Eternal vigilance is the price of liberty;
Power is ever stealing from the many to the few.
– Anti-slavery activist Wendell Phillips
It is close to midnight and a group of eight high-level CFOs from the major pharmaceutical companies sit anxiously around a conference table. They all have binders with TransCelerate BioPharma written boldly in black across the cover. These powerful individuals (CFOs from Bristol Meyers Squibb, Eli Lilly, GlaxoSmithKline, Pfizer, Johnson & Johnson, Genentech, Sanofi, Abbott, and Astra Zeneca) are members of TransCelerate’s marketing division.
TransCelerate is a consortium born in 2012, whose mission is to accelerate the development of new drugs and bring them quickly to market. There are two reasons for the high level of anxiety that the CFOs in the above meeting are feeling; first, the research and development of new drugs has been slower than predicted and profits not as massive as hoped for. They blame patent expiration and generic competition.
The second reason is alarming; NIMH may soon start cutting research funding and the pharmaceutical companies have depended upon their liaison with NIMH for funds and for political leverage. The pharmaceutical companies were aware of the possible cuts long before the NIMH formally announced its plans. They feel the pressure to expand their membership and forge ahead with new algorithms and new populations to aim at.
The new populations that are potential recipients of new drugs and algorithms are young children and, indirectly, the unborn infants of pregnant women. This would stand to reason as these two groups have been semi-protected until recently and are an untapped source for research and development of new drugs. Since the 1960s scare due to Thalidomide, when infants of mothers who had taken that tranquilizer were being born without arms and legs, pregnant women have themselves been leery of medications.
However, with the current trend toward diagnosing very young children with ADHD, autism-spectrum disorder and numerous sensory disruption conditions, women are re-visiting the concept of treatment at a very young age. Along with this, the promise of new drugs for anxiety and depression may invite more people, including pregnant women, to try the newer medications. They may be influenced by reports that severe depressive and anxious states have physical effects upon the body, and they may fear that the stress of depression and anxiety may harm the fetus.
The elaborate marketing campaign that TransCelerate has embarked upon is overwhelming in its strategies for streamlining the research and development process for new drugs. An article in the journal CW Weekly points out that the Physician Payments Sunshine Act is a new law whose purpose is to improve financial transparency between doctors, teaching hospitals and the drug industry. The drug companies are hastily trying to fulfill the requirements to document payments and transfers of money from the drug companies to doctors and hospitals.
The Sunshine Act, along with potential funding cuts, is propelling the headlong dash along the superhighway. Perhaps more significantly in terms of vulnerable subjects for research, in this same journal article on pg 4 there is mention of TransCelerate’s focus on children, adolescents and minority populations. The journal quotes Dalvir Gill CEO of TransCelerate:
“’With this initiative we hope to work together with industry, academia, investigative sites and regulators to speed up the development of new drugs for children and adolescents, and we hope to improve the participation of minority patients in our clinical trials,’ said Gill.”
There is more to this story than the birth of TransCelerate and the rush for new drugs to fill the gaps in the available consumer population.
A disturbing case from Texas, for instance, involved a 12-year-old child, Johnson & Johnson’s drug Risperdal, Texas state officials, the Texas Medication Algorithm Project, the Texas state hospital, and the University of Texas. The core issue was money and promotion of the expensive drug, Risperdal, for children. The case is about payouts and influence and corruption, but more than that it is about the damaged done to a 12-year-old girl and the possibility of more cases like this in the future.
The girl was labeled with “oppositional defiant disorder” and placed in special education even though her grades were B’s and C’s. Her parents, who have three other children and run a small business, were not alarmed – they had no idea where this label would lead. At this time the University of Texas was doing a study funded by a pharmaceutical company to develop an “algorithm” for treating “mental illnesses” — specifically schizophrenia — with their psychiatric medications.
Court records later revealed that the study and its ties to the University, the State hospital and government-funded clinics in Texas led to psychological screening at the child’s school, in which she was identified as “suicidal” and referred to one of the clinics. Six weeks later a child protection worker came to the home to take the child to the state hospital. Her father absolutely refused, at which point the worker took emergency custody of the child and involuntarily hospitalized her.
The next months were a cycle of psychiatric medications and diagnoses ranging from depressive disorder, mood disorder, and psychosis. Her medications included Haldol, Geodon, Abilify, Cogentin, Depakote and Risperdal. The child recalls being injected, threatened, restrained, and having her head held down so that she would take the medication. She spent a great deal of her time crying in her bed.
Eventually — and luckily — a complaint against the Texas Mental Health system involved an investigator who began to look into the case (and who was suspended several times during that process). He uncovered documents showing that the drug company was spending millions of dollars to influence State officials, and in 2004 he laid out his charges for the New York Times.
Almost six months later the case went to court and the child’s parents saw her for the first time. It took another four months before a judge ordered her released from state hospital. The family sought and found a psychologist who would wean the child off her basket-full of medication, and it is reported that she was able, in time, to go back to school. Her parents noted that she is still not the child that she had been; the gleam in her eyes is still absent.
Unlike many heavily medicated children, this child survived. In January of 2005, six months after she was reunited with her family, Ron Paul introduced The Parental Consent Act into the House of Representatives, a bill which would have forbidden federal funds from being used for any mental health screening of students without parental consent. The bill died.
Seven years later, in January of 2012, Johnson & Johnson settled a lawsuit for $158 million for “overpayment” of medicare claims as a result of false and misleading marketing of Risperdal to children as part of the Texas Medication Algorithm Project. This settlement came after Johnson & Johnson had agreed to pay over $1 billion to the U.S. and a number of states to end civil investigation into Risperdal marketing practices
Along the superhighway we can expect to find accidents and probably some of them will be fatalities. There are, and will be, problems with algorithms (formulas) and as these are directly linked to diagnoses and selection of medication for the diagnoses this needs to be a topic for scrutiny. There are, and will be, problems with the age ranges of children involved in the research. As one study that will be researched for the next article is going to recruit infants of 18 months of age, this is also an area that needs attention. There are and will be problems with drug testing and whether the tests themselves are valid and reliable.
And, of course, there is the concern that the drug companies have historically found strategies to meet their marketing agendas even when there are regulations in place. We cannot leave them to their own devices. We cannot risk the harm that might come to our children and other vulnerable individuals. We owe them our eternal vigilance.
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Part 2 in this series will follow up on the issue of testing infants
and the current initiatives that TransCelerate has in store for us.