f the time, and in many instances less than HALF of the time!

Dr. Roses, one of the world's leading geneticists did not intend his comments as a criticism of existing prescription drugs. Rather, he was arguing for something called "pharmacogenomics," the use of human genetics to create "tailored" drugs for patients with different genes. This method, he believes would result in more effective pharmaceuticals and elimination of what he calls the "trial and error" method of prescribing drugs currently employed by most physicians.

While his vision of a future in which drugs are custom-designed for particular patients or groups of patients may be intriguing, the notion of physicians writing prescriptions by guess and by gosh is chilling.

And how bad is the problem? DRUGS DON'T WORK According to Dr. Roses, the problem is much worse than anyone might have imagined.

He told the audience that fully 90% of prescription drugs only work 30% to 50% of the time!

More important, some of the least effective drugs are the ones whose failure to be effective would have the most serious consequences.

For example drugs to treat Alzheimer's disease work 30% of the time or less!

Cancer drugs are at best effective 25% of the time, and in some instances, the effectiveness can be as little as 2%!

Drugs intended to treat hepatitis C are effective less than half the time.

Even drugs for more common and less life-threatening conditions have poor track records.

For instance, drugs to treat migraines are at best a 50/50 proposition.

Similarly, incontinence pharmaceuticals only work about 40% of the time.

Even widely used and expensive COX-2 pain relievers like Vioxx and Celebrex are far less effective than the public would be lead to believe.

What is perhaps most shocking about Dr. Roses' admission is that it came as no surprise to other drug industry executives. One industry expert asked to comment on Dr. Roses' claim said "Roses is a smart guy and what he is saying will surprise the public, but not his colleagues."

As it turns out, the fact that drugs do not work is one of Big Pharma's best kept dirty little secrets.

But, what about doctors? Don't they know whether or not the drugs they are prescribing are effective?

The short answer is no.

In this era of managed care and 7 minute time limits on patient visits, few doctors take the time to really research the drugs they prescribe. Instead, they rely on the handouts dutifully delivered by the "detail" men and women - the fancy name for salespersons used by Big Pharma - to assess the efficacy of new prescription items. CONSUMER ADS A CONSUMER CON But that's not all.

So-called "direct to consumer" advertising encourages patients to request specific drugs, and more often than not, doctors go along with those requests.

For example incontinence drugs are widely promoted in television ads that imply that they can provide miraculous improvement in this condition. What the ads do not say is that the drugs, to the extent that they work at all, are effective less than HALF THE TIME! More important, they don't mention that the drugs have potentially serious side effects. Given the significant quality of life consequences of incontinence, it is no surprise that the ads have caused a sharp increase in patients requesting such products or that doctors have given in to their patients and prescribed them.

But these drugs still represent an improvement in efficacy - right?

Wrong! THE OTHER DIRTY LITTLE SECRET Two recent studies have exposed another of Big Pharma's dirty little secrets: many of the new and expensive drugs they're pushing on patients and doctors are not as effective as the ones they're intended to replace!

Researchers in St. Louis examined claims data from a major Midwestern health provider to see if the actual results of using expensive pain relievers like Vioxx and Celebrex matched the assumed efficacy of the studies used to demonstrate their value.

The results of their analysis were reported in the November, 2003 issue of the Journal of Managed Care.

One of the things they examined most closely was the rate at which patients taking COX-2 inhibitors were also using drugs to prevent heartburn or ulcers. According to the research presented to win approval of these drugs, patients taking them shouldn't have to take the anti-ulcer and heartburn medications.

Well, as it turns out, like much drug company research, the claim was a lot of hooey!

Patients given the newer COX-2 drugs were also given prescriptions for anti-ulcer and heartburn medicines. The real stunner, though, was that the patients taking the newer drugs were actually prescribed the anti-ulcer and heartburn drugs MORE often than those on the older pain relievers - 20% for the new drugs vs. 18% for the old!

Now, understand what's happening here. A bottle containing 50 capsules of a COX-2 inhibitor like Vioxx or Celebrex is going to set you back around $180.00. In contrast, you can buy a bottle of 200 generic ibuprofen tablets for around $13.00, 500 acetaminophen (Tylenol) tablets for around $12.00 or 500 generic aspirin tablets for around $7.00!

The whole rationale for taking the more expensive drug is that you wouldn't have to take a second drug to protect against ulcer or heartburn with the newer medication. Otherwise why would you pay the extra $160.00? As it turns out, that's not true, so all the hype about COX-2 inhibitors is little more than a way for Big Pharma to fatten its profits at the consumer's expense - once again!

Still, the phony assumptions about COX-2 inhibitors only tell half of the story.

The other half comes from another study published in the Journal of Managed Care Pharmacy. THE REST OF THE STORY In a September, 2003 article, researcher Brenda K. Motheral, Ph.D. examined the cost-effectiveness of ulcer treatments.

Currently, most physicians prescribe expensive drugs like Prilosec or Nexium, the so-called Proton Pump Inhibitors or PPI's as the first line of attack. If that should fail, most often they recommend surgery. The only problem is that the assumption underlying the PPI treatment - that ulcers are caused by excess stomach acid, aspirin, or stress - is wrong! Researchers have discovered that in 90% of the cases, they are caused by a bacterial infection that can be easily treated with a combination of cheap antibiotics and bismuth subsalicylate e.g. Pepto-Bismol!

According to Dr. Motheral, the bismuth-based therapy is both cheaper and more effective than using PPI's. This is no small consideration. Ulcer medications are among the most widely prescribed, and are costly. A typical prescription for a PPI runs between $150 and $200 per month, and patients generally have to take them for their entire lives. This can come to hundreds of thousands of dollars over time - indeed PPI's account for fully 8.9% of total drug costs and a huge proportion of drug company profits. But they represent something else as well: hundreds of thousands of dollars per patient that are not available for other medical care.

And keep in mind - even when an ulcer is surgically removed, if the cause is a bacteria, it will come back! So the risk and expense of the surgery would have been for nothing.

Dr. Motheral put it in perspective "Given that patients pay portions of premiums and copays, promoting cost-effective treatment decisions ultimately controls not only payers costs buy also patients' out-of-pocket expenditures."

It's not just the St. Louis researchers, however, who are blowing the lid off Big Pharma's efficacy scam. Take for example high blood pressure drugs.

Last year, Big Pharma got a windfall when the National Institutes of Health moved the goalposts on high blood pressure. It used to be that blood pressure of 130/85 was considered normal. But late in 2002, the Institute of Medicine decided that was no longer the case and created a new category "prehypertensive," for people with blood pressures between 120/80 and 139/89. All of a sudden Big Pharma got tens of millions of customers for its expensive high blood pressure drugs!

What they didn't know was that at that very moment, someone was about to pull the rug out from under them.

A December 2002 article in the Journal of the American Medical Association (JAMA) reported the findings of a study encompassing over 42,000 individuals comparing the benefits of four types of high blood pressure drugs - diuretics, ACE inhibitors, calcium channel blockers and alpha-adrenergic blockers. The news was, to say the least, unwelcome in Big Pharma's corporate offices.

What the researchers discovered was that cheap, generic diuretic drugs that have been around for years were far superior to the new and expensive high blood pressure medication Big Pharma has been touting.

The individual results were stunning. In the case of ACE inhibitors, the patients averaged 2 points higher on systolic pressure and had a 15% higher risk of stroke. For African-American participants, the risk of stroke was 40% higher! For calcium channel blockers systolic blood pressure was only about 1% higher but they had a 38% greater risk of developing heart failure. The portion of the study using the alpha-adrenergic blocker was actually stopped because people taking the drugs had a 25% higher rate of heart disease than those on diuretics and were suffering double the rate of heart failure!

Given these facts, it would make sense for the medical community to push diuretics, but that doesn't seem to be happening. There's too much money at stake for Big Pharma to give up their hypertensive drug cash cows.

For example Pfizer's Norvasc, which sells for around $172 for a month's supply was projected to earn the company $4 billion in 2003, and that's just one example. Like Norvasc, most of these drugs, regardless of class, cost around $175 for a month's supply. With tens of millions of new potential customers, Big Pharma is not about to give up its market without a fight.

One of their latest tactics is to simply stop manufacturing diuretics.

Doctors in Norway recently protested Merck & Co.'s decision to stop making Dichlotride, the only pure form of hydrochlorotiazide (the most commonly used thiazide) available. There is no generic alternative available on the market. Although Norway's situation is unusual in having no generic alternative, it is not apparently unique, as several other European countries have reported difficulty in obtaining the thiazide diuretics as well.

Although the problem has not yet spread to the United States, can there by any doubt that what Big Pharma is really doing in Europe is testing whether it can get away with suppressing a cheaper alternative to its expensive and ineffective anti-hypertensives? Can there be any doubt that they will do the same thing here if they believe they can get away with it?

Not if you know Big Pharma!

REGULATORS FAIL TO ACT Where, you might ask is the government? After all, how can Big Pharma advertise these drugs as being effective when they are not? Doesn't the government regulate pharmaceutical advertisements? Won't it make sure that they are truthful?

The answers to those questions are yes, and no.

Yes, the government is supposed to regulate pharmaceutical company ads. Specifically, they are supposed to look out for ads that are misleading. With Big Pharma spending over $2.8 billion on direct to consumer ads, this certainly is an important task. The trouble is that the FDA is falling down on the job.

Since direct to consumer ads were first allowed in 1999, the proportion of FDA citations per complaint regarding drug advertisers has steadily dropped. In the most recent year for which complete data are available, the FDA cited one company for each eight complaints it received. The year before, however, it had cited one company for each seven complaints.

What is more important, though, is that it took on average six months from the time an ad campaign was initiated until some action was taken. This meant that a misleading ad could run for HALF A YEAR before anything was done about it. Even then the most likely action would be to ask the drug company to stop running the ad.

And that's just the average!

It took the FDA a full year to tell the giant Aventis pharmaceutical company to stop running misleading ads about its drug Taxotere.

But even when warning letters go out, they're hardly more than a slap on the wrist.

FDA Commissioner Mark McClellan has promised to make enforcement measures tougher, but only time will tell if he means what he says.

The good news is that the FDA Commissioner seems sincere in his promise, and now with studies such as those done in St. Louis and for JAMA, there is a growing body of evidence on which to base regulatory decisions. Still, it remains to be seen whether real change will take place, or whether Big Pharma will be able to use its influence to squash critics. Until the future is clear, consumers will have to rely on the old adage that holds "If it sounds too good to be true, it probably is."

Karl Theis Jr

http://groups.msn.com/exposureofthetruth

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