Newer doesn’t mean safer and better

The guiding principle of new pharmaceuticals among careful physicians is to not jump on the newest, latest drug. That’s because many times they are no better than older, known drugs. The newer ones are also typically more expensive. “The great majority of ‘new’ drugs are not new at all but merely variations of older drugs already on the market,” said Dr. Marcia Angel, former Editor-in-Chief of The New England Journal of Medicine and author of The Truth About the Drug Companies. By changing one molecule in a top-selling drug just as a patent is about to expire, the pharmaceutical company can get another twenty years of patent rights and sales.

Of the seventy-eight drugs approved by the FDA in 2002, only seventeen contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market....The me-too business is made possible by the fact that the FDA usually approves a drug only if it is better than a placebo. It needn't be better than an older drug already on the market to treat the same condition; in fact, it may be worse.

And for drugs that have innovative compounds, it can take several years on the market, with the drugs given in real life settings on people of all types, for the full side effects and dangers to come to light.

Michael Lascelles’ entry at PharmaWatch is a valuable cautionary note about jumping on early drug promotions. Pfizer’s newest cholesterol lowering drug torcetrapib, which they touted as the next “would-be blockbuster,” was found to raise blood pressure as much as 15 mmHg! Diabetics appear at special risk. The amount of the blood pressure increase has been estimated to increase stroke mortality by 20% and heart disease by 12%. The American Heart Association actually pulled their latest research from this week’s AHA meeting and rejected their study, which is saying a lot since Pfizer is one of their sponsors.