A Win for the FDA and for 3 Companies – Gilead, BMS and Merck

J0302914 Over the past several weeks, there have been several goals scored that have made headlines.  Nearly all of them have involved the World Cup.  Another occurred in medicine.  This week The New York Times reports that the FDA will approve a once a day combination HIV medication – not only a goal, but a head butt to the heart of AIDS.

A once daily combination is as much of a landmark as many other breakthroughs in HIV treatment.  Even the headline for the New York Times got it wrong, saying this was a "New Medicine for AIDS is One Pill, Once a Day,"  indicating a headline writer who can’t distinguish between AIDS and HIV infection.  This is a pill that is a treatment for HIV, not AIDS, and the significance is huge.

The new pill combines Sustiva, sold by BMS with a combination of Viread and Emtriva.  The new combined drug as of yet, has no name.  No matter. 

This is not only a scientific breakthrough, it is a breakthrough of the ability of the regulatory agency (FDA) and the companies (BMS and Gilead) to come together and make something happen that will benefit the common good.  Merck is involved because it sells Sustiva under the name of strocrin in developing nations.  The companies had to struggle with the new formulation to make it work.  It took, according to the Times, about a year to make combination to actually form a pill rather than a gluey mess.  This success should be included in communications plans for FDA, PhRMA and the companies involved as an example of the need to focus society on benefit and not just risk. 

For this tremendous accomplishment, they should all be lauded.  A lot.  It should be lauded by government, by developing nations, by AIDS service organizations and by the public health establishment. 

You see, the advent of a one a day pill speaks loudly for compliance.  A prior concern about those in developing nations was that balancing a regimen of several pills a day would prove too heavy of a task, especially without healthcare infrastructures, and lead eventually to a drug resistant virus.  A once a day pill makes that far more unlikely if it is sold there at a reasonable price. 

According to the Times,

Going to a single pill could especially be important in poor countries, where patients have less access to medical care and more people are illiterate or uneducated.  The vast majority of the nearly 40 million people in the world infected by H.I.V., the first that causes AIDS, are in developing nations.

This makes one wonder though, if Senator Grassley (R-Iowa) will march up to HHS to knock on the door to offer congratulations with cameras of news organizations in tow.  He should.  It would be a more fitting headline than the one a few weeks back when he marched up to HHS to offer objection to the way Ketek is being handled.  Maybe this time, they would let him in.

One note of caution. This is a breakthrough.  But it is incumbent on the companies to ensure that this breakthrough does not signal that HIV is manageable like diabetes.   It should be an inherent part of any marketing campaign, that the companies involved go to lengths to assure the at-risk population that this is not a cure.  The possibility of resistance to any drug regimen is always a threat.  This development cannot be construed as an ok that infection is tantamount to a daily vitamin supplement.  The companies have that obligation. 

This entry was posted in FDA Image, FDA Policy, Pharma Industry Image. Bookmark the permalink.