DC Medical Malpractice & Patient Safety Blog

Blood clots that develop in the large veins of the calf can kill if they break off and travel up to the heart. That's what is called a pulmonary embolism, the killer of some 100,000 Americans every year. Now there's evidence that statin drugs for lowering cholesterol, and thereby preventing clogging of the arteries in the heart (thus lowering heart attack risk), may also lower the risk of clots developing in the veins, and dramatically so.

But don't demand a statin drug prescription from your internist just yet. You have to understand your own statistical risk first.

According to a major study of 18,000 patients, as reported in the New York Times, the patients who took the potent statin drug Crestor (rosuvastatin) had a 43 percent lower risk of blood clots in the leg veins than patients who took a placebo pill in the same study.

That's an impressive number. But more revealing, perhaps, is the actual number of patients that percentage represents. In the 18,000 patients, only 94 developed blood clots -- 34 in the group taking Crestor and 60 in those taking the dummy pill, thus the 43 percent difference. But the overall risk is so small that no responsible doctor would recommend people take a statin drug long-term to prevent blood clots in the legs, UNLESS you have some specific high risk for such blood clots -- such as a history of having them in the past.

This blog has made a similar point with other "breakthrough" reports on drugs -- actually on the same study with the same drug, when it reported in late 2008 that Crestor might reduce heart attack risk even in patients without high cholesterol. You have to count the actual numbers of patients affected and understand where you fit, before you can make an intelligent commitment to long-term use of a drug. This issue is discussed in more depth in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

Never underestimate the ingenuity of the pharmaceutical industry in promoting its products to the American public. The latest example: The "Real Age" questionnaire that millions of people have filled out on the Internet, to tell them if their "real age," based on lifestyle and family history, is younger or older than their chronological age.

It turns out that the company that sponsors the Real Age web site sells to pharmaceutical companies the detailed information it receives from patients who fill out the 150 questions in its survey. The actual names and email addresses of patients do not get transmitted to the drug companies, but Real Age sends emails to patients on behalf of the drug companies, and these emails are targeted to what a drug company thinks that patient might be interested in, based on the patient's responses to the Real Age questions.

All this happens, according to a report by Stephanie Clifford in the New York Times, whenever a patient clicks "yes" to the multiple opportunities offered during the Real Age questionnaire to "become a member" of the Real Age community. Once a patient says yes to membership, his information becomes part of a database that is then combed to see what pharmaceutical drugs might appeal to the patient.

"It's free," as the Real Age web site keeps reminding people.

But is it really? Patients who are drawn toward a drug by "direct to consumer" pitches like this are likely to sign on for a prescription they may not really need, and every prescription drug carries side effects that may outweigh the drug's benefits. In the early years of a drug's marketing, when manufacturers are most keen on pushing their products, the risks are not fully known to the medical community. That's because the studies done on drugs to win FDA approval are usually limited to a few thousand carefully selected patients.

The safest approach to using prescription drugs is explored by Patrick Malone in his new book, The Life You Save. See chapter 7.

The PSA screening test for prostate cancer causes far more men to undergo unnecessary and harmful treatment than it saves lives, according to two large new studies. As reported by Gina Kolata in the New York Times, one study that followed 77,000 American men for a decade found zero benefit in lowered death rates, while the other study, which followed 182,000 Europeans for nine years, found that only seven lives were saved for every 10,000 men screened with the blood test.

And for every one of those saved lives, forty-eight men were told they had cancer and underwent unnecessary treatment. That treatment can cause impotence or incontinence if it involves surgery, or problems with bowel elimination if it involves radiation.

The problem is not so much the test but the disease. Prostate cancer is usually very slow to grow, and in the cases where it is aggressive, it may already be too late to save the patient when it is discovered.

Both studies were published in the New England Journal of Medicine.

The same issue, on a less dramatic scale, applies to mammography screening for breast cancer. According to Dr. Michael Barry, who wrote an editorial in the NEJM accompanying the research studies, about ten women receive a diagnosis of breast cancer and undergo needless treatment for every one woman whose life is saved after having a mammogram. Breast cancer is much more dangerous than prostate cancer, so screening can still be warranted.

What doctors need, and still do not have, is a way to sort out cancers that would be deadly without treatment from those that would not.

The bottom line for patients is to ask careful questions of your doctor and understand the numbers before you decide whether cancer screening is right for you. Patrick Malone's new book, The Life You Save, has a chapter that helps patients sort through the statistics of cancer screening.

The U.S. Supreme Court has rejected a strong push by the pharmaceutical industry to win immunity from lawsuits filed by injured plaintiffs. In a 6-3 decision in the case of Wyeth v. Levine, the Supreme Court ruled that the Food and Drug Administration's approval of a drug's label does not mean that the manufacturer has no obligation to improve the warnings on the label if new information comes to the attention of the manufacturer.

This is a big victory for patient safety. The case will help doctors too, by keeping the pressure on the drug manufacturers to keep their product labels up-to-date so that doctors can be educated about the safest way to use drugs. Medical leaders, such as a group of editors of the New England Journal of Medicine, had filed "friends of the court" briefs urging the Supreme Court to take the side of the injured patient.

The heroic patient who pushed this case was Diana Levine, a Vermont musician who lost her arm and her career after being injected too rapidly with an anti-nausea drug called Phenergan. The drug is well known to cause terrible injuries if it gets into an artery. She contended, and the jury and the Vermont Supreme Court agreed, that the drug's manufacturer, Wyeth, knew about this risk and should have warned doctors on the label to avoid the "i.v. push" technique that carried a high risk of inadvertent injection into an artery.

A study published in February 2009 in the Journal of the National Cancer Institute reports that low levels of alcohol consumption may be responsible for about 5% of cancers in American women (or 30,000 cases a year), Thomas Maugh writes in a Los Angeles Times story. This newfound risk of low or moderate consumption of alcohol may offset its cardiovascular benefits.

For more than seven years, the British-led research followed more than 1 million women between ages of 45 and 75. That is one in every four U.K. women in their age group. The study found that “[h]aving a daily drink was associated with 11 additional breast cancers per year per 1,000 women, one additional cancer of the oral cavity and pharynx, one additional cancer of the rectum, and 0.7 additional cases each for esophageal, laryngeal and liver cancers.” Two drinks a day doubles the cancer rates, and a third drink triples the figure.

Leader of this research, Naomi E. Allen of the University of Oxford, thinks it’s too soon to draw a conclusion on whether women should abandon their daily drinks. Allen is working on a separate study of potential cardiovascular benefits using the same group of study subjects, which she and other scientists hope will bring the overall benefits and risks of alcohol consumption to light.

It's always intimidating to undergo an MRI scan or CT scan. The machines are loud and enormous and seem to swallow your body. For all the trouble and expense, patients deserve the very latest scanning equipment and should have their images read by only the most highly qualified doctors. Alas, there is a quiet scandal in the $100 billion/year medical imaging industry. Patients cannot count on the best unless they insist on it.

As quoted by Gina Kolata in the New York Times, radiology leaders say, in the words of one: "The system is just totally, totally broken." That from Dr. Vijay Rao, chair of radiology at Thomas Jefferson University Hospital in Philadelphia. One big problem is that insurers pay standard rates for scans, even if a scan on a 10-year-old machine produces a blurry image and results in patients undergoing unnecessary surgery or missing a diagnosis. There is also no financial incentive for scanning facilities to have the images interpreted by sub-specialists with more expertise in the body part being studied. But there is a big financial incentive for doctors to own their own scanning equipment, and that results in many unnecessary referrals for scans when the doctor's judgment about the patient's needs is clouded by financial conflicts of interest.

Wise patients should ask pointed questions before submitting to any imaging scan. Here is a list, adapted from Patrick Malone's new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, available at Amazon.

1. Is the scanning machine the latest generational available? If not, is there another facility nearby that has the latest generation? (In MRI scans for example, the stronger magnets on newer machines make for crisper images.)

2. Does the doctor who wants me to have this scan own the scanning equipment or the scanning facility? (If so, get an opinion from another doctor with no financial interest about whether you need the scan at this facility.)

3. Who will interpret the images? Is that doctor a sub-specialist in what's being studied? (Examples of radiology sub-specialties include musculo-skeletal, neuroradiology (brain and spine), abdominal and chest.) If not, can we get a second reading from a sub-specialist?

4. Is the scanning facility accredited by the American College of Radiology? (This ensures that basic standards are met, such as the technologist who runs the scanning machine being certified and the machine being regularly inspected for proper functioning.)

Involved patients will also want to sit down with the doctor and look at the images together. You will notice how much more detail comes out when the scan has been done on an up-to-date machine by well-trained personnel. In the New York Times article, you can see in a knee scan how the ligament is blurry on the left-side image but comes out clearly in the image on the right -- a slanting striated structure that connects the middle of the top of the tibia to the back of the femur.