Updated: 19 May 2015May's blog was motivated by three items in TraQ's May newsletter: Use of 'liquid gold' in two news items and an EU-funded report that showed 'a clear tension between the plasma derivative (PD) and the blood/blood components sectors'. Links to articles are provided below:
- Unregulated USA stem cell industry is wild west', in which liposuction fat was described as 'liquid gold' because patients pay big bucks for fat-based stem cells
- Canberra Red Cross calling on donors to consider donating 'liquid gold' plasma
- EU-funded report calls for changes to plasma regulation
1. USA'S QUACK FAT-BASED STEM CELL INDUSTRY
- Unregulated USA stem cell industry is wild west', in which liposuction fat is described as 'liquid gold' because patients pay big bucks for fat-based stem cells.
The liquid is dark red 'soup', a mixture of fat and blood, is pumped out of the patient's backside (fat ass?), treated with a chemical, run through a processor, and injected into knees, elbows, faces, penises, you name it.
The 'soup' is rich in stem cells, magic bullets that, according to some doctors, can be used to treat just about anything from anti-aging to face-lifts to multiple sclerosis to ALS.
It's quackery, critics say. But it's a mushrooming business,almost wholly unregulated.
Those profiting call it "patient-funded research". Others say charging patients to participate in medical research is unethical, unauthorized, for-profit human experimentation.
The number of stem-cell clinics across the U.S. has surged from a few in 2010 to more than 170 today. Many clinics are linked to large, for-profit chains such as Cell Surgical Network.Of course, it's quackery. Another example of medical professionals with vested interests promoting unproven treatments for gain.
2. AUSTRALIAN RED CROSS'S 'LIQUID GOLD'
The Australian Red Cross Blood Service (ARCBS) in Canberra promotes plasma donation via plasmapheresis because of a growing need.
A spokesperson said that plasma is used for 18 different treatments including burns victims, trauma patients and cancer patients, plus being used successfully as an immunity booster.
"We call it liquid gold because it can save so many lives."
Hard to decipher this news item. The spokesperson is likely referring to blood components (e.g., fresh frozen plasma, cryoprecipitate, etc.) and plasma derivatives. Most donated plasma in Australia is processed by the plasma fractionator, CSL Behring, to make many products that ARCBS buys back, I assume, and distributes to hospitals. If incorrect, please let me know.
And Australian donors are not paid, in the same way that Canadian plasmaphereis donors are not paid for plasma, although I assume some is sent for processing to manufacturers and sold back to CBS. From CBS's 2013-14 Annual Report (p. 40):
'Given that self-sufficiency is not operationally or economically feasible in a volunteer, unpaid model, Canadian, Blood Services strives to maintain a sufficiency of 30 per cent for immunoglobulin (Ig).
The demand for Ig, continues to rise in Canada and internationally, and, to meet our needs, Canadian Blood Services purchases, surplus recovered plasma (from voluntary donations) from the United States for fractionation.'Seems that Canada supplies 30% of its own plasma for immunoglobulins, a plasma derivative / plasma protein product. But buys the rest --'recovered plasma' donated by unpaid, volunteer American blood donors -- from non-profit US blood organizations. Really?
The worldwide PD market was estimated at $11.8b USD in 2009. Plasma truly is liquid gold, especially for manufacturing companies like Grifols with a global market share of about 20%. In 2013 Grifols net profit rose by a whopping 34.6% to €345.6 million.
3. EU REPORT CALLS FOR CHANGES TO PLASMA REGULATION
An EU-funded report looked at the plasma industry and produced several recommendations based on what industry wanted.
- EU-funded report calls for plasma regulation rethink
- Please see Further Reading for the actual report.
- The International Plasma Fractionation Association railed against the trend for ever-larger clinical trials for new or modified plasma products, most pronounced for coagulation factor products, making it harder and more expensive to run clinical trials.
- Call for harmonization of regulations covering the selection of donors and plasma in the USA and Europe because, for example, mutual recognition of inspection reports could cut costs.
- IPFA expressed concerns and suggestions related to regulations on donation, e.g., legal status of eligibility criteria, mandatory presence of medical staff, recall/exclusion for (v)CJD.
- For example, they said a permanent presence of a physician in a plasmaphaeresis centre adds significant costs without adding any substantial benefit. Qualified health professionals (nurses or who knows who) can do the job.
- The Report also notes a clear tension between private, for-profit companies supplying plasma derivatives to a steadily growing market, including unproven clinical uses, and the public sector, supplying a relatively stable demand for blood and blood components.
Stem cells, plasma, and even molecular blood typing as in April's blog, While my guitar gently weeps -- It's all about the money, folks.
Are the quack fat-derived stem cell entrepreneurs all that different from the paid plasma industry shilling IVIg as the latest and greatest for who knows what?
Or that different from molecular genotyping companies and their advisory TM experts implying that any blood transfusion without genetically matched donors is 'bad blood' or not 'best practice' or so 20thC?
Those trying to influence decision makers are powerful lobbyists with vested interests in the $ billions.
And sometimes with support and collusion from transfusion medicine's 'thought leaders'.
Rather than promote body tissues as 'liquid gold' I'd rather promote a 'heart of gold'. Silly me? A losing battle but one worth fighting.
- Heart of Gold (Neil Young, Madison Square Garden, 2008
- Canberra Red Cross calls on donors to consider donating 'liquid gold' plasma
- Unregulated USA stem cell industry is 'wild west'
- EU-funded report calls for plasma regulation changes
- Key Findings (6 pp): EU-wide overview of the market of blood, blood components and plasma derivatives
- Full Report (139 pp): EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients (Creative Ceutical Report, revised by the European Commission to include stakeholders' comments)