Pot, meet kettle

I’ve just come across what may be the most astonishing comment I’ve ever seen in defense of a drug company. I have read and reread this comment, and I still find it hard to believe.

From the mouths of litigators

Bayer, the German based pharmaceutical giant, is being sued by more than 10,000 patients who have reported serious health problems as the result of taking Bayer’s cholesterol lowering drug called Baycol (which was taken off the market in 2001). Some of those lawsuits have been brought by families of patients who have died from kidney failure caused by Baycol.

Bayer representatives deny the allegations that Baycol has caused death and permanent health damage. Nevertheless, the company has already settled almost half of the cases, with some payouts reportedly up to $1.2 million.

But not all of the lawsuits have been settled out of court, and the first of them to reach the litigation stage began its trial two weeks ago in Corpus Christi, Texas. And that’s where we hear the comment that stopped me in my tracks, straight from one of the attorneys for Bayer.

According to the New York Times, he stated that Baycol was taken off the market because physicians had not been prescribing the drug as directed.

Amazing, but true. That’s the best defense the Bayor legal team could come up with. They actually want us to believe that Baycol is not to blame for those deaths and for hundreds of patients who will spend the rest of their lives receiving dialysis treatments. In fact, (as the statement implies) Baycol might still be on the market if only doctors could be trusted to read the label and correctly prescribe the drug. It’s not Baycol’s fault – it’s all those negligent doctors! (They must have missed the presentation (given over a $1,500 dinner or a free round of golf) on the proper way to prescribe the drug.)

But even if there was some misunderstanding on the part of physicians, Bayer executives were apparently well aware that their product was more dangerous than other statin drugs throughout the entire period Baycol was available. Let’s have a look.

Telling timeline

The statin drug market is huge – one of the largest moneymakers for international drug companies. In the year it was taken off the market, Bayer had projected $600 million in annual sales of Baycol. There was just one problem. Baycol created a dangerous side effect called rhabdomyolysis (known more simply as rhabdo), which causes muscle cells to deteriorate and enter the blood stream. Muscle weakness and pain are the obvious symptoms, with the most serious cases leading to kidney failure, paralysis and death.

A quick timeline of the life of Baycol reveals just about everything you need to know about how the dangers of this drug were balanced against its market value:

June 26, 1997 – Baycol approved by the FDA.
June 27, 1997 – “Simple and safe no longer appears to be a viable marketing platform,” states an executive of a Bayer marketing partner in a memo in which he expresses concerns that Baycol is known to cause adverse drug interactions that, “could be magnified at higher doses.”
Early 1998 – Bayer begins marketing Baycol.
Summer 1998 – Doctors begin reporting serious side effects with Baycol usage.
May 1999 – The FDA approves a stronger dosage of Baycol.
October 1999 – The FDA warns Bayer that sales materials of Baycol are “false, lacking in fair balance or otherwise misleading.”
July 2000 – The FDA approves yet another higher dosage of Baycol
November 2000 – An analysis by Bayer shows that Baycol users have 5 to 10 times greater chance of developing rhabdo than those using other statin drugs.
July 2001 – Having received increasing reports of deaths attributed to Baycol use, the FDA expresses concerns to Bayer executives.
August 2001 – Bayer removes Baycol from the market.

All of this information was revealed as the Corpus Christi trial got underway and Bayer company memos were made public for the first time.

The tradeoff

As I’ve mentioned many times in previous e-Alerts (most recently in “Rolling Back the Red” 11/25/02) the mainstream medical establishment has done a wonderful job of selling the idea that lower cholesterol levels are the end-all and be-all of cardiovascular health. Unfortunately, that fact simply isn’t true. But that doesn’t stop people from continuing to risk the side effects of statin drugs in order to get that dreaded LDL level down. And it certainly doesn’t stop the drug companies from continuing to look for cholesterol-lowering stars.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

Sources:
“Papers Indicate Bayer Knew of Dangers of Cholesterol Drug” Melody Peterson and Alex Berenson, The New York Times, 2/22/03
“Bayer: Cannot Forecast Litigation Outcome” Sitaraman Shankar, Reuters, 2/26/03
“Investors Dropping Bayer’s Stock for Fear of Baycol Lawsuits” Mark Landler, The New York Times, 2/27/03