Sickening: How Big Pharma Broke American Health Care and How We Can Repair It

by John Abramson

Using the pre-side-effect pain scores provided a statistical way to remove the bias created by forcing the dose of Neurontin up to twice the FDA-approved maximum and causing side effects that could have tipped off half the people treated with Neurontin that they had been assigned to the active-treatment group.

Except that dosing may have been what was effective. Perhaps the sode effects were not causing am unblinding but were signals of efficacy. The study seems inconclusive to me.

The real harm is the false reassurance of protection from cardiovascular disease the guidelines provide, distracting both doctors and patients from the harder but more effective work of adopting healthy lifestyle habits.

This is an assertion that needs to be studied, too.

Because the participants in this short-term study were young — average age forty-four — and in good health, these results almost certainly underestimate the frequency of statin-related symptoms experienced by the older and sicker people who typically take these drugs for many years.

Causality hasn't been shown here. More anectdata.

It is just plain scientifically and morally wrong that drug companies are not required to make the data from their clinical trials for statins (and indeed for all drugs) available for independent analysis and review before the results are published as individual studies, incorporated into meta-analyses, or included in guidelines.

Amen to this.

Is the new technology that is driving up the cost of our health care providing enough value to justify

It would be very helpful to know how this health spending breaks down.

In the 1960s, the death rate for children in the United States was lower than the average for nineteen other developed countries,* resulting in an average of 3,250 fewer deaths of U.S. children each year over that decade.

He keeps mixing rates and coubts, which is typically done for emotional purposes.

U.S. households nearly tripled, from $85,000 in 1984 to $236,500 in 2009.

Inflation adjudtmrnt?

This means that more than nineteen out of twenty of the studies having the greatest impact on doctors’ practice are commercially funded — and significantly more likely to show positive results for the sponsor’s product.

Correlation, not causation. Transparency is vital for EBM to work, and doctors are not data scientists. Independence and regulation are essential.

But reporting a miss as if it were a hit, by altering the primary outcome after a study has been completed, is a flagrant methodological foul.

Indeed!

The PBMs collect the rebates in return for including the manufacturers’ high-cost, low-value drugs in their formularies with low co-pays, thereby increasing their use.

Is this projecting one case study to the whole market? How do we establish how widespread this problem is (ineffective drugs)?

does not assess whether the price that will be charged for a new drug is fair in terms of the value it provides.

This can be very tricky to assess.

From the journals’ perspective, the loss of these articles would compromise their prestige and reduce the impact-factor rating that determines advertising revenue.

I disagree

Many of the examples in this book were chosen to demonstrate that difference.

Which begs the question: how corrupt are the journals really? Does the data extend across all articles? What percentage?

The conventional uncoordinated approach to testing had a much lower threshold of success. The risk of a vaccine being found effective compared to placebo (that is, nothing) but inferior compared to one or more of the other vaccines was avoided, allowing more winners into the marketplace.

Time was of the essence and any effective and safe solutions were needed. We could fine tune it later. Don't let the perfect be the enemy of the good.

But the public ought to have the right to demand that the ads contain accurate and relevant information instead of compelling but unsubstantiated emotional impressions.

Ha! Why should pharma be different than anyone else? (sarcasm)