In the early part of 1988, I heard on national news about RetinA. Being at the age of 41, I thought how wonderful to now have a drug available to improve skin appearance.

During that time of my life, my husband and I had an opportunity to travel, and we were camping around the entire country for a year, totally enjoying the experience. We stopped briefly in Mexico, and I noticed that Retin-A was being sold in the drug stores. I decided, since it was a prescription drug, not to try it on my own.

In May 1988, I had an appointment at a doctor's office in Jackson Hole, WY, where there was a physician's assistant on duty. While at the appointment, I asked for a prescription of the highly publicized Retin-A drug. He, without hesitation, prescribed the drug, 0.1 percent, and told me to apply it under and over my eyes for a period of 16 weeks, at which time I would notice an improvement in my appearance.

I picked up the drug at a local pharmacy, and the pharmacist asked me if I knew how to apply the cream, and I said, "Yes, I have just been told." The package insert was not included with the tube. I remember that evening being excited about applying this drug and remember saying to my husband, "Here's to eternal youth."

We went about our daily activities of exploring the countryside. I applied the drug evenings until, after the fourth application, I noticed a severe burning around my eyes. I stopped using the drug immediately and started applying a moisturizer to soften and heal the skin. The skin was burned and felt extremely tight. I fully expected the area to clear up normally, as I had experienced many sunburns in the past.

However, I looked in the mirror and made a facial expression, and I couldn't believe my eyes. All the skin under my eyes, distorted in wrinkles, far exaggerated from the normal expression lines. I was totally distraught at the sight of my face and immediately became extremely nervous and very upset.

I made an appointment with a dermatologist and spoke to him about the drug. He cringed when I told him the strength which I had applied around my eyes. I had been concerned that scarring might occur, but he assured me that it would not on such shortterm use.

I became totally traumatized as the time went on and I noticed no change in my appearance. My weight dropped to 89 pounds, and I started having nightmares. I spoke to more and more people in the medical community, and no one had heard of such a severe reaction. I then realized that little was known about the effects of this drugs to the skin in the eye area.

We ended our trip early, and returned home. I became established with a local dermatologist who, more than anyone, helped me through this trauma. He monitored the situation for me, addressed my concerns, and I always hoped he might see improvement or might have read something new on the drug.

I continued my investigation by contacting the drug information center through the University of Rhode Island. They helped me to file an adverse drug report with the FDA, and also they sent me a copy of the original study published in the Journal of the American Medical Association in January 1988. I was totally surprised to

find out that the study had been carried out on only 30 people. However, the reprint listed the names of the researchers, who I immediately wrote to in hopes of some suggestions for my skin condition.

I also contacted the public relations department at Ortho Pharmaceutical to ask for their help and recommendations. At the same time, I requested that the contents from the Retin-A tube be examined. The quality assurance laboratories at Ortho Pharmaceutical reported that all parameters inspected were within required specifications.

Also, I wrote to all physicians listed in magazine articles on the topic. All of my efforts seemed in vain, as I received very little help all that was offered to me was to use a moisturizer. I was also told by physicians that I would be better off to stay out of the sun. This severely affected my lifestyle, as I had always enjoyed outdoor activities of going to the beach, swimming, sailing, hiking, and camping, and had always spent all of my relaxation time out of doors.

So, as well as my appearance being affected, my lifestyle was drastically changed, and I was constantly fearful about the care and future of this skin condition.

I had one of my physicians call the clinical director at Ortho Pharmaceutical, and Dr. Thorne told my physician that the drug had never been tested in the strength and manner in which I had applied it. I talked with plastic surgeons, and one of them took pictures of the condition and put me in touch with Money Magazine, who was doing a story on "The Selling of Retin-A." A representative from the magazine came to Rhode Island to interview me.

I also wrote to Mr. Ken Feather from the FDA, stating my whole story and mentioning the adverse drug report which I had filed. Mr. Feather answered my letter, stating that the drug was only approved for treating acne but that physicians were free to use it as they wanted and that the drug did get a lot of publicity for use on wrinkles.

I had been writing to Dr. Kligman, and finally I heard from him and made an appointment at the Center for Human Appearance in Pennsylvania. Not having noticed any improvement in the skin condition, which happened a year ago, I naturally looked forward to this appointment for possibly some medical help, and, if none was available, at least I wanted to show the doctor who had codeveloped the drug what could happen to someone as a result of the wrong strength of the drug being prescribed and wrong instructions on how to apply it.

I also thought that if no help could be offered, a negative result of this drug would be useful for research purposes. Dr. Kligman's only advice was to use the drug again in the proper strength and application. How could he think I could apply this drug to my face again?

In the summer of 1989, after all of my investigations into medical procedures to reverse or correct some of this chemical damage to my skin-I looked into collagen, chemical peels, plastic surgery, grafting, even skin replacement, and, still being totally physically and mentally upset, I sought psychological counseling. My life had become one of existence without participation.

The face is an extremely difficult area to overcome accidents to, as it is how you present yourself to society. I worked with a psychologist for almost 1 entire year and told him my innermost feelings on this event and what happens to someone relatively comfortable in life who suddenly loses confidence. I was also put on antidepressant drugs.

I consistently worked with my dermatologist, worked with the psychologist, and took the antidepressant drugs. Finally, in the fall of 1990, I started to feel better and started noticing improvement in the skin condition and started participating in life again.

I appreciate the opportunity to tell my story, and I hope that it will help to protect future consumers. I certainly learned the hard way to question the media and advertising and not to jump into using a prescribed drug without proper instructions. Coming from a stable background and having held responsible positions in society, I never could have anticipated the emotional upset a situation like this could have caused, and today deeply sympathize with individuals self-conscious about all skin problems, but particularly in the facial area. I am also extremely upset that this drug has caused me to lose 21⁄2 years of normal activities in my life. I feel very strongly that drugs should be tested and researched much more thoroughly before being released to the media and society at large. Thank you.

[The prepared statement of Ms. Meader follows:]

Mr. Chairman, Members of the Sub-Committee, my name is Nancy Meader. I am here to testify about an adverse reaction I had to the Retin A drug.

In the early part of 1988, I heard on national news about Retin A. Being at the age of 41, I thought how wonderful to now have a drug available to improve skin appearance. During that time of my life, my husband and I had an opportunity to travel; and we were camping around the entire country for a year totally enjoying the experience. We stopped briefly in Mexico, and I noticed that Retin A was being sold in the drug stores. I decided, since it was a prescription drug, not to try it on my

Own.

In May of 1988 I had an appointment at a doctor's office in Jackson Hole, Wyoming, where there was a physician's assistant on duty. While at the appointment I asked for a prescription of the highly publicized Retin A drug. He without hesitation prescribed the drug (.1%) and told me to apply it under and over my eyes for a period of sixteen weeks at which time I would notice an improvement in my appearance. I picked up the drug at a local pharmacy, and the pharmacist asked me if I knew how to apply the cream and I said, "Yes, I have just been told." The package insert was not included with the tube. I remember that evening being excited about applying this drug and remember saying to my husband, "Here's to eternal youth."

We went about our daily activities of exploring the countryside. I applied the drug evenings until after the fourth application I noticed a severe burning around my eyes. I stopped using the drug immediately and started applying a moisturizer to soften and heal the skin. The skin was burned and felt extremely tight. I fully expected the area to clear up normally, as I had experienced many sunburns in the past. However, I looked in the mirror and made a facial expression, and I couldn't believe my eyes. All the skin under my eyes distorted in wrinkles far exaggerated from the normal expression lines. I was totally distraught at the sight of my face and immediately became extremely nervous and very upset. made an appointment with a dermatologist and spoke to him about the drug. He cringed when I told him the strength which I had applied around my eyes. I had been concerned that scarring might occur, but he assured me that it would not on such short term use.

I

I became totally traumatized as the time went on, and I noticed no change in my appearance. My weight dropped to 89 lbs., and I started having nightmares. I spoke to more and more people in the medical community, and no one had heard of such a severe reaction. I then realized that little was known about the effects of this drug to the skin in the eye area.

We ended our trip early and returned home. I became established with a local dermatologist who more than anyone helped me through this trauma. He monitored the situation for me, addressed my concerns, and I always hoped he might see improvement or might have read something new on the drug.

I continued my investigation by contacting the Drug Information Center through the University of Rhode Island. They helped me to file an adverse drug report with the FDA, and also they sent me a copy of the original study published in the Journal of the American Medical Association in

-2

January of 1988. I was totally surprised to find out that the study had been carried out an only thirty people. However, the reprint listed the names of the researchers who I immediately wrote to in hopes of some suggestions for my skin condition.

I also contacted the public relations department at Ortho

Pharmaceutical to ask for their help and recommendations. At the same time I requested that the contents from the Retin A tube be examined. The Quality Assurance Laboratories at Ortho Pharmaceutical reported that all parameters inspected were within required specifications.

Also I wrote to all physicians listed in magazine articles on the topic. All of my efforts seemed in vain as I received very little help all that was offered to me was to use a moisturizer. I was also told by physicians that I would be better off to stay out of the sun. This severely affected my lifestyle as I had always enjoyed outdoor activities of going to the beach, swimming, sailing, hiking, and camping and had always spent all of my relaxation time out of doors. So as well as my appearance being affected, my lifestyle was drastically changed, and I was constantly fearful about the care and future of this skin condition.

I had one of my physicians call the Clinical Director at Ortho Pharmaceutical, and Dr. Thorne told my physician that the drug had never been tested in the strength and manner in which I had applied it. I talked with plastic surgeons, and one of them took pictures of the condition and put me in touch with Money Magazine who was doing a story an "The Selling of Retin A." A representative from the magazine came to RI to interview me.

I also wrote to Mr. Ken Feather from the FDA stating my whole story and mentioning the adverse drug report which I had filed. Mr. Feather answered my letter stating that the drug was only approved for treating acne but that physicians were free to use it as they wanted and that the drug did get a lot of publicity for use on wrinkles.

I had been writing to Dr. Kligman, and finally I heard from him and made an appointment at the Center for Human Appearance in Pennsylvania. Not having noticed any improvement in the skin condition which happened a year ago, I naturally looked forward to this appointment for possibly some medical help; and if none was available, at least I wanted to show this doctor (who had co-developed the drug) what could happen to someone as a result of the wrong strength of the drug being prescribed and wrong instructions on how to apply it. I also thought that if no help could be offered, a negative result of this drug would be useful for research purposes. Dr. Kligman's only advice was to use the drug again in the proper strength and application. How could he ever think that I could apply this drug to my face again?

In the summer of 1989 after all of my investigations into medical procedures to reverse or correct some of this chemical damage to my skin I had looked into collagen, chemical peels, plastic surgery, grafting, even skin replacement and still being totally physically and mentally upset, I sought psychological counseling. My life had become one of existence without participation. The face is an extremely difficult area