I can extract side effects.

Chapter 256 New Thalassemia Drug Launched Overseas
"FDA actually agreed?"

Wei Kang was a little surprised at the moment, he just casually said two conditions that he wanted to try, and he didn't expect the other party to really agree.

Unexpectedly, the FDA actually agreed.

Not only has the anti-sale ban on painkillers been revoked, but they can also submit clinical data directly to the FDA and take the fast track to apply for listing.

In addition, the three cardiovascular and cerebrovascular drugs, antihypertensive drugs, anticoagulant drugs and antithrombotic drugs, are all in the third phase of clinical trials and can be used for overseas clinical trials in Eagle Country.

As for the cat-abdominal medicine, anti-allergic medicine, scar cream and hair removal cream, they are also in the ranks of packing applications.

"Is the FDA so kind?"

Weikang couldn't understand why the FDA was so easy to talk about.

Under normal circumstances, the FDA only welcomes life-saving drugs that can treat malignant diseases, such as anticancer drugs.

Or a drug that is unique and has no competing products, such as Alzheimer's in specific drugs.

For other drugs, the FDA's review standards have always been very strict, and it is better to lack than to overuse.

Especially drugs such as painkillers, which are relatively highly substitutable and touch a lot of interests, have always been stern and unselfish. If they say that they are banned, they will be banned, and there is no room for flexibility.

So this 180-degree turn of hospitality really made Wei Kang a little puzzled.

He faintly felt that something was wrong, but he couldn't see it for a while, so he could only put it aside for the time being.

Anyway, as long as I abide by the law and don't leave any excuses for the other party.

I believe that the other party has nothing to do with themselves.

Next, Sanqing launched overseas clinical trials of a batch of new drugs.

The FDA has generously allowed Sanqing to provide Huaxia's clinical trial data this time. In Eagle Country, it only needs to supplement the clinical trials of different races such as whites and blacks, so as to achieve the universality of the drug for multiple races.

In this way, the number of clinical people required is much smaller, and the approval time can be greatly shortened.

The FDA generally has very strict requirements for the Phase III clinical trials of drugs, usually requiring the participation of tens of thousands of people, and randomized double-blind control.

Randomized double-blind control is the gold standard of clinical trials. All patients are randomly divided into two groups, one group takes drug treatment and the other group takes placebo.

As for whether the patient was taking the drug or a placebo, the subjects did not know, nor did the treating doctors. Only a third-party independent monitoring member knew which group the subjects were assigned to.

Only in this way can the effectiveness of clinical trials be guaranteed to a great extent.

A drug needs to be at least 30% more effective than the placebo group in Phase III trials before it can be called clear and credible.

And the statistical analysis should show that this effectiveness is supported by reliable data, not due to random luck.

According to the FDA's previous instructions, it is expected to be approved if the effectiveness reaches 30%.

Of course, the higher the effectiveness, the better.

However, in some acute and severe diseases, the double-blind drug experiment is undoubtedly a bloody and cruel experiment.

The patient is about to die, but they are assigned to the control group and given a placebo, which often causes huge ethical controversy and is considered immoral.

Therefore, Sanqing’s previous anticancer drugs and other drugs did not undergo double-blind experiments.

Because the probability of self-healing of advanced cancer is close to 0, and the objective effective rate of placebo is close to 0, if a drug can achieve a very high objective effective rate in treatment, it is almost 100% effective, which does not require double blinding The comparison can also be seen.

This is different from diseases such as colds and coughs. Most of these diseases can be cured by themselves relying on human immunity. No medicine is needed, and more than 90% of people will heal on their own. If given medicine, the self-healing rate will be higher.

Therefore, for this kind of disease that can be healed by the human immune system, in order to obtain definite evidence of the effect of the drug, it is necessary to conduct a double-blind controlled clinical trial, so as not to mistake the immune self-healing after taking the placebo as a drug. therapeutic function.

Drugs such as anticancer drugs, as long as the objective effective rate is higher than the standard therapy, the sample size reaches a certain number, and the side effects are tolerable, they can be recognized by the FDA as a breakthrough therapy, and they can be listed on the market with priority review.

This time, the thalassemia gene drug is also going through the green channel of innovation approval.

Skip countless tedious and disgusting approval procedures, and enter the third phase of clinical trials as soon as possible.

And considering that thalassemia is a rare disease, the number of clinical patients has also been greatly reduced, only a few dozen people are enough.

In short, the green light is turned on throughout the process, and we strive to promote the marketing of this new drug as quickly as possible.

******
Eagle Country, West Virginia.

It's one of the states with the worst painkiller epidemic in the Eagle Country, known as the epicenter of the opioid crisis.

Alexander limped into the clinic and came up to the doctor.

"Doctor, I'm here again. I've run out of painkillers, and my thigh still hurts. Please give me some more medicine."

He has been here several times, and he speaks to the doctor with ease.

The doctor said with a sullen face, "Didn't I just prescribe you the medicine for two weeks? Why did you finish it so quickly?"

Alexander said with a hippie smile: "After taking this medicine for a long time, the effect will not be so long-lasting. I will take an extra tablet once in a while, and I will feel much better."

The doctor suddenly felt a terrible headache, and another patient addicted to painkillers, if he continues to eat like this, it is really hopeless.

He couldn't help shaking his head and said: "This medicine is addictive, don't take too much, you don't want to overdose and die at home like little George."

Alexander shrugged nonchalantly and said, "Do you think I want to? I have an old problem of sciatica, and I can only take painkillers so that I won't die from the pain."

The doctor knew that he was right. Most people in the Eagle Country were like this. Seeing a doctor is too expensive. If you have a minor problem, just take two painkillers, and the problem will be solved.

Especially for chronic diseases such as sciatica, there is no particularly good cure. The only way to relieve it is to take painkillers.

He took out his pen and was about to write a prescription when he hesitated for a moment: "Recently, a new painkiller has been released on the market, and it works very well. Let me prescribe this for you."

Alexander asked puzzledly, "Why did you change my medicine? I ate the one last time very well."

The doctor swiped and signed: "Listen to me, this medicine is not addictive, so you don't have to worry about dying in the garbage dump in the future."

Alexander was taken aback, with a look of disbelief on his face: "Are there any non-addictive painkillers? Then why didn't you prescribe it to me before?"

The doctor lowered his voice and said, "This drug has been on the market for a while. It was banned by the FDA before, so I couldn't prescribe it to you. Now that the ban has been withdrawn, you can buy it."

Alexander was furious when he heard this: "Damn FDA, such a good painkiller is not allowed to be sold, and only gives us addictive junk drugs. It is unreasonable. I must go to the Internet to expose its ugly face of disregarding human life."

******
Eagle Country, CA.

Solomon has been waiting for several months. At the beginning, he was looking forward to receiving a call from Sanqing soon to go to Huaxia to participate in the clinical trial of thalassemia gene medicine.

However, until all the acquaintances he knew had recovered and returned home, he did not wait for a call

The long wait has exhausted all his patience, and he has begun to doubt life.

At this moment, he finally received a call from the far east.

The sweet voice on the phone told him that he could participate in the Phase III clinical trial in Yingguo.

This is almost the same, saving a trip, he snorted coldly in his heart, the impatience of waiting finally eased.

Especially after seeing the name of the cooperative clinical hospital - Mayo Clinic, he showed a satisfied smile.

(End of this chapter)