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We’ve discussed FDA barriers to clozapine and side effects of all antipsychotics. Tonight we’ll zero in on Risperdal its producer, Johnson and Johnson, and the FDA.

First, we’d like to say that for those listeners who are benefitting from Risperdal, the best antipsychotic is one that’s working for you. We’ll be talking about people for whom it’s not working so well.

Our guest for this discussion is Gardiner Harris, author of the NYT bestselling book “No More Tears: The Dark Secrets of Johnson and Johnson.” Mr. Harris, a Yale graduate, is a freelance investigative journalist who was previously an reporter for the WSJ and NYT covering public health and the pharmaceutical industry.

Most book chapters are exposes of trusted Johnson and Johnson products, from Baby Powder to cancer drugs, and are getting media attention, but we shine a light on the section about Risperdal.

Questions:

1. First let’s talk about Risperdal benefit. Tell us about efficacy studies, including the CATIE trial and what they showed about Risperdal. (Dr. Jeffrey Lieberman of Columbia University who led CATIE was a recent guest).
2. How do atypicals compare in price to older drugs like Haldol?
3. What role did J& J and the FDA play in selling them to cash-strapped states?
4. What are state budget trade-offs?
5. What role did NAMI play?
6. In this podcast, we mostly focus on adults with schizophrenia and psychosis-spectrum illnesses, but briefly, what was the off-label market (seniors and kids) for Risperdal and why did it take over sales?
7. What role did psychiatrists play?
8. Please talk about gynecomastia. (breasts, lactation)
9. How did whistleblowers and lawyers help to change J & J practices? Why were no executives convicted?
10. Do you have advice for consumers who seek the best medication for themselves or their loved ones?

Links:

book: https://www.amazon.com/No-More-Tears-Secrets-Johnson/dp/0593229878/ref=tmm_pap_swatch_0

author: https://gardinerharris.com/

CMS website/Physicians Payment Sunshine act:

https://openpaymentsdata.cms.gov/

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Randye Kaye
Mindy Greiling
Miriam (Mimi) Feldman