Archive for category Medicine in the News
Natural Human Genes May Not Be Patented 061313 – Relevance of the Supreme Court Decision
Posted by admin in Medicine in the News on June 13, 2013
Today 061313 the Supreme Court decided “natural” human genes may not be patented. This issue was perhaps forced into the public spotlight when Angelina Jolie recently had a genetic test for mutant BRCA1 and BRCA2 genes and decided to have a double mastectomy and go public about it.
The social media has been ablaze after Mrs Jolie-Pitt’s decision perhaps highlighting the public’s confusion on the topic. Mutations in BRCA1 and BRCA2 genes have great relevance as they indicate very high statistical probability for the development of deadly variants of breast cancer over such a person’s lifetime. Mrs Jolie-Pitt removed healthy organs with a high probability of later developing a deadly disease. Many people had a hard time wrapping their heads around such a concept. This is kinda like “The Matrix meets CSI.”
Others realized that the current lay of the land with a company named Myriad Genetics holding a patent on the genes might be rocky. The genetic test for BRCA mutations stood at a hefty several thousand dollars prior to that suit that rose to the Supreme Court. Now that the court has apparently decided that human genes cannot be patented will this lessen the cost of the test and make it available to more woman?
Maybe and Maybe not.
It is not all about the genes. Myriad has been working on the variants of these genes for a number of years. If another company enters the BRCA1 and BRCA2 testing market, they will essentially start from scratch. Who knows what relevance they can attach to their tests should they come to market.
Hopefully this move by the court will have positive effects on the breast cancer gene testing market, but at this point it is unclear.
Best Regards,
John Di Saia MD
CRE Superbug: Should You Be Scared?
Posted by admin in CHS, Medicine in the News on March 8, 2013
Superbug stories are not uncommon in the media these days. This story involves the new cre superbug or carbapenem-resistant Enterobacteriaceae. In simple terms these bacteria are resistant to many of the antibiotics we use to treat them. In this case the bacterium is resistant to the “Imipenem” class of antibiotics. Is this really a serious health concern?
A new superbug is on the rise in U.S. hospitals, according to the U.S. Centers for Disease Control and Prevention. The family of germs, dubbed CRE for carbapenem-resistant Enterobacteriaceae, evades some the strongest antibiotics, making infections almost untreatable.
Source: abcnews.go.com/Health/cre-tops-list-scary-superbugs/story?id=18666434
Your level of worry should probably relate to your overall health. These bacteria do not attack like the plot elements of your average B movie. Are you a medically-complicated patient in an intensive care unit or a long term acute hospital (LTAC?) Another report on this cre superbug reveals that 4% of these infections occur in acute care hospitals and 18% in LTACs. Healthy people do not get this infection on the streets of their neighborhoods. I know the media didn’t tell you that part. 
The lesson here is to stay healthy and out of the hospital. Despite the fact that the media tends to hype these superbugs, if you are healthy, you are probably safe from the new cre superbug.
Best Regards,
John Di Saia MD
Stolen Laptop, HIPAA and $1.5 Million Dollar Fine
Posted by admin in Medicine in the News on February 11, 2013
Massachusetts Eye and Ear Infirmary, a teaching hospital for Harvard Medical School, and Massachusetts Eye and Ear Associates, Inc., an associated practice, have agreed to pay $1.5 million to settle charges that the institution, collectively known as MEEI, violated HIPAA regulations when 3,600 patient records were stolen in 2010.
The theft occurred in February 2010, when a laptop containing unencrypted prescription data and other clinical information on patients and test subjects was stolen. According to the U.S. Department of Health and Human Services, MEEI negligently failed to take key steps to secure patients’ protected health information
Source: healthcaretechreview.com/stolen-laptop-hipaa-fine/
The concept of electronic medical records is probably the latest fraud perpetuated upon the medical community. Government explained what a great saver of both money and time it would be. It seems that it just increases the probability of loss rather than the other way around. This medical group in Massachusetts realized this when a laptop was stolen.
HIPAA, the healthcare privacy law, states that electronic devices must be secured. In the age of cyber theft this just might be a practical improbability. Well the stolen laptop amounted to a 1.5 million dollar fine. You see electronic medical records make the access of a great deal of protected information a snap, so that laptop was just chock full of violations. You would not be able to carry that many charts in the old fashioned paper format without a fork lift anyway.
Best Regards,
John Di Saia MD
Insulin Pens Used on Multiple Patients – CNN Story
Posted by admin in Medicine in the News on January 23, 2013
Hundreds of veterans may have been exposed to hepatitis B, hepatitis C and HIV because of medical oversights that allowed insulin pens to be used on more than one patient at a Veterans Administration hospital in Buffalo, New York, according to a memo from the Department of Veterans Affairs to Congress.
“On November 1, 2012, officials at the (Veterans Affairs Western New York Healthcare System) reported that while conducting pharmacy inspection rounds on the inpatient units, they discovered that insulin pens intended for individual patient use were found in the supply drawer of the medication carts without a patient label on them,” said the memo, obtained by CNN through the office of U.S. Rep. Brian Higgins, D-New York. “Although the disposable needles were changed each time it was used, the insulin pens intended for individual patient use may have been used on more than one patient.”
Source: cnn.com/2013/01/14/health/new-york-va-virus-exposure
/index.html?eref=rss_mostpopular
This one seems like hyperbole really; that is if the story is accurate.
It is true that insulin pens are a convenience item meant for individual patient use. They probably shouldn’t have been at the Veterans Administration in the first place as they cost more than standard insulin devices.
But if the needles were really changed between patients, the real risk of viral transmission is essentially zero. This seems more an example of Congregational grandstanding than anything else. Having served as a resident at a Veterans Administration hospital, it would not surprise me if the claim about the needles being changed between patients is not true however.
Best Regards,
John Di Saia MD
Patient Impressions of What Doctors Are Paid
Posted by admin in Medicine in the News on July 20, 2012
In an orthopedic surgery journal, an interesting study has been published. It concerns patient impressions of what surgeons are paid for surgery by insurers in particular Medicare. I lifted a graph to demonstrate a point:
Source: download.journals.elsevierhealth.com/pdfs/journals/0883-5403
/PIIS0883540311005559.pdf
Here patients were asked what a surgeon was paid by Medicare and what he should be paid for a few operations. The interesting thing is that patients believed that the doctor should be paid 8-10 times what he actually is paid for surgery. This helps explain why surgeons move toward cosmetic work. It also helps explain why many plastic surgeons are not always so interested in insurance work in general.
These findings fall in line with my experience with patients for reconstructive plastic surgery. They figure we are paid less than the procedure should be worth. They are just unaware of how much less than that figure we are talking.
Best Regards,
John Di Saia MD
P.S. This study concentrated on the reimbursement figure for the actual surgery itself. It did not take into account other mechanisms of non-payment Medicare has for surgeons after surgery (for one global fee periods.)
Probiotics May Help With Antibiotic-associated Diarrhea
Posted by admin in Dr D's Truth, Medicine in the News on June 15, 2012
The use of probiotics appears to lower the risk of developing diarrhea while taking antibiotic therapy, based on a systematic review of 82 randomized clinical trials in the May 9 issue of JAMA.
In fact, when examined individually, most of the studies showed no significant benefit from using probiotics. However, when the results of 63 of these trials were pooled in a meta-analysis involving 11,811 subjects, the use of probiotics decreased the relative risk of developing antibiotic-related diarrhea when compared with not using them, the investigators found.
Source: familypracticenews.com/newsletter/family-practice-news-e-
newsletter/singleview120510/data-supporting-probiotics-benefit-found
-weak-but-favorable/6d8ead9a961ffe6b20e752e2534d159e.html
For anyone who has heard the over the top claims in advertising that probiotics are going to elevate you to the higher plane of astral health, an evaluation of 82 studies shows they probably help with the diarrhea you get from taking antibiotics. That “probably” is because the studies were so poorly performed that they many lacked statistical significance.
As probiotics are “healthy bacteria” you would figure that if they did anything they would potentially help with the diarrhea you get from killing bacteria in your gut with antibiotic treatment. This finding in that light is really no surprise.
Best Regards,
John Di Saia MD
Botox Not Working for John Mayer
Posted by admin in Medicine in the News on May 25, 2012
John Mayer is still waiting for his singing voice to return after his damaged vocal cords were frozen twice.
Mayer says he’s still without much of a singing voice, but that hasn’t stopped him from writing hits, and now he thinks he might just stay away from the microphone. He says, “I can’t sing, so I’m writing.”
Talking about his throat problems, he tells talk show host Ellen DeGeneres, “It’s not a health concern whatsoever, but it has taken me out of singing. I tried to beat it the first time and couldn’t. What they actually do is they cut this thing out of your throat and then they inject your vocal cords with Botox, which freezes your vocal cords so that this thing can heal without smacking up against the other side. I just need more Botox next time.
Source: music.msn.com/music/article.aspx?news=729027
Botox is used in some “medically necessary” applications as well as the cosmetic. As I have mentioned before, I use botulinum toxin to help ease my wife’s migraine headaches.
In Mr Mayer’s case, Botox is being used used to temporarily freeze a vocal cord so it can heal after surgery. Botox like any drug is not always effective. Mayer reports hopes that a higher dose will work better.
Best Regards,
John Di Saia MD
Promising New Breast Cancer Treatment Trades Cancer for Tungsten
Posted by admin in Medicine in the News on May 21, 2012
Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, and Kelly decided to get a double mastectomy. The manufacturer recalled the Axxent Flexishield in February 2011 after the breasts of 10 women were contaminated with fragments of tungsten. The number has since risen to 29.
Source
We have discussed my misgivings with the 510(k) FDA Clearance before. This Axxent Flexishield product had apparently been given this type of approval by the FDA. Now there are women with tungsten particles within them that had apparently been inadvertently shed from a shield used in the process.
The 510K pathway is a short cut in the FDA approval process for technology that is viewed as substantially equivalent to technology already out there. Calling something equivalent without further study is a judgment call that has a risk element within it. The tungsten particles within the breasts of some of the women who had this treatment are that risk element manifesting itself.
New treatment comes with new and different risks than treatments with a long track record. I tell my patients this each time they tell me of something that is “cutting edge.” There is an edge that cuts for you and an edge that cuts against you. New treatments often do not have substantial understanding of that second edge. When these new technologies have been given abbreviated evaluation by the FDA, people are going to be angry. Some of them are going to sue.
I hope the women with these embedded tungsten particles do not turn out to have significant morbidity. A new uncertainty in breast cancer treatment is not welcome news to any breast cancer survivor.
Best Regards,
John Di Saia MD
More Sexual Side Effects For Propecia Label
Posted by admin in Medicine in the News on May 1, 2012
I have discussed my experience with Propecia here before. Now the FDA has decided to expand their list of sexual side effects for Propecia (the hair and peeing drug) to include:
A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.
Source: fda.gov/Drugs/DrugSafety/Informationby
DrugClass/ucm299754.htm
The FDA goes on to state that “clear causal links” are not established. On the basis of personal experience, I would disagree on that. I modify the dose to get the side effects into acceptable ranges. This might possibly qualify as an off label use of the drug. The effects in a given person will vary of course.
Best Regards,
John Di Saia MD
Reader Laura on Tanning Beds & Skin Cancer
Posted by admin in Medicine in the News on March 8, 2012
Reader Laura’s Comment:
“FDA advisers urge stricter regulation of tanning beds”
Do you think that stricter rules for tanning beds will help with the rate of skin cancer? Have you seen a rise in the number of people coming to your practice with skin cancer?
Skin cancer is the most common cancer. The incidence has been rising and studies have linked increased risk to tanning beds as well as other sources of UV light exposure. I am not big on regulating everything however. People should simply be responsible for their own actions.
When you use tanning beds, you increase your risk of skin cancer, skin aging and the like. Adults need to be aware of these risks. Restrictions on adolescents might be reasonable however.
Best Regards,
John Di Saia MD
Originally posted 2010-05-24 07:30:17.
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