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What People With Cancer Need to Know about Coronavirus (COVID-19)

Cancer Prevention and Treatment Fund: June 22, 2020

The coronavirus can infect anyone, young or old, healthy or frail.  Here’s what you need to know.

People who are over 60 or who have cancer and other serious health conditions, and their loved ones, need to be especially careful.  Anyone with high blood pressure, heart disease, diabetes, or cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.  For other types of cancer, treatments such as chemotherapy, targeted therapies, immunotherapy, and radiation, can weaken the immune system and possibly cause lung problems. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus.

If you had scheduled medical appointments, surgery, screening, or other procedures that were considered not urgent or not immediately life-threatening, those were probably postponed. This is for everyone’s protection.  Many hospital staff,  including doctors, nurses, receptionists, and cleaning staff, have been exposed to the virus and don’t know whether they can infect others.  You don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures for other medical conditions.  And, you don’t want your medical center to be less able to fight the coronavirus at a time when it is spreading throughout your community.  However, non-urgent medical appointments are being rescheduled again in most communities, so don’t delay rescheduling important medical procedures, tests, or check-ups.

The coronavirus is spreading in all 50 states, in urban, suburban, and rural areas, so it is important to listen to health experts (and governors or mayors) who tell you to stay home, limit contact with others, and keep a distance of 6 feet away when you or your family members or caregivers go grocery shopping or other essential activities.  Unfortunately, some governors, mayors, and state legislators have reopened businesses for political reasons, even in states where the virus is spiking.  Even if you are staying at home as much as possible, the fact that others in your community are going to restaurants, stores, and hair salons will put you at greater risk when you make essential visits to the supermarket, to work, to the doctor, or spend time outdoors, because you may come into contact with people who are infected because they aren’t being as careful as you are.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.  Since it is new, nobody has immunity from it.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through invisible or very tiny droplets when a person coughs, sneezes, sings, exercises – or even when they breathe or talk normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

The virus is thought to be most contagious in the days just before or after a person develops symptoms, but it is possible to catch the virus from infected people who have no symptoms at all.  Experts still don’t know how contagious the virus is when a person has it but never develops symptoms.  This is crucial information that scientists are trying to find out, especially since experts believe that many young children never develop symptoms, while other children get very sick and some have died from the coronavirus.

These droplets with the virus (as well as fecal matter containing the virus) can end up on surfaces where it can survive for hours or even days. When you touch these surfaces and then touch your face, you can be exposed to the virus. That’s why it’s important to wash your hands regularly.  If you don’t have antiseptic wipes, you can wipe down surfaces in your bathroom, kitchen, and other rooms with bleach of rubbing alcohol to help prevent exposure.

What about food or food packaging?  The risk of catching the virus from packaging is very low, but since the virus can survive for up to 24 hours on cardboard and up to 3 days on plastic and stainless steel, it’s a good idea to wash your hands for at least 20 seconds after handling mail, takeout containers, and packaging from groceries. You can also disinfect food packages using a cleaning product that kills viruses, but DO NOT use bleach or other disinfectants on fruit, vegetables, or any other food.

What are the symptoms of COVID-19?

Symptoms tend to start between 2 and 14 days after coming into contact with the virus.  Although some people have compared the symptoms to a cold or flu, there are some differences. The CDC says that people with these symptoms or combinations of symptoms may have COVID-19:

  • Cough
  • Shortness of breath or difficulty breathing

Or at least two of these symptoms:

  • Fever
  • Chills
  • Repeated shaking with chills
  • Muscle pain
  • Headache
  • Sore throat
  • New loss of taste or smell

Those are the most common symptoms.  However, children or adults can have other symptoms as well, including heart problems and “covid toes” that look like a minor case of frostbite.

Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe.  These are the ones that require immediate medical attention:

  • difficulty breathing or shortness of breath
  • persistent chest pain or pressure
  • confusion or inability to awaken
  • blueish color in the lips or face

People who are older than 60, people with high blood pressure, and people who have existing serious health conditions, such as heart disease, lung disease, and diabetes, are more likely to develop severe illness and complications from COVID-19. This includes people who are receiving cancer treatments that can weaken the immune system.  The most serious complications include pneumonia, stroke, blood clots, organ failure, and death.

How can I protect myself and others?

The best way for anyone to protect themselves is to avoid being exposed to the virus. There are no proven cures or vaccines, so don’t be fooled by false claims (especially those made by telemarketers).  The one medication that has been proven to help very ill patients by reducing the number of days of hospitalization is remdesivir, which is not widely available and has not been proven to save lives. In one study, an inexpensive steroid, dexamethasone, has been found to reduce the chances of dying among COVID-19 patients on ventilators or those requiring oxygen, but not other patients.  Research is continuing to make sure those results are accurate.  Despite the hopes of the White House, experts now agree that hydroxychloroquine with or without azithromycin is not a good treatment for COVID-19 because it has been found to increase heart problems and has not been shown to prevent or treat COVID-19.

Another possible treatment is blood plasma from people who recovered from COVID-19.  A study of 20,000 hospitalized COVID-19 patients who received these transfusions early in their illness reported that it did not cause harm, but the study did not prove that the transfusions were beneficial.  Research is continuing to find out if this helps patients fight the disease.

“Social distancing” or “physical distancing” refers to staying away from other people because it is impossible to know who has the virus.  The safest people in your life are the ones you are living with who are not exposed to others who might have the virus (in other words, they are not going to work or spending time close to other people). Staying at home and not seeing your friends and loved ones is not fun, but it is essential for your own safety and for everyone else’s.  If everyone does that now, the spread of this virus will be reduced sooner, and some of these restrictions will no longer be necessary in a few weeks.

New research shows that face masks are important in helping to prevent the spread of the coronavirus.  The main protection of masks is not for the person wearing the mask, but rather for other people who come in contact with the person who wears the mask. Even if you don’t think you have the coronavirus, wearing a mask is important, because you might have the virus without knowing it, and because your wearing a mask reassures others who see you that you won’t infect them.  Bottom line:  masks reduce the spread of the virus, and help protect other people in addition to possibly protecting you.  Since most of us can’t get coronavirus tests every day, that’s especially important  to wear whenever you are out in public or with people you don’t live with.  But you should NOT be out in public or with people you don’t live with except when absolutely essential.  Even though some states have re-opened, that doesn’t mean it is safe for you to go to all the places that are open.  Especially avoid indoor areas where you are likely to be close to others for more than a very short period of time (15 minutes) or whose workers are close to many other people, such as a tattoo parlor, hair or nail salon, restaurant, or movie theater.  If you must go to a store, try to go to one that makes appointments with customers or limits the number of customers, and spend less than one hour indoors to reduce exposure to any coronavirus that is in the air.

In summary:

  • stay at home or go outside in your yard or neighborhood where you can keep at least 6 feet away from others
  • avoid public spaces where there are other people, especially indoors
  • avoid public transportation and unnecessary travel
  • avoid all social gatherings that are indoors or where people are close together
  • work from home
  • stay at least 6 feet away from people when out in public (indoors or outdoors)
  • avoid physical contact in social situations, such as shaking hands, hugging or kissing

AND

  • wash your hands using soap and water for at least 20 seconds, especially after being out in public
  • use alcohol-based hand sanitizer when soap and water aren’t available (or wash your hands as soon as you get home)
  • avoid touching your face when your hands aren’t clean or you are out in public
  • avoid contact with people you don’t know very well
  • put the toilet seat down before flushing in a shared or public bathroom
  • clean and disinfect surfaces you touch daily, including things you might not think of like doorknobs, light switches, faucet handles, and phones. Make sure you use a cleaning agent that is effective for killing viruses.

If you have a weakened immune system or other serious health problems, here are extra steps to protect yourself:

  • Make a plan with your doctor to monitor for symptoms
  • Avoid friends and family except those you live with or depend on for essentials.  Otherwise, rely on your phone to maintain contact.
  • Have a plan with your loved ones or caregiver if you or they get sick
  • Have the medications you rely on and order any you need in advance (to be delivered, if possible)
  • Ask a friend or family member to shop for groceries for you
  • Wash your hands (20 seconds with soap and water) even more often if you are exposed to others

What should I do if I develop symptoms?

If you develop more than one of the symptoms listed above, call your doctor.  If you have severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. Do not just show up at the doctor’s office with symptoms:  Call them first so you have tell them about your symptoms and any other health problems so that they can help decide what to do.  If you do become sick, you can take the following steps to protect others:

  • Stay home, unless you need essential medical care
  • Wear a facemask when you are near others.  (People caring for you should also wear a facemask).
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one or two weeks have passed since you first noticed symptoms or your fever goes away for 3 full days without fever-reducing medicine.  If you have been diagnosed with COVID-19 based on test results, you should follow these steps until you have 2 negative test results taken 24-hours apart, your fever goes away without fever-reducing medicine, and your symptoms improve.

What if my other scheduled medical treatment is delayed?

When a person is diagnosed with a serious disease, they are likely to want treatment as soon as possible. If you don’t have COVID-19, you don’t want to be exposed to it during surgery, testing, or follow-up appointments. Treatment or testing may seem more urgent than it really is, but it is definitely more important than going to a restaurant, store, or beach.  Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@center4research.org and we’ll get back to you as soon as possible.

CPTF’s Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting

Cancer Prevention and Treatment Fund: February 26, 2020


Cancer Prevention and Treatment Fund’s Public Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting

Thank you for the opportunity to share our views today. The Cancer Prevention and Treatment Fund understands the need for effective new treatments for metastatic lung cancer. However, the data provided by the sponsor does not provide evidence that Cyramza improves survival, and it may worsen quality of life.

Although there are not yet enough long-term data to determine how Cyramza affects patients’ survival, the data that are available are not promising. Survival rates are almost identical with the drug or placebo (HR 0.92). It is important to note that the survival rates were never significantly different, but the difference was smaller as longer-term data were analyzed. We agree with the FDA that based on the confidence intervals, the drug could potentially worsen survival by about 30% — or could possibly improve survival by 30%. That risk of shortening overall survival is especially important because of the other risks of the treatment.

Let’s look at the number of deaths that occurred within 30 days of treatment in the RELAY trial. Of the 221 patients taking Cyramza, 6 died from adverse events, compared to none in the placebo arm. FDA specified that one of these was caused by drug treatment, while a second may have been caused by the drug. Although the FDA agrees with Lilly’s assessment that the other deaths are not caused by the drug or drug combination, those data aren’t made available so we can’t draw conclusions. But even if it is only 2 deaths, that’s almost 1% of the patients – not an irrelevant number! Since this shows that Cyramza can be fatal for these patients, and there is no currently no evidence that it significantly increases overall survival on average for lung cancer patients, the FDA expressed a great deal of concern about this indication. If Cyramza benefits any specific types of patients in terms of overall survival, there is no evidence of who those patients are likely to be.

Patients treated with Cyramza had a 7 month improvement in progression-free survival. This may be meaningful to patients if it is also associated with an improvement in quality of life. However, the data from the RELAY trial do not support this.  The sponsor spins these results to conclude that the quality of life of life is not worse in patients taking Cyramza, but in fact, patients in the placebo group had fewer symptoms, such as shortness of breath, pain, and daily activity level, as measured by the Lung Cancer Symptom Scale. Our Center has worked with many seriously ill patients over the years, and we’ve found that
patients care about two outcomes: 1) will they live longer and 2) what will their quality of life be in the days, weeks, months, or years they have left. The only patients that care about progression free survival are the ones that don’t understand what it means. When patients are told a drug is promising based on progression free survival, it is confusing and frankly misleading to most patients. They think it means they will live longer.

The results of the research are also worrisome regarding the FDA’s measures of specific adverse events. 72% of patients treated with Cyramza experienced a grade 3 or higher adverse events compared to only 54% of patients treated with placebo.

  • 29% of patients treated with Cyramza experienced a serious adverse event compared to 21% of placebo-treated patients.
  • Bleeding and hemorrhage occurred twice as often in patients treated with Cyramza,
    compared with placebo.
  • Grade 3 hypertension was roughly 5x more common among those treated with Cyramza compared with placebo. Overall hypertension was roughly 4x as prevalent among the Cyramza group.  I disagree with the sponsor’s assertion that hypertension is no big deal. In fact, heart disease is the #1 killer of men and women in the U.S. and hypertension is called “the silent killer.” Yes, there are medications for it, but they also have side effects that can be debilitating.

Overall, the study’s results suggest that when Cyramza is combined with erlotinib and compared with placebo plus erlotinib, the potential benefits of Cyramza do not outweigh the known risks. Given the data provided, there is no justification for rushing to approve this particular treatment.

We respectfully request that you advise FDA to not approve this indication for Cyramza without evidence that it improves overall survival enough to outweigh the risk for adverse events and reduced quality of life.

After FDA’s Cancer Director Dr. Richard Pazdur instructed the Advisory Committee at length that progression free survival was acceptable evidence for approval even if there was no evidence of overall survival, and even if more effective treatments were already available, the Advisory Committee voted 6 in favor of approval and 5 opposed.

The Cancer Prevention and Treatment Fund can be reached at info@stopcancerfund.org or at (202) 223-4000.

Drugs to Quit Smoking Can Affect Mental and Physical Health: the Truth About Chantix and Zyban


Everyone knows that smoking harms health and that the habit is difficult to quit. Unfortunately, some products that help people stop smoking can also be harmful – perhaps too harmful to consider using.

In June 2011, the U.S. Food and Drug Administration (FDA) announced new concerns about the safety of Chantix. Their announcement came in the months after two reports by independent researchers that there were more reports of deaths and violence from taking Chantix than any other drug.[1]

These reports added to concerns about two stop-smoking drugs, Chantix and Zyban. In July 2009, the FDA had already announced “black box” warning labels on both drugs. A “black box” warning is the FDA’s most serious caution and indicates that a drug carries significant health risks.  The black box warnings for Chantix and Zyban warn of the mental health risks associated with their use, which can include changes in behavior, depressed mood, hostility, and suicidal thoughts.[2]

These warnings were recommended as the result of information gathered from clinical trials, as well as a series of reports to the FDA’s Adverse Event Reporting System. Zheng-Xiong Xi, MD, PhD, a researcher at the National Institute on Drug Abuse, found that Chantix was associated with incredibly dangerous side effects in many individuals, including suicide attempts and seizures, as well as psychosis, depression, and serious injuries resulting from dizziness, loss of consciousness, movement disorders, and visual disturbances.These problems have been noted among individuals with a history of mental illness but also have occurred among individuals with no prior history of mental illness.[3]

Analysis from reports to the FDA’s Adverse Event Reporting System similarly shows that some people who used Chantix and Zyban began experiencing changes in behavior, depressed mood, and suicidal thoughts shortly after starting the medication. The symptoms usually ended shortly after the medication was stopped, but some people still reported symptoms after stopping the medications, while still others did not even begin developing the symptoms until after they stopped taking the drug.

Neither Chantix nor Zyban contains nicotine, unlike other smoking cessation aids such as chewing gum and the patch. Nicotine withdrawal can also cause mental health problems similar to those caused by Chantix and Zyban, such as depression, anxiety, irritability, restlessness, and sleep disturbance. However, the mental health risks of these two drugs far exceed the symptoms suffered by people with nicotine withdrawal.

Zyban is another name for Wellbutrin, an anti-depressant. Its marketing as a smoking-cessation drug came about after researchers noticed that smokers who took Wellbutrin for depression had less desire to smoke. GlaxoSmithKline carried out additional research in order to get approval to sell Wellbutrin under a different name as a medication to quit smoking. However, like most anti-depressants, the pills–whether they are called Wellbutrin or Zyban–can cause an increase in suicidal thoughts.  Antidepressants have carried black box warnings about suicide risks since 2004.

Chantix: News about increased risk of suicide, violent behavior, and other mental health problems

From the approval of Chantix in May 2006 until July 2009, the drug was linked to reports of approximately 100 suicides, 200 suicide attempts, and almost 5,000 serious psychiatric events. Doctors are not required to report deaths or serious complications to the companies that make the medication or the FDA, although drug companies are required to do so.  Because most doctors don’t report, it is assumed that the numbers are much higher and that those problems have continued since 2009.  In fact, in May 2011, the Institute for Safe Medication Practices (ISMP) revealed that hundreds of cases of suicides, psychotic reactions, hostility, aggression and other serious problems tied to Chantix had not been properly reported to the FDA by Pfizer, the drug’s manufacturer. Among the 589 delayed reports of severe problems, there were more than 150 suicides-almost doubling those previously known.  Thomas J. Moore, the ISMP senior scientist who analyzed the data, stated that, based on the FDA’s adverse event reports, Chantix is the riskiest of all drugs sold in the U.S. In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities recorded as any other drug.[1]

The discovered reports coincide with a study by Moore released in December 2010 examining all of the most serious adverse drug events reported to the FDA since 1968. Chantix had the largest number of reported cases of violence (408).[1]

A large 2011 study found that Chantix was 8.4 times more likely to lead to suicide or self-injury compared to nicotine replacement products like nicotine gum or patches. There were 1,818 reported cases of suicidal thoughts or behavior for Chantix and only 50 for nicotine replacement products.[4]

Increased risk of heart attack for patients with cardiovascular disease

Research has shown that these stop-smoking drugs affect not only mental health, but can also jeopardize physical health. In June 2011, the FDA warned that Chantix may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. After reviewing a randomized clinical trial of 700 smokers with stable cardiovascular disease, the FDA found that certain events, including heart attacks, were reported more frequently in patients treated with Chantix than in patients treated with placebo (2.0% vs. 0.9%).[5]

Do the risks outweigh the benefits? NCHR says YES

Quitting smoking is usually a step towards improving one’s health, but doing so at the risk of mental or heart health is not a good compromise.  Instead, there are other, safer ways to quit smoking.

The unreported deaths and serious injuries for people taking Chantix raises questions about whether other information is being withheld. Since most doctors don’t report adverse reactions to the FDA, it is likely that Chantix has caused many more deaths and injuries than reported. For that reason, we believe that Chantix is not a safe choice. At the very least, the mental health of anyone taking Chantix or Zyban should be closely monitored by a healthcare professional. Additionally, if you have a history of cardiovascular disease, consult your doctor before taking Chantix, and if you experience new or worsening symptoms of cardiovascular disease, contact your doctor immediately.

If you or someone you know is trying to quit smoking, be aware of the symptoms associated with quitting, and if symptoms develop, a healthcare professional should be consulted.

Controversy Over Black Box Warning

In 2014, the makers of Chantix lobbied the FDA to remove the black box warning on the drug, citing a meta-analysis, an observational study of hospital records, and reported adverse events to argue that dangerous side-effects were not as common as previously believed. However, we question the results of the meta-analysis, since many studies on Chantix were excluded.

Meta-analysis is a valuable tool, but its accuracy depends on the quality of each study and whether they fit together. The five studies included in the meta-analysis consisted of one study of schizophrenics, one study of depressed patients, and 3 studies of mentally healthy patients. It is important to study schizophrenics and depressed patients, but those data should not be analyzed together with 3 studies that exclude such patients.

To consider the implications of studies that claim to show that Chantix does not have serious psychiatric side effects, it is important to realize that most people with acute psychiatric side effect from medication do not end up in hospitals or the ER. Psychiatric side effects are often not reported in medical records. Because psychiatric commitment laws depend on acts of violence, not threats of violence, many people with dramatic psychiatric symptoms end up in jail, not in hospitals. In fact, some studies show that there are more mentally ill individuals in the criminal justice system than in psychiatric facilities.

Removal of Black Box Warning

After hearing the testimony about these shortcomings from NCHR President Diana Zuckerman and numerous other experts, the FDA decided to keep the black box warning on Chantix in 2015. However, in response to industry pressure, the FDA removed the black box in 2016[6], and the warnings that were in the black box are now part of the label under a heading of “Warnings and Precautions” for both Chantix and Zyban.[7, 8] Thus, although the official black box warning for Chantix has been removed, there are still warnings on their labels about the psychiatric risks of Chantix and Zyban. In addition to the label, which most patients do not read, the Medication Guide listed on the Chantix manufacturer’s website warns of the potential side effects of “New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions.”[9] These warnings are also on the home page of Chantix.com. Zyban has a black box warning about suicidal thoughts, and warnings similar to Chantix on the label and medication guide.

Below are the current “Warnings and Precautions” listed for Chantix and Zyban:

Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider if they experience such adverse events.

Neuropsychiatric adverse events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with ZYBAN for the occurrence of such symptoms and instruct them to discontinue ZYBAN and contact a healthcare provider if they experience such adverse events

Below are the previous black box warnings for both Zyban and Chantix:

ZYBAN:

Serious neuropsychiatric reactions have occurred in patients taking ZYBAN for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking ZYBAN who continued to smoke.

CHANTIX:

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family or caregiver notice agitation, hostility, depression or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Additional Resources:
Chantix Citizen Petition
Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix
Quitting smoking: women and men may do it differently

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

  1. Moore TJ, Glenmullen J, Furberg CD (2010) Prescription Drugs Associated with Reports of Violence Towards Others. PLoS ONE 5(12): e15337. Retrieved 27 May 2011 at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015337
  2. U.S. Food and Drug Administration. “Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban.” Press release. FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban. 1 July 2009.
  3. Xi ZX. Preclinical Pharmacology, Efficacy and Safety of Varenicline in Smoking Cessation and Clinical Utility in High Risk Patients. Drug, Healthcare and Patient Safety. 2010;2:39-48. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21278851
  4. Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. (2011) Suicidal behavior and depression in smoking cessation treatments. PLoS ONE 6: e27016.
  5. U.S. Food and Drug Administration. FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease. 6 June 2011. Retrieved 6 July 2011 at http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm
  6. FDA. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. FDA.gov. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-description-mental-health-side-effects-stop-smoking. December 16, 2016. Updated March 8, 2018.
  7. Chantix. [Package Insert]. New London, CT: PF PRISM CV; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf
  8. ZYBAN. [Package Insert]. Brentford, United Kingdom: GLAXOSMITHKLINE; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020711s048lbl.pdf
  9. Chantix. [Medication Guide]. New York, NY: Pfizer; 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=557&section=MedGuide

Report Claims More Women than Men Injured by Medical Devices

The ICIJ used the Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database to conduct the research. This data is publicly available and contains eight million reports which have been filed by doctors, patients and manufacturers when a medical device is suspected of putting someone at risk, causing injury or resulting in death.

Steps had to be taken to identify the gender of those within the database as although the FDA gathers information on the sex of patients, this data is not made publicly available. Therefore, in order to overcome this obstacle, the ICIJ realised that the sex of patients was sometimes disclosed through pronouns and adjectives within the incident reports submitted to the FDA.

The ICIJ group followed four steps to identify the gender of those in the FDA MAUDE database:

1. Generate a set of labels

This stage involved classifying patient sex in 1,000 incident reports from the MAUDE database. Patient sex was classified as female, male or unknown.

2. Assign rules to the computer

The group used rules to train the computer to conduct automatic sex classification on the data.

3. Validate the results from the computer

Humans looked at the results from the computer and implemented additional rules to improve the quality of the results.

4. Run the code against all of the data in the FDA Maude database

Using 1997-2017 (the same time frame as the Implant Files investigation), the computer assigned a gender to 23% of patients with 96% accuracy.

The ICIJ claim that the algorithm created using the above steps was able to positively identify the sex of the patient in more than 340,000 injury and death cases. These findings reported 67% of these people were women and 33% were men.

Talking about the findings, the ICIJ stated: “The trend we noticed is consistent with studies that have shown that women experience higher rates of hip-implant failure than men and have stronger immunological reactions to metal-containing devices.”

Other experts within the industry were keen to voice their opinion over the importance of looking at the effects of medical devices on different genders. Diana Zuckerman, president of the National Center for Health Research commented: “Having information about sex is very important because some products differ in safety between men and women.”

Madris Tomes, founder and CEO of Device Events and a former FDA manager described the ICIJ’s work as critical. Tomes said: “It has long been unclear why the FDA’s device division redacts data elements that are so vital to scientific study…age, sex, and even the outcome of the adverse event are redacted by the device division but not the drug division.”

“But, if we are to look at allergy and autoimmune issues (presented in the FDA Immunology panel’s meeting on Metals in Implants) resulting from the metals and polymers in the hips, this could provide a second reason why the revision rates for women is higher than it is for men. It is an area where more research is necessary, and it shows the need for the FDA to un-redact fields which are so important for patients, physicians and hospitals to evaluate the safety of devices”, she added.

This report is part of the well-known Implant Files, which began from a report on medtech adverse events last year.

Read original story here.

NCHR Testimony on Research Needed on Immunological Responses to Metal in Implants

Diana Zuckerman, PhD, National Center for Health Research, November 13, 2019


Thank you for the opportunity to speak at this Advisory Committee meeting today regarding immunological responses to metal in implants.

The National Center for Health Research is a nonprofit research center that focuses on the quality of medical products and procedures and does not accept funding from medical device companies or pharmaceutical companies. I’m here today to share my perspective as a scientist as well as a patient.  I am trained in epidemiology and served on the faculty at Vassar and Yale and as a researcher at Harvard.  I’ve also worked in the U.S.  Congress on FDA issues and as president of the National Center for Health Research I have  a great deal of experience with FDA regulatory issues.

In addition, I got a hip implant 10 years ago, and I’m glad to say my experience has been a very good one.  But at the time I was deciding on the surgery, neither the surgeons I interviewed nor the research literature provided the kind of information I needed to make an informed choice.  In fact, one surgeon recommended a metal-on-metal hip for me because I was relatively young and active.  Fortunately, I was already aware of metal debris issues so I did not make that choice.  But the lack of information then and now was very clear to me as a patient.  I was not able to obtain scientific data from the surgeons or online, including PubMed.

I want to say that this has been one of the most interesting and informative FDA meetings I’ve attended, and the speakers have provided a great deal of important information.

What Research is Needed?

I’m here to talk about the big picture.  We’ve heard this morning about a great deal of research findings and the need for more and better research.  I want to emphasize that we need much better pre-market studies, not just post-market studies.  Pre-market clinical trials are often lacking because of the 510(k) process, but even when premarket clinical trials are conducted, they are often inadequate to provide the information patients deserve.

We need clinical trials and other well-designed studies of large number of patients, and as one of the speakers said this morning, we need to compare information about patients who have good experiences with their implants with those who do poorly with their implants.  These studies need to include a patient population with sufficient diversity in terms of age, sex, race, BMI, activity levels, allergies, and metal sensitivity, to determine how safe and effective the products are for these subgroups.

We need clinical trials and big data analyses that follow patients for years in order to evaluate the effects of wear and changes in immune responses over time.

We heard this morning that patch testing is inadequate to identify which patients will have a negative reaction to an implant, and that other diagnostic testing also has limitations.

I also want to express our concern with the tendency to extrapolate results from an implant used in one part of the body to implants made of the same materials that are intended to be used in another part of the body.   We know from listening to patients that this can result in terrible problems.

We are also concerned about extrapolating results from an earlier version of an implant to a newer implant, when the newer implant differs in ways that could affect safety and effectiveness.  Those differences might be different metals, changes in size or shape, differences in manufacturing, or numerous other changes typically made in an effort to improve implanted devices.

We encourage the FDA to require that studies specifically look for adverse events that are related to immune reaction or wear.  These adverse events might be local or might be systemic, and some of these events would not necessarily be included in studies asking about all adverse events.

Perhaps most important, we need comparative effectiveness studies that compare clinical effectiveness and patient-centered outcomes.  I know that the FDA rarely requires comparative effectiveness studies, but those are the types of studies that are most likely to provide useful information for patients and their physicians.

If certain implants seem to be causing certain reactions with certain kinds of patients, wouldn’t it be very important to know how that compares to other alternatives of the same kind of implants? We can’t treat all hip implants that are polyethylene and metal as if they’re all the same.  We can’t treat all metal-on-metal implants as if they’re the same. We need to compare different models, different implants made in different ways with different materials by different companies and get the kind of real data that patients and physicians can use to make informed decisions. Until then, it won’t be possible to figure out to what extent negative responses and implant failures are due to patient vulnerabilities or sensitivities and how much is due to the difference between various devices.

For more information about this public meeting, read these articles here or here.

Teens Are Being Hospitalized After Vaping: Here’s What We Know So Far

Parents, Yahoo! Lifestyle: August 27, 2019.


Last month, a 17-year-old from Texas named Tryston Zohfeld‘s lungs suddenly failed. He was rushed to Cook Children’s Hospital in Fort Worth, Texas and put into a medically-induced coma while the situation only worsened. X-rays found that the teen had a total blockage of his lungs. Ruling out diseases like pneumonia, doctors finally concluded that the lung inflammation and inability to exchange oxygen and carbon dioxide Zohfeld was experiencing had been brought on by chemicals the teen had been inhaling from his vape pen, which he had been regularly using since 8th grade.

While Zohfeld was grateful to be released from the hospital after an 18-day stay, his story is just one of several cautionary tales related to vaping and e-cigarettes that are making headlines nationwide. A 20-year-old from Utah named Alexander Mitchell was recently “on death’s door” after his lungs failed. The young man had been using e-cigarettes. Also this summer, 18-year-old Chance Ammirata’s lung collapsed. The Miami student admitted to vaping about one Juul pod every two days (roughly the equivalent of 10 cigarettes-worth of nicotine a day) for a year.

Now, the U.S. Centers for Disease Control and Prevention (CDC) is conducting an ongoing investigation into cases like these. Here’s what you need to know.

[…]

The Dangers of Vaping for Teens

With hope, the ongoing CDC and FDA investigations will offer parents more answers about the link between e-cigarette use and lung disease, but in the meantime, experts are noting that teens are an especially vulnerable group.

Diana Zuckerman, PhD, president of the National Center for Health Research told CBS News, “It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke.” She explained that a young person’s size might be a factor in how they experience the effects of the chemicals, noting, “The same amount of vaping for a child that weighs, say, 100 pounds, is a bigger issue than for somebody who weighs 200 pounds.”

At the same time, e-cigarettes that include nicotine put teens at risk of addiction, which amplifies their risk of illness. Teens who use nicotine can become addicted in just days. Yale Medicine pediatrician Deepa Camenga, M.D., says that nicotine affects teens differently than adults because “teens are just more vulnerable than adults are to developing an addiction to nicotine. As a result, it may be harder for teens to stop because their brain is still growing and developing.”

Potential Lung Damage Symptoms from Vaping

The CDC notes that “in many cases, patients reported a gradual start of symptoms” including:

  • breathing difficulty
  • shortness of breath
  • and/or chest pain before hospitalization
  • in some cases, mild to moderate gastrointestinal illness including vomiting and diarrhea and fatigue

People who experience illnesses after vaping are encouraged to report the incident to the FDA here.

 

Read the original article here.

Sample Vaping Letter

If you’re concerned about the epidemic of e-cigarettes and vaping, contact your two U.S. Senators to let them know how you feel!  A sample letter is below.  Here is a link to find the names and contact info for your senators.


Dear Senator_____:

I am very concerned about the dangers of e-cigarettes and I am writing to ask you to require that Congress address this serious epidemic.  Action is urgently needed since the Centers for Disease Control and Prevention (CDC) is investigating reports that more than 250 people, including many teenagers and young adults, have suffered harm and in some cases, hospitalization because of lung injuries from vaping.

One man in Illinois has died and vaping is strongly suspected as the cause of his fatal illness.

Scientists are studying whether certain brands of e-cigarettes are most likely to be harmful, and whether the lung damage is caused by the chemicals, contamination or other causes.  Meanwhile a range of vaping products are widely sold and teens and adults are being seriously harmed.

In 2016, the Food and Drug Administration’s (FDA’s) Center for Tobacco Products (CTP) issued regulations aimed at restricting access to e-cigarettes and requiring studies of their risk.  The regulations were supposed to go into effect in 2018, but were delayed.  Meanwhile, the FDA has failed to require the companies to prove that their products are safe.

The industry and the scientists they have hired claim that vaping helps people to quit smoking, but that has not been proven.  Meanwhile, we now know that vaping can cause serious lung damage in just a year or two.  That’s faster than cigarettes, which generally take decades to cause serious harm.

After initially delaying the regulation of e-cigarettes for 4 years, the former FDA Commissioner, Dr. Scott Gottlieb, modified his views, calling vaping an epidemic, and vowed that the agency would take appropriate action.

Please become a co-sponsor of the SAFE Kids Act (S. 655), which would ban most flavoring from e-cigarettes.  These flavors are a major reason why children like to vape.  In addition, please contact the FDA and urge the agency to immediately restrict the marketing of e-cigarettes and require that these devices be drastically restricted until the companies submit conclusive safety data through the PMTA process.  The current delay is harming unknown numbers of teens and adults.

  Sincerely,

Teens Are Being Hospitalized With Lung Damage From Vaping At An Alarming Rate

Emily Reily, Yahoo! Entertainment: August 14, 2019.


A surprising number of teens are suffering from lung damage, and it appears to stem from vaping.

Young Adults Getting Lung Damage

Several cases of severe lung damage were reported in Wisconsin last month, and it’s got medical professionals talking.

“It’s mind-boggling. I’ve never heard of a smoker ending up in the hospital in their teens,” says Dr. Diana Zuckerman, president of the National Center for Health Research.

We Have Evidence Now

And we have real, concrete examples of lung damage in young people.

A teen who said he vaped one Juul pod every two days for a year eventually suffered a collapsed lung.

“He didn’t have the symptoms that might have warned him that something was wrong — until something was really terribly wrong,” added Zuckerman.

[…]

Studies Confirm E-Cigs Are a Bad Idea

The journal “Pediatrics” published a study last year on e-cigarettes, noting that there is a slew of toxic chemicals in them. Some of those chemicals are linked to cancer.

“It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke,” adds Zuckerman.

Read the original story here.

Allergan Breast Implants Linked To Cancer Recalled After FDA Request

Lauren Dunn, NBC News: July 24, 2019.


Following a request from the Food and Drug Administration, Allergan is recalling its textured breast implants worldwide, the company said Wednesday.

The move comes after 38 countries already recalled the implant because of the higher risk of anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system.

[…]

The recall is “a very important step” toward reducing this type of lymphoma, women’s health advocate Diana Zuckerman said.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman, president of the National Center for Health Research, said in a statement. “This recall will reduce that risk but it won’t eliminate it, because not all women with BIA-ALCL had these specific types of implants.”

Last November, NBC News, along with its partner, the International Consortium of Investigative Journalists, found that BIA-ALCL is an emerging risk for women with textured implants.

In March, the FDA said BIA-ALCL is most likely caused by textured breast implants, which have a suede-like coating. But the agency stopped short of taking the implants off the market, noting it wanted to continue studying the disease and tracking cases. It’s estimated that of the 400,000 women in the United States who get breast implants each year, about 1 in 10 has textured implants.

Read the full story here.