BSA Decisions Ngā Whakatau a te Mana Whanonga Kaipāho

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Summary

Whether or not the drug Pulmozyme should be subsidised by the Pharmaceutical

Management Agency Ltd (Pharmac) was examined in an item broadcast on TV3's 20/20

at 8.30pm on 17 July 1995. The item reported that Pulmozyme ameliorates the

symptoms experienced by some people with cystic fibrosis. Having interviewed some

patients, their families and a clinician, and having referred to some research, the item

put the case for subsidisation to Pharmac which explained that the international research

did not justify the expense involved.

Mr Moore, General Manager of Pharmac, complained to TV3 Network Services Ltd

that the item was incorrect on a number of specific factual points and, overall,

unbalanced. It had failed to appreciate the clinical and economic issues involved.

Maintaining that there were no factual errors and that Mr Moore of Pharmac had been

given an opportunity to address the significant issues discussed, TV3 declined to

uphold most aspects of the complaint. However, as viewers should have been

informed that the apparently unaligned clinician interviewed – Professor Elliott of the

Auckland Medical School – was president of the Cystic Fibrosis Association and

supported subsidisation, TV3 conceded that the programme was not balanced on this

point. Dissatisfied with TV3's decision on the substance of the complaint, Pharmac

referred it to the Broadcasting Standards Authority under s.8(1)(a) of the Broadcasting

Act 1989.

For the reasons below, the Authority upheld the complaint that the item was unbalanced

in its failure to address adequately the ethical issues involved.

Decision

The members of the Authority have viewed the item complained about and have read the

correspondence (summarised in the Appendix). As is its practice, the Authority has

determined the complaint without a formal hearing.

The Programme

An item on TV3's current affairs programme, 20/20, examined whether Pulmozyme

should be subsidised by Pharmac – the Pharmaceutical Management Agency Ltd. The

item included comment from the head of Pharmac (David Moore) and referred to the

research which questioned the value of supplying the drug to all sufferers of cystic

fibrosis (CF). It was accepted that Pulmozyme was beneficial to some sufferers

although Mr Moore and a medical academic who specialised in CF (Professor Bob

Elliott) disagreed as to whether it was possible to identify that group clinically.

Professor Elliott argued that it would take a few hours at the most to do so.

The programme also included interviews with some people with CF. One (Paul

O'Halloran) spoke of the considerable benefits he had received from Pulmozyme. The

parents of two sons with CF (the Duncans) also spoke of the improved life style of their

son Ian while in receipt of Pulmozyme during a six month trial. However, they

reported that when the free supply stopped, the cost of the drug ($17,000 p.a. for each

son) meant that they had only been able to afford to pay for the Pulmozyme for one of

their sons.

As will be apparent, the programme dealt with issues which were potentially very

emotive.

Pharmac's Complaint and TV3's Reply

Initially Pharmac complained informally and began:

We spent considerable time and effort providing your team with information,

background and explanation for what could have been a sophisticated debate of a

complex issue currently facing health authorities in several countries. Such a

debate could have contributed to a mature understanding of basic problems

surrounding the high prices currently being charged for new medicines on the

market.

Instead your programme presented a simplistic them-and-us scenario that was

unbalanced, incomplete, misleading and at times inaccurate. For these reasons it

reflects very poorly on the standard of journalism.

Eight matters were listed which it was said contributed to the item's lack of balance and

four factual errors were alleged. TV3 responded informally and observed by way of

general comment:

PHARMAC would do well to realise that this is the level at which most New

Zealanders experience the health system, and PHARMAC's intellectual

justifications are a luxury for which most patients, particularly the chronically

sick, simply do not have the time and energy.

TV3 also explained the format of the 20/20 item:

PHARMAC is also being naive in expecting an enormous amount of detail to be

successfully reproduced in a television report. It is absolutely vital the detailed

research is done, and it was done by 20/20. But the real skill is in judicious and

responsible precis. PHARMAC displays a lack of understanding of the medium

if it believes that a lengthy account of comparative figures and calculations will

enlighten an audience one way or another – it is more likely to turn them off the

story entirely.

Pharmac then complained formally and wrote by way of introduction:

We question the social responsibility shown by 20/20 in taking such a one sided

approach to issues as serious as Pulmozyme and cystic fibrosis. These are tough

decisions for health professionals to make. The public portrayal of

misinformation, sensationalism and liberal use of anecdotal comment, while

making a great story, paints a false picture which, at the end of the day, is in no

one's interest, save that of the agency which uses such methods.

The following specific matters were cited as evidence of the item's lack of balance.

TV3's reply to each point is also recorded.

1.  Pharmac argued that the item was unbalanced to state that the drug would save

the country money. Further, Pharmac's calculations on the cost of the drug as

opposed to the cost of a hospital stay were not presented. TV3 responded that

Pharmac refused to accept that the findings of a major study of Pulmozyme were an

inappropriate basis on which to deny selective funding. Pharmac retorted that it was

well-versed in assessing scientific studies.

2.  It was misleading, Pharmac wrote, to use the anecdotal opinion of a young

couple to challenge the medical conclusion that a 6% reduction in lung congestion

through the use of the drug was not clinically significant. TV3 argued that the

patients were well able to judge this matter.

3.  Pharmac complained that the item incorrectly implied that Pulmozyme was

subsidised elsewhere. Australia, it observed, had rejected subsidisation. In reply,

TV3 maintained that the item did not imply that Pulmozyme was subsidised

extensively.

4.  Two matters were raised on the use of Professor Elliott to provide medical

opinion. First, the broadcast had not noted that he was also president of the Cystic

Fibrosis Association and a self-proclaimed CF patient advocate. Secondly, TV3 had

declined Pharmac's offers to provide a medical opinion in addition to Mr Moore's

comments.

TV3 upheld the first aspect and acknowledged that viewers should have been

informed of Professor Elliott's presidency of the Association. It added that this

information could have been equally as likely to enhance as to detract from his

credibility. On the basis that Mr Moore was given suitable opportunities to speak for

Pharmac, and the views of members of the Pharmacology and Therapeutics Advisory

Committee (PTAC) would have been superfluous duplication, TV3 declined to uphold

the second aspect.

In response, Pharmac believed that TV3's reliance on anecdotal reports rather than

including comments from a clinician showed either malicious bias or incompetent

research on its part.

5.  Pharmac regarded as unjustified the emphasis given to a trial of Pulmozyme in

Wellington which, it said, was poorly designed and, consequently, unlikely to provide

useful information. TV3 denied that the item had treated the trial as one of great

importance.

Pharmac also focussed on the ethical issues involved when a drug company supplies a

drug free of charge for a finite period. TV3 said in reply that it had spoken with the

bioethics academic suggested by Pharmac and claimed that he had no problems with

the format of the trial.

As it disputed TV3's comments on the point, Pharmac later supplied a letter from the

academic involved (Dr Seedhouse of the Auckland University Department of

Psychiatry and Behavioural Science) who strongly denied TV3's conclusion. He

reported his conversation with TV3's reporter in the following way:

... I tried to explain to her that she was researching a complex subject matter in

which there were many ethical issues, few if any of which are clear cut. She

told me that she was not interested in the ethical angle and repeatedly tried to get

me to say that the case was ethically unproblematic. But of course it is of deep

ethical concern, and I told her that if anything I was much more concerned about

the ethics of the pharmaceutical industry which indisputably is using these

patients at least in part for its own ends, and then seeking to exploit a

combination of their vulnerability and the antics of NZ's supine news-media to

ensure that it gets what it wants.

6.  Pharmac complained that the item did not explain that although it (Pharmac) did

not subsidise a drug, each hospital was able to do so from its own pharmaceutical

budget. Moreover, Pharmac questioned why Professor Elliott was not asked about this

point in relation to his own hospital. TV3 said that it was aware of the possibility of

hospital subsidisation but the issue raised in the item was why had Pharmac not

subsidised the drug.

7.  Why Pharmac asked, was the manufacturing company (Roche) not asked about

the high price tag for Pulmozyme, and why had it stopped supplying the drug free to

the two CF sufferers featured?

TV3 said it had asked the reason for the high price and believed the explanation to be

reasonable. The company had explained from the outset the limit about the length of

supply and, TV3 asked, why had Pharmac not continued to make the drug available at

a subsidised level?

8.  The item concluded with a brief report on a German study which found positive

results in the use of Pulmozyme. Pharmac queried why did the item not note that

Roche was the sponsor of that trial.

Because drug companies frequently provided free pharmaceuticals for such trials but,

nevertheless, the trials were the subject of independent monitoring and scrutiny, TV3

did not believe that the omission involved an imbalance.

Pharmac also alleged four factual errors. They were that the item implied, incorrectly,

that Pulmozyme was a cure for CF; that the drug was not currently available; that

some of the results of the German trial included in the broadcast were not included in

the report; and finally – as Pharmac's staff was described as consisting of

economists and pharmaceutical analysts – why the others on staff, especially

medical specialists, were overlooked.

In relation to the alleged factual errors, TV3 denied that the item contained the

implications claimed by Pharmac. With regard to the results of the German trial, it said

that the results given were provided by telephone, as had been other comments on the

trial, by H K Harms, Professor of Paediatrics at the University of Munich.

The correspondence between the parties and the correspondence to the Authority has

concentrated on the issue above numbered 1, ie whether the subsidisation of

Pulmozyme would save money overall, for example when compared with the costs of

hospitalisation for people with CF. As noted, there was agreement that it would only

benefit a percentage of CF sufferers in New Zealand. However, there was no

agreement on the percentage of people with CF who would benefit. It seemed to be

somewhere between 40–100 of the 300 CF sufferers. In addition, there was no

agreement on how that group would be identified, or indeed could be identified.

There was also disagreement on how much money, if any, would be saved by the

reduction of the number and length of the hospital stays of the people with CF who

would benefit from Pulmozyme, ie whether the savings from the reduced length and

number of hospital stays for a particular person with CF would meet the costs of

Pulmozyme for that person. While there was agreement that some sufferers do benefit

from Pulmozyme, there was also disagreement as to what degree of benefit justified a

subsidy. That last aspect is further complicated first, by the apparent disagreement

among observers as to what degree of improvement is medically significant, and,

secondly, whether the changes occur as a result of the drug or because of the normal

fluctuations in a person's condition.

Pharmac argued that a balanced programme would have addressed all the issues. TV3

in effect replied that as Pulmozyme helped some sufferers, subsidisation should involve

quality of life considerations in addition to financial savings. Therefore, it was implied,

Pulmozyme should be subsidised pending the publication of results from further trials.

The different approaches were summarised by Mr Moore of Pharmac in his final letter

to the Authority when he wrote:

It was easy and convenient to broadcast patient anger at the health system but

more difficult to understand the nature of often complex therapeutic concepts.

The end result was a popular documentary that irresponsibly played on the hopes

of people with a serious medical condition.

The Standards

The Authority assessed the complaint under s.4(1)(d) of the Broadcasting Act 1989 and

standards G1 and G6 of the Television Code of Broadcasting Practice.

Section 4(1)(d) requires broadcasters to maintain standards consistent with:

(d) The principle that when controversial issues of public importance are

discussed, reasonable efforts are made, or reasonable opportunities are

given, to present significant points of view either in the same programme or

in other programmes within the period of current interest.

Standards G1 and G6 require broadcasters:

G1  To be truthful and accurate on points of fact.

G6 To show balance, impartiality and fairness in dealing with political matters,

current affairs and all questions of a controversial nature.

The Authority's Findings

The Authority determined first the aspect of the complaint that the broadcast contained

factual inaccuracies in breach of standard G1.

As the broadcast clearly stated that there was no cure for CF, the Authority did not

accept that it was implied that Pulmozyme was curative. As the item reported that Ian

Duncan and Paul O'Halloran used the drug, although it was not subsidised, the

Authority did not agree with the complaint that the programme implied that Pulmozyme

was not available.

The Authority did not accept that the programme implied that the staff of Pharmac was

confined to "economists and pharmaceutical analysts". First, the item referred

specifically to "health economists" and, secondly, noted Pharmac's use of medical

advisers as consultants. That aspect was also not upheld, although the Authority

accepted that the approach taken tended to emphasise Pharmac's apparent focus (as

reported by 20/20) on financial considerations.

As TV3 was entitled to cite, in context, comment received from its telephoned inquiries

about the German study, although not included in the published literature, the Authority

did not accept that the reference to some individual patients showing a lung function

improvement of 40% was an inaccurate statement of fact. Moreover, the report said

there was a wide variation in lung improvement and, it was stated, the average

improvement was 10%.

The Authority thus declined to uphold any aspects of the complaint which alleged a

breach of standard G1.

The allegation that the broadcast breached the requirement for balance, impartiality and

fairness in standard G6 was much more difficult to resolve. The complainant and the

broadcaster had fundamentally different conceptions of the broadcast. In the

Authority's opinion, neither conception was clearly correct or incorrect.

As noted above, TV3 upheld the failure to report Professor Elliott's position as

president of the Cystic Fibrosis Association as a breach of standard G6. It declined to

take any further action on the point as it was possible that the reference could increase or

decrease his credibility as a medical spokesperson. The Authority agreed with TV3's

decision on this matter and the reasons given for it.

The Authority was not prepared to rule that the obligation in s.4(1)(d) of the Act to

present significant points of view had been contravened. It did not necessarily accept,

as TV3 argued, that Pharmac's advisers would have reiterated matters but it considered

that Pharmac's Mr Moore had been given ample opportunity to address the issues.

It is obvious that Pharmac takes very seriously its role when deciding which drugs

should be subsidised. As it is dealing with limited financial resources, it is apparent that

it seeks competent professional advice before concluding whether the benefits available

from a drug – such as Pulmozyme – outweigh the costs.

The Authority acknowledged that TV3 in the preparation of the item seemed to have

considered much of the same material about Pulmozyme as was available to Pharmac.

The Authority did not accept that the item suggested that the research evidence was

overturned by the anecdotal accounts. Nevertheless, TV3's investigation seemed to

present the conclusion that more weight should be given to the subjectively assessed

quality of life benefits – as shown by Paul O'Halloran, and Ian Duncan and his parents –

than had been given to these matters by Pharmac.

There is no infallibly correct answer to the question of whether or not Pharmac should

subsidise Pulmozyme. The Authority's task was to decide whether TV3 had complied

with the obligation in the broadcasting standards to present the issue so that the viewer

was aware of the conflicting pressures, and could weigh the respective points of view,

on clinical, ethical and compassionate grounds.

Because the decision reached by Pharmac not to subsidise Pulmozyme had included

ethical perspectives, and because TV3 felt justified in questioning that decision, the

Authority regretted that the broadcast had not dealt with the ethics of the New Zealand

trial. The Authority accepted that Dr Seedhouse advised TV3 that the manufacturers'

"compassionate" supply of Pulmozyme was a major ethical issue. The Authority is

aware that the practices used by the drug industry, like any major industry, are designed

at least partly to increase the company's profitability. It was an issue to which Pharmac

referred tangentially in the correspondence although the complaint did not directly refer

to the ethics surrounding the issue, such as a drug company's "compassionate" supply

of a particular drug to selected patients for a limited period only.

As has been explained, the Authority found this complaint difficult to determine. It

dealt with an issue – supply of an expensive controversial drug – which required difficult

medical, financial and ethical decisions that might in due course be reversed as new

research was published. It referred to a major company which, not surprisingly, was

concerned for a number of possible reasons with justifying the use of the drug. It also

dealt with an agency which, equally not surprisingly, was concerned to examine claims

carefully to ensure that the decisions to spend money are reached on the basis of the best

and most thorough information available.

In reaching a decision on whether the item was unbalanced because the ethical issues

had not been confronted directly, the Authority in addition to the matters canvassed

above, took into account the following issue.

TV3 explicitly focussed on the benefits of Pulmozyme to a sub-group of people with

CF. Professor Elliott maintained that the sub-group would be easy to identify.

Pharmac did not contest the point that Pulmozyme would be of benefit to the sub-group.

However, it did not agree that it was possible to identify that sub-group readily and,

therefore, seemed to be responding to the subsidy questions on the basis that the drug

should be made available to all people with CF.

This posed the question as to why the item did not explore the problems associated with

determining a suitable sub-group. Indeed, given the apparent ease by which a suitable

sub-group could be ascertained according to Professor Elliott, it could be asserted that

the item lacked fairness in not exploring the matter. The Authority considered that a

pertinent question would have been whether sub-groups had been identified in countries

where Pulmozyme is subsidised.

Taking all the points into account, the Authority decided that the item did not deal

adequately with the ethical issues, and the conflicting pressure exerted by those ethical

issues, which were inherent in the subject discussed. While the focus on the financial

and personal histories of some CF sufferers was presented in a way that did not

contravene standard G6, the Authority considered that the item's coverage of the ethical

issues was inadequate. Because of the inadequate way in which those issues were dealt

with, the Authority concluded that the broadcast breached standard G6.

For the reasons above, the Authority upholds the complaint that the

broadcast of an item on 20/20 on 17 July 1995 by TV3 Network services

Ltd contravened standard G6 of the Television Code of Broadcasting

Practice.

It declines to uphold the other aspect of the complaint.

Having upheld a complaint, the Authority may impose an order pursuant to s.13(1) of

the Broadcasting Act 1989.

The item complained about involved visuals and heartfelt personal accounts, and was

weighed in such a way that the substance of the story thus became enveloped in the

quality of life issue, to the detriment of important ethical considerations. The Authority

considered that the examination of the ethical issues might have gone some way to

explain why Pharmac did not subsidise Pulmozyme.

However, TV3 did provide Pharmac a reasonable opportunity to present its point of

view. Pharmac did not focus, either in the programme or its complaint, on the lack of

balance resulting from an inadequate consideration of the ethical issues which has

concerned the Authority. In the circumstances, the Authority decided to make no order.

Signed for and on behalf of the Authority

Judith Potter
Chairperson
18 January 1996

Appendix

Pharmac's Informal Complaint to TV3 Network Services Ltd - 21 July 1995

David Moore (General Manager) of Pharmac (Pharmaceutical Management Agency Ltd)

complained informally to Keith Slater (Executive producer) of 20/20 about the item on

Pulmozyme broadcast by TV3 at 8.30pm on 17 July 1995.

Mr Moore began:

We spent considerable time and effort providing your team with information,

background and explanation for what could have been a sophisticated debate of a

complex issue currently facing health authorities in several countries. Such a

debate could have contributed to a mature understanding of basic problems

surrounding the high prices currently being charged for new medicines on the

market.

Instead your programme presented a simplistic them-and-us scenario that was

unbalanced, incomplete, misleading and at times inaccurate. For these reasons it

reflects very poorly on the standard of journalism.

Mr Moore then listed the following which contributed to the item's imbalance.

i) Despite the item stating that the drug Pulmozyme would save the country

money, Pharmac's calculations on the cost of the drug as opposed to the cost of

a hospital stay were not presented.

ii) It was misleading to use the anecdotal opinion of a young couple to challenge

the medical conclusion that the 6% reduction in lung congestion through the

use of the drug was not clinically significant.

iii) While Dr Elliott (of Auckland Hospital) noted that the drug was subsidised in

some countries, the programme omitted to note that Australia had rejected

subsidisation for the second time. Further:

There was also no comment that the Ministry of Health has given the drug

only provisional registration for mild to moderate CF sufferers.

iv) Despite offers from Pharmac to provide a medical perspective, Dr Elliott was

the only source of medical opinion shown in the programme. However, the item

did not point out that Dr Elliott was president of the Cystic Fibrosis Association

and a self-proclaimed CF patient advocate.

v) The reporter gave great emphasis to the so-called drug trial in Wellington

despite being advised that it was considered to be poorly designed and unlikely

to provide useful information.

vi) No mention was made of the fact that hospitals have their own

pharmaceutical budget independent of PHARMAC and can fund

Pulmozyme if they deem it appropriate to do so - including Dr Elliott's own

hospital.

vii) The manufacturing company was not asked why it had put a high price tag on

the drug or why it had stopped supplying Pulmozyme to Ian Duncan and Paul

O'Halloran after six months.

viii) The broadcast did not note that the German study cited had been sponsored by

Roche, the marketeers of Pulmozyme.

Mr Moore then listed the following factual errors in the programme:

i) As there was no cure for CF, it was incorrect to imply that Pulmozyme was

curative.

ii) The broadcast ignored the fact that the drug, although not subsidised, was

available.

iii) On the papers available to Pharmac, the German study did not refer to 40%

improvements and, further, it did use a placebo control.

iv) The comment that "PHARMAC is run by economists and pharmaceutical

analysts" completely ignores the medical advisers, pharmacists on staff, and

the medical director who spent several hours in discussions with the

reporter.

Mr Moore concluded:

Your programme could have contributed to responsible and rigorous debate about

the difficult issues surrounding the subsidisation of expensive drugs with

unproved clinical efficacy. Instead it presented a one-sided and unbalanced view

of the issues involved.

PHARMAC accordingly requires you to correct the unbalanced presentation of the

issues surrounding the subsidisation of Pulmozyme in a form satisfactory to us.

TV3's Response to the Formal Complaint - 28 July 1995

Acknowledging Pharmac's interest and involvement in the broadcast, Keith Slater

(Executive Producer of 20/20) referred to his discussions with the item's reporter and

suggested that Pharmac's expectations were themselves "one-sided".

Mr Slater explained that the item focussed on the cases of two families whose children

had CF and for whom it was a "them and us" situation. Pointing out that the

programme reflected fairly their view at patient level, TV3 wrote:

PHARMAC would do well to realise that this is the level at which most New

Zealanders experience the health system, and Pharmac's intellectual justifications

are a luxury for which most patients, particularly the chronically sick, simply do

not have the time and energy.

Mr Slater also explained the format of the 20/20 item:

PHARMAC is also being naive in expecting an enormous amount of detail to be

successfully reproduced in a television report. It is absolutely vital the detailed

research is done, and it was done by 20/20. But the real skill is in judicious and

responsible precis. PHARMAC displays a lack of understanding of the medium

if it believes that a lengthy account of comparative figures and calculations will

enlighten an audience one way or another - it is more likely to turn them off the

story entirely.

In regard to the specific broadcast complained about, Mr Slater maintained that the

conclusions reached were based on the material provided and were the relevant and

interesting ones for the viewer.

Mr Slater then commented about the specific matters under the following headings.

1) Average Results

Pharmac refused, it was argued, to consider that the "low" figures it cited from

the Fuch's study to justify its decision were not representative of the sorts of CF

patients in New Zealand who were arguing for selective funding.

2) Calculations

Maintaining that there was not a great disagreement on the figures quoted by

Pharmac and Professor Elliott, TV3 said it was nevertheless clear that the drug's

high initial cost could be significantly ameliorated by subgroup targeted

prescribing. Mr Slater added:

20/20 was not aware that a new drug entering the New Zealand market

these days had to be proven cost-neutral before it could be considered for

funding.

3) Targeting

As a number of clinicians accepted that it was possible to identify a subgroup, Mr

Slater said that they had expressed to 20/20 some bafflement at Pharmac's rigid

stance that it was difficult to identify a subgroup.

4) Drug Company Figures

Pharmac, Mr Slater said, was disingenuous to hide behind Roche's original

figures which, Roche had told 20/20, had no application to the treatment of a sub

group.

5) Tone

Mr Slater commented;

Just as a matter of approach, [the reporter] is intrigued why PHARMAC,

who has had meetings with Paul Halloran (sic) and is presumably familiar

with his particulars, should describe him as a "young patient" when he is in

fact 32, and describe Rachel Jean, who has been his partner for 10 years

and his wife for 5 of them, as his "girlfriend". Does PHARMAC seek to

imply that these people do not fully understand what they are talking about?

Would it help the admirably qualified PHARMAC to listen to them more

closely if they knew that Rachel Jean has a Bachelor of Arts degree and is

currently working on her Masters, while holding an extremely taxing job as

a film producer?

6) Fluctuations in condition

Arguing that patients were able to perceive whether a drug made a difference, Mr

Slater said that 20/20 had not mentioned fluctuations in condition as the patients

spoken to were able to distinguish between variations in CF and the effects of the

drug.

7) Overseas Subsidisation

Mr Slater said that the funding of Pulmozyme elsewhere had been discussed with

Pharmac and Professor Elliott's comment contained the implication that funding

elsewhere was not universal. He wrote:

The important point to make here, though, was that the arguments used by

PHARMAC were not considered valid worldwide.

8) Registration

As Pulmozyme was acknowledged as safe and effective, the item had questioned

Pharmac's approach that it was in some way unproven as it had only been given

"provisional" registration.

9) Professor Bob Elliott

Expressing "intrigue" that Pharmac considered Professor Elliott's presidency of

the CF Association compromised his medical opinions, Mr Slater acknowledged

that he was both expert and advocate. It hoped that Pharmac staff were also

patient advocates.

10) PTAC (Pharmacology and Therapeutics Advisory Committee)

20/20 had decided not to interview John Hedley of PTAC (which reports to

Pharmac) because, as Pharmac had advanced his views, his comments would

amount to superfluous duplication rather than balance.

11) The NZ Trial

The item had not placed "great importance" on this trial. It was significant as it

allowed a small number of New Zealanders with CF to try out the drug and was

part of a multi-national study referred to at the end of the item.

12) Ethics

The item did not examine the ethical issues as the New Zealand trial was approved

by some and disapproved by other Ethics Committees. As another reason among

others, at Pharmac's suggestion, Bioethics Professor David Seedhouse was

spoken to and he had no problems with Roche's handling of the study.

13) Hospital Funding

20/20 was aware that hospitals could decide to fund Pulmozyme on an individual

basis. However, the question advanced in the programme was why Pharmac did

not fund the drug.

14) Cost of Pulmozyme

Roche had been asked about the high cost and had explained that Pulmozyme

involved DNA modifications which were expensive. As it seemed also to be

unique, 20/20 had accepted the explanation as reasonable.

15) Supply of Pulmozyme

The drug company had said that it would only supply the drug for the trial period

of six months and, Mr Slater asked, if Pharmac was concerned about this, why

had it not made the drug available at a subsidised level.

16) The German Study

As with similar trials, Roche provided free pharmaceuticals but the other aspects

of the study were subject to independent monitoring and scrutiny. That had been

confirmed by H K Harms, Professor of Paediatrics at the University of Munich.

Mr Slater then addressed the "so-called errors of fact".

i) The item had not implied that Pulmozyme was curative.

ii) The item made abundantly clear that the drug was available.

iii) Mr Slater wrote:

The reference to 40% improvements is a direct quote from Professor

Harms in the course of his telephone conversation with [the reporter]. The

reporter made it clear when she faxed PHARMAC with the copy she had

of the Professor's overheads of the study, that this was all there was in

English translation at that stage, and it was unavoidably incomplete.

Perhaps PHARMAC should itself take the trouble of contacting Professor

Harms.

Professor Harms, he continued, had advised that it would be unethical to run a

placebo controlled trial as Pulmozyme was known to be effective.

iv) The programme had explained that Pharmac consulted its medical advisers.

Mr Slater concluded:

The reporter maintains the item was contentious, but balanced. She has greatly

enjoyed her contact with the professionals in PHARMAC, and respects their

energy and dedication.

20/20 will continue to follow developments in the issue with great interest.

Pharmac's Formal Complaint to TV3 Network Services Ltd - 4 and 29

August 1995

On behalf of Pharmac, Mr Moore began:

Thankyou for the apologia on your recent documentary about Pulmozyme.

However, we note with concern the fact that you admit that the documentary was

one sided and then try to justify this.

We question the social responsibility shown by 20/20 in taking such a one sided

approach to issues as serious as Pulmozyme and cystic fibrosis. These are tough

decisions for health professionals to make. The public portrayal of

misinformation, sensationalism and liberal use of anecdotal comment, while

making a great story, paints a false picture which, at the end of the day, is in no-

one's interests, save that of the agency which uses such methods.

It advised that the details of the formal complaint would follow. The details were

contained in a letter dated 29 August in which Mr Moore of Pharmac wrote:

PHARMAC wishes to reiterate its concerns about your acknowledged bias in the

documentary and the seeming lack of social responsibility shown by 20/20 in

taking such one sided approach to issues as serious as the drug Pulmozyme and

cystic fibrosis.

He also expressed concern about the tone of TV3's letter which he found difficult to

understand in view of Pharmac's openness and, he observed:

PHARMAC fears that these attitudes have been present since you first began

work on the documentary and that the result was a biased and unprofessional

piece of work.

In response to TV3's comment about naivety, he wrote:

PHARMAC merely expected that details would be summarised correctly and

without bias. Either 20/20 was unable to do this, or you approached the

information with a bias toward certain information.

Before dealing with the specific points, he made three broad contentions:

l improvement in quality of life based on the one major clinical trial done is

only 1 - 2% (we note that you selected the 6% improvement in FEV1 but

ignored the quality of life statistics);

l Australia has twice turned down Pulmozyme and its subsidisation in the

UK is controversial;

l not even the pharmaceutical supplier claims that the drug saves money, as

you put forward.

1) Average Results

Stating that 20/20 was factually incorrect to claim that Pharmac refused to study

the "low" figures in Fuch's study, Mr Moore pointed out that Pharmac was well-

versed in assessing scientific studies.

2) Calculations

As 20/20 had combined the issues of the use and economics of Pulmozyme,

Pharmac said they were each only partially addressed. Thirty one days of

hospitalisation per year per patient were needed before the drug became cost

neutral for the patient. But the item neglected to advance any evidence that

Pulmozyme provided nowhere near such relief for the patient. Roche and the

Fuch's trial suggested that 3 days of hospitalisation per patient per year could be

saved.

He continued:

The second issue is of cost neutrality. A drug does not have to be cost

neutral to be subsidised, as long as the benefits from use of that drug

warrant its extra cost. Pulmozyme was not turned down because it is not

cost neutral, but because the extra costs outweigh the small benefits

offered.

3) Targeting

Expressing bafflement at the conclusions drawn by the specialist clinicians

consulted by TV3, Mr Moore said targeting patients had been discussed with

clinicians but difficulties lay in:

* setting guidelines for the group which would benefit

* the degree of benefit from Pulmozyme for this targeted group.

The guidelines from Professor Elliott did not specify criteria and, he said, good

journalism should have challenged this lack of specificity.

4) Drug Company Figures

Rejecting the claim that the drug company figures were misleading, Pharmac

commented that 20/20 seemed to have misunderstood the issue.

5) Tone

Pharmac, he said, had listened to people with CF but he did not accept that the

experience of one patient and his partner justified refuting the advice from some of

the best clinicians available in the field. The letter added:

On the subject of tone, we wish to reiterate our concerns with the tone taken

in the documentary in representing PHARMAC. Describing Mr David

Moore as an "ex-Treasury staffer" is both irrelevant to the issue of

Pulmozyme and demonstrates clear use of language which is not neutral.

This bias in tone was further accentuated by the omission of descriptions of

other PHARMAC personnel who are nurses, doctors and pharmacists by

training and experience. Viewing the documentary, one perceives

PHARMAC as a group of treasury economists, which simply isn't true. It

is a very diverse group of health professionals.

6) Fluctuations in condition

While taking into account TV3's comments, Pharmac questioned whether

anecdotal comments should be given priority over those from practising clinicians

and scientific evidence.

7) Overseas subsidies

Pharmac objected to the item's suggestion that Pulmozyme was subsidised

internationally.

8) Registration

Noting that registration was one of many factors when deciding on subsidisation,

Pharmac said it had highlighted the Ministry of Health's provisional registration

only because of the lack of long term evidence. The programme's question to the

Ministry indicated a misunderstanding of the various roles of each organisation in

assessing a drug's efficacy. It explained:

The Ministry of Health considers whether a drug works at all whereas

PHARMAC considers, how well the drug works and how much should be

paid for that drug's effect. Understanding of the Ministry of Health's role

would mean that 20/20 would have realised that the above question was

meaningless ["are you going to remove registration of Pulmozyme] in light

of the Fuch's et al study, as there is only one answer that the Ministry can

give, and adds nothing to the controversy about just how well does

Pulmozyme work?

Once again we noted 20/20's suspicious perception of PHARMAC motives

in your 28 July 1995 letter. Is it possible that 20/20 prejudged both the

issue and PHARMAC prior to producing the documentary?

9) Professor Bob Elliott

Why, Pharmac asked, has the item not made the point about Professor Elliott's

presidency of the Cystic Fibrosis Association and allowed the viewer to judge its

impact?

10) PTAC

20/20's refusal to speak to PTAC members was considered to be either deliberate

bias or a poor understanding of the clinician's role.

Further, your poor coverage of the Fuch's et al scientific trial, the only

authoritative trial on Pulmozyme to date in comparison to the attention given

to anecdotal reports from Roche's 16 person "trial" reinforces our view that

your documentary was either maliciously bias or incompetently researched.

Unfortunately, there is evidence for both views.

11) The New Zealand "Trial"

Mr Moore wrote:

You state that 20/20 did not pursue the ethical issues pertaining to Roche

NZ Ltd's trial in New Zealand. One of the reasons you state is that

"Auckland Bioethics Professor David Seedhouse-North ... said he had no

problems with Roche's handling of the study". Professor Seedhouse-

North has since stated that this is blatantly untrue. He does have concerns

about the ethics of Roche's handling of the trial and communicated this to

20/20.

This is a major discrepancy which we would like to see resolved. Did

20/20 apply its one-sided skills to the interview with Professor Seedhouse-

North, as it appears to have done with other evidence.

12) Hospital Funding

Repeating the point that hospitals could subsidise Pulmozyme from their own

budgets, Mr Moore asked why Professor Elliott was not questioned about his

own hospital's policy. Mr Moore then gave what he regarded as the probable

answer - scarce funds could be spent to better effect elsewhere.

13) The German Study

As the papers did not refer to the most important clinical paper available on

Pulmozyme (Fuch's study), 20/20's lack of understanding of the issues was

disclosed.

The formal complaint concluded:

In conclusion, your documentary:

l misrepresented, particularly by omission, the issues involved in our

consideration of Pulmozyme

l irresponsibly played on the hopes of people with a difficult condition;

and damaged, by biased reporting, public perception of both health

sector and PHARMAC

In doing this you ignored the depth of assessment of the drug, the international

controversy about marketing the drug.

Whether this misrepresentation was deliberate or the result of incomplete

understanding of the issues involved, it cannot pass unchallenged. PHARMAC is

keen that the viewers get a fair, complete, and balanced story.

PHARMAC repeats the request for a public apology.

TV3's Response to the Formal Complaint - 26 September 1995

TV3 assessed the complaint under s.4(1)(d) of the Broadcasting Act 1989 and standards

G1 and G6 of the Television Code of Broadcasting Practice.

Section 4(1)(d) requires that reasonable opportunities be given for the presentation of

significant points of view. As Pharmac's Mr Moore was given an opportunity to

respond on the key points in an item dealing with a complex issue and as Mr Moore had

taken advice from Pharmac's medical advisers and from PTAC, he was well informed

about the issues raised in the programme. TV3 thus concluded that the broadcast had

not contravened s.4(1)(d).

Standard G1 requires truthfulness and accuracy on points of fact. TV3 first dealt with

the complaint that the programme implied that Pulmozyme prevented death and, in

response, said the programme in fact stated or implied that CF was a fatal disease and

that Pulmozyme could only alleviate the symptoms.

The programme had also made clear, contrary to the complaint, that Pulmozyme was

still available to those who could afford it although it was not available on the

Pharmaceutical Schedule. TV3 added the programme's entire thrust was about the fact

that the drug was not on the schedule.

TV3 maintained that it was justified in reporting the results of the German study,

obtained by telephone directly from Professor Harms, and the programme had used the

word "indication" in presenting the results.

TV3 cited the transcript which referred to Pharmac and its advisers which, it said, was

factually correct.

Overall under standard G1, TV3 said that it had not been breached.

Turning to the aspects of the complaint which alleged a breach of standard G6, TV3

said Professor Elliott's opinion had been cited that:

"... for the small group of CF sufferers who need the drug most, it is cheaper to

give them the drug than treat them in hospital".

The professor believed that there were potential cost savings with Pulmozyme when

appropriately targeted. It was an argument with which Pharmac disagreed.

The programme reported the experiences of some CF patients and their families and,

TV3 recorded:

Whatever clinical evidence may indicate it was clear the Duncans and Paul

O'Halloran felt the drug was of benefit to them. It is clear from the programme

that hospitalisation for CF sufferers is intermittent. The programme mentioned

that winter is a particularly difficult time for CF sufferers.

Professor Elliott had reported on some American trials and said that the use of the drug

was funded in some countries. The drug's provisional registration in New Zealand,

TV3 added, was a detail which was not central to the item.

Pointing out that Professor Elliott was a leading expert on CF, TV3 maintained that his

presidency of the Cystic Fibrosis Association did not invalidate his views.

The New Zealand trial was not presented as statistically significant, TV3 continued, and

the fact that some hospitals funded Pulmozyme was not relevant to the issue of whether

Pharmac should fund the drug. TV3 also stated:

The cost of the drug was made clear by the programme. Why its costs so much is

irrelevant. Roche made it clear to all participants, and it was agreed in writing, the

trial would run for only six months.

Dealing with the German study, TV3 repeated that Roche supplied the drugs but did not

pay the doctors involved. Professor Harms had told 20/20 that Pulmozyme was the

most important drug developed for the treatment of CF in the last 10-15 years.

TV3 stated:

While the TV3 Complaints Committee is aware of the correspondence from

PHARMAC of the 29th August it has not responded to the specifics of that letter.

The Committee concluded it was primarily concerned with rebutting or debating

points made by the Executive Producer of 20/20 in response to the initial

correspondence to 20/20 from PHARMAC.

As for the complaint that the standards had been contravened, TV3 repeated its

conclusion that s.4(1)(d) and standards G1 were not transgressed. As for the other

aspect:

The TV3 Complaints Committee finds the programme erred in not informing

viewers of Professor Elliott's position as president of the Cystic Fibrosis

Association. However, that information may have enhanced his credibility as

much as detract from it.

Consequently, the TV3 Complaints Committee sees no benefit in the broadcast a

clarification.

Pharmac's Complaint to the Broadcasting Standards Authority - 25

October 1995

Dissatisfied with TV3's decision, Mr Moore of Pharmac referred the complaint to the

Broadcasting Standards Authority under s.8(1)(a) of the Broadcasting Act 1989.

Pharmac contended, he wrote, that the programme was one-sided, inaccurate,

unbalanced, unfair and mischievous.

TV3's Response to the Authority - 13 November 1995

In his response to the Authority's request for comments, TV3's Gerry Noble

(Managing Director) made three points.

First, he agreed with TV3's Complaints Committee's decision to focus on the aspects of

the complaint which related to the broadcast and to ignore the correspondence which

dealt with other matters.

Nevertheless, in response to Pharmac's complaint that 20/20's report on Professor

David Seedhouse-North's was "blatantly untrue", Mr Noble said the notes of 20/20's

reporter's conversation with the Professor were appropriate reported in the 28 July letter

to Mr Moore.

Secondly, dealing with the "The German Study", Mr Noble said he had also sighted the

reporter's notes of her telephone conversation with Professor Harms and they were

reflected in the item which was broadcast.

The third matter Mr Noble addressed dealt with the registration of the drug. He

reported:

While this matter was not canvassed in the programme I feel it is important the

Authority be aware Mr Mark Roland, Drug Evaluation Team Leader with the

Ministry of Health, is on record as saying "the Ministry does not register drugs

that don't work ... we know there is a target group of people for who the drug

does work". He stated "a drug is considered for provisional registration when

full safety and efficacy data is not known but there is a clearly defined need for a

limited group of people". Mr Roland emphasised provisional registration was

only granted when a drug is known to be safe and effective. Mr Roland

concluded, "Pulmozyme is in no danger of being deregistered.

In conclusion, Mr Noble expressed his agreement with the Complaints Committee's

findings.

TV3 had earlier provided the Authority with a news release from the Cystic Fibrosis

Association dated 5 October 1995 which reported that the Australian Minister for

Human Services and Health had accepted advice to subsidise Pulmozyme as it "appears

to offer effective treatment for some patients with cystic fibrosis". The release

concluded:

Pulmozyme is Roche's brand of dornase alfa, designed to breakdown the sticky

secretions in the lungs of cystic fibrosis patients. There are over 300 New

Zealanders affected by cystic fibrosis. It has been estimated that approximately

100 patients would qualify to try the treatment, and that possibly half would

continue on it as a long term treatment.

Pharmac's Final Comment - 1 December 1995

When asked to comment on TV3's response, Pharmac began:

Our basic concern is lack of balance. The points ignored by 20/20 may have

dampened the "angry" tone of the programme, but would have painted a much

more balanced picture for patients, prescribers and taxpayers.

The item, Pharmac continued, misinformed the public on the following points:

1. the perceived unethical nature of the drug's company's marketing

2. the refusal of the drug company to forward case study information during

the assessment process

3. an average improvement in quality of life from Pulmozyme, from clinical

trial information, of only 1% to 2%.

4. the simplicity of using anecdote in analysing this disease, because of the

high placebo effect and the apparent short duration of benefit, and the fact

that some patients feel better as their condition worsens

5. the controversial nature of subsidisation of the drug internationally, and that

the Australians had declined to subsidise the drug at that time also

6. the unsustainable nature of the back of the envelope calculations by the

President of the Cystic Fibrosis Association President, Professor Bob

Elliot.

Moreover, Pharmac wrote:

The public would have benefited from being given the opportunity to hear the

views of our medical advisers in face to face interviews, as was offered to but

rejected by 20/20.

In reply to the specific matters in TV3's report to the Authority, Pharmac argued that the

correspondence between TV3 and itself was relevant and that its letter of 29 August, in

rebuttal of TV3's of 28 July, was the basis of its formal complaint.

Secondly:

We have made our points about the German study in the latter correspondence to

TV3. We can only reiterate our claim that the 20/20 broadcast was misleading due

to an apparent lack of understanding of clinical issues and study protocols by the

20/20 investigating staff.

After agreeing with TV3's comments about registration, Pharmac turned to the

comments referring to Professor Seedhouse North. A statement from Dr North was

attached and Pharmac commented that it shared his concerns.

Pharmac concluded:

It was easy and convenient to broadcast patient anger at the health system but

more difficult to understand the nature of often complex therapeutic concepts.

The end result was a popular documentary that irresponsibly played on the hopes

of people with a serious medical condition.

The attached statement from Dr David Seedhouse, Editor of Health Care Analysis,

commented that despite cajoling by TV3's reporter he had not told her that he had no

ethical concerns about the practice of a drug company "compassionately" supplying a

drug and then withdrawing it. He gave the following account of his discussion with

her:

As I recall we had an extensive conversation ... . For my part I tried to explain to

her that she was researching a complex subject matter in which there were many

ethical issues, few if any of which are clear cut. She told me that she was not

interested in the ethical angle and repeatedly tried to get me to say that the case

was ethically unproblematic. But of course it is of deep ethical concern, and I told

her that if anything I was much more concerned about the ethics of the

pharmaceutical industry which indisputably is using these patients at least in part

for its own ends, and then seeking to exploit a combination of their vulnerability

and the antics of NZ's supine news media to ensure that it gets what it wants.

It is nonsense for the reporter to say that I said what she says I did. Contrary to

what she misunderstood I find the matter extremely troubling, so much so that I

have commissioned a special feature of articles on the subject of compassionate

supply for the international journal I edit. (Health Care Analysis: Journal of

Health Philosophy and Policy).