Liang asked in disbelief: “Then why exactly?”
Smith said: “Because in our opinion, that kind of hemorrhoid suppositories, the use of some cool analgesic ingredients, this kind of ingredients can let patients relieve pain,”
“But it just can relieve pain, in our opinion, these ingredients not only can not really treat the lesion, but also probably will therefore cover up the disease, thus delaying the scientific treatment of patients,”
“So, we also issued a warning some time ago, reminding patients using this drug to pay attention to screening and not to ignore the core problem because of the relief of surface symptoms.”
“In addition to that, we have also studied that something combined with tablets that used to sell very hot in China, which is said to be a special cold medicine made with honeysuckle and forsythia with some western medicine ingredients.”
“But after our research, we found that in that kind of drug, what really plays a therapeutic role are two western ingredients, one is a common drug to reduce fever and analgesia, acetaminophen;”
“And another is a drug specifically used to relieve allergies, rhinitis, and symptoms such as sneezing and runny nose, paracetamol, the two of them combined, just to treat fever and cold and runny nose.”
Speaking here, Smith spread his hands, serious and with a few helpless expressions, “Mr. Wei, I am also not deliberately against you, or against the entire Eastern traditional medicine.”
“But think about it, if you, JX Pharmaceutical, also casually use some plant ingredients, and then with the Western medicine ingredient metformin that can control blood sugar,”
“And then just claim to the public that this is a kind of Chinese medicine that can effectively lower blood sugar, then do you think we are likely to approve this kind of drug to market?”
“This is why, we have been very, very cautious about Oriental drugs, medicine is a very rigorous discipline, must be clear, clear to be, can not be irresponsible recklessly pieced together.”
Liang also felt a little embarrassed, said stiffly: “Mr. Smith, I do not deny what you just said these things, there are a few so-called Chinese medicines, or the combination of East and West,”
“There are indeed suspicions of hanging sheep’s head to sell dog meat, but I think, you can not be all rejecting because there have been such cases, all the Eastern traditional medicine drugs are beaten to death, there are still many, many excellent drugs.”
Smith nodded: “I certainly do not deny this point, but I want to say that even excellent traditional Oriental medicine drugs must meet all our FDA requirements before they can enter our market,”
“So if your drug wants to enter the U.S. market for sale, you must let us first understand all its ingredients, as well as the use of each ingredient with potential dangers.”
Liang asked rhetorically, “Then if, as you just said, the ingredients of many proprietary Chinese medicines are so complex that they may not even be explained by a few ingredients, or even to dozens or hundreds, how can we determine them one by one?”
Smith shrugged: “If it can not be determined one by one, then we have to no way to pass.”
Liang asked again, “Even if you know that this drug is very effective, but just because you can’t fully determine the ingredients as well as the effects, you refuse to market it?”
“Yes.” Smith said categorically, “Our attitude is this, even if this drug is really effective, but before we do not figure it out absolutely, it can not be marketed.”
Liang couldn’t help but ask: “Then don’t you think, this is also the loss for the American people?”
“Loss?” Smith heard this and said with more or less a contemptuous tone, “Mr. Wei, to be honest, for all the Eastern drugs I know of so far, we have plenty of alternatives in the U.S., and safer, more efficient alternatives at that!”
“Whether it’s about headache, brain fever, or about all organs, blood vessels and the nervous system, including the heart, liver, spleen, lungs, and kidneys, what you have in Eastern traditional medicine, we have in Western medicine, and the Western treatment methods are much better than the Eastern treatment methods!
FAQ Novel
Q: What are the key Western requirements for drug approval mentioned by Smith?
A: Smith emphasizes the need for clear pharmacokinetic tests, identification of active ingredients, assessment of toxic side effects, and determination of the metabolic cycle of drug components.
Q: Why does Liang believe Chinese medicines face difficulties meeting Western standards?
A: Liang argues that many Chinese medicines have complex prescription compositions, unlike Western chemical drugs with often a single active ingredient, making it hard to identify specific molecular formulas as required by Western regulations.
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