This article quotes a WHO medical officer as saying, “recipients of donations deserve the same protection as U.S. citizens. If expired drugs weren’t potentially harmful the FDA wouldn’t require expiration dates.” (This is almost a universal but a faulty assumption.)
The Associate Commissioner for the FDA in responding to the question in Item A of this Website, “Are expiration dates accurate?” answered, “YES”. She may have been correct, but she seems not to have fully answered the question. The FDA SLEP tests indicate that while the date that the company chooses to stamp on the bottle may be accurate for that date, the medicine may continue to be fully potent for perhaps many years after that date.
A former Secretary of the Florida Department of Health wrote, “As a physician, I would find it irresponsible for a healthcare professional to recommend the use of a prescription drug past the manufacturer’s established expiration date.” This over-generalization is grossly flawed, and is an indication that even people in high places have not had access to the facts regarding how expiration dates are determined.
If the high-ranking officials in the WHO knew that expiration dates are chosen by profit-motivated companies instead of being determined by laboratory analysis one would wonder if they would have ruled as they did, which is, “NO DOUBLE STANDARD IN QUALITY – if quality of an item is unacceptable in the donor country it is also unacceptable as a donation.” Consequently, perhaps much of the 2.5 billion dollars of so-called expired medicines that are returned to manufacturers just in this country alone may still be fully potent. Regardless, they are destroyed instead of going to folks who have no access to any medicine in much of the 3rd world.
The opposing view of expired medicines comes directly from the FDA itself who has surveyed the matter. Their Shelf Life Extension Program found that 90% of the medicines that they tested for the military were safe and effective far past their original expiration dates, at least one for 15 years past it. The former director of the FDA testing laboratory, Pharmacist Francis Flaherty is quoted, “Manufacturers put expiration dates for marketing, rather than scientific reasons.” One might interpret the word marketing to mean to make more money. The Medical Letter also provides much the same view of so-called “expiration dates”. (See Items B and #6 of this Website)
While doing extensive medical mission work in a 3rd world country, we served the entirely medically dispossessed folks. They couldn’t afford to buy needed medicines on their one to three-dollar a day incomes. Despite this adversity that country’s officials threatened to close down any clinics that might have any expired medicines on hand. The apparent consequence of that action is what Mr. Bode refers to in the above article. “Has anyone been harmed by expired drugs? Maybe, But I can definitely tell you that a lot of people died because they didn’t get expired drugs.”
In an attempt to find out why the WHO would have humans do without medicines rather than to permit them to have so-called expired medicines, I contacted a pharmacist/friend who works for a medical team that flies to world-wide disaster areas. I cannot vouch for his supervisor’s view of the reason, but the situation should be investigated for accuracy. He believes, “The WHO is dominated by Europeans. They control the decisions about dating. As a lever, they put pressure on developing countries not to allow organizations like (XX) to bring/donate short dated medicines. Their lever is that WHO will not provide grants/funding for nations that allow short dated medicines into their countries.” “From a narrow European view, this meant that there would be more business for the European pharmaceutical companies.”
If this view is accurate, it implies that economics has more to do with the death of many in the 3rd world than does the truth regarding the nature of expiration dates.
Here is a fact that is entirely disregarded in this matter. Medicines, at least in this country, are based upon the body weight of a 150-pound adult. At the 90% potency level of a medicine, i.e., the point that Remington’s Pharmaceutical Sciences defines as an expired medicine, it is actually the proper dose for a 135-pound person (150# X 90% = 135#). In the 3rd world country where I worked, I would estimate that the average body weight of a country person would be less than 120 pounds. Therefore, expired medicine might even be a slight overdose for those individuals!
Much of the reason for this Website is to highlight not only the ignorance surrounding this issue that I have raised, but, also, to highlight the reason for the ignorance. In my opinion it is due to those who know the facts of these issues but have chosen to deny them to physicians, pharmacists, nurses, legislators, bureaucrats, and, particularly, to consumers. The solution to this tragedy is for consumers to demand the truth in this matter. That can only come with the cooperation of the media. I hope that they will provide the public with the facts/truth of this matter.
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