Re: Last Inbox on TB Drugs

On TB drug research, IP, etc: In the recent inbox, it was pointed out that promising medications (in this case, for Tuberculosis) were being held back because they weren't profitable due to the fact that they weren't patented. It was suggested that perhaps government should pick up the tab on research to bring things like this to the market, which would no doubt benefit mankind. How about instead of goverment funded research, we de-regulate clinical trials so it becomes cheap enough to do through a kick-starter program or charitable donation (Gates foundation?). Currently it costs billions to test a drug and bring it to market. This makes charity in this area about as effective as donating to the March of Dimes (The joke being that the March of Dimes donates only a dime out of every dollar they obtain to the poor).

TB is endemic in plenty of 3rd world countries with no access to medications, what if the trials were conducted there on the cheap and the data used to approve the drug in the US? Currently, this is totally prohibited. You could have a favorable 30,000 patient study even in 1st world countries like Britain with a drug that have no impact on the drugs availability in the US.

FDA policies exist largely to favor the big drug companies, that's why, for instance, even drugs approved in the EU don't automatically get approved here--to insulate the companies from competition. Before trying more government to fix this, how about trying less?

I've got news for you - quite a lot of drugs are trialled on the cheap in 3rd world countries already.

That is often how they decide to run more formal trials in first world countries before giving final registration for use. The process for many big pharma companies is as follows: 1) find a market, 2) identify an illness within that market, 3) develop a drug (if there is one already available then develop a 'me too' isomer - see venlafaxine and desvenlafaxine for an example), 4) trial the drug on animals, 5) trial the drug in a poorly regulated part of the world, 6) trial the drug in the country where the majority of the sales will come from.

There are numerous famous cases of how this has been done (often with horrific results). A notable one being the trial of the antibiotic Trovan in Nigeria by Pfizer which resulted in the deaths of several children (who had not been informed of the risks).

I do agree though that first world governments do need to play a larger role in making sure that adequate advances are made in the treatment of diseases like tuberculosis (as a part of being responsible global citizens). Sadly, drug companies invest the lion's share of their research money into diseases that are largely first world problems (antihypertensives, psychotropics, potassium pump inhibitors etc.). This does leave the diseases of the tropics and the developing world largely neglected in terms of funding for new drugs and results in millions of deaths that could have been averted.

With tuberculosis in particular this has been a real issue in some parts of the world. In Papua New Guinea for example, a reliance on old fashioned long-duration treatments with drugs like isoniazid and rifampicin (which are decades old) has often enabled poor treatment compliance, which in turn has allowed multi-drug resistant strains of Mycobacterium tuberculosis to become a serious issue. What really annoys me on this one, is that it has taken the danger of these resistant strains crossing into Australia via the Torres Strait to get the government off of its ass and into gear on responding.

There are plenty of other diseases that are worthy of more attention also, among them leishmaniasis and schistosomiasis, which are nasty parasitic diseases that cause immeasurable suffering. What is noteworthy here too actually is that diseases like tetanus and whooping cough are still major causes of death in the developing world - these are largely preventable via innexpensive treatment and/or vaccination.

Things won't really change in that industry though until people become more educated and being to give more of a shit about the developing world. Disappointingly, my experience of most people in developed countries (like mine, Australia) is that they would rather bury their heads in the sand than grapple with the painful truth on this issue - especially if it means any money out of their pocket, however little.

I also agree that it can be fairly silly that some countries will not really take on board the very stringent rulings of other countries that particular drugs are safe. Though this argument is a little bit of a double-edged sword, as there have been cases where the FDA has approved a drug and the TGA here in Australia has not due to safety concerns (we seem to be a little less swayed by the drug companies on what does and does not get approved). I think safety based arguments like these are pretty reasonable.

On my knowledge of this area, I have worked in the pharmaceutical industry for a number of years and also studied quite a lot of pharmacology as an undergraduate. These days I work in the genetics of infectious disease resistance/susceptibility.

You don't even need to look to 3rd world countries. In many low income neighbourhoods the residents are often subject to clinical drug trials (Hep. C a notable one). 

I would add that in the past, drugs were not always researched and developed for profit. Back in the day, doctors worked for their patients, not their paychecks (ie. insulin therapy development - Frederick Banting). 

Medicine has become a profession of wealth instead of one of caring. I'm not saying doctors don't care, but you tell me it's not easier to care with 6 figures coming in.

The government should be putting in regulation which forces drug companies to contribute to a fund used to allow universities and other non-profits to develop drugs not deemed 'profitable'. Drug companies aren't hurting for money, which is why things like Cancer and Diabetes will NEVER be cured, WAY too much money in treating it. 

Just wanted to add, a good reason for all countried wanting to regulate their own drugs is that what one society may consider an 'acceptable' risk/benefit ratio, another may think too dangerous. An example would be how drug companies are not allowed to air prescription medication commercials on Canadian TV stations. As well, how it took quite some time for Naproxen to become 'off the shelf' instead of prescription only here in Canada compared with the USA. 

Another side note, but a large amount of the first nations people of Canada live in 3rd world conditions. TB is rampant on the reserves, much of it drug resistant. Drug resistant Chlamydia is also rampant as well as Hep C, syphilis, and other STI's. It's easy to think it's so bad 'in the 3rd world', but it's really an eye opener to see how citizens of a country like Canada 'live'. 

You have raised an excellent point Beezleybuzz. While Australia is decidedly first world, the conditions under which many Indigenous Australians live are nothing short of shocking. I must comment, however, that the Australian government has been lifting their game in recent years.

We currently have a system in place called 'Closing the Gap' (CtG) which provides very generous subsidies to Indigenous Australians for the cost of medical appointments and pharmaceuticals (where I would pay ~$35 for metformin under Medicate if I were diabetic, a patient under CtG would pay perhaps ~$6).

It hasn't fixed things, but it is at least a step in the right direction.

Another interesting thing the Australian government has started doing is putting in place an extra charge on drugs that are deemed to be unnecessarily cluttering up the place - namely 'me too' drugs. What I mean by a 'me too' drug is a drug that is essentially the same (either an isomer or something within the same class in terms of pharmacological action) as an existing drug that already fulfills the role required. This is meant to act as a disinsentive for drug companies to take the easy road of pumping out more of the same drugs rather than developing novel treatments.

Some examples of 'me too' type drugs:

Selective Seretonin Re-Uptake Inhibitors (SSRIs - treatment of anxiety and depression) - there are numerous drugs in this class that are all pretty similar on paper. Essentially, following the success of sertraline (Zoloft) a pile of other companies produced drugs with a similar action.

- sertraline

- fluoxetine

- paroxetine

- citalopram

- escitalopram

- fluvoxamine

Something similar has occurred too in the Protein Pump Inhibitor (PPIs - treatment of reflux) market with the following drugs all being roughly the same thing:

- esomeprazole

- omeprazole

- pantoprazole

- rabeprazole

Similar situations exist for the Angiotensin Receptor Blockers (ARBs), Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors), Calcium Channel Blockers (CCBs), and HMG-CoA Reductase Inhibitors (I won't give the full name it's too damned long).

It is worth noting that these drugs all treat what are essentially first world problems.