Teeth, Pain and the US Drug Industry
On a balmy summer evening in 2009, a painful soreness and sensitivity suddenly developed in the upper-left-molar area. My face was swollen; it looked slightly lopsided. I called and left a message on my dentist’s voicemail.
Early the next morning, his receptionist phoned back and said he would see me at eleven. Once I was seated in the chair, Dr. L. tapped each tooth and ascertained that the pain was coming from tooth #14. Because the endodontist he uses doesn’t schedule any appointments on Wednesday, Dr. L. prescribed a five-day dose of Clindamycin and I arranged to see her on Thursday at noon.
When I arrived, the front office was empty, save for handwritten thank-you notes from scores of patients gushing about Dr. M.’s caring manner and exemplary professionalism– displayed like Christmas cards all over the room. No receptionist or other person was on hand to greet an arriving patient. A full 10 minutes passed before Dr. M. and her assistant finally emerged from the back. There was no greeting or casual banter to put me at ease–both were cold and abrupt. It all seemed strange and inappropriate–I wondered if there could be something about me that was provoking such seeming hostility. Dr. M. took an X-ray of my tooth. They placed a dam on my face. The assistant said, “You know what I feel like doing?” I had no idea what this could mean.
As Dr. M. injected me with the anesthesia, I experienced a sudden, violent and excruciating shooting pain, like an electric shock–and screamed. Dr. M. said nothing and did not acknowledge my pain. Then, without ascertaining that I was numb, she immediately began working on the tooth. To my knowledge, the standard and necessary sequence in any such procedure is to wait for the anesthesia to take effect?usually several minutes. As she started to drill, I felt another sharp pain?less intense than the first one?and once again screamed involuntarily–the anesthesia seemed to have had no effect.
Dr. M. gave me two more injections of anesthesia. Obviously annoyed, she said I should have taken a sedative before I came. Neither she nor her assistant, Tina, expressed the slightest concern for my comfort.
Tina said to “go to your own, private place.” As Dr. M. continued to work, they carried on a private conversation, ignoring me entirely?first they talked about some person they both knew, and then I think, Obama. Their conduct seemed bizarre and unprofessional?it was very alarming. I felt trapped and helpless but thought it safest not to stop the procedure. The visit proceeded without further remarkable incident. Dr. M. once again reminded me that I should have been sedated.
Later, when the anesthesia wore off, the left side of my face was stinging severely and even more swollen than before. I thought I might be having an allergic reaction to the Clindamycin. The next morning I called Dr. L. His wife said that Dr. M. was treating me now and I should refer any problems to her. I called Dr. M. and she reminded me that it was Dr. L. and not she who had prescribed the antibiotic. She would not advise me as to whether to continue or stop taking it. (No one addressed the issue of the burning area on my face, which I continued to wrongly assume was a side effect of the Clindamycin.)
The following Friday, I had my second appointment. The burning sensation was still occurring. I mentioned it again?and at the third session as well. Each time, Dr. M. was silent and said absolutely nothing in response. As my final appointment drew to a close, she said that my sinus might be sore for a few days. She never suggested a follow-up visit.
Over the next few weeks the stinging persisted; it seemed to be getting worse.My attempts to seek medical evaluation of my condition revealed to me that the North Fork of Long Island has something of the character of a small town; health care providers have a collegial spirit.
Dr. L. said he had never seen a finer root canal and could not account for the painful burning–the only possible cause he could imagine was an insect bite.
My primary care doctor referred me to an oral surgeon whose office is right next to Dr. M.’s. He suggested I might need another root canal procedure called an apicoectomy, but did not address the facial burning.
No one made any effort to explain this alarming symptom. I poured out my troubles to our local librarian. She sent me to a kindly dentist seen by almost everyone who works at the library. He said one of the materials used to clean or fill the canals may have penetrated the root tip and inflamed the gum tissue?and I’d be OK in eight weeks.
But I wasn’t. So I began researching various substances he said could be causing the persistent burning–a symptom known as dysesthenia.
Interspersed with the dental information on the Internet were ads for lawyers. I contacted one?a former oral surgeon who specialized in dental malpractice. On the phone from Fort Lauderdale, he spoke in a rasping voice, with a thick New York City accent.
“That doctor, she injured a nerve when she gave you the injection. . . . The person you gotta see out on Long Island is Dr. S.” He repeated the name?it sounded different the second time; I could not convince him to spell it.
“See him and tell me what he says. But don’t tell him I sent you. They tremble when they hear my name. . . .”
Heretofore, I had a very dim understanding of how nerves are distributed in the body. Thanks to this lawyer, I learned I had a traumatic injury to a branch of the trigeminal nerve.
His Long Island expert was a major gun in the oral surgery field–trained at Harvard, he had headed up a department at a major teaching hospital and authored a study leading the FDA to issue a warning that a popular drug causes jaw necrosis.
The practice was located in a sprawling office complex in Nassau County. In its plush inner sanctum, the sun shone directly into my eyes as I tried to describe the burning, tingling, pulling sensation I’d had two or three days a week ever since that traumatic anesthesia injection. It was not excruciating pain?only 3 or 4 on a pain scale of 1 to 10?and sometimes only felt as if I were standing outside in sub-zero weather. At the moment I wasn’t feeling it.
This made it impossible for him to perform a few of the usual tests. But back in his consulting room, he said my “atypical head pain” was likely caused by the anesthesia injection. I asked if the injury could be attributed to medical error. He shook his head.
He wanted to start me on a daily dose of the anticonvulsant drug Neurontin (Gabapentin) immediately. Originally developed to treat epilepsy, it is commonly prescribed off-label and considered the drug of choice to manage all sorts of neuropathic pain (as well as fibromyalgia, smoking cessations, opiate withdrawal, and many other conditions); it is one of the most widely used drugs in America.
However, I learned from the Internet that nerve pain is intractable and doesn’t respond well to any medication, including this one?and anticonvulsants like Lyrica (Pregabalin) and Neurontin don’t actually promise they will relieve it, only?particularly when “sympathetically mediated”?help “manage” it in some patients.
“You should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking gabapentin,” read the ubiquitous warnings, such as this one posted on the NIH MedlinePlus web site. “You and your doctor will decide whether the risks of taking an antiepileptic medication are greater than the risks of not taking the medication.”
Maybe the scariest thing about Neurontin is that you can’t abruptly stop taking it or you could have a seizure. Even if you do withdraw gradually, you could still have a seizure.
I told Dr. S. that I had a better idea. Having read that capsaicin (the ingredient that gives cayenne pepper its heat), has been known for years to relieve muscle, nerve, and arthritis pain?and is sold in OTC creams and ointments such as Zostrix and Capsaicin-HP Arthritis Pain Relief?it seemed logical to give this relatively risk-free topical a try before braving Neurontin.
I’d read on Wikpedia that in 1997, a research team led by David Julius showed that capsaicin selectively binds to a protein that resides on the membranes of pain and heat sensing neurons. Prolonged activation of these neurons by capsaicin depletes substance P, one of the body’s neurotransmitters for pain and heat.
The result appears to be that the chemical mimics a burning sensation, the nerves are overwhelmed by the influx, and are unable to report pain for an extended period of time. With chronic exposure to capsaicin, neurons are depleted of neurotransmitters, leading to reduction in sensation of pain and blockage of neurogenic inflammation.
It sounded so utterly sensible and simple. Dr. S. looked annoyed.
“Where would you put it?”
“On my sinus area,” I said. Obviously, the only conceivable place. He ignored my suggestion.
When the lawyer called to ask how the appointment had gone, I told him. He said, “You’ll never prove the injection caused your injury,” and he hung up.
By now, through feverish late night browsing, I had discovered nerve injuries are not an uncommon problem in dentistry, although most involve the mandibular rather than the maxillary branch of the trigeminal nerve, as in my case.
On Internet message boards, patients still in endless agony years after dental “accidents” lamented that Neurontin given in higher and higher doses?in combination with higher and higher doses of opoids and antidepressants– “doesn’t begin to touch the pain.”
I learned–to my horror–that nerve pain when it persists for many months after the initial injury must be assumed to be permanent. It was now over six months for me.
My primary care doctor scoffed at my fears of Neurontin?so many of his patients were taking it. He thought I should see a specialist at the Columbia University neurology department’s head pain clinic. I wondered what they could do for me other than “sympathetically mediate” Neurontin.
The very young oral surgeon there spent an hour questioning and examining me, in a friendly, thorough, and professional manner. Since I resisted Neurontin, she suggested instead a tricyclical antidepressant. When I rejected this fallback option, the treatment ended.
I still hadn’t abandoned the notion of having my day in court. Finally, I found a lawyer who expressed an interest in my case–and drove 80 miles to Nassau County for an interview. He was uncertain if my case was winnable and if the forensic evidence was there. I was to consult with another expert who would help him decide.
The specialist, Dr. R., was an oral surgeon with a Ph.D. in neurology who specialized in trigeminal neuropathy. In the waiting room of his townhouse office, patients wandered in and out with needles of Lidocaine stuck in their nostrils. Some had spent years in search of pain relief after catastrophic dental work, and they laughed bitterly when I mentioned Neurontin.
Dr. R. was showing the effects of a busy schedule of pain mediation. He insisted my appointment would go more smoothly if I did not speak at all, except to answer his questions. I complied. He described that the sensory effect of nerve damage?the nerves apparently learn a pain response and keep firing away even without any stimulus?reminiscent of the phantom pain amputees sometimes feel in a missing limb. In my case, the toxicity of the anesthetic rather than direct needle trauma probably caused the injury.
Unfortunately, it would be difficult for me to prove that the dentist had done anything wrong. He said he had seen people like me spend approximately $30,000 of their own money on a lawsuit and lose because they were unable to prove malpractice.
I was bitterly disappointed at the outcome of this visit but grateful that at least he didn’t seem to be pushing Neurontin?The more I read, the more I shuddered at the thought of how close I’d come to having another medical nightmare to deal with.
Although Neurontin is now off-patent and available in generic form, over the decades it has provided Pfizer $12 billion in revenue.
Just after Pfizer bought Warner-Lambert for $87 billion in 2000?the third largest merger in U.S. history?the Justice Department began a criminal investigation based on the testimony of a former Warner-Lambert employee-turned-whistleblower who said he had been hired to aggressively promote Neurontin to doctors for unapproved uses?such as pain relief, bipolar disease, and depression?for which there was no evidence of its efficacy or safety.
The FDA prohibits drug companies from promoting drugs for nonapproved uses, but doctors face no such restrictions?they are free to prescribe them to patients.
Warner-Lambert’s strategy was to focus on respected doctors in the teaching hospitals who would serve as “Neurontin champions” and aggressively market it to their associates. One Harvard doctor was paid over $71, 000 in a three-year period to speak about Neurontin to other doctors. Company agents were planted at educational events to counter any unfavorable comments about the drug. Dozens of doctors were paid tens of thousands of dollars to talk to other doctors about how Neurontin, an epilepsy drug, could be prescribed for a dozen other medical uses that had not been approved by the FDA.
Thousands of physicians were paid to listen to pitches for unapproved uses of Neurontin and promote them at conferences–one well-placed doctor earned $308,000. More than one whistleblower testified that doctors were offered up to $1000 per day to allow a salesperson to actually be present at doctor-patient consultations and promote the drug over a period of hours.
Although Pfizer pled guilty to felony charges in 2004 and paid $430 million in penalties to settle charges, Neurontin was a blockbuster drug–earning $2.27 billion in 2002 alone (94 percent of it from off-label uses)?and multimillion-dollar penalties were just another cost of doing business.
The company faces over a thousand lawsuits for fraudulently promoting Neurontin–and causing some users’ suicides. In a major ruling last November, a U.S. District Court judge, in a suit initiated by the Kaiser Health Plan in California, determined that Pfizer illegally marketed Neurontin for unapproved uses. In her ruling, Judge Patti Saris states, “Kaiser has proven that there is little or no scientifically accepted evidence that Neurontin is effective for the treatment of bipolar disorder, neuropathic pain, nociceptive pain, migraine, or doses greater than 1800 mg/day.”
Dr. R. handed me a prescription for a conservatively low dose of a tricyclical antidepressant. After six weeks, he said, I might begin to see some improvement. And then the dosage could be raised. Tricyclicals, he explained, have fewer side effects than anticonvulsants?except, of course, the danger of developing a drug dependency.
I suggested that I might like to try capsaicin instead. He grimaced. “”Do you really want to get involved with that?”
Feeling cornered by the refusal of all the practitioners to prescribe anything other than dangerous systemic drugs, I yet hoped to find some?any?confirmation by the medical profession of a simple topical remedy I’d purchased online that was already providing me a measure of relief. I followed through on a referral to a neurologist at a pain clinic.
In his entire career, he said, he had come across only two cases remotely similar to mine; yet he could see my future was grim. “If you’ve had the pain this long,” he said, “it’s your ‘friend.’”
With a safety pin, he gave me a battery of pinprick tests; my hands were beginning to bleed. Before he could suggest taking Neurontin, I said, “I am using a topical liquid called Neuragen made in Canada out of plant extracts. It seems to be helping, particularly during the summer when my symptoms aren’t as bad.”
“Well anything topical you put on will help.”
“Gosh, you mean these topical ointments are better than Neurontin?”
His eyes lit up. “You, know, there’s a Neurontin patch.”
I practically shrieked.
“Well there’s also a Lidocaine patch?it’ll knock out the pain out for 12 hours.”
“Can’t it cause cardiac problems?”
“Well, what about capsaicin? What kind should I buy? –Zostrix? How do I use it?”
He didn’t seem to know. So I went into the pharmacy and looked at what they had and asked the pharmacist. He said, start with the weaker one.
I bought a tube and applied some when my symptoms were acting up and my cheek started to burn. The Zostrix burned, too. But it was a different kind of burning; after repeated applications, it seemed to diminish?along with the original pain.
Have I considered the possibility I may be wrong?–that the proper dosage or even a combination of Neurontin and tricyclical antidepressants?(as doctors, towed along by the medical-pharmaceutical complex insist) should be the bedrock of my pain management plan?
It’s a risk I’m willing to take. For now, I’ll take my chances and dab on Zostrix–for a fraction of the cost–and remain anticonvulsant- and antidepressant-free.