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Re: Should all drugs be generic? » Squiggles

Posted by Larry Hoover on July 28, 2007, at 10:11:31

In reply to Should all drugs be generic?, posted by Squiggles on July 27, 2007, at 8:49:38

IMHO, the word should should not even be applied to this issue. The world is a certain way, and has become this way by a complicated path of decision after decision, each made with good intention. My direct answer to your question is, "In your dreams."

> I know that there are social advantages to
> generic drugs, but I am uncertain about the
> safety of some them meeting the therapeutic
> index.

If you intend to use medical jargon, please ensure that you are using it correctly. Therapeutic index is the ratio of a drug's toxic dose to its therapeutic dose. What you are (likely) trying to reference is called bioequivalency, or sometimes, therapeutic equivalency. The latter subsumes the former, but often only bioequivalency is formally tested.

> Do the same drug companies make them as
> well as the non-generic?

Sometimes. Usually not.

> It would be kind of
> redundant wouldn't it, if they did.

How so? Stealing away a portion of the generic market with what one would assume to be a high quality copy of the branded form makes good business sense. It's usually done through a subsidiary, though, if it is done.

> Why not
> make all drugs generic at the lower price?
>
> Squiggles

And who is going to do any research thereafter?

The existing system has evolved in this particular format. It can costs 100's of millions of dollars to bring a single drug to market. It costs that much because the system has evolved to require multiple "phases" of research, each subsequent level depending on approval of the one before it. Remember thalidomide? Only the drug companies have the money to bridge the distance between academia/basic research and approved drugs. Social pressures are the cause of this expensive process.

You later make a comment about how drugs of fifty years ago were neither so expensive, nor so exclusively marketed. The first point is true, but the latter is false. Patented medicine, from Doan's Little Liver Pills, through to lithium carbonate, and on to Vioxx et al, has always been the way it's done.

Your beloved lithium could not pass current clinical trial requirements, IMHO. Just be thankful it got approved before the lawyers could sue the makers for thyroid toxicosis and kidney damage. Just consider how we accept *these* toxic effects without batting an eye, but we howl if one of the mose effective anti-inflammatory drugs in existence shows a correlation with heart attack. The causative link has never been demonstrated (unlike with lithium salts), as there are a number of possible alternative explanations for the statistical finding (e.g. subject selection bias), yet Vioxx is toast. And the lawyers get rich.

Lar

Time flies like an arrow. Fruit flies like a banana.

 

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URL: http://www.dr-bob.org/babble/20070719/msgs/772517.html