Drug Safety: Balance and Discretion Needed
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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
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September 21, 2007
This week in health and science – 9/21/07
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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.”
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September 14, 2007
This week in health and science – 9/14/07
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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.
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Related Posts:
- This week in health and science – 8/18/07
- Menopause – HRT, hot flashes and twins
- Lung health in women and children
August 31, 2007
Smoking (again)
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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.
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- Kids need all the nutrition help they can get!
- What not to do – if you want a long, healthy life
- This week in health and science – 9/21/07
August 26, 2007
This week in health and science – 8/26/07
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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?
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Related Posts:
- Women’s Health Weekly Review: June 15 – June 21
- Recent developments in breast cancer research
- Women’s Health Weekly Review: July 6 – July 12
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