Use more
Many generic drugs have promising new uses; But more incentives are needed to invest in them.
Drugs after the patent protection period have new uses, but they need more capital investment.
At the end of 20 14, a 66-year-old British man named Alistair had a seizure. The scan revealed shocking news. He has an inoperable brain tumor-glioblastoma-which may kill him in a few years. Not long after, he read an article in the newspaper, which pointed out that a cheap daily medicine cocktail was selected for its anti-cancer effect and helped a patient with the same disease. His doctor was unmoved and just said, "We can't stop you."
At the end of 20 14, Alistair, a 66-year-old Englishman, suddenly had a seizure. After checking the scanning equipment, the doctor told him a shocking news. He has a tumor on his head called glioblastoma, which cannot be cured by surgery. His time is running out. Not long after, he read an article in the newspaper, which mentioned a cheap cocktail therapy. The drugs involved are very common, and these drugs have more or less anti-cancer effects. The patient in the newspaper suffers from the same disease as him, and the application of this therapy has successfully alleviated the patient's condition. The doctor in charge of treating Alistair scoffed at this. "We can't control you."
Four years later, Alistair is still taking this medicine while taking "standard care" treatment. This cocktail was prescribed by Care Oncology, a private clinic in London, which recommended statins (a cholesterol-lowering drug), metformin (for treating type 2 diabetes), doxycycline (an antibiotic) and mebendazole (an anti-worm drug). These may sound radical, but they are actually safe and cheap generic drugs, and there is evidence that they have anti-cancer effects. Still, their labels don't say they treat glioblastoma-nor do they say they treat other cancers.
For many years, Alistair has been using this drug treatment model and receiving standardized treatment from doctors. The promoter of this cocktail therapy is the "Cancer Care Clinic" in London, which is a private clinic. It suggests that this therapy consists of statins (cholesterol-lowering drugs), metformin (drugs for treating type 2 diabetes), doxycycline (an antibiotic) and mebendazole (an anti-moth agent). This formula sounds incredible, but in fact, these drugs are safe, cheap, and all of them are conventional drugs with anti-cancer effects. Nevertheless, the labels of these drugs never say that they can treat glioblastoma or any related malignant tumor.
Lack of clinical interest is not uncommon. There is a huge undeveloped generic medicine cabinet, and there are undeveloped uses. These drugs were originally approved for one disease, but now the patent expires, showing prospects for other diseases. Thalidomide, a drug for morning sickness that has always been associated with scandals and disasters, has found new uses in leprosy and hematologic cancer. A drug for acne is now part of an effective treatment for leukemia. As we all know, Viagra comes from the failed job of angina pectoris.
Clinicians are not very interested in this. Many common drugs have the potential for re-development, but people have not realized this. These drugs used to be targeted at specific diseases, but now they have the potential to treat more diseases. The notorious morning antiemetic "thalidomide" can now be used to treat leprosy and some blood tumors; A drug for treating acne has become an effective method for treating leukemia. The famous drug "Viagra" is a failed product to treat angina pectoris.
The opportunity of "drug reuse" is enormous. Bruce Bloom, the owner of the American recycling charity Treatment at Your fingertips, said that 9,000 generic drugs have been approved. Pan Panchiaka of another charity, the Anti-Cancer Foundation, said that his team had found evidence of anti-cancer activity in nearly 260 non-cancer drugs. Most of them have lost their patent protection. The science that arouses people's interest in these drugs comes from animal preclinical laboratory work, case reports, small clinical trials and large-scale observation studies.
Expand the use of drugs, and have broad application prospects. Bruce Blue is the head of the American charity "Easy-to-Get Antidote", which is an organization that promotes "new use of old drugs". He said that about 9,000 commonly used drugs have been approved for expanded use. Pan Pantziarka, another charity affiliated with the American Anti-Cancer Foundation, found that about 260 non-anticancer drugs showed anti-cancer properties, and many of them had passed the patent protection period. The scientific interest in these drugs mainly comes from preclinical research involving animal experiments, case reports, small clinical trials and large-scale observation studies.
More and more large-scale screening studies are looking for choices from forgetting. After screening thousands of approved drugs, the National Institutes of Health (nih), an American research institution, identified 25 molecules that may fight drug-resistant bacteria, half of which are already approved drugs. California Institute of Biomedicine in San Diego has 12000 drug compound libraries for testing pathogenic pathogens. Therefore, two drugs are being tested: an anti-rheumatic drug called auranofin, which is used to treat tuberculosis; And clofazimine, a leprosy drug used for treating cryptosporidium parasite.
Some large-scale screening studies have gradually discovered the unknown efficacy of many drugs. After screening thousands of approved drugs, the National Institutes of Health (NIH), an American medical research institution, found that 25 specific molecules may be effective against drug-resistant bacteria. The California Institute of Biomedicine (CIBR) in San Diego has a sample bank containing 65,438+02,000 pharmaceutical compounds. Based on this sample bank, the research tested its inhibitory effect on pathogens caused by diseases. This experiment has achieved two important results: auranofin, an anti-rheumatic drug, was used for tuberculosis patients, and chlorphenazine, a drug for leprosy, was added to the drug for cryptosporidium parasites.
Drugs like this-generic, cheap and approved-can be developed relatively quickly and can treat new diseases. New molecular entities can cost hundreds of millions of dollars to test, and safety and toxicity problems mean that 45% drugs can't pass clinical trials. Reusable drugs with good safety can save about five to seven years of research and development time. The approval rate is higher, and some people think that the total cost is 60% of the new drug.
After the patent period has expired, it is cheap and allowed to circulate. Drugs like this have the potential of re-development and can be used to treat many new diseases. At present, the trial cost of new molecular solid drugs is about one million dollars, and with the emergence of various safety or toxicology problems, about 45% drugs will stop clinical trials. Changing drug use and obtaining safety approval can save five to seven years of drug research and development time. The passing rate of drugs is also higher. Some people estimate that the cost of "new drugs" is only 60% of that of new drugs.
multiple-choice
multiple-choice
People's interest in drug reuse has been on the rise, especially for drugs that can treat neglected diseases, rare diseases, cancer and mental health in poor countries. A recent study in the Journal of Psychiatry of the American Medical Association shows that statins, metformin and antihypertensive drugs have the potential to treat mental diseases such as schizophrenia and bipolar disorder. The antibiotic minocycline has been tested as a treatment for autism. Ammar Al-Chalabi, a neuroscientist at King's College London, hopes to reuse an hiv drug Triumeq to fight motor neuron diseases.
The concept of "new use of old drugs" has attracted more and more attention, especially in some backward countries, these drugs can be used to treat some diseases that have been neglected for a long time, some intractable diseases, cancer and psychological diseases. JAMA Psychiatric Association said in a recent study that statins, metformin and some antihypertensive drugs have great potential in the treatment of some mental diseases, such as schizophrenia and manic depression. The antibiotic minocycline has completed the trial of treating autism. Amar Al Chalabi? A neuroscientist at King's College London, he tried to expand the use of the anti-AIDS drug Abacavir. He found that this drug can be used to treat some neuronal diseases.
However, there is a problem. Katherine Arline of Shepherd Therapeutics, a biotechnology company that studies rare cancers, said that the company had no incentive to conduct clinical trials on generic drugs because of its high cost and possible irrecoverability. Once the cost of testing and registration is paid, the lack of patent protection means that any company can produce this drug. Some people describe generic drugs as "financial orphans".
However, problems always exist. Catherine Irene works for a biotechnology company that focuses on rare cancers. She said that the research and development cost of these drugs is actually very high, but the return is very low, so many companies have no plans to conduct related clinical trials. At the same time, once the company pays the trial fee and registration fee for these drugs, the plan will be ruined because there is no patent protection. Some people call these drugs whose patent period has expired "financing orphans".
One way is to change generic drugs and create some patents. This is the American pharmaceutical company Johnson & Johnson. J & ampj is close to ketamine, an anesthetic with a lot of evidence to support its use in refractory depression. Johnson & Johnson company J adjusted this molecule to create a variant that can also be inhaled. The cost of reformulation is high and there is a risk of reducing the efficacy of drugs. But Johnson & Johnson. Johnson & Johnson seems likely to get approval from the Food and Drug Administration.
One solution is to find ways to change these "old drugs" and let them get patent protection again. Companies that adopt this method include Johnson & Johnson Company in the United States, which provides a series of evidences for the anesthetic ketamine in the treatment of refractory depression. Johnson & Johnson fine-tuned the molecular structure of this drug, making it an inhalable drug. The reconstruction of drug structure is expensive, and it is likely to reduce the original therapeutic effect. But Johnson & Johnson seems to be able to get approval from the Food and Drug Administration.
For many years, ketamine, like many off-label drugs, has been a valuable but hard-to-obtain treatment. This promoted the development of ketamine clinics in the United States and Europe. In Britain, the Oxford Health Center, a unit of the National Health Service (nhs), will provide this service. But the nhs as a whole does not cover it, because it is not approved for this purpose, so the patient must pay 795 pounds (65,438 US dollars +0.058 US dollars) for three infusions; Johnson & Johnson company J's ketamine may be much more expensive.
For many years, drugs with unconventional uses, such as ketamine, were basically very expensive and difficult to obtain. Therefore, in the United States and Europe, the development of clinical application of ketamine has received some attention. The Oxford Health Organization is mainly responsible for the supply of the drug in the UK, and it is a subsidiary of the National Health Service (NHS). However, the NHS cannot afford antidepressants. If patients want to use this drug, they need to pay 795 euros (1.058 dollars) for three basic injections. The escort developed by Johnson & Johnson is more expensive than escort.
Several problems of reusing generic drugs in new indications. Mr. Bloom said that according to his experience, one-third to one-half of patients are reluctant to use drugs beyond the current standard of care-even if they know they have a fatal disease. Even if doctors are willing to prescribe over-the-counter drugs in principle, many people feel that they can't prescribe them because they are worried that they will bear legal responsibility if something goes wrong. Or, it may be controversial whether public health services or insurance companies will pay for drugs that are not approved for the disease.
Many factors have hindered the popularization of "new use of old drugs". Mr. Bloom said that from his experience, about 30% to 50% of patients are reluctant to use this unconventional drug, even in the face of diseases that may lead to death. And even if doctors are willing to try, they will still worry about some legal issues involving accountability in practice, because once something goes wrong, doctors will be responsible. Other arguments come from public health departments and insurance companies, who worry that these drugs are not qualified to treat certain diseases.