Chapter 1489 1517 A young man who tells the truth (I am the leader of the alliance
Chapter 1489 A young man who tells the truth (I am Liangchen, who is afraid of who will add ×1)
The FDA has the world's strictest approval system. Drugs approved by the FDA have a certain sacredness and can be directly allowed to enter the clinical practice without approval in a considerable number of countries.
But Dr. Huang stood on the podium and pointed his finger at the FDA!
Is this what a doctor should do?
Dr. Huang's eyes were extremely resolute, calm, and even a little indifferent.
He is just stating an objective fact, no matter who the opponent is or how powerful the opponent is.
The truth is the truth. He is the young man who believes in the truth and has not been erased from the world for many years.
Everyone was stunned and stared at the eighty-year-old Huang Lao and Zhou Congwen standing behind him.
"The annual output value of the medical equipment industry is about US$100 billion, but it is not as well known as the pharmaceutical industry."
"Innovation is the most powerful mark in our human genes. The unstoppable pursuit of innovation can improve patient care. I think this is the basis for cooperation between doctors and manufacturers."
"Both doctors and patients like newer equipment, but this new is based on enough experimental evidence."
"The new products developed by the company may not be safer and more effective than existing products on the market.
But the company will definitely promote it vigorously to doctors and hospitals to promote profits, drive stock prices up, and make shareholders happy. Everything is so reasonable.
You show the patients and say that if there weren't this innovative product, they wouldn't be alive now.
In 150 years, human life expectancy doubled because of innovation.”
When Mr. Huang said this, his eyes were as loud as a knife, and the old aura of his twilight years disappeared. He seemed to jump onto his own war horse, holding a spear, and charging into the battle desperately.
“New technology itself does not mean innovation!”
Huang Lao's low voice echoed in the conference room.
The new technique breaks the technical barriers between disciplines and is the most typical innovation, but he stands on the podium and tells everyone that new technology does not necessarily mean innovation.
The faces of the senior executives of the manufacturer are ugly.
"Take A dv vamed and its member companies as an example." Huang Lao Youyou said.
The white-haired old man was silent and looked at Mr. Huang solemnly.
"In 2001, lobbying costs more than $22 million. They worked very hard to make the equipment approval standards decline year by year. Equipment companies sent out lobbying corps to affect FDA approval."
"Through sweet words and speeches, we can explain at the hearing how the company puts patients first and pursues the best results. We want to ensure that new medical innovations can reach patients. We help save lives, improve human conditions, eliminate pain, and make the world a better place."
"There are so many words that you believe in yourself? I believe that you are the angels sent by the gods to the world to save the people of the world?"
Mr. Huang looked at the senior executives of many manufacturers in front of him jokingly.
"I know the medical device industry has a great influence in Washington, and you have provided secret donations to secretly fund political campaigns. Medical device companies also fund think tanks and patient advocacy organizations, and everything is lowering the threshold for approval."
"Technical approval experts who leave the FDA can work in many medical device companies, with high salaries, which is what they 'deserved'. You must think so."
"If supervision is not good, we need to reduce supervision. For every additional regulation, countless regulations will be reduced. This reduction may apply to certain areas, but it cannot and should not be used for equipment placed in the human body. Do you know the side effects of those consumables!"
As he said that, Mr. Huang raised his hand.
Zhou Congwen took out a stack of materials from the trolley box and put them on his boss's hand.
"Hip replacement is the procedure you have been promoting over the years, right?" Mr. Huang glanced at the senior executives of those companies. "In order to reduce costs, you don't have to prove that it is harmless to the human body, but choose metal cobalt."
"Cobalt is a shiny steel gray metal with a melting point of 1493℃ and a specific gravity of 8.9. It is relatively hard and brittle. Cobalt is ferromagnetic and is similar to iron and nickel in terms of hardness, tensile strength, mechanical processing properties, thermodynamic properties, and electrochemical behavior."
"But do you know what reaction will happen if the human body absorbs cobalt as a consumable for implantation in the body?"
As Mr. Huang said, shaking the materials in his hand with his right hand.
“This is the data on patients with abnormal behavior after hip replacement that I have summarized in the last five years.”
Stacks of information were clattering, like a storm, like a storm.
"Here, some patients start to have tinnitus after hip replacement surgery, and often repeat their words over and over again; some patients have difficulty breathing, swelling of both lower limbs, and symptoms of heart failure; some patients have similar conditions with Alzheimer's disease."
"And this is all because of the 501K process introduced by the lobby army after persuading the FDA."
Huang Lao's voice increased, especially when talking about the 501K process, it was like a glaring King Kong.
"Crash~" A stack of information was thrown out by Mr. Huang, and scattered like snowflakes.
During an avalanche, no snowflake is innocent.
At this moment, no consumables company is innocent.
"It proves that its equipment is basically equivalent to another type of equipment that already exists on the market. This regulation was originally intended to be an exception, but is essentially a loophole.
Unfortunately, this exception has become routine now. I regret to see that most devices are now regulated under this framework.”
"The reason why a medical device is approved is that it is basically equivalent to a certain medical device before. This medical device was approved because it is basically equivalent to an earlier device."
"Don't you think it's ridiculous! In order to reduce the cost of hip replacement, cobalt is used to replace it successfully without enough examples. So far, nearly one million patients in need have cobalt implanted in the bodies of their bodies!"
"This is a carcinogen! It can cause Alzheimer's disease, can lead to heart failure, and can lead to many fatal diseases!"
"And it entered the clinical and into the patient's body because of that damn 501K process."
Zhou Congwen stood silently next to his boss.
He knew everything the boss said, and this situation became even more serious in the last life and in the next ten years.
But I dare not say it.
The huge capital group behind it and those dark hands all daunted Zhou Congwen.
Being alone is the best choice, so Zhou Congwen chose it and could only choose to keep silent.
But after living a lifetime, his boss said everything on such an occasion, pointing directly at the capital behind the manufacturer and the FDA.
Brave!
Chapter completed!