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An Awful Idea: Paying to Get Into a Clinical Trial

This article at Stat by Rebecca Robbins really caught me eye. It describes clinical trials where the participants are being asked to pay thousands of dollars just to join the trial. There seems to have been an increase in this sort of thing lately, and I’ll be completely clear: I think that’s a terrible idea that needs to be dealt with quickly.

FDA regulations permit such charges in “extraordinary circumstances”, such as when a drug is so expensive that it would never otherwise be tested. But the people trying this – small outfits doing rejuvenation-through-young-blood-donors or stem cell therapy trials in Panama, that sort of thing – are bending that clause out of recognition. The idea isn’t that you announce a trial when you have no money and therefore claim that it won’t be run unless people pony up.

I have objections on principle, and objections in practice. The principles are these: we drug companies are asking people to be our experimental test subjects, and we can’t do without them. We’re asking them to take risks in order to advance our drug programs and medical science in general. So you’re going to ask people to pay for that? We should be paying them – in fact, we do. This is reminiscent of Jim MacDonald’s law of publishing, that “Money flows towards the writer”. If your publisher starts asking you for money to do editing and production, etc., you are probably being scammed (that link to John Scalzi updates the idea for the age of self-publishing). And if you are being asked to pay thousands of dollars just to get in the door of a clinical trial, I fear the same.

My objections in practice are that this idea is perfectly designed to take advantage of desperate patients and their families. I have the same problem with this that I have with eliminating the requirement to show clinical efficacy. Here, I’ll go get a consciencectomy operation so I have a free hand; they’ll surgically remove any shred of ethical behavior in me that they can find. (I figure this operation must exist, based on what some people get up to). Now I’m ready to enroll people in my clinical trial for Alzheimer’s, testing my proprietary blend of bioflavanoids and antioxidants. The pills may look like raisins with an enteric coating sprayed on them, but that’s because that’s exactly what they are. They’re just full of all-natural goodness, though, and for only $5,000 a head, you can get your elderly relative in a *Real Clinical Trial* for what just might be a *Cure For Alzheimer’s*! Wow! You know, I’m charging too little. I’ll bet I could fill the place up at $10,000/grandma instead, so why the hell don’t I do just that? I’m absolutely in the clear on bad side effects – there won’t be any, unless there’s some raisin allergy lurking out there in the population that I haven’t heard about. Primum non nocere, you losers – here, chew on a raisin, it’ll make you feel better. Maybe. Hey, maybe they’re also a preventative for Alzheimer’s. Register another trial! They’ll be lined up around the block for that one!

OK, if you think that there aren’t people who would do this, all I can do is advise you to look around you. Finally, consider how this looks. People are already up in arms about the amount that they have to pay for approved drugs that have been through trials and FDA review. How does it look to shake people down just for the chance to take an investigational one? No, no one needs this. It’s bad news in every direction. The FDA has the authority to do something about this, and they’d better.

36 comments on “An Awful Idea: Paying to Get Into a Clinical Trial”

  1. SirWired says:

    This has been going on for years. Right alongside places using a fake trial on clinicaltrials.gov as evidence that they are a legit operation. (Stem cell clinics take great advantage of that one, and don’t even bother to “enroll” patients in their “study”.)

    The most egregious, and longstanding, example of a “trial” allowing a quack to sell a dubious treatment to the desperate would be Stanislaw Burzynski, who has been pulling off that scheme since the mid-80’s with his “anti-neoplaston” cancer therapy. He’s allegedly been running that stuff through Phase I/II for decades now, but never actually finishes, because then he might actually have to reveal it’s actual efficacy, or lack thereof.

    (He also has a longstanding record of legal and professional threats against critics, just in case you thought he might be anything less than a horrible person.)

    1. I was just going to mention the good “Doctor” Burzynski. His company still trades, ticker BZYR at a whopping 3c/shr.

  2. Once A Chemist says:

    So it would be possible to pony up big bucks to participate, only to learn later that you had been placed in the placebo group?

    1. db says:

      On the plus side, maybe they’d send a refund check to your estate.

  3. Barry says:

    Charging participants (mustn’t call them patients) in a clinical trial is a terrible idea for reasons Derek has so succinctly laid out. But the status quo ante has its own problems. The biggest in my mind is that that drug companies running clinical trials necessarily have a conflict of interest so gross that no one mentions it. Phase III clinical trials should be run (on the inventing company’s funding) by a trusted third party that has no direct financial stake in the outcome.
    Until we make this change, every drug and every vaccine and every device approved must bear the legitimate suspicion that the clinical findings reported were exactly what the company’s bottom line dictated because the investigator dictated the clinical outcome.

    1. Nameless says:

      And then the third party that conducts more succesful clinical trials gets more repeat customers than those who dont play around with the cutoffs in the statistic or whatever new trick statisticians can come up with. I fear this would shift the problem to someone else but not resolve it.

      1. Ed says:

        In an ideal/fantasy world, clinical trials ought to be run directly by the NIH. That could be at cost to the pharma companies (or even government funded, if anyone is politically willing to triple the NIH budget and completely rework the incentive structures…)

        But in the real world I think that just passes the conflicst of interest into the morass of regulatory capture, government contracting, and pork-barrel funding…

        1. Isidore says:

          In my opinion it would be a very dark fantasy world in which a government agency runs the clinical trials.

          1. zero says:

            Why would a neutral party subject to public oversight be so bad?

          2. Hap says:

            There wouldn’t be any way around the process (and so it would be subject to absolute power dictums). It would not likely be under good public oversight; things that are supposed to be under public scrutiny often aren’t. Many of the people who could oversee the trials and would be likely to understand what was happening would have significant conflicts of interest. It would be a very high value target for regulatory capture.

            It could have benefits, I think, but the likely problems are pretty bad and difficult to circumvent (human and bureaucratic natures being what they are).

          3. Da Vinvi says:

            Sigh, only an American could think this is a bad idea. Let me guess, you think healthcare is a privileged, not a right?

          4. Vader says:

            Da Vinci, is it only Americans who understand the realities of human nature?

            It sure seems like it.

        2. DTX says:

          If companies had inappropriate influence on the outcome of clinical trials in the US & Europe, we wouldn’t see so many failures. Today, 86% of drugs fail in clinical trials. Those who made the comments above may not realize this.

          Previously, fraud in clinical data was a huge a problem in China. However, the Chinese FDA (now called NMPA) came up with an ingenious way to fight this. They put in a rule that if a company was found to submit fraudulent clinical data, the company could be banned for future submissions for 3 years. This was ingenious because it forced company’s to police themselves. That it was effective was obvious in that 80% of submitted New Drug Applications (NDA) were withdrawn (and 90% of these were from Chinese companies).

        3. Brent says:

          Hi Ed, I applaud the ideal world thought process…it helps find best decisions when iterating around a true north.
          One critical point to add to the NIH idea, best described by my experience whenever we post a bid for an NIH study: My phone and email blow up for weeks. Every woman and minority owned small business within the Beltway reaches out to offer us to allow them to bid on our behalf…in order to get the designations on a bid and increase odds of being awarded. For a simple cut of the revenue of course.

    2. David E. Young, MD says:

      You must know this, but phase III registration studies are highly monitored and are generally run by contract organizations (CRO’s) rather than the pharmaceutical company itself. Everything, and I mean everything must meet government specifications and scrutiny. Getting drugs approved is not an easy matter.

    3. matt says:

      I see no evidence the threat of being sued into oblivion, with trial discovery uncovering all the shenanigans involved, has not reduced the prevalence of this sort of corruption to very low, manageable levels.

      Yes, the drug company has an incentive to fake good results, but the threat of lawsuits and jail time seems to have made that shortcut undesirable. No action needed at this time.

  4. Isidore says:

    I prefer to keep government interference in business at a minimum, but this may be an area that a fund, perhaps jointly funded by industry and, say, the NIH, can be established to finance trials of companies that meet these “extraordinary circumstances”, which will have to be verified by some independent panel of experts. If the trial is successful and eventually there is a drug marketed that brings in revenue the company that benefited from this arrangement will have to pay back the money, if not it will be written off.

    1. Anon says:

      “this may be an area that a fund, perhaps jointly funded by industry and, say, the NIH, can be established to finance trials of companies that meet these “extraordinary circumstances”, which will have to be verified by some independent panel of experts.”

      That would fundamentally change the business model of drug companies. Currently, many medications are very expensive because the profit earned helps pay for very expensive phase III trials. Furthermore, the expense of phase III trials limits the number of compounds moving through the development pipeline (because development is so expensive, companies are reluctant to start phase III testing if there are hints that a compound might fail). However, if NIH starts paying for phase III trials then the economics underlying those business decisions would change. Companies wouldn’t be able to justify high prices if they don’t have to pay as much for drug development, and not loosing as much money on failed trials would encourage trials with “marginal” compounds. Those changes are not inherently negative, but they would definitely change the process of developing new medications.

  5. luysii says:

    Hopefully none of you have had to deal with the desperately sick. 50 years ago L-DOPA was still not released in the USA despite the spectacular results that had been reported from Europe since 1961 ! ! ! I was a Captain in the Medical Corps of the Air Force back then, and a desperate, pathetic, debilitated old man with Parkinsonism (who happened to be a Colonel (3 ranks above Captain)) begged me to get him into a clinical trail at the local University. He kept mentioning his rank, implying that I’d be shipped out to Vietnam if I didn’t. I did, not because of his pressure, but because docs always try to do what is best for the patient in front of them, regulations, insurance companies etc. etc. be damned.

    1. Frank says:

      Get into a trial is quite different than paying to be part of trial, correct?

      1. luysii says:

        Frank — correct. 50 years ago you couldn’t pay your way in. But just like the current college admissions scandal, money and power would find a way.

        Knowing the people running the trial, I don’t think they could have been manipulated to enter people, although knowing them as I did, you might consider what I did manipulation. But I would have done it for a Pfc in the unlikely event that a 18 – 30 year old had Parkinsonism (primarily a disease of the elderly.

    2. Anonymous says:

      I have been told stories from the “old days” that drug companies would allow employees access to their drugs at zero or low cost through the company (on site) pharmacy. John Sheehan (MIT, penicillin synthesis) started out at Merck where he helped with the R&D of streptomycin. His mother was sick and he was able to get still-restricted not-well-known or publicly available streptomycin for his mother and she recovered. (No Rx needed, just his Merck ID.) Her hospital doctors were flabbergasted and wanted to know how she got streptomycin when even THEY couldn’t get streptomycin. There are a few other stories like that floating around from that time period, the hayday of antibiotic miracle drugs. (Chloramphenicol was another one freely available to employees, I think.)

      Needless to say, those practices came to a halt and no longer exist.

  6. Justasking says:

    To Ed, And NIH people are more ethical than other people? How so? They have incentives to bend the data as well — grants, accolades, tenure, promotions, and the next trial. Scientific misconduct happens in academia too, see Retraction Watch for long list. It’s a product of being human. NIH or other government organizations are not the panacea, government workers are not more ethical than any other person, they have incentives to distort and falsify also.

    1. Hap says:

      NIH employees, not grantees. NIH employees aren’t more ethical than other people, but many of the cited problems are specific to academia and not relevant; they don’t have nearly as many incentives for fraud as academic people because there aren’t many money sources for them. The FDA has had insider trading problems, but those are likely easier to monitor and counter; similarly, to employment problems (“help us with this trial and you can get a sweet job after you leave.” would be a likely start).

    2. Ed says:

      All good points, and ones I was trying to acknowledge in part with my mention of “regulatory capture” (e.g. providing favorable results for pharma companies to get a cushy pharma consulting gig in the future). Certainly government managers have their own careerist biases to promote their own projects and successes, but for that matter so do pharma managers. However, it’s at least conceivable that not as many people will be incentivized to tilt the scales in an NIH-run trial. I certainly doubt we’d see as many glowing press releases about the latest dubious subgroup analysis…

  7. Anonymous says:

    I think there’s one other point that might be worth mentioning. Asking people pay substantial sums of money to join a clinical trial imposes a pretty strong selection effect on the population. Of course, normal clinical trials aren’t random selections either, but I think this would skew things to another level. For example, certain neuro drugs already have low/inconsistent effectiveness and high placebo noise–seems like this might make it even harder to get reliable trial results.

  8. MrRogers says:

    How would it tip the balance if patients in such a trial had to receive an appropriate amount of equity in the company?

    1. anon says:

      It’ll really clean the noise out of self reported assessment numbers

    2. anon says:

      It’ll really clean the noise out of any self reported assessment numbers

    3. cynical1 says:

      I guess no one is going to point this out. If you believe the politicians, the vast majority of Americans live paycheck to paycheck. Thus, participating in these trials would mostly be restricted to the rich (because insurance sure isn’t going to pay for it). So, in other words, only the rich get a shot at that non-placebo oncology trial with the newest, sweetest MOA with great phase II data which will of course cost even more because of that positive phase II data? On the other hand, perhaps it’s a way rich people can actually contribute something to society for a change. (And people say I’m cynical………)

      With that said, if rich people (or sick people) want equity in a company; buy their stock. And if this practice takes off, perhaps there is another career path for people like me who was thrown out of the industry and is underemployed. I’ll evaluate those trials for the rich people because most rich people are not very scientifically sophisticated as to be able to do it themselves.

  9. Insilicoconsulting says:

    Wouldn’t it help startups that park many NME’s just because they run out of funds? Such companies can be mandated to have stricter oversight and not make make any treatment claims or sell it as usual.

  10. mike krigg says:

    “Money flows towards the writer”. If your publisher starts asking you for money to do editing and production, etc., you are probably being scammed”

    Well, this looks quite a lot like a scientific journals… 😀 😀

    1. Narad says:

      There’s nothing inherently wrong with page charges; I spent over a decade editing (and sometimes formatting) a family of society journals, and it was strictly fee-for-service, run by a university press. This was not a lucrative gig, and the press was motivated to keep costs down precisely because the society was.

  11. Anon says:

    Main problem I have is that there is no fundamental difference between paying to be included in a “trial”, and paying for use of an unapproved and unproven drug. No difference whatsoever.

  12. MoMo says:

    This industry has gone from providing medicines to alleviate human suffering to one that schemes to make the Executives rich by whatever means possible.

    Anyone out there with a spine to point these facts out in the Boardroom?

  13. Jay Lenner says:

    Neither Medistem Panama (lab) nor Stem Cell Institute (treatments) profited from the autism trial. The $7,200 covered services that were provided by companies outside of the lab and clinic. All lab and clinic services (cord tissue processing, MSC culture, cryogenic preservation, syringe prep, 16 IV infusions, doctor visits) were provided free of charge. While not common in well-funded clinical trials, charging subjects for outside services in smaller, less well-funded trials is not without precedent. For example, Duke and Northwestern have both charged clinical trial subjects in the past. Furthermore, we published another clinical trial for MS in 2018 (https://www.clinicaltrials.gov/ct2/show/NCT02034188). Patients in this trial were charged nothing. We are currently completing a rheumatoid arthritis trial. (https://www.clinicaltrials.gov/ct2/show/NCT01985464) These patients were not charged. – Jay Lenner, VP International Operations, Stem Cell Institute in Panama

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