On October 6, Dr. Fugh-Berman was quoted in Review of Ophthalmology's article "Can Continuing Medical Education Be Saved?", regarding subtle marketing in industry-funded Continued Medical Education (CME). "'Can doctors pick up on overt advertising of a drug? Sure. But you’re never going to see overt advertising in a CME,' she says. For example, CME may suddenly be inundated with programs about a newly discovered system, such as the endocannabinoid system. 'Well, of course that was meant to prepare the market, for—surprise—an endocannabinoid drug.'"
On October 14, Margaret A. Winker, MD, Senior Research Editor for PLOS Medicine, reflected on the 2010 Policy Forum by Adriane Fugh-Berman that explored the ghostwriting behind menopausal hormone therapy (HT). She wrote, "[Dr. Fugh-Berman's] revelations of Wyeth’s promotion of HT, culled from a collection of documents obtained from litigation brought by more than 14,000 plaintiffs who developed breast cancer while taking Prempro and made public when PLOS Medicine and the New York Times intervened in the litigation, were remarkable for their breadth and impact, shocking even the most cynical reader."
On October 16, Dr. Fugh-Berman was quoted at length in the Washington Business Journalarticle "MedStar hospitals received more than $1 million from drug companies in 2013". She discussed how industry influences physician education through conferences and grand rounds, and "it ends up distorting the medical information that's out there," Fugh-Berman said. "Doctors don't realize how restricted the information stream is."
An October 20 WebMD article "Why Aren’t There Sex Drugs for Women?" linked to PharmedOut's "Don't Need Drugs To Score" fact sheet from last month.
Flibaserin's "Even The Score" campaign struck again with its "The Score is 26-0" flyer, supposedly describing the number of sexual dysfunction drugs approved for men versus women. As we've discussed, no drugs are actually approved to treat low libido in men or women, so we responded with another fact sheet called "The Score is 0-0".
On October 23, PharmaGuy John Mack linked to PharmedOut's fact sheet in his flibanserin coverage on Pharma Marketing Blog.
On October 27 and 28, PharmedOut Project Manager Alessandra Hirsch and volunteer staffperson Rebecca Holliman testified at the FDA's Patient-Focused Drug Development Meeting on Female Sexual Dysfunction.
They shared their concerns about Sprout Pharmaceuticals' "Even The Score" campaign for flibanserin from a young woman's perspective. They spoke about the many factors that affect libido, and how flibanserin "inherently implies that a woman who isn’t in the mood has something clinically wrong with her," Hirsch said, and asked, "do I lose the right to say no because there is a pill to 'fix me'?" Holliman noted that "a pill or device in a market with no infrastructure to educate women about the non-medical components of arousal is dangerously open to abuse."
PharmedOut's Resource of the Month: We break down everything you need to know about generic drugs in this "Fast Facts" sheet.
November's PharmedOut Fodder: Standards For FDA Drug Approval
In late October, John Fauber and Elbert Chu wrote an important article on how the FDA approves cancer drugs. Basically, a drug may be approved if a clinical trial shows success with surrogate markers (i.e. tumor shrinkage) even if clinical endpoints (i.e. surviving cancer, or a better quality of life) show no benefit.
In the 1990s, pharmaceutical companies pushed the federal government to get drugs approved more quickly. Silvana Martino MD, who is director of the Angeles Clinic and Research Institute and has served on FDA cancer drug advisory committees, is quoted in the article: "If you are a drug company, what is your goal? It is to provide sufficient data to get your drug approved. You will aim for whatever that least amount is. I think the bar is too low." She speaks to the pressure put on FDA to "make potentially beneficial therapies available as soon as reasonably possible," even if shortcuts are taken. "You don't have deep, solid studies that prove a point," she said. Fauber and Chu found that only three of 26 cancer drugs approved based on surrogate markers between 2004 and 2011 increase survival, and the benefits of successful drugs were modest.
60 Minutes also touched on this topic with their October 5th segment, "The Cost of Cancer Drugs", which focused on the $11,000/month price tag of Zaltrap (ziv-aflibercept), a colon cancer drug approved in 2012. Leonard Saltz MD at Memorial Sloan Kettering Cancer Center wanted to know if Zaltrap was really better than other treatments, and compared its clinical trial results to those of $5,000/month cancer drug Avastin (bevacizumab). Both drugs extended median survival by 42 days.
FDA requires all cancer drugs to yield better results than placebos and indicate progress on surrogate markers. But is that enough? Surely expensive cancer drugs should have to save more lives than placebos to be approved. We think these examples stress the need for comparative effectiveness research (CER), pitting drugs against each other and not just placebos to find the best treatment.
The Institute of Medicine, the Dartmouth Institute for Health Policy and Clinical Practice, The Agency for Healthcare Research and Quality, and the New England Comparative Effectiveness Public Advisory Council are working to make CER a greater part of our health care system. For now, barriers still exist, as Pharma is the biggest lobbyist in the country. Also, because of the Prescription Fee User Drug Act (PDUFA), FDA relies on industry for drug approval application fees.
Oncologists at Memorial Sloan Kettering rejected Zaltrap due to its unconscionable price, and its manufacturer quickly issued a discount. Perhaps this kind of physician activism, directed at industry and the FDA, could raise approval standards and make healthcare costs worthwhile.