Dolutegravir- why new does not automatically mean better

By Tom Boyles

As has been previously reported by Spotlight, a new and exciting anti-retroviral, dolutegravir, is soon to become widely available in South Africa. Whilst its very real advantages have been extensively reported, the potential disadvantages have received relatively little attention.

In the past when new HIV drugs have become available, the advantages have clearly outweighed the disadvantages for the vast majority of people. For example, when tenofovir became available to replace D4T (stavudine), the choice to switch was straightforward for most patients; similarly when the current first line drugs became available in a fixed dose combination (FDC). In both cases there were clear advantages and very few disadvantages for most patients so they quite rightly demanded the new drugs. Now that the dolutegravir roll-out is on the horizon, we see an impatience to access the drug. However, it’s important to realise that it might not be right for everyone and that new does not necessarily mean better. For patients to make informed choices, they need to know how the advantages of dolutegravir may or may not apply to them and weigh these against the potential disadvantages.

One issue with dolutegravir that has received considerable attention is the possible risk of serious birth defects if women conceive while taking the drug, details can be found here. This issue will not be discussed further here, other than to say that hopefully all women will be offered correct and up to date information as well as access to contraception so that they can make empowered decisions.

 

Six reasons to be cautious of dolutegravir

  • Potential risk of serious birth defects. See above.
  • Potential for insomnia. The commonest side effect of dolutegravir is insomnia, whilst this may be mitigated by taking treatment in the morning and may wane over time, it has led to some patients stopping the drug. Efavirenz has similar side effects when people first take it but many patients are now stable on efavirenz and free of this distressing side effect.
  • Potential for weight gain. It has not been widely reported, but early studies have suggested that dolutegravir might lead to weight gain in some patients. For example, a 2017 study found that virally suppressed patients who switched from an efavirenz-based regimen to dolutegravir (or a similar drug) gained around 3kg after taking it for 18 months. The effect was greatest for dolutegravir compared to other similar drugs. Another 2017 study found that among 462 patients who were virally suppressed and changed to dolutegravir, the average weight gain was also around 3 kg after only 9 months of treatment and was greater for women than men. While these are relatively small studies it is clear that one potential effect of switching from efavirenz to dolutegravir might be weight gain, which is associated with serious non-AIDS events, impacts body image, and can be a barrier to ARV adherence.
  • Skin and liver reactions. Almost all drugs used to treat HIV have been known to cause skin rashes or problems with the liver, and dolutegravir is no different. There is no suggestion that dolutegravir causes these problems more commonly than drugs such as efavirenz or lopinavir/ritonavir (tradename Aluvia). However, patients who are side-effect free on their current drugs do run a small risk of developing skin or liver problems if they change to dolutegravir.
  • Drug interactions. Dolutegravir rarely causes interactions with other drugs but it can be the ‘victim’ of drug interactions. Notably, it is necessary to double the dose when it is taken with rifampicin, the most important drug for treating TB.
  • Potential for the unknown. Possibly the most serious reason to be cautious about dolutegravir is the potential for as yet unknown side effects. History is littered with examples of drugs that were introduced with fanfare after successful trials, only to later be withdrawn from the market due to side effects that only became apparent when the drug was used by large numbers of patients and for a longer duration. This review lists 462 such examples from 1950 to 2013.

In conclusion

There are several clear advantages to dolutegravir, notably its tolerability and high barrier to resistance and few would argue against its use in patients in whom this is most relevant. For example, patients who are newly diagnosed with HIV, returning to care after a period of treatment interruption and therefore at risk of drug resistance, those suffering side effects on their current regimen e.g. lopinavir/ritonavir, or those taking complex multi-tablet regimens. I would certainly advise patients to choose dolutegravir under any of those circumstances.

However, the vast majority of patients in South Africa who will be offered dolutegravir, possibly over 2 million, are currently virally suppressed and side effect-free on an efavirenz based FDC. For those patients the balance of advantages and disadvantages is less clear cut. The fact that dolutegravir is well tolerated and is a potent suppressor of viral load are of limited relevance to patients who are already side effect free and virally suppressed. However, those taking dolutegravir for the first time run the risk of developing new side effects, be they rashes, liver problems, insomnia, weight gain, or some new unknown side effect. They will also need to take dolutegravir twice a day if they need rifampicin for TB treatment.

For these reasons, patients who are already virally suppressed and side effect free on the current first line FDC may have more to lose than to gain by switching to dolutegravir. A more sensible option may be to stick with their current regimen for now and see what side effects are seen in others before considering a switch. Hopefully, such patients will be counselled that in this case new does not necessarily mean better and they are empowered to make their own decisions on this important issue.

Dr Tom Boyles is a Senior Research Clinician at the Wits Reproductive Health and HIV Institute.

Report exposes bullying, harassment and abuse at UNAIDS

An independent commissioned following multiple allegations of sexual harassment and bullying by senior staff at UNAIDS has been released telling a story of patriarchy, harassment and abuse of authority.

At the centre of it all is UNAIDS head Michel Sidibe.

The full report is here:

http://www.unaids.org/sites/default/files/media_asset/report-iep_en.pdf

The report is titled: “Report on the work of the  Independent Expert

Panel  on Prevention of and response to  harassment, including sexual

harassment; bullying and abuse of power at UNAIDS Secretariat”

Spotlight will report in more detail in the coming days, but these are some of the highlights from the recommendations.

1. In light of the Panel’s conclusion that the Executive Director

and leadership of UNAIDS are responsible for a culture of impunity for

abuse of office, bullying, and harassment, including sexual

harassment, the Panel recommends that the Programme Coordinating Board (PCB) take urgent actions to ensure a safe and respectful workplace.

 

2. Decide if the Executive Director can continue in the role

The Panel recommends the PCB carefully consider the condition of the

organisation as found in this report and determine if the present

Executive Director can continue in the role.

3. The Panel has no confidence that the current leadership can

deliver cultural change when that leadership has been largely

responsible for the current malaise. The Panel believes that for the

recommendations to be genuinely implemented and UNAIDS to regain a

culture of dignity and respect, a change in leadership has become

necessary.

4. The Executive Director has publicly accepted that the UNAIDS

Secretariat has a problem that requires a solution. He initiated the

setting up of this Panel and other actions which he considers will go

towards the failure to respond adequately to allegations of abuse of

office, bullying and harassment. The Panel finds the solutions

proposed by the UNAIDS Executive Director are superficial and

insufficient. Moreover, these solutions demonstrate a lack of insight

into the magnitude of the problems and his own responsibility for

them. Our inevitable conclusion from the review is that the state in

which we find the organisational culture of UNAIDS is something for

which the leadership of the organisation must be responsible and held

accountable.

5. The leadership of UNAIDS has enabled a culture of preferment,

non-transparency and circumvention of process, and permitted a work

environment that allows abuse of office, bullying and harassment. The

measures necessary to recover from the current situation, and

to implement a genuinely open culture in which harassment, bullying and

abuse of power of all sorts are removed from UNAIDS and not tolerated

again, must move swiftly forward with humility, acceptance of

responsibility and credibility.

6.  Recondition the leadership team

The PCB should consider placing a freeze on new senior-level

appointments, especially that of the Deputy Executive Director, until

it makes the leadership decision. All new leadership appointments

should be influenced by the findings in this report, especially a

strong consideration for gender equality in all leadership appointments.

7. Change at the top that resets the tone and behavioural

expectations will have a big impact but will not be sufficient to

address profound cultural and systemic problems within UNAIDS.

The leadership team (‘Cabinet’) is in turmoil. One Deputy Executive

Director post is vacant, and the other recently-appointed Deputy

Executive Director has not yet had a fair chance to take hold of

matters. The Human Resources Director position will soon be vacant

upon a retirement. The Cabinet has perhaps been smaller and more

insular than it should be. A new Executive Director will want to make

the appointments they think necessary to move forward.

The PCB may consider reviewing the senior leadership structure in its

totality to ensure that all posts and post-holders are appropriately

qualified to lead the required changes.

 

Spotlight has been reporting on this issue since the outset.

Here is a letter a Group of 23 women, known at the G23 wrote, calling for Sidibe to set aside. This same group of women stood up the opening of the International AIDS Conference in Amsterdam earlier this year. They stood up at Sidibe took the stage, read a statement and walked out with many delegates cheering and following them.

Health-e and Spotlight also reported on threats by now suspended UNAIDS Nigeria Country Director Erasmus Morah to sue South African HIV activist and academic Vuyiseka Dubula unless she apologises for calling him “a sexual predator and a skirt chaser”. Read the article here.

Dubula issued a statement in response as well as the G23. “As African women who are members of civil society organisations that advocate for social justice, and as co-signatories on the letter Morah claims defamed him, we stand alongside Vuyiseka Dubula and all women who choose to speak out about sexual harassment, abuse and violence.  Now, more than ever, it is important that we stand up to those who would prefer us to be silent,” the women said.

Spotlight also published damning information during the Amsterdam conference from Paula Donovan. Co-Director of AIDS-Free World and its Code Blue Campaign. Donovan has been a tireless campaigner, highlight the reported abuse at UNAIDS, now highlighted in the report. Donovan also wrote that according to leaked information about UNAIDS Executive Director Michel Sidibe’s correspondence with McKinsey and Company, 2018 will mark the beginning of the end of UNAIDS: the embattled leader has hatched a plot to begin dismantling the agency as soon as this year. Donovan’s information is already being confirmed with several sources telling Spotlight that there are discussions for UNAIDS to be absorbed by the World Health Organisation. Activists are mobisling to resist such moves.

 

 

 

 

 

 

 

 

 

 

 

12 questions answered on the state of SAHPRA

In February 2018 the Medicines Control Council (MCC) was replaced by the South African Health Products Regulatory Authority (SAHPRA). Spotlight sent SAHPRA a list of 12 questions to gauge how things are going with the new regulator, particularly regarding the backlog of medicines to be registered.

The below responses were sent to us by SAHPRA Acting CEO Portia Nkambule on behalf of the SAHPRA board chairperson Professor Helen Rees. We quote these responses in full so as not to lose any of the rich and valuable detail.

1.   Question: Noting that SAHPRA was only officially established earlier in 2018, how would you assess progress so far in operationalising the new regulator and the various changes in structure and function when compared to the MCC?

Answer: SAHPRA has made significant progress since its establishment in February 2018, despite the recent challenges in the National Department of Health. This has included:

  • Board committees have been appointed.
  • SAHPRA operational policies have been developed and approved by the Board.
  • Reengineering and streamlining of procedures and processes for the registration of medicines, approval of clinical trials and authorisation of Section 21 medicines.
  • Implementing improved procedures for the review and approval of radiation control applications.
  • Establishing a new regulatory framework for medical devices and in-vitro diagnostic (IVD) products.
  • Developing and implementing a strategy to clear the inherited backlog of applications.
  • Developed a Fees /Performance metrics model.
  • Significant progress has been made with the appointment of a new SAHPRA executive and management team.
  • SAHPRA is in the process of relocating staff to a new temporary fit-for-purpose premises.
  • The transfer agreement for transferring  former MCC staff to SAHPRA, in terms of Section 197 of the Labour Relations Act, has been signed.
  • Engagement with other regulatory agencies to facilitate collaboration and new regulatory approaches.

2.  Question: Is SAHPRA fully staffed? If not, can you give an estimate of what percentage of posts are currently filled?

Answer: SAHPRA currently has 178 full-time employees and a similar number of external evaluators supporting regulatory activities currently. It is anticipated that with the transition to in-house technical evaluation as well as the implementation of new regulatory functions, such as the regulation of medical devices, additional staff will need to be employed. The SAHPRA business model has proposed a staffing complement of around 450 full-time employees to carry out all required regulatory functions and will be phased in over a period of five years.

3.  Question: Does SAHPRA have sufficient funding to perform its functions? Please elaborate if there is any short-falls.

Answer: SAHPRA has budgeted to ensure it currently has sufficient funding to perform its functions. SAHPRA’s funding is made up of user fees as well as a contribution from Treasury.

4. Question:  What is the current backlog for registrations? If possible, can you give a breakdown for generic v new molecular entity applications?

Answer: At its formation, SAHPRA inherited a backlog of about 16,000 applications comprising both pre-registration and post-registration amendment (variation) applications. These include applications for duplicates of generic medicines, clones of newer innovator medicines, as well as different strengths and dosage forms of medicines. Of the pre-registration applications in the backlog, about 3,400 of these are already in-process and awaiting finalisation. Of the post-registration applications, about 3,000 of these are in the process of finalisation. Further, applications for generic medicines comprise more than 90% of the current backlog.

5. Question: What measures have been put in place to reduce the backlog?

Answer: SAHPRA has committed to clear the inherited backlog of applications within 2 years. Clearing the backlog rapidly will enable the establishment of a new, efficient, and effective health products regulator in South Africa. SAHPRA’s backlog clearance strategy comprises three pillars: (1) reducing the number of applications that require evaluation, (2) segmenting and prioritising applications on the basis of public health need, and (3) implementing new models for evaluation that recognise work done by other national regulatory agencies. Implementation of the backlog clearance strategy has already begun and has involved engagement with industry stakeholders, detailing technical and operational implications, securing ring-fenced funding, and implementation of a dedicated backlog programme management office. SAHPRA is currently conducting a pilot of the new measures and approach to the backlog and anticipates full implementation early in 2019.

6. Question: It was previously indicated that the MCC/SAHPRA set a target of 36 months for the registration of new molecular entities and a target of 24 months for generic medicines. Are these still SAHPRA’s targets?

Answer: SAHPRA has set internationally benchmarked targets of 275 working days for the registration of new molecular entities and 180 days for the registration of generic medicines.

7. Question: What percentage of new molecular entities and generics respectively are currently being registered within the target periods?

Answer: Despite the recent challenges, SAHPRA has made significant progress with the registration of new chemical entities and generic medicines in terms of its set timelines.

8.  Question: Has SAHPRA registered any biosimilars? If not, are there any specific obstacles to the registration of biosimilars in South Africa – such as outstanding guidelines or protocols?

Answer: Guidelines for the registration of biosimilar medicines have been finalised and implemented. Biosimilar medicines are currently being evaluated and registered.

9. Question: From time to time there is a particularly strong public interest case to get a medicine approved more quickly (as for example presently with the TB drug delamanid, generics of the ARV dolutegravir, and with biosimilars of the cancer drug trastuzumab). Can you please describe the available mechanisms to get medicines registered more quickly when there is a strong public interest case to do so?

Answer: SAHPRA has prioritised the review of applications for products that address public health needs and emergencies, unmet medical needs, as well as shortages of medicines in the marketplace. SAHPRA is also prioritising the review of key generic medicines to encourage market competition and improve affordability.

10. Question: We note that while the SAHPRA website has replaced the MCC website, there is still no easy way to search for registrations as one would expect from a website of this nature in 2018. Will SAHPRA be introducing a searchable database of registered medicines in order to increase transparency and the public’s ability to access information?

Answer: SAHPRA is in the process of updating and finalising its new website and will be introducing tools and searchable databases, including of registered medicines, to improve public access to information. SAHPRA recognises that consistent and timely communication with key stakeholders is critical to ensuring good regulatory practices and the creation of a culture of transparency. In this transitional phase, SAHPRA is prioritising the implementing a formal communications strategy and systems as a matter of urgency.

11. Question: The possibility was raised previously that registration by other stringent regulatory authorities could be considered when registering medicines in South Africa. Has there been any recent developments or new plans in this regard?

Answer: SAHPRA recognises that the manufacture and distribution of medicines are increasingly globalized, cooperation between medicine regulators has become essential, and multiple models of regulatory collaboration are being implemented in all regions of the world, even amongst the most resourced and mature regulatory agencies. SAHPRA has implemented legislative amendments to enable such a framework and is developing systematic approaches that would allow work-sharing and recognition of assessments carried out by other regulators while retaining responsibility for its own regulatory decisions. In this regard, cooperative agreements with a number of regulatory agencies in other countries have already been established.

12. Question: Has SAHPRA’s functioning, especially regarding section 21 applications, fully returned to normal after the recent strikes at the National Department of Health building in Pretoria? Please elaborate.

Answer: SAHPRA has  completely reengineered its procedures and processes for Section 21 applications through the implementation of a new online application system to improve service delivery and access to unregistered medicines for patients. This new approach has resulted in user-friendly, streamlined application procedures for clinicians and has dramatically improved turn-around times for applications.

 

 

Is South Africa on track to meet NSP targets?

On World AIDS Day 2018 we assess how South Africa is faring against 10 key targets set in the National Strategic Plan (NSP) on HIV, TB and STIs 2017 – 2022. The current picture is mixed, with areas of impressive progress, such as HIV testing,  offset by some serious red flags, such as retention in care.

Of the 10 targets, we have assessed two as “Appears target will be reached”, two as “Target is within reach”, four as “Reaching the target will be difficult”, and two as “no sufficiently reliable figures”.

In future articles we will assess progress against other important issues in the NSP not covered here such as stigma, availability of data, and accountability in the public healthcare system. Accountability for the development of implementation plans and actual implementation is an ongoing problem with the NSP – although there are now signs that it may be addressed. The South African National AIDS Council (SANAC) reports that it is currently “developing an NSP Accountability framework and scorecard for accountability to achieve the goals of the NSP 2017-2022 for HIV, TB and STIs”.

“The accountability framework will assist in ensuring commitment to set priorities by individual role players in the current and subsequent NSPs,” SANAC explained in response to questions from Spotlight. “The Framework will nationally determine who should be accountable, for what, why and how. The development of the accountability framework will require extensive consultations to ensure ownership in the national response.”

SANAC also indicated that its mid-term review of the NSP will be published by August 2019. The mid-term review is expected to include up-to-date estimates for all the indicators covered in this article.

1.Reduce new HIV infections to less than 100 000 by 2022 (or 88 000 by 2020)

According to the Thembisa model (a sophisticated mathematical model of HIV in South Africa) there were around 275 000 new HIV infections in South Africa in 2017. This number is higher than the 231 000 estimated in the South African National HIV Prevalence, Incidence, Behaviour and Communication Survey 2017 (the HSRC survey).

Either way, given the current trajectory it seems highly unlikely that South Africa will get new infections down to below 100 000 by 2022. The Thembisa model projects that new infections will only drop to around 198 000  by 2022 (with the low end of the 95% confidence interval around this estimate at 184 000).

According to SANAC, the target for New infections has now changed to 88 000 by 2020, an even more ambitious, and arguably more unreachable, target.  “The change/adjustment has been made in line with  the global UN Prevention road map to accelerate HIV prevention strategies and reach national and global goals to end the threat of AIDS by 2030,” SANAC explained in a response to Spotlight. “The NSP Steering Committee agreed that the change in the targets according to the Prevention Revolution will be incorporated into the NSP M&E Plan (rather than in the NSP programme narrative).  The NSP M&E Plan will be available once approved by all SANAC structures.”

Verdict: Reaching the target will be difficult

2. Reduce annual new HIV infections in women and girls aged 15 to 24 to 30 000 by 2022

The targets section of the NSP lists the 30 000 target, while earlier in the NSP reference is made to bringing the infection rate in young women and girls down to less than 800 new infections per week (which works out to around 41 000 per year). Either way, it is widely agreed that reducing new infections in young women and girls is of critical importance.

According to the Thembisa model there was around 81 000 new infections in women and girls aged 15 to 24 in 2017 (this works out to just over 1 500 per week, rather than the more widely quoted 2 000 per week.). Thembisa projects annual infections in this group only dropping to around 58 000 by 2022 – almost double the target.

Verdict: Reaching the target will be difficult

3. The rate of mother-to-child transmission of HIV at 18 months must be below 2% by 2022

According to the Thembisa model the mother-to-child transmission (MTCT) rate was 4.81% in 2017. The model projects this dropping to around 3.5% by 2022. This number however includes transmission that occurs after 18 months, and the 18 month number might thus be very slightly lower. While there are other sources for MTCT rates, we prefer quoting the Thembisa estimates since the model factors in MTCT cases where the mother is not aware of her status – likely the majority of MTCT cases.

For the MTCT rate to come down further will require that a higher percentage of HIV-positive women of child-bearing age take antiretroviral therapy and achieve viral suppression. It will also require that we help more breastfeeding women who are not living with HIV to stay HIV negative – since women who become HIV-positive in the months they are breastfeeding account for a large proportion of onward transmission to children.

Verdict: Reaching the target will be difficult

Implement the 90-90-90 strategy for HIV

The 90-90-90 targets first proposed by UNAIDS were adopted in South Africa’s current NSP. There was previously some uncertainty regarding whether the three targets (described below) are to be met by 2020 (as per UNAIDS) or by 2022 (the end date of the NSP). Our understanding is that the agreed target date for South Africa is 2020.

4. 90% of all people living with HIV know their HIV status

The Thembisa model estimates that South Africa has already reached the first 90, with an estimated 90% of people living with HIV knowing their status in 2017. By contrast, the HSRC survey suggests that South Africa is just below the target, with around 85% of people aged 15-64 in South Africa who are living with HIV knowing their HIV status.

While South Africa appears to have done well on the first 90, maintaining a high score on the first 90 will require sustained testing efforts given that over 200 000 people are newly infected every year (and obviously do not know their status until testing). Thembisa projects that South Africa will reach around 92.4% by 2020.

Verdict: Appears target will be reached

5. 90% of all people with diagnosed HIV infection receive sustained antiretroviral therapy

According to the Thembisa model, South Africa is doing much poorer on the second 90, with only around 61.9% of people diagnosed with HIV receiving antiretroviral therapy in 2017. The HSRC survey paints a slightly rosier picture, estimating that around 71% of people aged 15-64 with diagnosed HIV infection are receiving sustained antiretroviral therapy. According to the Thembisa model projections South Africa will reach only around 70.4% by 2020.

South Africa’s poor performance on the second 90 is arguably the biggest red flag in the set of indicators examined in this article.

Verdict: Reaching the target will be difficult

6. 90% of all people receiving antiretroviral therapy are virally suppressed

In terms of the third 90, the Thembisa model estimates that around 77.8% of HIV positive people who were receiving treatment in 2017 were virally suppressed (the virus was so successfully suppressed in their bodies that it could not be detected with standard tests). Again the HSRC survey paints a more positive picture than Thembisa, estimating that 86% of people aged 15-64 receiving antiretroviral therapy have viral suppression.

Even though these figures are relatively high and may well go up with the introduction of dolutegravir-based antiretroviral therapy in South Africa, it is by no means certain that it will rise to 90 in the coming years and then be maintained above 90 (Thembisa projects around 86% by 2020).

Verdict: Target is within reach

A related indicator that does not directly form one of the three 90s, is the percentage of all people living with HIV who are virally suppressed (not just those on treatment as per the third 90). The Thembisa model estimates that 43.3% of all people living with HIV in South Africa were virally suppressed in 2017 (the implicit target based on the 90-90-90 target is 73%). Compelling scientific evidence shows that people who are virally suppressed do not transmit HIV.

Implement the 90-90-90 strategy for TB

As with HIV, TB also has a set of 90-90-90 targets that have been integrated into the NSP. Given that TB figures are harder to find than HIV figures, Spotlight twice wrote to the Department of Health to request the most recent estimates they have for these indicators. While the department did acknowledge our request, we did not receive any figures by the time of publishing. SANAC also failed to provide Spotlight with estimates regarding the 90-90-90 targets for TB.

Below we use the targets as they are presented in the final NSP. It is notable however that the 90-90-90 targets for TB has been taken to mean different things in different contexts. A recent Health Systems Trust publication describes the targets as “90% of people with TB will be screened, 90% will be initiated on  treatment, and 90% will successfully complete treatment” – which is not the same as the targets from the NSP used below. Where we found targets unclear we have attempted to clarify them with reference to the WHO’s version of the 90-90-90 targets for TB.

7. Find 90% of all TB cases and place them on appropriate treatment

The WHO’s version of this target is formulated as follows: “Reach at least 90% of all people with TB and place   all of them on appropriate therapy: first-line, second-line and preventive therapy, as required.”

In our understanding the indicator that most closely tracks whether we are finding people with TB is the case detection rate. According to figures available from the WHO’s TB data portal South Africa’s case detection rate was 68% in 2017. But the WHO also has the case detection rate at 68% for each of the last six years – something which does not inspire much confidence in this number. Neither the Department of Health or SANAC provided figures for this indicator despite various requests from Spotlight.

Recent testing campaigns in mining and other high-burden areas have been an important step in the right direction. Indications are that we are most likely still failing to diagnose many thousands of TB cases – one recent study found that most people with active TB who attend clinics in the Eastern Cape were not properly screened and tested. In addition to improving the quality of screening that should be happening at primary healthcare facilities, rapid and widespread implementation of the increased contact tracing and active-case-finding efforts described in the NSP will be critical if this target is to be met.

Verdict: No sufficiently reliable figures

8. Treat at least 90% of those diagnosed with DS TB and 75% of those with DR TB.

We understand “treat” here to refer to successful treatment as per the WHO version of this target. The WHO states it as follows: “Achieve at least 90% treatment success for all   people diagnosed with TB through affordable   treatment services, adherence to complete and   correct treatment, and social support.”

According to WHO figures around 82% of people with drug-sensitive TB and 55% of people with drug-resistant (MDR or Rifampicin Resistant) TB in South Africa were successfully treated in 2017. Neither the Department of Health or SANAC provided figures for this indicator despite various requests from Spotlight.

While reaching the 90% treatment success target for DS TB is within reach, reaching the target cannot be taken for granted given the many challenges facing the public healthcare system in South Africa. The introduction of better and less toxic treatments for drug-resistant forms of TB should help push the DR TB treatment success numbers up in the coming years.

Verdict: Target is within reach

9. Find at least 90% of the TB cases in key populations (the most vulnerable including people living with HIV with low CD4 counts, under-served, at-risk) and place them on appropriate treatment. Successfully

We have not been able to find reliable figures for this indicator. Neither the Department of Health or SANAC provided figures for this indicator despite various requests from Spotlight.

Verdict: No sufficiently reliable figures

10. Reduce TB incidence by at least 30%, from 834/100,000 population in 2015 to less than 584/100,000 by 2022

According to the 2018 World Health Organization (WHO) World TB Report, TB incidence in South Africa was 567 per 100 000 in 2017. At first glance it thus seems that we have already achieved the NSP target of less than 584 per 100 000. The reality is however more complicated. In 2018 the WHO made major adjustments to its TB estimates for South Africa. This included recalculating the estimate for 2015 as 759 per 100 000. A 30% reduction of this figure would set a target for 2022 of 531 per 100 000. The estimate of 567 per 100 000 is still above this level, but by 2022 South Africa will be well below this adjusted target if the downward trend suggested by the WHO’s figures  continues.

That said, there is significant uncertainty regarding TB incidence in South Africa and the picture might well change substantially as new information becomes available in the coming years. While the 567 per 100 000 figure may be the figure most often quoted, the WHO estimates that the real figure could be anywhere between 406 and 754 per 100 000.

Verdict: Appears target will be reached

Conclusion

  • Regarding HIV, the good news is that South Africa is doing well when it comes to HIV testing and where people living with HIV are on treatment the treatment is generally working and saving lives.
  • The bad news is that many people who are living with HIV are not on treatment – either never having started or having quit. Arguably the biggest challenge facing the public healthcare system today is to support many more people living with HIV to start and stay on treatment. Doing this in an often dysfunctional healthcare system will not be easy.
  • Regarding TB, the good news this year is that South Africa’s TB epidemic appears not to be quite as large as previously thought. TB rates appear to be coming down slowly, although it is hard to say with any certainty exactly how fast – chances are not fast enough.
  • The bad news is that even in 2018 many people in South Africa with TB do not get diagnosed. Again the available figures cannot be trusted, but even if the real figure is only half of the estimated 90 000 to 100 000, we are still facing a very serious situation.
  • Either way, it is clear that in addition to gathering better data on TB, as is being done with South Africa’s first TB prevalence survey, South Africa also needs better epidemiological models of TB along the lines of what we have for HIV.

Six advantages of dolutegravir

Dolutegravir is a critically important antiretroviral medicine that is set to become the backbone of South Africa and many other countries’ HIV programmes. While the drug has recently made headlines because of a potential safety risk, most of what we know about the medicine indicates that it represents an important improvement over existing medicines. (You can read more about the safety risk here.)

Dolutegravir is featured prominently in South Africa’s recently advertised antiretroviral tender – the award of which is expected early in December. The medicine is set to become part of the standard combination of first line medicines given to most people in South Africa living with HIV in 2019. Six generic combinations containing dolutegravir have been registered in South Africa according to a report in Business Day. At the time of writing the lowest private sector price for dolutegravir listed on the Medicine Price Registry is R705 (US$50) per month. (For more details on other countries in Southern and Eastern Africa see this briefing document.)

Dolutegravir was first approved by the United States Food and Drug Administration in 2013. It is part of a class of antiretroviral medicine called integrase inhibitors. When HIV infects a cell, it combines its viral genetic code into the human cell’s own code – this is called integration, using the integrase enzyme. Dolutegravir blocks this integration enzyme, so HIV can’t make any more copies of itself, hence ‘’integrase inhibitor’’. Dolutegravir is the first integrase inhibitor that would be widely used by people living with HIV in the developing world.

Why people are excited about dolutegravir:

  1. It is highly effective: Dolutegravir is very effective at suppressing someone’s viral load quickly (the amount of copies of HIV in the blood). This is important for the long-term health of the person taking it. An undetectable viral load also means a person will no longer be able to transmit HIV to anyone else.
  2. It is well tolerated: In clinical trials there have been far fewer side effects reported from people using dolutegravir as compared to people using the drug that dolutegravir will replace, efavirenz (EFV). This includes fewer central nervous system side effects such as depression and anxiety. The improved tolerability of dolutegravir should make it easier for people to adhere to treatment in the long term. While not totally free from side effects, it is a big step forward.
  3. It is easy to take: People only require a small dosage of dolutegravir. The small dose makes it ideal to combine in a single tablet with other antiretrovirals. It also means the pills can be much smaller.
  4. It has few interactions with other medicines: dolutegravir has fewer drug interactions compared to EFV. One interaction we know about is with the tuberculosis medicine rifampicin. This is important given high rates of TB and HIV co-infection. While more evidence is needed, right now people with HIV and TB are being given an increased dose of dolutegravir to account for the drug interaction. Another interaction is with a diabetes drug called metformin (where we drop the dose of metformin a little if used with dolutegravir). It also should not be taken at the same time as with antacids or food supplements, if possible (you can take these at a different time of the day).
  5. It has a high barrier to resistance: dolutegravir has a higher genetic barrier to developing drug resistance compared to efavirenz. This will reduce the need for people to switch treatment lines since it is anticipated that extremely few people will develop resistance to dolutegravir. This is also important for people who are already resistant to another type of antiretroviral medicine – called a non-nucleoside reverse transcriptase inhibitor (NNRTI).
  6. It can be more affordable: The smaller dose means less active pharmaceutical ingredient (API) is needed (the bit of the drug that actually works in the body). The low dosage means dolutegravir could be produced by itself profitably by generic manufacturers for around ZAR 300 / US$ 21 per person each year. A deal was announced in September 2017 capping the public sector price in 92 low- and middle-income countries at US$ 75 per person a year for a combination tablet of tenofovir, lamivudine and dolutegravir (TLD). This price cap was for countries covered in the Medicines Patent Pool (MPP) license, thus excluded 39 countries including Thailand and Malaysia despite the fact that the drug is not protected by any patents there. After one year of active advocacy with the MPP, the Clinton Health Access Initiative (CHAI), the originator pharmaceutical company and the generic supplier; treatment advocates succeeded to ensure that the pricing deal will be honoured in those 39 countries too given the MPP licence allows supply to countries where there are no patents. As per today all African countries could benefit from this deal except Algeria. This country and others excluded should take other steps to ensure price reductions, such as issuing compulsory licenses.

This is an edited extract from a new dolutegravir briefing developed by Health GAP. To download the colourful and informative briefing click here. 

Lotti Rutter and Maureen Milanga are Associate Directors of International Policy & Advocacy at Health GAP based in South Africa and Kenya respectively.

Let women decide whether they want to take dolutegravir

By Maureen Milanga and Lotti Rutter

An important new antiretroviral medicine called dolutegravir will soon become available to people living with HIV in various Sub-Saharan African countries, including South Africa. Unfortunately, many women might be denied access to this new drug due to an inability of regulators and health departments to see potential risks associated with the drug in the proper context. (See this article for more on the benefits of dolutegravir over current treatments.)

In May this year, preliminary findings from an observational study in Botswana raised a potential concern about the use of dolutegravir for women. Dolutegravir was in the process of being recommended in national HIV guidelines in almost 70 low- and middle-income countries, following the medicine’s earlier introduction in wealthier countries.

The concern relates to an ongoing observational study in Botswana (the Tsepamo study) that found a potential risk relating to the use of dolutegravir at the time a woman conceives. Preliminary analysis from the study showed that four women out of 426 who conceived while taking the medicine gave birth to infants who had neural tube defects. This worked out to a rate of 0.9%, higher than the average of 0.1% of women in the rest of the population. Updated data since shows an additional 170 births, with no additional neural tube defects reported (thus bringing the rate down to 0.67%). At the time of writing, the number of conceptions in the study are over 800, and no more babies have been born with neural tube defects.

Neural tube defects can be caused by a number of factors, such as a woman having insufficient folic acid at conception, or diabetes. The cause of these four cases is not conclusive and we do not know if dolutegravir causes birth defects when taken during conception. In fact, while an increase in neural tube defects was observed in Botswana, it has not been observed in any other countries conducting similar studies. In summary, it all may be by chance, or it may be a real danger. We need more time to be sure. The final outcomes of Tsepamo are expected in April 2019.

What the guidelines say

The WHO issued guidelines recommending dolutegravir as an alternative option for first line treatment of HIV in 2016. After the preliminary Tsepamo findings were released, the WHO issued updated guidelines in July 2018 outlining how countries should proceed in rolling out dolutegravir. The guidelines stated:

“Adolescent girls and women of childbearing potential who do not currently want to become pregnant can receive dolutegravir together with consistent and reliable contraception.”

And that;

“Woman-centred health services involve an approach to health care that consciously adopts the perspectives of women and their families and communities. This means that health services see women as active participants in and beneficiaries of trusted health systems that respond to women’s needs, rights and preferences in humane and holistic ways. Care is provided in ways that respect women’s autonomy in decision-making about their health, and services must provide information and options to enable women to make informed choices. The needs and perspectives of women, their families and communities are central to providing care and to designing and implementing programmes and services. A woman-centred approach is underpinned by two guiding principles: promoting human rights and promoting gender equality”.

Following the WHO caution regarding the use of dolutegravir many countries have taken a conservative approach on women’s access to this medicine, and in some cases slowed or stalled progress altogether. We understand a guidelines committee meeting in South Africa is scheduled for 30 November.
The conservative stance being taken in a number of countries restricting women’s ability to choose dolutegravir echoes other age-old struggles for women to be able to make choices about their own health. In this instance, some policy makers are changing treatment guidelines to recommend that dolutegravir be reserved only for men and for women above 50 years of age. In doing so they are taking away women’s right to make an informed choice over their own bodies and health needs.

Women of childbearing age have the right to make an informed decision on whether they want to use dolutegravir or not – and alongside that they have the right to be provided with access to a range of contraceptive options and termination of pregnancy services. The Tsepamo data is as yet not conclusive, and is one study from a single country. We do not know if dolutegravir causes birth defects when taken during conception. On the other hand, dolutegravir’s side effect profile of decreased risk of development of drug resistance, decreased costs, and superior ability to suppress high viral loads late in pregnancy, make it an important option for use in South Africa and the region.

This is an edited extract from a new dolutegravir briefing developed by Health GAP. To download the colourful and informative briefing click here.

Lotti Rutter and Maureen Milanga are Associate Directors of International Policy & Advocacy at Health GAP based in South Africa and Kenya respectively.

Letter to President Cyril Ramaphosa: Send a message to world leaders to commit financially to fighting Aids

Dear Honourable President Ramaphosa,

Greetings. Thank you for your tireless efforts to try to eradicate corruption and State Capture. We hope that these efforts will soon translate into a strong commitment to improve the quality of life of millions of our people, including their access to life-saving medicines and quality health.

As you know, we are rapidly approaching World AIDS Day on 1 December 2018. World AIDS Day this year is particularly significant given that it will take place as you meet with global leaders at the G20 in Argentina, and at the beginning of the sixth replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria — hosted by the government of France.

World AIDS Day 2018 should remind us all that the global AIDS crisis is far from over. In 2017, 1.8 million people acquired HIV while prevention tools remain out of reach, and violence, marginalisation and criminalisation of women, girls and key populations continue to put people at high risk of HIV infection.

Today 40% of people living with HIV still cannot access lifesaving antiretroviral treatment. Millions more people face ongoing adherence challenges and mortality — be it from treatment fatigue with limited opportunity for effective counselling or support and poor access to mental health services. We also face a vast and deadly TB co-epidemic, limited HIV service provision due to health worker shortages and numerous other health system challenges. The reality is that the barriers ahead of us must be confronted.

During the early days of the global AIDS response we fought for the idea that governments around the world have a responsibility to do whatever they need to do to get HIV treatment to the people who need it. While governments now acknowledge their role, we are a long way from the true victory that will come when treatment and prevention are available for all, and our health systems deliver the life-saving services people require. We cannot sit back and relax while people on the ground are dying.

Today almost everyone agrees that we need to provide prevention, treatment and care to all who need it. The global adoption of the “90-90-90” Fast Track targets are testimony to that consensus. We have reached a point in the AIDS response where the question is not so much what to do, but to ensure that quality evidence-based programmes — grounded in the communities of people affected — are actually implemented.

In this context we are alarmed that funding for these HIV programmes from donor governments has declined in recent years. In almost every low and middle-income country, gaps in funding are undermining the HIV response and treatment, prevention and care services are being rationed. Last year a study by Kaiser Family Foundation & UNAIDS found that donor government funding for the global HIV response had declined by 7% in 2016 and was at its lowest level since 2010.

This should be a stark wake-up call for you as President of one of the worst-affected countries in the world. It should be a wake-up call for anyone who cares about saving lives and ending the global HIV epidemic. Just as we’re on the precipice of success and have finally reached 60% of people living with HIV on treatment, we get another reminder that politics is enabling or disabling the AIDS pandemic.

Countries across the world have agreed to a global strategy. But we need the money to see it through. We need an ambitious acceleration of financing for the Global Fund to Fight AIDS, Tuberculosis and Malaria and to ensure that there is at least $18 billion pledged in 2019.

That is why we are asking you personally to make a statement on World AIDS day that includes a strong call on the leaders at the 2018 G20 meeting to ensure the funding increases and the international solidarity needed to deliver quality treatment and prevention services around the world.

We trust you will do this. Millions of lives depend on it.

This is a shortened version of the letter. Anele Yawa is general secretary of the Treatment Action Campaign and Mark Heywood is executive director of SECTION27.

The SADMON Files 5: When social media doesn’t go viral

By Anneliese King

In 2015 Sadmon Projects and Consulting was awarded a three-year, R352 million communications contract by the Department of Health. The tender was for an external service provider to run a mass media communication and social media mobilisation campaign.  The emphasis was on “mass”, and a successful social media strategy was therefore critical.

Sadmon refers to itself as an “owned online media channel for the NDoH to promote, educate and generate awareness of public health programmes”. This essentially means that Sadmon ran certain of the department’s social media accounts such as the department’s twitter account (@HealthZA).

A section in each of Sadmon’s monthly deliverable reports is dedicated to “measuring and monitoring digital platforms”. Spotlight obtained Sadmon’s monthly reports through a request in terms of the Promotion of Access to Information Act (PAIA).

Social media performance

From August 2016 Sadmon started implementing a social media strategy. The daily posts focus on a range of topics – often aligned to specific health awareness days in the Department’s calendar. The strategy is described as being developed around a content plan and “live social activation support” – tweeting and posting from events.

At the time of writing (more than two  years after implementation of the strategy started) the Department of Health has a mere 47 000 Twitter followers. To place this in context – the Department of Arts and Culture has 249 000. The South African Police 430 000, the Department of Basic Education 107 000, Home Affairs 73 000, the Department of Energy 20 000 and the Presidency 1 080 000. In two years under Sadmon’s management the Department’s Twitter following increased by just over 29 000. On Facebook the Department of Health’s account also isn’t performing particularly well – with its 41 000 Facebook followers only half of the Department of Arts and Culture’s 83 000. (We have rounded numbers to the nearest thousand.)

What seems abundantly clear is that despite Sadmon’s pages and pages of monitoring reports, their much-vaunted social media strategy was relatively ineffective when compared to other government departments. In addition, health is arguably one of the easier government departments for which to build a social media following given its direct impact on the lives of all people in South Africa.

It is hard however to assess whether the Department of Health received value for money for Sadmon’s social media work, since the department declined to provide Spotlight with invoices that would show what part of the R352 million budget went toward social media management.

The first six months

An analysis of the first six months of reports on their social media strategy provides some insight into how effective or ineffective their work really was.

August 2016

In August we see the first references to “content plans and crafted text posts”. The content plan in the deliverable report focuses on publishing two posts per day on various topics – including breastfeeding, HPV vaccine and condom use.

The month-on-month increase in Twitter followers is 608 and Instagram 8. There are 328 more Facebook (FB) likes.

The overall “mentions” are 4 262, but the highest number relates to a Mail and Guardian article on Julius Malema’s weight loss, which included a bizarre call by the KwaZulu-Natal ANC for the Health Minister to investigate. The story created a flutter on Twitter, and this contributed to the bulk of the social media activity. Considering that overall mentions were only five more than the previous month, Sadmon’s “digital strategy” does not seem to have gotten off to an auspicious start and there was no meaningful increase in social media engagement in the first month.

September 2016

Facebook likes are up with 344, Twitter followers by 564 and Instagram by 34. This growth, according to Sadmon, was attributable to their digital team’s involvement. The spin does not live up to scrutiny, however.

The overall mentions are 4 266 – 4 more than August. Moreover, once again, the bulk of these was from Twitter and related to an event that had nothing to do with the social media strategy itself. Then Deputy President Ramaphosa had introduced Max condoms in parliament with a forthright endorsement that they provided maximum pleasure and made “less noise” than the previous government condoms. It caused a sensation on Twitter.

Two Sadmon-generated posts made it onto the Department’s “top 5” for the month. The first, introducing the condom “flavours” received 57 “engagements” while a second, on the availability of the new condoms at clinics, received only 14.

In the last weeks, two significant new stories push mentions up with 1 000. The Minister vows to get to the bottom of the Life Esidimeni tragedy and the Johannesburg Mayor taking government department’s to task for unpaid bills. Once again the spike is extraneous to the bespoke messages being pushed out as part of the social media campaign.

October 2016

Facebook likes are up with 281, Twitter followers by 450 and Instagram with 26.

The top Twitter post for the month, with 22 “engagements” reads: “Today is Mental Health Day. The objective is to raise awareness of mental health issues making mental health care a reality worldwide”. The less-than-gripping content is accompanied by a graphic showing a skeleton with a red brain.

It is also important to note that spikes in social media engagements aren’t necessarily a positive reflection on a media strategy. So, for instance, a significant amount of social media activity for the month related to a media article in which the Minister links the importance of free education to the NHI. This elicited significant negative sentiment.

November 2016

Facebook likes are up with 736, Twitter followers by 1 043 and Instagram with 54.

The content plan for November is broken down into 1% generic messages, 90% for health awareness days, 3% MomConnect, 1% SA Demographic survey and 5% on Max condoms.

The Top twitter post receives 21”engagements”. Once again, the highest number of mentions relate to a media article completely unrelated to the social media plan – or even health. This time the Health Minister is mentioned in this Business Day article: “Fellow Ministers back Hanekom as ANC meeting on Zuma continues”.

December 2016

Facebook likes are up with 522, Twitter followers by 934 and Instagram with 46.

Social media mentions peak at 794 on the 1st of December during the live coverage of the World AIDS Day event. The top post for the month generated by the Department garners only 16 “engagements”.

January 2017

Facebook likes are up with 322, Twitter followers by 698 and Instagram with 39.

Overall volumes are down from December by almost 300, and engagements with 260. Once again, the highest number of mentions relate to a sensationalist media article in which the Minister says new doctors marry in December to avoid rural postings.

Value for money?

While Sadmon’s management of the Department of Health’s twitter account is not disastrous, there is little evidence of the kind of sophisticated social media campaigns one would expect as part of a R352 million contract. The evidence also shows that the Department of Health has not done particularly well on social media when compared to other government departments.

In response to questions sent to Sadmon CEO Cyril Sadiki, Sadiki was dismissive of the suggestion that Sadmon did not provide the department of Health with value for money. Other parts of this series of articles contain more comment from Mr Sadiki and the Department of Health.

This is part 5 of a five-part series investigating the Department of Health’s R352 million contract with Sadmon. There with be further follow-ups next week.

 While Spotlight is published by SECTION27 and the Treatment Action Campaign, its editors have full editorial independence – independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

 

The SADMON Files 4: Autopsy of the Phila communications campaign

By Anneliese King

In 2015 Sadmon Projects and Consulting was awarded a three-year, R352 million communications contract by the Department of Health. Spotlight analysis of reports Sadmon submitted to the department (obtained through a Promotion of Access to Information Act request) paint a worrying picture of multiple delays and constant miscommunication – all while the bills for the public purse keep mounting up.

July 2017 was a whopper of a month for Sadmon with an invoice of close on R17-million. One of the main activities relates to what now seems like the third launch of Phila, a wellness campaign run for the Department of Health by Sadmon.

The campaign was designed to generate “motivational health messages through innovative mass media communication”. The messages had to address knowing your health status, increasing physical activity, eating healthier food, adhering to treatment and good sexual health and to encouraging a safe, violence-free society.

The campaign had been a stop-and-start affair since Sadmon’s appointment and the conceptualisation of Phila as the overarching “master” campaign – with smaller sub-brands like She Conquers and Max Condoms. Phila is the Nguni name for “Door to Health or Life”.

A stop-and-start affair

In June 2016 the Phila campaign made its first outing at an event in Pietermaritzburg where it was “launched” with Max scented condoms, but then the momentum was lost.

The main problem was the reported on-going delays with approvals from the Department on what seems to have been every element of the campaign: the media schedule, the billboard and taxi branding, the radio scripts, the digital platform and the permission letters to “wrap” the NDoH building.

In August 2016, Sadmon states that they are still awaiting sign-off on the “Phila toolkit”. By September the Minister complains that the campaign is not yet up and running – (although one of the issues around a launch date was his availability). By the end of September, the Department has still not signed off budgets or any of the creative elements developed by Sadmon, which by now included an internal staff campaign.

In October 2016 Deputy President Cyril Ramaphosa and the Minister finally launched the campaign. Sadmon goes into production on ads and branding, but the end-of-October report show the campaign once again bogged down in bureaucracy: “the late approval of Phila ATL elements put the team under immense pressure to ensure flighting by end October/beginning November. Reduced Phila media budget and no approval on other plans like PR and stakeholder engagements diluted the impact of the launch. The digital team still awaits remote login details to the website as per resolution taken in September 2016.”

The “wrapping” of the Civitas building in Phila branding was finally done at the end of November.

The campaign limped along. Sadmon’s November 2016 report states: “NDoH missed opportunities to popularise Phila on the radio again, as a result of non-confirmed interviewees. Campaign performance has been jeopardised as interviews were not done concurrently with ATL flighting. Creative approval of Phila billboards and taxi branding artwork also were delayed and only approved on 25 November, a month after the first flighting started. Several ideas for Phila internal launch were presented, but a date has not been set for the staff launch which is a risk as the campaigned started externally without internal buy-in.”

In December 2016 it is reported that further PR opportunities to publicise Phila were “missed” as interviewees “were not confirmed on time”. The prepaid interview schedule was used for the Breastfeeding conference instead.

When asked about the delays with Phila, the National Department of Health defends Sadmon, stating that “the delay was due to departmental scheduling and other factors that were beyond Sadmon’s control as a service provider”.

“In health communication, priorities do constantly change because it has to respond to changing circumstances that cannot be ignored such as outbreaks,” the department explains. “When the Phila was awarded, the NHI process was still at its development stage. The need to heighten communicate on it became necessary to align it with Phila. Also, Phila had to respond to WHO and government annual priorities.”

Fast forward 

It is against this background that in July 2017 – ten months after it was “officially” launched – a new attempt is made to get Phila out of the doldrums.

An initial media budget of R40-million is approved, and a media advertising plan is signed off by the Department. The concept of “Phila Thursday” is adopted. It is a play on the “Phuza Thursday” phenomenon.

Sadmon says that “instead of buying junk food for lunch, people were encouraged to pack healthy meals from home, and instead of having takeaways for supper, they were urged to prepare homemade meals with plenty of vegetables for their families. These behavioural changes are aimed at starting a “health revolution”.

The plan is kicked off by introducing Phila Thursday in the press with a series of “call to action” health messages in five newspapers during week one, and seven papers in week two. Soon the lack of coordination between Sadmon and the Department rears its head again.

The end-of-month deliverable report “notes with concern that the Phila Thursday concept is no longer following the initial design. The idea was to feature short, punchy messages to capture people’s attention and introduce them to the main campaign brand – Phila. These messages were to have been aligned with the digital platform to create synergy.

What however transpires is that the strip ads were repurposed for longer format public health messages. As these were at odds with the output on social media platforms, Sadmon says it “undermined attempts at establishing the Phila brand”.

Three Public Service Announcements featuring the Minister “calling on all South Africans to embrace and rally behind the campaign” were however duly recorded.

So, with the handsome July invoice of R17 million in mind, let us recap.

In the basket, we now have an updated Phila strategy document, twelve newspaper strip ads, three different Public Service Announcements by the Minister, a generic radio ad, and a set of implementation plans (media schedules) for the coming months.

Other achievements in July

Sadmon’s PR team also “spent most of the month attending prelim planning meetings and produced strategic plans”. The key objective was to develop “practical, yet impactful activities” for the following campaigns:  Cancer policies, She Conquers Mpumalanga activation, HTS, TB screening and NCDs campaigns, Rotary Family Health Day campaign, Phila Thursday, VMMC and TB Prevalence Survey.

The following deliverables are listed:

  • A strategic plan and “media launch treatments” for Breast and Cervical Cancer policies.
  • A fact sheet, an Outside Broadcast schedule, media interview motivations and media invitations for a “She Conquers” event scheduled for a stadium in Mpumalanga.
  • Work on developing a “multi-sectoral media campaign” for HTS TB Screening and the Non-Communicable Diseases
  • Attended a feedback meeting on the Tuberculosis Prevalence Survey pilot project (this is the fourth feedback session on this topic – one was a full-day workshop)
  • Work on developing a creative approach and PR for Voluntary Medical Male Circumcision.
  • Identified “some proactive media opportunities” and arranged eight interviews, which according to Sadmon, was worth R761 376 in “free coverage.”
  • Ongoing “monitoring and measuring” of social media platforms and the “creation of messages.”

A curious little footnote to the July deliverables roster is the Phila “Safer Holidays” booklet. Auto Reach, a company that does turnkey “in-car activations,” was engaged to distribute the booklet at tollgates. It is not clear why this even mentioned as a deliverable in this month’s report since the Safer Holiday campaign had taken place in April/May, but even stranger is the fact that while the job was outsourced, Sadmon bill 42 hours for this task.

As usual, the management of the Red Ribbon Resource Warehouse is listed. The report highlights a “shortage of condoms and IEC materials” and the call register for July reflects a paltry nine telephone calls and 17 orders. The latter includes six branding events.

Since the Department of Health refuses to provide us with the invoices submitted by Sadmon (even though we requested this in a PAIA request), it is not possible for us to tell how the R17 million invoice was justified. The above represents our best reconstruction based on the monthly reports of work conducted.

Sadmon CEO Cyril Sadiki is dismissive of suggestions that Sadmon did not provide the Department of Health with value for money. “An evaluation of the Phila campaign will be able to make further objective determination in terms of value and impact,” he says. “To the extent that there were challenges and competing priorities that were experienced along the process of implementation those challenges were raised and handled accordingly.”

This is part 4 of a five-part series investigating the Department of Health’s R352 million contract with Sadmon.

While Spotlight is published by SECTION27 and the Treatment Action Campaign, its editors have full editorial independence – independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

The SADMON Files 3: Red Ribbon or red flag?

By Anneliese King

In 2015 Sadmon Projects and Consulting was awarded a three-year, R352 million communications contract by the Department of Health. An essential part of the contract was the oversight, management and stock control at the Department’s Red Ribbon Resource Centre (RRRC) where the National Department of Health’s condoms, branding and communication materials are warehoused.

From this central repository booklets, posters, leaflets and condoms are sent to Provincial Departments, Districts, hospitals and clinics, public and private companies, NGOs, churches, mines, schools and universities. It is a critical cog in the Department of Health’s communication machinery – and integral to getting health messages out.

According to documents obtained by Spotlight through a request in terms of the Promotion of Access to Information Act (PAIA), Sadmon cleared out the RRRC warehouse of “expired” goods in February 2016. These include old Khomanani collateral, overruns, and incorrectly printed material – some of which would have been produced on their watch when they were part of the consortium running the Khomanani campaign. Most, if not all,  of these materials would have been paid for with public funds. The following materials were cleared out:

  • 21 pop-up banners
  • 31 500 Khomanani folders
  • 400 boxes of Khomanani report files
  • 8000 (2009) Health workers letter
  • 10 500 copies of the 2007-2001 National Strategic Plan (A thick document)
  • 8 500 HCT posters (wrong protocol)
  • 504 000 JSI MMIS (universal precaution control) booklets or pamphlets.
  • 8000 expired condoms

When asked about this clear-out, Sadmon CEO Cyril Sadiki appears to contradict the documentation, claiming that “it is incorrect that there are any materials that were ever discarded”.

“All remaining Khomanani branded materials are subject of loss control management by the NDoH. Some of these materials contained content that required updating e.g. treatment protocol etc. Some materials, which are still relevant in terms of content, are still in use with the Phila and other sub-campaigns,” Sadiki said.

While the February 2016 clear-out raises red flags, a deeper dive into Sadmon’s deliverable reports reveals a faltering operation consistently hamstrung by lack of stock (or wrong stock), and no courier capacity to ship out ordered material. It also shows an extraordinary unresponsiveness from the Department of Health to concerns raised by Sadmon on a continuous basis.

12 months at the Red Ribbon Resource Centre

Based on reports submitted to the Department of Health by Sadmon (accessed by Spotlight through a PAIA request) we have compiled a 12-month birds-eye view of activities at the RRRC. While the RRRC is in some respects functional, there are also remarkably persistent issues.

June 2016

Stock control is an on-going issue at the warehouse.

Sadmon says the warehouse is running out of space. Despite “end-users” having made it “repeatedly” clear they don’t like Choice condoms, this brand was now clogging up 730 m2 of warehouse space. “Choice condoms are coming through every week. The warehouse now has more than 34.6 million, and they don’t move,” the report states.

The courier service for dispatching deliveries appears to have been stopped. “This is a serious issue, as we are picking orders that are still not going out because organisations don’t have the transport for collection.”

July 2016

The courier issue remains unresolved. “Some organisations call only to ask whether we still provide a courier service, and if not, they do not place an order as they are not going to manage the courier funds.”

Once again dwindling stocks of Information Education Communication (IEC) material is flagged.

“The challenge of material scarcity does not only affect the RRRC and the warehouse, but it is a challenge for our clients… we keep promising the client time and time again”.

Choice condoms keep flooding into the warehouse. The inventory now stands at 92 million with only 546 800 distributed.

On the upside, Sadmon reports that it successfully dispatched material from the warehouse to Durban for the AIDS conference.

August 2016

RRRC and warehouse activities are “on the decline” due to the absence of IEC material and courier service.

The report states, “few organisations have called the RRRC with a hope that they could receive IEC material. The rate of calls has reduced due to a lack of IEC. However, globally, there is also a negative change in distribution because of lack of transport. The reality, unfortunately, is that the gap between RRRC and clients is quite wide.

There is no capacity to “move material in general and condoms in particular”.

Another 10.23 Choice million condoms have flooded into the warehouse. While they managed to distribute 3.9 million condoms, the closing stock is still 6.5 million higher than it was at the beginning of the month. Condoms now occupy more than 11 000 square meters.

September 2016

New stock of the more popular Max condoms have arrived, but the report states that Choice condoms are moving at a “snail’s pace”.

The warehouse manages to circumvent the courier problem by dispatching “tons” of condoms to various provinces using the Society for Family Health. Mpumalanga makes its transport arrangements for a 10.5 million condom order. There are more than 87 million – mainly Choice condoms “taking up a lot of warehouse space”.

The lack of IEC material rears its ugly head again. The report flags the lack of stock against the background of “high” call volumes in preparation for World AIDS Day.

October 2016

The lack of IEC material takes on a new urgency with World AIDS Day fast approaching.

There is an exasperation to the tone of the report: “The RRRC is facing a challenge by promising the customer time and again that they shouldn’t give up calling as we are busy preparing the new material.”

There is some success in dealing with the condom glut. With the Department having authorised some courier deliveries they can dispatch just over 51 000 condoms – 32 million of these are the much-maligned Choice latex condoms.

The report makes the explicit point that on the 31st of October there were  “no Max condoms’ in stock” and requests an urgent review of IEC material for reprinting.

November 2016

Despite the recent stock woes, November somehow turns into a “very busy” time. The report refers to the “tireless” work done by staff in preparation for World AIDS Day. Casual staff were brought in to augment the regular staff component at the warehouse to handle the workload. “The RRRC received a few calls, and a huge number of clients came to collect their orders. The team was in charge of everything that happened when clients walked through the door.  We had to maintain a clean, organised space, file a range of paperwork, answer phones, and make sure the clients were not kept waiting. Many times initial impressions were the most important to keep clients coming back,” the report states.

It is not clear what lies behind the increased workload. The activity log does not suggest an extraordinary spike – 29 telephone calls and 31 orders are reflected. There is a reference to “several” collections and deliveries for which material had to be picked and packed – presumably branding and collateral or events, although there are only four listed for the month.

There is good news on the stock front however with 9 720 000 Max condoms received.

December 2016

As the festive season approaches, a “large number” of Max condoms are received, packed and distributed to various sites as per orders received

Sadmon’s warehouse team also manages the “enormous task” of delivery, distribution and branding for a World AIDS Day event held at Sinaba Stadium in Daveyton on Johannesburg’s East Rand (two gazebos, one stage banner, 90 teardrop banners, one small media banner, 17 pull-up banners and six tablecloths). There is also mention of 1 500 Max condoms, 1 500 female condoms and 2 000 lubricants for the event, as well as MomConnect water bottles.

The report states that no condoms were ordered or distributed after World AIDS Day.

January 2017

Packed orders cannot be sent out due to the unresolved courier problem.

The issue of low stock is flagged again. In August it seemed as if the “design of IEC material and Z-cards” was about to happen, but four months down the line, this seems not to have materialised.

On a positive note, the warehouse seems to have found a taker for some of the languishing Choice condoms with 12.450 million destined for the City of Cape Town and district.

February 2017

There is an uptick in activity.

A consignment of new posters, fact sheets and FAQ’s for the HPV vaccination campaign are delivered, as well as a new batch of sex training kits and Z-cards for the Family Planning Dual Protection campaign. The latter is for combating HIV, STI’s and unplanned pregnancy. Twenty-three thousand female condoms and 8,49 million male Max condoms are also received.

The fresh stock leads to an unprecedented 77 orders – the highest for any month to date.

March 2017

No reporting on RRRC in documents provided to Spotlight.

April 2017

No reporting on RRRC in documents provided to Spotlight.

May 2017

The report states that “the RRRC warehouse run by Sadmon is doing well so far” and “extremely busy” with Max condom distribution and the receipt of “new reprints from suppliers”.

The activity log, however, seems to suggest a standard month with 34 calls and 39 orders processed.

The issues of no transport and a lack of material comes up again, yet despite these problems, the warehouse is said to be “running at optimal level”.

June 2017

Picking and packing collateral for the World AIDS Day and the HEAIDS conferences in Durban are the main activities for the team this month. The report states that “all tasks assigned in June” were executed with “utmost excellence”.

July 2017

In July we are back to the low stock issues and “low activity” at the warehouse. The call register for July reflects only nine telephone calls and 17 orders due to a lack of condoms and IEC stock.

This is part 3 of a five-part series investigating the Department of Health’s R352 million contract with Sadmon.

While Spotlight is published by SECTION27 and the Treatment Action Campaign, its editors have full editorial independence – independence that the editors guard jealously. Spotlight is a member of the South African Press Council.