Cynthia Toussaint is a passionate advocate for pain patients and the face of a small nonprofit – For Grace – that is sponsoring a bill in the California Legislature that would limit health insurers' ability to steer patients to low-cost or generic medicines before approving stronger, more costly remedies.
Toussaint has testified twice before legislative committees about the devastation such policies, known as "fail first" or step therapy, can cause patients who need quick relief. “Fail first is good business for insurance companies because it is lining their pockets,” Toussaint told the Assembly Health Committee in 2010.
But in an interview with California Watch, Toussaint acknowledged that the battle is not just patients fighting big insurers. She said seven or eight drug or device companies have given her small nonprofit $30,000. The group has sponsored three bills that would limit fail-first policies, including this year's AB 369, which is being carried by Assemblyman Jared Huffman, D-San Rafael.
Records show that even though pharmaceutical firms are not listed as formal supporters of the latest bill to limit fail-first policies, Pfizer and Purdue Pharma, both of which make pain pills, have lobbied on it.
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“I think it would be nice if it was more out in the open,” Toussaint said of drug and device makers’ support for the bill. “Everyone has their interest. I think (pharmaceutical firms) want to build a path for different reasons than I want to build a path. For me, that’s an unusual place to be. I got involved because of the patients.”
Toussaint said she has eschewed Western medicine in treating her disease, complex regional pain syndrome, favoring swimming and Pilates for relief. While she mentioned Pfizer’s pain drug, Celebrex, as a remedy limited by fail-first policies in an opinion article, she said she hasn’t taken the drug.
A 2012 Pfizer disclosure report [PDF] says it spent $3,000 supporting For Grace. The nonprofit's website also lists Boston Scientific as a sponsor and links to a website describing its pain-blocking spinal cord stimulation device.
“I learned that they wanted (the anti-fail-first bill) to pass, and it made sense to me,” Toussaint said. “Their medications are going to be sold more. … I would like to abolish fail first. It’s for a different reason, but I don’t care. If anyone wants it to pass, I’m on their side.”
Pfizer spokeswoman Sharon Castillo said in a statement yesterday that the company's support of the bill "is rooted in the Company’s mission to advocate for policies at the state and federal level that improve patients’ access to medicines."
"We believe this bill is instrumental in doing just that, as well as empowering doctors and patients to have more control of health decisions," the statement says.
Major health insurers oppose the bill.
Nick Louizos, a lobbyist for the California Association of Health Plans, which represents insurers covering 21 million Californians, said in a letter to lawmakers that fail-first policies start patients “with a safer, more established drug regimen before progressing to other drug therapies that may result in harmful side effects or are more costly to the consumer.”
The group’s spokeswoman, Nicole Kasabian Evans, said given the escalating problems with drug addiction and overdose deaths related to opioid painkillers, step therapy programs “provide important patient safety” protections.
The nonprofit group Fail First Hurts is supporting laws against such policies in several states. Organization supporters include drugmakers Pfizer, Bristol-Myers Squibb and Amgen, according to its website.
Dr. Scott Fishman, chief of pain medicine for the UC Davis Health System, also testified before California lawmakers against step therapy protocols during two legislative hearings.
The U.S. Senate Finance Committee is looking at Fishman and the group he led, the American Pain Foundation, in a probe of the marketing of opioid pain medications. Senators are examining whether leading speakers and authors on pain treatment overstated benefits and underestimated risks of opioid painkillers, which are linked with mounting cases of addiction and overdose. Fishman has described his views on doctor-industry relationships in response to a ProPublica article about his advocacy.
While the Senate probe does not aim at the push to limit fail-first policies, one nonpartisan California group took a close look at their merits.
The California Health Benefits Review Program, which was established to examine proposed insurance mandates, reached no clear conclusion. The group found that insurers’ fail-first policies vary widely, even within the same insurance company. It found that the policies have no clear effect on any class of drugs, nor does any research reach clear conclusions on the effects of step therapy in the treatment of pain.
Doctors also are taking a side in the debate. The California Medical Association, which represents about 35,000 physicians, supports Huffman’s bill and favors limits on fail-first protocols.
In a letter to lawmakers, the doctors group says health insurer “tactics” can sully the doctor-patient relationship and result in treatment that’s not in the patient’s best interest.
“This process damages the doctor-patient relationship and can set back a patient years in their therapy,” states to a letter by Juan Thomas, a lobbyist for the medical association. The California Nurses Association also supports the bill.