|
|
Why didn’t the generic drugs mafia consult the doctors?
AS I WRECK THIS CHAIR By William M. Esposo
The Philippine Star 2008-02-03
|
|
Those who crafted the highly-suspicious House version of the Cheaper Medicines Bill did not invite the doctors to share their valuable insights.
Instead of consulting the key professionals who have the say as to what is prescribed for ailments and diseases, these doctors were assaulted in a vicious publicity stunt, making them appear as scapegoats.
One doctor who could have provided valuable insights is Dra. Suzette Lazo. Dra. Lazo is a Faculty member of the Department of Pharmacology and Therapeutics, UP College of Medicine , a past president, Philippine Society of Experimental and Clinical Pharmacology and a founding member and secretary of the Asia Pacific Chapter of the International Society of Pharmaco-vigilance. She has over 25 years of experience in the formulation and managing of new drugs and medicines.
Dra. Lazo wrote me this letter:
“Your piece today (January 20 column) took my breath away and reinforced my hope for the Philippines — thank you for writing it. It’s an excellent follow-up to your previous columns on the cheaper medicines bill.
No doubt the Senate Bill may be one sure answer to the high prices of drugs. I totally support it. Your piece echoes my sentiments towards the Congress version, this iceberg that may lead to problems of titanic proportions in an already overburdened health sector.
Still, even the Senate version may need some fine tuning. In this age of information and technology, so much information have given rise to islands of people knowing different things (technical versus techie wannabe); when some crossings are attempted, sometimes misunderstanding ensues. From your writings it would seem you were able to make it to “ Drug Island ” in good shape. Perhaps have some experience in this field.
Still, there are some points that I can bring up (and I swear no one is paying me to do this):
1. Issue of quality
A key testing method, in addition to chemical tests, is bioavailability/bioequivalent testing to determine therapeutic equivalence of a given generic product to a standard that has been established to have excellent performance in terms of drug efficacy and safety. This test is being done on every generic drug product in the United States . If a product passes the test it is deemed as “just as safe and effective as the standard preparation.” This is published for the entire world to see in what is called as “The Orange Book.” Here is a link to the online site”: http://www.fda.gov/cder/ob/
In the Philippines we have the capability to conduct this test and there are accredited centers that can do this test which have been properly audited by BFAD so that the results can be trusted. Alas, not all generic drugs in the RP market have been tested; in fact only a very small minority has undergone this crucial testing because currently they are not required to do so.
First of all, government must have the will to strengthen the drug regulatory body, BFAD! This includes increasing the budget, among other things. I have been told that this administration allots what may be the lowest percentage allocation for healthcare in the entire Philippine history. Health seems to be a low-priority issue, if at all. Government should put more money into DOH (instead of the pork barrel) and maybe review its decentralization policy.
Bioequivalence testing must be done for all generic drugs. It should start with drugs whose performance is of great critical importance to the patient’s survival, for instance cardiovascular drugs, anti-infectives and drugs used for convulsions. Secondly, there must be transparency and test results must be revealed to the public; therapeutically-equivalent generic drugs must be known, just like the FDA Orange Book model.
2. Counterfeit drugs
I and many of my colleagues are worried that the opening of the gateway to so many generic products through improperly regulated parallel imports will not only further stress an already overburdened BFAD but will further aggravate the problem of drug counterfeiting. Incredibly, greed can ablate all conscience totally and drug counterfeiters do kill for money! This problem does exist now in RP and it’s very possible that counterfeit drugs will ride the wave of not only the existing market products but also the numerous new generics that will arrive once the gate has been opened with the approval of the new generics bill.
3. Pharmacovigilance
Doctors are involved with the study of unwanted effects of drugs. These can be avoided but first we have to know what the problem is and adverse drug effects need to be reported. Developed countries have excellent systems already set up. We have to have our own because peculiarities in the way people react to drugs sometimes happen in different ethnic groups. We in the medical community are working on setting up a good reporting system in our country but this is much like climbing Mount Everest at the moment. These adverse effects include allergies ranging from mild skin rashes to the very severe and potentially fatal Stevens-Johnson reaction, bizarre side effects like aplastic anemia or total bone marrow shutdown to failure of treatment that happens when the patient receives poor quality medicine.
Drug development and manufacture involve very complicated technical processes and inputs from various scientific disciplines ranging from chemistry, pharmacy, molecular biology, statistics and medicine. Some drug molecules are more difficult to formulate than others and history is fraught with tragedies involving additions of excipient substances to the principal drug molecule (to make a liquid drug format for instance) that caused the tragic and untimely deaths of many innocents. The sulfanilamide disaster of 1937-38 in America is one example of many.
4. Alliances not adversaries
Government, academe and industry have worked together successfully in countries leading to scientific advancements such as the Human Genome Project and the Wellcome Trust SNPs Consortium.
This is hard to do but it can be done. Even here.” (End of letter)
So how come our congressmen didn’t consult experts like Dra. Lazo? Is it because there is profit in ignorance — the way our people have been exploited time and time again?
|
|
|
|
|
|
|
|
|
