Articles Posted in Health & Wellness

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FDA Considering Changes to 510(k) Process
At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of  surgically implanted medical devices like artificial hips, heart pacemakers, breast implants, spine screws, rods, artificial discs, intrauterine devices, metal screws, pins, plates and rods, artificial knees, or coronary stents. No matter what type of medical device you need, you deserve safe devices of only the best quality that are responsive to technological updates. As a patient, you should have the right to make a fully informed decision about whether you want to use a newer or older version of a particular medical device. The FDA is now considering making changes to its (infamous) 510(k) medical device approval process.

FDA Pressures Medical Device Manufacturers to Utilize Newer Technologies 

You only have to look at the evolution of cell phone technology to appreciate the abundance of technological changes that have occurred over the past decade. So, why should you be provided with the medical device equivalents of flip phones? That’s one of the key focuses of the proposed new changes to the 510(k) Approval Program the U.S. Food and Drug Administration (FDA) which would be incorporated in 2019. The 510(k) Approval Program, put in place originally in 1976, has provided an approval “short-cut” for medical devices which are based on medical devices currently on the market. I have written about the 510(k) process often on this site. The medical device currently on  the market, upon which the new product is based, is known as a “predicate device.” Historically, there have been no restrictions concerning the age of the predicate device. This is about to change.

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On November 27, 2018, Teva Pharmaceuticals announced a huge recall of all products containing the medication valsartan. The prescription medications containing valsartan may contain chemicals that are considered possible carcinogens.

So What is Valsartan?

Valsartan RecallValsartan is a drug used to treat hypertension, high blood pressure, congestive heart failure, and other conditions. It also improves health outcomes in people who have suffered a heart attack. Valsartan is part of a group of drugs called angiotensin receptor blockers (ARBs). The drug works in part by relaxing blood vessels to permit easier blood flow, which leads to lower blood pressure. Lower blood pressure leads to fewer strokes, heart attacks, and kidney problems.

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MRI with gadolinium-based contrast agentI’ve been representing people injured by defective medical devices and harm drugs for many years. Because I study these types of products on a daily basis, I have become leery about putting anything inside my body, whether it is an artificial joint like a hip or knee, or a prescription medication. As I often tell people–mostly joking but not completely–these days I am uncomfortable taking a baby aspirin.

Of course that’s not rational. Please hear me: there are important, helpful drugs and medical devices which improve lives, extend lives, and save lives. Paranoia is not your friend when you are facing a serious health issue. That said, it is always prudent to double check anything put into your body when a medical procedure is performed. Read about the product, get a second or third opinion.

In the past few years studies have identified troubling health problems in patients following the administration of gadolinium-based contrast agents (GBCAs) used during MRIs. Some people have gotten debilitating symptoms from these GBCAs. Let’s take a look:

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If you have any interest in artificial hips, you need to follow the work of Dr. Steven Tower. An orthopedic surgeon in Anchorage Alaska, Dr. Tower has built a one-man research laboratory studying the horrifying health effects of chrome and cobalt hip components. While hip manufacturers have been slow to produce meaningful studies on the ill-effects of metallosis on the human body, Dr. Tower decided to study his own patients. What he discovered could save lives.

Dr. Tower’s Backstory

Orthopedic Surgeon Steven TowerSteven Tower’s story is remarkable. He is featured in the Netflix medical device documentary The Bleeding Edge. Dr. Tower is an avid cyclist and needed a hip replacement several years ago. He chose the DePuy ASR metal-on-metal artificial hip because it was marketed to “exceptionally active individuals.” Several months after his hip replacement surgery, however, Dr. Tower noticed a tremor in his hand. His ears started ringing, his thinking became confused and he began repeating himself when he spoke. One night while attending a medical conference Dr. Tower had a mental breakdown and trashed his hotel room. He wrote all over the walls with sharpies and pens, and wrote on the hotel mirrors with soap. When he returned home he measured the metal levels in his blood, and the test results revealed 100 times the normal amount of cobalt that should be in his body. Dr. Tower soon arranged to have his metal hip components removed in a revision surgery. Within a month his thinking cleared and his other symptoms mostly disappeared. He was relieved, but also intrigued.

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Some drug companies pay doctors, who then prescribe the company's drugsYou scratch my back, I’ll scratch yours. Favors are often exchanged among friends and family. But what most people don’t know, or don’t want to know, is that questionable “favors” are also exchanged in professional and business relationships. Over the years, there have been reports that favors, or benefits, are too often exchanged between drug manufacturers and doctors and hospitals who prescribe medicines.

Recent studies have explored this relationship and compared data to see if drug makers are, effectively, paying doctors to prescribe their medications.

In 2010, the Affordable Care Act included a section called the Physician Payment Sunshine Act. This Act requires drug and device manufacturers to report any and all payments made to physicians and hospitals. Since 2013, 40.74 million records have been published and $24.92 billion dollars have been given to doctors and hospitals from drug and device manufacturers. The Sunshine Act has been successful at exposing these payments.

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You go to the doctor to get help, not to be hurt. And you take medicine to be healed, not to be harmed. However, some prescription drugs, like Actemra, may do the latter – hurt you instead of help you.

Rheumatoid Arthritis and Actemra
If you or a loved one have rheumatoid arthritis, you may have been prescribed or heard of Actemra. Rheumatoid arthritis (RA) is an autoimmune disorder that causes the joints to swell and become painful. Actemra, also known as tocilizumab, is a prescription drug that is injected weekly or infused monthly to aid patients with their symptoms and slow the progression of RA.

Recently, Actemra has also been prescribed to “help” those with giant cell arteritis. Giant cell arteritis (GCA) is a blood vessel disease that causes the vessels, primarily those in the scalp and head, to swell and become inflamed.

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Leukemia patient is prescribed drug Tasigna
If you have a specific type of leukemia—Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML—you may have been prescribed the chemotherapy drug Tasigna (nilotinib). Tasigna offers promise for some patients and may even be associated with remission of their disease—but it’s not without risks.

What’s more alarming, the drug’s manufacturer, Novartis Pharmaceuticals Corporation, may have known about those risks and failed to disclose them to you. People who have been harmed or lost loved ones due to Tasigna have sued Novartis. Here’s what you need to know.

What Is Tasigna?

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For many years my clients with failing artificial hips have asked me about the health effects of high cobalt and chromium levels in the body. These questions usually arise after clients get blood work done and the test reveals abnormally high metal levels. If you are reading this article, you probably already know that cobalt and chromium are two metals used in the construction of most metal-on-metal (MoM) artificial hip systems. In fact, cobalt and chromium are used to make artificial hips that are not metal-on-metal but instead use polyethylene liners, or ceramic heads, or other non-metal components. When metal components grind together, as they naturally do when a MoM artificial hip is implanted in a person, very small metal particles can be released into the tissue and the bloodstream. I wrote about the health effects of metallosis on the body over a year ago. You can check out that article here.

Cobalt poisoning from artificial hip implants
Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many neurological problems he has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.

What is Arthroplasty Cobalt Encephalopathy (ACE)?

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Taxotere and Permanent Hair Loss
Hair loss, or alopecia, is a common condition for many people, especially when they age. The exact reason for the hair loss can vary, but one particularly unpleasant cause is chemotherapy. However, not all patients will be affected the same way during chemotherapy, even when taking the same chemotherapy drug to fight the same type of cancer.

For example, some patients may only experience a slight change in hair color, while others will have thinning hair. Others may have hair loss, although the amount and areas of hair loss can differ among patients. For some unlucky patients, the hair loss is permanent. One such chemotherapy drug that causes permanent hair loss is Taxotere.

What Is Taxotere?

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Arthritis Drug Actemra Many things in life involve a cost benefit analysis. We’re constantly taking risks that can cause harm, but choose to take on that risk because the benefits outweigh the dangers. A good example of this is driving a car. There is a risk of getting into an accident, but the benefit of having on-demand personal transportation is easily worth it.

Prescription medications are no different. Each one is intended to provide a benefit, although each will always have at least some side effects or adverse reactions. The question is never, “does the drug have a side effect or adverse reaction?” Rather, it’s “how many side effects and adverse reactions are there and how bad are they?”

It’s no surprise to learn that many medications on the market today have numerous side effects and adverse reactions, some of them deadly. Yet, they’re available for use not only because the benefits may outweigh the risks for a significant number of consumers, but also because the makers of the medication are required to inform consumers of these risks. So a pharmaceutical company that fails to properly warn consumers of the risks of its drugs can get into trouble. That’s exactly the issue with Actemra. Continue reading →