Category: Pharmaceutical Research

The Sound of Silence

Check this out.  Spend a couple of minutes and watch the video. What you will see is a fascinating story of Pfizer, sort of accidently, discovering that its arthritis drug appeared also to be effective as a preventative against Alzheimer’s. BUT. After several years of internal discussion, they decided not to publish the data or do the clinical trials necessary to pursue the indication. Why? You be the judge. This report offers up two diverse reasons. One, the “science” of the data, obtained by analyzing insurance claims, wasn’t strong enough. OR. Maybe the drug’s upcoming patent expiry didn’t make further investments in further indications a prudent business decision. 

Bottom Line. Frankly, I find this story a little creepy. How many potentially significant clinical discoveries never get to see the light of day for whatever reason. And, more importantly, what should have been done here that should be done in similar cases in the future?

Think about it!

These Two Guys Just Did Something Really Annoying!!!

Screen Shot 2017-07-28 at 3.39.50 PM No, their misdeed was not having their picture taken behind the scraggiest plant I have ever seen, although their judgement here certainly could be called into question. Rather, the annoying thing that they did was to coauthor a scientific paper that demonstrated, apparently rather conclusively, that despite the rhetoric to the contrary, pharmaceutical companies over the past decade have spent significantly more on stock buy-backs and dividends than they have on drug development research. Whoops! Bottom Line. I realize that I am not that bright, but there is a pronouncement in this article that leaves me mortally confused. The authors protest that rather than investing in R & D for the good of mankind, pharmaceutical companies are perpetrators of a “social disease” known as “maximizing shareholder value.” HUH??? And there, my friends, is the problem. Every time management at a pharmaceutical company does something that in any other industry would be considered good corporate stewardship. i.e., pricing aggressively, fending off generic competition or minimizing tax rates, they are made to look like unfeeling  dolts. Robber Barons!!! As the battle rages in Congress over Repeal and Replace, thousands of demonstrators’ placards carry some variant of the pronouncement, “Healthcare is a right.”  If that pronouncement is correct, where does the profit motive of pharmaceutical companies fit in? Where indeed???

Old Story, New Spin!!!

Pill with dollar sign We all know this theme. It has been played many, many times over the years. You know, the one that claims that pharmaceutical companies must charge high prices for drugs to yield the funds to support research efforts to discover new drugs. BUT. Here is a new spin on that theme. A NYT article reports that private funding is accounting for an increasing percentage of drug development funds. AND. With cuts in Federal funding being proposed by Trump et al., private funding (i.e., pharmaceutical company money) is likely to become even more important. Bottom Line. Drug Development Research. Somebody has to pay for it. Want to do it through drug prices or tax dollars? 

“Partnering” Comes To Clinical Trials

   

In the traditional business model, pharmaceutical companies designed clinical trials and contracted the “leg work” out to “CRO’s.”  As with any such hand off, inefficiencies resulted.  In-house clinical trials professionals were often out of touch with realities in the field, CRO’s were seen as blocking clinical investigators from talking directly with pharmaceutical company scientists, etc. Expensive and time consuming changes in research protocols, inefficiencies in patient recruiting, etc. were often the result.  In times of increasingly constrained resources, such outcomes simply can no longer be afforded.

“Partnering,” a popular concept in many aspects of business in 2013, is thus becoming the new model for the conduct of clinical trials.  CRO’s are participating more actively in the design of research protocols, company scientists are becoming more available to clinical investigators and other signs of organizational membrane permeability are creating a win-win-win for pharmaceutical companies, CRO’s and clinical investigators alike.  

Bottom Line.  Increasingly, clinical trials need to be seen as requiring marketing to clinical investigators.  Partnering between drug companies and CRO’s is a big step in this direction.

Hear a BMS professional discuss clinical trial partnering at:

http://www.youtube.com/watch?v=jJg6SKjQyPo&list=UUUc29g4BFNpGsp4NWKlvIHA

It Takes A Community

(Sorry Hillary…Not A Village!)

Two interesting points to be derived from the same article.  First is a tip of the hat to our friends at Sanofi for funding an “innovation challenge” as a part of their initiative to engineer forward thinking in patient care.  It is trite but true to say that innovation is hot and getting hotter, and Sanofi ponying up $300,000 to fund an innovative endeavor seems like a win-win move to me.

Second, this year’s winner of the challenge is a mondo online registry of patients with rare diseases. The building of this registry necessitated  beneficial collaboration across several organizations that the challenge required, and the result of its construction will be enhanced efficiency in the conduct of clinical trials.  Crowd sourcing at its best.

Check it out at:

http://medcitynews.com/2012/12/expanding-tools-for-clinical-research-rare-disease-network-gets-sanofi-award-nod/