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The Ties That Bind − Topical Psoriasis Marketplace

The Topical Psoriasis MarketplaceI stopped treating my psoriasis years ago, when the exorbitant price of the topical fixed-combination corticosteroid my doctor prescribed made me throw up my hands in disgust at the pharmacy. Are such high prices random or part of a carefully thought-out strategy devised by manufacturers of topical creams and ointments for psoriasis? Unlike solving a puzzle, where all the pieces fit together perfectly in the end, there is no easy answer to this question.

Pharmaceutical companies rarely jump up and down to cheer their pursuit of the profit motive. During my many years in drug advertising and marketing, I continued to be surprised at the imaginative ways my clients managed to clear every regulatory hurdle in order to increase their profits. 

Companies with blockbuster drugs anticipate their drugs’ loss of patent protection with a strategic set of tactics. One tactic, called “pay for delay,” is an agreement in which a brand name drug company simply pays a generic company to not launch a version of an off-patent drug. Other common tactics include launching fixed-combination products (e.g., Taclonex [calcipotriene and betamethasone dipropionate]) or line extensions (e.g., Invega Sustenna [paliperidone palmitate]). 

Although not a business writer, I enjoy the sleuthing involved in piecing together bits of pharmaceutical flotsam and jetsam that to the casual reader might seem unrelated. This love of discovery is what sent me on an investigative journey to find out why Taclonex is so expensive, at $500 to $600 a tube.

The wild story behind Taclonex is true theater. The cast of characters: drug manufacturers and marketers Warner Chilcott and Leo Pharma. The plot, full of twists and turns, involves clinical guideline committees, clever marketing strategies, and business and legal ruses worthy of a Shakespearean comedy. To understand the story and its complicated plot, you first need to learn about some background events that affected the psoriasis drug marketplace during a 3-year period between 2006 and 2009. 

 

  1. Loss of patent: Dovonex (calcipotriene) Ointment loses its patent protection and goes generic in December 2007.

  2. Discontinuation: Warner Chilcott, in a marketing agreement with Leo Pharma, launches a dual-action product, Taclonex. This is a fixed-combination topical agent containing calcipotriene ointment in combination with a topical corticosteroid, betamethasone dipropionate. The year before, in preparation for the launch, Leo had discontinued Dovonex Ointment in the United States. Warner Chilcott and Leo continue to promote patent-protected Dovonex Cream.

  3. Updated guidelines: In 2009, the American Academy of Dermatology (AAD) releases a new psoriasis guideline that addresses the benefits of dual-action calcipotriene ointment and betamethasone dipropionate. The guidelines are created by dermatologists with financial ties to Warner Chilcott.

  4. Marketing: Promotional materials urge physicians to switch patients using Dovonex Ointment to Taclonex Ointment. Leo Pharma claims that this is good for patients because the combination product is more effective. 

Now that you have the background, let me share my perspective as a former advertising writer who believes that our prescription drug system is largely shaped by the needs and desires of industry, rather than consumers and clinicians.

 

RxBalance Observation #1

Around the time of the Taclonex launch, Leo Pharma and Warner Chilcott discontinued supplying Dovonex Ointment in the United States, even though the ointment was extremely popular with dermatologists and patients. In fact, many dermatologists would alternate prescribing calcipotriene ointment with betamethasone, a much cheaper alternative than prescribing a fixed combination. Is it possible that Warner Chilcott and Leo discontinued Dovonex Ointment to knock out competition for Taclonex, as now it was no longer possible to get the ointment? 

 

RxBalance Observation #2

Since treatment guidelines influence the prescribing habits of hundreds of thousands of US physicians, there are enormous financial ramifications to favorable coverage of a particular drug in a guideline issued by a national specialty society like the AAD. The 2009 AAD guidelines alluded to the benefits of a fixed combination of calcipotriene ointment with the topical corticosteroid, betamethasone dipropionate. However, the guidelines did not mention the decision to discontinue Dovonex Ointment or the impact of that decision on patient care. Instead, the guidelines state, “…calcipotriene ointment is no longer commercially available as an individual product in the United States.” The new fixed combination was certainly convenient, but why didn’t the AAD make a public comment about the loss of the widely used cheaper option (alternating use of two topical generics)? 

 

RxBalance Observation #3

During the establishment of the new psoriasis treatment guidelines, there were strong ties binding the guideline committee members to drug manufacturers. Virtually all the dermatologists on the 2009 AAD guideline committee were clinical investigators, published authors, and speakers for manufacturers of topical treatments for psoriasis. Several of the committee members were authors and reviewers of journal supplements for Warner Chilcott. Isn’t there a potential conflict of interest here? Could this conflict subtly cloud the doctors’ views, or at the very least, the words they chose to voice their recommendations?

In case any attorneys are reading this, please note: I am not accusing Leo Pharma, Warner Chilcott, or the AAD of engaging in illegal or unethical practices. I am merely using this example to speculate upon the “ties that bind” affecting certain events in the psoriasis marketplace.

12 Comments

  • Morgan on Oct 26, 2010 Reply

    I’d be interested to learn a bit more about natural remedies. I have been reading about seaweed powder baths but am a little dubious without any 3rd party research.

  • Mark on Jul 08, 2010 Reply

    Lydia,

    Indeed you deserve kudos for your knowledge, research, and recognition of the theatrics staged in the realm of pharmaceuticals. It is a pleasure to read your piece and the way you have presented it without spin or slant.

    I personally suffer from mild to mediocre plaque Psoriasis and was searching for references on the web recommending a superior replacement for the greasy Triamcinalone Acetonide ointment currently scripted. But I found your blog irresistible, revealing the root driving forces at work, behind their masks of benevolence.

    The information you bring to the surface is enlightening to say the least. Certainly the patient is unaware of the big picture schemes that someone at your layer can detect, if equipped with the intellect and skill set to do so. Thank you for your thoughtfulness in sharing it.

    It seems another example of how our capitalist society consistently evolves to saturate itself with greed on every facet.

    Best regards.

    Mark
    South MD USA

  • Martin Woodside on May 01, 2010 Reply

    Lydia Green:

    I would like to add a bit more (corrected) information to my above post. I followed your blog with interest but had neglected to observe that your are a trained pharmacist thus my additional post.

    First of all I misspelled the doctors name once and spelled it correctly once. It is Dr. Jenny Murase . She did her trials at UCLA IRVINE but has moved on to other settings in the years since.

    My first 5-6 years I used Premarin Vaginal cream as a topical skin application and then switched to Estrogel because it is less greasy and does not rub off on my clothing etc. I did appreciate how the Premarin cream kept my skin soft but There is no benefit (to the skin) by topical application. The benefit is derived from dermal absorption of the hormone into my system.

    My doctors observe my sucess but generally I self regulate my dosage. I have always been able “to tell” when my psoriasis wants to become active (usually in the fall) and I increase the amount and then taper off at other times. It has worked well. (Except for the PMS type mood swings caused when levels change). I now have a better understanding of what women go through. (smile).

    I vary dose between 2 to 4 grams daily (pump dispenser) (0.06% 17b estradiol).

    Further study indicates that I will probably have a much higher rate of psoriasis if I should ever discontinue the hormonal treatment. I do not plan to stop. The side effects are minor compared to the severe raging psoriatic arthritis I would otherwise have. (I probably would not be alive today)

    I am a healthy active miracle survivor by fluke coincidence of discovering Dr. Murase’s information via the internet.

    I will be forever greatful to professionals who make such information available to the general public.

    I refer to you as well Lydia Green.

    Profound thanks.

    Arnie M.
    Canada
    Best regards and feel free to ask me more

  • Martin Woodside on May 01, 2010 Reply

    Estrogen helps some people to keep psoriasis in remission. It certainly works for me. (I am a male 50-60 years of age)

    I have had life long psoriasis which I learned to live with just fine until around 2000 I got (the rare) psoriatic arthritis. It raged through my joints and disabled me. Dovonex healed the psoriasis (took 3 months) and the arthritis retreated with it and I am active again.

    My daughter inherited my psoriasis and the only 2 times in her life she was free of symptoms was when she was pregnant (hormones). I did research and discovered that Dr. Jenny Morase found similar results in clinical trials.

    Based on that I persuaded my doctor to prescribe topical estrogel that I have used now with good results for almost 10 years.

    Things were going so well that I became complacent in 2005 and did not renew the estrogel prescription . Two months later my psoriasis was back with a vengance. Lesson learned.

    I continue to use estrogel and am psoriasis free for 10 years (except for 2005) and plan to continue for life. There have been some side effects (slight breast growth) (PMS type symptoms (no-kidding) but at nearly 60 years of age I accept them happily compared to being in a wheelchair or dead. (The arthritis was severe in my case).

    As far as I know, this is the ONLY known medication that keeps psoriasis IN REMISSION . Sun tan , sea salts etc never worked for me.

    Search Dr. Jenny Murase for more accurate information. Mine was not a clinical trial but I forwarded my experience (as a male) to her and she was thrilled.

    Ironically my daughter is unable to benefit from HRT because her mother died young from breast cancer and she is succeptable.

  • Anonymous on Feb 24, 2010 Reply

    Thanks Lydia for this article. It is the most comprehensive piece I have found anywhere. I was caught by surprise this week when I found out that the dovonex ointment was discontinued. While researching, I read that Sandoz started the production of a generic Calcipotriene solution for treatment of the scalp a while ago, and I was hoping that they would also decide to produce the ointment soon. After reading your article however, I think that Sandoz probably received incentives from Warner Chilcott and Galderma to stay out of the profitable oitment market.

  • Anonymous on Feb 23, 2010 Reply

    Very interesting blog. I would add that psoriasis management involves the alternate use of steroids and non-steroidal treatments. It is important to stop using steroids for a period of time because a) skin gets used to steroids and they will no longer work; and b) it is not good to use steroids on a regular basis. To my knowledge, Dovonex and Vectical are the only non-steroidal topical medications on the market. Additionally, in my experience (I have moderate/severe psoriasis), ointments work better than creams. Taking Dovonex ointment off the market has forced me to pay higher prices for the Vectical. What a game these pharmaceutical companies play with our healthcare! It is infuriating.

  • Lydia Green on Jan 01, 2010 Reply

    If anyone wants to contact me, I have added a way to contact me via email. Go to “About Me”
    and Click on “View my complete profile” and you will see an email icon.

  • Anonymous on Nov 06, 2009 Reply

    Lydia,
    How may i get in contact with you? i don’t want to leave my email address for the world to see. do you have one buried somewhere that i may access? thanks.

  • ADAM on Oct 31, 2009 Reply

    Lydia – I would also be interested in additional information on the topic. Is there somethwere I can email you on this for more info? Is it possible to import the dovonex ointment from outside the US?

  • Anonymous on Sep 11, 2009 Reply

    Having just paid $400 for a tube of Vectical, I’m wondering, what is stopping the generic companies from producing generic calcipotriene?

  • Lydia on Jul 02, 2009 Reply

    Anonymous,

    I didn’t know how to contact you, but if you send me your email, I will respond.

  • Anonymous on Jun 26, 2009 Reply

    Lydia, this is very interesting. Do you have further information on this topic I may read? Thank you.

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