Medicine, Money & Your Health, Naproxin Update, Toxic Ayurvedic Remedies

• Medicine, Money, and Your Health

• • Economics and Ethics
  • The Pharmaceutical Industry
  • The Cost of a Patent
  • The Vioxx Story
  • Problems With The System

• Naproxen Update

• • Fear of Lawsuits
  • More About Naproxen Side Effects

• Toxic Ayurvedic Remedies

Medicine, Money and Your Health

Economics and Ethics

In my practice, I try to help people enjoy the best health at the least expense. Sometimes that involves lifestyle changes, sometimes vitamin and mineral supplements and sometimes pharmaceuticals. I think we should do our best to avoid the need for pharmaceuticals - for two reasons. First, drugs are more likely to cause side effects than are nutritional supplements. Second, they are often tremendously expensive. However, properly used, drugs can extend your life and improve your quality of life.

In this month's issue, we discuss the economics of pharmaceuticals and the quality of some herbal preparations (parts of the material in this newsletter ran as a column in the Olympic Business Journal). In addition, we discuss updated information about Vioxx® and Ibuprofen.

The Pharmaceutical Industry

When the pharmaceutical company Merck pulled its arthritis drug Vioxx® from the market, a fire storm of controversy erupted. News headlines called it a scandal, Merck's stock went into free fall, and the trial lawyers started circling for the kill. It seems everybody is lambasting the U.S. pharmaceutical industry these days. As a physician I've had my encounters with drug companies and I look at them with a jaundiced eye. However, the charges against the industry are shortsighted and naive. Let's pause and take a second look.

The Cost of a Patent

Patent a drug and you have seventeen years of protection. It can take up to ten of those years just to get your drug through the Food and Drug Administration approval process. You then have seven years to turn a profit. People argue that the industry spends billions on advertising instead of research and development. The sad truth is that in modern America, the "build it and they will come" idea is more often false than true. You can't wait for Aunt Anna to tell her neighbor about it. You could still be waiting when your patent runs out.

Newspaper columnists complain that the pharmaceutical companies stiff U.S. consumers for drugs that are less expensive overseas. What they don't tell you is that it costs upwards of $1.5 billion to develop a new drug and get it through the approval process. You go to sell it in Canada and the government says, "We're paying you this much -- take it or leave it." So, you take it. Remember, you've got seven years to pay off your $1.5 billion. When the industry opposes re-importation of less expensive drugs from Canada, it is simply trying to remain in the business of developing new drugs.

Where the foreign governments do not have their thumb on the scale, the U.S. drug makers shine. Geneic drugs are less expenive here, not in Canada. Over-the-counter drugs, too, are less expensive in the U.S.

The Vioxx Story®

Let's look at the recent Vioxx® story. This drug reduces arthritis pain as well as ibuprofen and similar drugs but causes much less gastrointestinal bleeding. Studies were published in 2002 showing that people who take doses of over 25 milligrams per day have an increased risk of heart attack. It wasn't clear with those first studies exactly what was causing the increased rate of heart disease. Was it that when patients took Vioxx®, they didn't take heart-attack preventing aspirin? Researchers were not sure, and though heart attack rates were higher with Vioxx®, overall death rates were not. Consider that serious gastro-intestinal bleeding, a major problem with the drugs Vioxx® replaces, can be fatal. There are no drugs for severe arthritis that are without hazard, and there are quite a few that are much more dangerous than Vioxx®.

Merck, the manufacturer of Vioxx®, financed several studies on these issues over the years. Merck published these studies. In September, a study showed that other drugs in its class are safer. Within a week, Merck pulled the drug. Some rheumatologists protest this decision, for they have patients who found pain relief with no other drug.

Now, tort lizards are claiming that Merck hid the facts. I don't believe them. The statement by Merck matches what I have heard from specialists in arthritis. Here is the testimony of Sandra Kweder, M.D. of the U.S. Food and Drug Administration given to the Senate. http://www.fda.gov/ola/2004/vioxx1118.html

For another example of our current tort system, look at Lotronex®. This drug is life transforming for many people with severe irritable bowel syndrome. Unfortunately, it causes a life-threatening blood vessel blockage in one of every 350 people who take it. Once this became clear, the drug was recalled. The "victims" of this "bad drug" then petitioned the FDA to renew their access to it. They said their lives were miserable without Lotronex®, and they thought the benefit well worth the risk. In 2002 the FDA approved their pe tition. Today the trial attorneys are still trolling for clients, and fat fees.

So, when someone bemoans the high cost of pharmaceuticals, remember that you are also feeding a lot of lawyers.

Problems with the System

Critics level the following charges, some of them true and valid:

• Drug companies promote newer, high-priced drugs when older ones often work just as well. [That's true, but the company that doesn't come up with shiny new drugs will be eaten by the competition.]
• Drug companies subsidize many studies, and tend to publish only the favorable ones. [That was true in the past, but leading journals are now starting to require them to reserve publication rights before the study starts and to publish no matter how it comes out.]
• Drug companies often file appeals to extend their patent by a few years. [That is true, and if they can show they haven't recouped their investment, they may win the extension, thus postponing the availability of generics.]
• Drug companies fund medical research and medical schools, thereby directing the course of medicine towards pharmaceuticals rather than towards nutrition. [Sadly, this is true, but the companies are not solely to blame. The academicians are culpable as well.]
• Drug companies sell drugs to industry and the government at a discount, leaving the cash-paying patient to pay the highest rates. [Yes, but the government pretty much sets its own prices, and wholesale customers always pay less than retail.]

I fully recognize the industry is not immune from the less-savory aspects of human endeavor. There are "behind-the-scenes" connections between physicians and drug companies that sometimes benefit us as a whole and sometimes harm us. These connections are sometimes well intentioned, sometimes not, but such is human nature.

The industry is not entirely run by angels, nor do I think it is fair to characterize it as uniformly callous and greedy. Just today I initiated the process for one of my patients to obtain an ordinarily expensive drug from GlaxoSmithKline -- for free. Although much of the criticism is valid, we shouldn't lose sight of the eggs this goose is laying, nor expect that goose to act more altruistically than the rest of twenty-first century America.

The point I'd like you to remember is that the U.S. pharmaceutical industry develops about 90 percent of the new drugs on the planet. European governments are thinking they need to make some changes to revitalize their sagging pharmaceutical industry, and they are looking with some envy at ours.

People spend thousands of dollars on discretionary items such as boats, golf, and hobbies. There comes a time when the most-desired item is health. If today we don't respect the rights of the drug companies, we and our children will find that the flow of innovation has ended.

More About Naproxen and Vioxx® and Heart Disease

Naproxen recently made it into the headlines on the coattails of the Vioxx® scare. How did this happen? Inflammation plays a role in causing Alzheimer's disease, so some researchers were comparing naproxen to placebo to measure the reduction in the frequency of Alzheimer's. This month they noted increased deaths from heart disease in the naproxen group. They immediately decided to stop the study. Did they figure that this previously unnoticed side effect of naproxen outweighed the benefit, or did the flap surrouning Vioxx® scare them off? I don't know. No one has published any real information.

Fear of Lawsuits

As to why the drug companies are running scared on this one, do the math. Gastrointestinal bleeding, a known side-effect, doesn't happen very often. There aren't many opportunities for a lawsuit. But half of all people get heart disease eventually. So the payoff on an ad that reads "Did you have a Vioxx® heart attack?" is high. Lotsa suits for the pharmaceutical maker to worry aout. Lotsa juries that can be asked to consider that maybe THIS heart attack was due in part to Vioxx®.

More About Naproxen Side Effects

Naproxen is an over-the-counter medication, often sold under the brand name Aleve®. It belongs to a group of painkillers known as Non-Steroidal Anti-Inflammatory Agents or NSAIDS. These drugs have long been known to have harmful side effects. The most serious is gastrointestinal bleeding, which can occur without symptoms. A second serious side effect is kidney failure, which can happen if the drug is taken by someone who is dehydrated (as occurs with diarrhea). These are the two most important side effcts; there are many others. To see the entire list of naproxen's side effects, check out this website: http://www.rxlist.com/cgi/generic/naproxsod_ad.htm. Most of the side effects rarely occur. To learn about the frequency of the more common ones, go to this website: http://www.rheumatoidarthritis.realage.com/content.aspx/topic/21.

Please, let's keep the NSAIDS information in perspective. This group of drugs - Aleve®, Advil®, ibuprofen, and aspirin - has been around a long time and people take, literally, tons of them a year. With the use of these drugs many people are active and happy who would otherwise be limping around or staying home. Despite the news pieces, there are no bodies littering the streets. What the headlines boil down to is some evidence of a new, apparently rare, side effect to add to the current long list.

Aleve®, or naproxen sodium, is a generally safe and effective drug. It is my personal favorite anti-inflammatory when I need one. The recent findings give me no reason to stop taking it. And if I were at serious risk of Alzheimer's dementia, I'd give serious consideration to taking it every day.

Ayurvedic Remedies of Questionable Quality

On December 15th, on National Public Radio's Morning Edition, a Boston doctor reported that about 20 percent of Ayurvedic remedies bought in New England stores contained alarming levels of lead and mercury. Ayurveda is the ancient system of medicine used in India. You can see and hear the story at http://www.npr.org/rundowns/rundown.php?prgDate=15-Dec-2004&prgId=3.

In 1987 when I studied Ayurvedic medicine in India, one of my teachers asserted that, as used in Indian medicine, heavy metals such as lead and mercury have tremendous therapeutic value. At present, I believe the burden of proof lies with the Ayurvedic practitioners. Those who sell such remedies are slipping a heavy metal of great potential danger into the American marketplace under the guise of an herb, and that is wrong and dangerous.

For this reason, the Indian herbs that we carry come from a safety-obsessed Seattle company that has every batch of raw herb certified as safe (and heavy-metal free) by the federal Food and Drug Administration.

CJK January 23, 2006