Big Pharma, Big Greed

The inside story of one lawyer's battle to stem the flood of
dangerous medicines and protect public health

Stephen A. Sheller, Esq.
with Sidney D. Kirkpatrick and Chris Mondics


reviewed by Mira de Vries

The title suggests that Pharma is immoral. As Sheller explains well, the real source of corruption is the unholy alliance between Big Business and Big Government, shutting out the interests of the individual consumer. He details how it works by describing the relationships between politicians and producers of drugs. Sheller's way of fighting pharma fraud is through the courts. This book chronicles his successes and failures.

The main, though by no means only, drug discussed by Sheller is Risperdal (risperidone in case you're taking a generic form), a supposed antipsychotic widely prescribed off-label to just about anybody who is disliked. Although he mentions other somatic adverse effects such as weight gain, stroke, and involuntary movements, he focuses on gynecomastia. This is the development of female breasts, an effect experienced according to Sheller by 12.5% of men and boys on this drug. Sheller wrongly claims that Risperdal is the only drug in its class that has this effect. He makes no mention of the mind-changing effects: lost affect and cognitive degeneration. Nor does he mention physical addiction, meaning permanent changes to the central nervous system rendering safe withdrawal after a certain period impossible. These effects occur not to 12.5% but to 100% of the people who take this or a similar drug.

Sheller rails against Risperdal's manufacturer, Janssen, for under-reporting the incidence of  gynecomastia on the package insert. What difference does the package insert make? Who reads it? Risperdal is usually administered by force. Victims are routinely injected while held down or handcuffed by police. Other people who are prescribed Risperdal are the elderly, the intellectually disabled, children, and the incarcerated. They are drugged into a stupor for the convenience of nursing home staff, caregivers, teachers, or warders. In the United States foster children are targeted. Parents often agree to administering Risperdal because they are lied to that it will alleviate their child's disability. Sheller mentions the elderly and the children, but nowhere in the book touches on the subject of coercion by court order.

Psychiatrists who prescribe Risperdal don't read the package inserts either. What would be the use? Every drug in their formulary is equally harmful but they have to prescribe something because that's what they are paid to do.

Sheller's proposals for protecting the public from Pharma ring familiar. They amount to compelling the cat to guard the cream. It won't work. For example, he calls for new laws
to regulate the widespread practice of prescribing drugs off-label. After all, if a drug hasn't been proven safe for a particular use, then it ought not be prescribed for that use.
But then in the very next sentence he contradicts himself:
In certain life-or-death instances, however, or if a physician is convinced beyond any doubt that it is the right drug to prescribe to their patient at that time, then the physician ought to be permitted to prescribe it.
How could a physician be "convinced beyond any doubt that it is the right drug to prescribe" if it hasn't been proven safe (or effective) for that particular use? Furthermore, every physician is always convinced that he is doing the right thing or that the situation demands it, particularly in psychiatry which has no treatments that are safe or effective.

Sheller does briefly mention non-pharmaceutical interventions, ironically, only regarding somatic conditions:
  • How do the risks and benefits of a new diabetes drug ... compare to a change in diet and moderate exercise?
  • Does a new cancer treatment extend a patient's life or simply mask the symptoms of disease?
When it comes to psychiatry he upholds, even encourages, belief in drug solutions:
  • most [pharmaceuticals] do what they claim to do when taken as prescribed;
  • [lives were damaged even of] patients who legitimately needed to be treated with the drug;
  • Janssen ... took away the rights of the children to safe and effective drugs for their ailments.

Psychiatric drugs never do what they claim to do; no one legitimately needs to be treated by psychiatric drugs; and there are no safe or effective drugs in psychiatry, including child psychiatry. The risk of gynecomastia is for naught.

I admire Sheller's work because it illuminates that drug approval is in reality an old boys' network. Too bad that at the same time he fuels the false hope that psychiatry is more than sham medicine.

Superstitions die hard. We will probably never totally eliminate the belief in a pill for every ill. But we could tackle Big Pharma by breaking up the marriage with Big Government. For that we have to shrink government.

Copyright MeTZelf