The CEO of a company that recently introduced a new and more potent opioid painkiller is blaming “false and misleading statements” – including allegations by a U.S. senator — for the continuing controversy over the drug.
“This misinformation has created negative perceptions about Zohydro ER,” wrote Roger Hawley, CEO of San Diego-based Zogenix (NASDAQ: ZGNX) in a letter to shareholders.
Extended release Zohydro is the first pure hydrocodone painkiller sold in the U.S. Unlike other hydrocodone products such as Vicodin, it does not contain acetaminophen – which can cause liver damage at high doses.
Addiction treatment experts have claimed Zohydro is 5 to 10 times more potent than Vicodin and have warned it is more likely to be abused by drug addicts because it does not come in a tamper resistant formula.
There is also controversy over the Food and Drug Administration’s decision to approve Zohydro over the objections of its staff and advisory committee, which warned Zohydro could be abused even more than currently available hydrocodone products.
“Critics of Zohydro ER have claimed that this treatment is 10 times stronger than other opioids, 10 times more ‘lethal’ than other hydrocodone prescription drugs, and that this is the strongest opioid available,” Hawley said in his letter to shareholders.
“All are gross misstatements and fail to consider each of the very different FDA-approved indications of each product and do not acknowledge that these products are used to treat a different severity of pain as reflected by their individual prescribing labels. The fact is, there are other extended-release opioids which are of higher strengths than Zohydro ER.”
Hawley also referred to another controversy over seminars conducted by two medical professors. Pharmaceutical companies paid as much as $25,000 to be at the meetings, which were attended by FDA officials involved in clinical drug trials, many of them involving prescription painkillers.
West Virginia Sen. Joe Manchin has been especially critical of the meetings.
“These allegations clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA’s decision making process,” wrote Sen. Joe Manchin, a West Virginia Democrat, in a letter last October to FDA commissioner Margaret Hamburg.
This month Sen. Manchin went even further, suggesting in a letter to Health and Human Services Secretary Kathleen Sebelius that Zohydro was approved by the FDA as a result of the meetings. He also introduced a bill in Congress to force the FDA to withdraw its approval of Zohydro.
“I am deeply troubled that the reason for Zohydro ER’s approval may be linked to allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars for the privilege to attend private meetings with FDA officials,” Sen. Manchin wrote.
“If true, we have an alarming explanation for the indefensible decision of the FDA to approve Zohydro.”
In his letter to shareholders, Hawley denied that anyone with Zogenix even attended the meetings.
“Without justification, inaccurate allegations have been made that Zogenix paid a university to arrange meetings with the FDA to secure approval of Zohydro ER,” wrote Hawley.
“The university in question has declared for the record that, in the meetings it arranged with FDA officials, no representation from Zogenix was present, nor was the company or its products ever discussed. In fact, Zogenix did not even exist as a company at the time of these meetings.”
Some pain patients who want access to Zohydro have told National Pain Report that it is Sen. Manchin who has a conflict of interest.
The senator’s daughter, Heather Bresch, is the CEO of Mylan Inc. (NASDAQ:MYL) a Pittsburgh-based pharmaceutical company that is one of the largest generic drug manufacturers in the world. One of Mylan’s top-selling drugs is a hydrocodone product containing acetaminophen.
Campaign records show that political action committees or individuals associated with Mylan have donated $127,000 to Manchin in the last five years — making Mylan the senator’s second largest corporate contributor.
“It’s obvious to anyone there is an agenda behind this,” wrote one pain patient who asked not to be identified. “(Manchin’s bill) is poorly written and contains outrageous claims. No senator would want to be associated with this bill, with his connections to Mylan so obvious.”
The husband of a woman who suffers from chronic back pain also questioned Manchin’s motives for opposing Zohydro.
“I have been outraged at the actions of a few, particularly Senator Manchin, who appears obsessed with derailing this new choice,” he wrote in an email to National Pain Report.
“But it was when I saw the connection between him, his daughter, Mylan, and significant (6 figure) campaign donations from his daughters company, well, that was too much. It would appear clear his effort is to remove a competitor in the guise of saving an abuser. “
Repeated calls and emails to Sen. Manchin’s office for comment were not returned.
Mylan’s corporate communications office also did not respond to National Pain Report’s requests for an interview with Heather Bresch.
Sen. Manchin has been sharply critical of other FDA actions related to painkillers – not just Zohydro. He has been a vocal supporter of reclassifying all hydrocodone products as Schedule II controlled substances, which would make them harder to obtain. Last month, the Drug Enforcement Administration published in the Federal Register a formal proposal to reschedule hydrocodone combination products from Schedule III to Schedule II.
Rescheduling would affect dozens of pain medications, including Vicodin, Lortab, Norco, and the generic hydrocodone produced by Mylan. Zohydro is already classified as a Schedule II drug.