‘Drug shortage imminent if Coronavirus epidemic persists’

Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), Professor Mojisola Christianah Adeyeye is a renowned Nigerian pharmacist. President Muhammadu Buhari appointed her the DG of NAFDAC on November 3, 2017. Before her appointment as NAFDAC boss, she was the founding Chair of Biopharmaceutical Sciences and a Professor of Pharmaceutics, Manufacturing Science and Drug Product Evaluation at the College of Pharmacy, Roosevelt University in Schaumburg, Illinois, United States (U.S.), where she spent seven years. She was also a Professor of Pharmaceutics and Manufacturing for 21 years at Duquesne University in Pittsburgh, Pennsylvania, US. She is Senior Fulbright Scholar and Specialist and 2008 American Association of Pharmaceutical Scientists Fellow (the first African woman fellow). She is also a Fellow of the Nigerian Academy of Science and Nigeria Academy of Pharmacy. Her research interests are in the areas of pre-formulation, early phase development of solid, semisolid and liquid dosage forms, and industry-based and intellectual property-driven late phase drug product development. She is the founder and President of Elim Pediatric Pharmaceuticals Rolling Meadows, Illinois. Through Duquesne University, she was able to develop an anti-retroviral (Human Immuno-deficiency Virus, HIV/Acquired Immune Deficiency Syndrome, AIDS) paediatric fixed-dose combination and received intellectual property on the formulations in the United Kingdom (UK) and South Africa. Adeyeye in this interview with CHUKWUMA MUANYA said there could be drug shortage in Nigeria if an epidemic like coronavirus persists. She also underscored the need for Nigeria to increase local manufacturing of drugs to avoid medicines insecurity.

Why do you raise the alarm on drug insecurity in Nigeria?
Nigeria needs to increase local manufacturing of drugs to avoid drug shortage that reflects drug insecurity. We import about 65-70 per cent from South-east Asia countries, mostly from China and India. If an epidemic like coronavirus persists, there could be drug shortage.

You also said West African countries need S50 million for preparedness and response. Please throw more light?
That statement is not from me.

From your statements it seems Nigeria does not have the capacity in terms of drugs to contain the coronavirus?
I did not say Nigeria does not have capacity to contain the virus

As an agency in charge of regulation of drugs and medical products, do we have registered drugs that could be used for coronaviruses?
There have been reports that some medicines are effective to some extent against the virus. A registered drug that was reported to be effective to some extent is chloroquine. The drug is under research for the virus. Pharma companies continued the rush of product development announcements this week as novel coronavirus (2019-nCoV) cases continued to spread in China and internationally.

On vaccines, the Coalition for Epidemic Preparedness Innovations (CEPI) more than doubled its number of current 2019-nCoV announcements over the past eight days. Firstly, CEPI said it has agreed with GSK to make the company’s adjuvant available to groups that CEPI is funding to develop vaccine candidates. Next, CEPI announced it is giving $8.3 million to CureVac to develop messenger RNA-based candidates—an addition to its existing grant to the German biotech. Meanwhile, CEPI also announced that Britain has given it $25.8 million in additional support to help combat the outbreak. Finally, CEPI launched a call for proposals from any qualified organization—nonprofit, for-profit, government or academic—willing to support “equitable access” to new coronavirus vaccines.

In related news, Inovio announced last week that it will work with Beijing Advaccine Biotechnology to put the Pennsylvania company’s DNA-based, CEPI-funded vaccine candidate through Phase 1 in China, while Reuters reported Thursday that Sanofi would share its “expertise and data” with CEPI and announce “a new coronavirus initiative within the next two weeks.”

Beyond CEPI, France’s Institut Pasteur announced last week that it had isolated a strain of 2019-nCoV detected in France, sequencing the whole viral genome. Reuters added that the nonprofit “is looking into developing a vaccine,” expecting work to take 20 months.

Meanwhile, Denmark’s ExpreS2ion Bio announced Thursday that it would use its Drosophila S2 insect cell expression system to develop a 2019-nCoV vaccine, saying it hoped to produce and test antigens in mice within 2-3 months.

Not to be outdone, California’s Vaxart also announced last week that it would develop an oral recombinant vaccine, while iBio said that it is working with Beijing CC-Pharming Ltd on a vaccine. The Texas-based company provided few details, but saw its stock rise 70 percent on the news (to 46 cents).

On drugs, a World Health Organisation (WHO) working group named Gilead’s investigational antiviral remdesivir as “the most promising candidate” for coronavirus drug R&D in a draft blueprint circulated last week. A coronavirus patient in Washington State also markedly improved after intravenous treatment with remdesivir on a compassionate-use basis,

The New England Journal of Medicine reported last week. Meanwhile, in a letter published Tuesday in the journal Cell Research, researchers at the Wuhan Institute of Virology (WIV) announced promising in vitro results from using remdesivir and the antimalarial chloroquine—each of which proved individually “highly effective” against 2019-nCoV.

Reuters reported Tuesday that WIV also took the opportunity to apply for a patent on the use of remdesivir against 2019-nCoV. Finally, Bloomberg reported Sunday that a medical team from Beijing’s China-Japan Friendship Hospital will “speedily” commence human tests of remdesivir in a randomized, double-blind, placebo-controlled study, with The New York Times adding Thursday that enrollment had already begun.

In other coronavirus drug news, Reuters reported Sunday that Thai doctors “have seen success” treating 2019-nCoV cases with AbbVie’s HIV drugs lopinavir and ritonavir in combination with flu drug oseltamivir “in large doses.” Chinese researchers said in an article in The Lancet last month that a hospital in Wuhan has also “quickly initiated” a randomized controlled human trial of lopinavir and ritonavir.

Meanwhile, Regeneron announced on Tuesday that it is expanding its existing agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA) by adding 2019-nCoV to the list of pathogens the company is using government funding to target, although the New York-based biotech did not say whether BARDA is offering any additional money.

Finally, Australia’s Biotron announced imminent plans to test small-molecule compounds—previously shown to have “broad-spectrum activity” against other coronaviruses—on 2019-nCoV, while The Lancet published a study analyzing data from BenevolentAI’s medical database which found that Eli Lilly’s and Incyte’s rheumatoid arthritis drug baricitinib “might block the viral infection process” for the disease.

On diagnostics, China’s BGI announced last week that it has produced 50,000 “real-time” coronavirus tests, which the press release said yield 2019-nCoV results “in a few hours.” The company also announced that it is developing a “metagenomic sequencing detection kit” that it says can monitor mutations and—in a separate release this week—said its new Wuhan-based laboratory is now ready to screen 10,000 samples daily for the disease.

Meanwhile, the United States Food and Drug Administration (U.S. FDA) issued an emergency use authorization (EUA) on Tuesday for a reverse transcriptase polymerase chain reaction (RT-PCR) 2019-nCoV diagnostic from the U.S. Centers for Disease Control and Prevention (CDC). Reuters said that the move would allow state laboratories to begin conducting tests on their own rather than having to send samples to CDC. The FDA said that several additional diagnostics developers “have already requested and received the EUA template for this outbreak.”

In a similar move, Public Health England announced yesterday that it would distribute its own diagnostic—currently available only in one lab in London—to 12 facilities across the United Kingdom, beginning next week.

Anglo-French clinical diagnostics company Novacyt also announced plans yesterday to secure an EUA for its Primerdesign coronavirus diagnostic, which detects “only the 2019 strain of the virus,” gives results in under two hours, and is thermostable, according to the press release. The company also said it expects the test to qualify for CE marking within two weeks.

Finally, Utah-based Co-Diagnostics last week announced “successful initial verification” of a new 2019-nCoV screening test, while the journal Clinical Chemistry published research last week from Hong Kong identifying two “real-time” RT-PCR assays that quickly detect the disease.

In other news (and in addition to the Gates Foundation’s increase in coronavirus funding to $100 million), WHO announced Thursday that it would co-host a “global research and innovation forum” next week in Geneva—a joint effort with the Global Research Collaboration for Infectious Disease Preparedness.The U.S. Department of Health and Human Services also last week issued a public health emergency declaration over the outbreak.

Are you supporting the use of chloroquine?
A caution must be taken because chloroquine, an old antimalarial that was banned from use should not be used for the treatment of malaria because it is no longer effective for malaria.

Are you doing any clinical trials in any antiviral or HIV drugs?
Clinical trial can be done on the drug where the disease is. NAFDAC does not do clinical trial. The Agency approves clinical trials
The President, Pharmaceutical Society of Nigeria (PSN), Mazi Sam Ohuabunwa, also warned of drug scarcity due to increase in Value Added Tax (VAT), border closure and Economic Community of West African States (ECOWAS) protocol etc. Do you agree with this concern? What can or is NAFDAC doing about this?

A conducive and enabling environment for pharmaceutical manufacturing will reduce drug insecurity. NAFDAC seizes opportunities to underscore the importance of an enabling environment (with lowered taxes, VAT) to energise the industry toward increased local production.

Is NAFDAC involved in the ongoing clinical trials for Lassa fever vaccine? NAFDAC is hosting Africa this month. What is the conference about? What informed it? What do you intend to achieve?
NAFDAC volunteered last year at the last meeting in Morocco to host the Third African Medicine Quality Forum (AMQF) meeting. The meeting will take place at the Transcorp Hilton Abuja from February 24 to 28, 2020.The AMQF was established in 2017 as a Technical Working Group of African Medicines Regulatory Harmonization (AMRH) that is jointly domiciled at AUDA-NEPAD and WHO, Geneva as joint secretariats.

The New Partnership for Africa’s Development (NEPAD) is an economic development program of the African Union. NEPAD was adopted at the 37th session of the Assembly of Heads of State and Government in July 2001 in Lusaka, Zambia.The goal is to build and strengthen the capacity of African countries in medicines quality control and regional post marketing surveillance, which in turn, will contribute significantly to reducing sub-standard and falsified medical products in circulation in the African markets.

AMQF is expected to drive the harmonization of Quality Control (QC) standards and practices and, ultimately the mutual recognition of QC tests among African countries. It is a platform for a holistic continental quality control agenda that facilitates sharing of best practices, an advocacy platform to raise the national and international visibility of National Quality Control Laboratories ((NQCL)

AMQF membership is open to heads of NQCLs from all African countries and formally reports to the African Medicines Regulatory Harmonization (AMRH) Steering Committee.

This meeting will convene all members of the AMQF including its Technical Committee (TC), leadership from USP, AUDA-NEPAD, WHO, Regional Economic Communities (RECs), Regional Health Organizations (RHOs) as well as other partners and key stakeholders. The meeting is sponsored by World Bank, NAFDAC, West African Health Organisation (WAHO), Bill and Melinda Gates Foundation (BMGF), AU-NEPAD, United States Pharmacopeia (USP), WHO and manufacturers. The theme for this year’s meeting is “2020: PERFECT VISION FOR QUALITY OF MEDICINES IN AFRICA”.

Among the objectives of the Abuja meeting are:
1. Reinforce the importance of quality control laboratories in post marketing surveillance
2. Strengthen regional/cross border collaborative survey of medicines in Africa as a means of protecting public health.
3. Familiarize Regional Economic Communities with instrumentation and analytical techniques to facilitate convergence for ensuring quality of medicines.
4. Complete the roadmap for strengthening National Quality Control Laboratories infrastructure and systems to help make informed, reliable and consistent regulatory decisions.
5. Emphasise the importance of Quality Control in the entire drug approval process: Manufacturing to Post-marketing.
6. Sensitize National Medicines Quality Control Laboratories on the importance of drafting laboratory strategic and business plan to ensure continual provision of Quality Control testing that meet international standards of quality.
7. Develop proposal to ensure that National Medicine Quality Control Laboratories have the required legal mandate and well-defined scope of activities.

NAFDAC advocates daily for quality of medicines in the nation’s supply chain through strengthening of our internal capacities, such as having quality control laboratories with modern equipment with trained personnel, strong post marketing surveillance, inspection of manufacturing facilities, and enforcement using international best practices.

NAFDAC looks forward to support and collaboration from all stakeholders in delivering safe and quality medicines, and all Nigerians towards a successful hosting of this continental meeting.I believe that at the end the meeting, the Heads of Quality Control Laboratories from the over 35 African countries would have achieved a clearer picture of the importance of the NQCLs and their convergence for collaborative reliance at the regional and continental levels. This realization will ensure that substandard, falsified and counterfeit drugs products will be reduced to a minimum. For more information about the meeting, visit: https://www.nafdac.gov.ng/ and https://whova.com/web/amqfa_202002/

How far with plans to dislodge open drug markets and replace them with better options?
These will be dislodged as soon as the wholesale centers are constructed. The one in Kano is under construction

How far with the full implementation of the bill on national drug distribution guidelines?
The draft of NAFDAC’s Good Distribution Practice Regulations for Pharmaceuticals is under review for gazetting
Would you say the incidence of fake and substandard or adulterated drugs is increasing or decreasing? If yes or no, why? What is the rate in terms of percentage now?

Substandard and falsified medicines prevalence is about 17 per cent. For antimalarials, the prevalence is less than three per cent. NAFDAC regulatory activities centre on reducing the prevalence through vigilance, post-marketing surveillance and enforcement. We don’t yet have the current prevalence. The Agency is working toward a new survey.

You recently launched a project to address drug abuse and misuse in Kano. How far with the programme? Please throw more light?
Drug Abuse launch in Kano and status: The Agency continues to be involved at the secondary school level to educate students about the danger of drug abuse and misuse.

Can fake drugs, medicines abuse and misuse be eradicated in Nigeria?
Substandard and falsified medicines (SFs) ​prevalence in Africa is about 10 per cent. SFs will be reduced to a minimum. To eradicate it will take a lot of efforts and a long time.

You recently increased the cost of registration of drugs and food products. Why?
The Agency increased the tariff for revenue needed to protect the population from unwholesome foods and SFs, and to enable the Agency to continue her regulatory activities

About six years ago, NAFDAC set up a committee on verification of herbal cure claims. I was a member of that committee. Has the agency given up on the development of herbal medicines?
The Agency has stepped up its focus on herbal medicines. An Herbal Medicine Product Committee was set up in 2019 to encourage herbalists and researchers to collaborate.

The issue of Johnson Baby Powder and cervical cancer has refused to go away. What is NAFDAC’s position on this?
The subject of link between talc powder and cancer has been a controversial issue, which continues to divide scientists. There is no clear scientific evidence on the issue.The evidence showing that talc may be carcinogenic remains inconclusive because a school of thought believes that talc in its natural state contains asbestos (a carcinogen) whereas another school of thought believes it does not. From the foregoing, it is the asbestos component of talc, if truly present, that is capable of causing cancer in talc powder. Generally, facts hold that there is asbestos-free talc as well as asbestos-containing talc, though the evidence about asbestos free talc is less clear.

So the simple answer is that talc powder made from asbestos-containing talc is capable of causing cancer whereas talc powder made from asbestos-free talc is not expected to cause cancer.For asbestos-containing talc powder which may be ‘yes’ and depending on the site of application (say, pubic area of a woman), the talc powder particles may travel through the private part, the fallopian tubes (oviducts) and eventually enter the ovaries to cause irritation and inflammation from which cancerous cells are able to develop. For asbestos-free talc powder which may be ‘no’, the absence of asbestos (the suspected carcinogen) makes it difficult for cancerous cells to develop.

NAFDAC conducts analytical tests before registration of all regulated products including talc powder to ensure their fitness (quality and safety) for use. Post marketing surveillance activities are being improved with inclusion of post marketing analysis of regulated products to ensure continuous conformity with the standards and requirements precedent to registration of the products at the outset.

If an untoward events or reactions are associated with the use of any product, including talc powder, the product can be banned or withdrawn from the circulation through a process of recall.If any talc powder could actually cause cancer it will not be registered for use in Nigeria because the result of its analysis would have revealed that it contains asbestos-containing talc. As earlier mentioned, if the product is suspected to contain any carcinogen it would be withdrawn from the circulation and/or banned.

The summary is that NAFDAC has the responsibility to safeguard the health of the nation hence a case of untoward health implication is being addressed on daily basis by the Agency.

There are concerns over the rise in drug abuse and misuse. Some schools of thought have blamed it on weak regulation. Why and how can this be addressed?
There are many and possibly different factors responsible for rise in incidences of drug abuse and misuse, treatment failure, sub-standard and falsified medicines as well as adverse drug reactions other than weak regulation by NAFDAC and/or Pharmacists Council of Nigeria (PCN).

For example, the rise in incidences of drug abuse in Nigeria has been attributed to decline in parental care, change in value system, unemployment, porous borders which aids smuggling, uncoordinated drug distribution system, policy defect such as availability of codeine-containing syrup as over-the-counter medicines in the country until a recent change, among others.

Furthermore, when the issue of sub-standard and falsified medicines is considered, evidence-based data shows that most of the drugs found wanting in this regards are imported products that are largely smuggled into the country. There is no doubt that some of them could have been as a result of regulatory circumvention and lapses.

A handful number of sub-standard and falsified medicines are also known to be produced in the country by unscrupulous citizens in hideouts outside the knowledge of NAFDAC. The heinous activities of these unscrupulous elements could not be without the knowledge of their close associates and some persons around the facilities where such heinous activities are carried out.

As a corollary to the common parlance that security is everybody’s business, the good people of Nigeria have the duty to report such activities suspected to impact negatively on human health. The healthcare providers, the regulatory agencies with relevant mandates and the media have a lot to do to stem down the incidences through patient/client counseling on rational use of drugs as well as public sensitisation, education and enlightenment. This is not just a case of weak regulation by NAFDAC and PCN.

The issue of adverse drug reactions can also be addressed by patient/client counseling and health education by healthcare providers, multi-sectoral collaboration in the area of public sensitisation, awareness creation, public campaigns, education and enlightenment for which the role of the media is key.