The curative effect of traditional medical treatment is less than 60%. Traditional medical care pays more attention to "standard course of treatment", and the medication and course of treatment for patients are similar. According to American statistics, the probability of this traditional treatment is less than 60%. With the rapid development of genomics, "precision medicine" not only challenges the traditional drug treatment methods, but also makes the medical and pharmaceutical circles better understand why some drugs only respond to specific people. Advocates of precision medicine hope to tailor the treatment plan for patients through precision medicine and improve the treatment response rate.
According to the data of Taiwan Province Medical Association, "precision medicine" is to tailor and select the most suitable course of treatment and drugs for patients according to the information of tumor genotype, individual gene expression, personal health status and clinical data, or to formulate preventive strategies according to this information. Through this treatment, we hope to maximize the role of drugs and minimize the risk of side effects of drugs.
The quality of precision medical research is uneven. However, foreign scholars question that many biomarkers are carried out in an open scientific mode, which greatly reduces the threshold for participation. Under the condition that there are no certain standards for hypothesis and experimental methods, the quality of the research is mixed, and the credibility of the research is naturally greatly reduced.
Take Erbisuzu injection (cetuximab) approved by the US Food and Drug Administration in 2004 as an example. This drug is mainly provided to patients with EGFR-positive metastatic colorectal cancer, and many health insurance benefits do not include patients with EGFR-negative. Subsequent studies have found that this drug is also effective for patients with negative EGFR, which means that there is no correlation between this drug and EGFR in terms of biomarkers and drug response rate. This result not only wastes money, but also makes many patients who could have received treatment unable to take medicine because they do not meet the payment conditions.
Accurate medical research needs consistency and standardization, and the problem of different biomarker detection standards in the detection of breast cancer gene HER2 surfaced. Most of these tests are to check whether a specific protein on the cell surface has a target, but there is no uniform standard for the critical value of positive and negative judgments in different laboratories. In addition, 33 foreign studies focused on the target of lung cancer "nucleotide excision and repair cross-complementary group gene protein1"(ERCC1), but the results were different due to many differences in diagnostic methods and determination methods. The above two examples show that if there is no consistent standard and evaluation mechanism for related research, it will greatly increase the difficulty of clinical application.
This year, the article published by the Biomarkers and Precision Medicine Committee of the National Medical College of the United States listed ten norms, which clarified the rights and responsibilities of * * * and legal entities, as well as the relevant norms of health administration, drug testing, insurance, clinical and research institutions. Through these norms, I hope that patients will not be reduced to "no medicine to cure."
The development of precision medicine in Taiwan Province Province is slow, and more integration is needed to promote the development. Li, chairman of the Taiwan Province Bio-industry Development Association, said in an interview with the media that in the field of precision medicine, from genetic testing and sequencing to clinical application, a lot of manpower is often needed. The development of precision medicine in Taiwan Province Province is a bit slow. For example, the data of Taiwan Province Biobank and Health Insurance can be compared with each other, but at present, there is no link between the two databases, which need to be integrated across departments and fields to make progress.