How Safe Are Your Medications... Really?

On January 31^st, Pfizer Inc. announced a recall of one million packets of birth control pills due to a packaging error that could raise the risk of an accidental pregnancy, by leaving women who take them without an adequate dose. The problem affects 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets. Both are manufactured by Pfizer, and are marketed in the U.S. by Akrimax Rx Products, under the Akimax Pharmaceuticals brand. Pfizer determined that some packets had too many active tablets, and others too few. Oral birth control pills work on a series of 21 hormone active tablets, and 7 inactive sugar pills, to regulate the menstrual period while providing contraception. The risk of unwanted pregnancy depends upon how many active tablets are missed. One day is not critical. But, the more days missed, the higher the risk. These particular tablets are not among the top one or two sellers; but, a local pharmacist reported that birth control packages, overall, comprise roughly 25% of all prescription sales. Nationally, about 38.9 million prescriptions are filled every six months, or about 78.6 million annually.

Pfizer learned that the problem was caused by both mechanical and visual inspection failures on the packaging line, which have since been corrected. The tablet packages have expiration dates between July 31, 2013, and March 31, 2014. They were released nationwide, to warehouses, clinics and retail pharmacies. Anyone who has the affected drugs should return them for exchange replacement promptly. The recall was not required by the U.S. Food and Drug Administration, (FDA); but was done voluntarily, with its approval. Which raises two interesting questions: What exactly does the FDA do? And, how safe are the medications we take...really?

In the 19^th Century, the contents of food and drugs sold in America were whatever the makers and sellers of them wanted to throw in. It was widely reported that Coca-Cola got its name from small amounts of cocaine in each batch. Opium was the principal ingredient in Laudanum, a widely used and popular tonic sold by the bottle, for "nerves". Patent medicines for every conceivable ailment were sold by druggists, in stores, and by travelling medicine shows. Many contained raw alcohol, petroleum derivatives, mercury, arsenic, and a vast array of other unsavory ingredients. And, of course, there was no oversight, no regulation and no requirements for content disclosure. Whatever sold was there to buy. Finally, in 1906, Congress passed the Pure Foods and Drugs Act, which culminated the efforts of about 100 bills that had been introduced over a quarter of a century, to rein in the appalling abuses that were so common place. The driving force behind that was Harvey Washington Wiley, then the chief chemist of the Bureau of Chemistry, then a part of the U.S. Department of Agriculture, the FDA's predecessor. Interestingly, the Department of Agriculture was created in 1862, not to insure safe food stuffs, but to increase food production during the Civil War.

The Act prohibited the interstate sale of mislabeled or adulterated food or drug products. However, there was no enforcement arm to insure compliance with the Act's mandate until the Food and Drug Administration was created in 1930. Even then, the FDA had scant authority to actually compel safer products. That had to await catastrophe, which came in 1961, with the horrifying revelation that Thalidomide had caused between 10,000-20,000 grotesque birth deformities. When what was considered the worst medical disaster in modern history came fully to light, the nation was outraged. Under a wave of public pressure, Congress passed, in 1962, the Kefauver-Harris Drug Amendments, which finally granted the FDA oversight authority over pharmaceutical manufacture. For the first time in American history, drug makers had to prove any drug was safe before it could be marketed to the public. Under its present authority, the FDA monitors the manufacture and sale of a rather large range of products, including safety of the national blood supply, cosmetic safety and labeling, the approval of both over-the-counter and pharmaceutical drugs, the labeling and safety of all food products and bottled water, (except meat and poultry), all medical devices for humans, all radiation-emitting electronic products, and even veterinary feeds, pet foods and veterinary drugs and devices.

Even so, herbal remedies, and vitamins and food supplements, both billion dollar industries, remain outside of FDA jurisdiction; and drug related problems constantly crop up. And, surprisingly, when these problems surface, the FDA cannot mandate recalls. That has to be the choice of manufacturers, who bluntly fear public indignation and ferocious lawsuits far more that regulatory action. How often do these recalls occur? The numbers are shocking. In 2006, there were 384; in 2007, there were 391 more. In 2008 that number jumped to 426; and in 2009, it skyrocketed to a staggering 1,742. In 2010, through June, the latest figures available, the number was "just" 296. And these numbers do not just include fringe manufacturers. Huge industry players like Johnson & Johnson, Pfizer, McNeil Consumer Healthcare, and others have had problems.

These numbers really call into question the efficacy of safety in the entire pharmaceutical industry. Analysts suggest several emerging problems, including the rapid proliferation of generic makers; the obtaining of chemical components from un-regulated or under-regulated sources, especially China; and, cost saving measures that compromise inspection, manufacture, labeling and product purity, and which can even lead to outright contamination. Generic manufacture seems to be a big area of concern because as many leading brand name drug patents expire, there is a rush to grab a piece of generic market-share, which accounts for about 75% of all drug sales. When speed of product availability is the primary goal, especially with a low generic mark-up, makers just don't spend enough time and money figuring out how to make the drug properly. Also, bulk sales to major buyers like hospital chains, and the breaking of those sales into smaller units for actual distribution frequently lead to serious mislabeling problems.

In the face of these mounting difficulties, there have recently been bills introduced into Congress to give the FDA far broader powers. But, with pharmaceutical manufacturers among the most profitable, powerful and best lobbied of the nation's major corporations, and with hundreds of billions of dollars in annual sales at risk, don't bet the farm on any quick fixes. The first regulatory act, weak as it was, took twenty-five years to pass; it took another twenty-four to create the FDA; and thirty-two more before it had any teeth. Therefore, the much-maligned trial lawyers appear, in the short run, to be the only finger in the dyke. Hopefully, it won't take another Thalidomide disaster to bring sanity back to our national health.