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Botox: Miracle drug for nearly everything
January 7, 2017, 5:52 pm
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Forget wrinkles. Botox is now being used to treat migraines, depression, twitching eyes, overactive bladders, sweaty palms and more. Some call it a marvel of medicine; others caution the risks are still unknown.

In 2014, Rosenthal, a clinical professor of psychiatry at Georgetown University School of Medicine, and Dr. Eric Finzi, an assistant professor of psychiatry at George Washington School of Medicine, published a study showing that when people with major depression got Botox, they reported fewer symptoms six weeks later than people who had been given placebo injections. “I’m always on the lookout for things that are unusual and interesting for depression,” says Rosenthal, who is widely considered an expert on the condition. “I’ve found Botox to be helpful, but it’s still not mainstream.”

It is also not approved by the US Food and Drug Administration (FDA) for depression, not that that stops doctors from prescribing it that way. Such off-label use of Botox, like that of any FDA-approved drug, is legal in the US. That is because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit, regardless of whether it has been proved to work for that condition.

Now, thanks in large part to off-label use, Botox is increasingly being drafted for problems that go far beyond its original cosmetic function, including for depression, excessive sweating, neck spasms, leaky bladders, premature ejaculation, migraines, cold hands and even the dangerous cardiac condition of atrial fibrillation after heart surgery, among others. The range of conditions for which doctors are now using Botox is dizzying, reflecting the drug’s unique characteristics as much as the drug industry’s unique strategies for creating a blockbuster.

Botox is a neurotoxin derived from the bacterium Clostridium botulinum. Ingested in contaminated food, it can interfere with key muscles in the body, causing paralysis and even death. But when injected in tiny doses into targeted areas, it can block signals between nerves and muscles, causing the muscles to relax. That is how it smooths wrinkles: when you immobilize the muscles that surround fine lines, those lines are less likely to move – making them less noticeable.

In 2015, Botox, produced by pharmaceutical maker Allergan, generated global revenue of $2.45 billion – more than half of which came from therapeutic rather than cosmetic uses. That non-cosmetic revenue is likely to balloon in the years ahead as doctors try out Botox for even more off-label uses and as Allergan conducts studies of its own.

The potential of the drug is enormous, but it is not without risks. Many medical experts agree that in small doses, Botox is safe when administered by a licensed professional, but not everyone agrees that its safety extends to all of its newer off-label uses.

In recent years, a number of high-profile lawsuits have been brought against Allergan in which plaintiffs claimed that off-label uses – for ailments including a child’s cerebral-palsy symptoms, for instance, or an adult’s hand tremors – resulted in lasting deleterious side effects. Still, the drug’s acceptance in a growing number of doctors’ offices worldwide, and its revenue growth, show no signs of slowing.

The drug has come a long way since its ability to smooth facial wrinkles was first discovered, by accident. In the 1970s, ophthalmologist Dr. Alan B. Scott started studying the toxin as a therapy for people with a medical condition that rendered them cross-eyed. “Some of these patients that would come would kind of joke and say, ‘Oh, Doctor, I’ve come to get the lines out.’ And I would laugh, but I really wasn’t tuned in to the practical, and valuable, aspect of that,” Scott told CBS in 2012. Scott named the drug Oculinum and formed a company of the same name in 1978. In 1989 he received FDA approval for the treatment of strabismus (the crossed-eye disorder) and abnormal eyelid spasms.

In 1991, Allergan bought Oculinum from a company of the same name for $9 million and changed the drug’s name to Botox. At the time, Allergan was primarily an ocular-care company that sold products like contact-lens cleaners and prescription solutions for dry eyes, bringing in about $500 million in annual sales. Allergan says it saw Botox as a drug for a niche population: it is estimated that 4 percent of people in the US have crossed eyes, for which the drug was initially approved, and Allergan made about $13 million in sales from the drug by the end of 1991.

In 1998, David E.I. Pyott became CEO of Allergan. He was enthusiastic about Botox’s wrinkle-reducing potential, he says, and pushed the company to conduct a series of studies on the matter. In 2002, Botox earned FDA approval for so-called frown lines–wrinkles between eyebrows–marking the first time a pharmaceutical drug was given the green light for a strictly cosmetic purpose. In 2001, the year before Botox was approved for wrinkles, it generated about $310 million in sales. By 2013, the year it was approved for overactive bladder, Allergan reported nearly $2 billion in revenue from Botox. From 2000 to 2015, use of the toxins for wrinkles increased 759 percent.

US pharmaceutical companies are prohibited from marketing a drug for unapproved purposes until they have submitted proof to the FDA of its efficacy and gotten the agency’s green light. If they skip that step, they are breaking the law, and the penalties can be steep.

In 2010, Allergan pleaded guilty and agreed to pay $600 million to resolve allegations that it unlawfully promoted Botox for conditions – including headaches, pain, spasticity and juvenile cerebral palsy – that at the time were not approved by the FDA.

It is unclear how the FDA’s focus will pivot with the next Administration. President-elect Donald Trump has pledged that in his first 100 days, he would be “cutting the red tape at the FDA,” and insiders have speculated that a Trump Administration would loosen the agency’s already limited oversight on off-label use.

But even if the laws remain unchanged, as long as off-label uses are permitted by law, expect doctors to keep pushing the boundaries of Botox’s applications – sometimes in the name of medical progress and sometimes with remarkable results.

 

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