1. Origin BioMed, Part 2: Quackery
Saturday, I discussed the “cyber letter” that the US Drug Enforcement Agency wrote to Halifax-based Origin BioMed, which has received a $7.9 million “investment” from Nova Scotia Business, Inc., in the form of an equity stake in the company.
The cyber letter told the company that its online advertising positioned the homeopathic Neuragen products as a drug, and as such “your products ‘Neuragen PN’ and ‘Neuragen Cream’ are prescription drugs [that] need to comply with all US drug laws.” This means the whole gamut of prescription drug regulation, including years of testing, double-blind studies, and peer review by both independent researchers and the DEA itself.
There is no way that the Neuragen products could successfully complete that arduous review, and so I suspect that the DEA cyber letter was the nail in the coffin for Origin BioMed. Very likely NSBI will lose nearly its entire $7.9 million investment.
Homeopathic remedies are accepted by some alternative medicine practitioners, but the medical establishment rejects them as quackery. In 2010, the Science Based Pharmacy blog published a detailed review of the Neuragen products, and of the single “clinical trial” of Neuragen ever conducted (paid for by Origin BioMed), and concluded:
Neuragen, despite its advertising, is not true homeopathy. It is a mixture of homeopathic remedies in an aromatic oil base of different oils. If we accept the results of the clinical trial as accurate (despite the numerous limitations), it’s plausible the geranium oil could be providing a therapeutic effect. However, given the significant limitations in the data, and the short duration of the study, the evidence of effectiveness isn’t convincing. Besides the questionable clinical significance, and possibly weak blinding, we’re left with a clinical trial result for a product that may not be the same as the products currently sold.
This study does not provide persuasive evidence of long-term effectiveness or safety. Neuropathic pain is already hard to manage and patients suffer tremendously as a result. New therapies — “natural” or otherwise — with few side effects are needed for this common condition. However, patients need science based treatments based on adequate controlled trials, which are of sufficient power, with better methods, and tested for at least a few months. Fortunately, a new trial of Neuragen set to finish in January 2011 looks like it may resolve some of the strong limitations in the BMC trial.
Neuragen has not been approved for sale by Health Canada’s Natural Health Products Directorate. What this means is it is not permitted for sale in pharmacies. Despite this, it is widely available. Health professionals who strive for a science based practice would do well to consider the numerous limitations in the clinical efficacy and safety data before recommending this product.
Oh, that 2011 “new trial” of Neuragen? It was sponsored by the Canadian College of Naturopathic Medicine in collaboration with the Queen Elizabeth II Health Sciences Centre. The US National Institutes of Health now require registration of all clinical trials before they begin so that studies with negative results can’t be ignored. Because of the reporting requirements, we now know that the 2011 Neuragen study was aborted — “withdrawn prior to enrolment” with the NIH — because of “funding limitations.”
There are a couple of issues here. First, as I asked Saturday, shouldn’t NSBI have an ethical filter? No matter what the possible export sales income from Neuragen may have been, the Nova Scotian government should not be in the business of promoting quack medicines. Tens of thousands of people were sold a bogus product, costing those people millions of dollars, and that scam — there’s no better word — was facilitated and financed by Nova Scotia Business, Inc. Is there no oversight body to investigate this? Where is the auditor general? Where is the provincial Office of the Ombudsman? Do any of our elected representatives care? What about minister of health, Leo Glavine?
Secondly, ethics aside, how did this NSBI investment go sideways? There’s much more involved in this story, and I’ll get more into it in Part 3 of this series tomorrow. But for now it’s enough to say that it looks like the whole debacle started with a lack of proper investigation of the company and its products, and as the company’s prospects deteriorated, rather than pull out and cut its losses, NSBI doubled down and threw good money after bad. An initial $1 million invested in 2007 was followed by $2 million more in 2008, $728,000 in 2009, another $2 million in 2010, $850,000 in 2011, and another $1 million in 2013, just weeks after the US DEA cyber letter was delivered to the company.
And yet, evidently, nowhere along the line of ever-increasing investment did NSBI pause, check itself, and commit the resources to fully investigate the value of the company’s sole export, its Neuragen line. Had such an investigation been conducted, surely it would’ve predicted that drug regulators, including the US DEA, would very likely eventually crack down on Neuragen.
But such investigations can only occur in organizations that have self-awareness, a culture that promotes and respects views contrary to the party line, and above all executives who can admit mistakes and cut bait when necessary.
As with the Neuragen “medicine” itself, the investment theory at NSBI seems to be that if you just believe, all will be cured.
2. Wild Kingdom
Both CBC’s Quirks and Quarks and the Chronicle Herald’s Frances Willick have related the remarkable discovery that the blackpoll warbler, a songbird weighing just 12 grams, migrates from Nova Scotia and other points in the Maritimes to South America over open ocean:
The data showed that four of the five blackpolls left Nova Scotia for New Jersey and then made landfall either in Puerto Rico or Hispaniola in the Greater Antilles. The birds travelled between 2,270 kilometres and 2,770 kilometres over water during a period of between 49 and 73 hours. The fifth bird left mainland U.S. and arrived in Turks and Caicos about 18 hours later, a distance of about 1,500 kilometres. From their stopovers in the Caribbean, the blackpolls flew to their wintering grounds in northern Colombia or Venezuela.
1. Film tax credit
Neither here nor there, but it’s curious that the cost of the Film Tax Credit — $24 million annually — is almost exactly what the Yarmouth ferry subsidy was last year.
2. Flight 624 lawsuit
Stephen Kimber points out that law firms take considerable financial risk to line up clients for potential class-action lawsuits, and very often the lawsuits result in justice for powerless victims. He cites McInnes Cooper’s successful $887-million class action lawsuit “on behalf of disabled veterans and their families” and Wagners’ $34 million suit on behalf of “hundreds of physically and sexually abused children at the Nova Scotia Home for Colored Children.”
Wagners is one of the firms considering a suit related to the crash landing of Flight 624.
3. Cranky letter of the day
I feel strongly that the people of Nova Scotia should not be required to give over their Sundays to hunting every autumn. I urge this — as a gun owner and a former hunter — because twice in my life I have been shot at by irresponsible hunters.
The first time, my father and I, while hunting along a logging road, were startled by the sound of a nearby gunshot and a bullet clipping branches as it passed our heads. We dropped to the ground, and our shouts were followed by the sound of someone rushing through the woods.
The second time, I was walking across an open field when two pheasants broke cover and flew up in front of me. Before I could react, I heard a gunshot and felt the sting of pellets hitting my back, the back of my head and both ears. I turned and saw a man, holding a shotgun, at the open door of a car stopped in the road going by the field. In response to my shouts, he tossed the gun into the car, jumped in and slammed the door, as the driver sped away.
As it turns out, I never went hunting again. It wasn’t a conscious decision. But I suspect the bloody welts and the sickening thought of what could have happened stirred me to identify more and more with the wild creatures being hunted than with those hunting them as a sport. Both incidents had occurred on a bright Saturday morning, under a clear blue sky, amid beautiful, natural surroundings. Getting shot at had been the farthest thing from my mind.
Proponents of Sunday hunting may point out the infrequency of such incidents, and they would be right. They may argue that things have changed, and hunters must now take a course on hunting safety. Again, they would be right. Some things have changed: Wearing high-visibility clothing is now more common, and the practice of taking “sound shots” is probably less common.
But there are some constants that haven’t changed, and aren’t openly acknowledged. Some hunters still look upon a hunting licence as an implied licence to drink while hunting. And, impaired or sober, there will always be irresponsible individuals who cannot be trusted to exercise the necessary self-discipline required to carry an instrument as potentially destructive and lethal as a loaded gun.
I am not alone in feeling uneasy about going into the woods during hunting season; and that is a shame. Autumn in Nova Scotia is a delightful time of year. Now, when working in the woods, I wear fluorescent clothing and am always on my guard.
I would hate to think there might come a time when I couldn’t have even one carefree day a week during that season to take my camera and go out to enjoy nature with my family.
Paul Patterson, Sydney Forks
In the harbour
Weird, these four-day holidays. No one’s out making news.
Today’s musical reference: