TGN1412 drug trial update: One patient may lose fingers and toes due to drug side effects

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Ryan Flanagan was a healthy, 21-year-old student living in London. Like many college students, Flanagan needed a little bit of extra money, and a prescription drug trial advertised on the internet looked like just the way to get it.

"He told us he would be paid 2,000 pounds ($3,500) and did not think there would be any problems," Sarah Brown, a 27-year-old family friend of the Flanagans, told UK-based newspaper The Sun.

On the night of March 14, only three hours after taking tablets of the drug TGN1412, Flanagan was suddenly admitted to Northwick Park Hospital in London.

"His mother got a call to say his head and neck were swelling up and his legs were purple," Brown says. As of March 15, Flanagan was alive but listed in critical condition.

Flanagan was one of six men admitted to the hospital after suffering severe adverse reactions to TGN1412, an immunomodulatory humanized agonistic anti-CD28 monoclonal antibody produced by the German-based pharmaceutical company TeGenero AG as a possible treatment for leukemia, multiple sclerosis and rheumatoid arthritis. One man's head swelled to three times its normal size, causing excruciating pain and leading to him screaming that he felt his head would explode.

Now, more than a month after the incident, doctors frankly don't know whether the adverse effects are reversible, especially for 20-year-old trial volunteer Ryan Wilson, who is the lone volunteer still hospitalized. Wilson had slipped into a coma for three weeks after taking the drug, and after awakening, discovered that he may lose parts of his fingers and toes, which had turned black because of his reaction to the drug.

"I'm told it's like frostbite and my fingers will just fall off," Wilson told the UK's News of the World recently. In addition to being in a coma for nearly a month, Wilson also suffered from heart, liver and kidney failure, septicemia, pneumonia and dry gangrene.

Marshall says her boyfriend -- a previously healthy, 28-year-old bar owner in London -- had changed beyond recognition immediately after taking TGN1412.

"I went in expecting to see his smiley face and curly, black hair, but he was completely lifeless," she says. "He's like a shell of who he is. He can't even move his eyelids. The machine is pumping out of his lungs. His chest is puffed out. His face is puffed out like the Elephant Man. A day ago, I was talking to him and he was fine, and now they are saying he could die at any moment."

Flanagan and the other men were part of a phase one research trial run by the American drug research company PAREXEL International. Since it was a phase one trial, TGN1412 had never been tested on humans before. In fact, the purpose of phase one trials is to test whether drugs are safe for humans. As the BBC News explains in "Q&A: Drug trials," "A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects." In other words, TeGenero technically could not be expected to have anticipated the adverse reactions experienced by the drug trial participants, as the whole point of a phase one trial is to determine whether a pharmaceutical is safe.

On March 15, TeGenero posted press releases that state animal-based studies previously ran on TGN1412 gave it no idea that such horrible effects would happen on humans. "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers," CEO Dr. Benedikte Hatz explained.

TeGenero AG Chief Scientific Officer Dr. Thomas Hanke reiterated, "The drug was developed in accordance with all regulatory and clinical guidelines and standards. In pre-clinical studies, TGN1412 has been shown to be safe and the reactions which occurred in these volunteers were completely unexpected." TeGenero AG also points out that the Medicines and Healthcare products Regulatory Authority (MHRA) -- which is the UK's equivalent to the FDA -- and the local ethics committee approved the PARAXEL-monitored clinical trial.

Like TeGenero AG, PARAXEL maintains that it did nothing wrong, as it fully complied with phase one clinical trial guidelines and did all it could to help the drug trial volunteers. In a March 15, 2006 press release, PARAXEL Head Dr. Herman Scholtz explained what happened during the trial and how the company handled the volunteers' severe adverse reactions:

"When the adverse reaction occurred, the PAREXEL clinical pharmacology medical team responded swiftly to stop the study procedures immediately and notified authorities. We worked in cooperation with the hospital intensive care doctors and the sponsor to have the volunteers given the best possible care, and to explore all possible treatment options.

Speculation over whether PAREXEL and TeGenero did in fact conduct the study properly has prompted the MHRA to look into the issue with the help of the Department of Health, the Metropolitan Police and the North West London Strategic Health Authority. MHRA CEO Professor Ken Wood told The Times that it would investigate whether PAREXEL or TeGenero should be held responsible for the volunteers' negative health effects, stating:

"Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken.

"There are several possibilities as to what might have gone wrong. We’ve had inspectors on site since yesterday trying to clarify what exactly the event was that caused this disaster.

"Has there been some manufacturing problem? Has there been some issue of contamination? Has there been a dosing error or is this indeed some completely unanticipated side effect of the drug in humans, which is specific to humans?"

As one might imagine, accountability is already an issue in this clinical trial disaster. Lawyers have been hired to represent the critically ill men, reports BBC News. One lawyer, Ann Alexander, says that the families of the volunteers have been receiving "mixed messages" during the days since the adverse reaction first appeared.

These mixed messages might partly have occurred because doctors had no idea what to expect, since TGN1412 had never been tested on humans before. Myfanwy Marshall, whose boyfriend is one of the victims -- a 28-year-old man who was listed in critical condition along with Flanagan and four others after the trial -- told BBC News that doctors have been working constantly to try and make the volunteers better and also have been communicating with the American and German scientists who developed the drug to learn answers -- yet they are still unsure.

"The doctors say they are in the dark. They don't know the drug or what it can do," Marshall told reporters. She went on to say, "It's a drug they haven't tested on humans before, so they don't know what they're dealing with. All they can do is look at how his body has reacted. They say he just needs to get the drug out of his system. They say he needs a miracle."

Bloomberg.com recently reported that the drug trial victims could be ill for the rest of their lives, according to their lawyers, and that their ordeal could make them vulnerable to immune system diseases like arthritis and lupus. Four of the men are not currently able to work, and have been advised not to go into public because of their vulnerability to infection.

Works cited:

Naughton, Philippe and agencies. "Two fight for lives after drug trial poisoning." Times Online. March 15, 2006

PAREXEL International. Press Release. March 15, 2006

"Q&A: Drug trials." BBC News. March 15, 2006

"Six seriously ill in London hospital as drug trial goes wrong." Breaitbart.com. March 15, 2006

TeGenero AG. Press Releases. March 15, 2006

"They say he needs a miracle." BBC News. March 15, 2006

"London Drug Trial Victims May Be Ill for Life, Lawyers Say." Bloomberg.com. April 21, 2006.

"Drug trial victim may lose fingers and toes." Reuters. April 18, 2006.

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