Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Tuesday, October 18, 2011

Entitlement demand by pharma CEO

Pfizer CEO: Direct-to-Consumer ads are a "fundamental right" !!

my posted comment:
To stop DTC (direct-to-consumer) bad ads contact: Deborah A. Wolf, JD, Regulatory Counsel, Office of Compliance FDA/CDRH DTC direct-to-consumer advertising for implanted medical devices such as hips and knees is driving sales and unrealistic expectations by younger/”boomer” consumers while joint replacement is the #1 expenditure of Medicare. In the September/October 2011 issue of AARP magazine, page 11, Johnson & Johnson touts a hip replacement by picturing a young-ish, attractive bicyclist (philanthropist) climbing a hill. IMPORTANT UNSTATED CAVEAT: The demographic for most hips is a woman in her seventies. Joint replacements are expected to function only for approximately 15 years. If a patient experiences device failure the doctor is not legally required to report the failure and there is no device warranty. FDA MedWatch does not provide a registry of post-market data nor does it systematically follow up on adverse events. The medical device industry gained pre-emption (entitlement) from state court in Supreme Court decision 2/2008 Riegel v. Medtronic placing patients in medical and legal purgatory. When devices are cleared for the U.S. market the FDA uses 510(k) process that does not require any clinical testing nor a vote by an advisory committee. Patient and Consumer Representatives on the advisory committee are not full stakeholders and are not allowed to vote.--- Sick and wrong! Public health and healthcare funding suffer for private greed.

No comments:

Post a Comment