You may have heard about the mistrial due to the hung jury in the recent case against Merck. I was surprised to read that there was only one member of the jury who refused to side with the other jurors in finding Merck liable. Not surprised that most found against Merck of course, just surprised that the juror count was so well publicized.
You know already that the editors of the New England Journal of Medicine (NEJM) accused executives at Merck & Co. (the maker of Vioxx) of suppressing damaging clinical evidence about their drug. Dr. Topol, a witness in the trial, explained that when he compared the published study of the 2000 trial with FDA records of the study, the number of heart attacks and deaths were higher in the non-published FDA data. His take on the inconsistency: "scientific misconduct."
There was more devastating testimony in the trial from Eric Topol, M.D., chairman of the cardiovascular medicine department at the Cleveland Clinic. An Associated Press (AP) article ("Doctor: Merck’s Habits ‘Appalling’" Associated Press, 12/4/05, cbsnews.com) captured Dr. Topol’s professional anger. Here are four highlights, or possibly lowlights, of his testimony.
1) On the window of risk
This trial concerned a man who had a fatal heart attack after only one month on Vioxx. Merck executives claim that heart attack risk associated with Vioxx only emerges after a year and a half of use. But Dr. Topol contended that existing research shows Vioxx may prompt heart attacks at any time after use begins.
2) On the suppression of negative results
Dr. Topol told the court that a 1999 trial sponsored by Merck showed that Vioxx was responsible for a 760 percent excess rate of heart attacks when tested against a placebo and another pain reliever. Merck executives decided not to publish that study.
3) On creative reinterpretation of the facts
A 2000 study found Vioxx increased heart attack rate by five times compared to another pain reliever called naproxen. In defense of their cash-cow drug, Merck executives noted that naproxen has cardioprotective qualities. This supposed difference between the drugs might have won over some non-skeptics, but not Dr. Topol, who explained that naproxen has NOT been shown to have any such cardioprotective qualities.
Now all of this is certainly damning of Merck executives. It also raises questions about the role of prescribing physicians. I have long argued that their claims to base their work on science are entirely false and misleading.
Their sometimes arrogant confidence that they stand on firm scientific ground is actually a lie. In reality, they stand on nothing more solid than drug companies’ own and drug company sponsored research. The ever-so-slight margin of demonstrated benefit over placebos in some cases, given the unwanted side effects that are caused, means that such drugs should never be used. They are of course, but not for the claimed clinical benefits, just for the money.
Many doctors wouldn’t even know the slim margins of benefit. They simply look superficially at the glossy promotional material, tally up their cut, and prescribe as much as they can. That’s a dangerous reality because sometimes the marketing provides a scandellous coverup of very dubious benefit or even clear evidence of harm.
The forces at work in this market based world of prescription drugs are very strong. It has long been clear that ultimately consumers need to have an authority to supervise the players to help ensure safety. Enter the FDA.
However, the Vioxx case along with many others, should provoke some serious questions about the effectiveness of the FDA in protecting the public. Quite clearly, when matters arise such as the thousands of lawsuits being faced by Merck, one should ask, who has allowed this situation to develop? Isn’t it the FDA’s job to prevent this harm?
The FDA is a sham. It plays its role in such a way as to make drug based medicine even more dangerous. Too many people have misplaced trust in the FDA. The beilef that if the FDA approves a drug it must be safe is no longer tenable for anyone. Undeniably, somehow, protection from the FDA just didn’t work with Vioxx.
The FDA has again been weighed in the balance and found wanting. Seriously lacking in judgement would be the mildest possible conclusion one could reach after any period of FDA observation. Yes, they do get some things right, I’m happy to say. But on balance, their enculturated values are so inappropriate for the role ostensibly performed they should be shut down and replaced with a totally new and hopefully effective organization.
Here is a case in point. On December 2nd the FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec. See my comments about the use of NeutroSpec and particularly the second half, where I question whether NeutroSpec should ever be used.
Clearly the known problems associated with NeutroSpec that were published on December 2nd should have resulted in its immediate withdrawal. Any reasonable person would have no difficulty in seeing the undue risk associated with the use of NeutroSpec. Why didn’t the FDA demonstrate this reasonable risk management? Whose interests are they serving?
Today the FDA has notified of the withdrawal of NeutroSpec. While I do welcome this decision it is one that causes me great concern. Why? Simply because the only events that could overcome the FDA’s obvious reluctance to take this action is further serious harm associated with NeutroSpec since December 2nd. That is, more people had to needlessly pay a high price for the actions and inactions of the FDA. In my mind, they are culpable and should be held to account.
The FDA update today:
NeutroSpec (Technetium [99m Tc] fanolesomab
Audience: Medical imaging specialists, hospital administrators and risk managers
[UPDATE Posted 12/19/2005] FDA issued a Public Health Advisory to alert patients and health care providers that Palatin Technologies Inc. and Mallinckrodt have agreed to implement an immediate voluntary market suspension due to serious safety concerns, making NeutroSpec unavailable for approved or investigational uses. FDA urges health care providers to discontinue use of existing stocks of NeutroSpec and to contact Palatin Technologies regarding their return. FDA is conducting further investigation into the deaths and adverse events associated with NeutroSpec and is working closely with the manufacturers of the product to evaluate the risks and benefits associated with its use.
Even the name "Public Health Advisory" is a bureaucratic linguistic distancing device. How comfortable FDA decision-makers must feel, remaining at an acceptable distance from the harm the medical and pharmaceutical industries cause, and which they oversee. Not for them, the daily interaction with distraught and grieving families – they are not people, they are merely "the market".
It is high time the FDA was thoroughly investigated. I would not call for an overhaul because the entrenched value system would quickly ensure a reversion to current practices. The time has come to accept that the FDA experiment has failed. A new — and real — watchdog is required.
We have previously pointed to many problems associated with the use and overuse of statin drugs. See for instance Think Again About Statins and Statins Deplete Essential CoQ10.
Now even the U.S. General Accounting Office (GAO) is critical of the marketing claims and research results related to the statins. They point out that the results of all statin drug trials from 1990 to 1999 (19 studies in all) were distorted.
What was the problem exactly? Well, it appears that the sample was biased and very unrepresentative of the population, including the target market for the class of drugs. The trials were mainly conducted using middle-aged men. They did not study the effects of the drugs on women, children, the elderly, or ethnic groups.
The GAO recognized the age / gender bias with this statement:
"The trials generally have not evaluated the efficacy of cholesterol-lowering treatment for several important population groups, such as women, elderly men and women, and minority men and women. Thus, they provide little or no evidence of benefits or possible risks for these groups."
Given the widespread prescription and sales to these groups we have clear evidence that clinical efficacy, if it is even seriously considered at all, takes second place to just selling the drugs. I say again, statins are all about money. They are completely unnecessary and unsafe and it is unwise to take them.
If you currently take statins, here’s a hint. Document your use and everything your prescriber says very thoroughly. Why? It will help when your loved one’s join the inevitable class action suit.
If you think your sunscreen is protecting you from skin cancer, you may well be correct. On the other hand, you may have to investigate your products of choice in order to be sure. Not all sunscreens are the same.
Research shows that while most brands of sunscreen do protect you from short-wave ultraviolet radiation, many do nothing at all to protect you from dangerous long-wave radiation. Not good news really.
So how can you tell if your brand provides the protection you need? Fortunately that’s pretty simple. Just look on the label to make sure it contains the ingredient that has been proven to block long-wave UV rays (see below).
Let’s consider the ABC’s of the suns rays, that is, the different types of ultraviolet radiation to which we are exposed.
UVA: This is long-wave radiation between 320 and 400 nanometres. It is responsible for most photosensitivity reactions, and also contributes to chronic skin damage and sunburn. It penetrates deeper into our skin than UVB radiation. Its level is relatively constant during daylight hours.
UVB: The midrange of ultraviolet radiation (290 to 320 nm) is the major cause of sunburn and chronic skin injury, including aging and skin cancer. It is most intense between 11 am and 4 pm. It is able to penetrate through 1 metre of water, and is reflected 17% by water, 50% by sand, and up to 80% by snow.
UVC: This wavelength of radiation does not reach the earth’s surface, as it is blocked by the ozone layer. However it is found in artificial light sources such as tanning beds. It may cause erythema, or sunburn.
Sunscreens work by "absorbing" the sun’s rays so that they do not hit the skin. Their relative effectiveness is measured by the Sun Protection Factor (SPF). The higher the SPF, the more, or longer the protection you receive.
The various components of your sunscreen may include agents that protect against UVB radiation such as cinnamates, salicylates, and para-aminobenzoic acid (PABA) and its esters. Parsol should be a component of any sunscreen, as it is the only chemical which blocks UVA, the long-wave radiation.
True sunblocks include titanium dioxide and zinc oxide. They are particularly useful on the more exposed body parts, such as ears and noses.
People in the southern hemisphere are heading off to the beach in large numbers while northern hemisphere dwellers are heading into the snow. Both are in need of good quality sun protection. Take care out there.
Attention deficit hyperactivity disorder (ADHD) is characterized by poor concentration, distractibility, hyperactivity and impulsiveness. Children and adults with the disorder can’t concentrate for long periods of time and are restless or tend to daydream. The disorder typically is treated with stimulant drugs. About 8 percent of U.S. kids have it, boys more than girls.
Neurofeedback, a drug-free biofeedback based approach to therapy, uses a computerized biofeedback system that allows patients to see depictions of their brainwaves on a screen. With coaching, they attempt to change the activity of certain types of waves and hence change their own behavior.
The technique has value in treating disorders such as autism, epilepsy, ADHD, learning disabilities, head injuries, post-traumatic stress disorder, addictions and depression.
Neurofeedback therapy usually isn’t given in the presence of ADHD drugs because of drug side effects, which can include depression, weight loss and insomnia. Treatment can be combined with a prescribed drug when necessary. Non-prescription vitamins, minerals and herbal treatments that are known to affect brain function are commonly employed. A treatment called chelation is used to remove heavy metals from the body. Lead, for example, causes learning disabilities.
The neurofeedback treatment usually consists of 10 to 15 one-hour sessions, preferably at least three times a week. The one-on-one coaching is similar to guided imagery therapy.
Although the medical profession tends to ignore the therapy and broad research is rare, neurofeedback has enough anecdotal mileage to deserve closer study. Dr. John Dye, a professor at the Southwest College of Naturopathic Medicine and a physician at the Scottsdale clinic, is offering the therapy with Leslie Sherlin, a certified neurofeedback practitioner.
The therapy is preceded by a physical examination and medical history. Nutritional, psychosocial and environmental factors that affect brain function are treated through dietary changes or psychological interventions.
Individuals who get biofeedback are outfitted with a hydra-head of 19 sensors adhered to specific points on the scalp. They pick up the brain’s electrical activity, assessing which waves are active in different parts of the brain.
The waves include the sharp-thinking beta type, the zoned-out alpha waves, the meditation/twilight-sleep theta waves and the delta waves of deep, dreamless sleep. The results are plotted on a brain map, which is compared to a "normal" brain map, based on information from five databases around the world.
Specialists like Dye and Sherlin can identify a spacey individual from a fidgety one based on a brain map. "The client gets to look at the brain activity on the computer and see when the brain is doing the right thing and getting on track," Dye said.
One-on-one coaching is the subtle therapy that provides the tools to change brain wave levels. "The harder you try, the more it doesn’t work," Dye said, commenting on the approach.
The ADHD problem in general is that the brain waves are too slow, concentrated in the alpha or theta ranges, resulting in poor mental focus. Individuals with ADHD tend to crave excitement, theoretically because it makes up for the slow brain waves and makes them feel normal. Some experts theorize that anxiety is an expression of this compensation.
This interesting and evidently quite encouraging combination of clinical practice and research is a very positive sign. You will find this at the Southwest College of Naturopathic Medicine, an accredited school of naturopathic medicine. See www.scnm.edu for more information about their ND program.