FDA: no "clear connection" between Fosamax and hip fractures

The drug Fosamax (alendronate) and other oral bisphosponates are widely prescribed as a treatment for osteoporosis - and as a preventive measure.  Ironically jaw bone damage is a now-recognized complication.  Recent reports  have suggested that it may increase the rate of serious hip fractures.  The FDA is not yet ready to jump on that bandwagon.  It reports in an advisory HERE that "At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. "

DOJ's RICO Win Against Tobacco

The Justice Department has won a big victory in the U.S. Court of Appeals for the D. C. Circuit. In U.S.A. v. Philip Morris et al. the court opinion upheld the 1,742 page opinion by District Judge Gladys Kessler finding the defendant tobacco companies liable under the federal Racketeer Influenced and Corrupt Organizations Act. (RICO) Some modifications were made regarding remedies.

The manufacturers and the Tobacco Council appealed from a judgment that they are "liable for conducting the affairs of their joint enterprise through a pattern of mail and wire fraud in a scheme to deceive American consumers." As Judge Jed Rakoff once remarked of Federal prosecutors mail fraud is "our Stradivarius". It was played well here but one would pick up a 1,742 page set of findings of fact about as slowly as one would a Stradivarius.

Fortunately there is an alternative. The findings have been extracted and aesthe他ically presented by Mike Freiberg, et al. It is a product of William Mitchell Law School's Tobacco Control Legal Consortium: The Verdict Is In: Findings from United States v. Philip Morris, The Hazards of Smoking (2006). It is available here from SSRN.

The headline is the conclusion:

4034. The foregoing Findings of Fact demonstrate that, over the course of approximately fifty years, different Defendants, at different times, took the following actions in order to maintain their public positions on smoking and disease-related issues, nicotine addiction, nicotine manipulation, and low tar cigarettes, in order to protect themselves from smoking and health related claims in litigation, and in order to avoid regulation which they viewed as harmful: they suppressed, concealed, and terminated scientific research; they destroyed documents including scientific reports and studies; and they repeatedly and intentionally improperly asserted the attorney-client and work product privileges over many thousands of documents (not just pages) to thwart disclosure to plaintiffs in smoking and health related litigation and to federal regulatory agencies, and to shield those documents from the harsh light of day.

Of particular note is that although the Justice Department attorneys attacked the role of tobacco defense attorneys (Shook Hardy, et al. prominent among them) (see decade-old reports here and here) the lawyers and law firms were not made defendants. Nor were ethics complaints ever filed against them. Statute of limitations presumably bar action at this point, leaving the story to historians' inquiry.

The decision upholding the findings should provide support for HR 1256 - a bill to bring tobacco marketing within the jurisdiction of the FDA, a Clinton Administration regulatory effort derailed by the Supreme Court in FDA v. Brown & Williamson (2000).