THALIDOMIDE’S RETURN to MARKET – NIGHTMARE DRUG RESURRECTED

In post-war Germany, circa 1954, seven chemists eager to snag a share of the increasingly lucrative sedative market went to work creating a sedating drug that would rival the only kind of its day, barbiturates. By 1957 those same German chemists were ecstatic to introduce their newly created drug to a public that was seeking a safe alternative to the highly addictive barbiturates. Chemie Grunenthal, the pharmaceutical parent who employed those chemists, named their new offering Thalidomide and marketed it as Contergen, maintaining through its huge advertising campaign that the drug held no addictive qualities and was, in fact, “completely safe.” In addition to its sedative qualities, Contergen also controlled nausea and, boasted its creators, produced “absolutely no toxic side effects.” It was appropriate too, Chemie Grunenthal hyped, for children who were “especially uneasy.”

It took three to four years for the public and its prescribing medical community of physicians and pharmacists to begin to seriously question the promising claims that now, by 1959 – 1960, appeared to have been made much too cavalierly by Chemie Grunenthal and its marketer, Distillers Ltd. of Great Britain, who had taken the pharmaceutical’s advertising half-truths one step further into the nightmare by adding that Contergen was “even safe for pregnant women.” That extremely harmful and unconscionably negligent labeling claim, with no research of any scientific integrity upon which to rely, would become responsible for literally thousands of deaths of European infants through at least 1967, the year Thalidomide was finally pulled from market and banned for such use.

Because Germany literally had no state sanctioned drug control until 1961, all pertinent experimentations and resulting test theories performed by Chemie Grunenthal were taken at the pharmaceuticals word. While a few trials had been run on pregnant rabbits, dogs, and monkeys in an effort to discern possible side effects, it was later proven that those trials had been rendered useless because the large doses of Thalidomide given to the animals had killed the fetuses.

It wasn’t until 1962 when experiments took place in the U.S. that researchers found the proof many physicians were sure existed, that Thalidomide indeed was solely responsible for the myriad of serious birth defects and physical malformations thousands of European, African, and Asian infants had been born with since as early as 1956, their mothers having been prescribed the drug for morning sickness during pregnancy. These studies in the U.S. were thorough, concluding that Thalidomide, when taken by patients any time from the thirty-fourth day post-menstruation to the fiftieth, was directly responsible for absence of limbs and ears, phocomelia with three fingers, thumbs with three joints, and very often damage to internal organs such as the bladder and uterus. Forty percent of thus-affected infants died before their first birthday.

The first public accusations levied against Chemie Grunenthal – -for its negligence in properly testing Thalidomide, for marketing a drug with side effects that caused bodily harm and for continuing to manufacture, market, and supply that drug after legitimate health concerns were raised by the medical community – -occurred toward the end of 1961. By May of 1968, the prosecutor of the county court of Aachen had filed a criminal lawsuit against the seven employees of Chemie Grunenthal. By December, 1971, it could be said that neither a sentence nor an acquittal had been handed down because while the pharmaceutical had been ordered to pay one hundred million deutschemarks in compensation to its victims in the spring of that year, the deciding court had pledged it more imperative to bring about change to the current system and its plethora of troubles than to wreak punishment upon those men responsible for it.

In the intervening years Thalidomide has proven again the subject of much controversy, but for different concerns than were present from the fifties through the early seventies, although worries over consumption by pregnant patients still remain, and with sound reasoning. Concerns now pertain to the serious side effects Thalidomide causes the cancer patients for whom it is currently being prescribed. In May of 2006 the Food and Drug Administration approved Thalidomide as an aid in the treatment of bone marrow cancers. When used in tandem with dexamethasone, the concoction appears to slow the growth of myeloma cells, preventing the cancerous cells from bonding onto the healthy bone marrow cells. It is unknown why Thalidomide works in this capacity, but researchers report that the drug does reduce inflammation and prevents the formation of new blood vessels, a necessity in starving off invading tumors. In 1998 Thalidomide was also approved to treat skin lesions caused by leprosy, the FDA nodding its assent after years of research on the drug – -which had continued since its withdrawal from market – -proved its efficacy for that purpose. Though more extensive research is yet required, clinical studies find that Thalidomide might also be used in treating cancers beyond the bone marrow type for which it is currently approved, including melanomas, brain tumors and kidney cancer.

Regardless of FDA approval, there remains not a small degree of controversy over the renewed prescribing of a drug that decades ago was proven to have caused severe and unalterable side effects. Children of mothers who were given Thalidomide in the 1950s are lobbying against the current approvals in fear that no matter the stringent safeguards now in place – -such as patient education, signed consent requirements and mandatory contraception – -there will almost undoubtedly be more babies born with severe malformations and disabilities for which Chemie Grunenthal was found guilty nearly forty years ago, an unacceptable risk according to those now-adults who consider themselves living proof of the dangers in resurrecting Thalidomide.