Allergan Seeks to Preserve a Drug Patent

Here's a novel idea for protecting your drug patent: sign it over to a Native American tribe. Allergan is trying to do just that with its blockbuster drug Restasis, according to a news release from the company.

According to the news release, Allergan has transferred its patents for Restasis to a Native American tribe in New York. The deal stipulates that Allergan will pay the tribe royalties of about $15 million a year in exchange for exclusive rights to the patents. For its part, the tribe will argue to the United States Patent Trademark Office that they have sovereign immunity, and hence the patent cannot be challenged by the U.S. government.

The move, if it works, would shake up the drug industry and perhaps give Native American tribes a significant new source of revenue. But make no mistake; it'll be the drug companies that will be the big winners. Restasis had sales of more than $330 million in just the past three months.

H7N9 Bird Flu is Still Around

Have you forgotten about bird flu? Well, don't, because it's still around. In fact the 2017 flu season was the worst ever, according to the CDC. From Oct. 2016 to the summer of 2017, the H7N9 strain of bird flu infected 759 people. About a third of them - 281 people - died. That's nearly as many as the total number of deaths in the four previous years combined.

CDC officials consider H7N9 to "the influenza virus with the highest potential pandemic risk", according to a weekly report from the agency. Fortunately, the virus has not yet evolved to be easily transmitted between humans; nearly all cases to date have been the result of contact with infected birds. But if the virus ever does mutate to become more easily transmissible between humans, watch out!

Health officials continue to monitor the virus closely for any signs that it is changing in ways that would make it a worldwide threat. But so far, all cases have been in China, Hong Kong, and Macao.

Innate Fitness May Affect Cancer Risk

It's been known for several years now that being physically fit reduces a woman's risk of breast cancer. But how? Is there something about actively engaging in an exercise regimen that reduces risk, or is it just a function of being naturally fit (called "innate" fitness)? Or both?

To try to address this question, researchers took advantage of groups of rats that had been bred to be either genetically "fit" or genetically "not fit". The two populations were created over many generations by exercising rats on a treadmill; those that could run long distances were bred to other rats that also ran long distances; those that were poor exercisers were bred to other poor exercisers. Over time, the groups diverged in terms of innate fitness.

In recent experiments, then, female offspring of the "fit" and "not fit" groups were exposed to a known carcinogen. None of the rats in either group engaged in exercise after birth, so any differences between the two groups must be attributable to innate fitness, rather than exercise per se. The results were strikingly different - the incidence of breast cancer was reduced by more than 70% in the "fit" rats, compared to the "not fit" rats.

It's not known yet whether an active exercise regimen would reduce the risk of breast cancer in the "not fit" rats. Undoubtedly that will be tested next. But for now, the new information is that there's something about the metabolism of innately fit rats (and perhaps humans) that protects against breast cancer, even if they're not routinely exercising.

The researchers looked only at breast cancer as their measured endpoint in these experiments, but perhaps fitness affects the risks other cancers as well.

Childhood Leukemia Treatment to Cost $475,000.

Remember that new gene-based therapy for childhood leukemia that was approved by the FDA this past summer? (See this blog, July 15, 2017). Novartis, the company responsible for developing the therapy, has finally put a price to it; $475,000 for a full treatment regimen, according to an article in The Guardian.

Consumer groups are worried that prices such as this will usher in a whole new era of expensive medical treatments. At some point we have to ask - is the price for a health- or life-saving procedure just too high? How will we pay for such treatments? If health insurance companies cover the treatment, then surely they'll recover their costs by raising the price of health insurance for us all.

The company claims that the price is justified by its need to earn a return on its investment. Hmmm....

Sperm Count in Western Males is Declining

Is male sperm count declining? It's been a topic of debate for some time now. The problem is that the decline, if it exists, has been so slow that it has been difficult to measure.

To answer the question of whether or not male sperm count is declining, researchers conducted a massive meta-study (an analysis of many previous studies) of male ejaculate sperm concentration and total sperm count. Authors of the meta-study looked for all previous studies of sperm concentration and sperm count in Western men (men from North America, Europe, Australia and New Zealand) published between 1973 and 2011. In all, the meta-study included data from 185 previous studies involving almost 43,000 Western men over almost 40 years, making it the largest such study ever. In order to avoid problems associated with changing laboratory methods, the authors included only studies that used the same laboratory analysis method throughout.

The results showed a decline of sperm concentration of only 1.4% per year (that's why it was so hard to see in individual studies). But over the nearly 40-year time span, that's a decline of over 50% in ejaculate sperm concentration! Total sperm count declined even more; by 60%, in fact.

Of course, no one has any information yet on just why the decline might be occurring. But with fairly definitive evidence now that it is occurring, we can expect researchers to turn more aggressively to the question of why, and what might be done about it.