Why has the FDA relented in pediatric cancer studies?

When the children-are-not-small-adults and the children-are-therapeutic-orphans mantras became US law in 1997, there was broad social consensus that in medical treatment everything is different in children compared to adults. The key catch in this concept is that newborn babies are indeed different from adults, but they grow. During adolescence, the body matures long before the young person comes of age legally. On a formal level, the mentioned mantras blur the different legal and physical meanings of the term “child”. We associate with children sweet, vulnerable babies and infants, not tall adolescents. But legally, adolescents remain children until they come of age. For drug approval, everybody under 18 is officially a child. The sad key to understand the perpetuating of this confusion is the material interest of pediatric researchers who, via pediatric laws, got the affluent pharmaceutical industry to pay for “pediatric” studies, even if they were pointless. The result are “pediatric” careers in academia, regulatory authorities, industry, and commercial clinical research.

The Food and Drug Advministration (FDA) rewarded countless “pediatric” cancer studies in all age groups. But not all malignancies among minors are completely different from adults. Two key examples are leukemia and melanoma, which occasionally affects people under 18. Two international “pediatric” melanoma studies in adolescents aged 12-17 years had to be terminated. They offered treatment below standard-of-care. Doctors refused to refer further patients. Industry has developed new drugs against melanoma. State-of-the-art treatment is two drugs; the “pediatric” melanoma studies offered only one. These studies were driven by a conflict of interest. There is no “pediatric” conventional melanoma. It’s the same disease before (very rare) and after the 18th birthday (more frequent). Google “pediatric melanoma conflict of interest” and read the publication that pops up first.

Acute lymphoblastic leukemia (ALL) is the most common malignancy in minors. Most young patients can be treated by chemotherapy. But when chemo failed, the prospects were dire until recently. Then, a six-year-old girl was healed in a cutting edge study. Google “Emily Whitehead”. The treatment that saved her (tisagenlecleucel/ Kymriah) is now approved in up to 25 years.

Since 2019, the FDA recommends that industry should include adolescent patients with cancer into adult studies. Google “considerations inclusion adolescents adult oncology studies” and read the first hit, an FDA guidance document. With this, the FDA indirectly admits that all “pediatric” cancer studies rewarded between 1997 and 2019 were pointless, at least in adolescents.

The FDA has relented in adolescents because the scientific evidence of “pediatric” cancer has grown thinner and thinner. But in minors under 12, it still demands pediatric cancer studies. This approach follows the European Union (EU) that since 2007 enforced many such studies. None had positive results. Many pediatric cancer research institutions support the FDA, claiming this will advance cancer treatment. It will not. But this is another story.

When your child gets cancer, don’t trust blindly. Emily survived in a good study. In an EU-demanded study she would probably have died. Click https://www.book2look.com/book/mMqwf6ap9C to learn more. The book will come out January 2022.

Are there drugs that work in adults but not in children? The diabetes example

Several antidiabetic drugs are not FDA-approved in minors under 18y (“children”). Do they not work? They do. To understand the FDA reasons, we have to step back a bit.

When the children-are-not-little-adult mantra became law in 1997, the FDA offered all pharmaceutical companies financial rewards for pediatric studies. There are two types of diabetes. In one, the body stops producing insulin and can no longer control blood sugar, probably due to an autoimmune mechanism. It’s called type 1 diabetes mellitus (T1DM), previously also called juvenile diabetes because it also occurs in minors. In the other diabetes type, people eat too much and don’t exercise enough. Initially, the body produces enough insulin to lower the blood sugar level caused by hamburgers, candy, or whatever. After a while, the body’s cells become insulin resistant. The body produces more and more insulin, but can no longer lower blood sugar sufficiently. It’s called type 2 diabetes mellitus (T2DM). It occurs also in young people who are overweight.

In the “pediatric” T2DM studies that were performed from 1997 on after the “pediatric” law was introduced, all included adolescents were massively overweight. All tested antidiabetic drugs lowered the blood sugar, but not to a statistically significant extent. The decisive issue in all these “pediatric” studies was not the participants’ age, but that they all were massively overweight. The body does not change at the 16th, 17th or 18th birthday.

Several professional groups and institutions benefited from these studies. Involved researchers could publish “pediatric” diabetes studies, could present their groundbraking results at scientific conferences, could network with other pediatric researchers, and advanced their academic career. The involved companies got patent extensions, allowing them to sell their patent-protected drugs longer before cheaper generic drugs could be sold. The healthcare professionals and scientists running the studies had their jobs. The only ones who didn’t benefit were the young patients themselves, and their parents.

Antidiabetic drugs are often cited as an example of medicines that do not work in children. But it’s wrong. The decisive factor is not the birthday, but that young people become overweight. It is one of the many problems of our time. There is food in abundance and people can kill their boredom or frustration with activities at the computer, iphone, or other gadgets while sitting and moving little apart from eyes, fingers and mouth. It’s a very serious problem. But the T2DM studies are a pseudo-solution. On the surface, they appear to contribute to fighting juvenile diabetes, but they don’t. Welcome to our modern world.

Parents asked to permit participation of their loved ones in such a “pediatric” study should refuse. Institutional Review Boards (IRBs)/ ethics committees (ECs) should reject such questionable studies.

Whoever comes across the argument in a discussion that some drugs do not work in children should use this example to argue against it.

“Pediatric” studies in bacterial infections

Humans and higher animals have a childhood, bacteria don’t. And only humans have a childhood formally defined by conventions and the law. Animals live by the laws of the jungle, as pets, workhorses, or other uses. Bacteria and humans interact sometimes for mutual benefit, like billions of bacteria in our gut, sometimes to our detriment when bacteria multiply rapidly in wounds, organs, or the entire body. Without intervention, this kills. Penicillin, produced by fungi to keep bacteria at bay, was the first widely produced antibiotic. Today there are many more.

When bacteria attack and kill, they don’t ask for an ID. But for new antibiotics, the regulatory authorities demand separate pediatric studies. Why? There are rules. Medically, these rules and the studies they demand make limited sence, but financially and politically, they do.

The antibiotic moxifloxacin is FDA-approved in over 18s (“adults”) for various simple and complicated infections. For approval in minors, the developer would have to submit ‘pediatric’ data in under 18s. Can a 15y-old die of bacterial infection? Yes. Would moxifloxacin help? Yes.

The mentioned rules are based on the children-are-not-small-adults mantra that claims that in minors everything is fundamentally different. True for small babies, but not for school age children or adolescents. The children-are-not-small-adults mantra emerged in the US and was amplified by the European Union (EU). The EU makes commitment to “pediatric” studies a condition for adult drug approval, disregarding that adolescents often already have an adult body (mostly, the mind lags behind J). Drug developers must negotiate a “pediatric investigation plan” (PIP) with the European Medicines Agency (EMA). The moxifloxacin PIP demands ‘pediatric’ studies for complicated intra-abdominal infections in patients aged 3 months to 17y. You don’t believe? Google EMEA-000492-PIP01-08-M01. Some “pediatric” moxifloxacin studies have already been completed.

Bureaucrats love simple tasks they can pursue without reflecting further. “Pediatric” studies have become a condition for drug approval. From such studies profit those that work in the authorities, pediatric researchers that publish them, and health professionals & scientists in clinical research and industry that run them. They all have a job. At the end, all this is paid by those who buy amoxifloxacin, other antibiotics, or other drugs.

What minors really need is the right dose of antibiotics, and excluding toxicities in very young babies.

Most moxifloxacin PIP studies have not yet started. Moxifloxacin is just an example. There are many other antibiotics and other drugs against viral, fungal, and parasitic infections. “Pediatric drug develoment” emerged half a century ago out of concerns of toxicities in newborns that were treated with antibiotics. The concept emerged that all minors are “therapeutic orphans”. It became a machinery where drug developers are forced to commit to pointless studies. Otherwise, their drug is not approved. This machinery keeps many people busy. But there is no medical sense.

Parents should refuse their children’s participation. Institutional review boards (IRBs)/ethics committees (ECs) should not allow such studies to start and should suspend ongoing comparable studies. It’s time for the scientific community, patient advocacy, and the general public to address this issue.

“Pediatric” studies in young mothers with birth depression

Being sad is a normal response to a loss or bad experience. But life goes on and you get over it in time. A persistent state of grief that has nothing to do with experiences understandable to an outsider is depression. Called melancholy a century ago, it was thought to reflect internal conflicts. Today we accept internal and external reasons, interactions between them, and know many details what goes wrong in the brain. But there is no definitive explanation, and probably never will be. Depression is serious and can lead to suicide. Along its rational perception, antidepressants were developed. For a long time depression was thought not to exist in children.

A special type of depression occurs relatively frequently around birth – a serious danger for mother and child. But there is treatment today, including antidepressants.

The authorities classify mothers before their 18th birthday as “children” and demand “pediatric” birth depression studies from drug developers. Getting pregnant under 18 is difficult enough already without depression. Women under 18 are physically mature to give birth, but their overall position is precarious. The “pediatric” studies in young mothers under 18 are a particularly disgusting outgrowth of the children-are-not-small-adults mantra.

You don’t believe? Google EMEA-002051-PIP02-16. See the European Union (EU) “pediatric investigation plan” (PIP) that demands “pediatric” studies in allopregnanolone/bexanolone (it’s the same drug) for “postpubertal girls” before their 18th birthday. The drug is approved in birth depression in adults. The EU is far away? Google NCT03665038, a study in female 15-17-year-old adolescents with postpartum depression, recently completed in the US.

The struggle for a self-determined life of women is going on in civilized countries for many years and will continue. It is particularly disgusting that young mothers in a difficult personal situation are abused for pseudo-scientific studies which will reveal nothing new. The 18th birthday does not correspond to any physical change. Drugs that works in 18-year-olds work the same in 17 or 19-year-olds.

Brittney Spears, a modern pop star, was put under the conservatorship of her father when she suffered a psychological breakdown. It took long court battles and the free Brittney movement until she was finally allowed to take care again of her own life and money. The young mothers that were enlisted in the above mentioned pseudo-scientific study are not famous pop stars, and their abuse goes unnoticed. Modern times.

I am a medical doctor and worked as global head pediatrics of two very large companies. Now I am independent.

Where drug regulatory agencies have their say, they enforce pointless “pediatric” studies, even in birth depression. It will not be easy to stop them, but this blog series and the books I am publishing are a beginning.

Rheumatic diseases in minors, conflicts of interest, and why an institution with the abusrd name CAPRI (Center for Adults with Pediatric Rheumatic Illness) exists

Rheumatic diseases in minors are rare, in contrast to the common rheumatic diseases that that affect adults more and more as they get older. In contrast to cancer, chronic arthritides are not life threatening. But they make life difficult. Several ones also affect young humans. A generation ago, young patients with chronic arthritides faced a lifetime of misery. Parents were fortunate to find a competent specialist. Even the best treatment just alleviated symptoms and could not prevent a childhood of pain. Things have changed with modern targeted medicines.

Chronic childhood arthritides came into the focus of medicine and research when the general living conditions gradually improved and research turned to new, previously unnoticed fields in the flood of deadly childhood diseases. Rheumatic childhood diseases took longer than pediatric oncology until serious improvement was achieved. Early anti-inflammatory drugs were aspirin, then steroids, then non-steroidal anti-inflammatory drugs (“NSAIDs”). But only modern, targeted medicines, including monoclonal antibodies and other biologics, allowed decisive therapeutic breakthroughs.

When still only mild anti-inflammatory medicines and steroids were around, US researchers established the “Pediatric Rheumatology Collaborative Study Group” (PRCSG) to ease the fate of the affected minor and their parents. The PRCSG and later its European counterpart “Pediatric Rheumatology International Trials Organisation” (PRINTO) expanded during the heydays of “pediatric drug development”, when scientists assumed that all diseases in minors are fundamentally different. The term “juvenile idiopathic arthritis” (“JIA”) was coined as an overall umbrella term for all chronic forms of arthritis in young (“pediatric”) patients that begin before the 16th birthday. Seven different diseases are currently subsumed under “JIA”. PRCSG and PRINTO profited massively from government-rewarded “pediatric” studies. Both established powerful roles in the international world of pediatric rheumatology.

There is nothing “pediatric” in the diseases under the umbrella term of “JIA”. They can start at a young age, but they don’t change the 16th or 18th birthday. When meanwhile adult patients with such a disease go to an adult rheumatologist, they are often misdiagnosed and treated wrongly. If the patients or their parents are lucky, they discover the “Center for Adults with Pediatric Rheumatic Illness” (CAPRI) at The Brigham and Women’s Hospital, Boston, MA, USA.

Why has the term “JIA” not been abandoned? The organisations that run “pediatric” JIA studies have a high interest to maintain the illusion that “JIA” is something “pediatric”. Medical professional organisations are powerful, but also inert. High-ranking representatives make decisions about strategic issues. If they have a hidden interest in the continuation of a flawed disease classification, they don’t seek scientific discussion, but use their academic authority to cement the status quo. Every year counts.

This challenge is part of “pediatric drug development”. While the FDA has partially relented, the EU continues to demand “pediatric” studies for all new drugs and vaccines. Both the FDA and the European Medicines Agency (EMA) want to save face. Although the FDA has partially relented, it maintains together with the EMA the official position that separate “pediatric” studies are needed. They are filling the world with pointless studies, that often even harm young patients and their parents, specifically where they demand comparison to traditional, sub-standard treatment. It’s time for representatives of patient advocacy group to position themselves against this theater.

The fight against cancer in children, and how conflicts of interest slipped in

Cancer, leukemia, and other malignancies are very rare in children. They came into the focus of medicine and research only when the general living conditions began improving, and research turned to new fields that had previously gone unnoticed in the flood of deadly childhood diseases. Flawed assumptions had to be overcome. Such as that cancer and leukemia only exist in adults, or that you can’t do anything anyway. First breakthroughs came with the treatment of childhood leukemia with chemotherapy.

New combinations (“cocktails”) of chemotherapy agents were tested and continuously improved survival rates. Today, we associate therapeutic breakthrough with new drugs. Childhood cancer was a historical exception. Effective drugs existed already, used and approved in adults. Researchers did not expect that minors with cancer would fare better, but they did. Minors have greater reserves, given the chance to prove this. Towards 2000, the fine-tuning of chemotherapy cocktails plus additional support such as the acceleration of red blood cell production by state-of-the-art drugs reached a plateau. Childhood cancer started to leave its habitat of a historical exception. People knew that new technology would be required. How?

Three movements. (1) New, targeted anti-cancer agents showed serious improvements in adults. (2) Childhood cancer became associated with “pediatric drug development”, based on the children-are-not-small-adults mantra that everything is different in “children”. (3) Breakthroughs occurred. Not because of, but despite “pediatric drug development”.

Childhood cancer researchers demanded easier access to new anticancer compounds for adults. US and European Union (EU) pediatric laws demand “pediatric” studies for all new drugs, including anticancer drugs, in minors. The catch: the 18th birthday is an administrative point in time. Bodily, nothing changes.

Chemotherapy is rather primitive. It poisons systematically the whole body in the hope to kill enough malignant cells and the immune system will clean up the rest.

The next breakthrough came in chemotherapy-resistant acute lymphoblastic leukemia (ALL), the most common childhood malignancy, by engaging the patient’s immune system. Blood is drawn, white blood cells are trained to kill ALL cells, the blood is re-infused. It’s also called CAR-T cell therapy. Of course, it’s much more complicated. For example, the immune system often overreacts (as we also know from COVID-19 infections). A cytokine storm causes high, life-threatening fever. The fever can be treated with high-tech drugs and biologics. Emily Whitehead was the first child who survived. Today she is a young, healthy woman. Youtube her name and learn more.

The key assumption behind the pointless “pediatric” cancer studies is the desire that what worked half a century ago with chemotherapy should also work with modern targeted drugs: Giving them to minors will help. But this assumption is wrong. Chemotherapeutic agents attack almost all cells. Targeted therapies are different. The only ones that profit from these

pointless “pediatric” cancer studies are researchers and scientists in academic medicine, regulatory authorities, and life science industry.

The FDA has relented. Today, it recommends inclusion of adolescents into adult anticancer studies, which is reasonable. But the US followed the EU by authorizing the FDA to demand studies with new anticancer drugs in children up to 11 years. The EU did so since 2007, without any breakthrough.

Childhood cancer research has taken two avenues. One saved Emily’s life by serious research. The other one runs pointless studies. Companies must pay them, or they don’t get adult approval. This second avenue is stronger in the EU. But today studies recruit worldwide, including the US. Would Emily have been recruited into such a pointless EU-demanded study, she would probably be dead.

Why do researchers and authorities demand separate “pediatric” studies

Not long ago relatively little could be done against diseases. Nor did people know their cause. Today we know about bacteria, viruses, & more. Back then people prayed a lot, but whether this helped was a question of faith. Many children died early. Things changed eventually with improved hygiene, clean water, better nutrition, clothing, housing, vaccinations, and drugs. Effective drugs are relatively new in human history. Previously, there were opiates and alcohol for pain relief, sleeping, or relaxation. An infected wound killed, unless a surgeon amputated. Military surgeons were skilled at this.

Drug are developed at the interface of science, medicine and industry. Vaccines have massively reduced child mortality. Without modern drugs, millions who have a normal life today would long have died, including accident survival, diabetes, childhood cancer, heart disease, & more. Previously, you could buy in a pharmacy and self-medicate. Today you need a prescription. Only approved drugs can be prescribed. This puts several layers between individual and treatment: doctors, pharmacists, licensing authorities, reimbursement institutions, & more. Modern drugs can also be dangerous. Thalidomide led to thousands of birth defects. Enter children.

US and European Union (EU) laws demand separate studies in children. Children have the right to tested medication, haven’t they? Sounds good, but there is a catch. We associate with children cute, little, vulnerable humans. But legally, minors up to the age of majority are children. Under the guise of concerns about health and safety of “children,” a coalition of researchers, regulatory agencies, and others enforce futile studies in adolescents that are physically already mature, and grossly exaggerated studies where dose-finding could be done with much less effort.

Many diseases have lost their horror. Effective treatments exist now for many previously fatal or terrible diseases. More effective drugs are being developed. Today, we focus on diseases that were previously ignored: rare diseases (and, of course, currently the ongoing COVID-19 pandemic). For all new drugs, authorities demand studies in minors under 18, supported by “pediatric” researchers. Parents are told that without clinical verification there are risks. But once a drug (or vaccine) is approved in adults, we known its risks in humans. No drug that works in an adult will let a 17-year-old drop dead. The only exception are newborns, and more so premature newborns.

Every century has its own challenges. One of uurs is that high trust in authorities allows “pediatric” research, where researchers publish paper after paper on banalities, such as that insulin works also in humans under 16, and similar groundbreaking discoveries. Fifteen-year-olds are not another species. Nothing happens in the night of a birthday.

The FDA has relented in many areas. Today it accepts that drugs for epilepsy work also in minors. But in most areas the demand for “pediatric” studies continues, resulting in “pediatric” careers in research, government and pharmaceutical industry. The EU demands continue, and as we live in the age of globalization, EU-demanded studies endanger also

American children. It’s time for parents to take a critical look, refuse participation in questionable studies, and call for a change in the pediatric laws. It’s time for pharmaceutical industry to develop a critical position towards official requirements.

Why was vaccination against COVID-19 not offered earlier for children?

The US recently approved COVID-19 vaccines in children 5 to 11-year-old, almost a year after in adults. Why the delay? It is based on the children-are-not-small-adults and children-are-therapeutic-orphans mantras that entered the world of drug development and treatment half a century ago. Mantras have a true core, but get flawed when applied blindly. Babies are indeed vulnerable, but minors do not stay babies until they come of age. An entire “industry” of academics emphasizes that “children” need separate studies, supported by regulatory authorities and others. They emphasize for good reason. Many specialists in research, authorities, & more, making a living of preaching and performing separate pediatric studies, exploiting the public trust in science and our protective instincts towards children. Which villain would dare speak out against better medicine for children? But medicines and vaccines treat the body, not the legal status. Adolescents have a mature body long before the 18th birthday, although the mind usually lags behind. Bodily, they are no longer “children”.

The first vaccine studies included persons from 16 and 18 years on, followed by separate studies in 12-15-year-olds, then in 5-11-year olds. The narrative claims that vaccines’ efficacy needs to be proven in “children” of the various age groups. But adolescents are bodily no longer “children”, 5-11-year-olds are no longer babies. When viruses attack minors, they do not ask for an ID. Minors need adequate doses for drugs and vaccines, not separate proof of efficay. The studies in thousands of minors that led to approval of COVID-19 vaccines in adolescents were futile, those in younger children grossly exaggerated. Dose calculations were all that was needed, followed by confirmation studies with few participants.

The outlined framework is not specific for COVID-19. It regards all drugs and vaccines. That is one reason why it is so difficult to crack. After the thalidomide desaster with thousands of birth defects worldwide the world was in shock. Nobody wanted any more disasters. But the alleged protection of “children” has become a machinery for justifying and conducting at best pointless and often harmful studies.

The more people are vaccinated against COVID-19 and the more more contagious virus variants emerge through mutation, the more also minors are infected. We could have started protecting minors much earlier. For those over 5 we “only” waited a year, for the younger ones we continue to wait, justified by flawed mantras.

European Union (EU)-demanded “pediatric studies” will be performed until 2024. Parents should refuse to allow participation of their loved ones, specically in age groups where vaccines are already available.

Parent and patient advocacy groups should take up this issue and critically discuss the justification of separate studies in “children”. Without pressure on politicians, the relevant laws will never be changed, and the theater of pointless studies will go on forever. Not only will this damage confidence in science and clinical research, but there is also the risk that parents will, out of general fear, refuse to allow their children to participate in meaningful studies that might save their lives. The more this will be discussed, the more also

professional groups of nurses, pharmacists, medical doctors and other health professionals will hopefully take a position and distance themselves from questionable “pediatric” studies.

Clinical studies in minors: The largest abuse in medical research since the Tuskegee trial

Clinical studies evolved with modern drug development. When penicillin was produced industrially a first time during World War II, complicated studies were unnecessary. Patients with bacterial infections were literally snatched from their deathbeds by penicillin. Drug development accelerated, and the range of treatable diseases expanded. New antibiotics and drugs for pain, insomnia, diabetes, birth control, & more emerged. A German company developed and marketed thalidomide for all sorts of ailments, including insomnia, nervousness, and nausea in pregnancy. In the late 1950s, it was discovered that it had caused thousands of severe birth defects worldwide. Never US-approved (but in Canada), it became a turning point in drug development. From 1962 on, US law demanded studies for new drugs. Back in the 1950s, toxicities had been reported in babies treated with antibiotics. To avoid damage lawsuits in the litigious US, companies now inserted “pediatric warnings” into drug labels. This, in turn, led to a concept that claimed all children were “therapeutic orphans”.

Legitimate concerns for babies became the narrative that all drugs are dangerous in all children if not tested separately. The children-are-not-small-adults and children-are-therapeutic-orphans mantras invaded medicine, science, and politics. Confidence in science was high. US lawmakers decided to reward pediatric studies by patent extensions. Companies could sell drugs longer at a higher price. And here the big challenge began.

No need to be a doctor to know that 15-year-old teenagers who are bigger and stronger than mom or dad are bodily mature. No need to be a shrink to know that the mind is usually lagging behind. The FDA defined “children” first by below 17, today below 18 years. But drugs treat the body, not the legal status. “Pediatric” studies in minors, including bodily mature adolescents, became big business for researchers. All scientists complain about a lack of funds. For “pediatric” research, a bonanza started. It became worse when the European Union (EU) expanded the obligation for “pediatric” studies. Today, studies are performed worldwide. Also American children are threatened by EU-demanded studies. Industry paid pediatric researchers for studies. They were futile in adolescents, massively exaggerated in young children. Minors don’t remain as vulnerable as newborns until they come of age. Thousands of questionable “pediatric” studies are today performed worldwide.

The opinion that most pediatric studies are excessive is not shared by most medical and pharmaceutical professionals worldwide. In fact, I am one of very few. But I know what I am talking about. I am a medical doctor, was global head pediatrics in two large international pharma companies, am independent now, and publish & write books about this challenge.

The definition of children as under 18 is a legal, not a medical one. There are no drugs that work in adults and don’t work in children. Kids are not another species.

In my blogs, I will address two sides. I will warn parents that are asked to let their child participate in a study. Studies in minors can safe lives, or can harm. And I offer online seminars for pharmaceutical companies where I explain how to push back against potentially harmful studies demanded by the FDA and the European Medicines Agency (EMA).

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