Mental Health Unit is a ‘disaster’, says Public Service Commissioner

By Kathryn Cleary

The Public Service Commission (PSC) made a surprise visit to the Cecilia Makiwane Mental Health Unit – 10 days after Spotlight published its investigation into a whistleblower’s plea about the unit’s dire state.

The visit to Cecilia Makiwane Hospital (CMH) in Mdantsane, Eastern Cape, was led by Commissioner Lulu Sizani on 16 August.

Though it was “unannounced”, a press release was issued two days before inviting media to attend.

“We decided to come not because we wanted to write our own story, or wanted to dispute what was covered in the story … Our job is not only to know and put out what we’ve seen, but also to propose measures to correct what is not right,” Sizani told journalists who accompanied her on the tour.

Spotlight attended the PSC’s tour of the unit. We found increased security presence at the hospital compared to our previous visit, as well as a boot check at the gate. The grounds of the hospital remained unkempt; with old medical equipment abandoned in the corridors along with rubbish and weeds. However, the passageway leading to the Mental Health Unit had been given a facelift. The weeds and grass had been tended to, and rubbish collected.

The old wards next to the unit were also empty and swept clean; previously Spotlight reported that these wards were a security concern to patients and staff. A grounds worker told S

potlight they had been cleaning for the past two days, and other sources questioned the timing of the PSC’s visit after witnessing the sudden bout of cleaning.

A Mental Health Unit with no psychiatrist

Security guards with metal detectors met Sizani and media at the entrance to outpatient ward 13.

Sipiwo Mfengu, area manager of nursing based at the hospital, told Sizani that the Mental Health Unit did not have a specialist.

CMH is a teaching hospital and, according to Health Professions Council of

Metal barriers seperating patients and staff,. Photo: Kathryn Cleary

South Africa (HPCSA) regulations, a specialist must sign off on intern logbooks. The unit has not had a specialist since December 2018.

Mfengu said the hospital’s clinical manager, Dr Yose, signed intern logbooks. Information previously shared with Spotlight highlighted that Yose was not a psychiatrist, and was unable to attend to specific clinical concerns within the unit.

HPCSA communications manager Priscilla Sekhonyana said any deviation from regulations brought to the council’s attention would be investigated but Spotlight cannot confirm if an investigation is under way.

Sekhonyana said if a department lacked a specialist, secondary responsibility for training interns rested with senior medical staff. She added that each department should have a named supervisor to coordinate training.

Patient wards, recreational areas and seclusion rooms

Mfengu told Sizani that the unit saw between 1,000 and 1,300 patients each month, about 70 patients a day, and the unit’s bed utilisation rate was upwards of 70% to 80%, sometimes 90%.

The day of the visit the unit had 19 female and 20 male patients out of 25 total available beds per ward. Wards 9 and 10, male and female wards respectively, were stark.

Patient beds were all in one open space with thin metal barriers, resembling cages, separating them from the staff stations.

The fenced-in recreational areas of each ward consists of a concrete courtyard, cement benches, a table and a few mattresses. Sometimes male patients had access to a pool table, a punching bag and an old TV. The female recreation area was much smaller, and positioned at the front of the ward next to the entrance walkway, allowing visitors to look inside. Most patients in both wards were asleep in the courtyards; some were on mattresses but the rest were on the ground.

Inside each ward are two “seclusion rooms”. These small concrete rooms are

A seclusion room at CMH

tucked into the back corner of the wards and have a toilet, sink and sometimes a mattress. The rooms are equipped with cameras, but none is functional. Patients are monitored through a small window with a metal screen placed between the room and the nurses’ station.

Mfengu told Sizani that patients were placed in seclusion for a maximum of two hours at a time.

Sizani called for safety issues of the seclusion rooms to be addressed urgently. “For me, it’s very scary, it needs to change immediately,” she said.

Still no answers to cries for a new hospital

Spotlight previously reported that there was no funding to upgrade the Mental Health Unit or to move it to the new hospital, which was confirmed during the PSC’s visit.

Eastern Cape Department of Health spokesperson Sizwe Kupelo later told Spotlight that there were plans to build a 600-bed Mental Health Unit.

“Interim arrangements [are] to move patients to the recently refurbished old [outpatient] area, further renovations for this area are planned as an immediate intervention.”

He added that National Treasury (NT) had met with the department to discuss possible funding for the CMH Mental Health Unit, as well as Fort Beaufort’s Tower Hospital, which is a long-term psychiatric facility. The CMH unit is an acute facility.

“[The Department of Health] has to submit a request in this regard,” said Kupelo.

National Treasury communications officer Malehlohonolo Kasa told Spotlight it had a joint engagement meeting with the Eastern Cape Department of Treasury and other departments, including health, during the week of the PSC’s visit.

“We can confirm that NT officials spoke of opportunities that have been made available by national government through NT in the form of Budget Facility for Infrastructure (BFI) to assist with the financing of strategic infrastructure projects. NT merely reminded the [Eastern Cape] to make use of opportunities that are presented through this facility for large infrastructure projects.”

Kasa stated that applications for this year’s BFI closed at the end of May, but eligible departments were encouraged to apply for the next financial year.

PSC left in shock

After the visit Sizani called the unit “a disaster” and described it as being in “a total state of neglect”.

“It’s like a place that is deserted or has been deserted for many years,” she said. “I’m deeply hurt. It’s not something that happened last month or last year; it’s in a state of disrepair. You’ve seen the wires outside, uncovered in the passages, the walls are falling apart.”

She said a detailed report that included recommendations would be submitted to Eastern Cape Premier Oscar Mabuyane and Health MEC Sindiswa Gomba on 5 September.

“Within two months there will be something happening,” Sizani said. “We will come again to see whatever things that [the Department of Health and the premier] say they will do. We will monitor from time to time and report on interventions they have put in place.”

Kupelo declined to comment on the PSC’s visit until the report was available. Spotlight also inquired about ongoing clean-up efforts at the unit coinciding with the PSC’s visit, but did not receive a response.

Jay Kruuse, director of watchdog group the Public Service Accountability Monitor (PSAM), called for Sizani’s report to be made public.

“This will support efforts to improve accountability and ensure corrective action within the Eastern Cape Health Department, which has failed in various respects to deliver adequate services at the unit.”

Although the PSC visit made headlines around the province and brought promises of improvement for the unit, in some respects conditions worsened the following week.

Stockouts cause panic

From 19 to 22 August, medications in the unit ran critically low, resulting in stockouts and chaos for both clinical staff and patients.

Information shared with Spotlight indicated that first and second line antidepressants, Citalopram and Fluoxetine, were out of stock at the facility. Other vital medication, including Olanzapine, Quetiapine, Aripiprazole and increments of Risperidone, were also out of stock.

According to the National Department of Health’s 2015 Standard Treatment Guidelines and Essential Medicines for hospitals, Citalopram, Fluoxetine, Olanzapine and Risperidone are essential psychiatric medicines used to treat major depressive disorder, general anxiety, obsessive compulsive disorder, panic disorder, post-traumatic stress disorder, schizophrenia and bi-polar disorder.

Sources told Spotlight that doctors and patients were at a loss in terms of treatment. With stock continuing to run low, doctors are forced to alter treatment, which can lead to patients experiencing adverse reactions.

Kupelo said stock was a national problem. “The province is going to use alternative treatments,” he said.

Spotlight requested clarity on what he meant by “alternative treatments”, but did not receive a response.

Kruuse was concerned about Kupelo’s comment.

“The medicines that are currently unavailable are essential psychiatric medicines that should be managed and dispensed by suitably qualified medical practitioners,” he said.

“Psychiatrists are best placed to medicate and to make decisions to alter treatment for patients with severe mental health conditions. This unit has not had a psychiatrist since late last year, which partly explains why their care has and continues to be compromised.”

* The Mental Health Review Board (MHRB) for the Eastern Cape central region declined to comment on the investigation. Spotlight was referred to the provincial Department Of Health but Kupelo said he does not respond to queries concerning the MHRB.

Spotlight on NHI: What has actually changed in the new Bill?

By Sasha Stevenson

National Health Insurance (NHI) has been long in the making. A new iteration of the policy has been released every few years for the past eight years, culminating in the NHI Bill tabled in Parliament two weeks ago. The detail of this legislation is important. NHI will not deliver universal health coverage because we want it to. We have to design it so that it does. That is where law- and policy-making come in.

While it is beyond the scope of a short article to traverse the full history of the law making process, we consider here what has changed between the 2018 draft Bill and the version released in August 2019, to see how, if at all, thinking and planning for NHI is developing.

The short answer is: not as much as we hoped.

Despite what was reported to be hundreds of submissions on the Bill, the 2019 Bill largely maintains the approach of the 2018 draft Bill. Indeed, of SECTION27’s detailed submissions, only one concern (the deletion of section 4 of the National Health Act that guarantees free health services at public health establishments) has been remedied. This is a worry given the nature of the concerns that we, and no doubt others, raised, in the interest of securing a health system that really does serve all in South Africa.

The most notable change in the new Bill is in relation to the Minister’s powers. As SECTION27 we raised the alarm about an over-centralised and unaccountable NHI Fund structure in the 2018 Bill.

The governance structure of the NHI Fund is vitally important given that it will be responsible for huge sums of money and big and important decisions. A governance structure should be designed so as to ensure transparency and to provide for checks and balances. Designing the structure in this way is not about distrust of specific individuals involved, but rather about ensuring best practice and good governance. Governing structures cannot be designed in the mere hope that all actors will be benevolent and act in the best interests of the country.

The 2019 Bill centralises the Fund even further than the 2018 Bill. Its governance hangs largely on the Minister of Health. The word “independent” is removed from the description of the Board of the Fund and it is rendered accountable to the Minister, rather than to Parliament. It is appointed by the Minister rather than by Parliament. The Minister, rather than Cabinet, appoints an ad hoc panel to conduct interviews and recommend candidates to the Minister for appointment. The Minister may remove members of the Board or dissolve the Board. The Minister, rather than the Board itself, also now appoints the Board chairperson.

This further concentration of power is a grave error.

Population coverage is another component of the Bill that has seen a change. There has been some improvement in population coverage between the 2018 and 2019 Bills in that refugees are now entitled to the same coverage as South African nationals and all children are entitled to an undefined set of “basic health care services”. However, in the 2019 Bill, asylum seekers and undocumented migrants are entitled only to pre-hospital emergency medical services and services for notifiable conditions of public health concern (conditions such as Ebola, cholera, tuberculosis, etc). This removes the current and 2018 Bill entitlement to maternal health care services, contrary to South Africa’s commitment to reducing maternal deaths, and removes the right of asylum seekers and undocumented people to receive treatment for HIV and other communicable diseases, a clear public health threat.

In addition, in providing only for pre-hospital emergency medical services, it places people in the invidious position of receiving care in an ambulance but not covering emergency medical treatment and stabilisation in a health facility. Are ambulances to take accident victims or those experiencing a heart attack but not covered by the NHI Fund due to their immigration status home to die?

While the 2018 version of the Bill, published shortly after the exposure of the Life Esidimeni disaster, included the prioritisation of services for people with mental illness, this prioritisation has been removed in the 2019 version. It seems that the political moment for mental health has passed.

The role of provinces, long a mystery in the NHI development process, remains concerningly unclear in the 2019 Bill. The Bill spells out for the first time that the provincial equitable share (the funding that pays for almost all services in the public sector), will be shifted to the Fund. Despite the loss of funding, the provinces are meant to be “managing agents” of service delivery. It is still however unclear how they will accomplish such a task, and how they will relate to District Health Management Offices, to be established as “national government components” albeit at district level, to coordinate services in each district; or to Contracting Units for Primary Care which are meant to operate at sub-district level and receive money directly from the NHI Fund to pay health service providers.

The governance and accountability structures of the district and sub-district level structures are not provided for, and neither is the division of funds to pay for what appears to be a multi-layered bureaucracy.

Finally, another structure – the Office for Health Products Procurement – is newly introduced in the 2019 Bill. This office will be responsible for “setting the parameters for the public procurement of health related products”, including medicines, medical devices and equipment. It appears that any health facility providing services under NHI (whether public or private) must purchase health related products from a Formulary established by the Office for Health Products Procurement, which provides for both the product in question and the approved suppliers of that product. All health procurement then will be determined by the Office for Health Products Procurement.

While effectively managing procurement could well lead to price savings (as medicine tenders in the public sector have done), more information on the Office and of its governance and operations is needed to ensure that it does not further the enormous opportunities for corruption in health procurement.

The detail of this Bill matters. I have been told that it is only lawyers who care about the legislation, everyone else just wants to focus on the vision of NHI. The problem is that the vision, if it is not built into the defining systems and structures, is no more than a mirage. We have to do justice to this vision of universal health coverage, and doing so requires going beyond rousing speeches and unconditional support. It requires engaging with the details and ensuring that the new funding system we develop is capable of furthering health for all.

 

  • Stevenson is the head of the health rights programme at SECTION27.

 

 

Opinion: Approval of new TB drug lays bare crisis in TB research

NSPReview8

Last week the United States Food and Drug Administration approved the drug pretomanid for use in combination with bedaquiline and linezolid “for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary tuberculosis (TB)”.

The phrase “in combination with” is critical since the evidence on which the approval is based is mostly from a trial in which the three drugs were used in combination.

This highlights one of the key challenges in TB research today – disentangling the impact of single drugs from the impact of combinations of multiple drugs.

In this particular case, there is no way to know whether the combination of bedaquiline, linezolid and pretomanid worked because all three drugs made critical contributions, or whether it worked because two of the drugs worked very well and the other just moderately, or not at all.

It is not implausible that the success of this three-drug combination is mainly due to bedaquiline and linezolid. In fact, much improved XDR-TB survival rates have been seen in South Africa in recent years as these two drugs were more widely provided and both are now included in the World Health Organisation’s list of preferred drugs for the treatment of MDR-TB. Critically, these improved outcomes were seen without pretomanid.

Though the quality of the scientific evidence still isn’t what it should be, few would disagree today that bedaquiline and linezolid are highly effective drugs that should be included in any drug combination to treat MDR or XDR-TB, providing, of course, the patient is not resistant to either.

By contrast, we really do not know much at all about pretomanid. The key trial on which its approval was based, called Nix-TB, was a single-arm trial of 109 people – in other words, there was no blinding and no comparison with a control regimen. While single-arm trials are generally a bad idea – because it provides much less reliable evidence – it was an appropriate design in this case. That is because when the trial started there was no real standard of care for the treatment of XDR-TB – with five-year survival in South Africa being below 30%. Randomising patients to such odds would have been unethical.

The Nix-TB trial was rightly hailed as a breakthrough when its first results were reported in October 2016.The fact that most trial participants sick with XDR-TB were cured – and cured in six months without hearing loss (common with some older TB treatments) – was a major leap forward. Dr Francesca Conradie and others involved with the NixTB trial conducted here in South Africa were part of something historic and extraordinary.

But, nevertheless, it can both be true that the Nix-TB trial was a major breakthrough and that one of the drugs in the NixTB trial regimen might not work very well or at all.

We have hardly any published evidence from randomised controlled trials (RCTs) in which pretomanid has been compared to other drugs. For example, we do not have a trial in which XDR-TB patients were randomised to receive bedaquiline, linezolid and either pretomanid or delamanid (delamanid has a similar action to pretomanid but has been used much more widely). A head-to-head comparison of delamanid and pretomanid is obviously needed, yet somehow such a trial has not yet been prioritised. We also do not have pretomanid trials similar to the phase III RCTs conducted for delamanid and bedaquiline (the latter is still under way).

To the contrary, some of the more recent developments of pretomanid have raised red flags. Both in the STAND and now the SimpliciTB trials, the MDR-TB section of the trials are essentially single-arm trials. That is to say all MDR-TB patients in these trials receive regimens containing pretomanid – meaning there is no group of MDR-TB patients in the trial with which to make comparisons. Such a single-arm design was appropriate in NixTB, but is shocking to see in an MDR-TB trial where good control regimens exist. That pretomanid’s developer, the non-profit TB Alliance, has chosen this path is disappointing.

In addition, as part of the FDA process some rather disappointing results emerged from the STAND trial – indicating that the pretomanid-containing regimen in that trial could not be shown to be non-inferior to the standard treatment for drug sensitive TB (DS-TB) and that the pretomanid-containing regimen was associated with substantially more deaths and more severe adverse events than standard DS-TB treatment (see page 115 in this dossier). The FDA would, of course, have taken into account that the risk benefit calculations look quite different for XDR-TB than in DS-TB, which is probably why bad news like this was not a deal-breaker for an XDR-TB approval. As an aside, it is unacceptable that this data has only come to light through the FDA process and that it has not yet been published in a medical journal.

On a more positive note, Doctors Without Borders (MSF) has stepped into the evidence vacuum and is conducting an RCT called TB-PRACTECAL in which regimens containing pretomanid are being compared to a WHO-recommendations-compliant local standard of care which does not contain pretomanid. This trial, expected to report findings in 2021, is probably our best bet for knowing whether pretomanid can be used to treat MDR-TB. For the time being, using pretomanid to treat MDR-TB, even in a clinical access programme as some have suggested, seems to be putting patients at unnecessary risk given that we have other good drugs available about which we know a lot more. An XDR-TB and hard-to-treat MDR-TB clinical access programme on the other hand would be a good thing, given that this group of patients really don’t have many other viable options.

Hopefully pretomanid turns out to be a safe and extremely effective drug. We desperately need it to be.

However, until we have more evidence, we should keep our minds open to the possibility that pretomanid may not be effective or may only be moderately effective – and hope no major safety issues emerge as more people are exposed to the drug.

 

New tuberculosis medicine studied in South Africa approved in United States

By Amy Green

Despite the fact that often-deadly extensively drug-resistant tuberculosis (XDR-TB) is found in roughly 127 countries, up until now it has been treated with a ‘kitchen sink’ approach. Doctors, using their discretion, throw many often-toxic drugs into a lengthy treatment regimen – unsure if the combination will lead to a cure. XDR-TB is by definition resistant to many key tuberculosis medicines used today.

The United States Food and Drug Administration (FDA) on Wednesday approved the medicine pretomanid used in combination with specific other medicines for the treatment of XDR-TB. The approval brings hope to many in the field while others see the move as hasty and caution that it may set a dangerous precedent. Pretomanid is only the third new TB medicine to be approved by a leading regulatory authority in the last fifty years following on bedaquiline and delamanid earlier this decade.

Pretomanid was approved for use as part of a combination regimen including existing drugs bedaquiline and linezolid for the treatment of adults with pulmonary XDR-TB and treatment-intolerant or non-responsive multi-drug resistant TB (MDR-TB).

This three-medicine regimen, called BPaL, drastically shortens the treatment duration for XDR-TB from the current 18 months or longer to just six months. It has been shown to cure around nine out of 10 XDR-TB patients in a trial conducted in South Africa.

One of the principle investigators for the NixTB trial – which generated most of the evidence for the FDA decision – local scientist Dr Francesca Conradie described this as a “watershed” moment for the fight against hard-to-treat forms of TB.

“The annals of time are measured before and after Christ, whether you agree with that or not. Now people will refer to the history of drug-resistant TB as pre-Nix or post-Nix – that is the significance,” she said.

Paul Sommerfeld, who heads up the United Kingdom-based non-profit TB Alert, said drug resistant -TB has been a death sentence for far too many people for far too long.

“With pretomanid and other new drugs, cure rates for XDR-TB can be greatly increased,” he said. If there is also political will to introduce these drugs in every country, local communities and the individuals within them facing treatment can truly believe that they will be cured and in much shorter time with safer, more tolerable medication than those used in current regimens.”

But some have raised concerns that the decision is based on weak evidence and could set a dangerous precedent for other novel TB drugs in the future.

“We are excited and encouraged about the opportunity for people with difficult-to-treat forms of TB to have access to shorter and simpler treatments,” Lindsay McKenna, from the United States’ Treatment Action Group (TAG), told Spotlight.

“But we are concerned that this regimen, and specifically the new agent pretomanid, was only studied in a small group of 109 patients in the NixTB trial, which goes against the usually-stringent requirements of most new medicines,” she said.

Also, she said, the NixTB trial was started in a time where the prognosis for patients with XDR-TB was extremely poor, and much has changed since drugs like bedaquiline and delamanid have come into wider use over the past few years.

For example in South Africa, in 2012, only 19% of XDR-TB patients used to be cured even if they completed the gruelling two years of toxic treatment, according to the National Department of Health’s head of drug-resistant TB Dr Norbert Ndjeka. By 2016, 67% of XDR-TB patients in South Africa given bedaquiline were cured.

While BPaL achieved 90% cure rates in a clinical trial setting this might not be the same in a programmatic setting which has less patient support and more confounding factors.

However, said Ndjeka, more than one in 10 people drop out of current XDR-TB treatment because of its long duration and multitude of side-effects, risking death as well as the spread of this resistant bacteria in their communities. According to Ndjeka, having a drastically shorter regimen with much fewer side-effects could improve the drop-out rates.

A single-arm trial

McKenna noted that the single-arm NixTB trial was not randomised and controlled, which is the usual standard by which new drugs are measured by regulatory bodies.

Conradie said that NixTB couldn’t ethically include a control arm, which would compare BPaL with the then standard of care, because historic XDR-TB treatment has such devastatingly poor success rates.

“It is a small body of evidence, I agree. While 109 patients were exposed to pretomanid in NixTB, over 1,000 in total have been exposed to the drug. We know it is safe. It doesn’t cause heart or liver problems. And there are many incidences of drugs being registered without a control arm where there were clear benefits to the regimen and where clinicians had no other treatment options for example with hepatitis C,” said Conradie.

McKenna said that while this is true, TAG would advocate for more studies to be undertaken to compare BPaL with, for example, the current bedaquiline-containing 18-month regimen currently being used in South Africa.

There are also questions about the benefit of pretomanid over delamanid, another new TB drug which has already been studied in higher numbers of patients and is already registered in many countries. The drugs have a similar mode of action and activists have called for a head-to-head study comparing BPaL to a similar regimen that replaces pretomanid with delamanid.

In its submission to the FDA about the BPaL regimen, TAG requested the body to grant pretomanid conditional approval, as it has done in the past for urgently-needed drugs with smaller bodies of evidence. Such conditional approval would have required pretomanid innovator the TB Alliance to conduct further trials of pretomanid to keep its approval status.

According to the Global TB Community Advisory Board’s testimony submitted to the FDA, full approval for pretomanid could “set a precedent with the potential to lower the evidentiary standard for the future approval of new TB drugs and regimens” noting the importance that “well-intentioned efforts to expeditiously serve the needs of TB patients today do not inadvertently do a disservice to TB patients in the future”.

Implications for South Africa

But what does a decision made by a United States’ regulatory body mean for South Africa?

The World Health Organisation (WHO) is set to discuss this evidence in a November meeting, meaning the earliest time it would issue recommendations to this effect would be early next year. Previously South Africa had not waited for WHO approval to make changes to its TB programme, as was the case with the introduction of the TB medicine bedaquiline.

“Most of the research has been done in South Africa and clearly we would like to be either the first country, or among the first, to offer it to patients,” said Department of Health deputy director-general Dr Yogan Pillay. “But the issue is cost. Because the numbers of patients with XDR-TB are small, around 1,000 a year, it would be hard to negotiate price reductions based on large numbers.”

Rather than a routine and programmatic adoption of the regimen into the country’s guidelines, the department is looking to reach an arrangement where the BPaL regimen would be used in an “operational research setting”.

Pillay said that in anticipation of the FDA’s announcement, a meeting had been arranged for August 20 with stakeholders to discuss this potential arrangement with the focus being on multi-drug resistant TB (MDR-TB) patients. MDR-TB is TB that is resistant to rifampicin and isoniazid, two of the key tuberculosis medicines.

Although the focus on MDR-TB might seem peculiar, Ndjeka said that “there are 10 times as many MDR-TB patients, 10,000, compared to 1,000 XDR-TB patients a year, and for us the real benefit will come when we give newer and more effective regimens to greater numbers of people”.

The latest available data on the bedaquiline-containing nine-month MDR-TB regimen in the country showed a 73% cure rate and a 9% drop-out rate.

The objective would be to garner evidence for the BPaL regimen’s efficacy in MDR-TB to inform local and global guidelines to this effect. While Ndjeka said his department will also advocate for the inclusion of XDR-TB patients in this operational research arrangement – which could mean the country accesses the drugs for free – “it will still be a good thing if we only get it for MDR-TB”.

Even though the country won’t need to wait for WHO approval, Ndjeka said that “unfortunately it’s not a TB programme decision and involves the South African Health Products Regulatory Authority and other stakeholders”.

He added that it took about 18 months for both bedaquiline and delamanid to get past the red tape required to introduce the drugs locally.

“Realistically, considering the bureaucracy we’ve experienced in the past, I see it only coming to South Africa next year June or maybe even August – and that’s if we are fast,” he said.

Marius, a Cape Town-based participant in the Nix-TB trial, said that prior to joining the trial, lengthy treatment for XDR-TB in 2011 interfered with his job and quality of life. “I couldn’t take it anymore. For nine months I took 23 tablets every day. Every day, an injection. It was terrible and still I was not being cured. I felt dizzy the whole day and could only stay lying down,” he said.

A six-month course could help patients keep their jobs as they would need less time off work and could contribute to the wellbeing of entire families when bread winners fall ill.

Said Marius: “This new treatment is good. I can do what I want to do. And I feel like the old Marius again.”

Disclosure: Spotlight editor Marcus Low is a member of the Global Tuberculosis Community Advisory Board referred to in this article.

The plan to revive medicines regulation in South Africa

By Catherine Tomlinson

The South African Health Products Regulatory Authority (SAHPRA) is responsible for the regulation of medicines in South Africa to ensure that medicines marketed in the country are safe, effective and of good quality. In addition, SAHPRA is responsible for the regulation of medical devices, clinical trials and radiation-emitting devices.

SAHPRA replaced South Africa’s previous medicine regulatory authority, the Medicines Control Council (MCC), in February 2018 with the objective of creating an effective regulator that is responsive and publicly accountable and able to make timeous regulatory decisions. However, SAHPRA inherited many historical challenges that plagued the MCC, including slow regulatory decision times, an extensive backlog of pending regulatory applications, and a culture of non-transparency and resistance to public accountability. Since its formation, SAHPRA has developed a range of plans to overcome these challenges, which were outlined in its recent 2019/2020 annual performance plan.

Inherited challenges

At its establishment, SAHPRA inherited a massive backlog of around 16 000 medicine regulatory applications from the MCC. These include applications for “new registrations, variations, duplicates, clones, multiple doses and different dosage forms”.

While 50% of backlogged applications were submitted in the past five years, the backlogged applications date all the way back to 1992 and include applications for high priority public health products, including medicines for HIV, tuberculosis, cancer and diabetes.

The University of Western Cape’s Henry Leng and colleagues have highlighted the adoption of policies to promote generic access as key drivers of the accumulated backlog. In the early 2000s, South Africa adopted policies to fast-track the registration of medicines of high public health priority and to promote generic access. The adoption of these policies led to a large influx of applications for the registration of multiple generic versions of high priority products.

In general, the registration and availability of multiple generic versions of individual medicines is critical to improving medicine access, because competition between generic suppliers drives down prices and improves affordability. Research conducted by the United States’ medicines regulatory authority, the Food and Drug Administration, has shown that it generally takes the introduction of multiple generic products to bring down prices, as the first generic companies to enter the market tend to price their products close to the prices offered by originator companies.

While broad generic competition plays an important role in enabling medicine access, the introduction of policies to promote generic access in South Africa contributed to a regulatory backlog, as they were not coupled with an expansion of capacity at the regulator to process the influx of applications. At the same time, South Africa has struggled with “frivolous” regulatory filings by companies that fail to market their products after receiving registration. In a review of eight priority medicines, Leng et al. found that only 54% of registered generic medicines were actually marketed in the country following registration. Leng et al. suggested that the comparatively low cost of filing for registration in South Africa may encourage filings by companies without serious intentions to market their products, and cautioned that time and resources spent by the regulatory authority on fast-track approval of unmarketed products for which there are already existing alternatives, delays the registration of new products for which there is no equivalent in the country, or existing competition.

Inadequate capacity

SAHPRA has indicated that even without the large inherited backlog, the regulatory authority does not currently have the capacity to timeously process new applications. Evidence shows that while SAHPRA receives an average of 4 700 new applications annually, it is only able to process around 2 550 applications per year. With inadequate capacity to process backlogged and new applications, timelines for registration of medicines in South Africa are typically extremely long.

Research conducted by Keyter et al. demonstrated that the median time for approval of new chemical entities by the MCC was 1 161, 1 678, and 1 422 calendar days in 2015, 2016 and 2017, respectively. Keyter et al. further demonstrated that the median time for approval of fast track applications was 1 218, 921, and 609 calendar days in 2015, 2016 and 2017, respectively – far slower than the regulatory authority’s target for approval of fast-track applications in 250 days.

Slow regulatory decision times in South Africa have serious public health consequences, as they impede access to important and life-saving medicines, as well as cheaper generic versions of medicines, long after they are available on the global market. Recognising this challenge, SAHPRA has set a target to reduce regulatory decision times to 275 working days for new chemical entities and 180 days for registration of generic products. SAHPRA has also set a target to clear the regulatory backlog in two years.

The recently released annual performance plan outlines SAHPRA’s plans to “re-engineer” the regulatory authority to achieve its targets. Its plans include (among other interventions) the strengthening of its human resource capacity, the introduction of a new fees model and the digitisation of key processes.

SAHPRA’s strategy to address the medicine regulatory backlog

SAHPRA has set a target to clear the regulatory backlog in two years – but notes that, at current capacity with no new applications, clearing the backlog will take up to eight years. SAHPRA’s annual performance plan clarifies that the regulator has developed a costed strategy to clear the backlog and has secured ring-fenced funding for the backlog clearance strategy from the government, development partners and donors.

SAHPRA’s strategy to reduce the backlog involves three key elements, including reducing the number of backlogged applications to remove applications that are no longer relevant, prioritising the remaining applications for review according to public health needs and risk, and implementing new regulatory pathways to reduce regulatory decision times.

Given that the regulatory backlog dates back to 1992, it is expected that some applications may no longer be of commercial interest to applicants or of public health relevance. SAHPRA will seek to remove applications that are no longer relevant through requiring applicants who submitted applications in 2013 or earlier to indicate that they would still like their applications to undergo review through a survey template and requiring all applicants to update their applications to meet current requirements. SAHPRA has already begun to implement this and noted in a May 2019 communication that 3 000 applications in the backlog have already been deemed to be withdrawn. Moving forward, SAHPRA has indicated that it will prioritise the remaining backlogged applications for review according to public health risk and need. Public health need will be based on the government’s priority therapeutic areas and unmet medical need, and public health risk will be based on the complexity and type of application and “level of prior scrutiny by recognised regulators”.

In addition to reducing the number of applications and prioritising applications for review according to public health need and risk, SAHPRA has committed to implementing “new evaluation models” to clear the backlog, as well as to facilitate timeous registration of new applications. This strategy will involve the implementation of so-called reliance pathways to facilitate greater collaboration and information sharing with other regulatory authorities.

Reliance pathways provide mechanisms for collaboration across global regulatory agencies, and with the World Health Organisation, by creating pathways that allow regulators to access and use data and reports, and rely on other evaluator decisions, in domestic regulatory decision making. Reliance pathways provide important mechanisms to reduce times to regulatory decision making when capacity challenges impede timeous local decision making. Medicine regulators in both developing and developed countries struggle to manage their workloads and make timeous regulatory decisions due to increasing application volumes, and the need to monitor the compliance of foreign producers to good manufacturing practices (GMP).

Historically, South Africa’s medicine regulators (the MCC and SAHPRA) have not utilised reliance pathways – despite arrangements and collaborations in place with other regulatory bodies to facilitate their use – and selected instead to conduct full scientific reviews of quality, efficacy and safety data for all regulatory applications. However, SAHPRA has now committed to operationalising these pathways to address the backlog and reduce regulatory decision times for new applications. SAHPRA has further indicated that it will formalise processes to facilitate the use of several different reliance pathway models, including full review, abridged review, verified review, recognition and notification – each requiring different levels of local review and evaluation.

Implementation of the “abridged review” model, for example, would allow SAHPRA to rely on regulatory data and evaluations from other agencies (such as the European Medicines Agency), while requiring local review and evaluation of domestic contextual issues – such as the interaction of the medicine under review with HIV treatment.

Building SAHPRA’s human capacity

A further challenge faced at SAHPRA is its limited human resource capacity to effectively fulfil its mandate. According to information provided to Spotlight by SAHPRA’s CEO Portia Nkambule in November 2018, SAHPRA then had 178 full-time employees and around a similar number of external evaluators supporting regulatory activities. SAHPRA is seeking to significantly increase its staff capacity to around 450 full-time staff over the next five years and has already initiated a hiring drive, advertising more than 100 new posts in May 2019. SAHPRA has further indicated that staff members were recently transferred from the National Department of Health’s Pharmaceutical Trade and Product Regulation programme to SAHPRA under a section 197 transfer agreement and, according to SAHPRA’s annual performance plan, the transferred staff will support core programmes responsible for medicines evaluation and registration and authorisation management.

While SAHPRA is seeking to strengthen staff capacity in all of its programmes, the 100 recently advertised posts included 17 new posts for medicines regulation and 19 posts for the backlog clearance project. A key goal of SAHPRA is to build its internal capacity to fulfil its medicines regulatory functions, unlike the MCC which relied heavily on external evaluators. SAHPRA’s annual performance plan explains that its reliance on a “dwindling” number of external evaluators creates difficulties in managing and optimising regulatory decision times due to the lack of contractual performance agreements with external evaluators. The annual performance plan clarifies that while SAHPRA hopes to absorb some external evaluators as internal staff, it will also seek to build its internal capacity through upskilling existing staff and recruiting new staff – but notes challenges in attracting and recruiting new internal evaluators.

SAHPRA did not respond to requests for more information on the difficulties it is facing in recruiting new internal evaluators. However, recruiting challenges faced by SAHPRA may include challenges identified by regulatory authorities in other jurisdictions – such as shortages of required skills in the domestic labour market and difficulties in competing with higher salaries offered by the industry.

Opportunities and challenges for public engagement

SAHPRA has taken significant and commendable steps since its establishment in February 2018 in outlining reform plans and processes to improve its functioning to effectively fulfil its mandate. In addition to the adoption and initiation of a strategy to address the regulatory backlog and its efforts to build its staffing capacity, SAHPRA has developed plans to digitise key processes and implement a new fees model (among other interventions). These steps have been taken despite significant challenges faced by the new regulatory agency in its first year of operations, including staff protests and the closure of its offices in the Civitas building due to unsafe working conditions.

While SAHPRA should be commended for its important work to date, responsiveness to the public and accountability remains a challenge despite the regulators commitments to improving and demonstrating transparency and accountability. Health NGOs in South Africa continue to express frustration due to the non-responsiveness of the regulator following requests for information and engagement. Additionally, despite questions Spotlight sent SAHPRA for this article, no responses were received.

In December 2018, SAHPRA CEO Nkambule noted that the regulatory authority was seeking to create a culture of transparency and that in the current transitional phase it would prioritise the implementation of a formal communications strategy and systems. SAHPRA’s annual performance plan notes that a communications strategy has been drafted and has been approved to be implemented during 2019. The plan further adds that through implementing the communications strategy, SAHPRA will endeavour to (among other goals) “develop mechanisms to allow all stakeholders to communicate easily with the regulator including being able to lodge queries and complaints”.

Beyond the implementation of a communications strategy, the Minister of Health should introduce legislative reforms to require greater transparency and accountability from SAHPRA. Vawda and Gray recently undertook a review of secrecy provisions contained in section 34 of the Medicines and Related Substances Act No 101 of 1965 and concluded that section 34 “violates the right to access to information in section 32 of the Constitution of SA”. They added that section 34 “appears to grant the MCC/SAHPRA unfettered authority to refuse access to information, except on limited grounds, based on its sole discretion”. Vawda and Gray recommended the amendment of section 34 to accommodate the right to access to information and added that the regulatory reform processes underway “provides an opportunity to redress a serious anomaly in our regulatory framework, and to align it with our constitutional paradigm, in order to reflect greater openness, transparency and accountability in our public institutions”.

As SAHPRA moves forward with the development and implementation of plans to re-engineer the authority, there is significant scope for civil society to monitor developments to demand meaningful transparency and accountability from the regulator (including necessary regulatory reforms) and ensure that the development and implementation of reforms serve the public interest.

 

 

 

Opinion: Right of access to affordable meds watered down in Presidential Compact

By Mark Heywood, Zain Rizvi

In May 2018, the Department of Trade and Industry (dti) finally unveiled a new policy that would help to rein in pharmaceutical industry profiteering. The Intellectual Property (IP) Policy of the Republic of South Africa, offered a fresh vision of how to improve medicine access. Phase 1 of this policy concentrated on issues to do with IP and public health. It recognized “the dire circumstances that ensue from lack of [medicine] affordability” and endorsed a range of measures to improve access. The policy was adopted by cabinet, and as such represents official government policy today.

The policy had been many years in the making. It was developed by an Inter-Ministerial Committee on Intellectual Property, debated extensively and arrived at via a thorough democratic process. It is in line with international law and recommendations made by the UN Secretary General’s High Level Panel on Access to Medicines. According to the policy its “aim is to ensure that South Africa protects IPRs and at the same time achieves its objectives of promoting national development imperatives, which include, among others, boosting local manufacturing, promoting innovation and ensuring equitable access to medicines.” It proposed a range of reforms, and new laws, that could make a real difference in people’s lives.

But the pharmaceutical industry has fought back.

On July 25, President Cyril Ramaphosa signed the Presidential Health Compact in a blaze of publicity. The Compact, which came into being after stakeholder consultations, promises a new commitment to fixing the public health care system. It includes a pillar on Access to Essential Medicines. Unfortunately though, pharma’s fingerprints have crept in, watering down the language on medicine access compared to the IP policy and raising concerns about expected new legislation. The Compact lists as one of its interventions:

“Finalise the South African National Policy on Intellectual property in a manner which balances the objectives of access with the need for IP protection to encourage pharmaceutical innovation, promote further research and development as well as attract future investment in the country.”

The suggestion here that the IP policy that Cabinet has adopted after an extensive democratic process is not finalized is either an error or an attempt to reopen the policy process through the backdoor. Either way, it is deeply concerning.

The Compact also seems to include new language and objectives. A few changes here and there may seem trivial. But these are not by any means innocent edits. They re-introduce tired and discredited arguments that could have profound health consequences, disproportionately counting in lives of the poor.

Let us explain exactly what we mean.

In South Africa, we have a growing cancer epidemic and cancer medicines provide a good example of what these words could do. The World Health Organization (WHO) has listed the drug lenalidomide, a treatment for multiple myeloma (a difficult and aggressive blood cancer), as an “essential medicine.” That means the WHO believes every health system should have it. We do not. Why? Because of its cost – a month’s treatment is priced at ZAR 60,000. A year’s worth costs ZAR 730,000.

In India, by contrast, a year’s course is available for less than ZAR 30,000.

What is responsible for this staggering difference? Why are cancer medicines often only accessible to the rich in South Africa?

The answer is prescription drug patents. Intellectual property blocks medicine access. Contrary to what industry claims, medicines are not expensive because they are costly to produce, or because they are expensive to research and develop. Medicines are expensive because of the monopolies that patents give their manufacturers.

In the case of lenalidomide, the patent-holding company in South Africa—Celgene—holds 32 patents that could block competition until 2028. This over-patenting is not unusual: a Fix the Patent Laws and Cancer Alliance report found the patents office had granted 92 patents on just 24 cancer medicines, delaying affordable generic access.

Unfortunately though South Africa does not examine patent applications before it grants them. Other countries, like India and Brazil, do. Among developing countries, the South African “system” is an over-patenting outlier. The consequences are unconscionable.

In early August, the Cancer Alliance sent a letter to Minister of Health Dr Zweli Mkhize that included a formal request that action should be taken by the government to ensure the affordability of lenalidomide. The Cancer Alliance is currently waiting for a response from the Minister. One action the Minister could take is to grant “compulsory licenses” on lenalidomide’s patents to authorize access to low-cost treatment. This is an important power to prevent patent abuses that is permitted by our existing laws but has never been used. It should be used and urgently accompanied with new laws that build on the reforms proposed by the 2018 IP policy and prioritize public health.

The IP policy that Cabinet has adopted is imperfect, but it is principled. It is grounded in the constitution, noting that when balancing private and public interests it must “first and foremost engender the ethos of the South African Constitution.” And, most importantly, it recognizes the “constitutional imperative to increase access to medicines” as a component of section 27 of the Constitution, which guarantees the right to access health care.

In contrast, the Compact’s language on access to medicines largely echoes industry talking-points, shifting the focus away from health. It designates two organisations—the South African Medical Association and Pharmaceutical Society of South Africa—as leading this work, none of which represent patients. It also presents false choices between balancing access, and innovation, research and development, and foreign investment. These have always been a distraction.

Cabinet has already recognized this. The IP policy, which cabinet approved, noted that there was “an inconclusive link” between increased IP protection and economic development, based on studies from the World Intellectual Property Organization and Nobel Laureate Joseph Stiglitz.

Similarly, a recent analysis found that less than 10% of the patents granted in the country over a decade were filed by people living in South Africa, undermining the claim that patents are linked to local innovation. In addition, South Africa accounts for less than one percent of the global pharmaceutical market. To suggest that South Africa’s efforts to increase access to medicines would impact global innovation is simply disingenuous.

We have been here before. In the early 2000s, HIV medicines were inaccessible to all but the wealthiest. Before the Treatment Action Campaign’s campaigns for affordable medicines a month of anti-retroviral medicines cost over R5 000. Today, the same medicines cost less than R500. In those days corporate profiteering, mixed with AIDS denialism, led to the preventable deaths of hundreds of thousands of people. Arguments about investment and innovation were trotted out to defend the indefensible. Today, nearly five million people living with HIV are alive and well because of access to affordable medicines.

But while we may have solved the problem of affordability for HIV medicines, we have not for almost every other illness. The root causes of high prices—unchecked patent-granted monopolies—remain in place. Once again, thousands of lives are being lost on the altar of profiteering. This is why South Africa must urgently adopt a new patent law. Many lives depend on it.

  • Mark Heywood is the Editor of the soon-to-be-launched Maverick Citizen and former Executive Director at SECTION27. Zain Rizvi is a law & policy researcher at Public Citizen.

 

 

Is scaling up active case finding the missing piece in our TB response?

By Sean MacDonell 

South Africa has one of the highest burdens of tuberculosis (TB) in the world. The World Health Organization (WHO) estimates that 322 000 people in South Africa had active TB disease in 2017, meaning they were presenting symptoms and could spread the TB bacteria. Approximately 60% of these people were also living with HIV. TB is the leading reported cause of death among people living with HIV and in South Africa overall (although models indicate that HIV still causes slightly more deaths). 

Increased access to antiretroviral treatment (ART) has meant that fewer people with HIV have developed TB and died of TB. But what else can be done to reduce TB rates besides improving access to ART for people living with HIV?

Although TB rates are slowly decreasing globally, there appears to be consensus in the TB research community that more must be done in order to reduce TB rates more quickly. One area where more can be done is active case finding (ACF).

What is active case finding?

People with TB are often diagnosed through passive case finding (PCF) when they present to clinics (primary health care centers) with TB symptoms. ACF is generally considered to be any other method of reaching people with TB outside of the primary health care system. According to the WHO, ACF is “the systematic identification of people with suspected active TB, using tests, examinations or other procedures that can be applied rapidly.” 

Because ACF is often defined as anything that is not PCF, different definitions have been employed by different people in different studies. This creates difficulties when trying to compare ACF interventions, as people may be describing distinct interventions while calling both ACF. 

Regardless, the purpose of ACF is widely agreed upon: to find people with undiagnosed active TB and to link them with treatment in order to help them get healthy and to reduce the period of infectiousness. Once people with TB start taking treatment, they become non-infectious very quickly. By the time someone goes to a clinic for help, that person may have transmitted TB to as many as ten or fifteen other people–ACF can help prevent these onward transmissions by getting people onto treatment more quickly.

In this way it is thought that greater ACF efforts particularly among high-risk groups will greatly reduce the number of people with active TB. High-risk groups for TB are people living with HIV, children, the elderly, mine workers, inmates, military personnel, and healthcare workers – in addition to people in the same household as someone with active TB or other close contacts of someone with TB.

Currently, ACF has not been widely undertaken in South Africa due to the stress it would put on the already overburdened health care system. “It comes down to perceived resources and disease burden being attended to in primary health clinics,” explains Erika Mohr-Holland, a Khayelitsha-based epidemiologist for Doctors Without Borders whose focus is on drug-resistant tuberculosis (DR-TB). “If health care workers are attending to a lot of sick people it becomes a lesser priority to see those who are perceived as well.” Therefore, there has been little focus on ACF and prevention. “It’s all on treatment,” says Mohr-Holland.

Contact tracing

One form of ACF is contact tracing. It is defined by the WHO as “the identification and follow-up of persons who may have come into contact with a person with active TB.” The WHO assumes each person has at least three close contacts. Contact tracing is probably the most widely implemented form of ACF in South Africa. 

Contact tracing was one of the ACF interventions in the ZAMSTAR study, a cluster randomised control trial carried out in areas with high burdens of TB/HIV in South Africa and Zambia. Contact tracing was performed through frequent household visits and screenings for contacts of patients with active TB. This resulted in a relative reduction in TB prevalence (the percent of the population who has TB) of approximately 22% compared to matched communities where these interventions were not implemented. 

 Mobile clinics

The use of mobile clinics for TB screening is another form of ACF.  Mobile clinics are clinics operated out of specialized vehicles and  are typically located in areas that do not have immediate access to primary health clinics. Mobile clinics can be especially useful as they can reduce barriers to access, such as the cost and time of travelling to a clinic. They can also tailor the services they offer to the communities that they are in. 

Both mobile clinics and house-to-house visits were used to conduct TB screenings in the DetecTB study, a cluster randomised control trial in Zimbabwe. Both interventions used sputum smear-microscopy. However, the mobile clinic intervention detected more TB cases than house-to-house visits. This led to a relative reduction in TB prevalence of 40% in the mobile clinic community compared to before the intervention.

Mobile clinics may more readily provide access to chest radiography, or x-ray, (CXR) as a screening tool. CXR is cheaper than other screening methods, is shown to provide accurate results in high TB/HIV burden areas, and may detect TB prior to someone developing symptoms. 

What needs to be done

Cost is one of the main barriers to implementing ACF interventions in resource limited countries. However, mathematical models can help us predict the costs and benefits of different ACF interventions. One recent model found an aggressive scaling-up of ACF could reduce the incidence of TB in South Africa by 55% and reduce mortality by 72% by 2025 (compared to 2015 numbers). Another found that scaling-up of ACF could reduce total patient costs by 28 billion rand between 2016 and 2035. The further development of reliable mathematical models, particularly with a focus on the South African context,  should be prioritised. 

It is not always clear which intervention, or combination of interventions, may be best for a certain district, province, or segment of the population. Therefore, in addition to more modelling work, there is a need for more cluster randomised control trials to determine the effectiveness of these different interventions. Large studies such as ZAMSTAR, DetecTB, and Kharitode are giving important indications of what works and what does not, but we still need more evidence. 

However, waiting until more trials are conducted and the evidence is even clearer is not an option given South Africa’s high TB incidence. We simply cannot afford to wait. Current evidence leaves little doubt that TB prevention through some form of ACF, probably both increased contact tracing and mobile CXR clinics, must be scaled up in order to accelerate the fight against TB. Whether or not the resources will be found to do this properly will be a good measure of the South African government’s commitment to fighting TB.

  • MacDonell is a Spotlight intern and a student at Carleton College in the United States.

Another Eastern Cape psychiatric facility damned

A courtyard behind the male ward.

Housing the mentally ill in a condemned building with little security sounds like something out of a horror movie. But for the patients and staff of the Cecilia Makiwane Hospital (CMH) Mental Health Unit this is not a movie; it’s reality. The building, in the heart of Mdantsane, East London, is in disrepair: windows are broken, there’s exposed electrical wiring and abandoned medical equipment. There is no psychiatrist, security is virtually non-existent and staff and patients are traumatised.

While this regional hospital was reborn into a plethora of new beautiful buildings and facilities in March 2017, the Mental Health Unit was left in the decaying old hospital. The unit is not accessible from the new hospital gates and staff, patients and their families have to navigate the tricky side streets of Mdantsane to find the old entrance. If you’re lucky enough to find it, the security is abysmal; a friendly guard simply waves vehicles through without so much as a boot check or taking your name. There are no cameras and there’s barely a fence.

Parking is next to the ambulances; it appears that emergency medical services got stuck in the old building too, along with family medicine and an NGO.

A seemingly abandoned wheelchair lying in water in a yard.

The Mental Health Unit is made up of wards 11-15. You walk down the dark cement passageway; the old theatre is to the left and clusters of forgotten and decrepit medical wards to the right. Most of these wards have been closed off with rusty gates – some locked, others just appear to be. Old hospital beds and wheelchairs remain trapped inside these closed off passageways, along with overgrown grass and heaps of rubbish. By the time you reach the Mental Health Unit you wonder if anyone still works there, amidst the overwhelming neglect.

The unit is the only acute psychiatric facility in the Buffalo City Metro area, serving a population of over 755 000, with the next available facilities two hours away in Queenstown and Fort Beaufort.

Last year the unit made headlines in Eastern Cape community newspaper Grocott’s Mail as well as eNCA’s current affairs programme Checkpoint, as part of Health-e News’ two-part documentary series, The Writing on the Wall. Now, following a desperate plea from a whistleblower, a former staff member, Spotlight revisits the story.

The passage leading to the Mental Health Unit.

Fire brings condemned hospital building to light

According to the source, a fire broke out in the female ward of the unit on 6 July. However, Eastern Cape Department of Health spokesperson Sizwe Kupelo disputed that there was a fire in the ward.

“What happened was a faulty microwave had an electrical fault and caused the microwave and nearby curtain [to catch on fire]. The fire did not spread to the building,” said Kupelo. The department blamed a “negligent” staff member.

Internal documents seen by Spotlight state that the fire was caused by faulty plugs in the unit, and that there had been two other electrical faults the following week. The documents highlight that the hospital’s management and infrastructure staff were aware of old electrical points, an issue that heightened staff concerns.

The former staff member claimed that firefighters could not enter the ward at the time of the emergency, due to its structural instability and lack of access points. According to documents seen by Spotlight, firefighters on the scene reported that the building was not up to safety standards and should not be in use.

Buffalo City Metro was approached for comment but did not respond by the time of publication.

The documents further reveal that in previous years the old hospital building did not acquire fire safety certification, forcing the department to build a new hospital. This information shocked staff, who had only heard rumours of the building being condemned.

Records show that members of hospital management, including the quality assurance manager and a senior manager in the Provincial Department of Health, knew for years that the old hospital was not safe.

A metal gate used as a barrier in one of the wards.

However, Kupelo accused staff of using the fire to agitate for the relocation of the Mental Health Unit, and suggested that staff for that reason made allegations that the building was not safe.

“We used a specialist to assess the building safety including electrical installation and these are found to be within the acceptable levels,” he said.

Kupelo said the Head of the provincial Department of Health Dr Thobile Mbengashe had attended two meetings with staff and conducted in loco inspections of the facility.

“[The HOD] agreed with parties to move the remaining services at the old wing of the hospital and all parties agreed, including the doctors. The HOD made it clear that the priority is the safety and wellbeing of the patients.”

Spotlight posed immediate follow-up questions requesting clarification on where the remaining services would be moved but did not receive a response.

A follow-up meeting was scheduled for 29 July, but Spotlight cannot confirm if this meeting took place.

“It is unacceptable that the doctors take wide strike while the matter of the patients’ safety [is] being addressed,” said Kupelo.

Poor security leaves patients, staff at risk

Spotlight entered the facility with ease and, according to the source, other unwanted visitors do too. The whistleblower said vagrants were often found in the abandoned wards near the Mental Health Unit, which posed a safety risk to patients and staff.

Kupelo said that security issues would be immediately addressed, including installing security cameras, restricting and controlling access and ensuring that the entire facility is adequately fenced and secured.

The Mental Health Unit consists of two 25-bed wards – one for men and one for women. Both are medical wards that house acute patients with varying diagnoses. Some patients are dangerous and they are not separated.

On 16 June 2017, a revolt in the men’s ward resulted in serious damage to the facility and caused trauma for patients and staff. Police were called to intervene and patients were transferred to other institutions, mainly Tower Hospital in Fort Beaufort. Five days later, after hospital management and the Department of Health failed to react to the revolt, ward nurses took to protesting against their working conditions. Patients were transferred for a second time.

“It’s very difficult because you’ve got the constant pressure to admit sick people,” said the former staff member. “These are ordinary dormitories, with no barrier [between patients and staff]. Eventually after 16 June they put a security gate which a patient broke not long after. There is no barrier, so you sit in your office and the patients break through. I feel sorry for the nursing staff because they work under very difficult conditions.”

The source told Spotlight that as a result of the dangerous conditions, the unit faces challenges when admitting children and young adults for fear of their safety.

According to the whistleblower, the risk is high for abuse.

“We know that sexual abuse in wards is rife. The big thing is we have to put all the different pathologies and age groups in one ward. There is not even a single room to separate them. So if you’ve got an adolescent that’s small in stature and you’re worried about abuse, where do you put them?”

On top of safety concerns, the former staff member says that security staff members were poorly trained, recalling that frequently weapons from patients were missed by security, photos of which were published by Grocott’s Mail last year.

Not enough staff, not enough rehabilitation

Exposed electrical wiring in the corridor.

Documents shared with Spotlight outline the dire staff shortages at the unit, including the lack of a psychiatrist.

“There has been no psychiatrist since December 2018,” said the former staff member. “They can’t get anyone there because our name is so bad. No one wants to come here, to Cecilia. We’ve got good staff but you can’t work under these conditions for the long term.”

Along with critical staff shortages, dismal infrastructure and a lack of safety and security; there are no recreational facilities for patients. There’s only an empty cement courtyard.

“There’s very little rehabilitation going on. It’s basically pharmacotherapy. That’s the reality, there’s nothing else to do,” said the former staff member.

The future of the unit?

Patients sitting next to exposed electrical wiring in the courtyard.

Despite commissioning a new psychiatric facility for Cecilia Makiwane in 2012, the Department of Health has failed to deliver on its promises.

Kupelo said that following the fire “we agreed to conduct, using a specialist to assess the structural, safety, and design, a suitable service platform to accommodate the patient move to the new refurbished facility”.

Spotlight sent follow-up questions asking for clarification on the new facility but did not receive a response.

The documents seen by Spotlight suggest that the department has no money to complete the scheduled renovations of the hospital, and that a new facility would not be plausible for another five years.

The department’s 2017/18 budget shows that R695-million was set aside for the eight psychiatric hospitals and units in the Eastern Cape, including the CMH Mental Health Unit. This was R100-million more than the 2016/17 allocation of R596-million. However, during the 2017/18 financial year the initial budget was cut by R195-million (roughly 28%) to result in a final adjusted budget of R500-million, which was R96-million less than the 2016/17 budget that had been fully spent. 

The Ombud investigates Tower, leaves CMH to the wayside

On 27 March 2018 Spotlight understands a formal complaint was laid with the Office of Health Standards Compliance (OHSC) for the Ombudsman to investigate the Mental Health Unit’s various issues. The complaint contained harrowing information about the unit dating back to 2007. Although the OHSC acknowledged receipt of the complaint on 6 April, it appears that no investigation took place.

OHSC spokesperson Ricardo Mahlakanya could not confirm to Spotlight that there was an individual investigation into the unit. “In the report on Tower Hospital (another hospital in the Eastern Cape) we made the recommendation that a mental health administrator be appointed to look after all mental health services in the province,” he said.

In the 2018 report on Tower Hospital, Cecilia Makiwane is mentioned only once and that’s in reference to a Tower Hospital patient who was recovering from burn wounds. The report does not address CMH’s Mental Health Unit.

Health Ombudsman Malegapuru Makgoba hauled the Tower Hospital whistleblower over the coals in August last year. This, according to some activists, has set a dangerous precedent for the future of whistleblowing in South Africa’s medical field.

This attitude towards whistleblowing has sounded alarm bells for the watchdog group, the Public Service Accountability Monitor (PSAM).

“This is cause for concern that we raised with the Tower Hospital exposé,” said PSAM director Jay Kruuse. “When people finally go public, there is backlash directed at them and at [staff] who have been working in intolerable conditions.”

Kruuse said the documents that Spotlight has acquired reveals significant levels of patient violation at Cecilia Makiwane and he described the revelations as “damning”.

“One would have thought that amidst the critical findings from the Tower Hospital investigation and the acknowledgement by the health minister, corrective action would have followed. The material suggests strongly otherwise,” he said.

“We have come from the Life Esidimeni deaths that occurred following the transfer of patients to NGOs, to the human rights violations at Tower Hospital rightly exposed by staff and interested and affected parties. All of these cases show that those who have mental health conditions and who are extremely dependent on the state for their day-to-day care are treated less humanely.”

Kruuse emphasised that whistleblowers and staff should not be victimised for speaking out, considering that they, as well as patients, have already been victims to the current conditions.

*The South African Society of Psychiatrists declined to comment on the investigation at this time.

**Budget information provided by PSAM

Kathryn Cleary is a health journalist with Grocott’s Mail in Makhanda, Eastern Cape, and was commissioned by Spotlight to write this article.

Graphs that tell the story of HIV in South Africa’s provinces

By Marcus Low and Sean MacDonell

The most recent outputs of the Thembisa mathematical model (version 4.2) of HIV in South Africa not only allow us to see the burden of HIV at the country level, but also allow for provincial comparisons. Through several tables, graphs, and maps, we illustrate how the HIV epidemic differs in each of the country’s nine provinces.

1. Which provinces have the most people living with HIV?

The table below shows which provinces have the largest number of people living with HIV. The ongoing increases in these numbers are both positive and negative. On the negative side, it reflects the fact that the rate of new infections remains high; on the positive side, it reflects the reality that people with HIV are not dying at the rates they used to since antiretroviral therapy is keeping millions of people alive. 

ProvinceNumber of people living with HIVPrevalence
KwaZulu-Natal202947018.23%
Gauteng191259013.05%
Eastern Cape85932913.04%
Mpumalanga70517415.41%
North West52459313.59%
Limpopo5150918.99%
Western Cape4522106.76%
Free State419631

14.62%
Northern Cape817787.13%

KwaZulu-Natal is clearly at the centre of South Africa’s HIV epidemic. The province has more people living with HIV (over two million) than North West, Limpopo, Western Cape, Free State, and Northern Cape combined. In interpreting these numbers one should of course keep in mind that KwaZulu-Natal is South Africa’s second most populous province behind Gauteng – which partly explains the high absolute numbers, but not entirely.

2. What percentage of the population is living with HIV in each province?

To contextualise the number of people living with HIV in a province in terms of the size of provincial populations we can look at the percentage of a province’s population who are HIV positive (also known as prevalence). In the same table above we can see that KwaZulu-Natal still tops the list with an incredible 18.23% of the population living with HIV.  While Free State ranked eighth for the absolute number of people living with HIV in the province, it ranks third in terms of prevalence at 14.62%. Despite the large absolute number of people living with HIV in Gauteng (nearly two million), the province ranks only fifth in terms of prevalence at 13.05%. Here we can see how prevalence has changed over time in South Africa’s four most populous provinces: Eastern Cape (EC), Gauteng (GT), KwaZulu-Natal (KZ) and Western Cape (WC). While the prevalence of HIV continues to rise in the Eastern Cape, KwaZulu-Natal, and Western Cape, we can see that it has now begun to fall (albeit slightly) in Gauteng. Prevalence continues to rise in most provinces for the same reasons that the absolute number of people living with HIV is rising, although prevalence is also impacted by changes in the province’s population.We can also conceptualize prevalence using the map above. One interesting trend is that provinces in the east of the country tend to have higher HIV prevalence than provinces in the west. (See the column on prevalence in the table for exact numbers.)

3. How many new cases of HIV are there each year in each province?The graph above shows the number of people newly infected with HIV each year in the four most populous provinces. Here we can see that KwaZulu-Natal has dramatically reduced the number of new HIV infections, now having fewer people newly infected with HIV than in Gauteng. While the number of new HIV infections continues to come down in the Western Cape, a much flatter line suggests a slower rate of decline than in the other three most populous provinces. 

4. The 90-90-90 targets

The 90–90–90 targets are a set of global goals established by the United Nations Programme on AIDS and HIV. By 2020, the goal is that “90% of people living with HIV will know their HIV status, 90% of those who know their HIV-positive status will be accessing treatment, and 90% of people on treatment will have suppressed viral loads.”

These targets provide a good measure of how well different provinces are performing in key areas such as the provision and promotion of HIV testing and helping people who test positive to start treatment and to stay on treatment.

Province% of HIV-positive individuals diagnosed% of HIV-diagnosed individuals on ARTFraction of ART patients virologically suppressed (RNA count <1000 copies/ml)% of HIV-positive individuals on ART with VL <1000
Eastern Cape90.14%61.60%87.19%48.41%
Free State89.24%73.40%91.48%59.92%
Gauteng88.93%60.89%87.29%47.27%
KwaZulu-Natal92.46%72.41%91.74%61.43%
Limpopo91.66%73.26%85.23%57.24%
Mpumalanga90.45%73.53%88.09%58.60%
Northern Cape90.81%83.02%84.42%63.66%
North West89.21%57.65%87.87%45.20%
Western Cape88.73%65.53%89.79%52.24%

The table above displays 90-90-90 targets for each province. This allows us to examine how each province is either achieving or falling behind each target of 90%. The fourth column is the product of the three target percentages; in other words, it is the percentage of all people living with HIV in the province who are both accessing antiretroviral treatment and have suppressed viral loads. As this fourth column represents 90% of 90% of 90%, a province achieving all three targets would have at least 72.9% in the fourth column. In other words, at least 72.9% of people living with HIV in a province would be accessing ART and would have viral loads below 1000 if they are meeting all targets. 

In the table above we can also see that the Northern Cape is closest to achieving this target percentage as 63.66% of people living with HIV are both accessing ART and have suppressed viral loads.

It is clear from the table that the greatest barrier to achieving the 90-90-90 targets is ensuring that people with diagnosed HIV are taking antiretroviral treatment. Only in the Northern Cape is the percentage of people with diagnosed HIV who are taking treatment over 80%. While North West comes close to achieving the first and third targets, only 57% of people with diagnosed HIV in that province are on treatment.

The dynamics between the three 90s can be interesting. For example, when a province suddenly initiates a lot more people onto treatment, we may at first see a reduction in the percentage of those with suppressed viral loads since many of the new patients will still have unsuppressed viral loads. Either way, ensuring that those who know their status receive the treatment and care they need is a priority in order for South Africa to achieve the 90-90-90 targets. The graph above shows the percentages of people with HIV who are both on treatment and virally suppressed for the four most populous provinces from the year 2001 until 2018. KwaZulu-Natal and Gauteng have consistently high rates, while there has been a slight drop-off in the Western Cape and Eastern Cape during the last few years.

Note: The graphs in this article were produced using RStudio and the ggplot2 package. Graphs are exclusively based on publicly available Thembisa model outputs. Spotlight takes full responsibility for any errors or misrepresentations there may be in the graphs.

 

 

 

 

What are we to make of the ADVANCE trial results?

By Dr Michelle Moorhouse and Dr Simiso Sokhela

With over 5 million South Africans on life-saving antiretroviral therapy, making treatment safer, more potent and cheaper is a priority, especially in the context of rising drug resistance across the country. However, antiretrovirals are developed largely in richer countries, while Southern African populations, with high levels of TB, hepatitis B, and a large proportion of women desiring pregnancy, are not represented in the studies.

The 48-week results of ADVANCE, a ground-breaking HIV treatment study conducted by Ezintsha, a division of the Wits Reproductive Health and HIV Institute, was presented at the prestigious IAS conference in Mexico on 24 July 2019, and published in a top medical journal, the New England Journal of Medicine.

ADVANCE assessed two newer antiretrovirals, dolutegravir and tenofovir alafenamide fumarate (TAF), that are now used in richer countries, in people with HIV starting antiretroviral therapy (ART), against what we currently use in South Africa. These two new drugs (TAF is not even registered in South Africa, awaiting a much-delayed licence from the South African Health Products Regulatory Authority (SAHPRA)) both have toxicity benefits over the drugs they replace. They are cheaper to make and give us a smaller tablet size, which has other cost benefits beyond the cost of production. Dolutegravir appears almost unbreakable, in terms of resistance.

The following three regimens were compared in ADVANCE:

  • Dolutegravir, TAF, FTC
  • Dolutegravir, TDF, FTC (A regimen being introduced in South Africa.)
  • Efavirenz, TDF, FTC (Currently the most commonly used regimen in South Africa.)

All three regimens investigated in ADVANCE performed extremely well, with high rates of viral suppression, very little resistance, and few people stopping their study regimen as a result of side effects. In fact, participants stopped their study medication more as a result of personal or social factors, rather than side effects – older people and those employed had the best outcomes. Almost everyone “failing” their treatment, that is where their viral load starts going up, were able to control their virus again with a simple adherence intervention, whatever drug regimen they took.

Even so, there were some differences in side effects across the study arms. We saw an increase in weight in the dolutegravir-containing arms of the study, consistent with recent reports of weight gain associated with this class of drug. The weight gain in ADVANCE was worse in women; those also receiving TAF; and those with more advanced HIV (lower CD4 counts and higher viral loads).

At this stage, the potential mechanisms for the weight gain are poorly understood. In ADVANCE, weight gain did not appear to be associated with the things that worry us with people being overweight, such as changes in blood pressure, cholesterol or blood sugar, but it may be too early to see these effects, as they have only been followed for 48 weeks. We will follow the patients further, hopefully for the next few years, to see if the weight gain causes metabolic problems. It is complex to understand the implications of these findings, especially as we are facing an epidemic of obesity in South Africa, irrespective of HIV status.

The ADVANCE study and its results are important for a number of reasons. When newer antiretrovirals (ARVs) such as dolutegravir and TAF are developed, most of the research is conducted in richer countries, with studies that recruit mainly white middle-aged men – this is not representative of the majority of people with HIV who will ultimately be treated with these drugs. The ADVANCE population was 99% black, almost 60% women and the average age was 32 years, which reflects the demographics in Southern Africa more accurately, and so the results are very relevant to large HIV treatment programmes such as ours.

Once new ARVs are approved, little is known about their safety in pregnancy; whether they can be used with drugs used to treat TB; effectiveness in everyday people with HIV – all of which we consider to be the “real world” effectiveness of ARVs. ADVANCE did not exclude people with advanced HIV or other common illnesses; participants who developed TB or became pregnant were allowed to stay in the study and so the data gleaned from ADVANCE helps us understand more fully the utility of newer ARVs such as dolutegravir and TAF in these groups. In ADVANCE, most participants were given isoniazid to prevent TB, and as a result we saw hardly any new TB in the study, confirming the effectiveness of TB preventive therapy.

Because of concerns about neural tube defects, a severe birth defect that is often severely disabling or fatal, that were seen with women conceiving on dolutegravir in Botswana, we have been monitoring women who become pregnant and their infants very carefully in ADVANCE. The number of pregnancies is too small to be meaningful but to date, there have been no neural tube defects in ADVANCE.

Although ADVANCE took place in inner-city Johannesburg only, we recruited a very diverse African population, with 60% of study participants being from across South Africa and the remaining 40% from other African countries, mainly Zimbabwe. This makes the results of ADVANCE applicable to other countries in sub-Saharan Africa, where dolutegravir is already being rolled out or where rollout is imminent, as in South Africa. This is important, as there is a paucity of data from randomised studies of the regimens investigated in ADVANCE in African populations. On account of this, the results of ADVANCE have been shared with global bodies including SAHPRA, World Health Organization (WHO), the US Food and Drug Agency (FDA) and guideline committees to inform their processes are guided by data relevant to populations being treated.

Another unique feature of ADVANCE is the fact that it was designed by a consortium of leading international HIV clinicians and researchers, with input from global bodies such as the WHO, Clinton Health Access Initiative, as well as treatment advocates and activist groups including HIV i-Base, AfroCAB, the Treatment Action Campaign, and the South African government. It was funded by USAID, Unitaid, the South African Medical Research Council, and study drugs were donated by Gilead Sciences and ViiV Healthcare.

 

For us, the key message is that South African patients and healthcare workers can achieve amazing results simply by following Department of Health guidelines – sort out the adherence when the viral load goes up, and use TB prevention. Weight gain is an issue with more data needed, but the guidelines recommend lifestyle changes, something all of us, whatever our HIV status, should be doing.

Both Dr Moorhouse and Dr Sokhela are from Ezintsha, a division of the Wits Reproductive Health and HIV institute.