Feeds

Pharma bucks recession with ‘treatment-resistant’ conditions

While the pharmaceutical industry cites “patent expirations” for falling earnings, it could add an “i”.

Patient expirations explain the demise of Vioxx, Bextra, Premarin/Prempro, Avandia, Paxil, Chantix, Seroquel, Ketek, the previously popular Baycol, and fen-phen.

Forty years of marketing the “diseases” of menopause and aging – Over 35? You Might Be at Risk for Menopause! – ended when hormone replacement therapy was found to cause, not prevent, the symptoms women feared.

A decade and a half of osteoporosis profits collapsed when bone drugs Fosamax, Boniva, and Actonel were found to cause, not prevent, fractures and jawbone death in some cases. Nor did it help that Boniva czar Sally Field allegedly broke a bone.

And speaking of causing, not preventing, SSRI/SSNI antidepressants are linked to so many suicides – 660 in newspaper reports alone – the pharma-founded and operated American Foundation for Suicide Prevention (AFSP) is staging massive anti-suicide walks in June – against an epidemic it largely created.

Even asthma inhalers are causing deaths they were supposed to prevent.

What’s a pharmaceutical industry in the middle of a recession with nothing in the pipeline to do?

Say hello to “monotherapy” and “treatment-resistant” conditions.

Expensive and dangerous drugs that don’t work are now said to not work as monotherapy. You need to add a second or third drug.

Conditions that don’t respond to expensive and dangerous drugs that don’t work are now said to be treatment-resistant – not treated with the wrong drugs or even given the wrong diagnoses.

Monotherapy and treatment resistance keep patients taking their meds – including ones that fail as monotherapy – in the absence of any evidence the meds are working. They up sell a patient who was on one med into taking two or three meds and double or triple revenues especially if meds are required for side effects.

But most importantly, monotherapy and treatment resistance shift the emphasis from pharma’s failure to a patient’s “failures”: It’s not our drug that’s not working. It’s your treatment-resistant condition.

Monotherapy has often been the hallmark of drugs that don’t work in pediatric “conditions” like bipolar disorder, ADHD, major depression, generalized anxiety, social anxiety, passive-aggressive, oppositional-defiance, and obsessive-compulsive disorders and other personality and conduct disorders that surfaced when pharma exactly had medications to treat them. (And states had disability tax dollars to pay for them.)

But children with treatment-resistant depression, aggression, mania, anxiety, mood, and psychotic disorders, bipolar disorder, and ADHD are also now being seen – and enrolled in clinical trials.

While some say a developing child is by definition too young to have treatment-resistant anything, that was also said about schizophrenia, which is suddenly “recognized” in 4 to 6-year-olds as the FDA considers pediatric schizophrenia drugs next month.

Lilly-funded Gabriele Masi, M.D., hopes increasing “awareness of childhood-onset schizophrenia” will overcome “hesitancy on the part of clinicians to make a diagnosis,” in the journal CNS Drugs.

Meanwhile in March, the FDA approved Lilly’s Symbyax, a combination of Zyprexa and Prozac as the first medication for “Treatment Resistant Depression” (TRD) in adults.

A CHILD'S IQ CAN BE AFFECTED BY MOTHER'S EXPOSURE TO URBAN AIR POLLUTANTS

A mother's exposure to urban air pollutants known as polycyclic aromatic hydrocarbons (PAHs) can adversely affect a child's intelligence quotient or IQ, a study reports. PAHs are chemicals released into the air from the burning of coal, diesel, oil and gas, or other organic substances such as tobacco. In urban areas motor vehicles are a major source of PAHs.
The study, funded by the National Institute of Environmental Health Sciences (NIEHS), a component of the National Institutes of Health, the U.S. Environmental Protection Agency and several private foundations, found that children exposed to high levels of PAHs in New York City had full scale and
verbal IQ scores that were 4.31 and 4.67 points lower than those of less exposed children. High PAH levels were defined as above the median of 2.26 nanograms per cubic meter (ng/m3). A difference of four points, which was the average seen in this study, could be educationally meaningful in terms of school success, as reflected, for example, in standardized testing and other measures of academic performance. However, the researchers point out that the effects may vary among individual children.
"This research clearly shows that environmental PAHs at levels encountered in an urban setting can adversely affect a child's IQ," said Linda Birnbaum, Ph.D., director of NIEHS. "This is the first study to report an association between PAH exposure and IQ, and it should serve as a warning bell to us
all. We need to do more to prevent environmental exposures from harming our children."
The study was conducted by scientists from the Columbia University Center for Children's Environmental Health. It included children who were born to non-smoking black and Dominican-American women age 18 to 35 who resided in Washington Heights, Harlem or the South Bronx in New York. The children were
followed from utero to 5 years of age. The mothers wore personal air monitors during pregnancy to measure exposure to PAHs and they responded to questionnaires.

At 5 years of age, 249 children were given an intelligence test known as the Wechsler Preschool and Primary Scale of the Intelligence, which provides verbal, performance and full-scale IQ scores. The test is regarded as a well validated, reliable and sensitive instrument for assessing intelligence. The researchers developed models to calculate the associations between prenatal PAH exposure and IQ. They accounted for other factors such as second-hand smoke exposure, lead, mother's education and the quality of the home caretaking environment. Study participants exposed to air pollution levels below the average were designated as having low exposure, while those exposed to pollution levels above the median were identified as high exposure.
"The decrease in full-scale IQ score among the more exposed children is similar to that seen with low-level lead exposure," said lead author Frederica P. Perera, Dr.P.H., professor at Columbia's Mailman School of Public Health and director of the Columbia Center for Children's Environmental Health.
"This finding is of concern," said Perera. "IQ is an important predictor of future academic performance, and PAHs are widespread in urban environments and throughout the world. Fortunately, airborne PAH concentrations can be reduced through currently available controls, alternative energy sources and
policy interventions."
The NIEHS supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, visit our Web site at <http://www.niehs.nih.gov>.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <www.nih.gov>.

Example Feed Article 3

This is an example of a feed article. It is in the "Feed" category, in the "Feed" section.Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.