"Ethical pharmaceuticals"?

[joobz]

From what I can tell based upon papers of theirs, their idea is to simply attach poly(ethylene glycol) to a protein drug and call it a new drug.
PEG is quite well known to improve the blood residence times of many circulating compounds and is nothing new. So far, many groups have shown it to be an effective, near ubiquitous way to improve a formulation.

However, companies own the patent rights to PEGylation (Nektar for one).

I can be fairly certain that there are going to be patent issues here, because I would be suprised if any company who patented a protein drug didn't also include polymer variants of that protein drug as well.

We'll see.

The only thing that irked me is the "clinical trials in India" point. This is somewhat of a dodge since I'm willing to bet India has less legal restrictions to performing clinical trials which would make me question the whole "ethical" point of their pharmaceutical.

 

[Rob Lister]

Reading this thread so far, my only initial comment it, go with this 'new way' of doing things only if you are happy with the existing drugs we have and really feel improvements in them, or completely new ones, are not really necessary.

The big pharmaceuticals will go under -- or become something else -- if the idea in the OP is actually put into place.

R&D is a killer cost (well above 10% but I have no references).
Advertisement is a killer cost (well below 40% but a very necessary evil)
Law Suits are a killer cost (not that I did NOT say potential law suits - they are inevitable and MUST be build into the price)

There are many other 'killer costs' such as dead ends, competitor products, etc., that make the pharmaceutical business a risky business indeed.

If you like the advancement of medicine in general, then think trice before opting into the alternate plan described.

 

[joobz]

R&D is a killer cost (well above 10% but I have no references).

Some companies have R&D with budgets close to 30 percent. in comparison, generic companies will commonly have R&D budgets in the <5% range. (from a patent infringement case that can't be mentioned).


Generics also have a HUGE profit margin. I'm not saying pharma companies don't milk it. But generics aren't a benevolent alternative by anymeans. They are just a step or two above herbal companies (who I consider to be super evil).

 

[Mojo]

...which would make me question the whole "ethical" point of their pharmaceutical.

Well, the question I really had is: is there any way in which this is particularly "ethical" (other than that they've chosen to call it "ethical pharmaceuticals")?

 

[casebro]

Well, the question I really had is: is there any way in which this is particularly "ethical" (other than that they've chosen to call it "ethical pharmaceuticals")?

I worked in the animal meds field in 1971. At that time "ethical drugs" were those sold only to vets, regardless of legal classifications. It was at the behest of the maker. Different era, different country, different definition.

 

[joobz]

Well, the question I really had is: is there any way in which this is particularly "ethical" (other than that they've chosen to call it "ethical pharmaceuticals")?

To answer you directly, As far as I can tell. NO
Not at all
In no way shape or form.
Ethical in this term is purely a marketing tool made by a researcher for "unethical" reasons.


Foremost of which is that he patented the idea and didn't place it into public domain. Had he published it and did a "open source" method, then he could claim a altruistic view. BUT, it is my guess that the university that owns the patent wants money for the patent.

That isn't unethical, but it's far from altruistic, which is what they want you to believe.

 

[Rob Lister]

Some companies have R&D with budgets close to 30 percent. in comparison, generic companies will commonly have R&D budgets in the <5% range. (from a patent infringement case that can't be mentioned).


Generics also have a HUGE profit margin. I'm not saying pharma companies don't milk it. But generics aren't a benevolent alternative by anymeans. They are just a step or two above herbal companies (who I consider to be super evil).

And advertising has a huge impact. No matter how good the drug, if you don't advertise it, nobody will get it. Advertising to doctors only is an very inefficient way of going about it (they get spammed more than your email). In most markets, R&D and Advertising are generally equivalent costs as a rule of thumb. Sure, an absolute cure for all forms of cancer would require little advertising, but unstopping the snot in your nose a little better, or differently, than other drugs might require some research. A doctor prescribing such a thing is not going to do so unless 1) the information is available AND, 2) a patient asks for it by name.

 

[JamesM]

I was a little baffled by this story. There must be something I'm not getting. It seems that all they've done is modify the molecule slightly. This is standard practice during the 'lead optimization' phase of drug design.

Quite apart from all that, it's hopeless as a strategy for creating a new model of drug discovery. It relies on modifying existing drugs - this requires pharmas to still exist and be sufficiently profitable to pump money into R&D to generate the molecules in the first place. Even then, you'll have to wait for the patent on the original drug to expire - pharmas are very good at ring-fencing their drugs with patents that cover all feasible chemical modifications which might still impart some sort of bioactivity.

If, on the other hand, the chemical modification is non-trivial, then the probability of activity rapidly plummets to zero.

 

[kellyb]

Reading this thread so far, my only initial comment it, go with this 'new way' of doing things only if you are happy with the existing drugs we have and really feel improvements in them, or completely new ones, are not really necessary.

The big pharmaceuticals will go under -- or become something else -- if the idea in the OP is actually put into place.

R&D is a killer cost (well above 10% but I have no references).
Advertisement is a killer cost (well below 40% but a very necessary evil)
Law Suits are a killer cost (not that I did NOT say potential law suits - they are inevitable and MUST be build into the price)

There are many other 'killer costs' such as dead ends, competitor products, etc., that make the pharmaceutical business a risky business indeed.

If you like the advancement of medicine in general, then think trice before opting into the alternate plan described.

I've read this post three times now, and really, I just don't buy it.
I'm very well aware of the concept that the free market is what drives technology, medical and otherwise, but I'm still not seeing our present situation as being the only possibility.
I think diverting funding away from other things, to be put into academic medical research, which could then be put into government pharmaceutical plants, could not only happen, but could be more cost-effective than what we're doing now.

 

[69dodge]

And advertising has a huge impact. No matter how good the drug, if you don't advertise it, nobody will get it. Advertising to doctors only is an very inefficient way of going about it (they get spammed more than your email). In most markets, R&D and Advertising are generally equivalent costs as a rule of thumb. Sure, an absolute cure for all forms of cancer would require little advertising, but unstopping the snot in your nose a little better, or differently, than other drugs might require some research. A doctor prescribing such a thing is not going to do so unless 1) the information is available AND, 2) a patient asks for it by name.

A company letting people know about its drug is useful. Two companies each trying its hardest to convince people to buy its drug instead of the other company's similar drug is a waste of money. I'm not sure which is more common, but if it's the second, we should think of some way of avoiding that waste.

(I don't mean, it's a waste from each company's individual point of view, given the current system. Of course it isn't; otherwise, they wouldn't do it. But looking at the big picture, it's quite clearly a waste; so why not change the current system?)

 

[Asolepius]

Lots of good comments here. Worth pointing out that the UK scene is different from US. Over here we have regulation of pharmaceutical prices, linked to promotional and R & D costs. There are limits to what drug companies can spend on promotion, and we have no direct to consumer advertising.

It's quite correct that, if this group has developed a molecule that is sufficiently different to circumvent a patent, then theoretically they will need to do a full development programme, from preclinical toxicology right up to large scale phase III studies. They will need to budget at least £250m to do this. Obviously they don't have the resources to do it in house, so they will have to contract it all out at even higher cost. I would love to see the business plan for such an enterprise, because presumably it's based on the expectation of making a loss. The gain comes from the NHS saving money. So the NHS should stump up the £250m.

But I have a niggling worry that there might be some regulatory chicanery. The UK's regulatory body the MHRA should apply exactly the same standards to this molecule as they do to everything else (with the notable exceptions of homeopathy and herbs, but don't get me started on that). But what if the benefit to NHS costs is high enough to justify political action to dilute regulatory standards? The politicians should not forget Northwick Park too quickly.

Just a thought on the US scene. I sympathise with patients who are burdened with such high costs of essential drugs, but this is a political issue not a commercial one. The US government won't set up a proper welfare system, or regulate the drug companies to the extent they are here. The UK system is very far from perfect, and has its own deep problems over costs of treatments, but this new development is very much a result of the UK health care system.

Perhaps I should declare an interest. I have worked for 33 years in the pharma industry, most of that in drug development. It's a very profitable sector, but is high risk. Drug companies are not charities, but even so several are doing charitable things in developing countries. Like the NHS, they are far from perfect, and vulnerable to all the usual human frailties, many of which I have observed over the years. They'll do whatever the regulators will let them do, which is why we need regulation. If we had the same degree of that for the tobacco companies nobody would smoke.

 

[Art Vandelay]

On the front page of today's Grauniad:

Scientists find way to slash cost of drugs

Well, that's deceptive, right there. It won't lower drug costs, in fact it will increase them. It will simply change who pays drug costs, making them seem cheaper.

When you think about it the answer has to be "yes" - after all pharmaceutical companies are profitable.

That's rather fallacious thinking. Just because it's profitable in the private sector doesn'tmean it will be in the public sector. And not all pharmaceutical companies are profitable.

Well, the question I really had is: is there any way in which this is particularly "ethical" (other than that they've chosen to call it "ethical pharmaceuticals")?

Well, there's the sense in which everything is ethical. The word "ethical" can be considered to simply mean "dealing with ethics". It's usually implied that it means "consistent with some set standard of ethics", but really, and system of ethics is, by definition, ethical.

Last I heard, Big Pharma spends more on advertising than they do on R&D. Like 10% for r&d, 40% for advertising. But they sure do cry about the r&d costs.

It's odd how people seem to think that the percentages are relevant.

 

[patnray]

Another point to consider: just because the final product is chemically different than the original drug does not mean they have evaded the patent protection. If they manufacture the original drug and then modify it they have probably violated the patent. This only works if they can produce the new version without the original version as an intermediate step.