FDA assures Americans that its review process guarantees “Drugs are safe and effective”. But anyone who watches TV knows from drug commercials that the agency-approved drugs can cause heart disease, kidney damage, cancer, or death. Safe? Not really. And effective? Most people Think that if a doctor prescribes it, the drug will work. The same goes for over-the-counter drugs. You’ll learn that your definition of effective is very different from the FDA’s definition!
How do smart consumers shop?
How do you decide which mattress, smartphone or toaster to buy? Some people are just looking for the best deal. Others rely on advertising. Smart consumers check ratings and reviews, preferably from unbiased sources such as Consumer Reports (CR).
This nonprofit consumer organization independently tests products and does not accept advertising. Their analysts review cars, TVs, laptops, headphones, and a variety of other consumer products in a scientific and objective manner.
Results are reported in an easy-to-understand graphical format. There is usually a rating number that allows you to compare one car to another.
For example, CR ranks the 2023 Toyota Camry Hybrid as the most reliable midsize sedan 90while Hyundai Sonata 2023 ranks as 80.
What about a sports utility vehicle (SUV)? They’re extremely popular right now, but which one scores the best? 2024 Suburu Forester tops compact SUV rankings 87.On the other hand, CR rates the Mitsubishi Eclipse Cross as 56.
In the market for a vacuum cleaner? Miele Complete C3 Marin on sale for $999 84 Rated CR.Below is the Dyson Big Ball Multi Floor, scored 56 Price $309.98.
How do you know how well your medication is working?
We hope doctors, pharmacists and patients will be able to use similar systems to evaluate medications.Most health professionals know nothing about this current The effectiveness of the medications they prescribe or dispense. They also may not have a good way of assessing potential hazards.
People are exposed to too much medical information through television advertisements. Pharmaceutical companies present their medicines in the best possible light. Actors play people partying, hiking or frolicking on the beach. Children and dogs are the protagonists in these ads.
While the people on screen are having a great time, the announcer will often recite a long list of side effects as fast as possible. This is a very effective distraction technique. Such ads rarely provide data that can help patients decide whether a particular drug is helpful or harmful.
Beware the Relative Risk Reduction (RRR)!
Pharmaceutical companies have figured out a way to confuse medical professionals and patients. So cunning!
The trick is to use what’s called “relative risk reduction” or deposit reserve ratio. Former FDA Commissioner Dr. Stephen Hahn fell into this trap.
He described the benefits of convalescent plasma in the fight against COVID-19. He announced that if 35 out of 100 patients received plasma transfusions from people who had recovered from severe coronavirus infections, the lives of 35 patients could be saved.
Many people are impressed and might consider such treatment. However, this is completely misleading. RRR always makes it feel like things are much better than they really are.
Dr. Eric Topol is a renowned cardiologist. He is founder and director of the Scripps Research Translational Institute, the Gary and Mary West Chair in Innovative Medicine, professor of molecular medicine and executive vice president of Scripps Research. Dr. Topol has published more than 1,200 peer-reviewed articles. He told NPR that FDA Commissioner Hahn made a mistake when describing convalescent plasma transfusions for COVID-19:
“I don’t recall the FDA or the commissioner making a mistake as serious as this one. “Serious mistakes damage your credibility. “
Dr. Hahn later revised his RRR statement to say:
“What I should be better saying is that the data shows a relative risk reduction, not an absolute risk reduction.”
In our article about this disappointment we wrote:
“It turns out that the claim that 35 lives were saved for every 100 patients treated was completely false. The study Dr. Hahn mentioned did not have a placebo group. All people in the study who had COVID-19 received Convalescent plasma.
“One group of patients received plasma within three days of hospitalization. The other group subsequently received intravenous plasma. Mortality was assessed one week later and again 30 days later. Early plasma recipients had a mortality rate of 9% after seven days, compared with delayed The mortality rate among plasma recipients was 12%. After one month, 22% of early plasma recipients died, compared with 27% of delayed recipients.
“Absolute risk reduction (ARR) is between 3% and 5%. That doesn’t sound as impressive as the 35% Dr. Hahn originally quoted. “
Most of the headlines you read in newspapers about drug “advances” report RRR rather than ARR. This makes the drug appear to be very effective. However, don’t fall into the trap that the FDA commissioner fell into.Always seek relevant information absolute risk reduction!
The amount needed to treat helps assess the drug’s effectiveness:
However, there is one method that could be very useful if more health professionals and patients used it. Calculate the number of people needing treatment (Neural Networks) or the amount required to damage (NNH) would be very helpful.
There are several websites that provide this information for many medications. One of them is theNNT.com.
Here’s how NNT works. The analysis relied on data from randomized controlled trials. This number can give an idea of how much a drug helps individual patients. Instead, NNH describes the statistical risk of a drug being harmful.
Antibiotics vs. Sinusitis:
An example of how medications work are antibiotics to treat sinusitis. 1 in 17 people recover within one to two weeks.This produces 17 NNT.
On the other hand, one in eight people is harmed by antibiotic side effects. This is actually a pretty good outcome, although more people are harmed than benefited.
Identical data percentage:
“6% get help (7-14 days cure)
12.5% experienced harm (adverse drug reaction)”
Aspirin vs. heart disease:
Another example is taking aspirin to prevent an initial heart attack. Analysis shows one in 333 people would have to take aspirin to avoid non-fatal heart attack (NNT=333). On the other hand, one in 250 people experienced severe bleeding (NNH=250).
Identical data percentage:
“Risk of heart attack reduced by 0.3%
Risk of major bleeding increased by 0.4%”
Antihypertensive drugs and heart disease, etc.:
This can be shocking to both doctors and patients. Most people believe blood pressure medications protect them from adverse consequences. The NNT website reports the following statistics:
“Five years of blood pressure medication prevents death, heart disease and stroke”
“Benefits of NNT:
“1 in 125 people were helped (death averted)
1 in 67 people get help (stroke prevention)
One in 100 people got help (Preventing Heart Attack: Fatal and Nonfatal Myocardial Infarction and Sudden or Rapid Cardiac Death)”
“Dangers of NNT:
“1 in 10 people suffer harm (drug side effects, discontinuation of medication)”
Identical data percentage:
“97% of people don’t see any benefit
0.8% received help to prevent death
1.5% received help through stroke prevention
1.0% were helped by preventing heart disease”“10% are harmed by drug side effects, please stop taking the drug”
Of course, this doesn’t mean people with high blood pressure should stop taking their medications.Control high blood pressure Very important! But it’s also important for doctors to be accurate when telling patients how effective a drug is at preventing problems.
You can read more about “The pros and cons of treating mild hypertension” at this link.
Understand the effectiveness and risks of medications:
NNT calculations can help patients better determine the odds of benefit compared with harm. Patients should ask their healthcare provider about any recommended NNT for prescription. Doctors and pharmacists can calculate these numbers by visiting ClinCalc.com/stats/NNT.aspx. However, it requires data from well-controlled trials.
In his book, Disgusting: How Big Pharma is ruining American health care”, Dr. John Abramson tells his readers how to calculate NNT themselves:
“NNT is easily calculated by dividing 100 by the absolute risk reduction.”
Dr. Abramson goes on to calculate the NNT for statins:
“Similarly, for people who already have cardiovascular disease, the absolute risk of death within five years is reduced by 1.25% for patients who receive statin therapy, so to prevent a single death with five years of statin therapy, the NNT was 80 (NNT = 100/1.25). Again, statin treatment did not protect the other seventy-nine from death.”
If consumers can use independent ratings to make informed decisions about their cars, computers, or coffee machines, why can’t they get objective information about the risks and benefits of medications prescribed by their doctors?
Ask how your medication is working!
When your healthcare provider gives you a prescription, why not ask some questions:
• What are my chances of benefiting from this medication? Please provide numbers!
• Can you share with me the absolute risk reduction? mine Health issues?
• Can you tell me the therapeutically required number (NNT) of this drug?
• What is the number needed to cause harm (NNH)? What are the most common side effects and the most serious adverse reactions?
• Are there any symptoms I should be aware of?
• What symptoms require urgent action?
• How can I contact you promptly if a serious problem arises? Can you give me your cell phone number so I can text you if I need urgent care?
Please share your own experiences with medication in the comments section below. Do you want to know the likelihood that your medication is working or could cause harm? If you think a friend or family member might benefit from this article, please scroll to the top of the page and send it by clicking the email icon. Thank you for supporting our work.