A Carcinogen in My Coffee

I feel like this is another step in the plan for Big Brother to take over our lives and regulate us to death. Seriously. Or maybe its just another way for the lawyers to get rich over stupid lawsuits.

There is a lawsuit making its way through the Los Angeles court system that wants companies who make or sell coffee to warn consumers that there is a potential carcinogen created in coffee brewing that could cause cancer. As part of Proposition 65 in 1986, California businesses need to warn customers that there could be a risk involved in consumption or use of a product. So the lawsuit claims that customers need to be warned about coffee consumption. When I first read this article, I asked 'what are they thinking?'

First of all, there are plenty of other things in this world that could cause us cancer - lets start with sunshine, drinking water, inhaling air, eating, and more.

Second, we do not need more regulation that would increase the cost of doing business.

Third, there is no proof that the chemical, Acrylamide, involved is even a carcinogen.

So as someone who has wondered, from time to time second to second, as to why I have been so lucky to get cancer twice, I really do not to waste my time trying to figure out if I drank a 'bad' cup of coffee at some point. I have plenty of other things to worry about - like where is my cell phone or what is that new pain in my back. I don't even live in California and it really just irritates me that money is being wasted on this.

Obviously the lawsuit was filed by someone who is not like me and doesn't have any dependence on their morning cup of joe.

I would seriously like to take the money wasted in this lawsuit and especially the legal fees, be put into something useful, like a cure for cancer.

Talcum powder and other safe ingredients

I have seen some crass ads recently about 'if you used talcum powder and got cancer, you need a lawyer'. I had no idea what they were talking about it. Until I saw an article about how Johnson & Johnson has lost yet another lawsuit regarding talcum powder.

Supposedly talc is a carcinogen and if you used J&J baby powder it could have caused your ovarian cancer. J&J of course claims that it is not. But now lawyers are involved and it is in the hands of the courts. Since J&J has now lost two cases, it does not look good for them.

This brings me to the issue of supposedly safe ingredients that turn out to be really bad for you. If you think about it, this has been going on for eons. Think about what used to be in so called 'patent' medicines. Everything thing under the sun. Many of them were found to be harmful or even fatal.

Now in modern times, the lawyers run everything.

But the harm has been done. I used to use J&J baby powder regularly. Is that why I got cancer twice? I give up. I have no idea why I am so 'healthy' but I will assume talcum powder is not what did me in.

21st Century Cures Act

This is a looming problem as the pharmaceutical industry lobbies its way through Congress. The Act would enable the pharma industry to postpone longer availability of generics, allow fewer safeguards for new drug development which will supposedly enable faster cures. But would do nothing to stop even higher prices on new drugs.

" Rather than simply charging less, the industry is pushing for watered-down safeguards it claims will lower development costs and get patented drugs to market sooner and cheaper. It will deploy 1,200 lobbyists to try to pass the 21st Century Cures Act. This bill has already passed the U.S. House of Representatives and will have its companion bill introduced in the Senate."

"This initiative is being sold as enabling new cures to treat rare and difficult-to-treat diseases by increasing funding for biomedical research at the National Institutes of Health. But, at the same time, the pharmaceutical industry will be able to use this bill to undermine FDA safety requirements by making it easier to get their drugs approved more quickly. The industry blames rising drug development costs on the FDA's drug approval process, which it says is too lengthy."

The FDA is not there to slow approvals but to keep American's safe. Using Vioxx as an example, this drug was approved and then found to cause thousands of heart attacks and deaths. 

"Investing in scientific research is, of course, a no-brainer. But the Cures Act will not only do that. Under the bill, research funding would be increased at the expense of lowering patient protections and reducing access for affordable medicines.

A key responsibility of the FDA is oversight to ensure that the risks of new drugs and medical devices don't outweigh the benefits.

Well-designed Phase III clinical trials conducted by pharmaceutical companies to get their drugs approved by the FDA are critical for weeding out unsafe and ineffective drugs. More than a third of the drugs that enter Phase III testing fail to gain FDA approval for this reason.

One of the main advocates behind the 21st Century Cures Act, The Manhattan Institute, cites drug development costs of Phase III clinical trials as a barrier to medical innovation and rising costs."

But the problem isn't with the FDA approval process. Its that 1/3 of the drugs going through Phase III trials fail because the drugs don't work. Where is the patient safety if the drug doesn't work or has too any side effects?

"...the pharmaceutical industry will make exaggerated claims and call for reforms gutting safeguards in the name of reducing drug prices. It will contest how its products save lives, extolling the virtues of their government-backed monopoly pricing power that in reality exploits our poor and sick. The 21st Century Cures Act will be included in this campaign."

Prescriptions and regulations and confusion

You might have guessed I take a few prescriptions these days. Actually I have a whole pile. Every weekend I sit down and fill our pill boxes for the week. My husband has one prescription and vitamins. I have a lot more.

I get my prescriptions from three places - the local pharmacy, the insurance company's mail order pharmacy, and the insurance company's specialty pharmacy. I got promoted to the specialty pharmacy this year for some reason. Its not that they really charge more, they just like to make my life more complicated.

What really annoys me about prescription medications are the stupid rules. The latest new rule is that I couldn't just call my pain management doctor for a refill on my break through pain meds (because the new cats hid the other bottle when they 'explored' the shelf in my closet), they had to make sure I had an upcoming appointment with the doctor. They even called me twice to make sure. (Then I explained how the cats hid my prescription which caused me to think that I had run out when I hadn't.)

The other rule that annoys me is that because of the 'opioid' crisis (which I recognize is a real and growing) problem, pharmacies want patients to have used up almost all their prescription before providing a refill. I know that pain medication use can lead to opioid abuse but not everyone.

I am picky about my prescription use. I use one of those lovely box a day pill box for years and have to take pills at three different times during the day (on an empty stomach, after eating, and before bed). If I was really good I would take some pills in the middle of the day as well but since I NEVER remember, that is not going to happen any time soon.

I also think about how often I take certain prescriptions which are prescribed 'as needed'. If I think I am taking them too often, I will take a minute to think how often I am taking them and why and if I need a doctor visit for a potential issue.

I feel I can manage my prescriptions myself and don't think I need any more rules to help me manage them. And about those prices? Well that's another story.

How much does that cost?

You go shopping and you can find price tags and signs to tell you the price. You go to the dentist or eye doctor and ask them for a price before a procedure and they tell you the price. You call the hospital and ask for a price and they can't tell you. Don't you want to know what something will cost before you have the procedure?

Here in Massachusetts they passed a law 18 months ago requiring hospitals to provide pricing in 48 hours. But many of the hospitals didn't meet that requirement when called for a price.

I really like this idea that hospitals provide pricing up front. The purpose of the law was to providing pricing transparency. It makes sense. So why don't they provide it? I have no idea. One of the hospitals called, out of 23, had a person dedicated to answering these requests. I think more hospitals should do this. Maybe the rest were not equipped for these questions.

Okay, not a very profound thought this morning but I need to get to work on time.

Dense Breast Tissue and Laws

I feel conflicted about this one. There are new state laws enforcing that women with dense breast tissue must be notified by their medical providers. Okay, that's great but then what do they do?

Yes there have been women diagnosed with breast cancer which was not seen on mammograms but that is a small number. Advocates for this law want to help women be in more control of their healthcare. Advocates against it are concerned about overdiagnosis and additional costs - particularly in states where insurance companies are required to pay for ultrasounds after clean mammograms.

And doctors have said they don't have the tools to do much with the information.

"New ways of classifying dense breast tissue could put even more women in the category of receiving dense breast notifications, said Dr. Priscilla Slanetz, who recently wrote a New England Journal of Medicine article questioning the effectiveness of dense breast notification laws.

One reason she wrote the article, she said, was "in our state [Massachusetts] very few of our primary care providers have any knowledge about breast density and strengths and limitations of these different tests" for supplemental screening.

The same may hold true in California, where a small survey of primary care doctors found that only half of them had heard of the state's 2013 dense breast notification law and many felt they didn't have enough education to address what breast density meant for their patients.

On this point, both supporters and critics of the laws agree: doctors need better tools to help their patients identify their individual cancer risks."

Okay, so now we have people who want to have these laws but we do not have a way to deal with the information. How helpful.

Please take a nanosecond to feel sorry for Myriad Genetics

They have become lawsuit happy. The Supreme court has said no company can hold the patent to a gene last summer. This means that Myriad Genetics has lost their monopoly, huge prices, and ability to strong arm the breast cancer population with their patent on the BRCA genes Okay that nanosecond is now long over.

Now we can get on the road to reality. Myriad has decided that since they have lost their patent, their lawyers are going to get rich. They are in the "let's sue so we can keep our monopoly as long as possible".

"Last week's ruling by Judge Shelby is perfectly clear about all that is at stake for Myriad:

Although Plaintiffs [Myriad Genetics] have shown that they are likely to suffer irreparable harm through erosion of their test pricing structure, loss of their share of the testing market, and loss of their exclusive patent terms if an injunction does not issue ... Plaintiffs are unable to establish that they are likely to succeed on the merits of their claims.

In other words, Myriad's earnings will undoubtedly take a serious hit from increased competition, but this fact cannot override the substantial doubt about whether they will prevail in their legal claims."

I hate people that are lawsuit happy.

But this underscore additional issues with genetic testing and personalized medicine.

"Not only have the courts pushed back on Myriad's monopoly, at the end of 2013, the Food and Drug Administration (FDA) moved to stop the direct-to-consumer genetic testing company 23andMe from marketing and selling its DNA testing service without approval.

As with all medical drugs and devices we must balance the desire for innovative new treatments with our demands for safety and efficacy. As more labs and companies enter the BRCA testing market, we must ensure that these tests are properly regulated to protect public health and patient interest. Genetic tests claiming to provide medical information must be analytically and clinically validated so we know that what companies are telling customers is in fact accurate. Nor should companies be permitted to overpromise the benefits of genetic testing or to drum up people's fear of disease in order to sell more tests. All genetic testing should be accompanied, both before and after testing, by independent and professional genetic counseling so that potential customers understand the limitations of testing, their individual test results and all of their medical options.

Finally, we should refuse to allow companies to hoard, for their own gain, our medical and bio-data collected through the process of testing. Critics of Myriad have long noted that the company stopped contributing to the primary international database on genetic mutations related to breast cancer, in what is widely seen as a move to further capitalize on their monopoly access to more than a million women's family history and genetic information. Similar critiques have been made that 23andMe is using its customers' bio-data and familial information to launch new business products."

Genetic testing is the new thing. I'm  not ready to turn my DNA over to just anyone. And I would be very upset if they tried to upsell me on additional tests based on what I already have...

But I will follow this story and see where it ends up. But I never felt sorry for Myriad Genetics.

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?)

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.

End of life medication

In Electionovember (this is not a political post), Massachusetts residents will have the opportunity to vote on End of Life Medication. There are several requirements to the law:

• Must be an MA resident
• Must have been given less than six months to life
• Must be capable of making and communicating medical decisions
• Must voluntarily make a wish to die and make an informed decision.

I will vote for this. First of all, I think it should be an option. If you are dying and in pain and there is no hope, why can't you say 'that's it' instead of lingering in pain for a few more weeks? If you disagree, you do not need to make the choice to do it.

The problem with these laws when they try to pass them, is people start saying 'well I would never do that' and people come out of the woodwork saying my neighbor's hair dresser's cousin's friend was given 3 months to live and 20 years later they are still here. Everyone has the right to their own beliefs and this is a law that would allow people to make a difficult decision if they wished.

What if you had something like Parkinson's or Alzheimer's which is irreversible and incurable and you knew you were destined to die over a period of months or years and you could make the decision while you were capable that you wanted to be prescribed end of life medication when you got down to the bitter end? If you know your lot in life is to die a slow and painful death, wouldn't you want a way to avoid the pain if you could? We do not know what is in our future and we could all end up in that circumstance. I think we should be allowed to have that choice if we choose to.

Law, religion, and medical care

This story saddened me. A 16 year old girl who was 13 weeks pregnant died from complications from leukemia in the Dominican Republic. The Dominican Republic constitution forbids abortion which I believe is within their rights to decide as a country. This is probably due to the main religion of the country - Catholicism. Her doctors were concerned that chemotherapy would induce an abortion. It took 20 days to reach the decision that she could receive chemotherapy. At that point she miscarried, had a cardiac arrest and could not be revived.

While I am certainly not going to get into a discussion on the Catholic church's opinion of abortion or the Dominican Republic's Constitution, nor discuss the subject of teen pregnancy, I do feel that the purpose of the Hippocratic Oath was to do no harm. To me this means taking care of the patient first. Where was the sense of urgency in making this decision to let her receive chemotherapy? Why wasn't the concern for the life of the mother taken into consideration?

It is just very sad that politics and religion interfere needlessly with medical care in this day and age.

Ambulance chasing law suits

There are more lawyer jokes I think that any other profession, maybe except golf jokes. 'What do you call 1000 lawyers at the bottom of the sea? A good start.' Ha, ha.

I am not a lawyer, I am a marketing person who also works in the non profit world. There is an overlap there. For a few years I worked for a legal non profit promoting continuing education for attorneys. Through that job, I met MANY lawyers. Most of them were nice normal people practicing law (why do lawyers and doctors practice when the rest of us work?) but some of them were not in it for altruistic reasons, they were in it for the money. You could tell. But I digress.

The one thing that I really detest about the practice of law is the ambulance chasing syndrome. I read a book recently by a former attorney, now author (who's name escapes my chemo brain) about a law office near a bad intersection. At every accident at the intersection, they would run out and assess the litigation potential. It is not unknown. We also see the billboards near many cities - "Have you been subject to medical neglect? Did your doctors do you harm? Call us toll free and we can sue!' Lovely people, lovely premise.

But what really burns me up are the ones who focus on a cancer diagnosis. Did your doctor miss your tumor? We can sue! Did you know the odds of survival are lower for breast cancer detected at later stages? They promise to address 'delayed diagnosis due to doctor oversight'.  These people are the cause of rising malpractice premiums forcing doctors out of medicine. Thank you (not).

With someone with a couple of cancer diagnoses under my belt, I can tell you one of the biggest issues we have when facing a diagnosis is why didn't we get it ahead of time? Why, why, why? We spend many hours wondering why we were the ones with cancer, why they didn't find it sooner, and the big one - am I going to live? And the ambulance chasers prey on these fears and making it even more difficult to cope with the cancer roller coaster.

I am not saying that doctors never make mistakes - they are human after all. But a tumor has to reach a certain size before it is detectable by current technology. There are also many more benign tumors than malignant tumors. Sometimes mediation is needed and possibly litigation but that is not the correct way to address a medical error. Start with a conversation and not a lawsuit.

That Supreme Court Case Explained

Or its a good thing I am not a lawyer... I find this very complicated. You know that Supreme Court case where they are going to hear six whole hours of arguments on the new health care law and then make a ground breaking decision. If you read the article it is a brief summary of something that is very complicated and citing laws going back over 130 years and deciding if it is a tax or not.  The two contended issues are mandating Americans to purchase health insurance and opening Medicaid to more people.

The Supreme Court gets to decide:

• If this is a tax and if it is a tax it can't be disputed until after it has been in effect so the whole thing would be put off until 2014 or later.
• Then if it is not a tax, then is it legal for Congress to require people to pay for insurance or pay a penalty and it might be an intrusion on individual liberty.
• Next if it is unconstitutional can this requirement be split from the rest of the whole health care reform act. 
• Finally they get to decide if the Medicaid expansion is unconstitutional or not.

I find it pretty amazing that this can be settled after only six hours of arguments and then the Supreme Court justices get to go think, talk over coffee, play basketball, or whatever it is they do and a decision will be announced and life will go on. Until another big issue is brought to the Supreme Court.

I once visited the Supreme Court. I worked for a legal non profit which was part of ACLEA, a legal education organization. They had their annual conference in Washington DC and we got a special tour by someone important at the Supreme Court, but not by a justice. I learned all sorts of fun things about the Supreme Court.

• They didn't have a court house until the 1930s. They bounced around different places in Washington DC.
• The newest member of the Supreme Court gets to be the secretary and take notes for the rest of them. If you think about it - it can be 20 years or more between each new justice and that's a lot of note taking. (So next time one is sworn in, listen for a big sigh of relief from Washington.)
• There is a higher court that the Supreme Court. There is a basketball court upstairs. (See wikipedia for proof I'm not making this up and check the notes on the fifth floor.)

But I digress. This is a big case, which is why it gets six hours instead of a lot less, so we should all pay attention to its outcome.

Doctors and manufacturing companies

Doctors are the main marketing target of the companies who manufacture drugs and medical devices. However the companies are restricted from 'buying' their 'prescription' pads. There is an important relationship between the doctors and the companies - doctors can provide valuable feedback to the companies on the efficacy and side effects their products. Its sort of like never ending clinical trials. The companies want to make sure that there is an open line of communication from the doctor back to them.

The problem is it really can't be an open line from the company to the doctor. The doctor needs to make medical decisions based on the best interest of the patient and not based on the best interest of the manufacturer who bought him dinner last week. Now the government is stepping in and will force companies to publicly report all payments made to doctors who are not on their employees and will fine them significantly if they don't comply.

I'm not a fan of the government having to make silly little laws that will create huge piles of paper work - or gigabytes of data on line - which this certainly will. There is enough paperwork around in the world already. However I do want to know if my doctors receive payments from any companies and could in anyway be swayed by their financial compensation.

I definitely would want to look up my doctors. Partly out of curiosity and partly out of concern that they are giving me the medications that are best of me. One of my doctors, who shall remain nameless, always seems to want to switch my medications for newer ones - always the newest brand name drugs. I assume that he is doing it because these new meds might help me more than the ones that have been around for a while or ones that I have already tried and didn't really work. I mean that is why we have all this medical research going on - to come up with better treatments for the patients.

If you look at it from the company's point of view, they are restricted from marketing to their primary targets. As a marketing person, I can see how that would be very difficult. Putting ads in consumer based magazines about their new medications is one way to do it but then patients go blind trying to decipher the fine print of side effects before asking their doctors about them. Its a tough balance but I like to see the restrictions so the doctors make medical decisions on my ailments not financial ones on their wallets.

When medicine goes wrong

How do you undo a surgery? Well you can't restore all the little nerves, blood vessels, tendons and muscles to their pristine  untouched state - that just doesn't work. But you can have implanted thingies removed and replaced with a newer model. But this means the whole mental, financial, physical stress of the original surgery all over again and more. I mean we hear about the cases of the doctors took out the wrong part, or someone received the wrong medication or wrong dose, or got an infection in the hospital. But what happens when its a much bigger mistake affecting thousands?

One example from this morning's news is that a child who received a transplanted blood vessel and two others who received kidneys now all have hepatitis C. These were all traced back to a single donor and a testing error at a tissue bank and some delayed communication. These three people now face lives full of illness. How do you undo that one? You can't. Ever.

But here is a much larger example of medicine gone bad. There was a French company which used non medical grade silicon in its breast implants - silicon meant to be used for mattresses (ick!). The company was stopped in 2010 but there are 30,000 French women with their implants, 1000 of whom have had them rupture so far. The French government is recommending that all 30,000 women have these removed. There have also been 8 cases of cancer possibly linked to the implants and one death.. A rupture is very painful and requires additional surgeries. So the French government has banned them. But the company had made 300,000 implants over the 12 years in operation - some went to the UK and many went to South America and other parts of the world.

The British government is downplaying the cancer risks from these implants and claim they don't have a cancer link. But they didn't mention the risks of them rupturing, recommend consulting with the implanting surgeon if there are concerns and are not recommending removal of this brand of implants.

But BACK UP A MINUTE, a company used inferior quality materials to make medical implants and where are the fines, penalties, lawsuits? I am not a fan of stupid lawsuits but in this case where 30,000 women are going to have to have a second surgery. Even if France's national health care pays for it, that is still a lost cost. What about the emotional and physical strain?

Yoo hoo, the 'morons' (and I use that term loosely, feel free to substitute a stronger word if you want) who made the decision to use the inferior silicon and the other 'morons' who approve them should be held accountable in some way - financially, civilly, and criminally. Some where a long the manufacturing pipeline there was some deception which will cost millions of dollars/pounds/Euros to the general public as well as physical pain and suffering and emotional distress when faced with more surgery.

This is a situation which is relatively scary. I mean it was caught here but what about other cases of this we do not know about elsewhere in the world? Medicine when done wrong is really hard to undo and should be avoided at all costs.

Supply & demand vs. price gouging

For a little economic lesson this morning, (don't worry I did take and pass both micro and macro economics in college but that was a long time ago and I don't remember much) one of the basic free market principles is supply and demand - how supply determines demand and hence sets pricing and more.

Medications are developed and manufactured by the companies who own the brand and are often sold for some giant price. As with any manufacturer, a pharmaceutical company will run into the same issues any other would - production issues, lack of raw materials, broken machinery, etc. These cause disruption in production and availability. Some production down time is allowed for - annual factory maintenance etc - but not all down time is  planned. This causes shortages - thus reducing supply.

When this happens in your grocery store, you buy a different brand or go with out. But when it is a life saving medication, its not that simple. New guidelines are being put in place so that manufacturers have to be more proactive in informing people about shortages and be better about preventing them. In the meantime, when there are drug shortages the scumbags (and I use the term loosely) who get the remaining amounts of the drugs and sell them to the hospitals at astronomical prices. Also known as price gouging.

As we live in a very reactive political world, there is legislation being introduced next week to make this price gouging by 'unscrupulous drug dealers' (a/k/a scumbags) into a federal crime. These people are forcing hospitals already in a belt tightening time, to greatly overpay for something that is needed to save lives. They get rich, a few people die, who cares? Right? WRONG! It should be a crime. And the money the hospitals are overpaying for these necessary drugs could be used to help other people as well.

This is the kind of thing that just ticks me off and makes me crazy. Its right up there with the 'losers' (and I use that term loosely) who claim they have cancer for the money and sympathy but are healthy. Grr!