where PY is the number of “patient years,” P is the number of patients and Y is the number of years for which patients live after diagnosis. Calculating with the conservative prevalence estimate of 1 in 500, there may be approximately 600,000 ASD patients in the USA alone. These persons may live for an average of 76 years. Using the conservative age of 3 years for the time of diagnosis, PY may be calculated as follows.
To put this number into perspective, let us consider Alzheimer's disease, a disorder that is considered to represent the largest market by big pharmaceutical research companies. Calculating with P=9 million (say 15% of people above 65 years of age will have Alzheimer's disease in the Unites States) and Y=6 (Alzheimer's disease patients live, on average, for 6 years after first diagnosis), PY=54 million for Alzheimer's disease. The actual numbers may slightly vary. The number of Alzheimer's disease patients is actually smaller than 9 million but the disease may be diagnosed earlier and patients may live longer than for 6 years after diagnosis. On the other hand, the number of ASD patients can easily be twice or even three times higher than the presently estimated 600 thousand. Thus, it is clear ASD represents an unmet medical need that is comparable in order of magnitude to the largest neurological disease market, that of Alzheimer's disease. Thus, ASD should be of major interest to pharmaceutical research companies even when the 17-year patent expiration rule is considered.
[Update: Now listen to Pfizer’s (Geodon, Neurontin, Xanax, Zoloft, Chantix; through Wyeth merger, Effexor, Ativan, Pristiq, Prevnar) Robert Ring, newly partnered with Autism Speaks. echoing the title of the study ( HERE ) . Of the partnership, Ring says, “This a real opportunity to really make a difference for a huge unmet need using expertise we’ve acquired over a number of years. In fact we’re working right now to build a pre-competitive consortium amongst our competitors, including Lilly (original manufacturer of thimerosal; maker of Zyprexa, Prozac, Cymbalta, Symbyax, Stattera), Roche (Valium, Klonopin, Tamiflu), Novartis (Ritalin, Tofranil, Trileptal; vaccines: Fluverin, Menveo), Janssen (Johnson & Johnson: Risperdal, Haldol), and trying to agree that this is an important population to be developing medicines for…”]
The study abstract was sent to me by Ben Hansen, a Michigan mental health activist and satirical blogger (Bonkers Institute HERE ) Hansen was covered by the New York Times when his Freedom of Information Act inquiry of Michigan Medicaid turned up evidence that an Eli Lilly account executive may have influenced drug prescribing within the program, which had generated a 100% rise in child drug prescriptions in just 10 months.
The association of antidepressants in pregnancy and autism is not a competing theory as far as the cause of the autism epidemic, both due to the fact that relatively few mothers of children with autism were exposed the drug in pregnancy and also because all roads seem to lead to Rome in autism: the most prevalent theories which are held up as alternatives to vaccine-cause—such as the highway study ( HERE ) or the Depakote association ( HERE ), invariably point to either substances in common (“The most significant source of metals to the atmosphere is resuspension of dust from roads by moving vehicles and from other paved and unpaved surfaces by wind.”
SSRI findings may in fact be supportive of the thimerosal theory because the adverse cellular effects of SSRIs share many overlaps with cellular damage by thimerosal, namely mitochondrial injury (mercury and thimerosal in mitochondrial damage: HERE and HERE and HERE ; SSRI-induced mitochondrial damage: HERE );and disruption of the assembly of tubulin in the brain (mercury: HERE ; SSRI: HERE ). In the end, SSRIs may merely be a facilitator in a one-two punch effect—a substance which wears down infants’ immune resistance to subsequent exposures.
Eli Lilly, like all pharmaceutical makers, is long practiced at quarantining the blame for a range of adverse effects on bad genes. Regarding Eli Lilly’s relationship to autism, the company now bears the brunt of being the first American distributor of both thimerosal and SSRI antidepressants. But being in the hot seat for cause is not the only reason pharmaceutical companies cling to the genetic alibi—there’s also the issue of drug profits lost to “alternative” treatments. If there’s an epidemic and the condition is not genetic, then there’s hope for prevention and perhaps recovery. As far as treatment is concerned, why would hopeful families tolerate the side effect profiles for certain psychiatric drugs which only suppress symptoms when other, far safer remedies targeting or preventing the underlying mechanisms of autism and related conditions are available? Imagine another marketing formula in which H is the value of “effective treatment” + “prevention” and the sum is future autism drug profits.
HPY= goose egg
As far as autism’s impact on the psychopharm market, considering the following:
That doesn’t mean pharma won’t occasionally follow the cues of autism recovery research. Once the Lancet paper and its disturbing investigation into gastrointestinal disease, vaccines and autism were knocked out of the way in 2010 (only to be rectified in 2012 with the exoneration of co-author John Walker-Smith: HERE ), a surprising number of industry funded studies cropped up which happily associated GI dysfunction with autism, some even brazenly promoting new symptom reducers. But for many drugs companies, a step in the right direction will only land on another toxic solution: following the discovery that glutamate feedback may be disrupted in schizophrenia and autism (interesting that both mercury and the antiseizure drug Depakote—a suspected but rare cause of autism—induce glutamate feedback disruption), drug companies rushed to find chemicals with sedating properties which could be shown to do something to glutamate so that the drug could be called a “targeted treatment.” The problem is, like past psychopharmaceuticals, these drugs would not necessarily do anything therapeutic to the “target”. No matter though—whatever the drug did do could be spun as clinically beneficial, as has been done for antidepressants and other classes of psychotropes (for one example of lab spin, the testing methods used in killed-animal drug studies cannot distinguish between DNA synthesis in the brain which occurs as a part of supposedly beneficial “neurogenesis”—cell division and proliferation— and DNA synthesis which occurs as a part of cell death, yet the FDA looks the other way). Once researchers found a likely candidate—in this case, variations of a “metabotropic glutamate agonist antipsychotic” ( HERE )— companies lined up for FDA approval . A small hitch in the approval process has been that glutamate agonists appear to have an even higher level of lethal neuroleptic malignant syndrome than either first or second generation antipsychotics ( HERE ). Nothing a little spin and a lot of cash can’t fix.
Neuroleptics in particular have a questionable history. The drugs were originally used to deliberately induce Parkinsonism under the ham-fisted idea that Parkinson’s was somehow antithetical to psychosis. Those with advanced Parkinson’s disease—so the thinking went— generally don’t show any emotion at all, much less the throes of psychosis.
Fortunately, an activist and database programmer named Steven Helgeson figured out how to untangle the FDA Adverse Events Reporting System. He created a searchable site for the purpose of consumer education ( HERE ).
Adriana Gamondes is an Age of Autism Contributing Editor and one of the Facebook administrators. She lives in Massachusetts with her husband and recovering twins.
WARNING: Withdrawal from psychiatric drugs and sedatives can often be more dangerous than continuing on a medication. It is important to withdraw extremely slowly from these drugs, often over a period of a year or more under the supervision of a qualified specialist. Withdrawal side effects are sometimes more severe than the original symptoms or problems, though many withdrawal effects resolve with time.
For more information on drug side effects and a professional guide to withdrawal methods and risks, see Dr. Peter Breggin’s Your Drug May Be Your Problem , often viewed as the PDR of adverse psychopharmaceutical effects.
Pharm-Free Resource List for information on psych drug-free recovery and prevention of autism and related disorders (also see blog sidebar for organizations), drug side effects, media reports, coercive legislation, legislative activism and where to get help:
Special Needs Kids Go Pharm Free: Nutrition Focused Tools to Help Minimize Meds and Maximizing Health and Well-Being by Judy Converse, MPH, LD, RD
Healing and Preventing Autism: A Complete Guide by Jenny McCarthy and Dr. Jerry Kartzinel
Medication Madness: A Psychiatrist Exposes the Dangers of Mood Altering Drugs by Dr. Peter Breggin
Pharmageddon by Dr. David Healy
Drug Induced Dementia: A Perfect Crime by Dr. Grace Jackson
For a frequently updated interactive database on drug risks as well as a comprehensive adverse events reporting site, Rxisk was created by reform psychiatrist Dr. David Healy, advocacy journalist Robert Whitaker and an international panel of drug and data experts as an alternative to the FDA’s increasingly unnavigable Medwatch site.
For a long list of resource links and a media database on drug risks, illegal prescribing practices, news on legislative activism and research fraud, visit Psychrights founded by Zyprexa Papers whistleblower, attorney Jim Gottstein.
Former law librarian and activist Vera Hasner Sharav founded Alliance for Human Research Protection , one of the oldest and most influential medical rights advocacy networks in the US which focuses on corruption in human trials and drug and vaccine risks and marketing fraud. Ms. Sharav contributed a chapter to Vaccine Epidemic by Mary Holland and Louise Kuo Habakus.
Alternative treatment resource list from International Society for Ethical Psychology and Psychiatry .