Information laundering for big pharma

My friend Lisa sent me an excellent article by Richard Smith, former editor of the British Medical Journal:

Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

“Journals have devolved into information laundering operations for the pharmaceutical industry”, wrote Richard Horton, editor of the Lancet, in March 2004 [1]. In the same year, Marcia Angell, former editor of the New England Journal of Medicine, lambasted the industry for becoming “primarily a marketing machine” and co-opting “every institution that might stand in its way” [2]. Medical journals were conspicuously absent from her list of co-opted institutions, but she and Horton are not the only editors who have become increasingly queasy about the power and influence of the industry. Jerry Kassirer, another former editor of the New England Journal of Medicine, argues that the industry has deflected the moral compasses of many physicians [3], and the editors of PLoS Medicine have declared that they will not become “part of the cycle of dependency…between journals and the pharmaceutical industry” [4]. Something is clearly up.

Citation: Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138.

Read the whole thing.

Comments

[alphabitch]

Excellent article [or speech, whatever -- see also his 2003 article in the British Medical Journal (BMJ 2003;326:1202-1205 (31 May), if you're interested - may require subscription, I'm not sure].

Smith's suggestion about making study protocols and results available on regulated websites is an extremely good one; I know that investigators conducting federally-funded studies will soon be required to do something very much like that. It's my opinion that such a thing will eventually make the process more transparent and make "peer review" actually mean something.

[Flint]

This is the era of "Shame is dead" and the unthinkable is thinkable and do-able now unfortunately. Medicine has lost its hallowed glow as the "healing arts" have become an industry, with all of the graft and corruption that goes along with that dubious distinction.

We've had secret funding to NIH researchers, lobbyist on the FDA review panels, advertising pressures applied to scientific journals, kickback schemes to physicians from big Pharma.

So isn't it a big success for the "deregulation" advocates?

[Barbara]

Big Pharma used to have integrity, it's hard to believe, but those days are long gone. There are simply too many $$ riding on the success of drugs, and the depths to which it has sunk in foisting half-safe drugs of dubious efficacy on doctors and patients is truly alarming. The simple, sad truth is that you are not justified in assuming the trustworthiness of the the drugs you are prescribed, or the knowledge and integrity of the person who prescribes them.

[Flint]

Amen.

[MYNIPPON]

In other words, is there that we can believe now? Almost all politicians in Washington owe something to the pharma industry. The FDA receives money from them too. The doctors and hospitals get research grants and funds from them. Some doctors even get "bribes" from pharma sales reps. Now even the journals are behaving like tabloids.

[mudkitty]

Big Pharma used to have integrity? Hmmm. Doesn't pass the smell test.

[Barbara]

It was a long time ago that the founder of Merck decided to essentially forego patent protection on an antibiotic that was important for public health. That strikes me as showing a certain amount of integrity.

But even 15 years ago, there was a different culture at pharmaceutical manufacturers -- business people were loath to gainsay the judgment of scientists and doctors who were primarily responsible for drug development research and clinical trials. Many decisions where clinicians used to have the last word are now the responsibility of business people. Not all the time, not everywhere, but that is something that has changed, and that gives a completely different kind of slant to the "cost benefit" analysis that always takes place in determining how or if to market a given product.

[Lindsay Beyerstein]

Marcia Angell, the former NEJM editor and author of "The Truth About the Drug Companies" agrees that the pharmaceutical industry used to be more ethical. Prescription drugs haven't always been the centerpiece of medicine. The old guard drug manufacturers felt they had a public trust to uphold. A lot of them were privately held family firms. Today, in an age of publicly traded companies and multi-billion dollar blockbuster drugs, it's a whole different story.

[Flint]

Well it looks like they are still at it:

http://www.nytimes.com/2005/05/31/business/31trials.html?th&emc=th&oref=login

Frankly nothing is going to change as long as every thing is linked to the stock market and the government is in bed with industry.

The SSRI stuff has always puzzled me. In the nineties my doc wanted to put me on the SSRI because of some complaints I had regarding sleep disorders and fatigue.

I looked at the SSRI literature then and saw the warnings about depression and suicidal thoughts when you stopped and decided not for me thank you. I chose to use an amino acid called 5HTTP and fish oil. I managed it well. Later it turned out that the cause of my problem was a central nervous system reaction to a betablocker that a doc had put me on.

I knew that there was going to be trouble when they started giving these to kids. It may also be much worse than reported too. It turns out that when they looked at the cases of the teenage mass murders the vast majority of them were on the SSRIs in one flavor or another.

That is not to say that the SSRIs were the cause, because these were clearly troubled teens and they would have been natural candidates for such medication by any competent physician, based on the risk/benefit information that was given to them. It is how ever suspicious and what is referred to as a correlative event... or it hapened at the same time.

A note on the fish oil... it is now part of the American Pyschiatric Associations consensus protocols to use fish oil while using the SSRIs. It turns out that if you stop them, 50% of the patients fall back into clinical depression. If they are on therapuetic does levels of Fish Oil that drops to 10%. The brain matter is composed of EPA and DHA, the essential ingredients of Fish oil.

PS. a note on the betablockers... my cardiologist is one of the best known in the US and has an international reputation. Lots of Presidents and government guys fly out to see him. He didn't believe it was a CNS reaction until I showed him the page in the PDR where it listed 15 of the major symptoms of a CNS reaction and instructions to stop the medication immeadiately if one of them occurred.

You can not rely on your physician to know this stuff, even the best can't keep up with it all and to make matters worse even the stuff published is insufficent because as the link above shows... big pharma ain't talking unless its favorable to them.

[Barbara]

I used to take NSAIDs for rheumatoid arthritis, which caused me severe gastric side effects, for which I took some other kind of drug, which kind of helped. Just like the NSAIDs only kind of helped my arthritis. More recently, I took Vioxx (lucky me, but I took it for a short time only --I now smile pleasantly when I take these prescriptions like a guest at a party who really doesn't want to eat the food being offered but is too polite to say no, I fill it once, take it fitfully and never refill it). Now there's evidence that long-term use of NSAIDs might actually exacerbate the joint erosion that is the biggest risk of arthritis --

so point one: All drugs have side effects, even those that have been on the market a long time, and people too willingly forego making their own decision on whether side effects are "worth" the pain (I stress that NSAIDs really and truly are only palliative, so the trade-off is a little easier to make here).

Point two: Doctors rarely discuss non-medical alternatives or do so only in superficial and pessimistic terms. Arthritis is seriously helped by strength training (good muscles protect and cushion the joints), just as diabetes can be helped by changes in diet. But doctors aren't fitness trainers or dietitians and tend to underestimate the power that these people might have in helping their patients.

Point three: Vioxx (like a lot of other drugs) was overused, and reflects one of the most pernicious trends in the release of new drugs -- the push to "convert" as many patients as quickly as possible to a drug that is even less proven than most. This is a big change over prior generations of doctors who only reluctantly adopted new drugs, even when pushed to do so by manufacturers. The FDA used to count on this conservatism in the hope that if latent problems not detected during testing were detected in the early stages of use, it would affect thousands rather than millions of people. Obviously, with dtc advertising and other aggressive practices (such as pushing a drug to be used for the marginal patient such as me, rather than someone for whom it is the only alternative) the FDA's strategy is now a big fat nonstarter.

Point four: NONE and I really do mean NONE of these drugs has ever been subject to thorough long-term testing, their potential side effects over the long-term are simply unknonwn -- yet people are routinely expected to take them for life. Which makes point two all the more shocking.

Drugs should always be a last resort. If you even stop and think about it a little, you will realize that if a drug is truly powerful and effective, it is not surprising that its power would result in long-term harms as well as long- or even short-term benefits. The FDA looks only at short-term harms, and fairly acute ones at that. There is gross misunderstanding, even among physicians, about what FDA approval implies and doesn't imply. I think every medical school should require doctors to take a class in the FDA approval process.

[mudkitty]

I'm no martyr. Why SHOULD drugs always be the last resort? I smell a value judgement. I'm tired of all anti-drug biases. But I'm also tired of the Phamas pleading poor.

I for one, an sorry they took Vioxx off the market. Man, it worked. Way better than any opiate I ever took. Sorry folks, it doesn't get you high. I speak as someone with long time (for real) back problems (the number one health complaint in the world, you know.)

[Barbara]

But mudkitty, Vioxx probably would probably not have had to be taken off the market if it had been marketed and used responsibly -- that is, if it had been offered as a lower tier choice. Its expense alone probably made this prudent, but its newness should have also been a consideration.

I am not making a value judgment, just encouraging people to think about alternatives to drugs before they think about drugs because there is a lot that is unknown about the long-term effects of nearly every drug. I took Vioxx along with a half a dozen other NSAIDs over a ten year period and found them to be something much less than a godsend or panacea, but there are lots of conditions (like hypertension) where the use of drugs is a no-brainer, because they do work better than any alternative and the risks to health of uncontrolled high blood pressure are pretty severe.

[Flint]

Hi Barb:

Just wanted to respond to your post. I take care of two elderly parents in their mid to late 80's. I care less about bias and more about what works. Arthritis and pain management are constant problems...

1. "Now there's evidence that long-term use of NSAIDs might actually exacerbate the joint erosion that is the biggest risk of arthritis --"

Possible yes, but one study does not a fact make and I can only find one so far.

2. "so point one: All drugs have side effects, even those that have been on the market a long time, and people too willingly forego making their own decision on whether side effects are "worth" the pain."

absolutly true and I would go further... every drug, every OTC remedy, every food, every supplement has side effects and everyone has to make a risk/benefit decision (just like a physician) on what works for them and the risks they are willing to take.

3. "Doctors rarely discuss non-medical alternatives or do so only in superficial and pessimistic terms. Arthritis is seriously helped by strength training (good muscles protect and cushion the joints), just as diabetes can be helped by changes in diet. But doctors aren't fitness trainers or dietitians and tend to underestimate the power that these people might have in helping their patients."

- Doctors are forbidden by law from say that you should take a nutiritional supplement
for any medical condition. You can say I would like to take these and doctors can, as
my mother's Neurologist does, say things like "yes that would be very helpful, very
good."

- Some Doctors... some are really hooked on their "God Complex" and don't like you to
have a sense that its your health, your body, or that you know anything. These docs
can kill you with their own arrogance. Avoid them... especially if they won't talk
with you.

- Some Docs... have no training in cellular biology and little incentive in finding out
what works or doesn't. These are the a pill for every malady... take two and don't
call me except for a presription renewal. Problem handled go away.

- Some Docs are great! Doctor Dean Edell who does a regular radio show, said it well,
"IF there were one prescription that I could write that has a greater impact on human
health and so many benefits for such a broad range of health problems... it would be
exercise. Exercise often, eat right, use supplements wisely and don't go crazy over
any of it."

4. :Vioxx (like a lot of other drugs) was overused, and reflects one of the most pernicious trends in the release of new drugs -- the push to "convert" as many patients as quickly as possible to a drug that is even less proven than most."

We have become a pill oriented society, less likely to make the "life style" changes that produce good health and more likely "silver bullet" pill solutions. Many Docs have simply responded to their patients demands and many have realized the economic incentive to do so. Big Pharma has capitalized on this with the ad blitz campaigns.

5. "NONE and I really do mean NONE of these drugs has ever been subject to thorough long-term testing, their potential side effects over the long-term are simply unknonwn -- yet people are routinely expected to take them for life. Which makes point two all the more shocking."

Not true... the NSAIDS, in particular alleve... have been subjected to over thirty years of tests and not just a few, but thousands. CV complications are not only not evident, but actually they reduce the risk of CV events by 10%, where 81 MG of aspirin reduces it by about 25%. The gastric complications though is very real. Again you are back to risk/benefit.

6. "I think every medical school should require doctors to take a class in the FDA approval process."

After my dad almost died from a drug interaction to two prescriptions that my doc had put him on, I was upset and about it and talking to a visiting nurse-practioner about it. I said you know I never have this kind of problem with my doc and she said "Do you know why? I know your doctor and he was a pharmacist before he decided to go back to med school and become an MD."

Better that they should do additional course work in biochemistry, cellular biology, and pharmacology.

Mudkitty...

"I for one, an sorry they took Vioxx off the market. Man, it worked. "

Its back on the market and if your doc wants you to have it you can get it now. It is back to risk benefit decisions now. The COX2 inhibitors do inhibit certain fats in the body that the body uses as its primary inflamitant. The theorey of heart disease is changing from:

high cholesterol = heart disease

to

inflamation of the arterial walls causes unstable plaques
and platelet aggregation = heart attack

VIOXX and that whole class of drugs causes the latter, but if your pain is that bad and you don't mind the risk... go for it. With my folks I've asked myself they are in their 80s and we all die of a heart attack sometime... so wouldn't pain relief trump the risk over time? How much time do they have left?

One supplement that is extremely beneficial and the most potent anti-inflammitant they know of is Fish Oil. It vastly reduces coronary heat disease, increase the "good" cholesterol, has potent anti-depressant actions, and virtually no side effects. The only know problems are that nursing mothers need to watch for mercury contamination (some brands are monitored for this) and the occasional "fish burps." Fisol is good for the latter.

BE informed:

American Arthritis Foundation:
http://www.arthritis.org/conditions/NSAIDS/Straight_Talk_FAQ.asp

What the docs use:
http://www.reutershealth.com/wellconnected/doc48.html

A brief and moderately okay view of alternative life style programs:
http://tsangenterprise.com/news82.htm (there are better ones than this but too long)

[Quisp]

Have you seen this, Lindsay? I'm betting yes. What do you make of it?

[Flint]

Quisp...

That raises the old fear hackles up doesn't it? The question is what will they do with the information that they pick up? There are a whole lot of factions that want the internet regulated and managed.

[michael jones]

I found some really essential facts about rheumatoid arthritis here! Thank you for the post and everything! Good site!