David's New Book

Thursday, July 15, 2010

Antibiotics and Avandia


I have been following with interest the potential scandal over the handling of controversial data on GSK’s Avandia by GSK.  It appears, based solely on various new reports that GSK deliberately tried to cover up negative data concerning the safety of this oral drug for the treatment of diabetes.  Of course, until we have full disclosure we won’t know if this is a scandal or not. But the discussion prodded me to think about the pharmaceutical industry and its ambivalence towards antibiotics.

To many, the pharmaceutical industry is a parasite that does little other than contribute to the rising cost of health care.  The industry may be the source of life-saving drugs for cancer or important symptom-relieving drugs for painful conditions such as rheumatoid arthritis, but the costs of therapy remain unreasonably high.  The public frequently views pharma as greedy beyond belief.  The Avandia scandal does nothing do alleviate these concerns regardless of the ultimate outcome at the FDA.  GSK’s settlement of lawsuits for billions of dollars doesn’t help either.

But GSK is one of the few remaining large pharmaceutical companies actively involved in antibiotics research.  It also diligently pursues opportunities for new antibiotics outside GSK, thus providing opportunities for academia and for biotech in the antibiotics area.   While I presume that GSK is involved in antibiotics because they still believe that the market is a viable one, even if their only or main motivation is humanitarian, I won’t complain.  Some companies, like J&J (who has since abandoned most antibiotics research), have openly stated that their motivation for remaining in the area was humanitarian and societal concerns.  Nothing wrong with that!   But these companies get little credit for their efforts in public opinion.

The Infectious Diseases Society of America has proposed the 10 x 20 initiative – that is – deliver 10 new antibiotics active against resistant bacteria by 2020.  This can probably only be achieved through the auspices of the pharmaceutical industry.  Although this is a great public relations campaign, it is, of course, completely unrealistic.  The initiative is also only undermined by the Avandia scandal. The problem for antibiotic research posed by scandals such as the one around Avandia is that it simply reinforces the already negative opinion of the pharmaceutical industry in the eyes of the public.  That, in turn, makes it harder for politicians to back measures designed to provide incentives for the industry to remain or to get re-involved in antibiotics research and development.  Most of the measures being considered will involve increased monies going, directly or indirectly, from taxpayers to an industry already disliked and distrusted by the public.

The sad thing is that the Avandia scandal may not be a scandal at all.  It is possible that the e-mail messages released by the press have bee taken out of context and that there was never an intention by GSK to cover up anything of any scientific value or validity.  We may get a better idea of what went on in GSK during the next few days and months as the FDA and others examine the case more closely. But the truth is almost irrelevant as far as the damage to GSK’s image and the deepening public distrust of the pharmaceutical industry is concerned. 

As the industry struggles to provide more and more personal care options for serious diseases such as cancer, the more the industry will be resented by the public.  It seems like Alice in Wonderland to me.  The industry provides drugs that work for small populations of seriously ill patients but must charge a high price to provide a sufficient return on investment to their shareholders.  If the industry can show that these prices are justified based on the value provided to society and for healthcare overall, then why should we complain?  There is, in any case, no way the industry can provide drugs designed for very small populations without charging a high price.  They would simply lose money.  So, while I can understand resentment at the high prices being charged, I also think a little injection of reality into public thinking wouldn’t hurt.

I say all this because one future direction for antibiotics is to provide curative treatment for seriously ill patients with particular resistant infections.  This would be another example of a small population where high prices for therapy would be required.  But with the industry shooting itself in its public opinion foot, all I see is the abyss for new antibiotics.