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when a father in hangzhou took his 6-year-old child to the hospital for mycoplasma pneumonia, he found that the imported azithromycin "xishumei" that his other child had been given for the same mycoplasma pneumonia half a year ago was no longer available in the same tertiary hospital. only the domestically produced azithromycin "bazhu" was available.

after two days of infusion of domestic azithromycin, the child's condition did not improve and the high fever continued to recur. as parents, we were naturally very worried. after many twists and turns, we finally got imported azithromycin in another hospital by adding an extra bed (outpatient treatment was still not available). that night, the child's high fever subsided, and three days later, he was discharged from the hospital after recovery.

one can fully imagine the anger of a father when he encounters such a fucked-up thing:

just for the difference of a few dozen dollars, my precious son will suffer from the pain for 2 more days and bear the risk of worsening of his condition?! if you don’t give my child good medicine, i will fight you!

the father found out that in the 2023 national drug procurement negotiations, the price of imported medicine cialis was 5.58 yuan per bag, while the lowest price of domestic azithromycin was 0.98 yuan per bag. for a three-day course of treatment, the price difference was 14 yuan, so cialis was not selected. of course, this is the price difference for oral drugs. the price difference for injectable azithromycin will be higher, but only in the double digits.

in recent years, the "soul-bargaining" in the national drug procurement negotiations has led to some imported drugs being excluded from medical insurance and rejected by hospitals. this is indeed a common phenomenon. when many people seek medical treatment, they find that some of the imported drugs they used before have disappeared quietly.

then the most critical question comes:

will the lack of imported drugs affect our access to medical care? will there be a significant difference between imported and domestic drugs with the same ingredients?

let me first state the conclusion:

the same drug ingredients, when produced by different manufacturers, will indeed have different efficacy and adverse reactions, and the specific differences can be large or small, with some being as big as 95 points and 90 points, and some being as big as 98 points and 61 points.

however, please note that the difference here is mainly between original research drugs and generic drugs, not between imported drugs and domestic drugs. it is just that due to the development stage, imported drugs are mainly original research drugs, and domestic drugs are mainly generic drugs. this does not mean that imported drugs are definitely better than domestic drugs, nor can it be said that domestic drugs are as good as imported drugs as a whole. we should face up to the gap, but don't belittle ourselves.

although original drugs and generic drugs contain the same active ingredients and many of their content specifications are exactly the same, there are still differences in actual clinical applications.

the first difference is the gap in preparation technology

a capsule, a bag of powder, a tablet, and a bottle of powder are different dosage forms of drugs, which contain the core active ingredients, such as azithromycin, as well as the excipients required for the formulation process.

some drug excipients help the active ingredients dissolve for better absorption, some prevent the active ingredients from being destroyed by gastric acid, and some wrap the active ingredients to allow them to be released slowly and evenly (such as ibuprofen sustained-release capsules). without these excipients, many active ingredients in drugs cannot produce therapeutic effects if taken directly.

here comes the point. after the patent protection of the original drug expires, only the structure and production method of the active ingredient will be disclosed. it does not include a complete set of formulation methods, let alone an entire drug production line and experienced technical personnel.

to use an analogy that may not be quite appropriate, there is no secret to the cooking process of peking duck, but even if the same duck is used, the quality of the duck roasted in different restaurants can vary greatly.

original drug manufacturers often have strong r&d capabilities and strict production quality control. the rich exclusive income during the patent period can also support them to continuously accumulate technical experience and improve production processes. however, generic drug manufacturers may be limited by key formulation process technology, or they may not be able to use high-standard excipients because the price has been lowered, which ultimately leads to the same active ingredients producing drugs with different efficacy.

the second difference is the difference in adverse reactions

as a medicine, in addition to caring about the efficacy, we also need to pay special attention to adverse reactions, which are often called side effects.

if there are two drugs with the same ingredients and the same content, and both have a clinical efficacy of 95%, one has an allergic reaction rate of 1/1000 and sells for 50 yuan per box, and the other has an allergic reaction rate of 5% and sells for 20 yuan per box, which one would you choose? i don't know how others choose, but i will definitely choose the more expensive one with less allergic reactions.

the occurrence of adverse reactions is mainly related to the purity of the drug. whether it is a chemically synthesized or naturally extracted drug, impurities will inevitably be mixed in. in organic chemical reactions, there are sometimes "isomers" that are a millimeter apart. some impurities are harmless to humans and animals, some impurities may cause allergies, and some impurities may be lethal when they reach a certain concentration.

those of you born in the 1980s may have memories of when we were young, we had to do a painful skin test before each penicillin infusion to make sure you were not allergic to it before we could get the infusion. but now doctors usually just verbally ask you if you have any drug allergies and then prescribe antibiotics.

of course, this is due to the replacement of antibiotics, but more importantly, it is due to the advancement of drug purification technology. in the 1990s, my country's antibiotic production technology had just started, and the quality control level was worrying. the drugs produced were generally mixed with considerable impurities, which often led to drug allergies and even deaths.

after several generations of scientific research, the purification process of antibiotics is now quite mature, so the allergic reactions to antibiotics have been reduced by several orders of magnitude. the bioengineering major at east china university of science and technology, where i majored in undergraduate studies, was formerly one of the first antibiotic manufacturing majors in china, and a lot of credit goes to my teachers’ teachers.

however, the fact that the purification process of antibiotics is mature does not mean that the purification process of all drugs is mature and reliable. there are some drugs with extremely high purity requirements, especially intravenous drugs, where even extremely small amounts of impurities may cause major adverse reactions. at this time, the gap in strength between different pharmaceutical companies is reflected.

let’s go back to the case encountered by the hangzhou father at the beginning of this article. pfizer’s zithromax is azithromycin, and hainan beite pharmaceutical’s bazhu is also azithromycin. if you have a choice, which pharmaceutical company would you trust more?

the third difference is the gap in drug approval process

for a genuine original drug (not including a certain lotus developed in 15 days) to be marketed, it needs to go through a large-scale randomized double-blind phase iii clinical trial to determine that the drug has significant efficacy and adverse reactions are within an acceptable range, and then it can obtain approval for sale. this process usually takes several years and costs hundreds of millions. the efficacy and safety of original drugs are proven by direct experimental data.

but generic drugs are different. they only need to pass the "consistency evaluation" before they can be put on the market.

in short, we already know from pfizer's zithromax that azithromycin is safe and effective in treating mycoplasma pneumonia. now that the patent for this ingredient has expired, other pharmaceutical companies can produce azithromycin without authorization. as long as they can prove that the composition, content, solubility and other values ​​of the azithromycin they produce are consistent with those of zithromax, they can directly obtain approval.

according to statistics, after the expiration of the patent of zithromax, 629 azithromycin drug approvals have been approved in china, involving 312 pharmaceutical companies. obviously, it is impossible for all these pharmaceutical companies that have passed the consistency evaluation to use production lines with the same process standards as pfizer to produce azithromycin drugs.

in addition to the well-known reasons, it is inevitable that there will be some flies and tigers involved in the approval process of chinese drug approval.

personally, i don’t have that much trust in generic drugs.

but then again, not all categories of drugs have significant differences between original research drugs and generic drugs. in fact, most drugs are "usable". what i mean by "usable" here is that the effectiveness can meet the basic requirements, and the adverse reactions are not outrageous. the comprehensive score is roughly the difference between 95 points and 88 points. 95 points is of course better, but 88 points cannot be said to be unusable.

what really affects our medical treatment is the situation where original drugs score 95 points, while generic drugs score 61 points or even 58 points... it cannot be said to be common, but it does exist.

some constructive suggestions:

the national drug procurement negotiations are certainly a good thing for saving medical insurance funds and reducing the burden of medical treatment on the people, but if the work can be more meticulous and humane, when there is a large gap between original drugs and generic drugs, high-priced original drugs can be given a break, giving patients more choices, even if it is a self-funded choice, it can make everyone feel more secure.

don't kill them all.