Surgical Injury from Harmful Materials - A Nightmare for my Friend

My friend Angela is in the middle of a debacle that probably should surprise no one, but is just as difficult and frustrating all the same.

Several years ago she had surgery. Not long afterwards, she had new symptoms that made her surgeon take pause… eventually it was discovered that the cause of the problem was a mesh fabric used as a part of the surgery. It wasn’t left there by mistake; it was part of the surgery. It was supposed to be there. It was manufactured to be left in someone’s body. It was new to the market, and there’s where part of the problem is. It’s called Mentor’s OB Tape.

Follow up surgery has not rectified the problem. The most recent theory is that the mesh has migrated to other areas of Angela’s body. She is left with problems and pain. The next step is probably another surgery — seek and remove — find those other pieces of mesh in other places, dig them out, replace them, sew them into place. Bloody, messy, ugly, horrible.

Here’s the kicker: Recently Angela learned that the manufacturer of the mesh realized there were problems with rejection of Mentor’s OB Tape soon after it was introduced to the market — meaning — just after Angela’s original surgery. Did they recall it? Or notify the hospitals that had purchased it of problems? No. Instead they just quietly withdrew it from the market and replaced it with another mesh. Now there seem to be thousands of women who have had similar symptoms and rejection problems, like Angela’s. Lawsuits are being filed. Thousands of warning websites exist. There are problem reports on the NIH website.

Angela is quite the detective. She has been emailing the researchers who published the original studies that said there were problems with the mesh. Some have replied to her. She has even tracked down the doctor who holds the patent for the mesh who now lives in France.

France?

I have to wonder whether he is French. Or did he flee the US in anticipation of the lawsuits?

This is one more in a series of substances and products being approved by the FDA and used on (what turns out to be) guinea pig human patients, to make the ultimate discovery that it’s harmful to those patients. In some cases, patients have died after their guinea pig experiences. (I do not know if that’s the case with Mentor’s OB Tape.)

And what can patients do to protect themselves? In the short term, probably nothing except to look at the bigger picture of what’s happening at the FDA approval level. We’re hearing too frequently of approvals gone awry. I don’t know if it’s the case with this mesh, but too many approvals are taking place because research that turned up problems is being hidden by the manufacturer seeking approval.

No easy answers — just a warning that anyone can be a victim of the system. Angela was. I was. And you can be, too. And this will continue to happen until the FDA begins requiring access to all the studies being done about newly introduced drugs and materials — not just those good outcomes the manufacturers want them to see.
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Update! (4/19/08) — Angela has started a blog — her experience, research, surgeries and lawsuit. Check it out.

               

Vytorin, Zetia, Zocor, Confusion and What You Should Do Now

We used to see the ads on TV. Your cholesterol goes out of whack because of two things: cholesterol from the food you eat, and genetic cholesterol problems. So, being the good and wise patient you were, you discussed the subject with your doctor and he or she suggested Vytorin. Why? Because it was said to battle both types of cholesterol. And that can help prevent heart attacks and strokes.

Turns out that those clever marketers at both Shering Plough and Merck — the manufacturers of the components of Vytorin — had us all fooled. Billions of dollars later (yes — I mean billions!) they announced that — oops! Vytorin not only doesn’t work to reduce cholesterol and protect us from heart attacks and strokes, but it might even cause us additional cholesterol problems, worse than we had before we took the drug!

This isn’t really new news — the results of the most recent study were actually released back in January. The point is only raised today because it became official when announced at this week’s meeting of the American College of Cardiologists. But since then, there have been a few aspects of the announcements that most patients don’t understand, or haven’t thought about. So — here’s some food for thought:

What exactly is Vytorin? It is a combination drug. Shering Plough makes one statin (cholesterol-lowering drug) called Zetia. Merck makes another one called Zocor. Their brilliant marketing minds decided to mix them together because two kinds should lower cholesterol even better than one, right? Turns out, that wasn’t always right.

If the drug doesn’t work, then how did it get FDA approval to begin with? Good question. It was approved for sale in 2004, presumably because the FDA bought the argument that the two components, both Zocor and Zetia would work in combination. Fooled the FDA! (nothing new)

Why doesn’t it work? Turns out that the bigger question being asked isn’t so much whether or not any of these statins really lower someone’s cholesterol levels; rather, the question is whether or not lowering someone’s bad cholesterol really prevents heart disease or stroke. Evidently, just because someone’s LDL (bad cholesterol) is lower doesn’t mean they are really protected.

How can that be? We’ve known for years that LDL needs to be low, and HDL should be high for protection. That’s actually what was disproved from this test — that the assumptions about LDL and HDL may be wrong!

Who is most upset at this news? The answer is probably a four way tie:

Doctors are very upset because they were fooled (and who likes to be made a fool?) How will they ever trust Merck or Shering Plough again? (OK — not sure how they trust Merck after the vioxx scam anyway?)

Insurers are very upset because they have been paying big bucks for Vytorin (when it was launched, it cost $2.34/tablet). Generic statins, which would have been more effective for patients would have cost a fraction of the price.

Investors / stockholders of both Merck and Shering Plough are hurting — their stock value has nose-dived.

And the pharmaceutical reps who work for both companies, and sell doctors on the drugs are angry — through no fault of their own, the rug has been pulled out from under their career legs. No doctor will ever prescribe Vytorin again. And anything sold by Merck or Shering Plough will be suspect.

We patients should get mad, too. We should be angry because the FDA allowed itself to be fooled and approved a drug — yet another one — that is not beneficial to patients, and can harm them, too.

What should patients do if they take Vytorin, Zetia, Zocor or any other statin? Don’t change anything until you check with your doctor. The bottom line of the study doesn’t seem to be that any of them are dangerous. Instead they just aren’t effective.

See your doctor. Ask tough questions. And partner with him or her to decide what to do next.

               

FDA Advisers Endorse Return of Multiple Sclerosis Drug

03.08.06, 12:00 AM ET

WEDNESDAY, March 8 (HealthDay News) — A U.S. Food and Drug Administration advisory panel voted unanimously Wednesday to allow the promising but controversial multiple sclerosis drug Tysabri back on the market.

The advisers continued to discuss certain controls on who could use the drug, which has been linked to a rare but potentially fatal brain infection. The panel members agreed to a manufacturer plan for a mandatory patient registry; they were scheduled to decide later in the day who would be allowed to enroll in the registry, and how tightly drug use would be limited, the Associated Press reported.

While the full FDA generally follows the recommendations of its advisory panels, it is not required to do so. The agency is expected to render its final decision on the drug by the end of the month.

Physicians and MS patients alike were heartened by the decision, which came during the second day of two days of deliberations.

“Tysabri is a very important step forward despite the fact that there are some concerns and limitations concerning its safety, but the safety risk at the moment, in the range of about one in 1,000, is probably well worth taking for patients with more severe or unstable disease,” said Dr. Joseph Herbert, director of the Multiple Sclerosis Care Center and chief of neurology at New York University/Hospital for Joint Diseases in New York City.

“Patients with rapidly progressive or aggressive MS are probably at far greater risk because of the disease than they are from a potential rare side effect of the drug,” Herbert said.

MS patient and attorney Karen Miller, 49, told the committee that Tysabri “is as close as it comes” to a miracle drug. Miller credited the drug with a renewed ability to ride her bike, wash her windows and run daily errands, the AP said.

“I am at the end of my road, in terms of what I can take. I want it to be my choice,” another MS patient, Barbara Crooks, 48, told the news service.

Tysabri’s manufacturers, Biogen Idec Inc. and Elan Corp, pulled the drug off the market in February 2005 after three patients taking it developed progressive multifocal leucoencephalopathy (PML), a progressive, neurodegenerative disease. Two of those patients died.

The removal took place just three months after the FDA had granted accelerated approval of the drug for the treatment of relapsing forms of MS.

In February, the FDA announced that Biogen and Elan could resume clinical trials for MS patients who were previously treated with the drug under an investigational study.

According to the National Institute of Neurological Disorders and Stroke, multiple sclerosis is an unpredictable disease of the central nervous system that can range from relatively benign to somewhat disabling to devastating. Most MS patients experience their first symptoms between the ages of 20 and 40, and most suffer muscle weakness in their extremities and difficulty with coordination and balance. These symptoms may be bad enough to hamper walking or even standing; in worst cases, MS can produce partial or complete paralysis.

Tysabri is a monoclonal antibody, engineered to attach itself to white blood cells called lymphocytes and prevent them from entering the brain, where they do damage that causes the disabling symptoms of MS. Tysabri had also been used to treat Crohn’s disease.

One of the biggest issues in bringing the drug back to market is what kind of risk-management plan should be implemented. An initial plan submitted to the FDA by the manufacturers was considered insufficient.

“There’s no question with this kind of essentially lethal risk that there is going to have to be some kind of risk-management program,” Dr. Robert Temple, director of the FDA’s Center for Drug Evaluation and Research, said at a Tuesday news conference.

Other features of a risk-management plan could include restrictions on who gets the drug, administering the drug at a registered infusion center, and monitoring all patients on the drug for at least five years. The drug may be restricted only to individuals with more severe forms of the disease, patients who have failed other therapies, and patients who are not taking other immunosuppressants.

“The three cases that did develop PML were all patients who were on other immune modulator drugs,” Herbert noted. “If we use Tysabri judiciously and as a monotherapy, it is possible that the risk will turn out to be lower than we imagine.”

Tysabri is only the second prescription drug to be returned to the market after being taken off. The other was Lotronex, used for irritable bowel syndrome, which was withdrawn in 2000 but allowed back on the market two years later.

“Lotronex was a unique drug with value for some people,” Temple said. “The drugs that disappear permanently tend to be drugs that tend to have substitutes.”

More information

Find out more about Tysabri at the U.S. Food and Drug Administration.

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