Archive for the ‘prescription medicines’ Category

Must be expecting things to go wrong

Monday, February 5th, 2007

The Bush administration just put into effect a new law that frees manufacturers from product liability suits for damages caused by vaccines or drugs produced for use in avian flu.

The law, enacted in 2005, gives the Secretary of Health and Human Services the power to grant immunity to companies based on an assessment of risk to public health.  HHS has just invoked that clause “based on a credible risk that an avian virus spreads and evolves into a strain capable of causing a pandemic of human influenza.”

Of course, if the government and manufacturers knew that these products were beneficial and unlikely to cause harm, these measures would be unnecessary.  And of course, if they knew that there was a likelihood of harm, they would make every effort to shield themselves and their profits far in advance of any real threat of a pandemic.  Draw your own conclusions about the benefits and detriments of the treatments they are proposing.

Birds are now drinking Tamiflu

Saturday, January 13th, 2007

Robyn Klein sent me a fascinating article Tamiflu® (oseltamivir phosphate) resistance and suggested that it would make an interesting blog. It was indeed an interesting article. The active antiviral metabolite of Tamiflu passes through us unchanged, is not altered by our water treatments, and ultimately will be picked up by the bird population in their drinking water. This will give avian viruses an excellent opportunity to build resistance to Tamiflu.

Frankly, the influenza virus does not seem to need this latest advantage. Even in the relatively small population of human avian flu victims treated with Tamiflu, one has already had a resistant strain. And resistance was seen early on in the test tube and test animals. When the next epidemic/pandemic influenza rages across the world, there is no doubt that resistance will build rapidly. This means that the drug would be virtually ineffective. Although, I do not think it was all that effective to begin with. Certainly, avian flu victims are not surviving very well, even though they get Tamiflu. This is blamed on the length of time that often passes between the onset of symptoms and treatment. Still.

Worst of all, though, is that there is virtually no discussion of the side effects of Tamiflu. Its ability to cause psychosis and suicide received a flurry of attention and led to some additional warning labels on the drug. But a deafening silence reigns when it comes to its potential ability to cause birth defects. In the approval process, Tamiflu in pregnancy did cause birth defects. “There were a variety of defects detected in developing [rabbit] fetuses. Most of the observations were an increased incidence of minor skeletal abnormalities and variants. The sponsor has argued that most of the incidence values were within normal range and were not considered real. However,… coupled with the ossification problem in rats and mortalities associated with bone problem in marmosets it is suggested that [Tamiflu] may have effects on bone.” This dilemma was fixed by language on the label saying that pregnant women should not take Tamiflu – unless the benefits outweigh the risks. Whatever that means.

I have not found any additional research on Tamiflu and birth defects. I did read, however, that the drug was being dispensed to pregnant women in South East Asia, so perhaps we will learn more eventually.

There are indications that Tamiflu may cause bone problems in adult animals but, in testing, these were attributed to genetic defects in the lab animals. The government did not require additional testing. And Tamiflu is much more toxic to newborns and is passed through breast milk. Again that problem was solved by labeling: The drug should not be taken by women who are nursing children – unless the benefits outweigh the risks. Whatever that means.

My advice: Forget Tamiflu and stockpile the herbal remedies the Eclectic physicians used in the 1918 pandemic instead.

About the spread of Tamiflu into our water ways: http://www.ehponline.org/realfiles/docs/2007/115-1/ss.html

Documents submitted in support of FDA approval of Tamiflu

http://www.fda.gov/cder/foi/nda99/21087_Tamiflu-pharmr.P1.pdf

http://www.fda.gov/cder/foi/nda99/21087_Tamiflu-pharmr.P2.pdf

Quitting cigarettes

Thursday, January 4th, 2007

A recent small study suggests that Hypericum spp. (St. John’s wort) may help people quit smoking. The study was based on research showing that some prescription antidepressants can help people quit smoking, and hypothesized that St. John’s wort might have a similar effect but with fewer side effects. The participants took 450 mg of standardized (0.3% hypericin and a minimum of 4% hyperforin) twice daily. Almost 38% were not smoking 12 weeks later. This study did not have a control group but other studies suggest that maybe 17% of those determined to quit are able to do so cold turkey. The study is well reasoned and admits that it is preliminary, cautioning us not to “over interpret the results.”

They also note that Zyban (buprion, an antidepressant studied in smoking cessation) yielded about the same results but was only available by prescription, cost $120/month plus the cost of a doctor visit, and up to 48% of those taking it experienced side effects such as dry mouth, seizures, insomnia, and headaches. They even calculated that patients with good insurance coverage actually might only spend $20 on the drug. In contrast, St. John’s wort is readily available at a cost of about $11/month and at most 7.5% suffered side effects of GI disturbances and photosensitivity.

Anyone who has smoked knows that quitting smoking involves much more than overcoming nicotine addiction. Smoking, like drug use and overeating, is a form of self-medication. I have found that adaptogens are useful in helping people maintain their resolve to quit smoking. I will now be advising people to take St. John’s wort as well to provide some more focused emotional relief.

In the study, the participants began taking St. John’s wort for a week before their “quit date.” The study also suggested that it might be better to take it for a while longer before that date as studies suggest that the effect of the herb builds slowly in most people. The same is true of adaptogens, so it probably makes sense to have people take both for 3-4 weeks before trying to quit.

Lawvere S, Mahoney MC, Michael Cummings K, et al. A phase II study of St. John’s wort for smoking cessation. Comp Ther Med 2006; 14:175-184.

Taking drugs that do not work

Sunday, December 3rd, 2006

I was going to write a light hearted blog about TV ads that have caught my attention. Like the one that asks if I am hindered by my mobility. Apparently, if I am getting around too much, I might want a wheelchair. Or the ad where mom plunks down a bucket of fried chicken on the table and the kids run and get in the car. “It will take a while for them to get used to dinner at home,” she says. Yes, there is nothing quite as unexpected as dinner at home, even if not home cooked. But then I started exploring one of my favorite ads for a new antidepressant and got side tracked into more serious issues.

The ad begins by citing a government study showing that 70% of the people taking prescription anti-depressants remain depressed. That is amazing. Why are so many people ignoring cost and side effects and taking these ineffective drugs?

Probably patients and their doctors simply assume that the drugs are working “a bit” and that life would be worse off without them. This is a false assumption as people either respond or do not respond to a medication. In fact, close to 90% of prescription medicines only work in 30-50% of those who are prescribed them. It follows that, leaving aside the placebo effect of doing something about one’s state of mind and having someone (the doctor) identify it as a biochemical problem, one’s attitude toward life would remain the same with or without these antidepressants.

Another reason may be that it can be difficult to quit the drugs. Most of the antidepressants in question are SSRI (serotonin reuptake inhibitors), and one of their benefits is supposedly that they are not addictive. However, it turns out that they may make you feel absolutely miserable when you stop them, especially if you do so abruptly. One site claims that about 1/3 of those who stop taking SSRIs experience some or all of these effects: Stomach upsets, flu like symptoms, anxiety, dizziness, disturbingly vivid dreams (basically a euphemism for nightmares), and sensations in the body that feel like electric shocks. This is referred to as the SSRI discontinuation syndrome. It is said to be different from drug addiction although the distinction somewhat escapes me.

And those who have the hardest time quitting are apparently newborns and young infants. They are exposed to the drugs in utero and through breast milk, and can suffer very serious withdrawal symptoms when either their mom, or they at birth, quit taking the drugs.

So, for many (actually the majority), SSRIs are going to be expensive, ineffective, have numerous side effects, and be difficult and painful to quit. Nonetheless, the medical establishment favors SSRIs over St. John’s wort (Hypericum perforatum). The latter is often helpful in depression, has few side effects aside from changing the metabolism of other pharmaceutical drugs the patient may not be taking, and there is no “St. John’s wort discontinuation syndrome” for those cases where it is not the right choice for the patient. Go figure.

For more information on SSRI discontinuation syndrome see

http://www.antidepressantsfacts.com/addiction-withdrawal.htm

The statistics on how often prescription medicines may not work are from http://www.ghchealth.com/glaxo-chief-our-drugs-do-not-work-on-most-patients.html