Thanks to Jeffery, Dick, William, Jay, Moises, and Phil for their responses to our search for a paid video star. You will be contacted by the marketing team. Be sure to prepare your brokerage accounts to prove that you have made 50-plus percentage gains with your Global Investing stocks. I have too, but I am not considered to be a neutral observer for some reason.

 

There will be no newsletter tomorrow because I am attending an Oppenheimer conference on Israeli stocks at the same time as the water is being turned off both in my home and my office (which are in the same building.)

 

Our newsletter recommends GlaxoSmithKline, a UK drugmaker which has been in the new of late. GSK was formed by merger with SmithKline (of New Jersey) and many of the events described occurred in the USA.

 

According to today’s New York Times (Science Times), the dispute between Dr. Steven Nissen, the Cleveland Clinic cardiologist, and the British drugmaker Glaxo over the type 2 diabetes drug Avandia included not just competing press releases and medical journal articles casting doubt on each others’ research, but also a key May 10, 2007 meeting between executives of the drug co. and the cardiologist before his article came out.

 

The meeting was recorded (as is legal in Ohio) by Dr. Nissen, but he did not tell the Glaxo team.

 

Both sides knew more than they let on. The drug firm execs knew that their study, supposedly double-blind, would undermine Dr. Nissen’s contention in an as-yet-unpublished article in the New England Journal of Medicine that Avandia raised heart attack risks in diabetes patients. Dr. Nissen did not reveal the details of his study but the drug execs appear to have received an advance copy from the Journal, supposedly a no-no. They said they had contradictory data which they were not supposed to have because the large randomized RECORD trial was billed as being double-blind, and had not yet been handed to GSK.

 

Dr. Nissen’s conclusions were based on a statistically imprecise method called meta-analysis combining multiple trial data rather than patient level analyst. Meta-analysis without careful controls correcting for the mounting imprecision of the results, when I studied statistics in grad school, was what made you flunk the course. The margin of error goes up the more you combine different databases using different methodology. The cardiologist did not do a time-frame analysis of how long patients were on the drug before heart attacks occurred, which undermined his conclusions.

 

Yet after Dr. Nissen’s article appeared (when the NYTimes does not say), GSK’s head of research, Dr. Moncef Slaoui, in an internal emailed message, agreed with his conclusions that heart attack risks increased with Avandia. He said “the risk for ischemic events” ranges from “30 percent to 43 percent”. These are horrific numbers but the newspaper does not say when and to whom Dr. Slaoui sent this email, nor how it got a hold of it.

 

Nor does it tell us how Dr. Slaoui reached this conclusion.

 

Meanwhile, the US FDA, reacting to criticism in a new Senate report questioning the safety of Avandia, yesterday told doctors it is reviewing information on the drug but recommends that patients continue taking it.

At the same time, Rep. Rosa DeLauro (D., Conn.), chair of the House appropriations committee (controller of the FDA’s budget) called for the FDA to remove Avandia from the market until its safety and effectiveness can be evaluated. She took up the cudgels against the drug because safer alternatives exist. A rival drug, Takeda Pharma’s Actos, has been shown to lower glucose as well as Avandia while causing a lower risk of heart attacks.

 

A report published earlier (Sat.) in the New York Times based on work by the Senate Finance Committee accused Glaxo of knowing about the risk of heart attacks with Avandia, but says it hid this from the public and the FDA. The Senate report was critical of the FDA’s support of Avandia, and included studies by FDA doctors who said in 2008 the drug poses serious heart-related dangers to patients and should be pulled from market.
On Mon., FDA drug division leader Dr. Janet Woodcock said data linking Avandia to heart problems has been “inconclusive.”

 

“We have possession of no new information that raises additional alarm about the drug,” she added. However, Woodcock said some people in the FDA believe the drug should be withdrawn.

 

In a statement, Glaxo noted that a public health posting on the FDA’s Web site reading “There are no new FDA conclusions or recommendations about the use of rosiglitazone (Avandia) in the treatment of type 2 diabetes.”

 

Last June, GSK released the results of the RECORD study which, GSK said, showed that there is no serious risk of heart attack or death from Avandia. Woodcock said the agency got the results of the trial in mid-2009. She said the agency was looking at the RECORD data and would discuss it at an advisory committee meeting in July.

 

According to Dow Jones, Dr. Robert A. Vigersky, president of The Endocrine Society, questioned why the meeting wouldn’t be held until July when the agency received the data last year. “Is that by virtue of the fact that you need that amount of time to get the data analyzed?” he asked. He added, “Is there any way this could be accelerated?”

 

Woodcock responded that the FDA needs time to “look very closely” at the study because its results are “at odds” with other studies associating Avandia with heart attacks. When RECORD was released, some doctors questioned whether it was statistically adequate enough to draw conclusions. The Senate report charged that Glaxo knew since at least 2004 that RECORD was statistically “underpowered.”

 

Investing conclusions follow for paid subscribers. While I studied statistics, I never studied heart surgery. One of my daughters-in-law is attached to the Cleveland Clinic, but not in cardiology.

 

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