According to a Reuters report titled "Merck deleted Vioxx dangers: journal" on Friday Dec 9, 2005 11:01 AM ET by Ransdell Pierson in New York, Merck has been found to be less than honest. Not exactly news in itself, I’ve never encountered a single honest drug company. However the story is interesting because it documents surprisingly well just how Merck ‘ducks and weaves’ around the truth when drug money is at stake.
It was no less than the prestigious New England Journal of Medicine that said Merck & Co. withheld information about the dangers of arthritis drug Vioxx in a key study. The journal said said it had determined that Merck deleted data about three heart attacks among Vioxx users, and other relevant data, prior to submitting its analysis from the so-called Vigor trial to the Journal in 2000.
The drug trial at issue compared the safety of Vioxx with naproxen, a widely used rheumatoid arthritis drug. This was a classic example of marketing by published ‘scientific’ article. The journal’s website states: "The evidence has raised questions about the integrity of the data on adverse cardiovascular events in the article and about some of the article’s conclusions."
Now for some ducking and weaving. Merck responded by saying it promptly and appropriately disclosed the results of the study, correctly stated possible risks of Vioxx and extensively disclosed the Vigor data to the medical community. Now that sound fine doesn’t it. The trouble is, it is nothing more than an exercise in covering their back. What they didn’t do was publish an adjustment with full disclosure in the journal where their deceptive article appeared. It was left to stand, to ensure maximum marketing advantage of their known-to-be-dangerous drug.
Some of the rest is now well-known history. We know that Vioxx was withdrawn in September 2004 after being shown to double the risk of heart attack and stroke in patients taking it for over 18 months. More than 6,000 lawsuits have been filed against Merck in the United States, alleging Vioxx caused heart attacks and deaths.
This is quite damning of Merck. Analysts said the information from the journal could hurt Merck as it defends itself against Vioxx-related lawsuits. Merck shares fell 2 percent on the New York Stock Exchange on the news and another 4.7 percent in after-hours trade. Merck stock fell to $28.87 on the Inet electronic brokerage from a close of $29.68 on the New York Stock Exchange.
Merck’s protests of innocence have a decidedly hollow ring. Some of their claims in their defense have been refuted by documents received by the journal. Rather weakly Merck said in a statement about the ommited serious cardiac events: "We also note that these additional events did not materially change any of the conclusions of the article."
However, the journal contended the omissions of the additional heart attacks resulted in an "understatement" of the heart risks of Vioxx, and asked that the authors of the study "submit a correction to the Journal." This is close to a stinging rebuke in civilized scientific communication.
Even without inclusion of those three heart attacks, the Vigor article showed that rheumatoid arthritis patients taking Vioxx had about five times the incidence of heart attacks as those taking naproxen. One has to wonder if prescribers ever think for themselves. Have they lost critical thinking skills? Are they simply too reliant on drug companies, in every respect?
Rather pathetically Merck later defended the heart-safety of Vioxx, theorizing that Vioxx had done no harm but that naproxen had somehow protected patients from heart attacks. Why would they attempt such an argument to defend a drug that they knew was killing people? That’s very simple to understand. Vioxx remained on the market and generated annual sales of $2.5 billion by 2003, bolstered by splashy Merck ads.
Here is a recent story from a large-circulation newsletter that I just couldn’t resist sharing. It is about providing a rating for doctors (M.D.s) based on how consumers (or patients, doctors’ customers) find their services. Take a look at this.
They lurk in the neon-lit depths of office parks and hospitals. Some are nearly as elusive as Bigfoot. Sometimes they’re distracted, sometimes superior and overbearing, sometimes they’re simply inept. They’re the Nightmare Doctors. And once you’ve experienced one, you’ll never look at an M.D. quite the same way again.
Last week I came across a New York Times article that contained several choice Nightmare Doctor stories. My favorite was that of a woman whose doctor said she needed a myelogram; a scan of the spine that requires a spinal tap. She reminded him that she’d recently had one on his recommendation. The problem was, the film from her previous test wasn’t in her file and couldn’t be found. When he continued to press her to take the test, she suggested that it might be time to refer the matter to her lawyer.
The film was found within half an hour.
Amazing. Her doctor was actually comfortable sending her to get a spinal tap so that he and his office staff wouldn’t be inconvenienced. That’s one for the Nightmare Doctor Hall of Fame.
But now patients are fighting back.
One woman, whose doctor refused to tell her why he had prescribed a certain medication, later found out she had hepatitis A., which can be easily transmitted to family members. Not only did she change doctors, she started a web site called RateMDs.com for those who want to expose Nightmare Doctors to the world. And if you happen to like your doctor you can submit glowing reviews as well.
Some professional associations and insurance groups are also taking steps to encourage Nightmare Doctors to change their ways. One health plan organization withholds doctors’ bonuses if they’re not highly rated by patients. And a group of health insurers in California divide several million dollars among 35,000 doctors according to patient ratings.
One professor of medicine at Harvard Medical School believes that speed and technology have become the priorities in modern medical systems, prompting some doctors to forget the human element. And then there are those doctors who just don’t get it. For them we prescribe a healthy dose of RateMDs.com.
When I visited the site I found this statement.
RateMDs.com is changing the way the world looks at medicine by providing patients with the unique opportunity to rate and read about their doctors.
This is a new website, so please add your doctors and rate them!
So, how is this new website going? On my visit today, Saturday, December 10, 2005 the site statistics displayed were these: Total Ratings = 18,012 with Total Doctors = 19,336 and Ratings Added Yesterday = 92. I’d say it going, or at least growing, quite well.
The site seems to only have ratings for doctors in the United States, but I wouldn’t be at all surprised to see this spread to include other countries. I wonder if there’s a similar site for lawyers!!
A factor that plays a significant role in osteoporosis risk is celiac disease (CD). Official estimates are that more than 1.5 million people in the U.S. may have celiac disease, a condition in which gluten reduces the small intestine’s ability to absorb essential nutrients, such as calcium. I believe the real incidence is several times the estimated level.
Gluten is found in the grains: wheat, rye, oats and barley (remember WROB, because they rob you of health). It is vital to recognize that gluten is impossible to remove from any product that is made from any of these grains, which makes a genuinely gluten free diet quite a challenge for many people.
Unfortunately, the symptoms of celiac disease are often so subtle that many people don’t even know they have it. Many who do know they are celiacs are unaware that its untreated long-term complications can be fatal and they deliberately ignore advice to follow a gluten free diet.
Part of the problem is that because there are no drugs for the disease and the only treatment is to follow a strict gluten exclusion diet, most regular doctors pay the disease little attention. This directly or subtly conveys inappropriate attitudes to the condition in diagnosed patients.
One study reported in the Archives of Internal Medicine earlier this year investigated the link between celiac disease and osteoporosis in 840 subjects (260 had osteoporosis). Blood tests revealed that CD was much more common among subjects with osteoporosis. In addition, subjects with the most severe cases of celiac disease tended to have the most severe cases of osteoporosis.
Subjects who were diagnosed with CD were asked to follow a gluten-free diet for one year. Bone mineral density (BMD) (measured before and after the follow up year) was considerably improved in subjects who followed the non-gluten diet.
It is very important that people take celiac disease seriously and learn to strictly avoid gluten. It does take effort but it does eliminate the dangers of untreated CD. Osteoporosis is a debilitating condition with an insideous onset. Avoiding osteoporosis is one very good reason for a celiac to be sure to remain gluten free.
Don’t neglect your vitamin D. Many studies have demonstrated a range of health implications associated with inadequate vitamin D intake. These range from bone weakness due to the inability to properly use calcium without this vitamin right through to seriously reduced ability to fight cancer. Indeed, some studies have shown such a strong link between low vitamin D and cancer that it is thought the condition may actually be in the causal chain.
A study that appeared in the October 2005 issue of the Journal of Nutrition claimed that vitamin D deficiency is widespread. When Boston University Medical Center researchers analyzed dietary and supplement use data from more than 8,200 subjects across the U.S., they found that less than five percent of adults over the age of 50 were getting an adequate amount of vitamin D.
That is a serious concern. Now as winter approaches in the northern hemisphere daylight becomes more scarce. This compounds the problem because, as you know, vitamin D is "the daylight vitamin". We actually make vitamin D when we have sufficient contact from sunlight directly on the skin.
So, be sure to get some direct sunlight on your skin (but do not over do it and never, ever burn – remember to be sun smart to avoid skin cancer). You may find it helpful to review the vitamin D rich food sources at Healthy Vitamin Choice to ensure you get plenty of this very important vitamin. There are some other important details there too.
Remember, some research clearly suggests most people over 50 aren’t getting enough vitamin D. There may also be a need to add a supplement into your diet.
Some very interesting research is conducted by professional nurses. For some reason it rarely receives the attention it deserves. Here is a report on recent nursing research that fortunately did receive some attention.
The head of nursing research at St. Jude, Pamela Hinds, lead a recent study of terminally ill children. Describing the results to ABC News she said her team was "stunned" to find that children are not only up to the task of participating in end-of-life decisions, they’re also good at it.
Pamela Hinds’ St. Jude team recruited twenty patients who ranged in age from 10 to 20 (the average age of the group was 17). All of the young subjects had advanced stages of cancer, and all of them participated in three types of end-of-life decisions: initiation of terminal care, agreeing to a do-not-resuscitate order, or enrollment in a cancer drug trial.
Each of the subjects was interviewed one week after meeting with parents and doctors to decide on a course of action. Eighteen patients accurately recalled all of the treatment options available to them, and each of the patients in this group recognized that the decision they made would most likely result in their own death.
According to child developmental theories, children in this age group should be somewhat narcissistic about their personal desires. But the St. Jude research found that the children were primarily concerned for others.
For instance, the ABC report notes that a patient named Samantha agreed to participate in a trial for a new drug because it might lead to a cure for someone else. Another patient – 17-year-old Jaleesa – also signed on for a drug trial. "I would want someone to do the same for me," she said.
Ironically, it’s the prospect of death that seems to give these kids a positive perspective. St. Jude Chaplin Lisa Anderson told ABC that the young patients have "a very strong sense of finding meaning in this experience."
The potential comfort from the feeling of support arising from a child with a life-threatening disease being able to participate with doctors and parents in making treatment decisions is considerable. For more details see the following resources.
"End-of-Life Care Preferences of Pediatric Patients With Cancer" Journal of Clinical Oncology, Online publication ahead of print, 9/19/05, jco.org
"Children with Cancer Can Plan Own Treatment" Nils Kongshaug, ABC News, 11/20/05, abcnews.go.com
I think further research would continue to surprise people whose understanding of the capabilities of children is based more on outdated theory than daily or regular experience. Many children who have to face major challenges in life could teach us all a thing or two.