當然,這也不能都怪 FDA了...
和法律不是萬能一樣,政府也不是萬能的。
一句名言:" It 』 s not about what you did, it 』 s about what you can prove."
一個新葯要上市,必得證明1)有療效,2)副作用小。
FDA 的正常批准程序是要求藥廠提供兩個正面的測試報告。這裡面的可操作空間就很大。
有規定,FDA請的鑒定專家,不得與藥廠有連帶的經濟利益。但是藥廠神通廣大,令FDA對某些專家,放棄(waiver)了這一規定。
螳螂捕蟬,黃雀在後。
如果說病人是蟬,醫生,專家,政府官員是螳螂,那拿大頭的是藥廠就是黃雀了:
(too long to list them all)
......
Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.
Ben Hansen, a member of the Michigan Department of Community Health Recipient Rights Advisory Committee, has been investigating the atypical makers' involvement in the Medicaid programs in Michigan and other states and says that none of the states with CNS contracts require prior authorization for the atypical drugs.
Mr Hansen published some of the results of his investigation in the Spring 2007 Newsletter of the International Center for the Study of Psychiatry and Psychology. By using the FOIA, Mr Hansen says he has obtained nearly a thousand pages of documents which show that Medicaid is being "milked like a huge cash cow."
According to Allen Jones, a former Medicaid fraud investigator, the long list of corporate sponsors for CNS includes: AstraZeneca, Janssen, Bristol-Myers, Pfizer, Lilly and Glaxo.
Back in 2002, Mr Jones found that Janssen was using CNS to funnel payments to state officials who controlled the Medicaid preferred drug lists in Pennsylvania to ensure that Risperdal would be on the list.
For his part, the leader of the Minnesota CNS program, Dr Adson, was paid $5,200 by AstraZeneca, Glaxo shows $331,947 going to him, and Pfizer gave him $1,000, in 2004 alone.
Also, in 2006, Dr Adson received $83,325 from AstraZeneca and roughly $6,100 from Bristol-Myers, according to a compilation of disclosure forms by the Pioneer Press and the watchdog group Public Citizen.