Chapter 11: Regulatory Procedures: A Critical View

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Chapter 11: Regulatory Procedures: A Critical View

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Dr. Alexanian offers his views on the "regulatory climate" at MD Anderson, another source of difficulties for the institution. He explains the reasons why MD Anderson has created an increasingly cumbersome set of regulations for clinical research. He notes that early regulatory mechanisms facilitated research, but the current system exists for future government review processes. As an example of how current review processes may hinder research, Dr. Alexanian offers the example of Dr. Bart Barlogie's use of thalidomide (most likely without regulatory approval, he notes) to successfully treat patients dying of myeloma. He contrasts two attitudes toward clinical research: "Do no harm" versus "Try only after exhaustive review and delay." Dr. Alexanian also explains that because of complex internal regulatory procedures, MD Anderson is often the last institution to enter patients into multi-center clinical trials.

Identifier

Alexanian_R_02_20140605_S11

Publication Date

6-5-2014

Publisher

The University of Texas MD Anderson Cancer Center

City

Houston, Texas

Topics Covered

The Researcher; The Clinician; Critical Perspectives; MD Anderson History; Institutional Processes; Obstacles, Challenges; Beyond the Institution; MD Anderson and Government; Critical Perspectives on MD Anderson; Professional Practice; The Professional at Work; Understanding the Institution; The Institution and Finances; Research, Care, and Education

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.

Disciplines

History of Science, Technology, and Medicine | Oncology | Oral History

Transcript

Raymond Alexanian, MD

And one of the second peeve—well, not peeve—second issue that you may wish to bring up with others is that as the years have developed, the regulatory climate has become more oppressive so that it has become much more difficult to develop new programs or new treatments or new techniques, and there is a sense that the regulatory machinery is maintained more to follow the process of review rather than attempting to expedite the research. It used to be the original period, the regulatory review was, say, well, how can we improve that research, how can we add more resources, and how can we add more departments to your combined therapy project? That was the internal review.

Now the review is more focused on are we following the rules so we don’t make any mistakes, so that we don’t approve drugs that shouldn’t be approved, or we’re focusing on if we make a mistake and we’re audited by the FDA, are we going to be disciplined. There’s more of a self-protective emphasis rather than an original emphasis.

Of course, I’m speaking as an old-timer here, so that I recognize that we need the regulatory review because there are throughout the country a small percentage, perhaps less than 5 percent, of scientists who abuse the rules, who do improper things, avoid getting consent, and cut corners and this. It’s like police work, when we have police mainly to protect 95 percent of the people from the 5 percent who speed or rob or steal or do other mischievous things. That’s why we have police. So now we have a regulatory group to protect us from the 5 percent, but then we, in a way, impede the other 95 percent. You have not heard that before?

Tacey Ann Rosolowski, PhD

Oh, I have heard that before. I mean, there are a number of individuals who’ve talked about the regulation processes and some—I mean, I interviewed Ralph Freedman [Oral History Interview], who obviously was very involved in institutional review boards and very concerned about these ethical issues. And there have been a number of people who’ve spoken about, you know, the poisonous things that can happen when people do cut corners and what can happen to the individual who’s found out.

Raymond Alexanian, MD

Do they mention poisonous things happening here?

Tacey Ann Rosolowski, PhD

Yes, they have mentioned some things. I mean, never by name, but issues that have arisen.

Raymond Alexanian, MD

Well, there’s always a small—there’s always a thief among you when there’s so many people. And the question is—you might look into the history of—like, for instance, you’ve heard of the drug Thalidomide.

Tacey Ann Rosolowski, PhD

Oh, yes.

Raymond Alexanian MD

Thalidomide used to cause birth defects. But then when Dr. Barlogie was here with me, and then had since moved to Arkansas, he was faced with a patient who was dying from multiple myeloma, and he looked for an opportunity to treat this patient. And I have enormous respect for him because he is one of the more adventurous scientists who has led us forward in this area. So he had heard from another scientist in Boston that this old drug, Thalidomide, would do certain things in the test tube that might help patients with myeloma because of its particular features.

So it happened that Thalidomide had already been commercially approved to treat some rare skin problems that patients with HIV had, so he could then give it to patients with myeloma, which he did. And I won’t go into whether he had regulatory approval or not. I suspect he didn’t, as I would not have. And he found that it was successful and it was effective. Then that class of drugs became one of the major classes of drugs that were used as effective treatment for myeloma. And although one could have followed a regulatory pathway which might have taken several years to develop in terms of approvals and grants and money and drug and so on and so on, here this was given empirically and found to be effective. So I’m not saying this is what you trade off for in terms of the regulatory things.

Tacey Ann Rosolowski, PhD

Well, there’s no doubt that very complicated and increasingly complicated ethical dilemmas and research dilemmas arise as you’re investigating novel treatments.

Raymond Alexanian, MD

Well, you know, the ethical dilemma, there was a man called Hippocrates who said, “Do no harm.” Let’s say, as an example, you have something that might be useful but has no harm, no side effects that you know of, [unclear] others, and has not been tested in such a process. The ethical dicta was do no harm, not don’t try anything because it might do some unknown harm we hadn’t seen.

So I have tremendous respect for Dr. Freedman, but the “do no harm” thesis when applied across the board means “do not try” or “try only after we have had exhaustive reviews and approvals and delays.” It probably shouldn’t surprise you that when there are clinical trials that are multi-center trials, that in these multi-center approvals that we are usually the last institution to get our approvals through the mill, that many times a trial has been completed by the time we even enter it.

Tacey Ann Rosolowski, PhD

Why is that?

Raymond Alexanian, MD

I think it’s because our regulatory—unless it’s changed in the last couple of years, our regulatory apparatus is so oppressive that, first of all, many of our scientists know that and don’t even bother joining, saying, “Well, don’t wait for us. We have all this and that to do.” Or, “Okay, we’ve started,” and by the time the trials are moving on, the trial needs fifty patients in the trial and they have already enrolled forty-five, says, “Okay, we’ll enroll one or two at the end.” So it’s very oppressive, so it’s not worth—and it might be useful for somebody to get a poll on how many multi-center trials we are participating in—

Tacey Ann Rosolowski, PhD

Interesting.

Raymond Alexanian, MD

—and how late they—from the time it was approved and from the time to when we were allowed to enter, that time frame is the longest; has been.

Tacey Ann Rosolowski, PhD

Interesting, yeah. I wasn’t aware of that. You’re the first person who’s mentioned that lag.

Raymond Alexanian, MD

In contrast, when the trial is initiated here and, therefore, we have the, let’s say, resources of drug support or grant support and begun here and we are asking others to join us, at those trials we’re the first. So I’m talking about—so there’s some variability. Certain trials, if they’re initiated here, we’re the first. If they’re initiated elsewhere, we’re often the last. So there’s a mixed—

Tacey Ann Rosolowski, PhD

Right. Interesting. Very interesting.

Chapter 11: Regulatory Procedures: A Critical View

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