1. Provide the title of your story or series and the names of the journalists involved.
"Boning Up On Bone Drugs" by Katharine Davis Fishman.
2. List date(s) this work was published or aired.
June issue, MORE Magazine.
3. Provide a brief synopsis of the story or stories, including any significant findings.
I had incurred an "atypical" femur fracture after taking bisphosphonates for 13 years. The article reports on whether and when bisphosphonates are safe to take. It describes my own experience, explains osteoporosis (and osteopenia)for the lay reader and tells what bispohosphonates do to treat it, reports on the history of the drugs and their approval by the FDA, reports on studies that have been done on bisphosphonates and their risks, and in two sidebars explains the FRAX test and medicines now in the pipeline. It concludes that bisphosphonates should be used for osteoporosis, not osteopenia, unless the patient's FRAX score indicates high 10-year-risk of hip and or other osteoporotic fractures, and that if she then takes the bisphosphonates she should be checked at 3 to 5 years to determine whether she still needs it.
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
I read many studies in medical journals, as well as Merck's literature on Fosamax and material on the website of the National Osteoporosis Foundation, plus material on the FRAX test. Most significantly I read the report by an FDA statistician when the Fosamax was up for approval, questioning Merck's data on the drug's effectiveness. Since the FDA approved the drug anyway, this report was not widely known. It was an exhibit in a lawsuit against Merck by a patient who had contracted osteonecrosis of the jaw.
5. Explain types of human sources used.
I interviewed a number of leading endocrinologists and surgeons who research osteoporosis and treat patients for it. Their positions on the safety of the drugs varied: I sought different viewpoints. Neither Merck nor the FDA would allow me interviews with their researchers or officials, so I had to make do with answers supplied by the pr department. I called the lawyer for the patient suing Merck after contracting osteonecrosis of the jaw, and he gave me the exhibit number for the FDA statistician's report. I then went down to the Federal Courthouse in Manhattan, retrieved the document and copied it. I also talked to a researcher who tests drugs in the pipeline.
6. Results (if any).
My conclusion, as described above, is that while bisphosphonates prevent a lot of fractures in elderly patients with severe osteoporosis, other patients should not be taking the drugs unless they have actual osteoporosis (not osteopenia) or a high FRAX score, and if they take a drug they should be checked every three to five years to see if they still need it.
7. Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
No one has challenged this piece, and indeed the FDA recently issued a black box warning about the use of bisphosphonates. The statistician's report that I mentioned in the article has now been more widely noted. A support group of patients with the same type of bisphosphonate femur fracture wrote and thanked me, and succeeded in getting a meeting with high officials at the FDA. Then the warning was issued.
8. Advice to other journalists planning a similar story or project.
I would simply suggest that they go about it as I did, speaking to all sides and remaining skeptical, asking very thorough questions, and reading up before they do interviews so they come in fully prepared. That, of course, is what every good reporter does.