Bad press didn’t hurt Sovaldi™ (sofosbuvir) after all. The Hepatitis C virus (HCV) treatment drew the wrath of three members of Congress, who demanded that developer Gilead Sciences justify its $84,000 price for a full 12-week treatment course of Sovaldi. The company offered its justification and didn’t have to worry about too much fallout from the criticism, since its three Congressional critics were top Democrats in the Republican-majority House of Representatives.
Even better for Gilead, which barely began marketing Sovaldi at the end of 2013, sales of the HCV treatment zoomed into eight figures—high enough to place near the top of GEN’s latest version of its List of Top 25 Best-Selling Drugs, reflecting drug sales reported for 2014.
Unlike last year’s Top 25 Best-Selling Drugs of 2013, this year’s list had only 24 drugs generating total sales of $3 billion or more. That allowed the 25th best-selling drug of 2014 to make this year’s list (it appeared in GEN’s Top 20 Best-Selling Drugs list in 2012 but missed 2013), despite sales in only the high-$2 billion range.
Biopharma is in a transition period as the blockbusters of the past decade fade. They have either fallen off the proverbial patent cliff (Novartis’ Diovan, which lost US exclusivity in 2012) or succumbed to a stronger U.S. dollar against European and Asian currencies despite rising sales (Novo Nordisk’s NovoLog, which also missed this year’s list). At the same time, the next generation of multi-billion-dollar drugs takes time to build the billions in sales needed to make the best-seller list—but can be expected to do so starting next year.
At the top, last year’s winner finished #1 again, and with higher sales than 2013. Indeed more than half (16) of the Top 25 best-selling drugs did better in 2014 than the previous year. Among the top three disease categories, six best-selling drugs have indications for forms of cancer, and five for arthritis. Five indications—asthma/COPD, diabetes, heart disease, HIV, and multiple sclerosis—are each represented on the list by two best sellers.
One likely top-seller of 2014 not on the list is Boehringer Ingelheim’s Spiriva, which racked up €3.552 billion ($4.019 billion) in 2013. However, BI will not release full-year 2014 data until April 22, just as it waited until April 2014 to release 2013 data, explaining its absence from GEN’s list.
Top-selling drugs are ranked based on sales or revenue reported for 2014 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), diseases indicated, 2014 sales, 2013 sales, and the percentage change between both years.
Chances are you’re hitting the sauna after an intense workout to help lose weight, but the time you spend sweating it out could also promote better heart health. A recent studypublished in JAMA Internal Medicine has found that not only are saunas safe for people with poor heart health, but they may also reduce our risk for fatal cardiovascular events and all-cause mortality.
“Further studies are warranted to establish the potential mechanism that links sauna bathing and cardiovascular health,” authors of the study said in a statement.
Lead researcher from the University of Eastern Finland Dr. Jari A. Laukkanen and his colleagues recruited 2,314 men between the ages of 42 and 60 from eastern Finland. Researchers set out to determine any potential link between number of sauna bathing sessions per week and each man’s risk for sudden cardiac death (SCD), fatal coronary heart disease (CHD), fatal cardiovascular disease (CVD), and all-cause mortality. After 21 years of follow-up, the research team identified 190 cases of SCD, 281 CHD, 407 cases of CVD, and 929 deaths from all causes.
The risk for SCD among men who reported two to three sauna bathing sessions per week was 63 percent lower compared to men who reported one sauna bathing session per week. Men who reported two to three sauna bathing sessions per week were also 23 percent less likely to develop CHD, 27 percent less likely to develop CVD, and 24 percent less likely to die from all causes compared to men who reported one sauna bathing session.
Compared to men who reported one sauna bathing session, men who reported four to seven sauna bathing sessions per week had a 63 percent lower risk for SCD, 48 percent lower risk for CHD, 50 percent lower risk for CVD, and 40 percent lower risk for all-cause mortality. Risk for fatal cardiovascular events dropped by over 50 percent in men who reported spending more than 19 minutes in a sauna.
“Although we do not know why the men who took saunas more frequently had greater longevity (whether it is the time spent in the hot room, the relaxation time, the leisure of a life that allows for more relaxation time or the camaraderie of the sauna), clearly time spent in the sauna is time well spent,” Dr. Rita F. Redberg, from the University of California, San Francisco, and editor-in-chief of JAMA Internal Medicine, said in a related Editor’s Note.
According to the Harvard Medical School, dry heat from a sauna can reach as high as 185 degrees Fahrenheit, causing skin temperature to soar to around 104 degrees Fahrenheit. After spending a couple of minutes in a sauna, the average person loses around a pint of sweat. While the body is reacting to such high heat, pulse rate increases by 30 percent or more, and the heart nearly doubles the amount of blood it is pumping each minute.
Source: Laukkanen J, Zaccardi F, Khan H, Laukkanen T. Association Between Sauna Bathing and Fatal Cardiovascular and All-Cause Mortality Events. JAMA Internal Medicine. 2015.
From the desk of Zedie.
Vasalgel, a reversible, non-hormonal polymer that blocks the vas deferens, is about to enter human trials. How will rhetoric change when male bodies become responsible for birth control?
Vasalgel, a reversible form of male birth control, just took one step closer to your vas deferens.
According to a press release from the Parsemus Foundation, a not-for profit organization focused on developing low-cost medical approaches, Vasalgel is proving effective in a baboon study. Three lucky male baboons were injected with Vasalgel and given unrestricted sexual access to 10 to 15 female baboons each. Despite the fact that they have been monkeying around for six months now, no female baboons have been impregnated. With the success of this animal study and new funding from the David and Lucile Packard Foundation, the Parsemus Foundation is planning to start human trials for Vasalgel next year. According to their FAQ page, they hope to see it on the market by 2017 for, in their words, less than the cost of a flat-screen television.
So how does Vasalgel work? It is essentially a reimagining of a medical technology called RISUG (reversible inhibition of sperm under guidance) that was developed by a doctor named Sujoy Guha over 15 years ago in India, where it has been in clinical trials ever since. Unlike most forms of female birth control, Vasalgel is non-hormonal and only requires a single treatment in order to be effective for an extended period of time. Rather than cutting the vas deferens—as would be done in a vasectomy—a Vasalgel procedure involves the injection of a polymer contraceptive directly into the vas deferens. This polymer will then block any sperm that attempt to pass through the tube. At any point, however, the polymer can be flushed out with a second injection if a man wishes to bring his sperm back up to speed.
Unlike most forms of female birth control, Vasalgel is non-hormonal and only requires a single treatment in order to be effective for an extended period of time.
The Parsemus Foundation’s messaging on Vasalgel has focused on making the technology appealing to men. In a New York Times op-ed published this year, Elaine Lissner of the Parsemus Foundation pitches the product to “a 20-something or 30-something man, out on the dating market” who is worried about the effectiveness of the pill, given how many women forget to take pills during any given cycle. This pitch, too, is a plea for help. The Parsemus Foundation has to rely on donations and crowdfunding in order to bring male birth control to the market. Long-term treatments like Vasalgel are much less appealing to potential funders in the pharmaceutical industry who, as they observe, would much rather “sell pills to men’s partners every month.” Why sell a flat-screen television to a man, after all, when you can rent one to a woman for a decade?
In other words, the medical industry’s investment in the multibillion-dollar female birth control industry might block men’s access to male birth control just as effectively as Vasalgel would block their sperm. But a contraceptive polymer like Vasalgel would be a major medical innovation for more than just the man about town looking to copulate without consequence. In fact, male birth control could be the next major medical advance in women’s health, as strange as that idea seems.
If the use of polymer contraceptives were to become widespread, male birth control would completely transform the ways in which we understand sexual and reproductive health. Ever since men started wrapping animal intestines around their penises hundreds of years ago, we have been approaching birth control as a way of temporarily preventing fertilization inside a woman’s body. But what if we haven’t been able to see the forest through the ovaries? What if we could use polymer contraceptives like Vasalgel to block sperm at the source, rather than implementing expensive, convoluted, and potentially harmful contraceptive countermeasures inside women’s bodies?
If Vasalgel were to become as widespread and inexpensive as the Parsemus Foundation expects, unintended pregnancies could be substantially reduced. According to the Center for Disease Control, nearly half of pregnancies in the United States are unintended. That figure rises to 80 percent of all pregnancies among women age 19 and younger, and to 90 percent below age 15. The physical, financial, and emotional toll of an unintended pregnancy can be immense. As a report from the Guttmacher Institute notes, the average cost of an abortion is $485, which “pose[s] a major financial burden for women seeking these services,” who are often lower income. Not all unintended pregnancies are unwanted, however, and given the fact that modern birth control has deep roots in Planned Parenthood founder Margaret Sanger’s belief in eugenics, the benefits of male birth control for lower-income families in particular should not be overemphasized.
Even if we set the prevention of unintended pregnancies aside, however, the potentially deleterious side effects of female birth control are enough to justify the implementation of Vasalgel on their own. As WomensHealth.Gov notes, side effects of the birth control pill include an increased risk of heart disease, high blood pressure, blood clots, nausea, irregular bleeding, and depression. Less common methods of contraception like diaphragms and sponges can cause the rare and life-threatening toxic shock syndrome (TSS). Injections like Depo-Provera can cause bone loss and the use of intrauterine devices (IUDs) can potentially cause rips or tears in the uterus itself. It would take a commercial announcer a full minute of speed-reading to list off all the risks of every form of female birth control. Interrupting ovulation and fertilization is a complex process that requires a degree of hormonal regulation, often impacting other areas of a woman’s health.
What if we could use polymer contraceptives like Vasalgel to block sperm at the source, rather than implementing expensive and potentially harmful contraception inside women’s bodies?
But as luck would have it, you don’t have to tamper with testosterone in order to block sperm. It might seem as if men are unstoppable sperm machines, especially given the fact they produce 1,500 of them per second. But because sperm are as fickle as they are plentiful, technologies like Vasalgel and RISUG need not interfere with the production of sperm itself in the same way that female birth control often interferes with ovulation. Like the Little Dutch Boy walking by a dike on the brink of bursting, Vasalgel can simply plug up the vas deferens and stop an entire sea of sperm from crashing through. It promises to be a parsimonious solution to the age-old problem of preventing unwanted pregnancies. This is nothing short of Occam’s razor for your testicles.
While the way Vasalgel works inside a man’s body might be simple, its cultural impact would be complex. The Religious Right, in particular, has grown accustomed to a world in which regulating access to birth control means regulating women’s bodies, rather than men’s bodies. Although the Affordable Care Act began offering women no-to-low-cost contraceptive coverage in 2010, the Supreme Court’s now-infamous Hobby Lobby ruling this summer allowed “closely-held corporations” to offer health insurance plans without contraceptive coverage. The Hobby Lobby ruling is already being used to try to undermine Obamacare’s contraceptive requirement altogether. This week, Missouri state Representative Paul Wieland’s lawsuit against the U.S. Department of Health and Human Services went to the Eighth U.S. Circuit Court of Appeals. The court will consider whether or not it is constitutional for “closely-held corporations” to be able to opt out of contraceptive coverage while states like Missouri cannot.
If Vasalgel became popular and affordable enough to surpass female birth control, it would put the Religious Right’s opposition to contraception to the test.
Lost in all of this legal conflict, however, is the fact that Hobby Lobby, of course, still covers vasectomies. But what if vasectomies were cheap, non-invasive, fully reversible, and as widespread as the female birth control pill? Would businesses like Hobby Lobby begin to object to them? If Vasalgel became popular and affordable enough to surpass female birth control, it would put the Religious Right’s opposition to contraception to the test. As The New York Times reported in 2012, many on the Religious Right justify their opposition to some forms of birth control by equating them with abortion because they “prevent the implantation of a fertilized egg in the uterus.” But if men’s bodies became the primary site for birth control, would religious leaders shift their rhetoric and take issue with a technology like Vasalgel on the grounds that it prevents life on a massive scale? Or do debates about life only have meaning when they take place over women’s bodies?
If the Parsemus Foundation’s optimistic timeline for the release of Vasalgel holds true, we may be forced to confront these questions sooner than expected. In the meantime, men, prepare for the possibility that you may soon take over primary responsibility for contraception from your wife or girlfriend. The future of birth control is coming and soon it might be inside of you.
Despite common preconceptions, there is no correlation between intelligence and behavior. That being said, when you think of an intelligent person, we are conditioned to think that their behavior would be boring and wholesome – like sitting in a library or sitting in front of a computer.
Well, throw that preconception out the window. Science has proven that intelligent people typically lead lifestyles that would make their mothers shake their heads. Believe it or not, there is actual scientific research that shows that people of higher intelligence stay up later, do more drugs, and have more sex. The days of the nerd stereotype are over…
The following studies support my previous statement:
1) Intelligent People Are Night Owls
A recent study in Personality and Individual Differences, which is the peer-reviewed “Official Journal of the International Society for the Study of Individual Differences (ISSID)”, researchers hypothesise that people of higher intelligence are drawn to what are known as “Novel Behaviors”. Novel Behaviors are categorized as new behaviors that are believed to be evolutionary advantages, because they enhance our problem solving abilities. Basically, it’s an evolutionary push towards new thinking and new ideas.
From the study: “Survey of ethnographies of traditional societies suggests that nocturnal activities were probably rare in the ancestral environment, so the Hypothesis would predict that more intelligent individuals are more likely to be nocturnal than less intelligent individuals. The analysis of the National Longitudinal Study of Adolescent Health (Add Health) confirms the prediction.”
The study concluded that people of higher intelligence have different circadian rhythms (sleep cycles). The study makes one very clear correlation: The higher the IQ – the later people stayed up. These results come from a sample group of more than 20,000 people.
2) Intelligent People Do More Drugs
Although it seems like the opposite would be true, people with higher IQs are more apt to experiment with psychoactive drugs. A National Child Development study reported on in Psychology Today, people who have high IQs (both in childhood and adulthood) are much more likely to experiment with psychoactive drugs than people with low IQs.
According this study which was published in the UK in 2010: “Net of sex, religion, religiosity, marital status, number of children, education, earnings, depression, satisfaction with life, social class at birth, mother’s education, and father’s education, British children who are more intelligent before the age of 16 are more likely to consume psychoactive drugs at age 42 than less intelligent children.
…there is a clear monotonic association between childhood general intelligence and adult consumption of psychoactive drugs. “Very bright” individuals (with IQs above 125) are roughly three-tenths of a standard deviation more likely to consume psychoactive drugs than “very dull” individuals (with IQs below 75).”
The belief behind this is that the use of psychoactive drugs are evolutionarily novel and different from the general behaviour of our ancestors.
3) Intelligent People Have More Sex
Now, this is a research result that really doesn’t fit with the “nerd” stereotype, but the research makes sense. Researchers in the UK found that students studying at universities such as Oxford and Cambridge spent more money on sex toys than at other universities. Annalisa Rose, 23, who works at Honey, a high-end sex shop in Williamsburg, Brooklyn. explains her theory: “The correlation probably has something to do with the open-mindedness that comes with intelligence. I think that the ability to engage in an open sex life comes with the abilities of introspection and logical thought, and those require some level of intelligence. If we’re talking about an open sex life that comes from an emotionally healthy place, sexual morals are mostly made up anyway and intelligent people can rationalize past them…High-achievers aim for excellence in all areas of their life, so it makes sense that achieving sexual happiness is one of their goals.”
If that concept seems like a stretch, The Telegraph reported that students at more prestigious colleges spent the most money on sex toys, implying a propencity to experiment in their sex lives.
Here is a list the top 5 Universities that spend the most amount of money on sex toys per year:
1) Cambridge £9,793
2) Oxford £9,689
3) Manchester £5,441
4) Lancaster £4,103
5) York £3,751
Correlation Does NOT Imply Causation
Now, I don’t want people to get the idea that staying up late, doing drugs, or playing with sex toys makes you smart. That’s not what I am saying. Just because there is a correlation does not mean that these activities are the cause. The point here is that the stereotypes associated with smart people are generally incorrect. In reality, smart people are more likely having more fun – not less.
HPV vaccine can prevent certain cancers and other diseases in men caused by human papillomavirus (HPV). CDC recommends that you get your boys and girls vaccinated at 11 or 12 to prevent cancers caused by HPV.
Do you know why boys need HPV vaccine too?
A lot of parents know that HPV vaccine protects girls against cervical cancer. But did you know that vaccinating boys can protect them against cancer, too?
HPV is short for human papillomavirus, a common virus in both women and men. HPV can cause cancers of the anus, mouth/throat (oropharyngeal cancer), and penis in men. Every year, over 9,000 men are affected by cancers caused by HPV.
Cases of anal cancer and cancers of the mouth/throat are also on the rise. In fact, if current trends continue, the annual number of cancers of the mouth/throat attributed to HPV is expected to surpass the annual number of cervical cancers by 2020.1
Many of the cancers caused by HPV infection could be prevented by HPV vaccine.
One HPV vaccine—Gardasil—is recommended by doctors and health experts for boys at ages 11-12 to prevent infection with HPV that could lead to cancer. HPV vaccine also helps prevent most cases of genital warts. HPV vaccination of boys is also likely to benefit girls by reducing the spread of HPV infection.
HPV vaccine is recommended at ages 11-12 for two reasons:
- HPV vaccine produces the highest immune response at this age.
- HPV vaccine must be given before exposure for it to be effective in preventing cancers and other diseases caused by HPV.
If you haven’t already vaccinated your sons (and daughters!), it’s not too late. Ask your child’s doctor at their next appointment about getting HPV vaccine. The series is three shots over six months’ time. Take advantage of any visit to the doctor—such as an annual health checkup or physicals for sports, camp, or college—to ask the doctor about what shots your preteens and teens need.
Is HPV vaccine safe?
HPV vaccine has been studied very carefully and shown to be safe. Approximately 67 million doses of HPV vaccine have been distributed in the U.S. since 2006, and no serious safety concerns have been linked to HPV vaccination. Common, mild side effects reported include pain in the arm where the shot was given, fever, dizziness, and nausea.
Some preteens and teens—even boys—might faint after getting the HPV vaccine or any shot. Preteens and teens should sit or lie down when they get a shot and stay like that for about 15 minutes after the shot. This can help prevent fainting and any injury that could happen while fainting.
How can I get help paying for HPV vaccine?
Families who need help paying for vaccines should ask their doctor or other healthcare professional about Vaccines for Children (VFC). The VFC program provides vaccines at no cost to children younger than 19 years who are uninsured, Medicaid-eligible, American Indian, or Alaska Native. For help in finding a local healthcare professional who participates in the program, parents can call 800-CDC-INFO or go to the Vaccines & Immunizations website..
- Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011; 29(32):4294-301
The human papillomavirus (HPV) is pretty nasty – not only can it trigger genital warts, but if it’s not controlled by the immune system, researchers have found that it can also lead to a range of cancers.
Most famously, various strains of the virus are involved in more than 99 percent of cervical cancer cases. But scientists have recently found that HPV can also triggeranal and oral cancer, and although current campaigns are targeted to young women, both males and females could benefit from being protected.
There are already two effective vaccines on the market, Gardasil, which protects against four strains of the virus, and Cervarix, which protects against two. But new research published in the New England Journal of Medicine has revealed that a new vaccine, Gardasil-9, can protect against, you guessed it, nine strains of the virus.
A randomised, double-blind clinical trial of 14,215 women aged between 16 and 26 found that Gardasil-9 can protect against five additional strains when compared to Gardasil – HPV-6, 11, 16, 18, 31, 33, 45, 52 and 58.
This means that the new vaccine could in theory prevent 90 percent of cervical cancers, compared to the 70 percent Gardasil currently stops. Overall there are 14 strains of HPV associated with cervical cancer (out of 100 known strains), so being able to protect against more than half of them is a big step forward.
As Cathleen O’Grady reports for Ars Technica, the new vaccine was also associated with more side effects than the current options, but they weren’t severe:
“In the Gardasil-9 trial, the nine-valent vaccine was associated with more side effects, but the effects were not comparably dangerous to the kinds of cancers prevented by the vaccine. The slightly higher rate was to be expected, the researchers note, because the new vaccine has more virus-like antigens. The most common effects included swelling and pain at the injection site, and some patients experienced headaches, nausea, dizziness, and fatigue.”
Despite these side effects, it’s hoped that the new uptake will be encouraged in both males and females – something that’s important given how common the virus is.
“The female-only campaigns leave men who have sex with men unprotected,” lead author of the paper Elmar Joura, from the Medical University of Vienna in Austria, told O’Grady.
At any given time, one quarter of Americans have HPV, and it’s estimated that almost all sexually active people will be infected at some point in their life. And if these infections aren’t cleared up by our immune systems, they can lead to cancers.
The researchers are also hoping that the new vaccine may help increase the uptake of the vaccine, which in the US in particular is low, with only 33.4 percent of girlshaving completed the course of three HPV vaccines, compared to 60.4 percent in the UK and 71.2 percent in Australia.
While a vaccine that protects against only some types of cancer may not be as headline-worthy as a new treatment or a cure, it’s incredible that we have a quick and easy way to protect ourselves against a whole range of cancers. And even more incredible that not everyone who is able to use it chooses to do so.