In July 2018, the movie “I am not the God of Medicine” caused a stir in China. The story is about Chinese leukemia patients who can’t afford expensive imported drugs and have to smuggle in Indian versions of generic drugs, generating heated debate on topics such as law, humanity and life.
Many lung cancer patients also resonate. Because before the third generation of targeted and immune drugs were available in China, there were people who bought the Indian version of generic drugs or API powder through similar routes.
Legal considerations aside, can patients actually take generic drugs or drug powders? Here we talk about the differences between generic and powdered drugs and genuine drugs in terms of efficacy and side effects from a medical practitioner’s perspective.
First, you need to understand the definitions of these drugs.
Understanding patented drugs, originator drugs, generic drugs and APIs
Patented drugs, which are the first drugs in the world to be patented, generally have a 20-year protection period and cannot be copied by other companies.
Originals are drugs that have passed the patent period and are produced by the original manufacturer.
Original drugs, which are manufactured by the original manufacturer after the expiration of the patent period, can only be applied for and registered after strictly designed phase I-III clinical trials, in which a certain number of humans are verified to be safe and effective, in addition to cellular and animal experiments in the preliminary laboratory to confirm their effectiveness.
Generic drugs, which are generic versions of the original drug, are identical to the original drug in terms of dose, safety and efficacy (regardless of how it is taken), quality, action, and indications. When a patented drug has passed its protection period, other companies can make a generic version. Compared to the original drug, the cost of large-scale clinical and research studies is eliminated, and the price is relatively low.
API drugs, also commonly referred to as pharmaceutical powders because they are usually in powder form, are upstream products of normal pharmaceuticals that theoretically have some pharmacological effect but require further processing to become a real drug.
Here is a special mention of genuine drugs and pirated drugs.
Genuine and pirated are opposites, generally involving the ownership of copyright in works, publications, and so on. Extending to drugs, we can argue that any drug produced without the consent or authorization of the patent owner is a pirated drug. According to the above definition, patented and original drugs are undoubtedly genuine drugs.
Genuine drugs are expensive, not because the drug companies are “shady”, but because of the high cost of research and development, the high risk, and the many distribution channels.
If you’re not a drug company, you’re not a drug company.
A pirated drug is a drug that is produced without a license during the patent period, which includes the patent license of the originator company and the license of the country. In general, the key to piracy is “copyright,” and the text defines a generic drug as follows: “A generic drug is a copy of the original drug that is identical in dose, safety and efficacy (regardless of how it is taken), quality, action, and indications. It is a drug that can be copied by other companies when the protection period of the patented drug has expired”. In this definition, a generic drug is a drug that is produced after the patent has expired and can be produced by everyone after the patent has expired, in which case there is no longer any question of whether it is a genuine or pirated version.
But the reality is a bit more complicated. In fact, there are many “generic” drugs that are produced before the patent expires (such as some Indian drugs), which are allowed to be produced locally and may not be considered pirated locally, but globally, especially for the manufacturers of the original drugs, these “generic” drugs are considered pirated. These “generics” are considered pirated drugs, and they may even initiate patent litigation over them.
Also, APIs are not strictly considered drugs, and I tend not to classify them as pirated drugs.
People may not know this much, but they know that there are “real” drugs and “fake” drugs. The company’s main goal is to provide the best possible service to its customers. But the “fake” here is not the same as our concept of fake drugs, meaning that there is no patient data to confirm the efficacy of our country. For those new drugs that have been proven to be effective abroad but not approved in China, we provide for access to treatment through participation in clinical trials.
Are generic drugs and APIs, with the same efficacy and safety as the original drug?
What are the benefits of generic drugs?
The protagonist of “Medicine God” is a leukemia patient. He initially bought the original Swiss drug and spent more than $500,000 in 2 years, but then had to switch to the Indian version of the generic drug. The first time I saw this, I had to switch to a generic version.
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1. Generic drugs
According to our pharmacopoeia standards, the quality of generic drugs that have been marketed in China are basically qualified. The company’s main goal is to provide the best possible service to patients.)
It is important to note that “bioequivalence” is not the same as a guarantee of actual clinical efficacy or even adverse effects. We may be able to assume that a generic drug is similar to the original drug, but after all, it has not undergone large-scale clinical studies to confirm its safety equivalence in humans.
In addition, different countries regulate generic drugs differently. The quality of generic drugs is more assured in Europe and the US, but the quality of generic drugs made in some developing countries is harder to control. So, when you can’t afford an expensive original drug, buying a generic drug from a reliable source that has been approved by the State Food and Drug Administration (CFDA) is an optional alternative.
2. APIs
It generally cannot be taken directly because on the one hand it lacks the other auxiliary ingredients and dosage forms necessary for the drug to work optimally in the complex environment of the human body; on the other hand, it may not be pure enough to be safe to take, and just 0.1% of impurities can cause serious adverse reactions.
In addition, APIs are manufactured and sold at a lower threshold than generics, and quality is even less assured. Some unscrupulous businesses may add invalid ingredients to the powder to deceive patients by substituting poor quality for good. Therefore, it is definitely not recommended to go for APIs.
Anti-tumor drugs are an important weapon to control advanced tumors. The first drug regimen used after diagnosis of an advanced tumor is called first-line therapy. The effective duration of first-line therapy determines, to some extent, how long patients will ultimately live. Therefore how to choose drugs, especially first-line treatment drugs, should be very carefully.
In general, original drugs can extend the duration of effectiveness of first-line therapy to the longest, generics may be slightly shorter, and APIs will be even shorter. Participating in clinical trials is the best way to get free access to the original drug. You can consult your doctor at major hospitals and also get free access to the latest drug, and the individual clinical studies are not allowing patients who have taken the raw material powder to be enrolled.
So do I still need to go overseas to buy the drug?
Currently, drug substitution is a practice that wanders into a gray area. According to the Drug Administration Law, “Any drug that must be approved in accordance with this Law and is not approved for production or import, or must be tested in accordance with this Law and is sold without inspection, is considered counterfeit.” Therefore, drugs that are not yet available in the country, whether effective or not, are considered counterfeit; buying a large number of overseas drugs on behalf of others may constitute a crime.
Why are our laws so strict? One reason is because drugs are extremely special commodities that require clinical validation and have different adaptations for different ethnic groups. The most important thing is that the Chinese are not necessarily using the drugs that work in Europe and America, or they are effective but have a lot of side effects. So if regulation is not in place, it can have extremely serious consequences.
India is known as the “third world pharmacy” because it produces cheap and effective generic drugs. The company’s main goal is to provide the best possible service to its customers. The group of buyers is not as glamorous as in the film, each is a “god of medicine”. The data shows that more than half of the overseas anti-cancer drugs purchased online have been proven to be counterfeit products, with some buyers mixing fake drugs with the real ones, and some even with all the fake ones, causing many patients to miss out on their illness and lose money. Therefore, we don’t recommend that patients buy drugs overseas when they are available at home.
“God of Medicine” is a good movie, but the movie is not the same as reality, so you can’t “put it in your place”.
The movie is a good movie, but the movie is not the same as reality.
Doctors are always there for you.
Co-Author: Dr. Wenfeng Li, Guangdong Provincial People’s Hospital Guangdong Lung Cancer Institute