In the health arena, the three most important developments of the last 100 years are disinfection, microsurgery, and pharmaceuticals.
The first two continue to deliver benefits to the ill and injured. The third, pharmaceuticals, produces some spectacularly effective results. Think Advair Diskus, without which some asthma sufferers would have died, or Synthroid, the synthetic thyroid hormone that has allowed hypothyroid victims to live more or less normal lives.
If that isn’t convincing, think of the lives both Amoxicillin and Azithromycin – powerful, broad-spectrum antibiotics – have saved. Or Metformin, one of the oldest diabetes drugs on the marketplace, and still one of the best blood sugar regulators available. Metformin is also used to treat polycystic ovary syndrome, or PCOS, and may in future be used to treat the symptoms of aging like heart disease, senility, and cancer. It may even be used to extend the human life span to 120 years!
Infamous Recalls: And Then There Was Thalidomide
German pharmaceutical company Grunenthal GmbH received a patent for thalidomide in 1954, and as soon as 1956 began marketing thalidomide for morning sickness, insomnia, coughs, colds, and headaches.
It took another five years for the drug to produce enough deaths and deformities that the public demanded its removal. In 1961, thalidomide was taken off the market after causing serious birth defects in about 10,000 children (half in West Germany), and deaths in another 2,000 children.
Even though thalidomide’s effect on the fetus occupies only a 13-day window, the results were horrendous. Arms and legs failed to develop. Less frequently – but more fatally – organs failed to develop. Thalidomide babies were also born without eyes or ears.
The class action lawsuit in Germany was dropped, presaging the way future pharma lawsuits would be handled if tort reformers got their way. Either that, or lawsuits would be handled out of court, giving lawyer-rich Big Pharma the field advantage in every case.
Case Closed (Sort of) …
The New Zealand thalidomide suit was finally settled in 2013, for $81 million U.S. dollars – a far cry from the actual costs, but better than nothing.
Because the drug was never actively marketed in the United States, thanks to the FDA’s reluctance, no suit has ever been brought to trial successfully. In 2013, U.S. District Judge Paul Diamond allowed 50 lawsuits to go ahead, rejecting arguments that the statute of limitations vis à vis thalidomide had run out.
In spite of that, the cases continue to be contaminated with charges of “bad-faith advocacy”, as one firm – attempting to dismiss presumably non-winnable cases en masse – refused to let a special investigator interview the plaintiffs, who were apparently never fully informed of their rights or of the likelihood of success.
One Good Thing …
The thalidomide tragedy prompted the U.S. Food and Drug Administration, or FDA, to tighten its regulations surrounding drug development. Unfortunately, 15,000 individuals – give or take a hundred – are not enough to oversee the yearly development of about 50 new drugs, and the continuing production of about 500 drugs (out of 1,500 approved since the FDA began its work in 1938).
Even though pharmaceutical development is no longer the “Wild West” of the medical industry, mistakes continue to happen. Drugs continue to find their way into the marketplace with inadequate or improper testing, and the FDA continues to behave, perhaps inevitably, like a long-tailed cat in a room full of rocking chairs.
Some of the more egregious failures (i.e., drugs dropped from production, recalled, or involved in lawsuits) include Actos, a diabetes drug, fluoroquinolone (an antibiotic), Yaz (birth control), and Zoloft (an antidepressant). In addition, there were the medical scopes from Olympus Corp. – scopes about which an Olympus company official told American executives not to warn hospitals. Not a pharmaceutical, granted, but a good example of how design and manufacturing flaws combined with advertising and sales efforts, can make products dangerous.
If you or a loved one is taking prescription medication, the best advice is “let the buyer beware (caveat emptor)”, because the FDA can’t be everywhere. If you experience side effects or widespread discomfort, consult your doctor. There are other treatments available. You might even want to consider “natural” or holistic remedies, which can range from acupuncture to Ayurvedic or Chinese medicine, – even to herbs, spices and over-the-counter vitamins and supplements.Read More