Drug Safety: Balance and Discretion Needed
Most of us have had a bad reaction to a medication or at least an unexpected side effect. You may even know someone who died from a reaction to a drug. At least one report* claims the number of people killed from a drug reaction at more than 100,000 a year. And of course we are all familiar with drugs like Vioxx which were pulled off the market.
The July issue of Discover magazine has an article by Jeanne Lenzer titled “Medicine’s Magic Bullets?”. In it she discusses the issues of harm caused by medications. Some of the problems she points out include doctors not having the time to look up detailed information about drugs from the manufacturers and that doctors are not scientists and do not necessarily have well-honed critical thinking skills to be able to fully evaluate the science.
Other studies such as one published in JAMA found that “industry sponsored research was positive 87% of the time compared with 65% positive for research that was not industry sponsored”.
Balance
My personal opinion is that most likely pharmaceutical companies are skewing the results in their favor at times. On the other hand there is the issue of study sizes. Phase I and II trials for drugs only have a few hundred people in them and even the Phase III trials only have at most a few thousand. Side effects and other complications may not be apparent until many thousands or millions of people are taking a medication.
Experience in science and working for a company with a pharmaceutical division (although I did not work in the pharmaceutical division myself) tells me that these companies have put millions of dollars and many years into developing these drugs. And they have lots of well-educated scientists that have families to support who need to be paid each week (and who are already not getting paid as much as they should). Somehow the drug companies have to make a profit if we are to get any new medications for anything - unless it becomes publicly funded.
On one hand there is criticism for releasing drugs that may not have been fully or properly tested and on the other hand the push for approving drugs even faster - particularly for those for people who are dying or suffering greatly.
A balance needs to be achieved for making certain that new drugs are well tested with the more urgent needs of those who don’t have that kind of time to wait. Better public understanding of the costs of developing these medications also needs to be considered to understand the motives and pressures that companies have for exaggerating their safety and efficacy claims.
One possible solution would be an increase in the number of publicly funded studies to help offset the tendency of companies to skew and exaggerate their own studies.
Discretion
Doctors and patients need to use more discretion when considering new medications. In many cases lifestyle changes could eliminate or reduce the need for some drugs. Doctors need to educate their patients better about these changes and they need to do so before the problem is too severe and results in medication becoming a necessity as it does in some cases. It would also be helpful, when time and ability permit, for doctors to examine more carefully the claims of pharmaceutical companies.
Patients need to take more responsibility for their own health as well. Following their doctor’s advice for lifestyle change needs to be taken more seriously. A self evaluation of the severity of their symptoms should also be encouraged. The heart risks associated with a medication like Vioxx may be appropriate for someone who would otherwise be disabled by severe arthritis, but not for someone for whom weight loss and exercise may eliminate or sufficiently reduce their discomfort.
More Information
For more information you may want to read some other articles on this topic by Jeanne Lenzer such as Drug Secrets - What the FDA isn’t telling or her paper published in PLoS: What Can We Learn from Medical Whistleblowers?.
Also of possible interest is the blog Eye on FDA.
* according to an article in the Journal of the American Medical Association in 1998 and mentioned in the Discover Magazine article
September 21, 2007
This week in health and science - 9/21/07
Catherine from women 4 hope gave Three Tips For Healthy Living this week. Two of the tips I talk about quite a bit myself - nutrition and exercise. But she also brings up another good one I wouldn’t have thought about: “Give yourself some “me” time each and every day, even if you think you don’t need it.”. Being alone sometimes is definitely something I need!
The Women’s Hair Loss Project is a web site for women who have lost or are losing their hair to share their stories. I haven’t lost mine - but I know some women in my family lose quite a bit as they get older. Plus sometimes stopping birth control pills can result in hair loss! I hadn’t realized that before!
Tara from Aetiology wrote about Streptococcus agalactiae (”GBS”) recently which is “one of the most common causes of meningitis in newborns”. I had never heard of before, but then I’ve never had a baby. Tara also wrote about the recent Facebook fiasco where they deleted all pictures of women breastfeeding their babies. What the hell is wrong with people anyway?
Ruth at Eating Fabulous wrote about two foods I really like recently: spinach and pumpkin pie! I eat spinach nearly everyday! Either in a salad or steamed. If it protects me from ovarian cancer too, that’s even better! The pumpkin post just made me hungry! I’d love to try that pumpkin butter, too bad they add sugar to it. I guess it wouldn’t be sweet enough by itself - but if it was sweetened with fruit juice that might be good. And by the way Ruth - I’m from the town that Popeye came from!
Angioplasty celebrated its 30th birthday recently! Before then “1 in 4 heart attack patients died, today over 95% survive!” - from A Hearty Life.
The Cheerful Oncologist reports some good news - “The US Senate is looking at a bill that would force pharmaceutical companies to disclose any payments or gifts they make to doctors.”. I honestly couldn’t tell if The Cheerful Oncologist himself is for or against it though, but it sounds like a good idea to me.
And lastly - there is a site about HPV testing that you may would to visit soon: theHPVtest.com “offers information regarding HPV and cervical cancer, as well as testimony from cancer survivors and an opportunity to sign up for an OBGYN appointment reminder. You can also sign up to receive a free “Choose to Know” bracelet.”
September 14, 2007
This week in health and science - 9/14/07
As usual ramunas at Cancer Genetics has some informative posts about tests to determine the best breast cancer treatment for a given patient including predicting a patient’s response to hormone-suppressing therapy, the cancer’s sensitivity to chemotherapy and whether a patient is at high or low risk of the cancer recurring after surgery (3 Genomic Tests for Therapy Decisions). In another post a test called the Mammostrat is discussed which can “classify patients into high, moderate, or low-risk categories for disease recurrence”.
Dr. Val did a good job of explaining the news story that came out recently claiming that “Human-Animal Embryo Experiments” were going to be allowed. I thought to myself, ‘I bet what is really going on makes sense and is not a big deal and that the headline was written by someone just trying to get attention’. Apparently I was right - all they are really wanting to do is use “animal egg shells (without the nucleus that contains the majority of their DNA) as mini incubators for human stem cells”. She explains it all here: Britain Allows Human-Animal Embryo Experiments
There was a post this week at Eye on FDA about how food is inspected and about how there are proposals in Congress that would require more frequent inspections. Apparently “federal officials inspect companies growing and processing salad greens an average of just once every 3.9 years”! That’s scary news for someone like me who eats a lot of spinach! Read more: Receipe for Reform - Is Food the Next Frontier?
There is now more research concluding that cell phones do not cause cancer. I never believed they did. I wonder if we will keep hearing more about it or if people will be convinced now?
In heart health news - I’ll admit I’m suprised to hear this: Women Are Less Likely To Make Lifestyle Changes That Favor The Heart. I really would have guessed that women more than men would try to stay healthier. I wonder if its because traditionally it was believed that men were more likely to have heart disease so women take it less seriously?
At Eating Fabulous it was reported that peanut butter is being used to combat malnutrition in Malawi (sub-Saharan Africa). That’s great - but I wonder if many people there are allergic to peanuts? Do they have access to emergency medical treatment if their kid has an allergic reaction to it?
In other heart news “researchers at Children’s Hospital Boston have developed pulmonary-valve replacements for infants and children which could grow as the child grows older“. I had no idea they needed to be replaced as kids grew. And I knew someone who needed a valve replaced in highschool, but may she was big enough at that time.
That’s all for this week - yes I’ve been busy and haven’t posted much recently.
August 31, 2007
Smoking (again)
I’ve wrote about smoking a couple of times recently. I promise I won’t start doing it all the time.
I wanted to do this follow-up though.
The NYC Health Department has a new report out called “Who’s Still Smoking“. This report says that “two thirds of the city’s smokers – almost 800,000 adults – tried to quit in the past year, but only 17% of those succeeded. Data from the survey identify emotional distress and binge drinking as possible obstacles to quitting”.
In NYC there are 240,000 less people smoking now than in 2002. The decreases have been seen in the Bronx, Manhattan, and Queens but in Staten Island the numbers have not gone down.
The press release has some good tips for quitting too: New report on smoking shows who’s quitting, who’s not.
In other smoking news - almost 2 million older people in China today are expected to die from emphysema and related diseases due by second-hand smoke according to a report published in the Lancet recently.
The Cheerful Oncologist blogged about this recently too. I would guess, like the commenter over there, that some of the problem is due to the pollution from industry in China. But as China is going ban all tobacco advertising, promotions and sponsorship by 2011 at least they are trying to do something about the smoking problem.
August 26, 2007
This week in health and science - 8/26/07
I haven’t been happy with anything I’ve started to post lately. Here’s my pick of this week’s posts which are all much better than mine:
Nutrition
Ruth at Eating Fabulous wrote about a paper in Cell concerning vitamin K and osteocalcin: the “formation of osteocalcin is dependent on Vitamin K” and “osteocalcin appears play a role in glucose metabolism by regulating the cells that produce insulin in the pancreas and release it into the bloodstream”.
Cancer
Gloria blogged about a new study that indicates tha a diabetes medication might be effective against cancer: “Tumor cells that lack the regulatory gene p53 can be killed by the widely-prescribed diabetes drug Metformin”.
Heart Health
Kendra James wrote this week about “what happens to my heart during sex“. Apparently there are 4 stages our hearts go through: Arousal, Plateau, Orgasm and Resolution.
Women’s Health
Kristen at Lively Women discussed issues concerning breast enhancement surgery while contemplating her friends decision to have it done. What are your thoughts on this surgery?
August 18, 2007
This week in health and science - 8/18/07
All week I had planned to write another post but everyday something came up and prevented me from doing it.
Women’s Health
Hsien-Hsien at Eye on DNA wrote this week about “What happens after a positive breast and ovarian cancer (BRCA) genetic test?“. Most people apparently don’t change anything in their llife.
Nutrition
At Eating Fabulous there is a post about 10 superfoods. They were orginally written for men’s health - but apply to women too.
Heart Disease
It may be that a person’s waist to hip ratio is a better indicator of future heart problems.
Smoking
I’ve written a bit about smoking lately - The Cheerful Oncologist writes this week about what goes through the mind of someone smoking for the first timd and last time?
Aging
A 94-year-old great-great-grandmother who left school at the age of 12 just got a master’s degree! We need more people like this to help eliminate many misperceptions of aging.
Other
At www.scientificblogging.com there is a post about a paper in The Lancet about how 90% of the population in developed countries have high blood pressure. Lifestyle factors are largely to blame - low physical inactivity, a high salt, high fat diet, alcohol and smoking.
Ruth reported this week about the new vaccine for multiple sclerosis that is being tested. The vaccine seems to help people with MS and there is currently a trial taking involving 290 more patients.
Tris at The Homely Scientist writes about West Nile Virus and how it is leading to a better understanding of mutation and lethality.
August 11, 2007
This week in health and science - 8/11/07
I’m a little late this week. Here’s what I think are the most interesting blog posts and news of the week:
Genes and DNA
Hsien-Hsien Lei wrote about a disease associated with aging: exfoliative glaucoma and how it has been discovered that one gene - lysyl oxidase-like 1 (LOXL1) is responsible for it. Exfoliative glaucoma can result in glaucoma and possibly cataracts, lens dislocation, and central retinal vein occlusion resulting in blindness. About 10-20% of people after age 60 are affected to some degree by exfoliation syndrome.
Penny at Genetics and Health reports that there may be evidence of a genetic link between inflammatory bowel disease and ankylosing spondylitis.
Razib at ScienceBlogs has a post about lactase persistence and how it spread through human populations, which I found interesting as I am very lactose intolerant.
Women’s Health
Gloria of Cancer Commentary blogged about how although exposure to sunlight raises the risk of skin cancer the higher vitamin D levels acquired has benefits also. Most recently some data suggesting a connection to breast cancer: “the lower the levels of vitamin D in a woman’s blood-stream, the greater the risk of her developing breast cancer at post-menopausal stage.”
Aging
Elizabeth at GenBetween writes about how older workers who are not retiring are “driving corporations to offer flexible work arrangements“. Baby Boomers seem to be a driving force of change in many aspects life like work, healthcare, etc. I can’t wait to see what they do next!
Kendra at A Hearty Life blogged about how many elderly patients refuse treatments recommended by their doctors. Treatments refused include cardiac catheterization and surgery, chemotherapy, radiation, intubation, dialysis, and transplantation. I think that if more medical procedures were more effective and less physically painful/uncomfortable that less people would refuse them.
Nutrition
David Bradley from Sciencebase discusses how taking multivitamins, mineral supplements, and antioxidants can be dangerous. In particular he writes about how “copper ions sometimes act as antioxidants and sometimes as pro-oxidants”. Personally, for now I prefer to eat right and not take any supplements - someday more will be known about what and how much to take is safe or helpful.
Ruth at Eating Fabulous reviewed Fiber One Chew Bars (Oats and Chocolate) recently. She says they were “texture just right: chewy, but not rough, not dry, doesn’t crumble, and doesn’t take ages til you can swallow without injuring your throat.”. Generally I try to avoid anything with added sugar anymore, but if in a hurry they sound like a good choice to keep in mind.
Other
Dr. Val has a good post about the dangers of drinking raw milk - cows are not clean animals and can carry bacteria that are harmful to people. There are reasons why we started pasteurizing milk: “This process has virtually eliminated milk borne illness in this country, including the transmission of Tuberculosis, Salmonella, E. coli, and Listeria.”
Dr. Val also writes about how to report side effects of medications directly to the FDA - I had no idea this was possible to do!
The Biotech Weblog reports that E. coli has been linked to Crohn’s Disease and that a possible new target for treating high cholesterol may developed: “proprotein convertases may play a role in regulating the concentrations of high-density lipoprotein cholesterol (HDL-C)”.
Elisa at HealthyConcerns.com writes about her experience with a corneal ulcer - something to be aware of if you wear contacts.
August 9, 2007
Smoking Part 2: What should be done?
A recent report by the World Health Organization (WHO) predicts that 1 billion people will die from diseases related to tobacco in this century. However the number of deaths could be reduced dramatically if governments banned smoking in public and work places, banned cigarette advertisments and increased tobacco taxes.
Despite the fact that right now 5.4 million people are still dying each year due to tobacco, in some places smoking levels are beginning to decline. For example the New York City smoking rate has decreased by 20% since 2002 to only 17.5% of the population. NYC achieved this rate in part through anti-smoking ads as well as through higher taxes and bans on smoking in public places.
The dangers of cigarette smoke are very severe. One carcinogen from tobacco is called NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) and is known to cause lung cancer - it is only found in people’s bodies due to tobacco. Recent research has shown that 2nd hand exposure to tobacco smoke increases levels of NNK by 6% for each hour of exposure!
Given all the dangers of tobacco smoke - and how many lives could be saved if people were not exposed to it - it seems that banning smoking in all public places is the only logical thing to do.
As non-smokers also bear some of the costs of smoking related illnesses - including tax payer funded research into these illnesses which could be better spent on non-lifestyle preventable diseases - aggressive campaigns to discourage smoking also seem justified. What do you think?
August 3, 2007
This week in health and science - 8/3/07
It’s World Breastfeeding Week - from August 1st to the 7th! Read more at Health Observances.
Cancer
ramunas lists some very nice characteristics of hereditary, familial and sporadic cancers.
Gloria at Cancer Commentary wrote about the new technique that is being developed for detecting pancreatic cancerusing light. Pretty cool stuff, and one that is close to my heart as my dad had pancreatic cancer.
Allergies
I wish I could afford a hypoallergenic cat! Still way too expensive for me! Maybe in a few years - read more: Hypoallergenic Cat, Anyone?
Healthy Choices
Kristen at Lively Women has a great list of 5 things young people should do to stay healthy - do you have anything to add?
Other
Earlier this week I wrote about the problem of hospital cleanliness including problems with MRSA. This week Penny at Genetics and Health wrote about how the bacteria mutated and evolved in one dying man.
I hope I never need one, but if I do, I’m glad to hear they are making big improvements in artificial hips.
MyDocHub Blog has a great list of the Early Symptoms of Pregnancy - I didn’t know pregnancy could cause all of these. Of course they could be symptoms of something else too.
July 27, 2007
This week in health and science - 7/27/07
(With so many good blog posts and news stories out there - more than I can write about - I’m going to test posting once a week with highlights of the stories that caught my attention. Hopefully you will find them interesting too!)
Allergies
The journal Allergy reports that a new sublingual immunotherapy, called ‘SLIT’, shows promise in treating cat allergies by placing allergen containing drops under the tongue.
In other allergy news, Ruth from Allergizer reports that a new process to inactivate peanut allergens has been discovered.
Cancer
At Lively Women Kristen discusses the recent survey conducted by the American Cancer Society indicating that many Americans do not really have a good understanding of cancer - many people tend to believe popular wisdom rather than facts about cancer.
New data suggests that dietary calcium may reduce the risk of developing breast cancer - read more from Gloria at Dairy Calcium May Reduce Risk of Breast Cancer
Ramunas has a really informative post at www.cancer-genetics.com about gene-expression profiling oncotests: Gene-expression Profiling in Cancer | A Brief Review
That whole cancer and low cholesterol thing that came out this week - I was avoiding it, but thankfully Dr. Val wrote a good post about it. She describes it as a “gross misinterpretation of the metanalysis”.
Biotechnology
Two really cool things this week: a neuroprosthetic chip made to be implanted in the brain which may make it possible in the future for paralyzed people to control a prosthetic device with their thoughts. And a robotic ankle that is light and flexible and also allows people to walk more normally.
Nutrition
At Eating Fabulous Ruth brought up a good point about eating fruit peels and pesticides - we’re usually told the peeling is good for you - has more vitamins, fiber, etc. - but much pesticide residue is left behind?
Longevity
FuturePundit reports the news that in states where people take the latest drugs they have longer life expectancies. I wouldn’t have expected this and didn’t know which state you lived in made that much difference.
Other News
Hsien-Hsien Lei ran a poll on her blog concerning whether or not you would like to have your whole genome sequenced. She also wrote about the Personal Genome Project - which sounds pretty cool, except there is no way I would have my medical records made public - my DNA - yes!, but not the medical records.
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