Note: Some of the material in this report may be too graphic for sensitive readers and children.
Everyone knows that medicine has saved countless lives. Civilization might not exist today without it. But in the most-prescribed country in the world, prescription drugs also are a leading cause of death.
According to Harvard University's Center for Ethics, each year properly prescribed drugs in the U.S. cause about 2.74 million serious adverse drug reactions and about 128,000 fatalities: 350 deaths a day.
In 2014, the world's top ten pharmaceutical firms pulled in $429.4 billion in revenue. Their profits ranged from ten to 43 percent.
With all that money at stake, it's easy to see why you don't always get the whole truth about a drug's risks. In recent years, major drug companies have paid over $13 billion to resolve federal, civil and criminal allegations of fraud, many involving popular and widely used drugs.
One drug is a chilling case in point. It's an antipsychotic pill called Risperdal, made by Johnson & Johnson's pharmaceutical subsidiary: Janssen.
Josh Scholl was in seventh grade when he noticed something upsetting.
Josh Scholl: And I'm like, "This isn't normal". So I went to my parents and I'm like, "Hey, there was this lump under my breast. Could you guys check it out?" And they felt it and they were like, "Oh, that's not right". And so we went to the doctor's for it.
Sharyl: You were like, a 10- year-old kid at the time.
Josh Scholl: Uh-huh.
The pediatrician said not to worry, but Josh's mom knew better. She wondered if one factor could be Risperdal, the prescription medicine Josh had been taking for four years for tics from Tourette's syndrome.
Cynthia Scholl: I'm one who likes to research things. So I got on Google right away and started researching boys and medicines, and found a few moms out there who had posted their kids were on Risperdal who also developed lumps. So I called the pediatrician back and said, "I want him off this medicine". And so we stopped it that day.
Sharyl: What was the pediatrician's response when you linked the lump in his breast to the medicine?
Cynthia Scholl: I think they just thought I was a paranoid mom and agreed to switch the medicine just to appease me. But I don't know, mom's intuition, I just, I knew something was wrong.
Mom was right. She didn't know it then, but thousands of boys taking Risperdal were growing female breasts. Some of them even produced milk.
It's a condition called gynecomastia, shown in an image of an unidentified Risperdal patient. It can happen when a male has a spike in a naturally occurring hormone called prolactin. Experts say Risperdal can cause prolactin levels to rise.
Josh Scholl: I remember one of my best friends had a swimming pool, and we would all go to his house and go swimming and none of them had like, larger breasts or any lumps or anything.
Sharyl: Did you ask your friends or you just
Josh Scholl: I asked one of 'em. I asked the best friend if he had like, ever noticed anything about his breasts and he was like, "No, I never noticed". And I'm just like, "Oh, okay. That's, that's weird that it's happening to me then".
Cynthia Scholl: He stopped taking the medicine, but the breast continued to grow. It was over I think a two-year period where they, they said, "Wait six months. It'll be gone in six months". Well, we waited the six months. It continued to grow. Then, he noticed the lump in the other side.
It turns out there's a dark backstory. At the time, Risperdal, an antipsychotic, wasn't approved for use in children at all. But as federal whistleblowers would later allege, Janssen instructed sales reps to market Risperdal as safe and effective for all kinds of childhood disorders, such as Tourette's syndrome, ADD and autism, knowing it posed serious health risks.
Philadelphia attorney Stephen Sheller represents Josh. He tried the first Risperdal case last year: an autistic boy who developed size 46 double-D breasts.
Key evidence was an internal document known as Table 21 from the original Risperdal study in 2002. Sheller says it showed 7.8 percent of Risperdal patients whose prolactin levels shot above normal after 8-12 weeks developed prolactin-related side effects, like gynecomastia.
Janssen insiders seemed concerned in internal documents: "How do you want to handle the one significant value?" asks a reviewer. "This may be notable". "I think we need to discuss this somewhere in the manuscript".
Instead, the head of the Risperdal study eliminated Table 21, according to Sheller.
Stephen Sheller: He specifically made the decision not to tell the public, not to tell the doctors, not to tell even the FDA or anybody about this study that they did in 2001 or 2002 that specifically finds the association, even though the law requires it.
A year after the original Risperdal study was published without Table 21, Josh was prescribed Risperdal and developed the very problem it seemed to warn about.
Cynthia Scholl: We saw our child, who was this outgoing happy kid who had all these friends, becoming more regressed. He was shy. He stopped going out with his friends. Wouldn't take his shirt off at the beach. Wouldn't change in front of anybody.
Josh Scholl: Yeah, it was very difficult because me personally, I ran cross-country starting my eighth grade year and so cross-country starts in the summer. It gets really hot. So all my friends would take their shirts off, and I was self-conscious. I didn't wanna take my shirt off. I'm like, "Oh, it's 90 degrees but, you know, do I wanna take my shirt off 'cause I have these breasts?" And, you know, no one else had to make that decision. And then, if I did take it off, I felt self-conscious. I was looking around town like, "Oh, is that person in that car looking at me? You know, is my friends looking at me?" You know, it was, it was really bad.
Johnson and Johnson had no comment on Josh's case and declined our interview requests. In a statement, the company said it "did not withhold any relevant data". As to why Table 21 was left out of the original Risperdal study, a spokesman implied it wasn't relevant because the researchers concluded, "there was no direct correlation" to breast growth in boys.
Josh believes otherwise. There are no photos of him at his worst: he stopped having his picture taken. Like some with severe gynecomastia, he chose a drastic solution: a double mastectomy.
Cynthia Scholl: We went to the breast surgeon who, after seeing him, said he had the largest breasts in a boy that he'd ever seen in this area and agreed to do the surgery. He had a bilateral mastectomy done. So he was off school for about six weeks.
Sharyl: It must be a fairly traumatic surgery?
Cynthia Scholl: It was very traumatic for him. He had double drain tubes. He had those in for a week. He had home nursing coming twice a day, but he couldn't move. He had to lay flat on his back 'cause whenever he would move, the tubes would move and they'd be painful. They actually did reconstructive surgery. One side was bigger than the other, so they had to remove the nipple, and they removed a lot of the tissue and replaced the nipples.
Sharyl: How old was he when he had the surgery?
Cynthia Scholl: It was two months before his 13th birthday, so he was 12-years old.
Almost no one ever knew why Josh was out of school those six weeks. He's one of 10,700 Risperdal patients now suing drug maker Janssen.
Sheller: The risks are being hidden from the public, because the companies want to be able to sell as much of their product as possible.
Parent company Johnson & Johnson told us, "Risperdal has helped and is still helping millions of patients with debilitating mental illnesses and neurodevelopmental conditions as part of a comprehensive treatment plan".
Cynthia Scholl: I've recently learned about what some of these boys have gone through. I didn't know some of 'em are lactating. I didn't know some have developed third breasts, and Josh was fortunate to not have to go through those steps, I think because we were diligent and caught on to it quickly and got it taken care of, but my heart goes out to the kids that weren't as lucky.
Today, it takes a lot of guts for Josh to talk publicly about what happened to him, and even more to show it. But he's done hiding his scars.
Josh Scholl: About the experience, it was one that I wish I didn't have to go through. And I hope all the other kids that are going through it, you know, I feel bad that they had to go through it too because, yeah, the company, I think they knew that it developed gynecomastia. And, you know, to make us, all of us go through it, you know, it's not just like it's me and a handful of other people. It's thousands of people that are going through it. So to make all of us go through it just and they knew just to make a profit, it's sickening.
In 2013, Johnson & Johnson paid $2.2 billion to settle a host of criminal and civil fraud claims: illegally marketing Risperdal and other drugs; paying kickbacks to doctors and nursing home pharmacies to prescribe Risperdal, knowing it posed stroke and other serious risks to older patients; and claiming Risperdal lessened diabetes risk. It did the opposite. Johnson & Johnson wouldn't say how much money its made from Risperdal or how many are taking it.