Category Archives: drugs

Opiate addiction in a market economy

In the US, there has been a huge increase in deaths from heroin overdoses. Why?

In the past two decades, opiate use in the US has soared, and so have deaths from overdoses. The amazing story explaining why is told by journalist Sam Quinones in his 2015 book Dreamland: the true tale of America’s opiate epidemic. Quinones spent years interviewing users, parents of users, drug dealers, researchers, police and others. Dreamland is fascinating reading, telling the stories of individuals and communities caught up in the opiate epidemic.

There are two parallel stories involved, involving legal and illegal drug use. The legal side concerns painkillers. US doctors have long used morphine as a painkiller, but only as last resort because of the risk of addiction. Then came the “pain revolution,” during which opiates became acceptable and often prescribed in ever-increasing amounts.

The change in attitude was driven by commercial considerations. The company Purdue Pharma developed a time-release opiate pill, gained government approval for its sale and embarked on a massive marketing campaign to win over doctors. A key part of the sales pitch was that because there was no euphoria from an immediate hit, the drug was hardly ever addictive. To back this claim, Purdue representatives referred to an obscure publication.

Quinones found that doctors went along with these claims, with no one bothering to look at the publication. Its authors had forgotten about it and didn’t know it was being used to justify massive opiate prescribing. (Like Quinones, I’m not distinguishing between opiates and opioids.) As it turned out, the claims about there being little addictive capacity were wrong.

The marketing pitch was that if someone has pain, prescribe Vicodin or OxyContin, and if the pain continues, up the dose. Before long, huge swathes of the population were seeking prescriptions. Some unscrupulous doctors set up pill dispensaries, writing scripts for anyone who asked. Users would get their prescriptions filled at a low price subsidised by the government and sell portions to others to maintain their habit. At these dispensaries, lengthy queues would form of people waiting for their drugs.

The areas of the country most affected were those where the economy was in decline, so many residents faced bleak times. Quinones tells about small and mid-sized towns in Ohio and neighbouring states, subject to deindustrialisation and despondency about civic pride and public life. Addiction took hold, but it took a while before authorities realised the scale of the problem. One reason was that the parents of those most affected were ashamed to admit their son or daughter was an addict. They were white middle class.

The Mexican connection

In the small Mexican state of Nayarit, poppy seeds grow abundantly. Boiled down, they form a sticky substance called black tar. It is heroin. Some entrepreneurs from Nayarit came to the US and began building a heroin franchise operation. It was like nothing before.

Previously, most heroin imported to the US came from Asia, especially Afghanistan, brought in through New York and distributed by gangs. This heroin was often cut, namely adulterated, as it moved down through the distribution chain. Many small-time dealers were themselves addicts; dealing is a way of making money to support a habit. The heroin business is highly profitable, leading to violence between operators and drawing the attention of the police. It is devastating to poor inner-city areas, especially black neighbourhoods.

The Nayarit entrepreneurs developed a different model. They brought in poor young men from Xalisco, a small city in Nayarit, who were willing to work at low pay in the US because the alternative was backbreaking work on sugar fields at even lower pay. These young men were paid a wage, so they had no incentive to adulterate the heroin they delivered. Furthermore, they were not users themselves. They lived in barren apartments and were given old cars to make deliveries. After a few months they were sent back to Mexico.

            The Nayarit entrepreneurs had several rules. They did not use violence and did not carry guns. They sold only to whites, as this was considered far safer. And they marketed only in areas where the previously established heroin operations were absent, such as Portsmouth, Ohio.

The Nayarit operators used a pizza-delivery model. They prepared black tar in carefully measured amounts tied up in balloons. They would hand out a mobile phone number to prospective users. When they received an order, a courier (one of the boys from Xalisco) would drive to the location with balloons of black tar in his mouth and spit out the appropriate number, for example two balloons for $40. It was high quality heroin provided promptly and reliably. For white addicts, this was enticing. There was no need to go to a seedy neighbourhood and negotiate with addict sellers.

            The operators would check in with their clients to ensure service was satisfactory, calling to ask whether the courier was on time and provided the goods. If a client didn’t call for a few days, the operators might ring and ask if there was a problem. They would lower prices to build their clientele, and sometimes give out free samples to win favour.

            If police pulled over a courier, he would swallow the balloons. Initially, police sent couriers back to Mexico. They were replaced within days. Later, some courts sent couriers to jail with long sentences. They were replaced too, with little interruption to business. Xalisco seemingly had a bottomless reservoir of poor young men willing to take chances to make money. Their reward was to impress their friends and families back home by taking them to expensive restaurants and building nice houses.

The Nayarit heroin operation happened to expand at just the time that opiate addiction was dramatically expanding due to sales of painkillers. For example, a high school football player might be injured and given OxyContin for the pain, developing an opiate habit. To maintain the habit, it was easy to switch to black tar, provided so conveniently.

The first major signal of this emerging opiate problem was deaths due to overdoses. A few individuals, in different parts of the US, started expressing concerns, but it was difficult to gain attention due to the pain revolution and the low profile of the black tar distribution operation. It was striking that the death were not blacks in big cities but whites in small towns. In many cases, parents did not know their children were addicted until they overdosed and died. The parents included politicians, doctors and judges. So why didn’t they speak out? The reason, according to Quinones, was shame. In white suburbs, heroin addiction was stigmatised as something happening somewhere else, to a different class of people. Many parents made up false stories about how their children had died. So it took a while before a few courageous parents started speaking out, raising the alarm.

Drugs and profit

In the US, there has been a so-called war on drugs since the 1930s, when federal authorities began a scare campaign about marijuana, whose use then was concentrated in immigrant communities. Illegal drugs were demonised. Meanwhile, legal recreational drugs, notably tobacco and alcohol, were massively advertised. Then came pharmaceutical drugs, also massively advertised.

            Drug issues are difficult to summarise briefly, especially because government pronouncements, media reports and advertising have cemented in certain attitudes. A simple contrast is between a policy of harm minimisation and one of regulated markets.

Markets are never “free,” but are shaped by government regulations, cultural expectations and social values. In the US, regulations enabled the profit motive to foster addiction and destroy communities.

The company selling legal opiates, Purdue Pharma, ended up making billions of dollars per year on the back of a massive marketing operation based on the claim that time-release opiate painkillers were hardly ever addictive. Profits drove the rapid expansion of use.

Making addictive drugs illegal is a different way to regulate a market. The trouble is that when the demand is inflexible, and alternatives are less enticing, this creates a strong incentive for organised crime. The result, often, is distribution via gangs, reliance on violence and corruption of the police and other authorities.

What is fascinating about the Xalisco distribution network is that it offers a different model for success in selling illegal goods: agents paid a salary rather than a commission, provision of high-quality service and goods, and avoidance of violence.

The US model for dealing with drugs has been disastrous for the people there and in the rest of the world. Tobacco is the world’s most damaging drug, and it was entrusted to large corporations with a huge incentive to expand sales. Alcohol is another damaging drug, again promoted heavily. Then there are pharmaceutical drugs, including morphine. Meanwhile, making some drugs illegal created different sorts of markets. The US war on drugs has contributed to corruption and the world’s highest imprisonment rate.

Quinones does not engage with arguments or efforts for law reform or a different way of managing drugs, instead simply telling the story of the different players in the US morphine/heroin saga. A compelling treatment of the US war on drugs is Johann Hari’s book Chasing the Scream.

In the US, there seems no end in sight for the toxic relationship with drugs. If ever there was a case for moving away from profit as a driving force, this is it.

There has been one good result. Overdose deaths in white middle-class areas have changed the attitudes of some politically conservative communities and politicians, creating more understanding and sympathy for opiate addicts. Perhaps there is some hope for change.


Sam Quinones

PS In recent months there has been some media coverage of opiate addiction problems in Australia.

Brian Martin
bmartin@uow.edu.au

The daily fix

Caffeine is the world’s most popular drug, but it has some dangers.

caffeine-detox

Nearly everyone takes it but hardly anyone refers to it as a drug. I’m talking about caffeine.

It’s in coffee, tea, soft drinks, chocolate and some pharmaceutical drugs. It’s the “energy” in energy drinks. There’s a booming legal drug industry built around caffeine.

In the early 1980s, I was involved in a group called Community Action on Science and the Environment. One of our projects concerned caffeine. We studied the medical literature and produced a leaflet. Even back then, the evidence was pretty clear. If you’re getting more than about 200 milligrams of caffeine per day – the amount in two cups of coffee or four cups of tea – it’s quite likely you’re having adverse physiological effects such as headaches or digestive disorders. You might also suffer withdrawal symptoms.

Health_effects_of_caffeine
Source: wikipedia

If you want to be entertained while learning more about caffeine, get the new book Caffeinated by Murray Carpenter. He is a caffeine aficionado, touring the world to test and collect exotic products. The items on his shelf include:

Amp energy gum, 6 Hour Power energy shots, and Jitterbeans “highly caffeinated” candy. Cans of Red Bull, Rockstar 2X Energy, and Mega Monster energy drinks. There are bottles of Mountain Dew and Coke, and the cans of Diet Coke and Diet Pepsi … There is a small package of roasted and ground cacao, which I purchased in Chiapas, where it is grown. … (p. xii)

AmpGum

Carpenter also delves into the worldwide political economy of caffeine, probing the expanding industrial connections and advertising operations.

I’m unusual in not getting much caffeine. I don’t drink coffee, tea or soft drinks, but do have some chocolate. One benefit is that I get plenty of sleep and wake up refreshed, without the need for a pick-me-up. Despite this unusual level of caffeine avoidance, I wanted to know more about what I’m missing, for good and bad. Caffeinated provides plenty of information.

Benefits and adverse effects

There has been a great deal of research on the effects of caffeine, including using the rigorous method of double-blind trials. Caffeine undoubtedly has some positive effects, especially in mental acuity. If you are doing something that requires alertness – such as driving a truck long distance, or staying up all night to write an essay – caffeine is a drug of choice.

The benefits of caffeine have been studied especially in relation to two groups. The first is athletes, for whom caffeine can give an edge in motivation and performance, though it can be addictive, with the benefits less for habitual users. The second group is soldiers, who need to overcome fatigue; the military has sponsored lots of research.

combat-coffee

However, although caffeine provides alertness and energy, it is a short-term fix, and it’s not so clear whether regular users obtain much benefit compared to non-users. Caffeine can mask a lack of sleep, and performance might benefit nearly as much from proper sleep as from continual doses of the drug.

Carpenter quotes two researchers, Jack James and Peter Rogers, in a 2005 literature review in the journal Psychopharmacology as saying:

Appropriately controlled studies show that the effects of caffeine on performance and mood, widely perceived to be net beneficial psychostimulant effects, are almost wholly attributable to reversal of adverse withdrawal effects associated with short periods of abstinence from the drug. (p. 70)

After reading this, I felt my low caffeine intake was vindicated – until I read further to find that many other researchers disagree with James and Rogers, citing studies showing better memory and attention in a routinely caffeinated state.

For most people, though, caffeine is taken less for immediate performance benefits than as a habit, often attached to social rituals. Regular caffeine intake may be rationalised as a quest for a tasty drink, whether a good cup of coffee, a decent cup of tea or a refreshing cola. According to Carpenter, “The varied preferences for different forms of caffeine in all corners of the globe suggest that it is the drug itself that is the object of our desire” (p. 71).

caffeine-addiction

Advertisers do what they can to make their drinks attractive, but they seldom highlight the key ingredient. Imagine a drink advertised as “a quick and easy way to get your daily fix”.

Some drug users take a great interest in the taste of the delivery mechanism. There are wine connoisseurs, but have you ever heard of grape juice connoisseurs? Without caffeine, would the quest for a delicious coffee evaporate?

There is increasing research interest in the adverse effects of caffeine. One important problem is anxiety. Studies of individuals prone to panic attacks show that caffeine increases the risk of an attack; a placebo does not. Even more surprising is that caffeine can trigger panic attacks in individuals who never had them before, but who are close relatives of those who have had them. There’s apparently a genetic component in susceptibility to caffeine-induced anxiety.

coffee, coffee

Caffeine in soft drinks creates the physical dependence that keeps imbibers coming back for more. In this way, caffeine is implicated in the problem of obesity.

Another rising problem is mixing caffeine with alcohol, as in some drinks now on the market. The problem is that alcohol impairs judgement but the caffeine masks the effects, so young users take more risks.

Just 10 grams of caffeine are enough to kill you. This would be require chugging 200 cups of tea, but ingesting a lethal dose is much more feasible with tablets. I remember a high school science experiment in which we extracted caffeine from tea leaves. We were awed that such as small amount of a white powder, obtained from a seemingly innocuous source, could be deadly.

caffeine_synthetic
synthetic caffeine

Marketing caffeine

Marketers usually avoid mentioning the caffeine in their products. Starbucks emphasises the quality of its coffee, while energy drinks such as Red Bull refer to energy, not caffeine.

red-bull

Carpenter provides a fascinating tour of regulatory reactions to the increasing number of caffeine-loaded products. In the US, companies have long avoided regulation through an early classification of caffeine as GRAS (Generally Recognised as Safe), but the Food and Drug Administration has started paying attention to the plethora of new products delivering caffeine, and companies try to avoid regulation by setting their levels just below what has historically been treated as acceptable.

Downplaying caffeine’s role is disingenuous, but entirely understandable. Caffeine is a drug, so to admit that a drug is the primary attraction in any product is fraught with both regulatory and moral peril. But there is another reason to divert the public’s attention from caffeine’s key role in commerce. If Starbucks acknowledged the caffeine’s importance, then it would be more difficult to charge four dollars for a coffee drink. Consumers might prefer a Jet Alert tablet (you could buy a hundred for less than the price of a double latte). Starbucks Refreshers drinks, with fifty milligrams of caffeine, could easily be replaced at half price by a Diet Mountain Dew. (p. 206)

jet-alert-tablets

Ironically, caffeine’s popularity is triggering regulatory interest in many countries. When caffeine was consumed in ritual settings of drinking tea and coffee, its adverse effects were less visible, though some individuals over-indulged. With the expansion of caffeine intake through soft drinks and energy drinks, sometimes mixed with alcohol, the hazards are becoming more obvious, for example when youth take shots containing multiple caffeine tablets. The spotlight is now being thrown on all uses of caffeine.

However, although some health-conscious individuals may modify their intake of caffeine, and regulators attempt to control some of the more risky products, the caffeine-industrial complex continues apace. There is a lot of money to be made by hooking ever more customers into demanding their daily fix in the guise of a costly delivery vehicle, whether coffee, tea, soft drink, energy drink or chocolate.

energy-drinks

Reflecting on the benefits and risks of caffeine can be useful when considering policy on other drugs. All drugs have benefits and risks, after all, and there is no obvious cut-off point for deciding whether and when a drug should be banned, taxed, available only on prescription, or otherwise condemned or controlled. The adverse health effects of caffeine could be reduced by removing it from food and drink, but at the expense of creating a huge black market and stimulating organised crime. As you get your daily lift from caffeine, you can use your greater mental acuity to consider how best to address habits that are increasingly caffeinated.

Brian Martin
bmartin@uow.edu.au

Murray Carpenter, Caffeinated: How Our Daily Habit Helps, Hurts, and Hooks Us (New York: Penguin, 2014)

Caffeinated

Addendum

Melissa Raven offers the following historical angles on caffeine.

Coffee Cantata by Johann Sebastian Bach
The early 18th century enthusiasm in Western Europe for coffee amongst the middle classes was affecting Prussia’s economy. The country’s monarch, Frederick the Great, wanted to block imports of green coffee as Prussia’s wealth was being drained by the huge sums of money going to foreign exporters. Also the right to sell coffee was intended to be restricted to four distillers but the fashion for drinking coffee has become so widespread that the law was being flouted and coffee beans illegally roasted. The Prussian king condemned the increase in coffee consumption as “disgusting” and urged his subjects to drink beer instead. Frederick employed coffee smellers, who stalked the streets sniffing for the outlawed aroma of home roasting. However such was the public outcry that eventually he was forced to change his mind. As a satire on the whole affair, Bach wrote the “Coffee Cantata,” a humorous one act operetta about a stern father’s attempt to check his daughter’s indulgence in the much loved Saxon habit of coffee drinking.
http://www.songfacts.com/detail.php?id=18529

coffee-cantata

LONG before the multi-coloured hippie experience there was another group of long-haired men and women who went in for drink, drugs and sex. The Bohemians, as they were known, lived in Paris in the 1840s. Although their sexual and drinking habits raised eyebrows, what really shocked Parisians was their use of a stimulant drug in large quantities. According to a later medical textbook it ‘made the sufferer tremulous, subject to fits of agitation and depression. The sufferers loses colour and has a haggard appearance’. The drug was coffee,
Wells, Troth. (1984, October). Our daily fix. New Internationalist, pp. 14-15. http://www.newint.org/issue140/fix.htm

From Melissa’s PhD thesis (http://ro.uow.edu.au/cgi/viewcontent.cgi?article=4688&context=theses), p. 303
Hennessey (1993) documented an epidemic of deaths, predominantly female, due to kidney failure resulting from long-term use of compound analgesics such as Bex and Vincents in Australia from the mid-1950s to the 1970s. Although the damage was directly caused by the combination of phenacetin and aspirin, the high caffeine content of these products (APCs – aspirin, phenacetin, caffeine) fostered the dependence that led to the cumulative effects (p. 6). Advertising in influential Australian women’s magazines also played a major role in encouraging and indeed normalising use. Compound analgesics were constructed as the solution to everyday stresses experienced by women (particularly housewives).
Citation: Hennessey, Eileen (1993). A cup of tea, a Bex and a good lie down. Department of History & Politics, James Cook University of North Queensland.

Pharmacrime and what to do about it

Is the pharmaceutical industry more dangerous than the mafia? Peter Gøtzsche thinks so.

PeterGotzschePeter Gøtzsche

Did you know that the third leading cause of death in western countries, after heart disease and cancer, is adverse reactions to prescription drugs? Did you know that large pharmaceutical companies usually control the trials of their new drugs, and sometimes manipulate the published results by misclassifying deaths, excluding some participants and not revealing studies that came up with null results? Did you know that some of people listed as authors of drug studies published in leading medical journals have had little or nothing to do with the research, have not written the papers, and are paid for their symbolic role? Did you know that several major pharmaceutical companies have paid fines of over one billion dollars for corrupt practice? Did you know that government drug regulators in several countries have become tools of the companies they are supposed to regulate? Did you know that hundreds of thousands of people have died from drugs when the company executives knew about and hid information about the hazards?

This information has been known to critics of large pharmaceutical companies — commonly called big pharma — for many years. There have been powerful critiques written by former editors of medical journals and as well as exposés by whistleblowers. Now there is a new book that puts together the case against big pharma in a more comprehensive and hard-hitting way than ever before: Peter C Gøtzsche’s Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare (London: Radcliffe, 2013).

DeadlyMedicines

The bulk of the book is a critical examination of research findings concerning pharmaceutical drugs, serving to illustrate general points. For example, chapter 4 is titled “Very few patients benefit from the drugs they take,” seemingly a startling claim. Gøtzsche gives some hypothetical examples of how results of drug testing might sound encouraging but actually disguise a very modest effect, and how double-blind trials that are not properly blinded can give misleading results. He then cites studies of antidepressants to show that the actual situation is probably worse than his hypothetical examples.

Different chapters in the book deal with conflicts of interest, pharmaceutical company payments to physicians, drug marketing operations, ghostwriting of articles for medical journals and the inadequacy of drug regulators, among other topics. Each of these chapters includes case studies of particular drugs or company operations. Then come chapters about particular drugs, abuses and companies, for example chapter 14 on “Fraudulent celecoxib trial and other lies.” Gøtzsche exposes corrupt practices, including the hiding of trials that did not show a benefit, disguising adverse drug reactions, promoting a new highly expensive drug that is no better than an existing one, making false statements about the benefits and risks of drugs, applying pressure on drug regulators, and suppressing information about dangerous drugs on the market.

Gøtzsche relies heavily on published studies (including his own) to back up his claims: the book is thoroughly referenced, with numerous citations to articles in medical journals. Deadly Medicines and Organised Crime is in the tradition of rigorous and knowledgeable exposé. Some previous books along the same line include Marcia Angell’s The Truth about the Drug Companies and Jerome Kassirer’s On the Take. Angell and Kassirer had been editors of the prestigious New England Journal of Medicine.

Gøtzsche has impeccable credentials to write a critique of big pharma. He started his career working for a drug company, and saw dubious operations from the inside. He qualified as a doctor and then worked as a medical researcher for many years. Most importantly, he is a key figure in the Cochrane Collaboration, a group of medical researchers who scrutinise the full complement of studies of particular drugs, drawing conclusions about benefits and risks.

Undertaking a meta-analysis of drug trials seems like an obvious thing to do. What makes the Cochrane Collaboration significant is that it is largely independent of the drug industry. The industry’s influence is so pervasive that many trials are fraudulent or misrepresented, many publications are ghostwritten by company staff, and evaluations by drug regulators are biased due to company pressure. Being relatively independent of this influence makes an enormous difference.

As well as obtaining insights from his involvement with the Cochrane Collaboration, Gøtzsche has had personal involvement in trying to influence drug policy. Being from Denmark, on various occasions he has provided information to the Danish drug regulator on crucial issues, such as that a new drug is far more expensive than an existing one, but no more effective. Yet the regulator on many occasions has served drug company agendas by approving drugs, costing the government large sums of money and providing no added benefit to patients.

Here is Gøtzsche’s summary of problems with drug regulation.

We don’t have safe drugs. The drug industry more or less controls itself; our politicians have weakened the regulatory demands over the years, as they think more about money than patient safety; there are conflicts of interest at drug agencies; the system builds on trust although we know the industry lies to us; and when problems arise, the agencies use fake fixes although they know they won’t work. (p. 107)

In describing the unethical and damaging activities of the drug industry, with case after case of egregious behaviour, Gøtzsche sometimes expresses his exasperation. This comes across most strongly in the chapters on psychiatric drugs, many of which are useless or worse, cause addiction and massive damage, yet are widely prescribed due to massive marketing.

Gøtzsche’s book is filled with information and thoroughly referenced, yet perhaps its most striking feature is his claim that big pharma is organised crime, as indicated in the title. At first this may sound exaggerated, or just a metaphor, but Gøtzsche is quite serious. He looks at definitions of organised crime and finds that big pharma fits in all respects: the companies knowingly undertake illegal actions that bring them huge profits and kill people, and they persist in the same behaviour even after having been convicted of criminal activity.

At many points, Gøtzsche asks rhetorically what is the difference between the activities of big pharma in promoting addictive and destructive drugs and the activities of drug cartels producing and selling heroin.

organised-crime-cartoon

Calling big pharma organised crime is in a tradition of pointing to double standards in the way behaviour is labelled. The term “terrorism” is usually applied to violent acts by small non-state groups; some scholars have pointed out that many governments use violence to intimidate populations in way that fits the usual definitions of terrorism. They call this “state terrorism.”

If the operations of big pharma are a type of organised crime, except killing many more people than the mafia, what is to be done? Gøtzsche has a chapter spelling out ways to bring drug testing and regulation under control. One important step is for all drug testing to be done by independent scientists, rather than by the companies that manufacture the drugs. Another is to disallow payments from drug companies to physicians, researchers, medical journals, and regulators. Gøtzsche draws an analogy: what would people think if judges received payments from prosecutors or defendants? It would be seen as corrupt, of course. Company payments to physicians, journals and regulators should be seen as corrupt too.

doctorPayment176

Gøtzsche’s recommendations are sensible and, if implemented, would transform the way drugs are used in society. If this happened, company profits would plummet, which means that companies will do everything possible to maintain the current system. As well as saying what should be done, there is a need for a strategy for bringing about change, and the strategy has to involve citizen campaigners as well as concerned researchers and physicians. Just as the movement against smoking has involved a wide range of campaigners and methods of action, so too must a movement against corruption in healthcare. Deadly Medicines and Organised Crime is not a practical manual for such a movement, but it is essential reading for movement activists, especially so they will know what they are up against.

For readers thinking about their own health, and the health of their friends and family members, Gøtzsche provides important messages. He suggests not taking any drug unless it is absolutely necessary, because benefits are minimal and there are always potential harms. In this category would be included antidepressants and drugs to lower cholesterol and high blood pressure, for example. If you’re going to take a drug, then it’s usually better to take an old one, because newer ones are probably no better, cost vastly more, and are less well tested for harms.

olderisbetter

If you want to know more about the drugs you take, seek independent advice. That’s not easy, because so many researchers, medical journals, physicians and regulators are in the pay of the industry. Reviews by members of the Cochrane Collaboration are a good place to start. So is Deadly Medicines and Organised Crime. Gøtzsche provides enough references for even the most assiduous reader.

Brian Martin
bmartin@uow.edu.au

 

I thank Melissa Raven for useful comments on a draft of this comment.