"Lives are at stake."
"Lives are at stake."
As we enter the ninth day of the government-imposed community quarantine, it appears there is still no let-up in the way Covid-19 has been wreaking havoc upon us, as the number of those getting infected seems to double every day.
And it is for such reason we could not afford any dilly-dallying in coming up with decision and the implementation of any policy. And that includes approval of medications, materials, equipment, medical kits, etc. which are necessities and could prove crucial in combatting this dreaded virus.
The whole week, my news feed in my Facebook page has been flooded with articles on medication said to have been approved by China or other countries as effective in treating COVID-19. There was also a news article which stated The Institute for Science and Technology Research of the Polytechnic University the Philippines had developed ethyl alcohol. I also received a press release from the Chinese Embassy baring they are donating 100,000 surgical masks, 10,000 N95 masks, 10,000 sets of personal protective equipment and 100,000 test kits. The latter is on top of the 20,000 test kits the University of the Philippines claim they can produce once given the green light.
However, to date, we have yet to hear whether we have already received the medication being claimed as a cure. We haven’t even heard if the government has already procured such medication. For the ethyl alcohol PUP has developed, they are still at a loss on how to get approval from the Food and Drug Administration—as well as the funding for its mass production.
With regard to the test kits, both for the UP-produced and those donated by the Chinese government, we haven’t heard yet if they are ready for use already. The Department of Health is still short on test kits. In fact, it has ruled out mass testing contrary to the directive of the World Health Organization which is Test, Test, Test.
And this falls on the lap of the FDA, being the responsible agency in approving these kits, medications, equipment and other materials for use. And we are more concerned with the COVID test kits as it seems there has been an undertesting for persons suspected to be carriers of the virus.
And with the rising number of people infected and dying because of the dreaded virus, not only FDA has to act on the Chinese-donated and the UP-developed test kits, it also has expedite its approval on applications for on-site testing kits.
To make things clear, there are two kinds of testing kits, the Real Time Polymerase Chain Reaction or RT-PCR, wherein a patient is swabbed and then processed in a PCR laboratory and may take one to two days to get the result. There is also the lateral flow method, where a drop of blood is extracted. It is no different form a blood sugar test conducted at home, with the result readily available in 15 minutes. One line means negative; two lines means positive.
One applicant for a lateral flow method test kit is Wandfo Biotech, whose kits have been used and proven effective in other countries.
Having been used and tested in other countries, Wandfo applied for a Certificate of Exemption for Product Registration along with its application for License to Operate last March 19. While all products normally undergo testing before being allowed to be sold in the market, a Certificate of Exemption can be issued to a product as long as it has been approved in another country like China, South Korea, the United States and European countries.
The Wandfo on-site test kits bear the approval of the CHINA FDA and the CE Mark, which is given to product allowed to be distributed and sold in Europe.
However, to date, FDA has yet to act on Wandfo’s application, which is rather unfortunate as time is of the essence here. In a statement, FDA admitted it has yet to approve an application for COVID-19 point-of-care test kit or rapid test kit such as Wandfo’s lateral flow method.
While arguments have been raised against the lateral flow method such as a person will only test positive on the second or third tests from the onset of the symptoms. But then, as the kit is easy to use just like taking blood sugar test from home, one can easily do a repeat test every two to three days.
This is very much unlike the PCR method wherein you have to line up for testing in the already-congested hospitals (assuming they have the test kits), and wait for up to two days to get the results.
And that could be the fastest time you could get the PCR test result as right now, we only have four PCR laboratories to process the tests.
In a situation like this, we could not afford any delay. FDA has to act on all pending applications before its office. Lives are at stake.
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The other day, I came out with an article entitled “Oligarchy is back.” This was prompted by my getting hold of a signed press statement from Bantayan Island Power Corporation, regarding its court battle with Vivant Energy Corporation.
Following up on the story, I happened to talk to a source who insinuated the possible involvement of the Aboitiz clan. But with the abnormality of the situation caused by the COVID-19 scare, I failed in getting the side of the Aboitiz Group.
And while I did not categorically state they were the owners of Vivant, I would like to extend to them my sincerest apology in dragging their name.
Again, my apologies.