Investigation Report No. 3168File No. ACMA2014/144

Broadcaster Australian Broadcasting Corporation

Station ABN – ABC TV

Type of Service National Broadcaster

Name of Program 7pm TV News

Date of Broadcast 5 December 2013

Relevant Code Standards 2.1, 2.2, 3.1 and Section III of the ABC Code of Practice 2011 (revised in 2013)

Date finalised 7 July 2014Outcome The ABC:

did not breach standard 2.1 [reasonable efforts to ensure accuracy]

did not breach standard 2.2 [materially mislead the audience]

did not breach standard 3.1 [corrections and clarifications] complied with Section III

of the ABC Code of Practice 2011 (revised in 2013) (the Code).

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 2013

BackgroundOn 11 February 2014, the Australian Communications and Media Authority (the ACMA) commenced an investigation into a complaint about a segment of the program 7pm TV News broadcast on 5 December 2013 by the Australian Broadcasting Corporation (ABC).

7pm TV News is a half-hour news program broadcast nightly across Australia. It is described on its website as follows:

Live across Australia, the latest from ABC News, following today's top stories and live coverage of events as they unfold. Plus comprehensive analysis and original reporting from ABC reporters around Australia and the world.1

On 5 December 2013, the program included a segment entitled ‘Bad Medicine’ with Sophie Scott reporting on a Therapeutic Goods Administration (TGA) investigation into the promotion of a drug as a contraceptive on the manufacturer’s website.

The introduction to the segment was:

An investigation is under way to determine whether a drug company has been promoting its popular acne treatment as a contraceptive. The drug called Diane is only approved for skin and hormone problems. It was temporarily banned in France earlier this year following a spate of deaths relating to blood clots.

A transcript of the full segment is at Attachment A.

On 13 December 2013, the complainant wrote to the ABC identifying three statements in the introduction (above) to the broadcast which it alleged were inaccurate.

The complainant requested that the ABC make a corrective statement on-air and on-line.

The complaint to the ABC and subsequent complaint to the ACMA are extracted at Attachment B.

On 24 December 2013, the ABC responded admitting that the TGA investigation had not been current at the time of broadcast, apologising for the error and advising that a correction had been published on the News Corrections page on its website. It stated that, ‘as the body of the story accurately reflected the legal status of the drug and that it is still effective and approved for use when properly prescribed, the ABC does not believe any further corrective action is required.’

The ABC News Corrections page is at: http://www.abc.net.au/news/corrections/ 2

The ABC’s response to the complainant, and submissions to the ACMA, are extracted at Attachment C.

This investigation has considered the ABC’s compliance with the Code in respect of standards 2.1, 2.2 (accuracy), Section III (resolved complaints) and 3.1 (corrections and clarifications).

Matters not pursuedThe complainant also submitted that the statement concerning the ‘ban’ in France did not comply with Code standards 4.1 (gather and present news and information with due impartiality) and 4.5 (do not unduly favour one perspective over another).

1 http://www.abc.net.au/tv/programs/abc-news/ 2 The ABC has advised the ACMA that the correction was published on 20 December 2013

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20132

As the complainant did not first complain to the ABC about alleged compliance with standards 4.1 and 4.5 of the Code, as required under section 150 of the Broadcasting Services Act 1992 (BSA), the ACMA has not pursued these aspects of the complaint in this investigation.3

The complaint to the ACMA also concerns some material included in a separate ABC News article linked to the ABC News Corrections page on its website. This has been considered only in so far as it is relevant to the ACMA’s consideration of the ABC’s compliance with standard 3.1 of the Code. As the ACMA does not have jurisdiction to consider on-line material, further allegations about the accuracy of factual statements in this material are not considered.

AssessmentThe assessment is based on submissions from the complainant and the ABC, correspond-ence between the ABC and the complainant and between the ABC and the ACMA, and an electronic copy of the broadcast provided by the ABC. Other sources have been identified where relevant.

In assessing content against the Code, the ACMA considers the meaning conveyed by the relevant material that was broadcast. This is assessed according to the understanding of an ‘ordinary reasonable’ viewer.

Australian courts have considered an ‘ordinary, reasonable’ viewer to be:

A person of fair average intelligence, who is neither perverse, nor morbid or suspicious of mind, nor avid for scandal. That person does not live in an ivory tower, but can and does read between the lines in the light of that person’s general knowledge and experience of worldly affairs.4

The ACMA considers the natural, ordinary meaning of the language, context, tenor, tone, visual images and any inferences that may be drawn. In the case of factual material which is presented, the ACMA will also consider relevant omissions (if any).

Once the ACMA has applied this test to ascertain the meaning of the material broadcast, it then assesses compliance with the Code.

Issue 1: AccuracyRelevant Code Standards2. Accuracy

2.1 Make reasonable efforts to ensure that material facts are accurate and presented in context.

2.2 Do not present factual content in a way that will materially mislead the audience. In some cases, this may require appropriate labels or other explanatory information.

The ABC principles relevant to standards 2.1 and 2.2 include:

The ABC requires that reasonable efforts must be made to ensure accuracy in all fact-based content. The ABC gauges those efforts by reference to:

3 The complainant was advised of this by way of email correspondence on 13 February 20144 Amalgamated Television Services Pty Ltd v Marsden (1998) NSWLR 158 at 164-167.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20133

o the type, subject and nature of the content;

o the likely audience expectations of the content;

o the likely impact of reliance by the audience on the accuracy of the content; and

o the circumstances in which the content was made and presented.

The ABC accuracy standard applies to assertions of fact, not to expressions of opinion.

FindingsThe ACMA finds that the ABC did not breach standards 2.1 and 2.2 of the Code.

Standards 2.1 and 2.2

In applying standard 2.1 of the Code, the ACMA usually adopts the following approach:

Was the particular content complained about factual in character?

Did it convey a ‘material’ fact or facts in the context of the relevant segment?

If so, were those facts accurate?

If a material fact was not accurate (or its accuracy cannot be determined), did the ABC make reasonable efforts to ensure that the ‘material’ fact was accurate and presented in context?

In applying standard 2.2 of the Code, the ACMA usually adopts the following approach:

Was the particular material (the subject of the complaint) factual in character?

If so, was that factual content presented in a way that would materially (i.e. in a significant respect) mislead the audience?

Statement one - An investigation is under way to determine whether a drug company has been promoting its popular acne treatment as a contraceptive

The ACMA considers that this was a factual statement; it was specific, unequivocal and capable of independent verification.

The complaint is that the statement was inaccurate because ‘no investigation was underway’.

The ABC does not dispute that this was an inaccurate factual statement. In its response to the complainant of 24 December 2013, it advised the error had been corrected on the ABC News Corrections page.

The ABC said that ‘the reporter was aware that there was no current investigation by the TGA at the time of the broadcast but that the script had been changed in the production process resulting in the incorrect statements broadcast’.

In its complaint to the ACMA, the complainant said that it doubted the ABC’s explanation for the error’s occurrence, and if the explanation was accepted at ‘face value [it did not] …comprehend what news the broadcast was intended to communicate’. In its view, in the absence of any current investigation there was ‘no news in the broadcast’.

There is no requirement under standard 2 that an explanation for a particular error be provided. The circumstances in which an admitted error is made could be relevant to an assessment of efforts made to ensure accuracy. Irrespective of the merits of the explanation given by the ABC, in this case it has admitted the error concerning the timing of the TGA investigation.

The ACMA finds that the statement that an investigation ‘is under way’ was not accurate.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20134

The ACMA is satisfied, having regard to the ABC’s admission of error, that the statement ‘an investigation is under way’ was not accurate and presented in context and that factual content was presented in a way that could have materially misled the audience.

Accordingly there was a failure to comply with standards 2.1 and 2.2 of the Code.

In respect of the ABC’s efforts to ensure that the remaining facts in statement one concerning the TGA investigation were accurate and presented in context, the ACMA notes that the ABC had regard to the following information:

prior to 3 December 2013, Bayer’s website included the statement ‘Product Type: oral contraceptive’5

on 3 December 2013 the ABC advised the TGA of a reference to the drug as a ’contraceptive’ on the drug company’s website

on the same day the TGA advised the ABC that it would investigate the matter to determine whether any action was required and noted:

In Australia, Dianne 35 ED is currently indicated for:

The treatment of signs of androgenisation in women, such as severe acne (involving inflammation of or nodularity risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree Diane-35 ED will also provide effective oral contraception in this patient group.6

On 19 December 2013, the TGA advised the ABC that the matter was investigated by the TGA and corrected on the drug company’s website7.

Later in the segment, the reporter stated ‘The manufacturer’s website referred to the drug as a contraceptive, prompting the Therapeutic Goods Administration to investigate whether Bayer was illegally promoting the drug.’

The accuracy of the factual assertion that the TGA had investigated whether Bayer had been promoting its acne treatment as a contraceptive has not been disputed and is verified by the email exchange between the TGA and the ABC in December 2013.

Apart from the timing of the TGA investigation, the ACMA is satisfied that the ABC made reasonable efforts to ensure that the material facts concerning the investigation were accurate and presented in context. Further, the factual content in statement one would not have materially misled the audience as to the nature of the TGA investigation.

When failure to comply is not a breach

In respect of the phrase ‘an investigation is under way’ in statement one, the ABC has submitted that, shortly after receiving a complaint about the broadcast, a correction which was adequate and appropriate in all the circumstances was added to the ABC News Corrections page. The complaint was therefore resolved and the initial failure to comply with standard 2 of the Code does not constitute a breach of the Code.

Section III of the Code provides:

The ABC seeks to comply fully with the Code and to resolve complaints as soon as practicable.

5 ABC Screenshot dated 3 December 2013 of Bayer Australia website last updated 15 July 20136 Email from the Australian Government Department of Health Inc the TGA to the ABC dated 3

December 20137 Email from the Australian Government Department of Health Inc the TGA to the ABC dated 19

December 2013

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20135

A failure to comply will not be a breach of the Code if the ABC has, prior to the complaint being made to the ACMA, taken steps which were adequate and appropriate in all the circumstances to redress the cause of the complaint.

To illustrate, a failure to comply with Standards 2.1 or 2.2 (Accuracy) will not be taken to be a breach of the Code if a correction or clarification, which is adequate and appropriate in all the circumstances, is made prior to or within 30 days of the ABC receiving the complaint.

For the reasons set out at Issue 2, below, the ACMA is satisfied that the correction concerning statement one was made in an appropriate manner and as soon as reasonably practicable. For those reasons, the ACMA also considers that the steps taken by the ABC to redress that aspect of the complaint were adequate and appropriate in all the circumstances.

The ACMA is also satisfied that the ABC took these steps prior to the complaint being made to the ACMA, since the correction on the ABC News Corrections page was published on 20 December 2013 and the complaint to the ACMA was received on 30 January 2014.

Accordingly, under the terms of the second paragraph of Section III of the Code, the ABC did not breach standards 2.1 or 2.2 of the Code.

Statement two – The drug called Diane is only approved for skin and hormone problems

The complaint is that this statement was inaccurate because the drug is indicated for oral contraception amongst women with signs of androgenisation, and is ‘approved as an effective oral contraceptive in women treated for signs of androgenisation.’

In its response to the complaint of 24 December 2014, the ABC noted that the segment reported that, ‘Diane and its generics are only approved for acne and other hormonal problems and not as a standalone contraceptive’ and that this was consistent with the product information for the drug and with TGA advice.

The ACMA considers that the statement was a factual statement; it was specific, unequivocal and capable of independent verification.

The statement was included in the introduction and was followed by contextualising statements by the reporter in the segment:

it is the drug of choice for women with acne because of the increased risk of clots Diane 35 and its generics are only approved for

acne and other hormonal problems – not as a standalone contraceptive health authorities confirm that anecdotally lots of women still take Diane solely for

contraception lawyers say Australian doctors could face legal action if a patient becomes ill taking

medication contrary to approvals in a statement Bayer Australia says there’s no new evidence to change the

prescribing methods and the benefits outweigh the risks if the medication is used as directed.

The segment also featured an interview with a woman who had been prescribed the drug for skin problems (by a doctor who did not assess her family history) and suffered from a blood clot, an interview with a representative of the National Prescribing Service discussing the higher risks in taking it as a contraceptive, and a lawyer saying that doctors could face legal action if it is prescribed contrary to approvals. As discussed at Issue 1 above, the reporter

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20136

also said the manufacturer’s website referred to the drug as a contraceptive, prompting the TGA to investigate whether Bayer was illegally promoting the drug as a contraceptive.

In the context of the segment as a whole, the ACMA considers that the ordinary reasonable viewer would have understood that the drug is approved for skin and hormone problems, because of the risk of clots it should not be prescribed solely as a contraceptive, and it should only be prescribed in accordance with TGA approvals.

The ACMA accepts the ABC’s submission that the segment was consistent with the TGA advice (referred to above).

It is also consistent with safety advisory information for consumers on the TGA website for products containing cyproterone with ethinyloestradiol, such as Diane-35 which noted:

The TGA has completed a review of safety information available for these products and found an increased risk of venous thromboembolism (VTE)

However, it has been determined that the medicine’s benefits continue to outweigh the risks when used for indications approved by the TGA and outlined in the product information

Health professionals and consumers are reminded that the products should be used with caution in patients who have risk factors for VTE

The products are approved for the treatment of androgenisation in women, such as severe acne and hirsutsm, and also provide contraceptive cover when used in this patient group.8

The complainant was concerned that the segment had the potential to cause distress for those who had been correctly prescribed the drug and who also wished to use it as an ‘effective oral contraceptive.’

The segment did not state that the drug is not an effective contraceptive for women in this patient group. The ACMA considers that, consistent with the TGA health advisory, the more pressing public health message in the segment was that, even if prescribed for skin and hormone problems, Diane-35 poses a higher risk for women who have risk factors for VTE, and these factors must be assessed before it is prescribed.

The ACMA is satisfied that the ABC made reasonable efforts to ensure that the material facts concerning TGA approvals were accurate and presented in context, and that the relevant factual content was not presented in a way that would materially mislead the audience.

Statement three – It was temporarily banned in France earlier this year following a spate of deaths relating to blood clots.

This was a factual statement; it was specific, unequivocal and capable of independent verification.

The ACMA considers that the ordinary reasonable viewer would have understood that the drug was suspended in France as a result of deaths from blood clots.

News items about the re-introduction of Diane-35 in France following an 8 month suspension confirm that sales of the drug were suspended after four deaths caused by clotting over the past 25 years were linked to its use.9

8 http://www.tga.gov.au/safety/alerts-medicine-diane-35-130205.htm#.U6ElR_N--70 – Safety Advisory 30 May 2013

9 http://www.reuters.com/article/2014/01/15 ; http://www.theguardian.com/world/2013/jan/27/france- diane-acne-drug-deaths ; http://www.france24.com/en/20130130-france-halts-sale-acne-drug-diane-

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20137

In its complaint to the ABC of 13 December 2013, the complainant proposed the following as part of the corrective statement it sought from the ABC:

Earlier this year, the European Medicines Authority (EMA) confirmed that the benefits of Diane-35 ED continue to outweigh the risks. This confirmation was prompted by activities by the French Health Authority, which had temporarily suspended the marketing authorisation of Diane-35 ED. This suspension was due to concerns that the product was being inappropriately prescribed as an oral contraceptive rather than for its indications in France, which is for severe acne, and their concern for its safety for this use. It is well known that this class of medication carries a risk of blood clots and Bayer monitors and reports all of these events to health authorities. In France, Diane-35 ED is only approved for the treatment of acne in women. The marketing authorisation suspension was immediately lifted when the European Commission endorsed the findings of the review by the EMA when it found the benefits of the product continued to outweigh the risks.

The ACMA considers that the material factual assertions in statement three are verified by information in the public domain and are consistent with the complainant’s statement.

The ACMA is satisfied that the material facts were accurate and presented in context, and there is no need to assess the ABC’s efforts to ensure accuracy. In addition, factual content was not presented in a way that would have materially misled the audience.

The complaint to the ACMA was that the term ‘ban’ was sensationalist and that the reference was used to suggest the Australian investigation should be treated with more seriousness and

gravity, and it claimed that the statement was in breach of standards 4.1 and 4.5. As noted above, since this Code complaint was not made to the ABC in the first instance, the ACMA has not considered this particular complaint.

Issue 2: Correction

The next question for the ACMA is whether the correction concerning statement one was made in an appropriate manner and as soon as reasonably practicable as required by standard 3.1.

Standard 3.1

3. Corrections and clarifications

3.1 Acknowledge and correct or clarify, in an appropriate manner as soon as reasonably practicable:

a. significant material errors that are readily apparent or have been demonstrated; or

b. information that is likely to significantly and materially mislead.

The ABC has submitted that the correction on its News Corrections website page of 20 December 2013, was appropriate ‘given that the body of the story accurately reflected the legal status of the drug and that it is still effective and approved for use when properly prescribed.’

The correction is as follows:

35; http://www.heraldsun.com.au/news/acne-drug-linked-to-four-deaths-france ;

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20138

Diane drug approvals

7pm TV News:  On December 5, in a story about the anti-acne medication Diane 35, the ABC reported that an investigation ‘is under way’ by the Therapeutic Goods Administration into claims the drug's manufacturers Bayer have breached laws that prevent them marketing the drug as a contraceptive.  This is incorrect. The TGA investigation into Bayer had been completed the day before and Bayer’s website amended at the time of the broadcast.  View related report.10

The related report hyperlinked in the correction is an article on the ABC News website, updated on 13 December 2013, ‘Australian women being prescribed the drug as a contraceptive despite regulator warnings’. 11

Extracts are at Attachment D.

The complaint is that the correction is ‘deficient, unsatisfactory and misleading.’ The complainant contended that:

the correction states only that the TGA investigation … ‘had been completed’. It offered no clue as to what the result of the investigation was. The truth … was that the TGA considered no further action was required. By reason of this omission the ABC’s correction reinforces rather than dispels the impression a viewer may have had that the TGA was pursuing Bayer for wrongly marketing Diane as a contraceptive;

the linked ABC News website … is further misleading and confusing in light of the ABC’s acknowledgment that no investigation was under way…It contains a statement that the TGA said it would investigate claims that the drugs’ manufacturer Bayer breached laws that prevent the marketing of the drug as a contraceptive and that this statement is ‘completely at odds’ with the acknowledged fact that there was (even by 5 December) no current investigation;

the linked ABC News website states that an ABC news investigation has found that the drug ‘is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication.’ This allegation was not even made in the broadcast which went no further than Sophie Scott’s remark that ‘Health authorities have confirmed that anecdotally lots of women still take Diane solely for contraception’.

The ABC submitted:

The ABC does not agree that it was a critical omission in the correction not to mention that the TGA had determined that no further action was required. It was implicit in the correction that no further action was required. The correction said ‘The TGA investigation into Bayer had been completed.’ Any reasonable viewer would have understood from this that the TGA was not engaged in an ongoing investigation. The ABC is only obliged, under section 3.1 to correct the specific errors made in the broadcast, which it did.

In relation to the linked ABC News website article, the ABC said that it noted that its accuracy is not a matter for the ACMA and bears no relation to whether the correction is satisfactory. Notwithstanding this, it believes the report to be accurate because:

the line, ‘The TGA said it would investigate claims the drug’s manufacturer … breached laws that prevent them marketing the drug as a contraceptive http://www.abc.net.au/news/2013-12-05/women-prescribed-banned-contraceptive-

10 http://www.abc.net.au/news/corrections/11 http://www.abc.net.au/news/2013-12-05/women-prescribed-banned-contraceptive-pill/5136370

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 20139

pill/5136370, was in the past tense and was intended to describe the sequence of events outlined in the story – that is, after the ABC contacted the TGA, they indicated that they would investigate the claim, which they did – the line, therefore, was correct at the time and is correct now;

the ABC stands by the accuracy of the line, ‘An ABC News investigation has found [the drug] is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication’. The evidence can be found within the story in the statements of an NPS pharmacist…who says ‘anecdotally, the NPS does have information to suggest that women are using Diane solely as a contraceptive agent,’ and ‘Off-label prescribing… is a reasonably widespread practice’. This was corroborated by a South Australian solicitor…who said that there were examples among his clients of off-label prescribing.

In an appropriate manner

The ACMA considers that a correction, generally, should:

adequately identify the material being corrected;

acknowledge that the material was incorrect; and

explain the correct position.

In this case, the ACMA considers that the correction of 20 December 2013 on the ABC’s News Corrections website adequately identified the material being corrected (the investigation ‘is under way’), specified that this was incorrect and explained the correct position, being that the investigation had been completed the day before the broadcast.

In these circumstances, information as to the outcome of the TGA investigation as specified by the complainant would have gone beyond the ABC’s obligations under standard 3.1.

As soon as reasonably practicable

The complaint to the ABC was made on 13 December 2013.

The correction was published on 20 December 2013. The ACMA considers that seven days (considering the scope of the whole complaint that had to be evaluated) was a reasonable time for the ABC to verify the mistake and take appropriate corrective action.

The ACMA finds that the ABC’s correction was made as soon as reasonably practicable under the terms of standard 3.1 of the Code.

The ABC News website article

The ACMA does not accept the ABC’s submission that the linked ABC News website ‘bears no relation to whether the correction is satisfactory.’ By linking the website article to the correction, the ABC is, in effect, asking the reader to have some regard to its contents as associated with the correction.

The ACMA’s role is to assess whether the ABC corrected the error in an appropriate manner. While it is acknowledged that the primary focus is the correction itself, to the extent that the linked website article was relevant to the correction, the ACMA has considered whether it undermined the appropriateness of the correction.

The ACMA is of the view that, while the word ‘would’ may be ambiguous, the ABC News website article as linked to the correction can be read consistently with the correction. In all the circumstances it did not undermine the information contained in the correction.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201310

For the above reasons, the ACMA considers that the ABC complied with standard 3.1 of the Code.

Accordingly, the ACMA finds no breach of standard 3 of the Code.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201311

Attachment A Transcript of the segmentThe presenter: An investigation is underway to determine whether a drug company has been promoting its popular acne treatment as a contraceptive. The drug, called Diane, is only approved for skin and hormone problems. It was temporarily banned in France earlier this year following a spate of deaths relating to blood clots. Medical reporter, Sophie Scott has the story.

Sophie Scott: It’s the drug of choice for Australian women with acne, but this highly effective medication has potentially deadly side effects.

Interviewee: My skin did clear up, and – but sadly it nearly killed me.

Sophie Scott: [Interviewee’s name] took Diane for four months and developed a life-threatening blood clot in her lung.

Interviewee: Like somebody had a knife and they were stabbing me in the back.

Sophie Scott: [The interviewee’s] doctor didn’t know her medical history, and that her mother had a history of blood clots. Because of the increased risk of clots, Diane and its generics are only approved for acne and other hormonal problems – not as a standalone contraceptive.

National Prescribing Service representative: Good morning, NPS medicine line, this is-

Sophie Scott: Health authorities confirm that anecdotally lots of women still take Diane solely for contraception.

National Prescribing Service representative: Research has found that that risk is about one and a half to two times higher than women - in women who take another type of oral contraceptive.

Sophie Scott: The manufacturer’s website referred to the drug as a contraceptive, prompting the Therapeutic Goods Administration to investigate whether Bayer was illegally promoting the drug.

[Screen shot of Bayer website including ‘Product type: oral contraceptive.’]

Lawyers say Australian doctors could face legal action if a patient becomes ill taking a medication contrary to approvals.

Lawyer: If a medical practitioner is prescribed [the drug] outside of the regime that it’s approved for, and then the female has adverse health consequences as a result of that, there could certainly be liability against the prescribing medical practitioner.

Sophie Scott: In a statement, Bayer Australia says there’s no new scientific evidence to change the prescribing methods, and the benefits outweigh the risks if the medication is used as directed.

Sophie Scott, ABC news.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201312

Attachment BComplainant’s submissionsThe complainant submitted the following to the ABC (relevantly):

1. The news report stated that ‘an investigation is under way to determine whether a company has been promoting its popular anti-acne treatment as a contraceptive’. This is not correct. We are concerned that our email of 4 December 2013 was not taken into consideration for the on-air story or the ABC online sources. Our email of 4 December 2013 to [ABC staff member] made clear that we had liaised with the Therapeutic Goods Administration and that it had advised [the drug company] that no further action was required.

2. It was stated that [the drug] is ‘only approved for skin and hormone problems’. This is not the case in Australia. The Australian Product Information... states that:

The treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful or idiopathic hirsutism of mild to moderate degree.

[The drug] will also provide effective oral contraception in this patient group.

The complainant then submitted the following to the ACMA (relevantly):

[...]

5. The ABC has on its ‘Corrections and Clarifications – ABC News’ website published a correction to the Broadcast...

6. The ABC correction links to what is described as a ‘related report’, ‘Australian women still being prescribed [the drug] as contraceptive pill despite regulator warnings’ which is marked as ‘updated Fri 13 Dec 2013’...

7. [The original complaint] took issue with three aspects of the ABC news report:

(a) The broadcast stated that ‘an investigation is under way to determine whether a company has been promoting its popular anti-acne treatment as a contraceptive’. In fact no investigation was under way. This aspect of [Bayer’s] complaint was subject to the ABC correction. For the reasons set out below [Bayer] regards the ABC correction as deficient, unsatisfactory and misleading.

(b) The broadcast stated that ‘[the drug] is only approved for skin and hormone problems’, and that ‘[the drug] and its generics are only approved for acne and other hormonal problems’. These statements are incorrect. Australian Product Information... states that [the drug] is indicated for effective oral contraception amongst women who are being treated for signs of androgenisation. This part of [Bayer’s] complaint was rejected by the ABC. [Bayer] complains to ACMA about the rejection

The complainant then detailed the third limb of its original complaint (which will not be considered by the ACMA for the reasons outlined above) before continuing as follows:

The False report of a current investigation

8. The ABC accepts and admits that the broadcast was incorrect in claiming that an investigation ‘is under way’, and a correction has been published about that.

9. [Bayer] still has four concerns about this aspect of the broadcast, and the ABC’s conduct in the face of its admitted incorrect claim.

10. First, the ABC response was that the reporter, [reporter’s name], was aware there was no current investigation but that her script was changed by a producer and the presenter to incorrectly state that an investigation was under way.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201313

11. If this explanation is accepted at face value, [Bayer] does not comprehend what the broadcast was intended to communicate. In the absence of any current investigation as to [Bayer’s] practices, there was, in [Bayer’s] view, no news in the broadcast. So [Bayer] doubts this explanation.

12. Second, the ABC’s ‘correction’ states only that the TGA investigation into [Bayer] ‘had been completed’. It offered no clue as to what the result of the investigation was. The truth (as set out in [Bayer’s] letter of complaint) was that the TGA considered no further action was required. By reason of this critical omission the ABC’s correction reinforces rather than dispels the impression a viewer may have had that the TGA was pursuing [Bayer] for wrongly marketing [the drug] as a contraceptive.

13. Third, the ABC print report, which is linked to the ABC correction, is further misleading and confusing in the light of the ABC;s acknowledgement that no investigation was under way. The ABC print report contains a statement that the TGA said it would investigate claims that drugs’ manufacturer [Bayer] breached laws that prevent the marketing of the drug as a contraceptive. This statement is completely at odds with the acknowledged fact that there was (even by 5 December) no current investigation. This is a further incorrect, unfounded, and damaging statement that the TGA is to investigate possible breaches of the law by [Bayer], when the ABC has accepted that the TGA investigation had been completed; and as [Bayer] has previously advised the ABC through its letter of complaint, no further action was required.

14. Fourth, the ABC’s print report states that an ABC news investigation has found that [the drug] is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication. This allegation was not even made in the broadcast which went no further than [the reporter’s] remark that:

‘Health authorities confirmed that anecdotally lots of women still take [the drug] solely for contraception’.

The elevation of this apparent attribution of anecdotal statements from unnamed authorities to a positive finding by ABC news investigation that [the drug] is still routinely prescribed off-label is unsubstantiated and in [Bayer’s] view incorrect. Certainly no substantiation for it is set out in either the broadcast or the ABC’s print report.

15. In these respects [Bayer] regards the purported correction (and by incorporation through link, the ABC’s print report) as inadequate, further misleading and contrary to principle 2 (accuracy) and principle 3 (corrections and classifications) and the corresponding standards in section 4 of the ABC’s Code of Practice. The link to the ABC’s print report should be removed and the ABC ought not to continue to publish the ABC print report because it is misleading and inaccurate.

[The drug] allegedly approved only for skin and hormone problems

16. [The drug] is indicated for oral contraception amongst women with signs of androgenisation (see para 7(b) above).

17. Contrary to this fact the broadcast stated that [the drug] was only approved for acne and other hormonal problems.

18. The broadcast stood by its news report in this regard. Its proffered defence was not based on any information provided to [Bayer]. The ABC’s response asserts only that its report that [the drug] and its generics were only approved for acne and other hormonal problems was consistent with product information quoted by [Bayer] and advice received by ‘News’ (we assume this means ABC’s news department) from the TGA. This is a general assertion, wholly devoid of any detail or reasoning that enables it to be accepted, or even understood.

19. [The drug] is approved as an effective oral contraceptive in women treated for signs of androgenisation. The ABC report has the potential to cause confusion, anxiety, distress and error amongst women being treated for signs of androgenisation by the prescription of [the drug] who also wish to use [the drug] as an ‘effective oral contraceptive’.

20. In these respects the broadcast is contrary to principle 2 (accuracy) and corresponding standards 2.1 and [2.2]. The ABC’s decision to stand by this aspect of the broadcast is contrary

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201314

to principle 3 (corrections and clarifications) and standard 3.1 of its code of practice. In [Bayer’s] view, the ABC ought accept this position, and publish an unambiguous, clear and transparent correction in the form described in paragraph 25 below.

The complainant then detailed the third limb of its original complaint, which will not be considered by the ACMA for the reasons outlined above.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201315

Attachment C

ABC submissionsThe ABC responded to the complainant as follows:

1. ABC News advises that the reporter was aware that there was no current investigation by the TGA into Bayer at the time of the broadcast. Her script reflected that; unfortunately it was changed by a producer and the presenter incorrectly said that an investigation ‘is under way’

ABC news apologises for this error and any confusion or misunderstanding that may have occurred.

2. The story reported that ‘Diane and its generics are only approved for acne and other hormonal problems not as a standalone contraceptive’.

That is consistent with the product information you have quoted and the advice received by News from the TGA.

[...]

The ABC submitted the following to the ACMA:

Statement 1 - ‘An investigation is under way to determine whether a drug company has been promoting its popular acne treatment as a contraceptive’

In relation to 2.1, the ABC accepts that it was incorrect to say that an investigation ‘is underway’ and confirms that [the reporter] was aware that there was no current investigation. There is no reason not to accept ‘at face value’ the explanation that it was changed by a producer.

This error was acknowledged in the ABC’s original response to [the drug company] and was appropriately the subject of a correction on the ABC’s Corrections page.  This online correction was appropriate given that the body of the story accurately reflected the legal status of the drug and that it is still effective and approved for use when properly prescribed.

The ABC does not agree that it was a critical omission in the correction to not mention that the TGA had determined that no further action was required. It was implicit in the correction that no further action was required. The correction said ‘The TGA investigation into [the drug company] had been completed...’ Any reasonable viewer would have understood from this that the TGA was not engaged in an ongoing investigation. The ABC is only obliged under section 3.1 of the Code to correct the specific errors made in the broadcast, which it did.

In relation to the ‘print report’, we note that its accuracy is not a matter for ACMA and bears no relation to whether the correction is satisfactory. Notwithstanding this, the ABC believes the report is accurate. Specifically:

- The line ‘The Therapeutic Goods Administration (TGA) said it would investigate claims the drug's manufacturer [the drug company] breached laws that prevent them marketing the drug as a contraceptive’. http://www.abc.net.au/news/2013-12-05/women-prescribed-banned-contraceptive-pill/5136370, was in the past tense and was intended to describe the sequence of events outlined in the story. That is, after the ABC contacted the TGA, they indicated that they would investigate the claim, which they did. The line, therefore, was correct at the time and is correct now.

- The ABC also stands by the accuracy of the line: “An ABC News investigation has found [the drug] is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication”. The evidence can be found within the story in the statements of NPS pharmacist [name], who says ‘Anecdotally, the NPS does have information to suggest that women are using [the drug] solely as a contraceptive agent,’ and ‘Off-label prescribing... is a reasonably widespread practice.’ This was

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201316

corroborated by South Australian solicitor [name] who said that there were examples among his clients of off-label prescribing.

The ABC does not consider 2.2 to add anything further in relation to statement 1. The primary value of the story was always that there are women who had been prescribed [the drug] for their acne but continued to use it as a contraceptive despite the fact that other safer alternatives existed. There was, and continues to be, a genuine public health benefit in highlighting that women may be unnecessarily exposing themselves to risk by using the drug when safer alternatives are available. These details were accurately reported in the story and viewers were not misled. 

In relation to the failure to comply with 2.1, Section III of the Code of Practice is relevant.  Shortly after the ABC received the complaint from [the drug company], a correction which was adequate and appropriate in all the circumstances was added to the ABC’s Corrections page.  The complaint was therefore resolved and the initial failure to comply with 2.1 does not constitute a breach of the Code.

Statement 2 – ‘The drug, called [name], is only approved for skin and hormone problems’.

The ABC stands by the accuracy of this statement. The TGA Public Summary states that the indications for the drug are:

“The treatment of signs of androgenisation in women such as severe acne refactory to prolonged oral antibiotic therapy and idiopathic hirsutism of mild to moderate degree. [drug name] will also provide effective oral contraception in this patient group. If hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis. INDICATIONS AS AT 18 SEPTEMBER 1997: For the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. [The drug name] will also provide effective oral contraception in this patient group...” https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=63C7D889568C4045CA257CB0003CA942&agid=(PrintDetailsPublic)&actionid=1

The Product Information released by [the drug company] itself reflects this:

[The drug] is a progestogen-oestrogen combination for the treatment of signs of androgenisation in the woman. At the same time, it is a reliable contraceptive for women who suffer primarily from these signs or in whom acne and similar conditions occur or deteriorate under the use of other ovulation inhibitors. http://www.bayerresources.com.au/resources/uploads/PI/file9335.pdf

A similar form of words is used by the TGA in the safety advisory of 30 May 2013:

Products containing cyproterone with ethinyloestradiol, such as [drug name], are approved for the treatment of androgenisation in women, such as severe acne and hirsutism, and also provide contraceptive cover when used in this patient group. http://www.tga.gov.au/safety/alerts-medicine-diane-35-130205.htm#.UxkNzfmSx8E

It is clear from this that the standard and specific indications for the drug is for acne and that its use as a contraceptive is an ancillary benefit or effect. The point being that it should be prescribed for treatment of acne with its contraceptive qualities known and taken account of. Any reasonable reading of this suggests clearly that it should not be prescribed as a contraceptive in the first instance. This is consistent with the safety advisory, which also notes that: “the TGA has concluded that the risk of VTE with use of products containing cyproterone with ethinyloestradiol [drug name] appears to be around 1.5 to 2 times higher than for combined oral contraceptives (COCs) containing the progesterone, levonorgestrel, and may be around 4 times the risk in non-users of COCs” http://www.tga.gov.au/safety/alerts-medicine-diane-35-130205.htm#.UxkNzfmSx8E

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201317

It is a misrepresentation to suggest that “[The drug] is indicated for oral contraception amongst women with signs of androgenisation” when the clear intention of the TGA is that it is indicated for treatment of acne.

The report did not suggest that [the drug] is not an effective contraceptive. It did state that the drug was not indicated for use as a “stand-alone contraceptive”, which is a correct statement. Rather than creating “confusion, anxiety, distress and error” as [the drug company] claims, the report has corrected any confusion that may have been caused by [the drug company] suggesting on its website that [the drug] is indicated for use as a stand-alone oral contraceptive. It also highlighted the valuable information for women that [the drug] has a higher risk of dangerous side-effects than other drugs which are indicated for use as a stand-alone contraceptive.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201318

Attachment DExtracts from the ABC Website

Corrections and Clarifications – ABC News (Australian Broadcasting Corporation) News corrections website 12

[Published 20 December 2013]

Diane drug approvals7pm TV News:  On December 5, in a story about the anti-acne medication Diane 35, the ABC reported that a an investigation ‘is under way’ by the Therapeutic Goods Administration into claims the drug's manufacturers Bayer have breached laws that prevent them marketing the drug as a contraceptive.  This is incorrect. The TGA investigation into Bayer had been completed the day before and Bayer’s website amended at the time of the broadcast.  View related report

Related report – ABC News website13

Updated Fri 13 Dec 2013

Australian women still being prescribed Diane 35 as contraceptive pill despite regulator warningsAustralian women are still being prescribed a contraceptive pill temporarily banned in France earlier this year, in breach of the advice of the medicines regulator.

An ABC News investigation has found [the drug] is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication.

It can be used as contraceptive in women with hormonal problems.

The Therapeutic Goods Administration (TGA) said it would investigate claims the drug's manufacturer [the drug company] breached laws that prevent them marketing the drug as a contraceptive.

The drug was described as a "contraceptive" on the company's website until this week, when it amended the site following inquiries from the ABC.

Diane 35 was temporarily banned in France in January following a spate of deaths after its regulator found the increased risk of blood clots outweighed its potential benefits.

The TGA's advice on the drug has long been that it is only approved for use as a short to medium-term treatment for acne and other hormonal conditions.

While it also works as a contraceptive for prescribed patients, it does not have approval for that specific use.

The medicine is not listed on the Pharmaceutical Benefits Scheme and sales of the drug are hard to track.

Woman describes stabbing pain after developing blood clotGold Coast woman [name] developed a blood clot in her lungs after being on [the drug] for four months.

12 http://www.abc.net.au/news/corrections/13 http://www.abc.net.au/news/2013-12-05/women-prescribed-banned-contraceptive-pill/5136370

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201319

[Name] was prescribed the medication by a doctor who was not her usual general practitioner and failed to pick up a family history of blood clots.

"It was like someone had a knife and they were stabbing me in the back and it was very difficult to breathe," she said.

She was in hospital for two weeks and had to be on blood-thinning medication for months.

"If it's just prescribed without thorough investigation I think it should be not allowed," she said.

"My skin did clear up but sadly it nearly killed me."

Medical history important to take into account, says pharmacist

Not-for-profit group National Prescribing Service (NPS) MedicineWise says it regularly receives calls from women who take the medicine as a contraceptive.

NPS pharmacist [name] says many women started on the pill for acne but stayed on it long-term to prevent pregnancy.

"Anecdotally, the NPS does have information to suggest that women are using [the drug] solely as a contraceptive agent," she said.

"Off-label prescribing... is a reasonably widespread practice.

"I don't think there's a need for concern particularly as long as the prescriber is taking into account the risk factors, taking into account medical history."

Retail pharmacists support their position, telling the ABC the drug is still routinely stocked on shelves but that sales had dropped off following negative publicity in January.

The active ingredient in Diane 35 is cyproterone with ethinyloestradiol and it is also sold in Australia under the generic names [drug names].

In May, the European Commission overruled French authorities and the ban on [the drug] was overturned.

Risk versus benefitPublished studies indicate the risk of blood clots from Diane 35and its generics is up to two times higher than other oral contraceptives and four times higher than women not taking the pill at all.

Some doctors are less concerned about risks posed by Diane 35 and its generics, saying there is a higher risk of blood clots during and after pregnancy, which the pill prevents.

Obstetrician [name] says doctors need to take a detailed history of patients when prescribing Diane 35 and monitor patients closely.

"Prescribing the pill is not a simple thing at all," he said.

"It's important that every woman who is being treated with the contraceptive pill of any type, whether it's Diane or any type, that they're not given endless repeats of prescriptions for the pill - that every opportunity is taken to review the woman."

[Name] says Diane 35 did have a role to play as a medication.

"This class of contraceptives are very commonly used and they have a valuable role in managing patients for example who have polycystic ovary syndrome," he said.

"Women should not be afraid for a prescription for the pill if they take all the precautions."

The TGA says its review of the safety information was that the benefits outweighed the risks and it should continue to be available for acne and other androgenisation conditions.

Medicos risk lawsuits if patients become ill, say lawyersA spokeswoman for Bayer says the medication had a favourable benefit-risk profile when used as directed.

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201320

"[Diane 35 has been available for over twenty years and there has been no new scientific evidence to change the positive benefit-risk assessment conducted by the regulatory authorities," she said.

"The benefits of [the drug] outweigh the risks for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age."

South Australian solicitor [name] is representing women in a class action against the makers of other contraceptives Yaz and Yasmin

[Name] says there were examples among his clients of off-label prescribing.

[Name] warned doctors who prescribe Diane 35off-label they could be exposing themselves to potential law suits if patients become ill.

"If Diane 35 has been approved for the treatment of severe acne then it should only be prescribed to women that have that complication," he said.

"Further to that, it also is a requirement that they've tried other means of treatment prior that's been unsuccessful.

"If medical practitioners aren't following that strict criteria then they certainly could be liable for the damages suffered."

ACMA Investigation Report 3168—7pm TV News—ABN – ABC TV–5 December 201321