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Boosted saquinavir literally saved my life, so I am not as down on Roche as others. Hivid (ddC),when combined with Zerit, also seemed to keep me healthy in the days before HAART. Saqunavir will be one of the first PIs to go generic and may provide a low cost alternative to Kaletra if Abbott ever lowers the price of ritonavir. The GEMINI study also showed boosted saquinavir/ritonavir to be comparable to lopinavir/ritonavir in efficacy with better lipid profiles. To quote AIDSMed.com, "Dr. Walmsley noted, 'These data are of considerable importance because they confirm that Invirase offers treatment-naïve patients an effective treatment to control the virus with significantly smaller increases in triglyceride levels than lopinavir, the most commonly prescribed PI.” http://blogs.poz.com/peter/archives/2008/07/roche_abandons.html
Hi Peter, I stumbled across your blog for the Jesse Helms piece, but then found this one. I just wanted to add my own perspective on the astronomical pricing of Fuzeon. I'm a chemical engineering grad student and had the opportunity last year to attend a conference at Roche and visit their production facility for Fuzeon. When Roche decided to try to produce this drug on a clinical scale, most people thought (some people still do think) they were crazy for trying. Fuzeon, aka enfuvirtide, is a linear peptide, a type of molecule most had assumed would never be pharmacologically or economically feasible for a drug company to develop and manufacture. I make peptides as part of my research (admittedly for a completely different purpose), and I can tell you I was absolutely astonished at the complexity and cost of their Fuzeon plant. I do not mean that it was wasteful--their manufacturing process is incredibly streamlined and well-designed; nevertheless, peptide synthesis uses massive amounts of reagents and solvents and extremely complex and expensive purification methods for the amount of product you get out. I am not trying to say that all $25,000/year was justified. But I do know that they could have only priced the drug so low before they would lose money rather than make money on it. Fuzeon really isn't anything like any other drug out there, and unfortunately, that uniqueness involves a great deal of added cost (not only from the manufacture, but also the research, development, and clinical trials required for a type of molecule that has never been used as a drug before) to both the company and the end user.
Thanks for that TAG/saquinavir link, Peter. Unfortunately, as I stated in your AM thread, I'm one of those unfortunate folks who were put on this med when it first came out and developed cross-resistance to all PI's. Combined with the fact that for that first year my insurance policy would not pay for viral load tests until several "medical necessity" protest letters by my HIV specialist, by the time we saw what was going on it was too late. If we'd had those viral load tests I would assume my doctor would have switched me quicker to something else. Or at least I must assume that this is what happened. I'd read previously about this saquinavir mishap but this is more detailed. I swear when I read stuff like this I wish I could sue.
I haven't been involved in the struggles with pharma and HIV drugs, but there's something that creeps me out when someone's business title is "Global Leader, HIV Franchise"! I tend to think of a franchise as something like McDonalds.
I've received a couple of emails about this posting I'd like to share. Mark Harrington, TAG's ED, reminded me about the saquinavir dosing debacle, which has been well documented online: http://www.aidsinfonyc.org/tag/tx/sqv.html Also, another reader pointed out that I failed to mention an additional important contribution Roche has made in the field of AIDS -- Amplicor. This is the leading HIV viral load test we all take, and let's face it -- it would be hard to manage our disease without it. In my defense, this post deals entirely with Roche Virology, and Amplicor comes from Roche Diagnostics, a separate entity within the House of Roche. But yes, they deserve kudos for this.
Mark -- I agree, this isn't "good news" -- I never said it was. But it's not devistating news either, or signs of a worrisome trend.
John -- as far as the pipeline is concerned, I'd agree with Paul Dalton's analysis (see the link he provided -- http://www.thebody.com/content/art47196.html?mtrk=9045233 -- it's well worth reading) -- compared to recent history, it's pretty skimpy. We had a burst of new drugs hit the market over the last two years, so when they were in the pipeline, it was more flush than I had seen it previously. That said, I remember that in years past, the pipeline could look skimpy at times, and then it would start to fill up again. It has ebbs and flows, like everything. I do think you give far too much weight to pinning your hopes on compounds in early development. You'll find that old farts like me, and most other AIDS treatment activists, have learned the hard way how to keep those promising press releases and phase I trials in perspective. The vast majority never pan out. The worst thing you can do is to start championing an early compound, drumming up a false sense of hope before the cake has actually been baked (in a controlled clinical trial). I'm not saying ignore them -- that would be equally lazy. But look at them with a healthy dose of scientific skepticism. Follow them, ask questions about them, report on them, but don't start a fan club for them before they've proven themselves.
POZ Guy
I wish I was in a position that I could ban their medications to spite them for giving up on finding better meds to help keep me alive! F**K ROCHE! I do not feel sorry for them. They cannot handle the grief? Then get out of the business of medications!
October 23, 2008