Here at the SoPD we are politically neutral.
That said, we will report on events that directly impact the world of Parkinson’s disease research (without adding any personal opinions). This week a vote took place that may have implications for the Parkinson’s disease research community over the coming year.
Here we will discuss what has happened and what it means for the Parkinson’s research community.
Researchers voting. Source: Science
On the 3rd February, the organising committee of the Commission G2 Massive Stars, part of the International Astronomical Union (IAU) announced that it would not hold any scientific meetings in the United States of America as long as a temporary ban on the entry of any persons from Libya, Sudan, Somalia, Syria, Iran, Iraq, and Yemen, is in place.
This vote was in response to the January 27th signing of Executive Order 13769, which limits the number of refugees arriving in the USA to just 50,000 and suspended the US Refugee Admissions Program (USRAP) for 120 days (after which the program will be resumed with new conditions for individual countries). The order also imposes a temporary travel ban on the 7 countries listed above for 90 days, after which an updated list will be made. Notably the suspension for Syrian refugees is indefinite, but the order allows for exceptions to be made on a case-by-case basis. (Source: Wikipedia).
With just 12,450 individual members (from 74 countries, including Iran), the IAU’s decision is purely a small symbolic gesture. And while their vote has nothing to do with Parkinson’s disease, we note that other scientific research organisations (and many individual scientists) are making/contemplating similar measures/gestures – not simply calls to boycott US-based conferences but also particular scientific journals (for more on this click here).
Of particular importance to the Parkinson’s community is the Society for Neuroscience (SfN) meeting to be held in Washington DC in November of this year (luckily the annual Parkinson’s disease and Movement disorder conference will be held in Vancouver this year). Each year, 30-40,000 scientists and advocates from around the world gather at these SfN meetings to share/discuss novel findings and form new collaborations. A great deal of Parkinson’s research is discussed at these meetings and the associated satellite meetings that take place the week before or after.
The president of the SfN has already issued a press release regarding the executive order (Click here to read that), but many researchers are already pulling out of invited presentations. For example, Adrian Owen, a well-known neuroscientist from Western University (Ontario) publicly announced on twitter that he was refusing an invitation to present a lecture at the meeting in Washington DC:
At the time of publishing this post, a federal appeals court had denied a Justice Department’s request to lift the restraining order and allow the immigration ban to continue. The 9th U.S. Circuit Court of Appeals in San Francisco has asked for the Justice Department to file a counter-response by 3pm Monday (Click here to see that statement), which means that the restraining order remains in place for the next 24 hours at least.
Whether the restraining order is lifted and Executive Order 13769 is brought back into effect is a matter for the courts to decide. The outcome, however, is already having an impact as many scientists symbolically refuse to attend conferences in the US (it will be interesting to see what attendance is this year at the SFN meeting).
We are not going to speculate on the possible consequences of Executive Order 13769, except to say that 2017 may not be a bonanza for US based research conferences. We will be watching events as they unfold and will discuss them here if they relate to the Parkinson’s community.
The banner for today’s post was sourced from ABC News
Science conference. Source: JPL
This week over 40,000 neuroscientists from all over the world have gathered for the annual Society for Neuroscience conference in sunny San Diego. It is 5 days of non-stop presentations of scientific results.
One of the presentations made this year was delivered by Dr Russell Kern, executive vice president and chief scientific officer of International Stem Cell Corp (ISCO). It dealt with the controversial on-going stem cell clinical trial in Australia. In the presentation, Dr Kern outlined the study and gave an update on the first patient in the Phase 1 clinical trial, who was transplanted at the end of July. The second patient is scheduled be treated in the next three weeks. A total of 12 are expected to be treated.
During the three months following the first surgery, the attending physicians observed no signs of complications (which is a very good thing). Unfortunately, according to San Diego Union Tribute, Dr Kern is then said to have implied that ‘there are some indications of efficacy in relieving symptoms of the movement disorder’. In addition, Dr Kern suggested that ‘the patient’s handwriting has improved’.
Long time readers of this blog know that we have been extremely critical of this trial from the start (Click here and here to read them). We make no apologise for this. The pre-clinical data that has been presented thus far in no way justifies taking these particular cells to the clinic. We believe it irresponsible. And our opposition is supported by many other researchers in the Parkinson’s research field (Click here for an example).
It defies belief, however, that Dr Kern would suggest to a conference audience or a media outlet that a patient who is 3 months post surgery could be exhibiting functional improvements. It is widely acknowledged in the Parkinson’s disease research field that it takes 2-3 years for the cells (that are transplanted into the brain) to mature and become functional (click here for more on this). In addition, during their preclinical studies Dr Kern and his colleagues observed very little in the way of behavioural improvements 12 months after transplantation (when compared to control conditions), so how is it that they are seeing such rapid improvements in their first human subject?
If Dr Kern’s suggestions of functional improvements are based solely on the unblinded observations of the clinician and the patient, then sharing such information publicly is extremely inappropriate. Unprofessional at best, but potentially unethical. At the very least, any suggestions of functional recovery in cases like these should be supported by brain scans (indicating increases in dopamine activity) and blinded, unbiased investigator scoring. Otherwise any reported outcomes could simply be due to the placebo effect (as the patient knows that he has been transplanted), and thus not valid for a Parkinson’s community desperate to see positive results in a potential therapy.
We also have concerns regarding the financial feasibility of the current study. Shares in ISCO have fallen from their giddy highs of $2.50 a share back in 2010 to a recent all-time low of just $0.055 (valuing the company at less than $6 million). According to their most recent financial statement, the company is burning $343,000 per month (for the year ended December 31, 2015), and the company ended 2015 with a cash position of just over $530,000. They partly resolved this problem in March of this year by issuing more shares (Source), but one does worry that this kind of activity can not be maintained indefinitely.
Here at the SoPD, we are very keen for cell transplantation to become a viable treatment option for people with Parkinson’s disease in the very near future. But the approach must be rigorously tried and tested, and presented to the highest standards before it can be considered feasible. As we have said before, the standards surrounding this particular trial (demonstrated by inappropriate disclosures of information during an ongoing clinical trial) are lacking.
FULL DISCLOSURE – The author of this blog is associated with research groups conducting the current Transeuro transplantation trials and the proposed G-Force embryonic stem cell trials planned for 2018. He has endeavoured to present an unbiased coverage of the news surrounding this current clinical trial, but when unacceptable statements are being made to media outlets, well, he is human and it is difficult to remain unbiased. He shares the concerns of the Parkinson’s scientific community that the research supporting the current Australian trial is lacking in its thoroughness, and will potentially jeopardise future work in this area.
It is important for all readers of this post to appreciate that cell transplantation for Parkinson’s disease is still experimental. Anyone declaring otherwise (or selling a procedure based on this approach) should not be trusted. While we appreciate the desperate desire of the Parkinson’s community to treat the disease ‘by any means possible’, bad or poor outcomes at the clinical trial stage for this technology could have serious consequences for the individuals receiving the procedure and negative ramifications for all future research in the stem cell transplantation area.