Updated: 15 June 2015
June's blog is stimulated by May's issue of 'AABB News' featuring 'Advancing Cellular Therapies Together'.
The blog's title derives from a Marvin Gaye classic covered by Creedence Clearwater Rival in 1970.
Frankly, the rah-rah! uncritical tone of the AABB articles surprised me. They mentioned logistical challenges to academia - industry partnerships but not one, repeat, NOT ONE, of the well known pitfalls when industry funds medical research. Didn't even allude to such problems existing.
Why no mention of pitfalls? Is it because of AABB's self-interest in promoting a business line?
In her editorial, 'Advocating for Cellular Therapies', AABB president Lynne Uhl writes:
'AABB will continue to advocate for clear regulatory pathways that avoid overly burdensome requirements for existing cellular products and promote rapid translation of novel findings from CT and regenerative medicine research to treatments for diseases.'Sounds logical that AABB would advocate for easier access of medical discoveries to the marketplace where they can help patients. But the stance aligns with industry's usual complaint that governments set up needless roadblocks and should just get out of the way because industry will ensure patient safety. Really? LOL!
Let's take a brief closer look at AABB News' cellular therapy features.
AABB NEWS ARTICLES
A few selected highlights from 3 articles:
1. Evolving partnerships between academia and industry (p.4)
'As state and federal government funding...has declined... industry support has allowed many academics to continue their research, and academic institutions ... justify such collaboration as a pathway for the commercialization of important discoveries for the common good.'2. Academia and industry collaborate in cellular therapy partnerships (pp. 8-10)
This article is an interview with Yongping Wang, MD, PhD, scientific director of the stem cell laboratory at the Children's Hospital of Philadelphia (CHOP) and Deborah Sesok-Pizzini, MD, MBA, chief of the blood bank and transfusion medicine division at the CHOP.
'The partnership gives both parties a new outlook on their work. It also brings together the different strengths of the two enterprises, which hopefully results in synergy.'3. Advancing cellular therapies through partnerships (pp. 12-17)
'The ultimate goal of these partnerships is to develop a mutually beneficial relationship that will result in scientific advancements.'
'Many institutions and companies form partnerships drawing on each other's strengths to ease and speed the journey to market.'
California Institute for Regenerative Medicine (CIRM): 'We are working to remove the barriers that slow research, without compromising safety.'WHY RESEARCHERS AND UNIVERSITIES LOVE INDUSTRY FUNDING
- Government research grants are getting harder to obtain.
- Researchers may lose positions without outside research money because public universities increasingly suffer from decreased government funding and expect staff to be self-funded, especially in medical faculties.
- Industry funding combats the long-standing bias that universities are 'ivory towers' divorced from the real world.
- Outsourcing cheaper, as those in blood industry know
- Adds credibility, especially if researchers are seen as 'thought leaders'
- Access to research facilities cheaper than building them
- Well educated staff who work for free, inc. PhD students
- Way to recruit scientists and see future staff in action
- Form of advertisement, if researchers are in same field
- Free advertising as universities tout industry partnerships to combat 'ivory tower' stereotype
The short answer is just about everything. Of course, just because Big Pharma funds a study does not invalidate it. Most studies with commercial applications are funded by industry. But the scientific community needs to assess every aspect of such studies carefully using the hallmarks of critical analysis of scientific literature.
I'll highlight two threats that industry funding poses to medical research:
1. Easier Research
Industry tends to fund technology- and drug-based research because they are its business lines and such research happens to be easier. Big Pharma and the biotechnology industry doesn't fund difficult qualitative research on soft skills such as communicating, conflict management, human relations, negotiating, team building, etc. Why would it?
Yet soft skills deficiencies account for serious errors in patient care. For example:
Communication deficiencies are common causes of adverse transfusion events. Patients with special transfusion needs such as those requiring irradiated or CMV-negative blood components are particularly at risk when communication fails.The spectrum of communication deficiencies includes the following failures:
- Physicians not communicating with nurses, technologists, pharmacists, etc., and vice versa
- Attending physicians not communicating with residents and interns
- Staff from one unit not communicating with another unit
- Staff on one shift not communicating with the next shift
- Documentation not accompanying patients from facility to facility
- Educational research to improve health professional communication
- Technology-based mistake-proofing tools like Blood Loc, a combination-lock-secured disposable bag that ensures positive identification occurs before blood can be unlocked and transfused
Of course, to make the point, I've given an apples-and-oranges example of competing research needs. But make no mistake, within transfusion medicine many pressing research needs compete for limited funds.
For example, on 25-26 March 2015, the U.S. National Heart, Lung, and Blood Institute (NHLBI) hosted a conference on 'State of the Science in Transfusion Medicine', for which AABB provided highlights. Priorities identified included
- Need to integrate basic science within clinical trials design
- Research to determine how to make better products, whether synthetic, bioengineered or 'pharmed'
- Several other themes:
- Donor health and safety
- Transfusion requirements of different patient populations, particularly pediatric and neonatal patients
- While my guitar gently weeps (Musings on the seduction of technology)
Having industry control which research
gets done is not good.
gets done is not good.
2. Funding Effect
Financial interests can influence research outcomes in many undesirable ways. (See Resnick below) Besides outright fraud, well intentioned researchers may produce biased results unconsciously.
For example, suppose I'm a university researcher who's increased my prestige and job stability because I've obtained a $1 million contract from Big Pharma to collaborate on investigating a new cellular therapy in what industry calls the 'niche area of oncology'. (Who knew cancer was a niche business line?)
A negative research result or one that shows only a marginal benefit will not further my career. But I'm ethical and have no intention of deliberately skewing results. Resnick below explains the nitty-gritty of what can go wrong from start to finish:
- Problem selection
- Research design
- Data collection
- Data analysis
- Data interpretation
- Publication and data sharing
Collaboration and partnerships between academia and Big Pharma (and other health-related industries) are facts of life. Such collaboration has many benefits and many pitfalls.
Can the transfusion medicine community, particularly NA leading organizations such as AABB, please take its self-interest blinkers off and give members some credit for having a brain?
Vacuous, Rah! Rah! articles undermine AABB's credibility. I expect better from an organization I've respected and been a member of for 40 years.
Sidebar: Does 40 year membership mean I'm eligible for 'emeritus / life membership' in AABB?AABB proposed bylaw change:
"Emeritus Membership to be renamed Life Membership with the eligibility requirement to be changed from 10 consecutive years of Individual Membership in AABB to 30 consecutive years."As always, comments are most welcome.
The version of the blog's title song that I I prefer is CCR's.
- I heard it through the grapevine (Creedence Clearwater Rival, 1970)
Not much longer would you be mine
I heard it through the grapevine
I'm just about to love my mind
What did I hear via the grapevine of AABB News? That respected organizations like AABB now mindlessly promote academia-industry collaboration as if it was the greatest invention since sliced bread. And not a whisper, not a hint of the real possibility of down-sides. Clearly they're industry's poodles.
- Voicing concern that industry funding distorts academic research (ScienceNordic, July 4, 2014)
- Resnick DB. Ethical problems concerning academic-industry collaborations Source: Conference: 'Science and Integrity in the Modern University' (Delft Technology University, The Netherlands, 28 Mar. 2013)
- As drug industry's influence over research grows, so does the potential for bias (Washington Post, 24 Nov. 2012)
- GlaxoSmithKline funded Avandia trial, a drug that was shown to raise the risks of heart attacks and caused 83,000 heart attacks and deaths before it was withdrawn.
- Each of the 11 authors received money from GSK. Four were employees and held company stock. Seven were academics who had received grants or consultant fees from GSK.