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Saturday, April 17, 2010

The FDA Shuts Down Common Infant Vaccine

The FDA Shuts Down Common Infant Vaccine After Startling Discovery Testing reveals "substantial" presence of potentially cancer-causing animal viruses in not just one - but three - common vaccines. What other "unknown" contaminants are we subjecting our kids to?

Time for the Truth about GardasilMust-read information for anyone considering immunizing their children with this vaccine.

Wednesday, April 14, 2010

Don’t Patients Know Best? - Doctors Need to Listen

In Reporting Symptoms, Don’t Patients Know Best?

About six years ago, my doctor gave me some samples of a drug to treat pain from an injury. I took it for a few days and then woke up one morning with a big red blister on my tongue. I’d never had anything like it before, and I wondered if the pills might be to blame. They weren’t helping much anyway, so I quit taking them. The blister went away. I mentioned it the next time I saw the doctor, but he said it must have been a coincidence.

Not long after, the drug, Bextra, was taken off the market in the United States. It had been linked to heart attacks and also to a dangerous condition called Stevens-Johnson syndrome — which can cause mouth blisters, among other things.

There’s no way to know if Bextra caused my problem, but it seemed like a reasonable idea, and I never understood why my doctor was so quick to dismiss it.

The episode came to mind when I read an article in the March 11 New England Journal of Medicine by Dr. Ethan Basch, an oncologist who treats men with prostate cancer and does research at Memorial Sloan-Kettering Cancer Center in New York. He argues that doctors, researchers, drug makers and regulators should pay more attention to patients’ firsthand reports of their symptoms while they take medicines, because their information could help to guide treatment and research, and uncover safety problems.

Direct reports from patients are rarely used during drug approval or in clinical trials, Dr. Basch says. If patients’ comments are sought at all, they are usually filtered through doctors and nurses, who write their own impressions of what the patients are feeling.

In addition, he writes, doctors and nurses “systematically downgrade the severity of patients’ symptoms” and sometimes miss side effects altogether. One result is “preventable adverse events” — for instance, suicidal thoughts in young people taking antidepressants, or severe constipation in people taking a drug for irritable bowel syndrome, both of which might have been detected earlier if symptoms had been systematically tracked.

Dr. Basch, 42, said he first became interested in this subject around 2003, when he attended a presentation of the results from a study of a new cancer drug. The researchers had not found fatigue to be much of a problem, but other doctors in the audience said their patients had suffered terribly from it while on the drug, so much that some had to quit taking it. Somehow, the study had completely missed that finding.

Intrigued, Dr. Basch began to study people receiving chemotherapy, and to compare symptom reports by patients with those from doctors and nurses. The differences were striking. For every problem — fatigue, nausea, appetite loss, vomiting, diarrhea, constipation — patients reported it earlier and more often than did doctors and nurses.

Why does this happen so often? There’s no simple answer.

“There is a sensibility among some old-school clinicians that they have a better sense of their patients’ experience than patients do themselves,” Dr. Basch said. “But doctors and nurses bring their own biases to the evaluation. They might say, ‘Mrs. Smith always exaggerates her fatigue — she says 9, but I rate it a 6.’ ”

Three clinicians asked to rate the same patient’s nausea will often give three different scores, he said.

The tendency to downgrade symptoms may be based on the doctor’s knowledge that a patient is in the early stages of an illness and could be much worse. Or the doctor may be making mental comparisons with other patients who are sicker: “You think your nausea is bad, you should have seen the patient I saw this morning, let me tell you,” as Dr. Basch put it.

Sometimes, he said, the downgrading may reflect wishful thinking by doctors, who may think that a certain drug will help patients and don’t want to take them off it.

Another reason, Dr. Basch said, is that “we live in a litigious society.” Describing a problem in a chart creates a record that the doctor may have to act on. “There may be a defensive lack of documentation,” he said.

But he went on, “Increasingly, scientifically, we believe that whatever Mrs. Smith says is what Mrs. Smith is experiencing, and it’s important to know how patients themselves feel about how they’re doing.”

But the doctor’s perspective is important, too, he said, and he suggested that symptoms be rated the way the Web site Metacritic rates movies: it posts two types of score, one from the public and one from professional critics.

“I want both,” Dr. Basch said.

Sometimes the information is lost altogether, when doctors and patients, distracted by test results and treatment plans, forget to discuss symptoms. “This is where a checklist could help,” he said.

Mistakes and distortions in reporting symptoms can be compounded in studies, where one researcher collects the information, another retrieves it from the chart and enters it into the study record, and still others evaluate it. The results can be like playing telephone.

“There are multiple steps of transcription and information filtering,” Dr. Basch said. “We know there are omissions and misinterpretations at every step of data transmission. We know information gets lost.”

Patients may also tell doctors one thing and then write another in their own reports, Dr. Basch said; most say their written accounts are closer to reality.

The idea of not telling doctors the whole truth struck a guilty chord with me. Growing up, I got weekly hay fever shots that I don’t think helped me at all. But I kept hoping they would, and the doctor was very kind, so whenever he asked if I was feeling better, I said yes, even though I actually spent most of August and September sneezing my brains out. This charade went on for years. Would I have been more honest in a diary? Maybe.

The Food and Drug Administration does have a system, Medwatch, that lets doctors and patients report problems that they think are adverse events from drugs already on the market. But it’s a passive system that waits for reports instead of actively surveying patients. Many people don’t know about it, and it has failed to catch some important adverse events, Dr. Basch said.

A better approach, he says, would be to have large numbers of patients filling out questionnaires before and after drugs are marketed. In an e-mail message, he said, “For example, in the postmarket setting we could ask 5,000 selected patients starting Bextra to report monthly (you would have reported the mouth sore without knowing if relevant or not, and this would then be pieced together with other reports).”

If patients had been asked to report their symptoms while the drug was still being tested, he added, problems might have been detected before it was even approved.

Gathering the patients’ information would cost money, but not much compared with the overall cost of drug development and clinical trials, Dr. Basch said, adding that it would also save money by heading off potentially expensive problems.

Dr. Basch said he was surprised to find drug companies enthusiastic about his research.

“You’d think it would not be appealing to them, because you’re generating more adverse events,” he said. “But the grade of the data is superior. You catch a lot of baseline symptoms before people start the drug, so you can understand what’s probably related to the drug versus what’s related to the patient’s arthritis or whatever they had before the trial.”

Although the regular reporting may sound like a nuisance for patients, researchers find that many people are eager to have their say. In one study, Dr. Basch said, subjects “typed volumes” into a small online text box, even though they couldn’t see what they were typing after the first few sentences.

“We’d get two pages of stream of consciousness,” Dr. Basch said. “The clinicians became overwhelmed.”

The challenge is to create surveys that focus on what’s relevant — and yet still provide a way to describe symptoms the researchers hadn’t anticipated. Dr. Basch is working on it, for the National Cancer Institute.

“Patients have a lot to say,” Dr. Basch said.

We’re just waiting for someone to listen.

Tuesday, April 13, 2010

If Doctors Were as Honest as NASCAR Drivers

click for full image detail

Saturday, April 3, 2010

Prescribing Under the Influence

Good discussion of how drug company influence can cause doctors to endanger patients.

Prescribing Under the Influence
By E. Haavi Morreim

Gifts to doctors from drug companies have implications for patient interests.

It�s morning report in the Department of Pediatrics at an academic medical center. A senior faculty member is working through a case with a group of residents and interns. "First we saw these symptoms. Now that the laboratory results are back, how does that change what we think?"

In the back of the room, there�s a table with bagels and juice. On the table is a supply of pens, notebooks, and little stuffed toys, all with a pharmaceutical company logo prominently displayed. Next to the table is a representative from the drug company.

When you ask doctors whether this kind of drug marketing is effective, the answer is always the same: "It doesn�t influence me at all. They�re not going to buy my soul with a laser pointer." In a recent syndicated newspaper column, one doctor commented, "I blame the pin-striped MBAs, who mistakenly believe that physicians are going to prescribe certain medicines because the company plies them with pens."

The truth is, the physicians may need to reconsider. This kind of advertising is crucial to sales. A doctor is not going to prescribe something he or she has never heard of, and it�s the drug representative�s job to get the products� names in front of the physicians. Maybe the drug representative does that while the resident is slathering cream cheese on a bagel; maybe it�s while the intern is saying, "Oh, what�s this cute little stuffed bear?" Either way, the doctor stops and spends a moment.

In private practice, the little gifts are often even more important. If you�re a drug representative, physicians are usually not interested in talking to you unless you have something to catch their attention. Then you can get your three sentences in: "We�ve got such and such on the hospital�s formulary now." Or "The new form of this drug can be given once a day instead of four times a day. The patients will love it." It�s a way to get in the door so that your information rather than somebody else�s reaches the doctor�s brain.

Marketing at Work

A recent letter in the Journal of the American Medical Association illustrates how effective drug advertising can be. It describes a patient who came into the hospital with an infected insect bite. The intern who first saw the patient first sensibly wanted to prescribe a nice, inexpensive penicillin, which is the drug of choice for a minor infection. But the resident overruled the intern and favored a more "modern" choice for this "severely" ill patient. He decided the patient had to have a brand-new antibiotic�at $183 a day.

The attending physician who supervised the house officers checked into the incident. It turned out the resident had just been wined and dined by the drug representative whose company made the new antibiotic. Think marketing doesn�t do any good? Think again.

The evidence is not just anecdotal. In a classic 1982 study, researchers explored physicians� perceptions of two medications where there was a distinct discrepancy between what the company was touting as the virtues of the drug and what the science said.

The first group of drugs was cerebral and peripheral vasodilators. The drug company representatives were suggesting that these medications might be a good treatment for dementia. The theory was that if you increased the circulation to the brain�if you oxygenated it�you could alleviate senility. The scientific literature, however, said that not only were vasodilators no good for dementia, but they could actually make it worse because if you dilate the vascular beds throughout the body�which these medications do�you may actually decrease the flow of blood to the brain.

The other medication studied was propoxyphene (Darvon). The drug representatives were promoting the use of Darvon for pain from fractures and major surgery. The scientific literature said, "At best, Darvon is as effective as aspirin."

The study focused on physicians� perceptions, so the researchers conducted a telephone survey of internists in the Washington area. All the doctors in the study probably thought, I get my information from Science; I don�t listen to those drug representatives. But it turned out that 71 percent of those interviewed believed that inferior cerebral blood flow was a major cause of dementia, and almost a third of them found vasodilators useful in managing geriatric patients. For Darvon, almost half of them believed that it was more potent than aspirin. The physicians could not possibly have gotten this misinformation from the scientific literature.

Another study tracked the prescribing patterns of two groups of 10 physicians who had been taken by pharmaceutical companies on all-expenses-paid trips to luxury resorts. Each day, the doctors participated in seminars for several hours. The rest of the time, they enjoyed the amenities of the locale.

All 10 doctors on each trip were interviewed, and the majority of them insisted that they were in no way influenced in their prescribing habits. Several said, "Maybe I was indirectly influenced by important scientific information that I might not otherwise have heard, but nothing else would influence me."

The study then compared the physicians� prescription patterns for almost two years prior to the trip with their prescriptions for almost a year and a half after the trip. The first group had been hosted by the makers of an intravenous (IV) antibiotic�Drug A. The second heard about an IV cardiovascular medication�Drug B.

The prescriptions for Drug A increased from 81 units before the trip to 272 units afterwards; in other words, they more than tripled. Drug B went from 34 units to 87 units, more than doubling. In the case of Drug B, the use those doctors made of the medication went well beyond the nationally agreed-upon standard of care.

New Techniques

And the drug companies are getting more and more sophisticated about their marketing techniques. Now they can go to the American Medical Association and buy biographical data on individual doctors including their prescription license numbers. Then they can buy information from pharmacies about what a particular physician is prescribing and keep track of what tends to influence him or her: This guy goes for gold address labels. That doctor likes to be taken out for vegetarian food.

The pharmaceutical companies are also making increasing use of samples. Admittedly, the samples can be very useful. They are a way to see whether the patient does well or poorly on a particular drug; they provide a time cushion for people to get to the pharmacy for the rest of the prescription; they can be used to help poor patients; and, in general, patients tend to be pleased to get them�"This is the only thing I�ve ever gotten from a doctor that�s free."

But in the long run, the samples aren�t free. The drug representatives only leave samples for the very latest, most expensive drugs. Once you finish the sample, the doctor almost never shifts you to a less expensive drug. So the samples are often a way of getting you launched on the newer, more expensive medication. That�s a problem not only because you end up spending a lot more money than you might need to, but also because some of the newer drugs have not been out long enough for us fully to appreciate the potential side effects.

This is not to say that profit is evil or that business is evil. The pharmaceutical industry has done some great work, developing a host of marvelous drugs in the past 20 or 30 years. They�ve been a godsend for thousands and thousands of people, who in many cases, can save money by avoiding costlier, more invasive treatments.

You�re not going to get this kind of vigorous productivity if you�ve got some government bureaucrat dictating five-year plans for drug research; you need a free market. And if the companies are going to continue to produce new drugs, they have to sell the ones they�ve developed, which means they have to market them.

The Role of Physicians and Consumers

On the other hand, there are some questionable things going on, and both physicians and consumers need to be part of the solution. Physicians need to avoid being na�ve. They need to quit protesting that because they�re scientists, marketing doesn�t influence them. They need to understand that the pen and the golfing trip are not designed to buy their souls; these "perks" are designed to foster familiarity and comfort with the drugs and sometimes create a gift relationship and the gratitude that goes along with it. That makes them very effective marketing tools.

Consumers also have to be more realistic. So many people feel entitled to the latest, greatest, hottest medications and treatments, but most of us are financially insulated by our insurance from the cost of this care, We�re not willing to spend more, but by golly, we want our health plan to cover everything under the sun. That can�t go on. The economics won�t work.

A classic example was bone marrow transplants for breast cancer. In one particularly famous case, a woman with advanced breast cancer was told that her only hope was a bone marrow transplant. When her HMO denied the treatment, she sued and got the court to mandate coverage. In similar scenarios all over the country, many other insurers started to cover it.

Several years later, when there were finally randomized, controlled trials of bone marrow transplants for breast cancer, this treatment proved to be no better than conventional chemotherapy. By that time, 30,000 women had had bone marrow transplants at a cost of $3 billion. That�s $3 billion while 44 million Americans are pounding on the door trying to get any access to health care at all. Ultimately, we all need to become more savvy about the medical and economic dynamics of the wondrous new drugs that are touted to cure what ails us.

Friday, April 2, 2010

Example of Science Serving Marketing - Pfizer Payments to Doctors - Hospitals

For Good discussion of how drug company influence can cause doctors to endanger patients see: Prescribing Under the Influence

See example of corrupt science below this article!

Pfizer Discloses $35 Million In Payments To Doctors, Hospitals For Research And Promotion
02 Apr 2010

Pfizer, the largest drug maker in the world, disclosed 35 million in payments during the second half of 2009 to doctors who consulted or spoke on behalf of drugs and to the medical centers that tested them, The New York Times reports. This is Pfizer's first disclosure of this nature. "While other pharmaceutical companies have disclosed payments to doctors, Pfizer is the first to disclose payments for the clinical trials. The disclosure does not include payments outside the United States" (Wilson, 3/31).

"The drugmaker made the disclosure as part of a government settlement after it pleaded guilty last year to illegally promoting more than a dozen of its own drugs. It also paid a record $2.3bn fine in connection to the deal," the Financial Times reports. "Pfizer said the disclosures were in line with healthcare reporting provisions included in the new healthcare reform law that was signed by US President Barack Obama, last week" (Kirchgaessner, 4/1).

The Wall Street Journal: The payments reached 4,500 doctors and 250 medical research institutions. They "included an average of $5,000 each to about 1,500 health-care professionals to provide input and advice about the needs of patients. Also, about 2,800 professionals received an average of $3,400 apiece to serve as speakers who educate peers about the safe and appropriate use of Pfizer drugs, the company said." About 250 hospitals shared in $15.3 million for research, clinical trials and recruiting trial participants (Rockoff and Loftus, 3/31).

The Associated Press: Pfizer posted its payment data in a searchable database. "Data posted by three other drugmakers so far has not been so user-friendly, said Allan Coukell, director of the Pew Prescription Project, a consumer group." The database also provides information about nonmonetary rewards, such as meals, travel, office wall charts and other items. The firm spent $1.7 million on business-related travel for doctors in the six month period. The new federal law will require even more rigorous disclosure, to include items that cost $10 or more. If expenses and payments to a single doctor top $100, they will have to be reported the U.S. health department (Johnson, 3/31).

This information was reprinted from with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at


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I Fired My First Doctor on Day 15

The day after our visit with Dr. Star, we had an appointment with Dr. George Babbitt (whose code-name alas, won’t make sense without a background in American Literature).
As it happened, this first appointment with a physician did absolutely nothing to ease my growing suspicion of modern cardiac medicine. He reiterated the message from Dr. Ghoul: my medical needs could not be met in Naples and I was being referred to a surgeon in Tampa for a heart transplant.

I asked Dr. Babbitt about the Lipitor dose he had prescribed me. By then, I had already found for myself the safety and efficacy FDA studies that originally approved Lipitor. These studies had used doses of 2.5 mg and 5 mg daily. Yet interestingly, the lowest available dose of Lipitor manufactured by the pharmaceutical company, Pfizer, was 10mg – double the highest dose used in the FDA studies for safety and effectiveness!

If that wasn’t enough to raise my eyebrows, Dr. Babbitt prescribed 80 mg daily doses of Lipitor – 16 to 32 times the doses used in the FDA studies. I told my doctor about my research on the FDA studies.

“You shouldn’t worry about those FDA reports – I have studies showing that 80 milligrams per day are safe, and more effective than those lower doses.”

I asked him who had done his studies.


I didn’t tell him that I was already aware of the Pfizer sponsored studies.

I suspect that Dr. Babbitt never saw the actual Pfizer studies, but had simply taken the word of a “detail man,” a representative of a drug manufacturer who calls on doctors to promote the products from that company. I wondered if he would be so enthusiastic about high-dose Lipitor had he actually read the study.

In 2005, the New England Journal of Medicine published a report funded by Pfizer that described the efficacy of high-dose Lipitor in cardiovascular disease. The authors concluded that high-dose Lipitor (80 mg) was superior to a ‘standard dose’ (10 mg) in reducing negative cardiovascular events in coronary heart disease (CHD) patients. Ten thousand CHD patients participated in the five-year study. Half of them received a daily dose of 80 mg of Lipitor, while the other half received a control, ‘standard’ dose of 10 mg/day.

The Pfizer study observed a reduction in major cardiovascular events in the high-dose Lipitor group (heart attack and/or stroke) over the course of the experiment. In the 80 mg group, 8.7% (or 434 patients) suffered a major cardiovascular event, compared to 10.9% (or 548 patients) of patients in the standard 10 mg group. When you do the math, that’s a difference of 2.2% – or 104 fewer cardiovascular incidences in the high-dose Lipitor group – a statistically significant improvement over standard treatment. Furthermore, only 126 patients in the 80 mg/day Lipitor group died from cardiovascular problems during the study, as compared to 155 in the 10 mg/day group.

I was surprised to discover that treatments were tested and put into practice with such small efficacy ratings. But, 2.2% is better than nothing, right?

Not when you take into account that in this same study, 158 deaths due to non-cardiovascular events occurred in the 80 mg/day group (3.2%), versus only 127 (2.5%) in the lower dose condition. Cancer, particularly lung and gastrointestinal, was responsible for more than half of these deaths. Hemorrhagic stroke and other, non-traumatic causes contributed to the remainder of non-cardiovascular deaths in both treatment conditions. However, this difference of 31 more deaths from non-cardiac related causes in the high-dose group brings the total deaths to 282 in the 10 mg Lipitor group, and 284 in the 80 mg group – statistically, that means there was no difference at all. Your chances of survival were actually 1 in 5000 lower if you took a high dose rather than a standard dose of Lipitor.

Between the actual statistics revealing the serious side effects associated with Lipitor and other statin drugs, and the failure to improve overall survival rate by using higher doses of Lipitor, I suspected that my doctor, had he actually been up on the facts, could have made a wiser choice. However, the professional to whom I was entrusting my life didn’t seem to be as well informed on the subject as I was. Later I was to discover that this isn’t unusual; it doesn’t take much research to be better informed than some doctors.

However, it was easy to understand why the drug salesmen from Pfizer only talked about the (tiny) advantage in reducing cardiac events and failed to mention the fact that there was no overall advantage in reducing death.

So why were the patients in the high-dose Lipitor study dying more frequently from non-cardiovascular causes? At this point, the mechanisms underlying this effect are unclear – we just can’t tell. But as one expert in the field wrote, “we need further reassurance as to the safety of this approach before making this higher dose a standard practice in CHD pharmacological therapy.” Despite their prevalence, the statins are not the only available method that can be used to lower LDL-C levels. Hybrid therapies with other drugs, natural therapies, and nutrition can all be effectively used for this purpose. But my highly paid doctor didn’t know that, either.
I mentioned to Dr. Babbitt that, in spite of all the testing done so far, my cholesterol levels had never been checked, even though Bunny had asked on three different occasions for my cholesterol, LDL, HDL and triglyceride base levels, as well as for reports on relevant things like current kidney and liver functions. “Wouldn’t it be a good idea to know what Sam’s present levels are, so that we have a baseline against which to measure?” she persisted.

Evidently Dr. Babbitt had liberated modern medicine from the restraints of science, as well as from the need to listen to the concerns of, or share information with his patients. His response was, “It doesn’t make any difference where they are now, because I know I want them lower.”
I also expressed my concern about statin drugs’ effects on liver function. The University of California had recently issued a report to the effect that statin users do run a serious risk of liver damage following prolonged use. They strongly recommended frequent blood tests to monitor liver function, so that the doctor would be able to end drug therapy immediately, should any abnormalities appear.

“Shouldn’t we check my liver function, so we have a baseline to measure what effect Lipitor is having on my liver?”

“No, if your liver starts acting up we can deal with it then,” was his reply.

“What about CoQ10?” I asked next. Statin-induced CoQ10 depletion is well documented in pre-clinical and clinical studies, leading to detrimental cardiac consequences in both animal models and human trials. Furthermore, this drug-induced nutrient deficiency is dosage related (recall my 80 mg/day dose) and is usually seen more frequently in the context of either a pre-existing CoQ10 deficiency (such as in the elderly) and in heart failure patients. One source from an unnamed MD said, “Prescribing statin drugs without also including CoQ10 constitutes malpractice, in my opinion!”

Dr. Babbitt’s response: “We don’t use CoQ10.”

“I see,” I said. And I did.

I asked several other questions at that appointment, but my doctor grew increasingly annoyed and impatient. Dr. Babbitt was the first doctor I fired. And since Dr. Babbitt happened to be Dr. Ghoul’s partner, I actually got a two-for-one deal.

Does Your Heart Doctor Have a Drug Company “Pimp”? [1]
By Layne Lowery

Cardiologists are more than twice as likely to receive direct payments from drug companies for consulting and other services, a recent national survey concluded.

A study published in the April 26 issue of the New England Journal of Medicine says despite the potential for conflict of interest—almost EVERY practicing physician in the United States has some type of relationship with pharmaceutical manufacturers. The study says these relationships vary based on the kind of practice, patient mix, medical specialty and professional activities. Researchers at Massachusetts General Hospital, Yale University, the University of Melbourne, and Royal Melbourne Hospital in Australia conducted the first national survey of 1,662 practicing physicians in late 2003 and 2004 to study these relationships. They surveyed doctors in six specialties to determine the extent of their financial ties with the pharmaceutical industry—and the factors that predict those ties.

Study findings indicate drug and device manufacturers hand pick the doctors with whom they’ll form the strongest ties. In addition to direct payments, study results show cardiologists are also more likely to be paid honoraria than pediatricians, anesthesiologists or surgeons.

Study co-author Eric Campbell, Ph.D., an Associate Professor of Medicine at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School, notes the strategic implications of these “hand-washing” practices. Campbell said “if the drug and device industry can influence cardiologists, they can likely influence the prescribing practices of other doctors.”

[1] Reprinted with permission of Health Resources,