November 3, 2024, 10:43 AM IST
Most of us are aware of the concept of drug side effects, which can be either negative or positive. The goal of any drug manufacturer is to minimize negative side effects. If side effects are severe, a drug is unlikely to receive approval from regulatory authorities. Additionally, most side effects are evaluated over short time frames; therefore, effects that only become apparent after prolonged use—such as over decades—may go undetected. Drug manufacturers often aim to minimize the disclosure of side effects, revealing only those they cannot conceal or are legally required to disclose..
It’s important to recognize that all individuals are epigenetically different, so just as specific foods affect us in varied ways, specific drugs also have different effects on each person. This variability makes it difficult to identify all side effects during drug trials. It is not unreasonable to assume that there are certain side effects that your doctor may not be aware of. For example, it has long been known that many diabetic medications can increase the risk of heart disease. However, manufacturers of these medications are only required to demonstrate that their drugs lower blood glucose levels, not that they do not increase the risk of heart disease.
I personally had to stop using Avandia after discovering its potential risks, and I switched to Actos, only to stop that as well for the same reason. This led me to change my diet and lifestyle.
If you are a diabetic, your doctor may be so concerned about your risk of heart disease that they recommend you take statins as a preventive measure. Interestingly, the reverse is also true: if you are a heart patient taking certain drugs, your likelihood of developing diabetes significantly increases.
Understanding side effects and adverse drug reactions (ADRs)
The distinction between side effects and adverse drug reactions (ADRs) is often misunderstood. A side effect refers to unintended effects of a drug that occur within the therapeutic range, usually an undesirable secondary effect in addition to the desired therapeutic outcome. Side effects can vary among individuals.
An adverse drug reaction (ADR) is defined as “a response to a medicinal product that is noxious and unintended.” It is estimated that between 3% and 7% of all hospitalizations are due to ADRs, which can occur at normal therapeutic doses. In contrast, drug overdoses represent a different issue entirely.
The leading cause of ADRs is multiple drug interactions. It is crucial for individuals taking several medications to check for potential adverse interactions. The situation becomes even more complex as individuals can respond differently to each drug. The Food and Drug Administration (FDA) in the U.S. maintains a database of ADRs, which healthcare providers are required to report and is publicly accessible. Medscape also offers a drug interaction checker that can be useful. Of course, discontinuing medications altogether would eliminate this concern.
NNT & NNH of drugs
Having explained the concepts of side effects and ADRs, let’s discuss how various drugs are evaluated in terms of their performance. Two critical criteria in drug evaluation are Number Needed to Treat (NNT) and Number Needed to Heal (NNH).
Number needed to treat (NNT) refers to the number of patients a doctor or researcher needs to treat to prevent one additional adverse outcome, such as death. For instance, if a cancer drug reduces the mortality rate from 30% to 25%, the NNT is calculated as 1 divided by the reduction in mortality rate (0.30 – 0.25), resulting in an NNT of 20.
Number needed to harm (NNH) refers to the number of patients who need to be treated for one to experience a harmful side effect. For many drugs, the NNH is often lower than the NNT. For example, for statin drugs, the NNH for muscle pain is 21, meaning one in every 21 patients may experience muscle pain.
A tutorial video linked below will help clarify the concepts of NNT and NNH, as well as illustrate how drug companies may legally misrepresent the benefits of their products through statistical jargon.
To illustrate, consider statin drugs. According to The NNT Group, the NNT for statins prescribed for five years to prevent heart disease in individuals without prior heart issues is 104. This means 104 people must take statins for five years to prevent one additional heart attack. Meanwhile, the NNH of 21 indicates that five out of those 104 patients will likely experience muscle loss.
It is alarming to note that when all causes of death from ADRs, adverse drug events (ADEs), medical procedures, and diagnostics are considered, medical care itself becomes a leading cause of death in America, surpassing heart disease and cancer.
The Statistics for Statin drugs is shown below as a verbatim quotation:
“In Summary, for those who received statins:
Benefits in NNT
No statistically significant mortality benefit
1 in 217 avoided a nonfatal heart attack (myocardial infarction)
1 in 313 avoided a nonfatal stroke
Harms in NNH
1 in 21 experienced pain from muscle damage
1 in 204 developed diabetes mellitus”
Opioid crisis
Another example of neglect by Pharma industry is the Opioid Crisis. Recently, opioid lawsuits were settled for $26 billion, to be paid by four companies over the next 18 years. However, those who suffered will see little compensation, as most funds will support state and local efforts to address the opioid crisis. Many Americans struggling with opioid addiction have transitioned from prescription pain pills to street fentanyl, which is even more dangerous. Most pharma companies view such settlements as merely a cost of doing business. Without personal liabilities or jail time for executives, this behavior persists.
Confessions of a Pharma executive
The consumption of medications is not as benign as commonly believed. All medications carry side effects and ADRs, and drug companies often minimize the disclosure of these risks. Dr. John Virapen, a former executive at Eli Lilly, has publicly exposed issues within the drug industry. Key quotes from his YouTube video that is posted at the end of this blog include:
1. “They (Pharma industry) are not interested in curing any disease you may have. They are more interested in making you get diseases. They are interested in symptomatic treatment. They want patients who are diabetics, cardiology patients, Parkinson’s disease, Rheumatoid Arthritis, Arterioses, because you live a long time and the drugs you have to take, you take that for the rest of your life.”
2. “Few years ago, Eli Lilly was fined by a Pensilvania court 1.4 billion dollars for knowingly selling a schizophrenic drug Zyprexa to elderly patients which made them sleepy and also diabetic. Eli Lilly is the largest producer of diabetic drugs in the world.”
3. “But it (the news of settlement) never came out, you know why, because the press, also works with the Pharma industry just like the Government does.”
4. “The Pharma company uses the media to implant its dirty work on you. You never get to know the truth until it is too late. So you have to raise your awareness to a higher level. Don’t take for granted what you doctor is telling you because doctor is insane.” “They don’t know much about the medicine and they don’t care much about the patient. They think about how much they can get paid and this is how the Pharma industry reigns, stays in power. They buy the doctors. The doctors don’t get their information from anywhere’s else except the Pharma industry and I know because when I was a salesman, the Pharma company used to tell me ; never talk side effects. They talk of something called FAB ; Features, Advantage, Benefits. Talk about side effects was a taboo. for I know that. I also know that they hide the dangers side effects because I was in charge of the critical trial for Prozac.”
5. “Late US president George Bush’s father was a Director of the Board of Eli Lilly. Also one of George Bush’s advisor was a Vice President of Eli Lilly. Rumsford was also a Vice President in the Pharma industry.
Eli Lilly is one of the largest political contributor to the Republican Party.”
6.”That ladies and gentlemen is the highest form of corruption. It is called lobbying.”
Here are the YouTube videos referred above.
Dr. John Virapen on the Drug Industry
Pharma not in business of Health
To read the complete article on Times of India, Click Here
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