I reached menopause just as the first warnings about dangerous side effects of hormone replacement therapy (HRT) were trickling into news stories. So I never took HRT. The hot flashes were a nuisance, but I figured they wouldn’t kill me. Eventually they faded away.

I saw a news program on HRT shortly after it became controversial, and on this program a smiling woman doctor who wore pearls with her lab coat said taking hormones reduced the risks of Alzheimer’s. I prescribe them for female patients with close relatives who have Alzheimer’s, she said. Just as a precaution.

My mother had Alzheimer’s, even though she took HRT. But if it lessens the odds, I wondered, maybe I ought to look into it. However, I never did.

Now I know it’s just as well I didn’t. Last week Natasha Singer reported in the New York Times that Wyeth, maker of the best-selling HRT drugs Premarin and Prempro, was paying ghostwriters to plant pro-HRT articles in medical journals.

“The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia,” Singer writes.

Well. As near as I can find out from an Internet search, taking hormones either increases the likelihood of dementia, or it has no impact on the likelihood of dementia, depending on whose data you choose to believe. But these days nobody is saying it decreases the likelihood of dementia.

I don’t know if the smiling doctor was a shill or a dupe, but apparently she was wrong. And she seemed so sure of herself.

Singer says Wyeth paid a medical communications firm to draft the papers, which were mostly review articles “in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment.” The articles may not have been out-and-out lies, but it seems they tweaked available research to show Premarin and Prempro in the best possible light.

Wyeth then solicited well-known physicians to sign their names to the articles, even though they contributed little or nothing to them. The articles appeared in several medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. Doctors who read the articles had no way to know that Wyeth was the initiator and sponsor of the work.

The practice of planting ghostwritten articles was uncovered by attorneys preparing suits against Wyeth. The attorneys found evidence other pharmaceutical companies have done the same thing with other drugs. And one can see why; in 2001 sales of Premarin and Prempro soared to nearly $2 billion. Sales declined after 2002, when a federal study found a link between HRT and increased risks of breast cancer, heart disease and stroke.

It was a stroke that killed my mother, by the way, not the Alzheimer’s.

Mercenary Science

Related to the practice of fake research papers is, well, fake research, period.

Recently President Obama nominated epidemiologist David Michaels to be the head of the Occupational Safety and Health Administration (OSHA). This is a little ray of good news in an otherwise bleak summer. Dr. Michaels, a research professor at George Washington University, in recent years has been warning us of “mercenary science” — industries paying scientists to cast doubt on the research of other scientists in order to avoid or stall regulatory action.

In the June 2005 issue of Scientific American, Dr. Michaels published an article called “Doubt Is Their Product,” in which he wrote,

Uncertainty is an inherent problem of science, but manufactured uncertainty is another matter entirely. Over the past three decades, industry groups have frequently become involved in the investigative process when their interests are threatened. If, for example, studies show that a company is exposing its workers to dangerous levels of a certain chemical, the business typically responds by hiring its own researchers to cast doubt on the studies. Or if a pharmaceutical firm faces questions about the safety of one of its drugs, its executives trumpet company sponsored trials that show no significant health risks while ignoring or hiding other studies that are much less reassuring. The vilification of threatening research as “junk science” and the corresponding sanctification of industry-commissioned research as “sound science” has become nothing less than standard operating procedure in some parts of corporate America.

(Last year Dr. Michaels published a book by the same title. I have not read it, but it has received good reviews.)

This issue goes far beyond just the pharmaceutical industry, of course. The petrochemical industry is paying scientists to cast down on global climate change, for example. Industry also uses mercenary science to avoid safety regulation. Dr. Michaels has personally conducted research into the health effects of toxins such as asbestos and beryllium, both of which cause deadly lung diseases (such as mesothelioma) if breathed, and both of which are often workplace hazards.

Scientists had estimated “safe” levels of beryllium in the 1940s. At the beginning of the Clinton Administration these standards had not been updated, even though there was copious evidence workers were falling ill from beryllium exposure. When OSHA began the process of tightening workplace exposure standards for beryllium, a company that produced beryllium hired a consulting firm that specialized in product defense to fight the government. The consulting firm’s scientists could not prove the old standard was safe. Instead, they produced “research” that cast doubt on other research showing it unsafe. This is how “mercenary science” works.

In the case of drugs, Dr. Michaels reminds us of phenylpropanolamine (PPA), for decades a common ingredient in over-the-counter decongestants and “diet” pills. “Reports of hemorrhagic strokes in young women who had taken a PPA-containing drug began circulating in the 1970s,” Dr. Michaels wrote.

Over the next 20 years, the FDA raised questions about PPA’s safety, but the trade association representing the drug’s manufacturers—including Bayer, Sandoz (now part of Novartis), Wyeth and GlaxoSmithKline—rejected the agency’s concerns, employing scientists and lobbyists to keep PPA on the market.

Eventually the FDA and the manufacturers struck a deal to abide by the results of study by Yale University School of Medicine. But in 1999, the Yale study confirmed that PPA caused hemorrhagic stroke.

Did the manufacturers withdraw the drug, which by then had annual sales of more than $500 million? No. Instead they turned to the Weinberg Group, a product-defense consulting firm based in Washington, D.C., to attack the study and had their attorneys put the researchers through grueling legal depositions. … The FDA finally advised manufacturers to stop marketing PPA in November 2000. The agency estimates that the chemical caused between 200 and 500 strokes a year among 18- to 49-year-old people.

Products that used to contain PPA included Alka-Seltzer Plus, Dexatrim, Dimetapp, and Robitussin CF Cough Syrup.

And do we want to talk about Vioxx? There was evidence even before the drug was approved for sale in 1999 Vioxx that might increae risk of heart attack. Then, in early 2000, a clinical trial revealed that participants who took Vioxx for an average of nine months had five times the risk of heart attack as those taking a Aleve. So scientists working for Merck, who made Vioxx, concluded that Aleve must reduce risk of heart attack by 80 percent. See? Bad statistic goes away.

Vioxx was not withdrawn from the market until 2004, when even Merck couldn’t ignore the fact that its customers were dropping dead. “One FDA analyst estimated that Vioxx caused between 88,000 and 139,000 heart attacks—30 to 40 percent of which were probably fatal—in the five years the drug was on the market,” Dr. Michaels wrote.

For years the pharmaceutical industry has been one of the forces against health care reform. There are reports that the Obama Administration has struck some kind of deal with Big Pharma to get its backing of the current reform package. Pharmaceutical companies are not likely to change their underhanded practices anytime soon.

And as for the wider uses of mercenary science — this paragraph in Dr. Michael’s 2005 article caught my attention:

Emphasizing uncertainty on behalf of big business has become a big business in itself. The product-defense firms have become experienced and successful consultants in epidemiology, biostatistics and toxicology. In fact, it is now unusual for the science behind any proposed public health or environmental regulation not to be challenged, no matter how powerful the evidence. Currently representatives of indoor tanning salons are hard at work disparaging the designation of ultraviolet radiation as a cause of skin cancer.

Now, four years later, strong warnings finally have hit mainstream media saying that “the ultraviolet light used in tanning beds is as carcinogenic as asbestos, arsenic, radium and cigarettes.” No doubt somewhere some well-paid scientists are preparing a paper claiming “… but we need more research to be sure.”