Global Book Network - Terence Mix, Author of The Price of Ovulation

Added: 2026-05-07

[00:00:01][music] [music] >> Hello everybody. I'm Paul Raiden. We've all heard those pharmaceutical commercials with a seemingly endless litany of possible side effects.

[00:00:21]Everything from trouble swallowing to suicidal thoughts to death.

[00:00:26]Those side effects seem so terrifying that we wonder out loud, who would ever take that drug? And we find ourselves laughing at the absurdity of such detailed disclaimers, but there's nothing funny about the drug and its side effect that our guest today has done battle with. Terrence Mix has written an eye-opening exposé called The Price of Ovulation, the truth about fertility drugs and birth defects and a solution to the problem. Welcome Terry, glad to have you with us today from Carlsbad, California.

[00:00:55]Glad to be here. You know, on the on the face of it, fertility drugs look like a reasonable solution to couples who want children but have been unable to conceive, but that wasn't the case for a drug called Clomid, right?

[00:01:11]That's correct. Although, I will say that I never took a position that Clomid should be removed from the market. It had a place in the market and actually it was uh since it was taken orally rather than an injection like a lot of the other fertility drugs. Uh >> [clears throat] >> it was something very commonplace that could be done at home. Mhm. And so, uh my position always with the FDA was that there's not a a warning of the risk. There is an increased risk, but that doesn't mean if you take it, you will have a child with birth defects.

[00:01:47]Right.

[00:01:48]>> risk. Okay.

[00:01:50]All I wanted the FDA to do is put a warning in there and warn people of that risk. Yeah.

[00:01:55]>> percentage of risk.

[00:01:57]Makes sense. You got involved as a lawyer representing the Brian Horst family whose son was born with severe birth defects in 1970. Give us a little background about that case and how it fell into your lap.

[00:02:11]Yes, I was a young lawyer then um in my early 30s and I was sharing office space with a woman attorney and she had this case and she felt she was in over her head and I had trial lawyer experience with some significant verdicts at the time and she asked me to get involved.

[00:02:33]I at that point in time I'd never participated in a drug product case. It was a highly specialized field. Still it was.

[00:02:42]And she asked me to get involved and this particular child was born without hands.

[00:02:48]The problem was there really had not been a lot of evidence developed in the medical literature on the risk birth defect risk for fertility drugs in general and Clomid in particular.

[00:03:01]Uh by the way the the generic name which is probably even more important today is clomiphene citrate. Clomiphene citrate is the generic name. Clomid is a brand name.

[00:03:15]And um so I sat down I I looked at the package insert.

[00:03:20]The first thing that struck me was that the uh animal studies showed that it caused birth defects.

[00:03:28]Now mind you uh Clomid was first marketed in the late six actually 1967 the year same year as it coincidentally I became a member of the California State Bar. Uh-huh.

[00:03:42]And the first thing I thought about is there was a drug by the name of thalidomide. A lot of people have heard that. Sure.

[00:03:49]Yeah.

[00:03:50]It turns out chemical is the most teratogenic terato meaning birth defect causing. Okay.

[00:03:57]Teratology being the study of birth defects. Mhm.

[00:04:00]So I'm educating people as I go here.

[00:04:03]Yeah, it's fine. Fine.

[00:04:06]And uh the thalidomide event had occurred in late '60s about the time this drug was about ready to be marketed late '50s early '60s I should say.

[00:04:18]And um it was because of thalidomide that they started doing animal studies.

[00:04:25]Teratology animal studies.

[00:04:28]Rat, mice, ro- rabbits.

[00:04:33]And lo and behold, it caused birth defects in the rat and the rabbit.

[00:04:39]Now, here's what shouldn't have happened is that they even though the these animal studies came out w- about at least two or three years before it was first marketed approved marketed.

[00:04:54]The initial pre-market studies clinical studies they call them. Mhm.

[00:05:00]Uh were not designed to assess a risk of birth defects at all. Huh. And that's one of the things I found out when I started when I got involved I started taking depositions.

[00:05:13]Um the all drug companies have a medical research division.

[00:05:19]And I took the deposition of the physician who oversaw that for the drug company which at the time by the way was Richardson-Merrell.

[00:05:29]It's not called that anymore. It's gone through several revisions. Yeah. But uh back then it was Richardson-Merrell and it was a well-known drug company uh if anybody knows what Vicks Vapor Rub was.

[00:05:44]Sure. That's one of their major That was one of their drugs that really got the company started. Mhm. Uh So, anyway, um what I learned when I took this doctor's deposition is he admitted that the study the pre-market study upon which it was approved for marketing never was designed to assess birth defects, whether there was a risk of birth defects. Mhm.

[00:06:13]Now, um many years later and uh one of the trials I was in the first trial as you mentioned was Brian Horrocks.

[00:06:23]That was a verdict came in a long time April 15, 1974.

[00:06:30]Wow. Tax day, yeah. Yes. And we just experienced that.

[00:06:35]And what I decided to do is I needed to communicate to the FDA that there is no warning and I'm hearing that by the guy that was overseeing the pre-market studies that it was never designed to assess that risk. Mhm.

[00:06:57]And so what happened is there was a uh This is the early early '70s.

[00:07:04]The the FDA started having advisory committees.

[00:07:08]Mhm. Where they get some of the top experts in the country.

[00:07:13]And uh feed them the information to get feedback from them. And so allows the FDA to make certain decisions on whether more studies are needed or ready for approval etc. And as I started feeding some of this information I was including some recent medical research I did. And this is again was after my verdict.

[00:07:37]Mhm. Uh because quite frankly there was not a lot I didn't I did have the animal studies during the trial.

[00:07:45]And we had some other information about increased risk for spontaneous abortions.

[00:07:52]Usually you caused by abnormal chromosomes in the fetus.

[00:07:58]And but I in terms of really good studies that I that was not available at the time.

[00:08:05]And um anyway, I was in that regard I was quite fortunate to get that verdict.

[00:08:12]Yeah.

[00:08:14]It did get me involved.

[00:08:17]And I started doing research, actually going over to the UCLA Biomed Library and as the next chosen that was a difficult, but actually that's a great facility for medical research.

[00:08:32]And I started doing more and more research and I started feeding this to the FDA and the FDA finally said okay, Mr. Mix why don't you come on out to Rockville, Maryland and make your presentation in front of an advisory committee. It was like who me?

[00:08:49]>> [laughter] >> In front of some of the top experts in the country this upstart young lawyer from California is going to tell them what they should be you know learning? Yeah.

[00:09:01]>> [clears throat] >> But I did it. Yeah, talk about imposter syndrome.

[00:09:04]>> [laughter] >> My only supporter was my wife who came along with me and she was in the audience.

[00:09:10]And uh they the conclusion which was a I'd say a partial success is they would not buy my argument that the drug was teratogenic.

[00:09:23]That's again that's that's that word about teratology.

[00:09:27]Um but they realized they had a problem.

[00:09:32]This drug has been approved again it was in '67.

[00:09:37]And that I had this presented this evidence that it was never designed to assess that risk. So, how can you offer it for marketing and not let the people know that oh, well, you've got more work to do?

[00:09:52]Yeah.

[00:09:53]So, um the And this, by the way, this the letter to the drug company telling it you need to do more studies.

[00:10:04]It's in my book.

[00:10:07]And did it ever happen? No. The drug company kept delaying and delaying and delaying and the FDA kind of dropped the ball on it.

[00:10:16]Mhm.

[00:10:17]But they did acknowledge that that that was deficient. Now, a few years later in one of my trials and I had not a lot of these cases. I had about eight or nine of them over this period of about two decades.

[00:10:34]And I was in trial in uh I think it was around 1993.

[00:10:41]And I had a a child who by the way years later I went to his wedding. Oh, no kidding.

[00:10:49]And when this all happened, you know, he was only like three or four years old.

[00:10:55]Um and he, by the way, was also in the they were in this family living in the San Diego area. But I wasn't living in San Diego at the time.

[00:11:05]Defense lawyer, uh a guy who I had respected. He's a very defense lawyer. And on several of these cases it was his firm that I was up against.

[00:11:16]And um he put on the commissioner of the FDA as his expert that the drug company complied with the standard of care.

[00:11:28]But what they didn't tell him is what I knew and I had deposition transcript testimony from the the guy in charge.

[00:11:39]And and I got him I said, "No, look let me ask you this. If if you're you're if there's any concern you had animal studies that showed it could cause birth defects, right?

[00:11:51]So, would they be complying with the standard of care with that information?

[00:11:54]They didn't design the study to assess that the drug caused birth defects, right? has potential cause of birth defects.

[00:12:02]And they didn't assess that risk? Mhm.

[00:12:04]Would that be complying with the standard of care? He said, "Oh, no. No, that would not."

[00:12:09]He thought they had done it. Aha. The case settled the next day.

[00:12:14]At a at an amount it's very significant amount for the 1993 numbers. I can't tell you the amount because I was I had to commit to putting this in but agreeing that it was secret.

[00:12:27]Well, without getting too too deep in the weeds because a lot of this is in in your book that I think would be fascinating to read, but going up against a huge pharmaceutical company like you did with their army of lawyers would seem like a fool's errand. And the book details some of the roadblocks that were thrown your way, and I thought that was fascinating.

[00:12:45]Yeah, that's all part of it. That's what you run into. Uh and the the a lot of juries think well, it's got the FDA seal of approval. It's got its Okay. Mhm. Now, mind you and this is important and most people I think know this that all drugs have side effects.

[00:13:06]And what the FDA's responsibility to determine whether the adverse risks are Uh let me put it differently. That the benefits outweigh the risks. Right, right. Okay. Mhm.

[00:13:21]>> [clears throat] >> And also that they warn about the risk.

[00:13:25]And therein was where most litigation against pharmaceutical companies, that's that's the area of litigation is did the company where there bigger risk that they are warning about. Mhm. And bigger risk can be more than just a different risk.

[00:13:43]It can be that it that occurred more frequently than they're warning about.

[00:13:47]Mhm.

[00:13:49]And that's because everybody that is going to get go to their doctor and get a prescription for a prescription drug.

[00:13:58]Okay. Has a right to know what those risks are. Right. And the the when when it's a prescription drug, you rely upon your physician. And your physician relies upon the package insert.

[00:14:11]Uh the the labeling.

[00:14:14]Uh there's also a book that still exists to this day called the Physicians' Desk Reference.

[00:14:21]Mhm.

[00:14:22]>> Okay.

[00:14:23]Uh they rely upon that.

[00:14:26]But again, they've got to rely upon what they're told by the drug company. Right.

[00:14:31]Right. And the biggest complaint I've had, and I've voiced this before many times, is that they have the fox guarding the henhouse.

[00:14:44]All of these studies are done by the drug company who has spent millions and millions probably in today's terms billions of dollars to research and develop the drug product. Okay.

[00:14:59]But they're the ones that do the study and report the findings to the FDA.

[00:15:03]>> Ah.

[00:15:04]Well, yeah, that is the fox's uh >> Would you say they're a little biased?

[00:15:08]Yeah, right. Well, you know, it's it's awful because you know that that pharmaceutical companies have made great strides, and they've done great things for consumers, but you got to know the risks. Uh and how do you how do people how do consumers inform themselves of risk if nobody including the government or their doctor or the drug company is telling them?

[00:15:32]Yeah, well one of the things I I one of the books I've written um, which is this one here. Can you see it? Yeah.

[00:15:41]American Guinea Pig? Mhm. Talks about the failings of the FDA.

[00:15:46]Um, this was written on about six or seven years ago.

[00:15:54]And I have a The first part of that book has a a number of the let's say the controversial drugs that went into litigation.

[00:16:05]And the the stories of each of them.

[00:16:08]First part of the book is has all of these in there.

[00:16:13]And then I have suggestions of things where they can go to the internet and check up on the the risk. Mhm. Well, that's good. Uh, and and what the sites were at least the the sites that existed there at the time I did the book.

[00:16:29]But uh, that is that is a big issue.

[00:16:33]Well, what do you hope readers get out of this book, The Price of Ovulation?

[00:16:39]The biggest thing the first part as you know um, Paul the the first part of the book uh, is is about what I ran into. Right.

[00:16:52]I I knew the whole purpose of the book was to get the warning out there. To let the people and this is not just something I'm just throwing out there.

[00:17:00]Okay? This is based upon medical research I have done.

[00:17:04]Uh, it's true I'm a lawyer. I'm not a physician. I'm not a I don't have a PhD.

[00:17:08]I just have a JD. Okay?

[00:17:11]But I have been exposed to an enormous amount of medicine during the 59 years I've been prac- I'm 86 years old now. Holy mackerel.

[00:17:22]So I probably make you feel like a kid, right? Well, you're the oldest guy I've talked to today and I've only got you've only got 13 years on me, so But the So the first part is all about the that first period of my experiences in litigating these cases.

[00:17:39]The latter part of the book gets into the a lot more of the science particular chapters 19 and 20.

[00:17:47]And and it's because of the discovery that I made that cholesterol is a critical part of the development of an embryo.

[00:18:00]And a deficiency in cholesterol can lead to birth defects. Mhm.

[00:18:06]Now a lot of people uh that take um statins Mhm.

[00:18:13]reduce the cholesterol. I take one much I've for years, decades I've been taking statins. Mhm.

[00:18:20]And it's it and it's good because it decreases the cholesterol.

[00:18:26]But an embryo, okay, you're an embryo for the first 8 weeks and then you're a fetus.

[00:18:34]The embryonic period is where most of the formation occurs.

[00:18:38]Mhm. Okay, as [clears throat] a fetus it's more the growth and and development.

[00:18:44]So most birth defects are caused in the embryonic period.

[00:18:49]And during the first phase of the embryonic period a a fetus, excuse me, an embryo needs the cholesterol provided by the mother.

[00:19:06]Okay?

[00:19:09]Eventually in the latter part the embryo begins to develop any of its own ability to develop synthesize uh the cholesterol that it needs to form.

[00:19:23]And I've done a lot of research I did back 18 years ago. About 18 years ago is when I wrote this book. Mhm. And I did a lot of research in that area. And self-education because genetics get involved in this whole issue. And it's in the book.

[00:19:40]And so the the reason I wrote that the book in the first person I know cuz I knew I was going to be giving a lot of technical stuff.

[00:19:51]Mhm. To convince people that what I have to say has a lot of backup to it.

[00:19:58]A lot of science to support it. Yeah.

[00:20:00]And that's in the the latter part of the book. But the importance of cholesterol resulted in me learning through animal studies that supplementing cholesterol to an embryo that would otherwise be being deformed either because of its own in inability or that it's getting another product okay?

[00:20:28]That's that's going to depreciate the estrogen excuse me the cholesterol that it needs.

[00:20:35]>> Right. Mhm.

[00:20:35]>> [clears throat] >> All right.

[00:20:37]Yeah.

[00:20:38]And the animal studies showed that you take a drug product and these are rats mice I believe primarily rats and mice.

[00:20:49]You take the a drug that you know is going to reduce cholesterol and cause a birth defect.

[00:20:56]And they ran studies and you see all these different abnormalities came out.

[00:21:01]Take the same drug same type of animal and you supplement and and and the the the the animals getting the teratogenic drug at the same time and you put a supplement for cholesterol, no birth defects. Huh. That opened a huge door to me as I comment in uh chapter 20 that here's a potential that could reduce birth defects and that's not just in people taking fertility drugs.

[00:21:34]Mhm. That large Well, it's the could result this could save thousands and thousands worldwide children who are otherwise born born with a birth defect related to the deficiency of cholesterol. Yeah.

[00:21:50]Well, Okay. And some women not knowing may take a statin drug when they conceive and they can produce birth defect. At one time there was strong warnings about that from the FDA. If you're taking a statin and you're going to get pregnant, stop the statin. Right. Right. Yeah. For that very reason. Sure. They've kind of gotten more lenient about that. I've read the current material on it now and I'm not very happy with it. Mhm. But [clears throat] I would never suggest that anybody that read my book or listening to me today would self-medicate and say, "Okay, I'm going to I'm going to take cholesterol. What I'm going to take my fertility drug. I'm going to take my clomiphene citrate or clomid but I'm going to also take a drug that uh will raise my cholesterol." Yeah.

[00:22:45]Well, That's I'm not recommending that at all. It it's the And more importantly, I'm hoping that epidemiologists out there that do these studies will study this and and determine what would be a safe level for any person.

[00:23:05]That's what I recommend and that's the greatest discovery that I made in doing this book.

[00:23:11]I which by the way I spent three and a half years writing this and I >> [laughter] >> reviewed over a thousand studies most of which are cited in the book. Well, there's great information in the book and there are solutions in there as you just talked about. The book is called The Price of Ovulation, The Truth About Fertility Drugs and Birth Defects and a Solution to the Problem. And not only does it delve into the fertility drug case itself, but gives readers a fascinating behind-the-scenes look at what goes on working on a case like this. Terry, thanks so much for joining us today. I highly recommend the book and thanks for your time.

[00:23:44]Okay, thank you for seeing me and hearing me.

[00:23:47]>> [laughter] >> Absolutely. And thank you folks for spending a few minutes with us on the Global Book Network. I'm Paul Riding.

[00:23:52]We'll see you next time.

[00:23:56]>> [music] [music]