Farrah Fawcett had guts. The heart-stoppingly beautiful woman steamed up the airwaves in the ‘70s as Jill Munroe in the hit TV series Charlie’s Angels, and redefined the poster business when an iconic shot of her in a red swimsuit sold an unrivalled 12 million copies. But she ditched the obvious cheesecake career path to give a wrenching portrayal of an abused woman in “The Burning Bed” and followed up with strong performances in “The Apostle” and as a rape victim looking for vengeance in “Extremities.” Her acting career was somewhat checkered, but she sure didn’t take the easy route that was more than available to her.
Many women cheered, too, when Farrah posed for Playboy at the age of 50, proving that sexy doesn’t end with middle-age.
When she was diagnosed with anal cancer in 2006 she showed equal courage. Furious about leaks to the tabloids that could only have come from full access to her medical records, she set a trap at the UCLA Medical Center and spurred new privacy policies.
At first she was told she’d beaten the cancer after the tumor was removed; anal cancer is highly curable if caught early. But the cancer returned with a vengeance and spread to her liver. She made headlines when she went for alternative treatment in Germany, and in April was again hospitalized, reportedly because of a blood clot that resulted from her treatment overseas.
Farrah had taken a camera to record the doctor’s appointment where she discovered that the cancer had returned, and she asked her friend Alana Stewart to continue filming her absolutely unsparingly as she went through treatment. Stewart was unhappy about filming some highly personal moments, but Farrah insisted that this, after all, is what cancer is.
The resulting footage was made into a documentary called “Farrah’s Story." An estimated nine million viewers tuned in to a devastatingly honest portrayal of what cancer can do, both physically and emotionally. And even though she had perhaps the most famous hair in the world, it began falling out like just about anyone else’s hair after chemotherapy, and so the documentary shows Farrah taking a razor to it—just like anyone else.
Anal cancer is very rare. In the US just 5,290 new cases will be diagnosed this year and only about 710 of those will die. It’s believed that the human papillomavirus, HPV, causes anal cancer. HPV is extremely common and about 80 percent of the population will contract it at some point in their lives; however an estimated 90-95 percent of those cases will clear themselves.
Persistent infections, which can cause the lesions that lead to cervical or anal cancer, usually take hold because of a weak immune system, often caused by poor diet or smoking—smoking can increase the chance of getting a persistent infection by up to 27 times. Having many sexual partners also dramatically increases the risk. Conversely, a diet high in fruit and vegetables can decrease the risk by 50 percent or more.
A doctor should check out any symptoms like bleeding or itching around the anus, swollen lymph nodes in the groin or anal area, changed bowel habits or an abnormal discharge. A digital exam during a Pap test, colonoscopy or prostate cancer screening will usually pick up problems.
The controversial Gardasil vaccine also tries to protect against four HPV strains, two that cause 67-70 percent of cervical cancer and two that cause genital warts. A recent study shows it to be
about 17-45 percent effective against pre-cancerous cells, and there is some concern that any of the 40-odd other cancer-causing strains of HPV might move into the vacancy left by the four Gardasil strains. Gardasil has been associated with a number of side-effects from syncope and convulsions to immune diseases, ALS and even death, although no links have been proven.
Our heartfelt condolences to Ms. Fawcett’s family and friends.
Thursday, June 25, 2009
Monday, June 15, 2009
Gardasil, Oprah, and Crazy Talk
Me, I don’t watch Oprah. Nothing personal—I just don’t watch a whole lot of TV. But I do occasionally read the Oprah magazine, and find it to be exceptionally well written and usually informative. Would I take everything as gospel? Nope. But would I dismiss it out of hand? That’s also a nope.
Newsweek is apparently far better at the dismissing business.
Ambushed by an intriguing cover, featuring a totally deranged-looking Oprah and a story title that read, CRAZY TALK – OPRAH, WACKY CURES AND YOU, who could resist? So I didn’t.
I don’t know a thing about Suzanne Somers. Couldn’t tell you what The Secret is if it bit me. And no doubt Newsweek writers Weston Kosova and Pat Wingert made some excellent points about both (60 supplements a day? Seriously? Does Ms. Somers rattle like a rainstick?)
But I’ve been researching HPV and Gardasil a lot, so my attention was caught by mention of one of Oprah’s ‘regular experts,’ Dr. Christiane Northrup. Again, I don’t know a lot about her, but what I have heard always seemed pretty sensible, so it was rather a shock to find Newsweek putting her in the crazy category when she talked about Gardasil.
“Where I’d put my money,” she’s quoted as saying, “is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing. All right?”
You can practically hear the guffaws as the writers note that “…Oprah (did not) question Northrup’s assertion that women can stop the spread of a cancer-causing sexually transmitted disease by eating healthy foods. There is, Wood (Susan Wood, former head of the FDA’s Office of Women’s health) says dryly, ‘no evidence that money spent on general health promotion’ will do that.”
Now, I really hope that their general level of research is a lot better than that, because clearly they don’t know what the devil they’re snickering at. And nor does Ms. Wood, unless they truncated her comments.
True, Gardasil aims to protect women against four strains of HPV, the human papillomavirus, which is a virus that is spread through sexual and sometimes not-so-sexual skin-to-skin contact. And persistent infections, caused by any of about 40 strains of HPV out of more than a hundred, can indeed cause cervical cancer.
What these authors don’t seem to have properly researched is that roughly 80 percent of the population will be infected with HPV at some point in their lives, and as many as 95 percent of those infections will be cleared by the body. It’s only when an infection becomes persistent that it causes trouble. And why does an infection fail to clear itself?
Because of a crappy immune system. And why would an immune system be crappy? Often—not always, of course, but often—because of a crappy diet, sorely lacking in fruits and veggies.
A University of Arizona study that was reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be somewhat less protective than vegetables, but still proved to be a valuable addition to creating a strong immune system.
Smoking, incidentally, also damages a body’s natural immunity, increasing the risk of developing pre-cancerous lesions by up to a whopping 27 times, presumably because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. For more info on that, check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.
Strengthening the host is usually far more effective than trying to stop a virus, which has a nasty habit of sending in different strains as a replacement disease (think the common cold). Given that the latest studies show Gardasil to be only 17-45 percent effective against pre-cancerous cells, I’d certainly keep chowing down on the broccoli and kohlrabi, myself.
So Northrup is certainly not out in left field when she talks about enhancing the immune system so that one can resist ‘that sort of thing.’ On the contrary, science is on her side.
And when I read an article that is so obviously slanted towards the premise that Oprah is nuts and spreads 'crazy talk', it makes me wonder how accurate Newsweek's previous offering, showing President Mahmoud Ahmadinejad of Iran looking as if he has failed to eat his prunes for far too long (where do they GET these pictures?) is going to be when I get to it.
Newsweek is apparently far better at the dismissing business.
Ambushed by an intriguing cover, featuring a totally deranged-looking Oprah and a story title that read, CRAZY TALK – OPRAH, WACKY CURES AND YOU, who could resist? So I didn’t.
I don’t know a thing about Suzanne Somers. Couldn’t tell you what The Secret is if it bit me. And no doubt Newsweek writers Weston Kosova and Pat Wingert made some excellent points about both (60 supplements a day? Seriously? Does Ms. Somers rattle like a rainstick?)
But I’ve been researching HPV and Gardasil a lot, so my attention was caught by mention of one of Oprah’s ‘regular experts,’ Dr. Christiane Northrup. Again, I don’t know a lot about her, but what I have heard always seemed pretty sensible, so it was rather a shock to find Newsweek putting her in the crazy category when she talked about Gardasil.
“Where I’d put my money,” she’s quoted as saying, “is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing. All right?”
You can practically hear the guffaws as the writers note that “…Oprah (did not) question Northrup’s assertion that women can stop the spread of a cancer-causing sexually transmitted disease by eating healthy foods. There is, Wood (Susan Wood, former head of the FDA’s Office of Women’s health) says dryly, ‘no evidence that money spent on general health promotion’ will do that.”
Now, I really hope that their general level of research is a lot better than that, because clearly they don’t know what the devil they’re snickering at. And nor does Ms. Wood, unless they truncated her comments.
True, Gardasil aims to protect women against four strains of HPV, the human papillomavirus, which is a virus that is spread through sexual and sometimes not-so-sexual skin-to-skin contact. And persistent infections, caused by any of about 40 strains of HPV out of more than a hundred, can indeed cause cervical cancer.
What these authors don’t seem to have properly researched is that roughly 80 percent of the population will be infected with HPV at some point in their lives, and as many as 95 percent of those infections will be cleared by the body. It’s only when an infection becomes persistent that it causes trouble. And why does an infection fail to clear itself?
Because of a crappy immune system. And why would an immune system be crappy? Often—not always, of course, but often—because of a crappy diet, sorely lacking in fruits and veggies.
A University of Arizona study that was reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be somewhat less protective than vegetables, but still proved to be a valuable addition to creating a strong immune system.
Smoking, incidentally, also damages a body’s natural immunity, increasing the risk of developing pre-cancerous lesions by up to a whopping 27 times, presumably because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. For more info on that, check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.
Strengthening the host is usually far more effective than trying to stop a virus, which has a nasty habit of sending in different strains as a replacement disease (think the common cold). Given that the latest studies show Gardasil to be only 17-45 percent effective against pre-cancerous cells, I’d certainly keep chowing down on the broccoli and kohlrabi, myself.
So Northrup is certainly not out in left field when she talks about enhancing the immune system so that one can resist ‘that sort of thing.’ On the contrary, science is on her side.
And when I read an article that is so obviously slanted towards the premise that Oprah is nuts and spreads 'crazy talk', it makes me wonder how accurate Newsweek's previous offering, showing President Mahmoud Ahmadinejad of Iran looking as if he has failed to eat his prunes for far too long (where do they GET these pictures?) is going to be when I get to it.
Sunday, May 17, 2009
Farrah Fawcett's Cancer, HPV and Gardasil
Farrah Fawcett, like Jade Goody, has focused our attention squarely on the tiny, but very real, dangers of HPV. Last night a documentary dealing with the iconic actress’ struggle with anal cancer aired to an audience of an estimated 8.9 million viewers.
In March all eyes were on reality TV star Jade Goody, who died at the appallingly young age of 27 from cervical cancer. Now Fawcett, known for her portrayal of an abused woman in The Burning Bed and for her longtime role in Charlie’s Angels, has highlighted the perils of anal cancer. In 2006 she was diagnosed with the highly curable cancer and initially was thought have beaten it; the disease, however, returned and spread to her liver.
Furious about on ongoing series of detailed leaks about her condition to the National Enquirer, and knowing that they could only come from staff at the UCLA Medical Center, 62 year-old Fawcett set a trap worthy of the French Resistance and spurred new legislation in California to safeguard patient privacy—and she’s continued to tackle her disease with equal energy, even sharing with the public what was originally supposed to be private video footage of her ordeal as a way to spread awareness.
At least those 8.9 million viewers, then, are now to some extent familiar with the disease. Anal cancer is even rarer than cervical cancer. The American Cancer Society estimates that in 2009 there will be 5, 290 new cases diagnosed in the US, mostly in people in their 60s, and about 3,190 of those will be found in women. Because anal cancer can be treated very effectively if found in time, only about 710 of those cases will die.
It’s thought that the human papillomavirus, HPV, is the cause of anal cancer. As with cervical cancer, many—even most—people will be infected with the virus at some point but it clears itself in roughly 95 percent of cases; only when an infection becomes persistent does it cause real trouble. Smoking, sleeping around, and weakening the immune system through poor diet all increase the chances of an infection becoming persistent (smoking alone can increase the chances by up to 26 times), and in the case of anal cancer, having anal sex is certainly a risk factor. Some patients, however, have no risk factors.
Symptoms can include bleeding or itching around the anus, pain in the anal area, a change in bowel habits, a lump in the anal area, swollen lymph nodes in the anal or groin area, and abnormal discharge from the anus.
Problems can usually be detected with a digital exam during a Pap test, colonoscopy, or prostate cancer screening. Anal cytology testing, a relatively new test that’s rather like an anal Pap smear, can also be performed if a patient is high risk for one reason or another. Fawcett’s battle highlights for us yet again the importance of regular screening.
The new Gardasil vaccine (in use since 2006) aims to protect against two of the most commonly cancer-causing strains of HPV, 16 and 18, as well as two that cause genital warts, although a recent study shows that 16 has for some years been losing ground to non-vaccine types. Because there are more than 100 different strains of HPV, and of those more than 40 can cause cancer, replacement diseases may well be an issue if non-vaccine types decide to fill the biological vacancy left by 16 and 18.
Two recent placebo-controlled studies showed that Gardasil decreased the risk of different types of pre-cancerous cells by 17 to 45 percent. It’s not known how long the vaccine will remain effective but a recent study showed strong protection against HPV type 16 alone for 8.5 years.
The vaccine has been associated with a number of side-effects, including Guillain-Barré Syndrome, an unusually rapid form of ALS, paralysis, and convulsions and epilepsy. No causal link has been definitively proved as yet; critics point to a high number of VAERS reports, particularly compared to Menactra, a vaccine that is aimed at a similar population. When three young girls in Spain lost consciousness and convulsed—the two we know most about have been in and out of intensive care ever since—health authorities determined that the vaccine had not caused the convulsions, but could have triggered them.
Germany and Scotland are both considering changing or ending their HPV vaccination programs because of concerns about the efficacy of the program. Many people are looking to other preventatives currently in the development pipeline, such as an ointment made with GML that would also protect against HIV.
Because of the potential side effects and less than complete protection provided by both Cervarix and Gardasil, consumers should research the pros and cons of the vaccines for themselves Regardless of your opinion about Gardasil as an HPV preventative, however, HPV is indeed an issue that we should all be aware of, and one can only be thankful to public figures like Farrah Fawcett who are willing to go very, very public to that end.
Meanwhile, my very heartfelt prayers are with her, and with her family and friends too.
In March all eyes were on reality TV star Jade Goody, who died at the appallingly young age of 27 from cervical cancer. Now Fawcett, known for her portrayal of an abused woman in The Burning Bed and for her longtime role in Charlie’s Angels, has highlighted the perils of anal cancer. In 2006 she was diagnosed with the highly curable cancer and initially was thought have beaten it; the disease, however, returned and spread to her liver.
Furious about on ongoing series of detailed leaks about her condition to the National Enquirer, and knowing that they could only come from staff at the UCLA Medical Center, 62 year-old Fawcett set a trap worthy of the French Resistance and spurred new legislation in California to safeguard patient privacy—and she’s continued to tackle her disease with equal energy, even sharing with the public what was originally supposed to be private video footage of her ordeal as a way to spread awareness.
At least those 8.9 million viewers, then, are now to some extent familiar with the disease. Anal cancer is even rarer than cervical cancer. The American Cancer Society estimates that in 2009 there will be 5, 290 new cases diagnosed in the US, mostly in people in their 60s, and about 3,190 of those will be found in women. Because anal cancer can be treated very effectively if found in time, only about 710 of those cases will die.
It’s thought that the human papillomavirus, HPV, is the cause of anal cancer. As with cervical cancer, many—even most—people will be infected with the virus at some point but it clears itself in roughly 95 percent of cases; only when an infection becomes persistent does it cause real trouble. Smoking, sleeping around, and weakening the immune system through poor diet all increase the chances of an infection becoming persistent (smoking alone can increase the chances by up to 26 times), and in the case of anal cancer, having anal sex is certainly a risk factor. Some patients, however, have no risk factors.
Symptoms can include bleeding or itching around the anus, pain in the anal area, a change in bowel habits, a lump in the anal area, swollen lymph nodes in the anal or groin area, and abnormal discharge from the anus.
Problems can usually be detected with a digital exam during a Pap test, colonoscopy, or prostate cancer screening. Anal cytology testing, a relatively new test that’s rather like an anal Pap smear, can also be performed if a patient is high risk for one reason or another. Fawcett’s battle highlights for us yet again the importance of regular screening.
The new Gardasil vaccine (in use since 2006) aims to protect against two of the most commonly cancer-causing strains of HPV, 16 and 18, as well as two that cause genital warts, although a recent study shows that 16 has for some years been losing ground to non-vaccine types. Because there are more than 100 different strains of HPV, and of those more than 40 can cause cancer, replacement diseases may well be an issue if non-vaccine types decide to fill the biological vacancy left by 16 and 18.
Two recent placebo-controlled studies showed that Gardasil decreased the risk of different types of pre-cancerous cells by 17 to 45 percent. It’s not known how long the vaccine will remain effective but a recent study showed strong protection against HPV type 16 alone for 8.5 years.
The vaccine has been associated with a number of side-effects, including Guillain-Barré Syndrome, an unusually rapid form of ALS, paralysis, and convulsions and epilepsy. No causal link has been definitively proved as yet; critics point to a high number of VAERS reports, particularly compared to Menactra, a vaccine that is aimed at a similar population. When three young girls in Spain lost consciousness and convulsed—the two we know most about have been in and out of intensive care ever since—health authorities determined that the vaccine had not caused the convulsions, but could have triggered them.
Germany and Scotland are both considering changing or ending their HPV vaccination programs because of concerns about the efficacy of the program. Many people are looking to other preventatives currently in the development pipeline, such as an ointment made with GML that would also protect against HIV.
Because of the potential side effects and less than complete protection provided by both Cervarix and Gardasil, consumers should research the pros and cons of the vaccines for themselves Regardless of your opinion about Gardasil as an HPV preventative, however, HPV is indeed an issue that we should all be aware of, and one can only be thankful to public figures like Farrah Fawcett who are willing to go very, very public to that end.
Meanwhile, my very heartfelt prayers are with her, and with her family and friends too.
Wednesday, May 13, 2009
Health Authorities May Ditch Gardasil and Cervarix
Gardasil and its rival Cervarix cost governmental health programs, insurance companies and individuals billions. Most governments have approved vaccination programs on the assumption that if an HPV jab guards against the two viruses that cause 70 percent of cases of cervical cancer, then the vaccine will eliminate roughly 70 percent of new cancer cases.
Oops. Real-life study results don’t bear out that assumption at all, and now that Gardasil has been found in two placebo-controlled studies to reduce pre-cancerous cells by just a meager 17 to 45 percent, both Scotland and Germany are reconsidering their hugely expensive HPV vaccination programs.
13 leading scientists in Germany have said that the vaccine is leaving women vulnerable to other strains of the virus and that information about its effectiveness is misleading. The Robert Koch institute, which makes recommendations about publicly-funded vaccination programs in Germany, is reassessing Gardasil and expects to issue a report within about two weeks. As one expert said, "The results of the studies clearly contradict many overly optimistic pronouncements. Women are entitled to be adequately informed."
Women in the US are apparently not as entitled to be informed, as recent news reports about Gardasil have focused primarily on information that the vaccine has proved to be extremely effective against HPV strain 16 for up to 8.5 years—a statistic that now appears to be rather beside the point.
Senior public health experts in Scotland also warned that HPV vaccines might not be as effective as expected after reviewing the two large-scale studies of Gardasil. Although the competing vaccine Cervarix is administered by the National Health program in Scotland, Cervarix uses the same VLP-type vaccine along with a novel adjuvant to target the same cancer-causing viruses. Specific data about Cervarix’s efficacy is not currently available.
The randomized, placebo-controlled trials of Gardasil followed 17,622 women who underwent Pap testing at the start of the trials and then every 6 to 12 months. All the women showed no exposure to 14 common HPV types and had normal Pap smears to begin with. After 3.6 years abnormal cells were reduced by between 17 and 45 percent, depending on the type.
Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.
Results Unsurprising
A study published earlier this year in the Journal of the National Cancer Institute (JNCI) looked at both early and invasive cervical cancers from 1980 to 1999 in a New Mexico population. The study found that HPV types 16 and 18 had caused 66.3 percent (not 70 percent) of cervical cancers and, more worryingly, that type 16 was already being replaced by types other than 16 or 18 (the two strains covered by both Gardasil and Cervarix).
Although this replacement was taking place pre-Gardasil, experts have long theorized that one or more of the many other strains of HPV could fill the biological niche left by elimination of 16 and 18. This kind of ‘replacement disease’ has already been seen with the pneumococcal vaccine Prevnar. It’s unclear at this point whether replacement diseases have been the cause of Gardasil’s disappointing results as Merck did not release an analysis of the types of HPV found to have caused the abnormalities in the study subjects.
Merck is having better luck with Gardasil’s efficacy against genital warts. Gardasil, unlike Cervarix, also guards against two wart-causing strains and reports from Australia show that new diagnoses of genital wart infections have dropped by 48 percent.
Meanwhile, women who are weighing the pros and cons of the Gardasil vaccine, now have more complete information, even if—distressingly—the results of the two studies have received little publicity. Reports have associated convulsions, paralysis, epilepsy, numbness etc. with the vaccine, although as yet no causal link has been established.
Oops. Real-life study results don’t bear out that assumption at all, and now that Gardasil has been found in two placebo-controlled studies to reduce pre-cancerous cells by just a meager 17 to 45 percent, both Scotland and Germany are reconsidering their hugely expensive HPV vaccination programs.
13 leading scientists in Germany have said that the vaccine is leaving women vulnerable to other strains of the virus and that information about its effectiveness is misleading. The Robert Koch institute, which makes recommendations about publicly-funded vaccination programs in Germany, is reassessing Gardasil and expects to issue a report within about two weeks. As one expert said, "The results of the studies clearly contradict many overly optimistic pronouncements. Women are entitled to be adequately informed."
Women in the US are apparently not as entitled to be informed, as recent news reports about Gardasil have focused primarily on information that the vaccine has proved to be extremely effective against HPV strain 16 for up to 8.5 years—a statistic that now appears to be rather beside the point.
Senior public health experts in Scotland also warned that HPV vaccines might not be as effective as expected after reviewing the two large-scale studies of Gardasil. Although the competing vaccine Cervarix is administered by the National Health program in Scotland, Cervarix uses the same VLP-type vaccine along with a novel adjuvant to target the same cancer-causing viruses. Specific data about Cervarix’s efficacy is not currently available.
The randomized, placebo-controlled trials of Gardasil followed 17,622 women who underwent Pap testing at the start of the trials and then every 6 to 12 months. All the women showed no exposure to 14 common HPV types and had normal Pap smears to begin with. After 3.6 years abnormal cells were reduced by between 17 and 45 percent, depending on the type.
Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.
Results Unsurprising
A study published earlier this year in the Journal of the National Cancer Institute (JNCI) looked at both early and invasive cervical cancers from 1980 to 1999 in a New Mexico population. The study found that HPV types 16 and 18 had caused 66.3 percent (not 70 percent) of cervical cancers and, more worryingly, that type 16 was already being replaced by types other than 16 or 18 (the two strains covered by both Gardasil and Cervarix).
Although this replacement was taking place pre-Gardasil, experts have long theorized that one or more of the many other strains of HPV could fill the biological niche left by elimination of 16 and 18. This kind of ‘replacement disease’ has already been seen with the pneumococcal vaccine Prevnar. It’s unclear at this point whether replacement diseases have been the cause of Gardasil’s disappointing results as Merck did not release an analysis of the types of HPV found to have caused the abnormalities in the study subjects.
Merck is having better luck with Gardasil’s efficacy against genital warts. Gardasil, unlike Cervarix, also guards against two wart-causing strains and reports from Australia show that new diagnoses of genital wart infections have dropped by 48 percent.
Meanwhile, women who are weighing the pros and cons of the Gardasil vaccine, now have more complete information, even if—distressingly—the results of the two studies have received little publicity. Reports have associated convulsions, paralysis, epilepsy, numbness etc. with the vaccine, although as yet no causal link has been established.
Monday, May 11, 2009
Gardasil and Conflicts of Interest in Cancer Studies
It’s just been one thing after another for drug companies lately. Hot on the heels of revelations that Gardasil maker Merck had published several issues of an entire fake medical journal—as well as maintaining a list of nay-saying researchers and doctors to be ‘discredited’ or ‘neutralized’—comes a new study regarding potential conflicts of interest in cancer study reporting.
A team from the University of Michigan looked at more than 1,500 cancer studies published in well-regarded journals like Cancer, The New England Journal of Medicine and The Lancet.
Although researchers are supposed to disclose any conflict of interest the boundaries are often unclear, and the study found that there are many such potential conflicts that could influence more favorable reporting of results when financial backers are involved.
The study found that where a potential conflict existed, randomized trials were more likely to link patient survival to a particular treatment.
Furthermore, although conflicts such as industry funding, co-authorship with industry employees or consulting fees were declared in only 17 percent of studies published in the eight major journals, a review of authorship credits found conflicts in a whopping 29 percent.
Also, 62 percent of industry studies focused on treatment while only 36 percent of non-industry studies did so. Conversely, 47 percent of non-industry studies looked at epidemiology, prevention, risk factors, screenings or diagnostic methods, while only 20 percent of industry studies did so—a compelling argument for moving away from purely market-driven research.
The study’s authors concluded that "attempts to disentangle the cancer research effort from industry merit further attention, and journals should embrace both rigorous standards of disclosure and heightened scrutiny when conflicts exist."
The study is to be published in the June 15 issue of Cancer.
Skewed drug trial reporting
The UM study is just the latest in a long line of studies critical of drug company ploys and drug trial reporting.
Earlier this year a UCSF study found that ‘skewed’ reports of drug trial in medical journals are often written either by physicians involved in the development of the drug, or by specialized companies that attribute authorship to doctors who have participated in the trials. Such articles typically emphasize the positive reports of the trials.
Bias was shown, according to the study, both by lack of publication of trials with unfavorable outcomes and by selective reporting of data. Trials with favorable outcomes were about five times more likely than those with unfavorable outcomes to be published; there were often many discrepancies between the results the FDA received and the published data; and one-fourth of the results of trials testing the effectiveness of new drugs were not published at all within five years after the FDA approved them.
Studies on bias in medical journals shouldn’t be taken lightly by either publishers or doctors. Many doctors decide which therapies to use based largely on what they read in medical journals, and evidence of potentially biased and incomplete reporting ought to be seriously worrisome—particularly for patients who rely on their doctors to have good information.
For example, our pediatrician and my daughter’s gynecologist are both really pushing for our girls to get the series of Gardasil shots. Gardasil, by protecting against four strains of HPV (human papillomavirus) is intended to stop cervical cancer before it starts. But how accurate and complete is the information our doctors have been getting about Gardasil?
A team from the University of Michigan looked at more than 1,500 cancer studies published in well-regarded journals like Cancer, The New England Journal of Medicine and The Lancet.
Although researchers are supposed to disclose any conflict of interest the boundaries are often unclear, and the study found that there are many such potential conflicts that could influence more favorable reporting of results when financial backers are involved.
The study found that where a potential conflict existed, randomized trials were more likely to link patient survival to a particular treatment.
Furthermore, although conflicts such as industry funding, co-authorship with industry employees or consulting fees were declared in only 17 percent of studies published in the eight major journals, a review of authorship credits found conflicts in a whopping 29 percent.
Also, 62 percent of industry studies focused on treatment while only 36 percent of non-industry studies did so. Conversely, 47 percent of non-industry studies looked at epidemiology, prevention, risk factors, screenings or diagnostic methods, while only 20 percent of industry studies did so—a compelling argument for moving away from purely market-driven research.
The study’s authors concluded that "attempts to disentangle the cancer research effort from industry merit further attention, and journals should embrace both rigorous standards of disclosure and heightened scrutiny when conflicts exist."
The study is to be published in the June 15 issue of Cancer.
Skewed drug trial reporting
The UM study is just the latest in a long line of studies critical of drug company ploys and drug trial reporting.
Earlier this year a UCSF study found that ‘skewed’ reports of drug trial in medical journals are often written either by physicians involved in the development of the drug, or by specialized companies that attribute authorship to doctors who have participated in the trials. Such articles typically emphasize the positive reports of the trials.
Bias was shown, according to the study, both by lack of publication of trials with unfavorable outcomes and by selective reporting of data. Trials with favorable outcomes were about five times more likely than those with unfavorable outcomes to be published; there were often many discrepancies between the results the FDA received and the published data; and one-fourth of the results of trials testing the effectiveness of new drugs were not published at all within five years after the FDA approved them.
Studies on bias in medical journals shouldn’t be taken lightly by either publishers or doctors. Many doctors decide which therapies to use based largely on what they read in medical journals, and evidence of potentially biased and incomplete reporting ought to be seriously worrisome—particularly for patients who rely on their doctors to have good information.
For example, our pediatrician and my daughter’s gynecologist are both really pushing for our girls to get the series of Gardasil shots. Gardasil, by protecting against four strains of HPV (human papillomavirus) is intended to stop cervical cancer before it starts. But how accurate and complete is the information our doctors have been getting about Gardasil?
Friday, May 8, 2009
Are Gardasil Benefits Worth the Potential Side Effects?
The Gardasil results so far are in: a 17 to 45 percent reduction in abnormal Pap smears.
Merck’s newest press releases publicizes a study that showed a 96% protection against HPV strain type 16, (which causes some 53.2% of invasive cervical cancers) over 8.5 years—and sure, that’s impressive. But the drug company’s marketing department probably hoped that journalists wouldn’t read the rest of the press release too closely, particularly on a Friday. Or, come to that, ask about type 18, which causes 13.1% of cervical cancers and goes curiously unmentioned.
But about those reductions in abnormal Pap smears.
Two randomized, placebo-controlled trials of Gardasil followed 17,622 women who underwent Pap testing at the start of the trials and then every 6 to 12 months. All the women showed no exposure to 14 common HPV types and had normal Pap smears to begin with.
After 3.6 years, the results were as follows:
· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significance associated with a high-risk type of HPV
· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion
· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion
· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion
Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.
Now, if you’re one of the women who’s suffered an abnormal Pap smear and/or cervical cancer, those results probably look pretty good to you.
But—seriously? That’s it? 17 to 45 percent reduction?
And I’m curious. Given that type 16 supposedly causes the vast majority of 66-70 percent of cervical cancer (18 trails it by a mile) but was shown in a study published in the Journal of the National Cancer Institute to be losing ground to non-18 types, did anyone check the results for evidence that other strains of HPV are becoming more common? Does anyone care?
Heck, I was starting to waver again on the news that cases of genital warts have dropped dramatically, according to recent reports from Australia. And I’m constantly looking at the Gardasil issue. I always keep in mind the possibility that at some point the pros might outweigh the cons (cons like the potential for some particularly nasty, if unproven, side effects as well as the unknown of replacement diseases like those that popped up with Prevnar.)
But if that’s all the protection we’re looking at just in the short-term, when women have been less exposed to HPV of all kinds than they probably will be later in life, not vaccinating seems like a no-brainer.
Merck’s newest press releases publicizes a study that showed a 96% protection against HPV strain type 16, (which causes some 53.2% of invasive cervical cancers) over 8.5 years—and sure, that’s impressive. But the drug company’s marketing department probably hoped that journalists wouldn’t read the rest of the press release too closely, particularly on a Friday. Or, come to that, ask about type 18, which causes 13.1% of cervical cancers and goes curiously unmentioned.
But about those reductions in abnormal Pap smears.
Two randomized, placebo-controlled trials of Gardasil followed 17,622 women who underwent Pap testing at the start of the trials and then every 6 to 12 months. All the women showed no exposure to 14 common HPV types and had normal Pap smears to begin with.
After 3.6 years, the results were as follows:
· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significance associated with a high-risk type of HPV
· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion
· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion
· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion
Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.
Now, if you’re one of the women who’s suffered an abnormal Pap smear and/or cervical cancer, those results probably look pretty good to you.
But—seriously? That’s it? 17 to 45 percent reduction?
And I’m curious. Given that type 16 supposedly causes the vast majority of 66-70 percent of cervical cancer (18 trails it by a mile) but was shown in a study published in the Journal of the National Cancer Institute to be losing ground to non-18 types, did anyone check the results for evidence that other strains of HPV are becoming more common? Does anyone care?
Heck, I was starting to waver again on the news that cases of genital warts have dropped dramatically, according to recent reports from Australia. And I’m constantly looking at the Gardasil issue. I always keep in mind the possibility that at some point the pros might outweigh the cons (cons like the potential for some particularly nasty, if unproven, side effects as well as the unknown of replacement diseases like those that popped up with Prevnar.)
But if that’s all the protection we’re looking at just in the short-term, when women have been less exposed to HPV of all kinds than they probably will be later in life, not vaccinating seems like a no-brainer.
Cervarix versus Gardasil
The battle’s on. And let the marketing campaigns and medical sniping begin.
GlaxoSmithKline said today that the results of a comparative HPV vaccine study it had sponsored showed that Cervarix generated between two and six times as many antibodies as Gardasil.
Both vaccines utilize novel “virus-like particles,” VLPs. These are created by inserting DNA into yeast cells to make a genetically-engineered ‘seed stock’. The resulting paste is cultured in a fermenter to increase cell mass and then incubated; eventually the antigen VLPs are filtered from the paste and blended with adjuvants. The paste is then cleaned and reused.
Both vaccines protect against HPV strains 16 and 18, thought to be responsible for 66 to 70 percent of cervical cancers, although one study recently showed 16 to have been losing ground to strains other than 18 (there are believed to be up to 120 strains of HPV) for some years. Gardasil also protects against two wart-causing strains.
But Cervarix also uses a novel adjuvant containing aluminium salt and monophosphoryl lipid A (MPL), and according to GSK that makes a big difference in antibody levels—a claim that made a Merck spokesman sniff disparagingly, “It's disease efficacy that's really the most important, and we certainly have very high efficacy against some very important disease endpoints."
Cervarix has been used in the EU for some time and was chosen over Gardasil by Britain for its country-wide vaccination program. However, the FDA is currently looking it over for approval in the US, where Merck has had the market to itself up until now.
Both vaccines have been associated with side-effects including paralysis, convulsions and immune disorders, although no causal link has been proven and the CDC beleives that HPV vaccines are safe.
Approval for Cervarix in the US could come by the fall—so if you think the Gardasil campaign up to now has been aggressive, honey, you ain’t seen nothin’ yet.
GlaxoSmithKline said today that the results of a comparative HPV vaccine study it had sponsored showed that Cervarix generated between two and six times as many antibodies as Gardasil.
Both vaccines utilize novel “virus-like particles,” VLPs. These are created by inserting DNA into yeast cells to make a genetically-engineered ‘seed stock’. The resulting paste is cultured in a fermenter to increase cell mass and then incubated; eventually the antigen VLPs are filtered from the paste and blended with adjuvants. The paste is then cleaned and reused.
Both vaccines protect against HPV strains 16 and 18, thought to be responsible for 66 to 70 percent of cervical cancers, although one study recently showed 16 to have been losing ground to strains other than 18 (there are believed to be up to 120 strains of HPV) for some years. Gardasil also protects against two wart-causing strains.
But Cervarix also uses a novel adjuvant containing aluminium salt and monophosphoryl lipid A (MPL), and according to GSK that makes a big difference in antibody levels—a claim that made a Merck spokesman sniff disparagingly, “It's disease efficacy that's really the most important, and we certainly have very high efficacy against some very important disease endpoints."
Cervarix has been used in the EU for some time and was chosen over Gardasil by Britain for its country-wide vaccination program. However, the FDA is currently looking it over for approval in the US, where Merck has had the market to itself up until now.
Both vaccines have been associated with side-effects including paralysis, convulsions and immune disorders, although no causal link has been proven and the CDC beleives that HPV vaccines are safe.
Approval for Cervarix in the US could come by the fall—so if you think the Gardasil campaign up to now has been aggressive, honey, you ain’t seen nothin’ yet.
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