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Dr. Sidney Wolfe

Doctor Wants FDA to Warn About Testosterone Side Effects

On this episode of Drugwatch Radio, I welcome a fellow consumer advocate to the show, Sidney Wolfe, M.D., founder of Public Citizen’s Health Research Group. Wolfe founded the group in 1971 and since then, the group has been holding the Food and Drug Administration (FDA) and pharmaceutical companies accountable. Their petitions have been successful in getting many harmful drugs taken off the market.

On this show, Dr. Wolfe and I discuss testosterone replacement therapy products like AndroGel, the No. 1 testosterone drug in the country. Testosterone drugs — used to treat low testosterone or Low T in men — are in the spotlight because of studies that show they pose a risk for heart attacks and strokes.

The problem is the manufacturers of these drugs have not warned the public.

Public Citizen and Wolfe stress that these drugs need stronger warnings because of significant heart attack risks. Another concern is that men who don’t actually have a clinical diagnosis of low testosterone are using these drugs.

On Feb 25, 2014, Public Citizen filed a petition to the FDA demanding the agency immediately require a black-box warning –the FDA’s strongest warning – for cardiovascular risks on all testosterone therapy drugs.

Testosterone Therapy Drugs and Their Troubling Side Effects

Wolfe recently published an article in the British Medical Journal (BMJ) detailing the side effects of testosterone therapy and the troubling trend of overprescription in the U.S.

According to Wolfe, the mounting studies that point to increased risk of heart attacks – including one that involved 55,000 men – should be enough evidence for the FDA to require a warning.

Some of the facts are startling.

The latest NIH-funded study published in PLoS One found that for men aged 65 and older, about 1 in 167 on testosterone could expect to have a heart attack. For those younger than 65 with pre-existing heart conditions, that risk is 1 in 100. Each year, millions of prescriptions are written for these drugs, and that number is quickly increasing.

The FDA responded by saying it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”

Wolfe writes, “In the face of such accumulating evidence to the contrary, this FDA statement is reckless, from a public health perspective.”

He also points out that there are now about 27 studies on testosterone therapy. Thirteen of these, which were funded by drug companies, showed no risk at all. The other 14 studies revealed a risk of heart problems.

The fact that the drug industry didn’t pick up on these risks is not surprising to Wolfe. After all, a large part of the FDA’s budget comes from drug companies.

Wolfe says that it is “the dangerously close connection between the FDA and the [drug] industry” that has slowed down the process of adding warnings to testosterone replacement therapy drugs.

Of course, this is not the first time Abbott Laboratories, parent company of AngroGel maker AbbVie, has seemed to downplay the risks of its products.

Maker of AndroGel, Abbvie, Has Troubling Roots

Wolfe found it ironic that the company that spurred him to leave the NIH and create the Health Research Group is back in the spotlight over four decades later with another questionable product that may end up causing a number of health issues.

While working at the National Institutes of Health (NIH), Wolfe became aware that half of the IV fluids in the country made by Abbott Laboratories were contaminated.

Instead of recalling the contaminated fluids, Abbott convinced the government that they should only be pulled if people got sick, because there would be an IV fluid shortage. This reasoning didn’t sit right with Wolfe.

“I did a little digging and found out there were plenty of other companies making IV fluids, with plenty of stockpiles. The idea that there would be a shortage was ridiculous,” he said.

So Wolfe and Ralph Nader, whom he had known previously, fired off a letter to the FDA demanding it recall the fluids immediately. Initially, the FDA reacted negatively, but two days later it recalled all the IV fluids. These IV fluids caused what is now viewed by the Centers for Disease Control and Prevention (CDC) as the biggest hospital outbreak of infection caused by a product.

Up to 8,000 people suffered blood infections, and hundreds lost their lives.

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If you suffered side effects from a testosterone replacement drug, call our Patient Advocates at (866) 245-8650.


Transcript

Michelle Llamas: On this episode, Dr. Sidney Wolfe of the nonprofit advocacy group Public Citizen joins me. He founded the Health Research Group, one of many arms of Public Citizen, in 1971. He is the former director and now continues to be its senior adviser. Prior to founding the Health Research Group, Dr. Wolfe worked as a researcher and medical doctor for the National Institutes of Health (NIH).

This episode’s topic is testosterone replacement therapy. It is used to treat a condition known as Low T, a condition when men may not have enough testosterone. Many experts see an alarming trend in the use of these drugs, and a growing number of studies point to an increased risk of heart problems, especially heart attacks. Public Citizen and Dr. Wolfe are fighting to get the FDA to place a warning on these drugs.

Dr. Wolfe and I also discuss the dangerous closeness of the FDA to the pharmaceutical industry: Whose interests is the FDA serving?


Michelle: I am talking with Dr. Sidney Wolfe of Public Citizen, and now he’s the founder and senior adviser of Public Citizen’s Health Research Group. Thank you for joining us today, Dr. Wolfe.

Dr. Wolfe: Nice to be with you.

Michelle: Can you tell us what led you to found the Health Research Group?

Dr. Wolfe: Ironically, there’s a strong connection between why I left the National Institutes of Health, where I was taking care of patients and doing research 42 years ago, and the issue of testosterone. The common dominator is Abbott Laboratories, that spun off the company AbbVie, that makes AndroGel — the number one … testosterone-contained product. Just go back, essentially, 43 years ago, I was at NIH in the Public Health Service, taking care of patients and doing research of various kinds, and I got a call from someone who I had done my residency with, and he said, “Do you realize that half of the intravenous fluids in the United States are contaminated?” I said, “Yes, but I assumed they would be recalled because you wouldn’t want to let something like that go.” And he said, “That’s why I’m calling you.”

Instead of recalling these intravenous fluids made by Abbot Laboratories … the company … had convinced the government that there would be such a public health crisis if they recalled what amounted to half the IV fluids, that they had to leave (them) in the market. So they were going to say, “Take care of your patients with these, and if the patients get sick, then discontinue the IV.” And I said, “That’s incredulous; it sort of defies all the concepts of prevention.”

And I did a little digging and found out that there were plenty of other companies making IV fluids with plenty of stock piles; the idea that there would be a shortage was ridiculous. … Ralph Nader, who I had known before, and I wrote a strong letter to the FDA, demanding that they recall all these products right away. This was in March of 1971, and it got a fair amount of attention because it was someone saying other than what the government had said, namely that you couldn’t recall them. …

Although, initially, the day of our letter, they reacted negatively, two days later, they recalled all these Abbott intravenous fluids, so in a way Abbott Laboratories was then responsible for probably the number one reason why I left NIH to start this group and do these kinds of things — trying to get the FDA to do things it should have done but wasn’t doing. That particular episode has now been viewed by the Centers for Disease Control as the biggest outbreak of hospital infection caused by a product ever in history. It’s even much larger than these compounded drugs that are causing problems with people. The estimate was between 2,000 and 8,000 cases of blood infection and between 200 and 800 deaths just from that. It was preventable; they should have avoided most of the deaths.

Fast-forward now. AbbVie, the company making AndroGel, is … the subject of what we are talking about today.

Michelle: Yeah, so that’s kind of interesting, I don’t want to say it’s come full circle almost, in a way, but what started you into this — you’re back fighting them again, I guess.

Dr. Wolfe: The principle that was established, at least for me and the information, the education I got from that episode about 30-40 years ago, (was) that if you do your research carefully and point out that the government has the information but it isn’t doing something, you can get somewhere. Over the years, we have succeeded in getting slightly more than two dozen drugs taken off the market. Some it took longer than others, such as Darvon and Meridia and so forth and so on, but that’s the principle. If there is a drug that doesn’t have any unique benefit — and one can hardly say that an infected IV fluid has a unique benefit — and it has unique risks, which this did, (it needs) to come off the market.

In other cases, which is the circumstance with testosterone, we don’t think it should come off the market. We think that a large proportion, the majority of prescriptions, are not necessary, and they’re really causing an outbreak of, essentially, steroid drug abuse. We are familiar with the athletes who take steroids — one of the main of which is testosterone — and they get in trouble, but a lot of other people are getting in trouble, with heart attacks and other kinds of things, as a result of using testosterone. In many cases, they haven’t even been tested to see what their testosterone levels (are). In other cases, they have vague symptoms that may not have anything to do with testosterone, and yet they’re taking these drugs

So, it’s the same framework 43 years later: There’s a problem. It’s been clearly identified, and the FDA is not doing what it should. In fact, the FDA, the latest position they took was they have not been convinced there’s an increased risk of heart attacks and other cardiovascular disease with testosterone. They are completely wrong, and they’re going to have to do something. And the question is why don’t they do it sooner?

There’s a total of really 7½ million prescriptions a year, and the petition we filed, we only focused on the AndroGel and the patches and the oral drugs — that’s about 5 million. There’s another 2½ million prescriptions for the injectable form, so it’s a widely used drug. As I said, a majority of the people should not be getting it, so they’re not getting any benefit. And they’re getting the risk of a doubling of heart attack in the first three months after starting to use it, to compare with the rate of heart attacks in the same people before that.

Michelle: Now, with those side effects, the main ones that you noticed are the cardiac risks – like you said, heart attacks, strokes, things of that nature. But you still think there is still enough benefit to keep these things there and not go for an out-and-out ban?

Dr. Wolfe: There are a small number of people who have very low testosterone levels and who have some serious symptoms — weakness and so forth. It’s a small fraction of those that are taking it, and for that group of people, it’s effective. For most of the people who are using it, there really isn’t any good evidence of effectiveness. And if those people are aware of the risk, they should be able to say, “OK, I do or do not want to risk a doubling of heart attack, and if I do, I understand the risk and I think the benefits may outweigh the risk.” But that is a very small fraction of the use.

One of the things that I wrote about in this article published in the British Medical Journal is that the new use of testosterone in the United States is 17 times higher — adjusted for the … population in the United States — than it is in the UK. And direct-to-consumer advertising is certainly a reason. … Probably in the UK, there is also some overuse, but it is obviously not anywhere near as much as in the United States. So, yeah, there may be some room – there probably is some legitimate use for it — but the number of prescriptions would be more like three-quarters of a million … as opposed to 7½ million. I would guess it would go down by 80 or 90 percent. And this is what eventually is going to happen. The question is, is it going to happen soon enough for people who are going to be injured in the interim?

We are talking about probably over half a million prescriptions a month, and so that’s a lot of people. The study that was published a few weeks ago, funded by the NIH, showed that the rate of heart attacks after starting testosterone was high enough so that 1 out of 100 men using testosterone per year — extra 1 out of 100 per year — had a heart attack. That’s not some rare, rare kind of risk.

Michelle: No, no. It isn’t.

Dr. Wolfe: Unfortunately too common, and people don’t know about (it). … The FDA not only has failed to put any warning – there’s no warning anywhere on these drugs for heart attack or cardiovascular risk … the FDA is asleep at the wheel on the advertising. If you go to a website called AndroGel.com — the website for the No. 1-selling product — you will see a quiz there. Most of the questions on the quiz are very nonspecific. It could be someone who is depressed, having difficulty falling asleep, they’re having difficulty with work, and so forth and so on.

Michelle: Yeah, anybody could basically have a problem and need AndroGel.

Dr. Wolfe: They could. They have two symptoms that are at least compatible with low testosterone — namely libido problems and problems with an erection — but even those problems, particularly the libido problems, can have a psychological origin. So the fact that a quarter of men in the United States using these products have never even had a testosterone test, is a glimpse into the picture of how big the number of people that really are taking it without any evidence or legitimate use for the drug.


Michelle: You mentioned the buzzword there: direct-to-consumer advertising. I think a lot of people don’t really understand the concept of that, and the fact that the United States and New Zealand are the only countries in which this practice is actually legal. And you mentioned now the study with comparing the U.S. numbers of prescriptions to the UK — now the UK does not have direct-to-consumer advertising.

Dr. Wolfe: That’s correct, as you just said, nowhere in the world other than the United States and New Zealand — which has been sort of wavering as to whether they think it’s a good idea — have direct-to-consumer advertising, and it works. The reason the companies spend billions of dollars on direct-to-consumer advertising is that it works. It convinces patients to go in and say, “You know, you’ve never mentioned this, but I read or saw on the tube or somewhere else, in a newspaper ad or whatever, I saw that this is great, and why don’t we try that?” Patients, misinformed — which the FDA is responsible for, because they allow this advertising to occur — may go to a doctor who’s sort of on the margin, and the doctor may be misinformed because the doctor may see these same kinds of ads.

So, it really is a unique, health-endangering practice to have direct-to-consumer advertising. It’s a fairly recent thing. It started big time in August of 1997, when the FDA greatly loosened the restrictions for what you had to do when you put an ad on television or anything like that. Since then, it’s just taken off big time, and there’s no doubt that products sell more because of direct-to-consumer advertising. And the fact that the FDA could, but doesn’t, regulate the content of these ads as well as they should — testosterone is a good example — just encourages the companies not only to overstate the benefits, expand the idea of who should use it, but understate the risk. What we are arguing is that the combination of not regulating advertising and making people think that the drug is better and safer than it is, and not putting warning labels on, leads people to say, “Well, this is pretty good, and it doesn’t seem to have any risks, like no risk of heart attacks.”

We think that the FDA is going to be forced quickly to change the label and put this on, not only change the labels which doctors read, but also have letters sent to doctors, warning them about this. … AndroGel already has – and all these products already have — a patient Medication Guide, which is regulated by the FDA. The main warning on the patient Medication Guide is if you use this gel, don’t let children or your partner or wife or whatever be exposed to it, so it’s a warning for unintentional use. There’s really, in terms of heart damage, no warning for intentional use — the intentional use is the person who is using the gel or swallowing the pills or putting the patch on or injecting the drug.

Michelle: So they make it sound like the only danger there is if someone accidentally touches you, which anyway is kind of a horrific thing. I don’t know if you would want to use something where if somebody touched it, they’d have an issue with it.

Dr. Wolfe: We’re talking about several million prescriptions per year – just the AndroGel alone.

Michelle: We talked about, too … the whole thing about the direct-to-consumer advertising and the actual condition now that’s being, sort of, in my opinion, almost made up to blanket-cover a lot of people. Like you were saying, if they took that quiz, that could basically apply to just about anybody that read it. … The buzzword for that term is now Low T, and now that’s on the radio, it’s on the TV, it’s everywhere. They start off with, “Are you tired? It could be Low T.” We talked about the actual condition — which I think the medical term is hypogonadism.

Dr. Wolfe: It means you are not producing enough testosterone. In addition to having a low testosterone level, which would require you to have a measurement – which a quarter of the men haven’t even had — you also have to have some specific symptoms that relate to low testosterone. Simply having some tiredness or whatever else and a slightly low testosterone isn’t enough. Normally, and without any kind of implication or health consequences, as men grow older their testosterone levels go down. There is nothing wrong with that; it happens. … To treat someone who has a lower-than-they-used-to-have testosterone level, because of that, is just really doing an injustice to them. They’re getting the risks of these drugs — increased heart attack — with no benefits at all.

Michelle: And I think we mentioned now the gels are what are really popular right now, but I do notice that the FDA is possibly about to approve a new long-acting injectable testosterone product.

Dr. Wolfe: Our petition filed was for two things. 1. To get the FDA to immediately put a black-box warning to warn doctors and to warn patients. 2. To cancel the deadline, which is February 28th, to make a decision on whether to approve a new long-lasting injectable form. When this was discussed at an FDA advisory committee meeting in April of 2013, there was no mention of what was already known about these cardiovascular risks. They focused on some problem worrisome enough, that when you injected this, it was injected in oil and some people they got pulmonary emboli, little droplets of oil. Fortunately no one died at all. They discussed that; that was the main topic of discussion in terms of safety. There was no discussion of previous evidence of increased cardiovascular problems, including heart attacks, from studies that had already been published at that time. So the FDA really will be further irresponsible — beyond not putting a black-box warning on — if they decide to approve the new long-lasting injectable form of testosterone, called Aveed.

The study that has prompted this most recent wave of concern was a study of 55,000 men who were using testosterone — that study published in PLoS Medicine a month ago.

Michelle: That’s a huge sampling.

Dr. Wolfe: And you need a database that large to start answering questions: Are younger people at risk? And the answer is yes, if they have a history of heart disease. That was the first time they had looked at a large number of younger people. Is it just heart attack and other things? And they looked just at heart attack. They looked at the first three months of use in people after they hadn’t used it for at least a year, and in three months, they had a doubling of the heart attack risks.

Michelle: That’s pretty big.

Dr. Wolfe: It is. We would like to remind people we have a website — worstpills.org — which has information about a number of drugs we say you should not use, and on the website is the full text of this petition that we filed on the 25th of February, 2014, to put a black-box warning. It explains all of the reasons for the petition and why there’s a downside to this whole thing.

Michelle: I would also encourage listeners to go there because not only does it have the testosterone information, it’s got a lot of other questionable drugs that the FDA is probably not talking about — the manufacturers are definitely not talking about. Definitely a good place to go if you want to check up on any of the pharmaceuticals you or a loved one might be taking.

Dr. Wolfe: It’s even more than questionable. We categorize drugs … there are several hundred Do Not Use drugs, where there is no evidence of any unique benefit. There’s other drugs that are just as effective and don’t have the unique risks that cause us to categorize these drugs Do Not Use. And then there are other drugs, such as testosterone, where we think there should be a black-box warning. We are basically de facto saying, don’t use unless you not only have a low testosterone level, but one of these relatively rare — compared to the use of these drugs right now — conditions that is a consequence of low testosterone.


Michelle: We talked about all the tests and the studies that are kind of just coming out now. At the time that the FDA approved all these products, do you think they basically had somewhat knowledge of this and approved them anyway? Or they really just didn’t have enough data but they went ahead and just said, “OK, go ahead”? Why do you think they went ahead and approved them at the time, and don’t really think there is a problem now?

Dr. Wolfe: The evidence wasn’t clear until almost four years ago, because the first study that was published was a randomized, placebo-controlled trial in older men who had some weakness. They had low testosterone levels, and weakness, at least, can be a consequence of low testosterone. They randomized these people; half of them got a placebo, and half got testosterone. They couldn’t even finish the study because it was stopped because of an increased cardiovascular risk in the people who had been given the testosterone.

After that study, there are now 27 studies — mostly small studies — that someone put together in what we call a meta analysis. That was published almost a year ago, and that study showed that there was about a 50 percent increase in cardiovascular risk. But one of the most interesting things about that study was there were 27 studies — 13 of them were funded by the drug industry, and if you looked just at those 13 studies, there was no risk at all. If, instead, you looked at the 14 studies that weren’t funded by the drug industry, there was over a doubling of risks. So clearly, not surprisingly, as the author said, maybe the drug industry doesn’t see some risks that have actually occurred.

So the fact that the FDA hadn’t paid attention to that study, because they claimed, when they made a statement a couple of weeks ago, that they haven’t concluded that there was a risk — and they claimed that they really got back to looking at this only in November of 2013, which is after that study with the industry-funding studies was published — that’s really irresponsible on their part. We have stated, and I will restate it now, that for the FDA to conclude in the face of all this evidence that they haven’t reached the conclusion that there is an increased risk is really a reckless conclusion. The FDA is part of the public health service. It is doing the public no health service to make conclusions like that, and de facto encourages more of this massive use — we would argue misuse for most people — of testosterone products.

Michelle: … Previously I spoke with your colleague Dr. Michael Carome. We talked a little bit about the FDA approval process and user fees and the fact that the drug companies are so involved in a lot of the processes that the FDA actually does. Do you think that their involvement with the FDA – the kind of crossing of their data and everything — has something to do with sometimes how lax the FDA is with certain drugs?

Dr. Wolfe: It’s now 21 years — almost 22 years — since the Prescription Drug User Fee Act was passed. It passed in 1992 and basically says (that) most of the money the FDA gets for reviewing drugs is not going to come, as it always had in the past, from the U.S. Treasury, but it comes directly in cash payments from the drug industry. There’s no question — we actually surveyed a lot of physicians in the FDA after that law had been in effect for a few years — that the attitude at the FDA is much more conciliatory towards the industry than it was before. There’s certain deadlines that are set that the FDA have to make, such as the current deadline for deciding whether to approve this injectable testosterone product.

There is no doubt that since 1992, the relationship between the FDA and the industry has changed. Privately … people in the FDA say that because they are paying our salaries, the FDA looks upon the industry as their clients. So this is another example, since … AndroGel was approved after the time that this went into effect. Yes, there is no doubt in my mind that a lot of the decisions to approve drugs that are known to be too dangerous — in the case of AndroGel, it was not that clear — but there are other drugs, such as the weight reduction drug, Meridia (sibutramine), where the FDA’s doctor who was in charge of the review said, “Don’t approve it. It’s too dangerous.” The FDA advisory committee said, “Don’t approve it. It’s too dangerous.” They approved it.

Only after it had been on the market for about 13 years were there enough people killed in a randomized trial — that Europe had ordered, not the FDA — to take it off the market. We had asked the FDA twice, in a petition, to ban sibutramine. No doubt, user fees and the dangerously close connection between the FDA and the industry is the cause of a number of things, and I would argue is the cause why the FDA has not yet done anything in terms of letting people know there is an increased risk of heart attack and other cardiovascular disease with all these testosterone products

Michelle: You’re not even saying, “Hey, let’s ban it.” You’re saying, “Let’s just give people the information to make a good decision, on their own.” (I’m) thankful that Public Citizen and other watchdog groups are around. It seems like without a third party involved, the FDA sometimes is sort of content to sort of wait until something really bad happens, and then they go and say, “Hey, all right. We need to do something about this.”

Dr. Wolfe: I think that’s exactly right. I mean you would think that the government is supposed to be regulating the industry, but because of the financing by the industry of the FDA and other things, they have gotten dangerously close. I think it’s necessary for a third party – we’ve been doing this now for over 42 years — to get in there and push them apart and take action, really against the FDA, to the extent that it lets dangerous drugs on the market, or it doesn’t adequately warn once they find out the drugs that are on the market are dangerous.

Michelle: And in some cases, I think, with a lot of diabetes drugs, for instance, we are having all those classes that are coming out that are having pancreatitis issues and pancreatic cancer even tied to them — I think Victoza is one that Public Citizen has also been talking about.

Dr. Wolfe: We filed a petition more than a year ago to take Victoza off the market.

Michelle: That one was serious.

Dr. Wolfe: It causes pancreatitis. It may cause pancreatic cancer, but certainly causes pancreatitis, as do all the other drugs in this new family of so-called GLP or incretin drugs. The FDA, again, has just issued a statement — published in the New England Journal of Medicine yesterday — in cahoots with the industry, I would suspect, and the European Medicines authorities, saying, “Don’t worry” …

Michelle: That surprised me that the EMA got involved. Sometimes they are actually a little more strong on these things than the FDA is.

Dr. Wolfe: The conclusion is wrong. They should not be giving out assurances of safety. They are false assurances. These drugs are not safe. They have no unique benefit not shared by dozens of other older drugs, that we know much more about in terms of the safety, and they have unique risks. There is no other class of diabetes drugs that causes pancreatitis and may – again, may — cause pancreatic cancer.

Michelle: Pancreatitis itself is already pretty serious

Dr. Wolfe: Yes, acute pancreatitis carries a significant mortality risk.

Michelle: … This is the first time, I think, that they flat-out, like you mentioned, decided to give people this sort of false assurance that it was safe, even though at the end, they’ll say, “Oh, but actually we’re still studying it.”

Dr. Wolfe: They’re studying it, but in fact the labeling of every one of these drugs talks about pancreatitis. So on one hand, they’re giving false general assurances that there’s no problem, but they require all the companies to put in that there have been cases of pancreatitis. In many cases, there is no other explanation for the cases; these are people who are not alcoholics; they’re not people who had gallbladder disease and other things that can cause pancreatitis.

Michelle: Sort of disheartening that an agency that you think is going to be looking out for your best interest all the time, actually is a little too close to the drug industry. What do you think is going to happen with this testosterone thing? Hopefully they are going to listen to the petition and at least put a warning on it. Where do you feel like this is going to go in the future?

Dr. Wolfe: I think it is inevitable that there will be a black-box warning, so the question is not that. It’s how soon will it happen? With over a half of million prescriptions a month, every day they delay is causing, literally, more heart damage to people who are using it. So it is an urgent situation, and they are obviously not acting urgently. It is now a month, today, since the paper was published. Again, it’s not the first paper, but it’s certainly the largest one, in terms of 55,000 people using testosterone. And they haven’t done anything, other than to say, as they did on January 31st, “We have not concluded (there are) risks.” …

The people who don’t have industry ties (who) have looked at these data pretty much said, “Yes, there’s increased risk of cardiovascular disease” — in the most recent study, heart attacks themselves, new heart attacks in people who have not previously had heart attacks anywhere near as commonly before they started taking the drug. So it is not really a close call. It is just a matter of when they do things, and that’s often the case when bringing things to the FDA’s attention. The evidence is crystal clear. The main reason they don’t act is they’re getting huge amount of pressure from the companies that fund them, to delay action, because even when if they act a year from now, they will be allowing companies to sell more than a billion dollars’ worth of testosterone products.

Michelle: Exactly. They can get a little bit more money out of it before there’s a warning. Another thing … I’ve actually seen the first few lawsuits actually coming up, from guys that have had issues, that have had heart attacks and strokes. That’s a whole other financial issue there, when the whole mass tort thing starts.

Dr. Wolfe: We don’t get involved in those things at all, but certainly the companies should be aware of that — that sort of subtracts money off of all the money. It’s like printing money, is selling testosterone. In a sense, it really is too closely aligned with what people more commonly know about abuse of testosterone or steroids. Alex Rodriguez and other well-known athletes wound up building up their muscle with this stuff. But here, you’ve got doctors writing prescriptions for people, the majority of whom really cannot benefit from it, and yet they are subject to increased risk of heart attacks. That’s just not right, and the FDA needs to step in as quickly as possible and stop this.

Michelle: Thanks so much, Dr. Wolfe, for coming on and talking about this. It’s one of those things that is sort of coming into the spotlight from various media and everything. Is there anything that you might want listeners to know — a final word about testosterone or maybe worstpills.org, for instance?

Dr. Wolfe: We are independent. We don’t take any kind of funding from anyone that would influence our decisions on the drug. And worstpills.org — we have a print newsletter, which has 160,000 subscribers, and we have a website. … We just are sending out an e-alert to our subscribers — the electronic subscribers. It also has the updated version of our book, “Worst Pills, Best Pills” — the last edition of which was published in 2005. And it has every month’s new issue of worstpills.org. We have up there now the full text of our petition earlier this week to the FDA, to put a black-box warning on testosterone, so people can find out all of the reasons why we are very concerned about the health of people who aere using these drugs.

The overall organizational website is www.citizen.org. Find out what other parts of our group (are doing). Our Health Group is just a small part of the overall organization. We have three full-time doctors, and we spend most of our time looking at the safety of drugs — prescription drugs, over-the-counter drugs — and medical devices, but there are other parts of the organization that people will also be interested in, so it’s just citizen.org.

Michelle: Awesome. Well, thank you so much for joining me today, Dr. Wolfe.

Dr. Wolfe: Good talking to you, Michelle.

Last modified: October 27, 2014

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