"Ethical pharmaceuticals"?

[Mojo]

On the front page of today's Grauniad:

Scientists find way to slash cost of drugs

Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.

The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.

...

Multinational drug companies put the cost of the research and development of a new drug at $800m (£408m). Professors Shaunak and Brocchini say the cost of theirs will be only a few million pounds.

OK, producing cheaper drugs may be desirable, and what is proposed here may be legal, but is it "ethical", and is it sustainable? What they seem to be proposing is to let "Big Pharma" spend money developing new drugs, then, at comparatively little cost, tinker with them just enough to obtain a separate patent, thus undercutting the pharmaceutical companies.

They say, further on in the story,

"We have become so completely dependent on the big pharmaceutical industry to provide all the medicines we use. Why should we be completely dependent on them when we do all the creative stuff in the universities? Maybe the time has come to say why can't somebody else do it? What we have been struck by is that once we have started to do it, it is not so difficult."

Certainly, it would be better if we could use public funds to develop new drugs and supply them to the NHS at lower cost, but is that public money available?

The drug companies are only prepared to put in the sort of investment necessary to develop new drugs because the patent system gives them a temporary monopoly during which they can recoup their investment. If this monopoly is undermined in the way suggested, there may no longer be a good case for them to invest in the sort of development currently carried out.

 

[Darat]

Am I missing something. If they've "tweaked" something about the drug enough to make it a new drug then surely it's as likely to have unwanted effect as any other new drug?

 

[Solus]

I pay over four hundred dollars for my medication. If the drug's structure can be "tweaked" ever so slightly that would be a great thing. My medication costs a fortune and I need it to live any semblance of a normal life. I don't have good insurance either so I"m basically screwed, I'm lucky I have a family that can afford to help me. The drug companies make enough profit I'm all for changing the drug slightly to get around those lousy patents. I think they should get a one year monopoly or at most five, not twenty years!

 

[ponderingturtle]

I pay over four hundred dollars for my medication. If the drug's structure can be "tweaked" ever so slightly that would be a great thing. My medication costs a fortune and I need it to live any semblance of a normal life. I don't have good insurance either so I"m basically screwed, I'm lucky I have a family that can afford to help me. The drug companies make enough profit I'm all for changing the drug slightly to get around those lousy patents. I think they should get a one year monopoly or at most five, not twenty years!

You know that many drugs would never have a monopoly then, because they are patented before they are approved.

 

[kellyb]

Certainly, it would be better if we could use public funds to develop new drugs and supply them to the NHS at lower cost, but is that public money available?

I could be wrong, but aren't there economic models that predict such a method would quickly pay for itself?

 

[Darat]

I could be wrong, but aren't there economic models that predict such a method would quickly pay for itself?

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

 

[Mojo]

Am I missing something. If they've "tweaked" something about the drug enough to make it a new drug then surely it's as likely to have unwanted effect as any other new drug?

The new drug still has to be tested, just as any new drug does, but they don't have the expense of the basic research into identifying a new target and developing a drug for it.

 

[Mojo]

I could be wrong, but aren't there economic models that predict such a method would quickly pay for itself?

Yes, but try getting the government to put up the money up front.

 

[Crazycowbob]

This has, more or less, been done for years, in the form of generic drugs (though some are in fact made by the same company that makes the "name brand") Generics on average cost a fraction of what name brand does, and typically goes through more stringent testing, as it has to provide the exact same benifit, with no additional side effects than the name brand, in order to be made available for sale.

It has had little to no effect on the major manufacturers as far as I have seen.

 

[Pyrrho]

Do not forget the cost of preclinical testing and clinical trials. Plus, the behavior of an altered molecule may be markedly different from the original. Here in the US, "generic" medications still have to show safety and efficacy, even if they are different compounds of the same active substance. Generics companies haven't had to pay for the exhaustive preclinical and clinical work, so they can sell more cheaply.

 

[Darat]

I thought "generic" drugs were identical to the original drugs?

(ETA - I mean the drug itself - inactive ingredients, shape of the tablet and so on may vary.)

 

[kellyb]

Yes, but try getting the government to put up the money up front.

Seems like they could sort of ease into it, one drug at a time, with a minimal initial investment?
I think Brazil has successfully done that to some extent.

ETA:
Here's what I was thinking of on the Brazil thing:
http://www.coha.org/NEW_PRESS_RELEA...razilian_Government_over_AIDS_Medications.htm

 

[Mojo]

I pay over four hundred dollars for my medication. If the drug's structure can be "tweaked" ever so slightly that would be a great thing. My medication costs a fortune and I need it to live any semblance of a normal life. I don't have good insurance either so I'm basically screwed, I'm lucky I have a family that can afford to help me. The drug companies make enough profit I'm all for changing the drug slightly to get around those lousy patents. I think they should get a one year monopoly or at most five, not twenty years!

If the drug company didn't get enough of a monopoly to make them think it was worth their while to do the research, you might not have your medication at all. Drug development is expensive and risky, and they're in it for the money, after all. Cut their potential returns and they might decide there are less risky ways to turn a profit.

 

[casebro]

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.

Don't they have generics in England already? Why is this plan news?

 

[ponderingturtle]

I thought "generic" drugs were identical to the original drugs?

(ETA - I mean the drug itself - inactive ingredients, shape of the tablet and so on may vary.)

To my knowledge they are, this seems to be more about drugs in the same class, like various SSRI's or what ever. And the new drug would also be under patent.

 

[Solus]

That was ignorant of me. A patent lasts twenty years, that's ok. However exclusivity last five years. With exclusivity the drug can only be made by one company and hence the price is exorbitant. I knew it was five years not twenty what was I thinking?

http://www.fda.gov/cder/ob/faqs.htm#What%20is%20the%20difference%20between%20patents%20and%20exclusivity?

 

[brodski]

They say, further on in the story,
Certainly, it would be better if we could use public funds to develop new drugs and supply them to the NHS at lower cost, but is that public money available?

Two words to strike fear into the heart of any bureaucrat implementing a funded program "state aid".
Although the money MAY be available (we're currently in the middle of a Comprehensive Spending Review), using public money in that manner would probably be illegal under EU competition rules.

 

[fuelair]

I thought "generic" drugs were identical to the original drugs?

(ETA - I mean the drug itself - inactive ingredients, shape of the tablet and so on may vary.)

!) "tinkering" with the molecule/molecular structure in even small ways almost guarantees changes - in what the drug does. how it does it, how fast it works, how long it works, whether it works well or poorly or at all, whether it cures ,kills or does nothing - testing is definitely a prerequisite.

2)generics have frequently been produced whose filler material has affected (if nothing else) the rate at which the actual drug is absorbed into and distributed through the body. The drug itself may be exactly the same but if the inactive ingredients affect its' delivery then.....


Do not mistake me as a fan of big pharma (if only because I believe drugs should be - if a price differential exists - cheapest in the place they were developed) just noting the potential care areas when chemistry is discussed.

 

[kellyb]

Is this idea pretty much that the government could get in on the "me too" drug craze that pharmaceutical companies already do to each other?
http://mednews.stanford.edu/stanmed/2005summer/drugs-metoo.html

 

[Pyrrho]

I thought "generic" drugs were identical to the original drugs?

(ETA - I mean the drug itself - inactive ingredients, shape of the tablet and so on may vary.)

They're supposed to be...

http://www.fda.gov/cder/consumerinfo/generics_q&a.htm

7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

The active ingredient has to be the same, but:

http://counsellingresource.com/medications/discount-drugs/generics.html#generic_differences

However, it should be noted that current regulations permit a variation of approximately 20% either way in the bioavailability of the active ingredient. (The specifics of the permitted variation in bioavailability hinge on the FDA's technical definition of bioequivalence, which requires that there be no statistically significant difference in bioavailability.