Fen-Phen - Phen Fen - Dr. Gerson H. Smoger

Fen-Phen (by Gerson H. Smoger, Trial Magazine) 

Fen-Phen (by Gerson H. Smoger,  Ph.D., Published 1997)

Recent headlines have indicated that the once highly touted "wonder" diet drug combination known as "fen-phen" has quickly induced a considerable amount of litigation throughout Texas and the rest of the nation, including a Federal MDL assignment to Judge Louis Bechtol in Philadelphia. While inherent suspicions of "mass" torts have developed in recent years, especially those that have led to considerable advertising, in the case of "fen-phen" the suits and the advertising are well deserved.

Fen-phen itself is a rather catchy name for a combination of fenfluramine ("fen"), sold under the trade name Pondimin, and phentermine ("phen"), which was sold under various trade names. The flurry of litigation against the manufacturers of these drugs began when a Mayo clinic study reported that 24 fen-phen users had developed heart valve problems. It was fueled when on November 13, 1997, this and other studies led the United States Department of Health and Human Services (DHHS) to announce that everyone who took fen-phen or Redux (generically named dexfenfluramine) should see a physician to determine if they exhibited signs of heart or lung disease.

This announcement was made in conjunction with the recommendations of the Food and Drug Administration (FDA), Centers for Disease Control (CDC) and the National Institutes of Health (NIH). The recommendation essentially stated that if anyone displayed any signs or symptoms of heart or lung disease, they should have an echocardiogram done. Additionally, even people who had taken these drugs and not exhibited heart or lung disease were informed that they should have an echocardiogram done before undergoing any procedure which may cause bleeding, even teeth cleaning, in order to minimize the risk of bacterial endocarditis, a potentially fatal infection of the heart.

Fenfluramine and phentermine themselves belong to a class of drugs called anorexiants, i.e. drugs used in the treatment of obesity. Defenders of these drugs indicate their necessity, because obesity itself may increase the risk of hypertension, coronary artery disease, type II diabetes, gallbladder disease, sleep apnea and gout, as well as some forms of cancer. However, manufacturers of these "diet drugs" are and have been equally aware of the fact that any drug therapy which seems effective in combating frank obesity is enticing to a general population obsessed with weight loss, not to mention being more remunerative for the manufacturer.

In 1973 Pondimin (fenfluramine) first came onto the US market. In part, it was designed to increase the body levels of the neurotransmitter serotonin by inhibiting the body from breaking down this chemical as well as by causing increased amounts of serotonin to be produced. The designed result was to affect the brain by depressing the central nervous system and regulating mood and appetite in order to promote a feeling of fullness and a consequent loss of appetite. In 1973, the FDA approved Pondimin for use. However, it needs to be noted that in the 1974 Physician's Desk Reference (as well as the 1977 PDR and the 1997 PDR) it was indicated that Pondimin was recommended for short term (a few weeks) use. The PDR further stated that the limited usefulness of agents of this class should be measured against possible risk factors inherent in their use.

From 1973 to 1977, Pondimin was not recommended for patients who had symptomatic cardiovascular disease including arrhythmia or for those who were severely hypertensive. Chest pain was listed as a miscellaneous adverse reaction. There was no warning for primary pulmonary hypertension in the 1973 PDR, but by 1977 there had been four cases reported under "Precaution" which later changed to "Warning" in the 1997 PDR.

In April 1996 a related drug, American Home Products' Redux (dexfenfluramine), was approved for marketing in the United States after a scientific advisory panel initially voted 5-3 against its approval. By June 1997 -- just 14 months after its release -- doctors had written almost 2.5 million prescriptions for Redux. While Redux was being launched, its sales people visited 140,000 doctors to encourage its use. Meanwhile, fen-phen has been a big business for both doctors and drug companies for several years with some 18 million prescriptions being written in 1996 alone. In all it is estimated that up to 6,000,000 Americans have taken either Pondimin or Redux. Unquestionably, then, the manufacturers, principally American Home Products, diet clinics and diet doctors have made substantial sums prescribing the fen-phen combination and Redux.

This massive marketing and sales campaign extended the use of these drugs far beyond what was recommended and ignored clear danger signs. When any drug is developed there are primary issues which must be investigated both before its release and during the course of its effective life: 1) does it work for its intended use?; and 2) is it safe? Certain corollary issues must also be addressed, such as: to whom should the drug be given; whether there are limitations based on risk by whom in the patient population the drug should be taken; how much should optimally and safely be given (dose); what is the proper period of time to give the drug; whether there are any serious side effects; and, lastly, whether the drug has any harmful interactions with other drugs.

While fenfluramine and phentermine each had the approval of the FDA for sale in the treatment of obesity, the fen-phen combination was never an "approved" use, though American Home Products was well aware of this drug cocktail being advertised and routinely used throughout the United States. Indeed, such "off label" uses of a drug are not regulated by the FDA, because the FDA does not control medical practice. However, doctors who make off label use of drugs run a risk of being sued in medical malpractice cases, particularly if they do not gain their patients' consent. Other abuses in the way that these drugs were prescribed, with the knowledge of the manufacturer, included allowing users to stay on these drugs for extremely long periods of time -- often much longer than the recommended course of treatment. Indeed, while the risks of serious side effects were reported to go up dramatically after 3 months of use, many of the Mayo Clinic study patients were on the drug for six months or more. Prescriptions were also not limited to persons truly obese, but rather the drugs were routinely prescribed to those individuals who just wanted to lose a few pounds.

It is hardly surprising then that physical problems have been caused by these drugs. It has been reported that early signs and symptoms of problems with these drugs have been shortness of breath, fatigue, and swollen ankles. More serious has been the heart valve damage in which the mitral valve and other valves in the heart have developed a white coating, allowing blood to flow backwards and causing heart muscle damage. In extreme cases, this has necessitated valve replacement surgery and even caused death. Another specific condition of note has been observed to be primary pulmonary hypertension (PPH), which is an otherwise extremely rare disease of the lungs where abnormally increased blood pressure occurs in the blood vessels in the lungs. PPH tends to develop silently and can be quite serious and even fatal. The last major side effect has been of a neuropsychological nature, in which individuals taking these chemicals have had psychotic episodes, gross changes in mood or behavior, or memory and cognitive loss.

In conclusion, at the threshold of this litigation, it appears clear that there are both serious and meritorious claims which are being brought against the manufacturers who produced and oversold these so-called "wonder" drugs, particularly American Home Products, the manufacturer of Pondimin and Redux, as well as against certain "diet" physicians and clinics who unfortunately made rather casual and careless use of them.

Fen-Phen - Phen Fen - Attorneys - Texas - Smoger Law Firm!