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Re: lack of proof antidepressants addictive » mcp

Posted by Larry Hoover on September 7, 2004, at 10:13:10

In reply to Proof of antidepressants being addictive, posted by mcp on September 5, 2004, at 22:40:35

> FDA Warning
> Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery
>
> Sounds like crack babies to me. Now before you all attack me I am just making a point that they are addictive. I am not condemning them all together. I know they have helped many people, present company excluded

I'm sorry, but it's not evidence of addiction at all.

This is the definition of drug addiction (adopted from WHO guidelines) used by the FDA until 1988, when the Surgeon General sought to bring tobacco under the jurisdiction of the FDA. To suit that end, and that end alone, the definition was changed by Kessler, by dropping the criterion of intoxication.

"Drug addiction is a state of periodic or chronic intoxication produced by the repeated consumption of a drug (natural or synthetic). Its characteristics include: (i) an overpowering desire or need (compulsion) to continue taking the drug and to obtain it by any means; (ii) a tendency to increase the dose; (iii) a psychic (psychological) and generally a physical dependence on the effects of the drug; and (iv) detrimental effects on the individual and on society."

In other words, "intoxication" was a crucial component in defining addiction. This was further emphasized in 1978: "In 1978 the WHO reiterated the importance of the concept of intoxication, stating that 'psychotropic' substances considered for control by the international community must be capable of producing both a state of 'dependence' and 'central nervous system stimulation or depression, resulting in hallucinations or disturbances in motor function or thinking or behavior or perception or mood' (WHO, Technical Report Series. No. 618. 1978. p.8)."

This earlier definition required *all* criteria to be met. Only (iii) applies to SSRIs.

For example, GlaxoSmithKline, the manufacturer of Paxil, insists that the drug is not habit-forming. In court papers, the FDA defines habit-forming drugs as those that cause "drug-seeking behavior," <<added emphasis, refers to criterion (i), above>> prompting users to escalate the dose for psychological or physical gratification. "This is not to say that SSRIs, like beta blockers, steroids and many other drugs, do not create a physical state in which abruptly ceasing the product causes a discontinuation syndrome . . . but it is not habit-forming," the FDA says.

It is quite clear here that the FDA is distinguishing between discontinuation syndrome and criteria which apply only to addiction. (Sorry, unreferenced. Forgot where I got this from, but it flows from a California class action lawsuit. The judge ruled, "...The FDA's Safety Review of the Paxil NDA did not reveal incidents of tolerance, dependence, or drug seeking behavior. Additionally, the FDA did not object to the "Paxil is non-habit forming" claim in its reviews of the broadcast advertisements. Finally, Paxil has not been shown to provide the "high" traditionally associated with addiction.....First, while these facts support the contention that Paxil may not be "addictive" in the strict clinical sense, they do not address Plaintiffs' critical claim that the GSK statements might nonetheless be misleading to the members of the consuming public who are targets of the ads. Second, these facts invite too much reliance on the FDA's prior approval. As noted above, the circumstances of those approvals as well as the FDA's standards in granting those approvals are not necessarily the same standards to be applied here....") The judge is clearly making a distinction between medical terminology and colloquial language. There is a problem if people misunderstand what they're being told, certainly, but there is no evidence that there was an intent to mislead.

The IOM has a much simpler definition of addiction entirely. "This and other IOM committees have defined drug addiction as a brain disease similar to other chronic, relapsing conditions, such as heart disease and diabetes, and manifested by a complex set of behaviors that are the result of genetic, biological, psychosocial, and environmental interactions (IOM, 1995, 1996)."

The APA uses the following conceptual definition for the DSM, and the WHO for the ICD: "Medical diagnostic systems have defined addiction as compulsive use of a drug that is not medically necessary, accompanied by impairment in health or social functioning (APA, 1994; WHO, 1992)."

By international treaty, the following definition of drug dependence (what is colloquially thought of as addiction), was adopted for use in 1992.

"A definite diagnosis of dependence should usually be made only if three or more of the following have been experienced or exhibited at some time during the previous year:

(a) a strong desire or sense of compulsion to take the substance;

(b) difficulties in controlling substance-taking behaviour in terms of its onset, termination or levels of use;

(c) a physiological withdrawal state ... when substance use has ceased or been reduced, as evidenced by the characteristic withdrawal syndrome for the substance; or use of the same (or a closely related substance) with the intention of relieving or avoided withdrawal symptoms;

(d) evidence of tolerance, such that increased doses of the psychoactive substance are required in order to achieve effects originally produced by lower doses (clear examples of this are found in alcohol and opiate dependent individuals who may take daily dose sufficient to incapacitate or kill non-tolerant users);

(e) progressive neglect of alternative pleasures or interests because of psychoactive substance use, increased amount of time necessary to obtain or take the substance or to recover from its effects;

(f) persisting with substance use despite clear evidence of overtly harmful consequences, such as harm to the liver through excessive drinking, depressive mood states consequent to periods of heavy substance use, or drug related impairment of cognitive functions; efforts should be made to determine that the user was actually, or could be expected to be, aware of the nature and extent of the harm ..." (WHO, 1992)


The only criterion applying to antidepressants is (c). Three or more criteria are required. Antidepressants do not now, and never have, met the medical definition for addictive substances, under any system of medical classification ever used.

Now, with respect to the medical issues arising from neonates born following exposure to prenatal antidepressants, see:

From the National Post, August 17

Obstetricians Attack Drug Advice to Pregnant Women

Canada's obstetricians are urging pregnant women who take Prozac and other newer antidepressants not to rush to abandon their pills, saying Health Canada's recent alert about the drugs is not scientific.

The Society of Obstetricians and Gynecologists of Canada also wants the confidential information collected by the government and drug companies that led to the advisory to be released.

"It's important that the public is not unduly alarmed. [But] there is nothing new that hasn't existed before", said Dr. Vyta Senikas, the society's associate vice-president. "We certainly would be very keen to see this 'post-marketing' study that they have. We have no idea as to the content of the information, its validity, nothing, because they haven't published it."

Health Canada warned women last week that newborns exposed to a widely prescribed class of drugs known as SSRIs and other newer antidepressants while in the womb can develop complications at birth, including breathing and feeding problems, seizures, jitteriness, rigid muscles, and constant crying. The government says the advisory was based on international and Canadian reports as well as "proprietary" information provided by drug
manufacturers.

But a leading Canadian expert on pediatric toxicology said the advisory did little more than create "huge anxiety" for already vulnerable women. "The advisory was not well prepared, it is not sufficiently evidence-based, and I think it puts hundreds of women at huge anxiety levels," said Dr. Gideon Koren, director and founder of Motherisk, a Toronto-based program which counsels women on the risk of drugs and other chemicals to their babies. "More scary, I believe, that many [women] would consider maybe even stopping cold-turkey their SSRIs in pregnancy," Dr. Koren said. Motherisk received hundreds of calls last week following Health Canada's advisory about the potential adverse effects of antidepressants on newborns.

The alert applies to SSRIs, or selective serotonin reuptake inhibitors, and other newer antidepressants, including Prozac, Paxil, Zoloft, Effexor, Celexa, Luvox, Remeron, Wellbutrin, and Zyban (Wellbutrin's smoking-cessation drug). Health Canada stressed women should not stop taking the drugs without speaking to their doctor. But the advisory said doctors may consider decreasing the dose in the third trimester of pregnancy.

The Society of Obstetricians and Gynecologists of Canada says the advice is "not based on scientific evidence." Dr. Koren went further, calling the advice "totally inappropriate." He said case reports, as well as five epidemiological studies, show babies whose mothers took SSRIs and other newer antidepressants in late pregnancy can experience withdrawal symptoms.
"Yes, there is a discontinuation syndrome, but in a very small percentage of babies--between 5 and 20 per cent." None of the symptoms reported so far in babies exposed to SSRIs appear to be life threatening, and Dr. Koren cautioned that it can be far riskier to babies and their mothers for depression to go untreated during pregnancy.

An article by Dr. Koren published in April in the Archives of Pediatric Adolescent Medicine, now posted on the Society of Obstetrician's website (http://www.sogc.org/sogcnet/sogc_docs/press/pdfs/Discontinuation_Syndrome_Following.pdf), warns untreated depression increases the risk of miscarriage, prematurity, and growth retardation. Risks to the mother include suicidal thinking, suicide attempts, and post-partum depression.

"What does not come clear from the advisory is that the risk of the untreated depression is huge, and the risk of the discontinuation syndrome is limited, the numbers are not large. And that does not come through here," Dr. Koren said.

SSRI-exposed babies who experience withdrawal need sedation, Dr. Koren said. The babies are now treated with phenobarbitol, an oral barbiturate. But the drug does not reach the brain receptors that are craving the drug. Dr. Koren's group is considering doing a study to determine whether it makes more sense to administer the same SSRI at birth, and then gradually reduce the dose, the same way babies exposed to heroin or morphine are treated.

In the meantime, he said, as a rule, babies born to women who are depressed and take antidepressants during pregnancy should not be sent home after 24 hours. "Most kids in Canada go home within one to two days. This is a subgroup that should stay for longer, not just for the baby, but to make sure the mom is balanced and feeling okay."

I also did a literature review of the risks of untreated depression and antidepressant exposure during pregnancy, before I knew of the Koren article. I came to the exact same conclusions. I could post it here, if anyone's interested.

Lar


References:

APA (American Psychiatric Association). 1994. Diagnostic and Statistical Manual of Mental Disorders: DSM-IV. 4th Edition. Washington, DC: American Psychiatric Association.

IOM. 1995. The Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector. Washington, DC: National Academy Press.

IOM. 1996. Pathways of Addiction: Opportunities in Drug Abuse Research. Washington, DC: National Academy Press.

WHO (World Health Organization), 1978.Technical Report Series. No. 618. Geneva: World Health Organization.

WHO (World Health Organization), 1992. International Statistical Classification of Diseases and Related Health Problems. 10th Revision. Geneva: World Health Organization.

 

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