Merck Sued Again

Over the past week, more lawsuits against Merck & Co, makers of the recalled drug Vioxx, gained traction.

Plantiffs claim that bone medication Fosamax caused osteonecrosis of the jaw. Merck is going to argue there’s no proof, and that they met the requirements to warn patients.

Who’s right?

What’s Fosamax?

Fosamax is a treatment for osteoporosis that promotes stronger bones to reduce risk of fractures. It’s a serious problem – the economic cost annually from osteoporosis related fractures is more than $10 billion.

The older you get, the higher the risk gets. One third of women have hip fractures by age 90.

Bones are often broken when someone falls down or trips, something that also happens more often with aging due to weakened muscles and reduced coordination.

Fosamax and its relatives prevent osteoclasts from resorbing bone tissue, which can help prevent further degeneration of bones. They were initially hailed as “miracle drugs” because they reduced risk of certain types of fracture by up to 50%.

The Claims:

Fosamax may hurt the bone in the jaw. Osteonecrosis of the jaw (ONJ) is when bone gets exposed and doesn’t heal properly. As you can imagine, it is extremely unpleasant and difficult to treat.

Does Fosamax cause it?

Merck says no. But the science almost surely points to an increased risk of ONJ. It may not be large, but it’s there, and even moreso for certain uses of the medication. Intensive use for certain acute conditions, for instance, has a very high rate of ONJ.

Upper range of estimates of ONJ sufferers puts it at 5,000, and the lower ranges less than 1,000. The lowest put it at several hundred. More than 10 million prescriptions for Fosamax alone have been filled since 1995.

But despite the small numbers, the damage is there, and Merck did not warn patients as clearly as the FDA warned them to in 2005, when the data became compelling.

Development of ONJ is typically associated with comorbid cancer. One analysis claims 46.5% of sufferers had a history of multiple myeloma, 38.8% metastic cancer, and 6.2% prostate cancer.  If true, this is important, because it makes a big difference in deciding whether or not to prescribe it.

Conclusion

It looks bad for Merck.

But they will pull out no stops in their defense and point to the general safety of the product, and attack the validity of the plaintiff’s complaints.

One of their likely tactics is to argue that the cases of ONJ developed before they knew of the risks and had an obligation to inform patients.  Considering that they didn’t fully follow the FDA’s instructions for warning, it looks like an uphill battle.

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Sources:

Down to the bone
A Review of the Literature on Osteonecrosis of the Jaw in Patients with Osteoporosis Treated with Oral Bisphosphonates: Prevalence, Risk Factors, and Clinical Characteristics
Osteochemonecrosis of the Jaws due to Bisphosphonate Treatments. Update

Do Vaccines Cause Autism?

There’s nothing more scary for parents than the thought that they might hurt their children. The controversy about vaccines and autism is frightening, but seems to have little scientific backing.

It started in 1998. The Lancet reported on 12 children with gastrointestional problems that they believed were caused – at least partly – by vaccinations. They claimed those problems contributed to autism and other conditions in the children.

Initial research seemed to support their argument: Unusual levels of measles virus RNA (a type of DNA) was found in certain parts of the kid’s bodies. But on two levels their analysis was refuted: by massive analysis of hundreds of thousands of children and autism, and by carefully examining their scientific method.

Epidemiological studies

Massive amounts of evidence shows that the large increase in autism over the past few decades is not associated with vaccination.

One study in Denmark compared 500,000 children vaccinated against 100,000 who weren’t. They had pretty much the same chance of autism.

The measels, mumps and rubella (MMR) vaccine was started in 1988 in London and no correlation was found between that and an increase of autism. Additionally, the vaccination efforts initially were distributed in clusters: not everyone got it at once. No such cluster effect was found in autism rates.

Similar data show that introduction of MMR in Japan in 1993 was not correlated with increase in autism rates.  One thing is consistent: analysis of tens of thousands of kids shows again and again no risk for autism associated with vaccine use.

Refuting the science

How might vaccines cause autism? The most prominent theory was that they somehow trigged an “aberrant immune reaction” that caused damage to the brain. The gastrointestional upset, for instance, might allow toxic proteins to reach the brain that otherwise wouldn’t.

The evidence for this theory was that a few kids with autism had been shown to have measles virus RNA in parts of the body where they shouldn’t be, like inside certain blood cells.

Suspicion of this theory was raised when multiple other studies were unable to replicate the findings.

D’souza et al carefully analyzed the reports and showed that their results were most likely because of mistakes. Either because of false positives or because of mistakes in the lab with how the materials were dealt with.

Thimerosal

Another theorized problem was the presence of thimerosal in vaccines. Superficially, it seems insane to include it; it is, after all, mercury, and we all know how dangerous that is.

Thimerosal, however, is a specific type of mercury called ethyl mercury, which is biodegradable and does not cause toxic build up in the body. Similarly large epidemiological studies have shown that it is not associated with autism.

Finally, all vaccines are now available without thimerosal.

Conclusion

There is no denying that diagnoses of autism have really, really increased over the last few decades. But it’s hard to say why. Increased recognition must play a large part, as well as diagnosing milder cases that would have previously been ignored.

It is also possible that other environmental issues play a role.

Vaccines are extremely important to protect children from diseases.

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Sources:

Vaccines and Autism: Evidence Does Not Support a Causal Association
No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells From Children With Autism Spectrum Disorder
Has the Measles-Mumps-Rubella Vaccine Been Fully Exonerated?

Does the FDA keep us safe?

Research into new medications is how we learn if they work and if they’re safe.  It’s the only protection we have against snake oil and worse.  But disasters like Thalidomide and Vioxx – not to mention the dozens of products recalled monthly – remind us that the FDA screws up every now and then.

That’s because drug companies often pretty much lie to get their drugs approved.  Here’s how.

1) Report results that didn’t happen

Amazingly enough, some drug companies take studies that show their product doesn’t work, and they report that it does!  This has happened at least 11 times with studies into antidepressants.

Another form of this is to write a conclusion that’s different from what the actual results show.  Because of time pressure, doctors don’t have time to actually read all the papers thrown at them, and often just read the abstract, which contains the pro-drug message like:  “Conclusion:  Fake drug has been shown to be safe and efficacious in treating extreme bladder discomfort.”

2) Use faulty statistics

There’s a reason Benjamin Disraeli said “there are lies, damn lies, and statistics.”  The sheer amount of ways to manipulate the data from studies by statistics is mind-boggling.  The simplest is to report that something is statistically significant when that doesn’t mean anything.

For instance, a drug can have a statistically significant effect on blood pressure – but that effect is tiny and meaningless.

3) Use inappropriate measuring systems

Some things are easy to measure, like someone’s height or weight.  Others, like mental states and attitudes, are a lot harder.  Psychological assessments range from solid to extremely shaky, like the infamous Rorschach blotch test.

Thank God no drug has been approved because of results of a Rorschach blotch test.  But drug companies always use the measuring system that puts their drug in the best light, even if it doesn’t mean it actually works.

4) Don’t use placebo

When you don’t test your treatment against placebo, absurd things happen.  Like the gastric freezing procedure to treat ulcers, which consists of putting a balloon full of frozen liquid into the stomach to cool it off.  It worked great – until it was tested against a placebo, or a fake treatment.

Guess what?  The placebo worked better.

5) Don’t test against other drugs

You’d have to be crazy to forget about testing against a placebo.  But what drug companies almost never do is test their drugs against other drugs that already exist.

Vyvanse, for instance, is a new medication for ADHD that is chemically identical to Dexedrine.  It’s a hell of a lot more expensive, so there’s no way that it’s ever going to be tested if it’s actually better to the treatment that already existed.

6) Ignore the FDA

This is by the far the stupidest thing a drug company can do.  You’d have to be crazy to ignore what the FDA tells you to do in testing your medication.  But that’s exactly what Sam Waksal did with the breakthrough cancer drug Erbitux.

They told him to conduct certain studies and change some of his protocols.  He didn’t.  The worst part is, Erbitux was a drug that could help treat cancer in some of the worst cases.  Then Sam was surprised when his drug was rejected!

7) Pressure patients to give the results you want

If you give patients a test at the start of the trial, like a mood inventory scale, and then again at the end of the trial, they won’t answer the same.  Their past experience biases how they respond the second time around.

Also, you can subtly pressure participants to give results you want by leading questions.

8)  Test it for short periods of time

Take a drug that needs to be taken for months if not years, like an anti-depressant.  Why not just test it for a few weeks?  Not only will you save money, you won’t have to learn about the nasty side effects caused by long term use.

Everyone wins, except the patients.

9) Test it on a few people

Who cares if your drug will be taken by millions?  Test it on only several hundred people.  That makes it even easier for you to run the test again if you are so unlucky as to get bad results.

10) Test it on people who’re different

Test your drug on people who are healthier than those who will eventually take it.  You’re almost guaranteed better results.

Prozac, for instance, while now used for dozens of reasons including pain management, was initially tested on mild-to-moderately depressed people – not people who were extremely depressed.  Stuff like that explains why antidepressants don’t work nearly as well as they’re supposed to.

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Do you trust the drug companies?  Why or why not?