Shadow Dance: is alcohol safer and more effective than SSRIs?

This is the fifth in the Dance series tackling the crisis in healthcare

We have dug a deep hole. The regulatory hoops through which a company has to jump are now so minimal that it would be easy for us to get alcohol, nicotine, benzodiazepines or opiates on the market as antidepressants. Opiates in fact have a much better track record than SSRIs for treating severe depression – melancholia. Benzodiazepines, which are close to alcohol in pill form, have lots of positive trial results for depression, so there is little question that we can get postive results for alcohol also. Alcohol also has anxiolytic properties that have been of benefit in social situations for centuries.

Alcohol with all its risks is a good example because we are happy to have it available over the counter. Prescription only drugs are available on prescription only precisely because we have every reason to think they will be as risky as or riskier than alcohol.

The prime factors that prevents companies bringing alcohol on the market as an antidepressant are patent status and consumer familiarity. Consumer familiarity provides a source of competing information that companies cannot control. In contrast, SSRIs, statins or bisphosphonates are unknown quantities making it possible to manage the views of doctors and patients more readily.

Getting on the Market

The regulatory requirements regarding clinical trials allow us multiple opportunities to get a positive result for alcohol. For some antidepressants only one third of trials have been positive. Regulators will conceal the fact that they have seen studies where alcohol has failed to beat placebo. As a result patients and doctors need not be aware of negative studies.

In the trials we run, we can use as our yardstick of success not lives saved or people returning to work or people objectively performing better or people in their own estimation performing better but rather a change in score on rating scales. These rating scales are sensitive to the side effects of the drug and side effects may produce a benefit on the scale whether or not there is a benefit for the underlying condition. The anxiolytic or sedative effects of alcohol (or the stimulant and anxiolytic effects of nicotine) would produce substantial benefits on scales like the Hamilton rating scale for depression or scales for anxiety.

Rather than comparing alcohol against a known treatment in cases of severe mood disorders, we can compare it against placebo in a set of mild problems. And we can improve its profile by screening out anyone showing a good response to placebo or a bad reaction to alcohol during the first week of the study.

In these trials, placebo effects might well account for 80-90% of any improvements found on rating scales. Nevertheless, the studies will be deemed a successful demonstration that alcohol “works”. Regulators and academics will happily give doctors and the public the impression that 100% of the apparent benefits of alcohol for depression stem from the alcohol and none from placebo factors.

In a proportion of our alcohol studies, investigators may find out later that not all the patients actually existed. For us non-existent patients come with one great benefit – they do not have troublesome side effects. The trend towards non-existent patients is likely increasing as clinical trials of more recent alcohols have been outsourced to Mexico, Eastern Europe, India and elsewhere. But even if some journalist finds not all our patients actually existed, it will make no difference.  Once on the market, our license to sell alcohol as an antidepressant will not be revoked.

In one important study we did of alcohol for maintenance treatment of depression (a particularly lucrative market), it proved no better than placebo in 30 North American study centers, but turned out to be dramatically better than placebo in 2 Mexican centers. When all the centers were added together, the overall results for alcohol were marginally superior to placebo.  The regulators approved this study. The published account of the study gave no indications that alcohol only “worked” in Mexico.

We can therefore do studies in which more people die on alcohol than placebo, fail to get back to work on alcohol compared to placebo, in which alcohol proves better than placebo in perhaps no more than 33% of cases on our chosen rating scale, and in these 33% of cases proves better in only 3% of centers, and we will still be able to market alcohol as an “antidepressant”.

Making the Market

After approval, in order to make our market, we can of course only publish the trials in which there were positive findings. But we can publish these multiple times, giving the impression that there were far more positive trials than in fact there were.  We can aim at having up to 50 publications for each trial. Our ghostwriters can also take a negative study and polish the results to make it look positive. Ghostwriters never mention studies that have failed to show efficacy.

In due course when it comes to shaping the marketing campaign for alcohol, the data generated by these studies is almost free-floating content that can be molded into almost any shape we might wish. For instance, if an opportunity arises in the painkiller market, because another compound like Vioxx has run into trouble, some minimal benefits that may have been registered in the trial, in terms of feeling slightly better in painful situations, can be polished by ghostwriters into a series of articles that trumpet the analgesic qualities of alcohol in order to take advantage of any opportunity that has opened up.

While we are busy getting beer on the market as an antidepressant, several other companies can file for product patents on whiskey, gin, brandy, wine, port, and even on Irish as opposed to Scotch whiskey, or Japanese as opposed to Scottish scotch.  The combined marketing of both our and other companies can encourage doctors to put patients on combinations of whiskey, gin, brandy and port, or even combinations of Scotch, and to keep patients on these combinations for extended or indefinite periods of time.

Based on the published trials, guidelines will have to endorse alcohol for use in nervous disorders and perhaps owing to its excellent safety profile have it as a first line therapy. Depending on how clever companies are with the trials they run, or choose to publish, the guideline makers may put whiskey forward as a first line treatment with brandy second line and gin third line. This is probably more likely to happen if whiskey makers have a greater presence than gin-makers in the country in which the guideline is being written.

Staying on the Market

When it comes to the side-effects of alcohol, ghostwriters can hide these under terms such as ‘failure of response’ or perhaps list an initial side effect such as ‘nausea’ when in fact the individual had nausea, vomiting, followed by an epileptic convulsion. They can also simply fail to mention problems by saying they have only included those problems that appeared at a 10% rate or more.

When patients have an adverse effect on alcohol, such as a convulsion, we can dismiss this as anecdotal – not evidence based. In contrast, we can write up any dramatic improvement on alcohol during its early period on the market in both the academic and mainstream media, even featuring it on television and radio, under headings like “alcohol saved my life”.

One helpful feature of the trials we have to undertake to bring alcohol to market is that they only have to last for six to eight weeks.  This is helpful as very few of the problems that might be expected from alcohol (or nicotine) emerge in a six to eight week period.  For any problems that appear later, we can argue that no placebo controlled data support the claimed adverse event, and both we and doctors have to operate only on the basis of the scientific evidence.

If there is an increase in epileptic convulsions on alcohol compared to placebo in the course of our clinical trials but this is not statistically significant, we can rely on journals, regulators and academics to say there is no evidence for any increase in the rate of convulsions.

Should there be any hints of liver problems on alcohol in the course of our trials, which is unlikely because of the short duration of the trials, we can attribute this to the depression or other nervous problem for which the person is being treated. Even though the entire medical literature up till then might not have a scrap of evidence that depression causes liver dysfunction, and there may be a substantial amount of other evidence that alcohol causes liver dysfunction, within an astonishingly brief period of time (weeks) we have the ability to get a significant proportion of the medical profession to agree that it is well known that depression causes liver dysfunction.

If some people have difficulty stopping alcohol, we can depend on a bias doctors have (helped by us) to ensure that any symptoms on stopping alcohol will be put down to the nervous problem that was being treated in the first place rather than to dependence and withdrawal. We can be pretty sure that twenty years after alcohol is first marketed that a majority of doctors will fail to recognize that it causes dependence. They will instead be likely to explain to patients that its just like insulin – their bodies are not producing enough alcohol and they need to continue treatment for life.

In the case of pregnancy, this bias and our marketing, means that we should be able to make alcohol one of the most commonly prescribed drugs in pregnancy within a few years. And indeed compared with other antidepressants, a glass or two of wine per day is positively harmless. Doctors will tell women who avoid coffee, soft cheeses etc. that leaving their nerves untreated will harm their babies.

Finally, we know from past experience with other drugs that in a few years’ time alcohol is likely to be linked to suicide and perhaps violence.  We have a number of academics who we can enlist to produce graphs to show that as alcohol consumption has gone up that suicide and violence rates have fallen in countries like Holland or in parts of the United States. One of the advantages of getting studies like this published in a leading journal like Archives of General Psychiatry is that we can depend on the editor to refuse to publish any correspondence that might be critical of the study.

We can organize for cost utility analyses as thick as telephone books to demonstrate that the cost of alcohol is minimal compared to the quality of life gained. Provided the analysts stick to the published data, we can show that if governments pay for access to alcohol for large segments of the population, that there will be a net benefit to society.

Doctors – don’t you love them

A major difference between prescription and over the counter drugs lies in a curious inversion of the stranger-neighbor phenomenon. We are in general wary of strangers and comfortable with neighbors. We neglect the fact that we are most likely to be abused or harmed by someone we know. Neighbors and relatives are familiar and we think we can manage the risks.

In this scenario alcohol is familiar while alcohol and nicotine as antidepressants are strangers. We have a feel for the traditional risks of alcohol and nicotine but far from treating therapeutic alcohol or other new drugs as strangers and regarding them as dangerous and risky, mediated through our local risk-laundering service (doctors), we will treat these prescription only drugs as safer than traditional alcohol or nicotine, even though prescription-only drugs are so precisely because we have every reason to think they will be riskier than drugs like alcohol.

If this seems to push the argument too far, consider that we regard prescribed amphetamines as safe enough to give to children, even toddlers, while the authorities jail others for possession of street amphetamines on the basis of the risks they pose. The same is true for prescribed as opposed to proscribed opiates, and other drugs.

Doctors provide us with other services. Getting treatment from a doctor suspends the natural caution that our consumers might feel about taking our new chemical. Even though prescribed alcohol has now been tested in protocols in which it looks safer than and as effective as SSRIs and doctors know what the risks of traditional alcohol are, they are it seems prepared to act as though prescribed on-patent alcohol comes risk free. This is partly because unlike traditional alcohol doctors never get a hangover from prescribed alcohol and never crash because of it.

In fact making alcohol, nicotine or opiates available through doctors is a way to hide hazards such as liver failure, lung cancer or dependence on average for 10 to 15 years from the time that people in the street have begun to claim that their liver failure or lung cancer stems from our drug.

Not only can the medical profession be depended on to deny a link while patients are reporting a link but even after regulators put black box warnings on alcohol about a risk, even if that risk is a lethal one, most doctors will still deny that this risk happens.

Doctors finally provide us with significant insurance against product liability. In the event that a doctor testifies that he would have given alcohol no matter what the warning on it, we are legally immune to any product liability actions stemming from its use.

What’s not to like about doctors? We need to work out what we think about recent moves to have cheaper prescribers, in the form of nurses and pharmacists. It’s always risky fiddling with a winning formula.


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Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. Yes, the product, the marketing campaign, getting it on the market, making sure it stays on the market. Good, all well-run companies draw up this clever marketing plan to make sure their product is first in the queue, bought by the traders and marketed to the consumer.
    Alcohol is marketed in this way and we all know what a few drinks do to us. They make us happy, carefree, sometimes irresponsible, but who cares. We are all in it together, having a few drinks and being just a little bit on the wild side.
    I take David’s point, that alcohol, could be branded an antidepressant.
    Why not? It does the business, we feel great, in good company, and to hell with everthing. We are among friends, who are all drinking, too, so, another one, why not?

    But, and a big but, when you are alone with a pill, shaped like a jelly bean, that promises even greater delights, more happiness, more contentment, more social involvement than alcohol could ever give, then it is so tempting to take this little pill and not to worry, because it is not alcohol; it is tried and trusted medication; it might be better than alcohol because your doctor doesn’t like you drinking alcohol, he says it makes you depressed, but this little pill won’t make you depressed, because it has ‘chemical properties’ which have been proven to bring you up and keep you up, whereas alcohol brings you up and then brings you down very quickly leading to perhaps a few more drinks than is perhaps safe or wise, whereas the little pill will keep you up and not let you down, ever.

    This little pill will not let you down, ever. It has been designed to keep you up, to keep you in a place they have told you to be, forever and ever.
    Give me a nice, ice cold, glass of Soave, anyday, over the tantalising, jelly bean shaped pill that makes people addicts. OK, wine is addictive, too, but the marketing plan is the same scenario developed and organised by specialists.
    Coca-cola is addictive, irn-bru is addictive, nicotine is addictive; but, ssris, have a peculiar, distasteful taste in the mouth, the mind and the body, that is seriously miscast and criminal marketing.

  2. Well written! This sort of institutional analysis reminds me of the Australian man who patented the wheel not too long ago: http://bit.ly/18yCWa. It has some nice parallels, I think.

  3. This proposal makes enough sense to be downright spooky. At least in the US, patients are always advised to be patient and stick with your treatment because “it may take your doctor a long time to find just the right cocktail for you.” They utter this phrase without a hint of irony.

    Psychiatry: “California Rocket Fuel”
    http://www.socialanxietysupport.com/forum/f30/california-rocket-fuel-effexor-and-remeron-183484/

    Mixology: “Long Island Iced Tea”
    http://cocktails.about.com/od/atozcocktailrecipes/r/lng_islnd.htm

    Which of these professions is more scientific right now?
    And which would you rather talk to, if you were feeling real bad?

  4. An article in the Canadian Medical Journal is worthy of attention with respect to advertising and marketing of drugs.
    “Direct-to-consumer prescription drug advertising in Canada: Permission by default?
    David M. Gardner, Barbara Mintzes, Aleck Ostry
    “The advertising of prescription drugs aimed directly at the public is prohibited in most countries, including Canada. However, a shift in interpretation of the policy governing this marketing strategy, known as direct-to-consumer advertising (DTCA), has occurred in Canada, resulting in its partial introduction without public and parliamentary debate. …..In 1996, a policy statement that set out to define the boundary between information dissemination and advertising suggested that Health Canada was ready to relax its interpretation of the Act.4 It stated that Health Canada “recognizes the importance to the pharmaceutical industry and to the general public of being able to disseminate and access nonpromotional information regarding drugs for human use.” The effect of this statement was tacit approval of help-seeking advertisements for serious diseases. A policy paper released in November 2000 suggested an even more liberalized reinterpretation of the Act. It explicitly stated that help-seeking and reminder advertisements, but not product claim advertisements, were legal…..The problems with this system are evident. Advertisements can be released to the general public without being reviewed by government regulators or their delegated bodies. ……a television advertisement for Zyban (bupropion) was allowed to run for months, although Health Canada judged it to contravene the law…..Examples of drugs marketed to the public that were soon found to be harmful include benoxaprofen, cisapride, alosetron and troglitazone.The finding that 20% of new drugs eventually receive new black box warnings on the product monograph after marketing or are withdrawn from the market because of serious safety concerns supports the concern that DTCA may contribute to public harm…..There is ample evidence that DTCA has increased consumer awareness of advertised prescription products and that this has affected consumer behaviour and physician prescribing practices.”
    In contrast, advertising of alcohol is prohibited in Canada.
    I’m off to have a large G&T.

  5. It seems that diet pills can shorten life expectancy quite severely by affecting areas of the body. Diet pill advertising has caught out women who want to lose weight. Apparently, it is being considered, to have these pills, prescription only, as they appear to be quite dangerous.

    Surely, with ssris, they have all shot themselves in the foot, by not being allowed to sell ssris over the counter. If they were safe, we could go and buy them in our local chemist. But, no, it is only our doctor who is allowed to give them to us and according to the leaflet, the doctor is warned that if the patient experiences akathasia,1 in 1,000, see your doctor, or serotonin syndrome, 1 in 10,000, see your doctor, or, even worse, frequency unknown, thoughts of harming or killing yourself, see your doctor.

    Well, I think, we all agree, seeing your doctor, is the shifty tactic deployed to put all onus on the doctor. The doctor, the doctor, the doctor, the doctor, this is what the leaflet says, and we all now know that that is about as much use as using a wet hankerchief to wipe your nose.

    My point is, frequency unknown, are the most deliberate, sabotaging two words, that these corrupt pharma companies have put together. Frequency unknown, is known, and poor little doctors are not quite up to our expectations in seeing beyond frequency unknown.

    Frequency unknown, has put a lot of people in an unknown and unquantifiable loophole, almost schizophrentic situation, whereby heavy numbers of people are in this ‘frequency unknown’ category which we really have to quantify. It is not good enough that we are unknown, we are known, so ………………………………………..?

  6. Reinventing the wheel:
    Benzodiazepine use and risk of dementia: prospective population based study
    (Published 27 September 2012). BMJ 2012;345:e6231
    “In this prospective population based study, new use of benzodiazepines was associated with increased risk of dementia. The result was robust in pooled analyses across cohorts of new users of benzodiazepines throughout the study and in a complementary case-control study. Considering the extent to which benzodiazepines are prescribed and the number of potential adverse effects of this drug class in the general population, indiscriminate widespread use should be cautioned against.”
    Over thirty years ago we knew not to give BZPs to the elderly, not because of “dementia” but because they developed delirium. Dementia, usually meaning Alzheimer disease, is very poorly diagnosed leading, of course, to the use of the “new” anti-Alzheimer drugs – whether you had AD or not.
    There is a little bottle in front of me with a label saying “Drink Me”. I wonder…….

  7. I once met a woman who’d grown up in one of the more hardcore South Side Irish enclaves of our fair city. She recalled an old saying back there that, “Some people are just born a couple of drinks below sea level.” Yikes, I thought. A folk theory of chemical imbalance. I was grateful I hadn’t grown up in HER neighborhood or I would have been hitting the sauce from the age of seven. It hardly needs saying that we met at an AA meeting …

    The point being that there are strong parallels between those who become addicted to alcohol for its anxiolytic and mood-elevating properties, and long-term takers of “legitimate” antidepressants. Both may begin their drug careers in a similar state and for similar reasons. Both may become all the more firmly attached to their drug as its benefits diminish and its ill effects mount – in part, because trying to quit becomes ever more daunting. And both may be convinced that they need their drug “every day, for the rest of their lives, like a diabetic needs insulin, not to get high but just to function normally.” There was a time years ago when that was exactly how I saw my antidepressants – and my drinking.

    “That’s just your disease talking,” would have been the reaction of many of my friends in AA. Maybe, maybe – but when one’s inner “disease” does such a pitch-perfect imitation of one’s psychiatrist, it’s not easy to tell it to just shut up. The psychiatrist is likely to say, “The drinking has got to stop; you are just self-medicating.” But when his alternative is to keep “medicating” for life on psychiatry’s terms, including taking ever higher doses of ever more meds as the symptoms worsen, “self-medication” looks less and less like a vice or a cop-out, and more like simple do-it-yourself psychiatry.

    The knowledge bases of those studying drug and alcohol addiction, and those studying depression, anxiety, mania etc. have grown far apart in recent decades. If psychiatrists could be honest enough to admit the possibility of overlap between the physiology and psychology of the “bad drug” and the “good drug” experience, we could learn a tremendous amount. Instead, I’m afraid psychiatry is simply determined to muscle addictionology aside. It’s becoming all too common for people hospitalized for drug and alcohol addiction to emerge with prescriptions for multiple antidepressant and anti-anxiety drugs.

    Twenty years ago it was at least recognized that the benzodiazepines were “close to alcohol in pill form”, as David Healy says, and alcoholics should be strongly cautioned against their use. Now, for instance, the VA finds itself in a bind where its psychiatrists are putting at least one benzo, sometimes two, in the medication “cocktail” of each soldier treated for major PTSD, almost all of whom are abusing alcohol or drugs. Then, when the soldier applies for a VA residential substance abuse program, they are rejected because of a longstanding no-benzo rule. The solution being advocated of course is for the substance-abuse people to join the 21st century and dump their outmoded ideas for “evidence-based medicine.” The results will be grim, I’m afraid, for the long-term health and happiness of the soldiers involved.

    Behind the satire in this column is some real wisdom, and a warning that I wish psychiatry would heed.

  8. Basically, undeniably, unequivocably, it is the ‘sit down and shut up’ pill.

    Shall we call it ‘sd-su’s (sit down-shut up) rather than ‘selective serotonin reuptake inhibitors’ which means ‘absolutely nothing at all’ as far as I can make out.

  9. Chris Anderson says:

    Gee, it must be a total joy to be a patient of this guy. His therapeutic tools of Sarcasm, Irony and deep cynicism would provide nourishment and a nice warm glow to anyone suffering from a mental illness. Not.

  10. Honestly, I think alcohol is safer than prescription anti-depressants. Just one single SSRI pill permanently ruined me and my ability to enjoy alcohol permanently.

    I used to get a euphoric, happy, and relaxed feeling from drinking alcohol. I was 20 years old at the time when I first began drinking alcohol and in America that’s too young to buy alcohol. I had a hard time getting alcohol for myself because most everywhere required ID when purchasing alcohol. This prevented me from drinking more than a couple times a week.

    I was having some anxiety at this age and I was led to believe that alcohol was bad for you and was addicting anyway. I thought to myself that maybe I shouldn’t drink alcohol anymore and get some medical help from a doctor for my anxiety as that would be the healthier route.

    Well, after talking to a general practitioner for about 15 seconds about anxiety, led them to prescribe me Escitalopram. I was told it was mild and non addicting and takes weeks before you can notice a difference.

    This made me think that this drug must be really mild which is perfect because I didn’t need something strong anyway. I took the pill and had the worst reaction in my life. Day long panic attacks and vomiting. I threw the medication away immediately. After recovering from the reaction I felt better, but…slightly different.

    I noticed I didn’t really get excited or happy about anything anymore. Sex drive was lower as well. It was like my emotions were a little flattened.

    A few months go by and I try and drink alcohol again. The alcohol didn’t give me that happy feeling anymore. It just made me tired and maybe a little relaxed, but no more euphoric happy feeling. I miss the happiness that came with drinking alcohol. Now I have no incentive to drink it anymore. It makes me sad.

    I blame the SSRI for causing this. All it took was one of these pills to cause my permanent side effects.

    In my opinion, these SSRIs should not be handed out like candy from doctors and should only be used as last resort treatment to patients. I think the only people that should be prescribed them are people that are forced into mental hospitals, patients on verge of suicide, or after all other healthier treatment options have been tried.

    Another thing that could have prevented my problem is lowering America’s alcohol drinking age. I have no idea why 21 is the legal age to drink, when 18 is the legal age to join the military or buy cigarettes. America is one of the few countries where its illegal to purchase alcohol at 18. So pointless.

    I would have much rather been a happy drunk than what I am now.

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