Skip to main content

Is ‘Right-to-try’ bill right?

The bill would exempt doctors and drug companies from liability of prescribing and supplying experimental drugs
​.

​


image courtesy: Scienceblogs

'Right-to-try' is being debated fiercely in US as the American Congress is considering a bill on the topic. It is a practice allowing patients diagnosed with terminal illnesses to use drugs that are yet to be approved and are out of clinical trials, but have passed the first clinical test of safety. However, usage of even such drugs also requires Food & Drugs Administration (FDA) approval. The bill in the US Congress however, seeks to eliminate this FDA approval and monitoring of the process.

The Trump administration has supported the bill and this is termed by many as a part of the administration's passion for deregulation. In all 33 states have already passed 'Right-to-try' laws. Efforts of Goldwater institute, a libertarian non-profit organisation that drafted the model law, have led to passing of the laws in the states. In general, overall anti-regulatory environment in the society appears to have provided strength to the 'Right-to-try' moment.

Those supporting the bill claim that as it is the terminally ill patients have no hope for cure from the regular drugs that are given to them. So, why not allow them to try new drugs though it is little risky proposition as all stages of clinical trials are not completed yet. In the process of receiving approval after completing all phases of trials, the drug will be available after long time. But if allowed it to use before that it may be successful in some cases and save life to terminally ill patient.

​. . . Continue reading​


ᐧ

Comments

Post a Comment

Popular posts from this blog

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...
Post a Comment
Read more

Evidence for Atypical Antipsychotic Drugs Called into Question

Despite massive advertising and booming prescriptions, use and sales, the new atypical antipsychotic medications such as Seroquel and Abilify – used to treat schizophrenia , bipolar disorder, depression and other illnesses – lack sufficient evidence to support their widespread and generalized usage. This according to a new study out of the Stanford University School of Medicine and University of Chicago. In the past decade, atypical antipsychotics have rocketed past many commonly prescribed, but older antidepressant and other psychiatric medications. Although initially touted as having few side effects, followup studies have found that atypical antipsychotics have serious side effects, including significant weight gain that can lead to diabetes and heart disease. “Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, M.D., Ph.D., a Stanford associate pro...
Post a Comment
Read more

In India, there is no separate guidance on pregnancy reporting

How will we conclude that the subject is illiterate? Dr Prakash Atlam The guidelines don’t use the term illiterate. Their focus is subject’s ability to read and/or write. Schedule Y treats anyone who is unable to read or write in the same way. See the excerpt below. If the subject or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form. While designing a protocol we found that there are high likely chances of worsening of some of the symptoms. Do we have to wait for these to happen and report it as SAE or in case we define them in the protocol upfront then can we prevent from expediting reporting it as SAE? Om Please see suggested guidance from ICH. Exemption from reporting such events would require prior agreement with regulatory authorities. ICH E3 12.2.2 Display of Adverse Events: All adverse events occurrin...
Post a Comment
Read more