Phen-Fen - Dying to be thin

Vernellia R. Randall
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The concern for getting "healthy" and losing weight is as much an "obsession" as ever. People are willing to do, try, undergo, and take just about anything in order to LOSE WEIGHT. It is a diet product manufacturer's "dream" and the health care industry's biggest nightmare. But, who are the winners in this "rollercoaster" ride? Who are the losers? And what can/MUST the health care industry do ethically and legally?

Introduction

Last year 65 million Americans spent $50 billion to lose weight, and Congress is convening a series of hearings on diet-industry abuses, including health risks and fraud.⁽¹⁾ Many dieters are inspired purely by vanity, but many others are hazard-ly overweight and are looking for a "cure". While diet products and programs go in and out of vogue, the American public places its trust in the Food and Drug Administration (FDA), pharmaceutical manufacturers, and physicians (in real space and "cyberspace) to provide safe products for this "ailment".

But at what cost?

By July 1997, the Mayo Clinic reported 41 cases of valvular heart disease⁽²⁾ (only two of which were men) and even one death from this "off label" drug prescription. The number has risen dramatically since then. Lawsuits are being filed by the dozens per day, and now there is even a national class action suit in the making.

One out of three Americans is considered obese or 20% over ideal weight. Obesity-related conditions are estimated to contribute to 300,000 deaths yearly, ranking only second to smoking as a cause of preventable death.⁽³⁾ Despite numerous commercial campaigns and health behavior modification programs, obesity remains a prevalent condition among Americans. According to a 1993 National Institute of Health Technology Assessment Conference, long term management of obesity is the most challenging aspect of weight control for many individuals.

Obesity confers increased risks for diabetes, coronary artery disease, and certain cancers including those of the breast, ovary and cervix.⁽⁴⁾ Mortality increases as a function of body mass index (BMI) in adults aged 30 to 74 years. The effects are even more pronounced in younger adults, and is a major killer of African Americans and women. The American Heart Association recently upgraded obesity to a major risk factor for coronary heart disease. It is estimating that treating obesity is as cost-effective as treating other chronic diseases such as hypertension.

During the early and mid-1990s, millions of Americans turned to what appeared to be a promising combination of prescription drugs to help them lose weight.⁽⁵⁾ There medications - fenfluramine and phentermine - were known as fen-phen. Taking fenfluramine and phentermine together, in low doses, was just as effective as taking either drug alone, with quicker results and yet with fewer side effects. Or so it seemed.

When reports about the heart-valve abnormalities in the patients studied at the Mayo Clinic (who took the off-label drug combination "fen-phen") hit the news, people all over the country who had taken these medications headed to their doctors offices for evaluations to see if their hearts had been affected. Too many, like the author of this annotated bibliography, felt that the promise of a thinner, happier life was contained in two little syllabals: fen-phen.

The following articles are annotated in this bibliography:

One Half Phen in the Morning, One Half Fen at Dinner: A Proposal for FDA Regulation of Off Label Uses of Drugs

RAISING THE BAR: Pharmacists Role in Preventing Diet-Pill Related Lawsuits

Rushing to Judgement on Fen-Phen and Redux™: Were the FDA, Drug Manufacturers, and Doctors Too Quick to Respond to Americans' Infatuation with a Cure-All Diet Pill for Weight Loss

The FDA and Public Access to New Drugs: Appropriate Levels of Scrutiny in the Wake of HIV, AIDS, and the Diet Drug Debacle"

Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions

Eating Disorders

Linnen v. A.H. Robins Company, Inc.

The Real Thing: In Quest to Weed Out the Rotten Apples, Some State Medical Boards are Taking a New Tack. They're Shifting Their Focus from Punishing Incompetent Doctors to Improving Overall Quality of Care

Prescription for Tragedy Just Name the Rx Drug, And You Can Buy It Online: Online Rx Drugs a Deadly Threat

Janda' Monique Carter is graduate of Purdue University, W. Lafayette, IN, in 1987 with a BS degree in Mechanical Engineering and Pre-Medicine. She has completed 2/3rds of her MS degree in Food Process Engineering from University of Illinois, Champaign-Urbana and is a Registered Engineer-in-Training. Janda worked as an Engineer for 11 years with both General Motors Corporation (Michigan) and The Quaker Oats Company (Illinois). She is currently employed as a Teaching Assistant with UDSL's Academic Excellence Program and as a Patent Law Intern with The General Electric Company's Aircraft Engine Division. Upon Graduation from the University of Dayton School of Law, she will practice Intellectual Property Law in the private or corporate sectors. Ms. Carter may be contacted at the following E-mail address: janda_carter@hotmail.com.

Annotations

Jamie A. Wilsker, One Half Phen in the Morning, One Half Fen at Dinner: A Proposal for FDA Regulation of Off Label Uses of Drugs, 6 Journal of Law and Policy 795, Spring 1998.

The author leads its readers through a virtual tour of all areas surrounding the FDA, diet drugs generally, off-label use (like with fen-phen) specifically - even including the "creation of fen-phen."⁽⁶⁾The author leads its readers through a virtual tour of all areas surrounding the FDA, diet drugs generally, off-label use (like with fen-phen) specifically - even including the "creation of fen-phen."⁽⁶⁾

Ms. Wilsker has a strong policy based paper and she gives major pros and cons (with a stronger emphasis on the cons) of the FDA "succumbing to the drug manufacturers pressures to rush to market new drugs."⁽⁷⁾ She aptly highlights one of the main controversies involved with fen-phen… […under current FDA statutes, drug manufacturers cannot distribute off-label information because its considered illegal promotion. Physicians, through, are free to prescribe approved drugs for off-label purposes without the protection of long-term studies and FDA approval for the new use."]⁽⁸⁾

This Note and Comment is extremely thorough - with a healthy dose of medical, historical, political, pharmacological, regulatory, psychological, and legal insight. This author does a great job moving her readers through material while giving them plenty to chew on along the way.

Many attorney's representing plaintiffs in fen-phen litigation are taking the position that the drug manufacturers should have curtailed off-label uses. However, the Modernization Act of 1997 (21 U.S.C. § 301, available at <http://www.fda.gov>) flies right in the face of such theories. Ms. Henry denounces the FDA's Modernization Act of 1997 (21 U.S.C. § 301) as a open door for drug manufacturing "to pocket extra profits from the enhanced sale of drugs for up to five (5) years before it completes rigid safety and effectiveness tests."⁽⁹⁾Many attorney's representing plaintiffs in fen-phen litigation are taking the position that the drug manufacturers should have curtailed off-label uses. However, the Modernization Act of 1997 (21 U.S.C. § 301, available at <http://www.fda.gov>) flies right in the face of such theories. Ms. Henry denounces the FDA's Modernization Act of 1997 (21 U.S.C. § 301) as a open door for drug manufacturing "to pocket extra profits from the enhanced sale of drugs for up to five (5) years before it completes rigid safety and effectiveness tests."⁽⁹⁾

Many "loop holes" are prevalent throughout this Act's contents - in light of the seriousness of the implications. Most of the Act's principles are based purely in economic philosophies. And as is known, often doing "what's right" and doing what "financially" seems best - are two different things.

Arguments of legal theories embraced in 1^st Amendment fundamentals are also not persuasive to this author. Unlike the Court in Washington Legal Foundation v. Friedman, 13 F. Supp.2d. 51, 51-69, (D.D.C. 1998), which concluded (using the four-prong Central Hudson's, 447 U.S. 557, 563 (1980), commercial speech analysis) that the speech involved with the Act (specifically drug companies giving economic information to managed care organizations and large-scale buyers of health care products and the dissemination of off-label product information) is "neither unlawful not inherently misleading"⁽¹⁰⁾; Ms. Henry acknowledges that in many cases "off-label prescribing" is the standard of care, yet maintains that this law will likely cause more abuses of power.

The author does an excellent job of presenting all of the concerns surrounding the issue of off-label prescribing. The detailed manner in which Ms. Henry describes this well known, but not so well understood practice provides great insight and challenges the reader.

Carol Ukens, "RAISING THE BAR:" Pharmacists Role in Preventing Diet-Pill Related Lawsuits", Drug Topics, No. 10, Vol. 142, May 18, 1998.

In a quest for someone to "pay for the ills" associated with the phen-fen diabolical - a new target has arisen. The dispenser of the "meds". The gatekeeper of all prescription fillings… Bob the Local Pharmacist.

This article talks about the law evolving in this area to include a "duty to warn" about such dangers (as the fen-phen combination) - based on a "person coming to fill a prescription that wasn't morbidly obese." The theory is that since the pharmacist knows that the fen-phen prescription is only to supposed to be prescribed for patients that are dangerously (and obviously) overweight, "Bob" shouldn't fill the 'script. But, what if it was one's (thin, thoughtful, authorized) friend or family member who happened to be getting the prescription filled…? Should the pharmacist be responsible to telling the non-obese person that they can't have the phen-fen because it wasn't meant for someone their size? How will health care consumers respond to this type of "privacy invasion"?

Another factor is what behavior exactly rises to the level of "crossing the line." That delicate line from being the basic "filler of prescriptions responsible for noting any obvious toxicity issues, to that of actually "intervening in medical care" or "treating the patient."⁽¹¹⁾ State regulations typically set standards that pharmacists must follow. While a real possibility of civil liability exists within states for improper dispensing of medicine⁽¹²⁾, to be held to the standard of one who is intimately knowledgeable about your medical history, etc. is an entirely different thing.

Ms. Ukens does a good job of addressing the potential dangers of privacy, mistake, etc. involved with having one other than the physician who knows the patient responsible for monitoring (and in effect) the practice of medicine. The courts are starting to have a change in philosophies, but for now her statements seem right on point.

Apryl A. Ference, "Rushing to Judgement on Fen-Phen and Redux™:" Were the FDA, Drug Manufacturers, and Doctors Too Quick to Respond to Americans' Infatuation with a Cure-All Diet Pill for Weight Loss", 9 Albany Law Journal of Science & Technology 77 (1998).

Apryl Ference dedicates a section of her comment to another disturbing angle: the need to stop trivializing risks to women's health and idealizing "Barbie-like" images. She specifically noted the American Society of Plastic and Reconstructive Surgeons' media campaign referring to "small breasts as a disease that required medical treatment."⁽¹⁴⁾ Additionally, although the "safety and efficacy of certain new diet drugs on the market haven't been demonstrated beyond one year", the FDA has been convinced to approve both Xenical to and Meridia. These two drugs have been reported by the FDA to have possible links to breast cancer and hypertension, respectively).⁽¹⁵⁾

When will enough be enough? Sure obesity is a serious problem that not all can cure with willpower and aerobics - but would patients voluntarily ingest what is known to be a higher cause of deaths in women? Not likely. Then how can the FDA continue to allow these potentially deadly products on the market without more definitive studies or more required informed consent. The FDA needs to place more reliance on drug studies by FDA reviewers before approving new drugs. Further, safety studies should be conducted for off-label drug uses.

Steven R. Salbu,  The FDA and Public Access to New Drugs:" Appropriate Levels of Scrutiny in the Wake of HIV, AIDS, and the Diet Drug Debacle, 79 Boston University Law Review 93 (February 1999).

This author asserts that hazards such as with fen-phen could be reduced with new congressional and administrative guidelines.⁽¹⁶⁾ He believes that new standards would allow novel drugs to get to market expeditiously, yet require on-going research to catch any possible undetected hazards missed during the traditional 3-phase new drug testing. In the case of conditions that have no known "cure" / effective treatment (i.e. AIDS, Alzheimer's), the FDA could be less conservative. Conversely, with conditions like obesity (where there is considered a known treatment of diet and exercise), heightened scrutiny of new drugs would be proscribed. This author asserts that hazards such as with fen-phen could be reduced with new congressional and administrative guidelines.⁽¹⁶⁾ He believes that new standards would allow novel drugs to get to market expeditiously, yet require on-going research to catch any possible undetected hazards missed during the traditional 3-phase new drug testing. In the case of conditions that have no known "cure" / effective treatment (i.e. AIDS, Alzheimer's), the FDA could be less conservative. Conversely, with conditions like obesity (where there is considered a known treatment of diet and exercise), heightened scrutiny of new drugs would be proscribed.

The focus of this article is on FDA guidelines solving the problem. Here, the notion is that liability rides with the FDA and legislators in their big comfy offices. Discussion of the Modernization Act of 1997 (if it had been around in time) and its effect on off-label advertising might likely have increased the occurrence of fen-phen related problems - so why would one suggest that legislators have the answer.

While "interactive consideration" (where the FDA evaluates both the severity of the disorder and the availability of safe and effective alternative treatments)⁽¹⁷⁾ would give a factor based approach, it surely doesn't address the subjective nature of the factors. Especially when race and gender are added into the mix. This "chronic disease" does not fit into one neat little box - that one formula based standard will fix. The "diet and exercise" standard regime has not worked for hundreds of thousands.

The author does not just provide statistics, but explains the impact that they have. This commentary is well written substantively and in its presentation.

Elizabeth D. Azari & James M. Beck, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug Law Journal 71 (1998).

The writing team of Azari and Beck look at the traditional law of informed consent - a tort very applicable in health care law - in the face of the recent phenomenon and diet drug combination, fen-phen. These authors take a somewhat sarcastic look at informed consent even being a viable option for doctors who were prescribing not just that diet drug combination, but rather to any "off-label" prescribed medicine.

Serious problems abound throughout one of their theories: the notion that "off-label" use is purely a "matter solely of FDA regulatory status"⁽¹⁸⁾ and not something patients need to "worry their pretty little heads about" (allowing them to make a well-reasoned decision). While every "minute detail" is not necessarily for every patient, as a former user of fen-phen, a person currently feeling the effects of some of its known side effects and adverse symptoms - there are some things a patient needs to know. There are some decisions - like whether to choose to take an "experimental " drug combination and possibly die quickly from primary pulmonary hypertension, or to another drug or even just go with the old stand-by of diet and exercise.

The thrust of the entire piece is "off label is ok, for the good of the patient", etc. because it is an "accepted practice of medicine." Structurally well written, but leaves a few holes regarding final recommendations.

Eating Disorders, Harvard Mental Health Letter, No. 5, Vol.14, Pg. 1, November 1997., Harvard Mental Health Letter, No. 5, Vol.14, Pg. 1, November 1997.

Interestingly, Harvard Medical School reports that eating disorders were equally common (in 1996) among whiles and blacks, and in all social classes; yet in the same paragraph they talk about a connection of these disorders in young girls involved with ballet, competitive swimming, and gymnastics.⁽¹⁹⁾ I have to wonder just how many of those girls were of color.

While well written structurally, I found myself frustrated after my first cursory reading of this article because the authors do not back many of their findings with references. There is a bibliographic listing offering further reading - there were still questions about some of the various vaguely mentioned "studies" or "surveys."⁽²⁰⁾

Thomas F. Linnen and other v. A.H. Robins Company, Inc. and others, 1999 Mass. Super. LEXIS 552, *1, Superior Court of Massachusetts, at Middlesex, December 7, 1999.

In this, the first wrongful death case brought against a manufacturer of fen-phen since its full force use in 1996, manufacturer AH Robins and others were sued by the heirs-at-law of Mary Linnen for negligent failure to warn, breach of express warranty and violation of Mass Gen. Laws (in tort damages). Ms. Linnen has been prescribed the anorectic drug combination "fen-phen" in May of 1996 by a Dr. Ann Landzberg following a series of tests. On June 5^th, after complaining of shortness of breath, Ms. Linnen was directed to stop taking the medicine and died in February of 1997.⁽²¹⁾In this, the first wrongful death case brought against a manufacturer of fen-phen since its full force use in 1996, manufacturer AH Robins and others were sued by the heirs-at-law of Mary Linnen for negligent failure to warn, breach of express warranty and violation of Mass Gen. Laws (in tort damages). Ms. Linnen has been prescribed the anorectic drug combination "fen-phen" in May of 1996 by a Dr. Ann Landzberg following a series of tests. On June 5^th, after complaining of shortness of breath, Ms. Linnen was directed to stop taking the medicine and died in February of 1997.⁽²¹⁾

The Massachusetts Superior Court was not persuaded by Defendants arguments following their move for summary judgement. Their motion was denied (except as to failure to warn plaintiff directly) based on the well established Learned Intermediary Rule. Judge Brassard's decision was succinct yet thorough.⁽²²⁾

Robin F. DeMattia, The Real Thing: In Quest to Weed Out the Rotten Apples, Some State Medical Boards are Taking a New Tack. They're Shifting Their Focus from Punishing Incompetent Doctors to Improving Overall Quality of Care, Modern Physician, pg. 24, December 01, 1998.

Ms. DeMattia places much of the onus on the problem of incompetent physicians (and the cause for physicians being so free to prescribe the drug fen-phen) squarely on the plates of state medical boards and their antiquated repertoire. Ms. DeMattia criticizes the boards that are still focusing on disciplining doctors for retrospective conduct based reasons (substance abuse, sexual misbehavior)⁽²⁴⁾ vs. overall quality of care visions.

The author's overall recommendations regarding improved quality (requiring physicians keep sufficient documentation, make appropriate diagnoses, conduct physicals and keep patient histories appropriately)⁽²⁵⁾ are spelled out concisely and backed with strong policy articulations.

The author does a good job of addressing the potential dangers of not taking legislative / agency type action toward improved health care. Expansion of her proposals would be advantageous for specific concerns like what occurred with off-label prescription writing of fen-phen; but more particularly with assuring that those who are not represented by quality care, minorities, the poor and women are able to receive the level of service they need.

Sharyl Attkisson, Eye on America Investigation: FDA Doc Claims Fen-Phen Cover-up, http:/cbsnews.cbs.now.story/0,1597,181616-412,00.shtml, *1, aired on CBS Nightly News April 13, 2000. http:/cbsnews.cbs.now.story/0,1597,181616-412,00.shtml, *1, aired on CBS Nightly News April 13, 2000.

What a firestorm of controversy involved in this report. Rarely seen, the Federal Drug Administration's key reviewer of fen-phen, Dr. Lutwak⁽²⁶⁾, speaks out say what so many involved with this drug duo either suspected or have heard someone say they suspected.

Dr. Lutwak's statement: "I felt from the very beginning the drug companies were covering up. I felt from the very beginning that these drugs were dangerous"⁽²⁷⁾ is exactly what the manufacturer of the "forbidden" part of fen-phen didn't want disclosed (especially from such a credible source) and Ms. Attkisson presented it in fine fashion.

This reporter has done an excellent job summing up the key points surrounding this controversy and skillfully bringing to light new ammunition for those affected by the drug - including the hopeful information (for those preparing future lawsuits against the manufacturer) that even more new evidence may be available regarding what the manufacturer knew and didn't know - and when.

I did discover one minor error in the 24^th paragraph of this report. There, Pondimin is referenced as "fen-phen,"⁽²⁸⁾ however, Pondimin is only the FEN in "fen-phen." Pondimin is actually the commercial name for Fenfluramine - the part of the drug combination pulled from the shelves. The other drug pulled in September 1997 was Dexfenfluramine - the "cousin of fen" - (sold under the commercial name Redux). Generally a good source (with other investigative links) regarding strategies for potential fen-phen litigation.

Liz Brody, Prescription for Tragedy Just Name the Rx Drug, And You Can Buy It Online: Online Rx Drugs a Deadly Threat, The New York Pose, All Editions, Pg. 006, March 12, 2000.

"Is your anorectic daughter secretly taking fen-phen?"⁽²⁹⁾"Is your anorectic daughter secretly taking fen-phen?"⁽²⁹⁾

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Contact Information:
Professor Vernellia R. Randall
Institute on Race, Health Care and the Law
The University of Dayton School of Law
300 College Park 
Dayton, OH 45469-2772
Email: randall@udayton.edu