How Bad Does It Have to Get?

A recent study in PLoS One by E. Ray Dorsey, et al, found that between 1995 and 2005, the money spent on biopharm and medical device research has increased hugely across the board, and by as much as 369% in at least one therapeutic area. We have not, however, seen a comparable rise in the number of drugs approved by the FDA. Although the authors readily admit that their conclusions are based on a “sample of convenience,” they ring true to those of us in the industry. Whether you think that new drugs cost $600M or $1.2B to bring to market doesn’t really matter – we have thrown ever more money at a constantly diminishing return.

The authors suggest that now the limiting factors are non-financial, and solutions include bringing people and ideas together in more productive ways, bringing down the cost of clinical trials (though they don’t explore what this would take), openly disseminating the results of negative trials, and increasing the flow of people and ideas between organizations.

These all point to the need to revise and harmonize our processes, break down the functional area silos, increase the intelligent standardization of data and processes, and develop approaches that are nimble, flexible and adaptable. We need greater transparency in regulatory discussions and decision-making, which will help us to interpret regulations better and stop being so ultra-conservative in our work. Most of all, we need to understand that breaking the work into ever smaller pieces and parsing them out to ever more internal and external groups guarantees that no one sees the full picture, and so no one can control it. All of these changes must happen not only within organizations, but across them as well, to result in the best possible solutions.

The current approach is both failing and unsustainable. Neither government nor the public will tolerate the current mix of risk, benefit and cost. Unless our clinical trials enterprise changes dramatically, we will find ourselves forced to lower the prices we charge while maintaining the current costs. That is not a future that we, as future patients, should support.

The referenced study is at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0007015
Photo: Dwarf ginseng, reputed to have calming medicinal properties. Taken at Sharon Hollow Nature Preserve, April 2007.
© 2009, Kit Howard

Upholding the Scientific Method

Many thanks to Mark Uehling, from ClinPage, who distilled my recent rants to their pure essence, namely:

By not sharing our clinical trial operational processes, we are violating the most basic tenet of scientific research, which is to share methods and data in order to progress. Without this, we jeopardize the future of our entire enterprise.

Amethyst crystal embedded in clear quartz, photo from www.wilenskyminerals.com

For those of you reasonably familiar with my fairly wordy style of writing… Hmm. That doesn’t do it. It’s usually good to learn new things, and recently I was made aware that… No, I don’t think that’s it either. OK. Here goes. I’m practicing being less wordy!

That was hard! My philosophy has always been “write it down, then edit to 50% of the size.” While editing is still good, I don’t have the bandwidth for that much rewriting, so I’m trying something new. This blog will still be a space for observations and rants, but my goal is to practice getting to the point quickly. Maybe in time it will become a habit! So here goes.

Recently I learned about OpenClinica, a free open-source clinical trials software system from Akaza Research. It apparently has been used in many trials by government, academia and in the industry. They join a growing trend of organizations no longer willing to accept industry’s rules (excuses?) of high costs and selective pipelines where treatments are developed only if they match a marketing strategy. Organizations like OneWorld Health, founded by Victoria Hale (one of my very few heros), a non-profit drug company that develops treatments for third world diseases. Or like the Parkinson’s Disease Society, that funds research to the tune of £4M per year.

Granted, these organizations have an advantage. They often receive their compounds from companies that have found them and don’t want to develop them, so much of the cost and risk of the initial research is mitigated. They generally don’t have shareholders demanding high profits. But they also don’t expect 7, 8 or 9 figure salaries, and it seems that their primary goal is treat patients, whereas much of industry seems to regard that as second to profits and personal wealth.

Most of us want to do the right thing, though, and one way is reconsider what we keep confidential and what we share. No, not chemical formulae or marketing strategies! I’m talking about clinical trials processes. How we develop our protocols, and SAPs, and CRFs. How we recruit our subject, monitor our data, resolve our queries. What we query. How we pass data between functional areas. There are efficient and inefficient ways to do these things, and we’ve been reinventing them for 20 years as new companies start and existing companies reorganize. It’s time for everyone to be open about how they do these things, and let the best approaches bubble to the top. And don’t tell me this is part of competitive advantage – no one out there is getting drugs to market dramatically faster than anyone else!!! Here’s a radical concept – let’s compete on the merits of the treatment or device itself!

Photo: St. Johns Wort, Auckland Botanical Gardens, Auckland, New Zealand. c. 2008, Kit Howard.