Tag Archives: breast cancer

Trump Administration Censoring Women’s Health Info on Government Sites

Without much fanfare, valuable health information is being scrubbed from government websites.

Haven’t heard about this? That’s because it hasn’t gotten the press it should. While much media attention is spent on the Trump administration’s position on DACA or the latest trade agreement, the administration’s systematic withdrawal of health content – especially women’s health – from Health and Human Services run websites is a serious danger that can potentially harm patients.

In its THIRD report on censorship at the Office of Women’s Health, the Sunshine Foundation found that office’s breast cancer website and a page on reproductive health organization is now gone. If you try to go to either one, it redirects to a different page.

So, why is the administration doing such a thing? Good question. A spokesperson for HHS recently told ThinkProgress the following:

“The pages were removed on December 6, 2017 because content was not mobile-friendly and very rarely used. Before we update any of the information…we engage in a comprehensive audit and use analysis process that includes reviewing other federal consumer health websites to ensure we are not duplicating efforts or presenting redundant information.”

I find this information hard to believe considering breast cancer is the most common cancer among women. Also, this isn’t the first time the administration has launched a salvo against health information that it apparently finds objectionable for some reason.

Back in December, the administration informed officials at the Centers for Disease Control and Prevention – part of HHS – of a list of 7 prohibited words and phrases not to be used in documents for the agency’s budget request. And those words and phrases? “Vulnerable,” “entitlement,” “diversity,” “transgender,” “fetus,” “evidence-based” and “science-based.”

If this all sounds ridiculous, it’s more than that – it is deplorable, a word the administration is all too familiar with. But instead of getting angry, do something about this.

Contact HHS Secretary Alex and let him know you won’t stand for this kind of dangerous censorship. His email is Secretary@HHS.gov and phone number is 202-690-7000. And if you want to tell him via President Trump’s favorite medium, Twitter, Azar’s handle is @SecAzar.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

First At-Home Genetic Test For Breast Cancer Risk Approved

The FDA has approved the first at-home genetic test for breast cancer risk. For the first time, the agency authorized 23andMe’s test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews.

After DNA analysis from a self-collected saliva sample, the results then detail whether a woman is at an increased risk of developing breast and ovarian cancer and whether a man is at an increased risk of developing breast or prostate cancer. It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations. Furthermore, only a small percentage of Americans carry one of these 3 mutations. Most breast cancer mutations that increase a person’s risk are not detected by this test.

Therefore, you are not completely out of harm’s way if you test negative for the 3 mutations. Due to the mentioned caveats, the agency indicated that patients should not solely rely on this test, nor should the test be used to determine a cancer treatment. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn’t account for every possible outcome.

Alanna McCatty
Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

What Could Be Bad About an At-Home Test for Breast Cancer Risk?

If you could take a test and have it determine whether you are at an elevated risk for developing breast cancer, who wouldn’t want to know such valuable information? And what if you could do it in the comfort of your home, without a prescription? That’s the crux behind 23andMe’s at-home genetic test, which the FDA just approved yesterday.

While at first glance the test seems like a real breakthrough and a new tool in the fight against cancer, the reality is that its impact will likely be more muted. And even worse, it could give some people a false sense of security and others a cause to worry for no good reason.

One of the test’s biggest appeals is that it is easy. Spit in a small tube, then send it back to 23andMe, which will examine the saliva for variants in 2 genes, BRCA1 and BRCA2. The presence of those variants is associated with a significantly higher risk of breast and ovarian cancer in women, and breast and prostate cancer in men, according to the company.

Before you go to 23andMe’s website to order a test, there are a few things you should know. The variants that are associated with the higher risk of cancers are most common in those of Ashkenazi Jewish descent. So if you are not an Ashkenazi Jew, there’s little reason for you to have the test done. Second, it only tests for 3 mutations that may cause cancer, even though there are far more, a point not lost on the FDA.

“The test only detects three out of more than 1,000 known BRCA mutations,” the agency said in a news release. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.”

A larger problem I see with this kind of test is that it eliminates the role of a physician to properly interpret the results and provide guidance for the patient. Many who have the test done and find they don’t have the mutations may get a false sense of security that they won’t get breast or ovarian cancer. On the other hand, those who find they do have the mutations may needlessly worry – having the mutation does not guarantee you will get cancer.

While the decision to have any genetic test is up to the individual, this new at-home variety brings with it a host of caveats. A test can tell you a lot of things, but not everything, which is why it’s best to meet with a doctor when it comes to any serious health issues.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

Quick Hits: Penicillin Allergies and Surgical Infections, FDA Okays Drug for Metastasized Breast Cancer & More

Patients who were reported to be allergic to penicillin were 50% more likely to experience surgical site infections (SSI), according to a study by Massachusetts General Hospital. Researchers examined 8,385 patients who underwent 9004 different procedures from 2010 to 2014 including hip and knee reconstruction, hysterectomy, colon surgery, and coronary artery bypass. Out of those patients who underwent surgical procedures, 922 (11%) reported a penicillin allergy, and 241 (2.7%) had an SSI. Posted October 9, 2017. Via Clinical Infectious Diseases.

The opioid addiction medicines buprenorphine and methadone can be given to patients that take tranquilizers such as benzodiazepines and other drugs that impact the central nervous system (CNS), according to an FDA review. Although the agency says that combining the use of drugs containing buprenorphine and methadone (e.g. Subutex, Bunavail, Suboxone and Diskets) with benzodiazepines such as Xanax (aloprazolam), Klonopin (clonazepam) and Ativan (lorazepam) or CNS depressants can increase serious side effects, the risk of opioid abuse outweighs these risks.

However, the FDA notes that patients should be made aware by their doctor of the increased risks –- including overdose and death — of combining opioid addiction drugs with CNS depressants, which also includes sleep drugs such as Ambien (zolpidem), muscle relaxants and antipsychotics, such as Abilify (aripiprazole) and Seroquel (quetiapine). Doctors should also work with patients to manage use of benzodiazepines and CNS depressants when starting opioid addiction therapy, and look at tapering use of those drugs as well. Posted Sept. 25, 2017. Via FDA.

The FDA has approved Verzenio, a new medication that will treat a common type of breast cancer after it spreads to other parts of the body. According to the FDA, “In the study, 19.7 percent of patients taking Verzenio experienced complete or partial shrinkage of their tumors for a median 8.6 months.” Patients should be cautious when using this new drug because it is associated with serious side effects including diarrhea, neutropenia, elevated liver blood tests and blood clots. The FDA also warns that pregnant women should avoid taking Verzenio because it may harm a developing fetus. Posted September 28, 2017. Via FDA.

Alanna McCatty
Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.

 

Alanna McCatty
Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

Mammogram Pros and Cons (Yes, There Are Cons)

Mammogram Pros: They save lives. Mammograms are estimated to reduce cancer rates by 15%. Translated, that means that over a 10-year period if 2,000 women get screening mammograms, 1 will have her life saved.

Mammogram Cons: They cause significant harm. Over those same 10 years, of those 2,000 women 10 will undergo treatment for no reason — because of a cancer that never would have grown. Further, 200 of those 2,000 women will “experience important psychological distress including anxiety and uncertainty for years because of false positive findings,” according to a Cochrane review on breast cancer screening with mammography published in 2013.

These pros and cons apply to screening mammograms, which are those conducted on healthy women with no symptoms or history of breast cancer.

The overtreatment of breast cancers might be acceptable if the treatment was simple, low cost and reasonably pain-free. However, that is not how cancer care is today. Cancer treatment is a life-altering invasion of women’s bodies that can harm nearby organs, increase her risk for a secondary cancer and make it more difficult to treat an actual or secondary breast cancer.

A new research paper based on a national survey just published in JAMA shows just how skewed women’s perceptions of the benefits and harms of mammograms are.

When asked, more than 90% of women knew the 4 benefits of mammograms listed in a recent study. The benefits were (in no order) that mammograms can:

  • Save lives: 92% had heard this before and 66% called it “very Important”
  • Lead to earlier treatment: 96.2% had heard before and two-thirds called it “very Important”
  • Peace of mind: 92.2% had heard this before and 56.5% called it “very Important”
  • Find cancer early: 91.2 had heard this before and 65.9% called it “very Important”

Looking at the 7 questions about mammogram harms, I found a very different picture. Fewer women knew there were potential harms and the women ranked them lower.

  • Some breast cancers found by mammograms are treated with potentially risky surgeries or meds that would not have needed such treatment after all. 39.7% had heard of this before and 28.7% said it was “very Important”
  • Some breast cancers that are found by mammograms are so slow-growing that they would not have caused any health problems for women in their lifetime. 26.5% had heard of this and 21.5% called it “very Important”
  • Women who receive positive mammogram results, even if eventually it turns out they do not have cancer, may feel anxious and stressed. 77.6% had heard before and 23.5% found this “very Important”
  • Mammograms, like all x-rays, expose women to very small doses of radiation, which could increase risk for cancer. 67.4% had heard of this and 19.6% said it was “very Important”
  • Mammograms can find something that looks like cancer but eventually turns out not to be cancer. This is called a “false-positive” or “false alarm.” 75.4% had heard before and 23.4% called it “very Important”
  • Mammograms can lead to increased costs to women because of follow-up tests and procedures. 50.1% had heard this before and 18.8% said it was “very Important”
  • Mammograms can lead to increased costs to the health care system because of follow-up tests and procedures. 42.7% had heard before and 15.1% said it was “very Important”

Needing Few Slogans, More Science

The benefits of mammograms can by synthesized down to 2-3 word slogans like “Mammograms Save Lives” which is true, but it’s also true that “Mammograms have risks of harms.”

Face it, everyone knows someone who has had a breast cancer diagnosis. Between the education campaigns, the pink ribbons and the walks, the fear and loathing of breast cancers surround women and create an atmosphere of mammogram worship. “If I get a mammogram,” I think to myself, “then I won’t die of breast cancer.” Unfortunately, that’s not true. Some breast cancers are too aggressive and virulent to control or “beat,” no matter how early caught.

Somehow the message in America has changed from “Mammograms might help find cancer at a time when medicine can fight it,” to “If you get a mammogram every year you can prevent or avert breast cancer.” And that’s silly. At this point we don’t understand how and why breast cancer occurs so we can’t promise anyone that anything you do will let you avoid it.

It’s a challenge in a world of threats to maintain rationality instead of placing undue faith in a screening program that has plenty of flaws. It may be the best we’ve got, but after 30 years of “early detection saves lives,” don’t we deserve better? How about a screening program that can detect the difference between a cancer or pre-cancer that is a danger and those cancers that will never grow into a threat?

Suzanne B. Robotti
Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.

‘Cooling Cap’ May Lessen Hair Loss in Women Undergoing Chemo

For women undergoing chemotherapy, losing one’s hair is one of the treatment’s most devastating side effects. However, researchers have discovered a “cooling cap” that is placed on the scalp may help women with breast cancer lose less hair as a result of chemotherapy.

Researchers, led by those at the Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine, enrolled 182 women with either stage I or II breast cancer who planned to have at least 4 cycles of either taxane or anthracycline-based chemotherapy. The women were randomly chosen to receive the scalp cooling device or not cooling therapy.

The main purpose of the trial, appropriately named SCALP, was determine the safety and efficacy of the device in reducing hair loss (alopecia) in patients undergoing chemotherapy. Secondary endpoints were whether patients in the device arm needed a wig or scarf and overall quality of life.

Slight more than half of the participants in the cooling group didn’t need a wig or a scarf, while everyone in the control group did, the researchers reported in JAMA.

“With scalp cooling, we are lowering the temperature of the scalp, thereby constricting the blood vessels and reducing the flow of blood to the hair follicles, which will help reduce hair loss by limiting the amount of chemo drugs reaching the follicles,” lead study author Julie Nangia, MD, said in a statement.

View a video about the cooling cap and research on it from Dr. Nangia.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

Quick Hits: Safety Issues for Hep C Drugs, Breast Cancer Treatment Side Effects & More

More than 1,500 additional cases of liver injury have been discovered that are associated with the newest class of hepatitis C drugs. In October, the FDA first identified 24 cases involving safety issues related to the 9 new antiviral drugs for hepatitis C, including Harvoni (ledipasvir-sofosbuvir), Olysio (simeprevir) and Sovaldi (sofosbuvir). While these drugs appeared to lower the hep C virus to undetectable levels in the majority of patients, some of them experienced reactivation of hepatitis B that had serious health consequences, including liver transplant and death. An investigation by the Institute for Safe Medicine Practices of FDA adverse events data identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of liver injury. In a further 761 cases, the adverse event was failure of the antiviral drug against the virus. Posted January 25, 2017. Via ISMP.

Almost half of women undergoing treatment for breast cancer experience side effects. Researchers in a study asked 1,945 women with early-stage breast cancer about 7 treatment side effects: nausea and vomiting, diarrhea, constipation, pain, arm swelling, shortness of breath and breast skin irritation. About 45% reported at least one of the side effects was severe or very severe. And when women got chemotherapy, the risk of severe side effects doubled. However, when chemo was conducted with radiation, the odds of severe side effects were just 30% higher. Posted January 24, 2017. Via Cancer.

Last year, the FDA approved only 22 new drugs, a sharp drop from the 45 that were given the green light in 2015. The 22 new medicines are the lowest number approved since 2010. There are several reasons for the decline, according to John Jenkins, director of the FDA Office of New Drugs. There were fewer drug applications filed before the FDA and the agency either delayed or rejected more applications last year compared to the prior 2 years. In addition, 5 drugs whose approval was expected in 2016 ended up winning approval in late 2015. Posted January 2, 2017. Via Reuters.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

Are New Cancer Drugs Really Medical Miracles?

We live in an age of miracles. New drugs reach the market with mind-dulling frequency. Diseases and conditions that used to kill can now be cured or managed as a chronic disease. Hepatitis C and AIDS are good examples. Because of these breakthroughs, there is a perception that death should be fought in every circumstance and every death is preventable.

Cancer drugs are an area where we are seeing a lot of new therapies rushed to market. On Dec. 4, the New York Times ran an article about cancer and immunotherapy. Immunotherapy was and still is expected to be the path to “beating cancer.” Very generally speaking, a healthy immune system has a built-in shut-off valve so that it will stop before attacking healthy cells. Cancer cleverly masquerades as healthy cells so that they don’t trigger the immune system. Immunotherapy takes the brakes off of the immune system to wonderful effect — in some cases, cancerous tumors shrink and even disappear within weeks.

Although the FDA has fast-tracked many immunotherapy drugs, the excitement is slowly dissolving into horror at the unanticipated outcomes. People who should be healthy and cancer free are dying of immunotherapy side effects that might be preventable. Immunotherapy drugs perform as wanted, but don’t stop. They attack all the body’s systems and can destroy healthy organs. With criminally few follow-up studies to identify the side effects, long-term effects and interactions with other drugs, doctors are unprepared for what might and is happening to these patients. As many as 20% of patients are suffering and succumbing to organ failure, high fevers and more, according to the Times article. Doctors are reaching out almost randomly to other doctors to try to compare reactions, find patterns and manage deadly side effects.

This isn’t the first time cancer drugs have been offered too quickly based on short or unsubstantiated research. Ethical medical scientists know that new protocols can’t be based on a single study, particularly one that has substantially different results than ones testing similar methods. Werner Bezwoda, a doctor in South Africa in the early 1990s, presented a study at the American Society of Clinical Oncology’s meeting and published the same study in major journals. He claimed that a regimen of high dose chemo (enough to bring women to the edge of death) followed by stem cell transplants (to bring them back) cured late-stage breast cancers.

Not surprisingly, women facing death from breast cancer demanded this “life saving” protocol. It was soon found that Bezwoda had faked reports and treated women without consent and without appropriate oversight. The study was quickly withdrawn.

It’s estimated that between 4,000 and 9,000 women died worldwide directly due to doctors following this faked research. It took only a few years before better constructed studies proved that aggressive treatment with chemo and stem cell replacement offered no better outcomes and much worse quality of life compared to standard treatment. Waiting those few years, denying those women the protocol they thought would save them would have been by far the better course. Women died unnecessarily and painfully. They would have been better served to have used the existing regimen.

Saving lives is every doctor’s goals. Living longer is all most cancer patients want to do. But proper testing demands that enough people are enrolled in trials so that side effects can be found and a reasonable level of efficacy is proven. Does the drug work or will it kill you after it kills the cancer?

We aren’t going to be able to stop “fast tracking” of drugs — that genie is out of the bottle. But we can and should demand ongoing and robust (more than one study) aftermarket testing to find out if the drug actually saves lives and what the longer-term side effects so they can possibly be neutralized.

Every drug has potential side effects. But without a reasonable idea of it will work and what the side effects and long-term effects are, how can it be fair to offer that drug to a dying person? It’s just like snake oil, offering false hope, and in some cases, even shortening the patient’s life.

There is dignity and value in having time to prepare for a death. It’s heartbreaking to watch a parent or friend die and I would never advocate for giving up. But it’s the patient’s determination when aggressive, low probability and painful care is too much. Without honest assessments and clear information on the often deadly side effects of medicines, the patient’s values are lost.

Suzanne B. Robotti
Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.

Quick Hits: Hormone Replacement Therapy Cancer Risk, Metformin and Weight Loss, & More

Hormone replacement therapy (HRT), which is used to treat the symptoms of menopause, may increase breast cancer risk dramatically. A new study that followed more than 100,000 women over 40 years found that women who took HRT (an estrogen and progestin pill) for about 5 years were nearly 3 times more likely to develop breast cancer compared to those who were just taking an estrogen pill, or nothing at all. And the longer a woman was on HRT, the higher the cancer risk became, according to data published in the British Journal of Cancer. For example, the breast cancer risk was 3.3 times higher for women on HRT for 15 years. While about 14 in 1,000 women in their 50s are expected to develop breast cancer, the rate is 34 in 1,000 for women on HRT, the study argues. Posted August 22, 2016. Via The Telegraph.

A common diabetes drug may help to reduce weight gain that results from atypical antipsychotic use in children with autism. The atypical antipsychotics Risperdal (risperidone) and Abilify (aripiprazole) are approved by the FDA to treat irritability in children with autism. A research team enrolled 60 children and adolescents between the ages of 6 and 17 with autism. Children were also taking an atypical antipsychotic for at least a month and experienced at least a 7% increase in body mass index (BMI) since starting the medication. The children were then randomized to receive either placebo or metformin. Those on the placebo saw no change in the BMI, while those on metformin experienced a statistically significant change, the researchers reported in JAMA Psychiatry. Posted August 24, 2016. Via JAMA Psychiatry.

The severity of side effects from breast cancer hormone treatments may be influenced by whether a patient expects side effects to occur. A new study examined 111 women who had undergone surgery for breast cancer and were about to start hormone therapy with tamoxifen or aromatase inhibitors. At that point, the women were asked about their expectations of side effects. They were then asked again after 3 months and 2 years of treatment. At the beginning, 8% expected no side effects, 63% expected mild side effects and 29% said moderate to severe effects. The results, published in Annals of Oncology, showed that women who expected side effects to be bad had nearly twice as many side effects after 2 years than women who expected no side effects or mild ones. In addition, the women who expected severe side effects tended to have lower quality of life during treatment. Posted August 24, 2016. Via Medical News Today.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

MS Drug May Boost Risk of Some Types of Cancer

A drug used to treat multiple sclerosis (MS) has been linked to an increased risk of colorectal cancer and leukemia.

People who were treated with Novantrone (mitoxantrone), had colorectal cancer rates that were 3x higher than the general population, according to an analysis by German researchers. Even more disturbing, the rate of leukemia in patients that took mitoxantrone was 10x higher than the general population of Germany

However, for breast cancer and other types of cancer, people who had taken mitoxantrone were no more likely to develop those diseases than the general population.

German researchers, led by Mathias Buttmann, MD, of the University of Würzburg, examined 676 people with MS treated with Novantrone from 1994 to 2007 and followed them until 2010. 37 people (5.5%) were diagnosed with cancer after taking the drug: 9 people with breast cancer, 4 with colorectal cancer and 4 with acute myeloid leukemia. Results were published in the journal Neurology.

3 out of the 7 people with colorectal cancer died from the cancer during the study, while the 4 people with leukemia went into remission after treatment and remained alive through the study’s conclusion.

Incidentally, Novantrone is also approved as a chemotherapy agent to treat breast cancer, leukemia and non-Hodgkin’s lymphoma.

Factors such as how much Novantrone and whether patients were taking another immunosuppressant drug were also looked at to see if they influenced the risk of developing cancer. However, only being older when starting the drug was associated with a higher risk of developing cancer.

“Despite an increased risk of acute myeloid leukemia and colorectal cancer, the overall rate of cancer was low enough to justify still using this drug for people severely affected by MS if no better treatment is available,” Buttmann said in a statement. “Novantrone is the only approved treatment for people with secondary progressive MS without relapses and should be considered in people where the disease is evolving quickly.

“Also, many of the new and highly effective MS drugs are not available to people in a number of countries for economic reasons, so Novantrone is being used for people with very active relapsing forms of the disease.”

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

Many Cancer Drugs Approved Without Proven Significant Benefit

Many of the new cancer drugs approved by the FDA may not extend a person’s life, and all because the agency allows the approval of such medications using standards that may not accurately measure a patient’s ability to live longer.

An analysis, published in Mayo Clinic Proceedings, calls into question the FDA’s accelerated approval program, and whether there is any real benefit to many cancer drugs that can often cost $10,000 or more per month and come with many side effects.

In an effort to bring more drugs to market, the FDA will often approve drugs using standards based on what are called surrogate endpoints, or surrogate measures of effectiveness. With cancer drugs, an example is a CAT scan that can determine if a tumor is shrinking or not. However, surrogate endpoints cannot establish overall survival or quality of life changes associated with a medication.

The FDA’s own guidance states that surrogates used for accelerated approval should be “reasonably likely to predict” living longer. However, surrogates used for traditional approvals should be “established.”

Yet, of the 25 drugs that were given the FDA nod under the accelerated approval between 2009 and 2014, 14 of them lacked proof that they extended life or maintained quality of life, the researchers reported. The 30 drugs approved under traditional approval fared somewhat better: Only 11 of them lacked such evidence of additional survival or quality of life benefit.

“In cancer clinical trials, surrogate endpoints, such as tumor shrinkage or slowed tumor growth, may be used as proxies for outcomes that matter to patients — living longer or better — in order to gain earlier approval of new drugs,” lead author Vinay Prasad, MD, MPH, a hematologist at Oregon Health & Sciences University, said in a statement.

Avastin (bevacizumab), a biologic cancer drug used to treat many different types of cancer, won accelerated approval for an additional indication of breast cancer in 2008 after it study demonstrated it boosted progression-free survival, a surrogate endpoint, by 5.5 months. Later studies did not replicate this result, and no increase in survival or quality-of-life improvement were ultimately found.

However, Avastin was associated with many dangerous side effects, such as hemorrhage, heart attacks, heart failure, and perforations in the intestines, nose and stomach. The FDA subsequently withdrew the biologic’s breast cancer indication in 2011.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.