LIBRADOL

Report of the Council on Pharmacy and Chemistry

The Council has authorized for publication the following report which explains why Libradol was found ineligible for New and Non­official Remedies.

W. A. Puckner, Secretary.

Libradol is manufactured by Lloyd Bros., Cincinnati. According to a circular (a “readily removable” label) which accompanies the trade package, its “uses” are: “In colds, croup and acute bronchitis. In local congestions; in lung trouble, in acute inflammations of this or any other organ, especially if pain or soreness be present. In lumbago, sciatica, or in rheumatic pains of the joints or muscles. Applied to the forehead, it induces sleep.”

Libradol is offered in two forms, “Libradol Mild” for infants and supersensitive persons which is said to be “destitute of drug energy” and Libradol “Regular” which is “highly medicated,” the “constituents” being “DRACONTIUM, SANGUINARIA, CEPHAELIS, MELALEUCA, LOBELIA, LAURUS, CAPSICUM, TOBACCO.”

According to a circular, “The sanitary plasma Libradol” is a “homogeneous, highly medicated, and exceedingly potent compound, in plastic form,” which “carries the energies of its drug constituents and the high antiseptic qualities of Laurus Camphora and Melaleuca.” It is stated: “The Drug Influence of Libradol is necessarily different from that of any known single member of the Materia Medica. But yet, no mystery either in medicine or of pharmacy is claimed as a part of its composition or process of manufacture. It is a thing peculiar to itself, the result of the study of the drugs from which it is derived and compounded. These drugs may be studied at leisure by whoever cares to do so....”

The following information bearing on the composition of Libradol was furnished by Lloyd Brothers in response to a request from the Council to aid in the consideration of the preparation:

“ ‘Compound Lobelia Powder’ has been, since 1852, official in the American Dispensatory, in the first edition of which (1852) its formula is given, as follows:

“ ‘Take of Lobelia, in powder, twelve ounces; Bloodroot and Skunk Cabbage, in powder, of each, six ounces; Ipecacuanha, eight ounces; Capsicus, in powder, two ounces. Mix them.’

“This preparation came increasingly into demand with the Eclectic profession, the principal use for which it was first employed (as an emetic), being finally displaced by its local application in bronchial pneumonia troubles, when sprinkled on a greased cloth and applied to the chest.”

“In 1898, Dr. Finley Ellingwood petitioned Lloyd Brothers to make for him, in plasma form, ready for application, a compound carrying the ingredients of the old ‘Compound Lobelia Powder,’ strengthened by the addition of Melaleuca leucadendron, Laurus camphora and Nicotiana tabacum. Experiments not very encouraging in a pharmaceutical sense were made, and it was not until repeated requests had been made that a product was at last satisfactorily prepared and forwarded to Dr. Ellingwood (1900), with no thought other than that of serving him personally in his practice. This product he used and commended to his professional friends, and under his commendation it came into professional demand.”

An examination of the information submitted by Lloyd Brothers showed Libradol to be in conflict with the principles and rules that govern in the acceptance of articles for New and Non­official Remedies as follows:

Composition (Rule 1).—The information which has been received gives little idea of the actual composition of the preparation; for example, the statement that Libradol “carries the energies of its drug constituents and the high antiseptic qualities of Laurus Camphora and Melaleuca” gives no indication as to the part or parts of the Laurus Camphora or Melaleuca employed. If the statement is correct, that Libradol “is a homogeneous, highly medicated, and exceedingly potent compound,” it is essential that the several potent ingredients be stated clearly and not merely hinted at by their qualities. Other conflicts with Rule 1 might be enumerated, but the foregoing citations state the direct conflict; and this has not been removed, although an inquiry was sent to Lloyd Brothers for a statement of the amount of each potent ingredient in a given quantity of Libradol.

Indirect Advertising (Rule 4).—The recommendation for the use of Libradol in the treatment of colds, bronchitis, lumbago, sciatica and rheumatic pains, which accompanies the trade package, is prone to lead the public to depend on it in cases where definite treatment is imperative.

Unwarranted Therapeutic Claims (Rule 6).—Libradol is recommended in a great variety of conditions and is especially claimed not only to relieve pain, but to remove the cause of pain. This is explained as follows: “In the study of the physiological action of many drugs, it was found that the constituent remedies in this combination exercised a most salutary influence, not only upon the sensibility of the nerves involved, but upon the capillary circulation within the diseased area, the muscular structures therein included, and, subsequently, upon the course of the advancement of the congestive and inflammatory processes, and upon secretion, exudation, adhesion, induration, hypertrophy, suppuration and excretion.”

Granting, for the sake of argument, that carefully controlled experimental clinical evidence were available to substantiate this statement with reference to a single case of pain, the statement would be misleading when considered as a general explanation of the preparation’s relieving pain by removing the cause of pain when taken in connection with the conditions for which it is recommended and in which pain is even a minor symptom. Still, if pain were relieved in these cases by removing the cause, the patient would be cured of the conditions which give rise to the pain, and these include: “Acute pain in the chest;... acute inflammation in the chest;... persistent local pain;...” (This might be interpreted as including tuberculosis; pneumonia; cancer, and appendicitis.) “lumbago; sciatica; articular rheumatism” (gonorrheal infections?).

Name (Rule 8).—The name, derived from Dolar and Liber, suggests the claimed action of the preparation (the relief of pain) rather than the drugs said to be presented by it.

Irrational Composition (Rule 10).—It is quite possible that Libradol will relieve pain in certain instances and that the drug constituents present in Libradol “Regular” make this more effective than “Libradol Mild” which is “destitute of drug energy”; this, however, is no justification for the use by physicians of a cataplasm containing or made from skunk cabbage, bloodroot, ipecac, melaleuca (oil of cajeput?), lobelia, laurus comphora (camphor?), capsicum and tobacco. The combination is thoroughly irrational and a reminder of a past century. Further, the Council knows of no evidence to support the following claims:

“As a stimulant Capsicum has the power of neutralizing depressant remedies like Lobelia and Tobacco.”

“Our association of its desirable constituents with those of Lobelia, in connection with the modifying influence of Capsicum, Melaleuca, and Laurus Camphora, permits a more free use in Libradol than would be possible were it to be employed alone.”

“Capsicum, Melaleuca, and Laurus Camphora in Libradol tend to counteract the excessive relaxative and depressant effects of Lobelia.”

“The great value of Melaleuca in Libradol is its quality of modifying and controlling the action of the associated energetic constituents of the drugs Tobacco and Lobelia, which reduce congestion and inflammation, but which would, unsupported, be too depressant.”

Libradol is inadmissible to New and Non­official Remedies because its composition is complex, irrational and semi-secret, and because its name and the unwarranted therapeutic recommendations made for it will lead to its ill-advised use.—(From Reports of Council on Pharmacy and Chemistry, 1920, p. 65.)