It is a wonderful book that highlights historical aspects of vaccine invention, especially Louis Pasteur's life, and moves to explain what, in the author's opinion, is not so good about vaccine development and its implementation for public health.

The book starts with a description of Pasteur’s struggle to prove the germ theory and how he patiently convinced the public and peers that the prevailing belief of spontaneous creation is false. The author has brought out the historical aspects in one of the finest ways, and that makes a mark on me, who has read reasonably well about Pasteur. The author’s elaboration on his public experiments, the power to question his own findings, and politely accepting irrational criticism are commendable. His writing on events, which led to the first rabies vaccine, are immersive.

As a doctor practicing outside the US, I am unable to comment on the aspects the authors state about the FDA. The claims of the author are worrying. I accept that healthcare is seen as a business in most parts of the world. While early clinical research had transparency. Post-2003, the year I graduated with my MD, I could see a shift to massive commercialization. The FDA needs to be more transparent about approving drugs and devices. Many other writings concur with the author's concern about the conflict of interest among FDA members who often simultaneously give consultation to pharma industries. It is like a Court Judge providing consultation to the suspect. I also agree that many firm conclusions of FDA are taken back after some time. In healthcare, a well-made conclusion rarely goes wrong wholly. Having said that, the author uses very strong words to criticize the FDA. But we need more evidence to confirm the allegations made. And it is challenging to prove many of his accusations since we need strong willpower and government support to even initiate an investigation.

The author has provided several solutions to the problem as a non-medical person. I appreciate his giving his solutions free-to-share permission. Here are my thoughts on it.

Solution 1: Eliminate pay offs in Clinics to promote vaccinations- I fully agree that such practice can be easily manipulated for business. In developing countries, I have seen the practice of giving benefits to mothers vaccinating their children with polio drops. The pulse polio immunization in India and many other countries has been the main reason behind the near eradication of polio in these countries. Such financial incentives to people benefit the community when done with good intention. But the practice of financial benefits to the doctor is against Hippocrates' principles.

Solution 2: Practice informed consent without prejudice- I agree that informed consent for vaccination is critical for an ethical practice. Forcing a vaccine during a pandemic, especially the regulations during COVID in many developing countries, was a grave mistake. All global agencies failed to correctly assess the vaccine's benefit with reference to infection. The COVID vaccines ( mRNA-Adenovirus vector-inactivated) were believed to prevent infection from COVID. So, the public believed that taking a vaccine could prevent infection and hence it would also prevent transmission. The vaccine was rolled out in late 2020. But in early 2021, the virus mutated from the original Wuhan Variant to the Delta variant. This new variant escaped the vaccine defense and infected vaccinated individuals. But, in India I felt vaccinated individuals had lesser infection severity. As a health care worker, I was offered the choice of either the adenovirus vector vaccine or the inactivated virus vaccine. Since adenovirus vector vaccine was a new platform, I chose the inactivated virus vaccine, which was an established platform made by a producer on whom I had faith. Coming back to the point of what would have happened when a person declines COVID vaccine ? The person could have developed a less severe infection. A person, irrespective of the vaccination status, is any way at the risk of transmitting the infection to others. So, the regulation should have been compulsory mask use when a person moves in public, which will prevent the spread of infection in the community in case the person is infected with the virus.

Solution 3: Parents should decide what is right for their children- I fully agree. Parents are the best judges to identify what suits and what does not suit their children. All parents want their children to be healthy. Many times, I have seen parents identify which antibiotic does not suit their children. They also identify minor vaccine-related adverse effects when they see it repeatedly after vaccine use. For example, longer duration of fever after a, say, MMR vaccine compared to polio vaccine. But exceptions are those parents who tend to be ill-informed or believe untrue stories about medicines and vaccines. I have seen many parents avoid polio drops for their kids, which is not a correct decision, in my opinion, since we know that getting polio is riskier than the rare vaccine side effects.

Solution 4: Delay Hepatitis B vaccination until a pre-teen year. Solution 5: Eliminate Gardasil from the list of recommended vaccines. I fully agree with the author. The fear of the author of vaccines causing some illness in the long run is a genuine concern. This can be confirmed only by a long-duration cohort study. Immunologically, vaccines can create abnormal autoimmunity in children and even in adults. I do not see any studies on that line. However, a simpler approach would be to restrict the vaccine to high-risk individuals. Has childhood vaccination lowered the rates of acute infection? The answer is yes for many diseases like polio, tetanus, mumps, measles , rubella, etc. Has Childhood vaccination reduced a child's overall health after growing as an adult? The answer is may be Yes or No. I am not saying that increased doses of vaccination as a child are causing illness in adults, but there is nothing wrong with assessing that aspect.
I see a long-term study that compares chronic illness among children fully vaccinated as per CDC guidelines and the less privileged children say in Africa will shed more light on the question. The list of vaccines in the CDC is ever-increasing, and I see no strong evidence to support it. Vaccination programs in India , especially the government ones, cover only essential vaccines, which have been proven to help the at-risk individuals. Despite a very low cover for influenza vaccine, we see mortality lower than what the US reports.

Solution 6: Use True Placebos and not chemically active products as a placebo in trials- I needed to understand what the author is trying to explain fully. In randomized studies on drugs, the comparator is usually the standard care given for the illness at that period, and if no treatment is available, then a placebo is used. Having seen the multi-centric drug trials in India , the argument that the placebo harms the participants and hence the new vaccine appears to be safe does not seem acceptable to me. Here is what the drug companies may do. In the initial study, they check if the new drug or vaccine is as good as the comparator. In other words, no pharma will market a drug that is inferior to the present medicine. Then, if they want to manipulate the data, they may show it as superior to the present drug. In practice, I take 3 to 5 years before using a new drug ( except for drug-resistant infections and a few others). But since many of my peers will start to use the new drugs once it is available, I see the outcomes in their patients. Many times, a drug as old as metformin for diabetes will fare as well as a new drug, which is expensive. It is a complicated scenario. Pharma companies are essential for the discovery of new medicines. When they invest money in drug research, expecting early returns is not bad. But human intentions make it wrong. A good solution would be public-private funding where the government bears the burden of research, which will decrease the loss to the Pharma.

Solution 7: Be transparent – publish all drug and vaccine trial data. I agree with the suggestion. But it isn't very easy. Making the data open will not improve the genuine nature of the data. It can still be manipulated. However, supervision by a body of government who have the right to contact any patient enrolled in a particular study will improve the truth in the data. Vaccine or drug-associated adverse events, when cross-verified by a third party who is neutral, will automatically regulate the data entry.

Solution 8: Test individual vaccine ingredients for safety,

Solution 9: Label Aluminium content in vaccines – include a warning - I agree and also disagree on this. The solution offered by the author is very difficult to implement. A simpler solution is to use the time-tested vaccine adjuvants and use newer adjuvants only after extensive research. Now, why does Pharma use new ingredients? It is to improve the shelf life, lower the transport requirements, or increase the immunogenicity of the vaccine. This needs good financial and infrastructure planning. Discussing this further will be so confusing for a non-medical person. So, I will stop here. As for the use of Aluminum in vaccines. Even food and water have Aluminum . If a child is healthy, then it will be metabolized. The argument of the author is less convincing for me. But an expert in Clinical biochemistry should explore the doubt.

Solution 10: Remove vaccine manufacturers' liability protection. This law was originally formed so that pharmaceutical companies could research new drugs without fear of legal litigation. However, during the early phase, drugs and vaccines were tested adequately before clinical use. Most safe vaccines have a 1 in a million serious adverse event. I am not sure how the law can handle this.

Solution 11: Declare vaccine risk in advertising : Not sure if this will help. A lay person may not be able to interpret the risk. It is the doctor who should assess and decide if the person will benefit from the vaccine. Furthermore vaccine risk varies between ages. For instance, the mRNA vaccine for COVID caused cardiac inflammation in the young, but not the elderly. This was identified only in post-marketing. So, vaccine risk should be studied well before the widespread implementation. Again, the regulators should give their best to assess risk without bias.

Solution 12: Legally treat vaccines as drugs: It should be the case even in US. In India drugs, vaccines and devices come under a single umbrella

Solution 13: After Antibiotic therapy delay vaccine: True for vaccines against bacteria. Not sure if it holds good for viruses

Solution 14: Ban Consumer drug and vaccine advertising: Agree

Solution 15: Disallow mandate of vaccine unproven for safety or effectiveness: Vaccine mandates is a very wrong practice except when it can harm the society in a big way. I have already said for COVID that if a person does not get vaccinated then they may only harm themselves and not others since it lowers the illness severity and does not prevent transmission. But if a vaccine prevents infection itself like the polio vaccine then it has community benefits.

Solution 16: Eliminate consumer penalties for non-vaccination: Agree. I would quote the example of Djokovic who was banned from Australian open when he refused vaccination. Ideally he should have been allowed to play if the day’s COVID test was negative . Many sports like cricket followed this test to allow playing method. Such mandates on vaccines which only lower the severity of illness not the illness acquisition should be condemned. Especially for vaccines whose safety is unknown either due to lack of data or conflicting data.

Before I conclude I appreciate the author having placed all the necessary references in the second half of the book.

Even though the tone of the author is quite strong, every one interested in public health should read this book even if they do not agree with the author. He has raised an important question of believing the medical science. Faith of the patient on the medical system is the cornerstone of a community health, and we should strive to keep it HEADS-UP

An if you in America, be happy that you can write such a book, which is a big risk in some countries and even a thought impossible in many.

Louis Pasteur Condemns Big Pharma: Vaccines, Drugs, and Healthcare in the United States