Baycol calls for an Asprin
The withdrawal of Bayer's Lipobay/Baycol amid safety concerns casts a shadow over the largest drugs class in one of the biggest and fastest-growing categories - anticholesterol treatments. Statins, including Baycol, notched up $13.5bn sales last year. But Baycol's high incidence of side effects — particularly in conjunction with gemfibrozil, Pfizer's cholesterol treatment — seems to set it apart from other statins. Baycol's forecast $1bn share of the market this year – 8% – is now up for grabs. If rivals picked up those sales in proportion to their US market shares, Pfizer's Lipitor would gain about $450m-$500m, Merck's Zocor would pick up $200m and Bristol-Myers Squibb's Pravachol about $100m1. More about the statins next month, when our scientific consultant reviews the market.
Unfortunately the withdrawal of Baycol comes in the midst of what are already difficult trading conditions. And this is where a product pipeline is important. In Bayer's case there are some promising products: vardenafil, a drug to treat erectile dysfunction, which is due on the market in 2002, along with a new antibiotic and two cancer drugs which could be launched within two to three years. Bayer's website says that for the medium term there are 42 products in the pipeline, of which 18 are in clinical trials. But they cannot compensate for the loss of Baycol.
In a press conference Manfred Schneider, Bayer's chief executive said, 'There can be no doubt that the withdrawal of …Baycol is an exceptionally serious and negative occurrence. The decision to take the product off the market has far-reaching economic consequences for our company, but in the interest of patient safety and health we were left with no choice.'
And that is just the point. The pharmaceutical industry is heavily regulated, but when there are possible side-effects, the results are often tragic, and expensive. We cannot be too careful.
But all is not necessarily lost for drugs consigned to the pharmaceutical scrap-heap. Some side-effects can be positive. For instance when minoxidil, launched several years ago as a treatment for high blood pressure, was given to men, it was noticed that they were growing excessive hair, including in places – the tops of their heads – where they hadn't had hair for some time. It is now available otc. Some other drugs seem to come back from the dead. Over 40 years ago, thalidomide was launched to combat morning sickness in pregnancy, with disastrous results. However, more recently, the drug has made a comeback as a treatment for leprosy and severe AIDS-related mouth ulcers. Seemingly, there is a market for everything, it is just a case of finding the right one.