This film is adapted from real events. However, just like its Hong Kong translation of the name "Xing Ming Xiong", the real event was somewhat brought into the American style of personal heroism in the process of being adapted into the film. In reality, the exorbitant profits and substance abuse of the Dallas Buyers Club were ambiguously watered down in the movie (the passage of applause until the end was simply glorified and sublimated). Of course, the adaptation made in the name of "artistic processing" is understandable. However, compared with the moving plot and the superb acting skills of the leading actor and supporting actor, the FDA drug approval system, a controversial issue in recent decades, is also worth talking about.
The U.S. Food and Drug Administration (FDA) is a federal government agency directly under the jurisdiction of the U.S. Department of Health and Human Services. Its main function is to supervise and manage food and drugs produced and imported in the United States. Under the authorization of federal law, the FDA implements a number of safety supervision functions, including the supervision of prescription drug testing, manufacturing, advertising, marketing, and drug safety. Among many powers, the drug approval system gives the FDA the power to live and kill new drugs, and this is directly related to the commercial interests of pharmaceutical companies. Huge drug R&D costs may have been exhausted in the face of the once extremely stringent and lengthy approval process. It is conceivable that pharmaceutical companies had a hostile attitude towards the FDA at that time.
And as shown in the film, the spread of AIDS in the 1980s was once out of control. Compared with the outbreak of the epidemic, drug development is inevitably lagging behind, but at this time medical research on AIDS is not without progress. However, between the new drug and the patient is still a lengthy clinical trial and approval that may last several years. As a result, the FDA's drug approval system has become a natural target for desperate patients and AIDS activists. The higher the voice of pharmaceutical companies and the public, the involvement of political forces becomes inevitable. Finally, under heavy pressure, the FDA made a compromise and formulated a "rapid approval plan" under the authorization of Congress to accelerate the approval of drugs for the treatment of "serious or life-threatening disease or condition" . These provisions to speed up the examination and approval process were all extended to be applied in 1992 and incorporated into relevant laws. With the formal implementation of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, the FDA now has four special approval channels, namely Fast Track and Priority Review (Priority Review), Accelerated Approval and Breakthrough Therapies. Drugs that enter the special approval channel can complete the approval cycle within a few months or even weeks at the earliest.
But in fact, sometimes only time can detect the real drug hazards. After the fast-track gate was opened, it is not uncommon for drugs that have been quickly approved by the FDA to have safety problems. A large number of drugs are not discovered until they are on the market until they have serious side effects. The Journal of the American Medical Association has reported that drugs that have passed the FDA’s rapid review can be approved only after small-scale trials in a relatively narrow audience. The rapid approval system has led to too few drug research and testing, and important information such as follow-up research and test reports of drugs after rapid approval often cannot be followed up in time. Whether the FDA's rapid approval system is suspected of being abused by pharmaceutical companies has also been repeatedly questioned.
Here I want to mention another American drama. In the last episode of the last season of Boston Law, Denny challenged the FDA's approval system because he needed a drug that was also not approved by the FDA but could treat Alzheimer's. He also appealed the case to the Supreme Court. Despite Alan's full defense, the result was not as expected. It is worth mentioning that in reality, cases concerning whether patients have the right to use unapproved drugs also exist. In the 2006 "Abigail Alliance Citizen Petition to FDA" case, Abigail Alliance believed that the FDA should allow patients diagnosed with serious or immediately life-threatening disease to use drugs that have completed Phase I of clinical trials . Although this claim was supported by the First Court of Appeals in May 2006, it was overturned after a retrial in March 2008. The U.S. Supreme Court did not accept the appeal application for this case.
Here, I would like to end with a summary statement from a lawyer defending the FDA's drug approval system in Boston law. This wonderful statement can be said to point out the drug approval system, and even the seemingly unreasonable length of this system, the real rationality contained in it. This passage also represents some of the thoughts that this article wants to express, and sharing it with you can be regarded as providing a different perspective. "If this man is dying of an incurable disease, why not give him the unapproved drug? Who does it hurt? First of all, Mr. Crane is not necessarily terminal. I know the disease can take unpredictable courses, particularly when it comes to progression, and all with the same ending. The FDA bans experimental drug use with good reason, because this does not just involve the individual patient. If untested drugs are suddenly made available, people will forgo entering into clinical drug trials. Promising drugs might not be studied, and therefore, never reach the market. That hurts over five million people have Alzheimer's. Something tells me we'd have plenty of subjects for clinical trials.
Why shouldn't a person have a right to medical self-defense? This court rejected that right in marijuana cases where there were other treatments available. We let women abort viable fetuses to protect their own lives. A person may shoot and attack dead in self-defense. Shouldn't this man be able to take a drug to save himself, uh, especially, if, uh, it's his only hope? No. First of all, dying people are willing to assume any risk, including taking dangerous , untested drugs, which could kill them sooner. But again, what's the downside-the downside is clinical trials get shortchanged, interfered with. The safety and efficacy of these drugs is at stake, not to mention millions of lives.
My grandmother has Alzheimer's. She's one of those five million people. She sits at home waiting for a cure, desperate for FDA approval, which could very well be delayed by letting... we've seen how pharmaceutical companies work. It's not about finding cures so much as it is finding markets, selling. If they get to peddle promising but untested drugs, we all know they'll do it. Drugs that engender false hopes, ones with higher profit margins if they get to skip the testing. Investors will pump their money into snake oils that dress up well. This is not a scrupulous industry, your honor. They most certainly don't deserve a pass on clinical trails, and that is what will effectively happen if untested drugs are okayed by this court.
We already have a problem in this country of rushing unsafe drugs to the market-it's epidemic. And as soon as we allow patients, especially the desperate ones, to exempt drugs from testing, it is going to get exponentially worse. Fewer people will be saved.
Rather, more will die."
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