zzzWhat? Huh? Oh, hi!

So, about the air traffic controllers, ray lahood, and sleeping on the job?

NPR had a blog post about this which hits some good points.
Nurse: as a former (and hopefully never again) night-shift worker, this is near and dear to my heart! Studies on nurses (and others) have shown that a brief nap can increase alertness significantly, yet the transportation department secretrary says basically that air traffic controllers can nap on the job over his dead body!  As this post above points out, smoking, eating, pooping = ok, but scheduled napping = not ok?  couldn’t they actually be causing danger with this inflexibility? i don’t know how this stuff is regulated, but it seems. . . bad.
Lawyer: OSHA could probably institute rules about required nap periods available for overnight workers, and if they can’t, Congress could give them the power to. The more data we can give them, the better.
In terms of lawsuits, I imagine it would have to be abundantly clear and unavoidable that the employer knew its policies were putting passengers (patients, etc.) at risk, and willfully ignored the danger, to get anywhere at all. So more studies, more articles, more publicity.

Nurse: we’re talking not only the health of workers, but the safety of the peopel who are depending on them– in this case, passengers, in my case, patients. these are not low-stakes jobs, people! we’re not just talking about the night watchman at sears here!
let’s get ray lahood to work overnight shifts for the next two weeks and stay awake the whole time. . . . who’s with me?

A Pack A Day Keeps the Jobs Away…

NYT recently published this article about employers — particularly health care employers — adopting policies that they don’t hire smokers.

Lawyer: I have no problem with this as comes to healthcare organizations.

Nurse: In general, it seems like if an organization’s mission is to promote health, then it’s reasonable to expect its employees to uphold that to an extent– not smoking at work, on the grounds, etc, but really, isn’t what they do at home their own business if it’s not illegal or damaging to the company? I guess there’s an argument to be made that it is damaging to the company, both in terms of image/mission and in terms of finances, but. . .  shouldn’t there be a line between our work lives and our personal lives somewhere? Where? When we sign on to work for a company, we aren’t signing away all of our lives and our time.

Lawyer: Sure, but isn’t there an argument that you’re not just choosing to smoke sometimes — you become a smoker? Given that it’s addictive, and we’re not really talking about the occasional — or even daily — cigarette, but rather a habit?

Nurse: Generally speaking, we can do things that are bad for us, right? We can eat too much cake, we can drink to excess, we can stay up too late. . . and if it doesn’t bother other people, who cares? So when is somking crossing that line, if it’s not during work hours? It might, but. . . when?

Lawyer: Can you tell if someone is a smoker? Smell of smoke, etc? Maybe there would be an argument for an honor system rule, but not for testing for nicotine at random and firing people for testing positive. I’d be interested to get your take on whether the American Cancer Association could do this. If they can, are hospitals really that different?

Lawyer: Also, this quote just kills me:

“If enough of these companies adopt theses policies and it really becomes difficult for smokers to find jobs, there are going to be consequences,” said Dr. Michael Siegel, a professor at the Boston University School of Public Health, who has written about the trend. “Unemployment is also bad for health.”

Um, so… quit? And then you can be double-healthier. People who are characterizing this as discrimination are missing a major point about discrimination: smoking is a behavior. It’s something you decide to do or not do — not a quality that you have and cannot change, such as race, gender, sexual orientation, national origin, arguably religion — the things we forbid discrimination against.

Nurse: I agree that it is not discrimination based on an innate charactaristic, which is all well and good, but. . . legally, can a company discriminate on anything it wishes outside of a few specific things? Can we refuse to hire people who smell bad (not unrelated. . .)? Or people who are alcoholics? What about people with terrible fashion sense? What about morbidly obese people?

Lawyer:  Here are the rules:

The U.S. Equal Employment Opportunity Commission (EEOC) is responsible for enforcing federal laws that make it illegal to discriminate against a job applicant or an employee because of the person’s race, color, religion, sex (including pregnancy), national origin, age (40 or older), disability or genetic information. It is also illegal to discriminate against a person because the person complained about discrimination, filed a charge of discrimination, or participated in an employment discrimination investigation or lawsuit.

Non-protected reasons for preferring one person over another? a-ok. It’s not illegal to prefer some people over other for reasons not on this list.

Nurse: If so, then, sure, have at it. If you don’t like it, don’t work there, or else quit smoking, or learn to hide it. At my job, they do random drug testing. So I don’t use drugs, and if I do, I accept that I could get caught and I could be terminated. If I wasn’t willing to accept that, I would work somewhere else.

Lawyer: Slightly different there, because drugs are illegal, right? I mean, they have a colorable claim that they’re firing you for violating drug laws. Or  that it’s totally reasonable to keep you away from the cabinet where you keep the vicodin — that you are uniquely unqualified. And perhaps more importantly, you have no claim that you have a right to do drugs.

This type of project seems to have three motivations:

Economic: (cheaper to run, since employees are healthier and more productive)

Image: health care facilities, at least, are trying to help people be healthy… isn’t unsettling to see people in scrubs outside smoking?

Public Health: Reduce smoking in general

Nurse: I think the economic incentive is crystal clear. In terms of image, that seems reasonable. It also matters in jobs like nursing because let’s be honest, who wants someone who smells like an ashtray leaning over them for 12 hours when they don’t feel good to begin with? I’m not just being rude, I’ve had patients ask me to have a particular tech stay out of their room for just that reason.  In terms of public health. . . I’m all for a lot of public health efforts, I think it’s great that you can’t smoke in bars an all that, but when is an employer being too paternalistic? I would resent it if my boss was allowed to fire me if I got a speeding ticket, wasn’t wearing my seatbelt, got drunk on a saturday, or had unsafe sex. Those are public health issues, too.

Lawyer: I’m curious — what do you think about a church refusing to employ a secretary who is unmarried and cohabitates?

Hey, are you using that kidney?

Nurse recently read a quite peculiar news story: a pair of incarcerated sisters in Mississippi were offered release from prison on the condition that the healthy one donate a kidney the one on daily dialysis.


OOPH! Um, wow. While organ donation is great, the healthy sister is willing, and all that, I call shenanigans. If, as the governor is saying, there is no reason, like threat or rehabilitation, that either sister needs to remain incarcerated, then he should let them go. Period. Fine. Ok.

If one sister wants to donate her kidney, super! Swell! These things can both happen. But. . . once you combine them, you are getting into very murky waters. I see it as very coercive, which is never an appropriate way to make a medical decision. The health risks to the donor are not zero. And if she is making a health decision weighted with “freedom vs. life in prison,” we have issues!

So let’s take it out of the equation. If the sisters are released and then one donates her kidney to the other, without any incentive, then all is well. If they are released and the healthy sister says “uh, nevermind!! j/k!!” then she wan’t really giving true consent in the first place. She was coerced. You can’t pay people for organs for just this reason.

In the future, then, can we tell any other prisoner that they can go free provided they leave a working organ at the door??

Thanks for the 60 years of marriage, honey, but I have to cut you loose.

NYT ran a story this weekend about the practice of “spousal refusal” — that is, one spouse refusing to pay for the other’s long-term medical care (think nursing home) so that the ailing spouse can have the care covered by medicare. Which it otherwise wouldn’t be if they have assets of more than $110,000. (Assets including, you know, the money you were planning to live on for the rest of your life, since you’re retired, and stuff.) Nurse and lawyer take a look at some of the complexities of this practice — which seems heartless, but then, so do the alternatives, no?

Nurse: Yikes! Well, my first instinct is, can you blame ‘em? The cost of nursing home care is so outrageous, and it’s true that medicaid pays less than a regular consumer, so I totally get the instinct. If you’ve saved your whole life for a comfortable retirement and then you are basically S.O.L. because your spouse has a particular kind of illness that medicare won’t cover the cost for, that is pretty lousy.

Lawyer: I wonder if the consequences of signing a refusal form like that are limited to health benefits, or if they endure or extend. (In other words, is there some kind of “penalty” you end up paying?)
It also made me wonder why the man in the story who was being sued by the state hadn’t just transferred more of his assets. If the whole point was saving for the next generation, couldn’t he have avoided the problem by giving as much of it to his children/family as he could (depending on tax situation?) I’d also note that surely that suit could settle for far less than the cost of the care, making this kind of thing economically efficient for the refusing spouse.
Nurse: The counter-argument presented in the article talks about millionaires gaming the system. . .which I see is possible, but probably not really the issue. It’s more about people who made a lot of sacrifices to amass some savings who are never really going to see it now.  I don’t think it’s really a good thing to essentially “cheat” this way, but what you are allowed to keep and still be covered by medicaid isn’t super generous. . . and it sort of discourages saving, in a way.
Lawyer: Sure does. (If we assume that people are thinking about this and planning for it. Which some people are.) Why don’t they raise the amount of savings you’re allowed to have, and still qualify? It’s $110,000. That is… not much, in terms of life savings for retirement. They could set it considerably higher, avoid the “millionaire problem,” and keep people’s savings from being wiped out by catastrophic illness. This is crazy-making because of course spousal refusal is no kind of solution to the huge problems we face. And it might seem to make our health care budget crunch worse. But for the people facing the choices at the time, they have to do something.
Nurse: So. . . let’s reform the system! (that is apparently my standard answer, no?). You know what’s cheaper than nursing homes, has better outcomes, and better patient and family satisfaction? Home care! Day programs! There’s a place for nursing homes, we need them. . . but they aren’t the only option in a lot of cases, but they may be the easiest to set up, or the only one that has some insurance benefit.
Lawyer: Love it! The problem isn’t refusal — it’s that the cost of care if way too high. The article mentions that in New York, home care is covered by the same kind of benefit. I wonder how the decisions get made — I imagine it’s not by the patient/family, given your info on satisfaction.
If you were going to design a policy, how would you do it? Who gets home care and who goes into a nursing home? By disease? By preference? By. . . what? Are the decisions made by people who have financial incentives one way or the other?

I like this solution because it seems like it shouldn’t be controversial. It… works better AND costs less? AND doesn’t involve letting a government official appear to be making very personal decisions for you? But then, we’ve had all kinds of good ideas that can’t get any traction. The political system is busted. Beyond belief. Excuse me while I go bang my head against the desk for a few hours before I start working on solutions that won’t involve congress.

Arizona strikes again.

Lawyer says:

Since last week’s news of Arizona’s new organ transplant/medicaid rules, denying certain types of transplants for medicaid patients as a cost-saving measure, I have been thinking about what to write here.

All I have been able to come up with is this:

Shame on you, Arizona government. This change is unacceptable. You are telling your citizens that their lives, which we can likely prolong and improve, are not worth the cost, and they can only get life-saving care if it is not on your dime. There are many things I believe a state should guarantee for all its citizens, but even if I were to strip most of them away, life-saving medical care would always be on the list. What’s worse, you’ve taken people to whom you have already promised such care and kicked them off the waiting list — unless they can raise hundreds of thousands of dollars. The life of a person with abundant resources is not worth more than the life of a working-class husband and father. Shame on you, Arizona.

Paging Doctor Nurse!

Nurse and Lawyer’s dad sent on an article about the IOM report on the future of nursing. It was also discussed on Talk of the Nation this week. The report talks a lot about education for nurses and how advanced-practice nurses can help address the shortage of health care providers expected to worsen when new health care laws take effect.

Lawyer: Well, Nurse may be on track to be one of those nurses with doctorate degrees that the report says we need! So that’s one way to work for change. Get your boots on the ground.

Nurse: The education issue is huge. And divisive. While I agree that more education is good, and it seems reasonable to move towards a standard of a bachelor’s degree for entry-level nursing, it’s also true that some of the best nurses I know have associates’ degrees.

The article talked briefly about the idea of post-graduate clinical residencies for nurses– and I think that is  a very exciting idea. This is already widely practiced in a very haphazard way by hospitals who have various residencies, preceptorships, and externships for new graduate nurses, but there is no standardized way to do it and a nurse can be lisenced without any experience outside of school. Clinical skills and experience are largely obtained in your first nursing job.

Lawyer: Interestingly and mildly tangentially, that is also true of lawyers — though some (and an increasing number of) law schools have clinical programs where students work on real cases under faculty supervision, it’s still standard practice for newbies to have no practical experience. This (along with the student debt problem) accounts for some of the phenomenon of new graduates going so often into big law firm jobs, rather than working for smaller organizations that could really use the help — big firms have the resources to provide the training that isn’t required as part of the degree.

Nurse: Finally, the standard of education varries greatly. Some places are really pushing for NP’s to require doctorates rather than just masters’ degrees. The DNP degree has been created for this purpose, although a PhD in nursing also exists with a more academic/research focus.
Nurses with advanced degrees tend to be in somewhat different roles than ADN or BSN nurses– they are often educators, or specialists, or managers, serving as resources. They may teach, or do research, or direct nurse-led programs. They may work in primary care or alongside physicians in prescribing and treating. Some (but not many!) work in policy areas.

Lawyer: The Penn program mentioned in the NYT article seems to be getting at caring for people in a way that reduces demand for services. A kind of preventive care that kicks in only after a major incident — preventing relapse, rather than preventing disease to begin with — but still a step in the right direction.  At the risk of getting all econ here, with a shortage of this magnitude, we’ve got to increase supply AND cut demand. It seems to me that nurses could be useful in cutting demand.

Nurse: I agree. readmissions is a huge problem that can be addressed with good follow-up care, and nurses are a great way to do that. Not only will it lessen the burden on the system, but it is good for patients and good for health. This might be one of those situations that needs a very well-designed and executed study to prove that it saves money, since it involves laying out cash upfront. It’s a different way of thinking and those are sometimes hard to sell.

Lawyer: How do we effect change at the cultural level? (If I knew the answer to that. . . jeez.)

Nurse: It’s too bad that there’s so much infighting within the health care professions. Who doesn’t want nurses in expanded roles? What? Physicians? I call shenanigans.

Lawyer:  We need to pay nurses more. There, I said it. Not just to attract more nurses (though that would probably happen), but also because people will then take them more seriously as professionals and be more willing to entrust them with major tasks. (cf. NYT’s discussion of kindergarden teachers a few months ago.)

Nurse: Good point. I have had many people as me, if I’m considering getting my doctorate in nursing, why I don’t just go to medical school since it’s 4 years anyway, and I’d get paid a lot more. And it’s true, I would. My answer is that even nurses practicing in primary care have a different philosophy of care, in general, than physicians do.  But why that pay gap? For education and training, perhaps? Doesn’t hold much water when the nurse is doctorate-prepared. (Another reason to standardize residency programs for nurses– gets rid of that excuse entirely!).

Lawyer: We just need to keep fighting the idea that nurses are inherently less smart, useful, skilled, etc., than are doctors. (I’ll save my feminism rant for another day, but, yeah.) Just because many doctors have significantly more training than many nurses doesn’t mean that it has to stay that way.

Is there a role for law here? The Patient Protection Act is certainly a major force here, and a force for good, but it’s also creating a lot of issues that we need to solve. There are all the traditional answers to what law can do here — malpractice reform to cut costs, various iterations of who pays for which government programs — but could there be something else?

Nurse: Look at nurse practice act– these are different state by state, and the scope of practice varries from state to state. Some states require NP’s to work under physician supervision, some have prescriptive authority, some can function totally independently. Why does it need to be fragmented this way?

Lawyer: California’s is available here: http://law.justia.com/california/codes/2009/bpc.html (scroll down to Chapter 6: Nursing). Lots and lots of rules. This is one of those things that really has to be regulated by state law — it’s one of those types of things that seems like a state issue, not a federal issue. (That’s highly technical, I know.) There is an organization that promulgates “Uniform Law” — they very carefully draft laws that make sense to have agreement on and then try to persuade states to adopt them — but they have a really hard time getting enough states to adopt things to make them worthwhile. Still, this seems like the sort of topic where that kind of unity would be useful. (There is a Uniform Healthcare Decisions Act, and a Uniform Healthcare Information.

Sign here, ma’am.

Nurse and Lawyer recently read a story on the NPR website about computer programs designed to educate patients prior to a procedure as part of the informed consent process. We took it on, with a little help from Geek (AKA Mr. Nurse, who is just finishing a Masters’ in educational technology).
Nurse: i think there are some interesting questions about risk and informed consent in here. there isn’t any data about whether patients are actually more informed, or whether it’s just that we have a trail showing that they are (or at least that they clicked through the information).

Lawyer: My immediate question regarded how precisely defined the procedures are. If you watch an explanation of what your doctor is going to do, but it’s a standardized version, and what he’s actually planning to do on you specifically is slightly different, where does that leave you? The article doesn’t give much information about how detailed they are.

Nurse: Well, with most procedures, there’s some leeway– if you have a colonoscopy, they might find a polyp, and if they do, they might clip it. If you have surgery, they might find something unexpected, and they might repair it. So it almost has to be general to an extent.

i’m sure some patients will still not read the information or will not absorb it, but in this case, it seems like it’s easier to absolve the doctor/hospital from questions about whether the consent was informed. a standard consent form lists the procedure and the physician performing it, and it states that the physician has listed the risks and benefits. it doesn’t actually state what these risks are, necessarily (some do, and some have more detail). So it’s pretty much word against word that the information was covered.

Lawyer: This certainly allows you to prove that the information was presented — which, I agree, is probably the hospital’s biggest concern (as separate from the docs, who may actually care if their patients understand, at least some of the time.) Whether the information was understood or not — I’d love to see some studies on whether patients who get a face-to-face standard explanation can later report better or worse than patients who get these electronic versions what the details of the procedure are.

Nurse: Or if they get both!

i’m not sure if this is good or not– of course, some of the burden of informed consent falls on the patient, but many physicians treat informed consent as cursory at best (ever see house?).

Lawyer:  This strikes me as an innovation that would shift more of the burden to the patient — if all the info is there in front of them, they then have to absorb it and ask questions. And that might be a good thing, though it’s worrisome in that patients giving consent for things are often not at their most calm and rational.

Geek: I’ll chime in here, since it sounds like you’re returning to the question of how well this informed consent program does the job of informing the patient (it certainly does the job of verifying consent, at least in the opinions of the hospital lawyers). From what I can tell after viewing the Emmi Solutions demo online at http:/ /www.emmisolutions.com/demo, their program is well-designed. It offers a very straightforward overview to the user of what information is being presented, and the user has the ability to navigate that information as they see fit (skipping ahead or returning to previously covered topics, for example). There’s a clearly marked option to enter questions, although where those are directed isn’t obvious—hopefully, at the physician. The combination of voice narration with sparse text and visuals makes it come across a bit like an animated PowerPoint presentation, but that’s not necessarily a bad thing. A lot of the research on e-learning warns against too much information at once (cognitive overload).

Nurse: I am frequently asked to “get consent on the chart” for a procedure that I find that the patient does not understand at all. I usually advise them not to sign unless they are sure their questions have been answered– and this annoys some people with M.D. after their names. I worry that if there’s a computer doing some of the teaching, this problem will be worse in a way and physicians will take even less ownership of the process.

Geek: As someone who is personally afraid of surgery, I wonder whether the clean, almost cartoonish graphics used in the Emmi program make serious medical procedures seem too easy, too sterile. Stomach surgery doesn’t seem really dangerous when you don’t see any blood. The program seems biased in favor of gaining consent, although as you suggest, this is probably the case using the “old-fashioned” method as well.

Lawyer: Is there a legitimate role for nurses here, as liaisons? (Both traditionally and in a forward-looking, problem-solving way?) Is your concern that doctors might care even less? How will doctors being less responsible for the actual dissemination of information make the informed consent process less effective, if patients are actually getting more information before they consent?

Nurse: Well, only in that I think the communication is important, and not only because it provides information. I think it also builds trust and can be therapeutic.

Geek: This kind of electronic record also presents a new communication problem: it’s perfectly possible for the program to play without someone watching it. Emmi Solutions doesn’t know if you leave the room during the section of the program about health risks; it also doesn’t know if you deliberately mute the program and just keep clicking “next,” although I don’t know whether that kind of deliberate negligence on the part of a patient would hold up in court.

Nurse: Patients, as lawyer said, could come out with more information and more ownership, which is good. if you can go over information at your own pace, in privacy or with support, you are clearly more likely to understand it, and these programs seem to promote that. whatever the outcome, though, it’s impressive to see the healthcare community engaging with the process of informed consent in a new way.

Lawyer: Agreed!

Take two of these, and hope you don’t get fired.

NYT reports today about some companies who have started including prescription drugs in their random drug testing, and dismissing employees who test positive EVEN WHEN THEY HAVE A VALID PRESCRIPTION.

Nurse: So, random drug testing at work is not news, nor is the fact that these tests often include presription drugs– but what IS significant about this case is that having a valid prescription does not get you off the hook. There are a lot of problems with that, obviously– some drugs are tested for when others are not, people with a legitimate need for a drug can be fired for using it, people who are able to perform their jobs safely are fired out of concern that they could potentially at some point be impaired, maybe others too . .. ?

Lawyer: Also some privacy concerns — your employer doesn’t have a right to know your private health information, whether or not they use that information to fire you. Might deter people from taking their prescribed drugs because they’re afraid of losing jobs.

Nurse: It seems like the entire thing could be conducted through a third-party company. . . and IF the employer was not firing people for legal precriptions they would never know about them, which makes sense. But you’re right, it seems like a privacy violation for your employer to test your urine for various substances that you have a right to use, legally speaking, and then fire you for it, especially because they cannot prove that you are using them at work. If you take a vicodin after work, your urine will test positive for hydrocodone. that’s even less your boss’ business than if you took one at work. Now, this isn’t totally screwball, because there are legitimate concerns that an employee of say, an auto plant could be a danger to herself and others if she was impaired. Many of the medications under discussion (like hydrocodone and oxycodone, which are the narctocics in vidodin and percocet) legitimately can impair your ability to operate machinery, and they are labeled as such.  So sure, I understand the concern.

Lawyer: But. . . is the situation such that one could be a danger to others without exhibiting any signs whatsoever of altered behavior? Is this an across-the-board kind of effect? Nobody can drive safely when intoxicated — but do these drugs affect everyone that way?

Nurse: Well, no, and it matters how  much you’ve taken, what your tolerance is, and your general suceptibility to those side effects. Some people will be totally safe and some will be impaired. But what troubles me is that it is widely practiced to test if there’s cause to do so– someone is behaving strangely, appears impaired,  etc. Why do employers feel this is insufficient? Do they have a leg to stand on, legally? Is it really safer to use random tests than targeted ones?

Lawyer:  I agree that this is very troublesome, especially in jobs that don’t seem to have abnormally high safety risks. The question about a leg to stand on legally is a tricky one, and the NYT article starts to get into some of the problems.

The biggest one that occurred to me on a skim-through was the Americans with Disabilities Act — which forbids employers to fire people for having any kind of disability that don’t significantly interfere with their ability to do their job and even requires the employers to make any reasonable accommodations necessary for disabled employees to work there.
So if you have an employee who needs a strong pain medication. . . you see where I’m going with this. They need a reasonable belief that the person’s condition is interfering with their job. Hence, no need for random testing. Let alone firing.  It seems like they are moving to suggest that a positive result on a random drug screen might constitute grounds for reasonable belief that the person cannot do their job. Nurse, is this feasible? (this is probably shaped by the answer to my question above.)
Nurse:I agree with you that the present standard addresses this. If they have data that shows that a high percentage of employees who are involved in accidents have tested positive for legal precription drugs, then they are adressing a problem (even if they are doing so illegally/imorally/whtever). If not, then they are not, and  this whole thing is bogus.
Lawyer: And yet, the testing is surely expensive, as is the turnover in the work force — they must be finding it somehow worthwhile.
Nurse:And again, if using certain prescription medications makes one inelligible to perform the job, that needs to be an up-front disclosure, right? Ok, so a person with epilepsy cannot be a truck driver. That makes sense. Can a person with pain then not work on an assembly line? If they are going to make that argument, they better do it loudly and before anyone is hired, or has worked there for 20 years. Do you suppose the company in the article has any data to back them up?
Lawyer: This is a good point — if someone does a job perfectly well and safely for 20 years, exhibits no change in behavior, and is fired because of a health condition, that seems pretty indefensible. Changing the rules after someone has made a real investment in signing up with you sure looks bad.
Nurse: Now, I can imagine this being somewhat more complicated among people who have access to such drugs as part of their jobs– nurses, pharmacy techs, etc. For us, a positive drug test is probably somewhat more serious even if there is a legitimate explanation because we are in a position to steal drugs. Having a prescription doesn’t mean you didn’t steal them. I’d like to think people don’t do this, but evidence does not back me up. But even if this more delicate situation, I don’t think it can be justified unless it is proven that your ability to carry out your duties safely is compromised.
Lawyer: I would add that at the very least, I would expect the employer to offer a long-time employee an alternate assignment if they believe a prescribed drug or health condition is interfering with the employee’s ability to safely perform his or her job.
Nurse: Lots of employers, especially in healthcare, offer rehab, repeat testing, etc. for use of illegal drugs or illegally used prescription drugs. That doesn’t make sense if you are talking about a legit precription, but it just goes to show you that there are more lenient pathways that don’t lead to a nation of zombie-employees showing up stoned every day.
Lawyer: Repeat testing doesn’t do the trick here. In fact, this company offered it. But then you’re in a great position: go off the meds your doc prescribed for you for a health condition so you can pass the test, or lose your job.

Patients vs. Proof: Are Clinical Trials Ethical?

NYT had an interesting article last weekend about a promising new melanoma drug that was in clinical trials right now – profiling a pair of cousins in the trial, one who got the drug and one who didn’t get it. And couldn’t get it, despite the fact that it seemed to be helping. What an ethical pandora’s box we have here!The core dilemma:
In order to really know that a drug is both safe and effective, we have to do controlled clinical trials with a lot of patients – and to do these trials, we need a control group. Sick patients who aren’t getting the drug.

If we have a drug that shows great promise, it seems unethical to deny it to half of the patients. But at the same time, we can’t prove that it’s really a good drug without doing so, so ultimately, we get a great benefit as a population by making that “sacrifice” of some patients in the trial. It would be true if people were lab rats – but they’re not. Every patient is somebody’s kid, parent, sibling, etc.

So what can we do??

The regulatory pieces:
Besides just being good science/ arguably the best policy in terms of only spending healthcare dollars on treatments that actually work, companies do these trials because that’s what the FDA requires to approve the drug. And without FDA approval, the company can’t market the drug. If they can’t market it, they can’t make any money off it.

There is, however, an exception: a drug that shows great promise can be offered BY THE COMPANY that made it for “compassionate use,” or “treatment use,” that is, use, prior to approval. But this creates a problem: who would want to be in the study, where they might be in the control group and not get the drug, if it were available outside of the study context? Companies generally have little incentive to offer investigational drugs to non-trial patients, because they need approval to market the drug, and if they can’t market the drug, they can’t make any money, which pays for research and development, so. . . nobody would ever make new drugs.

How can we fix this:

Dad: I think a lot depends on the clinical trial design. Many have cross-over provisions if the patients don’t respond (i.e. if they get placebo). They can then get the “active” drug.   This is difficult in the case of cancer in which the time frames are long and the endpoints are generally  survival based.

Nurse: Although survival is certainly not the only benchmark for a drug’s success, especially in cancer. There’s a lot of discussion in evidence-based medicine about whether interventions increase survival, which is great, but it’s only one piece of the puzzle.

Lawyer: How does that work, though? Do they just put a check in the “didn’t work” box after the patient doesn’t respond in a fixed time-frame?

Why shouldn’t we just allow free access or marketing, as long as it’s clear that we don’t know for sure whether this works, once we’ve been through basic safety trials? In other words, if we think it’s safe, should the FDA, either directly or through the incentives they create, stand in the way of more sick patients being able to get the drug?

Nurse: Well, isn’t part of the FDA’s mandate to protect the public from totally bogus nonsense? I mean, think about supplements not regulated by the FDA and how much confusion that generates.

Dad: Safety has not been demonstrated for this drug. The Phase I trial was only 31 patients. Often, it takes thousands or more to identify serious safety concerns. This happened with Remicade [a drug Dad was instrumentally involved in. Or dare we say, invented.]

Nurse: That’s good to know/remember. This article, with its approach of profiling two specific patients, kind of mirrored (and encouraged) the public reaction to promising advances– as in, they have to have it and they have to have it now– when they may be jumping the gun. The article mentioned a promising breast cancer treatment from years ago that didn’t pan out. That happens, and I think that people may be a little misled and also may be unable to judge well if they are really starved for a crumb of hope.

Lawyer: What do they do with treatments for really rare diseases? Where the prospects of finding thousands of patients in a decent time frame isn’t so good?

Nurse: Also, as medical doctors, (even though they are researchers), shouldn’t they have some level of concern for patients as opposed to solely for data? At some point, shouldn’t we place patients’ well-being or relief of suffering above perfect data?

Dad: Then you would never find out if it really worked, and it would cost everyone a lot of money.

Nurse: Well but that’s where a crossover type design could be helpful. I think it’s inhuman to say to a patient, “we’re sorry, even though you are clearly deteriorating rapidly and your tumors are getting bigger, we refuse to try any other treatment because we might sully our results.”  And sure, it’s great if we prove that the drug increases survival, but if we have a fair amount of evidence (even if it’s not perfect evidence) that it has some beneficial effects, isn’t that good too? Why does death have to be the endpoint? That seems like a problematic element in the design.

Nurse: I wonder if there’s a way to do a retrospective study that would give us some insight– look at previous patients who received the chemo as a control. It’s not perfect, but perhaps it’s necessary from an ethical standpoint.

Lawyer: And don’t we already use lots of treatments that are FDA-approved, but really don’t work very well? They’re just the best we’ve got? I guess the question here is, are these better or worse than existing treatments? If we’re trying to improve, we need to know if we are — or not.