Buying the Pharma, Part II

LIKE WITH MY gun rights essays from a few months back (Whiskey & Gunpowder, July 27 and Sept. 7, 2005), there wasn’t supposed to be a second installment to this essay, either. But reader feedback to the original piece has been pretty profound, and Greg, Byron, and I all felt that some more ink should be devoted to the Big Pharma/FDA conspira…er, relationship, especially since some reader comments have given us a chance to delve even deeper into the issue.

First off, though, I want to thank all the Whiskey & Gunpowder readers who took the time to write after reading “Buying the Pharma.” Clearly, the “dynamic” between the FDA and Big Pharma is a subject that many are passionate about. The dangers and side effects of prescription drugs are such subjects as well, judging by the number of folks who wrote in with personal anecdotes about patent drugs gone wrong. One such read like this…

“My family has casualties of the ‘greater good’ equation…the present medical/government establishment delivers political medicine instead of health care. The system cannot be fixed.”

But this kind of feedback didn’t really surprise me. What did surprise me was the number of people who wrote in to chastise me about taking aim at Big Pharma: zero.

And in Big Pharma’s Corner…Nobody!

After “Buying the Pharma” ran, I expected at least a 50-50 mix between A) responses that condemned prescription drugs, the FDA, and the pharmaceuticals industry as corrupt or hazardous (or both), and B) responses that defended patented medicines as universally lifesaving, and taking me to task for daring to try to show otherwise.

This did not happen. I received not a single anecdote about the wonders of prescription drugs — not one personal story from anyone who’s still with us today or whose life has been made better because of Big Pharma. Yet we received multiple letters from folks who’d turned away from the mainstream’s drugs and had enjoyed success with natural or herbal alternatives. One reader even vehemently challenged my assertion that drugs, on the balance, save more lives than they take…

About the closest thing I got to a pro-drug response was the reader who wrote:

“One of my childhood friends died of polio one month before the vaccine became available. He would probably be alive today if the approval process was just a little faster…All the testing in the world will not save everyone, and extended testing costs some people their lives… I believe most people do benefit from the drugs they take…”

Though I’m sorry for this reader’s loss, I can’t help but think he’d be singing a different tune if that same friend had survived his polio (with or without a vaccine’s help), only to be struck down by a COX-2 inhibitor drug he was taking for relief from the vestiges of his childhood disease. The “greater good” scenario in which all drugs should be allowed as long as they save more lives than they take is a seductive one — if you or someone you love isn’t on the short end of that equation.

I think the better scenario would be that the government we elect and largely pay for actually put our interests (like life) ahead of big business interests. But that’s just me.

Another reader wrote in with this semi-challenge:

“Maybe without the drugs people would be dying earlier, instead of dying at the age of 70, then live to 75 and then die from an ADR, which is better…”

To this reader, I’d say the notion that dying later of a painful or wasting drug side effect, rather than sooner of a sudden heart attack or stroke, is hardly universally considered “better.” I personally would much rather die at 70 from a massive coronary while doing something I love than suffer along, feeble and miserable from the muscle-wasting side effects of some heart attack drug until it finally killed me at 75…

But to put this in real terms, I looked up life expectancy data for the average American in the 550-page Health, United States, 2005 report issued by the Centers for Disease Control. What I found was this: For Americans aged 65, there has been no spike in life expectancy that correlates with the explosion of drug prescriptions through the ’80s, ’90s, and so far in the 21st century. The numbers look like this:

Average remaining life expectancy for Americans aged 65 (both sexes):

1960 = 14.3 years
1970 = 15.2 years (+ 0.9 years)
1980 = 16.4 years (+ 1.2 years)
1990 = 17.2 years (+ 0.8 years)
2000 = 18.0 years (+ 0.8 years).

As you can see, the biggest jumps in life expectancy happen before the modern drug boom. In the 1980-2000 period, when Big Pharma really started dominating medicine, the upward trend in life expectancy has actually decreased by 23.9% over the average from the previous two decades.

Clearly, Big Pharma’s “miracle” drugs — which more than half of us in the United States are now taking, remember? — aren’t extending our lives, and may actually be shortening them. Is there any other way to interpret these data?

Mother Nature Muzzled — and Muscled

A lot of readers wrote in to talk about natural cures that aren’t widely available, or that conventional MDs don’t seem to know about or prescribe. Several have concluded (as I did long ago) that there’s more to this lack of choices than simple ignorance. Some kind of conspiracy is clearly afoot that keeps us mired in a world of health care in which patented drugs are virtually our only treatment option.

As articulated by one reader:

“There are always interests who try to use the government to limit our access to herbs, vitamins, and minerals, etc. that might help us.”

I couldn’t agree more. And if you’re on the fence about it, let me offer you some proof…

In September of 1997, an FDA panel convened at the request of Big Pharma concluded that Cholestin, a nutritional supplement for cholesterol control (derived from ordinary red yeast rice), was actually a drug — because its active ingredient was a naturally occurring substance that was nearly identical to lovastatin, a patented chemical in Merck’s Mevacor cholesterol drug…

They moved to ban sales of Cholestin in May of 1998, but the motion was stuck down in federal district court. Nobody denies Big Pharma, though — especially when the FDA is its hired gun — and the ban ultimately took effect in 2000, after a U.S. court of appeals decision upheld the FDA’s original finding.

Never mind that Cholestin was shown in more than 20 clinical trials to reduce cholesterol by an average of 25-40 points in just two months — without dangerous side effects, and at a fraction of the cost of “statin” drugs. These benefits didn’t enter into the FDA’s thought process at all. Only the possibility that an overpriced patented drug’s sales might suffer mattered, apparently.

Here’s how one reader described the FDA’s merciless attitude toward alternatives:

“If herbs were responsible for even 1% of the deaths that you show are caused by ADR, you would have an immediate ban — no questions asked. You had a few deaths from ephedrine…from people who purposely took larger doses than recommended and ephedra was banned immediately… Meanwhile, you have approximately 100 people die annually from acetaminophen poisoning…

“I have two doctors in my family, so I don’t hate doctors. If you read the statistics, the conclusion is obvious. We are sacrificing lives for money.

“I can’t expose the Big Pharma/FDA conspiracy of greed much better than that. But this isn’t even the half of what some readers have concluded about the nature of drug-based health care in America today. Consider how deep this fellow sees the rabbit hole going…

“The truly sad thing is there are many alternative treatments out there that are denigrated by the medical establishment for self-preservation reasons…It’s all about the money! Ever wonder why we still haven’t found a cure to some of the world’s major diseases, after all these years, and billions of dollars? If they actually cured something, they’d be out of business! Where’s their motivation?”

And here’s a really sobering perspective from the ol’ mailbag:

“But if one really wants a conspiracy angle, consider this…Medicare is going to go broke long before Social Security does. In the case of Social Security, the approach has been to keep raising the retirement age, since ‘dead people don’t collect benefits,’ as one senator remarked. Could it not be that the hidden solution to the Medicare problem is free prescription drugs…give them all the drugs they want and they will obligingly die off so we won’t have to keep sending them checks? Sound a little too far-fetched and Machiavellian? I wouldn’t put anything past the government/Big Pharma nexus myself.”

Wow. I hope it’s not really that sinister. But then I look at the life expectancy figures again and I think, well…

Haphazard Testing = Hazardous Ingesting

As if any further evidence were needed to cast doubt on the purity of Big Pharma’s relationship with the FDA, consider this:

The New England Journal of Medicine reported that in 1991, before the passage of PDUFA (which allowed Big Pharma to pay a fee to have their drugs approved faster), 80% of the testing for pharmaceutical approvals was conducted by qualified faculty members at medical universities. Safety oversight for these school-conducted tests was handled by the university’s own physicians…

But today, fully 75% of these drug trials are contracted out to private (read: “for profit”) testing firms. Why? Because it’s faster — and also very likely because it’s not as stringent. According to a Bloomberg article from November 2005, the safety oversight and review process of these private entities leaves a lot to be desired. That report exposed:

· Incomplete or sketchy record-keeping
· Criminal negligence resulting in death
· Inadequate training of test administrators
· Insufficient involvement of physicians in drug trials
· Falsified or inadequate credentials of administrating “doctors”
· A lack of safeguards for ensuring that test subjects are qualified for trials
· The use of illiterate immigrants incapable of giving informed consent as subjects.

Not surprisingly, these testing companies are paid by Big Pharma — and aren’t directly overseen by the Food and Drug Administration. So who makes sure these drug trials are both safe for participants and accurate enough for the FDA to evaluate a prospective drug for approval?

Private, for-profit institutional review boards. These boards are organized and certified (for whatever that’s worth) by the FDA — yet they are also paid by Big Pharma! And in some cases, both these supposedly objective IRBs and the testing centers themselves are owned by the same people, the Bloomberg piece reveals…

Bottom line: Since PDUFA passed Congress, the majority of both the testers of drugs for potential FDA approval AND the “objective” overseers of those tests are cashing their paychecks from the pharmaceuticals industry.

Remember, these are the kinds of folks that gave VIOXX the green light.

Think there’s a connection between abuses in this privatization of drug testing and review and the number of hazardous drugs making it to the market? I think these numbers from Part I of this essay speak for themselves:

· Drug recalls increased 2.42 times — Recalls jumped from 1.56% of new drugs released during the 1993-1996 period (when mostly pre-PDUFA drugs were in the approval pipeline) to 5.35% in the 1997-2001 period

· ADRs outpaced prescriptions 2.44 times — From 1994-2004, the number of new prescriptions filled in the U.S. increased 59%. But the number of adverse drug reactions recorded over this same period jumped by 145%

· ADRs multiplied 4.44 times since pre-PDUFA levels — In 1990, there were around 80,000 ADRs reported. By 2003 (the last full year I found data for), that number had ballooned to 355,000.

Of Stakes and Mistakes…

A couple of readers responded with negative comments that had to do with the paragraph or two of pure speculation I added at the end of “Buying the Pharma,” in which I offered an opinion or two about the near future of investment in the pharmaceuticals sector, given the avalanche of liability lawsuits the industry now faces…

Here’s a pair of the nastier ones:

“Thanks for the useless garbage up front to get to the real point that small-cap Pharma with technology could be a better buy. That insightful little analysis…is useful, but scaremongering just puts you in the same league as Cheney’s disingenuous approach to starting a religious war in Iraq.”


“You’re just as bad as the FDA…this is just a long, involved set-up to flog high-risk stocks that you…have a personal interest in.”

To these readers, I say:

First off, anyone who reads Whiskey & Gunpowder knows that I’m not a financial analyst. Not by a long shot. However, I realize that the bulk of our readership IS interested in the future of investment — and so I try to add a bit of my own opinions about where the smart money might be headed on those rare occasions when I actually have one…

However, in the interest of full disclosure, I DO NOT personally invest in stocks or other securities, nor do I have any vested interest in any such securities that readers of these and other Agora pubs may be exposed to. I don’t make a single penny in any way if any of them tank or become the next Microsoft…


For those who are curious, I put my money into mutual funds and retirement accounts; real estate; women (one sweet, sexy woman in particular); fine whiskeys; and motorized, golf club-shaped, or loud and lead-slinging toys that I have no hope of ever extracting my money from. So to all of you who’d write in to accuse me of having some financial agenda attached to what I write in these pages, know this: You’re wrong.

And finally, I want to thank the hawk-eyed readers who spotted my mistake in the handling the statistics in the first part of this essay. Here’s how one reader gently (and quite rightly) brought the error to my attention:

“Jim writes that the odds of dying from an adverse drug reaction are 1 in 1,000 while the odds of dying from all external causes are 1 in 1,750, and then says, ‘You’re around 60% as likely to die this year from prescription drugs as from all external causes combined.’

“In fact, it’s even worse than Jim says. 1 in 1,000 (0.001) is LARGER than 1 in 1,750 (0.00057), not smaller. So he should have said ‘you’re around 175% as likely to die this year from prescription drugs as from all external causes combined.’

“Scary stuff.”

Yes, scary stuff indeed, all of it. Until next time…

Dreadin’ Pharmageddon,

Jim Amrhein
Contributing Editor, Whiskey & Gunpowder
April 4, 2006