Have any of you ever heard a pharma executive say something like this to their investors:
We ask you to recognize that your investment in our company may not be as profitable to you as it has been historically. At the same time, we ask you to recognize that our scientific efforts serve a fundamental public good, the improvement of human health. We seek to maintain our talented and dedicated workforce because we feel that this human capital is the best way for us to achieve our underlying goal: to provide safe, innovative and life-saving medicines for people that need them. This can only be achieved through a more thorough understanding of what this industry strives to accomplish and we ask you, as investors, to consider what you intend to accomplish through your investment in our company.
I know, I’m a naive schmuck.
Inspired by a DrugMonkey post, here is some useful data on NIH funding for those in Southern Arizona.
Congressional 8th District: Giffords
DC phone: (202) 225-2542
Tucson phone: (520) 881-3588
Total NIH funding = $5,760,729
UA is technically not in Gifford’s district so most of this is to private companies, but we all know those companies locate here due to interactions with UA (or are spinoffs from UA).
Most of us UA funded NIHers live in Gabby’s district so its probably also worthwhile knowing data for Congressional 7 (physically contains UA)…
Congressional 7th District: Grijalva
DC phone (202) 225-2435
Tucson phone (520) 622-6788
Total NIH funding = $187,058,087
Almost all of that is to UA. Not small potatoes! A 3% cut on that means a $5,611,743 hit to the Tucson economy. That number is slightly exaggerated due research expenditures that leave here but assuming a (very reasonable) 75% salary outlay per grant its still $4,298,807.
My previous post led me to peruse the Health Policy and Reform page at NEJM, which I had not seen before. Some very interesting and pertinent data and opinions there. I love this idea from Moses and Martin:
Create a New Class of Bonds
States and the federal government might issue bonds to support innovation in biomedical science and health services, with preference given to high-risk research and diseases important to public health. Such bonds have long been used to support athletic facilities, airports, and roads. They provide a mechanism for private investment to meet public needs.
Surely everyone has seen the news of the new proposal to return NIH budgets to 2008 levels. Calls for those of us in the public sector research enterprise to call or write our Congress Critters are coming from all of our professional organizations right now. If you’re going to call or write your rep, it might be worthwhile to have some numbers in hand to remind that staffer of the impact of NIH research. We all talk about impact on health outcomes, etc., and maybe some of us talk about economic impact of NIH investment but the role of NIH research in private sector development has been harder to pin down (and some of the previous adversarial industry vs. academia spats have not helped). A major argument I have heard from Republicans is that while NIH research is nice and all, the main driver for health care innovation is the private sector. The primary innovation area is widely viewed as pharmaceutical development. This brand spanking new NEJM paper throughs a serious wrench into that argument.
For the too lazy to click crowd, here is a pretty table from the paper:
My favorite part of this, and the argument I am going to use, is that new indications for existing drugs is coming almost entirely from public sector research. There are serious cost savings opportunities to be found going this route and FDA approvals for new indications is just the tip of the iceberg.
Unfortunately for me, my rep, who is almost always responsive to these things, is not able to do the job she has done so terrifically for the past several years right now. I have a feeling, though, that her friends, family and staff can be counted on for strong NIH funding support so I’m gonna ring up the local office.
You may remember that not so long ago I wrote about what looked like a drug discovery success story for pain: anti-NGF therapy for osteoarthritis. Well, it looks like that success was short-lived. Somehow I missed this over the Christmas break, but, the FDA has ended trials on anti-NGF therapies for osteoarthritis due to development of avascular necrosis in some patients. Nothing positive can come of avascular necrosis and the pulling of several trials would suggest that this is a drug class effect (or at least suspected to be). Anyway you cut it, this is bad news.
Too good. There needs to be some sort of special award for this.
Watching the TV and reading some of the blogs it is clear that some in the media think that the tone of the speech was too celebratory and that the applause from the audience was excessive. It shocks me that so many in the media are incapable of understanding that while we needed a memorial for what happened, we did not need a eulogy from the President (talk about needing to “sharpen our instincts for empathy”). We needed a reason for hope, a reason to find joy. The somewhat raucous nature of the applause in the arena last night reflected that. With each long applause we replaced our overwhelming grief with hope.
President Obama combined our grief and need for hope perfectly in his tribute to 9 year old Christina Taylor Green:
Here was a young girl who was just becoming aware of our democracy; just beginning to understand the obligations of citizenship; just starting to glimpse the fact that some day she, too, might play a part in shaping her nation’s future. She had been elected to her student council. She saw public service as something exciting and hopeful. She was off to meet her congresswoman, someone she was sure was good and important and might be a role model. She saw all this through the eyes of a child, undimmed by the cynicism or vitriol that we adults all too often just take for granted. I want to live up to her expectations. I want our democracy to be as good as Christina imagined it.
My first thought upon hearing the news was terror. One of my dearest friend’s wife (also a dear friend) is active in the local Democratic party and would be very likely to be at the event this morning. He would likely be there too. To make matters worse, the Safeway is across the street from their house. I called him, he’s home sick and she’s at a Democratic party meeting but not at the event. Great relief.
Back to the TV. They report Giffords is dead. I call my wife, who is in Mexico visiting her parents. We talk for 30 seconds. I break down not even realizing that the line has gone dead. I’m sitting there crying into the phone thinking I’m talking to my wife and the phone rings. I realize the line cut out and get a little laugh. I’ve got it back together and we’re talking. She works in the hospital and has experience with the trauma team. Her thoughts are on what’s happening in the hospital so we’re talking about that. TV reports that Gabby is alive… Continue reading
With all the recent layoffs in Pharma, coupled with the axing of many analgesic drug development programs within these institutions, its nice to finally see a success (albeit of potentially short longevity — more on that later). The treatment is Tanezumab. Tanezumab is a humanized antibody against nerve growth factor (NGF). The biologic effectively blocks NGF interaction with its receptors, TrkA and p75. Basic researchers in the pain field have been working on the idea of blocking NGF function as a pain treatment for some time now. In fact, I’ve written about this before:
[in response to a question from Whimple] On your other question, are there examples where the clinical never would have been possible without the preclinical the answer is also yes. My example is not a good one because I likely would have been able to instigate a trial but it would have been much more difficult without the preclinical. On the other hand, the anti-NGF treatments for chronic pain are an excellent example of where it would not have been possible. We have known for a long time that NGF is involved in preclinical pain models and in human pain. We have also known that genetic mutations in humans that block NGF signaling (mostly receptor mutations) cause a terrible disease wherein people with the mutation have profound mental retardation, total lack of pain and inability to sweat. While it was the view of most researchers that this was due to a developmental issue, it was not known if blocking NGF signaling later in life would lead to similar deficits and this made any trial on anti-NGF therapies impossible due to very serious safety issues. After decades of preclinical work it is now known that anti-NGF treatments later in life do not cause similar problems and this animal work has made the safety issue a much smaller issue. So, due to literally thousands of papers on NGF signaling in animal models we have a good idea that these treatments will not cause devastating side effects in humans and these therapies are now late in clinical development. If they gain FDA approval I expect that they will become important treatments for chronic pain disorders. That is but one of several examples wherein animal work was absolutely neccessary to develop new pain treatments.
Onto the trial… (Lane et al. 2010 NEJM) The idea was to see if tanezumab would have efficacy for osteoarthritic knee pain. Rather than looking for efficacy in a currently treatable population, the investigators went for the gold and chose to study the effect of tanezumab in advanced osteoarthritis of the knee patients that did not receive pain relief from analgesics (mainly opiates) that are generally used in this patient population. They recruited about 450 patients and broke them into 6 groups: placebo and escalating doses of tanezumab. Treatment was given over 16 weeks and after that time frame they moved to open label. The results are striking: Continue reading
1-0 over the Rays!! This could be the year!!!!!