It’s easier to transform people into new patients than it is to treat the truly sick
” Early diagnosis has become one of the most fundamental precepts of modern medicine. It goes something like this: The best way to keep people healthy is to find out if they have (pick one) heart disease, autism, glaucoma, diabetes, vascular problems, osteoporosis or, of course, cancer — early. And the way to find these conditions early is through screening. ”
Diethylstilbestrol in utero effects on the human male genital tract ; DES Sons 1976 follow-up study
The in utero effects of DES (Diethylstilbestrol) on the human male genital tract are reported in this follow-up study of male offspring of DES-treated mothers. Both anatomical and functional abnormalities were significantly greater in the DES-exposed males as compared to control males whose mothers were all participants in a prospective, randomized double blind study of the effects of DES on pregnancy at the Chicago Lying-in Hospital during the early 1950s. Epididymal cysts, hypotrophic testes and capsular induration of the testes were among the more common genital lesions found in 27% of 134 DES-exposed males as compared to a 7% incidence in 119 control males. Spermatozoa analyses revealed severely pathologic changes (Eliasson score greater than 10) in 29% of 28 DES-exposed males and 0% of 18 control males (with or without genital i.e., physical abnormalities). Abnormal findings on physical examination combined with sperm abnormalities (Eliasson score greater than or equal to 5) were found in 29% of DES-exposed males versus 0% of 18 control males. Cytologic examinations did not reveal malignant cells from the following materials: urines before and after prostatic massage or ejaculation, prostatic fluids and aspirates from epididymal cysts.
Sources: Structural and functional abnormalities in the sex organs of male offspring of mothers treated with diethylstilbestrol (DES), NCBI, 1976 Apr;16(4):147-53., PMID: 772199
Better communication needed in health screening programmes
Screening always sounds good – catch disease early, while it can still be treated – but the reality includes overdiagnosis – picking up “diseases” that were never going to cause any problem – and screening has side effects.
The problem is that doctors and researchers have known about these downsides of screening for decades, but the message hasn’t got through to patients.
Because screening is a mixed bag of benefit and harm no one should impose their own values onto another person…
Daughters of women prescribed DES have also been prone to cancer.
Anne Needham, who as a young woman had a hysterectomy for cancer, sued White Laboratories, makers of a DES drug.
Lawrence S. Charfoos – an attorney in the litigation – and Stephen Fenichell detail the case and provide a history of DES development, research linking it early to cancer, the FDA’s approval, the pharmaceutical company promotion, and the medical community’s involvement.
It is a source of concern, not a cause for high alarm in mothers generally
” Breast milk’s high fat and protein content tends to attract heavy metals and other contaminants that make their way into a woman’s body from the environment, and are then passed on to newborns, albeit usually in minuscule amounts. The study examined the milk of mothers who live in a community near the state line of West Virginia and Ohio, where a DuPont plant had contaminated the drinking water with perfluorooctanoic acid, or PFOA, a chemical used in processing plastics. Chemicals found in infants. The detection of the chemical in the community’s drinking water led DuPont to settle a class-action lawsuit for $107 million in 2005 and put the residents in a unique position for scientific study. The scientists found no immediate signs of harm in the children, and noted that since the source of contamination has ended, the children are unlikely to suffer long-term health effects. […] pediatricians agree that breast milk’s nutritional, immune-boosting combination of fats, carbohydrates and proteins far outweighs the dangers of its environmental pollutants. Formula has been recalled for containing broken glass, metal fragments and bacteria, and common contaminants in water, another option for some mothers, include weed killers, insecticides and chlorine byproducts. ”
Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety
” The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of “actors” and collaborators. ”
Martha Rosenberg to Ronald Kavanagh:
You were an FDA drug reviewer from 1998 to 2008, working on well-known drugs like Cymbalta, Zyprexa, Concerta, Invega, Provigil and Saphris, and encountered the same kind of coercive working environment as the device reviewers.
What are some of the ways in which safety risks were minimized in drug evaluation and review? Would you give an example?
Like they are trying to pull the wool over the FDA’s eyes?
That is shocking. Wouldn’t the FDA managers want safety risks investigated?
You have recounted that this is what happened to you with the nerve gas drug pyridostigmine.
Another FDA reviewer turned down pyridostigmine before you?
So, you were just stating what should have been obvious?
Why would the FDA and DoD allow troops to be put in this kind of harm’s way?
Your training as a pediatric clinical pharmacologist has made you especially sensitive to drug risks for children. What are some of the unique drug risks children face?
Are there other risks with one-size-fits-all doses? Are the risks just ignored?
You have also spoken about the dangers of certain ADHD drugs and presented some damning data about Cephalon’s stimulant Provigil.
One of the pharma doctors actually tried to downplay SJS with modafinil, saying a child was hospitalized, but was not in the “burn unit,” according to the transcript.
The recent revelations of reprisals against FDA device reviewers must not have surprised you at all.
That is similar to the FDA’s claim with the device reviewers. Why do efforts to silence free speech always seem to be couched as “trade secrets”?
Still, the FDA transparency meeting transcripts indicate you not only went to members of Congress, you appealed to the Health and Human Services inspector general.
And in addition to this alleged wrongdoing, the public is at risk from unsafe drugs that were approved?