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.



Comments

Popular posts from this blog

FDA Restricts Use of Diabetes Drug Avandia

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used.
By Daniel J. DeNoon
WebMD Health News

Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug.

The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval.

The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control.

New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos. Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia.

"Avandia will be available to new pat…

Isotretinoin in India: A tragedy in the offing

Isotretinoin in India: A tragedy in the offing
Wednesday, March 28, 2007 08:00 IST 
Seema Thakral

Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased risk …

The Connection Between Sedatives and Fractures in Elderly Patients

Johns Hopkins Health Alerts:
Prescription Drugs
The Connection Between Sedatives and
Fractures in Elderly Patients
All drugs have potential side effects. Indeed, at some point you've probably squinted down the laundry list of possible side effects on the package insert of your medications. Common drug-related side effects include blurred vision, drowsiness, dizziness, dry mouth, heart palpitations, erectile dysfunction, memory impairment, and nervousness. Fortunately, many of these drug side effects occur in only small numbers of people. Now researchers have called into question the connection between sedatives which can cause dizziness and the potential for falls in elderly patients. They point out that well-meant policies discouraging sedative use in older people to prevent falls and fractures may not be necessary. Starting in 1989, New York State required doctors to fill out prescriptions in triplicate for benzodiazepines, the most widely used class of sedatives. Tw…