Posted on March 24, 2011 by Albin Paul
U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects.
Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No
Compare that to the Indian Law System
Madras High Court in India allowed a stay on immediate withdrawal of drugs banned due to Severe Side Effects. The pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries successfully managers to convince the legal system to set aside the safety of patients & to get a reversal of the ban for a short period. DCGI has a long way to go before effective PV can be enforced in India. The systems failed in France very recently even with the strong arm run EU PV policy in place,
The French Regulatory system was rocked recently in its disability to handle PV issues in proper maner. A report from the Inspection Generale des Affaires de Santé (IGAS). Mediator a lipopenic drug (a drug to lower fat levels in the blood) was discovered to have appetite suppressant qualities and was heavily over-prescribed by doctors whose patients wished to lose a little weight. Controversially, the drug stayed on the market despite a succession of warnings over its side-effects, which include heart valve disease and pulmonary hypertension. It is thought that as many as 2,000 people may have died from the severe Adverse Drug Reactions (ADR) incurred by their use of the drug. However, already in 1997 the drug was banned in the US and in Switzerland ; with France following suit 12 years later. The European Medicines Agency warned in 2002 of the risks associated with the medicine, however the warnings went unheeded.
Filed under: Drug Safety, Patient Safety, pharmacovigilance | Tagged: adverse drug report, Drug Safety, pharmacovigilance, post market surveillance | Leave a comment »
Posted on March 10, 2011 by Albin Paul
A new survey of 500+ clinical research site professionals outlines the impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.
The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.
Analysis of the survey findings shows that
- 66% of large organizations report an increase in trials conducted
- 60% of trial sites report increasing difficulty in managing trial profitability
- 40% report increasing difficulty in recruiting and retaining subjects
- Training remains a major issue, even though over 50% report an increase in training
- 80%+ of nurses want more QA training
- 60%+ of all respondents want more FDA Audits training
The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.
- Google (or other search sites) was the primary information tool
- Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
- Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors
CRST suggest that clinical research sites should:
- Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
- Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
- Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”
Full results of the survey are available on the CRST website www.crstnet.com
Lester Levine, 484-798-7503
Filed under: clinical research, Clinical Trial | Tagged: clinical research, clinical research training, Clinical Trial, clinical trial training | 1 Comment »
Posted on March 8, 2011 by Albin Paul
Posted on March 8, 2011 by Albin Paul
Dr. Pauline Chen in the NY Times reports that “When Patients Share Their Stories, Health May Improve”. HC Catalyst uses the same methodology to increase patient adherence to prescription medicines.
hcCatalyst Adherence Driver uses patients to motivate other patients to stay adherent. And, we do this without remunerating, scripting or training. It’s genuine and without the liability issues associated with paid or trained spokespersons.
Details on http://www.hccatalyst.com/solutions.html
Filed under: patient adherence | Tagged: patient adherence | Leave a comment »