Generic Brands: Are they really Equivalent?

When we are prescribed steroids, we sometimes choose to use the generic brand because it is cheaper. Why spend tons of money on the brand name if you can get the same cream for a lower price?

Well, we may need to rethink our bargain.

A study done in 1991 showed that not all off-brand topical steroid products hold up to their supposed counterpart.

From the abstract: “Six generic formulations of 5 topical steroids were compared for bioequivalence with their trade name counterparts using an in vivo vasoconstriction assay. Two of the six generic forms were found to show significantly less vasoconstriction then the respective trade-name topical steroids.”

Without even meaning to, you could be using a topical steroid that is less potent than the prescribed objective. I have not been able to find evidence that this has been rectified since the 1990’s. This is extremely troubling, something that needs attention if it is still an ongoing occurrence.

What is more discouraging is the fact that this relates to ALL generic drugs, not just to topical steroids.

In 2011, a Supreme court decision was made: If there is a side effect seen in a brand name drug, the company must place it on the label. However, the generic company is not under such law and does not have to share those findings on the label.

As explained by Dr. Roger Steinert in his article, Generic vs Brand-Name Drugs: An Ongoing Debate, he describes the fatal flaw of how generic drugs work. The FDA says that the generic brand must 1) use the same concentration of active ingredient as the brand name and 2) same route of administration as the brand name. However, they are not reviewed and are not as monitored as their brand name “counterpart”. This leaves an immense room for error.

So, next time you pick up that generic brand, remember what you are paying for. What a backwards world we live in…

 

Study From: A Double-Blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Arch Dermatol. 1991;127(2):197-201. Olsen EA.

They Struggle, Too

In September of this year, I had the privilege to accompany ITSAN (the International Topical Steroid Addiction Network) to the CSD/AAD conference in Washington, D.C. as a patient advocate. CSD stands for “Coalition of Skin Diseases” and AAD stands for “American Academy of Dermatology.” There were many dermatologists present, as well as non-profit groups with their patient advocates.

Before flying into D.C., I already had anxiety knowing that many dermatologists weren’t going to 1) know about Red Skin Syndrome or 2) were going to brush me us off as not real.

On the first day, we mostly met with the non-profit groups. However, the second day was geared mainly towards dermatologists. For awhile I was feeling oddly used. I knew that when we had to go speak on Capital Hill, they’d want me to share my story to get what they wanted, not because it would help me in any way about Red Skin Syndrome. So, I had mixed emotions all day long.

What didn’t help was that at the end of all the meetings Day 2, we ran into an older doctor who told us he didn’t like prescribing steroids very much. Intrigued, we sat down with him. We then entered into an hour long conversation about how his method is to dowse his patients in steroids 6x a day to get rid of the eczema. I think I stopped taking him seriously when 1) he looked at me (and I look WAY better than I have been) and told me “I’d consider you severe atopic” and 2) then went to get up and touch my face without my permission. I told him very bluntly he was not touching my face. If someone starts a sentence off with “I know this may sound conceited, because it is…”, how am I supposed to find you educated? Our conversation was getting nowhere with him and it was very disheartening.

On that same day I had met with everyone from Florida and we exchanged names and how we should go about getting business done on Capital Hill. There were two other advocates amongst all the dermatologists. One was for vitiligo, and one was for alopecia. Both of these conditions are known in the dermatology profession. When my turn came, I felt a bit of  the ‘deer in the headlights’ come on when I tried describing Red Skin Syndrome. One doctor in particular stared at me and asked,

“How old are you?”
“I’m 27.”
“Oh.”
“Why how old do you think I am?”
“I thought you were a teenager.”

Others nodded in agreement that they thought I was much younger. I felt defeated in a sense since I wasting viewed as this young, meek advocate, not the educated adult that I am.

Well, the next day, I rode into Capital Hill feeling slightly inadequate. All the legislation that we had been learning about didn’t directly affect or help my fight for awareness, but I tried to find a way for my voice, in my conscience, to matter.

At one point, I was alone with two other dermatologists. One was from the Orlando area, one was from the Melbourne area. The one from Melbourne also had his wife and son with him. While waiting to meet with our representative (Mica), we spoke to his assistant about our wants and needs. When I waited to share my story, I was able to listen to these dermatologists speak about their troubles and business woes due to how the system is run. I suddenly felt a twang of empathy for them. I believe that doctors should be regulated, but it seems the system in place is making it very difficult for them to practice good medicine. They are run down, unable to give their patients adequate attention. They are fighting with insurance companies, being forced to stay later and later at the office to finish menial paperwork, searching for affordable medications for their patients since prices have skyrocketed, and now are faced with their compounding rights being highly regulated. These are things, as a patient, I have never thought about.

So, when it came for me to speak, I felt much better speaking out for the entire group’s plight, not just my own. It helped me realize that patients are not the only ones struggling. Yes, there are plenty of doctors who still give patients a hard time about Red Skin Syndrome and need to be better educated on steroid use, but there are also doctors who are probably just so exhausted that they are going to be defensive.

The way the system is being run now is for money. Representative Mica even bluntly opened up about one of our legislative asks. There is a call for more research money, of which he whole heartedly agrees. However, when I explained our condition he said it was sad that I would most likely not see any research being funded for my condition since it doesn’t generate a profit. This may not be verbatim, but he said, “Generally they will put money into research if they know they’ll see a profitable return, but with you, they wouldn’t be getting that.”

Even HE sees the uphill battle we face. It’s unfair to push us aside because we don’t fit into their pockets.

So that is why I heavily push and advocate for PREVENTION. If the medical community was aware of the correct way to utilize topical steroids, and what the consequences are if they overprescribe them, then we have a fighting chance to keep patients away from this turmoil. And not only does the medical community need to be educated, but so does the public. Too many times we are given a medication and not taught what it is, how to use it, why we are using it, and what the side effects may be when used.

So doctors, please understand that we are just fighting for our health since the system doesn’t seem to be. And patients, please understand that doctors are fighting for their sanity since the system doesn’t seem to be.

The struggle is real. #WeNeedReform

Topical Steroid Label

Whenever we purchase a prescription, there is always an insert or attached label outlining that specific drug’s usage. More often than not, we toss it into the trash. What we should be doing is taking the time to read the insert because it holds extremely valuable information. However, on the contrary, there is misguided information that needs to be looked at closely.

The following is seen on the insert for Clobetasol Propionate, a Class 1 Super Potent steroid:

In bold letters: do not use for more than 2 weeks, 50g per week, because it can suppress the HPA axis.

First off, it warns not use to this for more than 14 days. What it does not say is “Do not use for more than 14 days unless your doctor thinks it’s cool.” There is a definite reason why it states that warning despite what your doctor tells you.

HPA axis suppression is not something you, or your doctor, should take lightly. You are highly increasing your chances of developing Red Skin Syndrome and creating an imbalance in your adrenal glands.

Also, what does 50g a week mean to you? Most likely nothing because you are not a doctor and have no idea how to measure out 50g.

Let’s say your doctor gave you a tube that was 60g large, and their instructions were to “use on flaring areas once a day.” That was it. That was all they told you. Well, your thighs, hands, elbow area, and neck are flaring. These areas combined, using the fingertip method, come out to around 10g a day of use. 10g x 7 days = 70g a week. That is over the maximum limit of use.

But let’s take this further. In bold, the insert states:

“Precautions: General: Clobetasol Propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2g per day.”

2g per day! That is around 4 fingertip units a day.

2g x 7 days a week = 14g a week. So, more accurately, 50g a week is WAY too much. Even if 14g a week is seen as the ‘minimum’ to cause HPA axis suppression, that means THERE IS A POSSIBILITY it can happen with just 14g a week, which in turn shows there is a LARGE POSSIBILITY it will happen at the ‘safe usage’ of 50g a week.

That 36g difference is remarkable. This is something that rarely ever gets explained in a doctor’s office. When a doctor gives you the instruction to “use sparingly”, this is what they should be explaining to you.

But let’s move on.

When using steroids, adults are not equal to children.

“Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their large skin surface to body mass ratios.”

First off, the word systemic should bounce out. If any doctor tells you that topical steroids “are not systemic”, they are lying to you. Just because you are not orally using them, does not mean they do not penetrate our skin and enter our system.

And two, this should put up a huge warning flag. If 14g a week is the lowest dose they saw suppression in for adults, try halving that, or even one quarter. That would be between 4g and 8g a week for small children and babies. And, because they are smaller, there is a larger chance of suppression. Besides, in bold caps, the insert says, “Use in children under 12 years of age is not recommended.” If a doctor prescribes this to a child under 12, especially a baby, know that this recommendation should read more as a forbiddance.

“If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of clobetasol propionate should be discontinued until the infection has been adequately controlled.”

First off, you’ve got the vague “promptly” in there. Give us actual numbers, perhaps, “1-2 days”. And secondly, you should NEVER use steroids on an infection. It will just make them worse. Check out Tinea Incognito.

“#5 Patients should inform their physicians that they are using clobetasol propionate if surgery in contemplated.”

I had never heard of this before, so I do hope this information is shared in the doctor’s office and not left for the patient to (not) read in the insert.

And last, but certainly not least, in lovely bold writing, “should not be used on the face, groin, or axiliae”. This isn’t a recommendation. This is a definite warning.

Different Instructions for the Same Steroid

If things weren’t confusing or muddled enough, it has come to my attention that a steroid can have different recommendations in different countries. The steroid is the same and yet guidelines are blatantly different.

Let’s take Diprosone for example. This is a Betamethasone Dipropionate topical steroid.

In the UK, it states:

  • Do not use on any other skin problem as it could make it worse especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, genital itching, nappy rash, cold sores, chickenpox, shingles or other skin infections. Ask your doctor or pharmacist if you are not sure.
  • Talk to your doctor or pharmacist before using diprosone ointment. This medicine should not be used under bandages or plasters.
  • Side effects that may happen with oral or injectables corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children.
  • If the ointment is used more often than it should, or more than prescribed, it can affect some of your child’s hormones. This may affect their growth and development.
  • If Diprosone Ointment is used in children, it should not be used on any part of their body for more than 5 days.
  • Do not put the ointment under your child’s nappy, as this makes it easier for the active ingredient of the medicine to pass through the skin and possibly cause some unwanted effects.
  • Usually for adults and children, a thin layer of Diprosone Ointment should be rubbed into the affected area of skin twice a day.
  • Do not use the ointment on your face for more than 5 days.
  • Do not use a large amount of ointment on large areas of the body, open wounds or areas of the body where joints bend for a long time (for example every day for many weeks or months).
  • Most people find that when the ointment is used correctly, it does not cause any problems. However, if you use the ointment more than you should, particularly on your face, it can cause redness, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin, in the skin, inflammation of the hair follicles; excessive hair growth, reduced skin pigmentation; allergic skin reactions; dermatitis (skin inflammation); other skin infections, thinning of the skin and red marks.

In Australia, it states:

  • Do not use Diprosone if you have:

a viral skin infection, such as cold sores, shingles or chicken pox, a fungal skin infection, such as thrush, tinea or ringworm, tuberculosis of the skin, acne rosacea, inflammation around the mouth, skin conditions with ulcers,

Unless your doctor tells you.

(^^^^^^^ That seems unbelievably risky).

  • Do not use Diprosone just before having a bath, shower or going swimming.
  • Tell your doctor if: you are pregnant or breast feeding.
    Your doctor will tell you if you can use Diprosone during pregnancy or while you are breast feeding.

(^^^^^ again, whatever your doctor tells you? Why can’t the pamphlet tell me? Or is it that nobody knows and everyone is just guessing…)

  • Apply a thin film of Diprosone Cream or Ointment or a few drops of Diprosone Lotion to the affected skin or scalp twice daily. Massage gently until it disappears. For some patients, once daily application may be enough for maintenance therapy.
  • It is important to use Diprosone exactly as your doctor has told you.

(^^^^^ What if they tell you to go against the guidelines?)

  • Do not use Diprosone for more than four weeks at a time unless your doctor tells you.

(^^^^^^ And here is my point!)

  • Do not use Diprosone under dressings or on large areas of skin unless your doctor tells you

In the UK pamphlet, it says you should not use steroids on an infection site, even though the AU pamphlet says you can do it if your doctor instructs you to do so.

In the UK pamphlet, it says you should not use this steroid under occlusion, yet the AU pamphlet says it is ok if the doctor tells you to do so.

In the UK pamphlet, there doesn’t seem to be a set time recommendation to use the steroid (except for children and for the face), while the AU pamphlet says to use it no longer than 4 weeks unless your doctor says to do so, but doesn’t say how long to use it on the face.

In both pamphlets, it seems to leave pregnant women under the discretion of their doctor or their pharmacist.

Over and over in these pamphlets, there seems to be a lot of “just ask your doctor” or “unless prescribed by your doctor”. What happened to facts? What happened to “these are the guidelines and they need to be adhered to for the patient’s safety”? Moreover, there are doctors who get paid to prescribe certain drugs to patients, so where is the ethical line? Want to check out your doctor? Dollars for Docs

Also, RSS is not a side effect listed. It never is and should be. Red Skin Syndrome is not just a small symptom or side effect that will go away very quickly. This condition affects so much more than just your skin!

Doctors should also be educating their patients about steroid use, the good and the bad, as well as staying up to date with medical findings and research. Even a well meaning doctor can over prescribe this medication so it is pertinent that you know all there is about topical steroids before you begin use.

 

Medical Terminology Explained

One of the many ways we can feel left out of the medical loop is the jargon that leaves us perplexed and, most likely, uninterested in trying to understand our ailment. The doctor either says some fancy words or we end up reading a pamphlet that looks like ancient hieroglyphics. It can be daunting and when we just want relief, we don’t delve any further than the reaching to take a prescription from the doctor.

The time has come for us to decipher some very important medical terminology so we, as patients, can be best informed about our condition and what may lie ahead if we take a certain treatment.


Antiproliferative: of or relating to a substance used to prevent or retard the spread of cells, especially malignant cells, into surrounding tissues.

Atherosclerosis: a disease in which plaque builds up inside your arteries. This can cause different problems including coronary heart disease, carotid artery disease, and chronic kidney disease.

Atrophy: waste away, typically due to the degeneration of cells, or become vestigial during evolution. Picture

Axillae: Armpit

Bioethics: the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in biology and medicine. It is also moral discernment as it relates to medical policy and practice.

Corticosteroids: any of a group of steroid hormones produced in the adrenal cortex or made synthetically. There are two kinds: glucocorticoids and mineralocorticoids. They have various metabolic functions and some are used to treat inflammation. The ones we usually deal with are glucocorticoids that stop inflammation.

Candidiasis: infection by fungi of the genus Candida, generally C. albicans, most commonlyinvolving the skin, oral mucosa (thrush), respiratory tract, or vagina; occasionally thereis a systemic infection or endocarditis. It is most often associated with pregnancy,glycosuria, diabetes mellitus, or use of antibiotics. Picture

Concomitant: naturally accompanying or associated.

Cutaneous: of, relating to, or affecting the skin.

Demodicidosis: skin disease of the pilosebaceous units associated with human Demodex mites that involves predominantly the face and head. Picture

Edema: a condition characterized by an excess of watery fluid collecting in the cavities or tissues of the body. Picture

Efficacy: the ability to produce a desired or intended result.

Emollient: a preparation that softens the skin.

Erythema: superficial reddening of the skin, usually in patches, as a result of injury or irritation causing dilatation of the blood capillaries. Picture

Exacerbation: an increase in the severity of a disease or its signs and symptoms; a worsening.

Granuloma Gluteale Infantum: a rare skin disorder of controversial etiology characterized by oval, reddish purple granulomatous nodules on the gluteal surfaces. Picture

Gynecomastia: enlargement of a man’s breasts, usually due to hormone imbalance or hormone therapy. Picture

Hirsutism: abnormal growth of hair on a person’s face and body, especially on a woman. Picture

HPA axis: The hypothalamic–pituitary–adrenal axis is a complex set of direct influences and feedback interactions among three endocrine glands: the hypothalamus, the pituitary gland(a pea-shaped structure located below the hypothalamus), and the adrenal (also called “suprarenal”) glands (small, conical organs on top of the kidneys).

Hyperkeratosis: thickening of the stratum corneum (the outermost layer of the epidermis, or skin), often associated with the presence of an abnormal quantity of keratin, and also usually accompanied by an increase in the granular layer. Picture

Hyperpigmentation: the darkening of an area of skin or nails caused by increased melanin.

Hypertrichosifs: a skin abnormality that results in excessive growth of hair. It can be localized to one part of the body, or affect in full. It can affect men or women and is mostly secondary to a genetic disease that causes a hormonal disorder. Picture

Hypopigmentation: the loss of skin color. It is caused by melanocyte or melanin depletion, or a decrease in the amino acid tyrosine, which is used by melanocytes to make melanin. Picture

Iatrogenic: of or relating to illness caused by medical examination or treatment.

Immunosuppressive: (chiefly of drugs) partially or completely suppressing the immune response of an individual. Topically, there is Protopic and Elidel.

Impetigo: a contagious bacterial skin infection forming pustules and yellow, crusty sores. Picture

In vivo: (of a process) performed or taking place in a living organism.

Intertriginous: area where two skin areas may touch or rub together, like armpit or groin

Kaposi Sarcoma: a rare tumor that is named after the dermatologist who first described it in 1872. It is caused by a type of herpesvirus. Picture

Lichen Sclerosis: an uncommon condition that creates patchy, white skin that’s thinner than normal. Picture

Malassezia Folliculitis: an inflammatory skin disorder that typically manifests as a pruritic, follicular papulopustular eruption distributed on the upper trunk of young to middle-aged adults. Picture

Mastocytosis: disorder that can occur in both children and adults. It is caused by the presence of too many mast cells in your body. You can find mast cells in skin, lymph nodes, internal organs (such as the liver and spleen) and the linings of the lung, stomach, and intestine. Picture

Milia: a small white or yellowish nodule resembling a millet seed, produced in the skin by the retention of sebaceous secretion. Picture

Molluscum Contagiosum: a chronic viral disorder of the skin characterized by groups of small, smooth, painless pinkish nodules with a central depression, that yield a milky fluid when squeezed. Picture

Morbidity: is a term used to describe how often a disease occurs in a specific area.

Occlusive: Of or being a bandage or dressing that closes a wound and keeps it from the air.

Ocular Hypertension: an eye pressure of greater than 21 mm Hg. It usually occurs for a long time and doesn’t match with glaucoma.

Perioral Dermatitis: a common skin rash that mainly affects young women. The rash affects the skin around the mouth. Use of a steroid cream on the face seems to trigger the condition in many cases. Picture

Phimosis: a congenital narrowing of the opening of the foreskin so that it cannot be retracted.

Purpura: a rash of purple spots on the skin caused by internal bleeding from small blood vessels. Picture

Stellate Pseudoscars: white, irregular or star-shaped atrophic scars occurring over the sun-exposed areas of the forearms. Picture

Stratum Corneum: the horny outer layer of the skin.

Striae: a linear mark, slight ridge, or groove on a surface, often one of a number of similar parallel features. Picture

Synthetic: made by chemical synthesis, especially to imitate a natural product.

Systemic: of, relating to, or affecting the entire body.

Tachyphylaxis: rapidly diminishing response to successive doses of a drug, rendering it less effective. The effect is common with drugs acting on the nervous system.

Telangiectasia: a condition characterized by dilation of the capillaries, which causes them to appear as small red or purple clusters, often spidery in appearance, on the skin or the surface of an organ. Picture

Tinea Incognito: a fungal infection (mycosis) of the skin masked and often exacerbated by application of a topical immunosuppressive agent. The usual agent is a topical corticosteroid (topical steroid). Picture

Vasoconstriction: the constriction of blood vessels, which increases blood pressure.

Vitiligo: a condition in which the pigment is lost from areas of the skin, causing whitish patches, often with no clear cause. Picture