Can Genes be Patented?

After several years of court battles and reversals of previous court decisions, there’s still no final decision on whether or not a human gene variant can be patented (see "Patenting Human Genes - An Update.") A company called Myriad Genetics believes that it holds a valid patent on the two gene variants known to confer a high risk of breast cancer, called BRCA1 and BRCA2. The company makes over 80% of its total revenue (over $350 million a year) from its BRACAnalysisR test for the presence of the gene.

To bring you up to date since my last post on this issue, two lower courts ruled that the patent was invalid. Then in 2011 the U.S. Court of Appeals for the Federal Circuit reversed the decision of the lower courts, ruling that the Myriad Genetics patents on the BRCA1 and BRCA2 genes were valid. But that was not the end of it. Last month the U.S. Supreme court issued a statement that it would “vacate”, or dismiss the Court of Appeals’ decision. In effect, the Supreme Court kicked the case back to the Court of Appeals “for further consideration”. It’s a gentle way of asking the lower court to reconsider their decision, without the Supreme Court itself having to issue a ruling.

In a previous decision in an unrelated case, the Supreme Court made it clear that structures or processes governed by “the laws of nature” cannot be patented. By kicking the Myriad Genetics case back down to the Court of Appeals, the Supreme Court seems to be asking the Court of Appeals to consider carefully whether the sequence of a gene is governed by the laws of nature, and hence not patent-eligible.

As long as the issue remains undecided, Myriad Genetics continues to have exclusive control over the BRCA gene test and will continue to profit from it. Given the way the Supreme Court seems to be leaning on this issue, it may be in Myriad Genetic’s best interest to drag the court battle out as long as possible. We can expect the company to defend its putative patent vigorously once the Court of Appeals takes up the case again.

The High Cost of Specialty Drugs

Generally speaking, the smaller the market for a drug, the more expensive the drug is. That’s because it costs a lot to develop, test, and market a new drug – on the order of $500 million or more. The pharmaceutical company must eventually recover those costs through drug sales or they couldn’t stay in business. As a result, some drugs, called “specialty drugs” because so few patients need them, can cost upwards of $100,000 per year.

Who should pay for the high cost of specialty drugs? Insurance companies argue that these drugs are costing them too much, and they’d like to shift some of the cost to the patients in the form of co-pays on the order of 30% or more. But some patients worry that even at $30,000, they still won’t be able to pay for their drugs. Responding to public pressure from patient’s advocacy groups, at least 20 states have passed or are at least considering laws that would limit the out-of-pocket drug expenses to patients. And they have surprising allies – the very pharmaceutical companies that manufacture and sell these expensive drugs. That’s because the drug companies know that high co-payments discourage patients from taking their medications, thereby lowering drug sales. In some cases pharmaceutical company representatives have even helped state legislators draft the legislation!

The impending federal health care law (now called Obamacare by many politicians) would also set limits how much patients have to pay for drugs. But the law doesn't take full effect until 2014, and right now no one knows whether or not the law will still be in effect by that time. In the meantime, the issue of who pays for really expensive drugs is being resolved state by state.

Limiting Antibiotic Use in Farm Animals

On Jan. 7, 2012 on this blog, I suggested that the FDA would probably not try to limit the indiscriminate use of antibiotics in farm animals until the problem of antibiotic resistance got much worse. I’m happy to say I may have been wrong. This week the FDA announced that it is issuing “guidance” to farmers, veterinarians, and drug companies in an attempt to get them to voluntarily use fewer antibiotics solely to increase meat or milk yield in healthy animals. The animal agriculture industry uses nearly 30 million pounds of antibiotics per year, mostly in animal feed, even when the animals are healthy.

Compliance with the FDA’s new guidance will be voluntary for now. That leaves one wondering whether it’ll have any real effect. But apparently the FDA is serious about this. The FDA has promised to monitor the usage of antibiotics over the next three years. If antibiotic use does not decline as the FDA hopes, the FDA will “…consider further action as warranted….”. The message to the animal agriculture industry is clear; reduce the use of antibiotics voluntarily, or we’ll reduce it for you. 

It’s the right approach. The FDA is well aware that the meat production industry relies heavily on antibiotics to increase yield. The agency has no desire to disrupt a major U.S. industry unnecessarily. Yes, it’s important that we do something to try to do something about the current rapid rate of development of antibiotic resistance, but that has to be balanced against the potential negative consequences of taking too severe an action too quickly. The FDA’s attempt at a little arm-twisting might just work. And if it doesn’t, action can always be taken later.

FDA Not Ready to Ban BPA

In response to a petition from the Natural Resources Defense Council (NRDC) that bisphenol A (BPA) be banned from food packaging, the Food and Drug Administration (FDA) says that there is not enough scientific evidence that BPA is harmful to humans to warrant banning the chemical at this time. It’s a predictable and defensible statement from a government agency charged with safeguarding the public health. How else should they act without evidence?

BPA is used as a softening agent in hard plastics such as reusable water bottles and baby bottles, and in the plastic lining of food cans. It belongs to a class of chemicals called “endocrine disruptors” that mimic the effects of the hormone estrogen. In animal studies, toxic doses of BPA may disrupt growth and development or cause endocrine or nervous system disorders. No one knows for sure if it’s harmful at the much lower doses to which humans are exposed, but many consumers continue to be concerned.

The FDA continues to study the health effects of BPA. The agency is likely to act quickly if evidence of harm ever emerges. In the meantime, for people who remain concerned the agency offers advice on how to limit one’s exposure to the chemical.

Companies that make consumer products, on the other hand, don’t feel obligated to wait for scientifically defensible evidence – the court of public opinion is enough for them. Baby-bottle makers and some canned food companies are already searching for alternatives and phasing out their use of the chemical wherever possible.

Abstinence Doesn’t Resonate with Teens

Teen pregnancy and birth rates vary widely by state, according to the Centers for Disease Control and Prevention (CDC). The highest rates were in five southern states; Arkansas, Mississippi, New Mexico, Oklahoma, and Texas. Mississippi topped the list, with 65.7 births per 1,000 teens aged 15-19 in 2008. The lowest rates were in four northeastern states; Connecticut, New Hampshire, Massachusetts and Vermont. New Hampshire had the lowest teen pregnancy rate, with only 19.8 births per 1,000 teens.

The Guttmacher Institute, a non-profit organization focused on sexual and reproductive health and education, was quick to point out that the five states with the highest teen birth rates all require that abstinence be stressed in their education programs on sex or HIV, whereas none of four states with the lowest rates specifically require that abstinence be stressed. The implication is that teen birth rates are lower when students are provided with comprehensive, evidence-based sex education than when they are just told that abstinence is a goal.

Critics of the findings say that there are many other differences between the states with the highest and the lowest teen pregnancy rates, including racial and cultural differences. However, the disparities remain even when race is factored out.

Of course a correlation does not prove causation. But it’s still an interesting hypothesis, that stressing abstinence is not an effective way to reduce teen pregnancies.