[Pseudo-Cushing’s] Michigan woman nearly dies after herbal supplement found to be laced with steroids

MADISON HEIGHTS, Mich. (WXYZ) – Since 2004, the U.S. Food and Drug Administration has received more than 26,000 reports of adverse events and complaints about dietary supplements.

Jody Higgins of Madison Heights, Michigan made one of those complaints to the FDA, after she says she found out the herbs she had been taking were making her seriously ill.

“I really thought I was going to die I was getting so sick,” Higgins said.

Back in 2015, Higgins says her legs started hurting.  She says she didn’t have great health insurance, and she was hoping for a more holistic approach, so a friend referred her to Far East Ginseng Herbs and Tea in nearby Sterling Heights.

“They suggested that I take something that was called Linsen Double Caulis. I had never heard of it before, and it appeared to have all herbs on the label,” Higgins said.

Higgins says for a while, she felt better, and when she stopped taking the Linsen Double Caulis, the leg pain returned. So, she says she kept taking it for nearly a year, even though she started noticing strange symptoms.

“Within four months I had gained 80 pounds,” she said.

She suddenly had facial hair growth, severe facial swelling, extremely swollen ankles, and had dark purple stretch marks all over her body.

“I wasn’t recognizable,” said Higgins.  “I couldn’t stand for longer than 2 minutes. I couldn’t cook. I couldn’t wash my clothing. I could barely get in the shower.”

After visiting several doctors, Higgins was eventually referred to University of Michigan Endocrinologist Dr. Ariel Barkan.

“The minute that I said I had been taking a Chinese herbal remedy, he said ‘you’ve been poisoned. I know it.’ Those were his exact words,” said Higgins.

“Her situation was pretty shaky,” Barkan said.

Barkan sent the Linsin Double Caulis herbal supplement to the Mayo Clinic for testing.

“They were loaded with Dexamethasone … [which] is a medication.  It’s a synthetic steroid, very potent, very long acting, and if we take it for quite some time, we develop what is called Cushing Syndrome,” said Dr. Barkan.

Higgins was diagnosed with Cushing Syndrome, and Barkan says she could have died if she hadn’t sought help.

“The mortality for untreated Cushing Syndrome is 50% within 5 years,” said Barkan.  “ … immunity is completely suppressed. And when you don’t have immunity, the first virus, the first germ may cause [a] fatal infection and you will die.”

Higgins says once she stopped taking the Linsen Double Caulis, the facial hair went away, but she’s still struggling with her weight. Barkan says her health should improve, although it will take time.

Both doctor and patient say they have contacted the FDA about this, and they each have a warning about taking herbal supplements.

“Please just be very cautious,” Higgins said.

“Don’t touch it. Don’t touch it, you’re playing Russian roulette,” said Barkan.

Jody Higgins says she met with an investigator from the FDA’s criminal division.

An FDA spokesperson would only say that they do not discuss possible or ongoing investigations.

The lawyer for the store where Higgins says she purchased the supplement told us the owners will not be commenting on, but the owner did say they no longer sell this product.

From http://www.fox4now.com/news/national/madison-heights-woman-herbal-supplement-caused-life-threatening-illness

History of Cortisone’s Discovery

It was Christmas Day in 1914 when the Mayo Clinic chemist Edward C. Kendall, PhD, first succeeded in isolating pure crystalline thyroxin using 6,500 pounds of hog thyroid glands, a success that would set him on the course for making one of the greatest discoveries in medicine in the last century.

His pivotal discovery, according to William F. Young, Jr., MD, MSc, chair of the division of endocrinology, diabetes, metabolism and nutrition at the Mayo Clinic College of Medicine, would lead Kendall, a self-described “hormone hunter,” to conduct adrenal experiments that would eventually change the course of medicine in ways he couldn’t have imagined. Kendall and his team’s discovery of cortisone would lead not only to a breakthrough treatment, Young said, but a Nobel Prize and international acclaim.

In an interview prior to presenting the Clark T. Swain Memorial History of Endocrinology Lecture at ENDO 2017, Young said that understanding the history behind such a monumental discovery can help endocrinologists see how hormone research has evolved, and provides insight into how to make advances in basic science and improve patient care. In preparing to tell Kendall’s story, Young completed archival research at Mayo and uncovered information that has not previously been published, he said.

“The cortisone story originated at Mayo Clinic, where I have been on staff for 33 years,” Young told Endocrine Today. “Although much of this story is not new information, it is not familiar to the current generations of endocrine scientists and clinical endocrinologists. It is a story of discovery science, clinical intuition, persistence, team science, patient volunteerism and sacrifice, hopes, and dreams.”

‘A big oak tree’

When Kendall first took on the project of preparing better adrenal extracts to potentially treat Addison’s disease in 1930, he was already thinking bigger, Young said.

“He once said, ‘I want to grow a great big oak tree … I am not interested in a bunch of blackberry bushes,’” Young said.

During his experiments at Mayo Clinic, the cost of bovine adrenals rose from 0.20 cents a pound to $3 per pound, equivalent to $42 per pound today. In 1934, Kendall struck a deal with Parke Davis Co., were he would extract “adrenalin” at no cost for the company if it would, in turn, deliver to him 600 pounds of bovine adrenals each week, Young said. He would then use the adrenal cortex for his studies.

In addition, Kendall struck a side deal with Wilson Labs, Young said, for an additional 300 pounds of bovine adrenals per week, to produce a cortical extract for them. He would in turn use the adrenal medullas to boost his production of adrenalin for the Park Davis deal.

“From 1934 to 1949, virtually all of the adrenaline used in North America was manufactured at Mayo Clinic in the small town of in Rochester, Minnesota,” Young said. “This lab ran 24 hours a day, in three shifts. By 1949, over 150 tons of adrenal glands had been processed at Mayo Clinic … $12.4 million in research supply dollars.”

A new discovery

In 1934, Kendall recognized through his work that the adrenal cortex produced more than one hormone, Young said. Over the next year, Kendall’s group isolated five crystalline compounds, naming them compounds “A” through “E” based on their order of identification. Compound “E” — what would later be named cortisone — was found to be biologically active, Young said.

Interest in synthesizing the active hormone from the adrenal cortex grew as part of the American war effort in the 1940s, Young said, and the U.S. National Research Council made it a priority. By 1948, 9,000 mg of “compound E” had been synthesized for clinical study; 2,000 mg were given to each of three investigators at Mayo Clinic for studies in patients with Addison’s disease and the remaining 3,000 mg were saved for future study.

In 1948, a patient known as H.G., a 28-year-old women with progressive inflammatory arthritis, presented to the clinic, Young said. After an unsuccessful treatment with the Swedish hepatoxin lactophenin — a therapy used at the time that induced jaundice in some patients, leading to remission — her physician, Philip Hench, went to Kendall for help. Kendall agreed to give Hench some of the remaining 3,000 mg of “compound E,” if Hench could convince Merck to grant permission.

The clinicians did get permission, and H.G. began treatment. Within days, Young said, the improvement was remarkable. Reading from the original, handwritten notes of Hench and his colleagues in rheumatology, , Young detailed the patient’s progress:

“Rolled over and turned off the radio with ease for the first time in weeks,” the notes said from “day 3.” “No more trembling of knees when moving.”

The clinicians were so amazed, Young said, that they filmed H.G’s progress. Young, who obtained the original films from the Mayo Clinic archives, showed footage of a crippled H.G. struggling to stand, only to be walking normally.

“They started taking videos because they realized no one would believe them,” Young said as the video played. “That they actually had something that could affect, up until this point, a crippling disorder.”

Hench came up with the acronym “cortisone,” adapted from corticosterone.

The discovery became international news. In December 1950, Kendall, Hench along with Tadeus Reichstein, received the 1950 Nobel Prize in Physiology and Medicine — just 27 months after H.G. received her first dose of “compound E.”

The future of corticosteroids

Today, Young said, corticosteroids are used for their anti-inflammatory and immunosuppressive properties across the field of medicine. Natural and synthetic glucocorticoids are used to treat a wide variety of non-adrenal diseases, from allergies, to gastrointestinal disorders and infectious diseases.

The important story of patient H.G. — and the scientific journey of Kendall and his colleagues — still resonates, Young said.

“My hope is that this story will remind us of our endocrine heritage and give us an opportunity to recognize the unlimited potential for discovery, research and clinical investigation that is taking place in research laboratories and clinical endocrine centers across the globe,” Young said in an interview. “In the current environment in the U.S., where federal research funds are being cut back, it is important to recall where the major advances in research and public health have come from.”

“There are many other messages in the presentation,” Young said. “For example, the importance of ‘team science’— a phrase only recently coined — has been in place for decades. It is team science that has led to many of the major advances in medicine, including the therapeutic use of corticosteroids.” – by Regina Schaffer

Reference:

Young WF. A Chemist, a Patient and the 1950 Nobel Prize in Physiology and Medicine: The Stories Behind the Stories on Cortisone. Presented at: The Endocrine Society Annual Meeting; April 1-4, 2017; Orlando, Fla.

Disclosures: Young reports no relevant financial disclosures.

 

From http://www.healio.com/endocrinology/adrenal/news/online/%7Bd8d71bcc-a981-418e-9d41-af4b2dcaa48f%7D/history-of-cortisones-discovery-offers-lessons-in-team-science-persistence

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