This didn't take long

The Supreme Court announcement last month probably surprised no one more than Myriad Genetics who had 'patented' the BRCA genes. But is anyone surprised that less than 30 days later they have already sued two competitors who have rolled out BRCA tests?

That's right, lose your patents, your lawyers are bored so its time to start litigation. What a productive use waste of money.

Please, I am sure since the genes were first discovered others have figured out how to test them. Maybe Myriad should come up with ways to test for some of the other myriad of genes out there? (Or was that a really bad play on words?)

More on the breast cancer treatment gap

A few weeks ago I blogged about the breast cancer treatment gap where women who are told they are BRCA positive only have surgical options to lower their risk of breast or ovarian cancer. It turns out this is growing in significance because of genetic testing progress.

This started when Angelina Jolie announced she had a prophylactic bilateral mastectomy because she was BRCA positive. Unless you have been living under a rock you couldn't have missed that story in the news recently.

While many people are supportive of her decision, some are not. Here is an article on the other side of the issue - which shows how some people are not in favor of this type of prophylactic surgery. I think this kind of decision is very personal but unfortunately there are not a lot of options for those with who test for the genetic mutation.

We can also add in the fact that insurers often are reluctant to pay for the tests. Not just the BRCA test but others for Cowden's syndrome or Li-Fraumeni syndrome, both of which are shown to raise risk for breast and other cancers.

Finally, let's top this all off with the fact that University of Alberta researchers have pinpointed markers for sporadic cases of breast cancer - meaning ones without a family history. Or about 80% of all breast cancers could be caused by these markers. They suggest that women with the marker could then proceed with prophylatic options. We know what that means.

So let's add it up:

• Researchers are finding genetic causes to more cancers.
• Insurers don't want to pay for genetic tests.
• The only options for women with the genetic mutations or markers are significant disfiguring surgery with long term complications.

So where does that leave the patients? Over the barrel without a lot of options.

What would you pay?

Would you pay $4000 for something that is only should cost $99? Apparently women who get a BRCA test pay nearly $4000 for something that should cost around $99. This because of the monopoly Myriad Therapeutics has by patenting the genes. I know I have logged about this before so may you call me redundant.

We are still waiting for the Supreme Court's response to the argument that gene's can't be patented. But Myriad is so sure that there will not be a problem for them, they are planning further profits later this year.

"Without competition, Myriad can effectively charge whatever it wants. Later this year, the company said it would begin incorporating the BRCA test into a 25-gene cancer-risk evaluation and phase out the à la carte BRCA test by 2015. For that broader test, it projects a gross profit margin of 87 percent."

I wouldn't mind an 87% profit on my investments. Would you? I'm just awaiting the Supreme Court''s response.

Misconceptions about breast cancer risk

Last night we had dinner with a friend who's mother had breast cancer more than 15 years ago. She was talking about her concern about getting breast cancer. I think both her grandmothers and a couple aunts had breast cancer. Several of them had bilateral mastectomies. This is dating back decades to the 1970s and earlier.

She has not been tested for the BRCA genes because it would require her mother to be tested and she didn't want to put her mother through that. That was probably 15 years ago and she hadn't asked since. She was very concerned and sounded like she was sure she would get breast cancer.

I asked her a couple questions. What stage cancer did all her relatives have? She had no idea. She thought they were relatively advanced because of the bilateral mastectomies. But those were done in the 1970s when more radical surgery prevailed.

I also said that the BRCA genes only account for 5-10% of all breast cancers. But I did suggest that even though she was told years ago that she would have to have her mother get tested for the BRCA gene first, maybe times had changed and she could be tested now. She is going to ask her doctor about that now.

Her other comment was that there is cancer on both sides of her family and both her parents had cancer which further reinforced her thought that she would definitely get cancer. 

I was somewhat surprised at her misconceptions that she was sure she would get cancer because of her family history. Yes she is probably at higher risk than the average population of getting cancer. But there is  no reason to think she definitely will get cancer. And with regular mammograms and annual physicals, anything would probably be caught early.

I think this is a case of her mind getting ahead of reality. You start thinking well everyone else got cancer so I will too and I'll die some kind of horrible death as a result. I hope I was able to reassure her that she is doing the right thing and cancer is not a certainty for her.

Breast Cancer Patients Go to Washington

Today is a big day. Around here it is Patriots Day which means there are parades (mostly yesterday), Revolutionary re-enactments, pancake breakfasts, award ceremonies, a little road race called the Boston Marathon, and a minor hint of spring - its a tropical 32 degrees right now.

In Washington DC, its typical pomp and circumstance, the ego battles, and political denials, as well as oral arguments in the Supreme Court on the patent-ability of human genes and the genome. The ACLU, breast cancer patients, scientists, Biotech companies, and more are all meeting together to hear the oral arguments and then the Supreme Court will make some big decisions.

At the root of the matter is are human genes and the genome patentable? They have been awarded patents in prior years. For example, Myriad Genetics patented BRCA1 and BRCA2 genes using the grounds that they isolated them so they should be able to patent them. Then they developed the breast cancer BRCA tests which they sell for a paltry $3340 and have earned $2.1 billion on these tests. They want to retain their patent because it makes them rich. Some scientists say the gene patents allow them to earn money from their research.

On the other side,  people like the ACLU say they are naturally occurring and therefore should not be patented. And that the patents actually restrict research.

Personally I don't think naturally occurring things should be able to be patented. Does someone want to patent the crab grass in my lawn? Then they can pull it out because I'm not going to pay them for it (free weeding).

Maybe they can patent the tests that are done using the genes but not the genes themselves. Other people could then patent their own tests and there would be competition and someone wouldn't be $2.1 billion richer on a test that some insurance companies won't cover because of the cost. (Patients first please.)

Medical research often includes genetics and molecular level testing these days. Our legal system needs to catch up to current scientific research. If genes are patented, will we have to start tattooing their bodies to show where other people own bits and pieces? What if someone patented the human heart, would they get a fee every time someone had heart surgery. Let's think rationally here.

Its about time

Finally, they have done enough research (because the researchers always need to be sure and there are plenty of them out there) to say that there is no connection between breast cancer and thyroid cancer.

For years there have been questions on this. Basically women are more likely to get both. Breast cancer is the most common woman's cancer (I think) and thyroid cancer is most common in young women and growing in incidence. Both are hormone (endocrine) related cancers so I guess it seemed they were connected.

Standard procedure has been for women with both to be tested for Cowden's syndrome which is a genetic condition that has both cancers are indicators. I was tested and I do not have it.

So basically this tells us that all medical research can be proven wrong over time. Can you name one thing that 'they' have not told us was good for us and now is bad or was bad for us and now is good? Which is why everything always needs more research.

DNA mapping

Hmmm.... I like this concept of mapping the DNA of  cancer patients. Actually the UK's National Health Service has announced a plan to map the DNA of 100,00 patients with rare diseases and cancers. (And the immediate comments on the article are how did the British government come up with the 100 million pounds to pay for this during the time of austerity.)

Politics and financing (and squabbling) aside I think this is a good idea. I have always wondered why I have been lucky enough to have cancer twice while the rest of my family remains healthy. If my DNA would tell something about it, I would welcome the opportunity to learn more about me.

Actually I would not be surprised if a lot of the secrets of us less than healthy people could be discovered in our DNA. Now that the price has dropped significantly to between 5 and 10 thousand pounds, it is getting within the range of affordability (come on, work with me if some cancer drugs can cost upwards of $100,000/year this is affordable). Maybe a little more money should be spent on looking at why some people seem to get the ailments. (I could be their poster child.) Instead of just throwing money at a cure.

An ounce of prevention is worth a pound of cure.

Patenting Genes Again

I have blogged about this before here and here. Who owns our genes? According to Myriad Genetics, which 'owns' the BRCA genes and tests and gets to charge $3,000 per test, they own the two BRCA genes. That sounds stupid, doesn't it? Apparently Myriad Genetics is full of rocket scientists who believe they can own parts of the human body that naturally occur. Maybe we can start selling patent rights to our big toes or something to pay our medical bills.

Well stupidity now faces the US Justice system as the Supreme Court announced on 11/30/2012 that they will hear the case on whether companies can patent human genes. As science and medical research grows and focus more and more on genetics this ruling could affect medical research in decades to come.

The two sides come down to this:

"The justices' decision will likely resolve an ongoing battle between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward."

If we take this a step farther could lawn seed companies claim they own the genes in the grass seed they breed to make greener lawns so that we would need to pay rent to walk barefoot on the grass? Or someone could patent oxygen and we could start paying rent to breathe.

I am sure that the people with the BRCA gene would be happy to get rid of it so if Myriad wants to own the gene, why can't people get paid to have it taken out of their body?

I am in favor of the scientists, patients, medical research, and good health. I am against corporate greed.

I mean, seriously? Get over it. But now since it is going to the Supreme Court I am sure your lawyers will be rich by the time a decision is reached.

New BRCA tests

New BRCA tests have been developed that are faster and less expensive than the ones done by Myriad Genetics. I think this is great news. Myriad has claimed they patented the BRCA genes but these new tests were developed in Canada so maybe they escaped the long arm of the law.

I had blogged about this before and Myriad was still waiting for a final ruling on their patent. The Supreme Court had thrown it out because they said the laws of nature can't be patented.  This I agree with. Now that a second test has been developed on the genes it reinforces this idea that the genes shouldn't be patented. How could it be that a single company could have power over women needing this test? This is where laws need to catch up with technology.