muslimtents.com

and also in the Bible go to 2 Kings 5:14 and then we have almost 100 years of scientific research and medical practice - how can science and medical practionners disregard all this - I found an explanation in Postmanian "bullshit" - specifically Ueber-Eichmannism (for  academic references on bullshit go to http://bullshitcitynorth.blogspot.com).

Frankly, the current story re: phage therapy makes me sick. I am thinking of entitling my next paper: Superbugs, phage therapy and bullshit!