Eighteen years ago, when she was in her early 30s, Cindy Steinberg severely injured her back at work when an unsecured filing cabinet and the cubicle walls stacked behind it fell on her. Although the diagnosis for the product development manager at a learning-technology company just outside Harvard Square was torn ligaments and damaged nerves — between thoracic disc levels 7 and 10 — it took five years for doctors to find an effective combination of treatments for her chronic pain, including an opioid pain reliever called Lortab, which is similar to Vicodin. “I was in total disbelief that I could be in this much pain and there wasn’t anyone or anything that could really help me,” says Steinberg. Doctors treated her in a “demeaning, disbelieving, dismissive, and distrustful” manner, she adds.

This dismissive attitude toward pain patients — an attitude held not just by some doctors but also by the public at large — has only gotten worse in recent years, thanks in large part to relentless publicity of cases involving illegal abuse of opioids (also known as narcotics). To put it bluntly, chronic-pain patients all too often are seen as potential drug abusers first and as suffering human beings second.

In the latest sign of this trend, in October, the US Food and Drug Administration issued a recommendation that will further restrict access to drugs like Vicodin and Lortab that contain the opioid hydrocodone. This may or may not do anything to reduce the prescription drug abuse problem in this country, but it will almost certainly hurt legitimate pain patients who need treatment.

Essentially, we’ve got the picture backward. In terms of sheer numbers, the epidemic of chronic pain is far larger than what some call an “epidemic” of prescription pain reliever abuse. The Institute of Medicine estimates chronic pain afflicts about 100 million American adults. By comparison, 16,651 people died in opioid-related deaths in 2010, according to the Centers for Disease Control and Prevention, and only 29 percent of those deaths involved opioids alone (the others involved alcohol and other drugs). These deaths occur in the context of 210 million prescriptions for opioids filled in 2010 nationwide, according to a prescription- and patient-tracking service.

Yet it’s opioids — and people who need them — that get vilified. That vilification is based on somewhat exaggerated fears of addiction. Addiction is real and horrible — but is often less of a risk than people assume. The government pegs the risk of addiction somewhere between 2.7 percent and 30 percent. Some studies show that the risk of abuse or addiction is only about 3.27 percent. For people with no prior abuse or addiction problems, the rate may be as low as 0.19 percent.

For her part, Steinberg is now off opioids entirely and uses another kind of medication for her pain. But she had no trouble with opioids while she was on them. “I took it at the same dose for 10 years with no negative side effects except for constipation. I felt no ‘high.’ I never increased my dose,” she says. “The same is true for people in my pain-support group — they don’t get high, they just get relief from their pain.” She is appalled that the government, particularly the FDA and the Drug Enforcement Administration, seems determined to scare physicians and pharmacists away from prescribing drugs that can help.

In June, for instance, the DEA won an $80 million settlement from Walgreen Co., the country’s largest pharmacy chain, for filling orders for opiods through a Florida distribution center, opioids that made their way onto the black market. That’s great, but Walgreen Co. has also tightened its rules in ways that might prove harmful.

Walgreen’s new opioid policy says pharmacists may at times have to contact prescribing physicians to discuss factors such as the expected length of therapy and the “previous medications/therapies tried and failed.” Whether this shift will help the drug abuse problem is unclear, but it is already making things tougher — and the process even more fraught with shame — for legitimate pain patients.

Because of her chronic pain, Steinberg left her original career and is now the national director of policy and advocacy at the Connecticut-based US Pain Foundation.

She has not had a minute, much less a day, since her accident without pain. Her spine is so unstable that she can’t hold herself up long; when she tries, the muscle spasms can become unbearable. So she copes. She stays upright for an hour or so, then lies down for 25 minutes, back and forth, all day long. “It gets worse the longer I am upright, sitting or standing.” She still goes to concerts at Symphony Hall, but has to lie down at intermission. When she flies, she buys two seats so she can lie across them.

There are millions of legitimate pain patients like Cindy Steinberg who do not abuse opioids. They should not be penalized by the behavior of the relatively few people who take the drugs irresponsibly.

BY THE NUMBERS

$635 billion
Estimated annual cost of chronic pain to the US in medical treatment and lost productivity

$72.5 billion
Annual direct health care cost of prescription painkiller abuse

Sources: Institute of Medicine, Centers for Disease Control and Prevention

The US Food and Drug Administration’s recent decision to restrict access to hydrocodone-containing drugs such as Vicodin may or not may not do anything to reduce the prescription drug abuse problem. But it will almost certainly hurt legitimate pain patients who need the drugs.

The federal government, and America’s public debate in general, has focused almost exclusively on the supposed “epidemic” of prescription pain-reliever abuse, not on the far larger problem of chronic pain in America.

But consider the numbers. In 2011, the prestigious Institute of Medicine issued a report showing that out of 238 million American adults, 100 million are living in chronic pain, and many, though certainly not all, are disabled by it. (This number is undoubtedly an underestimate because it does not count children, people in the military and people in nursing homes.) Chronic pain is, by some measures, the main reason people go to doctors and is a bigger problem than heart disease, cancer and diabetes combined. People with chronic pain are at roughly twice the normal risk of suicide.

By contrast, the prescription pain reliever abuse problem is much smaller. In 2010, according to the federal Centers for Disease Control and Prevention, 16,651 people died in opioid-related deaths. (“Opioid” is the term scientists now prefer, instead of “narcotic.”) Obviously, that’s 16,651 people too many. But those same government figures show that only 29 percent of these 16,651 deaths involved opioids alone – the rest involved alcohol, benzodiazepines or other drugs. Yet it’s opioids – like the legitimate pain patients who need them – that get vilified.

It’s estimated that 12 million people a year are abusing opioids. But the denominator in this equation is never mentioned, and it’s huge. In 2009, 200 millions prescriptions for opioids were filled nationwide, according to the SDI Vector One National database, a privately owned prescription and patient tracking services.

Moreover, the government continues to see prescription drug abuse as a law enforcement, not a public health, issue. Recently, for instance, in the wake of genuine and infamous problems with “pill mills” in Florida, the Drug Enforcement Administration cracked down on Walgreens, the largest pharmacy chain in the country, imposing an $80 million settlement.

Okay, that’s great. But Walgreens’ response has been to make it tougher for pain patients to get the drugs they need. Walgreens’ says its new policy “may, at times, require” pharmacists to contact prescribing physicians to make sure the diagnosis, the exact billing code, the expected length of therapy and the “previous medications/therapies tried and failed” are correct. Once again, whether this action will have a positive effect on the drug abuse problem is unclear. But it has already imposed extra hurdles for legitimate pain patients.

Put bluntly, we’ve got the shoe on the wrong foot. The common presumption – by the government and, unfortunately, by some physicians as well – is that every pain patient is likely to be a real or potential drug abuser. That’s simply not true. Many pain patients take opioids and other drugs for years, even decades, without abusing them.

For the record, I’m no fan of Big Pharma, or even opioids. Opioids are highly imperfect drugs with lots of side effects, not even counting the risks of dependence, hormonal and immune problems or the potential for abuse. Opioids can reduce pain, but they often fail to eliminate it. What they can do is allow some people to manage their pain enough to get on with their lives.

Bottom line? The FDA’s decision to make drugs like Vicodin less available punishes the wrong people. It may or may not make it harder for determined street abusers to get the drugs, but it will certainly make it unnecessarily hard for legitimate pain patients to do so.

In a move designed to combat drug abuse but likely to put further burdens on pain patients, the US Food and Drug Administration yesterday announced that it is recommending tighter controls over opioid pain relievers such as Vicodin and Lortab that contain hydrocodone.

The shift in policy – the subject of a controversial hearing in January, 2013 – will limit the number of refills a patient can get before going back to his or her doctor for a new prescription. It will also mean that a patient must physically take each prescription to a pharmacy, instead of allowing doctors to call the prescription in. For patients in severe, chronic pain and those with physical limitations, these requirements are likely to pose significant difficulties.

In the statement on its website, the FDA said that opioids (narcotics) do allow people living with chronic pain to “manage their pain as well as significantly improve their quality of life.” But the FDA also said it had become “increasingly concerned” in recent years about the “abuse and misuse of opioid products.”

The FDA said that by early December, it would formally submit its recommended changes to the Health and Human Services Department. It added that the National Institute on Drug Abuse (NIDA) is expected to concur with the new recommendations and that a final decision on the new policy will be made by the Drug Enforcement Administration (DEA), which, in 2009, asked for the change. In bureaucratic language, the change involves moving products that contain hydrocodone in combination with another drug such as acetaminophen from classification as a Schedule III drug to classification as a more restricted Schedule II drug.

In practice, said Cindy Steinberg, a chronic pain patient and National Director for Policy and Advocacy at the US Pain Foundation, a nonprofit advocacy group, the change will impose serious hardships on the 47 million Americans who currently take hydrocodone-containing products.

With hydrocodone-containing products in their current, Schedule III classification, a pain patient can see a doctor once a year, get a prescription with five refills – meaning a supply of the drug for six months – and then call the doctor for another prescription good for another six months, which the doctor can call in to the pharmacy.

Once hydrocodone-containing products are placed in Schedule II, a pain patient would be able to get a supply of the drug for up to three, not six, months at a time. A patient will then have to have another visit with the doctor and physically take each new prescription to the pharmacy. Instead of seeing a doctor just once a year, a patient would have to go to the doctor every three months.

The change is “extremely detrimental” for pain patients, said Steinberg in a telephone interview yesterday, not just in terms of pain control but in terms of the costs of added visits to the doctor and even the ability to get those extra visits in an already-overburdened health care system. Steinberg testified at the FDA’s hearing on the proposed change last January that “rescheduling hydrocodone combination medications is a drastic measure that will have far-reaching negative consequences; chief among them will be loss of pain control for millions of Americans.”

In a telephone interview with the New York Times, Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research, said the FDA was aware that changing the prescribing rules would affect patients but that the impact on public health caused by abuse of the drugs had reached a tipping point.

Pain relievers are in the news again — and the news isn’t great.

Acetaminophen, the active ingredient in Tylenol, is the focus of a series of scary investigative articles by ProPublica, the online new organization. The bottom line of the series: about 150 people per year die from accidentally taking too much acetaminophen, and even though the line between a therapeutic dose and a dangerous dose is slim, the FDA (and the drug companies that sell the products) have done little to warn consumers.

To be sure, treating pain with any medication is an intrinsically dicey, though often necessary, business. Opioids can reduce pain, though not entirely, and carry the risk of dependence, immune and hormonal changes and, in some cases, abuse and overdose.

In some ways, acetaminophen is the slipperiest of all the pain medications to understand because it’s not just in over-the-counter medications such as Tylenol, but in a whopping 600 prescription and OTC products, including cough syrup and in combination pain-relievers such as Vicodin, a mix of acetaminophen and hydrocodone. Some chronic pain patients have to limit their use of Vicodin not because of the hydrocodone, an opioid, but because of the risk of getting too much acetaminophen.

That’s why many pain specialists now advocate not giving pain patients combination drugs like Vicodin, but using separate pills – one containing an opioid such as oxycodone and the other, acetaminophen, Dr. Daniel Carr, an anesthesiologist and Director of the Program on Pain Research, Education and Policy at Tufts University School of Medicine, said in an interview. That way, if a patient needs to increase dosage of the opioid, that can be done without increasing acetaminophen as well.

Because acetaminophen, which comes in both prescription and over-the-counter formulations, is in so many products and because consumers often don’t read the fine print, they can ingest far more acetaminophen than they realize, significantly raising the risk of acute liver failure. In fact, lawsuits involving acetaminophen overdoses are on the rise.

Adding to the problem is the fact that acetaminophen has a narrow “therapeutic index,” which means that the dose at which it helps is very close to the dose at which it harms.

Acetaminophen is particularly dangerous in combination with alcohol. “When each of my kids became high school and college age, just because of the prevalence of drinking amongst young people,” said Carr, “I emphasized to each of them that if they are ever drinking and get some symptom like a headache or hangover, to never, ever take Tylenol. Alcohol augments acetaminophen toxicity.”

Even among nondrinkers, Carr said, acetaminophen can be risky if taken in excess. Some older people, he noted, take acetaminophen daily, which can cause them to lose salt through their kidneys and wind up with low sodium concentrations in the blood, a situation that can result in mental status changes that can mimic dementia.

Both the FDA and the maker of Tylenol, McNeil Consumer Healthcare, have been lax in responding to growing safety concerns, according to ProPublica.

In January, 2011, the FDA did tell drug manufacturers to limit the amount of acetaminophen in combined prescription products to 325 milligrams per dose. It also required that a black boxed label be added to prescription acetaminophen products warning of the risk of severe liver injury and allergic reaction. But it did not require OTC acetaminophen to carry such a label, even though some OTC pills contain as much as 500 milligrams of the drug.

The FDA also did make clear that people should not drink alcohol when taking acetaminophen and advised patients not to exceed a total 4,000 milligrams of acetaminophen a day. That 4,000 milligrams a day is “the threshold of toxicity,” said Carr, the point at which serious problems can occur. People who are malnourished or not in good health should be especially cautious about approaching this threshold.

McNeil has now changed its label for Extra Strength Tylenol, recommending a maximum daily dose maximum of 3,000 milligrams, but it has left the recommended maximum at 3.9 grams (3,900 milligrams) for Tylenol Arthritis Pain, an extended release product.

The actual statistics on acetaminophen hospitalizations and deaths are difficult to sort out. This lack of transparency is made clear by the ProPublica series, which analyzed three different sets of data – from the federal Centers for Disease Control and Prevention, the US Food and Drug Administration, and the American Association of Poison Control Centers (a nonprofit group that receives federal funds) to try to figure it out.

Using the CDC figures, ProPublica says that more than 300 people a year die from acetaminophen poisoning, while the FDA pegs the number at 980 deaths. The poison control group puts the number at 113.

For hospitalizations linked to acetaminophen poisoning, ProPublica cites yet another database, which shows about 33,000 people are hospitalized every year for this problem.

Some analyses suggest that more people die every year from acetaminophen poisoning, ProPublica says, than from NSAIDS, but this is a controversial point. (A 1999 study suggested that more than 16,000 deaths occur each year related to NSAIDS, but the lead author of that study emailed ProPublica to say he now thinks that estimate is too high.)

The ProPublica series comes down hard on both the FDA and McNeil. It says that the FDA has been egregiously slow in demanding specific safety changes, such as reducing the allowable daily dose of acetaminophen. The FDA also has failed to take simple steps such as making the 325 milligram dose per pill limit that now pertains to prescription acetaminophen apply to OTC. In a telephone conversation last week, an FDA spokesman said the agency “continues to assess the risks of acetaminophen-containing products” and that this involves a “lengthy process made more challenging by delays encountered as scientific data and advances emerge.”

The FDA has also been particularly slow to act, ProPublica said, on dosing instructions and drug concentrations of acetaminophen for children. Several deaths have been reported because of confusing dosing instructions for children. In 2011 the drug industry itself agreed to market just one concentration of pediatric acetaminophen to make things simpler. The FDA spokesman said the agency held an advisory committee meeting on the pediatric dosing issue in 2011 and is now “considering whether to modify the acetaminophen monograph.”

For its part, a McNeil spokeswoman said last week that the company has made some labeling changes “proactively.” On its website, the company notes that it has changed the labeling on some products.

It all seems unnecessarily confusing. My personal take on acetaminophen? Be really, really careful with dosing. Don’t drink at all if you take acetaminophen. And double check with a pediatrician all dosing for children.

(This post was originally published in WBUR’s CommonHealth blog, 10/01/13)

This may be the most delightful of all medical prescriptions: Chew a little raw garlic a couple of times a week and the risk of lung cancer drops by almost half. It drops by almost a third even if you’re a smoker.

News this good, not to mention this tasty, is rare in medicine, but that’s the conclusion of a large Chinese study published recently in Cancer Prevention Medicine.

The researchers compared 1,424 lung cancer patients with 4,543 healthy adults and asked them about their lifestyle and dietary choices. Granted, just asking people to recall their own behavior is hardly the ideal form of research. (Far more informative are studies that randomly divide people into two groups, give one group a treatment and the other group a placebo without revealing who’s getting what, and then compare the results.)

That said, the results from Jiangsu Center for Disease Control and Prevention in Nanjing are noteworthy, said John Milner, who has studied garlic chemistry for decades.

“This is additional evidence that garlic has some significant health benefits.” Milner, director of the Human Nutrition Center at the Agricultural Research Service at the United States Department of Agriculture, told me in a telephone conversation this week.

The new data from China fit with a longstanding body of research on garlic, which is high in sulphur-containing compounds, as a potential cancer-fighter. Sometimes called the “stinking rose,” garlic was first mentioned in the medical literature in 1550 B.C. in an Egyptian papyrus, then got a further whiff of credibility in 1858 when Louis Pasteur discovered that its juice kills bacteria.

Much of the biological action in garlic comes from its breakdown products, or metabolites, of allicin, which are released when raw garlic is chopped or crushed.

In the body, allicin and its breakdown products have numerous functions – reducing inflammation, combatting harmful oxygen molecules called free radicals, acting as a natural blood thinner, fighting bacteria, blocking cancer-causing agents (carcinogens), slowing down the rapid cell division that is the hallmark of cancer, enhancing DNA repair and triggering a phenomenon called apoptosis (cell death).

Interestingly, there are fewer health benefits from cooked garlic. However, “if you chop garlic and let it sit for 10 to 15 minutes, the active compounds are formed, then it doesn’t matter if you heat it,” Milner said. “Heating is only bad if you heat the [chopped] garlic right away.”

In 2009, researchers studying human urine samples found that consuming 3 to 5 grams a day blocked the creation of cancer-causing agents, carcinogens, called nitrosamines, which are found in some processed meats and are also formed in the body during normal metabolism.

Technically called allium sativum, garlic is in the class of plants that includes onions, chives, leeks and scallions, all of which have medicinal benefits like garlic, though these other plants have not been studied for their potential health effects as thoroughly as garlic.

According to the National Cancer Institute (part of the National Institutes of Health), preliminary studies suggest that eating garlic may reduce the risk of certain cancers, especially those on the gastrointestinal tract. These include cancers of the stomach, colon, esophagus and pancreas.

In a 2006 European study that involved people from 10 countries, higher intake of garlic and onions were linked with a lower risk of intestinal cancer. An older study (from 1994) called the Iowa Women’s Study had already showed that women who ate the most garlic had a 50 percent lower risk of colon cancer compared to those who ate the least.

Chinese studies in 1999, 2002 and 2005 have linked high consumption of allium-containing vegetables to lower risks of esophageal and stomach cancer, prostate cancer and stomach cancer, respectively. A 2005 San Francisco Bay-area study found that pancreatic cancer risk was 54 percent lower in people who ate larger amounts of garlic compared to those who ate less.

While these and other epidemiological studies comparing the dietary habits of large groups of people strongly suggest an anti-cancer effect from garlic and its vegetable cousins, proving that connection in interventional studies has been more difficult.

In one 2004 Chinese study, for instance, an extract of garlic (called allitridum) plus selenium seemed to reduce the risk of tumors in general and stomach cancer in particular. But a 2006 Chinese study interventional study found no such risk reduction in stomach cancer.

Complicating garlic research is the fact that some researchers use raw garlic while others various supplements or extracts; some supplements have not been thoroughly tested and may vary considerably in their content.

Ideally, said Milner, eating one-third of a garlic clove a day (about 1 to 3 grams) is a reasonable goal. “The bottom line,” he said, “is that, to get the benefits, that’s enough. You don’t have to go to exaggerated amounts.”

Although garlic is usually safe, it can interfere with certain medications, in particular anti-viral medications used for HIV/AIDS. Since garlic is also a natural blood thinner, pregnant women should probably not consume too much garlic, the National Cancer Institute website notes, nor should people taking prescription blood thinners and those about to undergo surgery.

(This post was originally published in WBUR’s CommonHealth blog, 8/16/13)

You may be in for a shock if you try to get a prescription for any controlled substance – from Ambien to opioid pain relievers – filled at Walgreens anywhere around the country.

Walgreens recently announced what it calls a new “Good Faith Dispensing” policy under which the pharmacy giant – the largest in the nation – is suddenly requiring its pharmacists to take “additional steps” to verify prescriptions for controlled substances.”

This process, the company says, “may, at times, require” the pharmacist to contact the prescribing doctor to make sure the diagnosis, the exact billing code, the expected length of therapy and “the previous medications/therapies tried and failed” are correct.

In plain English, this means that Walgreens pharmacists are going to call your doctor, or at least your doctor’s office, to see if your doctor did the right thing in giving you a prescription for pain relievers and other drugs. The policy is provoking distress and outrage among pain patients, physicians and others.

In a telephone conversation, a Walgreens spokesman denied that the aggressive new policy was specifically triggered by the Drug Enforcement Administration’s crackdown on the company in the wake of problems with infamous “pill mills” in Florida. Until recently, unscrupulous “patients” and unscrupulous doctors in Florida have colluded in diverting massive quantities of prescription pain relievers such as oxycodone (an ingredient in OxyContin) through fake clinics dubbed “pill mills.”

In June, Walgreens and the DEA announced an $80 million settlement to resolve the government’s charges that Walgreens failed to control the sales of opioid pain relievers in some of its stores.

The government said that distributors of pain relievers failed to monitor suspiciously large orders for opioids Necessary as that crackdown was, a presumably unintended result is that legitimate pain patients are finding it harder to get the medications they need.

Walgreens spokesman Michael Polzin told me that he was not sure precisely when the company’s “Dear Valued Prescriber” letter spelling out the new policy went out, adding that he thought it went out in April or early summer. (There is no date on the letter itself). The date of the DEA settlement was June 11, 2013.

Although pain patient advocates worry most about getting prescriptions for opioid pain relievers, Polzin confirmed that the letter actually stipulates new procedures for all controlled substances. In theory at least, that could make it harder for patients to get prescriptions for other drugs such as Restoril, Halcion, Sonata, Ambien and Lunesta.

Asked why Walgreens is taking this action now, Polzin said, “There’s been, as is well known, a sharp rise in the abuse of prescription painkillers in recent years and health care professionals of all practices are being asked to find better ways to make sure those medications are used for legitimate purposes.”

Asked specifically if the $80 million settlement imposed by the DEA triggered the company’s actions, Polzin said, “We actually imposed our Good Faith Dispensing policy before that settlement. We have done a number of things before reaching the agreement with the DEA to make sure we were fulfilling the obligations for dispensing controlled substances and making sure that our training and pharmacy staff were where they needed to be.”

He acknowledged that the new policy may mean that getting prescriptions filled “could take extra time – it does require us at times to get information from physicians’ offices.”

Whatever the motivation by Walgreens, the American Medical Association is furious. In a resolution in late June, an AMA committee chaired by Iowa dermatologist Marta van Beek called the Walgreens’ policy a direct “intrusion into medical practice.”

As the AMA committee put it, “pharmacists are not and under no circumstances should be required to confirm the appropriateness of a prescription; this decision is a purely medical one, completely in the purview of the treating physician.” The policy “will be very disruptive to physicians’ practices, interrupting visits and procedures and delaying other patients’ care.” The Walgreens policy may also seriously delay “delivery of medications to all patients.”

Van Beek added, in an email to me, “The physician-patient relationship is focused on the patient’s disease and how best to treat it in the context of the patient’s health and social factors. A pharmacy does not have this perspective.”

US Representative Michelle L. Grisham, a Democrat from New Mexico and a former secretary of health in that state, is also worried that the Walgreens’ policy “is endangering the health and safety of patients by delaying the filling of opiate prescriptions.” The policy may force patients “to go to multiple pharmacies to fill prescriptions, which could put patients in jeopardy with state Prescription Drug Monitoring Programs, she said in a letter to the New Mexico Board of Pharmacy.

In a telephone conversation, Grisham went further: Walgreens “policy is very over-reaching..[they] are vilifying the patient, which is outrageous.”

Pain patient Cindy Steinberg, national director of policy and advocacy at the Connecticut-based US Pain Foundation, acknowledges that “a pharmacist “is entitled to look for the authenticity of a prescription.” But, she told me, “this is now going over the line into judging the appropriateness of a prescription. That is outside pharmacy practice. They can’t question whether a physician can or should institute this therapy…“this is very harmful for people with pain who are simply trying to get their medications so they can have some quality of life.”

The new Walgreens policy is creating particular problems for pain patients in Florida. One South Florida chronic pain patient, Julee Payne, wrote me that she has filled her prescriptions with Walgreens for over 10 years. But now, she said, “we’re expected to drive around for hours to find a pharmacy who will/can fill our medications…”

The result of the new Walgreens policy, she said, is that pharmacists “have been given the absurd task of policing the doctors on top of everything else….It is truly a public health crisis here.”

(This post was originally published in WBUR’s CommonHealth blog, 8/12/13)

Overdose deaths linked to prescription pain relievers have increased dramatically among women in recent years, the Centers for Disease Control and Prevention announced yesterday.

And nobody really knows why.

Part of the increase may be due simply to a higher prevalence of chronic pain conditions in women, the CDC said, adding that “some of the most common forms of pain are more prevalent among women,” including abdominal pain, migraine and musculoskeletal pain.

Indeed, one of the more puzzling findings from the latest CDC figures is that the opioid-related overdose death rate was not highest among younger women, but among women aged 45 to 54.

Dr. Nora Volkow, director of the National Institute on Drug Abuse, suggested in an interview with The New York Times that this may in part reflect the fact that older women are appropriately prescribed pain relievers because they have more chronic pain. If death rates were driven purely by abuse, she said, then one would expect the death rates to be highest among younger women who are more likely to be abusers.

In addition, women on average weigh less than men – a fact that doctors may not sufficiently take into account – and therefore, at the same dose, may suffer more adverse effects.

To be sure, men are still more likely to die of an opioid-related overdose than women. But according to the CDC figures, overdose deaths linked to prescription pain relievers increased in women by about 400 percent between 1999 and 2010, compared to 265 percent in men. In 2010, 6,600 women died in overdoses linked to prescription pain relievers – four times as many as died from cocaine and heroin combined.

It’s important to remember, however, that while opioids such as OxyContin, Vicodin and Percocet are often singled out and vilified, only 30 percent of the opioid-related deaths in 2010 – 16,651 among men and women together – involved opioids taken alone. Often, people take opioids along with other drugs such as benzodiazepines and alcohol, a problem that physicians should be more aware of, said Christopher Jones, a health scientist at CDC in a press teleconference Tuesday.

It’s also important to remember that, while more than 16,000 people died of opioid-related deaths in 2010, NSAIDS – nonsteroidal anti-inflammatory drugs such as ibuprofen – can also be deadly, killing an estimated 7,000 to 10,000 American adults a year.

In the briefing for reporters, Dr. Thomas Frieden, director of the CDC, said, “These [opioids] are dangerous medicines and they should be reserved for situations like severe cancer pain where they can provide extremely important and essential palliation. In many other situations, the risks far outweigh the benefits.” Prescribing opioid medications, he added, “may be condemning a patient to lifelong addiction and life threatening complications.”

But that may be an overly draconian view of addiction risks. A 2008 review of 67 other studies of opioids in thousands of people with chronic pain put the risk of abuse or addiction at 3.27 percent, and for people with no personal or family history of drug or alcohol problems, the figure was even lower.

Indeed, the controversy over prescription pain relievers has become highly politicized recently, pitting anti-opioid activists who want to severely limit doses that doctors can prescribe against pain patients who fear their access to opioids may be curtailed.

CDC officials also touted the potential benefits of prescription monitoring programs, often called PMPs, as a way of curbing abuse of prescription pain relievers. These programs track prescribing and dispensing of the drugs in an attempt to stop patients from “doctor shopping.” CDC officials did not respond to a reporter’s comment questioning the value of such monitoring programs. A study done by CDC itself in 2011 failed to show that PMPs reduced opioid-related overdoses or deaths, although a different study by other researchers in 2010 was more favorable.

CDC officials also declined to respond in detail to a reporter’s question about aggressive marketing by pharmaceutical companies as a potential contributor to the increase in opioid pain reliever overdoses, although Frieden did note that there has been a legal settlement in which one company was compelled to make a large payment because of misleading or inaccurate marketing to physicians.

That was an apparent reference to a 2007 case involving three executives of Purdue Pharma who pleaded guilty in a US federal court to misleading regulators and the public about the addiction potential of OxyContin, agreeing to pay $634 million in civil and criminal fines.

 

So there I was at midnight, night after night, my neck pain screeching at a 10+++ on a scale of 10, popping ibuprofen by the handful, dutifully worrying about the well-known dangers of a painkiller-induced stomach bleed, but reassuring myself, “At least these pills are safe – not like opioids, the really dangerous stuff.”

Oops. Not quite right. It turns out that I, like many other people with chronic pain, had gotten my worries somewhat backwards: being overly fearful of opioids, which, of course, do have considerable risks, but not worried enough about NSAIDS — non-steroidal anti-inflammatory drugs — such as ibuprofen, Advil, Motrin, Nuprin, Aleve and others.

My mixed-up worries came straight from newspaper headlines, which play up the dangers of opioids (narcotics), and less frequently note the growing evidence for the risks of NSAIDS as well.

But a major new study in the medical journal The Lancet is helping set things straight. In it, British researchers pooled data from an impressive 639 randomized studies involving more than 300,000 patients, comparing various types of NSAIDS to each other and to placebo.

They found that both so-called “coxibs” (anti-inflammatory drugs such as Celebrex) and high doses of traditional NSAIDS such as ibuprofen raise by about one-third the risk of major “vascular events” such as non-fatal heart attacks, strokes and death. These newly-appreciated risks are in addition to the well-documented risks of gastrointestinal bleeding long linked to NSAIDS.

Put differently, the researchers found that for every 1,000 people with a moderate risk of heart disease taking high doses of the NSAIDs ibuprofen (2400 milligrams daily) or diclofenac (150 milligrams daily), about three would suffer a preventable heart attack, one of which would be fatal.

For unclear reasons, Naproxen (Aleve) seems to carry much less risk, a finding that has shown up in a number of previous studies as well.

This is serious, of course, especially for older people who tend to have more cardiac risks as well as more pain. In fact, because of the risks of NSAIDS, some older people with severe pain have almost no choice but to take opioids — which, of course, carry their own risks, including dependence, addiction, immune suppression, hormonal dysfunction and a greater tendency to fall.

But the news on NSAIDS is not the end of the world, says Dr. Don Goldenberg, chief of rheumatology at Newton-Wellesley Hospital. Though NSAIDS, especially at high doses, can be dangerous, “there is no medication that has no risk,” he says, and three heart attacks among 1,000 people taking the drugs is still a relatively small risk that may well be worth it for people suffering from pain.

For people with rheumatoid arthritis, an inflammatory disease, there are other medications such as methotrexate and biological agents like Enbrel and Remicade that have “revolutionized treatment for RA [rheumatoid arthritis],” Goldenberg says. “We don’t use NSAIDS as a cornerstone for RA anymore.”

For physicians, one clear take-home lesson from the new study is to be more careful about the particular type of NSAID they choose, says Dr. Marie Griffin, a professor of preventive medicine and medicine at Vanderbilt University and the author of a commentary accompanying the new study.

It is also important for patients to tell their doctors how much they think the NSAIDS are actually helping. “If you take NSAIDS and say to me, ‘I can’t tell, or I’m not sure if they’re helping,’ then you talk about it. People have to decide if this is really making a difference.”

It’s also crucial, adds Goldenberg, for both patients and doctors to understand the difference between analgesics, which are pain relievers, and anti-inflammatory agents, like NSAIDS.

With osteoarthritis, for instance, which causes pain but not because of inflammation, it doesn’t make sense to take NSAIDS but may make more sense to take a pain reliever such as acetaminophen (Tylenol), though, of course, acetaminophen has its own potential side effects,including acute liver failure. (Part of the problem is that acetaminophen is often added to cold and cough medications and combined in opioid drugs such as Vicodin, which means that a person can ingest significant doses of acetaminophen without realizing it. Acetaminophen is especially dangerous in combination with alcohol.)

The new data on NSAIDS, particularly the risks of the “coxibs” is particularly disappointing because drugs in this class, called Cox-2 inhibitors, were created more than a decade ago precisely to decrease the risk of bleeding from traditional NSAIDS.

Initially, these drugs were seen as a much safer alternative, but as more and more people began taking coxibs, the risks of coronary disease became more and more apparent. Two such drugs, Vioxx and Bextra, were eventually taken off the market for these reasons.

Although the Lancet study does not discuss non-drug treatments for chronic pain, there are treatments for which evidence for some efficacy exists. Exercise and physical therapy, for instance, can markedly reduce some types of chronic pain, as can acupuncture, massage and other forms of alternative medicine. For people with knee or hip arthritis, joint replacement therapy may also be an important option.

But, sadly, it’s still the case, as Griffin put it in her commentary, “Identification of safe and effective strategies for chronic pain is sorely needed.”

If we’re ever going to get serious about gun control in this country, I have a simple suggestion: mobilize women.

As the success of Mothers Against Drunk Driving demonstrates, when women put their collective hearts and minds toward something, they get it done.

Men still control Congress, which has done nothing for gun control. Of the 46 senators who recently rejected background checks, all but four were men.

(The four women, by the way, were Heidi Heitkamp, a Democrat from North Dakota; Kelly Ayotte, a Republican from New Hampshire; Deb Fischer, a Republican from Nebraska; and Lisa Murkowski, a Republican from Alaska. Heitkamp, may not have taken any money from the National Rifle Association. But Ayotte reportedly took $9,000; Fischer took $7,950; and Murkowski took $10,058.)

Morever, it’s men who own most of the guns — three times as many as women, according to the Pew Research Center for the People and the Press. I called and emailed the NRA to see how many of their members are women and got no response.

Men have also traditionally been more resistant to gun control. Polling data consistently show far greater support for gun control among women than among men. A recent NBC/Wall Street Journal poll, for instance, showed that while 65 percent of female respondents favor stricter gun laws, only 44 percent of male respondents did.

To be sure, if men had their own self-interest in mind, they would be leading the charge for gun control, not bucking it. After all, when it comes to gun deaths, “it’s mostly men killing men,” Daniel Webster, director of the Center for Gun Policy and Research at the Johns Hopkins Bloomberg School of Public Health, told me.

For women, living in a home with a gun raises the risk of suicide 4.6 times and the risk of homicide 3.4 times, according to studies cited by the Brady Campaign to Prevent Gun Violence. In fact, 73 percent of female murder victims are killed in the home, compared to 45 percent of male murder victims.

In the wake of the Newtown shootings, women do seem to be emboldened.

In January, as Maryland legislators were debating gun control, a bunch of women wielding strollers and babies showed up in the State House hallways to lobby for gun control. Legislators trying to push through found themselves in a “stroller jam,” surrounded by moms, kids and baby paraphernalia.

“The legislators couldn’t get by. They had to talk to us,” Shannon Watts of Moms Demand Action for Gun Sense in America told me last week. The strong gun control legislation passed and since then, the group Watts founded the day after the Newtown shootings, has amassed 100,000 members in 40 states and has staged 20 other stroller jams across the country.

Maternal instinct appears to be a motivating factor. Women want stronger gun laws “so they can send their kids to school and know they will come home alive,” says Lindsay Moran, a freelance writer, mother of two and former CIA operative who started a Facebook campaign “Enough is Enough: Responsible Gun Laws Now.”

“There is a collective outrage among moms that these kinds of things happen again and again and we can’t get any meaningful action,” Moran told me. “It’s baffling to me that reasonable people can’t distinguish between the Second Amendment right to bear arms and assault weapons.”

Myra Christopher, an ethicist at the Center for Practical Bioethics, put it this way: “If this situation is ever to change, women must take a stand and begin the process of transforming our culture.”

She’s right. It is about culture change. Change from mindless paranoia about the second amendment to plain common sense. Change from letting the NRA buy Congress to electing people with integrity. Change from the absurd belief that “guns don’t kill people, people do” to the truth: It’s the guns. And it’s women who really get it.

(This post was originally published in WBUR’s Cognoscenti blog, 5/6/13)

A few weeks ago, on an otherwise uneventful Sunday afternoon, I got an urgent call on my cell phone from my daughter-in-law, Robin, a vigorous 42-year-old. She was calling from her health club, barely “10 minutes into a decent run” on the treadmill

Suddenly, she told me, she had gotten a “hole” in her vision in her right eye, and zig-zaggy lines like lightening when she closed her eye, a predictable sign, she knew from past experience, that a migraine headache was about to start.

An exercise-induced migraine was not a total surprise for Robin, who has had about a dozen such episodes over the years. “It does make me scared to exercise for a few days,” she told me later. “But then I just get on with my life. I only get four or five migraines a year, so it’s not as scary for me as for some people.”

For years, exercise has been believed to be a significant “trigger” for migraines, along with other triggers, or premonitory symptoms, such as food cravings, being very tired, mood changes, increased urges to urinate, muscle aches, stuffy noses – all part of what Dr. Carolyn Bernstein, a neurologist and migraine specialist at Beth Israel Deaconess Medical Center calls the “build up of what’s changing in the brain before migraine pain gets going.”

But in a recent study in the journal Neurology, researchers explored the exercise-migraine link in a novel way.

They gathered 27 people, good sports and brave souls all, who reported getting migraines with aura that were triggered by bright or flickering light or strenuous exercise. (Migraine auras are typically visual symptoms like Robin had, but can also be other sensory problems or even difficulty speaking.)

The researchers, from the University of Copenhagen, then deliberately exposed the 27 volunteers in the lab to light stimulation, strenuous exercise or both. For the exercise stimulus, patients either went for an intense run or used an exercise bike for an hour, reaching 80 percent of their maximum heart rate. They were also exposed to bright light for 30 to 40 minutes, then were monitored for three hours afterwards and told to report any symptoms of migraine or migraine with aura.

Surprisingly, hardly anyone did. Only three patients reported an attack of migraine with aura after being exposed to light or exercise; three others reported a migraine without aura. Nobody got a migraine with exposure solely to light.

The fact that these triggers for migraine were not as powerful as long believed has left researchers scratching their heads.

Perhaps, suggested two headache specialists in an editorial accompanying the research, the triggers that people believe are harbingers of migraines are not so much triggers that lead to migraines as symptoms of a migraine already in progress.

“Are patients driven to exercise as a premonitory symptom and could their migraines be the cause, not the consequence?” they wondered. “Is the association with light simply reporting photophobia during the premonitory phase?”

Good questions, of course. But here’s an even more important one: What is a migraine patient – most of whom are young women like Robin – to do? Exercise? Not exercise? Avoid other supposed triggers as well?

“It’s a delicate balancing act,” the study’s lead author, Jes Olesen, said in an email. “People with migraines are often told to avoid triggers, including exercise, but exercise is a valuable health activity, and it doesn’t make sense to tell people with migraines to avoid all exercise.”

The solution, in other words, becomes a juggling act. If pounding up and down while running on the pavement or a treadmill brings on migraines, said Bernstein, perhaps exercising on a stationary bike or elliptical machine might help, though Robin has gotten migraines on elliptical machines, too.

If ramping up your heart rate triggers migraines, “you might walk for a while but not increase your cardiac rate.” If getting hot and sweaty brings on an attack, staying cool by swimming might be the solution.

Be vigilant, Bernstein said, and keep a diary of when migraines occur, noting exactly what was going on prior to the attack, including stress level, sleep loss, mood changes, exercise patterns and so on.

But don’t let migraines become an excuse not to exercise. “The idea is to understand how exercise affects your migraines, but don’t think it’s a license to say, ‘Okay, I won’t exercise.’ ”

Robin agrees: “If I think I’m close to getting a migraine,” she said, “I won’t exercise. But otherwise, I do.”

(This post was originally published in WBUR’s CommonHealth blog, 2/19/13)