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Clinical Trials of Cuban Lung Cancer Vaccine Continue

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Research cooperation between two countries that don’t communicate politically – the United States (US) and Cuba – allows a strange relationship to make strides against cancer. Now a Cuban lung cancer vaccine is in US clinical trials.

How did this strange relationship begin?

After Fidel Castro took over as president of Cuba, causing great harm to most of the middle class, over half the doctors fled the island. There is no doubt that his authoritarian, sometimes ruthless, leadership had unimaginable downsides, but there is a side that cannot be ignored. He was determined to bring Cuba to the forefront in science and medicine.

He sent thousands of people to other countries to study at top medical universities. Because Cuba was so isolated due to the American embargo and its geography, they lacked not only doctors, but medicines, as well as hospital and medical equipment and supplies. To service the medical needs of the population and reach the global standing Castro demanded, Cuba was forced to conduct research and create medicines within the country on their own – and it paid off.

Making strides against cancer

A famous American oncology doctor, Randolph Lee Clark, visited Cuba and Castro in 1980 with information about interferon, a promising drug for treating cancer. It intrigued Castro enough that he sent doctors to visit Clark and also to Finland to study their methods of purifying interferon from white blood cells. By the time the doctors returned to Cuba, a new laboratory awaited them along with an instruction from Castro, “Make interferon for Cuba.” These doctors worked tirelessly to reproduce the method for purification seen in other countries. In 42 days, they were ready with the process.

Meanwhile Castro sent Luis Herrera to Europe to learn information about genetic engineering, a science that was changing science throughout the world. Herrera brought this knowledge back to Cuba.  These two new scientific breakthroughs were the start of Cuba’s biotechnology development and recognition as a medical power.

Cuban lung cancer vaccine trials in US begin in earnest

For years, US citizens suffering from Stage 4 cancers, traveled illegally to Cuba for cancer treatments unavailable in the US. For many, what had been a death sentence, now became a chronic illness but one that could extend lives for possibly years. The CIMAvax vaccine from Cuban researchers, which was based on interferon and genetic engineering, extended lives.

This caught the attention of scientists at Roswell Park in the US. When President Obama opened the doors to a new relationship with Cuba, two Roswell researchers traveled to Cuba and met with scientists there. Roswell scientists wanted to learn more about CIMAvax and the Cuban scientists wanted to learn more about the world-class immunology treatments developed by Americans. They also wanted access to America’s advanced research equipment that could speed and enhance their work.

The relationship began in earnest after hearing a presentation made by Cuban doctors at Roswell Park in 2011. A 2015 trade mission led by Gov. Andrew Cuomo ended with an agreement between Roswell Park and Cuba’s Center for Molecular Immunology (C.I.M.). This was an agreement to initiate a clinical trial for CIMAvax targeting lung cancer – a trial approved by the Food and Drug Administration (FDA) to be held in the US and a first for a Cuban drug. This may be a boon to those with lung cancer brought on by asbestos exposure. In the Roswell trials CIMAvax is joined by a checkpoint inhibitor, nivolumab possibly making the vaccine even more successful.

Today, the clinical trial is still gathering information, but once it passes, it is expected to be cleared for used by patients in the US by the FDA. With travel – once again illegal – unnecessary for patients, it would be available to many more patients who have little hope at this time.

What about the future?

There is already an agreement for a biotech joint venture between the US and Cuba – a first. They also agreed to build a new biotech facility in Cuba for more research on cancer drugs. The facility will be jointly owned by Roswell Park and C.I.M. They visualize factories manufacturing new medicines for people around the globe.

Candace Johnson, president and chief executive officer of Roswell Park Comprehensive Cancer Center, said, “I know everything that we do with Cuba can be a challenge because of the relationship between our two countries,” Johnson said. “We’re very hopeful. It seems to me it would be very difficult … from the FDA’s perspective, if this drug has a role, that it wouldn’t be available in this country.”

Proactive Cancer Prevention

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Does cancer prevention mean never getting cancer? Not necessarily, but it can decrease your chances immensely. It all begins with you.

Proactive cancer prevention

Life, procrastination, even denial possibly get in the way of doing what we know we should do to be healthy individuals. Annual checkups, knowing our family’s health history, eating healthy foods, and exercising are just a few areas that can affect our health. What else can be done to protect overall health and even deter cancer?

First is the use of tobacco products

There is no safe amount of smoking. A study showed that even smoking fewer than one cigarette each day resulted in a 64 percent increase in death over people who never smoked. The more cigarettes smoked, the higher the percentage as it climbs to an 87 percent higher death risk when smoking between one and 10 per day versus never smoked.

Eating an overall healthy diet is key

Studies show that instead of focusing on one type of food or beverage as “good” or “bad”, it’s the entire diet over a long period of time that most affects our health. This nutrient intake includes supplements as well.  Supplements cannot replace the benefits of ingesting nutrients through foods – and can sometimes even be a detriment. Eat fruits, vegetables, whole grains, and beans and limit refined sugars and processed meats to reduce the possibility of acquiring cancer.

Premature death associated with extreme obesity

What is extreme obesity? In general, it is when a person is 100 pounds or more over their recommended weight for their height. Since this is usually measured in BMI rankings, it was found that people in the 40.0 – 44.9 BMI category lost over six years from their normal life span. Those at an even higher level of 55.0 – 59.9 BMI lost almost 14 years of life. To compare, smokers and extremely obese individuals had about the same years of life lost. These losses are generally due to heart issues and cancer.

Breast cancer prevention

Limit alcohol consumption. Latest recommendation to prevent breast cancer is to drink no more that one drink per day. Alcohol increases the risk of breast, colon, lung, kidney and liver cancers.

Stay active regularly.  Aim for 150 minutes each week with moderate activity or 75 minutes of aerobic activity. This will burn calories and also keep blood flowing.

Weigh the risks of hormone therapy over the rewards. If you decide to proceed, stay under a doctor’s monitoring as combination hormone therapy can increase risks if used for more than 3-5 years.

Protect yourself in the sun

Melanoma can be a vicious cancer, so protecting yourself when outdoors pays big dividends. This protection needs to be used on cloudy days as well as sunny. Stay in the shade, use a minimum of SPR 30 and reapply frequently – especially when going in and out of water. Cover skin when outdoors using tightly woven fabrics in bright or dark colors. Finally, completely avoid tanning beds or sunlamps. These will damage your skin and bring about skin cancer just as much as the sun.

Certain behaviors create risks

Hepatitis B increases risk of liver cancer. The hepatitis B vaccine is recommended for people at risk through intravenous drugs, people with sexually transmitted infections, and people exposed through their occupation in health care or public safety.

Human papillomavirus (HPV) is a sexually transmitted virus. It can lead to cervical cancers and squamous cell cancers on the head and neck. The HPV vaccine is recommended for girls and boys 11 and 12 and the Gardasil 0 for adults ages 9 to 45.

Practice safe sex. This will aid in protection against cancers of liver, lung, and various genital cancers. \

Don’t share needles. This behavior can lead to diseases that increase the risk of liver cancer.

Environmental cancer prevention

Many people still do not realize the dangers that may lurk in homes and offices built before 1978. For decades, asbestos was used in multiple ways – for insulation, tiles, mastic, shingles, popcorn ceilings, the list goes on. There is no safe level of asbestos exposure. Though it is primarily dangerous when disturbed, allowing fibers to float and be inhaled or land on clothing or furniture, it poses a hazard within any pre-1978 building.  For that reason, any type of renovation, or accident, or weather event that disturbs an asbestos laden material is dangerous. Inhalation can lead to lung cancer, asbestosis, and the fatal disease, mesothelioma. Always employ a professional abatement company when a project may involve asbestos. They will test any suspicious materials, and if necessary, clean and dispose of all contaminated debris.

There are other dangers that may be in your home. Search the Internet and you’ll find articles and preventative methods on talc (may contain asbestos), cleaners, makeup, as well as other products to check. A good place to start is ewg.org, a website of the Environmental Working Group that “empowers people to live healthier lives in a healthier environment.” Their research and education on common products can be eye-opening.

Begin today

No one wants to experience the symptoms or go through the treatments for cancers. There is so much we can do to lessen the risks – more than written here. What can you do to decrease your – and your family’s – risk for cancer? It’s worth making changes in lifestyle. Proactive cancer prevention can save your life.

Asbestos, Quebec Putting Asbestos Past Behind

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After a 120 year history, Asbestos, Quebec is putting its asbestos past behind. Asbestos is known throughout the world as a deadly mineral comprised of microscopic fibers. These fibers, when inhaled, can cause diseases such as lung cancer, the deadly mesothelioma, and asbestosis. There is no safe level of exposure according to the World Health Organization (WHO).

History of Asbestos, Quebec

In 1879, the Jeffrey Mine opened. This was the beginning of the town that bore the name of the mineral that brought wealth, high-paying employment, and – eventually – a negative notoriety to Asbestos, Quebec.

By the 1920s, the dangers of asbestos were known, but ignored. The mining companies were not willing to lose the large profits from the mines. The mineral was becoming recognized throughout the world for its many properties including insulation and fire-retardance. Products and new ways of using the mineral were rapidly created. Asbestos, Quebec became a well-known exporter of asbestos for the world. By 1969, Asbestos had to relocate from its original site to allow room for the Jeffrey Mine expansion.

However, by the 1970s and 1980s, demand began to decrease as the dangers of asbestos, known to mine owners and manufacturers since the 1920s, became known to the public as well.

It was 2011 before the mines closed, along with Jeffery Mine tours the public could take into the western world’s largest mine. With the mine closures, Asbestos was hit hard with unemployment, bringing about a need for new industries bringing jobs to the small town.

Bringing new business to Asbestos, Quebec

Town officials began a search for new businesses, but immediately ran into objections based on the town’s name. As far back as 2006, the idea of a name change was suggested to the citizens. At that time it was rejected by those who remembered the history of their town with pride, despite the reputation of asbestos. Even today, many people in Asbestos believe there is a use for asbestos under safe and controlled circumstances.

In 2019, Mayor Hugues Grimard stated, “If we want to go further in terms of economic development, then we don’t have the choice. The media attention of our past stays with us any time we do anything.” Not only the media is a roadblock, but also the reputation of the word, “asbestos.” Many corporations do not want that negative image attached to their company and products.

A few new businesses located to the town, but not nearly enough to replace the enormous economic impact of the asbestos mines. Companies that did relocate to Asbestos have to fight the town’s name with customers who often think their products contain asbestos.

And the new name is?

A notice says the “city council remains aware that the history of Asbestos and its heritage are very dear to everyone. This is why these elements will be taken into account throughout the process.”

To give everyone a chance to rename the town, the council opened the search for a new name to the citizens of Asbestos – even those as young as 14. There were several requirements for suggestions: they must reflect the area or people, no saints or other names of persons, and it must be in French. After collecting all the suggestions, a committee will review and select five or fewer to be voted on by the people. The winner will be announced in May, 2020 and Asbestos, Quebec will take on a new character – one without the dark history of asbestos.

FDA Examined Asbestos Testing in Talc Products

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It was 1971 the last time the U.S. Food and Drug Administration (FDA) examined asbestos testing in talc products in powders and cosmetics. The subject came to the forefront after finding traces of asbestos in several talc cosmetics and powders including a bottle of Johnson & Johnson’s Baby Powder, toy makeup kits for children from IQ Toys and other products, among them crayons and other makeup marketed to children and preteens over the past few years.

Why asbestos testing after almost 50 years?

The talc industry has long operated with little oversight from the FDA. In fact, manufacturers of talc products have no requirement to test for asbestos even now.

There has been a growing outcry from the public to ensure talc is clear of any asbestos as more and more people have pointed to asbestos-containing talc as the cause of various cancers. Recommendations were published last month from a panel of government experts. These experts were public health authorities and knowledgeable authorities on asbestos who defended plaintiffs who alleged contaminated talc products caused their cancers. They, and others, requested a “thorough review of the most effective and reliable ways to test for asbestos in cosmetic talc.”

Despite evidence to the contrary, industry groups criticize the recommendations asserting these would not improve safety. Johnson & Johnson (J&J) continues to defend the safety of its talc. They cited no asbestos was found in the samples provided to the labs hired by J&J. However, a 2018 Reuters report proved J&J knew for decades their raw talc and powders did test positive for asbestos, but they did not report that to the FDA.

How are asbestos and talc connected?

When mined, the two minerals are often found in the same areas. Collecting only talc is difficult. Both minerals have such small particles that they can be inhaled into the lungs and cause diseases such as mesothelioma and lung cancer.

At the February 4th hearing, a government toxicologist said, “a wide range of spear-shaped mineral particles – including but not limited to asbestos – can start the development of cancer and should be part of any new testing regime.

What are EMPs?

While milling talc, the process breaks down contaminants into elongated mineral particles (EMPs). A senior adviser with the National Institute of Environmental Health Sciences, Christopher Weis, stated at the meeting, “All EMPs have the ability to trigger” development of cancer and other diseases. “Short EMPs are not conventionally counted or included in lab reports. As a toxicologist, this is unacceptable.”

On the other side, Mark Pollak COO of a 600 member trade group, the Personal Care Products Council, said counting more mineral particles as potentially harmful is not supported by science and could provide misleading reports.

What happens with asbestos testing now?

According to Dr. Linda Katz, director of the FDA’s office of cosmetics and colors, experts from the FDA and other agencies will publish a white paper after a continued study on these issues. The date of the white paper is unknown and there is no deadline for deciding if there will be new rules on testing.

Scott Faber, senior vice president for government affairs at the Environmental Working Group (EWG), implored the FDA to advocate for more stringent testing and recommended a warning label be affixed to talc products to alert consumers to the possibility of asbestos present in the talc. Faber said at the hearing, “It’s time to end the honor system which has failed consumers for so long. Let’s not wait another 50 years to finally protect consumers.”

Talc Safety Topic of Congressional Hearings

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Talc safety has been a concern for years. More recently, the clear possibility of asbestos contamination in talc has led to heightened concern about critical diseases, such as mesothelioma and ovarian cancer being caused by use of talc based products.  

Why is asbestos connected to talc safety?

Both talc and asbestos are minerals found in underground mines. Geologists know that these two minerals are often found intertwined in veins, making cross-contamination a real risk.

Talc everyday uses

Aside from baby powder, talc is used in a wide range of cosmetics for its moisture absorption and silkiness. Recently asbestos was found in four cosmetic products from Claire’s and Justice – both catering to makeup for children. It was also used for feminine hygiene, crayons, children’s toys, chewing gum, and a plethora of common products. There is no safe level of asbestos as its microscopic fibers can infiltrate lungs and harbor the potential for developing into lung cancer, asbestosis, and the deadly mesothelioma for fifty years or more.

Congressional hearings on talc safety

Concerns recently grew when the FDA found asbestos in several products, including baby powder. An initial hearing was conducted in March of 2019 over cosmetic talcum powder’s safety. This hearing specifically focused on talc’s connection with ovarian cancer.

The second hearing was launched when the FDA found asbestos in a sample of Johnson & Johnson’s (J&J) baby powder in October 2019. Under consideration may be the use of warning labels or regulation of talc products.

Congress speaks

The hearing questioned the testing methods used.  William Longo, founder of Materials Analytical Service, stated, “Independent labs throughout the country and over the course of several decades have documented the presence of asbestos in consumer talc products, including Johnson & Johnson’s baby powder. The methods used in the past and today by the industry are not sensitive enough to detect trace levels of asbestos.”

While Longo once denied the presence of asbestos in talc, he stated there is now more sensitive testing. He also received access to thousands of internal J & J documents showing their knowledge of small amounts of asbestos in their talc for decades. There is no safe level, yet J&J kept this information from regulators and the public. Protecting the J&J brand and the public trust of their products was their focus. They now have paid out billions of dollars in thousands of lawsuits with thousands more in process.

The House of Representatives Subcommittee on Economic and Consumer Policy tried to convince the CEO of Johnson & Johnson, Alex Gorsky, to testify at the hearing. He turned down the invitation.

Charles M. Elson, director of the John L. Weinberg Center for Corporate Governance at the University of Delaware, said Gorsky’s refusal made sense as the “CEO and his advisers probably figured that the downside was greater to testifying than not.”