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Ron Unz's misguided attack on Merck over Vioxx

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In The American Conservative, Ron Unz compares the Vioxx litigation to the Chinese melamine scandal, and finds the American justice system lacking. (Also: Sailer; Roberts; and a plaintiffs' lawyer who makes the lay mistake of confusing a mass tort with a "class action".) But Unz's entire argument is based on an incorrect premise. Unz assumes that David Graham is correct in implying that Vioxx had "probably been responsible for at least 55,000 American deaths during the five years it had been on the market." But Graham is not. While Graham's text in the Lancet made wild allegations, the headlines were not supported by his underlying data, which found a relative risk of low-dose Vioxx of 1.24, which was not statistically significant. A later Lancet study confirmed that Vioxx and other COX-2s were no worse than other NSAID pain relievers when it came to cardiovascular risk.

And, of course, Vioxx was not merely a product of corporate profit-seeking; it had benefits over other pain relievers. Since Vioxx has been withdrawn from the market, serious ulcerations have increased 21%.

Merck's total legal bill for Vioxx is in the range of $8 billion and counting, though it correctly won the vast majority of cases taken to final judgment; the only ones it lost, it lost due to junk science. Merck's experience with Vioxx is certainly a damning indictment of the American justice system, but for reasons opposite than the ones Unz thinks.

2 Comments

The TAC needs to do some fact checking before publishing something like this. If Vioxx actually resulted in 500,000 premature deaths it would have shown up in the overall death rate. It didn’t. See “National Vital Statistics Reports” (http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_04.pdf). The overall and age-adjusted death rates fell from 1999 to 2005. Indeed, the age-adjusted death rate fell faster after 1999 than it did before.

If the 500,000 statistic was correct, there should have been at least 100,000 incremental deaths in the peak year from Vioxx. That’s 33 per 100,000 for the entire U.S. See any blips in the data of the magnitude? They don’t stand out…

Of course, the incremental deaths should really show up in the CVD (cardiovascular disease) mortality statistics. They don’t. See “US Death Rates 1975-2009″ (http://seer.cancer.gov/csr/1975_2009_pops09/results_merged/topic_graph_heartdis_cancer.pdf). Also see some Arizona specific data (“Trends in Age-Adjusted Mortality Rates of Deaths due to Cardiovascular Disease, Arizona and US, 1980-2004″ – http://www.azdhs.gov/azcvd/documents/pdf/az-burden-of-cardiovascular-disease.pdf). The Arizona data is not by itself particularly important (state level death rate variations are huge). However, the Arizona data exactly tracks the U.S. overall data.

Is it possible that Vioxx resulted in 50,000 deaths over the period in question? Sure. I don’t have anything approaching the background to evaluate such a claim. I wouldn’t be surprised either way as to the truth. For the record, I do have opinions on topics like this. I spent years deflating Thiomersal / autism claims…

However, there is a larger issue here. NSAIDs (Celebrex, Vioxx, Bextra, etc.) are all associated with incremental mortality. Indeed, even Naproxen (also a COX-2 NSAID) has been linked to higher death rates. However, these drugs are simply too valuable to give up. Ask the people who take them, if anyone has any doubts. For many, NSAIDs are the difference between a normal life and ongoing, severe pain.

This is why the FDA panel voted 31-1 to keep Celebrex on the market. The same panel also voted 17-15 to keep Vioxx for sale. Even excluding panelists with industry ties, the vote was 8-14 (losing) to approve Vioxx. If Vioxx was really as bad as some allege, why did 8 panelists (with no industry ties) favor its continued sale? Why was the vote in favor of Celebrex (which is also linked to CVD) almost unanimous? See “10 on FDA Vioxx panel had ties to companies ” (http://www.msnbc.msn.com/id/7031927/ns/health-arthritis/t/fda-vioxx-panel-had-ties-companies/#.T6lukFJpe18)

Thank you

Peter Schaeffer

P.S. I have no ties to the drug industry (other than as a customer). I was once prescribed Naproxen many years ago. It was astonishingly helpful even though I only took it for a week or two. I have taken Aleve (OTC Naproxen) from time to time.

A few more notes.

1. If Vioxx had anything approaching the impact TAC (The American Conservative) is suggesting, it would have shown up in the CVD death statistics first and foremost. It doesn’t.

2. Vioxx was withdrawn on September 30th, 2004. Many folks probably continued to take their pills for a few weeks longer. If Vioxx was really so deadly that removing it from the market for the last 3 months of 2004 had a material effect, then much larger increased in death rates should have shown up sooner. Indeed, since it was still on the market for most of 2004, the largest impact on death rates should have been from 2004 to 2005. In fact, the crude death rate rose from 2004 to 2005. Evidently, removing Vioxx raised death rates.

3. The age-adjusted death rates tell a more useful story. The age-adjusted (AA) death rate plunged from 2003 (832.7) to 2004 (800.8). From 2004 (800.8) to 2005 (798.5) it was almost flat. Removing Vioxx from the market stopped (for a while) progress in reducing death rates.

4. The introduction of Vioxx provides even stronger evidence. Vioxx was introduced on May 20th of 1999. However, sales were slow at first. Only 4.845 million prescriptions were written in 1999. The number of prescriptions rose to 20.630 million in 2000 and 25.406 million in 2001 (the peak year). The crude death rate rose from 847.3 in 1998 to 857.0 in 1999. However, it fell to 854.0 in 2000, and 848.5. Evidently an extra 15 million Vioxx prescriptions in 2000 reduced the death rate as did another 5 million in 2001.

5. The AA death rates tell an even better story. The AA death rate rose from 870.6 in 1998 to 875.6 in 1999. However, the extra 15 million Vioxx prescriptions reduced it to 869.0 in 2000 and another 5 million Vioxx prescriptions reduced it to 854.5 in 2001. As mentioned above, the AA death rate falls from 832.7 in 2003 to 800.8 in 2004 (with Vioxx still on the market for most of the year). It then essentially flat lines in 2005 (798.8).

6. The use of crude death rates is ultimately misleading. The American population is obviously aging. AA death rates make considerably more sense. In a few years, the baby boomers will start dying off in large numbers. The crude death might even rise. What does that demonstrate other than the pig coming out the other end of the Python?

7. Obviously everyone will die eventually and that 500,000 is an estimate of premature deaths. Premature by how much? A year? A month? One second? If the reduction is material it should show up in death rates (AA and crude). It doesn’t.

8. Death rates rise and fall for reasons clearly unrelated to Vioxx. The crude death rate rose from 1994 (866.1) to 1995 (868.3) and from 816.5 in 2004 to 825.9 in 2005.

9. See Table 8 http://www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_08.pdf for a comparison of 1998 versus 1999 death rates. The overall death rate fell in the 65-74 cohort while rising 75-84 cohort and the 85+ cohort. CVD fell in both the 65-74 cohort and the 75-84 cohort from 1998 to 1999. The CVD death rate rose for the 85+ cohort from 1998 to 1999.

See also Table 9 in http://www.cdc.gov/nchs/data/nvsr/nvsr50/nvsr50_15.pdf for a 1999 to 2000 comparison. As Vioxx prescriptions soared (quadrupling to 20 million) all 65+ death rates fell. The CVD 65+ death rate also fell.

10. In the last pre-Vioxx year the overall death rate was 847.3. In 2003 with Vioxx going strong, it was 841.9. In 2004 (14 million Vioxx prescriptions) it was 816.5. Of course, the age-adjusted data show that Vioxx “saved” even more lives. The 1998 AA rate was 870.6. The 2003 rate 832.7. The 2004 rate was 800.8.

11. The crude death rate was essentially flat from 2004 to 2005 when it should have fallen the most. The 65+ data is more dramatic. Table 9 of http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_10.pdf shows 65+ mortality rates fell every year from 1999 to 2008. So did the CVD death rates.

12. Any alleged linkage between Vioxx going off the market in 2004 and mortality statistics suffer from a basic flaw. Vioxx was recalled on September 30. September 30th isn’t Jan 1.

Thank you

Peter Schaeffer

P.S. I am not claiming that Vioxx was harmless. NSAIDs are (apparently) intrinsically dangerous. However, the incremental deaths were too few to show up in the overall mortality statistics and more decisively, too few to show up in the CVD mortality statistics.

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