It appears President Obama’s nomination for FDA chief is meeting resistance from his own party’s senators. Sen. Edward J. Markey (D-Mass), Bernie Sanders (D-VT) and Joe Manchin (D-WV) have come forward expressing their concerns over nominee Dr. Robert Califf. Both Markey and Sanders have placed “holds” on President Obama’s choice and Manchin is threatening to filibuster. Sen. Lisa Murkowski (R-AK) may join the resistance, though her reasons have more to do with GMO salmon than Califf’s deep ties to Big Pharma.
It appears President Obama’s nomination for FDA chief is meeting resistance from his own party’s senators. Sen. Edward J. Markey (D-Mass), Bernie Sanders (D-VT) and Joe Manchin (D-WV) have come forward expressing their concerns over nominee Dr. Robert Califf. Both Markey and Sanders have placed “holds” on President Obama’s choice and Manchin is threatening to filibuster. Sen. Lisa Murkowski (R-AK) may join the resistance, though her reasons have more to do with GMO salmon than Califf’s deep ties to Big Pharma.
“Holds” are procedural tools whereby a senator can stop an issue from reaching a vote in the full Senate.
Markey, Manchin and Sanders all want roughly the same thing before dropping their objections to Califf’s confirmation: FDA reform regarding the approval process for opioid painkillers. All three senators hail from states with huge recreational opioid abuse problems.
Markey is of the opinion that all opioid approvals should be reviewed by an FDA advisory committee and that the committee needs to consider addiction and abuse risks. The senator also wants the agency to remove its approval of OxyContin, a powerful narcotic painkiller, for pediatric use and wants an advisory panel to lead that effort.
Markey issued the following statement: “Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment.”
Manchin’s stance is related, but also brings up an issue on several people’s minds: Dr. Robert Califf’s “strong ties” to Big Pharma are entirely inappropriate and unacceptable for the head of the Food and Drug Administration. Manchin issued a statement in which he cited Califf’s 2014 financial disclosure as a clinical researcher at Duke University’s School of Medicine. The disclosure showed the receipt of consulting fees from a half-dozen Big Pharma players. It also listed Califf’s receipt of salary supporting drug maker grants.
Manchin opted not to use the “hold,” however. Instead, the senator intends to filibuster, during which time he will read letters from his constituents who have been affected by opioid abuse. Though there are exceptions to the “all-night oratory” popularized in fiction, actual filibusters rarely go that far.
In Manchin’s opinion, the FDA needs an unbiased leader who can help the agency respond to a growing problem with prescription drug overdoses and heroin use. “With his long-term, significant ties to the pharmaceutical industry, Dr. Califf is not the champion the FDA needs to tackle this deadly epidemic,” Manchin said.
It’s a very real problem, too. Deaths in the U.S. from drug overdoses hit record numbers in 2014 at 47,055. Opioid-related deaths have increased an alarming 200% since 2000. According to the CDC, this was driven by prescription painkiller and heroin abuse. The Center also found that overdoses are a major contributor to the increasing death rates of middle-aged white Americans. The heroin connection stems from people turning to often-cheaper heroin as a substitute for prescriptions such as hydrocodone.
A Department of Health and Human Services (HHS) representative said the opioid crisis is a “top priority.” HHS oversees the FDA and plans to contact Manchin about his concerns, though HHS still supports Califf. According to spokesperson Kevin Griffis, “Work at FDA and across HHS will continue on this important effort.”
Griffis also said, “Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new lifesaving therapies to the market, and we would like to see him confirmed as quickly as possible.”
One wonders which Big Pharma overlord issued that particular request. Judging by the ever-increasing speed with which new drugs and medical devices hit the market – and the ever-increasing rate of injuries associated with them – it’s hard to believe that the FDA is really doing its job.
Who Is Dr. Robert Califf?
The man who has senators throwing holds and filibuster threats is a cardiologist and researcher who has already been working at the FDA. Califf joined the agency roughly a year ago as a deputy commissioner. His has also held senior positions at Duke and founded a huge research center there. The center got over half of its considerable funding from Big Pharma.
Insiders believe that Califf will be approved despite his deep ties to the industry he would be in charge of regulating. The position of FDA commissioner has been open since February 2015 when Dr. Margaret Hamburg resigned.
One cannot deny that Califf’s accomplishments are impressive. He’s published over 1,200 papers and has spearheaded several large, company-funded clinical trials. He also has a strong interest in streamlining the clinical trial process, which would get new drugs on the shelves even faster than they show up now. This alone should keep people up at night.
Califf’s current position with the agency is the deputy commissioner for tobacco and medical products.
His financial disclosures read like a “Who’s Who” of Big Pharma:
- Amgen, Inc. (Neulasta & Enbrel)
- Bayer Healthcare LLC (Essure)
- Bristol-Myers Squibb (Orencia & Plavix)
- Eli Lilly and Co. (Cialis)
- Janssen Research & Development LLC (Duragesic/Fentanil narcotic painkillers)
- Merck & Co., Inc. (Gardasil HPV vaccine)
- Novartis AG (Ritalin)
- Roche AG (Bactrim, Boniva)
The HHS said that Califf donated all of his consulting fees to charity. However, one cannot donate travel, meals and lodging in the thousands of dollars. Califf’s institute at Duke gets about $320M annual funding with 63% of projects funded by Big Pharma and other medical companies.
Dr. Michael Carome, head of Washington-based advocacy group Public Citizen’s Health Research Group, said, “Now we’re asking him, after working for the pharmaceutical industry and medical device industry for decades, to lead the agency that regulates it – it’s impossible for him to shed those relationships and step into that role. There are people who have an in-depth understanding of clinical trials and industries the FDA regulates who have far less ties to them than Dr. Califf has accumulated.”
Califf defends his record and describes himself as a “staunch” advocate for patient safety.
Manchin isn’t quite impressed. The senator’s statement also mentioned Califf’s past work with Faculty Connection LLC, a North Carolina-based consultancy that “guides drug makers on product development and approval.”
Manchin said, “Dr. Califf’s past involvement [with drug makers] will have an impact on his effectiveness and leadership capabilities, and I cannot, in good conscience, allow his confirmation.”
Dr. Stephen Ostroff has been serving as the acting FDA commissioner since Dr. Hamburg resigned. The position of acting commissioner does not require Senate confirmation. If Califf’s chances at confirmation dwindle, the White House could make him the new acting commissioner, though no such plans have been announced.
The opportunities for clichés are as great as the objections to Califf’s nomination: putting the fox in charge of the hen house, “One cannot serve two masters…” the list goes on. Suffice to say, this is one of the more mind-boggling presidential appointments I’ve seen.
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