119. The Magic Pill (Fen-Phen)

1h 7m
A trendy new diet drug combination subjects millions of users to serious health effects, resulting in a monumental legal battle. Prelude: Cancer concerns force Belviq, a popular diet drug, to be withdrawn from the marketplace.
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Transcript

Support for swindled comes from Simply Safe.

For the longest time, I thought home security meant an alarm going off after someone broke in.

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Charlie Sheen is an icon of decadence.

I lit the fuse and my life turns into everything it wasn't supposed to be.

He's going the distance.

He was the highest paid TV star of all time.

When it started to change, it was quick.

He kept saying, no, no, no, I'm in the hospital now, but next week I'll be ready for the show.

Now, Charlie's sober.

He's going to tell you the truth.

How do I present this with any class?

I think we're past that, Charlie.

We're past that, yeah.

Somebody call action.

Aka Charlie Sheen, only on Netflix, September 10th.

This episode of Swindled may contain graphic descriptions or audio recordings of disturbing events which may not be suitable for all audiences.

Listener discretion is advised.

Those struggling with their weight know that it goes beyond willpower.

I wish I wasn't still hungry.

Is this enough?

It's late.

And I'm still hungry.

Weight loss is not just about willpower.

While we have different triggers, we face similar challenges.

Am I full?

Do I want more?

Have I had enough?

Maybe it's time to try Bel Vique.

Bel Vique is FDA approved for weight loss in adults who are overweight with at least one weight-related medical condition or obese.

When used with diet and exercise, Bel Vique can help you lose weight and keep it off.

When San Diego-based Arena Pharmaceuticals' Bel Vique hit pharmacy shelves in 2013, 12 years had passed since the U.S.

Food and Drug Administration had approved a new weight loss medication.

Bel Vique, otherwise known by its generic name, lorcasserin, was a twice-daily tablet that manipulated users' serotonin levels to trigger the sensation of being full.

Prescribed with a healthy diet and steady exercise, there was hope that this new little blue pill was the miracle cure for obesity that the world had been waiting for.

While most diet drugs work as an appetite suppressant in your stomach, Belvique works as a suppressant in your brain.

Belvique was approved by the FDA in June 2012 on the heels of Arena's company-funded study, which demonstrated that nearly 48% of its lorcasterin test group lost at least 5% of their body weight within a year, compared to just 20% of those taking a placebo.

Cholesterol levels and other risk factors for heart disease also improved for those on the drug.

Of course, no pharmacological solution is without side effects, and Bel Vique had its fair share.

The most common were headache, dizziness, fatigue, nausea, dry mouth, constipation, back pain, and cough.

Higher doses may cause mental problems, the label warned.

Talk to your doctor if you become depressed or have thoughts of suicide.

In patients with type 2 diabetes, weight loss may cause low blood sugar.

Stop taking Bell Vique and tell your doctor if you have prolonged erections or your breasts begin to make milk or increase in size.

Was it worth it?

Consider your options.

At that time, the only other long-term weight management medication on the market was Orlostat, brand named ZeniCal, which was as ineffective as it was unpopular.

Orlostat worked in the gastrointestinal tract by blocking the absorption of consumed fat, which was passed through the intestines undigested, leading to some unfortunate side effects.

The educational pamphlet that accompanied the drug literally recommended bringing an extra pair of pants to the office.

You may experience gas with oily discharge, increased bowel movements, energy need to have them, and an inability to control them.

No wonder Belle Veek received such a warm and probably wet reception.

They're calling it the miracle pill, a game changer.

That's what patients are saying about the new diet drug, Bell Vique.

Now the drug supposedly tricks the brain into thinking the stomach is full so people lose weight by eating less.

It's not just a fad diet because it's FDA approved.

Bell Vique was FDA approved, but with the catch.

The agency mandated Arena Pharmaceuticals conduct a long-term, double-blind, placebo-controlled clinical study to evaluate the drug's risk to cardiovascular health.

Just two years earlier, the weight loss pill meridia, or cybutramine, was withdrawn from the market after more than a decade when it was determined to increase the risk of heart attack and stroke.

According to adverse drug reaction reports voluntarily submitted to the FDA, Meridia was connected to 30 deaths and 224 non-fatal strokes.

and users as young as 20.

The actual number of incidents is estimated to be at least 10 times higher.

The The agency could not let that happen again.

So over the next four years, doctors observed the effects of Belvique on 12,000, quote, high-risk, overweight, or obese patients.

The conclusion was promising.

Not only was the drug effective, but it also met the FDA-mandated criteria for cardiovascular safety, quote, or casserole, facilitated sustained weight loss without a higher rate of major cardiovascular events than that with placebo.

However, the study also unintentionally revealed a previously unrecognized and alarming side effect of Bel Vique, an elevated risk of cancer, specifically colorectal, lung, and pancreatic cancer.

The FDA issued a warning in January 2020.

At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcasserin contributes to the cancer risk, the statement read.

However, we wanted to make the public aware of this potential risk.

We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.

The FDA completed its review within weeks and requested that Asai Incorporated, a Japanese company that had obtained the rights to Belvique from AREDA in 2017, voluntarily withdraw the drug from the U.S.

market.

We are taking this action because we believe that the risk of lorcasarin outweigh its benefits, the FDA announced.

Popular diet medications, Belvik Belvik and Belvik XR, have been recalled.

If you or a loved one took Belvik or Belvik XR and have been diagnosed with cancer, you may be entitled to financial compensation.

Naturally, this voluntary withdrawal exposed Asai to potential litigation from Belvique users.

The first lawsuit was filed in Missouri in September 2020, and efforts to reach a global settlement are still underway.

Plaintiffs allege that adequate warnings about elevated cancer risk associated with the medication were not provided to its users, and their case is solid, especially after it was revealed that the drug companies and the FDA knew about lorcacerin's carcinogenic nature as early as September 2010, when an FDA advisory committee initially denied approving the medication for that exact reason.

Before voting it down 9-5, the FDA committee heard concerns that lorcacerin may damage the heart, cause psychiatric problems, and even promote tumor growth.

Malignant tumors and lab rats had been present in early stage testing of lorcacerin.

Combined with other safety concerns such as suicidal thoughts and men growing breasts, the agency ruled that the risks associated with Belvique were not worth the meager weight loss rewards.

However, when Arena Pharmaceuticals resubmitted the drug two years later, a new group of FDA reviewers failed to consider or were somehow convinced to overlook the cancer concerns and it was approved.

Thus began the latest disappointing chapter in man's failed pharmacological battle against obesity.

A one-pill solution to stave off diabetes, hypertension, and cardiovascular disease remains the Holy Grail, and the developmental history of such a treatment is grim.

For example, in the 1930s, dinitrophenol, an industrial poison used as a base in bombs during World War I, was prescribed to speed up metabolism.

After being blamed for dozens of deaths, DNP was eventually labeled unfit for human consumption, and laws creating the Food and Drug Administration were enacted as a direct result.

In the 1950s, people tried injecting themselves with pregnancy and thyroid hormones to limit the unpleasantness that accompanies a low-calorie diet.

While also ineffective, this method produced incredibly dangerous side effects, including heart attacks.

Then came the amphetamine craze of the 1960s and 70s, great for speeding up metabolism and suppressing appetites, but also highly addictive and dangerous, as we now know.

Not that it matters.

Every treatment mentioned is still in use in some form or fashion to this very day, including DNP.

So too are the liquid diets that became popular in the mid-70s that caused people, primarily women, to drop dead from starvation, essentially.

This gave rise to an opposite approach in the 1980s, when diet foods became all the rage, including appetite-suppressing candies like this one.

AIDS helps you curb your appetite.

You eat less because you want less, so you lose weight naturally.

Let the AIDS plan teach you how to take off weight and help keep it off.

Try peanut butter AIDS.

Sounds delicious, I know.

However, the most notorious dieting trend occurred in the 1990s.

It was called FinFin.

a magic pill that boasted all those familiar promises.

Lose the extra pounds quickly, lose them easily, and lose them safely.

A new solution brought to you by all those familiar players, sociopathic pharmaceutical companies, and regulators asleep at the wheel.

There's no such thing as a free launch on this episode of Swindled.

They bribed government officials to find accounting for violations of the things they logged earlierly unethical.

Support for swindled comes from Simply Safe.

For the longest time, I thought home security meant an alarm going off after someone broke in.

But if the alarm is already blaring, it's too late.

The damage is done.

That's a reactive approach, and it leaves you with that awful feeling of violation, even if the intruder runs away.

That's why I switched to Simply Safe.

They've completely changed the game with Active Guard outdoor protection, designed to stop crime before it starts.

Their smart, AI-powered cameras don't just detect motion.

They can tell you when there's a person lurking on your property.

That instantly alerts SimplySafe's professional monitoring agents in real time.

And here's the game changer.

The agents can actually intervene while the intruder is still outside.

Talk to them through two-way audio, hit them with a loud siren and spotlight, and call 911 if needed.

It's proactive security, and that's real security.

I trust SimplySafe because there are no long-term contracts, no hidden fees, and a 60-day money-back guarantee.

They've been named best home security systems by U.S.

News and World Report for five years in a row, and I can see why.

Get 50% off your new SimplySafe system at simply safe.com/slash swindled.

That's 50% off your new SimplySafe system by visiting simply safe.com/slash swindled.

There's no safe like Simply Safe.

Sometimes loneliness, disappointment, or sheer boredom tempt young and old alike to indulge in food to the point where eating replaces other normal activities, often with consequences particularly sad for the young, for many of the natural joys of youth may slip away from the too fat.

Yes, many people do want to reduce for better appearance and for better health.

Is there a practical way to lose unwanted pounds?

Scientists, combining their knowledge of nutrition and human nature, are searching for an answer.

It was a few days before Christmas 1994 when Pam Ruff had an epiphany.

Ruff, a veteran medical technician at the MeritCare Medical Center in Fargo, North Dakota, was performing an echocardiogram on a 40-year-old patient named Susan Thompson to diagnose why she was experiencing shortness of breath and constant fatigue.

It was a bit early for Susan to be at risk for a heart attack.

I was scared because it looked like the doctors didn't know where this was coming from.

But what Pam Ruff saw on the screen was concerning.

The heart ultrasound revealed that Susan's aortic and mitral valves were shorter, thicker, and stiffer than those of a 70-year-old.

The valve lids were not closing tightly, letting blood regurgitate and compromising the heart's ability to pump efficiently.

Failure was imminent.

You see that?

That's the valve leaking.

That's what can cause shortness of breath in these patients, their lungs actually become flooded.

But what was most unusual about Susan Thompson's ailment is that it was the second time that month Pam Ruff had seen it in a relatively young patient with no history of heart disease.

They come in gasping for air and leave with an appointment for surgery.

The cardiologists in Fargo chalked it up to coincidence, but Pam had a different theory.

So she analyzed thousands of medical records on her own time, searching for etiological commonalities.

There was only one, Pam found, confirming her suspicions.

Every patient suffering from that particular heart valve abnormality had taken fenthen.

A decade earlier, in 1983, Dr.

Michael Weintraub, a pharmacologist at the University of Rochester, had a theory.

He wondered if combining fentermine and fentfluramine would offset the other's side effects while maintaining their supposed weight loss benefits.

Phentermine is a stimulant that triggers the release of dopamine, suppressing appetite, and fenfluramine is a downer that increases serotonin, which is linked to feelings of satiety.

Though they had been prescribed individually for years, neither had gained much popularity due to their unpleasant side effects, especially fenfluramine, which causes incredible drowsiness and fatigue.

Phentermine was already being sold as a generic, so Weintraub pitched his hypothesis to A.

H.

Robbins, the manufacturer of Pondamen, the brand name for fenfluramine, in hopes that it might be able to milk even more profit from its unpopular weight loss drug.

The company famous for robotuscin and chapstick commissioned a four-year study from Dr.

Weintraub, in which he would provide 121 clinically obese patients with his new drug cocktail to test its efficacy.

When the study concluded, the results were impressive.

Patients given the FinFin combination lost an average of 34 pounds in eight months, three times the weight loss experienced by the control group.

And the best part, the amphetamine-like side effects of fentermine were diminished, as were the dreadful doldrums brought on by fenfluramine.

This was a significant discovery.

Fenphen is two drugs.

One is fenfluramine, also known as pondamine, and the other is fenermine, which is a speed-like drug that's still on the market.

It was a brilliant combination, but the the problem is it was never tested.

The combination was never tested for safety, and no FDA approval was required, since both fentermine and fenfluramine had already been approved at different times as short-term diet aids.

This meant that fenfin could be prescribed off-label at the discretion of a medical professional.

This meant that A.H.

Robbins was sitting on a potential cash cow.

that required nothing more than marketing.

The only problem was that A.H.

Robbins had plunged into bankruptcy thanks to litigation related to its infamous Dowken Shield IUD.

The company was acquired by Madison, New Jersey-based conglomerate American Home Products, whose pharmaceutical unit, Wyeth Airst, was the nation's seventh-largest drug maker at the time.

To promote the results of Weintraub's study and the effectiveness of its recently acquired FinFin combo, AHP paid for a special supplement in the May 1992 issue of Clinical Pharmacology and Therapeutics, but sales remained painfully slow.

Until February 1995, an article titled The Pill Seekers appeared in Allure, a beauty magazine, promoting the weight loss benefits of thinfin.

That same article was later reprinted in Reader's Digest.

For most people, it was their first time hearing of the latest and greatest magic pill, and the timing could not have been better.

A National Institutes of Health panel had recently concluded that a third of the U.S.

population was overweight.

The World Health Organization would soon declare obesity a global epidemic, and an Institute of Medicine study stated that the disease should be treated like other genetic and biological diseases, with drugs and surgery.

The potential market for FinFin was growing larger every day, but American Home Products' primary concern was that that market would be flooded with generics in the very near future because the 20-year patent for Pondamen had expired.

So, through a series of acquisitions, the company partnered with a French laboratory that had developed a more refined and effective version of fenfluramine called Dex fenfluramine, or Redux.

It was being held as, quote, the most important weight loss discovery of the century.

But as a new medication, Redux would have to go through the grueling process of being approved by the FDA, which would take some time.

But there was no time to waste.

AHP wanted to capitalize on the recent publicity, so in 1996 it spent $52 million to hire sales reps and marketing firms to promote Fenfin to potential customers in doctors' offices.

The effort was tremendously effective in the context of an epidemic that was reportedly killing 300,000 people a day.

Overweight, doctors are prescribing the new Fenfen weight loss medication.

What about a pill that tells your brain you're not hungry?

By the end of 1996, Fenfin was the most popular diet fad in the country.

The healthcare industry could hardly keep up with the demand.

Doctors were coming out of retirement to write prescriptions.

Others saw patients in their living rooms or diagnosed them over the phone.

Additionally, an entire tourism industry evolved around the drugs.

Diet-centered pill mills lined the borders of states with the most lax FinFin laws.

Even time-tested diet plans like Nutra System and Ginny Craig had to pivot to the new pharmaceutical solution or risk going out of business.

The new miracle drug?

Time magazine asked in its September 1996 cover story.

Gone were the days of sensible eating and exercise.

Doctors wrote over 18 million prescriptions for FinFin in 1996 alone, and it is estimated that over 6 million people took the drug.

The Wall Street Journal projected that Redux could gross $1 billion for AHP and Wyeth in the following years.

maybe even more, if the drug offered additional benefits than weight management.

The New York State Psychiatric Institute was adamant about finding out.

In one of its studies, the institution wanted to test the theory that serotonin levels in children could predict delinquent behavior.

Through the court records of offending older brothers, researchers found 34 Black and Hispanic boys between the ages of 6 and 10 and injected them with fenfluramine.

Their mothers were paid $125.

The study was halted after the public expressed outrage.

Meanwhile, Pam Ruff, the medical technician in Fargo, had been expressing her outrage for over two years now about the emerging trend of heart valve issues in younger women who had been taking FinFin.

But nobody was convinced.

It was very frightening because

as time went by, I felt stronger and stronger and I really increased my efforts and worked harder and harder to get some attention.

Finally, in December 1996, while examining a patient, Dr.

Jack Crary, a cardiologist at Merrickare and Fargo, recognized and confirmed the phenomenon that Pam Ruff had described.

He reviewed the echocardiograms that Ruff had flagged.

If there were 12 cases of malfunctioning heart valves in their small town, population a little more than 150,000, Dr.

Crary feared, how many more were there throughout the rest of the country?

Malvular heart disease doesn't just pop up like that.

Somebody had to do something that there wasn't anybody else sitting in a chair but me.

I had to do something.

Dr.

Crary called an old friend and colleague, Dr.

Heidi Connolly, a cardiologist at the renowned Mayo Clinic.

She confirmed seeing similar cases.

A few patients with those exact symptoms had been referred to the clinic for heart surgery.

During those operations, she said, doctors found the defective valves covered in an unfamiliar, glistening, white, waxy, plaque-like substance.

It's unusual to find valve disease in a young population.

In addition, these valves had a very unusual appearance.

It's like a waxy substance that is attached to the valve and because of that, the valve is not able to close efficiently.

Dr.

Heidi Connolly and her colleagues from the Mayo Clinic agreed to lead a study into these unusual occurrences.

By early July 1997, it found 24 cases of that particular form of heart valve disease and were able to identify the culprit.

fenfluramine.

More specifically, Connolly concluded that fenfluramine destroyed the body's ability to control the amount of serotonin in blood plasma, and the excess adhered to human heart valves like barnacles on a boat.

Fentramine, the other fin in FinFin, was not implicated.

The Mayo Clinic's findings were set to be published in the August edition of the New England Journal of Medicine.

However, since a potentially massive public health risk was involved, The journal recommended making the data public as soon as possible.

Dr.

Connolly described the potential link between the unusual heart valve disease and fenfin during a nationally televised press conference on July 8th, 1997.

We have identified 24 women with an average age of 43 who were treated with the fenfen combination for approximately 12 months.

Most of these patients were identified by Dr.

Crary and his colleagues.

All 24 women were previously healthy.

They developed the same unusual form of heart valve disease.

None of the patients have died.

However, many have developed serious cardiovascular diseases requiring either medication or surgery.

And some words of advice tonight from the researchers at the Mayo Clinic.

If you are taking the FinFen combination currently, see your doctor to talk about the health danger.

This was another record day on Wall Street.

The Dow Industrials gained more than 100.

The U.S.

Food and Drug Administration issued a public health advisory in response to the Mayo Clinic study.

To determine the scope of the crisis, the agency sent letters to 700,000 healthcare practitioners and institutions around the country requesting information on similar cases.

By September 1997, the FDA had received 120 additional reports of FinFin-related valvular heart disease.

Long-term users were most affected.

The agency estimated that as many as 725,000 U.S.

patients were in danger, even if they currently had no symptoms.

The FDA calls the drugs silent killers.

Even if a person on them does not feel sick, they could be in trouble.

Just as concerning were the reports of fenfin-related primary pulmonary hypertension, an irreversible and terminal condition in which the blood vessels in the lungs tighten to the point of asphyxiation.

PPH was a known side effect of fenfluramine when it was approved.

but it was purported to be extremely rare, affecting only 20 patients per million.

But judging by the numerous reports that had come into the FDA, the condition appeared to be much more common than initially thought.

American Home Products downplayed the recent findings in a news release, calling the Mayo Clinic's data, quote, limited and therefore not conclusive.

The company claimed it was working with the clinic to investigate the matter further, but added a reminder that obesity itself is associated with serious health disorders.

As the number of cases continued to climb, the FDA had seen enough and encouraged American Home Products to voluntary withdrawal pondamine and redux from the market.

AHP had no choice but to comply.

The move was announced on September 15th, 1997.

Dexfenfluoramine, marketed as Redux, is coming off, as is fenfluoramine or pondamine, which is part of the two-drug combination called fenfen.

The response from FinFen's user base varied from anger to disappointment.

from fear to desperation.

If they sell them in Canada, I'll drive up there and come back with a carload, a 65-year-old woman told the New York Times.

There are people who can't live without those drugs, she said.

For me, Finthin is an alternative to dying.

For thousands of other people, Finthin was the reason they were dying.

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Patricia Buell developed severe heart problems after taking Fenfen, a diet drug the FDA banned in 1997.

She's now in line for a life-saving heart-lung transplant.

Stacey Rieger was no different than 6 million others who took the diet drugs Fenfen as magic pills to melt fat.

She lost 35 pounds, but now says an echocardiogram shows one of her heart valves is leaking blood.

Patients like Nicole Jackson, who lost 70 pounds in seven months, but now face heart surgery.

Too late for Linda Rhodes, who needed a heart valve replaced after taking Fenfen.

Sammy Kudner may need a lung transplant.

It's awful.

I mean it's just awful.

I mean I will never have my life back the way I want it.

I mean I'll never get to do the things I wanted to do.

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Mary Lennon wanted to lose 25 pounds in time for her wedding.

So in May 1996, the 29-year-old graphic artist from Quincy, Massachusetts, went to a doctor to explore her options.

She was prescribed the FinFin combination.

The results were almost immediate, but so were the side effects.

Mary stopped taking FinFin after just 23 days.

The dizziness, the shortness of breath, and the fatigue all seemed to dissipate when she got off the drugs, but a few months later, the former high school athlete couldn't climb a flight of stairs without passing out.

Mary Lennon was forced to postpone her wedding because she could barely get out of bed.

Soon, doctors would diagnose Mary with primary pulmonary hypertension, a disease that carries a four-year mortality rate.

Mary's time and options were limited.

She could opt for a heart and lung transplant with a 50% success rate.

Or she could, and did, choose the Flowland pump that requires the implantation of a tube directly into her chest connected to a purse-sized machine that she would have to lug around for the rest of her short life.

Mary Lennon would never be able to live an active lifestyle.

She would never be able to have children.

She had been robbed of a future.

All because she wanted to go from a size 10 to a size 8 to better fit into her wedding dress.

Mary told her fiancΓ© Tom that it was okay if he no longer wanted to marry her.

But Tom stayed by her side until she took her final breath on February 20th, 1997.

Mary Lennon had recently turned 30 years old.

Her parents filed the first wrongful death lawsuit against American Home Products on May 5th, 1997, two months before fenfluramine was withdrawn from the market.

The first of as many as 50,000 personal injury lawsuits that would follow.

After taking Fenfen, did you or someone you love have heart valve surgery?

If you or a loved one has used Fenfen or Redux, please listen carefully.

Symptoms include shortness of breath, chest pains, memory loss, and fatigue.

However, heart damage is possible without experiencing any symptoms.

American Home Products responded to the flurry of lawsuits by launching a $90 million public relations campaign.

The company threw millions of dollars at the nation's top epidemiologists and medical celebrities to produce studies demonstrating that fenfluramine and dexphenfluramine posed no permanent or serious health problems.

These results should be reassuring for the majority of patients who have been on redux, Dr.

Neil Weissman at Georgetown University said of his study, commissioned by AHP for $18 million.

The media took the bait.

Study of diet drugs finds no ill effect on heart, read the New New York Times April 2nd, 1998 headline.

Study, no heart damage from diet drug, wrote USA Today.

A false scare, reported the evening news.

But, as the New England Journal of Medicine discovered, these studies were misleading.

Weissman's research, for example, only analyzed patients who had taken redux for short periods of time, when in reality most FinFin users were taking the drugs for much longer, as it had been approved and prescribed.

Another study compared the heart valves of young FinFin users to a population of older non-users and discovered no difference in the rate of abnormalities.

This apples and oranges comparison was reported as good news.

AHP had gotten its money's worth, or at least its insurance company did.

AHP argued that the studies were necessary to defend itself in court and thus qualified as a claim.

A more legitimate follow-up study by the Mayo Clinic confirmed the initial fears.

Patients who had taken FinFin long term were more susceptible to both the heart valve disease and PPH, and their conditions did not improve once they passed the, quote, point of no return.

The number of new cases continued to mount.

I think that the public needs to understand that no product, no food, no device, no intervention is ever perfectly safe or perfectly effective.

The U.S.

Food and Drug Administration also found itself on the defensive, pointing out that every product we use has inherent risk.

While that may be true, how does a medication like Redux go from being approved for widespread use to being pulled from the market in less than a year?

A look back at the process leading up to the current events would only raise more eyebrows.

In a race to cash in on FinFin's overnight popularity, American Home Products intensely lobbied the FDA's medical review panel for a fast-track approval of Redux in September 1995.

During the hearing, the panel heard testimony from the drugs critics about how how fenfluramine and the newer dexphenfluramine caused significant brain damage in mice and baboons, similar to ecstasy-induced neurotoxicity, where serotonin levels plummet and stay there for weeks, resulting in a deep and sometimes permanent depression.

The drug makers argued that there was no evidence to suggest that redux would cause similar damage in humans.

There was no evidence because those tests had never been performed.

They had teams of people whose sole job it was was to try to minimize the warnings, resist strengthening the warnings at all costs, do whatever they could to convince the FDA that the warnings didn't need to be strengthened.

In addition to the PPH concerns, the potential brain damage combined with the drug's unremarkable results was enough for the FDA medical review panel to vote against approving Redux 5-3.

The story should have ended there.

However, After one of the FDA's panelists claimed to have misunderstood the instructions, a revote was scheduled for November 16th of that year, which coincidentally conflicted with the annual International Conference of Neurotoxicity that all of Redux's critics would be attending.

This time, the vote was 6-5 in favor.

Redux became the first weight loss medication approved by the FDA for long-term use.

Dr.

Leo Luttwack, an endocrinologist, was one of the FDA medical reviewers who consistently voted no.

He felt that Redux had not been thoroughly tested and that the side effects observed were less rare than the drug company had made them out to be.

Luttwack felt there would be considerable risk in granting approval, especially for a medication that only proved to be 3% more effective than a sugar pill.

I felt from the very beginning that the drug companies were covering up.

I felt from the very beginning that these drugs were dangerous.

Dr.

Luttwack's intuition would prove correct.

American Home Products and its drug subsidiary Wyeth knew far more about the risk of fenfluramine and dex fenfluramine than it had shared.

The company had been receiving and tracking PPH cases from Europe as early as 1994.

It was aware of more than 100 cases among patients taking pondamine, even though the drug's label said there had only been four.

AHP and YF executives also feigned ignorance when the Mayo Clinic exposed the medication's heart valve troubles.

This is the first time this kind of information has been received by us, the company's medical director, Dr.

Mark Dyach, told CBS, which was patently untrue.

More than 50 cases of the valve disease had been identified in adverse event reports since 1991.

The company described it as such internally, but listed it as something else entirely in its publicly submitted reports.

Not to mention, the Mayo Clinic had alerted AHP about its hard valve-related findings in March 1997, four months before the public was made aware.

Yet AHP stayed mom, and quote, lost the data that Mayo had provided.

Another $50 million worth of the dangerous drug was sold until the day it was pulled.

AHP's motivation to hide these unsavory facts was to avoid the dreaded black box warning, the FDA's strongest warning that indicates a drug carries a significant, potentially life-altering adverse effect.

Internally, the company had calculated that a black box warning on Redux, which was pending approval, would cost them more than $800 million in lost sales over a three-year period.

AHP had also determined that it could absorb 30 wrongful death lawsuits annually while still generating a healthy profit.

There's one thing that American Home Products did well, and that was marketing surveys and trying to see how they could market this product and sell as much as possible.

If they had put the same efforts into the safety studies, I don't think we'd be here today.

That's Dallas-based attorney Kip Petroff, who uncovered many of these damning facts during the discovery phase of the first personal injury lawsuit against American Home Products that went to trial in August 1999.

Until then, AHP had been settling out of court with victims to avoid setting a precedent and embarrassing public disclosure.

But this case was different because American Home Products was confident it would win.

Petroff's plaintiff, Debbie Lovitt, was a 36-year-old, overweight smoker from Grand Celine, Texas, who had been diagnosed with heart disease in 1989, seven years before even taking FinFin.

Despite Lovitt claiming that the drug combination had worsened her condition, she had only experienced shortness of breath and didn't even miss a day of work as a manicurist.

Even her own cardiologist testified that he didn't believe FinFinn was to blame for Debbie's ailments.

However, in a shocking turn of events, a jury in East Texas, a region historically sympathetic to big business, must have been disgusted by the facts presented in court because it found American home products to be 100% liable for Debbie Lovitt's medical issues.

Kip Petroff had pulled off the impossible and his client was awarded $23.4 million.

I think it is wonderful that we have made a statement that they cannot do this to people.

They can't do this to people just like me and you.

It's just wonderful.

AHP's lawyers didn't think it was wonderful.

There's no scientific evidence whatsoever to support this conclusion, one of them lamented, before immediately filing an appeal.

The Lovitt Award was eventually reduced to less than 10% of the original $23 million, but not before American Home Products' stock price tumbled, and for good reason.

The company was in full panic mode.

The case is likely to have far-reaching implications.

While American Home Products says it will appeal, the company still faces more than 3,000 other lawsuits.

Thousands of those individual lawsuits, as well as multiple state class action lawsuits, were soon consolidated into one massive class action lawsuit called Brown v.

American Home Products.

The Debbie Lovett verdict almost assuredly submitted a settlement for the 650,000 plaintiffs.

The case was heard in a federal district court in Philadelphia.

A pharmaceutical company agreed today to one of the nation's largest product liability settlements ever.

It covers millions of people who took diet drugs and involves billions of dollars.

A global settlement was announced on October 7, 1999.

With interest, it amounted to $4.83 billion,

one of the largest settlements ever in a product liability case.

The settlement covered all 6 million users of Pondamin and Redux, whether they had sued AHP or not.

It was in the best interest of those who used the drugs as well as the company, announced CEO John R.

Stafford.

even though he claimed the company had acted, quote, lawfully and responsibly at all times.

We made the decision to settle to avoid the uncertainty and distractions of litigation.

A settlement does not imply any wrongdoing on the part of the company.

Almost half a billion dollars of that nearly $5 billion settlement was used to pay the fees of over 100 attorneys.

$1 billion was earmarked for ongoing medical monitoring for those who took the drug but had not yet developed any symptoms.

and $2.5 billion was paid out to individual claimants based on the severity of their injuries.

Those with diagnosed hard valve disease received as much as $1.5 million each.

Those with minor complications were eligible for a refund on their $60 prescriptions.

The average payout amounted to less than $8,000,

and those payouts would take years to receive.

All the 6 million claimants had to do to collect payment was show proof that they had taken the drugs and had been diagnosed with hard valve damage.

The giant pool of money remained the same regardless of causation, so why would AHP care if people weren't telling the truth?

That was up to the lawyers to figure out.

What happened next was utterly predictable.

Shady attorneys and shady physicians colluded to manipulate echo cardiograms without their clients' knowledge.

Kickbacks were exchanged.

Some law firms employed medical staff or launched sonography clinics, which became known as Echo Mills, that performed hundreds of examinations per day.

Suspecting fraud, the trusts distributing the awards decided to review and re-review each case individually, which slowed the process considerably.

60% of patients tested had evidence of heart damage and filed a claim.

When those same claimants were retested later, that number dropped to just 5%.

Meanwhile, thousands of people whose health effects were overstated by their doctors and lawyers now believed that they had heart valve disease.

There's at least one confirmed case of a healthy patient undergoing completely unnecessary valve replacement surgery, and there's probably more.

It never ends.

Today's settlement, as big as it is, is not necessarily the end of FenFen litigation, because while any of the 6 million people who took FenFen can accept the class action settlement, they don't have to.

They can opt out now or in the future, file suit on their own, and take their chances with a jury.

A rare aspect of American Home Products global settlement was that it allowed users to opt out even after they learned the amount of their award.

Roughly 50,000 plaintiffs chose to do so, assuming they would win higher sums in state court, as evidenced by the Debbie Lovett case and others.

Their assumptions were mostly correct.

AHP settled as many of the opt-out cases as it could, as quickly as it could, especially after a jury in Oregon awarded a bus driver and her 40-year-old son $29 million.

All told, the FinFin debacle would cost American home products over an estimated $20 billion.

However, one of the largest remaining cases, a class action settlement for 400 opt-outs in Kentucky, was still being negotiated.

That saga would result in an entirely separate scandal of its own.

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There is no question this was a tragedy that should not have occurred.

And when there's a tragedy like this, there's no compensation that you can get to ever take away the hurt and the pain.

Stan Chesley had earned plenty of nicknames throughout his 40-year career.

The Cincinnati, Ohio-based lawyer has been called the Prince of Torts, the Master of Disaster, and the father of the class action lawsuit for winning an estimated $350 billion in settlements from major corporations for their roles in disasters and defective products.

Chesley made his name representing plaintiffs in the 1977 Beverly Hills Supper Club fire.

Most famously, he negotiated settlements with Dow Corning for their defective breast implants and the major tobacco companies.

There will no longer be billboards.

There will no longer be Joe Camel.

There will no longer be the Marlborough man.

The Marlborough man has just ridden out of town on Joe Camel.

Stan Chesley had also negotiated the Global Finfin settlement with American Home Products.

After its approval, Chesley took notice of what was happening on the other side of the Ohio River with a group of opt-outs in Kentucky.

If you've been hurt at work or in a wreck, the Melbourne Mills Jr.

Law Office is there to help you fight.

For personal injury, the man to call is Melbourne Mills Jr.

Lexington attorney Melbourne Mills, famous for being the first lawyer in America to advertise on TV, signed up hundreds of FinFin plaintiffs using his tried and true commercials.

A more impressive drunk than a courtroom lawyer, Mills combined his case with a more forceful attorney across town named Bill Galleon, but a few Finfin clients of his own.

Another Lexington personal injury attorney named Shirley Cunningham contributed another 100 plaintiffs to complete the Kentucky trio.

Together, the group had filed a class action suit in Boone County on behalf of their 431 clients, Guard et al.

v.

American Home Products.

In January 2000, Stan Chesley advised three of his clients to opt out of the global settlement so that he could file his own lawsuit in Kentucky.

Once the paperwork was completed, Chesley filed to consolidate his lawsuit with the Guard litigation, essentially weaseling his way in as co-counsel.

Once approved, he advised those three clients to rejoin the global settlement.

Bill Gallion, Shirley Cunningham, and Melbourne Mills, referred to collectively hereafter as GCM, agreed to let Stan, master of Disaster Chesley, negotiate the Kentucky settlement.

He'd already done it once.

He had established contacts at AHP.

The company had no interest in participating in another jury trial.

So the lawyers hashed out the terms.

GCM would split 74% of whatever attorney fees were received.

Chesley would get 21%.

And any other lawyers involved would share the remaining 5%.

Fair enough.

A settlement was reached between the 431 Guard plaintiffs and American Home Products in May 2001.

$200 million.

It was the largest per plaintiff settlement so far, which probably would have made the plaintiffs ecstatic.

had they ever learned the true amount.

Instead, GCM kept the numbers secret and began meeting with each client individually to negotiate their share of the settlement.

The lawyers would offer the lowest amounts possible and stress confidentiality.

They threatened that even telling a family member could result in fines or jail time.

In the end, only $45 million, or about 23% of the $200 million settlement, was distributed to the plaintiffs.

The remaining $155 million was deposited into the attorney's personal accounts.

Bill Galleon received $54 million, Shirley Cunningham received $48 million, and Melbourne Mills received $17 million.

Stan Chesley, the negotiator, would eventually receive his quote-unquote fair share of $20 million.

Nobody was the wiser until Bill Galleon's law partner grew suspicious and snooped through his partner's emails.

Bill had told his partners that the settlement was for $40 million, so Galleon's partner alerted Melbourne Mills' partner, who confronted his colleague.

Mills was surprised by the $200 million amount as well.

Galleon and Cunningham had told him that the settlement was for $150 million.

At the same time, Guard plaintiffs were complaining to the Kentucky Bar Association that GCM had been less than transparent about the payments.

The KBA launched an investigation into the matter, and the lawyers started panicking and began distributing additional monies.

We are pleased that we have been able to accomplish this for you, the lawyers announced to their clients, as if they had pried pried additional funds from AHP's greedy fingers.

This is highly unusual.

An additional $28 million was distributed to claimants for a total of $73 million, which was still $67 million short of what they were legitimately owed.

GCM also asked their clients for permission to donate any leftover funds to the charity.

Most agreed after being convinced the remnants amounted to about $100.

In actuality, GCM was referring to about $20 million,

and the charity it would be gifted to was a charity that they, the lawyers, had just created and owned.

The Kentucky Fund for Healthy Living was founded on the mission of addressing the health consequences of obesity.

Gallion, Cunningham, and Mills were its founders and board members.

They each received about a $60,000 salary.

The charity and the $20 million distribution were approved by Judge Joseph J.

Bamberger, who became a charity trustee himself when he retired as a circuit court judge in December 2003?

He was paid $50,000 plus expenses by the Fund for Healthy Living, a year after being named the Kentucky Bar Association's Outstanding Judge of the Year.

Bamberger would later be disbarred for his involvement.

It was bad enough that Fenfen gave them permanent heart damage, but then their own attorneys, William Gallion, Shirley Cunningham, and Melbourne Mills, ran off with most of the money.

The misdeeds of GCM would be publicized in November 2004 when a guard claimant walked into the office of another Lexington attorney named Angela Ford.

Ford contacted all 400-plus plaintiffs and convinced the vast majority of them to join a lawsuit against their former lawyers, including Stan Chesley.

A judge's ruling that the lawyers should repay their former clients a total of $42 million was later overturned on appeal.

In the meantime, those lawyers were enjoying their ill-gotten gains.

Bill Gallion, who already owned a 5,000-square-foot home in Lexington, purchased a chateau in France, four Porsches, and a luxury home in Florida.

Shirley Cunningham also took up residence in the Sunshine State.

In addition to his new million-dollar house, he announced that he was making a $1 million donation to the Florida A ⁇ M Law School in HBCU, where his mentor, Frederick Humphreys, served as the school's president.

In exchange for his endowment, the Cunningham Chair was created, a position that would be occupied by a distinguished legal scholar, who would also be a member of the teaching faculty.

Shirley Cunningham volunteered to be the chair's first occupant.

He received $100,000 a year plus benefits from August 2003 to April 2005 until a payroll audit revealed that he and 41 other FAMU employees had never actually stepped foot on campus.

When investigators unlocked the door to Cunningham's assigned office, They found him standing purposeless among the dust and unplugged electronics, flight luggage still in hand.

But not not even that was the most newsworthy event that involved the lawyers post-settlement.

Together, Bill Galleon and Shirley Cunningham founded Midnight Cry Stables and started purchasing horses, including a thoroughbred with a worrisome ankle they named Curlin, after Cunningham's great-great-grandfather, Charles Curlin, a slave who fought for the Confederacy during the Civil War.

Anyone familiar with horse racing history knows what happened next.

Curlin, courageous, and chasing home!

Curlin on the outside!

Curlin's courageous!

Streets and trying to hold!

Final finish!

It couldn't go to Curlin!

Curlin, I think, that'll buy a nose!

A final finish and a frantic finish there in the Preakness Stakes!

Curlin went on to win first place in 11 of his next 16 races and was named American Horse of the Year two years in a row.

When Curlin won the Preakness Stakes on May 19th, 2007, you can see Bill Gallion and Shirley Cunningham in the winner's circle hoisting the silver trophy.

Less than a month later, both men, along with Melbourne Mills, would be indicted on federal fraud charges.

All three men were held in the Boone County Jail until their trial began 10 months later.

Federal prosecutors alleged that GCM had engaged in an illegal conspiracy to hoard more than $94 million from their clients.

Bill Galleon's defense claimed there was a misunderstanding of the settlement agreement and that every claimant had been more than fairly compensated relative to similar Finn Finn litigation.

Shirley Cunningham's lawyers described their client as an innocent bystander just along for the ride.

And Melbourne Mills claimed that he was too drunk to have knowingly participated in the scam and that he too had been a victim of the backstabbing lawyers.

The jury concurred, with that last part at least.

After six days of deliberations, Melbourne Mills Jr.

was acquitted of all charges.

We got the greatest court system in the world.

This is the greatest country in the world.

With the greatest court system, I'm looking forward to getting back into it.

However, the jury could not reach a unanimous verdict for Gallion and Cunningham.

Deliberations continued for two more days until a mistrial was declared.

A new trial was scheduled, and the two lawyers were finally allowed to return home.

At the second trial, in April 2009, Gallion and Cunningham were convicted of multiple counts of conspiracy to commit wire fraud.

Bill Gallion, 58 years old, was sentenced to 25 years in prison.

Shirley Cunningham, 54, was sentenced to 20.

They were also ordered to pay $127 million in restitution, part of which would be recovered from the sale of their assets, including Curlin the racehorse, who was worth millions of dollars.

The Fin Finn claimants who were owed money were happy to claim the champion.

I really think that if he could talk, he would be really, really disappointed with the human race.

Years later, in August 2013, the Kentucky Supreme Court reinstated the earlier $42 million civil judgment against the lawyers, including Stan Chesley, but escaped criminal liability.

After collecting $17 million of the total, a judge ruled that Stan Chesley was on the hook for the remaining 25.

Chesley refused to pay.

The 78-year-old Prince of Torts had consistently maintained innocence and ignorance of any wrongdoing related to the Kentucky settlement.

The $20 million he had collected from it was prearranged and justified, he said.

Just like in that other case in which he was being accused of fraud.

The lawsuits accused Chesley of defrauding sexual abuse victims he represented during a settlement with the Diocese of Covington.

That particular lawsuit was eventually dismissed, but the Fin Finn settlement never went away.

Stan Chesley ultimately retired from law after 53 years to avoid disbarment in his home state of Ohio.

He also started liquidating assets and moving money around to conceal his wealth from the claimants whom the court said he owed.

In one maneuver, Chesley's law firm sold 33 cars to his wife, Susan DeLotte, a senior U.S.

district judge, for significantly less than they were worth and then bought them back at bargain rates to lower the value on the books.

He also wrote a million-dollar check to an entity called Corey Cummler, which was also later revealed to be his wife, Judge DeLotte.

On paper, Stan Chesley had managed to lose $90 million in less than a year.

The king of the settlement was open to settling with the Finn Finn claimants, but not at that $20 million figure.

I've always thought the most I owed was $6 million to $7 million, but nobody ever came came to me with that, Chesley told the Cincinnati Inquirer.

When someone wants to get it done, I will talk.

I always thought resolution was the way to go.

Chesley had no plans to back down.

High-profile attorney Stan Chesley is now counter-suing five of his former clients and their lawyer to stop them from collecting millions from him.

In September 2015, Stan Chesley sued Lexington lawyer Angela Ford and five of the Guard plaintiffs to prevent them from collecting the money they were owed and from finding out how much he was truly worth.

I was astonished when I first heard about it and thought it was comical, Bord told the inquirer.

But once the judge allowed it to continue, I didn't think it was so comical anymore.

Stan Chesley also sued the Hamilton County Sheriff's Office in November 2015 to prevent them from enforcing a warrant for his arrest after he no-showed a court hearing in the case.

It was evident to his critics that Chesley was dragging out the litigation for as long as possible, knowing that many of the Fin Finn claimants were already racing against the clock.

25 of the original 400 Kentucky plaintiffs had already died from complications.

But then, those more uncouth than I might suggest that karma came barging through the door.

Indian Hill 911.

Yeah, 911, this is judged a lot.

Okay, I have an officer at your house right now.

Please send more.

The three black men with guns are our house.

They're in your house right now?

Yes!

On December 15th, 2015, Stan Chesley and Judge Susan DeLotte were awakened at 10.45 p.m.

by three men surrounding their bed, pointing guns in their faces.

Where are the safes?

Where are the Rolexes?

The men demanded.

We only want Rolexes, motherfucker.

Earlier that night, the three armed men spotted a Rolls-Royce in the city and followed it to the most expensive home in Cincinnati, a 25-room, 27,000-square-foot mansion that's set on 300 wooded acres in Indian Hill.

The robbers waited for the lights inside to turn off before kicking in the basement door.

After ransacking the house, they ordered the occupants out of bed and into the garage at gunpoint while demanding keys to the cars.

Susan looked him in the face and said, here are keys.

I'm a United States federal judge.

And the FBI will look for you forever because he had a gun to my head.

Turned Turned out that gun was a 45 automatic.

Had to be a big gun for this guy.

Big, big, big gun.

When one of the assailants became physical with Judge DeLotte, Stan protested and was pushed down a small flight of stairs, fracturing his spine and pelvis.

Spooked by the commotion, the robbers fled without the vehicles.

Susan DeLotte traversed the woods barefoot and bloodied in her nightgown to a neighbor's house for help.

Within an hour of the incident, Indian Hill police pulled over a car for a traffic violation.

The three occupants matched the description of the robbers, and when the vehicle was searched, police found guns and stolen property, including Stan Chesley's driver's license.

21-year-old Terry Jackson, 20-year-old Demetrius Williams, and 20-year-old Daryl Kinney were arrested and each charged with multiple felony counts.

Kinney was also charged with vandalism and escape after kicking out the back window of the police cruiser and fleeing on foot.

All three men pleaded guilty and were sentenced to 34 years in prison.

Both Chesley and DeLotte spoke at their assailants, sentencing Herring.

These three men do not deserve any mercy, anything other than the most maximum sentence.

I hope they never get out of jail.

Stan Chesley and Susan DeLotte sold their Indian Hill mansion the following year to settle a lien filed by the IRS for $10 million in unpaid federal income taxes.

But the battle with the FinFin claimants continued.

The Ohio Supreme Court was forced to intervene twice before an appeals court ultimately upheld the ruling that Chesley owed the money in June 2018, noting that the lawyer had defrauded hundreds of clients through a high-stakes shell game and that his attempt to shelter assets to avoid paying the multi-million dollar judgment was the product of fraud.

Former attorney Stan Chesley hatched a scheme to defraud hundreds of creditors.

That's the ruling from the Sixth Circuit, and that upholds a lower court's ruling freezing Chesley's assets.

It seems it stems from the judgment against Chesley that was brought by plaintiffs that he once represented in the Fenfen diet drug settlement.

Chesley's law firm eventually paid $23.5 million to the FinFEN clients in October 2018 to settle their portion of the liability.

To date, Stan Chesley himself hasn't paid a dime.

It's been more than a decade since the diet drug FenFen was pulled from the market after it was linked to heart problems.

The drug maker American Home Products paid out billions in settlements, but all these years later, some victims are still fighting for their money.

Several of the FinFin victims from Kentucky, forever suffering the effects of the magic pill, have gathered in Cincinnati to demand Stan Chesley's arrest while hoping to collect what they are owed.

We're very sick people and we've been waiting, said Lisa Swager of Sawyersville, Kentucky, an unsatisfied victim who reportedly purchased seven Dodge Durangos with the settlement funds she had already received.

But that's none of my business.

Their Their injuries and grievances are legitimate.

I was supposedly awarded $5 million.

One of the higher-paid people, another victim, Evelyn Hopkins, protested.

I haven't gotten anywhere near that.

This money was to take care of us.

It's a shame that this man is living a life of luxury.

I have primary culminating hypertension from the disease, from the fitness.

I have a pacemaker.

I have stints in my heart.

I have a leaking valve.

I can't work any longer.

I have no energy.

I have no way to support myself.

He is living in a castle mansion.

Yeah,

it wouldn't hurt him to pay us, and he probably wouldn't even miss it.

He's got so much.

There's some of us that's gonna die before this self-with, and I might be one of them.

You know, it's destroying me, it's destroyed my family.

Swindled is written, researched, produced, and hosted by me, a concerned citizen, with original music by Trevor Howard, aka DeFormer, aka Corey Kumler.

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