I’ve been a bit remiss lately in posting, due to some exams and deadlines that have kept me unusually busy, but I wanted to briefly promote a new tool in the effort to develop novel, evidence-based therapies for cancer. The National Veterinary Cancer Registry (NVCR) is an effort to build a database of information about veterinary cancer patients. This will allow both epidemiologic studies using the data to better understand the patterns in naturally occurring cancer and also to connect patients with clinical studies of new therapies for their specific disease. This serves the veterinary patient population as a whole as well as the individual patient.
The NVCR is a joint effort between the CARE Foundation, Baylor University Medical Center (BUMC) at Dallas and the Texas Veterinary Oncology Group. This type of database has been of great value in improving the understanding and treatment of cancer in humans, and it is exciting to see such an effort beginning in the veterinary field. I encourage owners of pets with cancer to register your pets as a way to contribute to the growth of our ability to help others going through what you are going through.
Skeptvet, just a question – how will this group be different from other cancer specialty groups – others also have databases and clinical trials, right? Is it because it is focused on a veterinary-human collaboration of onco study rather than veterinary alone?
As I understand it, the goal is to create a national cancer registry for veterinary patients, which doesn’t currently exist. If successful (which means if people register), then this would be an invaluable research resource. I’m not sure if it will take off, but I think it has great potential to be a centralized database that researchers anywhere, in human and veterinary oncology, could draw on.
Ok, but may I ask another question? What about the ethical considerations of clinical trials in pets, who can’t give informed consent, as in, they won’t know/understand if they’re receiving a placebo in a clinical trial. For pets with cancer, time is often of the essence, as it is with owners as well. I realize this surely has to be based on owner consent, but all the same, what are the ethical standards here? This might be one obstacle the registry might be slow to take off, at least where trials are concerned and perhaps owners’ perceptions?
Not that it isn’t a wonderful idea, for the data collecting, research and improving cancer therapies.
Whenever there’s a clinical trial, human or veterinary, there is always the issue of the ethics of assigning some individuals to placebo. One can argue that at least humans can choose whether to take that chance, but of course the choices of people dying of cancer are constrained and not entirely free, so I’m not sure the situation is all that different for people than for animals. And since we take responsibility for the well-being of our animal companions, I think we have to face the responsibility of making such choices for them since they cannot make them for themselves. Without controlled research, we would not have many of the effective treatments that currently make our pets lives healthier and longer, so when considering the risks we should not overlook the benefits.
My own feeling is that one can argue the ethics from both sides. It is fairly easy to say that it is unethical to expose people or pets to a placebo when they have a serious disease because they will suffer from not receiving active treatment. And in cases where a treatment that is effective has already been established, this makes sense. So clinical trials should compare novel therapies to those that are already in use when such exist.
However, in cases where there is no effective therapy, we honestly don’t know if the new treatment is better or worse than doing nothing, so it is hard to argue that we should use an untested therapy on sick people (or animals) and not make the appropriate effort to determine if it is better than nothing. If it is, the placebo group will of course not do as well as the treatment group. But far more commonly, the treatment group is no different from placebo, and sometimes the treatment group actually does worse, so we can’t know ahead of time which group is actually getting the better deal.
And there is an ethical argument to be made that without properly controlled trials, all patients will be subjected to inadequately tested therapies of uncertain risks and benefits. Given that most new therapies are not improvements over placebo or existing therapy, not doing controlled trials means subjecting desperate more patients to treatments that are more likely to do nothing, or even make them worse, rather than help them. So the most ethical thing in terms of what is most likely to lead to the greatest good for the greatest number is to properly test all therapies against standard care, if such exists, or placebo if not. Some individuals will receive less effective treatment than they might have, but far more will be spared from receiving useless or harmful therapies that have never been properly tested.
I’m often faced with such decisions as a clinician. If I know the number needed to treat, then I have some idea of the liklihood that a given treatment will benefit my patients in general. But I can never know for certain if many treatments will actually help a particular patient. For example, 5% of young cats with blood in their urine have bacterial infections, and 95% do not. All these cats’ owners would like me to give them antibiotics “just in case.” Should I give antibiotics to every such cat? If I do, I will help 5%, harm about 15% (with diarrhea and vomiting from the drug) and do nothing for most. I will also contribute to antibiotic resistance, which harms many patients. If I don’t give them antibiotics, I will harm 5%, will spare 15% from harm, and will have no effect on the rest. And I will not add to the problem of antibiotic resistance. So what is the right answer? I feel as a clinician a responsibility to individual patients, so it is hard to deny therapy that might be helpful to a few. But I also understand that overall I am helping more and harming fewer if I refrain from giving the therapy. And the owners all wantt what’s best for their pet and care little about the rest of the pet population. Tough choices to be made and no perfect solution.
Thanks, skeptvet, you’ve said exactly what I thought you’d say, and very well put at that.
Cancer is tricky because of what little we do know and what more we do not know, but I would like to think the consensus would agree that the opportunity existing for further research, clinical trials and progress made in such research in vet med would be jumped upon.
Now let’s just hope woo doesn’t make it’s way into this effort!
How are they going to register the thousands of Oncomice etc? This is all getting very near the ethical bone, isn’t it?
so it is hard to argue that we should use an untested therapy on sick people (or animals) and not make the appropriate effort to determine if it is better than nothing. If it is, the placebo >>>>
Even if therapy is proven safe and effective it has not been proven safe and effective for the patient we want to use it for. The more we can measure outcomes of the patients we treat the better doctors we will be. My paperless vet software can automatically send data to someone without names and addresses. Most vet software can. Medical records could be sent to state boards automatically. State boards then could mine the data to measure ourcomes and have medical records to give owners. There is a lot of ways to measure outcomes if we would cooperate. When I was a kid I would watch the vet I worked for open up a case he lost and look inside before creamation. Without the owners consent I could not even get a dead dog checked for rabies the last time rabies was on my rule out. Ethics ??? There is a prospective randomized human knee trial where on the flip on a coin you got fake surgery with you knee opened up and nothing done or knee surgery with you knee opened and a procedure done. They have a brain surgery trial where half of the patients got a hole drilled into their skull with nothing done.
Art Malernee Dvm
Fla Lic 1820
true, but two wrongs (or a million) don’t make a right…….
Art, granted that we have to start somewhere, and the “guardian” of the pet is left to the decision-making process. The rest of your post was based on human intervention, those who were able to give informed consent, or, in some cases, were able to prior research the procedure/treatment before giving informed consent. This is where some of us cannot ignore the ethical questions. It’s sort of a conundrum. Science tells us it has the potential for progress and to benefit a majority in the long term. But, the human condition tells us there are tough choices to make for those without a voice.
Btw, you realize there are still pet owners who do not know how rabies is tested for. Once they learn the rather appalling nature of the procedure, well you know how that goes. Now the states/counties regulate rabies testing in acknowledged cases and some states or counties will not even consider quarantine measures for those cases of suspicion. Some pet owners are not even aware of their state or county requirements until they are faced with them.
Good article in nyt this morning about the lack of cooperation making data available even in FDA approved treatments. I wonder if all the Tamiflu the government stockpiled even works.
See
http://www.nytimes.com/2013/06/30/business/breaking-the-seal-on-drug-research.html?pagewanted=3&ref=science
Art
Yes, the AllTrials initiative has been very successful at getting the pharmas to open up. Lots to do still, but encouraging to see some movement.