Global Regulatory implications of ENERGY DRINKS. Are Regulatory Agencies like the US FDA to blame?

19th May, 2014
by Solomon Sackitey

Like the booming counterfeit drugs industry, the so-called multi-billion dollar energy drink industry, one of the fastest growing businesses in America, is a huge potential destruction of the lives of our future leaders.

It is about time the World Health Organization, UNICEF, The UN, The US FDA, The EMA, The African Union and the general public do something about this possible public health hazard.

A quick action to enhance educational awareness, preaching the potential dangers of such drinks and a swift regulation governing the production, manufacture and placing into commerce “energy drinks” cannot be overemphasized.

Read more here

Keeping unsafe and ineffective drugs off African homes

-Solomon Sackitey

Following the alleged South Korean Customs officials’ confiscation of smuggled drug capsules containing dried skin of dead babies , a number of concerned citizens have expressed their views about this inhuman drug development and marketing practice of some manufacturers believed to be in China.

This inhumanity is not the first in the history of healthcare products research and development around the globe.  A  few historical events that shaped oversight of human medicines research and marketing have been reported.

The good news is that, despite all these setbacks, the trillion dollar global healthcare industry has good intentions to make safe and effective products to make life more meaningful for humankind. The pharmaceuticals and medical devices sectors of this industry, among others, will continue to be strong in making life worth living.

From now on, here are some suggestions for African health regulators and policy makers:

1. Education of our African leaders. Thankfully, the Global African Diaspora Summit begins in South Africa (Sandton) from 23 – 25 May and our African Leaders and all attendees can bring their heads together to formulate a policy on stopping garbage to be dumped on ‘Mother Africa”.

2. Making our African leaders and Regulatory Authorities more accountable.

3a. Provision of funding to support more infrastructure and capacity building.

3b. Enabling African Drugs/Healthcare Regulators to travel overseas to inspect manufacturing facilities that market their products in Africa.

4. Restructuring of the Healthcare Regulatory System in Africa

5.  A commitment for African Healthcare Policy Makers to accept with open arms the contributions of the African people at home and abroad in addition to friends of Africa wherever they may be.

6. We need to take clues from South African medicinal product regulators to encourage and promote research and manufacturing of drugs locally by buying a majority of the drugs manufactured at home instead of heavy reliance on importation.

Are women and sorcery only to “blame” for infertility in Africa?

-Solomon Sackitey

Assisted Reproductive Technology policy and regulation in Africa.

It is the general belief in certain African cultures that the woman is always to blame when she has not borne a child. Some people are of the view that such a woman is a witchcraft, she has been cursed and therefore should be an outcast.

The fact of the matter is that men can be infertile and not just women. A woman may be fertile whilst the man is infertile. Men’s ego can be so huge that they would not want to seek medical health.

A lot of money and publicity have been directed towards maternal-child mortality but a little has been done when it comes to infertility and for that matter, Assisted Reproductive Technology (ART) in Africa. ART is a terminology used for helping women become pregnant by artificial or semi-artificial means, for example, artificial insemination, in vitro fertilization and cry-preservation, among others. ART does not have a universal definition to date and variations in the definition of this terminology are not uncommon (http://www.cdc.gov/art/) .

Millions of African men and women are reportedly infertile but are unable to have access to ART products, hospitals and clinics besides the money to afford professional consultation and treatment.

As more and more Africans are becoming more knowledgeable about the scientific and medical implications of infertility, ART products and professional services are gradually gaining entrance into the African Market.

So now, what are the policies and regulations for the practice of ART, registration and marketing of ART products in African countries, if any, and where can they be located?

What educational programs or other resources are in place to increase awareness of ART so that women should stop being subjected to inhuman treatments? What are African women doing themselves?

Steve Jobs’s Death and e-Clinical Trials

-Solomon Sackitey

FIRST OF ALL,  I WOULD LIKE TO DEDICATE A FEW “MOMENTS OF SILENCE” IN MEMORY OF APPLE COMPUTER’S CO-FOUNDER, STEVE JOBS (1955-2011).

In recent years, the impact of Information Technology on Clinical Trials has been profound, to say the least. Smart phones are now gaining momentum in the recruitment of clinical trials volunteers.

Additionally, Smart phones have been used in tracking counterfeit drugs in the developing countries and for pharmacovigilance initiatives (monitoring of post-marketing safety of drugs).

Computer Technology has been dictating the pace for the Regulation of  Biopharmaceutical products in the global healthcare market.

Apple Computer, under the leadership of the late Steve Jobs, has been one of the major players in the e-Clinical and e-Healthcare World. How do you think his death will impact new drug trials worldwide, drug regulations around the world, pharmacovigilance and e-Healthcare in general?

It appears though, that Apple had been very secretive about its technological innovations. Has this hampered innovation in the Technology industry in general and the Health Informatics sector in particular?  Is Apple now going to be more apt to sharing?

How about Apple’s influence in the classrooms? Great impact, very positive. How will Steve Jobs’s death impact all these?

Your take on Steve Jobs’s great loss to human development? How will Steve’s death impact Cancer Research?

We still love you, Steve and we will miss you dearly forever. May the Lord Grant You Eternal Peace!!!

Rest In Peace, Steve Jobs

Steve Jobs’s Passing Away

The Common Rule Redefined?

-Solomon Sackitey

The United States Health And Human Services has, on July 22, 2011, published for public comments, proposed rule changes for protecting human subjects in medical research. This vision has long been overdue in view of the rapid technological, regulatory and scientific advancements taking place globally.

Whilst the changes under consideration  focus mostly on the domestic front, it is not clear how they will impact the International Compilation of Human Subject Protections and the Office for Human Research Protections (OHRP)’s international outreach initiatives.

This aspect needs to be addressed clearly because it would take out the guesswork from studies done outside the United States where language and culture are big issues. Terminologies need to be clearly defined and allow for proper translations into the local languages in order to help citizens of those nations to make informed decisions prior to participating in human subject research studies.

Comments about the proposed changes will go a long way in bringing about the much-needed improvements while attracting and retaining research volunteers. What is your take on this proposal?