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Note: The testimony presented here consists of witnesses' prepared statements and are not official transcripts of the proceedings.

Submitted testimony for David Pariser, MD

Hearing of the House Government Reform Committee

"Accutane- Is this Acne Drug Treatment Linked to Depression and Suicide?"

December 5, 2000

Good afternoon, Mr. Chairman and members of the Committee.  My name is David M. Pariser, M.D.  I am a dermatologist in private practice in Norfolk, Virginia.  I am also the Chief of Dermatology and a professor of dermatology at the Eastern Virginia Medical School in Norfolk and am on staff at four Norfolk area hospitals. 

Since becoming a dermatologist, I have participated in over 150 research projects and clinical trials.  I have participated in numerous acne clinical trials for variety of pharmaceutical companies, including three trials funded by Roche Pharmaceuticals.  Although I have received funding in the past through the National Institutes of Health, I have not received funding from that agency in the past year.

In the 24 years that I have practiced dermatology, I have treated thousands of acne patients.  The severity of the disease in these patients varied, and I have used a number of different treatment regimens to treat the disease.

In addition to my medical duties, I am a member of the Board of Directors of the American Academy of Dermatology.  The Academy is the largest dermatological association in the United States and our mission is to promote and advance the highest possible standards in clinical practice, education and research in dermatology and related disciplines.  On behalf of over 13,000 members of the American Academy of Dermatology and our millions of patients, I wish to express my appreciation for your invitation to appear before you today.

Like many of my colleagues, I was drawn to this specialty for both intellectual as well as personal reasons.  As a young man, I suffered with severe acne and today my face bears the scars of my battle with this disease.  If you were to attend any meeting of the Academy, you would notice that many of my colleagues have the same appearance. 

Acne is not simply a cosmetic problem.  Acne is a disease, and in some cases a very serious skin disease.  Acne is the most common skin disorder of any age group and affects 85% of all teenagers, or more than 20 million Americans.  In about 30% of acne cases, mostly women, the disease persists well into adulthood.  It is not uncommon for dermatologists to have acne patients who are in their 30s and 40s. 

Acne has a significant impact on our economy.  Each year, Americans spend well over $100 million for nonprescription acne treatments alone.  Hundreds of millions more are spent each year on special cleansers and soaps, prescription therapies, and physician visits.  Time lost from school and work is also significant.

But what is acne, and how is it caused?  Acne is a disease of the pilosebaceous units.  The pilosebaceous unit consists of an oil gland (the sebaceous gland) connected to a hair follicle.  Although found all over the human body, pilosebaceous units are larger and more numerous on the face, scalp, upper back and chest ­ the same areas of the body where acne is more prevalent. 

In normal skin, the oily substance produced by the sebaceous gland empties onto the skin surface through the opening of thefollicle.  While we do not know the basic cause of acne, we do know that changes in the lining of the hair follicle occur that prevent the sebum from passing through the follicle to the skin's surface.  In acne, the cells that line the follicle are shed too quickly and clump together.  These clumped cells block the follicle's opening so that the sebum cannot reach the surface of the skin.  Bacteria that normally and harmlessly live on the skin, called Propionibacterium acnes, begin to grow in the hair follicle.  These bacteria produce chemicals that cause inflammation.  Inflammation is a response to disease or injury that is characterized by swelling, redness, heat and pain. 

There are a number of different types of lesions associated with acne.  They are called comedones, papules, pustules, and nodules or cysts.  Comedones are simply enlarged, non-inflamed hair follicles that are plugged with oil and bacteria.  A closed comedo, also known as a whitehead, appears on the skin surface as small whitish bumps.  An open comedo is also known as a blackhead because it looks black on the skin's surface.  The black coloration of an open comedo is not due to dirt, but discoloration of the sebum. 

Inflamed lesions vary in severity.  Papules are more serious lesions than whiteheads or blackheads.  Papules are inflamed comedones that appear as pink bumps on the skin and can be painful to the touch.  More serious are pustules and nodules.  Pustules are inflamed puss-filled lesions that resemble whiteheads, but with a red ring around the base.  Nodules or acne cysts are the most serious of acne lesions.  A nodule is a large, deep-seated, puss-filled, often painful lump. Acne with nodules often results in permanent scarring and requires treatment by a physician.

A dermatologist will classify the type of acne by the presence of particular types of lesion.  Papulopustular acne also known as acne vulgaris is characterized by the presence of comedones and mildly inflammatory lesions.  The severity of a case of papulopustular acne is determined by the ration of comedones to papules and pustules.  The higher the numbers of inflammatory lesions that are present on the skin, the more severe the acne.

Nodulocystic acne is more severe than papulopustular.  As mentioned, these lesions are large, inflamed and extremely painful.  The potential for permanent scarring is greatest with nodulocystic acne.  Scarring occurs as a result of a flaw in the skin's healing process.  As the skin tries to heal itself from the ravages of the nodules, pitting develops in the skin.

The most severe, and fortunately rare, inflammatory form of acne is called acne conglobata.  In this form of the disease, comedones with multiple openings, nodules, abscesses and draining sinus tracts are present.  Acne nodules are connected beneath the skin's surface to other nodules and bacterial infection is also present.  This type of acne develops primarily on the back, buttocks and chest.  It is extremely difficult to treat and sometimes requires surgery.  Scarring is often very severe and keloidal.  This type of acne is found in adults and not teenagers, primarily in males.

In addition to the lesions on the skin, acne has a number of psychosocial effects.  Dr. Sulzberger, a renowned dermatologist, once said this about acne:  "There is no single disease which causes more psychic trauma, more maladjustment between parents and children, more general insecurity and feelings of inferiority and greater sums of psychic suffering than does acne."

We now appreciate the significant impact that acne and acne scarring have on a person's outlook on life.  Recent studies have shown that people with acne suffer from social withdrawal, decreased self-esteem, reduced self-confidence, poor body image, embarrassment, feelings of depression, anger, preoccupation, frustration, and higher rates of unemployment.  These effects are interrelated, and may have a crippling impact on a young person's social life, academic achievement, and job status.

As a clinician, I often see patients with moderate to severe cases of acne that have difficulty making eye contact when speaking, look downwards when I speak to them, and often mumble their responses.  Many often cannot bear to look at themselves in the mirror.  These psychosocial symptoms are often exacerbated if the patient believes many of the lingering myths about the disease ­ that their case of acne is their fault.

Many people believe that acne is the result of poor hygiene.  Dirt or surface skin oils do not cause acne. Believing this myth can actually make acne worse as vigorous washing and scrubbing will irritate the skin.  Skin should be gently cleansed twice a day with a mild soap, patted dry, and if needed treated with an appropriate medication.

Acne is not caused by diet.  Extensive scientific studies have not found a connection between eating fried foods or chocolate and acne.  Of course, eating a balanced and nutritious diet always makes sense, but making a teenager feel guilty about the french fries that he ate for lunch is of no value in the fight against acne.

Acne is not caused by stress, although stress can influence acne.  The ordinary stresses of day-to-day living do not cause acne.  However, there are some stress disorders and forms of mental illness that are linked to the development of acne.  For example, bipolar disorder, also called manic depression, is often treated with lithium and other potent drugs.  Acne is sometimes a side effect of these drugs.

Acne is not improved by sunlight.  While some patients do get a temporary drying effect from sun exposure or exposure to the ultraviolet radiation of a tanning bed, this effect is both short-lived and dangerous, as exposure to the harmful rays of the sun and tanning beds is linked to the development of skin cancer.

Another myth about acne is that you have to let it run its course.  The truth is much more encouraging.  There are a number of systemic and topical treatments that are currently available to treat acne.  There is no reason that a teenager or adult should endure acne or run the risk of acne scarring today.

Your dermatologist has a number of effective acne treatments at their disposal.  After appropriate evaluation, your dermatologist may recommend certain cleansing agents, over the counter medications or may prescribe more potent topical and systemic drugs to treat your acne.  Your dermatologist can also help you to make more informed decisions on appropriate water-based, oil-free makeup and concealers.

Nonprescription products acne products include cleansers advertised for the treatment for acne.  In mild cases of the disease, these cleansers may be helpful.  In more advanced cases, however, these cleansers may irritate the skin and further aggravate the acne.  Other nonprescription products include benzoyl peroxide, a topical treatment that works by destroying the bacteria associated with acne.  This product does work well for mild cases of acne, if used continuously.  However, benzoyl peroxide has no effect on sebum production and does not slow the shedding of cells in the follicle that are responsible for blocking the follicle.  Another product, salicylic acid, does help to correct the abnormal shedding of cells and unclogging pores.  This product also has its shortcomings, as salicylic acid does not slow sebum production and like benzoyl peroxide must be used continuously.  Stronger versions of both of these drugs are also available by prescription.

A variety of topical and systemic prescription treatment regimens are available.  These drugs have varying mechanisms of action and all have side effects.  Some drugs may be prescribed in combination with other drugs.

Topical creams such as adapalene, azeliac acid, tretinoin, and tazarotene are prescribed to unblock oil ducts.  Adapalene is a retinoid-like compound that normalizes the differentiation of follicular epthethial cells resulting a decreased formation of comedones.  Individuals using adapalene are advised to avoid the sunlight and tanning beds and products containing salicylic acid.  Drying, itching, scaling and burning are common side effects of this product. 

Azeliac acid is a naturally occurring saturated dicarboxylic acid.  Azeliac acid acts as an antimicrobial, and itching, burning, stinging and tingling are common side effects.  In rare cases use of azeliac acid has resulted in contact dermatitis.

Tretinoin is a topical retinoid that decreases the cohesiveness of follicular epithelial cells, stimulating mitotic activity in these cells and causing the extrusion of the comedones.  As with adapalene, patients must avoid sun exposure and the drug must not be used on sunburned skin.  Although true contact allergy to the product is rare, individuals with sensitive skin may suffer blistering and redness using the drug.

Tazarotene is a member of the acetylenic class of retinoids and is also prescribed for patients with psoriasis.  Common side effects include desquamation, burning/stinging, dry skin, erythema and itching.  More rare side effects include skin pain, fissuring, localized swelling and skin discoloration.

There are also topical sulfur preparations that are prescribed for acne.  The exact mode of action for these agents is unknown, but it is believed that topical sulfur drugs both inhibit the growth of P. acnes and the suppress formation of free fatty acids in the sebum.  Local irritation is a side effect and these drugs have also been linked to life-threatening or less severe asthmatic episodes in susceptible people.

Antibiotics are also frequently prescribed for acne patients.  Antibiotics may be topical or taken orally (systemic).  Antibiotics work by killing the P. acnes bacteria.  Topical products are available in gels, creams and lotions.  Systemic antibiotics are prescribed for more severe forms of acne, as topical antibiotics are limited in their ability to penetrate the skin.  Of course, antibiotics do not address the other causative factors in acne and have significant side effects.  Antibiotic resistance is also on the rise.  Antibiotics must not be prescribed to women who are pregnant and some antibiotics may reduce the effectiveness of oral contraceptive pills, thereby increasing the risk of pregnancy during treatment.

Oral contraceptives are also prescribed to female patients to help counteract the effect of male hormones or androgens on acne.  The maximum benefit of oral contraceptives on acne is usually realized in 3 to 4 months.  Corticosteroids are an anti-inflammatory medication and may be injected by a dermatologist into very severely inflamed acne lesions to help heal the lesion.

If the acne fails to respond to these intermediate treatments, I will then prescribe an oral Vitamin A derivative known as isotretinoin or more commonly known as Accutane.  I believe that Accutane should only be prescribed by dermatologists, who have a special competence in the diagnosis and treatment of skin diseases, especially recalcitrant cystic acne.  This is to ensure the safety of the patient, which must always be our top concern.

Accutane has proven to be our most powerful weapon against recalcitrant, cystic acne, and has dramatically changed the management of this disease.  Despite its tremendous benefits, I do not prescribe this drug casually ­ it is a serious medication.  However, I do believe that the benefits of this drug far outweigh its risks ­ if I did not, I certainly would not have allowed my son, who suffers from acne, to take this drug.  My son recently completed a five-month course of therapy with Accutane.

Typically, patients with treatment resistant acne are placed on a five-month course of Accutane therapy.  After several months on the drug, most patients will see a dramatic decline in the number of nodules.  In a few cases, patients may require a second course of treatment. 

This drug has a number of side effects, as all drugs do, some of which are significant.  The most common side effects are mild or moderate in intensity and include dry skin, nasal dryness, and chapped lips.  Some patients also complain of fatigue. 

Before prescribing the drug, I counsel my patients about the risks associated with Accutane.  I instruct them to not to take any vitamin supplements containing Vitamin A while taking Accutane.  I tell them to avoid sun exposure while on the drug, a recommendation common to many acne treatments.  I test their blood to assess their liver function and the level of their triglycerides.  I warn them that they may have problems wearing their contact lens when taking Accutane and to see their ophthalmologist about obtaining eyeglasses.

Of course, this drug must never be taken by women who are pregnant or who may become pregnant during therapy.  I have systematized the pregnancy prevention program developed by the manufacturer into the routine of my office.  I speak frankly to my female patients about the devastating birth defects associated with the use of this drug, and the importance of not becoming pregnant while taking this medication.  I also discuss the importance of using two, not one, forms of contraception during the course of treatment ­ one hormonal form of birth control as well as a barrier method.  All women who are prescribed the drug must first have a negative pregnancy test prior to receiving their prescription and are told not to begin treatment until the second or third day of their next menstruation. 

I am aware of the warnings on the label concerning changes in mood, which were added to the label in August 1986, including depression, and monitor my patient's behavior.  These changes did educate physicians to look for mood changes in their patients.  I have heard anecdotes from colleagues who have had patients who responded negatively to the drug, and whose mood recovered after therapy was stopped.  These stories are fortunately very rare.  I am also aware of cases of suicide in patients with severe acne who have not been prescribed Accutane ­ young men for whom the burden of the taunting of their peers grew too heavy to bear.  Fortunately, these too are rare.  More commonly, I have seen the remarkable, positive changes in a patient's mood and demeanor due to the resolution of their disease.  It is as if a great burden had been lifted as their faces and bodies cleared of the acne.  Clearer skin facilitated social interaction, academic standing improved, and older patients felt more confident in their careers.  However, the Academy believes, and I share this sentiment, that more study on the psychiatric effects of this drug should be undertaken. 

If I have any doubts about my patients, whether I doubt that she will be compliant in using reliable birth control or if he has an underlying mental health concern, I will not prescribe this medication.  Indeed, the physician education materials provided by the manufacturer clearly instruct physicians not to prescribe this drug if they have any doubts whatsoever.  Should I note an adverse reaction in any of my patients taking Accutane, I alert the FDA's MedWatch program (which can be done by phone, fax, letter or email) and I contact Roche Medical Services using their toll-free number.

Given the many benefits of the drug, I am concerned about efforts by the FDA to substitute regulation for education.  The creation of a mandatory registry is not the best method to improve patient safety.  Regulation cannot and must not be substituted for the frank and personal discourse inherent in the physician/patient relationship. 

To date, the FDA has mandated only one mandatory physician/patient/pharmacy registry ­ for thalidomide.  Access to the drug is limited, as only physicians who are registered may prescribe the drug and pharmacists who are registered dispense the medication.  There are very few, if any, physicians in private practice who are registered to prescribe thalidomide.  Of the 57,000 dispensing pharmacies in the United States, only 8,000 initially enrolled in the registry and only 4,000 remain, due to the prohibitive costs associated with the registry.  Also, very few patients have been enrolled in the thalidomide registry ­ 11,000 over two years. 

Accutane, on the other hand, is prescribed to nearly 500,000 new patients annually and is a drug prescribed mainly by practitioners in private practice settings.  Nearly 50% of the members of the American Academy of Dermatology are solo practitioners and 27% of dermatologists practice in offices with two dermatologists.  Few dermatologists are in large single or multi-practice settings and fewer still are in academic practices.  Solo practitioners do not have the flexibility or resources to hire an individual solely dedicated to overseeing compliance with a mandatory registry, as would a physician in an academic setting with greater resources at his/her disposal.  Therefore, the treating physician would be compelled to refer their patient to a complete stranger for dispensing of the drug.  The patient would then be forced to have one of the most private of discussions with a doctor who is a stranger and who has not earned their trust.  The psychological effect of this change would certainly have a chilling effect on the tone and content of this conversation. 

Education, of all parties ­ physicians, patients, nursing staff and other medical support personnel ­ is paramount and must be an ongoing enterprise.  Efforts to educate patients should be, and have been, reevaluated and improved and new knowledge must be incorporated into our practices. 

New information about fertility and patient understanding about the efficacy of certain forms of contraception has been included in the new Accutane targeted pregnancy prevention program and physicians, nurses and other office staff must be educated about this new information so that we may begin to implement these recommendations.  Continuing medical education and nursing education programs are being amended to ensure that this new information is provided to all.  This is how it should be.  This is how we will further reduce the very small number of inadvertent pregnancies that continue to occur.  Substituting a mandatory registry over a redoubled physician and patient education effort is no guarantee of success.

I am also concerned that the effects of a registry may have unforeseen consequences for the care of patients with other diseases.  The National Institutes of Health and academic health centers are supporting research projects that examine the efficacy of this drug for a number of different diseases, including rosacea, ichthyosis, neuroblastoma, sarcoidosis, the prevention of skin cancers in individuals with xeroderma pigmentosum and nevoid basal cell carcinoma syndrome, and emphysema.  Indeed, the Italian counterpart to the FDA recently approved Accutane for use as a preventative treatment for neuroblastoma.  Institution of a mandatory registry could have a chilling effect on this type of research.
Thank you again for providing the American Academy of Dermatology with the opportunity to appear before you today.  I would be most happy to answer any of your questions.
 

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