Correspondence with PSR

Correspondence to and from PSR

Your ACCO Board was very concerned when the Professional Services Review (PSR) published inappropriate material pertaining to the management of skin cancer in thier June newsletter to Australian doctors. The PSR advocted that topical options were available for most skin cancers and ought ot be offered to all skin cancer patients. 

As we know, topical options are only available for two skin cancers; squamous cell carcinoma in situ and superficial BCC. 

ACCO wrote the following to the PSR in response to thier June newsletter.


Good evening PSR panel,Your June panel newsletter has been brought to our attention. 

https://www.psr.gov.au/sites/default/files/PSR%20panel%20newsletter%20-%20JUNE%202019.PDF

Specifically, your section “Topical treatment for skin cancers” is plain wrong in many respects. Indeed it promotes poor if not unethical medical practice in managing skin cancer. Note that I have no conflict of interest. I am no longer in medical practice. I am a full time cutaneous oncology academic. Our team includes skin cancer academics in Australia and USA. Some similar poor management suggestions were mentioned on the current draft on line wiki guidelines on managing BCCs and SCCs. Many of the poor practices promoted are similar to your brief comments. We have prepared a formal response to wiki guide draft. (attached). The same comments apply to your section. We regard it as an imperative that you retract that skin cancer section and issue a detailed correction in the next issue. Frankly, if an Australian doctor did one of the following:

  1. Use Imiquimod to manage SCC in situ – outside of TGA approval
  2. Use 5FU to manage superficial BCC – outside of TGA approval
  • Our team would regard such practice as inappropriate. Several other comments in your paragraphs on skin cancer are simply not supported by the research. These include:
  1. The evidence that non-surgical treatments have a better cosmetic outcome than surgery is without evidence base. Indeed there is data that suggests cosmetic outcome with surgery may be better than topical treatments when usage is on the face. Cosmetic advantages should not be used as a reason to choose one modality over another. It cannot be supported.
  2. Very few face defects following skin cancer excision require skin grafts. These will only be very large defects for cancers where no topical was ever a consideration. Hence your reference to grafting is inappropriate. In contrast, skin flaps on the face, performed well, can have excellent cosmetic outcomes.
  3. Imiquimod, topical 5FU and ingenol mebutate (IM) do not avoid long term scarring. Permanent scarring has been reported with all of these agents. Counselling of patients that avoiding surgery prevents scarring is misleading and poor medical practice.
  4. The side effect profile of imiquimod does not compare favourably to surgery. Studies of patients that have undergone both imiquimod and surgery indicate patients report fewer and shorter lasting complications with surgery.
  5. There is no quality evidence to suggest that 5FU works better on the face and scalp than elsewhere.
  6. IM is not indicated or demonstrated to treat ANY skin cancer. It is a treatment for actinic keratoses. A condition where surgery is not indicated. Surgery is not indicated as a treatment for actinic keratoses. 5FU is indicated for actinic keratoses and SCC in situ. The data for usage of 5FU for SCC in situ (SCCis) is very poor. The main procedural approach to SCCis is C&C or C&D, - not excisional surgery. Under unusual occasions surgery might be used to manage SCCis. As such, the indications for using 5FU or IM are completely different to the indications for surgery. Therefore, to suggest a choice of one over another when offering options is illogical. They treat different conditions.

The ACCO team request that you retract this section and publish a correction. The failure to do so would be to promote poor medical practice. Please reply to this email. ACCO will regard it as necessary to take further steps if this misinformation is not addressed. It would seem an imperative that if PSR are to publish recommendations for improved quality practice, - that they take care to get it correct.


The PSR responded with the attached letter

 


 

Your ACCO Board waited a week and responded as follows to the PSR. 

We write concerning our email to you dated July 8, 2019 and your reply dated July 9, 2019. The ACCO Executive has considered your response in detail and have decided to make the PSR June panel newsletter, our response to it, and your replie(s) the focus of our August ACCO newsletter to members. You advise that you have republished information placed on a third-party web site. We note that this third-party publication also offers no citations to support its claims. ACCO presumes that PSR would have taken reasonable steps to ensure the accuracy of information it publishes. Other paragraphs have citations, including others in the same June edition. Your section on topicals and skin cancer offers no citations. We note that you place weight on the fact that third-party web site is associated with a Government entity. As such, ACCO ask that you provide the following:

  1. Evidence that topical ingenol mebutate is listed under the Australian Register of Therapeutic Goods (ARTG) as indicated for the treatment of skin cancers. ACCO notes that ARTG is also associated with a Government entity.
  2. Evidence that imiquimod is listed under the ARTG for skin cancer management other than superficial BCC.
  3. Evidence that topical 5 FU is listed under the ARTG for skin cancer management other than squamous cell carcinoma in situ.
  4. Research evidence in peer reviewed journals that the three topical agents above can be used to manage skin cancers without risk of scarring.
  5. Research evidence in peer reviewed journals that managing skin cancers with the three above agents produces a better cosmetic outcome than from surgical interventions.
  6. Research evidence that adverse events using imiquimod to manage skin cancers compare favourably to surgical interventions.

There appears to be two issue here:

  • 1)       Improving informed consent when advising patients of skin cancer management options
  • 2)       Clinical practice advice on managing skin cancer

INFORMED CONSENT. ACCO is also concerned that appropriate informed consent is provided by clinicians in the lead up to decisions on skin cancer management. Your article is detrimental to provision of informed consent. ACCO will need to reiterate a correction and advise members to ignore your column on skin cancer and the advice therein.

ACCO advises members that for patients to appropriately self-determine their management choice:

  1. When managing superficial BCC, options discussed should include the option of topical imiquimod. Patients should be advised that adverse events using imiquimod can be more severe and longer lasting than curettage and ablation or surgical excision. Patients should be advised that topical treatment does not mean that permanent scarring is avoided. Relative clearance rates and recurrence rates of treatment options is an important component of informed consent.
  2. When managing squamous cell carcinoma in situ, options discussed should include the option of topical 5FU. Patients should be advised that topical treatment does not mean that permanent scarring is avoided. Relative clearance rates and recurrence rates of treatment options is an important component of informed consent.
  3. Other than when managing superficial BCC and / or squamous cell carcinoma in situ, no approved or effective topical options exist managing skin cancers. Informed consent for other cancers, including any invasive SCC or any BCC other than superficial type should include advice that there are no recognized topical options available.

ADVICE. ACCO remains perplexed that PSR claims not to provide clinical advice, and yet has done so on many occasions, including other paragraphs in that same June newsletter. If it is the intent for PSR not to provide clinical advice, then we suggest PSR do not do it.

ACCO is aware that many general practitioners are afraid of the investigative and punitive power of the PSR and feel that there is a continual threat of audit or investigation being held over them. While this may be an incorrect or exaggerated belief, the fact remains that these doctors will see communication from the PSR as a direction as to how they must practice, which unless it is followed will attract a penalty. If incorrect information is being propagated in official PSR communication it is likely to be followed to the letter by these doctors, and the PSR and Cancer Council must then take responsibility for the potentially negative outcomes of treatment that occur.

If PSR ever chooses to enter the domain of medical education, any advice provided should be evidence based and cited.  ACCO regards the June publication of advice re topicals in managing skin cancer by the Professional Services Review as unprofessional. ACCO will continue to advise members to comply with the ARTG listings and warns doctors not to venture into off-label prescribing.

Our August newsletter.

We will be reiterating this information regarding informed consent in the August newsletter and advise that your June newsletter be ignored as it provides information that is counter to appropriate informed consent and optimal evidence-based management for our patients with skin cancers.

Please be advised that when our August newsletter is published, we will include our full letters to PSR by way of online link. We will also provide an online link to your full letter dated July 9, 2019 as well as any other response that you might provide to ACCO between now and July 25, 2019.

We look forward to your further response. Anthony Dixon     Director of education                                                Stuart Anderson Chair


The following day, Tuesday July 16, 2019, ACCO received the following response from PSR.