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.