Biotechnology Scandals- Part 1

Biotechnology

has the potential to change our lives in profound, countless ways, from improving our health to enhancing our food supply.

Complex science, Corporate Greed, Ethical Debates

Biotechnology also has the potential to cause harm and create ethical dilemmas.

1. We can increase public awareness and understanding of the potential benefits and risks of biotechnology

2. Help build public trust in the scientific community

3. Identify the weaknesses in current regulatory frameworks and develop new policies and guidelines to ensure the safety and ethical use of biotechnology.

4. Anticipate potential risks and develop strategies to prevent them

Why should you care about biotechnology scandals?

Ethical Considerations

This aspect is important as they help protect the rights and interests of all stakeholders involved in biotechnology research and development.

Informed Consent

Safety

Privacy

Fairness

Transparency

Equity

Ethical Considerations includes?

Clustered regularly interspaced short palindromic repeats

CRISPR stands for?

CRISPR-Cas9

based on a natural immune system that bacteria use to defend themselves against viruses.

recognize and defend against the virus next time it attacks

Using CRISPR the bacteria snip out parts of the virus DNA and keep a bit of it behind to help them to?

cut and paste

By using this system, researchers can essentially "_______" DNA sequences in order to make precise edits to the genome.

Cas9 enzyme

acting as a pair of ‘molecular scissors’ that can cut the two strands of DNA

Guide RNA (gRNA)

consists of a small piece of pre-designed RNA sequence (about 20 bases long) located within a longer RNA scaffold. The scaffold part binds to DNA and the pre-designed sequence ‘guides’ Cas9 to the right part of the genome.

1. Recognition

2. Guide RNA (gRNA) binds to sequence

3. Cas9 enzyme binds to gRNA forming a complex

4. Cas9 enzyme cuts both strands of the DNA

5. The cut is repaired introducing mutation, resulting in gene editing

CRISPR-Cas9 Gene Editing Technology

He Jiankui

The CRISPR babies scandal is a highly controversial case that occurred in 2018, in which a Chinese scientist named _________ announced that he had created the world's first genetically edited babies using the CRISPR-Cas9 gene editing tool. He did so in order to make them resistant to HIV.

Lulu and Nana

He Jiankui announced at the Second International Summit on Human Genome Editing in Hong Kong that he had used CRISPR-Cas9 to edit the genes of twin girls named:

"three genetically-edited babies".

In his speech, He also mentioned about a second pregnancy under the same experiment.

No reports disclosed, the baby might have been born around August 2019, and the birth was affirmed on 30 December when the Chinese court returned a verdict mentioning that there were…

Amy

The baby was later revealed in 2022 as:

violated numerous ethical and regulatory guidelines

His announcement sparked immediate controversy and outrage from the scientific community, who argued that he had __________for human gene editing.

Alzheimer’s disease

As of early 2026, He Jiankui has resumed work in a government-backed research hub near Beijing. He is actively planning new gene-editing projects, including research on ________

a. Problems with informed consent from the babies' parents

b. The potential long-term health risks associated with gene editing

c. The ethical implications of creating genetically modified humans

d. The need for greater regulation and oversight of gene editing research.

e. Operated under the cloak of secrecy.

f. The event could easily happen again.

Some of the key ethical concerns raised by the CRISPR babies scandal include:

Henry T. Greely

Stanford Law School Bioethicist declared, "I unequivocally condemn the experiment,“ and later, "He Jiankui’s experiment was, amazingly, even worse than I first thought.“

Dr. Kiran Musunuru

one of the experts called on to review He's manuscript and who later wrote a book on the scandal, called it a "historic ethical fiasco, a deeply flawed experiment".

122 Chinese scientists

_____ Chinese scientists issued a statement criticizing his research. They declared that the experiment was unethical, "crazy" and "a huge blow to the global reputation and development of Chinese science“

Chinese authorities

suspended all of He's research activities, saying his work was "extremely abominable in nature" and a violation of Chinese law.

Dr. Eric Topol

a geneticist and researcher at the Scripps Research Institute, called the experiment "a misapplication of a powerful technology" and said that it "illustrates grossly unethical experimentation.“

Dr. Francis Collins

the director of the National Institutes of Health in the United States, called the experiment "a deeply unfortunate and largely avoidable event" and said that it "underscores the urgent need for international consensus" on the use of gene editing technologies.

He and his two collaborators, Zhang Renli and Qin Jinzhou

The three were found guilty of having "forged ethical review documents and misled doctors into unknowingly implanting gene-edited embryos into two women.“

-18-month prison sentence and a 500,000 RMB fine.

-Zhang and Qin were officially banned from working in assisted reproductive technology for life.

He, Zhang Renli and Qin Jinzhou consequences:

Somatic mutations

occur in a single body cell and cannot be inherited (only tissues derived from mutated cell are affected)

Germline mutations

occur in gametes and can be passed onto offspring (every cell in the entire organism will be affected)

The modifications will be spread over generations and could potentially change the whole human gene pool.

What’s Unethical About This?

Germline editing, which Lulu and Nana received, involves editing heritable DNA found in sperm, eggs and embryos.

Overt ethical concerns are raised by the possibility of permanent changes that edited people will carry and pass on to their children and their children’s children.

If Lulu and Nana have children, they will pass on the edit.

KJ Muldoon

In May 2025, an infant named _____ was treated for a deadly urea cycle disorder with a personalized drug, marking a shift toward safe, therapeutic gene editing for existing patients rather than embryo modification.

liver

Researchers developed a personalized CRISPR base editor to correct the specific mutation in KJ Muldoon’s ______, delivering it through lipid nanoparticles.

The Thalidomide Tragedy

is a cautionary tale of the dangers of using untested drugs during pregnancy.

a sedative and anti-nausea

Thalidomide was developed in Germany in the 1950s as a?

early pregnancy and by reducing the symptoms of morning sickness prevent miscarriage

In the late 50’s, thalidomide was believed to be a magical cure-all for the ills of early pregnancy and by reducing the symptoms of:

Alison Lapper

a Britist artist (photography, digital imaging, and painting). Her statement questions physical normality and beauty, using herself as a subject.

Parys

Lapper had a son,_______, with whom she was pregnant when posing for the Marc Quinn sculpture. He died suddenly from a suspected accidental drug overdose in August 2019, aged 19.

anxiety, trouble sleeping, "tension", and morning sickness

Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter. When first released, it was marketed as safe and promoted for:

About the Drug

By the mid-1950s, 14 pharmaceutical companies were marketing thalidomide in 46 countries under at least 37 different trade names.

Distaval (thalidomide)

made by Chemie Grünenthal GmbH's British counterpart, 1958–1962.

Thalidomide and Pregnancy

In the 1950s, scientists did not know that the effects of a drug could be passed through the placental barrier and harm a fetus in the womb.

10,000 babies

In the few short years that thalidomide was available, it's estimated that over _________ were affected by the drug worldwide. Around half died within months of being born.

peripheral neuritis developed in patients

There soon appeared reports of abnormalities in children being born to mothers using thalidomide.

limb deformities (phocomelia), facial abnormalities, and other serious health problems.

The birth defects caused by Thalidomide included

Fetal Impairment

Bilateral limb atrophy (legs, arms or both) – a condition known as phocomelia, bilateral limb absence (amelia), missing fingers or toes, palmature of the fingers or toes, extra fingers or toes, total or partial hearing loss, partial or total vision loss, paralysis (usually facial muscles), malformation of the digestive tube, malformation of the duodenum (most of the time lethal, before or not long after birth), malformation or absence of the anus, vital organs injury (most of the time lethal, before or not long after birth), death.

Adverse Effects

The precise mechanism by which Thalidomide caused these birth defects is still not fully understood, but it is believed to be related to the drug's ability to interfere with the formation of blood vessels, which is critical for the development of embryos.

Chirality and biological activity also plays a role in this.

importance of patient safety and the need for continued vigilance in the development

The Thalidomide tragedy is a powerful reminder of the ______and use of new drugs.

Thalidomide Today

Despite the drug's tragic history, it has shown benefits in treating various diseases, such as multiple myeloma, a type of blood cancer, and Hansen’s disease (leprosy).