Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

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Vaccines (21 posts)  RSS

The Flu Is One Gift That We Don't Have To Keep On Giving For People With Cancer

by Dr. Len December 17, 2013

 

It's the holiday season, a time of reflection, celebration and for many, giving gifts. But there is at least one gift that no one wants to get, and certainly no one wants to give: the flu. And for people with cancer, and those they come in contact with, the flu can be a very serious event. For that reason and many more, people more than 6 months old-and especially those in contact with people who have serious illnesses like cancer-should get vaccinated against the flu.

Too many of us think the flu is a minor inconvenience. But that is almost certainly because we confuse the typical cold or upper respiratory infection, which usually means discomfort and maybe a day or two off work.  Influenza is a much different and much more dangerous animal, especially to people with chronic diseases.

Over time we have become somewhat immune to the messages about the dangers of the flu, now that we have vaccinations and medicines which can treat the illness. Few are alive who remember anything about the great influenza pandemic of 1918:

"The influenza of that season, however was far more than a cold...The flu was most deadly for people ages 20-40...It infected 28% of all Americans (Tice). An estimated 675,000 Americans died of influence during the pandemic, ten times as many as in the world war. Of the US soldiers who died in Europe, half of them fell to the influenza virus and not the enemy (Deseret News) An estimated 43,000 servicemen mobilized for WWI died of influenza (Crosby)."

We have been fortunate not to have a repeat of that pandemic. But for some of us, the flu remains a deadly possibility, one that we might be able to prevent if we take the precaution of getting a flu shot.

People with cancer are among the groups at especially high risk of getting the complications of flu. And also let's not ignore the "risk pool" of people who live with patients with cancer and those who care for people with cancer. We tend to forget that those healthier folks who help people with serious illnesses can be the transmitters of this potentially serious and life-threatening infection.

Because of those risks, people with cancer and those they come in contact with really need to understand their options about getting vaccinated against the flu, and-assuming they don't have specific contraindications to the vaccine-if at all possible get it done. It is still not too late to get this year's flu vaccination. No one can predict when the vaccine "season" will peak or how serious it will be in any given year. But waiting until the last minute, when the story is all over the news, is not a good idea and it's not good medicine. And worse, it doesn't work. More...

Maybe It Really Is Different This Time For Patients With Advanced Melanoma

by Dr. Len June 03, 2013

Every convention and large meeting has a theme, and at the annual meeting of the American Society of Clinical Oncology in Chicago the theme is "Building Bridges To Conquer Cancer." But for me, the theme as articulated in my blog the other day is "Is it really different this time?" Some agree with me and some don't, but that's OK. I am wearing a badge that says I am a "35 year member of ASCO" (I actually have been attending these meetings longer than that) so I perhaps have a bit of a different perspective than those younger than me. And there is plenty of commentary to back up my well-meaning and hopefully thought provoking conservatism.

In one of the major "award" lectures yesterday, Dr. Charles Sawyers from Memorial Sloan Kettering Cancer Center in New York pointed out the disappointment we have had with many of our newer targeted therapies that once held the promise of truly making cancer a chronic disease. They are exciting in the beginning, but for many patients the responses are not long enough. As Dr. Sawyers noted, cancer cells eventually win the battle, and become resistant to the treatmentIn this context I was having another one of those ubiquitous hallway discussions with one of my friends and former colleagues who now runs a major advocacy/research organization focused on melanoma when she touted the new research and drugs available to treat advanced melanoma. And I said the words, "Is it really different this time?" to which she responded, "Yes, it is." And I said I wasn't so certain. So at her persistent urging, I went to the melanoma session yesterday to see for myself. And I sent my friend an email where I wrote, "You win" and to which she responded, "Told you so."

What changed? What made me eat the proverbial crow? Why is it different this time? More...

Genomics And Personalized Medicine: Is It Really Different This Time?

by Dr. Len June 01, 2013

Another year and another annual meeting for the American Society of Clinical Oncology in Chicago. This is a meeting that regularly attracts many thousands of doctors, researchers, pharmaceutical folks and others interested in the science and business of cancer from around the globe to learn, to discuss, to persuade, to educate on the progress being made in clinical cancer research and treatment.

And like every year, there are themes that emerge, that tend to dominate the discussions. And there are other themes that aren't so visible, that don't get as much attention yet in my mind are equally important as they reflect not only on the item of the moment but on how we deliver on the promises we have made in the past and the hopes we all have for the future.

Clearly, the dominant and visible theme at this year's gathering is personalized medicine.

What strikes me about this topic is that over the past year it has gone from a "niche" discussion to a dominant theme not only here at ASCO but everywhere I turn. I am even seeing routine television news shows and commentators talking about the promise of personalized medicine. A talk that I planned six months ago to deliver in a couple of weeks from now in Boston where I was going to discuss (once again) the promise of personalized medicine in cancer care is now passé. Everyone knows about it, thanks to the incredible coverage it has been receiving literally everywhere. Now anyone who has been paying attention to the evening news could give that talk. The topic is ubiquitous.

So what is personalized medicine? At heart, what this is all about is harnessing our exploding knowledge of the human genome and applying it to the treatment of severe disease for individuals based on genetic analysis. Our focus today is on cancer, but other diseases such as degenerative brain diseases also will be impacted by our knowledge of the human genome.

As I sat in a lecture yesterday afternoon on the topics of genomics and personalized medicine, I was amazed about how much knowledge we have garnered in what appears to be such a short period of time. We now are hearing about new approaches to analyze how cancer cells work to discover master regulatory cells. The promise, of course, now that we have insight into the pathways of how cancer cells work internally is that we can target our efforts to those master regulators and conquer them, thus converting the cancer cell back to normality. Sounds simple, but it's not. And it has taken a lot of research to get us to that point.

So one comes away from those discussions imbued with a new enthusiasm that the cure is around the corner. We are almost there. We will succeed--hopefully in the very near term.

But then I pinch myself and say, "Really?" More...

Annual Report to the Nation on Cancer Trends: Cancer Deaths Continue to Fall, But We Can Do Better

by Dr. Len January 07, 2013

The positive news continues: cancer death rates have continued to fall in the United States, for men and women, maintaining a trend that began in the early 1990's. That's the essence of a report released today by the American Cancer Society, the National Cancer Institute, the Centers for Disease Control and Prevention and the North American Association of Central Cancer Registries in the Journal of the National Cancer Institute.

The report, titled in part "Annual Report to the Nation on the Status of Cancer, 1975-2009" also features a special section on the burden and trends in Human Papilloma virus (HPV) associated cancers and HPV vaccination coverage levels. Unlike the continuing decline in cancer deaths in the United States, we could be doing a much better job of getting young folks vaccinated against HPV and reducing the incidence and death rates from several HPV-associated cancers, according to the authors of the report and an editorial that accompanied the report.

This report comes out every year. It is a summation of what we know about the trends in incidence rates for the most common cancers in the United States among both men and women as well as the trends in death rates from those cancers that lead to the highest mortality in the general population as well as specific ethnic groups. It is in a real sense a report card on our progress, which in large part is good but in a number of cancers, not so good.

The good news is what we have come to expect: since the year 2000, the overall cancer death rates have continued to decline 1.8% per year in men, 1.4% in women and 0.6% per year in children. That may not sound like much, but when you consider the fact that this is an average change seen every year, those numbers begin to add up. More...

Promising New Approach To Treating Cancer Means Hope For Many, But Remember This Is Just The Start Of The Journey

by Dr. Len June 02, 2012

Every year at this time cancer specialists and researchers from around the world descend on Chicago for the annual meeting of the American Society of Clinical Oncology (ASCO) to hear the latest breakthroughs in cancer research and treatment.

 

Through all the fog of all the information--which is impossible for any one individual to evaluate much less comprehend--there is always the search for the "buzz," or the next "big thing" that will make a huge impact on cancer treatment and the lives of the patients we care for and the people we love who are affected by cancer.

 

This year, it is apparent already that one of this year's "big things" are the reports of new success in an old and ongoing effort to harness the body's own defense mechanisms to fight cancer. And--being the skeptic that I can be at times--I will throw my hat in the ring that maybe this is going to be one of those events that truly will impact cancer care. But despite the enthusiasm, we must always temper our expectations with reality and lessons we have learned from the past that early success doesn't always tell us the whole story.

 

Without going into great detail here, the reality is that in early stage trials an antibody drug now called "BMS-936558" produced significant responses in a number of patients who had certain advanced cancers and had failed multiple prior treatments. In these studies, patients with melanoma, kidney cancer and non-small cell lung cancer showed responses to this new drug and some of those responses lasted for over a year.

 

When you see these kinds of results in cancers that are ordinarily difficult to treat, and in patients who have failed multiple other therapies, that becomes news. More...

A Declaration for the World, A Noble Mission For All

by Dr. Len September 20, 2011

There are few times in life when one gets to watch history being made. Today is one of those times.

 

I am in New York with a number of colleagues from the American Cancer Society and other committed organizations to observe a UN High Level Meeting which will--at long last--put non-communicable diseases on the international agenda. The impact of the decisions made here over the next two days can indeed change the face of global health forever. More...

The Genomic Era: We Have Reached A New Tipping Point In Cancer Research And Treatment

by Dr. Len June 06, 2011

I don't often write blogs about articles that appear in newspapers, but in this case I am going to make an exception for today's excellent front page story in the Wall Street Journal by Ron Winslow discussing the coming of age of genetics and genomics in diagnosing, treating and predicting the behavior of the disease we now know as cancer.

 

But even though Mr. Winslow may have pre-empted the thought that for me the seminal theme of this year's annual ASCO meeting in Chicago was related to the impact of genetics on cancer research and treatment, his well-written "scoop" won't prevent me from weighing in with my opinion that this year represents another one of those seldom moments when we reach a tipping point in cancer research and the application of that research to the diagnosis and treatment of cancer.

 

It was obvious literally from very beginning of the meeting when Dr. George Sledge--the President of ASCO--addressed thousands of cancer professionals from around the world and talked about the impact of the forthcoming era of personalized medicine.

 

In the past, we have had the chemotherapy era, where we were able to put combinations of toxic drugs together to cure and control some forms of cancer.  We have had the adjuvant era, when we learned that using chemotherapy could delay the progression of cancer after primary treatment, usually surgery.  We have most recently had the targeted therapy era, when we learned that drugs targeted at genetic changes in cancer cells could impact survival, sometimes substantially.  We wish we had a vaccine era, although there have been some practical successes and hopeful research that continues in that arena.

 

And now we have the genomic era. More...

The FDA verdict: Provenge Works In Prostate Cancer

by Dr. Len April 29, 2010

Today’s announcement by the Food and Drug Administration (FDA) that they approved Provenge® for the treatment of advanced, hormone resistant prostate cancer is significant for several reasons, not the least of which that it offers new hope to men with advanced prostate cancer where progress in treatment has been very slow in coming.

 

Equally important, it closes the door on decades of unfulfilled hopes that tumor vaccines and immunotherapy would eventually play a significant role in cancer treatment.  We now have a demonstrated success, which is especially important given the many near-misses that have occurred over the years.  This reinforces for many the dream that one day we would be able turn on the body’s own defense mechanisms as one more approach to treat (or one day—perhaps—prevent) certain cancers.

More...

A New Vaccine Holds Promise For Women With VIN

by Dr. Len November 04, 2009

An article in today’s New England Journal of Medicine reports some interesting and intriguing research that may help some women with a not uncommon pre-cancerous lesion of the vulva called vulvar intraepithelial neoplasia, or VIN.

 

By using proteins found in the cancer-causing human papilloma virus type 16 (HPV-16), the researchers were able to make a vaccine that actually led to an effective treatment for a small group of women with VIN, resulting in complete disappearance of the lesion in almost half of the women they treated.

 

You may have heard of HPV infections.  These are the viruses that cause cervical cancer.  Two of these viruses—types 16 and 18—are responsible for the majority of cervical cancers in the United States.  They are also the viruses targeted by currently available vaccines which prevent infection with HPV thus reducing the risk of developing cervical cancer.

 

It turns out that the same viruses are also related to VIN, especially type 16 which causes over 75% of VIN. (VIN is a superficial lesion on the vulva which can actually last for many years.) 

 

The problem is that the treatments for VIN are sometimes unsatisfactory, and the lesions can recur frequently after treatment.  Topical medicines, surgery and laser treatments are commonly used.  More recently, an antiviral medicine called imiquimod has been reported to be effective and less irritating.  About 1 out of 65 VIN lesions can resolve spontaneously.

 

And, just like what can happen in the cervix where the HPV infection progresses on to cervical cancer, untreated VIN can become an actual vulvar cancer.  Fortunately, this is uncommon.

 

In this current report, the doctors made a vaccine using cancer-causing proteins from the virus.  They treated women with advanced pre-cancerous VIN by giving them the vaccine under the skin of the arm or leg every three weeks for a total of three to four injections.  Side effects were tolerable, and frequently included a local reaction at the vaccination site in addition to flu like symptoms, chills and tiredness.

 

The responses in some of the women were remarkable: At one year, 6 of the 19 patients had a partial response to the vaccine. 9 of the patients (47%) had complete disappearance of the VIN, which lasted for at least another 12 months.  As a result, 79% of the women responded to the vaccine.  This compares to a complete response rate of 35% for lesions treated with imiquimod, according to the report.

 

Unfortunately, not all of the women had such positive responses to the vaccine.  Two of the participants went on to develop cancer, and one of those women had shown a previous partial response to the vaccine.

 

The researchers also measured whether the women’s immune systems responded to the vaccine.  All of the women in the study did have a response, and those with a complete resolution of their VIN at 3 months after treatment had much stronger responses compared to women who did not have a complete regression.

 

What’s interesting to me about this research is that it seems to work in a way that is different from what we have seen before.

 

We are all familiar with the typical types of vaccines, where the vaccine contains a protein from a virus or bacteria that is given to us when we aren’t sick with an infection and then prevents us from getting the same infection at a later date.

 

Here we have a situation where the woman is already infected with the virus, and her body has either not developed a response to the infection or become “tolerant” to the virus.  That’s usually a situation where vaccination doesn’t work.  Think of having the flu, then getting the flu vaccine.  Basically, it’s too late. 

 

That same theory carries over to the currently available cervical cancer vaccine.  If a woman has already become sexually active and infected with HPV, then giving her the preventive vaccine isn’t going to be effective in reducing her risk of cervical cancer.

 

But, for some reason, in this trial giving a piece of the virus to stimulate the immune system after the infection had set in did work. What I don’t understand is how that happened.  It just is not what one would ordinarily expect based on the science.

 

These doctors weren’t interested in making a prevention vaccine.  What they developed, as they report, was a therapeutic vaccine.

 

Maybe I shouldn’t be so worried about how this happened, and just be glad that in fact it did happen. 

 

The implications of this research are significant. 

 

First, it may mean that this vaccine will be studied further (this was a very small, early stage trial) and eventually be available for wider use in the treatment of women with VIN.

 

But—perhaps more importantly—it raises the question of whether a similar approach could be used in women who have advanced pre-cancerous lesions in the cervix.

 

These researchers have actually previously reported studies using the same vaccine in women with either advanced or treated cervical cancer.  In one study, they vaccinated women who had cervical cancer that was successfully treated surgically, and were able to induce an immune response to HPV-16 using this vaccine. 

 

As they stated in that article, the results of the study “indicates the potential of this vaccine for the immunotherapy of HPV 16-induced progressive infections, lesions, and malignancies.”

 

In plain language, if this vaccine is effective in VIN, and it can demonstrate the ability to cause an immune response in women who have already been diagnosed with cervical cancer, then maybe it can also be effective in treating women who have pre-cancerous cervical lesions as well.

 

I suspect it will be some time before we know the rest of the story as to whether this vaccine is truly effective in treating women with VIN or whether it can improve the treatment for women with pre-cancerous lesions of the cervix.  Patience is clearly going to be part of the process.

 

But if this theory holds up, then this report could be the foundation of a new approach to treating some not-uncommon pre-cancerous diseases.  And that is very exciting news indeed.

Side Effects and Selling of HPV Vaccine:What's Up?

by Dr. Len August 18, 2009

Two articles and an editorial in the current issue of the Journal of the American Medical Association (JAMA) about the side effects and marketing of the cervical cancer vaccine are probably going to raise questions.  They may also fuel the fires of concerns among some groups that have raised thorny political questions about the vaccine, especially as to whether or not this vaccine should be mandatory for young girls.

 

The primary “scientific” report in JAMA describes the results of a post-marketing surveillance program that monitors the side effects of new vaccines. 

 

The study, written by researchers from the Centers for Disease Control and Prevention and the Food and Drug Administration is fairly straightforward. 

 

In order to monitor reports of subsequent adverse reactions, the CDC and the FDA sponsor an adverse event reporting system called the US Vaccine Adverse Event Reporting System (VAERS).  Anyone can submit a report of a suspected vaccine-related adverse event to this system, even if they are not the patient, a family member, a physician or other health care professional.  Once the vaccine has been in widespread use for a sufficient period of time, those reports can be evaluated and researchers can determine whether or not there are any unsuspected safety signals, or if certain adverse events occur more frequently than would have been anticipated based on the initial clinical trials.

 

More than 23 million doses of the cervical cancer vaccine had been distributed in the United States between the date it was approved in June 2006 and December 31, 2008.

 

During that period of time, the VAERS had received 12,424 reports of adverse events following vaccination with the HPV vaccine.  Most of the reports came from the manufacturer, but unfortunately those reports did not have patient information so they could not be verified.  Also, many of the reports included multiple adverse reactions in single patients.

 

The most common reactions were syncope (fainting) in 15% of the reports, followed by dizziness, nausea, headache and reactions at the injection site.

 

772 of the reports--or 6.2%--were considered “serious.”  These reports included 32 deaths.  There were eight reports of serious allergic reactions, nine episodes of blood clots (deep vein thrombophlebitis or DVT) 31 episodes of ascending paralysis (Guillain-Barre Syndrome, or GBS) in addition to spinal cord inflammation, pancreatitis, blood clots to the lungs, convulsions, allergic skin reactions, and autoimmune disorders.

 

There were 1896 reports of fainting, and 15% of those reports included a fall.  Of the people who fell, about 2/3 had a head injury as a result of the fall.

 

The researchers tried to verify many of the more serious events, but were stymied by the lack of medical information that was available.  In addition, a number of the reports of serious events were based on hearsay, where the person who reported the event did not have first hand knowledge of the reaction.

 

Obviously, the greatest concern is with the reports of 32 deaths that may have been associated with the vaccine.  Of those cases where data was available, there were several different causes of death including four that were unexplained. 

 

The authors conclude that the safety profile was in line with what would have been expected from the initial clinical trials of the vaccine.  They did point out, however, that there was a higher rate of syncope and blood clots (DVT) than was expected.  They also noted that surveillance is continuing.

 

Syncope after vaccination is not a new problem with vaccinations.  The authors note that fainting after a shot is not unusual in young people, especially young women between the ages of 11 and 18. They emphasized the need for patients, families, and health care professionals to follow recommended precautions after giving this vaccine, in order to prevent more serious injury.

 

The authors also noted that this reporting system is “passive.”  That means it relies on people letting the CDC and the FDA know about adverse events.  They also think publicity increased the number of adverse events that were reported since there were three times the number of reports for this vaccine compared to the rate seen for all other vaccines combined.

 

Their conclusion?

 

“The post licensure safety profile presented here is broadly consistent with safety data from pre-licensure trials.  Because VAERS data must be interpreted cautiously and cannot generally be used to infer causal associations between vaccines and (adverse events), post licensure monitoring will continue and identified signals may be evaluated using epidemiologic observational studies.”

 

So that’s the science.  Now for the more controversial part of this report, which calls into question how this vaccine was marketed and what role medical associations may have played into misleading their physician members about the vaccine.

 

The authors of this article, from the Columbia College of Physicians and Surgeons in New York, refer to “critical and unresolved questions” about the vaccine in terms of how it was marketed, whether the vaccine was being targeted to those young women who need it most, and whether the medical societies were really unbiased in their presentations about the vaccine.

 

The authors maintain that by marketing this vaccine to prevent cervical cancer as opposed to preventing infection with a virus resulted in the vaccine gaining greater acceptance in the community and among physicians.  The authors claim that the public was led to believe that every young girl was at equal risk of getting cervical cancer, as opposed to focusing on young girls at greater risk of getting cervical cancer.  Those girls at risk are frequently economically and educationally disadvantaged which results in a lower likelihood that they will follow cervical cancer screening recommendations as they grow into adulthood.

 

To me, the most disconcerting allegations in this article are leveled at “professional medical associations” (PMAs) which are physician membership organizations that are highly regarded and have a significant nationwide presence.  The authors suggest that some of these organizations altered their professional focus and messaging surrounding cervical cancer as a result of corporate funding.  They established well-resourced speaker bureaus funded by the manufacturer to provide continuing medical education lectures, including carefully designed scripts and slides.  Even potentially controversial or difficult questions had very specific responses crafted as part of these kits. 

 

The authors conclude:

 

“As marketing of this HPV vaccine demonstrates, pharmaceutical company campaigns can undercut the most cost-effective and appropriate use of new agents to the detriment of adolescent health.  By making this vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk practically ignored…Under no circumstances should PMAs administer product-specific speakers’ bureaus, nor should they accept funding that requires them to report activity to the donor.”

 

These are serious comments. And don’t forget that they appear in JAMA, which is the medical journal published by the American Medical Association, the granddaddy of professional medical associations (although there is no suggestion that the AMA was engaged in any of these activities).

 

The editorial also discusses the complexity of decision making when it comes to evaluating the risks and benefits of a new medical treatment, such as the cervical cancer vaccine.  The writer points out persistent lack of knowledge about the vaccine, such as the impact on cervical cancer rates 20 or 40 years from now, and the fact that more long term studies about the vaccine were needed but have not yet been reported.

 

The opinion of the editorialist is bound to be the topic of discussion in the medical community:

 

“The net benefit of the HPV vaccine to a woman is uncertain.  Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened.  So rationally she should be willing to accept only a small risk of harmful effects from the vaccine. 

 

“When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit.  Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed.  The balance will also tilt if the adverse events are not calculated correctly.”

 

So what does the American Cancer Society recommend? 

 

Our guidelines call for routine vaccination of girls ages 11 and 12, and as young as 9.  We also recommend the vaccine for women ages 13 through 18 to “catch up” missed vaccines or to complete the series of three shots.  We do not believe there is sufficient evidence to recommend for or against routinely vaccinating women between the ages of 19 and 26, and those women should have an informed discussion with their health care professional about the benefits and risks of the vaccine.

 

All of this discussion led me to go back to our original guidelines publication.  We make every effort to have the best experts participate in our guidelines panels.  We do not take funding from industry to support our guidelines efforts, and we do not gain financially from producing our guidelines.  I do know that our panel spent countless hours reviewing the evidence, and discussing and debating many aspects of the HPV vaccine before they made their recommendations.

 

That said, I would be remiss if I didn’t note that a number of the experts on the panel do in fact have industry relationships related to the cervical cancer vaccine.  These are, after all, the experts that everyone seeks for their opinions.  I know many of them personally and by reputation, and all are highly regarded.  But as I noted in last week’s blog on whether or not physicians routinely recommend the vaccine, there are situations where I feel obligated to note potential conflicts, and this is one of those situations.

 

Ultimately, you will have to make your own decisions and conclusions about what all of this means—especially if you have a daughter who is eligible to receive the vaccine.  Far be it from me to tell you what to do, but I do continue to support our guideline recommendation. 

 

There is nothing in these articles that would make me change my mind.  Controversy is one thing, but good medicine is another.  And many experts I know and trust believe this vaccine continues to be “good medicine.”

About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

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