Global Development

• Cautions over Antidepressants’ Ill Effects on Children

• Link between Mercury-based Preservative and Autism

• Cannabis-based Drug Approved for Treating Multiple Sclerosisp.392

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D rug regulators in the UK have warned that most of the newer antidepressants may beharmful for children under 18. Assessing their effectiveness in treating depression in youngchildren, the regulators have linked some drugs with triggering suicidal thoughts, self-

harm and agitation. The announcement, made in a letter sent to doctors and health professionals,did however prompt some experts to remonstrate that the British researchers were overreacting.

The medications being examined are termed as selective serotonin reuptake inhibitors, alsoknown as SSRIs. These drugs have become the medicine of choice for treating depression in adults.

The health agency has advised against the use of six particular drugs: Paxil, fromGlaxoSmithKline; Zoloft, from Pfizer; Effexor, from Wyeth; Celexa and Lexapro, from ForestLaboratories; and Luvox, from Solvay. Only Eli Lilly’s antidepressant product Prozac has been assessedto be safe. Previously, the British authorities had discouraged the administration of Paxil and Effexorto children.

While only Prozac has been specifically approved for treating children with depression, it isbelieved that the prescription of other antidepressants for children is rising. According to an estimatemade by the British health agency’s advisory committee, there are 40,000 Britons under 18 takingantidepressant drugs.

Some medical experts believe that these recent trends of more children being prescribedantidepressants are emerging because medications are cheaper than psychotherapy for these troubledyoung people. The lack of trained child psychiatric professional and psychologists is another factor.

Antidepressants’ Ill Effects on ChildrenCautions over

The US Food and Drug Administration (FDA) is following up by investigating whether theresearch data did in fact support the link between the same medications and suicide in childrenand adolescents. The agency has also asked drug companies that conducted studies on eightantidepressants to provide the data in a format that makes comparisons easier.

By February, a panel of experts is expected to decide on the safety of giving the drugs tochildren, after what Russell Katz, Director of the FDA’s Division of Neuropharmacological DrugProducts, promises to be a more comprehensive study than the British review. More than 4,100children participated in the 20 studies conducted.

What has been rather alarming to consumers is the revelation that these data linkingantidepressants with the triggering of suicide in children have been privately held by drug companiesand only provided to government agencies. Vera Sharav, an advocate for patients’ rights, suggestedthat conflicts of interest had allowed scientific data to be kept secret by companies — much to thedetriment of the consumers’ right to information about the drugs’ harmful effects.

On the other hand, the researchers who do have access to the data claimed that the link isdifficult to establish in the first place. For instance, none of the children involved in the trials didcommit suicide, and there are research discrepancies such as in the different terms used to categorizevarious aspects of suicidal behavior.

Other experts were at hand to refute the findings as well. Dr. David Shaffer, a professor ofpsychiatry and pediatrics at Columbia University, pointed out that suicidal thoughts and suicideattempts are common in depressed children in the first place.

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and Autism

Link between

Mercury-based Preservative

Scientists and medical experts in the US are trying to determine whether a mercury-basedpreservative — Thimerosal — is the cause of the rising rates of autism among Americanchildren. It is once routinely used in routine vaccines given to infants and toddlers, before

being gradually removed since 1999. The preservative can still be found in flu shots and othervaccines though.

Parents of autistic children have claimed that their children’s symptoms like impededdevelopment and immune system defects were caused by a toxic accumulation of mercuryfrom vaccines, and many are seeking compensation from the government.

Most of the epidemiologists who testified said they doubted that thimerosal was responsiblefor causing autism, while there were a few toxicologists who expressed that they are becomingconvinced of a potential link. It was found that mercury levels were higher in children withautism. These children might be suffering from biochemical defects that prevent their bodiesprocessing the metal like normal children do. It is also suggested that testosterone might fuel thetoxic effects of mercury, as autism seems to affect boys more than girls.

On the other hand, other experts have stated than the rising trends of autism, both in theUnited States and elsewhere, can be explained by many other factors, such as rising awarenesson the parts of parents, doctors and teachers. After all, epistemological studies have shown noconnection between thimerosal exposure and autism.

The federal Centers for Disease Control and Prevention and the American Academy ofPediatrics have said no scientific evidence connects thimerosal with autism or other childhoodneurological disorders — amid accusations that the authorities had deliberately blocked accessby outside researchers to a vaccine database.

Dr. Frank DeStefano, a researcher at the disease centers, has presented a study — publishedin November last year — of school children in the Atlanta area who were given vaccines thatcontained thimerosal that found no increased risk of autism. But the findings were challenged,under allegations that the data were changed.

Dr. DeStefano said raw data from the study would be made available to other researchers.And two outside experts who have examined that information, Dr. Mark Geier, a physician, andhis son David Geier, who have been expert witnesses for parents seeking payment from theNational Vaccine Injury Compensation Program, said they had concluded that thimerosal wascausing autism in children.

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In the UK, drugs based on cannabis might soon beapproved for patients suffering from multiplesclerosis and severe pain.

The British company GW Pharmaceuticals hasdeveloped Sativex, the first drug in recent decades toinclude all the components of the cannabis plant. Sativexis a liquid extract containing marijuana to be sprayedunder the tongue.

The British authorities are, however, unwilling todiscuss details regarding the approval of the marijuana-based medication untilthey are formallyapproved. While theHome Office, whichoversees laws andpolicies on controlledsubstances, has alreadyindicated that theclinical trials for Sativexlooked promising andthe drug is likely to beapproved.

In clinical trials,Sativex provided somerelief from symptoms ofmultiple sclerosis andfrom pain caused by nerve damage. GWPharmaceuticals is also testing Sativex and othermarijuana products for treatment of schizophrenia, headinjuries, epilepsy, rheumatoid arthritis and otherconditions.

And with the German pharmaceutical firm Bayersigning a deal with GW Pharmaceuticals last year tomarket Sativex in Britain and other countries, Britishauthorization will lead to the approval of medicalmarijuana by the European Union as well.

Beyond that, GW Pharmaceuticals will be seekingapproval from the American Food and DrugAdministration (FDA). But the United States has a stricterpolicy against marijuana use and the review processfor Sativex may take a longer period of time.

The FDA has previously allowed personal suppliesof restricted pharmaceutical drugs to be imported —and marijuana advocates are already planning topressure the authorities to allow patients to obtain

Cannabis-basedDrug Approved

for TreatingMultiple Sclerosis

Sativex. Drug enforcement officials have dismissed thelikelihood of people being allowed to import the drugthough.

Sativex is the latest of drugs developed from isolatedelements of the marijuana plant. The most commonmarijuana drug now available is Marinol, its capsuleform approved by the FDA in 1985. Marinol isessentially a synthetic version of tetrahydrocannabinol(THC), the psychoactive component of marijuana, andis used to treat chemotherapy-associated nausea and

AIDS-related wastingand appetite loss. THCis only one of severalcannabinoids thatinvest the marijuanaplant with itsproperties.

Sativex has beendesigned tospecifically addresssome of Marinol’sshortcomings. It takeslonger for Marinol towork than smokedmarijuana because itmust be absorbed

through the digestive system. Because it is sprayed underthe tongue, Sativex is absorbed through mucusmembranes and will provide a quicker and more reliableroute of action than swallowing a pill. Sativex alsoincludes substantial levels of the cannabinoidcannabidiol, which is believed to have anti-anxiety andother therapeutic properties.

GW Pharmaceuticals researchers have maintainedthat Sativex, when taken properly, does not cause thekind of intoxication that people routinely experiencefrom smoking marijuana.

There have been concerns in US that the abuse ofmarijuana is associated with health problems such asrespiratory infections, impaired memory and learning,and panic attacks. Marijuana advocates retorted thatthe plant is less toxic than many modern medicines.There is strong optimism that the approval of the drugwill lead to greater appreciation and societal acceptanceof its therapeutic advantages.

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