http://www.sciencebasedmedicine.org/another-lawsuit-to-suppress-legitimate-criticism-this-time-sbm/[*quote*]
Another Lawsuit To Suppress Legitimate Criticism – This Time SBM
Posted by Steven Novella on July 23, 2014 (39 Comments)
Gavel-court-legal-law-lawsuit
I suppose it was inevitable. In fact, I’m a bit surprised it took this long. SGU Productions, the Society for Science-based medicine, and I are being sued
http://dockets.justia.com/docket/florida/flsdce/9:2014cv80781/443251 for an article that I wrote in May of 2013 on Science-Based Medicine
http://www.sciencebasedmedicine.org/enbrel-for-stroke-and-alzheimers/ . My SBM piece, which was inspired by an article in the LA Times, gave this summary:
The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).
The claims and practice of Dr. Tobinick have many of the red flags of a dubious medical practice, of the sort that we discuss regularly on SBM. It seems that Dr. Tobinick does not appreciate public criticism of his claims and practice, and he wants me to remove the post from SBM. In my opinion he is using legal thuggery in an attempt to intimidate me and silence my free speech because he finds its content inconvenient.
Of course, we have no intention of removing the post as we feel it is critical to the public’s interest. This is what we do at SBM – provide an objective analysis of questionable or controversial medical claims so that consumers can make more informed decisions, and to advance the state of science in medicine.
We also feel it is critical not to cave to this type of intimidation. If we do, we might as well close up shop (which I suspect the Tobinicks of the world would find agreeable). Defending against even a frivolous lawsuit can be quite expensive, but we feel it is necessary for us to fight as hard as we can to defend our rights and the work that we do here at SBM.
An interesting wrinkle of this suit is that Tobinick is claiming that my blog post is an “advertisement.” This is a legal maneuver as the threshold for forcing someone to remove an advertisement is much lower than the threshold for suppressing their free speech. I can only assume that he and his attorneys are not bothered by the fact that blog posts on SBM are blatantly not advertisements.
In the case of the Enbrel article he had to make the absurd claim that the post (which does not mention my own practice) was an advertisement for my neurology practice at Yale, designed to attack a “competitor.” He would have us believe that Yale neurology in Connecticut is concerned about a distant clinic. Further, Yale Neurology is an academic practice. Our problem is too many referrals and long wait times, not competitors. To see how desperate the claim is, he argued that because I use Botox, which can be used to treat symptoms following stroke, that his treatments for stroke represent a competitor. However, I don’t use Botox to treat stroke patients. I mostly use it to treat migraines, as I am a headache specialist.
Perhaps he feels that my 18-year career promoting science, critical thinking, and science-based medicine is just a cover so I can occasionally attack distant tangential “competitors.”
In any case, the fight is on. Here is a review of the salient points of my criticism of Tobinick:
Tobinick is not a neurologist, and yet he feels it is appropriate for him to treat multiple neurological conditions with an experimental treatment. It is generally considered unethical for physicians to practice outside of their area of competence and expertise. He is trained in internal medicine and dermatology and is certified in those specialties. He has never completed a neurology residency nor is he board certified in neurology.
Despite his lack of formal training and certification, he feels he has ushered in a “paradigm shift” in the treatment of Alzheimer’s disease – a disease that has proved challenging for actual neurologists for decades.
His treatment of choice is perispinal etanercept (Enbrel), which basically is an immunosuppressant drug. He is using this treatment for not only Alzheimer’s disease, but neurological deficits following stroke, traumatic brain injury, and pain resulting from vertebral discs. He therefore claims that the neurological deficits in these various conditions result from active inflammation (specifically tumor necrosis factor – TNF) and by inhibiting TNF “rapid improvement” in neurological function is possible.
These claims are highly implausible, and in my opinion reflect his lack of training and expertise as a neurologist. Strokes cause ischemic damage to the brain – brain cells in severe stroke die. Inflammation following stroke is incidental, not causative. Yet Tobinick claims that 10 years following a stroke, long after any neurological recovery would have occurred, patients can improve by inhibiting TNF.
He makes the same claim for Alzheimer’s disease, despite the fact that this is a neurodegenerative disease resulting in loss and destruction of brain cells. An anti-inflammatory drug is not going to bring back dead brain cells, yet he claims “rapid improvement” is possible.
The simplest explanation for the apparent response to his treatments is simply placebo effects. Stroke neurologists, for example, are acutely aware of the so-called “cheerleader” effect. Take a patient with chronic deficits, get them off the couch, give them any treatment and tell them it will make them better, and they will likely demonstrate increased functionality simply because they are making an effort they had not made for a while.
The only way to really know if the treatment itself is having any neurological benefit is with careful double-blind placebo-controlled clinical trials. Tobinick, however, has not produced such evidence. He has a long list of publications – all case series, observational studies, pilot studies, case reports, and reviews. I could not find a single double-blind placebo-controlled trial establishing the efficacy of his treatment for any of the conditions I listed above. (There are small studies for disc herniation showing conflicting results.)
At best his treatment should be considered experimental. I think the plausibility of the effects he is claiming is extremely low. It’s possible that an anti-TNF effect may be of some use, but given the type of evidence we have it is likely we are seeing mostly (if not completely) placebo effects.
Despite the preliminary nature of his evidence, the “paradigm shift” such claims would represent, and his lack of formal training in neurology, Tobinick has obtained a number of use patents
http://www.strokebreakthrough.com/wp-content/uploads/CV.ET_.Sept2010.final2_.pdf for his treatments. Use patents for medical procedures are still legal in the US, although they have been banned in many other countries, and many consider them unethical. The AMA has this to say:
http://www.wma.net/en/30publications/10policies/m30/ The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned.
The case highlighted in the LA Times story involved Ken Chiate, who brought his wife who was suffering from Alzheimer’s disease to Tobinick’s clinic for 165 injections of Enbrel over four years, at a cost of $800 each (that’s $132,000). During that time there were questionable subjective effects from the treatment, typical of placebo-only effects. Meanwhile his wife’s condition continued to relentlessly progress, as is typical of the disease, until she finally died in 2011.
I am not the only one to have concerns about Tobinick’s practices. The Medical Board of California filed an accusation in 2004, amended in 2005 and 2006, stating:
http://www.casewatch.org/board/med/tobinick/accusation.shtml From about 2000 to 2002, Tobinick, owned and operated a medical practice under the name “Institute for Neurological Research” in Los Angeles and Newport Beach.
During those years, Tobinick promoted and advertised a new off-label use for an FDA-approved drug, etanercept (Enbrel). He referred to his drug as DiskCure® [sic] and advertised it as “a new and innovative approach for back or neck pain without surgery,” and as a “breakthrough” in the treatment of disc-related back and neck pain.
Enbrel is a genetically engineered protein and immune response modifier approved by the FDA for treating several types of arthritis but not for back pain. Tobinick’s treatment involved injecting it near the spine.
Until May 2002, there had been no published, peer-reviewed, scientific studies showing the effectiveness of the treatment for back pain in humans. Nor had there been an approved, pending, or investigational drug application for this use of etanercept.
Tobinick’s advertisements for DiskCure constituted unprofessional conduct under the California Business and Professions Code.
Tobinick had also failed to obtain a fictitious name permit for the Institute for Neurological Research as required by law.
Tobinick agreed to serve one year on probation during which he was required to complete courses in ethics and prescribing practices and have his practice monitored by another physician or complete a professional enhancement program.
But now he is not only up to his old tricks, but he has greatly expanded the scope of his Enbrel claims and practice. He has his own “Institute for Neurological Recovery” in which he shows videos of select patients to promote his patented treatments.
This is all, unfortunately, a far too common pattern, one with which we at SBM are very familiar. There is definitely a need here to provide critical analysis of such extraordinary medical claims. That means, also unfortunately, that we will occasionally need to spend our time and resources defending our right to do so.
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Tags: Alzheimer's disease, Edward Tobinick, Enbrel, tumor necrosis factor
Posted in: Announcements, Legal
Leave a Comment (39) ↓
39 thoughts on “Another Lawsuit To Suppress Legitimate Criticism – This Time SBM”
Bob Blaskiewicz (@rjblaskiewicz) says:
July 23, 2014 at 7:47 am
Where do we send our checks?
Reply
Jeff Clegg says:
July 23, 2014 at 9:57 am
That was my first response too. Opening up the virtual wallet now…
Reply
BobbyGvegas says:
July 23, 2014 at 10:54 am
My first thought.
Reply
Steven Novella says:
July 23, 2014 at 7:52 am
Thanks for the offer, Bob. We certainly would welcome support. You can donate to SBM at the button above, or to SGU Productions (
http://www.theskepticsguide.org/support).
Just tag the donation with “legal defense fund.”
Or if you want to send a physical check, e-mail me directly and I will send you an address.
Reply
Randy Goldberg MD MPH FACP says:
July 23, 2014 at 7:58 am
This is called a SLAPP lawsuit (strategic lawsuit against public participation), and is explicitly against the law in 28 states and DC, including California. California, in fact, permits an accelerated anti-SLAPP motion. If he has filed his suit in California, I urge you to retain counsel and file a CCP 425.16 motion forthwith. If you win, he has to pay reasonable attorney’s fees.
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David Gorski says:
July 23, 2014 at 8:03 am
It’s Florida.
Reply
Peter S says:
July 23, 2014 at 8:17 am
From a quick search, Florida’s anti-SLAPP statute appears to apply only to governmental plaintiffs.
Reply
Peter S says:
July 23, 2014 at 8:04 am
It seems a stretch, to say the least, to have brought this claim under the Lanham Act.
Reply
Peter S says:
July 23, 2014 at 8:13 am
To clarify, the Lanham Act applies to commercial advertising or promotion. This site hardly seems that.
Reply
Unity says:
July 23, 2014 at 8:33 am
Time to contact Ken White and get him to send up the Popehat signal –
http://www.popehat.com Reply
David Gorski says:
July 23, 2014 at 8:35 am
He already knows. We contacted him. He helped Steve locate a Florida lawyer specializing in such cases, for which we are grateful.
Reply
Pingback: Legal thuggery directed at Steve Novella and Science-Based Medicine – Respectful Insolence
Stefan Harders says:
July 23, 2014 at 8:54 am
This is one of the times I’m glad to practise and publish in Europe. That guy, Tobenick, sounds exactly like another one of those assholes doing experiments on severely ill patients for money, thereby displaying a severe lack of empathy, and I’m free to say so without the risk of a pending lawsuit. Fight on!
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Frederick says:
July 23, 2014 at 11:14 am
WOW, That guy’s record is not really good and he think suing will help him?
Maybe a judge will reject his complaint, it is frivolous after all. The whole Advertisement angle is ridiculous. Your article is not a smear campaign either. You demand better evidence, which he does not have. I really hope you get a good judge that will see that it is ridiculous and That it is a slapp. Here In Quebec we now have a anti slapp law now ( loi anti poursuite bâillons we call it). The fact that he patented he “use” is quite weird, he want to be sure nobody else use that, Or test it. It is a sign i guess that it is dubious.
Extraordinary claims demands extraordinary evidence. In which language can we right that so he understand? he does not only need a double blinded placebo, but also a independently replicated experiment after his own. Than if it work, he’ll be famous. What wrong about that?
Anyway Let us know how the case is going. I’m already a Member of the SGU, My budget is limited, But I will certainly help SM as much as I can. Lucky for SBM there’s a Super good Lawyer on the staff!
But being Sued by a guy like him kind is evidence that you are doing you job right.
Bonne chance!
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Frederick says:
July 23, 2014 at 11:16 am
I want to had, As I express in another comment, I really don’t like cranks who make money out of patient with neurological disorder. So kick his ass.
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Mike says:
July 23, 2014 at 2:35 pm
A common tactic among quacks (e.g. Burzynski) is to use their patents as evidence for efficacy, but a patent office review typically only looks for novelty and non-obviousness, and not whether the invention described in the patent application works. It is probably easier to get a patent on a treatment that doesn’t work because it’s easy to come up with quackery that it novel and non-obvious.
Still, receiving a patent says little to nothing about whether or not a treatment is effective, so no, just knowing that Tobinick has patents is not evidence that his treatments are dubious.
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Nell on Wheels says:
July 23, 2014 at 11:17 am
Related article from 2008: Breakthrough or False Hope? Etanercept Case Report Draws Scrutiny
Most media reports presented the work as a “UCLA study.” Tobinick lists a UCLA e-mail address on the manuscript, and the private medical group where he works full-time is located in a building at UCLA’s medical plaza. According to the UCLA media office, Tobinick is a voluntary assistant clinical professor with UCLA’s Division of Dermatology. The office stated that his etanercept study did not go through the UCLA IRB. Greg Cole, associate director of the UCLA Alzheimer Disease Center (ADC), said that the center had nothing to do with Tobinick’s etanercept work.
…
Amgen, the maker of etanercept, distanced itself from the study… “This study was not supported nor endorsed by Amgen. While Amgen and others have long recognized the potential for TNF inhibitors to have an effect on neurological conditions, we have carefully examined this study and believe that at this time there is insufficient scientific data to support the use of a TNF inhibitor as a means of treating Alzheimer’s disease.”
Reply
goodnightirene says:
July 23, 2014 at 11:24 am
I’ve already donated to Dr Barrett’s fund, a case which seems to never be resolved, and is just as absurd in its obvious intent to get revenge for being exposed as a questionable practice or practitioner. Nevertheless, I will contribute what I can.
Reply
Ed Whitney says:
July 23, 2014 at 11:42 am
Actually, etanercept has been tested in randomized trials for lumbar herniated disc and spinal stenosis; there is uncertainty about its benefits but at least some decent scientific work is being done in this area. Freeman and Ohtori reported a therapeutic effect but Cohen did not; however, Cohen used a smaller dose (4 mg) than the other authors used. This is all recent work and does not justify Tobinick’s using it in 2002. But it is not in the same league as trying it out for Alzheimer dementia.
Ohtori S, Miyage M, et al. Epidural Administration of Spinal Nerves With the Tumor Necrosis Factor-Alpha Inhibitor, Etanercept, Compared With Dexamethasone for Treatment of Sciatica in Patients With Lumbar Spinal Stenosis. Spine 2012 ; 37 : 439 – 444
Cohen SP, White RL, et al. Epidural Steroids, Etanercept, or Saline in Subacute Sciatica A Multicenter, Randomized Trial. Ann Intern Med. 2012;156:551-559
Freeman BJC, Ludbrook GL, et al. Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation. Spine 2013;38:1986–1994
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Steven Novella says:
July 23, 2014 at 12:24 pm
Ed – these are small studies (less than 50 participants) with conflicting results, so hardly sufficient to establish efficacy, but I added a small addition to clarify.
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NotADoc says:
July 23, 2014 at 12:24 pm
Dr. Novella, you should take offense at his allegation that you are engaged in advertising at SBM. As a frequent reader, I knew you were in neurology, but didn’t know you were at Yale or that you specialized in headaches until reading this post. If you were indeed trying to advertise, I sincerely hope you would be a little bit better at it.
Good luck deflecting this. Hope you’re rid of this guy quickly.
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daedalus2u says:
July 23, 2014 at 12:56 pm
You might want to look at this paper
http://www.jci.org/articles/view/75073 It shows clinically significant effects in Parkinson’s due to a placebo treatment.
They knew it was a placebo effect because it was done in a double-blind placebo controlled trial.
The Etanercept results may or may not be placebo, because there has been no trial measuring them against placebo. I suspect that the very prompt acute effects may be due to the effects of Etanercept reducing inflammation, but that reduction in inflammation is only acute. It does not lead to resolution of whatever is causing the inflammation.
My hypothesis is that while Etanercept may acutely and temporarily improve things like Alzheimer’s by acutely reducing inflammation, it would very likely accelerate progression because physiology will respond and upregulate inflammation to compensate for the perturbation of Etanercept.
Each dose likely “ratchets” the state of neuroinflammation a little bit higher. If there are periodic MRIs, you could probably see the progression accelerate.
Since they have sued you, in discovery you should be able to get the records of the patients used for the case studies and so determine if they are likely placebo responses or not
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R.w.Foster says:
July 23, 2014 at 1:25 pm
May I reblog your original article? The one that knucklehead wants pulled down? Naturally, you’ll be sourced, Dr. Novella. Unless you happen to lose, then I suppose we could credit it to Dr. Scratcheenseiff…
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Paul Ingraham says:
July 23, 2014 at 1:38 pm
Bravo! Fantastic. I doubt Tobinick has a clue just how much of a Streisand Effect he’s in for. If he thought Google’s search results were unkind to him before, he hasn’t seen anything yet!
I love the toughness and ethical clarity of this response. Having endured my own legal incident a few years ago (after provoking the wrath of chiropractors), I know how surreal and stressful these kinds of threats can be. A firm decision to fight for the right to criticize is a perfect demonstration of why I’m proud and humbled to be involved with ScienceBasedMedicine.org. I’ll be doing my bit to help get that Streisand effect going. And munching my popcorn…
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Windriven says:
July 23, 2014 at 2:37 pm
His Wikipedia entry could use some editing :-)
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smh says:
July 23, 2014 at 1:43 pm
You are familiar with anti-SLAPP laws? He hasn’t got a chance. Make sure your lawyer is not a complete idiot.
http://en.wikipedia.org/wiki/Strategic_lawsuit_against_public_participation Reply
smh says:
July 23, 2014 at 1:48 pm
Don’t forget to sue for attorney’s fees.
Reply
Mikael Nylén says:
July 23, 2014 at 1:51 pm
This is an outrage!
I’m already donating to the SGU every month as a damned dirty ape, but I’ll make sure to send a bit more your way this month, every little bit helps!
/Mikael
Reply
thetentman says:
July 23, 2014 at 1:57 pm
Good luck with the lawsuit. Nobody on Yelp likes him either.
http://www.yelp.com/biz/tobinick-edward-md-los-angeles Reply
Windriven says:
July 23, 2014 at 3:12 pm
Neither do his reviewers at Healthgrades where he earned 2.9/5, below the national averages on every measure (except wait time where he was at the national average).
We all know the problems with these subjective reviews. But it is striking that there are quite a number of internists close by with similar numbers of reviews and much higher marks.
It would seem like the doctor is quite the entrepreneur, dabbling in hair removal and neurological research. I guess the two are related. There is hair on most heads. And there’s a lot of neurological stuff inside most heads. So … yeah, I can see that.
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CrankyEpi says:
July 23, 2014 at 3:00 pm
I realize this is off the main topic and rather trivial, but I feel you (Dr. Novella) are being overly kind by saying that “at best his [Dr. Tobinick's] treatment should be considered experimental.” Outside of the usual scientific connotation of the word “experimental,” I would think of a patient who has a bad disease and who has responded poorly or not at all to all other standard, science-based treatments. Not that the patient would be expected to be cured or respond really well, but rather that you don’t see at least the minimally acceptable improvement from standard treatments in this patient that you would see in others. So in an effort to help the patient, who may have certain peculiarities about his case, the physician might try an unusual treatment (“experimental”) and carefully observe whether the patient responds. I am describing a relatively rare scenario. Without this connotation I worry that non-science based people will interpret “experimental” to mean “let’s try it!” without qualifiers.
Okay, I did not read the LA Times article but it does not sound like this is Dr. Tobinick’s approach.
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Doug Attig says:
July 23, 2014 at 3:02 pm
Attorneys who take cases like this should be disbarred, IMO.
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Peter S says:
July 23, 2014 at 3:34 pm
It will be interesting to me to see their argument how they have satisfied the “commercial advertising or promotion” element of a Lanham Act claim. I fail to see it.
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Peter Kaplan says:
July 23, 2014 at 3:41 pm
Might I suggest crowdsourcing the cost of defending against the lawsuit? Adam Carolla and other podcasters are using this strategy to finance a defense against patent trolls who are suing them for bogus patent infringement. As of 7/23, they are closing in on half a million dollars (
https://fundanything.com/patenttroll?locale=en).
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Keith Eric Grant says:
July 23, 2014 at 3:49 pm
SMH mentioned Anti-SLAPP laws above. California has one of the stronger ones: California Anti_SLAPP Law
Anti-SLAPP laws are designed to provide a remedy against “Strategic Lawsuits Against Public Protection” (SLAPPs), often lawsuits with little merit but designed to intimidate and silence. See Public Participation Project
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Windriven says:
July 23, 2014 at 4:17 pm
One suspects that Tobinick filed in FL rather than CA because of less restrictive SLAPP laws in FL.
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Mike says:
July 23, 2014 at 4:22 pm
I wish you the best of luck in getting this lawsuit dismissed. Since neither you nor Dr. Tobinick are Florida residents, it would seem that he did some forum shopping to find a state without an anti-SLAPP law.
However, as a former patent practitioner, I strongly disagree with your statements about the patent system, which is a completely separate topic from this quack’s actions.
You write:
Use patents for medical procedures are still legal in the US, although they have been banned in many other countries, and many consider them unethical.
This argument sounds very similar to a Non-GMO Project statement on GMOs:
Most developed nations do not consider GMOs to be safe. In more than 60 countries around the world, including Australia, Japan, and all of the countries in the European Union, there are significant restrictions or outright bans on the production and sale of GMOs.
The basis for the U.S. patent system is enshrined in article 1, section 8 of the Constitution, which states:
The Congress shall have power … To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;
The modern patent system institutes a quid pro quo, whereby an inventor is required to publicly disclose how to make and/or use the invention in return for receiving a 20 year monopoly on practicing that invention. Because the patents are published online, a patent by definition cannot constitute “intentional withholding of new medical knowledge, skills, and techniques from colleagues.”
According to U.S. statute, a patentable invention must be novel and non-obvious at the time of the invention. Thus there is (at least in theory) a high bar to obtaining a patent, and a patent should not preclude people from using existing techniques. Patents are especially important in the pharmaceutical industry, where it can cost $1 billion to create the first pill, and a penny to create the second pill. Patents are an important tool for incentivizing drug and medical device development because they can help recover the large research and development costs. Thus, “use” patents are pursued in pharmaceutical and medical device patents all the time.
The WMA makes several distinctions between physicians and companies where that do not apply. For example, aren’t uses of medical devices and drugs considered medical procedures? The WMA seems to acknowledge the importance of patents but states that physicians are special because they “already have incentives [e.g. professional reputation] to innovate and improve their skills.” Well, under the same logic, physicians should never charge for care because any such charges might stop patients from getting the medical care they need and not charging would improve physicians’ professional reputations. Similarly, medical schools should not charge for teaching doctors, and doctors should not charge for training other doctors. Why are not all medical school teaching materials and lectures freely available online?
Basically, the WMA seems to just be coming up with reasons why doctors shouldn’t have to pay for development of novel medical techniques, while making excuses for why it’s ok to pay for (and not steal) pharmaceuticals and medical devices. The WMA also seems to dramatically understate the costs involved in developing new medical procedures.
Furthermore, even if one thought the use of patents on medical procedures to make money was unethical, merely holding a patent on a medical procedure and not enforcing the patent (as Elon Musk recently pledged to do for Tesla’s patents) costs the public nothing, so can not be considered unethical.
Is it possible to unethically assert a patent? Perhaps, by refusing to allow anyone to practice a life saving invention at any price or at a price considered to be too high, but such discussions are not because medical procedure patents are, by themselves, unethical. The WMA statement also discusses possibly problematic conflict of interests, but, again, this problem is irrelevant to whether medical procedure patents themselves are ethical or not. This debate is really about the costs of healthcare in general. Of course the costs of medical care are an important topic to debate, but a particular type of patent should not be singled out as unethical over any other cost involved in providing healthcare in the 21st century.
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KillCurve says:
July 23, 2014 at 4:26 pm
What a slimeball! So thrilled to see you fight!
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Kiiri says:
July 23, 2014 at 4:41 pm
You are right Dr. Novella, it was only a matter of time before someone thought to sue. Best of luck and keep fighting the good fight. Will be looking into making a contribution to the defense.
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