On the eve of his 18-month imprisonment after pleading guilty in connection with his use of a non-FDA-approved botulism toxin treatment on patients wanting to look younger, Dr. Jerome Lentini says he did what many docs do: use substances before they get a federal OK.
Lentini, 58, was giving Refinex, a non-FDA-approved brand, as well as Tritox, a brand labeled "not for human use," to at least 800 patients seeking "anti-aging" therapies at his A Younger You clinics in Salem and Tigard.
Federal authorities started looking into Lentini's practice after four people were seriously injured in Florida in November 2004 by another doctor using potent, research-grade Botox. While claiming there's a longstanding practice of doctors using substances before they're FDA-approved, Lentini also maintains the botulin distribution companies misled him. Federal prosecutors counter that doctors like Lentini should know better.
Before Lentini, who surrendered his medical license, begins serving time Thursday, Jan. 25, at the Federal Correctional Institution in Sheridan, he spoke with WW.
WW: How'd you end up in this position?
Jerome Lentini: I didn't find a lot of this information out until later. I was beginning to think I should have known better. And I probably should have known better. All the public got was what the FBI, the FDA and the Justice Department fed them. And they skewed it. They would say [the Botox] was non-FDA-approved, they would say it was for research purposes only, not for human use. But what they didn't include with that is that doctors never knew that. And the company never told us that until later....
I'm not entirely not guilty, because I should have looked into this. My goal was to give the best possible product to the patients at the cheapest price. I wanted to make it available to the public so that everyone could get Botox, because it has a tremendous effect on the women, and men too. Because once they get it, their self-esteem goes up, the wrinkles are gone and they keep coming back. The other point that I want to make is that they implied I was making tons of money. I didn't make any money.
Then why'd you plead guilty?
For a couple of reasons. One, when they first presented me with this evidence [of the company labeling the Botox], I thought, "I should have known better." I kind of turned a blind eye. And, my attorney told me that if I went to trial I would lose. When I asked her why, she said, "They win 98 percent of their cases." [The prosecutors] sent out 800 letters to patients saying I used bogus Botox on them.
So let's say you learned you were using an unregulated substance that worked very well, and you thought you'd never be caught—would you continue to use it?
To be honest with you [makes throatslitting motion], [it's] cutting my throat, but yes. Because that's the way we've always operated. Doctors do their research. And if they know something is better, they'll use it. At least that's how I was. If I knew a product was better, and there was research to back it up, I would use it if it was available.
Is this something doctors should be able to do?
Yes—because the FDA is bogged down in bureaucracy, it would traditionally take a long time to approve a substance. So a lifesaving drug could come out in another country, and they wouldn't have approved it for use here. Doctors have never been too conscious of the FDA. In fact, there are lots of products used in hospitals that are not FDA-approved...Digoxin [a heart medicine], Atropine [that] paramedics use.
Do you have any special plans for your last days of freedom?
I enjoy every day. I wake up in the morning and I think, "I'm not in prison, this is great." I can go down to Powell's Books and read. I'm free. I love being free. In a way, I was working 12-hour shifts in the emergency room, and then I had two clinics. I was working my head off. And this has given me a chance to kind of sit back and enjoy life.
The only FDA-approved botulism toxin in this country is Allergan Botox, giving that company an effective monopoly on the name Botox.
Lentini was dating his nurse, co-defendant Cathryn Garcia, who is now serving a one-year sentence.