Pharma Industry News Update: 27 June 2017
FDA to Study if Oncology Detailing Exaggerates Benefits
[From www.federalregister.gov] In the past 18 months, FDA has approved 27 cancer drugs. Although overall survival remains the gold standard for demonstrating clinical benefit of a drug, several additional endpoints are accepted as surrogates illustrating clinical benefit with regard to cancer and many drugs are granted expedited approval on their basis. These include disease-free survival, objective response rate, complete response rate, progression-free survival, and time to progression.
For clinicians who are not specifically trained in clinical trial design, interpreting these endpoints may be challenging. Pharmaceutical companies invest heavily in the development and distribution of promotional materials. such as detail aids, to educate oncologists about favorable clinical trial results.
Detail aids may contain carefully extracted data from clinical studies that, taken out of context, can exaggerate the benefits of a drug or contribute to physicians prescribing the drug for an inappropriate patient population.
The proposed study seeks to address six research questions.
- Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists
- New Cancer Drugs Have Limited Efficacy Extending Survival by Only 3.5 Months on Average
- Breakthrough Cancer Therapy DTC: Boldly Emphasizing the Positive
- Widespread Hype Gives False Hope To Many Cancer Patients
- Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data
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Astellas Slapped on Wrist Again by ABPI
For “Lamentable Lack of Concern for Patient Safety”
[From www.fiercepharma.com] Astellas’ U.K. unit was already suspended from the Association of the British Pharmaceutical Industry thanks to what the trade group last year called “serious breaches” of its code of practice. And now, that suspension has been extended.
The organization has tacked another 12 months onto Astellas’ penalty, it said Friday, citing cases that “have shown wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a ‘lamentable lack of concern for patient safety.'” And the re-suspension very nearly became an expulsion, it noted.
Stop Picking on Pharma Free Lunch to Docs
The Real Problem is Members of Congress Accepting Gifts!
[From www.washingtonexaminer.com] In a recent Washington Post op-ed, Dr. Nicole Van Gronigen made the case that Big Pharma successfully influences physician prescribing behavior via marketing. Specifically, drug reps do with with free lunches provided by the pharmaceutical reps, or educational dinners at nice restaurants. She reported a JAMA study correlating industry-sponsored meals with increased promotion of branded medication to Medicare patients.
The real question is, why are physicians the only ones under scrutiny for payments received from industry? Over $3 billion per year is spent lobbying Congress and federal agencies to influence laws and government contracts, potentially costing taxpayers hundreds of billions of dollars. They influence members of Congress not with a few slices of pizza for lunch, but with all-expense paid African safaris for lawmakers and their families.
- Oncologists Can Be Influenced By Small #Pharma Payments for Meals, Travel, Consulting
- The Who’s Who of “Health Care” (i.e., Pharma) Lobbyists, 2017 vs 2016 Budgets