I have written before about the uselessness of screening for prostate cancer in the past, which brought on the vitriole of some of my fellow MD bloggers, some of whom had vested financial interests in the perpetuation of this looney practice. But now we have none other than the inventor of the Prostate Surface Antigen (PSA) test, Richard Ablin, coming out to say today in an editorial that it is not only useless, but a public health disaster. He points out that 16% of men will be diagnosed with prostate cancer, but only 3% will die of it. The PSA is used to drive men with mildly elevated values into the medical machine that will leave them with medical bills, possible impotence and urinary problems. In spite of this, PSA testing was not shown to save lives in a US study I wrote about last year here.

In the editorial he writes:

I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster. The medical community must confront reality and stop the inappropriate use of P.S.A. screening. Doing so would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.

In the heat of the moment around healthcare reform maybe we should pay attention to this instead of Billy Tauzin’s whining? Anyone listening?

A recent study from the National Cancer Institute has found that most cancer drugs are not worth the money. For instance, Erbitux, the drug used for the treatment of lung cancer, extends life by only an average of 1.2 months, hardly worth the expense of $80,000 for treatment. The authors calculated that extending life by one year for the 55,000 Americans who die of cancer would cost $440 billion. Other examples of basically useless treatments that will cost you the farm include Avastin and Nexavar, both costing more than $34,000 for a course of treatment.

Of course the usual suspects were trotted out in the form of doctors who stated that for some patients Erbitux is a miracle.

More egregious practices mentioned included doctors using drugs off label or aggressively treating people with Mercedes like drugs who had advanced stages of cancer. Of course Americans don’t like to talk about rationing of healthcare, which Rick Lippin MD has been talking about in the email circuit as well as the fact that more care can be worse care, and that profiting off of the dying should be prosecuted as a crime.

Hear, hear! (or is it Here, here?)

Maybe we as doctors should teach people to grieve their dead and dying, rather than enable them to flee from reality by throwing our expensive technology at their loved ones and colluding in the myth that everyone can live forever (e.g. “Aunt Mabel is fighting her cancer and gonna win” kind of nonsense).

Hat tap to John Mack (@pharmaguy).

There is a front page story in the NY Times today showing how although death rates from heart disease and stroke have plummeted by more than 50% since 1950 the death rate from cancer has dropped by only 5%. This belies the much touted “war on cancer” which has been trumpeted in the media and amongst our leading medical institutions. I have long been annoyed by the cancer medical machine. The thing the bothers me the most about it how much people out and out lie (doctors, journalists, healthcare administrators) about the effectiveness of their treatments and so-called progress in this field. America spends more on cancer research and treatment than any other country. The result? Cancer death rates essentially unchanged, our healthcare outcomes second worse in the industrialized world. Surprised?

I guess we can blame the marketers who want to sell us low fat diet/breakfast cereals/high fiber/vitamins/etc, none of which have been shown to prevent cancer. And I have written here before about the lack of utility of breast and prostate screening although many readers have publicly and privately thrown eggs at me. Back then I wrote about studies showing that breast and prostate cancer screening only decrease your risk from that disease by 1 in 10,000 screened and don’t reduce overall mortality. Unless you are from France. So you can wear your pink ribbon if you want but it won’t necessarily do much good. Sorry to be so negative. 

Fact is that if you have metastatic cancer from whatever you can’t get rid of it, unless it is testicular or thyroid or some types of lymphoma. The treatments only slow down the progression. The “statistically significant improvements in survival” mean that if you take toxic chemotherapies you might live 12 weeks instead of 10. With more nausea and vomiting. Big deal.

[addendum: Fellow MD blogger (”Critical Condition“) Rick Lippin MD sent me this letter to Sen. Specter:

Classification: UNCLASSIFIED

Caveats: NONE

Doug

Thanks

Here is what I wrote in my blog-Open letter to my Senator who was instrumental in obtaining funding to continue this “failed war”

Feel free to circulate

(PS- America seems to have a penchant for declaring war on a number of things and then failing- War is our chief metaphor)

Rick Lippin

Senator Specter,                          Re “CURING CANCER”

Since I heard you make a similar comment I want to express my objection to your and  President Obama’s  use of the phrase “we need to cure cancer in our lifetime”

This phrase is not consistent with what experts know about the biology of cancer- over 200 different types I might add.

Senator -There is no “cure for cancer”.  Just like there is no “cure” for aging. We can cure individual patients with certain types of cancer thank goodness but indisputably the greatest risk factor for most cancers is cellular and bodily aging.

Declaring we “need to cure cancer” is well intentioned but naïve – harkening back to President Richard Nixon’s failed war on cancer from the 1970’s.

We must continue to chip away at the many factors that contribute to cancers but to suggest we will “cure” all is completely unrealistic and is actually irresponsible.

I share your interest in these diseases and applaud your own personal triumphs and political leadership in this arena.

Sincerely,

Richard A Lippin MD

Southampton,Pa

March 2009

This article just in from the Women’s Health Initiative Study, published in this month’s edition of the Archives of Internal Medicine, on the utility of taking multivitamins for postmenopausal women. Now since the marketing staff of the Drug Safety and Health News Blog have been conducting focus groups amongst the readers of the blog, we have learned that the average reader is a middle aged woman from Marin County CA with a family member with a history of heart disease and/or mental illness, who is concerned about developing osteoporosis, who has pondered over the utility of hormone replacement therapy, and who shops for organic foods and wants to put more fresh fruits and vegetables in her diet. That said, our readers should be interested in this post.

However, I am aware of the possibility that our readers have become attached to their multivitamins, having given up psychotropic drugs that they put high hopes in, but that turned to have more toxicity than therapy, or having flipped the bird at Sally Field and tossed their Boniva for osteoporosis prevention in the trash and turned to ‘natural’ vitamins and supplements instead. And since the Drug Safety and Health News has lost it’s advertising revenue from the pharmaceutical industry it is a bit going out on a limb risk losing it from the makers of vitamins and supplements as well. But any way (deep breath) here goes…

The study is from data from the Women’s Health Initiative, a large study conducted over many years on a range of health issues. The current article looked at 161,808 women with information collected on use of multivitamins over the course of eight years on average. There were no differences between women who did or did not take multivitamins in the risk of any type of cancer, heart attack or stroke. If anything the risk of death was increased by 2%, which was not statistically significant. Additionally, a report from last month from the Phyisicans Health Study, which reported on 14,641 male physicians over the age of 50, did not find any effect on any type of cancer or total mortality or heart disease with supplementation with vitamins C or E over the course of ten years.

I was watching public TV a couple of years ago when a researcher was being interviewed about the Beta Carotene and Retinol Efficacy Trial (CARET), in which 18,314 smokers took either beta carotene and Vitamin A or a placebo. He embarrassedly stated that the beta carotene (found in carrots and orange vegetables) and Vitamin, even though they are ‘anti-oxidant’ and theoretically should prevent heart disease and cancer, actually increased it in their trial.  In fact people on supplements equal to four carrots a day had 17% more heart disease and were 17% more likely to die than people on a placebo. People taking high doses of Vitamin A also doubled their risk of fracture, leading Denmark to ban vitamin fortified Kellogg’s breakfast cereals.Alpha-Tocopherol, Beta Carotene (ATBC) Cancer Prevention Study smokers treated with beta-carotene and alpha tocopherol (Vitamin E) had an 8% increase in death, while those with a prior history of heart attack had a 75% increase in heart attack with beta carotene therapy. People on Vitamin E had a 2% increase in mortality.all studies put together, there is an increased risk of heart disease with Vitamin A and beta carotene and no heart disease prevention with Vitamin E. Vitamin A and beta carotene when taken together are associated with a 29% increase in mortality.study of Vitamin E combined with Vitamin C showed that vitamins actually accelerated the progression of thickening of the coronary arteries, and doubled the risk of dying of heart disease. Another study of a combination of anti-oxidants, including Vitamins E, C, beta carotene, and selenium, showed that vitamins actually blocked the effects of anti-cholesterol treatment (simvastatin plus niacin) on reducing atherosclerosis and preventing heart attacks and strokes. The vitamins in this study interfered with the ability of the other medications to raise HDL (good) cholesterol. Looking at all studies combined in which Vitamin E was given with beta carotene, there was a 10% overall increase in mortality. So there it is (sigh).

I found that pretty surprising, given all the hype you hear about the benefits of anti-oxidant vitamins.

I later visited my sister-in-law Rossana (pronounced ROE – SSSS – ana, as my kids always point out) in the US Virgin Islands. Rumaging in her refrigerator while she was at work (hey I didn’t have anything else to do) I found several large bottles of vitamins and supplements. I looked at the ingredients and found that she was taking Vitamin A at several times the recommended daily levels. When she got home from work I confronted her about it.

Doug: “Rossana, why are you taking so many vitamins and supplements?”

Rossana: “I don’t have time to cook meals and eat enough vegetables, so this gives me what I need.”

Doug: “But did you realize that the amount of Vitamin A you are taking may cause osteoporosis?”

[It's true-- women taking the highest amounts of Vitamin A supplements

I don't want to be dodgy and name the company that made the vitamins and supplements she was taking, but I looked them up on the internet, and if you followed their recommendations, you would be spending $7,128 dollars per year on their products!

Even though in the laboratory there has been shown some connection between oxidative stress and heart disease, and in spite of the known role of vitamins C and E as anti-oxidants, you can't get around the fact that there is now a large body of research including studies with tens of thousands of patients that have shown that vitamins do not prevent heart disease or lengthen your life.

In fact, they may actually have the opposite effect.

I think the vitamins may be giving a boost to little tumors that wouldn't have been a problem otherwise.

I know the readers of this blog are going to protest and say they didn't use the right dose or right type of vitamins. But why don't you just get your vitamins from natural sources instead of a pill? And what about the conflicts of interest of those trying to sell you something? Here at Drug News and Health Safety we have been growing our own herbs and vegetables from seed. There is an added mental health benefit in helping the little parsley plants raise up their tired heads from the earth.

We can do it. Yes we can!

My daughter always wanted to take a pill when she wasn’t feeling well when she was a little girl, so my wife, after she had given her various cold remedies or whatever, would give her a pine nut. It was small, and tasty, and you could almost feel its beneficial effects.

For all you do, this (pine nut) pill is for you!

Kind of like obecalp, the fake medication sold to kids to make them feel better. See my post “Mommy Can I Have a Yummy Blue Pill?” Oh btw obecalp is placebo spelled backwards (I said that to make your head spin around like they did on the Exorcist).

Hat tip to Mrs. Bremner.

Bayer announced today that it is going to spend $20 million for an advertising campaign to reverse the effects of its ad campaign promoting the oral birth control pill, Yaz, as effective for the ups and downs of daily life as well as zits and other skin blemishes. This ad campaign was launched after Yaz was approved for birth control with added side benefits of helping premenstrual dysphoric disorder (PDD) and acne, however the ads showed women kicking around balloons that said stuff like “mood swings” and “fatigue” while they played the songs “Good bye to You” or “We’re Not Going to Take It.”

Goodbye to you too, Yaz

Following this they got admonished by the FDA which led to the unusual settlement of being an ad campaign out to UNDO the effects of the advertising. You see, it wasn’t approved to treat PMDD and acne, and in any case not all women have PMDD or untreated acne, even though the makers of Yaz certainly wish that that was the case. They were promoting it as a lifestyle drug, like look good, get laid, and feel good about yourself. What more could women want? Anyhoo in the new ads an actress looks into the camera and says:

You may have seen some Yaz commercials recently that were not clear. The F.D.A. wants us to correct a few points in those ads.

Indeed. Well first of all I really hate it when they take a perfectly good song and associate with some cheesy product. They should make musicians sign a contract that they will never sell out their tunes which run around in our heads. Second, that $20 million is “chump change” as one commenter pointed out, after they have already made their billions promoting a product for something that it wasn’t approved for, something that can be thought of as the cost of doing business, kind of like the billion that Eli Lilly paying as punishment for off label promotion of Zyprexa not being a big deal when they made 20 billion out of the deal. Finally, noone pointed out the fact that Yaz (and is sister pill Yasmin) (as I have written about before in “Is Your Birth Control Pill Driving You Bananas“) is the mosted posted about medication on medications.com, with most of the women complaining about how it makes them MORE depressed and anxious. Yaz also has drospirenone, a type of progesterone that can lead to elevations of potassium and potential heart failure.

How can it be that your birth control pill makes you depressed? Birth control pills (or oral contraceptive pills, or OCPs) are combinations of sex hormones related to estrogen and progesterone. Normally these sex hormones cycle throughout the month. In addition to controlling reproduction they also have effects on the brain, which is why they can cause anxiety and depression.

Taking the pill effectively blunts the normal variation in hormones; it also eliminates ovulation, which also affects sexuality. In fact, one study showed that strippers who were ovulating made $15 more per hour than strippers who were not ovulating,
and that strippers on the pill made significantly less than other strippers.

You can read more about the relative risks of heart disease and cancer in women of different ages and smoking status in my last post on this topic. However, I recommend using an IUD as the safest form of birth control, or a progesterone only pill.

A certain SOMEONE that I know who is a healthy middle aged woman had to undergo a colonoscopy cuz her gynecologist came up with a positive guaiac test (screening for internal bleeding). Only AFTER the scope did I start to wonder about if there could be false positives, and me ‘n goolgle learned that if you eat a lot of tomatoes you can come up false positive, and since she is Yugoslavian (har, har) she eats a lot of tomatoes. Her physician SHOULD HAVE warned her of that. Doh! Now her mammogram got flagged for additional testing and I am starting to wonder (yup) could it be false positive?

That is why an article in this weeks’s bmj about breast cancer screening caught my eye. Current recommendations state that women over 50 should get yearly mammograms, and pamphlets say that screening will save lives and decrease mastectomies, which, alas, is apparently not true. The article shows that one in 10,000 women will be saved from a death related to breast cancer if they get yearly mammograms. However, 5% of mammograms come up as false positives, meaning that women will have to wait for months with anxiety, coming back in for more painful and expensive tests, all for nothing. And what is more, over a ten year period there is a 50% chance of a false positive. That means that women getting mammograms as recommended can flip a coin; heads you get a false positive reading, tails you don’t.

And what is worse, if you are found to have a cancer in situ, which constitutes 20% of cases, that will likely lead to radiation, even though less than half of these cases will progress to a spreading cancer. Obtaining this information was described as lilke “trying to uncover a closely guarded state secret.”

Which brings us to the fact that breast cancer screening has not been shown to have any effect on mortality. The implication is that for each life saved from breast cancer, there is one life lost due to the effects of radiation treatment for something like cancer in situ that would never have progressed anyway.

In other words, breast cancer screening is of little substantive value.

Arghhh!

Let’s start making our list of useless screening procedures.

Hat tip to the Gary Schwitzer Health News Blog.

I don’t care if it may give me breast cancer or heart disease. Thanks, APHRODITE Study Team!!

APHRODITE Study Team? ROTFL!!

I SWEAR TO GOD I am not making up this goofy study name.

I wonder if the study investigators ever got horny at one of their research meetings? Or by looking at their data?

Anyway, seriously folks. The results of the “A Phase III Research Study of Female Sexual Dysfunction in Women on Testosterone Patch without Estrogen (APHRODITE)” study published in the NEJM today showed that if post-menopausal women who have a loss of libido put a testosterone patch on their arms that they will have satisfying sex once a month more than they are currently having, although there may be a risk of breast cancer or cardiovascular disease [read on]

I’ve got a tip for the marketers of this testosterone patch. If the women are having satisfying sex only once a month, and now they have it twice, why don’t you say that the drug results in a 100% increase in satisfying sex!!!

Ha ha ha ha ha!

OK folks all fun aside lets look at the data. In this study Davis et al (Davis SR et al NEJM 2008; 359(19): 2005-2017. November 6 2008) studied 814 women treated for 52 weeks with 300 or 150 microgram testosterone patches or placebo patches. There was an increase in “satisfying sexual episodes” of 2.1 in treated versus 0.7 for placebo, an increase that was statistically significant. There was about a 10% difference in scores on a sexual pleasure scale. 30% grew unwanted hair v 23% for placebo. Breast cancer was diagnosed in 4 out of 527 treated women and in none of the women on placebo.

That’s right folks, sex once a month. And possible risk of getting breast cancer.

And a beard.

Nonconclusive results about cancer you say. And Mrs Robinson asks if she has anything to worry about.

Well a recent study by Tamimi et al (J Natl Cancer Inst 2007; 99(15): 1178-1187) found that women who naturally had the highest testosterone levels (top 25%) had a two fold increase in breast cancer compared to women in the lowest 25%.

And another study by Maturana et al (Metabolism, 2008; 567 (7):961-965) found that postmenopausal women with elevated testosterone had increases in markers of inflammation and endothelial dysfunction, C-reactive protein (CRP) and endothelin, that have been associated with increased risk of atherosclerosis.

And let’s not forget the increased risk of heart disease and cancer associated with hormone replacement therapy (HRT) which I have written about before, and testosterone has to have a suspicion of similar risk.

The authors of the current study point to the fact that about a third of post-menopausal women have sexual dysfunction, and imply that even the meager gain they eak out with their patch is worth it in terms of keeping their mans happy. However they need to provide evidence for their implied claim that libido is killed by menopause and that women need to use a hormonal patch for that. They seem to hark back to the physician author of Feminine Forever, who implied that menopause was a disease to be treated with HRT, and that women became old crones, wrinkled and ugly, nasty, and incapable of sex, and that they needed HRT to treat this malady. Well I won’t belabor that now, and you can follow the links on this web site if you want to learn more about HRT, but I can tell you that controlled studies show it has no effect on libido, and only increases risk of cancer and heart disease. So there.

The authors imply that menopause is associated with an inevitable decline in libido for women, and that they need to take a drug to correct that. But I am not aware of any literature to support this conclusion, and if anyone has something, let me know. I mean, Mrs. Bremner seems to be doing OK so far.

As far as I know these testosterone patches are approved for hypogonadism in men with low testosterone, but are widely used off label for loss of libido in men and women. The APHRODITE study results may be used to promote off label use of the patches. Stay tuned.

The FDA posted some slides on this topic here.

Thanks to Marilyn Mann for sending me articles and comments on this topic.

[originally posted on November 6, 2008]

Therapy Patient wrote on November 12, 2008

What always bothers me about many studies (such as this one) is that they don’t seem test moderate treatments. Why would women be treated with JUST testosterone? That is not a treatment designed to bring a woman back to her former natural state. My female gynecologist, a UC San Francisco Medical Center clinical faculty member, Dr. Rikki Pollycove, recommends very low dosage hormone replacement. I am on Divigel (estradiol gel) 0.5mg which keeps me just barely out of the range of having hot flashes plus 25 mg. per day of DHEA (dehydroepiandrosterine) which I understand is a testosterone replacement. The DHEA DID increase my libido, but it wasn’t absent before I took it. However, the DHEA makes me think about sex in a way I had not done in a number of years (age 57 female). I’d be ready once or twice a day for sex if I had a ready partner. I found HRT difficult to adjust to due to side effects which for me are swollen, painful breasts, plus occasional hot flashes (which I do NOT have off HRT). On the positive side I think I have younger looking skin than my peers, and my vaginal tissue is moist and pliant rather than dried, and I have more sexual interest and ability. I am hoping it helps put off cognitive decline of aging, also.