Consumer-Generated Clinical Trials? Research Minus Science = Gossip
The internet, in democratizing knowledge, has led a lot of people to believe that it is also possible to democratize expertise.
– Commenter at Science Based Medicine
Regular readers of this blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.
Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of my patients to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.
In a recent lecture on Health 2.0, it was suggested that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild:
1. A rating tool was created to “empower” patients to score their medications (and user-generated treatment options) based on their perceived efficacy for their disease/condition. The treatments with the highest average scores would surely reflect the best option for a given disease/condition, right? Wrong. Every single pain syndrome (from headache to low back pain) suggested a narcotic was the most popular (and therefore “best”) treatment. If patients followed this system for determining their treatment options, we’d be swatting flies with cannon balls – not to mention being at risk for drug dependency and even abuse. Treatments must be carefully customized to the individual – genetic differences, allergy profiles, comorbid conditions, and psychosocial and financial considerations all play an important role in choosing the best treatment. Removing those subtleties from the decision-making process is a backwards step for healthcare.
2. An online tracker tool was created without the input of a clinician. The tool purported to “empower women” to manage menopause more effectively online. What on earth would a woman want to do to manage her menopause online, you might ask? Well apparently these young software developers strongly believed that a “hot flash tracker” would be just what women were looking for. The tool provided a graphical representation of the frequency and duration of hot flashes, so that the user could present this to her doctor. One small problem: hot flash management is a binary decision. Hot flashes either are so personally bothersome that a woman would decide to receive hormone therapy to reduce their effects, or the hot flashes are not bothersome enough to warrant treatment. It doesn’t matter how frequently they occur or how long they last. Another ill-conceived Health 2.0 tool.
When it comes to interpreting data, Barker Bausell does an admirable job of reviewing the most common reasons why people are misled to believe that there is a cause and effect relationship between a given intervention and outcome. In fact, the deck is stacked in favor of a perceived effect in any trial, so it’s important to be aware of these potential biases when interpreting results. Health 2.0 enthusiasts would do well to consider the following factors that create the potential for “false positives”in any clinical trial:
1. Natural History: most medical conditions have fluctuating symptoms and many improve on their own over time. Therefore, for many conditions, one would expect improvement during the course of study, regardless of treatment.
2. Regression to the Mean: people are more likely to join a research study when their illness/problem is at its worst during its natural history. Therefore, it is more likely that the symptoms will improve during the study than if they joined at times when symptoms were not as troublesome. Therefore, in any given study – there is a tendency for participants in particular to improve after joining.
3. The Hawthorne Effect: people behave differently and experience treatment differently when they’re being studied. So for example, if people know they’re being observed regarding their work productivity, they’re likely to work harder during the research study. The enhanced results therefore, do not reflect typical behavior.
4. Limitations of Memory: studies have shown that people ascribe greater improvement of symptoms in retrospect. Research that relies on patient recall is in danger of increased false positive rates.
5. Experimenter Bias: it is difficult for researchers to treat all study subjects in an identical manner if they know which patient is receiving an experimental treatment versus a placebo. Their gestures and the way that they question the subjects may set up expectations of benefit. Also, scientists are eager to demonstrate positive results for publication purposes.
6. Experimental Attrition: people generally join research studies because they expect that they may benefit from the treatment they receive. If they suspect that they are in the placebo group, they are more likely to drop out of the study. This can influence the study results so that the sicker patients who are not finding benefit with the placebo drop out, leaving the milder cases to try to tease out their response to the intervention.
7. The Placebo Effect: I saved the most important artifact for last. The natural tendency for study subjects is to perceive that a treatment is effective. Previous research has shown that about 33% of study subjects will report that the placebo has a positive therapeutic effect of some sort.
In my opinion, the often-missing ingredient in Health 2.0 is the medical expert. Without our critical review and educated guidance, there is a greater risk of making irrelevant tools or perhaps even doing more harm than good. Let’s all work closely together to harness the power of the Internet for our common good. While research minus science = gossip, science minus consumers = inaction.
hmmm…. I wonder
Wonder who gave that lecture.
Wonder how many “clinical trials” have their data manipulated, or hidden by interested parties
Wonder how many results from “clincal trials” done on limited defined populations are then extrapolated to be good for entire populations (CABGs done on the over 65s to take one example)
Wonder how many doctors prescribe drugs to groups for whom there’s no scientific evidence said drugs are good for (statins for those pre-heart attack)
Wonder what percentage of doctors practice medicine according to latest clinical guidelines (well actually, we know it’s only 54%)
Wonder how many procedures and techniques have been introduced by physicians without clinical trials only to be rejected as the herd moved on to the next pasture within a few years (remember lithrotripsy?)
Wonder how many physicians are prescribing a drug or using a device because of a financial arrangement not disclosed to their patients or colleagues
Wonder whether chronic pain is over- versus under-treated in this country (actually we know the answer to this too, which suggests that the crowd in the study wasn’t that stupid)
Wonder how many drugs have been withdrawn from the market following a successful clinical trial
Wonder how any expert can claim certainty despite all my wondering
Wonder if Joan Lunden actually ever uncovered enough in all her investigations to get all high and mighty about pyjama wearing bloggers
ooops, missed this
🙂
I think Health 2.0 tools provide consumers with many helpful resources, especially with disease management or support from others with similar conditions, but these tools don’t replace the valued relationship of a physician. Personally, I like science based medicine. As you note, there are risks of potential biases and false negatives, but the clinical trial process is designed to mitigate as many of these risks as possible.
Your clinical perspective provides a good balance to the claims of patient driven & web 2.0 style research. Do you have any thoughts about how a web 2.0 approach could provide useful data?
Clearly both the clinical trial model and the health 2.0 model are lacking in some respects. All the clinical trial biases identified in the post and in Matt’s comment are very much a reality. The biases or factors limiting reliability in the “crowdsourcing” health 2.0 model are also a reality. That’s not to say that neither model is useful. Otto von Bismarck famously compared law and sausage, saying that it’s better not to see how either is made. However, in the 21st century spirit of transparency, it is important for us to understand how clinical trials and health 2.0 resources develop their conclusions and recommendations. With that knowledge at hand, we can take a critical look at those recommendations. The danger lies in accepting conclusions without considering the process that yielded those conclusions. We have become adept at spotting the problems inherent in the clinical trial process as it currently exists. Over time, we will become equally adept at spotting the issues with “crowdsourced” clinical recommendations.
Thanks for the great comments, folks. I think we can all agree that good scientific methodology (a systematic approach to data interpretation that recognizes the inherent limitations and biases) is paramount. I would encourage us all to focus a healthy skeptical eye on research efforts on and off line. That’s why I’m a fan of “science-based medicine.” See http://www.sciencebasedmedicine.org for more.
The beauty of the “crowd-sourcing” techniques is that it aggregates the reasonable observational capacities of the crowd (by-in-large objective, reproducible, verifiable). A singular observer’s bias (good or bad) is nullified by the sheer weight of the crowd’s members singular observations. It trully is a “reasonable persons” assessment of an event — emphasis on event and the fact that events are always external and always subjected to the same observational behaviors of other members in the crowd. Contrast this with the notion of crowd-sourcing a “clinical trial” where what is being aggregated are internal opinions, feelings, beliefs, etc. This is the aggregation of the subjective, irreproducible and non-verfiable. Crowd-sourcing traffic patterns in not the same as crowd-sourcing menopause. The ponderables for traffic are easily discernable by all. The ponderables for menopause may or may not be known or expressed to there fullest. Bolt’s “11 wonders,” despite the rhetorical mish-mash, does point to serious problems with present “scientific” studies. But stretches all credulity with the implicit notion that all professional studies being flawed means all non-professional studies should be considered under the banner of crowd-sourcing.
There are many things not known in science or poorly known in an historical perspective. We have limited knowledge of vast area of the Moon’s geography, it is wholly illogical to assume that crowd-sourcing will fill this informational void. Why? Because the crowd does not have access to the observational skills to render singular observation that can be aggregated. Are there limitations in both methodologies? Of course. But a limitation in one does not mandate a strength in the other. And, singular successes do not assure generalized successes.
If the best shot the H20 pundits have to level at “clinical trials” is Bolt’s 11-wonders, they need to pack up their tents and go home. These are very serious topics during serious times. We have many without healthcare in this country and crisis-level financial troubles present and for years to come. The H20 vision has much to be admired, but has much that cuts to the image of creating a true healthcare caste system in the US. They would do well to trade the rhetoric laced with neologisms for reason and goals that address today’s healthcare realities.
Now David, a question — how about crowd-sourcing the legal profession? Certainly what’s good for the goose, should be good for the gander. I think we should crowd-source that question…
Sorry, I had to delete a comment because it violated BMJ copyright (an entire journal article was copied and pasted into the comments section). It was posted by Carlos Rizo MD PhD
http://im-patient.blogspot.com Apologies to Carlos.
Dr. Val you’re to be commended for your concern about consumer generated trials (and some forms of patient empowerment)!
I agree with most things you say.
It all depends on your goals. What do you want to know and/or achieve?
If you want to know whether drug I works better than drug C in a patient group P with respect to outcome O (yes PICO), than you will find the best evidence in a well performed controlled clinical trial, preferably a randomized trial (or even better a systematic review of RCT’s), performed by qualified personnel. We all know (don’t we?) the above mentioned limitations of a RCT, but those limitations are more pronounced in other kinds of trials, and certainly in the “non-professional studies” symtym refers to.
Sorry to say, Carlos, but the whole list of biases of a RCT doesn’t impress me (except that I have to scroll very long to and fro from comment to post). Isn’t this Jadad the same Jadad of the Jadad’s scale? This scale is (was) widely used to assess the quality of clinical trials. It’s a five questions scale composed of the following questions: 1) Is the study randomized? 2) Is the study double blinded? 3) Is there a description of withdrawals? 4) Is the randomization adequately described? 5) Is the blindness adequately described? Thus these critical questions serve a positive goal: to score the quality of the trial (for instance to in- or exclude it in a systematic review.
(Of course RCT’s cannot answer all clinical questions nor all your ‘wondering’).
However, I can imagine, that when the outcome is a QoL-outcome or simply/straightforward to measure and you don’t want to apply the results to a broader community that you just can let the patient decide (whether with health 2.0 tools or not). This of course is NOT a trial.
Example. Patients with hypoadrenalism miss all kinds of adrenal hormones, cortisol (and in primary forms aldosterone) fludrocortisone) are being replaced whereas the less crucial DHEA is not. RCT’s have shown that a low dose DHEA is safe and has a slight positive effect on QoL. Most endocrinologists now subscribe DHEAs if the patients wishes so. If the patients feels DHEA improves QoL (life), than she can continue taking it, if he/she feels no improvement or gets acne or ugly fat hair than the patient can stop. It is like trial and error then.
Other example: If you feel that blogging makes you a happier patient: than blog! Don’t wait for the evidence to show blogging is good for your health.
I can also imagine that online rating or tracking tools can be very helpful, depending (again) on the purpose. Not for hot flushes, indeed. But for instance to look for an unknown factor, that may cause food intolerance or insomnia. But non web 2.0 tools like diaries may do a good job too.
We must take care “patient empowerment” does not become a hollow fashionable phrase.
Patient empowerment is important, but not in the sense that the patient performs the trials. I like the terms patient/involvement and patient centered medicine: those things should be tested/done which matter mosts to the patients and the results should be communicated.
H20 tools can help to keep the patient informed.
Dr. Val you’re to be commended for your concern about consumer generated trials (and some forms of patient empowerment)!
I agree with most things you say.
It all depends on your goals. What do you want to know and/or achieve?
If you want to know whether drug I works better than drug C in a patient group P with respect to outcome O (yes PICO), than you will find the best evidence in a well performed controlled clinical trial, preferably a randomized trial (or even better a systematic review of RCT’s), performed by qualified personnel. We all know (don’t we?) the above mentioned limitations of a RCT, but those limitations are more pronounced in other kinds of trials, and certainly in the “non-professional studies” symtym refers to.
Sorry to say, Carlos, but the whole list of biases of a RCT doesn’t impress me (except that I have to scroll very long to and fro from comment to post). Isn’t this Jadad the same Jadad of the Jadad’s scale? This scale is (was) widely used to assess the quality of clinical trials. It’s a five questions scale composed of the following questions: 1) Is the study randomized? 2) Is the study double blinded? 3) Is there a description of withdrawals? 4) Is the randomization adequately described? 5) Is the blindness adequately described? Thus these critical questions serve a positive goal: to score the quality of the trial (for instance to in- or exclude it in a systematic review.
(Of course RCT’s cannot answer all clinical questions nor all your ‘wondering’).
However, I can imagine, that when the outcome is a QoL-outcome or simply/straightforward to measure and you don’t want to apply the results to a broader community that you just can let the patient decide (whether with health 2.0 tools or not). This of course is NOT a trial.
Example. Patients with hypoadrenalism miss all kinds of adrenal hormones, cortisol (and in primary forms aldosterone) fludrocortisone) are being replaced whereas the less crucial DHEA is not. RCT’s have shown that a low dose DHEA is safe and has a slight positive effect on QoL. Most endocrinologists now subscribe DHEAs if the patients wishes so. If the patients feels DHEA improves QoL (life), than she can continue taking it, if he/she feels no improvement or gets acne or ugly fat hair than the patient can stop. It is like trial and error then.
Other example: If you feel that blogging makes you a happier patient: than blog! Don’t wait for the evidence to show blogging is good for your health.
I can also imagine that online rating or tracking tools can be very helpful, depending (again) on the purpose. Not for hot flushes, indeed. But for instance to look for an unknown factor, that may cause food intolerance or insomnia. But non web 2.0 tools like diaries may do a good job too.
We must take care “patient empowerment” does not become a hollow fashionable phrase.
Patient empowerment is important, but not in the sense that the patient performs the trials. I like the terms patient/involvement and patient centered medicine: those things should be tested/done which matter mosts to the patients and the results should be communicated.
H20 tools can help to keep the patient informed.
Dr. Val you’re to be commended for your concern about consumer generated trials (and some forms of patient empowerment)!
I agree with most things you say.
It all depends on your goals. What do you want to know and/or achieve?
If you want to know whether drug I works better than drug C in a patient group P with respect to outcome O (yes PICO), than you will find the best evidence in a well performed controlled clinical trial, preferably a randomized trial (or even better a systematic review of RCT’s), performed by qualified personnel. We all know (don’t we?) the above mentioned limitations of a RCT, but those limitations are more pronounced in other kinds of trials, and certainly in the “non-professional studies” symtym refers to.
Sorry to say, Carlos, but the whole list of biases of a RCT doesn’t impress me (except that I have to scroll very long to and fro from comment to post). Isn’t this Jadad the same Jadad of the Jadad’s scale? This scale is (was) widely used to assess the quality of clinical trials. It’s a five questions scale composed of the following questions: 1) Is the study randomized? 2) Is the study double blinded? 3) Is there a description of withdrawals? 4) Is the randomization adequately described? 5) Is the blindness adequately described? Thus these critical questions serve a positive goal: to score the quality of the trial (for instance to in- or exclude it in a systematic review.
(Of course RCT’s cannot answer all clinical questions nor all your ‘wondering’).
However, I can imagine, that when the outcome is a QoL-outcome or simply/straightforward to measure and you don’t want to apply the results to a broader community that you just can let the patient decide (whether with health 2.0 tools or not). This of course is NOT a trial.
Example. Patients with hypoadrenalism miss all kinds of adrenal hormones, cortisol (and in primary forms aldosterone) fludrocortisone) are being replaced whereas the less crucial DHEA is not. RCT’s have shown that a low dose DHEA is safe and has a slight positive effect on QoL. Most endocrinologists now subscribe DHEAs if the patients wishes so. If the patients feels DHEA improves QoL (life), than she can continue taking it, if he/she feels no improvement or gets acne or ugly fat hair than the patient can stop. It is like trial and error then.
Other example: If you feel that blogging makes you a happier patient: than blog! Don’t wait for the evidence to show blogging is good for your health.
I can also imagine that online rating or tracking tools can be very helpful, depending (again) on the purpose. Not for hot flushes, indeed. But for instance to look for an unknown factor, that may cause food intolerance or insomnia. But non web 2.0 tools like diaries may do a good job too.
We must take care “patient empowerment” does not become a hollow fashionable phrase.
Patient empowerment is important, but not in the sense that the patient performs the trials. I like the terms patient/involvement and patient centered medicine: those things should be tested/done which matter mosts to the patients and the results should be communicated.
H20 tools can help to keep the patient informed.
Dr. Val you’re to be commended for your concern about consumer generated trials (and some forms of patient empowerment)!
I agree with most things you say.
It all depends on your goals. What do you want to know and/or achieve?
If you want to know whether drug I works better than drug C in a patient group P with respect to outcome O (yes PICO), than you will find the best evidence in a well performed controlled clinical trial, preferably a randomized trial (or even better a systematic review of RCT’s), performed by qualified personnel. We all know (don’t we?) the above mentioned limitations of a RCT, but those limitations are more pronounced in other kinds of trials, and certainly in the “non-professional studies” symtym refers to.
Sorry to say, Carlos, but the whole list of biases of a RCT doesn’t impress me (except that I have to scroll very long to and fro from comment to post). Isn’t this Jadad the same Jadad of the Jadad’s scale? This scale is (was) widely used to assess the quality of clinical trials. It’s a five questions scale composed of the following questions: 1) Is the study randomized? 2) Is the study double blinded? 3) Is there a description of withdrawals? 4) Is the randomization adequately described? 5) Is the blindness adequately described? Thus these critical questions serve a positive goal: to score the quality of the trial (for instance to in- or exclude it in a systematic review.
(Of course RCT’s cannot answer all clinical questions nor all your ‘wondering’).
However, I can imagine, that when the outcome is a QoL-outcome or simply/straightforward to measure and you don’t want to apply the results to a broader community that you just can let the patient decide (whether with health 2.0 tools or not). This of course is NOT a trial.
Example. Patients with hypoadrenalism miss all kinds of adrenal hormones, cortisol (and in primary forms aldosterone) fludrocortisone) are being replaced whereas the less crucial DHEA is not. RCT’s have shown that a low dose DHEA is safe and has a slight positive effect on QoL. Most endocrinologists now subscribe DHEAs if the patients wishes so. If the patients feels DHEA improves QoL (life), than she can continue taking it, if he/she feels no improvement or gets acne or ugly fat hair than the patient can stop. It is like trial and error then.
Other example: If you feel that blogging makes you a happier patient: than blog! Don’t wait for the evidence to show blogging is good for your health.
I can also imagine that online rating or tracking tools can be very helpful, depending (again) on the purpose. Not for hot flushes, indeed. But for instance to look for an unknown factor, that may cause food intolerance or insomnia. But non web 2.0 tools like diaries may do a good job too.
We must take care “patient empowerment” does not become a hollow fashionable phrase.
Patient empowerment is important, but not in the sense that the patient performs the trials. I like the terms patient/involvement and patient centered medicine: those things should be tested/done which matter mosts to the patients and the results should be communicated.
H20 tools can help to keep the patient informed.
Dr. Val you’re to be commended for your concern about consumer generated trials (and some forms of patient empowerment)!
I agree with most things you say.
It all depends on your goals. What do you want to know and/or achieve?
If you want to know whether drug I works better than drug C in a patient group P with respect to outcome O (yes PICO), than you will find the best evidence in a well performed controlled clinical trial, preferably a randomized trial (or even better a systematic review of RCT’s), performed by qualified personnel. We all know (don’t we?) the above mentioned limitations of a RCT, but those limitations are more pronounced in other kinds of trials, and certainly in the “non-professional studies” symtym refers to.
Sorry to say, Carlos, but the whole list of biases of a RCT doesn’t impress me (except that I have to scroll very long to and fro from comment to post). Isn’t this Jadad the same Jadad of the Jadad’s scale? This scale is (was) widely used to assess the quality of clinical trials. It’s a five questions scale composed of the following questions: 1) Is the study randomized? 2) Is the study double blinded? 3) Is there a description of withdrawals? 4) Is the randomization adequately described? 5) Is the blindness adequately described? Thus these critical questions serve a positive goal: to score the quality of the trial (for instance to in- or exclude it in a systematic review.
(Of course RCT’s cannot answer all clinical questions nor all your ‘wondering’).
However, I can imagine, that when the outcome is a QoL-outcome or simply/straightforward to measure and you don’t want to apply the results to a broader community that you just can let the patient decide (whether with health 2.0 tools or not). This of course is NOT a trial.
Example. Patients with hypoadrenalism miss all kinds of adrenal hormones, cortisol (and in primary forms aldosterone) fludrocortisone) are being replaced whereas the less crucial DHEA is not. RCT’s have shown that a low dose DHEA is safe and has a slight positive effect on QoL. Most endocrinologists now subscribe DHEAs if the patients wishes so. If the patients feels DHEA improves QoL (life), than she can continue taking it, if he/she feels no improvement or gets acne or ugly fat hair than the patient can stop. It is like trial and error then.
Other example: If you feel that blogging makes you a happier patient: than blog! Don’t wait for the evidence to show blogging is good for your health.
I can also imagine that online rating or tracking tools can be very helpful, depending (again) on the purpose. Not for hot flushes, indeed. But for instance to look for an unknown factor, that may cause food intolerance or insomnia. But non web 2.0 tools like diaries may do a good job too.
We must take care “patient empowerment” does not become a hollow fashionable phrase.
Patient empowerment is important, but not in the sense that the patient performs the trials. I like the terms patient/involvement and patient centered medicine: those things should be tested/done which matter mosts to the patients and the results should be communicated.
H20 tools can help to keep the patient informed.
Hilarious exchange on Twitter over this post:
David Harlow
healthblawg @symtym Free legal advice? I’m shocked, shocked … You get what you pay for.
Tim Sturgill
symtym @healthblawg Good, you got the point! Free medical advice (even crowd-sourced), you get what you pay for!
And to wrap up the twitversation (twialogue?) (since argumentative lawyer types always want the last word):
David Harlow
healthblawg @symtym I feel much better paying full freight for patented drugs now. I didn’t mean crowdsourcing in medicine is OK, just caveat emptor.
Health 2.0 has far greater utility then, as a prior commenter stated, for patient support groups. Sites that allow consumers to share first-hand experiences are uncovering information that isn’t available, known or openly shared by medical professionals with patients.
Our community at RealSelf.com focuses on the aesthetics and cosmetic medicine space. Site contributors are patients who voice their opinion on whether the treatments were worth it. In doing so, they also describe factors like cost, pain, and why they underwent the treatment.
This information exchange has uncovered highly significant patient safety information. Example 1: over a year ago patients of a procedure called Lipodissolve flooded RealSelf with terrible stories of near crippling side-effects. As the regulators watched on, Lipodissolve chains pushed their unregulated injections to unsuspecting consumers. It wasn’t until we worked with journalists at Allure Magazine and ABC 20/20 that these patient experiences became known to the masses. I’m proud to say that we had a direct impact on the bankruptcy of the 2 largest lipodissolve chains in the US. I still get mails from medical experts thanking us for taking on this public health issue.
Example 2: patients undergoing some forms of cosmetic injectables have reported on RealSelf unexpected side-effects from FDA-approved products. Anyone considering one of these treatments can now get this information before undergoing the treatment. Meanwhile, the gears of government grind slowly onwards. Just this week the FDA convened a panel to review public health concerns about cosmetic fillers. This may lead to new restrictions and labeling, yet every one of the side-effects being discussed in Washington is already part of the hundreds of discussions on RealSelf (between peers and with board-certified surgeons).
Where I agree with you (Dr. Val) is that consumer generated information should be balanced by including medical experts in the online information exchange. I reached this conclusion after watching consumers answering medical questions like what steps to take to combat post-surgery swelling. To that end we have several hundred doctors now active in our community.
HHmm..
I often wonder.
Is something true simply because the person before you learned it and taught it to you. How did that person gain his knowledge?
There was a time.. a long long time ago.. there WAS a time when society simply created answers to the unanswerable question to satisfy the need for conclusion or completion.
Do you remember when everyone thought the world was flat?
Seems to me that society is coming full circle and revisiting that notion of simply ‘creating’ the answers again.
These are definitely tough times.
I doubt you will find many readers ready to argue that they advocate the removal of science from medicine.
But in most cases, the genie is out of the bottle and we can not hide behind “science”. Our patients are off in the wild west of the web collecting and sharing their own clinical data — this is not the future but today.
Patient education and caution is appropriate.
But we should also look toward the future as reality and find ways to put methods/controls in place around these “health 2.0” exploration wherever possible so that patients can get some value out of their efforts while minimizing misinterpretation and misuse.
wow…. what a discussion! In some ways, the whole discussion over health 2.0, its pull towards the ‘wisdom of patients’ and its intersection with science based medicine is really centered on the concept of power-knowledge — or “I have power, because I have knowledge”. Science and medicine as professions and as institutions have played the power-knowledge game a particular way, based on expertise and based on training. But this is one form of power-knowledge. Another form lies with the patient and the public. It lies in the body itself and the experience of same. This knowledge has been eclipsed by the power of scientific knowledge. To me, it is not one vs. the other. Health 2.0 should be about finding the intersection of the two, where each form of power-knowledge influences the other for the better. And just as a side note, medicine is also an art……
This posting doesn’t take into the consideration how major drug manufacturers hide data about the safety and efficacy of its drugs, and produce data of scant clinical value. Conflicts of interest have thoroughly corrupted American medical research. There are dangerous potential for conflicts of interest when pharmaceutical and other for-profit businesses control the dissemination of findings generated by medical research.
The ability of drug companies to pick and choose the research they provide in support of their products is an outrageous conflict of interest and puts all patients in harm’s way. It can undermine public trust in and support for scientific research, endanger research subjects and patients, and boost medical costs by encouraging doctors and patients to use new treatments that are no better than cheaper alternatives.
Studies with positive findings are more likely to be published than studies with negative results. Even negative results can provide useful information about the effectiveness of treatments. Any tendency to put negative results into a file drawer and forget them can bias reviews of treatments reported in medical literature, making them look more effective than they really are.
With most clinical trials, investigators never give out information as to how people are doing. Most trials are failures with respect to actually improving things. The world doesn’t find out what happen until after a hundred or 500 or 2,000 patients are treated and then only 24 hours before the New England Journal of Medicine publication date.
Having all the information you can gather for the participants and investigators is essential to maintain good doctor-patient communication that is beneficial for cancer patients.
Dangerous drugs have been allowed to reach the market because conflicts of interest have become so endemic in the system of drug evaluation, a trend that has been exacerbated by the rise of for-profit clinical trials, fast-tracking drug approvals, government-industry partnerships, direct consumer advertising and industry-funded salaries for FDA regulators.
The collaborations between academia and industry has clearly brought discernible influence on clinicians, bringing with it erroneous results, suppressed data, or harmful side effects from these drugs.
There is an inherent conflict of interest when organizations provide guidelines for treating disease who receive funding from corporations that benefit financially from those recommended treatments. There is no proof beyond reasonable doubt for any approach to treating cancer today. There is only the bias of clinical investigators as a group and as individuals.
The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient. The choice of physicians to intergrate promising insights and methods remains an essential component of quality cancer care.
There should be more effective online patient networks to aggregate clinical data and effectively learn and research in real-time. Useful observational data can inform science and medicine and hopefully at a faster pace.
Clinical efficacy trials don’t do “real world” studies under “real world” conditions. Patient outcomes need to be reported in real-time, so patients and physicians can learn immediately if and how patients are benefiting from new drug therapies.
There is a need for quality peer-review, but there is also unlimited space on the Web to publish. It should be easier to publish well-designed studies that show if there is no effect to a treatment and therefore minimize publishing bias.