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Too Much Information!

Some people would like to manage their own health care without having to depend on a doctor. They consult Google, diagnose themselves, and treat themselves. The Do-It-Yourself trend in lab tests continues apace. Without a doctor’s order, patients can get legitimate and/or questionable lab tests directly from various companies such as Any Lab Test Now and Doctor’s Data (which has sued Stephen Barrett for exposing their fraudulent “urine toxic metals” test on Quackwatch). Now a new company, Talking20, has jumped on the self-testing bandwagon with an innovative product that allows people to prick their finger, put a drop of blood on a card, and mail it in from anywhere in the world. Multiple tests are done on a single drop of blood. Results will be available online within a week or even sooner.

What Does It Cost?

Talking20 has several options:

  • U-Pick Pack. For $99 you can select 5 tests from a list of 17, including Cholesterol (Total, HDL, and LDL), Estradiol (Estrogen), Progesterone, Testosterone, Homocysteine, CRP, HgA1c, Cortisol, and Vitamins A, B6, B9, B12, C, D3, and E. This works out to $20 per test, far less expensive than most other labs.
  • 2 year Gold Card Pack: For $995 you get 24 cards and they will do all the tests currently available on every sample you send in. They anticipate that hundreds of tests will be added over the next 2 years, including numerous proteomic and metabolomic tests.
  • 3 year Gold Card Pack: for $1295 you get 36 cards for all available tests. You can use these once a month or at any time you choose within the next 3 years. That works out to around $2 per test, which will drop much lower as more tests are added to the program.
  • Designer Pack: for $4995 you can request a new test and their team will move that molecule to the front of the development queue and give you 36 cards. If they are unable to provide the requested test, the money will be refunded.

How Is It Done?

They use mass spectrometry, which they say is the gold standard by which other tests are validated. I asked a company representative why all labs wouldn’t use gold standard spectrometry directly instead of conventional tests. Here’s what she answered:

Mass spectrometry has been used for decades in the analysis of various analytes from small samples.  Liquid chromatography combined with multiple reaction monitoring mass spectrometry is an emerging technique for examination of molecules from dried blood spots.  As the quantitation of endogenous and exogenous molecules from dried blood spots is still a field of investigation and specific methodologies are currently in development, our testing platform does not meet the requirements of a clinical diagnostic test platform and will be offered for research use only.

So – other labs are not using this technology due to the fact that it would interfere with their ability to meet clinical diagnostic requirements. For the personal tracking and research use that we are hoping to facilitate mass spec is the best option. We trust the accuracy of our data and actually believe it is equal or better to lab results. For regulatory purposes we do not plan on seeking certification for clinical or diagnostic use, as the cost to us would force us to raise our prices above what we want to offer to our consumers.

What Are Customers Led to Believe?

There is a disclaimer on their website:

Products sold by Talking20 Inc. have not been evaluated by the FDA and are intended for research use only. They are not intended to diagnose, treat, cure, or prevent any disease. The information provided by www.talking20.com is not a substitute for a face-to-face consultation with your physician, and should not be construed as individual medical advice.

But elsewhere they claim that their results “will be just as accurate as any other testing service”. I think most customers will be led to believe they are getting reliable tests whose results they can use to guide their health care.

Customers are encouraged to track changes in lab test values as they experiment with things that might influence those numbers. An example in their video is a woman with familial high cholesterol who eats hamburgers throughout a day and does a series of tests during that day, finding that her cholesterol rises more than she expected.

They are also told that there is great research potential in having large numbers of consumers tracking lab results and making correlations. There is even a research consent document.  I think it is unlikely that any such research could be published or relied on without validation of the accuracy of their tests. Even if their results were validated and they accumulated a huge body of data, fishing in that sea might catch more old boots than edible fish. Good science requires more systematic data collection.

What’s the Benefit?

As with any screening test, an occasional unexpected finding will lead to earlier diagnosis of a disease, and there will be testimonials that screening “saved my life”. Following cholesterol levels at frequent intervals may help motivate patients to comply with diet and medication. Patients may reconsider their use of vitamins and other diet supplements if they find no correlation between intake and improved blood levels, or between blood levels and symptoms. Patients who were going to get these tests anyway will save money.

What’s the Harm?

People will be doing these tests and drawing their own false conclusions. They have no way of knowing what the results mean for their health.  Some of the problems:

  • Definition of normal. Normal test results are determined by testing a large number of presumably normal people and cutting off the ends of the resulting bell curve. Typically, everything within 2 standard deviations of the mean is arbitrarily defined as normal. But that doesn’t mean every individual outside 2 standard deviations is abnormal, nor does it guarantee that everyone within the limits is normal. Imagine measuring the height of thousands of people and defining the extremes as abnormal. A man who is 6 feet 7 inches tall would be defined as abnormal, but that height might be perfectly normal for him, and someone in the “normal” range might have an excess of growth hormone with acromegaly.
  • False positives. Even without considering lab errors, when you do 20 lab tests on a healthy person, you are likely to get one false positive. Doing 100 tests would give you an average of 5 abnormal results that were of no significance to the person’s health, but that would lead to worry and further testing.
  • Uncertain meaning. Let’s say your vitamin E level is below the normal limits on the test. Does that mean something is wrong with you? Does it mean you should take vitamin E supplements? Would raising the level improve your health or reduce your risk of death? We don’t know: the necessary studies have not been done.
  • Margin of error. There is a margin of error in any lab test. If you repeat a cholesterol test 5 times in a row, you will get 5 different readings. I once had a patient who would agonize over a 5 point difference in successive cholesterol readings, and was not able to understand that those results were not significantly different. Blood alcohol tests have been ruled inadmissible in court when the lab failed to report the margin of error; a blood test showing 0.93 with a 0.20 margin of error might mean an actual level of 0.73.
  • Temporal fluctuations. Some blood levels can fluctuate widely over the course of a single day. In the case of female hormones, the levels vary continuously over the menstrual cycle. A quick glance at this graph shows why a one-time measurement of progesterone or estrogen levels is misleading. A level that is normal in one phase of the cycle would be abnormal in another phase. Women who adjust their use of bioidentical hormones as advised by Suzanne Somers are acting outside the realm of science.

Hormone cycle

Services like Talking20 are likely to attract the hypochondriacs, the worried well, the obsessive-compulsives, and the self-absorbed navel gazers. They are likely to do more harm than good. If you have ever had an abnormal test result and continued to worry even after a follow-up test was normal, you will know what I mean. People will inevitably draw their own conclusions from the data, resulting in unnecessary worry, expense, and useless lifestyle changes. Doctors are likely to be confronted with patients concerned about insignificant findings and false positive results from these tests, and some patients may come to distrust their doctors over these issues and reject conventional medical care.

Conclusion

Sometimes doctors order a lot of tests in the hope that something will turn up and are left scratching their heads because the “serum porcelain level” is elevated and they have no idea what that means or what to do about it. Ideally, doctors shouldn’t go on “fishing expeditions” in the laboratory. They should only order lab tests when they understand the test and when the results are likely to affect the management of the patient. Consumers indiscriminately doing 17 tests (and eventually hundreds or even thousands of blood tests) on themselves is a very bad idea. When the testing method has not been validated, it’s an even worse idea.

Of course, if this technology is validated and developed to the point that any number of indicated tests can be done on a drop of blood at very low cost, I will be among the first to celebrate.

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57 thoughts on “Too Much Information!

  1. BillyJoe7 says:

    I have only ever had one blood test done. And I did it myself….in a science lab in secondary school.
    In one of the prac classes, we were required to determine our own blood groups (mine was O- )

  2. Unfortunately the costs of medical equipment put do-it-yourself diagnosis out of reach of most.
    I’d like to have a CT scan machine, but they cost $100,000 each.
    The other day I inquired about a wireless transmission capsule machine for diagnosing GI disorders and was quoted $8,000

  3. weing says:

    It only takes 2 abdominal CTs to significantly increase the risk of radiation induced cancer.

  4. qetzal says:

    Additional reasons this service is very dubious:

    1) IIRC, finger-stick blood is not always an acceptable substitute for venous blood. Not just because of the reduced volume, but apparently because it doesn’t always give an accurate result compared to venous blood. (Depends on the analyte.)

    2) What, if anything, have they done to ensure sample reproducibility & stability between the user putting blood on the card, and the lab running their test? Does it matter if it’s shipped from FL on a hot humid summer day versus from ND on a cold dry winter day? What if the user doesn’t clean their finger well enough prior to the finger stick? What if they were just holding a donut?

    I could probably go on for a long time. Suffice it to say I can’t see using this service for anything other than entertainment purposes.

  5. BCA says:

    I use metabolomics in my research and even in a very controlled setting with cells in tissue culture you get a whole bunch of data that can be difficult to interpret. Also you have the issue that relating what is happening with metabolites in plasma to disease is not that straightforward. Plenty of papers in pubmed that show potential metabolite “biomarkers” of disease in plasma that didn’t hold up when larger groups of individuals were examined. Throw proteomics in the mix and there is no way the average person is going to figure out how that data relates to their health. Also from the company website I can’t find anyone affiliated with the company who has actually done proteomics or metabolomics. If they stick to the simple measurements like vitamin status that is one thing, but offering ‘omics analysis is a whole other issue.

  6. windriven says:

    It is fine to kvetch about people trying to manage their own health but the fact is that interactions with physicians are often difficult to arrange in a timely manner, expensive and frustrating for patients who may leave the visit no more settled about the state of their health than they were going in.

    Those of us with the time, connections and money can shop around for a primary care provider who has the combination of professional and personal skills to build a collaborative health care relationship with us. But many people don’t and for them a doctor visit can be little more than a cattle call.

    People pay huge insurance premiums. Their PCP is, rightly or not, the face of what they’re paying for. $600 a month for slam-bam visits that may not even involve a physician and may not address their health concerns may well have a role in prompting people to pursue self-diagnostics and even sCAM.

    What’s that doc? The vicissitudes of health care economics aren’t your fault? Well it isn’t the patient’s fault either. The patient is going to do what s/he can to manage his or her health. If it is easier to arrange a CBC and liver enzymes on their own, they’re going to do that. If they can easily get an appointment with a naturopath who will look them in the eye and listen to them and say reassuring (if totally bogus) things to them, some will do that to.

  7. Well said windriven, you covered well why labs direct is getting more popular, quite simply it cuts out the useless middleman (the MD that is).

    Considering it takes weeks to schedule appointments with certain physicians, going direct to the lab not only saves money, it saves weeks of unnecessary suffering.

    The MDs dont like this one bit for obvious reasons that have nothing to do with patients wellbeing.

  8. windriven says:

    @FBA

    When I lived in New Orleans I was able to get a pretty complete blood and urine panels which I would then take with me when I went to see my internist. It saved a lot of rigamarole for both of us. This is not possible where I live in the PNW. Luckily, I have the kind of relationship with my internist here that allows me to call her and have her order up the tests when it is convenient for me to have them done. Then we discuss them the next time I see her.

    Arrangements like this are not, in my experience, common. I don’t blame that on the physicians. It really is simply a fact of healthcare economics. Unfortunately, Obamacare will likely exacerbate this – at least in the near term as more demand views for a limited supply.

    It seems to me that health care providers should embrace some of these self-help initiatives and educate staff to help patients understand what results mean. I would argue that it isn’t an effort to cut the physician out but rather an effort to augment what patients perceive to be a very limited and one-sided relationship.

  9. goodnightirene says:

    I recently paid over $500 for my uninsured adult daughter to see a newbie physician for 10 minutes to order labs and write her a prescription for bp meds (her bp is dangerously elevated). The follow-up was another $100 or so and the labs were nearly $100–just to make sure her kidneys were okay (maybe some other things like that, but it was all just-in-case stuff). She has multiple other health issues which he wouldn’t even consider talking about. She was not treated with the same attention that I am at the same clinic. My care is managed–I get follow-up calls from nurses and am reminded to get my labs done, to get my mammos, etc. She got only precisely what we paid for–IN ADVANCE.

    I think I have to agree with windriven, in the sense that the existing system leaves a lot of people no good options. I also think docs need to be more activist about the problems. Talk about shruggies. One said to me once: “All the people I see are insured.” Well, duh!

    I’m happy to say that my daughter just got back on to insurance, and now my granddaughter (thanks to Obamacare) will be covered as well, and I can return to paying my own co-pays with my limited funds.

    I am glad to know about this particular sCAM, however. I always like to know about these things so as to be informed when I come across them.

  10. RobRN says:

    It amazes me that this is legal, even with all the disclaimers. Medical laboratories are accredited and regulated, often by more than one state, federal and professional entity, and testing kits & analytical instrumentation are subject to FDA approval. The interpretation of laboratory results can be quite complex and consulting with a medical professional who can correlate findings with the individual’s medical history is the best course. Also, performing lab testing that is not needed is a waste of money.

    But at least it’s a lot better than diagnosing AK!

  11. brendanlong says:

    I’m personally really excited about services like this. Yes, the results can be misleading if you don’t understand them, but rather than give up and say that these tests are too dangerous because people will interpret them wrong, it seems better to teach people how to interpret them. You don’t need a medical degree to understand statistics.

  12. weing says:

    “It seems to me that health care providers should embrace some of these self-help initiatives and educate staff to help patients understand what results mean.”

    Who would be liable in this situation if the patient misunderstands and lets an abnormality indicating a serious illness slip through? The physician of course. And he doesn’t even get paid for assuming the liability in this situation. I like your idea better about visiting your doctor to discuss the results.

  13. mousethatroared says:

    Honestly, I have no problem with self-testing in some cases. If one suspects they may be gluten intolerant, but they feel their doctor has blown them off, maybe a lab test would be better than the test diet that many folks resort too. Maybe home tests for UTI with a Nurse Practitioner at a call center who can call in an antibiotics prescription would be more cost/time effective than having to visit a doctor’s office.

    But it seems like many of these services encourage folks to waste their money on unvalidated tests that don’t get them any nearer to resolving their problem. On the other hand, I think windriven has a point. I think many people seek out these service because they feel they are getting no results with their doctor. Sometimes it seems that one must see a doctor a minimum of 3 times before they will even start to take your complaint seriously. It’s not surprising that some people want to cut to the chase and try to DIY.

    The problem is, IME as a laymen who’s read a lot on my own blood test result, a lot of this stuff is really difficult and requires not only a specific education but also clinical experience that helps you to put the test results in the context of ALL the patient’s symptoms and signs.

    Often – self-diagnoses is HARD, too hard and time consuming. In the end I think it’s more efficient to seek out a different or better doctor if you feel the one you are seeing is blowing you off. Then you can be considered a “doctor hopper”…or maybe you don’t have access to another doctor – can’t win for losing, they say.

  14. mousethatroared says:

    Just to be clear, I was speculating why folks may seek out these tests. It would actually be pretty cool to see a well done survey on why folks seek out this kind of testing. I don’t think it’s responsible to assume that it’s all hypochondriacs, or people dissatisfied with their health care provider or the uninsured without appropriate evidence.

  15. qetzal says:

    I agree that the concerns raised by windriven et al. are real and substantial. But eliminating a “useless middleman” in favor of a useless novelty test doesn’t solve anything.

  16. weing says:

    Ah yes. The therapeutic blood test.

  17. windriven says:

    @weing

    “Who would be liable in this situation if the patient misunderstands…”

    A valid point and I don’t have a facile answer. But the fact is that, at least in the US, physician practice is going to change; it is unsustainable in its current form. There aren’t enough physicians. There aren’t enough seats in medical schools – even after the current expansion. And the feds don’t seem interested in underwriting more residencies. We pay, as a nation, near enough to 20% of GDP on healthcare and a good many of the healthcare consumers don’t see that they are getting good value for their expenditure.

    Physicians and their professional associations can either manage these changes to their and their patients’ benefits or they can block, obfuscate, ignore or otherwise let others manage the change.

    Somebody is going to lead this parade. The future face of medical practice will depend on who does the leading.

  18. goodnightirene says:

    There seem to be two lines of discussion here. 1) The role of doctors and the doctor/patient relationship and, 2) the issue of the self-tests themselves.

    My question about the tests is that they are unregulated, so are they even worth bothering with or even accurate enough to bother with? I can see where these things would not bother a lot of people who don’t think much of “mainstream” medicine to begin with. People buy vitamins all the time in spite of the fine print.

    I think MouseTR is correct that we need to know more about who would use these tests. I would assume it’s altie people mostly, but that may not be right at all. I know some women who hardly ever go to the doctor simply because they do not want to be weighed–(and get the lecture they know is coming, in spite of what alties say about doctors not caring about nutrition). They would do these tests to find out what their cholesterol is, for example, without having to see the doctor. You can read a lot about how to interpret these tests in the book Dr. Hall reviewed and recommended a while back–written by a couple of cardiologists from the Cleveland Clinic. I use it all the time when I look at my own lab results. It helps me to ask relative questions when I see the doctor.

    I would like to think I could get my blood work done without fasting for 12 hours! Driving to the lab without coffee is hell.

  19. windriven says:

    @goodnightirene

    There are indeed, but the two are at least loosely related.

    Whether tests are available to patients directly or not is a different issue from whether some of the test providers may be unregulated or unlicensed. At a minimum any lab should be certified compliant to ISO 15189 and should probably be accredited by one of the major accreditation agencies.

    Many labs now allow black coffee as well as water during the fast. Mine (part of a major hospital group in the PNW) does.

  20. Harriet Hall says:

    My biggest concern is people ordering every sort of test willy-nilly. Indiscriminate screening tests do more harm than good. That concept is hard for most people (including many doctors) to understand.

  21. johnchoiniere says:

    Hey Harriet, I know this isn’t where the discussion has been focused, and I agree with all your points above – I just wanted to throw my name out there as a mass spectrometry expert if you ever have a need for one. Incidentally, I agree with the company that mass spec is a gold-standard level quantification technique.

  22. johnchoiniere says:

    Hey Harriet, I know this isn’t where the discussion has been focused, and I agree with all your points above – I just wanted to throw my name out there as a mass spectrometry expert if you ever have a need for one. Incidentally, I agree with the company that mass spec is a gold-standard level quantification technique, but that’s hardly the whole story.

  23. Harriet: Indiscriminate screening tests do more harm than good.

    Not as much harm as tests that are NOT done, to detect rapidly progressing diseases. I have seen people go from a manageable tumor to being inoperable in 4 weeks it took them to get through all the queues in the overworked medical system.

    I’d rather say a few words for these victims of red tape rather than blasting the 0.1% of worried well who order an extra cholesterol blood test.

  24. mousethatroared says:

    FastBuckArtist “I’d rather say a few words for these victims of red tape rather than blasting the 0.1% of worried well who order an extra cholesterol blood test.”

    I’ll just take that opportunity to say that someone who spends more than they can afford on unnecessary blood tests as well as risking possible negative health consequences is maybe not really “well”…similar to someone who has the same behavior with pain killers, gambling, dieting, shopping, etc. Even the words “worried” (anxiety) well (healthy), seem a bit on a contradiction.

    To me it seems rather like saying someone is an asthmatic well person, then complaining that their wheezing is impairing their health.

    If the medical profession chooses to think of them as well AND offers no help, no referrals, then it seems like they are missing out on that “holistic” approach much toted these days.

    To be fair, maybe the medical profession IS consistently attempting to offer help and referrals and these patients are resistant. Personally I haven’t seen people on this board claiming that and I’ve seen articles that suggest otherwise, but it could be the case, I suppose.

  25. BillyJoe7 says:

    FBA,

    “I have seen people go from a manageable tumor to being inoperable in 4 weeks it took them to get through all the queues in the overworked medical system”

    I’m going to call BS on this one.
    And if you can’t substantiate this claim I’m going to rename you BSA. ;)

  26. windriven says:

    @FBA

    “Not as much harm as tests that are NOT done…”

    That subject has been covered ad nauseum in these pages and Dr. Hall among others have argued compellingly that overtesting does do significant harm. Few tests are perfectly specific and selective. There will be false positives, false negatives, a lot of costs, invasive follow-ups and so forth.

  27. goodnightirene says:

    @windriven

    Nice to hear about the black coffee (I’ll ask!), but alas, I’m a latte-girl (born and raised in the PNW). Luckily, there’s a coffee place right next to the clinic–I just have to survive getting there in the first place. :-)

  28. Scott says:

    I have seen people go from a manageable tumor to being inoperable in 4 weeks it took them to get through all the queues in the overworked medical system.

    Uh-huh. Given that we’re talking about screening tests here, apparently your claim is that you somehow know that it was “a manageable tumor” before any tests were done. Nobody can say whether it was manageable before that or not; the test is the first data point.

  29. Armi Legge says:

    Great article Dr. Hall. Thank you for contacting them directly as well.

    It seems odd that they’re saying their test is as accurate or more accurate than conventional blood tests, yet in the same paragraph are claiming that it’s untested and unproven.

    Do you see value in certain at-risk populations getting some regular blood testing from a service similar to this (with a doctor’s input) to help limit time costs? For instance, a female athlete getting iron tests at periodic intervals.

    Thanks again.

  30. mousethatroared says:

    @goodnightirene – our medical network has a coffee bar in the same building as the lab (financial genius!). My experience is , even an experienced phlebotomist has a hard time telling the difference between someone who’s about to kneel over from a reaction to the needle and someone who is still in a pre-caffine semi-comatose state. I’ve had more than one peer at me and say worriedly “are you okay?”. Yes, I’m just pale, haggard and vague until I’ve had my latte.

  31. Harriet Hall says:

    @Armi Legge,

    “Do you see value in certain at-risk populations getting some regular blood testing from a service similar to this (with a doctor’s input) to help limit time costs?”

    I don’t see any value in getting blood tests from a lab that has not validated its tests. But validated testing by mail on a drop of blood would have a lot of potential, especially if the costs can be reduced. Such testing should be limited to evidence-based indications rather than shotgun screening.

  32. windriven: That subject has been covered ad nauseum in these pages and Dr. Hall among others have argued compellingly that overtesting does do significant harm.

    Do you seriously want these people showing up at the emergency room asking to get examined, instead of ordering a blood test online? Cause thats exactly what they will do if you deny them the ability to order the test.

  33. mousethatroared says:

    @FastBuckArtist – Did I miss the part were someone suggested denying people the ability to order these tests? Discussing the negative consequences of a service does not translate to an automatic assumption that the service should be banned.

    A person can talk about the negative consequences of cell phones. That doesn’t mean the person automatically wants to ban them.

  34. windriven says:

    @FBU

    “Do you seriously want these people showing up at the emergency room asking to get examined, instead of ordering a blood test online? Cause thats exactly what they will do if you deny them the ability to order the test.”

    Nope. First, I have far too powerful a libertarian impulse to deny anyone the ability to order nearly any test they want. But what value is a test that is unproven provided by a lab that is uncertified?

    Second, healthcare economics is a subject near and dear to me. I don’t want anyone treated in the ER who doesn’t have an emergent crisis to be managed. It is expensive care and it operates without sufficient follow-up to be useful for routine care.

    As an aside, it amazes me that some hospitals bitch about all the ‘uncompensated’ care they give in the ER when they could shunt much of that care to a clinic that wouldn’t cost, relatively speaking, much to build. Some hospitals and hospital groups – especially teaching hospitals – do this. If I were the god of healthcare I’d demand that every CP include a clinic as part of the package. A lot of the care could be provided by PAs and NPs under the supervision of a physician (as it is in many ERs).

  35. Alia says:

    One point here strikes me as a very important – the definition of normal. I know I fall outside many norms (like low blood pressure, slow heartbeat, low platelet count). Fortunately, I know this is normal for me, I know I’ve inherited it from my father, so I’m not worried (although some doctors get a bit shaky, when they see my blood pressure and go like “Are you all right, you don’t feel dizzy, you really don’t want to lie down?”) Conversely, I know that blood pressure well within norms is high blood pressure for me. But if I didn’t know that for example low platelet count is my norm, I might order such lab tests and get very upset.

  36. DugganSC says:

    I’ll agree with the difficulty of getting an appointment with a doctor. Here in Pittsburgh, my experience has been that, for general medicine, it takes 2-3 weeks before one can see a doctor. The majority of an appointment is indeed with a nurse (or waiting for the next person to show up. I’ve found that an hour appointment usually entails about a half hour of waiting overall), the doctor drops in for a brief summary of results, and then you’re kicked back out on the streets. Highmark operates a 24/7 call line that one can use to ask questions of nurses (which, frankly, is of great comfort when you start experiencing numbness in your fingertips and are debating whether you’re better off a) setting up an appointment 2-3 weeks hence for what could be a threatening condition or b) heading to an emergency room, forking over $80-90 on a co-pay, and then having to pay for another $150 of uncovered medical costs for waiting about a half hour before the doctor sends you home saying it’s nothing to worry about (the only times I’ve availed myself of this were 1) the time as a kid when my brother and I had severe poison ivy and my mother couldn’t find anyone willing to look at us for weeks and 2) a time back in Ohio when I suddenly started getting violent nosebleeds every few hours that wouldn’t stop until I could get the dried blood to plug up my nose). I’m not saying that we should have 24/7 access to doctors, but it would be nice to be able to see one within a day or two. On the plus side, when I’ve made appointments, about half the time, the problem’s gone by the time my appointment rolls around. Probably not so good if it’s something serious, of course.

    Anyhow, point… I had a point, I’m sure. Ah, right. The hotline idea could work if there were reputable places to have the tests done. Imagine a world where you start developing a severe sore throat, the nurse on the line listens to your symptoms, directs you to get a strep swab test and send it in, and then phones a few days later with your prescription for antibiotics. Somewhere in between, a doctor would have been consulted, and if it’s more serious, you might have to make an appointment, but 90% of people’s ills could be solved without leaving the comfort of home.

  37. BillyJoe7 says:

    FBA,

    “I have seen people go from a manageable tumor to being inoperable in 4 weeks it took them to get through all the queues in the overworked medical system”

    If you want us to treat you seriously, you are going to have to answer the following….

    BJ: “I’m going to call BS on this one.
    And if you can’t substantiate this claim I’m going to rename you BSA.”

    Scott: “Given that we’re talking about screening tests here, apparently your claim is that you somehow know that it was “a manageable tumor” before any tests were done. Nobody can say whether it was manageable before that or not; the test is the first data point.”

  38. @windriven

    The direct-to-patient lab services are a relief to an overloaded healthcare system. They reduce weeklong queues to see a health professional for people who need help fast.

    The safety concerns are a red herring, the blood tests Harriett complaints about are harmless, a drop of blood is extracted from the finger and sent for spectrometry. There is no harm in this whatsoever.

    The patient could make wrong conclusions from the test results? Sure. So can the doctor! I suffered my share of lab mistakes, 3 years ago a pathology lab failed to find an infection in a urine sample, this wasnt some dodgy online test, it was ordered by MD, collected at a hospital, analysed in a licensed pathology service.

  39. mousethatroared says:

    FBA “The safety concerns are a red herring, the blood tests Harriett complaints about are harmless, a drop of blood is extracted from the finger and sent for spectrometry. There is no harm in this whatsoever.”

    But what is the point? As a consumer I want to know what value I am getting. Information is not actually helpful if it’s not the information you need to improve your health. If a test is useful in diagnosing a particular disease or infection and that helps me get closer to an effective treatment, then great. A good example would be self-testing with diabetes. But if the test is just irrelevant information that doesn’t actually relate to my health status, what’s the point?

  40. mousethatroared says:

    FBA “The safety concerns are a red herring, the blood tests Harriett complaints about are harmless, a drop of blood is extracted from the finger and sent for spectrometry. There is no harm in this whatsoever.”

    But what is the point? As a consumer I want to know what value I am getting. Information is not actually helpful if it’s not the information you need to improve your health. If a test is useful in diagnosing a particular disease or infection and that helps me get closer to an effective treatment, then great. A good example would be self-testing with diabetes. But if the test is just irrelevant information that doesn’t actually relate to my health status, what’s the point?

  41. WilliamLawrenceUtridge says:

    The safety concerns are a red herring, the blood tests Harriett complaints about are harmless, a drop of blood is extracted from the finger and sent for spectrometry. There is no harm in this whatsoever.

    Overtreatment would seem to be a rather significant potential harm, not to mention opportunity cost, stress and in some cases false comfort (I must be fine, that website said my [whatever] levels were [some number], so I will stop taking my chemotherapy drugs).

  42. windriven says:

    @FBA

    “The direct-to-patient lab services are a relief to an overloaded healthcare system.”

    I don’t have a problem with direct-to-patient lab services so long as they are conducted using established and validated protocols by certified labs.

    I do agree with Dr. Hall and others that there is substantial potential for misuse/misunderstanding/misapplication of results of these tests. But that is an education issue, not specifically a regulatory one unless fraud is involved.

  43. Ed Whitney says:

    Question for Harriet or anyone who happens to know:

    There is a company called 23andme, which, for a fee, will apparently analyze your genome and give you your lifetime risks of coming down with various diseases. This is a direct-to-consumer genome project spinoff. I wonder how well its estimates are vetted and whether people are becoming needlessly alarmed by getting reports that they have, for example, a 79% probability of having Parkinson’s disease before the age of 75.

    I would imagine that medical geneticists have something to say about these genome marketing companies, but am not certain where to look.

    Any insights would be helpful. I suspect that many people are being alarmed by these analyses and are running off to get brain scans and God knows what else because of the information they are receiving from this company and others like it.

  44. Harriet Hall says:

    @Ed Whitney,

    I wrote a SkepDoc column in Skeptic magazine on direct-to-consumer genetic testing. It is clearly not ready for prime time. As Scott Gavura said “Our access to genetic information currently exceeds our understanding of what that information actually means.” See http://www.sciencebasedmedicine.org/index.php/direct-to-consumer-genetic-testing-road-map-or-tarot-cards/ These tests give percentages based on a group, not individual information. Not only do they unnecessarily alarm or falsely reassure, they can be downright wrong. In his book, Francis Collins tells how different companies gave him different risk percentages and guessed his eye color wrong. An African American man who wondered what part of Africa his ancestors came from discovered that his heritage was a mixture of other races, with no African component at all. I have almost as little interest in getting these tests as in reading my horoscope.

  45. weing says:

    “The direct-to-patient lab services are a relief to an overloaded healthcare system.”

    Be careful what you wish for.

    http://archinte.jamanetwork.com/article.aspx?articleid=1678815

  46. William: Overtreatment would seem to be a rather significant potential harm, not to mention opportunity cost, stress and in some cases false comfort

    The laboratory makes NO treatment recommendations and offers NO treatment services.

    The closest to treatment advice is sensitivity testing where the lab advises which antibiotic is most potent against bacteria in the sample. Even that is not treatment advice.

    There is no evidence direct-to-patient lab services lead to overtreatment.

    In my observations, exact opposite is true, the patient is more likely to take unnecessary, expensive and harmful medications on advice of an MD which they would not have taken on their own. Antibiotics, antacids and narcotic painkillers are top 3 offenders on that list.

  47. weing says:

    “In my observations, exact opposite is true, the patient is more likely to take unnecessary, expensive and harmful medications on advice of an MD which they would not have taken on their own. Antibiotics, antacids and narcotic painkillers are top 3 offenders on that list.”

    Then why do the test? Do you have any evidence for your claim? Correct me if I misunderstood, but didn’t you diagnose your own UTI with apparently negative lab results?

  48. @weing I sent another sample to a different lab, they found the infection, I got treated and was cured. The first lab didnt find it.

    Some evidence for my claim: costs of inappropriate prescribing, national study http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2856056/

    -36% of all prescriptions written were found to be not necessary
    -94% of patients have received at least one inappropriate, harmful or unnecessary prescription

    The doctors piling against direct-to-patient lab services dont have a firm leg to stand on, as their own record of prescribing harmful treatments is not a very good one!

  49. weing says:

    “The doctors piling against direct-to-patient lab services dont have a firm leg to stand on, as their own record of prescribing harmful treatments is not a very good one!”

    I’ll agree that an impartial party with extensive medical training can still make mistakes. What makes you think that an interested party with Google university training will make less? There is an old saying. “The doctor who treats himself has a fool for a patient and an idiot for a doctor.”

    Regarding the paper you referenced. Have you ever tried to get elderly patients off of benzos and darvocet? I have. It ain’t easy. Hopefully with use of EHRs and information sharing, we may be able to catch that Dr. X prescribed drug Y since you last saw the patient, who tells you there has been no change in meds and he didn’t bring them to verify for the umpteenth time.

  50. @weing I never tried to get an opioid addict off darvocet, I did try to tell an elderly sufferer of recurrent GI infections that taking Zantac for 2 years is not a good idea, without success.

    Why was the patient taking Darvocet in the first place? It’s been banned by FDA for causing heart attacks. That was Dr Primary at work dishing out toxic narcotics, not Dr Google! Thousands of toxic prescriptions in year in case of some very active individuals like this guy: http://bit.ly/ID2b6l

  51. WilliamLawrenceUtridge says:

    The laboratory makes NO treatment recommendations and offers NO treatment services.

    Sure. Just like the Quack Miranda Warning prevents patients from wasting their money on worthless supplements. Just like pharmacies aren’t endorsing homeopathy by stocking Boiron’s products. A nod and a wink to legal defense but a complete willingness to provide consumers what they want without any form of consumer protection.

    There is no evidence direct-to-patient lab services lead to overtreatment. In my observations, exact opposite is true, the patient is more likely to take unnecessary, expensive and harmful medications on advice of an MD which they would not have taken on their own. Antibiotics, antacids and narcotic painkillers are top 3 offenders on that list.

    As direct to patient lab testing a relatively new service, this is unsurprising.

    How systematic are your observations? How do you correct for confirmation bias, recall bias, or selection bias? Anecdotes are far too easy to misuse, particularly in people who promote CAM because a) their preferred quackery is actively protected from serious scientific scrutiny or oversight and b) because most CAM defines itself in opposition to real medicine, as if criticizing actual doctors were somehow evidence for homeopathy, acupuncture or herbal medicine. For instance…

    The doctors piling against direct-to-patient lab services dont have a firm leg to stand on, as their own record of prescribing harmful treatments is not a very good one!

    Bullshit. Doctors are trained to understand false negatives and positives in screening, to have a grasp of the risks and benefits of specific treatments, are trained and have extensive experience with how the body actually works from a biochemical level. In addition, they have orders of magnitude of experience more than the average consumer regarding disease and medical treatment. The discipline is also self-critical, requiring extensive annual ongoing education, recertification, medical review boards and extensive research to look for inappropriate habits – for instance, that study you linked. You, by contrast, are providing an example of the dangers of naive patients getting access to information they do not appropriately contextualize. That study looked at elderly patients (older than 70! A group who are often on multiple drugs because their bodies are beginning to fail) designed to estimate the changes of potentially inappropriate prescriptions. In Ireland. This has local implications for certain, but not world-wide ones and not for all patients.

    Narcotics are not toxic, they are effective pain relievers with significant adverse effect risks. Toxicity is in the dose. There are inappropriate uses of narcotics, fortunately there is also considerable oversight – leading to actions by state boards of medical examiners removing prescribing privileges like they did in the news story you linked to. I’m not sure why you see that as a stinging indictment of the system. To me it looks like the appropriate functioning of an oversight body.

    The day anyone comes up with a perfect solution that permits medical treatment that is always effective without any risk is a day we can all rejoice. Until then, we are stuck with the best we can manage to try to relieve the suffering of the sick while protecting them at the same time. In my opinion, unvalidated DIY testing has tremendous potential for harm and the companies profiting from it have no restrictions or oversight to mitigate this fact. Doctors wait for evidence to change practice for good reason – seemingly trivial recommendations can have tremendous harm.

  52. Scott says:

    The laboratory makes NO treatment recommendations and offers NO treatment services.

    Tests without treatment plans based on the results are meaningless. So one of the following must be true:

    1. You’re expecting the patient to figure out what to do based on the results. Not going to be effective.
    2. The tests are completely pointless and have no value.
    3. There’s an MD involved who is going to interpret the tests and determine what to do based on them. Said MD could have perfectly well ordered the tests themselves.

    You’re quite effectively demolishing the claim that there is any value here, all by yourself.

  53. Mika says:

    Speaking of leaving the MD out of the loop: https://www.crowdmed.com/

  54. Speaking of leaving the MD out of the loop: https://www.crowdmed.com/

    I had a look. Thats a strange online play-doctor site. The idea is interesting but the implementation is clueless to say the least..

    I went in to “Solve a Case”.. was presented with a description of a patient submission. I picked a woman with suspected thyroid condition. Then I was supposed to select a diagnosis right there. Without talking with the patient and without suggesting any diagnostic tests. WTF? The people running the site seem to be IT people and not medical professionals.

  55. TonyMach says:

    qetzal said the most important thing: What about sample stability?

    Forget about any definition of normal and don’t worry about all the other things that Harriet rattles down: if the sample is not stable then no amount of lab work will result in anything more than meaningless numbers on a piece of paper (or in an email).

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