sexta-feira, 9 de dezembro de 2011

Adverse Effects of InFuse


Medtronic markets its products aggressively. Their product, InFuse, has been a big hit in spinal surgeries, and now is also sold for dental surgeries. However, the marketing of InFuse has been riddled with corruption, and now lawsuits for devastating damage are emerging.
InFuse is the brand name for BMP-2,recombinant human bone morphogenetic protein-2. It is used to stimulate bone growth as an alternative to bone grafting. It was first approved by the FDA in 1999 for anterior lumbar fusions, but off-label uses were rapidly devised and Medtronic illegally marketed those off-label uses. In the face of clear indications of severe harm from InFuse, the FDA approved its use in dentistry in 2007.



Soft Tissue Swelling
The FDA finally issued a warning about InFuse, but only as it relates to use in the cervical (neck) spine. They acknowledge that it causes massive soft tissue swelling, can restrict the airway to prevent breathing, and has been known to result in deaths.
In a 2008 cervical spine fusion study of InFuse, 28% of the patients experienced severe swelling. A 2009 study found a 43% higher rate of complications among patients who received InFuse instead of a bone graft, which added an average of $15,000 to the cost of those surgeries. (Not to mention the trauma and misery that those patients suffered.)
Bone Formation in Spinal Canal
A 1999 trial funded by Medtronic was halted when CT scans showed bone formation in the spinal canal of 75% of the patients! But, it wasn't reported in a journal until 2004, after the FDA had approved the product. Three of the four researchers had financial interests in the trial's outcome.
The researchers had concluded that, although it's "not desirable", it wasn't really a problem. However, another study of five patients who had spinal canal bone formation from InFuse suffered neurological impairment.
Cancer
Bone morphogenetic proteins are growth factors known to encourage cell proliferation. Therefore, a study of the potential for cancer should have been an obvious area of research before unleashing InFuse on the public. Instead, it appears that such information was suppressed.
Before the hearings for Amplify, an updated version of InFuse, the FDA had received a study consisting of a five-year follow-up of patients who'd received InFuse. A total of 463 patients were included, approximately divided into half who'd received the BMP-2 device and half who had not. The results were stunning: There were 13 cancers in the InFuse group and 4 in the controls. That is 425% more cases of cancer among InFuse patients! Medtronic said it wasn't statistically significant. And, obviously, the FDA went along with it.
Auto-Immune Response
Because BMPs are naturally produced in our bodies, there must be concern about their artificial implantation resulting in auto-immune disorders. (It's known that implantation of collagen, which is an integral part of the InFuse product, can cause arthritis in lab rats. They are injected with collagen to stimulate adjuvant arthritis, which is indistinguishable from rheumatoid arthritis.)
For this reason, even Medtronic acknowledges a risk to fetuses by potentially knocking out their BMP in an immune response to it.
It appears that there are no studies to determine whether BMPs cause auto-immune responses in adults. Frankly, the lack of such studies is not particularly comforting.
Leg Pain
In a 2009 study, radiculitis, radiating leg pain, was reported by 23% of patients after fusion surgery using BMP-2, compared with 3% whose surgery was done with a traditional bone graft. That is, the risk of developing radiculitis after use of InFuse was 800% higher than with traditional bone grafting techniques.
Retrograde Ejaculation and Sterility
Retrograde ejaculation is sperm and semen entering the bladder instead of the urethra. It can lead to sterility. It's believed that BMP-2 has an inflammatory effect on the nerves around the spine—and that can include the nerves that control the movement of semen.
Two studies have clearly shown that retrograde ejaculation occurs five times more often when InFuse has been used in spinal surgeries. However, one of those studies was funded by Medtronic and the other was independent, done by Stanford. Although both showed approximately the same results in their data, the Medtronic study reported no effect from their product, whereas the other study made the connection.
A team of Croatian doctors raised questions about these anomalies. They sent letters to medical journals raising questions about their failure to link InFuse to retrograde ejaculation. Zdeblick and three other doctors beholden to Medtronic responded by absolutely denying any connection to their product.
Now that you know the sort of damage InFuse can do, let's take a look at how these adverse effects have been covered up:

Off-Label Use
It may be pointed out that most of the adverse effects have been the result of off-label use. That's true. However, the full story requires noting that off-label use of InFuse now constitutes about 85% of its sales. The fact is that Medtronic knowingly sold it for off-label use and even illegally marketed it for that purpose.
Dan Spengler, MD, is a former editor of a spinal medical journal and currently a professor of orthopedic surgery at Vanderbilt University Medical School. He notes, "There is no question, if you have a product, you want it to be published. It carries weight." He also noted that a 2004 article published in The Spine Journal (Spine J 2004; 4: 527-539) by authors who were beholden to Medtronic "just blew off the complications" of InFuse, and "It's a horrible article."
Regarding off-label use, Spengler stated:
It [the 2004 article] seems to be totally aimed at promoting BMP-2 off label without really saying so.
Obviously, when 85% of all use is off-label, then the vast bulk of adverse reactions will result from off-label use.
FDA's "Lost" Records
A single FDA advisory panel member, Stephen Li, PhD, pointed out that nine of the doctors who authored the research submitted to the FDA had financial stakes in InFuse, and that fact should raise questions about their findings being twice as good as research performed by non-affiliated researchers. He was ignored and the FDA approved the product.
Then, when it became impossible to ignore the harms produced by InFuse, the FDA took another look in 2010. The result of this second look was loss of damning records associated with the product. A Freedom of Information Act request resulted in being informed that the records had been lost. But then, different FDA officials stated that they'd been sent to a warehouse, but that, "To access those actually requires an extraordinarily long amount of time." Of course, they were then told that, "It doesn't mean the product isn't safe and effective."(1,2)
Medtronic also has these papers, but they outright refuse to produce them. They claim that they fully disclosed the information regarding InFuse. How they expect to be believed when they refuse to produce the paperwork that might support their claims is left unexplained.
Inventor Zdeblick's Part in Marketing
BMP-2 is a genetically engineered human protein, which is placed inside a cage, called LT-Cage, which maintains spacing between vertebrae. The cage is made of metal and is cushioned by an absorbable sponge of bovine collagen.
Thomas Zdeblick, MD invented the LT-Cage. His resultant association with Medtronic has made him wealthy, garnering over $22 million. Unsurprisingly, he has acted as a promoter and his research on it has clearly been designed to produce glowing results. His report even stated, "Of course, no patients in the rhBMP-2 INFUSE™ group had any graft site pain or complications."(3) That glowing statement should have raised alarms, but of course, in the Big Pharma world of the FDA, it didn't.
Zdeblick isn't one of the nine bought-and-paid-for doctors who were part of the glowing study presented to the FDA. However, Medtronic refuses to name the ones who were.
It Gets Worse
In 2009, Medtronic produced a study for a new version of InFuse. Called Amplify, this product is intended for functions that are off-label in InFuse. Having gotten away with their shenangans to use bought-off doctors in the InFuse trial, they upped the ante. 29 of the 63 surgeons involved had a financial interest in Medtronic. The company says, though, that it doesn't amount to a conflict of interest and didn't affect the results.
Who Do You Trust?
James Kang, MD, is an orthopedic surgeon who wrote a commentary on this topic in The Spine Journal. He questioned how the Stanford and Medtronic studies could come up with the same results, yet reach such opposing conclusions. He concluded that the only explanation was that the Stanford study was independent, while the Medtronic study was not. He wrote:
We must come to the hard realization that data analysis and interpretation in such studies can be biased in favor of funding sources. After all, it is against our nature to publish a negative result or an adverse event that condemns a product that is being studied if we are being funded by the sponsors of the product.
As with so many other medical products that have proven to be dangerous, the corporation that stood to profit from InFuse produced the studies used to gain FDA approval. Obviously, the FDA understands what's going on and is complicit in this wholesale criminal activity.
Should you be facing spinal, dental, maxilofacial, or other surgery involving bone grafting, it's critical that you discuss with your doctor what methods will be used. Should he or she say that the InFuse or Amplify products will be utilized, it's up to you—not the doctor—to decide if you wish to undertake the risks entailed. After all, you are the one who must live with the results—not the doctor.


http://www.gaia-health.com/articles451/000471-spinal-dental-bone-growth-sterility.shtml

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