Articles Posted in Health Alerts

The Federal Trade Commission announced today 11 law enforcement actions taken against firms deceptively advertising bogus cancer cures. The companies have been charged with making unsupported claims that their products have treated or cured various cancers, and some were charged with falsely stating that they had clinical or scientific proof of their products’ efficacy. The FTC’s Director of the Bureau of Consumer Protection stated that, “There is no credible scientific evidence that any of the products marketed by these companies can prevent, cure or treat cancer of any kind.”

Of the 11 complaints, six were resolved by proposed settlements with the remainder to be litigated by the FTC. The companies will all be required to notify consumers that there is little to no scientific evidence demonstrating the efficacy of the products to treat or cure cancer. The complaints arose out of a year-long effort by the FTC, the FDA, and a corresponding Canadian agency in which 112 websites were targeted. Of those, over 30% responded to the governmental warnings and closed their websites or altered the fraudulent claims. Warning letters were then sent to 23 companies.

To identify the companies and products targeted, follow the links below.

Most readers know that PTSD can be caused by intense trauma from accidents and injuries, but the question whether medical intervention itself can cause PTSD has not been extensively studied. Dr. Dimitry Davydow of the University of Washington’s School of Medicine reports in the Sept.-Oct. issue of General Hospital Psychiatry that as many as 22% of ICU patients will later suffer PTSD. This conclusion arose from the review of 15 medical studies and 1,745 ICU patients. The symptoms of PTSD include nightmares, sleep problems, flashbacks, irritability and anger, as well as emotional numbness. The risk of suffering PTSD increased if the patient had underlying mental illness, such as anxiety or depression, or was treated with certain sedatives that cause disorientation, confusion, or psychotic experiences.

Sources:

General Hospital Psychiatry, Vol. 30, at 421-34, Sept. Oct. 2008

According to a recent study presented at the British Pharmaceutical Conference in Manchester, England, 60% of woman may be risking the health of their babies by taking herbal remedies while pregnant. The study was authored by Lone Holst, a researcher in Norway, who studied 578 women giving birth in the UK. In the study population, 49% knew nothing about the safety risks of the products they were taking, and had taken the products on the advice of their family or friends, rather than their healthcare providers. In pregnant women over 40, 72% of women had used herbal preparations during their pregnancy.

The reasons for caution are many. Unlike prescription drugs, herbal preparations are not tested for safety and efficacy. Moreover, the active ingredients often vary from the amounts stated on the label. Manufacturers also fail to test the products to be certain that toxic contaminants are not present, and intentionally “spike” their products with pharmaceuticals to make the concoctions are more potent, without disclosing this to the consumer.

Even in the best of circumstances, it is difficult to test a single active ingredient for safety and efficacy. Diet supplements and herbal preparations are manufactured with a “kitchen sink” approach using the dangerous notion that a combination of ingredients are better for you, than a single, active ingredient. In fact, the interactions between these ingredients, and between the ingredients and other medications that the consumer may be taking, is not known and can be a set up for disaster and cause fetal harm.

The FDA has issued its first public disclosure of 20 drugs it is now investigating for safety concerns. The disclosure is the result of the 2007 Food and Drug Administration Amendments Act that mandated that the agency post on a quarterly basis information about drugs it is investigating based on adverse events reported by doctors. The information does not disclose the nature of the adverse events or the extent of the problem. The fact that a drug is listed is not intended to suggest that the agency has, in fact, concluded that the risk exists. The posting does not include all of the drugs currently being subjected to a further safety investigation.

The consumer now has more information at hand to make an informed decision about drugs a doctor prescribes. Hopefully, these disclosures will prevent unnecessary injury when the FDA and the manufacturer are aware of potential risks, and the unsuspecting patient is not. That is a gap that should, and must, be closed. Here is the list:

Arginine Hydrochloride Injection (R-Gene 10): Pediatric overdose due to labeling / packaging confusion

With increased attention being put on improper financial influences in medicine, by both the lay and professional press, you may be wondering how you can find out if your doctor is getting brown paper bags of cash from Big Pharma or a medical device manufacturer. The next time a doctor recommends a drug or a medical device, check with the Association for Medical Ethics to see if your doctor has improper financial ties with the manufacturer. As a result of a U.S. Department of Justice settlement with four medical device companies, Zimmer, Inc., DePuy Orthopaedics, Inc., Biomet, Inc., and Smith & Nephew, Inc., these back door consulting agreements must now be made public. (See our earlier post about this: Financial Ties) The Association for Medical Ethics maintains a searchable database that will tell you if your doctor is on the payroll of the company whose product he has just recommended: www.ethicaldoctor.org. Some of the information is shocking: two physicians listed made more than $8 million each from Dupuy Orthopaedics.

Now that’s a fact you would want to know before the doctor operated, isn’t it?

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Under the dubiously named Dietary Supplement Health and Education Act (DSHEA), diet supplements and herbal preparations are not approved by the Food and Drug Administration for medical use in humans. Thus, safety and formulation are solely the responsibility of the manufacturer; evidence of safety and efficacy is not required as long as they are not advertised as a treatment for a medical condition. As we have seen in diet supplement litigation (Talbert v. E’ola Products, Inc.), diet supplement manufacturers often promise the moon in selling their products to the consumer, while having little other than anecdotes to show when it comes to providing data for the safety or effectiveness of their products. Even assuming that the products are not adulterated (because of shoddy manufacturing protocols), have not been spiked (pharmaceutical drugs intentionally put into the supplement), and actually contain the ingredient at the levels claimed (often the “active” ingredient is missing or varies wildly), it is the exception, not the rule, that the manufacturer will have evidence that the supplement is safe for human consumption and actually works. With pharmaceutical drugs, the manufacturer foots the bill for such research. In the world of diet supplements, however, it is often independent researchers or the government (read: the taxpayer) that is burdened with the duty and cost of proving the safety and efficacy of a particular diet supplement.

At the Alaska Personal Injury Law Group, we are frequently asked to help those with serious orthopedic injuries. And our clients commonly face the debilitating consequences of arthritic changes that come from these injuries. So a discussion about glucosamine is in order. Luckily, unlike ephedra and other more dangerous diet supplements, glucosamine has not had a string of serious adverse events (it is not without side effects, however, so you need to read carefully before using glucosamine). But does it work?

Glucosamine is a natural compound that is found in healthy cartilage. Glucosamine sulfate is a normal constituent of glycoaminoglycans in cartilage matrix and synovial fluid (this is the “hydraulic” fluid in your joints). It is believed that the sulfate moiety provides clinical benefit in the synovial fluid by strengthening cartilage and aiding glycosaminoglycan synthesis. The question is, if you take the supplements, will the body put the critical compounds into your blood stream and use them where the arthritis lies? There have been multiple clinical trials of glucosamine as a medical therapy for osteoarthritis, but the results have been conflicting. Early clinical trials sponsored by a European patentholder, as expected, demonstrated a benefit from glucosamine. However, these studies were of poor quality due to shortcomings in their methods, including small size, short duration, poor analysis of drop-outs, and unclear procedures for blinding. Subsequent independent studies did not detect any benefit of glucosamine. This situation led the National Institutes of Health (yes, you the taxpayer) to fund a large, multicenter clinical trial studying reported pain in osteoarthritis of the knee, comparing groups treated with chondroitin sulfate, glucosamine, and the combination, as well as both placebo and celecoxib (Celebrex). The results of this 6-month trial found that patients taking glucosamine HCl, chondroitin sulfate, or a combination of the two had no statistically significant improvement in their symptoms compared to patients taking a placebo.

When we represent clients at the Alaska Personal Injury Law Group, we do our homework. When serious injuries occur, we have to become experts ourselves in the particular medicine being used to treat our clients. We thus comb through and rely extensively on medical literature in virtually every case we handle. We use it in our work with the medical experts we engage to help our clients, and we also share it with our clients.

And whether you realize it or not, you rely on medical literature every time you see a doctor or take any medication. This is because the engine of medicine runs on the data from medical literature. That data is what the FDA uses to decide whether to allow a medication or medical device to be sold, and what your doctor relies on to decide if a treatment, medical device, or medication will help you. Extraordinary rules and guidelines are put in place to make sure that the scientific findings in a particular study are objective and scientifically verified.

So it is always shocking when we learn that a manufacturer has taken liberties with the research data to make it appear that their product works when it really doesn’t. (We saw this repeatedly in the litigation against diet supplement manufacturers: Talbert v. E’ola Products, Inc.) We know why this happens: millions and sometimes billions of dollars are made by manufacturers in these endeavors, and greed can be a powerful motivator. Every time we learn about one of these situations, it reaffirms the need to vigilantly enforce the principles that guide regulators and researchers who develop research data. Western medicine is so profoundly effective because it is “evidence-based medicine”. If we allow clinical researchers to get into bed with the manufacturers, how can we trust that the research data they create for the manufacturers is valid, objective and truly “evidence-based”?

We have handled a number of cases at the Alaska Personal Injury Law Group where clients have developed balance and dizziness complaints after suffering a traumatic brain injury (TBI) in automobile crashes or similar assaults to the brain. It is not commonly known that these disorders flow from TBI, and attorneys often miss the connection. These disorders can develop in several ways, but a common mechanism is benign paroxysmal positional vertigo (BPPV). BPPV is a balance and dizziness disorder caused by a problem in the vestibular system of the inner ear which forms part of the body’s balance system. Small particles, or crystals, of the inner ear are dislodged with the trauma and this interferes with the normal function of the inner ear. This can cause episodic vertigo that can be quite disturbing to the client. If untreated, the episodes can recur for years and become part of the lasting and unfortunate legacy of TBI.

There are treatments for BPPV through a series of scripted movements by trained therapists designed to put these crystals back in their normal position. This is called a canalith repositioning maneuver, and significant improvement has been experienced by some clients.

To properly diagnose a patient regarding the many potential causes of balance and dizziness problems, a client often undergoes vestibular testing, but it has traditionally been aimed at finding a localized problem, a “site of lesion”. The major limitation of these site-of-lesion tests is that they assess structural and physiological changes within individual sensory or motor components in isolation, rather than in the functional context of balance control. A new type of testing has been developed called the Neurocom Balance Manager, which is designed to provide a comprehensive differential diagnosis of sensory, motor, and central functional impairments of balance control. Developed using methods created by NASA to study balance in astronauts, Neurocom uses a computerized dynamic posturography (CDP) system that professes to offer a more comprehensive means of diagnosing the patient, which hopefully will lead to more specific and helpful treatment.

Clients of the Alaska Personal Injury Group often have to decide whether to have knee surgery. When the underlying cause of pain and discomfort is arthritis in the knee, rather than a mechanical problem like a torn ligament, the arthroscopic surgery proposed by orthopedists is often not helpful. A surgeon will admit this if pressed, and now there is a study that addresses this very issue.

In an article just published in the Cochrane Database, researchers studied the outcomes of arthroscopic debridement surgery in patients with knee arthritis after reviewing the published literature regarding such surgeries. The researchers found that arthroscopic surgery does not improve pain or ability to function when compared to simple placebo and sham surgery. They also concluded that arthroscopic surgery led to little or no difference in pain levels or the ability to function in comparison to simple lavage (washing out) of the knee joint. Further, having arthroscopic surgery also comes with the additional risks of surgery, such as pain, infection, or embolism. The cautions that come with relying on this data is that the authors ultimately relied on only 3 out of the 18 studies they reviewed, and it is clear that some patients with particular injuries can be helped with arthroscopic surgery. The trick is for the patient to figure out if they are really in that small subset of patients who can be helped by the procedure.

With arthroscopic surgery of questionable value where no operable condition is causing their problems, clients are thus faced with relying on more conservative measures to ameliorate their pain and limitation from knee arthritis, such as physical therapy, viscosupplementation (injecting a cushioning fluid into the joint space), and medications to forestall more serious surgery like total knee replacement.

One of the unfortunate outcomes of serious orthopedic trauma faced by the clients of the Alaska Personal Injury Law Group is surgery for injured spinal discs. Whether it is soon after an accident like an automobile crash, or years later due to progression of their condition, clients often struggle with the decision about whether to have spinal surgery.

A harsh reality is that the “gold standard” in cervical disc surgery is removal of the herniated disc and fusion of the joint with bone and metal plates. The unfortunate results of this type of surgery often include recurrence of the original neck, back and arm pain, a limitation of neck movement, and increased stress on adjacent spinal levels that leads to arthritic changes in that joint, and sometimes yet another fusion. When a person’s own bone is taken for the fusion from the iliac crest of the hip, that operative site can also be a source of pain or disability.

In recent years, there have finally been some advances in spinal surgery for herniated discs with the development of disc implants intended to avoid fusion and preserve joint movement in the injured vertebral segment. There are several manufacturers now performing clinical studies of their new implants. In the journal Spine, a two year study of the Bryan cervical disc implants was just published. The researchers followed 115 patients, 56 of whom had the new implants. Their study showed that the patients receiving the implants had less arm and neck pain when evaluated at one and two years after surgery, and they retained greater neck movement than in the patients receiving a fusion. The researchers believe that retention of greater movement will ultimately lead to less biomechanical stress on adjacent joints, and therefore to less injury to surrounding joints.