Alaska Injury Law Blog

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.

Today’s news is that the Annals of Internal Medicine has just published a study concerning the effect of glucosamine sulfate on the symptoms and structural progression of hip arthritis. Following 222 patients over a 2-year period, the researchers evaluated the patients’ pain, function and stiffness at regular intervals in the 2-year period. They concluded that “glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis.” Translation: glucosamine supplements will do nothing for the pain in your hip—the pain is likely coming from what the cost of the supplements did to your wallet.

Source: Annals of Internal Medicine, Effect of Glucosamine Sulfate On Hip Osteoarthritis, 19 February 2008, Volume 148 Issue 4, at 268-277, >http://www.annals.org/cgi/content/abstract/148/4/268.

Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), http://www.clinicaltrials.gov/show/NCT00032890; AND http://www.ncbi.nlm.nih.gov/pubmed/16495392.

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"?

Today’s when-the-cat’s-away lesson involves Synthes, the manufacturer of an artificial spinal disc called the Prodisc. It turns out that doctors at about half of the medical facilities conducting clinical trials, i.e., performing surgeries, using the Prodisc stand to profit handsomely if the Prodisc is approved by the FDA. For example, 12 of the surgeons involved in the study had also invested in Synthes. The concern is that the study results submitted by the manufacturer to the FDA did not contain data about a large number of patients, some of whom said they had poor outcomes. Those critical of this conflict of interest suggest that the data casts the Prodisc, scientifically speaking, in “an overly flattering light.” Was it because surgeons in the study were also investors in the device? We can’t know for sure, but we do know that the research data is now tainted because of this impropriety.

This situation gives us yet another example of how conflicts of interest can distort scientific data and why the FDA and other gatekeepers should vigilantly eradicate them. The FDA should not accept data from clinical trials conducted by those who would profit from market approval of the device or medication being studied. The hospitals and universities conducting such trials should not permit their researchers and physicians to financially benefit from the studies being conducted. As professionals, the physicians themselves should recognize such conflicts of interest and refuse to participate as researchers or investors—attorneys, for example, are ethically barred from representing clients when such conflicts exist and are professionally bound to recognize when a conflict exists and refuse to represent a client when a conflict is present.

This situation with Synthes is also remarkable because these issues have actually come to light—most such conflicts of interest do not. Until the clinical data on the Prodisc is substantiated by objective researchers, surgeons and potential patients should steer clear of this device. If you can’t trust your doctor, who can you trust?

Source: N.Y. Times:
http://www.nytimes.com/2008/01/30/business/30spine.html;
Association for Ethics in Spine Surgery:
http://ethicalspinesurgeon.org/

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.

Source: Mayo Clinic Vertigo Rehabilitation; Mayo Clinic Vestibular Lab; Neurocom International, Inc.

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.

Source: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD005118/frame.html

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.

The surgeries involved only one cervical disc level with a focal disc herniation. Patients with retrovertebral compression, facet pathology, multilevel stenosis or significant degeneration are not currently deemed to be candidates for this type of implant.

Source: Artificial Disc Versus Fusion: A Prospective Randomized Study With 2-Year Follow-Up On 99 Patients, Spine. 2007;32(26):2933-2940; http://www.medscape.com/viewarticle/568297; http://www.bryandisc.com/about-bryan-disc.html

The coming issue of Clinical Cancer Research will publish two case reports concerning the progression of prostate cancer believed to have been caused by a dietary supplement "spiked" with pharmaceutical compounds. "Spiking" is, unfortunately, an all too common practice in that industry. While claiming to sell "all natural" products, and taking advantage of the regulatory limitations imposed on the FDA under the Dietary Supplement Heath and Education Act (DSHEA), www.fda.gov/opacom/laws/dshea.html , diet supplement manufacturers put consumers at risk by "spiking" their products with pharmaceutical compounds they know to work, when the herbal compounds do not. Unlike prescription and over-the-counter drugs, current law does not require nutritional supplements to undergo pre-market testing or approval for safety and efficacy.

This was a key issue in the first jury verdict in the nation against an ephedra manufacturer, a case the Alaska Personal Injury Group brought: Talbert v. E'ola Products, Inc., www.cfsan.fda.gov/~dms/ds-ephed.html . There, the manufacturer, whose product has since been confiscated by the FDA, "spiked" its ephedra product with the pharmaceutical drug, ephedrine hydrochloride. www.fda.gov/bbs/topics/ANSWERS/2001/ANS01114.html . In that instance, it caused a healthy young woman to suffer a cerebellar stroke.

The product analyzed by the researchers at University of Texas Southwestern Medical Center has led to an equally horrific outcome--virulent prostate cancer. The researchers report in the journal that the diet supplement, which they have declined to identify by name, contained the sex hormones testosterone and estradiol. Laboratory tests of the product on human prostate cancer cells found it to be a more potent stimulator of cancer cell growth than testosterone alone. Such compounds cannot be sold except by prescription. The spiked hormones are believed to have caused the two men to develop rapidly advancing prostate cancer within months of using the dietary supplement. Both men, before using the product, had low levels of prostate-specific antigen (PSA), a signal for prostate cancer and then presented with widespread cancer within six months, which is unusual. One of the men has died; the other is in the final stages of the disease and is expected to die within months. Notified of these findings, the FDA sent a warning letter to the manufacturer, and the supplement has now been removed from the market.

In addition to failing to list all the steroid hormones contained in the product, the researchers also found that the product’s label stated ingredients that were not present, and it also misrepresented the concentrations of the ingredients present. These kinds of failings are very common in this industry, and arise because of the lack of regulation over the industry's manufacturing processes. This type of misrepresentation and mislabeling is not just blatant consumer fraud, it can be dangerous when the concentration of an ingredient is too high.

Continue reading " Diet Supplement Found To Exacerbate Prostate Cancer--Another Spiked Product " »

A common problem an attorney has is how to be certain their client is receiving proper medical care. The attorney can collaborate with the client to be sure that the proper diagnostic steps are being taken. This not only helps further a client's case, but it also helps the client return to function. It is often the case that a better diagnosis can be obtained depending on what type of films are taken. A current debate is whether the MRI or arthroscophy is preferable in diagnosing a knee injury. Both have shown good diagnostic performance in detecting lesions of the menisci and cruciate ligaments. Nonetheless, arthroscopy has remained the "gold standard".

The British Medical Bulletin recently published an article examining this question. As might be expected, the answer was, "well, it depends". The results of the study were that MRI was deemed "highly accurate " in diagnosing meniscal and anterior cruciate ligament (ACL) tears. Because its use avoids the risk of surgery, it is "the most appropriate screening tool" before arthroscophy is performed. The results differed, however, depending on whether the medial and lateral meniscus and ACL were being examined.

British Medical Bulletin 2007 84(1):5-23.