Don’t Give More Patients Statins

This is a counterpoint to the earlier article on new guidelines for cholesterol management. It provides some very convincing arguments on why the new guidelines SHOULD NOT be implemented. They include:

1. these new guidelines are not based on new data. They simply redefine the inclusion criteria for prescription of statins, broadening the base. 
2. by eliminating the LDL level for the initiation of statin therapy, these guidelines will increase the number statin prescriptions by more than 70%
3. overall, statins do not offer protection against heart disease, and have significant side effects. Based on past data, approximately 140 patients would need to be on statins to prevent 1 heart attack or stroke, without any decrease in the number of deaths or seriousness of the illnesses. Out of this number, 18% would likely experience side effects
4. statins would provide false reassurance to patients, discouraging them from taking steps that actually decrease heart disease, such as exercise and dieting
5. decreasing cholesterol levels pharmaceutically does not have the same effects as doing it by non-drug methods

These new guidelines definitely benefit the pharma industry, and need greater scrutiny and debate before they are put into practice. Now read on...

ON Tuesday, the American Heart Association and the American College of Cardiology issued new cholesterol guidelines that essentially declared, in one fell swoop, that millions of healthy Americans should immediately start taking pills — namely statins — for undefined health “benefits.”

This announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs — a decision that will benefit the pharmaceutical industry more than anyone else.

The new guidelines, among other things, now recommend statins for people with a lower risk of heart disease (a 7.5 percent risk over the next 10 years, compared with the previous guidelines’ 10 to 20 percent risk), and for people with a risk of stroke. In addition, they eliminate the earlier criteria that a patient’s “bad cholesterol,” or LDL, is at or above a certain level. Although statins are no longer recommended for the small group of patients who were on the drugs only to lower their bad cholesterol, eliminating the LDL criteria will mean a vast increase in prescriptions over all. According to our calculations, it will increase the number of healthy people for whom statins are recommended by nearly 70 percent.

This may sound like good news for patients, and it would be — if statins actually offered meaningful protection from our No. 1 killer, heart disease; if they helped people live longer or better; and if they had minimal adverse side effects. However, none of these are the case.

Statins are effective for people with known heart disease. But for people who have less than a 20 percent risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness — as shown in a recent BMJ article co-written by one of us. That article shows that, based on the same data the new guidelines rely on, 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness.

At the same time, 18 percent or more of this group would experience side effects, including muscle pain or weakness, decreased cognitive function, increased risk of diabetes (especially for women), cataracts or sexual dysfunction.

Perhaps more dangerous, statins provide false reassurances that may discourage patients from taking the steps that actually reduce cardiovascular disease. According to the World Health Organization, 80 percent of cardiovascular disease is caused by smoking, lack of exercise, an unhealthy diet, and other lifestyle factors. Statins give the illusion of protection to many people, who would be much better served, for example, by simply walking an extra 10 minutes per day.

Aside from these concerns, we have more reasons to be wary about the data behind this expansion of drug therapy.

When the National Heart, Lung, and Blood Institute issued the last guidelines in 2001, they nearly tripled the number of Americans for whom cholesterol-lowering drug therapy was recommended — from 13 million to 36 million. These guidelines were reportedly based strictly on results from clinical trials. But this was contradicted by the data described in the document itself.

For example, even though the guidelines recommended that women between the ages of 45 and 75 at increased risk of heart disease and with relatively high LDL levels take statins, the fine print in the 284-page document admitted, “Clinical trials of LDL lowering generally are lacking for this risk category.” The general lack of evidence for LDL level targets is why they have been dropped from the current guidelines. In fact, committee members noted that cholesterol lowered by drugs might not have the same effect as cholesterol lowered by nondrug methods, such as diet, exercise and being lucky enough to have good genes.

The process by which these latest guidelines were developed gives rise to further skepticism. The group that wrote the recommendations was not sufficiently free of conflicts of interest; several of the experts on the panel have recent or current financial ties to drug makers. In addition, drug companies heavily support both the American Heart Association and the American College of Cardiology, despite them being nonprofit entities.

The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.

We believe that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy Americans. Instead of converting millions of people into statin customers, we should be focusing on the real factors that undeniably reduce the risk of heart disease: healthy diets, exercise and avoiding smoking. Patients should be skeptical about the guidelines, and have a meaningful dialogue with their doctors about statins, including what the evidence does and does not show, before deciding what is best for them.

John D. Abramson, a lecturer at Harvard Medical School and the author of “Overdosed America: The Broken Promise of American Medicine,” serves as an expert in litigation involving the pharmaceutical industry. Rita F. Redberg is a cardiologist at the University of California, San Francisco Medical Center and the editor of JAMA Internal Medicine.

Edited from “Don’t Give More Patients Statins”

By JOHN D. ABRAMSON and RITA F. REDBERG, The New York Times, November 13, 2013 

William Pollack, His Vaccine Saved Infants

William Pollack, a medical researcher who helped develop a vaccine that virtually eradicated a disease once responsible for 10,000 infant deaths a year in the United States, died on Nov. 3 in Yorba Linda, Calif. He was 87.

He had diabetes and heart disease, his son Malcolm said in confirming the death.

“A lot of people know who Jonas Salk is, but they should know William Pollack’s name, too. This disease was a major, major problem, and it’s been virtually eradicated”, said Dr. Richard L. Berkowitz, the obstetrics and gynecology director of resident education at NewYork-Presbyterian/Columbia hospital.

In 1980, Dr. Pollack and his colleagues received the Lasker Award, popularly known as the American Nobel Prize, for excellence in biomedical research.

William Pollack was born in London on Feb. 26, 1926, one of two children of David and Rose Pollack. His father was a carpenter. After serving in the Royal Navy during World War II, he received a Bachelor of Science degree from the University of London in 1948 and a master’s degree in chemistry there in 1950.

With his wife, Alison, he moved to Vancouver, British Columbia, in the mid-1950s to work as a researcher at the Royal Columbian Hospital. In 1963 he went to work for Ortho Pharmaceutical, a subsidiary of Johnson & Johnson known mainly for developing spermicidal jellies, contraceptives and intrauterine devices. (It is now part of Janssen Pharmaceuticals.) While pursuing his idea for an Rh disease vaccine, he earned a Ph.D. in zoology from Rutgers University in New Brunswick, N.J.

Dr. Pollack, who later taught immunology at Rutgers and Columbia, left Ortho after 25 years to work at other pharmaceutical companies before starting a company of his own, Quotient Pharmaceuticals Manufacturing, in Anaheim, Calif.

Besides his son Malcolm, he is survived by another son, David, who was a partner in Quotient, and by four grandchildren. His wife died in 2006.

In a 1967 interview with Science News, Dr. Pollack cautioned that the Rh gamma globulin solution he and his colleagues had developed was not a cure for Rh blood disease. To be effective, the vaccine has to be given to susceptible patients every time they become pregnant.

“The cure,” he said, “is for the next generation.”

William Pollack Dies at 87; His Vaccine Saved Infants

By PAUL VITELLO, The New York Times, November 12, 2013

The Story Of The Rhesus Vaccine

Dr. William Pollack was a senior scientist in the research laboratory of Ortho Pharmaceutical Company in Raritan, N.J., in the early 1960s when he began collaboration with two Columbia University researchers, Dr. Vincent J. Freda and Dr. John G. Gorman, to conceive a novel treatment for erythroblastosis fetalis, a blood disorder commonly called Rh disease.

Prior to that, researchers had developed other approaches to treating Rh blood disease, including potentially dangerous intrauterine transfusions, before the idea of a vaccine emerged.

The ailment is caused by seemingly superficial differences in the blood types of pregnant women and their fetuses.

Besides the biochemical traits that define the major blood types — A, B, AB and O — the blood of 85 percent of people carries a cluster of surface proteins known as the Rh factor, named for the rhesus monkeys in which it was first identified in 1940. Blood transfusions between people who have the Rh factor (known as Rh positive) and people who do not (Rh negative) cause severe immune reactions.

Rh disease occurs when a pregnant woman is Rh negative and her fetus is Rh positive. In the mixing of blood between the two during pregnancy, the mother’s Rh-negative blood cells produce antibodies that attack the blood cells of the fetus. Depending on the strength of the mother’s immune response, the effects on the baby can range from mild anemia to stillbirth.

Dr. Pollack and his partners devised an “ingenious” counterattack, as it was described in an introduction to their work in “Hematology: Landmark Papers of the Twentieth Century,” a collection published in 2000 by hematologist organizations.

The three men produced a vaccine that patrols the mother’s body, dispatches invading Rh-positive cells and causes no harm to the fetus. The vaccine was made from a passive Rh-negative antibody, which soon wears out. It not only solves the mother’s temporary immunity problem but also, more important, prevents her immune system from mounting a full-fledged response of its own, which would endanger the fetus she was carrying as well as any future ones.

The vaccine, a gamma globulin solution known generically as Rh immune globulin and later by its brand name, RhoGAM, was first tested on volunteers at the Sing Sing Correctional Facility in Ossining, N.Y., and later on 600 Rh-negative women in clinical trials. It worked 99 percent of the time, was approved by the Food and Drug Administration and went on the market in 1969.

In 1971, the World Health Organization recommended to its 193 member nations that Rh testing and treatment with immune globulin be made part of the standard protocol of medical care for pregnant women. In a follow-up report in 1998, the organization said the incidence of Rh blood disease, once estimated at 200,000 cases a year worldwide, had become rare.

Among his other contributions, Dr. Pollack was credited with devising the process in which the blood components needed to make the vaccine are isolated and recombined in a liquid solution.

William Pollack Dies at 87; His Vaccine Saved Infants

By PAUL VITELLO, New York Times, November 12, 2013

Another Shift in Cholesterol Management

Experts Reshape Treatment Guide for Cholesterol - NYTimes.com

A Task Force of American Heart Associations (AHA/ACC) has revised the use of statins to decrease the risk of cardiovascular events. In essence, these guidelines differ from previous ones in that they do not prescribe set numbered targets of LDL to achieve. The Task force claimed that previous targets were made up out of "thin air". By simply taking a station, a person at risk can decrease the risk of occurrence of cardio- and cerebrovascular accidents. It is hoped that these guidelines would refocus on other lifestyle measures.

We await the fall-out.

J Am Coll Cardiol. 2013;():. doi:10.1016/j.jacc.2013.11.005