The Wild Wild West
Let’s say your company has developed a drug and received FDA approval. Congratulations! You’re on your way to untold riches!
Just one catch: Some busybody (like the California Environmental Protection Agency) publicly lists your drug as a potential carcinogen.
No! What rotten luck! Now the FDA will remove your product from the market, all your R&D money is down the drain, and you’ll be buried with lawsuits galore.
Just kidding! The FDA isn’t going to do a thing, you big silly head. And the lawsuits won’t materialize because the mainstream media will mostly ignore all that California EPA business. And while the risks will be publicly acknowledged, they’ll be put in context – something like: “The therapeutic benefits outweigh the risks.”
See? Just a few people will have to suffer from cancer so that the larger population can enjoy all the wonderful benefits. And most of the other potential side effects aren’t even life threatening!
But with the next drug you develop you really should be a little more careful and consult The Dow Acceptable Risk Calculator? before you put your product on the market. The calculator is free, easy to use, and will help you compute exactly how many people you can put at mortal risk and still make an obscene pile of cash.
No kidding. There really is a Dow Acceptable Risk Calculator?. You can find it at dowethics.com/risk/#ARC, where you’ll also find this quote: “Acceptable Risk? is a voluntary initiative of Dow to safely predict the precise point at which profitability is threatened by danger to the public.”
So if you’re producing a drug or a toxic pesticide or a dangerous baby formula, you can go to that website, answer a few questions about profit projections, potential human or environmental casualties, etc., and you’ll get a quick idea of your product’s acceptable risk.
Appalling? Absolutely. And that’s why it’s a devastating satire.
Neither the dowethics site nor the Acceptable Risk Calculator? have any connection to Dow Chemical Company. As for their connection to corporate reality in general – you’ll have to make that call yourself.
I came across dowethics.com when I was researching a tip sent to me by my colleague Melissa Hickle, Managing Editor of the HSI Members Alert. Melissa recently discovered that tamoxifen – a drug used to treat breast cancer – was identified as a carcinogen by the California EPA more than 10 YEARS ago!
And that information led me to one of the most astonishing quotes I’ve ever read.
Making a list, revising it twice
In several e-Alerts I’ve told you about the pros and cons of tamoxifen. On one hand, this synthetic hormone-like drug effectively prevents estrogen from binding to breast cancer cells. That’s why tamoxifen is more effective than chemotherapy in treating estrogen- driven breast cancer tumors – the most common type of breast cancer tumor in postmenopausal women.
Unfortunately the list of tamoxifen side effects reads like a list of menopausal symptoms: hot flashes, nausea, vomiting, weight gain, mood swings, depression, and loss of energy. Add deep-vein thrombosis and pulmonary embolism, and you’ve got a drug that should make any woman wonder: Is this an acceptable risk?
In 1995, a scientific panel reviewed studies that linked tamoxifen use with an increased risk of endometrial cancer, which occurs in the lining of the uterus. The panel voted to recommend that the California EPA identify tamoxifen as a carcinogen. Zeneca Pharmaceuticals (the maker of tamoxifen) fought back and managed to keep the drug off the list. But the EPA persevered and tamoxifen was finally added to the list, September 1, 1996.
Of course, tamoxifen is still on the market, sold under the brand name Nolvadex.
So let’s go to the bottom line: In addition to the endometrial cancer warning, all postmenopausal women with breast cancer should know that the National Cancer Institute advises patients that tamoxifen may actually INCREASE the chance of recurrence of breast cancer when the drug is taken for more than five years. But according to Breast Cancer Action, many doctors are hesitant to take their patients off tamoxifen when they reach the five-year mark.
Furthermore, the Breast Cancer Prevention Trial (reported in the Journal of the National Cancer Institute in 2000) found that when tamoxifen is taken to prevent breast cancer, benefits do not outweigh risks in women with a uterus over the age of 60 (and “many women 50-60”), and most women over the age of 70 (and “many women 60-70”) without a uterus.
That astonishing quote I referred to above comes from Catherine Caraway of the California EPA. In 1995, Ms. Caraway told Science News that more than 400 of the items on the EPA’s carcinogen list were drugs.
Can you imagine if folic acid or St. John’s wort were found to be carcinogenic? They would be banned within a week. But drugs? They ride free because (we’re assured) their risk is acceptable.
“Chemicals Known to the State to Cause Cancer or Reproductive Toxicity” State of California Environmental Protection Agency, 3/21/08, oehha.org
“State Asks: Is Tamoxifen a Carcinogen? – California” Science News, 10/7/95, findarticles.com
“Tamoxifen on Trial: The Saga Continues” Nancy Evans, Breast Cancer Action, Newsletter #41, April/May 1997, bcaction.org
“Tamoxifen Used in Healthy Women: Risks and Benefits” National Breast Cancer Coalition, stopbreastcancer.org